MONDAY
February 8, 1993
Part III
Environmental Protection Agency
40 CFR Parts 700, 720, 721 and 723
Premanufacture Notification; Revisions of Notification Regulations, Exemptions for Chemicals in Quantities of 1,000 Kilograms or Less, and for Polymers, and Amendment to Expedited Process for Issuing Significant New Use Rules; Proposed Rules
(This reprint was prepared from the electronic file that accompanied the original signed documents transmitted to the Office of the Federal Register. This file was certified to be a true copy of the original.)
(This document appeared at 58 FR 7646 - 7701.)
Federal Register / Vol. 58, No. 24 / Monday, February 8, 1993 / Proposed Rules
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 700 and 723
[OPPTS - 50596; FRL - 3890 - 4]
RIN 2070 - AC14
Premanufacture Notification Exemption; Revision of Exemption for Chemical Substances Manufactured in Quantities of 1,000 Kilograms or Less Per Year; Proposed Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: Section 5(a)(1) of the Toxic Substances Control Act (TSCA) requires that persons notify EPA before they manufacture or import a new chemical substance for commercial purposes. Section 5(h)(4) of TSCA authorizes EPA, upon application and by rule to exempt the manufacturer or importer of any new chemical substance from the provisions of section 5 if the Agency determines that the manufacture, processing, distribution in commerce, use, or disposal of the substance will not present an unreasonable risk of injury to health or the environment. EPA is proposing to amend the current TSCA section 5(h)(4) limited exemption defined at 40 CFR 723.50 for persons who manufacture certain chemical substances in quantities of 1,000 kilograms or less per year. This proposed amendment would increase the volume limit to 10,000 kilograms or less a year. Also, this notice proposes to add a new section 5(h)(4) exemption category for certain chemical substances with low environmental releases and human exposures. To ensure that these chemical substances will not present an unreasonable risk, EPA has included procedural safeguards, including a 30 - day review, and other conditions in the exemption.
DATES: Comments must be received by April 9, 1993. If requested, EPA will conduct public hearings on the proposed rule amendments. Requests to make an oral presentation must be received by April 9, 1993.
ADDRESSES: All comments and requests to speak at the public hearing must be sent to: TSCA Document Control Office (TS - 790), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E - 201, 401 M St., SW., Washington, DC 20460, (Phone: 202 - 260 - 1532).
Comments should include the docket control number. The docket control number for this amendment is OPPTS - 50594. Since some comments may contain confidential business information (CBI), all comments must be sent in triplicate (with additional sanitized copies if CBI is involved). Comments on this proposed rule will be placed in the rulemaking record and will be available in the TSCA Public Docket Office, Rm. NE - G - 004 at the above address between 8 a.m. and 12 noon and 1 p.m. and 4 p.m., Monday through Friday, excluding public holidays.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (TS - 799), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E - 543 - B, 401 M St., SW., Washington, DC 20460, Telephone: (202) 554 - 1404, TDD: (202) 554 - 0551.
SUPPLEMENTARY INFORMATION:
Electronic Availability: This document, along with three other related documents, OPPTS - 50593, 50594, and 50595, is available as an electronic file on The Federal Bulletin Board at 9:00 a.m. on the date of publication in the Federal Register. By modem dial (202) 512-1387 or call (202) 512-1530 for disks or paper copies. This document and the three related documents are available in Postscript, Wordperfect, and ASCII.
The exemption for chemical substances manufactured in quantities of 1,000 kilograms or less per year became effective on August 26, 1985. The supporting rationale and background for that exemption were published at 50 FR 16477, April 26, 1985 and 47 FR 33896, August 4, 1982. While general background information is presented here, readers should also consult the preambles for those notices for further information on the objectives and rationale for the rule and the basis for the TSCA section 5(h)(4) ``will not present an unreasonable risk'' finding.
I. Background
A. Authority
Section 5(a)(1) of TSCA (15 U.S.C. 2604 (a)(1)) requires any person who intends to manufacture or import a new chemical substance to notify EPA 90 days before manufacture or importation begins. Section 5(h)(4) of TSCA (15 U.S.C. 2604 (h)(4)) allows the Administrator, by rule, to grant an exemption from any or all of the requirements of section 5 if he or she determines that the manufacture, processing, distribution, use, or disposal of a substance will not present an unreasonable risk of injury to health or the environment.
B. History
In early 1981, EPA received a petition from the Chemical Manufacturers Association (CMA) requesting exemptions from certain provisions of section 5 of TSCA for: (1) Site-limited intermediates; (2) chemical substances produced in quantities of 25,000 pounds or less per year; and (3) polymers whose precursor monomers are on the TSCA Inventory. On August 4, 1982, EPA proposed regulations for site-limited intermediates and for chemical substances produced in quantities of 1,000 and 10,000 kilograms or less per year (47 FR 33920). Also on April 4, 1982 (47 FR 33924), EPA proposed regulations for exempting certain polymers, and promulgated final regulations on November 21, 1984 (49 FR 46066). Final regulations for chemical substances produced in quantities of less than 1,000 kilograms per year were promulgated by the Agency on April 26, 1985 (50 FR 16477). Based on public comments, and the requirements under section 5(h)(4) of TSCA, the Agency decided to exempt only chemical substances produced in quantities of 1,000 kilograms or less per year from full section 5(a)(1) premanufacturing review. The Agency determined that it could not exempt site-limited intermediates or the 10,000 kilograms category chemical substances without requiring certain procedural safeguards designed to ensure low risk, such as requiring manufacturers to obtain a qualified expert review of their exemption application prior to submission. Industry commenters stated these procedural safeguards were overly burdensome. EPA decided it could not reduce those safeguards given its level of experience in 1985 and still make the required section 5(h)(4) findings that activities associated with the exempted chemical substance would not present an unreasonable risk.
In the 8 years since the low volume exemption was promulgated, EPA has enhanced its technical assessment capabilities considerably. For example, in searching for chemical analogues to assist in the review of the potential toxicity of a new chemical substance, the Agency is now able to perform automated chemical substructure searches. EPA toxicologists can now, as a result, quickly locate available toxicity data on chemicals with reactive substructures analogous to those of the new substances under review. With this and other enhancements to the review process developed since the new chemicals program began in 1977, the Agency believes that the production volume ceiling for the low volume exemption can now be raised to 10,000 kilograms or less per year and that a new exemption for low release and exposure chemicals can be promulgated without compromising the Agency's ability to identify and protect against substances that may present an unreasonable risk of injury to human health or the environment.
For a more extensive review of the history of the low volume and the site-limited intermediate exemptions, please refer to the Federal Register notices cited earlier in Unit I. of this preamble.
II. Discussion of the Proposed Amendments
1. Chemical substances manufactured at 10,000 kg or less per year. The Agency is proposing that manufacturers of all chemical substances manufactured in quantities of 10,000 kilograms or less per year will be eligible to apply for a new exemption category. (Note that throughout 40 CFR parts 721 and 723, the term ``manufacturer'' is defined in TSCA section 3(8), 15 U.S.C. 2602(8), to include persons who import the specified chemical substance, and the term ``manufacture'' is defined to include importation.) Upon approval, manufacturers will be permitted to manufacture up to 10,000 kilograms during every 1 - year period beginning on the date of review period expiration.
As with the current exemption, chemical substances will not be approved under the exemption if the Agency believes that they or their reasonably anticipated metabolites, environmental transformation products, byproducts, or impurities raise a concern for serious acute or chronic human health effects or significant environmental effects under reasonably anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal. Any submitted exemption notice will be denied if the Agency is unable to affirmatively find that manufacture, processing, distribution, use, and disposal of the exempted substance will not present an unreasonable risk of injury to human health or the environment.
The proposal provides that manufacturers requesting this exemption must submit notices 30 days prior to commencement of manufacture or import. EPA believes that the extra 9 days over the current 21 - day review period will be needed to perform risk assessments for the increased number of submissions received under this expanded low volume exemption and the low release and exposure exemption category described below.
Also in keeping with the current exemption, where manufacturers provide information on human exposure controls or environmental release controls to support the exemption notice, the manufacturers must maintain those controls throughout the duration of the exemption. Exemption notices containing inadequate human exposure or environmental release controls may be conditionally denied until the submitters provide sufficient information regarding exposure controls. Manufacturers are also bound to the manufacturing sites and uses approved in their exemptions.
The Agency is proposing to modify the restriction that only one low volume exemption holder be allowed for any given substance. Under the proposal, subsequent manufacturers of a substance for which one manufacturer already holds an exemption will be permitted to submit an exemption notice; however, subsequent manufacturers must, in addition to the normal requirements, affirmatively demonstrate that approval of their exemptions will not result in additional environmental releases and human exposures which, in the aggregate, will undermine the Agency's previous determination that the manufacturing, processing, and use of the low volume substance will not present an unreasonable risk of injury to human health or the environment. Subsequent manufacturers unable to make this affirmative showing will be required to submit either a full premanufacture notice or an application under another exemption prior to commencement of commercial manufacture. To prevent companies from applying for an exemption merely to preclude a potential competitor's exemption, the Agency is proposing to require submitters to certify that they will commence commercial manufacture of the chemical substance under the exemption within 1 year of the expiration of the review period. This certification must accompany submission of the exemption notice. If manufacture does not commence within 1 year, the submitter must withdraw the exemption in writing within 1 year of the expiration of the review period.
In accordance with current practice under the present 1,000 kilogram exemption, the Agency will generally perform the risk assessment under the new exemption as if the total amount permissible under the exemption (10,000 kgs) were being produced. However, EPA is proposing to permit submitters wishing their exemptions to be reviewed based upon annual production volumes lower than 10,000 kilograms to so indicate in their initial exemption notice. Submitters who so elect, however, would be bound by their election. Submitters who subsequently wished to increase their maximum production volume under the exemption would be required to submit a new exemption notice and cross-reference the original exemption number on the cover of the notice. If the new exemption is granted, it would supersede the previous exemption.
Regarding the transition period between the existing and proposed exemption, the Agency will continue to accept exemption notices under the terms of the current 1,000 kilogram or less exemption category until the final rule altering this exemption category becomes effective. At that time, the existing 1,000 kilogram exemption category would no longer be available. All exemptions previously granted under the 1,000 kilogram exemption will remain binding and effective under the superseded provisions of 40 CFR 723.50 even though such provisions will no longer be contained in the Code of Federal Regulations; however, the proposed exemption does not contain a separate 1,000 kilogram or less category. A manufacturer or importer who was granted an exemption under the prior 1,000 kilogram per year or less exemption will be allowed to submit a new exemption notice to increase the production volume up to 10,000 kilograms per year for the same chemical substance. If a manufacturer does apply for the 10,000 kilogram exemption, its notice will be reviewed for unreasonable risk at the increased production volume. A new risk assessment will be performed based on the information submitted in the new notice. A submitter of a subsequent 10,000 kilogram exemption will be allowed to continue to manufacture under the terms of the 1,000 kilogram exemption until a regulatory decision is made on the new exemption notice. If the new notice is granted, it will supersede the 1,000 kilogram exemption.
2. Low release and exposure chemicals. In connection with the Agency's overall pollution prevention strategy, EPA is proposing to add a new exemption category for chemical substances with low environmental releases and low human exposures during their manufacture, processing, and use. All manufacturers and importers of new chemical substances subject to PMN requirements meeting the stated release and exposure criteria would be eligible to apply for this low release and exposure (LoREX) exemption, regardless of production volume. The LoREX exemption is intended to encourage companies to develop manufacturing, processing, and use techniques which minimize exposures to workers, consumers, the general public, and the environment.
As with the low volume exemption, the Agency is proposing to require that the uses and manufacturing sites be restricted to those approved in the exemption notice, and that submitters also be bound to the approved release and exposure controls. EPA believes that these binding provisions of the LoREX exemption will, in many instances, prove to be an effective substitute to regulation under section 5(e) of TSCA. Thus, EPA expects this new exemption category to significantly reduce the administrative costs presently devoted to section 5(e) consent order development and review, and to permit manufacturers to commence commercial production of their new products more quickly, while ensuring against unreasonable risk to human health or the environment.
Potential submitters should be mindful that the principal focus of this exemption is on release and exposure, not toxicity. In light of this, the Agency will apply the release and exposure criteria strictly, and, although it will consider any relevant toxicological data submitted, it will be unable to conduct a thorough review of that data in many cases within the 30 - day review period. A primary goal of this exemption is to minimize the time and resources required to review new chemical substance submissions; to the extent that the Agency must undertake detailed examination of the inherent toxicity of a given chemical substance, that goal is compromised and a PMN notice would be more appropriate.
To satisfy the required section 5(h)(4) findings of unreasonable risk, the submitter would first have to meet the eligibility criteria in the following Table 1 indicating that exposure to the substance, and hence the risk presented by the substance, is low:
Table 1.--Proposed Low Release/Exposure (LoREX) Eligibility Criteria\1\
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
Type of Exposure or Release Eligibility Criteria for Exemption
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
Human Exposure
General Population Exposure...........
Dermal:............................. None
Inhalation:......................... None\2\
Drinking Water:..................... 1 mg/yr\3\
Consumer Exposure.....................
Dermal:............................. None
Inhalation:......................... None
Worker Exposure.......................
Dermal:............................. None
Inhalation:......................... None, unless adequate protection
provided
Environmental Release
Ambient Surface Water Releases........ No releases resulting in surface water
concentrations above 1 ppb\4\
Ambient Air Releases.................. No incineration releases above 1
æg/m3 maximum annual average
concentration \5\
Land/Groundwater Releases............. No releases to landfill unless
submitter demonstrates that the
exempted substance has negligible
ground-water migration potential
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
\1\ This table lists the minimum criteria required to apply for the exemption.
Based on the review of the notice, lower concentrations may be required by
the Agency for substances with potential for carcinogenic, neurotoxic, or
other effects.
\2\ No inhalation exposure permitted except as provided under the ambient air
incineration criteria.
\3\ Estimated average dosage resulting from drinking water exposures in
streams with maximum allowable concentration permitted under ambient surface
water criteria (1 ppm).
\4\ Concentration to be calculated using methods prescribed in 40 CFR 721.90.
\5\ Using following formula: (kg/day release after treatment) X (release days/
year) X 9.68 X 106 æg/m3.
To satisfy the human exposure side of the eligibility criteria, the submitter would have to show that there are no exposures to consumers or the general public (except as provided under the surface water and ambient air criteria) inherent in the proposed manufacturing, processing, or uses of the substance, and that any worker exposure which is likely to occur will be adequately controlled through use of engineering controls, work practices, and/or personal protective equipment.
In terms of environmental releases, LoREX eligibility criteria for releases to three environmental media are proposed. In assessing the potential for environmental release, the submitter should consider all routine releases from manufacture, processing, and use, including releases associated with cleaning of equipment and from disposal or cleaning of containers and packaging. For ambient surface water, the Agency is proposing that submitters either (1) prevent all direct and indirect releases of the exempted substance to surface waters; or (2) demonstrate that any releases to water that may occur will result in surface water concentrations of the substance that are no greater than 1 part per billion (ppb) using the surface water concentration calculation method described in 40 CFR 721.90. Based on Agency worst case assumptions for drinking water exposure estimates, surface water concentrations of 1 ppb will result in human drinking water exposures at or below the 1 mg/year LoREX drinking water criteria in nearly every case; therefore, compliance with the drinking water exposure criteria will be presumed from compliance with the 1 ppb surface water level. The Agency will reserve the right, however, to require lower surface water concentrations on a case-by-case basis when concerns for carcinogenicity, neurotoxicity, or other serious chronic effects are raised, or under conditions where actual drinking water exposures are likely to significantly exceed the 1 mg/yr dosage.
The proposed LoREX eligibility criterion for maximum annual average ambient air release concentration from incineration is 1 æg/m3. This level was derived from air exposure modeling estimates of maximum ground level concentrations from incinerator stacks, using worst case meteorological data sets. To determine whether a particular substance meets the criteria, submitters would calculate exposure levels using the method described in Table 1. As with drinking water exposures, the Agency may require lower air release levels in individual cases if concerns for chronic health effects are raised for the exempted substance.
For land/groundwater disposal, EPA is proposing that LoREX substances not be disposed of by landfill or other land disposal methods unless the submitter demonstrates that the groundwater migration potential of the substance is negligible. To make such a demonstration, a submitter will be required to provide data on the biodegradation and leaching potential of the exempted substance, or other data which clearly establishes that significant releases to groundwater will not occur. EPA suggests the following core set of tests to establish groundwater migration potential:
(a) An inherent biodegradability in soil test (40 CFR 796.3400).
(b) An anaerobic biodegradability of organic chemicals test (40 CFR 796.3140).
(c) Depending on the substance's chemical properties, either a sediment and soil adsorption isotherm test (40 CFR 796.2750) or a soil adsorption isotherm test (40 CFR 796.2700).
Although it is difficult to state in advance precisely what combinations of results from the above testing would clearly establish that the groundwater migration potential of a chemical substance is ``negligible'', some broad parameters may be given. For example, manufacturers who perform soil adsorption testing that result in values for the logarithm of the soil adsorption coefficient (``log Koc'') of their new chemical substances of 4.5 or greater will generally be found to have satisfied the ``negligible groundwater migration potential'' standard, unless persistent in the environment. Similarly, biodegradation test data demonstrating half-lives of chemical substances of under 1 week, or complete degradation in under 2 weeks, would satisfy the LoRex criterion in most instances. Hydrolysis data showing that a chemical substance hydrolyzes at a rapid rate would also generally be accepted by the Agency. Chemical substances which do not show either a 4.5 or greater Log Koc value alone or a half-life of under 1 week alone may nonetheless qualify for the LoRex exemption if the two values in combination, or together with other relevant data, support a conclusion that significant amounts of the substances will not reach aquifers.
EPA invites public comment on this and other generic criteria which might be useful in the groundwater migration determination. The Agency also intends to continue encouraging initiation of any testing. Such consultation frequently results in more relevant data and can often lower the submitters' test costs. Upon approval of a LoREX exemption, the submitter would be bound to the continuous use of the exposure and release controls described in the approved exemption, as well as the listed uses and manufacturing sites. The Agency will deny an exemption notice notwithstanding satisfaction of the exposure-based exemption criteria if it believes it cannot support the affirmative finding required under section 5(h)(4) of TSCA that the manufacture, processing, distribution, use, and disposal of the chemical substance, under the conditions described in the notice, will not present an unreasonable risk to human health and the environment.
EPA solicits comment on whether the LoRex exemption criteria are set at a reasonable level to allow new chemical substances with de minimis releases and exposures to qualify for the exemption. Are there alternative exemption criteria that would represent a reasonable proxy for de minimis exposure?
3. Exemption notices. To simplify the submission of low volume (LVE) and LoREX exemptions, and Agency review of them, EPA is proposing to require use of the PMN form (EPA Form 7710 - 25). Thus, submitters should supply the usual PMN information on chemical identity, impurities, trade names, production volume, uses, manufacturing sites, environmental release, and worker exposure. Given the importance of release and exposure information to the disposition of LVE and LoREX exemption notices, submitters should include as much information on these subjects as possible, including, where applicable, such items as an assessment of the potential for dermal and inhalation exposure, including magnitude, frequency, and duration; specific respirators used (e.g., NIOSH/MSHA-certified 19C Type C supplied-air respirator operated in pressure demand or positive pressure mode and equipped with a full face piece); specific information on the dermal protective equipment used (including any information on permeation); other control methods used (including information on their effectiveness); environmental release controls (including information on their efficiency); as well as details on work practices, standard operating procedures, etc. In assessing the potential for exposure, the submitter would be required to consider all routine worker activities during manufacture, processing, and use, including operations such as materials transfer, drumming, packaging or loading and associated unloading operations, sampling, etc. In assessing the potential for environmental release, the submitter would consider all routine releases during manufacture, processing, and use, including releases from processing, cleaning of equipment, disposal of empty containers, ``off-spec'' materials, processing waste, samples, etc.
Bald statements such as ``glove boxes will be used'' or ``the chemical will be manufactured in a closed system'' would be insufficient to document that worker exposure requirements of the LoREX exemption have been satisfied. For example, even manufacturing facilities controlling reactor operations via isolated control rooms may still involve potential worker exposures during such operations as sampling and drumming. Additional controls may be needed for these operations. Also, the efficiencies of such engineering controls as glove boxes or local exhaust ventilation (LEV) will vary according to manufacturer design, installation method, and user operations. Factors which may affect the operating efficiency of LEV include hood-to-source location, worker intervention, equipment installation, maintenance practices, and cross drafts. Because of such factors, actual efficiency may be lower than that claimed by the equipment manufacturer. Ventilation systems should be designed and operated in accordance with Occupational Safety and Health Administration (OSHA) standards such as 29 CFR 1910.94, and current recommendations of the manual Industrial Ventilation by the American Conference of Governmental Industrial Hygienists, and ANSI Z9.2 Fundamentals Governing the Design and Operation of Local Exhaust Systems published by the American National Standards Institute. The submitter would provide as much information as possible to demonstrate the effectiveness or efficiency of control methods, and procedures used to maintain the stated effectiveness of efficiency over time, as well as details on programs for worker safety training and hazard communication.
To the extent it is known or reasonably ascertainable by the submitter, physical and chemical property information for the chemical substance (e.g., vapor pressure, melting point, boiling point) would also be required under these proposed exemptions. This information would be listed on the last page of the PMN form. In EPA's experience, such information is generally available and would be helpful in assessing exposure controls and better characterizing the potential risk of the chemical substance.
The Agency believes use of the PMN form would prove beneficial to both it and industry, and seeks comments from experienced PMN and LVE submitters on this point. By providing a standard format for the required information, EPA expects to decrease the frequency with which it would have to conditionally deny incomplete exemption notices, thereby decreasing the length of time submitters would have to wait for disposition of their exemption notices and the Agency resources devoted to reviews.
Submissions not containing all of the required information would be declared incomplete. To reinitiate a notice which has been declared incomplete, a submitter would have to submit a complete new exemption notice form containing all the required information; partial submissions sent to EPA to supplement notices declared incomplete would not be accepted. Photocopied pages from previously submitted exemption forms would be accepted provided that the certifications page contains an original signature.
The proposal retains the provision which requires manufacturers of substances produced under the exemption to submit to EPA any test data or other information they obtain which indicates that the substance may not qualify for the exemption. The proposal also adopts the current PMN requirement that requires submission of any new information of which the manufacturer obtains possession, control, or knowledge during the review period if that information materially adds to, changes, or otherwise makes significantly more complete the information included in the notice.
4. EPA review of notices. EPA is proposing, and requesting comment on, the requirement that submitters submit exemption notices 30 days prior to intended manufacture of the low volume or LoREX substance. The Agency believes that an increase from 21 days to 30 days will be necessary in order to accommodate the projected increase in number of exemption notices under the higher low volume ceiling and new LoREX category. EPA is aware a longer exemption review period may make the exemptions less attractive; however, it believes that the modest increase to 30 days proposed is imperative to conduct the type of reviews necessary to support the legal finding that the exempted substance will not present an unreasonable risk of injury to human health or the environment. Moreover, EPA believes that the existence of these two exemptions categories would, on average, significantly expedite the introduction of many new products into the marketplace.
5. Determination that a chemical substance will be denied the exemption-- a. During the review period. Under this proposal, EPA would determine that a substance is ineligible for the low volume or LoREX exemptions if it finds that the new chemical substance does not meet the terms of the exemption, or that there are issues concerning toxicity or exposure that require further review which cannot be accomplished within the 30 - day review period. Such issues that may require further review include serious acute or chronic human health effects or significant environmental effects under anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal.
If EPA determines during the review period that an exemption notice should be denied, the Agency will notify the manufacturer by telephone that the substance is denied the exemption. The submitter will subsequently be notified by letter. The letter will explain the reasons for EPA's determination. The submitter will then have the option of resubmitting the exemption notice with explanatory or additional information, submitting a PMN, or not manufacturing the chemical substance.
b. After the review period expires. The Agency is proposing to amend the current provisions relating to revocation of exemptions after expiration of the review period. Under the proposal, a revocation could be effected if EPA, based on new information, determines that it can no longer support the ``no unreasonable risk'' finding required under section 5(h)(4) of the Act. This is a change from the corresponding provision of the current exemption which permits revocations whenever EPA determines that the substance ``does not meet the terms of this section.''
6. Inventory status. For the expanded low volume exemption category for substances produced in quantities up to 10,000 kilograms/year, the Agency is proposing to continue the policy of not adding such substances to the TSCA section 8(a) Inventory of existing chemical substances. Similarly, EPA is proposing to not add substances produced under the LoREX exemption to the 8(a) Inventory. Therefore, subsequent manufacturers of chemical substances for which exemptions have been granted to other companies under these two categories will be required to submit independent exemption notices or PMNs before commencing nonexempted commercial production of those substances.
7. Recordkeeping. The proposed rule would require manufacturers and importers to maintain records on (a) the production volumes of the chemical substance for which an exemption was granted, and (b) documentation of information in the exemption notices and compliance with the terms of the exemption. The records would be maintained for 5 years after the date of their preparation. These records would be kept at the submitter's manufacturing site(s). Recordkeeping at the site of manufacture is a new requirement. The Agency has found that it has been difficult to determine compliance with the regulations when records are not kept at the site. Also under this proposal, EPA would have the authority to require the manufacturer of an exempt substance to submit copies of these records to EPA upon written request. Manufacturers would be required to provide these records within 15 days of the written notification by EPA. This section in the proposed rule is intended to supplement the inspection and subpoena authorities of section 11 of TSCA.
8. User fees. Section 26(b) of TSCA authorizes EPA to require, by rule, the payment of a reasonable fee from any person required to submit data under section 4 or 5 of TSCA. Currently, EPA requires a user fee for PMNs, certain PMN exemption notices, and significant new use notices submitted under TSCA section 5(a) and 5(h). EPA is proposing to amend 40 CFR part 700 to require manufacturers and importers to pay fees for low volume and LoREX exemption notices. Currently, there is no such user fee requirement associated with the low volume exemption. The proposed fee would be $100 for small business concerns, and $2,500 for all others.
The fee for PMNs, certain exemption notices, and SNURs was originally promulgated on August 17, 1988. The supporting rationale and background for this rule is published in the Federal Register of April 20, 1987 (52 FR 12940) and the Federal Register of August 17, 1988 (53 FR 31248). These two documents should be consulted for further information on the objectives and rationale for the user fee rule.
9. Customer notification. The Agency is proposing to retain the requirement that manufacturers notify processors and industrial users of the use restrictions and of any controls specified in the exemption notice. Such notification may be given by means of a container labeling system, written notification, or any other method that adequately informs recipients of the applicable use restrictions or controls. As with the existing LVE, the proposal also requires that manufacturers (a) immediately cease distribution to any customers who violate use or control restrictions, and (b) notify the Agency within 15 days of learning of such violations.
To ensure compliance with the LoREX criterion, the proposal requires further that LoREX exemption holders distribute LoREX substances only to persons who agree in writing to not further distribute the substances until they have been reacted or otherwise rendered into a physical form or state in which releases and exposures above the LoREX criterion will not occur. The Agency recognizes that this distribution restriction may be problematic for manufacturers of some substances used in multi-tiered markets, but believes that some form of control over distribution is necessary. Commenters are encouraged to suggest alternative methods EPA might employ to ensure that distribution of the LoREX substance beyond manufacturers' customers will not present an unreasonable risk to human health or the environment.
10. Transfer of exemptions. Current Agency policy generally does not recognize transfer of exemption rights between manufacturers; however, given the increased frequency over the last several years of corporate mergers, acquisitions, buy-outs, technology transfers, and other forms of corporate succession, EPA believes that it is appropriate to reevaluate its exemption transfer policies in light of the proposed amendments and requests comments on this issue.
III. Rationale
A. Chemical Substances Manufactured at 10,000 Kilograms or Less Per Year
To better utilize its limited resources and lessen regulatory burdens on industry, the Agency undertook an examination of the review process for PMNs and PMN exemption notices to determine whether it was advisable to expand the categories of new chemical substances eligible for PMN exemptions. One of the first exemptions identified through this examination was the current exemption for new chemical substances manufactured in quantities of 1,000 kilograms or less per year. EPA believed that significant resource savings could be realized if the ceiling for the exemption could be raised to a level which would expand the pool of eligible new chemical substances while still permitting the Agency to make the requisite ``will not present an unreasonable risk'' statutory finding.
Those familiar with the PMN program will recall that in 1982 when the current low volume exemption (``LVE'') was originally proposed (47 FR 33920), the Agency included a separate category for chemical substances manufactured in quantities of 10,000 kilograms or less per year. However, that portion of the proposal was never promulgated. This was due mainly to uncertainty over the number and types of notices that would be received under the higher volume category, and also to an inability to reconcile industry concerns over some of the additional safeguards imposed upon the higher volume category and the Agency's belief that such safeguards were necessary (see the discussion in Unit I. of this preamble).
With the benefit of 8 years of experience under the 1,000 kilogram exemption category and the Agency's enhanced ability to gauge toxicity of new chemical substances based upon structural activity relationships, EPA is confident that it can now review a larger pool of chemical substances under the low volume exemption and identify within an abbreviated review period those substances which may pose an unreasonable risk to human health or the environment.
The basic rationale for proposing an expansion of the low volume exemption category is the same as that for proposing the exemption initially: chemical substances produced in lower quantities generally involve correspondingly lower human exposures and environmental releases, and consequently, present generally less risk than high volume substances. Beyond this, the Agency believes that the low volume exemption has been a very successful regulatory mechanism as measured by the level of EPA administrative resources needed to implement it and the relative burden it places on manufacturers. Because of this success, EPA believes that both its interests and the interests of industry and the public will be served by enlarging the portion of new chemical substances which may be manufactured under the exemption.
B. Low Release and Exposure (LoREX) Chemical Substances
In addition to the production volume-based category described above, EPA is proposing establishment of a new TSCA section 5(h)(4) exemption category based on low levels of environmental release of, and human exposure to the new chemical substance. Eligibility would be independent of production volume level.
The Agency believes that the concept of basing an exemption on low release and exposure offers several potential advantages over a volume-based exemption. First, an exposure-driven exemption generally provides a more direct gauge on the magnitude of risk presented by a given new chemical substance. Production volume alone is only an indirect indicator of exposures and releases. Secondly, EPA believes that the existence of a LoREX exemption will encourage pollution prevention (source reduction) techniques by rewarding manufacturers able to meet the low release and exposure criteria with more timely regulatory decisions, and in many cases, with less burdensome regulatory controls. Such a result would entail substantial time and resource savings for both EPA and industry.
1. LoREX criteria -- a. Human exposure. In determining the appropriate criteria for defining the types and/or levels of exposure which should constitute ``low exposure'' to humans, EPA considered three distinct populations: workers, consumers, and the general population. EPA believes that, for purposes of this exposure-based exemption, any direct exposures to the latter two groups would be, in the context of an abbreviated review period, inconsistent with the Agency's statutory obligation under section 5(h)(4) to affirmatively find that the exempted substances will not present an unreasonable risk to human health. Therefore, the Agency believes that any consumer and/or general population exposures (other than the negligible drinking water and ambient air exposures discussed later in this preamble) should automatically disqualify new chemical substances from LoREX exemption eligibility.
Exposures to workers, on the other hand, are fundamentally different than consumer and general population exposures in that they may be more readily monitored and controlled through engineering controls, workplace practices, and/or protective equipment requirements. Therefore, the Agency believes that it may, consistent with its section 5(h)(4) obligation, approve a high percentage of LoREX exemption notices where appropriate control measures are instituted in the workplace.
Workplace exposures may occur through inhalation, dermal contact, or ingestion. For dermal/ingestion exposures, the Agency believes it most appropriate to require manufacturers applying for a LoREX exemption to comply with the general dermal exposure requirements used in section 5(e) consent orders; namely, to require all workers reasonably likely to be exposed to LoREX substances to be provided with, and required to wear, chemical protective equipment which provides a barrier to prevent all dermal exposure to the substance. Chemical protective clothing used to provide this barrier must be demonstrated to be impervious to the substance under the expected conditions of use and duration of exposure. Such demonstration could be accomplished under 40 CFR 721.63(a)(3)(i)-(ii) by actually testing the material used to make the chemical protective clothing and/or by evaluating the specifications from the manufacturer or supplier of the chemical protective clothing to establish that the chemical protective clothing will be impervious to the exempted substance alone and in likely combination with other chemical substances in the work area.
Regarding inhalation exposure, the Agency will expect submitters for LoREX exemption notices to have (i) identified the workplace operations where inhalation exposure is likely to occur; (2) assessed the magnitude, frequency, and duration of potential exposure; (3) assessed the effectiveness of the various exposure controls; and (4) selected the method or combination of methods that will provide workers with the appropriate protection for the given workplace. While the Agency strongly encourages submitters to reduce workplace exposures at their source, where feasible, submitters could also support a claim of low worker inhalation exposure based on the use of appropriate respiratory protection equipment. The Agency believes it most appropriate for a submitter to comply with the general requirements regarding respiratory protection used in TSCA section 5(e) consent orders, which stipulate the use of respiratory protection in accordance with the National Institute of Occupational Safety and Health (NIOSH) regulations at 30 CFR part 11, and the Occupational Safety and Health Administration (OSHA) regulations at 29 CFR 1910.134. Similarly, the inherent physical or chemical properties of the substance submitted for an exemption may form the basis of a low exposure claim, as in a nonvolatile dye manufactured, processed, and used only in solution, such that inhalation to particulates will not occur.
b. Environmental release-- i. Water releases. The proposed LoREX water release eligibility criterion of 1 ppb surface water concentration was established on the basis of EPA's experience in conducting environmental risk assessments on PMN substances. The concentration level is to be estimated by the submitter using the method described in 40 CFR 721.90. Based on EPA's 14 years of PMN experience, aquatic toxicity concern levels have only very rarely been established at levels below 1 ppb. Thus, EPA is confident that the vast majority of LoREX exemption notices satisfying this criterion will not present an unreasonable risk of acute or chronic aquatic toxicity, and that the Agency's risk assessment capabilities will identify those few exemptions which may require more strict concentration levels to protect against potential aquatic risks.
ii. Air releases. The proposed LoREX air release eligibility criterion of 1 æg/m3 was, like the ambient surface water criterion, selected on the basis of experience gained in conducting risk assessments on over 18,000 PMN chemical substances since 1978. At this maximum annual average concentration, EPA believes that, using worst case estimates, the maximum human exposures downwind from incinerators will be toxicologically insignificant for most of the chemical substances it is likely to review under the LoREX exemption. As noted above, however, the Agency may require individual submitters to adhere to lower release levels for substances for which chronic toxicity concerns are raised during the risk assessment.
The proposed methodology for calculating maximum annual average concentration (see Table 1, footnote 5) to be used by exemption notice submitters was based on computer modeling similar to that used by the Agency in the PMN review process. Those interested in more detail on this methodology should consult the docket.
Submitters should also be aware that, although the proposal has not established generic eligibility criteria for fugitive air emissions unrelated to incineration, the Agency will review the potential for such emissions on a case-by-case basis, and will deny exemptions if the air emissions reach such levels as to undermine the Agency's ability to conclude that the substances in question will not present an unreasonable risk.
iii. Land/groundwater releases. The Agency is proposing to exclude from eligibility all chemical substances which will be disposed of via landfill unless the submitter demonstrates that the exempted substance has negligible ground-water migration potential. This ``zero release'' standard was deemed most appropriate because the Agency was unable to develop a broadly applicable method for estimating groundwater concentrations of chemical substances based on landfill disposal volume. Given the many variables involved in making such estimates (e.g., migration rates, biodegradation rates, sediment/soil adsorption rates), EPA does not believe it will be possible to develop a generic model for estimating groundwater concentrations for a significant number of substances with sufficient reliability to support the requisite ``no unreasonable risk'' finding. Consequently, the Agency believes that, in the context of an abbreviated review period, where in-depth case-by-case assessments of groundwater leaching potential are infeasible, prudence dictates that zero release be the primary standard.
Potential LoREX exemption submitters with no viable alternatives to landfill disposal would be given the option under the proposal of demonstrating to the Agency's satisfaction that their substance will not migrate to groundwater. A list of suggested tests to establish groundwater migration potential is contained in Unit II.A.2. of this preamble. If such a demonstration is made, a submitter would be permitted to landfill excess quantities of the exemption substance up to the amounts approved in its exemption. In all cases, however, the Agency strongly encourages submitters to strive for total elimination of releases through employment of the best available pollution prevention (source reduction) techniques.
IV. Major Alternatives Considered
A. Maximum Annual Production Limit
As an alternative to the 10,000 kilogram annual production limit proposed in this notice, the Agency considered raising the low volume production ceiling to either (1) 5,000 kilograms; or (2) 25,000 kilograms with a toxicity testing requirement.
Based on PMN data, EPA estimated that a 5,000 kilogram ceiling would increase the pool of chemical substances eligible from the current 1,000 kilogram exemption by 10 percent, or 21 percent of all PMN submissions. Although this increase is not insignificant, the Agency believes that it would not utilize this exemption to the extent possible, and that a higher volume ceiling, benefiting both EPA, the public, and industry, could be proposed consistent with the Agency's statutory mandate to make the ``no unreasonable risk'' finding; thus, EPA favored the 10,000 kilogram alternative over the 5,000 kilogram alternative.
The 25,000 kilogram option, with a ``minimum toxicity data set'' requirement, was also considered by the Agency during development of the proposed rule. This higher volume ceiling was projected to encompass approximately 38 percent of all new chemical submissions, a 27 percent increase over the number of submissions under the current exemption. Although EPA believes that increasing the maximum volume to this level could potentially save both it and industry considerable time and resources for a large number of new chemical substances, this option raised a number of concerns. Chief among those concerns was the cost of testing. If the Agency were to require LVE submitters to conduct the same ``core set'' of health and ecotoxicity testing it now requires of submitters of high volume/high exposure PMN substances under its ``exposure-based'' criteria pursuant to section 5(e)(1)(A)(ii)(II) of TSCA, the average per chemical cost of such testing would be over $50,000. Even if such a data development requirement were delayed until a specified volume of the chemical substance was produced, there is considerable uncertainty over how many potential submitters would find that form of an exemption preferable to a PMN submission. On the other hand, if EPA were to scale back the data development requirements, there is doubt that the Agency could make the requisite ``no unreasonable risk'' finding for many of the submissions. Consequently, in light of these uncertainties, EPA determined that it would be inadvisable at this time to propose a new low volume category for substances produced in the 10,000 to 25,000 kilogram range.
B. Site-limited Intermediates
The Agency originally proposed a site-limited intermediate (SLI) exemption category in 1982 but, as with the proposed 10,000 kilogram low volume category, never promulgated a rule for that category due to industry criticism of the proposed procedural safeguards and EPA's uncertainties over making the ``no unreasonable risk'' finding for this class of substances without such safeguards. EPA considered reproposing the SLI exemption category in this rulemaking, but decided against doing so mainly because it believes that most, if not all, SLI chemicals which would be approved under an SLI exemption would fall within the scope of the LoREX exemption category; therefore, the Agency believes that a separate SLI exemption is unnecessary. Nevertheless, EPA is outlining the parameters of an SLI exemption alternative in this section to solicit public comment on this concept.
If proposed as a separate exemption category, the SLI exemption would be available to all domestic manufacturers of chemical substances satisfying the definition of ``site-limited intermediates'', independent of annual production volume. Under the 1982 proposal, an ``intermediate'' was defined as ``any chemical substance which is (1) used as a reactant in the intentional manufacture of another chemical substance, and (2) is consumed in whole or in part in that reaction''; and a ``site-limited intermediate'' was defined as an ``isolated intermediate which is manufactured, processed, and used only at the site of manufacture and not intentionally distributed outside that site except as waste which will be delivered for disposal in accordance with applicable government laws and regulations, or for burning as a fuel''.
As with the low volume and LoREX exemption categories, the Agency would conduct a risk assessment of the SLI based upon the information submitted by the manufacturer, and would approve the exemption only upon a finding that the substance would not present an unreasonable risk to human health or the environment. Certain hazard or exposure concerns identified during the 30 - day review period would be grounds for a denial of the exemption notice. For example, significant human exposures or releases that could not be adequately mitigated through controls or waste treatment would prevent the Agency from making the requisite ``will not present an unreasonable risk'' finding.
The Agency believes, as it did in 1982, that site-limited intermediates as a class may be considered low risk because they are largely consumed in chemical reactions and thus do not generally leave the site of manufacture, either in emissions, waste or final products, except in relatively small amounts. Moreover, to the extent that workers may be exposed to SLIs at manufacturing sites prior to initiation of the chemical reaction, such exposures can typically be adequately controlled through employment of protective equipment, engineering controls, and/or workplace practices. However, as stated above, the Agency is not convinced at this time of the need for both an SLI exemption category and a LoREX exemption category. Therefore, The Agency will consider promulgating a separate exemption category for SLIs in the final rule only if either (1) the LoREX category is substantially altered in the final rule, or (2) public comment convinces EPA that there could be a significant number of low risk SLIs which would not satisfy the LoREX eligibility criteria.
V. Alternatives and Request for Public Comment
EPA requests comments and data on all aspects of this proposal, including provisions of 732.50 that EPA has proposed to retain unchanged from the 1985 exemption. EPA will consider all comments and data received during the comment period and may amend any provision of 723.50 where appropriate, based on these comments.
VI. Regulatory Analysis
A. Summary of Risk Assessment
1. 10,000 kilogram/year chemical substances. To assess the risk associated with raising the ceiling for chemical substances eligible for the low volume exemption from 1,000 kilograms/year to 10,000 kilograms/year, the Agency relied primarily upon the risk assessment developed to support the 1985 final low volume rule, along with the earlier version used to support the 1982 proposed low volume and site-limited intermediate rules.
a. Exposure assessment. The exposure assessment illustrates that, while low production volume in itself limits potential for exposure and environmental release, manufacture, processing, and use of such chemicals can in some circumstances result in significant exposures at both the 1,000 and 10,000 kilogram annual production levels.
i. Occupational exposure. Based on PMN data, the number of workers exposed during manufacturing ranged from an average of about four for chemical substances manufactured in quantities of 1,000 kilograms or less per year to an average of about eight for chemical substances manufactured in quantities of 10,000 kilograms or less per year. Duration of exposure associated with manufacture averaged about 5 hours per day at both production levels, and the average number of days of production per year was 62.
Only a limited number of PMNs included estimates of workplace concentration. The average concentrations associated with manufacture were most often in the ranges of 0 to 1 and 1 to 10 mg/m3 for airborne solids and in the 1 to 10 ppm range for vapors. EPA's evaluation of OSHA data (USEPA, OTS ``Site-Limited Intermediate Exemption: Occupational Exposure and Environmental Release Assessment.'' March 19, 1982) indicated a time weighted average (TWA) of 6 ppm, with a maximum value of 72 ppm for vapors. EPA believes that data obtained from OSHA monitoring activities provide more reliable estimates of workplace concentrations.
EPA's analysis of processing and use of low volume chemicals indicated that the wide variety of possible processing and use operations can result in a wider range and higher level of exposures than typically associated with manufacturing operations. The average number of workers exposed during processing and use operations exceeded the average numbers typically exposed during manufacturing. The number ranged from an average of 12 workers for a chemical processed in quantities of 1,000 kilograms or less per year to an average of 141 workers for chemicals processed or used in quantities of 10,000 kilograms or less per year.
ii. Consumer exposure. Consumer exposures were assessed for five use scenarios: photographic chemicals used in home darkrooms; spray adhesives; paints; dyes; and fragrances used in soaps and detergents. The use scenarios, which reflected actual uses reported in PMNs, were selected to represent divergent and potentially significant exposure situations. In these scenarios, the individual lifetime average daily exposures were estimated to range from 0.0016 mg/kg/day for a fragrance in soap to negligible levels for dyed fabrics.
According to EPA's analysis, many of the consumer use scenarios could result in relatively large numbers of consumers exposed. The numbers of consumers potentially exposed at the 10,000 kilogram production level ranged from 76,000,000 for a fragrance in shampoo to 98,000 for a spray adhesive. Because the concentration of a new chemical substance in a final product remains constant, the production volume is likely to affect only the number of consumers exposed, not the exposure level to each individual. Therefore, the number of consumers exposed at the 10,000 kilogram production limit is about 10 times the number that would be exposed at the 1,000 kilogram limit.
b. Environmental release. Environmental release from manufacturing and the resultant environmental concentrations were estimated for low volume chemicals. EPA relied on PMN data in estimating the duration and frequency of releases. However, PMN projections of the amount released were considered less reliable than other sources of information.
The exposure analysis indicated that the average quantity released to water is 0.08 percent of the production volume, with an upper bound of 0.4 percent. Amounts released to air average 0.03 percent of production volume, with a 0.2 percent upper bound. However, some processing and industrial uses result in more substantial release rates, with a range from 0.3 to 25 percent of the production volume released to water. Discharges of a new low volume chemical from a single site processing 10,000 kilograms of the chemical were estimated to produce environmental concentrations ranging from less than 0.0005 to 5.2 ppm in a receiving stream whose stream dilution factor was equal the national median for streams receiving effluent from industrial facilities.
In some cases, such as detergent additives, environmental release from consumer uses equaled the total production volume; however, the actual magnitude of environmental exposure was determined to be insignificant due to the low production volume, the wide distribution of release, and the small amount of new chemical typically contained in each consumer product.
c. Risk under exemption conditions. There are several elements of the proposed exemption amendment that would significantly reduce risks to human health and the environment.
Chemical substances with carcinogenic, teratogenic, neurotoxic, and other chronic effects appear to present the greatest risks even at relatively low exposures. The proposed provisions which permit the Agency to deny exemptions for substances which may present unreasonable risks for those effects should significantly reduce the likelihood that chemicals that present such risks would be manufactured under the amended exemption. If the exemptions for such chemicals are denied, or if their submitters are required to resubmit their exemption notices to provide for more stringent release and exposure controls, the range of potential risks would be substantially below the high end of EPA's estimates.
In addition, under the proposed amendments, EPA would continue to review all exemption notices during the 30 - day review period. This review will help ensure that manufacturers choose appropriate safeguards to control risks, as well as provide a screen to identify chemicals that do not qualify for the exemption.
2. Low release and exposure chemical substances. The risk associated with a given substance is a function of both the inherent toxicity of the substance and the exposure of the relevant organism to the substance. Therefore, to the extent that releases and exposures are maintained below certain critical levels, potential risks presented by the substance are minimal. In order to assess the potential risk associated with the proposed LoREX exemption, the Agency evaluated the proposed exposure and release criteria in the context of its experience conducting risk assessments on over 18,000 new chemical substances in the PMN program over the last 12 years. Based on this experience, EPA tailored its LoREX exemption criteria in a manner to exclude from eligibility the large majority of chemical substances which may present significant human or environmental risks under conditions of manufacturing, processing, and use. For those substances which meet the eligibility criteria but may nevertheless present significant risks due to unusually high predicted toxicity levels, the Agency will either deny the exemptions or condition approval upon satisfaction of stricter exposure and release requirements.
a. Human exposure. Due to the wide range of potential consumer and general population exposures which are possible from the universe of new chemical products, the Agency concluded that it could not develop any meaningful consumer or general population exposure criteria which would consistently screen out those substances which would present significant risks from direct dermal or inhalation exposures. Consequently, EPA has proposed to exclude from LoREX exemption eligibility all new chemical substances which entail any direct consumer or general population exposure (except for negligible drinking water and ambient air exposures discussed in Unit A.2.b. of this preamble) New chemical substances intended for use in paints, soaps, dyes, and other consumer products, therefore, would have to be reviewed by the Agency in a full PMN notice or under one of the other applicable PMN exemptions.
Under the proposed LoREX criteria applicable to workers, only those chemical substances with no dermal exposures and no unprotected inhalation exposures to workers will be eligible to apply for the exemption. Therefore, to the extent that pollution prevention practices, the required methods of control, engineering controls, protective equipment, work practices, etc., will maintain inhalation and dermal exposure below critical levels, potential risks presented by the exempted chemical substances will be minimal.
b. Environmental release. In terms of environmental releases, LoREX eligibility criteria for releases to three environmental media are proposed. For ambient surface water, the Agency is proposing that submitters either (i) prevent all direct and indirect releases of the exempted substance to surface waters; or (ii) demonstrate that any releases to water that may occur will result in surface water concentrations of the substance that are no greater than 1 part per billion (ppb) using the surface water concentration calculation method described in 40 CFR 721.90. Based on Agency worst case assumptions for drinking water exposure estimates, surface water concentrations of 1 ppb will result in human drinking water exposures at or below the 1 mg/year LoREX drinking water criterion in nearly every case; therefore, compliance with the drinking water exposure criterion will be presumed from compliance with the 1 ppb surface water level. The Agency will reserve the right, however, to require lower surface water concentrations on a case-by-case basis when concerns for carcinogenicity, neurotoxicity, or other effects are raised, or under conditions where actual drinking water exposures are likely to significantly exceed the 1 mg/yr dosage.
The LoREX eligibility criterion for maximum annual average ambient air release concentration from incineration is 1 æg/m3. This level was derived from air exposure modeling estimates of maximum ground level concentrations from incinerator stacks, using worst case meteorological data sets. To determine whether a particular substance meets the criteria, submitters would calculate exposure levels using the method described in Table 1. As with drinking water exposures, the Agency may require lower air release levels in individual cases if concerns for chronic health effects are raised for the exempted substance.
For land/groundwater disposal, EPA is proposing that a LoREX substance not be disposed of by landfill or other land disposal methods unless the submitter demonstrates that the substance will not migrate to groundwater. To make such a demonstration, a submitter would be required to provide data on the biodegradation and leaching potential of the exempted substance, or other data that clearly establish that releases to groundwater will not occur. EPA suggests the following core set of tests to establish groundwater migration potential: (1) An inherent biodegradability in soil test (40 CFR 796.3400); (2) an anaerobic biodegradability of organic chemicals test (40 CFR 796.3140); and (3) depending on the substance's chemical properties, either a sediment and soil adsorption isotherm test (40 CFR 796.2750) or a soil adsorption isotherm test (40 CFR 796.2700). EPA strongly suggests that submitters contact the EPA Prenotice Coordinator (telephone: (202) 260 - 1745) for guidance prior to commencement of the above testing.
Upon approval of a LoREX exemption, the submitter would be bound to the continuous use of the exposure and release controls described in the approved exemption notice, as well as the listed uses and manufacturing sites. The Agency would deny an exemption notice notwithstanding satisfaction of the exposure-based exemption criteria if it believes it cannot support the affirmative finding required under section 5(h)(4) of TSCA that the manufacture, processing, distribution, use, and disposal of the chemical substance, under the conditions described in the notice, will not present an unreasonable risk to human health or the environment.
VII. Economic Impact
The regulatory impact analysis estimates the costs and benefits attributable to the proposed regulation. In this case, the analysis also contains estimates for the three additional proposed amendments to Section 5 regulations, namely the Polymer Amendment, the Procedural Amendment, and the Non-5(e) Significant New Use Rule Amendment. Because these proposed regulations are amendments to current regulations, the costs and benefits are incremental, estimating the effect of the proposal with respect to the current regulation.
The costs and benefits associated with this proposed amendment are partially quantified; many of the benefits are unquantified but are expected to be of significant importance. Considering only the quantified costs and benefits, there is a cost savings in most instances. Assuming either 1,000, 2,000, or 3,000 annual Section 5 submissions, the savings as compared to the current regulation are estimated to be:
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Annual Cost Savings ($ Million)
Annual Number of Submissions ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
Industry Government
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1,000.................................... (0.2) - 0.4 1.3 - 1.5
2,000.................................... (0.4) - 0.7 2.5 - 3.1
3,000.................................... (0.5) - 1.0 3.8 - 4.6
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This proposed amendment affects the low volume exemption and establishes a low release/low exposure exemption (LoREX). Industry costs associated with the proposed amendment to the low volume exemption are reporting costs, delay costs, and a user fee. Per submission reporting costs are increased due to the more comprehensive submission requirements. Delay costs for those substances which qualify for the current exemption are slightly higher, while delay costs are significantly reduced for those substances which currently must submit a full PMN submission but would qualify for the proposed exemption. Delay costs are the costs associated with the delayed introduction of the substance into the market due to Section 5 regulations. In addition, a user fee has been added to the amendment.
Industry costs associated with the proposed LoREX exemption are also reporting costs, delay costs, and a user fee. Because this would be a new exemption, all of the submitters would have originally been required to submit a full PMN submission and would already be required to pay a user fee. Also, the reporting requirements are only slightly more than current requirements.
Unquantified benefits associated with this proposed amendment include increased voluntary use of pollution prevention practices by submitters and a greater emphasis on the use of low risk chemicals.
The Agency's complete economic analysis is available in the public record for this rule (OPTS - 50596).
VIII. Finding of No Unreasonable Risk
1. Statutory background. Under section 5(h)(4) of TSCA, EPA is authorized to exempt the manufacturer of any new chemical substance from all or part of the requirements of section 5 if EPA determines that the manufacture, processing, distribution in commerce, use, and disposal of the substance will not present an unreasonable risk of injury to human health or the environment. Section 26(c) of TSCA provides that any action authorized under TSCA for an individual chemical substance may be taken for a category of such substances. Under this proposal, EPA will be exempting chemical substances with production volumes less than or equal to 10,000 kilograms/year and chemical substances with low human exposure and low release to the environment. For each of these categories, as discussed below, EPA has made a finding that, as a general matter, chemical substances eligible for the exemptions will not present an unreasonable risk of injury when manufactured, processed, used, distributed in commerce, or disposed of under the terms of the proposed exemptions.
The term ``unreasonable risk'' is not defined in TSCA. The legislative history, however, indicates that unreasonable risk involves the balancing of the probability that harm will occur and the magnitude and severity of that harm against the effect of the proposed regulatory action on the availability to society of the benefits of the chemical substance.
2. Risks. In making the ``no unreasonable risk'' finding under TSCA section 5(h)(4), EPA first considered the risk posed by granting each of the exemptions. Risk is the combination of the hazard presented by a chemical substance and the exposure of humans or the environment to the substances. EPA's determination of the reasonableness of risk involves a consideration of factors such as environmental effects, distribution, and fate of the chemical substance in the environment, disposal methods, waste water treatment, use of protective equipment and engineering controls, use patterns, and market potential of the chemical substance. These variables are difficult to quantify and standardize, thereby requiring EPA to supplement available data with its professional judgment.
EPA's preliminary determination of no unreasonable risk is based on consideration of (i) the limitations on risk that would result from the safeguards built into the rule, including Agency review; (ii) the limitations on risk resulting from the restriction of exemptions to chemical substances manufactured at volumes of 10,000 kg/yr or less and to low exposure/low release chemical substances; (iii) the benefits to industry and the public provided by chemical substances manufactured under the exemption; and (iv) the benefits to the public and the Agency from the Agency's enhanced ability to utilize its limited resources on reviewing chemical substances and uses of high risk and concern. EPA recognizes that, even with the safeguards imposed by this rule, the proposed approach would not ensure that there would be no risk from chemicals manufactured under the exemption. The statute does not define no unreasonable risk to be zero risk. Rather, it defines no unreasonable risk as a balancing of risk and benefit. Because of the safeguards in the proposed rule, the requirement that the provisions of the approved exemption are binding on the submitter, and the restricted nature of the exemption categories, EPA believes that risks are not likely to be any greater than if the full PMN process were completed. Furthermore, the new chemical substances provide benefits to industry and to the public. These benefits are an important element in the finding of no unreasonable risk.
The proposed conditions of these exemptions are designed to mitigate risk, largely by the use of: (i) the reviews conducted by the Agency to assess whether the new chemical substances may cause chronic or acute human health or environmental effects; and (ii) the binding nature of the provisions of exemption notices, including the controls placed on exposure through worker protection requirements. For the LVE, EPA determined that risks would generally be low because low production volume chemicals typically are not expected to result in high exposure to humans or the environment. Similarly, the eligibility criteria for the LoREX exemption directly limit permissible releases of and exposures to the exempted substance. In addition to the general finding of low release/exposure, and therefore low risk for these categories, the restrictions and safeguards built into the proposed exemptions will ensure that the risks presented by the exempt substances are low. For example, worker protection requirements and release restrictions imposed through the terms of the exemptions will minimize exposure, and therefore, risk.
a. EPA review. Within the 30 - day review period, EPA is confident that it can identify chemical substances posing potential risks requiring more detailed and comprehensive review. EPA's abbreviated review plays an important role in the exemptions and in the finding of no unreasonable risk. EPA is proposing to lengthen the review period from 21 to 30 days to ensure that staff resources will be sufficient to review the increased number of exemption notices expected under the amended rule and the increased amount of information required of each notice. Information submitted will include production volume, hazard information, descriptions of the manufacturing, processing, and uses, releases to the environment, and certain physical/chemical data which EPA will assess in making a determination of risk. During this period, the Agency will have sufficient time to identify any problems that were likely to have been identified in a full PMN review. If EPA determines that a new chemical substance is not eligible for an exemption, manufacture could not begin. The manufacturer would then be required to comply with TSCA section 5(a)(1) before the substance could be manufactured for commercial purposes by submitting a full PMN to the Agency.
b. New information and EPA revocation. In addition to these safeguards, the proposed rule contains several other provisions that will further limit the possibility that exempted substances will present significant risks. Most important, the proposed rule establishes procedures for revocation of the exemption if EPA later determines that the substance may present an unreasonable risk. In addition, EPA would have the authority to require documents relevant to an exemption from the manufacturer (in addition to the information provided in the exemption notice), and the manufacturer would be required to submit promptly to EPA any new data indicating that a substance is ineligible. These provisions will ensure that eligibility for and continuation of the exemption will be determined on the basis of the best available information, regardless of when the information becomes available.
3. Benefits. EPA believes that these proposed exemptions will allow many manufacturers to introduce new chemical substances in commerce much more rapidly than via the PMN process. The time and resource savings will also benefit EPA which will, by utilizing its limited assets more efficiently, be able to apply more staff time to reviewing higher risk chemical substances and uses.
4. Pollution prevention considerations. The proposed LoREX exemption is expected to further the Agency's pollution prevention efforts by encouraging development of manufacturing processes and technologies which reduce chemical releases and exposures at their source. Such reductions not only limit potential risks to people and the environment, but also many times produce significant long-term cost savings to industry through the recapture and reuse of substances which would otherwise have been released into workplaces or the environment.
5. Risk/benefit balance. As discussed above, EPA has determined that the risk presented by exempting these chemical substances is low. At the same time, there are significant benefits to be achieved by the exemptions, which encourage innovation and permit manufacturers to introduce new chemicals into commerce more rapidly. Thus, EPA has determined that, as a general matter, the risks associated with low volume substances and low release/low exposure substances are outweighed by the benefits to society of exempting these substances from full PMN review.
6. Exclusion. Despite the low risk generally associated with low volume and low release/low exposure substances, EPA recognizes that for some substances that may meet the general requirement for these exemptions, it may not be possible to make a finding of no unreasonable risk. For example, a highly toxic chemical may present an unreasonable risk even if exposure to the chemical is low. Likewise, a low production volume chemical may present an unreasonable risk if it is hazardous and is manufactured or processed in a manner that would result in high human exposure or high release to the environment. Thus, although EPA is making a general ``no unreasonable risk'' finding for categories of chemical substances, EPA will continue to evaluate exemption notices on a case-by-case basis to determine if individual substances should be excluded from the general exemption categories based on the potential risks presented by those substances. For a further discussion of how EPA will determine when to exclude an individual substance from the general exemptions see Unit III. of this proposal.
IX. Rulemaking Record
Interested persons may submit written comments regarding this proposal to the TSCA Document Control Officer (TS - 790), Office of Prevention, Pesticides, and Toxics, 401 M St., SW., Washington, DC 20460. Commenters representing corporations or trade associations must submit three copies of all comments; individuals may submit single copies of comments. The comments must be identified with the document control number ``[OPTS - 50596]''.
EPA has established a record for this rulemaking (docket control number OPTS - 50596). The record includes basic information considered by the Agency in developing this proposed rule. A public version of the record without any confidential information is available in the TSCA Public Docket Office from 8 a.m. to 12 noon and 1 p.m. to 4 p.m., Monday through Friday, except legal holidays. The TSCA Public Docket Office is located in Rm. NE - G004, 401 M St., SW., Washington, DC.
X. Other Regulatory Requirements
A. Executive Order 12991
Under Executive Order 12291, EPA must judge whether a rule is ``major'' and therefore requires a Regulatory Impact Analysis. EPA has determined that this rule would not be a ``major'' rule because it would not have an effect on the economy of $100 million or more, and it would not have a significant effect on competition, costs, or prices.
This proposed regulation was submitted to the Office of management and Budget (OMB) for review as required by Executive Order 12291.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has determined that this rule would not have a significant impact on a substantial number of small businesses. EPA has not determined whether parties affected by this rule would likely be small businesses. However, EPA believes that the number of small businesses affected by this rule would not be substantial, even if all of the notice submitters were small firms, since the rule would generally reduce the burden and cost of full PMN requirements for such businesses.
C. Paperwork Reduction Act
The information collection requirements in this rule have been approved by OMB under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3502 et. seq. and have been assigned OMB control number 2070 - 0012.
The public reporting burden for this collection of information is estimated to vary from 96 to 116 hours per response, with an average of 106 hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy Branch, PM - 223, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503, marked ``Attention: Desk Officer for EPA.''
List of Subjects in 40 CFR Parts 700 and 723
Chemicals, Environmental protection, Premanufacture notification, Hazardous materials, Reporting and recordkeeping requirements.
Dated: January 19, 1993.
William K. Reilly,
Administrator.
Therefore, 40 CFR chapter I, is proposed to be amended as follows:
PART 700 -- [AMENDED]
1. In part 700:
a. The authority citation for part 700 continues to read as follows:
Authority: 15 U.S.C. 2625.
a. In 700.43 by revising the definition of ``Exemption notice'' to read as follows:
700.43 Definitions.
* * * * *
Exemption notice means any notice submitted to EPA under 723.50 or 723.175 of this chapter.
* * * * *
b. In 700.45 by revising paragraph (c) and the parenthetical text at the end of 700.45 to read as follows:
700.45 Fee payments.
* * * * *
(c) Persons are exempt from remitting any fee for submissions under 720.38 of this chapter.
* * * * *
(Approved by the Office of Management and Budget under control number 2070 - 0012).
PART 723 -- [AMENDED]
2. In part 723:
a. The authority citation for part 723 would continue to read as follows:
Authority: 15 U.S.C. 2604.
b. By revising 723.50 to read as follows:
723.50 Chemical substances manufactured in quantities of 10,000 kilograms or less per year, and certain chemical substances with low environmental releases and human exposures.
(a) Purpose and scope. (1) This section grants an exemption from the premanufacture notice requirements of section 5(a)(1)(A) of the Toxic Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture of (i) certain chemical substances manufactured in quantities of 10,000 kilograms or less per year, and (ii) certain chemical substances with low environmental releases and human exposures.
(2) To manufacture a new chemical substance under the terms of this exemption a manufacturer must:
(i) Submit a notice of intent to manufacture 30 days before manufacture begins, as required under paragraph (e) of this section.
(ii) Comply with all other provisions of this section.
(b) Definitions. The following definitions apply to this subpart.
Act means the Toxic Substances Control Act (15 U.S.C. 2601 et seq).
Category of chemical substances has the same meaning as in section 26(c)(2) of the Act (15 U.S.C. 2625(c)(2)).
Environment has the same meaning as in section 3 of the Act (15 U.S.C. 2602).
Environmental transformation product means any chemical substance resulting from the action of environmental processes on a parent compound that changes the molecular identity of the parent compound.
Metabolite means a chemical entity produced by one or more enzymatic or nonenzymatic reactions as a result of exposure of an organism to a chemical substance.
Serious acute effects means human disease processes or other adverse effects that have short latency periods for development, result from short-term exposure, or are a combination of these factors and that are likely to result in death, severe or prolonged incapacitation, disfigurement, or severe or prolonged loss of the ability to use a normal bodily or intellectual function with a consequent impairment of normal activities.
Serious chronic effects means human disease processes or other adverse effects that have long latency periods for development, result from long-term exposure, are long-term illnesses, or are a combination of these factors and that are likely to result in death, severe or prolonged incapacitation, disfigurement, or severe or prolonged loss of the ability to use a normal bodily or intellectual function with a consequent impairment of normal activities.
Significant environmental effects means:
(1) Any irreversible damage to biological, commercial, or agricultural resources of importance to society;
(2) Any reversible damage to biological, commercial, or agricultural resources of importance to society if the damage persists beyond a single generation of the damaged resource or beyond a single year; or
(3) Any known or reasonably anticipated loss of members of an endangered or threatened species. Endangered or threatened species are those species identified as such by the Secretary of the Interior in accordance with the Endangered Species Act, as amended (16 U.S.C. 1531).
The terms byproduct, EPA, importer, impurity, known to or reasonably ascertainable, manufacture, new chemical substance, person, and test data have the same meanings as in 720.3 of this chapter.
(c) Exemption categories. This exemption applies to (1) manufacturers of each new chemical substance manufactured in quantities of 10,000 kilograms or less per year under the terms of this exemption, and (2) any manufacturer of a new chemical substance satisfying all of the low environmental releases and human exposure eligibility criterion in the following Table 1:
Table 1.--Proposed Low Release/Exposure (LoREX) Eligibility Criteria\1\
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
Type of Exposure or Release Eligibility Criteria for Exemption
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
Human Exposure
General Population Exposure...........
Dermal:............................. None
Inhalation:......................... None\2\
Drinking Water:..................... 1 mg/yr\3\
Consumer Exposure.....................
Dermal:............................. None
Inhalation:......................... None
Worker Exposure.......................
Dermal:............................. None
Inhalation:......................... None, unless adequate protection
provided
Environmental Release
Ambient Surface Water Releases........ No releases resulting in surface water
concentrations above 1 ppb\4\
Ambient Air Releases.................. No incineration releases above 1
æg/m3 maximum annual average
concentration \5\
Land/Groundwater Releases............. No releases to landfill unless
submitter demonstrates that the
exempted substance has negligible
ground-water migration potential
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
\1\ This table lists the minimum criteria required to apply for the exemption.
Based on the review of the notice, lower concentrations may be required by
the Agency for substances with potential for carcinogenic, neurotoxic, or
other effects.
\2\ No inhalation exposure permitted except as provided under the ambient air
incineration criteria.
\3\ Estimated average dosage resulting from drinking water exposures in
streams with maximum allowable concentration permitted under ambient surface
water criteria (1 ppm).
\4\ Concentration to be calculated using methods prescribed in 40 CFR 721.90.
\5\ Using following formula: (kg/day release after treatment) X (release days/
year) X 9.68 X 106 æg/m3.
Manufacturers of chemical substances that qualify for an exemption under both paragraph (c)(1) and (c)(2) of this section may apply for either exemption, but not both.
(d) Chemical substances that cannot be manufactured under this exemption. A new chemical substance cannot be manufactured under this section, notwithstanding satisfaction of the criterion of paragraphs (c)(1) or (c)(2) of this section, if EPA determines, in accordance with paragraph (g) of this section, that the substance, any reasonably anticipated metabolites, environmental transformation products, or byproducts of the substance, or any reasonably anticipated impurities in the substance may cause, under anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal of the new chemical substance--
(1) Serious acute (lethal or sublethal) effects.
(2) Serious chronic (including carcinogenic and teratogenic) effects.
(3) Significant environmental effects.
(e) Exemption notice. (1) The manufacturer must submit an exemption notice to the EPA at least 30 days before manufacture of the new chemical substance begins. The notice must be sent in writing to: TSCA Document Control Officer (TS-790), Rm. L - 100, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. The date of submission will be the date on which the notice is received by the TSCA Document Control Officer. EPA will acknowledge the receipt of the notice by letter. The letter will identify the date on which the review period begins. The notice shall be submitted using EPA Form No. 7710 - 25 (``the PMN form''), which may be obtained from EPA by calling or writing the Environmental Assistance Division, TS - 799, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC. 20460. The notice shall contain all of the information on chemical identity, impurities, trade names, production volume, uses, manufacturing sites, environmental release, and worker exposure required under 720.45 and 720.50 of this chapter. The following additional information shall also be included:
(i) Type and category of notice. The manufacturer must clearly indicate on the first page of the PMN form that the submission is a TSCA section 5(h)(4) exemption notice, and must indicate whether the notice is being submitted under paragraph (c)(1) or (c)(2) of this section.
(ii) Production volume. (A) Manufacturers submitting an exemption under paragraph (c)(1) of this section will be assumed, for purposes of conducting the EPA's risk assessment, to be manufacturing at an annual production volume of 10,000 kilograms. Manufacturers who intend to manufacture an exempted substance at annual volumes of less than 10,000 kilograms and wish EPA to conduct its risk assessment based upon such lesser annual production level rather than a 10,000 - kilograms level, may so designate; however, manufacturers who opt to designate annual production levels below 10,000 kilograms shall not manufacture more than the designated amount of the exempted substance unless a new exemption notice for a higher (up to 10,000 kgs) manufacturing volume is submitted to, and approved by, EPA.
(B) Manufacturers submitting an exemption under paragraph (c)(2) of this section shall list the estimated maximum amount to be manufactured during the first year of production and the estimated maximum amount to be manufactured during any 12 - month period during the first 3 years of production.
(iii) Exposure and release information. The manufacturer must include a description of each type of manufacturing, processing, and use operation involving the new chemical substance, including identification of the manufacturing site and the estimated number of processing or use sites, situations in which worker exposure to and/or environmental release of the new chemical substance may occur, the number of workers exposed and the magnitude, duration, and frequency of exposure and environmental release, and the controls, work practices, or equipment which limit worker exposure and environmental release. Where a manufacturer provides worker exposure or environmental release control descriptions to support the exemption notice, the manufacturer must maintain those controls throughout the period of the exemption. Where the physical form of the new chemical substance contributes to the control of human exposures, (e.g., a non-volatile liquid form rather than a powder form), the manufacturer must continue manufacturing, processing, and/or using the new chemical substance in the physical form described. Where another manufacturer holds an exemption for the new chemical substance under this section, the manufacturer submitting a notice for the additional exemption under this section must also demonstrate that the additional human exposure to, and/or environmental release of, the new chemical substance resulting from its manufactured volumes will not present an unreasonable risk of injury to human health or the environment.
(iv) Certification. In addition to the certifications required in the PMN form, the following certifications shall be included in submissions under this section. The manufacturer must certify that:
(A) The manufacturer intends to manufacture or import the new chemical substance for commercial purposes, other than in small quantities solely for research and development, under the terms of this section.
(B) The manufacturer is familiar with the terms of this section and will comply with those terms, including the requirements to employ the controls, work practices, or equipment to control exposure to and release of the exempted substance which is described in the exemption notice.
(C) The new chemical substance for which the notice is submitted meets all applicable exemption conditions.
(D) For substances manufactured under paragraph (c)(1) of this section, the manufacturer:
(1) Intends to commence manufacture of the exempted substance for commercial purposes within 1 year of the date of the expiration of the 30 - day review period, and will withdraw the exemption in the event that such manufacture is not commenced within that time.
(2) Will comply with any applicable production volume limitations in accordance with paragraph (e)(1)(ii) of this section.
(2) Sanitized copy of notice. (i) The manufacturer must make all claims of confidentiality in accordance with paragraph (k) of this section. If any information is claimed confidential, the manufacturer must submit a second copy of the notice, with all information claimed as confidential deleted, in accordance with paragraph (k)(3) of this section.
(ii) If the manufacturer does not provide the second copy, the submission will be considered incomplete.
(3) Incomplete notices. If EPA receives a submission which does not include all of the information required under paragraph (e) of this section, the submission will be determined to be incomplete by EPA. To reinitiate an exemption notice which has been declared incomplete, a manufacturer must submit a completely new exemption notice form containing all the required information; partial submissions sent to EPA to supplement notices declared incomplete will not be accepted. Photocopied pages from previously submitted exemption forms will be accepted provided that the certifications page contains an original dated signature.
(f) Review period. EPA will review the notice submitted under paragraph (e) of this section to determine whether the new chemical substance is eligible for the exemption. The review period will end 30 days after receipt of the notice by the TSCA Document Control Officer. Upon expiration of the 30 - day review period, if EPA has taken no action, the manufacturer may consider its exemption approved and begin to manufacture the new chemical substance under the terms described in its notice and in this section.
(g) Notice of ineligibility--(1) During the review period. If the EPA determines during the review period that the new chemical substance does not meet the terms of this section, that the new chemical substance meets one or more of the exclusions set forth in paragraph (d) of this section, or that there are issues concerning toxicity or exposure that require further review which cannot be accomplished within the 30 - day review period, EPA will notify the manufacturer by telephone that the substance is not eligible. This telephone notification will subsequently be confirmed by certified letter that identifies the reason(s) for the ineligibility determination. The manufacturer may not begin manufacture of the new chemical substance without complying with section 5(a)(1) of the Act.
(2) After the review period. (i) If at any time after the review period specified in paragraph (f) of this section, EPA obtains information through a TSCA section 8(e) report or through any other source indicating that the new chemical substance does not meet the terms of this section, or that any of the exclusions set forth in paragraph (d) of this section may be applicable, EPA shall notify the manufacturer of that substance, by certified mail, that its exemption under this section will be revoked.
(ii) The manufacturer may continue to manufacture, process, distribute in commerce, and use the substance after receiving the notice under paragraph (g)(2)(i) of this section if the manufacturer was manufacturing, processing, distributing in commerce, or using the substance at the time the notification was received if the manufacturer submits written objections to EPA within 15 days of receipt of the notification. Such written objections must state the reasons why the manufacturer believes that the substance will not present an unreasonable risk of injury to health or the environment. Manufacturers not manufacturing, processing, distributing in commerce, or using the substance at the time of the notification may not begin manufacture until EPA makes its final determination under paragraph (g)(2)(iii) of this section.
(iii) EPA will consider any objections submitted under paragraph (g)(2)(ii) of this section and will make a final determination on whether to revoke the exemption. EPA will notify the manufacturer of the final determination by certified mail within 15 days of receipt of the objections submitted under paragraph (g)(2)(ii) of this section.
(iv) Within 24 hours of receipt of a final determination from EPA that an exemption is revoked, the manufacturer of the substance for which the exemption was revoked shall cease all manufacturing, processing, distribution in commerce, and use of that substance. The manufacturer may not resume manufacture, processing, distribution in commerce, or use until it submits a premanufacture notice under section 5(a)(1) of the Act and part 720 of this chapter and the notice review period has ended.
(v) Action under this paragraph does not preclude action under sections 7, 15, 16, and 17 of the Act.
(h) Additional information. If the manufacturer of a new chemical substance under the terms of this exemption obtains test data or other information indicating that the new chemical substance may not qualify for the exemption, the manufacturer must submit these data or information to EPA within 15 working days of receipt of the information. If, during the notice review period, the submitter obtains possession, control, or knowledge of new information that materially adds to, changes, or otherwise makes significantly more complete the information included in the notice, the submitter must send that information to the address listed on the notice form within 10 days of receiving the new information, but no later than 5 days before the end of the notice review period. The new submission must clearly identify the submitter and the exemption notice to which the new information is related. If the new information becomes available during the last 5 days of the notice review period, the submitter must immediately inform its EPA contact for that notice by telephone.
(i) Changes in manufacturing site, use, human exposure and environmental release controls, and certain manufacturing volumes. (1) Chemical substances manufactured under this section must be manufactured at the site or sites described, under the human exposure and environmental release controls described, and for the uses described in the approved exemption. Chemical substances manufactured under paragraph (c)(1) of this section and in specific annual production volumes designated pursuant to paragraph (e)(1)(ii) of this section must not exceed the 10,000 kilograms per year volume, or the designated volume, whichever is applicable.
(2) Any person who manufactures a new chemical substance under paragraph (c)(1) or (c)(2) of this section must comply with the provisions of this section, including submission of a new notice under paragraph (e) of this section, before:
(i) - Manufacturing the new chemical substance at a site that was not approved in a previous exemption notice.
(ii) Manufacturing the new chemical substance for a use that was not approved in a previous exemption notice.
(iii) Manufacturing the new chemical substance without employing the human exposure and environmental release controls approved in a previous exemption notice.
(iv) Manufacturing the chemical substance in annual production volumes above any volume specified under paragraph (e)(1)(ii) of this section.
(3) In an exemption notice informing EPA of a change in site, worker protection or environmental release controls, or use, the manufacturer is not required to provide the same information submitted to EPA in a previous exemption notice on that chemical substance. The new exemption notice, however, must indicate the identity of the new chemical substance; the manufacturer's name; the name and telephone number of a technical contact; and location of the new site, worker protection or environmental release controls, or use information. The notice must also include the EPA-designated exemption number of the previous submission and a new certification by the manufacturer, as described in paragraph (e)(1)(iv) of this section.
(j) Customer notification. (1) Manufacturers of new chemical substances described in paragraphs (c)(1) and (c)(2) of this section must notify processors and industrial users that the substance can be used only for the uses specified in the exemption notice. The manufacturer must also inform processors and industrial users of any controls specified in the exemption notice. The manufacturer may notify processors and industrial users by means of a container labeling system, written notification, or any other method that adequately informs them of use restrictions or controls.
(2) A manufacturer of a new chemical substance described in paragraph (c)(2) of this section may distribute the chemical substance only to other persons who agree in writing to not further distribute the substance until it has been reacted or otherwise rendered into a physical form or state in which releases and exposures above the paragraph (c)(2) eligibility criteria will not occur.
(3) If the manufacturer learns that a direct or indirect customer is processing or using the exempt substance in violation of use restrictions or without imposing prescribed worker protection or environmental release controls, the manufacturer must cease distribution of the substance to the customer or the customer's supplier immediately. The manufacturer must also report this action to EPA within 15 days under paragraph (h) of this section. Within 30 days of its receipt of the report, EPA will notify the manufacturer whether, and under what conditions, distribution of the chemical substance to the customer may resume.
(k) Confidentiality. (1) If the manufacturer submits information to EPA under this section which the manufacturer claims to be confidential business information, the manufacturer must clearly identify the information at the time of submission to EPA by bracketing, circling, or underlining it and stamping it with ``CONFIDENTIAL'' or some other appropriate designation. Any information so identified will be treated in accordance with the procedures in 40 CFR part 2. Any information not claimed confidential at the time of submission may be made available to the public without further notice.
(2)(i) Any person who asserts a claim of confidentiality for chemical identity under this paragraph must provide a generic chemical name that is only as generic as necessary to protect the confidential chemical identity of the particular chemical substance. The name should reveal the specific chemical identity to the maximum extent possible.
(ii) The generic name provided by the submitter will be subject to EPA review and approval in accordance with the procedures specified in 720.85(b)(6) of this chapter. The generic name provided by the submitter or an alternative selected by EPA under these procedures will be placed on a public list of substances exempt under this section.
(3) If any information is claimed confidential, the manufacturer must submit a second copy of the notice with all information claimed as confidential deleted. EPA will place the second copy in the public file.
(l) Determination of first manufacturer of a new chemical substance. (1) A person who intends to manufacture a new chemical substance under paragraph (c)(1) of this section may determine whether that particular substance is already being manufactured under that section and, therefore, subject to the requirements of paragraph (e)(1)(iii) of this section, by submitting a notice on the substance under paragraph (e) of this section. EPA will inform the manufacturer within the 30 - day review period whether another person is already manufacturing the substance under the exemption.
(2) Alternatively, the manufacturer may ask EPA whether another manufacturer is already producing the new chemical substance under this section. EPA will respond to this inquiry only if EPA determines that the manufacturer making the inquiry has shown a bona fide intent to manufacture in accordance with the procedures set out in 40 CFR 720.25(b)(2) through (b)(9).
(3) If EPA determines that the manufacturer has not shown a bona fide intent to manufacture the new substance under the terms of this section, EPA will promptly notify the manufacturer. The manufacturer may then submit a notice under paragraph (e) of this section or a notice under section 5(a)(1) of the Act.
(4) If EPA determines that the manufacturer has shown a bona fide intent to manufacture the new chemical substance under the terms of this section, EPA will promptly inform the manufacturer whether the substance is being manufactured under this section. If the substance is not being manufactured under this section, the manufacturer may submit a notice under paragraph (e) of this section. If the new chemical substance is being manufactured under this section, the manufacturer may submit a notice under paragraph (e) of this section if the manufacturer can demonstrate that the additional human exposure to, and/or environmental release of, the new chemical substance resulting from its manufactured volumes will not present an unreasonable risk of injury to human health or the environment. If such demonstration cannot be made, the manufacturer must submit a notice under section 5(a)(1) of the Act or one of the other section 5 exemptions.
(m) Exemptions granted under superseded regulations. Manufacturers holding exemptions granted under the superseded requirements of 723.50 (as in effect on [insert date 1 day before effective date of final rule]) shall either continue to comply with those requirements or apply for a new exemption pursuant to this section. If a new exemption for a chemical substance is granted under this exemption, the prior exemption for such substance shall be void.
(n) Recordkeeping. (1) Each manufacturer of a new chemical substance described in paragraph (c) of this section must maintain records of the annual production volume of the new chemical substance under the exemption and documentation of information in the exemption notice and compliance with the terms of this section. Such records must be retained at each facility owned or controlled by the exemption holder where the exempted substance is manufactured or processed. Records maintained under this paragraph must be retained for 5 years after the date of their preparation.
(2) Any person who manufactures a new chemical substance under the terms of this section must, upon request of a duly designated representative of EPA, permit such person at all reasonable times to have access to and to copy records kept under paragraph (n)(1) of this section.
(3) The manufacturer must submit the records listed in paragraph (n)(1) of this section to EPA upon written request. Manufacturers must provide these records within 15 working days of receipt of such request.
(o) Compliance. (1) Failure to comply with any provision of this section is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) Submitting materially misleading or false information in connection with the requirements of any provision of this section is a violation of this section and therefore a violation of section 15 of the Act (15 U.S.C. 2614).
(3) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation.
(4) EPA may seek to enjoin the manufacture or processing of a chemical substance in violation of this section, or act to seize any chemical substance manufactured or processed in violation of this section, or take other action under the authority of section 7 of the Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 1616).
[FR Doc. 93 - 2773 Filed 2 - 5 - 93; 8:45 am]
BILLING CODE 6560 - 50 - F
Federal Register / Vol. 58, No. 24 / Monday, February 8, 1993 / Proposed Rules
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 720
[OPPTS - 50593;FRL - 3889 - 9]
RIN 2070 - AC14
Premanufacture Notification; Revisions of Premanufacture Notification Regulations; Proposed Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: Section 5 of the Toxic Substances Control Act (TSCA) mandates that the Environmental Protection Agency (EPA, or the Agency) review the potential health and environmental effects of new chemical substances prior to their manufacture or import and take action to prevent unreasonable risks before they occur. Section 5(a)(1) of TSCA requires that persons notify EPA at least 90 days before they manufacture or import a new chemical substance for commercial purposes. Since 1979, EPA has reviewed over 20,000 section 5 notices for new chemical substances. During the intervening years, EPA has implemented a number of non-regulatory initiatives which have enabled the Agency to review a growing number of new chemical substances. In order to achieve further efficiencies and resource savings for both EPA and submitters of section 5 notices, the Agency is proposing a number of regulatory initiatives to reduce the administrative costs/burdens of the section 5 new chemicals program. These proposals would allow EPA to concentrate its limited resources on identifying and controlling those chemical substances most likely to present an unreasonable risk of injury to health and the environment.
DATES: Comments must be received by April 9, 1993. If requested, EPA will conduct public hearings on the proposed rule amendments. Requests to make an oral presentation must be received by April 9, 1993.
ADDRESSES: All comments and requests to speak at the public hearing must be sent to: TSCA Document Control Office (TS - 790), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E - 201, 401 M St., SW., Washington, DC 20460, (Phone: 202 - 260 - 1532).
Comments should include the docket control number. The docket control number for this amendment is OPPTS - 50594. Since some comments may contain confidential business information (CBI), all comments must be sent in triplicate (with additional sanitized copies if CBI is involved). Comments on this proposed rule will be placed in the rulemaking record and will be available in the TSCA Public Docket Office, Rm. NE - G - 004 at the above address between 8 a.m. and 12 noon and 1 p.m. and 4 p.m., Monday through Friday, excluding public holidays.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (TS - 799), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E - 543 - B, 401 M St., SW., Washington, DC 20460, Telephone: (202) 554 - 1404, TDD: (202) 554 - 0551.
SUPPLEMENTARY INFORMATION:
Electronic Availability: This document, along with three other related documents, OPPTS - 50594, 50595, and 50596 is available as an electronic file on The Federal Bulletin Board at 9:00 a.m. on the date of publication in the Federal Register. By modem dial (202) 512 - 1387 or call (202) 512 - 1530 for disks or paper copies. This document and the three related documents are available in Postscript, Wordperfect, and ASCII.
EPA published its final premanufacture notification (PMN) rule (40 CFR part 720) on May 13, 1983 (48 FR 21722) and subsequently amended certain parts of the rule on September 13, 1983 (48 FR 41132) and April 22, 1986 (51 FR 15096).
I. Background
A. Authority
Section 5(a)(1) of TSCA requires that persons notify EPA at least 90 days before they manufacture or import a new chemical substance for commercial purposes. For the purposes of TSCA, a new chemical substance is one that is not listed in the Master File of the TSCA Chemical Substance Inventory (``the Inventory''), which consists of substances reported under the Inventory Reporting Regulations (40 CFR part 710) of 1977 and also added via Notices of Commencement of Manufacture or Import (NOC)(40 CFR 720.102) from submitters of premanufacture notices (PMN).
B. History/Rationale
In this document EPA is proposing to amend the Premanufacture Notification (PMN) Rule to reduce the costs of administering the New Chemicals Program and to implement other efficiencies for EPA and submitters. A discussion of the basis for these proposed amendments follows:
1. Submission of correct chemical identities in section 5 notices and Bona Fide Inventory search notices. Based on the information reported to EPA, each substance in the Inventory is accurately and uniquely identified by a chemical name that is both systematic and descriptive (either a Chemical Abstracts (CA) Index Name or a CA Preferred Name). For each of the substances whose identities have not been claimed as confidential business information (CBI) by its submitter, a Chemical Abstracts Service Registry Number (CASRN) is also assigned to further identify that substance in the Inventory.
Since the compilation of the Inventory in 1979, EPA has routinely conducted Inventory searches to determine whether each substance newly reported in a PMN or a Bona Fide Notice is already listed. Whenever the Agency can quickly determine that a reported substance is already included in the Inventory, a submitter of a Bona Fide Notice does not have to file a PMN. Similarly, rapid searches of the Inventory may preclude submitters of section 5 notices from waiting for PMN review periods to expire. This may result in considerable time and resource savings for both industry and EPA, and eliminate the expenditure of resources to review or estimate the properties of such substances.
For both PMNs and Bona Fide Notices, a submitter must provide chemical identity information that EPA considers sufficient to accurately describe the substance in question. For PMNs, these requirements are specified at 720.45(a), and the corresponding requirements for Bona Fide Notices are stipulated at 720.25(b)(2)(i). An accurate chemical identity is not only necessary for determining whether a substance is included in the Inventory, but also to accurately assess the risk of a new substance and ensure that the substance EPA reviews is precisely the substance the submitter intends to manufacture or import.
Over the past 13 years of the PMN program, EPA has spent a considerable amount of time and resources developing the precise chemical identification data on PMN and Bona Fide Notice substances that are necessary for searching the Inventory and accurately assessing risk. The Agency's resource expenditure on a PMN or Bona Fide Notice is significant even when the chemical identity information is reported correctly. However, at least 25 percent of the submitted notices contain errors, discrepancies, or ambiguities in the reported chemical identity information. The process of identifying and notifying submitters of these problems, requesting and receiving acceptable corrections for the originally submitted information, and keeping track of the delays and suspensions of notice reviews during the correction process multiplies the Agency's initial review burden and utilizes an excessive amount of limited Agency resources.
Therefore, the Agency is proposing to require that submitters of section 5 notices and Bona Fide Notices provide for each reported substance the most currently valid CA Index Name or CA Preferred Name that is consistent with TSCA Inventory listings for similar substances, in order to reduce delays caused by incorrect or ambiguous chemical identities, to expedite Inventory searches, and to save resources. EPA believes this proposed requirement would benefit submitters as well as the Agency.
One of the principal benefits of this proposed amendment to submitters of new chemical notices is that the percentage of cases currently delayed or suspended due to chemical identity problems would be significantly reduced, since submitters would have resolved most of the chemical identity problems, discrepancies, and uncertainties before reporting substances to EPA. A lower percentage of cases being delayed or suspended would not only correspond to a reduction in the number of technical inquiries and requests for additional information from EPA, but also decrease the administrative burdens involving suspended submissions that are currently borne by both the chemical industry and EPA. In addition, significant reductions in chemical identity problems and administrative delays would enable the Agency to issue more rapid responses to Bona Fide Notices.
The currently valid CA names to be required up front from submitters under this proposal would almost always be consistent with TSCA Inventory listings for similar substances, since Chemical Abstracts Service (CAS), the authority on CA nomenclature, assisted EPA in developing chemical nomenclature for the Inventory. The Agency has, to a large extent, adopted CAS' nomenclature conventions. Submitters can consequently benefit from this consistency by being able to know before the start of the Notice review period just how the Agency will identify their substances for TSCA purposes. This knowledge would assist PMN submitters who wish to prepare chemical product literature at an earlier time that identifies the substance to potential customers, and in the case of importers, to the U.S. Customs Service. In addition, this information would help reduce the need to submit PMN corrections or chemical identity amendments.
By establishing correct chemical identities before submitting Notices to EPA, submitters could also more capably conduct their own searches in public sources of Inventory data. As a result, they would be able to determine more often when substances are already included in the Inventory, thus avoiding the submission of unnecessary Notices.
Submitters' early knowledge of correct substance identities would also enhance the chemical industry's compliance efforts with TSCA regulations. A number of submitters in the past have at some point found themselves out of compliance with TSCA by failing to submit PMNs or Inventory correction requests for certain substances they incorrectly thought were on the Inventory. The chance of a submitter inadvertently violating TSCA due to his/her confusion about how EPA would identify a particular substance would be largely reduced if submitters knew firsthand how their substances would most likely be identified for Inventory purposes.
EPA would also derive considerable benefits from this proposal. The Agency would no longer have to devote such extensive resources toward determining correct chemical identities and the most appropriate Inventory descriptions of substances reported in PMNs and in Bona Fide Notices. The current resource expenditure, already significant for each notice containing correct chemical information, is multiplied when the chemical identity information provided by submitters is incorrect, incomplete, or ambiguous.
This proposed amendment would also facilitate and lower the Agency's cost of searching the Inventory for newly reported substances. Since the Inventory has been continually developed based on CA nomenclature, Inventory searches would be easier to perform and more likely to identify matching listings with the use of correct CA nomenclature and CASRNs provided by submitters.
In order to reduce the chance that persons would unknowingly submit incorrect chemical names, this proposal would encourage submitters to obtain correct chemical identity information directly from CAS before reporting substances in PMNs and Bona Fide Notices. However, since the proposal allows submitters to obtain the specified chemical names from any source, persons would not be required to obtain this information from CAS.
2. Revision of the Bona Fide Notice requirements for requesting Inventory searches. Manufacturers and importers are responsible for determining whether a substance is a new chemical substance under TSCA and therefore whether they are subject to the section 5(a) notice requirements. The published TSCA Chemical Substance Inventory: 1985 Edition and the 1990 Supplement to the 1985 Edition Of The TSCA Inventory can often be used to determine whether specific chemical substances are already included in the non-confidential portion of the Inventory. Computer tapes containing chemical names listed in the Inventory, which are updated on a semi-annual basis and which the public can purchase from the National Technical Information Service (NTIS), can be used as alternatives to the printed Inventory editions for this purpose. In addition, persons may also choose to conduct searches of the non-confidential portion of the Inventory by accessing the services of any of several commercial or government databases containing Inventory substance information. In 1986, EPA discontinued its service of responding to public requests for routine searches of the non-confidential portion of the Inventory. However, the Agency continues to respond to written inquiries regarding complex chemical identification issues or clarification of Inventory nomenclature or listing policies.
Substances for which the chemical identities are claimed as CBI are listed by TSCA accession numbers and generic chemical names in the publicly available Inventory. Each generic name describes a possible set of similar substances in order to serve as a masked identity for a specific confidential chemical substance. If a chemical substance is listed on the public Inventory under a generic chemical name, it is usually difficult for the public to determine whether a specific substance consistent with that generic name is really a new or existing substance under TSCA. It has always been the Agency's responsibility under the statute to protect from public disclosure any information reported under TSCA that submitters claim as CBI. EPA protects each confidential substance identity by publishing only the generic chemical name chosen or agreed to by its submitter.
To enable a person to know if a given substance matches a confidential chemical substance identity listed in the Inventory, EPA established procedures at 720.25(b) to inform persons whether a substance they intend to manufacture or import is already included in the Inventory, or whether the substance is considered a new chemical substance subject to the section 5(a) notification requirements. Under these procedures, a person requesting this information from EPA first must demonstrate a bona fide intent to manufacture or import the substance by submitting in writing the information required at 720.25(b)(2). EPA will not honor any other request to search the confidential portion of the Inventory, since EPA can only disclose the existence of a confidential Inventory substance to a third party upon the Agency's receipt of a Bona Fide Notice, as stipulated in the Inventory Reporting Regulations and the PMN Rule, at 710.7(g)(1) and 720.25(b)(1), respectively.
Over the past several years, the number of Bona Fide Notices submitted to EPA has steadily increased. Of the Bona Fide Notice substances not found in the Inventory, approximately half have not been subsequently reported in PMNs by the submitters. This phenomenon is unexpected since in the Bona Fide Notice submitters included signed certification statements of their intention to manufacture or import these substances for commercial purposes. Further, there are a growing number of Bona Fide Notices which are found to be incomplete for which submitters fail to subsequently provide complete information, long after EPA notifies them that the minimum information requirements have not been met. These circumstances imply that many Bona Fide Notice submitters may not have a demonstrable intent to manufacture or import these substances.
Although EPA understands that changing business situations can nullify a company's commercial intentions, it is likely that many submitters have reported their bona fide intent prematurely, perhaps before they have sufficiently assessed the technical viability, marketability, or profitability of the substance. The Agency believes that submitters should have reached positive decisions on these and other criteria before genuinely possessing bona fide intentions to commercialize substances. Alternatively, many other submitters may have conditionally intended to commercialize certain substances, depending on whether or not the substances were already included in the Inventory. EPA believes that neither of these circumstances is consistent with a bona fide intent to manufacture or import under TSCA, according to the spirit and intent of 710.7(g)(1) and 720.25(b)(1).
In an attempt to promote the submission of Bona Fide Notices that reflect serious commercial intentions, EPA proposes to amend the PMN Rule and the Inventory Reporting Regulations by revising the requirements for Bona Fide Notices, such that the submitted information would more clearly demonstrate a genuine intention to manufacture or import a given substance for a commercial purpose. The Agency believes that the amended provisions of this proposal represent a well-balanced tradeoff from the existing information requirements and will help to ensure the integrity of the Bona Fide Notice program. The amended provisions would not require submitters to generate any new information that they would not already be likely to know at the time they truly have bona fide intentions. The required information concerns basic business and technical questions that any submitter would have already answered in order to make an informed decision to manufacture or import a substance. If one has not already invested the time and effort to seriously think about and answer the types of questions posed by the amended provisions, the Agency believes that it is highly unlikely that this person has established a bona fide intent to manufacture or import the substance. Thus, the revised provisions should not constitute an increased burden to submitters, since persons with a demonstrable bona fide intent should have already answered these questions before a manufacturing or importing decision is reached, and would be able to benefit from or utilize the information developed and obtained in responding to the questions.
EPA believes that these amended revisions would also improve the Agency's ability to protect the CBI of persons submitting notices under TSCA. It has always been the responsibility of EPA to protect from public disclosure any information reported under TSCA that submitters claim as CBI. According to 710.7(g) and 720.25(b), a specific chemical identity listed in the confidential Inventory can only be disclosed to a third party if that person has demonstrated a bona fide intent to manufacture or import the substance for a commercial purpose. Under the present provisions, however, there is the chance that some CBI may be disclosed to Bona Fide Notice submitters that, unknown to EPA, do not have genuine intentions to commercialize substances. Requiring Bona Fide Notice submitters to provide the information requested by the proposed amendments would improve the Agency's ability to protect the CBI of the original submitters of Inventory-listed substances by enabling the EPA to be more selective about which Bona Fide Notice submitters are entitled to receive specific CBI concerning Inventory-listed substances. Consequently, all submitters of PMNs for substances subsequently added to the Inventory or initial Inventory reporting forms could benefit from the resulting enhanced integrity of the Bona Fide Notice program. In addition, EPA would not have to spend significant resources processing notices that do not represent serious commercial intentions.
3. Amendment of the ``Two Percent Rule'' for polymers to allow submitters greater flexibility in determining the amount of monomer or other reactant used in the manufacture of a polymer. The PMN rule requires reporting new polymers on the basis of the amounts of monomers and other reactants used in the reaction, ``as charged'' to the reaction vessel, and on the dry weight of the polymer manufactured. This approach, which has been in effect since the Inventory reporting regulations were published on December 23, 1977 (42 FR 64572), was adopted because the Agency and the regulated community believed it would be difficult to identify the exact amount of monomers or reactants incorporated in the final polymer. The method of reporting the percent composition of monomers and other reactants ``as charged'' was viewed as a reasonable approach by chemical and polymer industries.
Due to advanced analytical capabilities developed over the intervening years, certain polymer manufacturers have asked EPA to revise the current ``Two Percent Rule'' to allow manufacturers the option of determining the amounts of monomers and other reactants that are ``in chemically combined form'' (incorporated) in a polymer as an alternative to the current practice of requiring reporting based on the amounts added (charged) to the reaction vessel. EPA has considered industry's request and is proposing an amendment to the ``Two Percent Rule'' to allow this optional reporting procedure. The Agency believes that allowing submitters to report on the basis of amounts incorporated in the polymer could provide a better indicator of physical, chemical, and toxicological properties of polymers. At the same time, this would allow manufacturers greater flexibility in commercial innovation, reduce the number of unnecessary PMNs representing slight variations in polymer composition, and provide greater consistency with international reporting policies. However, as will be described below, the Agency believes there are certain drawbacks and burdens involved in using the method of computation based on incorporated amounts of monomers and reactants.
Under the proposal, manufacturers would still be allowed to use the ``amounts charged'' method to determine the polymer chemical identity. However, they would also have the option of determining the amounts incorporated in the manufactured polymer. If a company chooses the latter method, EPA believes that it is reasonable to require that such manufacturers maintain in their records analytical data that demonstrate that the amounts of monomers and other reactants incorporated in the manufactured polymer have been accurately determined. This will allow the Agency and the company to verify compliance in a straightforward manner.
EPA recognizes that it was a matter of convenience, rather than one of science, to have thus far required reporting of the amounts of polymer reactants charged rather than the amounts incorporated; the former method requires only ``bookkeeping'', while the latter may require extensive and expensive analytical work.
After nearly 13 years of experience with the Inventory and PMN reporting rules, however, chemical manufacturers and EPA reviewers have come to realize that the convenience of the ``amount charged'' approach has drawbacks. In particular, the current approach of identifying many polymers based on monomers and reactants charged to the reactor in quantities significantly larger than the amounts found to be incorporated in the polymer does not properly represent the physical, chemical, and toxicological properties of the polymer.
Under the PMN rule, inefficiently incorporated reactants, reactants charged in large excess, and reactants with other functions besides their reactant ones are often likely to produce reportable polymers, even though the degree of chemical incorporation may be less than or equal to 2 percent. For example, free-radical initiators are often charged in quantities greater than 2 percent in order to start many polymer chains simultaneously and limit the amount of high-molecular-weight polymer produced. Chemical incorporation is inefficient, since many processes other than chain initiation can consume the initiator. The weight of the final polymer that can be attributed to fragments originating from the initiator is often less than two percent by weight. A manufacturer may use many different initiators, all charged at greater than 2 percent, to produce what would be the same polymer if the ``incorporated'' method of computation was used. The result has been what many manufacturers believe to be excess reporting. Similar problems arise with solvents that have reactive functions, and with neutralizing agents used in excess of their salt-forming capacities. Technical details concerning the ``Two Percent Rule'' are contained in the paper entitled, ``Supporting Document on Computation of Weight Percent of Reactants'', which is available in the public docket for this document [OPPTS - 50593].
Since the Agency has always believed the actual content of a polymer to be a better indicator of its physical, chemical, and toxicological properties, and settled upon the ``amount charged'' method of computation as a matter of convenience to industry, it now seems reasonable, in the light of experience, to allow the submitter to optionally use the amounts of monomers and other reactants incorporated, basing the computation on the ``imputed charge'' as described in the public docket for this document. Therefore, EPA is proposing an amendment to allow optional use of the method to determine percentage composition based on the amounts of reactants present in chemically combined form in the polymer.
The use of the ``incorporated'' method may have regulatory consequences. The percentage of chemical incorporation of a given reactant, and its ``imputed charge'' value, could possibly change and result in the need to submit an additional section 5 notice if there was a modification in the manufacturing process, either inadvertent or intentional, even if there was no change in the amounts and identities of the reactants charged to the reaction vessel. Changes in reaction temperature, in the type of catalyst or solvent used, or in the method and/or order of charging the reactants to the reaction vessel are examples of such processing modifications that could possibly affect the degree of chemical incorporation and the ``imputed charge'' of a given reactant when the charged amounts of reactants remain unchanged. Such a change could hypothetically cause the weight percentage of a minor reactant to increase from less than or equal to 2 percent to above 2 percent, resulting in the automatic requirement that this reactant be included in the Inventory description of the polymer. If this reactant was not originally intended to be included in the polymer identity for TSCA purposes, the processing change could result in the isolation of a different, reportable polymer substance before a section 5 notice was submitted. Consequently, persons could find themselves in violation of the PMN Rule, even though the charged amounts of the reactants had never been changed. Compared to using the ``as charged'' method, it would be more difficult to prevent this type of potential TSCA violation when the computation method based on incorporation is used. Thus, the potential regulatory liability to industry could increase to the extent that the ``incorporated'' method is used.
The proposed amendments make clear that an Inventory correction request or a PMN correction request received after the end of the notice review period will not be allowed to cover a new polymer identity that may occur if a processing change causes the ``imputed charge'' value of a reactant to increase from less than or equal to 2 percent to above 2 percent, when reported percent composition data are based on amounts incorporated. In addition, an Inventory correction request or a PMN correction request received by EPA after the end of the notice review period will not be allowed to cover a change in the TSCA chemical identity of a polymer that may occur if a submitter changes computation methods from the ``incorporated'' method to the ``charged'' method, or vice versa. A chemical identity correction request of this type will only be accepted if this request is received by EPA during the applicable section 5 notice review period.
4. Submission of multiple photocopies of section 5 notices. EPA, in order to complete its review of each section 5 notice within statutory timeframes, must currently make multiple copies of the PMN form and any accompanying documents to make them available to many technical reviewers in the Agency simultaneously. Making these copies presents difficulties in terms of time and expense to the Agency. For example, some documents received are in non-standard sizes, or have other characteristics that make photocopying difficult. Further, duplication of documents containing CBI requires special handling procedures. These problems lead to inevitable time delays for staff access to documents. Therefore, the Agency is proposing an amendment to require that, in addition to the original copy of the section 5 notice and attachment(s), plus one sanitized copy in which CBI has been deleted, submitters provide EPA with two additional copies of the notice itself that include all continuation sheets for information required in the notice and two additional copies of test data, other data, and any optional information provided as attachments to the notice. EPA believes that this proposal will expedite the PMN review process by allowing reviewers to have access to the documents in a more timely manner and enabling the Agency to shift resources from photocopying services to scientific reviews.
5. Electronic transmission of section 5 notices. EPA is proposing to amend 720.40 to allow reporting via magnetic or other electronic media. Because the Agency is still in the early stages of planning for reception of electronic submissions, it is premature to specify a format. However, the Agency is developing standardized electronic reporting formats and mechanisms such as submission by magnetic tapes, diskettes, and electronic forms. EPA believes that transmission of submissions via electronic media may be quicker than mail, if Electronic Data Interchange (EDI) is adopted as a transmission mechanism. In any case, direct loading of data to a computer system is more efficient than keystroke data entry and ensures data quality. Readers are referred to the Federal Register of July 30, 1990 (55 FR 31030) for further discussion of the Agency's policy on electronic reporting.
6. Standard form for Notices of Commencement (NOC). Manufacturers and importers are required at 720.102(b) to submit a NOC to EPA's Document Control Officer within 30 calendar days of the first day of manufacture or import for a commercial purpose. The NOC must be submitted by the PMN submitter. Currently, there is no required reporting form for a NOC. Although EPA provides a voluntary one-page NOC form to submitters with PMN receipt acknowledgement letters, submitters may use any type of letter or form that includes the necessary information. Many submitters routinely use the NOC form, and its use has simplified EPA's receipt of NOC information. In cases where the voluntary NOC form is not used, a significant number of NOCs has created difficulty because they were not recognized as NOCs or contained confusing, missing, or unnecessary information. These problems have resulted in a waste of time and resources for both submitters and EPA personnel who must prepare or review these notices.
EPA is proposing the mandatory use of a one-page NOC form, which the Agency believes would enable all NOC submitters to benefit from the simple, quick NOC process that users of the voluntary form already possess. The required use of such a form would also reduce EPA processing time for NOCs.
C. Other Initiatives Being Considered
The Agency is also considering the following initiatives but is not proposing any additional PMN rule amendments at this time.
1. Development of requirements that all reporting facilities provide certain information about their geographic location. To date, for PMN reporting purposes, the Agency has requested the street address of manufacturing, processing, and use facilities under the control of the submitter. The Agency is currently considering developing requirements for an EPA-wide policy which would require that all facilities reporting under any EPA-administered program provide certain information about their geographic location beyond the general street address. This information would assist environmental analyses and allow data to be integrated based on specific locational information. In addition, this approach would promote enhanced use of EPA's extensive resources for cross-media environmental analysis and management decisions. The policy is expected to include: latitude/longitude coordinates, specific method used, a text description of location, and an estimate of accuracy. In order to incorporate this policy into the PMN rule, the Agency has established a workgroup to analyze and propose requirements for this type of specific information in section 5 notices in order to better describe the sites of manufacture and processing of a new chemical substance. The Agency is requesting comments on whether this information should be included in all section 5 notices and NOCs.
At some future date, the reporting forms for all section 5 submissions may be revised to provide space for the entry of latitude/longitude coordinates for each site of manufacture, importation, or processing under the submitter's control, an indication of the specific method used to determine coordinates, a text description, and an estimate of accuracy. Many companies already report this data under other EPA rules, so providing this data would not be unduly burdensome. Also, it need only be determined once per facility, as the latitude/longitude coordinates presumably wouldn't change. Possible issues include the definition of ``facility'', as the site of research and development activity may be different than that of manufacture or importation. The possible need to submit additional and/or updated locational data with the NOC is also being studied.
2. Enhanced review of all confidential claims submitted to the Agency. The Agency is not proposing to amend the language of the rule pertaining to CBI. However, EPA is giving notice that it intends to review each PMN submission containing a CBI claim and make appropriate determinations on the validity of that claim. This higher level of scrutiny arises from EPA's conclusion that claims for CBI protections are being used indiscriminately without regard to statutory or regulatory restrictions. Because of this, and the need to handle all claimed material as CBI until such claims are verified, withdrawn, or rejected, CBI procedures consume an inordinately large amount of Agency resources that may not be justified.
EPA requests that PMN submitters carefully review and tailor each CBI claim so that only that information which must be confidential is claimed CBI. Submitters should review the statutory CBI provisions contained in TSCA section 14, the general CBI regulatory provisions contained in 40 CFR chapter I, 2.201, et seq. and the specific PMN CBI regulatory provisions contained in 40 CFR 720.80, et seq. before making any confidentiality claims.
Furthermore, if a submitter chooses to submit a CBI claim in a PMN (or other section 5 notice), the submitter must provide a copy of the submission (including all health and safety data) for the public file with all confidential data deleted as required at 720.80(b)(2). The failure to comply with this requirement may result in the PMN being declared incomplete in accordance with 720.65. If the submission is declared incomplete the notice review period for the PMN substance will not begin until the matter is rectified.
The confidentiality provisions of the Rule take into consideration the various requirements of the Act, including the need: (1) To provide nonconfidential material to the public, (2) to give EPA information it needs to respond to Freedom of Information Act (FOIA) requests, (3) to allow persons to assert claims of confidentiality, and (4) to reduce uncertainty about the criteria EPA will use in making confidentiality determinations.
The regulated community is reminded that confidentiality claims asserted in the PMN, including those for chemical identity, will be reviewed in accordance with the procedures set forth in 40 CFR part 2, subpart B.
Concerning chemical identity information included in health and safety studies provided in the PMN, the Agency considers the specific chemical identity always to be part of a health and safety study even when it does not appear in the study. As such, under TSCA section 14(b), EPA may not withhold from the public the data from health and safety studies, including specific chemical identity. The only exception to this policy is if disclosure would reveal confidential processes used in the manufacturing or processing of a chemical substance or mixture, or reveal the proportions of a mixture, or if the specific chemical identity is wholly unnecessary to interpret the health and safety studies. This issue was previously discussed in the final PMN rule of May 13, 1983 (48 FR 21739 - 21740). Specific language regarding EPA's authority to deny certain claims for confidentiality in a health and safety study appears at 40 CFR 720.90.
Lastly, with regard to CBI claims filed in a NOC, submitters are reminded that under no circumstances may they assert a CBI claim for chemical identity in an NOC if the submitted chemical identity was not claimed CBI in the PMN.
CBI claims asserted for chemical identities submitted in PMNs are not automatically renewed upon Notice of Commencement. EPA, consistent with the NOC regulations at 720.102 and 720.85(b), requires CBI assertions for the chemical identity of a substance to be fully substantiated upon Notice of Commencement. Despite the existence of a CBI claim for chemical identity in the NOC, the chemical identity will be placed on the public Inventory without further notice from EPA if not accompanied by appropriate substantiation of this CBI claim.
II. Discussion of Proposed Amendments
1. Correct chemical identity. EPA is proposing to amend 720.45(a) of the PMN rule to require that submitters of section 5 notices and Bona Fide Notices provide the most currently valid Chemical Abstracts (CA) Index Name or CA Preferred Name for each reported substance that is consistent with TSCA Inventory listings for similar substances. This proposal will require that a currently valid Chemical Abstracts Service Registry Number (CASRN) consistent with this CA Name also be reported for the substance if it already exists for that substance. Under the current PMN Rule, CA nomenclature is indicated as a preferred, but not a required, chemical naming system for PMN reporting. Therefore, submitters can presently identify the PMN substance using alternative nomenclature. The proposal would retain all of the other chemical identity information required at 720.45(a), including molecular formula and chemical structure information. However, for substances not able to be characterized by a single chemical structure, the submitted structural diagram must be as complete as one can reasonably ascertain. Failure to fully comply with the chemical identification elements of this requirement would result in the notice being declared incomplete by EPA pursuant to 720.65(c)(1). Such incomplete notices will not be processed or reviewed by the Agency until the chemical identification requirement is satisfied.
Although a CAS Registry Number (CASRN) is not routinely required for a reported substance if a CASRN is not already available, and though the proposal only requires that CASRNs be reported for substances that already have them, EPA strongly recommends that submitters provide CASRNs for all reported substances, especially when the chemical identity is not being claimed as CBI. Having more substances reported with CASRNs would save EPA resources involved with chemical review and Inventory searching. Submitters would provide a CA Index Name or CA Preferred Name that is consistent with the application of the 9th Collective Index (9CI) of CA nomenclature rules and conventions. Whether to report a CA Index Name or Preferred name for a substance depends on how well-defined the chemical identity of the substance is with respect to the existence of a definite molecular formula to describe it; any given substance can only be properly assigned either a CA Index Name or a CA Preferred Name, according to CA nomenclature policies. A CA Index name is assigned to any substance having a known molecular formula, whereas a CA Preferred Name is given to any substance having no definite molecular formula.
For well-defined substances appropriately named using CA Index nomenclature, the specific chemical name chosen as most accurately describing the substance should be based on all that the submitter can reasonably ascertain about its chemical structure, including, where applicable, the degree of structural specificity of the substance (i.e., whether or not specific isomers are intended to be produced in a reaction). For poorly defined substances properly named using CA Preferred nomenclature, the specific name of choice should be based on the submitter's knowledge of the identities of the chemical precursors used, the sources of the reactants (i.e., synthetic, isolated or obtained by processing from certain naturally occurring materials, etc.), the nature of the reaction, and the types of chemical substances constituting the product combination, etc.
For any type of substance reported, one needs to consider whether there are any impurities or byproducts of no commercial value existing in the product composition in order to know which product components are reportable. Impurities or byproducts of no commercial value are not considered reportable substances under TSCA.
When more than one substance results from a reaction, one should determine whether or not the product combination can be viewed for TSCA purposes as a mixture of separately reportable substances. For example, when the intended product combination is known to always be completely composed of a specific number of identified substances that do not react with one another, the combination can be represented as a mixture under TSCA. If this is not the case, then a single chemical name must be used to collectively describe the product combination as one substance.
Concerning the degree of chemical structure information that can be reasonably ascertained for a given substance, submitters should understand that, for TSCA Inventory purposes, all substances are categorized by EPA into two groups according to the degree of certainty about the chemical structure of a substance: Class 1 and Class 2. Class 1 substances are those of precisely known chemical composition for which a single, complete structural diagram can be drawn. Class 2 substances are those having chemical compositions not completely definite or known and, therefore, they cannot be characterized by definite, complete chemical structure diagrams. This proposal would require complete structural diagrams to be provided for Class 1 substances; Class 2 substances would require partial structure diagrams that are as complete as can be ascertained from the Class 2 chemical identity.
This proposed chemical identification requirement could be satisfied if the submitter uses the services of CAS, or the services of another chemical information organization, service bureau, or consultant that the submitter considers capable of generating correct CA names, chemical structure diagrams or molecular formulae where appropriate, and obtaining necessary CASRNs. Alternatively, the submitter could search publicly available databases to retrieve this information, if available, or attempt to generate a name without assistance from another person or organization, if the submitter has sufficient knowledge about CA 9CI nomenclature rules and conventions and about how similar substances should be named for the Inventory. Information describing CA nomenclature rules and conventions can be obtained from CAS. Printed copies of the non-confidential Inventory can be purchased from the Government Printing Office, and computer tapes containing this Inventory information can be purchased from the National Technical Information Service (NTIS).
Regardless of who or which mechanism the submitter uses to determine correct chemical identifications, in order to obtain the currently correct chemical names for substances before reporting them to EPA in section 5 notices or Bona Fide Notices, submitters would be expected to provide the party generating the CA nomenclature with the same chemical identity information that the submitter would have to send to EPA if reporting the substance in a PMN: the same types of information, levels of detail, and degrees of specificity, etc. The party assigning a chemical identity for the purpose of a substance being reported in a PMN or Bona Fide Notice should ensure that the name choice reflects the current CA nomenclature rules and conventions, as well as how similar substances are named for the Inventory, or else the chemical name will be incorrect and the notice could be declared incomplete by the Agency.
In order to meet the proposed requirement, submitters could choose between two optional methods of obtaining the chemical identification of any substance to be reported. These alternatives are described below as Method 1 and Method 2. Submitters would need to indicate in each notice which of the two methods is being used.
Method 1. A submitter using this method would obtain the correct chemical identification directly from CAS prior to submitting a notice to EPA. EPA understands that CAS would set up and operate a special extension of CAS Registry Services for identifying substances to be submitted under TSCA. CAS would provide such services pursuant to arrangements between CAS and persons informing CAS that their substances will be reported to EPA in a PMN, an exemption application, or in a Bona Fide Notice.
Submitters would call or write CAS directly for complete instructions on how to use the special extension of CAS Registry Services for TSCA submitters.
Submitters would be required to provide a copy of the chemical identification report obtained from CAS along with the completed PMN, to verify that they obtained the information directly from CAS.
EPA believes that most submitters would find it advantageous to utilize the services of CAS to meet this requirement. CAS is generally recognized as a world authority on substance identity, and is the ultimate source of the most current and correct CA nomenclature and CAS Registry Numbers. Furthermore, only CAS can generate new CAS Registry Numbers. CAS also developed the nomenclature conventions that are widely used by other organizations throughout the world, and has, since 1977, assisted EPA in the development of the TSCA Inventory and the identification of the Inventory's substances. Many submitters of section 5 notices have been voluntarily obtaining chemical identities from CAS on a routine basis before reporting substances to EPA, thereby benefitting from the early recognition and resolution of chemical identity uncertainties. Furthermore, due to CAS' familiarity with TSCA Inventory and nomenclature policies, EPA believes that chemical names and other chemical identity information assigned by CAS according to this method would almost always be acceptable to the Agency. For these reasons, EPA would strongly recommend that submitters use the services of CAS to satisfy the amended provisions.
Submitters should note, however, that if EPA disagrees with the identification assigned by CAS to a given substance, the Agency reserves the right to be the final authority on how a reported substance should be named and represented for the Inventory. In the rare event EPA does not agree with a chemical name, CASRN, chemical structure or molecular formula provided to a submitter by CAS for TSCA purposes according to Method 1, EPA would work with CAS under an existing technical support contract to either modify the submitted chemical identity when necessary or confirm that the CAS' identification is most appropriate, to ensure that a correct TSCA description is assigned. Using Method 1, there would be no delay or additional cost to the submitter resulting from an identification error by CAS or an identity verification request by EPA, and the review period would continue uninterrupted. EPA would assume responsibility for resolving chemical identity problems occurring when Method 1 is used.
Method 2. Using this method a submitter may obtain the required chemical identity information from any chemical information organization, service bureau, or consultant, from someone on the submitter's staff, or can retrieve or develop the proper CA identifications himself/herself. EPA emphasizes that with this method submitters would need to provide for each substance a correct CA Index or Preferred Name and other chemical identity information, as stipulated under 720.45(a), that are consistent with Inventory listings for similar substances. It would be the submitter's responsibility under Method 2 to seek the required information from a source the submitter believes to be sufficiently knowledgeable about CA nomenclature conventions and TSCA Inventory listings.
In contrast to Method 1, if a submitter uses Method 2 and reports any chemical identity information that is considered incorrect by EPA, the submitter, not the Agency, would be considered responsible for correcting the chemical identification. EPA would declare such a notice incomplete under 720.65(c)(1) and would not further process or review it until the submitter provides the fully correct chemical identity information stipulated under the proposed amendment.
Concerning the task of generating correct CA nomenclature, it should be noted that there are many chemical names on the CAS Registry File, particularly CA Preferred Names used for indefinitely described substances, that are not appropriate for uniquely identifying substances on the Inventory. Thus, the application of just the CA nomenclature rules to name a new substance would not guarantee an acceptable chemical name for TSCA purposes. One must also be familiar with the ways in which similar substances are listed in the Inventory.
Regardless which method is chosen by a submitter for properly identifying a reported substance, EPA remains the final authority in naming new substances under TSCA.
In order for submitters to have ample time to become familiar with the process of obtaining chemical identity information from CAS, another chemical information service, or a consulting party for obtaining chemical identifications, it is recommended that submitters contact their chosen source at least 1 or 2 months before the intended submission date of a notice. This is especially important the first time one would have to report under this proposed amendment.
EPA would also caution submitters, however, not to obtain or develop a chemical identification more than several months ahead of when they intend to submit a notice for the substance to the Agency. Due to occasional changes or modifications in CA nomenclature rules and conventions, a CA name that was not recently obtained or developed could represent obsolete CA nomenclature and, therefore, be incorrect or inappropriate for Inventory listing purposes by the time a notice is submitted. The Agency occasionally updates its Inventory listings for existing substances having identities that are affected by revised CA names and changes or modifications in CA nomenclature rules and conventions.
EPA anticipates that many submitters would consider chemical identity information and/or submitter identity information given to CAS (by Method 1) or another third party (by Method 2) to be confidential or trade secret information. It is the position of EPA that no information can qualify as TSCA-CBI until it is received by EPA in a notice reported under a provision of TSCA. Therefore, provisions for handling any confidential information first submitted to CAS or another outside party must be arranged directly with that party. Submitters should not assume that CAS or another outside party is required to adhere to EPA-regulated TSCA-CBI procedures regarding the possession, handling, labelling, storage, tracking, auditing, or other processing of this information.
However, based on currently available information, it is EPA's understanding that any confidential, proprietary, or trade secret information that CAS would receive by Method 1 of this proposal prior to it being reported to EPA would be handled in accordance with the long-established security procedures and policies that CAS has implemented to safeguard any confidential information provided by its customers. A considerable number of large corporations and government agencies appear to have entrusted their confidential substance information to CAS for database building and ongoing search/retrieval projects. There have also been many customers of CAS Registry Services, including submitters of section 5 notices, who have submitted their confidential substance descriptions for assignment of CA names or retrieval of existing CASRNs. Thus, it appears that CAS has had considerable experience in meeting the expectations of outside organizations for protecting their confidential information.
When submitting a chemical to CAS or any other information service, a submitter who indicates that the substance identity is confidential information should be aware that a CASRN for that substance may already exist due to CAS' prior knowledge from another source of the existence of that substance. In such a case, the chemical identity will already have been assigned a CASRN and placed by CAS in its publicly accessible files. Based on its knowledge of CAS' procedures, EPA believes that CAS currently does not place the substance identity into the publicly available CAS Registry File, if not already present there, when a submitter has requested confidential treatment of the information. However, EPA cannot ensure that CAS will continue this practice in the future, nor can EPA ensure how other services handle this type of information. As always, it is ultimately the submitter's responsibility to ensure that the information service it chooses to employ properly protects the confidentiality of its data, and does not utilize this information for its own gain against the wishes of the submitter.
Submitters choosing to use Method 2 should inquire how any other information service, consultant or party receiving their confidential information will handle, protect, and use such information.
Submitters sometimes do not possess complete chemical identity information about a substance they intend to import because of the proprietary chemical identity claims of certain foreign chemical exporters. In such situations, when the foreign exporter will not disclose confidential chemical identity information to the importer who submits a section 5 notice or Bona Fide Notice, submitters would be expected to request that the foreign exporting party follow the procedures specified by either Method 1 or Method 2. The chemical identity information could then be provided directly to EPA by the foreign supplier as a joint submission or as a letter of support which references the importer's notice and PMN User Fee TS Identification Number, according to 40 CFR part 700.
Some submitters of section 5 notices or Bona Fide Notices only know part of the chemical identity of their substances, because they contain or are manufactured from purchased substances having specific chemical identities that may be claimed confidential by the supplier. In such cases, the submitter typically identifies the substance only by tradename, generic chemical name, or in terms of partial composition information listed in a Material Safety Data Sheet (MSDS) or in other product literature.
In this situation, due to the complexity and logistical obstacles to generating correct CA nomenclature and other chemical identity information for a substance based on multiple submissions from different sources, EPA is not asking either the submitter or the chemical supplier to first develop or obtain a correct CA chemical identification of the given substance. Rather, the notice submitter would first report whatever is known about the substance identity to EPA in the section 5 notice or Bona Fide Notice, and would arrange for the supplier of the proprietary substance to send a letter of support containing the specific chemical identity of the supplied chemical directly to EPA, referencing the submitter's notice and User Fee TS Identification Number, if appropriate. The letter of support must contain the same PMN User Fee TS identification number used in the notice, so that EPA can be sure of properly linking the two submissions. EPA would not start the statutory review period until it receives all parts of a joint notice, or all necessary supporting documents providing chemical identity information for a notice.
2. Revised requirements for Bona Fide Notices. The Agency is proposing to amend 720.25 to revise certain provisions of the procedures to establish a bona fide intent. The proposal would reduce or simplify existing analytical information requirements, modify or clarify other existing information requirements, and request three other types of information in notices. This section, with its amendments, would supersede the corresponding section of the Inventory Reporting Regulations [710.7(g)].
Concerning the information currently required at 720.25(b)(2) to establish a bona fide intent, the proposal would eliminate the need for elemental analysis data [720.25(b)(2)(iv)] while reducing and simplifying the other analytical information requirements [720.25(b)(2)(v)]. Two other parts of this section, regarding chemical identity information, and the description of research and development (R&D) activities and use [720.25(b)(2)(i) and (iii), respectively] would be modified and/or clarified. There are three new information requirements that ask about the most probable manufacturing site and process to be used, as well as an approximate date when the submitter would be likely to submit a section 5 notice for the substance if it is not found in the Inventory. EPA believes that the proposal represents a balanced trade-off of requirements between the existing and amended provisions, which will enable persons to better demonstrate a bona fide intent while the Agency is better able to protect the CBI of the original submitters of Inventory substances. The additional information or data requested in the proposed amendment is easily ascertainable by the submitter, and would likely have been already determined by the time the submitter has a bona fide intent to manufacture or import a substance for a commercial purpose. Persons who have not obtained the information or made decisions about the substance requested by the proposed requirements would not appear to be at the proper commercial product development stage to have a true bona fide intent concerning this substance. According to 720.25(b)(2)(i) of the proposed amendments, submitters of a Bona Fide Notice must provide, as stipulated in the amended provisions of 720.45(a), a currently correct CA Index Name or CA Preferred Name, whichever is appropriate, a currently correct CASRN if the substance already has a CASRN assigned to it, plus a molecular formula and a complete or partial chemical structure diagram if they are known or reasonably ascertainable, as stated earlier in this Unit of the preamble. Having the currently correct CA identification for a substance is important to EPA, because the reporting of incorrect, inconsistent, ambiguous, or obsolete chemical names, molecular formulae or chemical structure information, or names that are not CA Index or CA Preferred Names, causes extra resources to be spent by EPA establishing the best descriptions for substances under TSCA, searching the Inventory, and performing risk assessments. Failure to fully comply with the chemical identification elements of this requirement would result in the notice being declared incomplete by EPA.
The proposed amendment would modify the current requirement for a description of R&D activities conducted to date on the substance and the purpose for manufacturing or importing it [720.25(b)(2)(iii)]. Since two different types of information are requested in this section and many submitters have in the past inadvertently omitted one of them in their notices, EPA proposes to make the requirements clearer by separating its requests for descriptions of R&D activities and purpose for which the submitter will manufacture or import the substance into different parts of the amended rule text [720.25(b)(2)(iii) and 720.25(b)(2)(iv), respectively]. In 720.25(b)(2)(iii)(A), EPA elaborates on its information request by listing some of the general types of R&D activities that should be reported. In addition, the year in which R&D was started by the submitter on the substance is also requested. EPA believes that these modifications will serve to better enable the submitter to indicate the scope and length of its commitment towards developing the substance for commercial use. EPA would prefer that this information be briefly stated in a few sentences.
In 720.25(b)(2)(iii)(B), EPA would provide an alternative reporting requirement for importers who do not perform R&D activities on the substance and have no knowledge of R&D activities that may have been conducted outside of the United States. Such importers would be allowed, in lieu of presenting research or development information, to indicate for how long, and in which country, a given substance has been in commerce outside of the United States, as well as to state whether they believe that the substance has already been used outside of the United States for the same commercial application(s) intended by the submitter. This alternative requirement would be similar to the current, informal EPA practice allowing such a prospective importer to satisfy 720.25(b)(2)(iii) by providing certain information on foreign commercial activity of the substance.
In 40 CFR 720.25(b)(2)(iv), for clarity, the term ``purpose'' has been replaced by the phrase ``major intended application or use'' because some submitters have misunderstood the type of information being requested and have not provided a description of the intended end use.
EPA is proposing to simplify the analytical data requirements at 720.25(b)(2)(v) to reflect the current practice of most submitters to provide an infrared spectrum to characterize the chemical substance. The proposal will require an infrared spectrum, unless infrared analysis is not suitable for the substance or does not yield good structural information for the substance. As an alternative in such cases, the proposal requires one to submit a spectrum or instrumental readout from another method of spectral or instrumental analysis that yields better structural or compositional information.
Section 720.25(b)(2)(vi) of the proposed amendment consists of a minor but new information requirement to estimate the month and year in which the person would intend to submit a section 5 notice for the substance if it is not found in the Inventory. EPA believes that a Bona Fide Notice submitter would have already thought about a future timeframe for reporting the substance under section 5 if it is a new chemical substance. The intent of this requirement is not to legally bind the submitter to a certain date for submission of a PMN. However, the information would be one of many factors which will help EPA to determine whether the person has demonstrated a bona fide intent. Also, if EPA could anticipate how many Bona Fide Notice submitters may report their substances in PMNs in a given year, the Agency may be able to better allocate resources for reviewing them.
Section 720.25(b)(2)(vii) of the proposal is a new requirement requesting the address of any one site under the submitter's control where the substance is anticipated to most likely be manufactured or processed in the future for a commercial purpose.
Section 720.25(b)(2)(viii) of the proposal is a new requirement by which a manufacturer must briefly describe the most probable manufacturing process that the submitter would use to produce commercial quantities of the substance. Importers would have the alternative of briefly describing how the substance would most likely be processed or used at a site controlled by the submitter, or if no processing or use of the substance is anticipated to occur at a submitter-controlled facility, a submitter could just state that such commercial activity is not expected to occur. This information is not intended to be legally binding, but rather to assist EPA in determining whether the submitter appears to have serious intentions for commercializing the substance in question.
The Agency would also like to make clearer the procedure a submitter intending to import the substance should use to allow a foreign manufacturer or supplier to provide confidential chemical identity information directly to EPA in order to complete a notice when the chemical identity is considered the proprietary information of the foreign party and cannot be disclosed to the submitter. As indicated by the proposed modification to 720.25(b)(3), it is the importer's responsibility to make all of the contacts and arrangements with the foreign party for the timely transfer of this information to EPA in such a manner that EPA can easily link the information to the importer's notice.
The proposed amendments to 720.25(b)(3) also indicate chemical identification requirements when submitters of substances to be manufactured or imported cannot possess full knowledge of the chemical identity of the substance to be reported because a purchased reactant or component used in the reported material has a confidential chemical identity that is the proprietary information of the supplier. Only in such a situation involving confidential trademarked or tradenamed reactants or starting materials, due to the complexity and logistical obstacles involved in generating correct CA identifications for substances based on multiple submissions from different sources, does the proposal allow the notice submitter to report directly to EPA all that is known about the substance identity. However, as previously discussed in Unit II of this preamble, the submitter must coordinate with the supplier to ensure that the remaining specific chemical identity information is sent by the supplier directly to EPA in a timely manner, in order to complete the notice and initiate review by EPA.
Further, EPA is proposing language in 720.25(b)(9) to describe what constitutes an incomplete Bona Fide Notice, and how EPA would handle one. When an incomplete notice is received and identified as such, EPA will immediately return the notice directly to the submitter. The submitter would then have to resubmit the completed notice, in its entirety, in order to have EPA perform the Inventory search and respond to the notice.
3. ``Two percent rule'' for polymers. Under this proposal, the Agency would amend 720.45(a) of the PMN rule and 723.250(f)(2)(iv) and 723.250(o)(1) of the Polymer Exemption rule to allow a manufacturer the option of reporting monomers and other reactants on the basis of (a) the ``amount charged'' to the reaction vessel, which is the sole method currently allowed, or (b) the amount reacted and incorporated in the manufactured polymer. The proposed changes to 723.250 are included in another action published elsewhere in this issue of the Federal Register. The current language in this regulation does not specify a basis for determining the percentage of monomer or reactant. However, as discussed earlier in this notice (Unit I.B.3 of this preamble), it has been EPA policy to require the percent (by weight) of a monomer or other reactant to be determined on the basis of the amount charged to the reactor, as a percentage of the dry weight of the manufactured polymer.
Concerning the use of the ``incorporated'' method, the percentage of chemical incorporation of a given reactant, and its ``imputed charge'' value, could possibly change if there was a modification in the manufacturing process, such as a change in reaction temperature or the method and/or order of charging reactants, etc. Such changes, which could be inadvertent as well as intentional, could possibly cause the weight percentage of a minor reactant to change from less than or equal to 2 percent to above 2 percent. If this reactant was not originally intended to be included in the polymer identity for TSCA purposes, the processing change could result in the isolation of a different, reportable polymer substance before a section 5 notice was submitted.
EPA emphasizes that a request to correct an initial Inventory reporting form (an Inventory correction request) or a section 5 notice (a PMN correction request) for which the review period has expired will not be accepted for the purpose of adding to the Inventory or to the Agency's PMN substance database, respectively, a new polymer identity that may occur if (1) a processing change causes the ``imputed charge'' value of a reactant to increase from less than or equal to 2 percent to above 2 percent, when reported percent composition data is based on amounts incorporated, or (2) the submitter changes from the ``incorporation'' to the ``charged'' computation method, or vice versa. If a different polymer is isolated under these circumstances that is not already in the Inventory, that polymer is subject to the PMN reporting requirements before it can be manufactured or imported for distribution in commerce.
4. Multiple photocopies of section 5 submissions. This proposed amendment to the PMN rule consists of a change in submission criteria at 720.40(d)(2) that will require submitters to provide EPA with one original and two copies of section 5 notices, in addition to a sanitized copy in which CBI has been deleted. Submitters would also be required to provide one original and two additional copies of any test data.
5. Electronic transmission of section 5 notices. This proposed amendment to the PMN rule at 720.40(a) is designed to promote the use of electronic media for data submission. EPA is investigating the use of magnetic tape, floppy diskettes and electronic data interchange as means to submit information. In making this proposal, EPA is participating in a nation-wide trend toward reducing reliance on paper for information transfer. EPA has already taken steps in TSCA and other program areas to encourage electronic submission, and wishes to expand this effort to the PMN review program.
Information may be submitted electronically (on magnetic or other media) once EPA publishes a format for electronic submissions. Pilot projects using electronic submissions for the Inventory Update Rule and Toxic Release Inventory Rule will be used as a base line for enhancements to developing a standard Agency-wide format. Such submissions must meet this format and all other media specifications published by EPA. Persons submitting electronically must still complete and submit on paper the Certification and Submitter Identification sections of EPA Form 7710 - 25; if attachments are submitted, the List of Attachments and all attachments must be submitted on paper.
6. Mandatory form for Notice of Commencement (NOC). Under the proposal, all PMN submitters would be required to use a standard one-page form to submit a NOC. In addition, the NOC information requirements at 720.102(c), have been slightly expanded; however, all information can be provided on the one-page standard form.
The proposal would require every NOC received at EPA on or after the effective date of the final rule amendments to contain the required information on the new standard NOC reporting form. This form would automatically be provided to each PMN submitter as an attachment to EPA's acknowledgement of PMN receipt letter sent to submitters shortly after each PMN is received. Many submitters currently use a similar, voluntary form mailed to them, to report the required information.
The current NOC information reporting requirements include specific chemical identity, PMN number, the date when manufacture or import commences, and substantiation of CBI claims for chemical identity. This CBI substantiation is required by the time a NOC is submitted. Failure to provide written substantiation of a confidentiality claim for the chemical identity with the NOC, as required under 40 CFR 720.85, may result in a waiver of the confidentiality claim and disclosure of the chemical identity to the public.
Some additional information is required under the proposal to make it easier for EPA not only to process NOCs but to verify that submitters are reporting information in NOCs that is consistent with specific PMNs for the substances in question. EPA expects that this additional information would occasionally identify cases in which submitters mistakenly reported the wrong PMN case number in the NOC, or erroneously listed a substance identity that is very different from that which they intended to commence. In addition, the new requirements would enable submitters to provide certain updated information that may no longer be correct or appropriate as reported in the PMN.
In addition to the current NOC reporting requirements, EPA is proposing to amend NOC reporting to require that complete submitter identity information, including the name and address of the submitter, the name and dated signature of the authorized official, and the name and phone number of a technical contact in the United States, be provided on the form.
The amended NOC provisions would also now require a generic chemical name, which could either be the same generic name provided in the PMN, a generic name as revised by the submitter, as long as it masks no more of the chemical identity than the original generic name provided, or an improved or corrected generic name agreed to via negotiation with EPA.
Since one's intention to initially manufacture or import a substance sometimes changes between the time of PMN submission and NOC, the proposal requires submitters to specify in the NOC whether commencement occurred via manufacture or importation and the address of the site(s) under the control of the submitter at which manufacture commenced.
In addition to reasserting a CBI claim for chemical identity, the proposal requests a clear indication of whether the submitter identity is also claimed as confidential. Confidentiality claims can only be asserted by the submitter if the corresponding claims were made in the PMN.
All of the above proposed amendments to information requirements for NOCs involve information that the submitter already would know by the time manufacture or importation of the substance has commenced. Consequently, providing this information in the NOC would not constitute a significant reporting burden. EPA will consider an NOC incomplete if it is not submitted on the new form with all the required information.
III. Alternatives Considered
1. Correct chemical identity-- a. Alternative 1. One alternative proposal being considered by EPA consists of requiring all submitters of section 5 notices and Bona Fide notices to obtain the correct chemical identity information directly from the Chemical Abstracts Service (CAS) using Method 1 as discussed in Unit II of this preamble.
EPA is considering this alternative proposal because the Agency believes that too much incorrect and incomplete chemical identity information may continue to be submitted in notices under the Agency's preferred proposal which allows a submitter to use other sources for chemical identity information (Method 1 or Method 2). The Agency believes that the level of EPA resource savings expected from mandatory use of the special extension of CAS Registry Services, which would require only minimal Agency screening and review of chemical identities in notices, cannot be achieved if submitters do not obtain substance identifications directly from CAS. Although EPA expects that most submitters will use CAS Registry Services for the reasons stated in Unit II of this preamble, the Agency realizes that in cases where submitters use alternative sources, EPA staff would have to invest significant resources to screen the quality of information. Further, the Agency would like to minimize the administrative burdens involved with notice suspensions, delays, submitter contact, and additional paperwork needed to properly amend notices that may be determined to be incomplete on the basis of incorrect chemical identity.
b. Alternative 2. This alternative is the same as EPA's preferred approach, allowing the use of Method 1 or Method 2 to obtain correct chemical identity information, except that submitters would have to obtain and report CASRNs for all substance identities that they do not claim as CBI, in addition to reporting CASRNs for all substances to which CASRNs have already been assigned.
Although having more substances reported with CASRNs under this alternative would save some EPA resources involved with chemical review and Inventory searching, the Agency recognizes that this approach could inadvertently discourage submitters from reporting substances without CBI claims for chemical identity as often as they should. Since EPA encourages and expects submitters to use CBI claims only when necessary, the Agency does not favor the use of this approach.
2. ``Two Percent Rule'' for polymers-- a. Alternative 1. Retain the current ``two percent rule'' based on the weight of monomer or other reactants ``charged'' to the reactor.
EPA considered this alternative because it is much easier to calculate the weight of monomer or reactant ``charged'' to the reactor instead of analytically determining the actual composition of the polymer. The typical percentages of monomers or other reactants ``as charged'' could be directly calculated from batch records, and these calculations could be routinely made, if necessary, by people who do not have scientific training. The simplicity of this type of calculation also reduces the burden of chemical identity review for the Agency.
In addition, EPA and industry have been using this method of calculation and Inventory listing for 13 years. Consequently, Inventory consistency would be enhanced concerning what polymer listings actually represent.
This method also provides less chance of error, which would prevent significant increases in EPA's enforcement/compliance monitoring burden and liability to industry. By using the percent incorporated method, submitters could inadvertently fail to comply with section 5 of TSCA due to some processing change (other than the amounts of charged reactants) varying the incorporated percentages. For example, if the percent of a certain monomer incorporated in the polymer was determined to be just slightly under 2 percent, the monomer's percent incorporation could possibly increase above 2 percent due to some processing change, such as a modest variation in reaction temperature. If the submitter had reported that this monomer was not to be included in the chemical identity of the polymer, he/she would be in violation of the PMN Rule whenever the percent incorporation of that monomer exceeded 2 percent, if the new chemical identity including that monomer is not already in the Inventory. Such a technical violation of TSCA would not be easy to prevent or detect.
The Agency also believes that this method correlates reasonably well with the percent incorporation of most monomers.
However, the Agency is aware that the current method of reporting polymers provides industry with less flexibility and innovation capabilities since it may require PMN reporting for even minor changes in manufacturing processes. There may be relatively poor correlation between the percent charged versus incorporation, particularly for non-monomer reactants. Bases, acids, or other reactants are often charged at much more than stoichiometric amounts in order to achieve a certain pH, to drive the reaction to completion, or to generate more polymer chains with lower molecular weight, etc. Finally, EPA believed that it should take industry's request for revision of the ``Two Percent Rule'' under consideration, in line with the advances in analytical techniques for determining percent ``incorporated'', the desire to ``harmonize'' to the extent reasonable the Agency's polymer reporting requirements with other international reporting requirements, and the Agency's belief that allowing percent ``incorporation'' more accurately reflects the physical, chemical, and toxicological properties of polymers.
b. Alternative 2. Change to a 5 percent rule based on the amount charged.
EPA considered this option because it accommodates most typical use levels of reactants such as free radical initiators, chain transfer agents, salt forming reactants, etc. It would also allow industry more flexibility to modify existing polymers without submitting PMNs, thereby, significantly reducing EPA's reviewing burden. Historically, industry originally requested this level during the development of the Inventory reporting regulations.
EPA believes that this option would require that the Agency review the toxicological implications resulting from this alternative since the potential for chemically modifying polymer structures is increased somewhat when a monomer or reactant is increased from 2 to 5 percent, causing a larger potential variation in physical and chemical properties. Further, this method may allow monomers with reactant functional groups at levels that currently concern the Agency, e.g., cationic polymers. This method would not correlate chemical identity with percent incorporation as well as the EPA proposed amendment. Finally, this approach would not be consistent with the Agency's goal of harmonizing to the extent possible EPA's method of reporting polymers with other international reporting practices.
EPA requests comments on these alternatives, in particular, on the difficulty of obtaining accurate, reliable data using the percent ``incorporated'' method and the percentage of polymer submissions in which this method would be used.
IV. Economic Analysis
EPA has evaluated the potential costs of the proposed amendments for potential submitters of section 5 notices. The Agency's complete economic analysis is available in the public record for this rule (OPPTS - 50593).
The regulatory impact analysis estimates the costs and benefits attributable to the proposed regulation. In this case, the analysis also contains estimates for the three additional proposed amendments to section 5 regulations that are published elsewhere in this Federal Register. These proposals would amend the Polymer Exemption Rule, the Low Volume Exemption Rule, and the Expedited Follow-up Rule. As these proposed regulations are amendments to current regulations, the costs and benefits are incremental, estimating the effect of the proposal with respect to the current regulation.
The costs and benefits associated with this proposed amendment are partially quantified; many of the benefits are unquantified but are considered to be of significant importance. Considering only the quantified costs and benefits, there is a slight cost increase for industry and a slight cost savings for government. Assuming either 1,000, 2,000, or 3,000 annual section 5 submissions, the savings as compared to the current regulation are estimated to be:
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Annual Cost Savings ($
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The aspects of the proposed amendment that have the greatest quantified cost impact on industry are the change in requirements for a bona fide TSCA Inventory search request and the requirement to provide correct chemical identification. Both requirements are expected to enable the Agency to more effectively utilize resources, thereby providing better service to industry. One of the major unquantified benefits of this proposal is the flexibility allowed industry by the changes to the ``Two Percent Rule,'' which allows industry to make minor compositional changes, providing more manufacturing control to the submitter and possibly reducing the number of section 5 submissions. Another unquantified change is the requirement to use a standardized form for notice of commencements (NOCs), the impact of which is expected to be minimal as most submitters are already using the form.
V. Rulemaking Record
EPA has established a record for this rulemaking (docket control number OPPTS - 50593). The record includes basic information considered by the Agency in developing this proposed rule. EPA will supplement the record with additional information as it is received. A public version of the record without any confidential information is available in the TSCA Public Docket Office from 8 a.m. to 12 noon and 1 p.m. to 4 p.m., Monday through Friday, except legal holidays. The TSCA Public Docket Office is located in Rm. NE - G004, 401 M St., SW., Washington, DC.
VI. Other Regulatory Requirements
A. Executive Order 12291
Under Executive Order 12291, EPA must judge whether a rule is ``major'' and therefore requires a Regulatory Impact Analysis. EPA has determined that this rule would not be a ``major'' rule because it would not have an effect on the economy of $100 million or more, and it would not have a significant effect on competition, costs, or prices.
This proposed regulation was submitted to the Office of Management and Budget (OMB) for review as required by Executive Order 12291.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has determined that this rule would not have a significant impact on a substantial number of small businesses. EPA has not determined whether parties affected by this rule would likely be small businesses. However, EPA believes that the number of small businesses affected by this rule would not be substantial, even if all of the Polymer Exemption notice submitters were small firms.
C. Paperwork Reduction Act
The information collection requirements in this rule have been approved by the Office of Management and Budget under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3502 et. seq. and have been assigned OMB control number 2070 - 0012.
The public reporting burden for this collection of information is estimated to vary from 18 to 21 hours per response, with an average of 20 hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy Branch, PM - 223, U.S. Environmental Protection Agency, 401 M. St., SW., Washington, DC 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503, marked ``Attention: Desk Officer for EPA.''
List of Subjects in 40 CFR Part 720
Chemicals, Environmental protection, Premanufacture notification, Hazardous materials, Recordkeeping and reporting requirements.
Dated: January 19, 1993.
William K. Reilly,
Administrator.
Therefore, 40 CFR chapter I, subchapter R, part 720 is proposed to be amended as follows:
PART 720 -- [AMENDED]
1. The authority citation for part 720 would continue to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2613.
2. Section 720.25 is amended by revising paragraphs (a), (b)(1), (2)(i), (2)(iii), (2)(iv), (2)(v), (3), and by adding paragraphs (b)(2)(vi), (2)(vii), (2)(viii), and (b)(9) to read as follows:
720.25 Determining whether a chemical substance is on the Inventory.
(a) A new chemical substance is any chemical substance that is not currently listed on the TSCA Chemical Substance Inventory.
(b)(1) A chemical substance is listed in the publicly accessible Inventory by a specific chemical name (either a Chemical Abstracts (CA) Index Name or a CA Preferred Name) and a Chemical Abstracts Service (CAS) Registry Number if its identity is not confidential information. A confidential chemical substance, on the other hand, is listed in the public Inventory by a TSCA Accession Number and a generic chemical name that masks the specific substance identity. The confidential substance is listed by its specific chemical name only in the confidential portion of the Inventory. A person who intends to manufacture or import a chemical substance not listed by specific chemical name in the publicly available Inventory may ask EPA whether the substance is included in the confidential Inventory. EPA will answer such an inquiry only if EPA determines that the person has a bona fide intent to manufacture or import the chemical substance for commercial purposes.
(2) * * *
(i) The specific chemical identity of the substance that the person intends to manufacture or import, using the most current, correct Chemical Abstracts (CA) name and the other correct chemical identity information stipulated in 720.45(a).
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(iii)(A) A brief description of the research and development activities conducted to date, including the year in which the person first started to conduct research or development activity on this substance, and the general types of research and development activities conducted thus far (e.g. synthesis, substance isolation/purification, formulating, product development, process development, end-use application, toxicity testing, etc.). The person must also indicate whether any pilot plant or production-scale plant evaluations have been conducted involving the manufacture or processing of this substance.
(B) If an importer is unable to provide the information requested in paragraph (b)(2)(iii)(A) of this section from the foreign manufacturer or supplier, the following information may be submitted:
(1) A brief statement indicating how long the substance has been in commercial use outside of the United States,
(2) The name of a country in which it has been commercially used,
(3) Whether or not the submitter believes that the substance has already been used commercially, in any country, for the same purpose or application that the submitter is intending.
(iv) A specific description of the major intended application or use of the substance.
(v) An infrared spectrum of the substance, or alternative spectra or other data which identifies the substance if infrared analysis is not suitable for the substance or does not yield a reasonable amount of structural information. When using alternative spectra or instrumental analysis, submit a spectrum or instrumental readout verifying use of that method.
(vi) The estimated date (month/year) in which the person intends to submit a Premanufacture Notice (PMN) for this substance if EPA informs the notice submitter that the substance is not on the Inventory.
(vii) The address of the facility under the control of the submitter at which the manufacture or processing of the substance would most likely occur.
(viii)(A) For substances intended to be manufactured in the United States, a description of the most probable manufacturing process that would be used by the submitter to produce the substance for non-exempt commercial purposes.
(B) For substances intended to be imported, a brief description of how the submitter is most likely to process or use the substance for a commercial purpose. If the importer does not expect to process or use the substance at any facility under his control, a statement to this effect should be included along with a description of how the substance will be processed or used at sites controlled by others, if this information is known or reasonably ascertainable.
(3)(i) If an importer cannot provide all the information required by paragraph (b)(2) of this section because it is claimed confidential by its foreign manufacturer or supplier, the foreign manufacturer or supplier may supply the required information directly to EPA and reference the importer's notice. If the appropriate supporting document from the foreign party is not received within 30 days after EPA receives the submitter's notice, the notice will be considered incomplete.
(ii) If a submitter cannot provide all of the required information as stipulated in 720.45(a) because the new chemical substance is manufactured using a reactant that has a specific chemical identity claimed as confidential by its supplier, the notice must contain chemical identity information that is as complete as can be known by the submitter. In addition, a letter of support for the notice must then be sent to EPA by the chemical supplier of the confidential reactant, providing the specific chemical identity of this proprietary reactant. The letter of support must reference the submitter's notice, including the PMN User Fee Identification Number chosen by the submitter for this notice, if applicable. If the appropriate supporting document from the supplier is not received within 30 days after EPA receives the submitter's notice, the notice will be considered incomplete.
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(9) If the required chemical identity information has not been reported correctly or completely in the notice (except as provided under paragraph (b)(3)(ii) of this section) or if any other required data or information has been omitted or is incomplete, EPA will consider the whole notice to be incomplete. As soon as an incomplete notice is identified as such by EPA, the Agency will immediately return the notice directly to the submitter. The submitter must then resubmit the whole, completed Bona Fide Notice to EPA in order to have the Agency perform the desired Inventory search and respond to the notice.
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3. Section 720.40 is amended by revising paragraphs (a) and (d) to read as follows:
720.40 General.
(a) Use of the notice form; electronic submissions. (1) Each person who is required by subpart B of this part to submit a notice must complete, sign, and submit a notice containing the information in the form and manner specified in this paragraph. The information submitted and all attachments (unless the attachment appears in the open scientific literature) must be in English. All information submitted must be true and correct.
(2) Information may be submitted on paper, or electronically, as follows:
(i) Information submitted on paper must be submitted in the form and manner set forth in EPA Form No. 7710 - 25, which is available from the Environmental Assistance Division (TS - 799), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. Information which is not submitted on a photocopy of the form (e.g., on a form created by commercial form-making software) must be in a format pre-approved by the Agency.
(ii) Information may be submitted electronically (on magnetic or other media) if and when EPA has published a format for electronic submissions. Such submissions must meet this format and all other media specifications published by EPA. Persons submitting electronically must still complete and submit on paper the Certification and Submitter Identification sections of Form 7710 - 25; if attachments are submitted, the List of Attachments and all attachments must be submitted on paper.
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(d) General notice requirements. (1) Each person who submits a notice must provide the information described in 720.45 and specified on the notice form, to the extent such information is known to or reasonably ascertainable by the submitter. In accordance with 720.50, the notice must also include any test data in the submitter's possession or control, and descriptions of other data which are known to or reasonably ascertainable by the submitter and which concern the health and environmental effects of the new chemical substance.
(2) A person who submits a notice to EPA under this part must provide to EPA an original notice and two copies of the notice itself and two additional copies of all test data and any optional information attached to the notice form.
4. Section 720.45 is amended by revising paragraph (a) to read as follows:
720.45 Information that must be included in the notice form.
* * * * *
(a)(1) The specific chemical identity of the substance that the person intends to manufacture or import, which includes the following:
(i) The currently correct Chemical Abstracts (CA) name for the substance, based on the 9th Collective Index (9CI) of CA nomenclature conventions, and consistent with listings for similar substances in the TSCA Chemical Substance Inventory (the Inventory). For each substance having a chemical composition that can be represented by a specific, complete chemical structure diagram (a Class 1 substance), a CA Index Name must be provided. For each chemical substance that cannot be fully represented by a complete, specific chemical structure diagram (a Class 2 substance), or if the substance is a polymer, a CA Index Name or CA Preferred Name must be provided (whichever is appropriate based on Chemical Abstracts Service (CAS) 9CI nomenclature rules and conventions),
(ii) The currently correct CAS Registry Number (CASRN) for the substance if a CASRN already exists for the substance in the CAS Registry File,
(iii) The correct molecular formula, for each Class 1 substance and any Class 2 substance for which a definite molecular formula is known or reasonably ascertainable,
(iv) A complete, correct chemical structure diagram for each Class 1 substance; a correct partial chemical structure diagram for a Class 2 substance or polymer, as complete as can be known, if one can be reasonably ascertained.
(2) For polymers, the submitter must also report the following:
(i) The specific chemical name and CAS Registry Number (if available) of each monomer and other reactant used, at any weight percent, to manufacture the polymer. Tradenames or generic names of chemical reactants or monomers are not acceptable as substitutes for specific chemical names.
(ii) The typical percent of each monomer and other reactant in the polymer (by weight percent of total polymer), and the maximum residual amount of each monomer present in the polymer.
(iii) The reactants used at 2 weight percent or less (based on the dry weight of the polymer manufactured) that should be included as part of the polymer description on the Inventory, where the weight percent is based on either (A) the weight of reactant charged to the reaction vessel, or (B) the weight of chemically combined (incorporated) reactant in the polymer.
(iv) The submitter must specify which method of computation is used; that is, whether the calculation is based on the weight of reactants ``as charged'' or ``as incorporated.'' If the submitter specifies on the basis of incorporated weights of reactants in the polymer, analytical data to support this determination must be maintained at the site of manufacture. The ``percent (by weight)'' of a monomer or other reactant is the weight of the reactant expressed as a percentage of the weight of the polymeric chemical substance manufactured. If the submitter uses the ``as charged'' method of computation, the weight of a reactant consists of its full amount charged to the reaction vessel. If the optional ``incorporated'' method of reporting is used, the weight of a reactant is the minimum weight of that reactant required by theory to account for the actual weight of reactant or reactant unit chemically incorporated into the polymeric substance manufactured.
(v) Measured or estimated values of the minimum number-average molecular weight of the polymer and the amount of low molecular weight species below 500 and below 1,000 molecular weight, with a description of how the measured or estimated values were obtained.
(3) Submitters must use one of the following two methods to develop or obtain the specified chemical identity information and identify the method used in the notice:
(i) Method 1. Using this method, the submitter would obtain the correct chemical identity information required by 720.45(a)(1) directly from CAS prior to submitting a notice to EPA.
(ii) Method 2. A submitter using this method can obtain the correct chemical identity information required by 720.45(a)(1) from any source, as long as the information is consistent with Inventory listings for similar substances. This section of the notice will be incomplete according to 720.65(c)(1)(vi) if the submitter uses Method 2 and any chemical identity information is considered incorrect by EPA.
(4) If an importer submitting the notice cannot provide all the information stipulated at 720.45(a) because it is claimed as confidential by the foreign manufacturer or supplier of the substance, the importer must have the foreign supplier follow the procedures at 720.45(a)(3) and provide the correct chemical identity information stipulated in 720.45(a) directly to EPA in a joint submission or as a letter of support to the notice, which clearly references the importer's notice and PMN User Fee Identification Number. The statutory review process will start upon receipt of complete, correct information from the foreign party.
(5) If a manufacturer cannot provide all the information stipulated in 720.45(a) because the new chemical substance is manufactured using a reactant having a specific chemical identity claimed as confidential by its supplier, the manufacturer must submit a notice directly to EPA containing all the information known by the manufacturer about the chemical identity. In addition, the supplier of any confidential reactant must submit a letter of support directly to EPA providing the specific chemical identity of the confidential reactant. The letter of support must reference the notice submitter's name and PMN User Fee Identification Number. The statutory review period will commence upon receipt of both the notice and letter of support.
5. Section 720.80 is amended by revising paragraph (b)(2) to read as follows:
720.80 General provisions.
* * * * *
(b) * * *
(2) If any information is claimed as confidential, the person must submit two copies of each notice form (or electronic submission) and any attachments.
(i) One copy of the form (or electronic submission) and attachments must be complete. In that copy, the submitter must designate that information which is claimed as confidential in the manner prescribed on the notice form (or in EPA's electronic submission instructions).
(ii) The second copy must be complete except that all information claimed as confidential in the first copy must be deleted. EPA will place the second copy in the public file. Once this copy has been in the public file for more than 30 days, any information contained within the copy will be presumed to be in the public domain.
(iii) If the submitter does not provide the second copy, or information in a health and safety study (except data claimed as confidential in accordance with 720.90(b)) is deleted from the second copy, the submission will be deemed incomplete and the notice review period will not begin until EPA receives the second copy or the health and safety study information is included, in accordance with 720.65(c)(1)(vi).
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6. Section 720.102 is amended by revising paragraphs (c) to read as follows:
720.102 Notice of commencement of manufacture or import.
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(c) Information to be reported on form. (1) The notice must be submitted on EPA (Form 7710 - --) (Form number to be assigned), which is available from the Environmental Assistance Division (TS - 799), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. The form must be signed and dated by the submitting person or authorized official. All information specified on the form must be provided. The notice must contain the following information:
(i) The specific chemical identity.
(ii) A generic chemical name (if the chemical identity is claimed as confidential by the submitter).
(iii) The premanufacture notice (PMN) number.
(iv) The date when the submitter commenced manufacture or import for a commercial purpose (indicating whether the substance was initially manufactured in the United States or imported).
(v) The name and address of the submitter.
(vi) The name of the authorized official.
(vii) The name and phone number of a technical contact in the United States.
(viii) The address of the site(s) under the control of the submitter where commencement of manufacture occurred.
(ix) Clear indications of whether or not the chemical identity and/or the name of the submitter is presently claimed as confidential by the submitter.
(2) If the submitter claims the chemical identity confidential, and wants the identity to be listed on the confidential Inventory, the claim must be reasserted and substantiated in accordance with 720.85(b). Otherwise, EPA will list the specific chemical identity on the public Inventory. Submitters who did not claim the chemical identity or submitter identity to be confidential in the PMN cannot claim either of these identities as confidential in the Notice of Commencement.
[FR Doc. 93 - 2774 Filed 2 - 5 - 93; 8:45 am]
BILLING CODE 6560 - 50 - F
Federal Register / Vol. 58, No. 24 / Monday, February 8, 1993 / Proposed Rules
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS - 50595; FRL3890 - 3]
Rin 2070 - AC14
Toxic Substances; Significant New Use Rules; Proposed Amendment to Expedited Process for Issuing Significant New Use Rules; Proposed Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: Pursuant to section 5(a)(2) of the Toxic Substances Control Act (TSCA), EPA is proposing an amendment to the notification requirements for selected new chemicals (40 CFR 721.170(c)(1)) that would authorize EPA to impose any of the provisions in 40 CFR part 721 subpart B and other provisions not included in subpart B using expedited rulemaking procedures to promulgate ``significant new use'' rules (SNURs) for substances not subject to section 5(e) Orders. Currently, the notification requirements in 721.170(c)(1) limit the type of activities which EPA can designate as a significant new use by expedited rulemaking without first issuing a section 5(e) Order. This proposed amendment would allow EPA to promulgate expedited SNURs for certain substances without issuing a section 5(e) Order for the substance, and thereby facilitate EPA's ability to efficiently and expeditiously regulate new chemical substances.
DATES: Comments must be received by April 9, 1993. If requested, EPA will conduct public hearings on the proposed rule amendments. Requests to make an oral presentation must be received by April 9, 1993.
ADDRESSES: All comments and requests to speak at the public hearing must be sent to: TSCA Document Control Office (TS - 790), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E - 201, 401 M St., SW., Washington, DC 20460, (Phone: 202 - 260 - 1532).
Comments should include the docket control number. The docket control number for this amendment is OPPTS - 50594. Since some comments may contain confidential business information (CBI), all comments must be sent in triplicate (with additional sanitized copies if CBI is involved). Comments on this proposed rule will be placed in the rulemaking record and will be available in the TSCA Public Docket Office, Rm. NE - G - 004 at the above address between 8 a.m. and 12 noon and 1 p.m. and 4 p.m., Monday through Friday, excluding public holidays.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (TS - 799), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E - 543 - B, 401 M St., SW., Washington, DC 20460, Telephone: (202) 554 - 1404, TDD: (202) 554 - 0551.
SUPPLEMENTARY INFORMATION:
Electronic Availability: This document, along with three other related documents, OPPTS - 50593, 50594, and 50596, is available as an electronic file on The Federal Bulletin Board at 9:00 a.m. on the date of publcation in the Federal Register. By modem dial (202) 512-1387 or call (202) 512-1530 for disks or paper copies. This document and the three related documents are available in Postscript, Wordperfect and ASCII.
SNURs require persons to notify EPA at least 90 days before commencing any manufacturing, importing, or processing activities designated by the SNUR as a significant new use. The supporting rationale and background for SNURs are more fully set out in the preamble to EPA's first SNURs issued under the Expedited Follow-Up Rule and published at 55 FR 17376 on April 24, 1990. Consult that preamble for further information on the objectives, rationale, and procedures for the rules and on the basis for significant new use designations.
I. Authority
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a ``significant new use.'' EPA must make this determination by rule after considering all relevant factors, including those listed in section 5(a)(2). The enumerated factors pertain to the potential for increased manufacturing and processing volume, increased exposure, and anticipated methods of manufacture, processing, distribution and disposal. Once EPA determines that a use of a chemical substance is a significant new use, section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA at least 90 days before they manufacture, import, or process the substance for that use. The mechanism for reporting under this requirement is established under 40 CFR 721.10.
II. Applicability of General Provisions
General provisions for SNURs appear under subpart A of 40 CFR part 721. These provisions describe persons subject to SNURs, recordkeeping requirements, exemptions to reporting requirements, and applicability of SNURs to uses occurring before the effective date of a SNUR. Rules on user fees appear at 40 CFR part 700. Persons subject to a SNUR must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under section 5(a)(1)(A) of TSCA. In particular, these requirements include the information submission requirements of section 5(d)(1) and 5(b), the exemptions authorized by section 5(h)(1), (2), (3), and (5), and the regulations at 40 CFR part 720. Once EPA receives a SNUR notice, EPA may take regulatory action under section 5(e), 5(f), 6, or 7 to control the activities on which it has received the SNUR notice. If EPA does not take action, EPA is required under section 5(g) to explain in the Federal Register its reasons for not taking action.
Persons who intend to export a substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret section 12(b) appear at 40 CFR part 707.
III. Discussion of Proposed Amendment
A. Section 5 of TSCA
Section 5(a)(1) of TSCA requires submission of written notice to EPA at least 90 days before commencement of commercial manufacture or import of a ``new chemical substance'' (which is a substance not listed on the TSCA Chemical Substance Inventory maintained pursuant to section 8(b)) and before manufacture or processing of any chemical substance for an activity which EPA determines, by rule, constitutes a ``significant new use.'' Upon receipt of such a premanufacture notice (PMN) or significant new use notice (SNUN), if EPA determines that there is insufficient information to evaluate the human health and environmental effects of the substance, and that the substance may present an unreasonable risk of injury to health or the environment, or that the substance will be produced in substantial quantities and may be anticipated to enter the environment in substantial quantities or there may be significant or substantial human exposure, then EPA may issue an Order under section 5(e) of TSCA to prohibit or limit activities associated with the substance.
After a company commences commercial manufacture or import of a PMN substance and submits a notice of commencement (NOC) of manufacture within 30 days as required by 40 CFR 720.102, EPA adds the substance to the TSCA section 8(b) Inventory. The substance is then no longer a ``new chemical substance,'' as defined by section 3(a) of TSCA, the manufacture of which would require submission of a PMN. The requirements of a section 5(e) Order apply only to the company who submitted the notice, whereas a SNUR applies to all manufacturers and processors of the substance. Consequently, once a substance subject to a section 5(e) Order is listed on the TSCA section 8(b) Inventory, any other company may manufacture the substance without being required to notify EPA or comply with any other restrictions under section 5 of TSCA, unless EPA promulgates a SNUR pursuant to section 5(a)(2) of TSCA.
Therefore, EPA has adopted a policy that when the Agency has raised concerns for a substance and has regulated that substance under a section 5(e) Consent Order, EPA develops a SNUR concurrently with the Consent Order. The SNUR defines a significant new use so as to require reporting to EPA before a manufacturer (including importers) or processor undertakes activities inconsistent with provisions of the Consent Order. In this manner, the Agency will have an opportunity to review those activities before they occur because, under section 5(a)(1)(B) of TSCA, any company wishing to undertake the activities designated in the SNUR must submit a SNUN to EPA at least 90 days before doing so. Ordinary ``notice and comment'' rulemaking procedures to develop a SNUR require more time than development of a Consent Order. However, the Agency can promulgate SNURs using the expedited procedures for SNUR development at 40 CFR 721.160 or 721.170 (54 FR 31298, July 27, 1989). Using these expedited procedures, EPA can generally promulgate a SNUR within a time frame similar to that necessary to issue a section 5(e) Order.
B. Expansion of Activities Available for Designation as Significant New Uses in Expedited Non-5(e) SNURs
EPA's ability to promulgate SNURs efficiently and expeditiously has been facilitated by EPA's New Chemical Follow-up Rule (also known as the ``Generic SNUR''), published on July 27, 1989 (54 FR 31298; 40 CFR 721.50 - 721.185). The Generic SNUR established a generic list of standard significant new use designations and established that EPA would generally promulgate substance-specific SNURs using expedited rulemaking procedures instead of the standard ``notice and comment'' rulemaking. (See also the proposed rule at 52 FR 15594, April 29, 1987.) This rule was designed to, among other things, reduce the time between EPA's completion of the PMN review and promulgation of a SNUR.
EPA is exploring additional ways to speed Agency action on new chemical substances and conserve Agency resources in the TSCA section 5 program. Among these proposed activities is this amendment to expand the types of expedited SNURs for new chemical substances that EPA may promulgate directly without first issuing section 5(e) Orders (hereafter referred to as ``non - 5(e) SNURs'') under 40 CFR 721.170. Whereas a section 5(e) Order applies only to the original PMN submitter who signs the Order, a SNUR applies to all manufacturers and processors of the chemical substance. The reporting requirements of a non - 5(e) SNUR apply also to the original PMN submitter (because, without a section 5(e) Order, the PMN submitter is not exempted by 40 CFR 721.45(i)). Since only one Agency action is required instead of two, and fewer EPA resources are necessary to obtain similar regulatory results, a non - 5(e) SNUR is more efficient than a combination of section 5(e) Order and ``5(e)-SNUR'' (under 40 CFR 721.160) to regulate new chemical substances.
A non - 5(e) SNUR is typically appropriate for PMNs on chemical substances expected to be toxic but where the PMN indicates the submitter's intention to limit activities, implement control measures, or otherwise adequately mitigate human exposures and environmental releases. Activities described in such PMNs may not present an unreasonable risk of injury to human health or the environment so as to warrant the issuance of an Order under section 5(e) of TSCA, but deviations from the described activities may present an unreasonable risk warranting the imposition of regulatory controls via a section 5(e) Order. In those cases, a non - 5(e) SNUR may be the least burdensome regulatory alternative for the Agency to pursue, as it will allow the PMN submitter to proceed with planned activities while requiring notification to, and review by, EPA for activities which have not been reviewed.
Based on experience gained from issuing over 200 SNURs under expedited follow-up procedures, EPA is proposing an amendment to 40 CFR 721.170(c)(1) that would authorize EPA to designate any of the provisions in 40 CFR part 721 subpart B using expedited rulemaking procedures to promulgate non - 5(e) SNURs. EPA may currently use the more time-consuming notice and comment rulemaking to promulgate non - 5(e) SNURs containing any of the significant new use designations in subpart B. However, section 721.170(c) currently limits the types of activities in subpart B which EPA can designate as a significant new use by expedited rulemaking without first issuing a section 5(e) Order. Significant new use designations available for expedited non - 5(e) SNURs are currently limited to environmental release activities and certain industrial, commercial, or consumer activities. However, other important designations, such as protection in the workplace and hazard communication, currently may not be promulgated in non - 5(e) SNURs via expedited rulemaking procedures. The absence of hazard communication provisions in current expedited non - 5(e) SNURs may result in failure to inform persons handling substances of their potential risks and proper precautionary measures to protect against such risks. Furthermore, a large percentage of the new chemical substances that EPA regulates under section 5(e) are regulated to control workplace exposures. However, worker protection activities currently may not be designated as significant new uses in expedited non - 5(e) SNURs. EPA should be able to select from all the possible designations in subpart B, in order to respond appropriately to the unique characteristics of the various new chemical substances which EPA reviews under section 5 of TSCA.
EPA already has the authority to designate hazard communication and worker protection provisions either by promulgating SNURs using notice and comment rulemaking procedures or by issuing a section 5(e) Order and promulgating an expedited ``5(e)SNUR.'' However, this proposed amendment would enable EPA to designate hazard communication and worker protection provisions by promulgating SNURs using expedited rulemaking procedures and without issuing a section 5(e) Order.
In addition, this proposed amendment would authorize EPA to promulgate expedited non - 5(e) SNURs with provisions not currently listed in subpart B. Occasionally, EPA has promulgated expedited 5(e) - SNURs containing provisions not in subpart B when necessary to match the terms of the section 5(e) Order. An example of a non-subpart B provision that EPA sometimes includes in a chemical-specific expedited SNUR is a provision that allows a specified amount of removal credit for a specified waste-water treatment technology, since the standard provision at 40 CFR 721.91(a)(4) does not account for waste-water treatment removal.
Similarly, EPA may occasionally use expedited procedures to promulgate non - 5(e) SNURs containing provisions not included in subpart B when the provision is necessary to match the information contained in the PMN. EPA uses expedited rulemaking to promulgate SNURs with a non-subpart B provision only when the provision represents a relatively minor deviation from the standard provisions in subpart B such that EPA does not anticipate a high likelihood of public interest in commenting on the provision. See 54 FR 31305, July 27, 1989. Nevertheless, as discussed below, the expedited procedures still provide interested parties an opportunity to comment on the SNUR.
C. Opportunity for Comment
The expedited rulemaking procedure for the Generic SNUR is based on EPA's experience which has demonstrated that very few comments on SNURs are submitted. (See, e.g., 52 FR 15596, April 29, 1987; 54 FR 31299, July 27, 1989.) However, the process EPA is proposing here is not intended to limit opportunity for public comment.
The current limitations in 40 CFR 721.170(c)(1) were contained in the original proposal of the Generic SNUR (52 FR 15596, April 29, 1987). As originally proposed, the Generic SNUR provided for immediately effective final SNURs. However, the final version of the Generic SNUR, as described below, ``significantly changes the proposed approach to provide a greater opportunity for public comment'' (54 FR 31299, July 27, 1989). EPA now believes that, given the expanded comment opportunity in the final Generic SNUR, the subpart B provisions available for expedited non-5(e) SNURs should be expanded.
Pursuant to the final Generic SNUR, EPA generally uses ``direct final'' rulemaking to promulgate follow-up SNURs on new chemical substances. Under direct final rulemaking procedures, EPA publishes the rule in the final rule section of the Federal Register and the SNUR automatically becomes effective 60 days from publication unless, within 30 days after publication, EPA receives written notice that someone wishes to submit adverse or critical comments. If EPA receives such a notice, EPA will withdraw the final SNUR and propose the rule in the proposed rule section of the Federal Register, establishing a 30 - day comment period. This procedure allows opportunity for public comment before a SNUR becomes effective, without unnecessarily delaying the rulemaking if no comments are likely to be submitted.
Furthermore, according to the current 721.170(d)(2), at least 7 days before expiration of the PMN review period, EPA must notify the PMN submitter of the Agency's human health or environmental concerns and the activities under consideration for designation as a significant new use. This procedure provides ample notice to the person most likely to have an interest in providing comment (the PMN submitter). Thus, the expanded non - 5(e) SNUR process proposed herein will still provide notice and opportunity for comment to all persons through the Federal Register and individual notice to the PMN submitter before the SNUR is published.
D. Timing of Section 5 Regulation
Generally, when a PMN substance is targeted for regulation under a section 5(e) Order, the statutory 90 - day review period must be suspended to allow sufficient time for Order development, review, and approval. In such cases, the PMN submiter may not commence production of the substance until the Order has been executed and all suspensions of the review period have expired. This process normally takes 3 to 6 months. In contrast, a PMN substance targeted for regulation under a non-5(e) SNUR does not generally require suspension of the review period beyond the initial 90 days because the specific use identified in the PMN does not present an unreasonable risk; rather, it is other potential uses of the PMN substance for which the Agency has concerns and for which the non-5(e) is developed. Consequently, PMN submitters of non-5(e) regulated substances may generally begin commercial production on the 91st day after submission of the PMN.
IV. Economic Analysis
The Agency's complete economic analysis is available in the public record for this rulemaking (OPPTS - 50595). The regulatory impact analysis estimates the costs and benefits attributable to the proposed regulation. In this case, the analysis also contains estimates for the three additional proposed amendments to section 5 regulations that are published elsewhere in this Federal Register. These proposals would amend the PMN rule, the Low Volume Exemption Rule, and the Polymer Exemption Rule. As these proposed regulations are amendments to current regulations, the costs and benefits are incremental, estimating the effect of the proposal with respect to the current regulation.
This non - 5(e) SNUR amendment would eliminate the need to develop a section 5(e) Consent Order in those cases where EPA determines that activities described in the PMN submission will not present unreasonable risk. The major industry benefit is the avoidance of the delay and costs associated with negotiating a Consent Order; generally, the submitter will be able to commence commercial manufacture immediately after the PMN review period. The submitter, along with other manufacturers and processors, will be bound by the expedited SNUR.
Industry savings from this amendment due to the avoidance of Consent Orders have not been quantified. Annual government savings are estimated to range from $240,000 to $960,000, depending on the number of submissions (range used was 1,000 to 3,000 annually).
V. Rulemaking Record
EPA has established a record for this rulemaking (docket control number OPTS - 50595). The record includes basic information considered by the Agency in developing this proposed rule. A public version of the record without any confidential information is available in the TSCA Public Docket Office from 8 a.m. to 12 noon and 1 p.m. to 4 p.m., Monday through Friday, except legal holidays. The TSCA Public Docket Office is located in Rm. NE - G004, 401 M St., SW., Washington, DC.
VI. Other Regulatory Requirements
A. Executive Order 12291
Under Executive Order 12291, EPA must judge whether a rule is ``major'' and therefore requires a Regulatory Impact Analysis. EPA has determined that this proposed rule would not be a ``major'' rule because it would not have an effect on the economy of $100 million or more, and it would not have a significant effect on competition, costs, or prices. While there is no precise way to calculate the total annual cost of compliance with this rule, EPA estimates that the cost for submitting a significant new use notice would be approximately $4,500 to $11,000, including a $2,500 user fee payable to EPA to offset EPA costs in processing the notice.
This regulation was submitted to the Office of Management and Budget (OMB) for review as required by Executive Order 12291.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has determined that this rule would not have a significant impact on a substantial number of small businesses. EPA has not determined whether parties affected by this rule would likely be small businesses. However, EPA believes that the number of small businesses affected by this rule would not be substantial, even if all of the SNUR notice submitters were small firms.
C. Paperwork Reduction Act
The information collection requirements in this rule have been approved by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3502 et seq., and have been assigned OMB control number 2070 - 0012.
Public reporting burden for this collection of information is estimated to vary from 30 to 170 hours per response, with an average of 100 hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy Branch, PM - 223, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503, marked ``Attention: Desk Officer for EPA.''
List of Subjects in 40 CFR Part 721
Chemicals, Environmental protection, Hazardous materials, Recordkeeping and reporting requirements, Significant new uses.
Dated: January 19, 1993.
William K. Reilly,
Administrator
Therefore, 40 CFR Chapter I, part 721 is proposed to be amended as follows:
PART 721 -- [AMENDED]
1. The authority citation for part 721 would continue to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. By revising 721.170(c)(1) to read as follows:
721.170 Notification requirements for selected new chemical substances that have completed premanufacture review.
* * * * *
(c) * * * (1) When EPA decides to establish significant new use reporting requirements under this section, EPA may designate as a significant new use any one or more of the activities set forth in subpart B of this part, as well as activities not listed in subpart B of this part. In addition, EPA may designate specific recordkeeping requirements described under subpart C of this part that are applicable to the substance.
* * * * *
[FR Doc. 93 - 2775 Filed 2 - 5 - 93; 8:45 am]
BILLING CODE 6560 - 50 - F
Federal Register / Vol. 58, No. 24 / Monday, February 8, 1993 / Proposed Rules
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 723
[OPPTS - 50594 ;FRL - 3890 - 1]
RIN 2070 - AC14
Premanufacture Notification Exemptions; Revisions of Exemptions for Polymers; Proposed Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: Section 5(a)(1) of the Toxic Substances Control Act (TSCA) requires that persons notify EPA at least 90 days before they manufacture or import a new chemical substance for commercial purposes. Section 5(h)(4) of TSCA authorizes EPA, upon application and by rule, to exempt the manufacturer or importer of any new chemical substance from part or all of the provisions of section 5 if the Agency determines that the manufacture, processing, distribution, use, or disposal of the new chemical substance will not present an unreasonable risk of injury to human health or the environment. This proposed rule would amend the polymer exemption rule at 40 CFR 723.250 to expand the criteria for eligible polymers, reduce the information requirements, and change the timing of reporting. These proposed amendments reflect criteria developed and used by EPA to assess the hazards associated with new polymeric substances. EPA has included procedural safeguards and other conditions in the proposed exemption to ensure that these polymers will not present an unreasonable risk.
DATES: Comments must be received by April 9, 1993. If requested, EPA will conduct public hearings on the proposed rule amendments. Requests to make an oral presentation must be received by April 9, 1993.
ADDRESSES: All comments and requests to speak at the public hearing must be sent to: TSCA Document Control Office (TS - 790), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E - 201, 401 M St., SW., Washington, DC 20460, (Phone: 202 - 260 - 1532).
Comments should include the docket control number. The docket control number for this amendment is OPPTS - 50594. Since some comments may contain confidential business information (CBI), all comments must be sent in triplicate (with additional sanitized copies if CBI is involved). Comments on this proposed rule will be placed in the rulemaking record and will be available in the TSCA Public Docket Office, Rm. NE - G - 004 at the above address between 8 a.m. and 12 noon and 1 p.m. and 4 p.m., Monday through Friday, excluding public holidays.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (TS - 799), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E - 543 - B, 401 M St., SW., Washington, DC 20460, Telephone: (202) 554 - 1404, TDD: (202) 554 - 0551.
SUPPLEMENTARY INFORMATION:
Electronic Availability: This document, along with three other related documents, OPPTS - 50593, 50595, and 50596 is available as an electronic file on The Federal Bulletin Board at 9:00 a.m. on the date of publication in the Federal Register. By modem dial (202) 512 - 1387 or call (202) 512 - 1530 for disks or paper copies. This document and the three related documents are available in Postscript, Wordperfect, and ASCII.
The polymer exemption rule was originally promulgated on November 21, 1984. The supporting rationale and background for that exemption was published at 49 FR 46066 on November 21, 1984 and 46 FR 54688 on November 3, 1981. Consult those documents for further information on the objectives, rationale, and procedures for the rule and the basis for the finding that polymers eligible for exemption will not present an unreasonable risk.
I. Background
A. Statutory Authority
Section 5(a)(1) of TSCA requires that persons notify EPA at least 90 days before they manufacture or import a new chemical substance for commercial purposes. A new chemical substance is any substance that is not on the inventory of existing substances compiled by EPA under section 8(b) of TSCA. Section 5(h)(4) of TSCA authorizes EPA, upon application and by rule, to exempt the manufacturer or importer of any new chemical substance from part or all of the provisions of section 5 if the Agency determines that the manufacture, processing, distribution, use, or disposal of the new chemical substance will not present an unreasonable risk of injury to human health or the environment.
B. History
In 1984, the Agency published a TSCA section 5(h)(4) rule granting an exemption for persons who manufacture or import certain polymers, set out at 40 CFR 723.250. This rule was developed in response to petitions by chemical industry groups. Notice of receipt of the petitions from industry groups was published at 46 FR 54688 on November 3, 1981. The proposed exemption rule was published at 47 FR 33924 on August 4, 1982 and the final exemption rule was published at 49 FR 46066 on November 21, 1984.
Since promulgation of the 1984 polymer exemption rule (the ``1984 exemption''), the Agency has reviewed over 9,000 polymers in the 90 - day premanufacture notification (PMN) review process and over 1,500 polymers submitted as polymer exemption notices. In the course of performing hazard and risk assessments for these polymers, the Agency has established informal guidelines for identifying polymeric substances that do not present an unreasonable risk to human health or the environment. These guidelines are based on (1) an ongoing review of the available literature on the toxicity of polymers, (2) analyses of various samples of the PMN polymer data base, (3) information provided by outside groups during and subsequent to development of the 1984 exemption, and (4) the professional judgment of EPA staff scientists.
The Agency would like to bring the 1984 polymer exemption criteria into closer alignment with the internal criteria currently being used to assess hazards of polymers. The Agency believes that expansion of the 1984 exemption criteria would increase the number of polymeric substances eligible for exemption and would result in resource savings to industry and the EPA without decreasing or compromising the level of risk reduction/management afforded by a 90 - day review of these same substances. The Agency is also proposing to reduce the information requirements, limit the Agency review, and change the timing of notice of manufacture for these ``low risk'' polymers. Overall, these amendments constitute a substantial revision of the existing rule.
II. Proposed Amendments
A. Summary of Proposed Amendments
1. Definition of exemption category. To be considered for exemption, substances must meet the definition of polymer in the rule. EPA is proposing to amend the definition of ``polymer'' to adopt the exact wording of the international definition of polymer which was agreed upon at the Organization of Economic Cooperation and Development (OECD) Expert Group Meetings on Polymers held in Toronto, Canada in January, 1990 and in Paris, France, in October, 1991. The definition is based on the 1984 polymer exemption definition with minor modifications. As with the current definition, the amended definition ensures that exempt substances have the structural characteristics common to the category of substances on which EPA has based its no unreasonable risk finding.
2. Classes of polymers ineligible for exemption. Section 723.250(d) of the 1984 exemption established certain classes of polymers that are ineligible for exemption. As with the 1984 exemption, polymers that degrade, decompose, or depolymerize would remain ineligible for exemption under this proposal. In addition, polymers that are prepared from monomers or other reactants that are not on the TSCA Inventory, and water-absorbing polymers with molecular weights (MW) equal to or greater than 10,000 daltons would be added to the list of ineligible polymers. This proposal would amend certain restrictions contained in the 1984 exemption for cationic polymers and polymers that contain certain particular elements. Under the proposal, the restriction on polymers that contain certain reactive functional groups that are intended or reasonably anticipated to undergo further reaction would be moved from paragraph (d) and included as part of the eligibility criteria for polymers with MW equal to or greater than 1,000 and less than 10,000 at 723.250(e)(1). Finally, the following classes of polymers would no longer be ineligible for exemption: (a) polymers that contain less than 32 percent carbon; (b) biopolymers, their synthetic equivalents, and modifications and derivatives of biopolymers; and (c) polymers made from reactants that contain halogen atoms or cyano groups.
3. Polymers eligible for the exemption. Polymers with number-average MW greater than 1,000 and polyesters that are made from a specified list of reactants would remain eligible for exemption. However, under this proposal, the Agency would set limits on oligomer content and reactive functional groups for polymers with number-average MW equal to or greater than 1,000 and less than 10,000. In addition, polymers with number-average MW equal to or greater than 10,000 and restricted oligomer content would also be eligible for exemption, with certain restrictions relating to potential inhalation exposure of respirable water-insoluble polymer particles. Polyesters would remain eligible.
4. General provisions. To qualify for this exemption, manufacturers and importers would be required to submit an abbreviated notice within 30 - calendar days after first manufacture or import of an eligible polymer instead of 21 days prior to manufacture (import) as required in the 1984 exemption. In this preamble and under the rule, references to ``manufacture'' and ``manufacturer'' include ``import'' and ``importer'', respectively, as defined in the PMN rule and as referenced in this rule.
Submission of specific information on the polymer would still be required, although the Agency proposes to eliminate certain data requirements, including information on production volume, use, residual reactant content, impurities, and byproducts.
With the elimination of the obligation to report many data elements, the use of EPA Form 7710 - 25 would not be required. In its place, the Agency would require submission of an abbreviated form which would limit the information requirements to the following elements: (a) submitter identification (company name, name of authorized official technical contact, telephone number of technical contact, site of manufacture or import), (b) date of commencement of manufacture or import, (c) type of polymer exemption, (d) chemical identity, and (e) certification that the polymer meets the conditions of the exemption and that submitters will provide worker protection or appropriate engineering controls to mitigate worker exposure where exposure to high MW water-insoluble polymers in respirable particle size is possible.
Under the proposal, polymer identity would be described by a Chemical Abstracts (CA) Index Name or CA Preferred Name in conformance with chemical identity requirements for all section 5 notices being proposed today in the Federal Register in a separate action under 40 CFR part 720. As required with the submission of all section 5 notices, submitters must provide all health and safety data in their possession or control with their notice.
Under the proposal, the Agency would maintain a separate list of exempted polymers for information retrieval purposes, but would no longer add these substances to the Inventory. Under the 1984 exemption, substances are added to the Inventory after receipt of a Notice of Commencement of Manufacture or Import. Such substances are listed with restrictions on residual monomers, reactants, and low MW species, as reported in the notice, and can only be manufactured within those prescribed limits.
As with the 1984 exemption, submitters would be required to maintain certain records. Under the proposal, submitters would be required to maintain a copy of the exemption notice at the reported site of manufacture or import, along with information that demonstrates compliance with the exemption, including analytical data that substantiates the submitter's claim of eligibility under criteria established for minimum number average MW and restricted oligomer content.
B. Discussion of the Proposal
The proposed rule adopts many of the provisions of the 1984 polymer exemption. However, as discussed above, some of the provisions of the 1984 exemption have been amended in light of the Agency's experience gained by its review of over 10,000 new polymeric substances. A discussion of these changes follows:
1. Definition of polymer. Under the proposal, the definition of polymer in the 1984 exemption would be revised to conform with the international definition of polymer recently adopted by OECD Member Countries, including the United States, Canada, Japan, and the Commission of European Communities. The revised definition retains the meaning and purpose of the 1984 exemption definition of polymer. The term ``monomer unit'', which would replace the non-standard term ``internal subunit'', would continue to define a grouping that is linked to two or more other molecules. Consequently, polymer molecules, defined as containing ``at least three monomer units which are covalently bound to at least one other monomer unit or other reactant'', would continue to require at least four precursor units, as in the current definition. The difference is that, under the proposal, at least three of the units must be internal, as opposed to only two in the current version; further, one of the non-internal groupings could come from an ``other reactant'' as well as from a monomer. The first change is slightly more restrictive and the second slightly less restrictive than the present definition. The net effect of the change, made to simplify agreement with protocols of the OECD, is expected to be minimal. ``Monomer'' and ``reactant'' would remain as defined in the 1984 exemption, and are consistent with the terms used for purposes of Inventory reporting and premanufacture notification, wherein ``reactants'' includes monomers, chain transfer and cross-linking agents, monofunctional groups that act as modifiers, and other end groups if they are incorporated into the polymer molecule.
2. Polymers ineligible for exemption. (a) Exclusion of certain polymers that are cationic or anticipated to become cationic in aquatic environments. The Agency continues to have ecotoxicity concerns for cationic polymers with specific characteristics. However, under the proposal the Agency would modify the current restriction on cationic polymers at 723.250(d)(1) to provide that certain cationic polymers will be eligible for exemption if (i) the polymer is a solid material that is not soluble or dispersible in water and will be used only in the solid phase (for example, polymers that will be used as ion exchange beads), or (ii) the equivalent weight of cationic groups (e.g., amine, phosphonium, sulfonium) in the polymer is equal to or greater than 5,000. Equivalent weight means the ratio of the MW to the number of cationic functional groups.
The proposed modifications are based on the following considerations: (1) The Agency has concluded that if a cationic polymer is not soluble or dispersible in water, it will not be available in the aquatic environment to cause toxicity to aquatic organisms and (2) the Agency has found that polymers with a cationic functional group equivalent weight of 5,000 or greater do not have sufficient cationic characteristics to cause the environmental effects seen in materials that have higher cationic charge densities. There are many cationic polymers that are submitted as PMNs and receive low hazard ratings for health or environmental effects, but are not eligible for the polymer exemption as it is currently written. The above modifications would increase the number of polymers eligible for this exemption, without compromising the level of risk assessment/management these polymers would otherwise receive in a full 90 - day PMN review.
The Agency is taking this opportunity to clarify an issue that has caused confusion to companies submitting polymer exemption notices in the past: For purposes of the 1984 polymer exemption, the Agency considers all amines (primary, secondary, tertiary amine, and quaternary ammonium) as groups that are cationic or anticipated to become cationic in aquatic environments. Based on the definition of ``cationic polymer'' in the 1984 exemption, any polymer that contains even one amine group is excluded from exemption. As a result, many polymers with very high amine equivalent weights (that is, very low amine content), such as polyamides, are excluded from the 1984 exemption. Under this proposal, polymers containing cationic functional groups may be eligible for exemption if the total equivalent weight of cationic groups is 5,000 or greater. All amine containing polymers with amine equivalent weights of less than 5,000 would be excluded from eligibility under this category.
(b) Exclusion of polymers with certain weight content of certain elements. The rule would continue to exclude from eligibility for exemption polymers containing certain levels of particular elements if they are present as an integral part of the polymer structure, or present as counterions in the polymer.
Elemental limitations were defined in the 1984 exemption and the Agency believes that the discussion and rationale for many of the elemental limitations in the 1984 exemption rule preamble and 1982 proposed rule are, in general, appropriate for this proposed rule. However, the Agency is proposing to expand the list of allowable elements set out at 723.250(d)(2)(ii)(B) and (C) to include chlorine, bromine, and iodine as the monatomic counterions; and fluorine, chlorine, bromine, and iodine as covalently bound to carbon. Currently, the Agency's internal review criteria do not identify concerns for polymers based solely on the fact that the above mentioned halogens are present in a polymeric substance as a covalently bound substituent or as a counterion. Therefore, the EPA believes it appropriate to allow for these elements to be present in exemptible polymers. The provisions at proposed 723.250(e)(1) would exclude reactive functional groups, including reactive halogen containing groups, and would continue to limit the exemptible substances to those determined to be of lowest concern. The Agency solicits comment on and suggestions (with rationale) for these and any other elements to be added to these categories.
(c) Exclusion of polymers that degrade, decompose, or depolymerize. The rule would continue the exclusion at 723.250(d)(3) for polymers that are designed or reasonably anticipated to substantially degrade, decompose, or depolymerize, including those polymers that could substantially decompose after manufacture and use, even though they are not actually intended to do so. The Agency believes that such polymers are likely to degrade to low MW species and/or residual reactants which present some of the major risks associated with such polymers. The 1984 exemption contains this same provision, and discussions on the topic can be found in the 1984 exemption rule and the 1982 proposed rule. The Agency believes the discussion and rationale for excluding polymers that may degrade, decompose, or depolymerize is appropriate for this proposed rule as well.
(d) Exclusion of polymers that are prepared from monomers or other reactants that are not already on the TSCA inventory. Under the proposal, polymers that are prepared from monomers or other reactants that are not on the TSCA Inventory would be ineligible for exemption at 723.250(d)(4). Hazard concerns for polymers are often based on a concern for residual monomers or other reactants in the polymer. Under the proposal, information on levels of residual monomers or other reactants would no longer be required on the notice form. Instead, the evaluation and regulation of any potential risks posed by existing chemicals that may be present as residuals in the polymer would be addressed by a separate EPA program under other TSCA authorities such as section 4 and section 6. Accordingly, the Agency proposes to restrict this exemption to those polymers manufactured using only Inventory-listed constituent monomers, chain transfer agents, initiators, or other substances that are present as an integral part of the polymer structure or are present as counterions in the polymer. Consequently, the Agency will still have the option of reviewing polymers that contain new chemical monomers or other reactants through the full PMN process and regulating any new substances of concern that may be present as residual monomers or reactants.
(e) Exclusion of water-absorbing polymers with number-average MW equal to or greater than 10,000 daltons. Under the proposal, water-absorbing polymers having MW of 10,000 daltons or greater would be ineligible for the exemption at 723.250(d)(5). A water-absorbing polymer is defined as a polymeric substance that, either in whole or in part, increases its volume when in contact with water. EPA believes that this category of polymers should not be eligible for the polymer exemption based on TSCA section 8(e) data recently received by the Agency on a water-absorbing polyacrylate polymer with a MW in excess of 1 million daltons. Preliminary data report squamous cell carcinoma and bronchio-alveolar carcinomas in a 2 - year inhalation study in rats. The exposure concentrations were 0.05, 0.2, and 0.8 mg/m3 . Preliminary pathology reports state that cancer was observed in the two highest concentrations. Since this polymer has a MW in excess of 1 million daltons, no remaining reactive functionalities, and no residuals with MW less than 1,000 daltons, the Agency believes that the water-absorbing properties of the polymer may have a role in the carcinogenicity findings. Based on the toxicity data that have been received by EPA to date, the Agency is unable to establish an exact MW limit for water-absorbing polymers. However, the Agency believes that it is reasonable to set the number-average MW exclusion for water-absorbing polymers at 10,000 daltons. As discussed later in this Unit, polymers with a number-average MW of less than 10,000, in general, can be expected to be absorbed by the lung and therefore have different detoxification mechanisms available to mitigate potential health hazards.
3. Elimination of specific exclusions contained in the 1984 exemption. In the current proposal, the Agency has removed three of the exclusion criteria present in the 1984 exemption at 723.250(d)(2), (4), and (5) including (a) polymers containing less than 32 percent carbon, (b) biopolymers, and (c) polymers manufactured from reactants containing halogen atoms or cyano groups. A discussion on why these limitations were removed is presented below.
a. Polymers containing less than 32 percent carbon. The 1984 rule at 723.250(d)(2) excludes from exemption eligible polymers with less than 32 percent carbon by weight. This exclusion was intended to limit availability of the exemption to the types of polymers that have been frequently reviewed in the New Chemicals Program. The requirement that polymers must contain greater than 32 percent carbon was an added safeguard to prevent exotic, or unfamiliar, types of polymers from being eligible for the exemption. Based on its experience reviewing over 10,000 section 5 notices for polymers since 1979, EPA has seen very few polymers with less than 32 percent carbon and those notices seen have been rated as of low concern.
The Agency now believes that the other criteria that must be met for a substance to qualify for the polymer exemptions will provide sufficient restriction to the types of polymers that would be eligible for exemption, and therefore removal of the 32 percent carbon limitation is justified.
b. Biopolymers. The 1984 rule excludes from exemption eligibility at 723.250(d)(4) biopolymers, synthetic equivalents of biopolymers, and derivatives and modifications of biopolymers. The Agency now believes that this condition can be removed entirely. Biopolymers were originally excluded from the polymer exemption based on EPA's limited experience with these compounds, the variety of substances within the class, and the potential wide range of uses for such polymers. The number of biopolymers reviewed as full PMNs has been small, and therefore EPA still has only limited experience with these compounds. However, EPA has had sufficient experience with many other classes of polymers to believe that biopolymers that meet the exemption criteria will not pose an unreasonable risk of injury to human health or the environment. The Agency believes that biopolymers that may be of concern, such as proteins and antibodies, would not be eligible for the polymer exemption due to the fact that they would not fall within the polymer definition in the exemption because they have a discrete MW. In order to be a ``polymer'', polymer molecules must be distributed over a wide range of MW. As an example, the highly toxic protein ricin has a definite structure and a discrete MW and would therefore not be eligible for the polymer exemption.
c. Polymers manufactured from reactants containing halogen atoms or cyano groups. Based on an analysis of health and ecotoxicity concerns for polymers received as non-exempt PMNs subject to the 90 - day review, the Agency now believes that this requirement is unnecessarily restrictive and should be eliminated altogether.
The Agency's intent in excluding polymers that contain halogen or cyano groups from exemption eligibility was, as stated in the polymer exemption rule of 1984, to ``exclude polymers that contain low MW species or residual substances composed of halogen atoms or cyano groups''. Information from the PMN database shows that when the content of low MW species of cyano- or halogen-containing polymers is below the levels specified by the proposed eligibility requirements for polymers with number-average MW of 1,000 or greater and less than 10,000 (and oligomer content less than 10 percent below MW 500 and less than 25 percent below MW 1,000), the EPA, in general, has low concern for the polymer. Further, EPA also has low concern for polymers with MW of 10,000 or greater (and oligomer content less than 2 percent below MW 500 and less than 5 percent below MW 1,000). Since, in the proposed exemption, eligible polymers may be made only from Inventory-listed monomers or other reactants, any remaining concerns over residual monomers can be dealt with under other TSCA authorities such as section 6. The proposed exemption criteria address the Agency's concerns for all low MW species including those containing halogen or cyano groups. It is hoped that the benefit of allowing manufacturers to commence production of more polymers eligible for exemption will provide incentive to submitters to manufacture materials with low concentrations of oligomeric species.
Further, as a matter of policy, EPA has not taken action on a PMN polymer under section 5(e) when the only concern was for an existing chemical present as unreacted monomer, i.e., residual monomer. Under this proposal, only polymers manufactured from Inventory-listed monomers would be eligible for exemption. Since the proposed criteria would restrict low MW species and any residual monomers would be existing chemical substances that would be addressed by a separate EPA program, the Agency believes that a separate exclusion from polymer exemption eligibility for halogen- and cyano- containing polymers is no longer necessary. The Agency believes that concerns for residual monomers in general and specifically those containing halogen or cyano groups would best be handled by an existing chemicals program initiative, and not on a case-by-case basis under section 5 in the new chemicals program.
4. Polymers eligible for the exemption (723.250). The Agency is proposing to amend the exemption criteria for polymers of 1,000 MW or greater by establishing two MW ranges with restricted oligomer content. Section 723.250(e)(1) would set out exemption criteria for polymers with number-average MW equal to or greater than 1,000 and less than 10,000, while 723.250(e)(2) would set out criteria for polymers with number-average MW equal to or greater than 10,000. The exemption criteria for polyester polymers manufactured using certain specified precursors would be retained under this proposal and redesignated at 723.250(e)(3). Under the proposal, polymers eligible for exemption include the following:
a. Polymers with number-average MW equal to or greater than 1,000 and less than 10,000. Section 723.250(e)(1) would exempt polymers with number average MW equal to or greater than 1,000 and less than 10,000 (and oligomer content less than 10 percent below MW 500 and less than 25 percent below MW 1,000) provided the polymer also meets the following criterion: the polymer may not contain reactive functional groups that are intended or reasonably anticipated to undergo further reaction as specified in 723.250(e)(1)(ii).
i. Restrictions on number average MW and oligomer content. As stated in the preamble language to the 1984 exemption published in the Federal Register on November 21, 1984 (49 FR 46081) the selection of MW as a risk-limiting criterion rests on two principles. First, a chemical must be absorbed by an organism in order to cause an adverse health or ecological effect, other than direct contact effects. Secondly, the ability of a molecule to pass through membranes and therefore be absorbed by organisms generally decreases with increasing MW (size).
Based on these principles, the Agency believes that low MW species content provides an appropriate indication of the concerns that EPA has for polymers, namely, the content of potentially absorbable low MW compounds. The proposal would include restrictions on the percentage of low MW components directly derived from the monomers or other reactants for 723.250(e)(1) polymers. The proposed criteria would require that oligomer content be less than 10 percent below MW 500 and less than 25 percent below MW 1,000. These values are based on a retrospective study conducted on over 100 polymers rated as having low concern, including their accompanying test data, an assessment of their potential to cause human health effects and environmental toxicity, and a rating of the expected amount of toxicity. This study, entitled ``Evaluation of Tentative Terminations in New Chemical Review,'' is available in the public docket for this rulemaking (OPPTS - 50594).
The 1984 polymer exemption requires companies to supply information on low MW species content, but these data are not part of the criteria for eligibility. Based on the 1984 polymer exemption, companies are legally bound to manufacture polymers with equal to or less than the percent of low MW species and residual monomer concentrations reported in the polymer exemption notice for a new substance. If a company desires to manufacture a polymer with higher amounts of low MW species or residual reactants than were reported in the polymer exemption notice, then a second polymer exemption application or a PMN must be filed. In the proposed approach, companies would be free to manufacture a polymer for which they had filed a polymer exemption notice with any MW characteristics or residual reactant content desired, as long as the percentages of low MW species did not exceed the levels specified in the exemption criteria.
ii. Restriction on reactive functional groups. The rule would exclude from eligibility under the 723.250(e)(1) criterion certain polymers that contain reactive functional groups that are intended or can reasonably be anticipated to undergo further reaction. The rule also would amend certain restrictions in the 1984 exemption.
As discussed in the 1984 exemption and the 1982 proposed rule, polymers that contain reactive functional groups may be capable of reacting with tissues or other chemical constituents of living organisms. Absorption of polymers containing reactive functional groups is also plausible since reactive groups often cause sufficient irritation to disrupt normal cell membrane barriers and facilitate penetration.
Consistent with 723.250(d)(6)(ii) of the 1984 exemption, polymers that contain certain reactive functional groups that generally lack reactivity in biological settings would still be eligible for the exemption under this proposal. Therefore, under 723.250(e)(1)(ii)(A) of the proposal, polymers containing only the following reactive and/or other functional groups would remain eligible for the exemption: carboxylic acid groups, aliphatic hydroxyl groups, unconjugated olefinic groups that are considered ``ordinary'', butenedioic acid groups, and those containing conjugated olefinic groups contained in naturally-occurring fats, oils, and carboxylic acids. Further, based on the Agency's experience in reviewing polymers since the 1984 exemption was promulgated, EPA now believes that the following groups generally lack or have low adverse reactivity in biological settings, and is therefore proposing to add them to the above list: blocked isocyanates (including ketoxime-blocked isocyanates) thiols, unconjugated nitrile groups, and halogens (except reactive halogen-containing groups such as benzylic or allylic halides).
iii. Approach to establishing other reactive functional group equivalent weights. In the 1984 exemption, the Agency established equivalent weight criteria which allowed low concentrations of reactive functional groups to be present in the polymer molecules. At that time it was believed that a level of less than 1 gram-formula weight of reactive functional groups in 10,000 grams of polymer was sufficient to ensure that the reactive functional group was substantially diluted by polymeric material. Based on the Agency's experience in reviewing polymers since the 1984 exemption was promulgated, EPA now believes that the reactive functional group equivalent weight of 10,000 can be lowered to 5,000. In addition, the Agency is also proposing to establish allowable equivalent weights at 1,000 for the combined weight of certain polymer reactive functional groups other than those in 723.250(e)(1)(ii)(A), which would not have an equivalent weight limit, based on the Agency's lower level of concern for these reactive groups. These groups would include the following: acid halides; acid anhydrides; aldehydes; hemiacetals; methylolamides, -amines or -ureas; greater than C2 alkoxysilanes; allyl ethers, conjugated olefins; cyanates; epoxides; imines; and unsubstituted positions ortho or para to phenolichydroxyl.
All other reactive functional groups would be required to have a combined equivalent weight of 5,000 or greater, including pendant acrylates and methacrylates, aziridines, carbodiimides, halosilanes, hydrosilanes, hydrazines, isocyanates, isothiocyanates, alpha or beta lactones, methoxy or ethoxy silanes, vinyl sulfones or analogous compounds and any reactive functional group not listed at 723.250(e)(1)(ii)(A) or (B).
This proposal would increase the number of polymers eligible for exemption under this category; however, the added complexity of this approach may not be justified relative to the number of additional polymers that might be made eligible. Specifically, the Agency is concerned that smaller businesses or those with limited technical resources would have trouble interpreting the exemption criteria for reactive functional groups, if the groups are complicated, and may choose not to use the exemption for eligible polymers. Such persons would, of course, have the option of using 5,000 as the equivalent weight if they are uncertain whether a particular reactive functional group is listed under 723.250(e)(1)(ii)(A) and (B). Therefore, the Agency is seeking comment on this approach and the alternative one discussed later in this document.
EPA believes that restrictions on reactive functional groups are not necessary for polymers with a number-average MW equal to or greater than 10,000 because polymers of this size would not be expected to be absorbed by biological systems.
b. Polymers with number-average MW equal to 10,000 or greater. Section 723.250(e)(2) would exempt polymers with number average MW equal to 10,000 or greater (and oligomer content less than 2 percent below MW 500 and less than 5 percent below MW 1,000), provided the submitter evaluates the potential for inhalation exposure to respirable particles of water-insoluble polymers and provides adequate notification and appropriate protective measures, if warranted, as specified at 723.250(e)(2)(i) through (e)(2)(v) of the proposed rule. The Agency is proposing to establish a separate category for polymers with number-average MW equal to or greater than 10,000 because this category of polymers is not readily absorbable by any route of exposure; further, low MW species below 500 and 1,000 will be restricted under this proposal. EPA does, however, have a concern for potential effects that may be caused by inhalation of respirable particles of water-insoluble high MW polymers. In the 1984 exemption, the Agency discussed its concern for potential health risks such as the development of fibrosis of the lung or other pulmonary effects that may result upon inhalation of polymers in particulate form. At that time the Agency believed that such exposure to polymer particulates was generally limited and expected to be of low concern. The Agency now believes that it may be inappropriate to make a ``no unreasonable risk'' finding for high MW water-insoluble polymers without requiring evaluation of potential exposure to respirable particles of such polymers. Thus far, the Agency has no data to warrant any concern for inhalation toxicity for water soluble polymers.
The Agency has received TSCA section 8(e) data that report irreversible lung damage on experimental animals when respirable size water-insoluble polymer aerosols are inhaled. Pulmonary damage induced by inhalation exposure to the subject polymers includes chronic inflammatory response, lymphoid hyperplasia in mediastinal or bronchial lymph nodes, nodular histiocytosis in mediastinal or bronchial lymph nodes, fibrotic alveolar lesions, interstitial fibrosis and alveolar tumors. The data also demonstrate that the onset of the polymer-induced damage may be delayed for as long as 6 months after exposure. The toxicity may be a result of ``overloading'' the clearance mechanisms of the lung; however, at this time the Agency does not have sufficient toxicity data to either confirm or discount the ``overload'' theory. The Agency does not have sufficient data to determine the precise MW and/or structural considerations that may facilitate the mechanisms causing toxicity, although data received to date indicate that lung toxicity is produced by water-insoluble polymers with a MW as low as 70,000 and at respirable concentrations as low as 4 mg/m3.
In light of these data, EPA has concerns for lung effects from water-insoluble polymers with MW of 70,000 or greater. Although to date EPA has no inhalation data on polymers eligible for the proposed exemption with MW of less than 70,000, adverse lung effects resulting from inhalation exposure to water-insoluble polymers with MW of 10,000 - 70,000 cannot be ruled out. Substances in the 10,000 - 70,000 MW range are, in general, not readily absorbed by any route of exposure. Thus if alternative lung clearance mechanisms are overloaded, lung toxicity would be expected to occur. Polymers with a MW of less than 10,000, in general, can be expected to be absorbed by the lung and therefore have different detoxification mechanisms available to mitigate potential health hazards. Further, EPA does not expect water-soluble polymers to exhibit lung toxicity because they are expected to rapidly clear the respiratory tract and therefore not cause an overloading effect. The Agency requests comment on the MW range anticipated to produce toxicity.
Currently, the New Chemicals Program, in response to the TSCA section 8(e) data referenced above, is more rigorously evaluating the inhalation exposure potential of water-insoluble polymers with MW greater than or equal to 70,000 that are submitted as PMNs or polymer exemption applications. In cases where the manufacturing, processing, or use of such polymers is expected to result in exposure to respirable particles, the Agency would use its regulatory authority under section 5(e) to limit human exposure. Under section 5(e) of TSCA, the Agency can limit or control the activities associated with a chemical substance if such activities may present an unreasonable risk to human health or the environment.
Under today's proposal, polymers ranging from 10,000 - 70,000 daltons (with the exception of water-absorbing polymers ineligible at 723.250(d)(5)) would be eligible for the exemption, provided the manufacturer evaluates potential inhalation exposure, and if such exposure exists, implements certain procedural safeguards to control inhalation exposure. This approach would allow the Agency to make a determination for purposes of section 5(h)(4) of TSCA that this category of polymers will not present an unreasonable risk to human health or the environment. Further, until more definitive data on the inhalation toxicity of high MW polymers are submitted to EPA for review, the Agency believes that the additional requirements for this MW range are a reasonable response to the TSCA section 8(e) data received.
The Agency has considered several alternatives for dealing with potential lung effects in the context of the polymer exemption which are described in Unit III of this preamble. Under the proposal, manufacturers of water-insoluble polymers with MW of 10,000 or greater would be required to certify that they are aware of the potential for harmful lung effects upon inhalation of certain high MW polymers, and would provide, at a minimum, worker protection in the form of a NIOSH-approved category 21C, 23C, or equivalent respirators if there is a potential for inhalation exposure to any respirable particulates of the exempted polymer. Alternatively, manufacturers could insure that workplace respirable dust does not exceed 0.5 mg/m3, as an 8 - hour TWA based on present data, to reduce worker exposure. Manufacturers would be required to notify processors and industrial users of potential inhalation exposures and would be required to cease distribution to customers who failed to provide the prescribed worker protection measures.
The Agency believes that a level of 0.5 mg/m3 will provide an adequate margin of safety in light of the data and that this level is technologically feasible. The Agency requests comment on typical airborne concentrations, particle sizes and respirable content of commercial products.
The Occupational Safety and Health Administration (OSHA) Permissible Exposure Limit (PEL) for respirable particulates, not otherwise regulated is 5 mg/m3 (29 CFR 1910.1000) as an 8 - hour time-weighted average (TWA). EPA assumes that companies are in compliance with the OSHA PEL and are controlling employee exposure to 5 mg/m3 or below by using engineering controls, respiratory protection, etc., as required by the standard. However, in light of the data noted above, EPA believes it is reasonable to require a lower limit for respirable particulates of water-insoluble polymers. To achieve compliance with the 0.5 mg/m3 exposure limit proposed by EPA, additional engineering controls, work practices, good housekeeping practices, or different respiratory protection may be needed. EPA prefers the use of process changes, engineering controls, and work practices to reduce inhalation exposure to acceptable levels, and believes that in many cases, companies already in compliance with the OSHA PEL of 5 mg/m3 would be able to achieve the 0.5 mg/m3 exposure limit by modifying and improving the existing work practices, housekeeping, and maintenance practices, to reduce the amount of dust generated, or by upgrading engineering controls or respiratory protection currently used. However, EPA realizes that the OSHA PEL does not apply to all workplaces and that there are different PELs for different industry groups such as construction. EPA requests comments and information on typical airborne concentrations of respirable high MW polymers and airborne particle size distributions measured in the workplace, and on process changes, engineering controls, work practices, etc., that would be needed to meet the exposure limit of 0.5 mg/m3 for respirable particulates of high MW polymers.
Examples of process changes to reduce inhalation exposure include manufacturing, processing, and using materials in solution, in pellet form, or as a wet cake instead of drying the material and handling it as a powder or in other particulate forms. Application methods other than spray application (e.g., roller coating, dip coating , etc.) can also reduce inhalation exposure as the potential for aerosol generation is reduced. In addition, good housekeeping practices, appropriate maintenance and good work practices, (e.g., wet mopping or vacuuming spills instead of dry sweeping, repair of leaks as soon as possible, etc.) can also reduce the amount of dust generated, and the potential for inhalation exposure.
Where engineering controls are employed as an alternative to respirators, the initial exposure assessment must be sufficient to insure that the airborne concentration of respirable high MW polymers does not exceed 0.5 mg/m3. In such cases, EPA recommends but would not require personal monitoring and requests comments on appropriate collection devices. Respirable cyclone dust samplers which are commonly used to differentiate the respirable fraction from larger particles in the aerosol may be inappropriate for high MW polymer materials. The performance of the 10 mm plastic cyclone (which is commonly used to collect respirable dust) has been criticized because an electric charge can accumulate on the plastic and distort the collection characteristics. EPA encourages the use of an impactor or other suitable collection device for sample collection for high MW polymer materials and is interested in comments.
c. Polyester polymers manufactured solely from reactants listed at 723.250(e)(3). The Agency has had sufficient experience in reviewing polymer exemption notices for polyester polymers that are prepared using reactants specified in the 1984 exemption rule that the Agency does not believe such polymers represent a risk to human health or the environment. Accordingly, the Agency believes that these polyester polymers should continue to be eligible for exemption. The only change EPA is proposing to this exemption is the deletion of a footnote that would no longer be applicable, because under the proposal all monomers and reactants used to manufacture the polymer must be on the TSCA Inventory.
There are many polyester polymer reactants that are not included in the 1984 polyester exemption list, and the Agency has had requests to expand the list. Except for the chemicals currently listed in the 1984 exemption rule, the Agency has no experience in evaluating polyester reactants in a shortened review period. Therefore, the Agency cannot make a ``no unreasonable risk'' finding for ``new'' polyester reactants without conducting a limited review of the polymers that contain the ``new'' reactants.
The Agency solicits comment on the relative merit of expanding the list of polyester reactants and also requests suggestions and supporting data for adding other polyester reactants to the current list. Potential health or environmental effects of these reactants will be evaluated by the Agency and any low concern reactants may be added to the list in the final rule. However, in the case of anhydrides, which were inadvertently listed in the title of di and tri basic acid reactants in the 1984 exemption, but not included as specific reactants, EPA still does not believe that a ``no unreasonable risk'' finding can be made for this class of substances that are used as reactants for polyester polymers. Certain anhydrides are known to be respiratory and/or dermal sensitizers and cause such effects at concentrations as low as 50 mg/m3. Based on these concerns, the Agency believes it cannot justify the addition of anhydrides to the list of polyester reactants.
5. Determination of eligibility. The Agency believes that, when a polymer is manufactured under the terms of the proposed exemption, it is reasonable for the manufacturer to take on a greater burden to demonstrate eligibility than under the 1984 exemption because EPA is proposing to eliminate its pre-manufacturing review of these notices. Under the 1984 exemption, the Agency did not require that submitters perform analytical measurements of the physical and chemical properties of polymers, but allowed manufacturers to determine compliance with the exemption conditions on whatever basis deemed appropriate by the manufacturer. These included using past experience by correlating observed or measured values of the properties of similar polymers to the polymer in question, using stoichiometric relationships based on knowledge of the starting materials and expected reactions, or using knowledge or process and purification steps.
Under this proposal, the Agency would no longer review the exemption notices, prior to manufacture of the exempted polymer. Consequently, the Agency expects the manufacturer to take the steps necessary to ensure that a chemical substance is eligible for exemption. Therefore, the Agency believes that it is necessary to require that a manufacturer maintain appropriate data to demonstrate that a substance meets the eligibility criteria for 723.250(e)(1) and (e)(2) to ensure compliance with the exemption. This requirement would not apply to the polyester exemption at paragraph (e)(3), since this category does not impose a minimum number-average MW or restrict oligomer content as criteria for eligibility.
Under 723.250(l)(2)(ii)(C) and (D) of the proposal, the Agency would require that manufacturers of exempt substances at (e)(1) and (e)(2) maintain appropriate analytical data to demonstrate that the polymer meets the minimum number average MW and corresponding restrictions on oligomer content. The Agency would not specify a particular analytical method to demonstrate compliance with the eligibility criteria, but would allow the manufacturer to use an appropriate method of analysis that generates the data to verify compliance with the criteria, such as gel permeation chromatography or vapor pressure osmometry. Performance of such analysis would be required prior to commencement of manufacture or import in accordance with the exemption.
EPA expects that if conditions, such as reaction temperature or sources for feedstock change, manufacturers will take steps to determine the effect of such a change so as to ensure continued compliance with the exemption. The rule would require that manufacturers maintain, at the site of manufacture, records demonstrating a substance's eligibility, along with a copy of the notice submitted to the Agency upon commencement of manufacture of the exempted substance. Manufacturers must follow the provisions of the exemption for research and development (R&D) activities during the period of evaluation of eligibility of a substance under the exemption criteria prior to actual manufacture under the exemption provisions. Such R&D activities would be subject to the R&D procedural and recordkeeping provisions in the PMN rule at 720.36 and 720.78, respectively.
6. Timing of notification. The notice procedure being proposed at 723.250(f) would require that the notice be filed within 30 days after manufacture or importation for commercial purposes instead of 21 days prior to manufacture of an eligible polymer as under the current exemption. This would allow EPA to capture some basic information on the exempted polymers and their manufacturers/importers with minimal reporting burden on the submitter. EPA recognizes that one of the major benefits of this exemption is that it allows companies to respond more rapidly to market demand and to introduce new chemical substances more quickly into commerce.
7. Information requirements. The Agency is proposing to amend 723.250(f) to eliminate certain data elements. To accommodate the abbreviated information requirements, the Agency is proposing to replace EPA Form No.7710 - 25 at 723.250(f)(1) with a modified form. Some of the 1984 exemption information requirements at 723.250(f)(2) will remain the same, including manufacturer's name, type of exemption, generic chemical identity, and test data and other data. Other provisions of the notice contents in the 1984 exemption at 723.250(f)(2) would be revised as follows:
a. Site of manufacture. The Agency is proposing to amend this requirement at 723.250(f)(2)(iii) to also include site of import for an imported exempt polymer.
b. Chemical identity. The proposal would amend the chemical identity information requirements at 723.250(f)(2)(iv)(A) to require a Chemical Abstracts (CA) Index Name or CA Preferred Name, CAS Registry number (or EPA Inventory accession or PMN number) for each reactant used at greater than 2 percent (by weight) to manufacture the polymer, or alternatively, incorporated at greater than 2 percent (by weight) in the polymer. Elsewhere in today's Federal Register, EPA is proposing to amend the ``Two Percent Rule'' to allow submitters greater flexibility in determining the amount of monomer or reactant used in the manufacture of a polymer. Manufacturers who choose to use the ``incorporated'' method, would be required at 723.250(f)(2)(iv)(A) to maintain appropriate analytical data to demonstrate compliance with the ``Two Percent Rule''. Any reactant charged to the reactor at greater than 2 percent (by weight) must be identified in the polymer name unless data are developed to ensure that the reactant is incorporated at 2 percent or less in the polymer. The proposal will eliminate the requirement for maximum percentage composition for each monomer or other reactant used to manufacture the polymer, and manufacturers would no longer be required to specify any reactants used at 2 weight percent or less in the manufacture of the polymer unless the manufacturer wishes to include such reactants as part of the polymer chemical identity. Further discussion on the ``Two Percent Rule'' rule appears below.
Under the proposal, the manufacturer would also be required at 723.250(l)(2)(iv)(C) to provide the CA Index Name or CA Preferred Name for the polymer and any CAS Registry Number that exists for the polymer. This requirement would be consistent with the Agency's proposal published elsewhere in today's Federal Register to require that submitters use CAS nomenclature in all section 5 notices.
Under the proposal, number-average MW, maximum weight percent of each monomer or other reactant that will be present as residual in the polymer as manufactured for commercial purposes, and impurity information will no longer be required on the notice form. However, under 723.250(l)(2)(C) and (D), the manufacturer would be required to maintain appropriate analytical data to demonstrate that an exempted polymer at 723.250(e)(1) or (e)(2) meets the specific number-average MW and restricted oligomer content criteria, as discussed above under Unit II.B.5 of this preamble. This proposal would allow the company to make the polymer with MW ranges, or residual reactant concentrations, etc., as the company desires, provided that these values fall within the exemption criteria.
Further, production volume and category of use would no longer be required since the exemption criteria are based primarily on a ``low hazard'' determination of the eligible polymer itself and do not require an exposure evaluation, except in the case of inhalation exposure to water-insoluble high MW polymers as discussed elsewhere in this document.
c. Certification. This requirement would be amended to require certification at 723.250(f)(2)(vii)(E) that the manufacturer of a water-insoluble polymer with a number average MW equal to or greater than 10,000 is aware of the potential for harmful lung effects upon inhalation of respirable particles of certain high MW polymers and would comply with the evaluation and notification requirements at 723.250(e)(2). Certification that the person submitting the notice has provided a currently correct chemical identity for the polymer using CAS nomenclature would also be required under the proposal at 723.250(f)(2)(vii)(F).
8. Two percent rule for polymers. In a separate regulatory action, the Agency is proposing to amend the ``Two Percent Rule'' for polymers to allow submitters greater flexibility in determining the amount of monomer or reactant used in the manufacture of a polymer. EPA believes that allowing submitters to report on the basis of amount incorporated in the polymer as an alternative to the current practice of requiring reporting based on the amount ``charged'' to the reactor will provide a better indicator of physical, chemical, and toxicological properties of polymers. At the same time, this will allow manufacturers greater flexibility in commercial innovation, reduce the number of PMNs representing slight variations in polymer composition, and provide greater consistency with international reporting policies. Further discussion of this issue is contained in the proposed PMN rule amendments being published elsewhere in this issue of the Federal Register.
9. Receipt and review of notice. Under paragraph (g), the Agency would continue to announce receipt of exemption notices in the Federal Register. However, the Agency would no longer review the exemption notice since the proposal would require submission of the notice within 30 days of manufacture of an exempted substance under terms of the exemption. In order to ensure compliance with the provisions of this exemption, the Agency expects to include as part of its on-going inspection process, an examination of pertinent records documenting compliance with the exemption requirements.
10. Recordkeeping. EPA believes that recordkeeping requirements are an essential component of an effective exemption enforcement program and would retain and modify this provision in the proposed rule at 723.250(l). Documentation of information in the notice would be used by enforcement personnel to determine compliance. The recordkeeping requirements would be amended at 723.250(l)(2)(i) to require that the manufacturer maintain a copy of the completed exemption form at the reported site of manufacture or the site of import. Under the provisions of the exemption, the manufacturer would also be required at 723.250(l)(2)(ii)(C) and (D) to maintain documentation which demonstrates that the first commercial batch of polymer manufactured for commercial purposes under the exemption meets the eligibility criteria for minimum number average MW and restricted oligomer content for (e)(1) and (e)(2) polymers. The proposed regulations at 723.250(l)(2)(ii)(D) would also require the generation of subsequent documentation to ensure compliance with the exemption if conditions occur, such as reaction temperature or sources for feedstock change, which result in a significant change in the manufacturing process. Further, manufacturers using the method of incorporation for determining compliance with the ``Two Percent Rule'' would be required to maintain documentation at 723.250(l)(2)(ii)(E).
Under the proposal, the manufacturer would further be required at 723.250(l)(2)(iv) to maintain documentation of the nature and method of notification of risk of inhalation toxicity for water-insoluble polymers with number average MW equal to or greater than 10,000 as specified at 723.250(e)(2)(iii) and (iv).
11. Inspections. Under the proposal, EPA would continue to periodically inspect all companies which have submitted TSCA section 5 notices, including exemptions. Those submitters with violations may be inspected more frequently.
To determine compliance with the exemption, the EPA inspector will focus on the information in the exemption notice and the company's records, including the analytical data documenting the substance's eligibility under the exemption.
12. Revocation. The proposed rule includes provisions to revoke the exemption for an exempted polymer and require a full PMN review if, subsequent to granting the exemption, EPA obtains information indicating that a particular polymer or category of polymers may present an unreasonable risk of injury to health or the environment. As new data are developed for certain polymers or category of polymers (such as the toxicity of high MW polymers), the Agency may conclude that an exempt polymer causes unacceptable risks. This is a change from the corresponding provision at 723.250(p) The current provision contains two separate provisions for notification of ineligibility, one that is applicable during the period from notice submission until commencement of manufacture, and a second that applies after commencement of manufacture. To reflect the proposed elimination of the 21 - day review period, the proposed revocation provision would provide a single procedure.
Under this proposed rule, if the polymer were eligible for exemption, the polymer would not be listed on the Inventory of existing substances. As a result, manufacture of the substance by anyone other than the company submitting the exemption application is precluded. Since the exempted polymer would still be a ``new'' chemical substance, revocation of exemption status under the terms of the proposed rule would be accomplished directly, without utilizing other TSCA authorities.
13. Confidentiality. The proposed rule at 723.250(h) has retained essentially the same provisions for confidentiality as the 1984 exemption and the final premanufacture notice rule (720.80, 720.85, and 720.90), including a requirement that submitters provide a sanitized copy of the exemption notice in which all confidential information has been deleted. Please consult the preamble to the 1984 exemption (49 FR 46080) for a further discussion of this issue.
14. Inventory status of exempted polymer. The TSCA Chemical Substance Inventory (Inventory) is a list of substances that are manufactured, imported, or distributed for a commercial purpose in the United States. Unless specifically excluded from TSCA reporting requirements, a substance not already included on the Inventory must undergo PMN review at least 90 days before commercial manufacture or importation can begin. Upon the completion of the 90 - day review period, a Notice of Commencement (NOC) must be submitted within 30 days following the commencement of manufacture or importation of the PMN substance for a commercial purpose. Since polymers which meet the exemption criteria would not be subject to PMN review, they would not be included on the Inventory. Instead, EPA would maintain an independent polymer exemption file. By not being included on the Inventory, exempted polymers will not be considered to be ``existing'' chemical substances under TSCA. All persons who intend to manufacture or import a polymer under the conditions specified in the exemption criteria would be required to submit an exemption notice, regardless of whether the polymer is already included in the special exemption file. If a manufacturer wishes to manufacture a polymer outside the scope of the proposed exemption criteria, a PMN or other section 5 notice will be required. In the case of a PMN, a polymer is added to the Inventory only upon the receipt of a NOC by EPA. Therefore, it is possible that a given polymer could be listed both in the special polymer exemption file and on the Inventory. Polymers that were reviewed under the 1984 polymer exemption rule and included on the Inventory would remain on the Inventory, with the restrictions concerning low MW species content and maximum residual amounts of reactants specified for each exempted polymer still in force.
15. Transition period between proposed and final rule. The Agency will continue to accept polymer exemption notices under the terms of the 1984 exemption at 40 CFR 723.250 until the effective date of any final rule that amends this section. At that time, all exemptions granted by EPA under the terms of the 1984 polymer exemption regulations will remain in effect; however, no new exemptions will be granted under the 1984 polymer exemption rules. Submitters who were granted an exemption under the terms of the 1984 exemption have the option of manufacturing under those terms or of submitting a new exemption notice under the amended regulations.
If an exemption holder continues to follow the 1984 exemption rules, the NOC requirements apply and the exempt polymer will continue to be listed on the Inventory with exclusion criteria, exemption category restrictions, and residual monomer and low MW species content limitations. The exemption holder and any subsequent manufacturers of the polymer must comply with these criteria, or submit a new exemption notice or PMN.
III. Alternatives and Request for Public Comment
EPA requests comments and data on all aspects of this proposal, including provisions of 723.250 that EPA has proposed to retain unchanged from the 1984 exemption. EPA will consider all comments and data received during the comment period and may amend any provision of 723.250 where appropriate, based on these comments. Additionally, EPA requests comment on the specific issues and options outlined below.
A. Other Polymers Considered for Exemption
1. Polymer salts. The Agency has also considered a proposal to exempt certain salts of polymers that are listed on the TSCA inventory.
During FY 1990, EPA reviewed over 500 PMNs on salts of TSCA Inventory-listed polymers that were submitted by chemical manufacturers. As a result of the Agency's analysis of the health and environmental concerns associated with these polymer salts, EPA determined that in these cases polymer salts generally represented a low hazard, based on structure/activity analysis. In the few cases where potential health and/or environmental concerns were identified in a preliminary review, the Agency determined that the concerns were based on an analysis of the corresponding existing chemical substance (amine or other basic components) used to manufacture the polymer salt, and not on the polymer salt itself. EPA took no action to regulate these salts during the PMN review period. The results of this review support the Agency's view that polymer salts of Inventory-listed polymers as described above, generally present a low risk to health and the environment. Further, Agency concerns associated with the amine or other basic component could be addressed through mechanisms other than requiring new chemical reporting.
The Agency does, however, realize that there exist many polymers listed on the Inventory that have never been subject to the scrutiny of the new chemical substance review. Because of that fact, it is difficult to make the determination that these polymers will not present an unreasonable risk to human health or the environment. It follows, therefore, that the salts of these Inventory listed polymers would have the same uncertainty associated with them. However, EPA believes that many polymer salts would be eligible for exemption under the criteria being proposed in Unit II of this preamble. The Agency invites comments on the treatment of salts of existing polymers as a separate category within the context of this rule.
2. Other polymers. EPA considered an option of an expedited 21 - day review of all polymers not meeting the exemption criteria which could actually be extended to 90 days if necessary. EPA did not propose this option because these polymers could potentially present significant risk, based on EPA's review of these polymers over the past 10 years. Therefore, these polymers could not be adequately reviewed in the 21 - day time frame. EPA believes that a closer examination of the conditions of manufacturing, processing, distribution, use, and disposal during a full 90 - day PMN review period is therefore necessary.
B. Notification and Timing of Submission
The Agency considered several options regarding the submission requirements and timing of submission of a polymer exemption application, as discussed below:
1. No reporting. The Agency considered an exemption which did not require a manufacturer to notify EPA that a polymer was being manufactured under the exemption, similar to the R&D exemption. As with the exemption for small quantities manufactured solely for R&D at 720.36, recordkeeping would be required to verify compliance with the exemption criteria. This approach would allow the manufacture of polymers meeting the exemption criteria without the submission of a section 5 PMN or an exemption notice. It would require that manufacturers of such polymers maintain extensive records to verify compliance with the exemption criteria. However, the Agency believes that this approach would eliminate any direct mechanism for monitoring compliance since the Agency would not know the identity of the manufacturer or polymer being produced under the exemption.
2. Notification on the first day of manufacture. This option would require that a company submit an abbreviated notice post-marked on the first day of manufacture. The Agency considered this option because it would assure timely reporting, which would aid monitoring and enforcement of the exemption. However, based on comments previously received from the Chemical Manufacturers Association (CMA) on the timing of the NOC, EPA recognizes that requiring notices to be submitted on the same day of manufacture would be difficult because of ``coordination difficulties or the press of other business.'' (48 FR 41140, September 13, 1983). As stated at that time, EPA believes that companies should be allowed some latitude in when they submit NOCs and that notices submitted a short time after manufacture begins should be accepted. However, under the proposed recordkeeping requirements, EPA believes that under the ambit of the R&D provisions, all information required to support a substance's eligibility under the exemption, including analytical data demonstrating eligibility of 723.250(e)(1) and (e)(2) polymers, would have to be available prior to first manufacture of an exempted polymer for commercial purposes.
3. Retention of 21 - day premanufacture notification. As with the current exemption, eligible polymers meeting the exemption criteria would be subject to a 21 - day review prior to the commencement of manufacture. EPA believes that such a reporting requirement would require the continuing use of substantial EPA resources to review the data. The Agency believes that this review period is unnecessary, based on EPA's finding that polymers that meet these exemption criteria will not present an unreasonable risk. By not reviewing this category, the Agency can focus its limited resources on those chemicals which pose a significant risk to society. The Agency also considered an option of requiring a 5 - day pre-manufacture notification. However, a 5 - day period may not provide sufficient time to acknowledge that a submission has been received, raising inquiries from submitters as to official commencement dates.
In order to ensure that companies correctly determine which polymers meet the exemption criteria, the Agency is developing a comprehensive technical support document. This will assist the company to establish that the polymer meets the terms of the exemption.
C. Eligibility Criteria
1. Functional group equivalent weight. The Agency also considered the alternative of standardizing the criterion for certain reactive functional groups at 723.250(e)(1)(ii)(B) at 5,000 equivalent weight instead of establishing both a 1,000 and a 5,000 limit based on the Agency's level of concern. Under the Agency's current internal review policy, polymers with a combined reactive functional group equivalent weight of greater than 5,000 are considered of low concern with respect to both health and environmental effects. While the concern for all of the listed reactive functional groups does not warrant this high 5,000 equivalent weight value, this approach would be a more straight forward threshold for the determination of eligibility for this exemption.
The group-specific values that EPA has proposed, however, correspond much better with the actual levels of concern for the individual reactive functional groups. By employing this method, the Agency feels it allows manufacturers the flexibility of producing more polymers which are of low risk without stringent requirements imposed for the sake of simplicity. The Agency solicits comment on the merits of both approaches. As stated above, the Agency is particularly interested in hearing from small businesses and others about the complicated nature of the first approach.
2. Residual monomer content. EPA also considered an option which would have retained the existing requirements that submitters provide such information as number average MW and residual monomer concentration. This requirement would enable EPA to evaluate on a random, periodic basis, information received in support of the certification that a submitter has met the specific exemption criteria for polymers, or to require more information in cases where the Agency may have some specific concerns or questions about the polymer. However, EPA believes that this reporting requirement would complicate the exemption scheme by placing an unnecessary burden on both EPA and submitter resources.
D. Inhalation toxicity
Inhalation concerns for high MW water-insoluble polymers are addressed in the criteria for polymer exemption and EPA is proposing to require that submitters certify that they acknowledge the concerns for inhalation toxicity for some water-insoluble polymers and will employ either worker protection or manufacturing controls to minimize exposure to respirable dust to the extent possible. Several alternatives have also been considered and EPA requests public comment and supporting data on the advantages and detriments of the options. The Agency solicits comments on the following alternatives:
1. No restrictions on water-insoluble polymers with MW of 10,000 or greater. EPA considered the alternative of not setting any restrictions on water-insoluble polymers with MW of 10,000 daltons or greater. The data base on polymer inhalation toxicity on water-insoluble polymers is extremely small; therefore it is difficult to characterize a limited data set as representative of all high MW polymers. To impose general regulatory restrictions based on a limited set of very specific data may not be justified. Further, there is a lack of test data on the specific factors which cause the toxicological effect. Without being able to identify the properties of a chemical(s) responsible for the toxic effect, it may be difficult to justify restrictions on the category of high MW polymers. The EPA would like to receive and/or encourage the development of data on the inhalation toxicity of higher MW polymers to establish the generality of the effect and the need for regulatory exposure limits under the polymer exemption.
Therefore, the EPA requests comment on the need to control exposure to water-insoluble polymers with MW of 10,000 daltons or greater in the polymer exemption rule. EPA also requests that any available negative inhalation toxicity data on higher MW polymers be forwarded to the Agency as part of public comment. Of course, persons must submit any positive data indicating ``substantial risk'' to human health or the environment under TSCA section 8(e).
2. Promulgate a section 4 test rule for high MW polymers. EPA considered the alternative of using other TSCA authority, e.g. a section 4 test rule, instead of limiting the exemption. The observed lung toxicity may be a physical effect, which to date, cannot be correlated with chemical-specific characteristics of any class of polymers, except water-absorbable polymers with MW of 1 million daltons or greater. EPA recognizes that PMN occurs on a chemical-specific basis and the lung toxicity caused by respirable dust may not be a chemical-specific phenomenon. Therefore, it is difficult for EPA to define a specific chemical category of concern or an appropriate test battery, at this time.
3. Exclude polymers from eligibility for exemption if it is reasonably anticipated that there may be inhalation exposure in manufacturing, processing, or use. Because the data received by EPA on inhalation toxicity are so limited and narrow of scope, and because EPA considered that the concerns could be mitigated by the exemption criteria discussed above, this alternative was considered to be an inappropriate burden relative to the magnitude of the known risk.
EPA requests comments on all alternatives considered in dealing with inhalation concerns along with any supporting data available on inhalation toxicity of polymers.
E. Polymers Containing High Cationic Functional Group
The Agency considered allowing, under the exemption, polymers which contain high percentages of amine (low amine equivalent weight) in their structures that would be restricted at 723.250(d)(1). The main concern for cationic polymers is for ecotoxicity, specifically, aquatic toxicity. There has been a significant amount of data collected to demonstrate that for the category of polymers with a high amine content, equivalent weight of 425 or less, there is sufficient mitigation of the risk, through the mechanism of humic acid binding, to render this polymer class of low concern for ecotoxicity. The Agency believes that these data sufficiently support the conclusion that high amine content polymers, as specified above, will not pose an environmental risk for aquatic toxicity.
EPA has, however, recently received data, through the provisions of section 8(e) of TSCA, with regard to toxicological studies performed on a polymer with high cationic functional group content. The test results demonstrated lethality in standard eye irritation tests in rabbits and has resulted in concerns for acute lethality as demonstrated by this polymer. The subject polymer met all provisions of the proposed polymer exemption and would have qualified for exemption if the low cationic functional group equivalent weight (high cationic content) provision was incorporated as part of the exemption criteria. It is for this reason that EPA feels that it would be inappropriate to include the high cationic functional group content allowance at this time. EPA is reviewing this category of polymers to attempt to delineate the parameters which may be responsible for this unusual effect. EPA requests any available standard rabbit eye irritation data on these types of polymers. EPA invites comment from the public on this class of polymers and the provisions in this rule for addressing them.
IV. Regulatory Analysis
A. Summary of Risk Assessment
1. Introduction. The Agency has decided to expand the applicability of the polymer exemption rule because EPA has determined that many of these substances are of low concern due to their lack of reactivity and their molecular size. The experience gained by the Agency from reviewing over 5,000 polymer submissions since the original polymer exemption rule in 1984 (49 FR 46066) has assisted in formulating the new set of criteria which will define what substances qualify for the polymer exemption. The hazards analysis for this proposed rule provides the evaluation of the information relevant to the Agency's conclusions that (a) polymers eligible for this exemption are generally of low risk and (b) sufficient information exists on the potential toxicity of polymers with certain characteristics to warrant their exclusion from the exemption.
2. Approach to risk analysis. The Agency based its risk analysis on (a) the effect MW has on the overall risk a chemical poses, (b) the specific concerns the Agency has had in the past from polymers submitted as PMNs, and (c) toxicological data available on particular chemicals.
The selection of MW as a risk-limiting criterion rests on two well-known and accepted principles of toxicology. The first principle is that, in general, in order to cause an adverse health or ecological effect, a chemical must first be absorbed by the organism. The second is that absorption of a chemical gradually decreases with increasing MW (size). Based on these two principles, the Agency reasoned that potential risks should generally be expected to decrease with increasing MW.
The second risk-limiting criterion is based on historical data gathered by the Agency in the course of reviewing several thousand polymers and identifying the concerns. This historical data gradually evolved into a set of internal Agency criteria for identifying either hazardous or high-risk substances. These internal criteria provide the basis for the proposed polymer exemption requirements that are set forth in this proposal.
3. Limitations to approach. The Agency realizes that there are limitations to the general rule that high MW substances will not be readily absorbed and therefore, will be of low concern. It is for these outlying cases that there are exclusions to this proposed exemption for certain polymers that remain subject to PMN. The Agency has reviewed a number of classes of chemicals to assess these risks. An EPA memorandum dated February 1, 1991, which discusses the environmental effects of polymers, is available in the public docket for this document (OPPTS - 50594).
4. Environmental risks. The Agency has evaluated a large number of polymers for their ecotoxicity in the course of reviewing PMNs. The identified environmental risks have formed the basis for several of the exclusions from the exemption to mitigate these risks. The environmental risk posed by polymers in general can be categorized both by MW characteristics as well as electronic properties. All polymers are divided into four classes depending on the type of electronic charge of the polymer: nonionic (neutral); anionic (negative charge); cationic (positive charge); and amphoteric (mixture of positive and negative charges on same molecule) polymers. The risk these different categories may pose is related both to electronic charge and MW.
a. Polymers with MW less than 1,000 daltons. Polymers with a MW of less than 1,000 that possess some degree of water solubility may be of concern. These polymers tend to exhibit much of the same behavior as polymers whose MW is greater than 1,000. These polymers are also of concern due to their potential to be absorbed through biological membranes and cause systemic effects.
b. Polymers with MW greater than 1,000 daltons. Polymers with MW greater than 1,000 are only considered a hazard for ecotoxicity when they are water soluble (or self-dispersing). They are not expected to be absorbed through biological membranes, and are expected to assert their toxicity by affecting the outer membranes of aquatic organisms or the near environment of the organism (e.g., over-chelation of nutrient elements). Insoluble polymers are not expected to be toxic unless they are ground up into fine particles. The toxicity of finely ground particles is due to indirect (physical) toxicity (e.g., the clogging of respiratory organs such as gills). Effects of this type only occur at high concentrations, i.e., acute toxicity values of greater than 1000.0 mg/L and chronic toxicity values of greater than 50.0 mg/L. The toxicity of finely ground insoluble polymers does not depend upon the chemical structure of the polymer.
i. Anionic (negatively charged) polymers. Polyanionic polymers which have a MW greater than 1,000 and which are water soluble (miscible or self-dispersing) are of concern for aquatic toxicity. Polyanionic polymers are divided into three subclasses: poly(carboxylic acids), poly(aromatic sulfonates), and poly(aliphatic sulfonates).
Poly(carboxylic acids) are of concern only for their toxicity to green algae. Toxicity to algae is moderate with toxicity values ranging from 1 to 100 mg/L (ppm). It appears that the mode of toxic action of these poly(carboxylic acids) is over-chelation of nutrient elements needed by algae for growth. When enough calcium (as divalent cation) is added to a polymer to satisfy its anionic charges, toxicity to algae is mitigated.
Poly(aromatic sulfonate) polymers with MW greater than 1,000 may be of moderate concern for acute toxicity towards fish and green algae. Polymers in this class have the following characteristic monomers: sulfonated phenols, sulfonated cresols, sulfonated diphenolsulfones, sulfonated diphenyloxides, and sulfonated diphenylsulfones.
Poly(aromatic sulfonate) polymers which have been shown to have low toxicity (i.e., acute toxicity values greater than 100.0 mg/L) or are highly suspected of having low toxicity are composed of the following monomers: benzene sulfonates and sulfonated naphthalene. The Agency does not have enough test data for these polymers to draw any firm conclusions about their toxicity. However, it is suspected that if these polymers show toxicity to aquatic organisms it will be to algae as was observed for the poly(carboxylic acid) polymers.
ii. Polycationic (positively charged) polymers. Polycationic polymers include polyamines (primary amines, secondary amines, and tertiary amines); quaternary amines; polysulfoniums; and polyphosphoniums. Polymers which are considered to have the potential for environmental toxicity have MW greater than 1,000 and are water soluble (miscible or self-dispersing). Polymers based on polyglucosamines (i.e., chitosan) are much less toxic than predicted and are no longer of concern.
For polycationic polymers, aquatic toxicity in clean water (i.e., total organic carbon [TOC] 2 mg/L) increases exponentially with increasing cationic charge density, i.e., protonated and/or quaternarized-N, S or P. Charge density is measured as percent amine-N for nitrogen-based polymers, equivalent weight of N, S, or P, or number of cations per 1,000 MW. Toxicity to aquatic organisms increases exponentially until about 2.5 cations per 1,000 MW (or 3.5 percent amine-nitrogen or an equivalent weight = 400), thereafter, toxicity becomes asymptotic.
5. Inhalation toxicity. Health concerns exist for certain types of high MW polymers that have been found to produce lung toxicity if inhaled. The Agency has received several TSCA section 8(e) and other submissions that report irreversible lung damage in experimental animals when respirable size polymer aerosols are inhaled. The data also demonstrated that the onset of the polymer-induced damage may be delayed for as long as 6 months after exposure. Observed toxicity may be a result of ``overloading'' the clearance mechanisms of the lung; however, at this time the Agency does not have sufficient toxicity data to either confirm or discount the ``overload'' theory. The Agency does not have sufficient data to determine the precise MW and/or structural considerations that may facilitate the mechanisms causing toxicity, although data received indicate that lung toxicity is produced by certain polymers with MW as low as 70,000 and at respirable concentrations as low as 4 mg/m3.
The Agency is considering how to deal with potential lung effects in the context of the polymer exemption. Because the 1984 polymer exemption criteria, and the criteria now being considered, are based on structural and compositional characteristics of polymers, it would be difficult or impossible to address concerns for the observed lung effects within the scope of these criteria.
Accordingly, EPA is proposing to require manufactures to provide notice of potential risks and also is proposing a revocation procedure, as described more fully in Unit II of this preamble.
B. Summary of Regulatory Impact Analysis
EPA has evaluated the potential costs of the proposed amendments for potential submitters of section 5 exemption notices. The Agency's complete economic analysis is available in the public record for this proposed rule (OPPTS - 50594).
The regulatory impact analysis estimates the costs and benefits attributable to the proposed regulation. In this case, the analysis also contains estimates for the three additional proposed amendments to section 5 regulations that are published elsewhere in this Federal Register. These proposals would amend the PMN rule, the Low Volume Exemption Rule, and the Expedited Follow-up rule. As these proposed regulations are amendments to current regulations, the costs and benefits are incremental, estimating the effect of the proposal with respect to the current regulation.
The costs and benefits associated with these proposed amendments are partially quantified; many of the benefits are unquantified but are expected to be of significant importance. Considering only the quantified costs and benefits, there is a cost savings. Since the number of section 5 submissions received by the Agency varies, this analysis used three scenarios, assuming either 1,000, 2,000, or 3,000 annual submissions, to reflect the expected range of submissions. The savings as compared to the current regulation are estimated to be:
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Annual Cost Savings ($
Million)
Annual Number of Submissions ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ?br>
Industry Government
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1,000......................................... 3.7 - 5.6 1.0 - 1.3
2,000......................................... 7.4 - 11.2 2.1 - 2.6
3,000......................................... 11.1 - 16.8 3.1 - 3.9
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The industry costs associated with these amendments are reporting costs, delay costs, and a user fee. Reporting costs are reduced from the current situation due to a reduction in submission requirements. Delay costs, defined as the cost of delayed introduction of the substance into the market due to section 5 regulations, are also reduced due to the elimination of the 21 - day pre-manufacture notification requirement. The user fee remains the same. In addition, the amendment makes a larger number of polymers eligible for the exemption, further reducing the reporting and delay costs for those substances.
The unquantified benefits include increased flexibility for industry due to the expanded exemption criteria. The amendments would require workplace controls for those polymers likely to pose a respirable health risk, allowing the submitter to utilize pollution prevention techniques and protect the health of their workers without the delay and effort required for a section 5(e) Order.
C. EPA's Approach to Making the No Unreasonable Risk Finding
1. Statutory background. Under section 5(h)(4) of TSCA, EPA is authorized to exempt the manufacturer of any new chemical substance from all or part of the requirements of section 5 if EPA determines that the manufacture, processing, distribution in commerce, use, and disposal of the substance, or any combination of such activities, will not present an unreasonable risk of injury to health or the environment. Section 26(c) of TSCA provides that any action authorized under TSCA for an individual chemical may be taken for a category of such substances.
While TSCA does not contain a definition of ``unreasonable risk,'' the legislative history indicates that the determination of unreasonable risk requires a balancing of the considerations of both the severity and the probability that harm will occur against the effect of the proposed regulatory action on the availability to society of the benefits of the chemical substance [H.R. 1341, 94th Cong., 2nd Session, 14 (1976)]. This analysis can include an estimate of factors such as market potential, the effect of the regulation on promoting or hindering the economic appeal of a substance, environmental effects, and many other factors which are difficult to define and quantify precisely. EPA must rely not only on data available to it, but also on its professional judgment. Congress recognized that the implementation of the unreasonable risk standard ``will vary on the specific regulatory authority which the Administrator seeks to exercise'' [Ibid.].
2. EPA's approach. In determining whether the category of substances manufactured under the exemption presents an unreasonable risk of injury to human health or the environment, the Agency considers more than just the inherent risks presented by the overall category of polymers. The Agency also considers the extent to which specific, automatic exclusions for polymers having certain characteristics affect the risks as well as the degree to which the development of specific polymeric criteria, have mitigated such potential risks. EPA analyzes to what extent the exemption criteria diminish or address potential risk.
The proposed polymer exemption will modify the requirements for eligible polymers from the current polymer exemption requirements and the general PMN requirements. EPA therefore compares the risks posed by the exemption with the risks which would have resulted from the same category of substances, if that category of substances had been subject to full notice submission requirements and 90 - day EPA review or, where applicable, the reporting requirements of the current polymer exemption and the abbreviated 21 - day review. Certainly it is not possible to eliminate all risks associated with the manufacture, processing, use, and disposal of a new chemical substance nor was this Congress' intent.
3. Application of no unreasonable risk factors. The following is an explanation of the consideration of factors relevant to the no unreasonable risk finding. The design of the proposed polymer exemption together with intrinsic properties of polymers significantly limit the risks of injury to human health or the environment that exempt polymers may present. Polymers as a general class are relatively unreactive and are not easily absorbed by bodily tissue. This proposal would exclude from eligibility, polymers with characteristics which would cast significant doubt on EPA's conclusions regarding low toxicity. EPA's conclusions regarding low toxicity potential for polymers that meet the proposed criteria are supported by the available data as well as EPA's professional judgement gathered over the course of reviewing over 10,000 polymers under the PMN and current polymer exemption requirements.
Under the proposed rule, certain polymers would be automatically ineligible for the polymer exemption. EPA has excluded those polymers for which: (a) The Agency still has insufficient data and review experience to find that they will not present an unreasonable risk, or (b) the Agency has found that, under certain conditions, polymers may present risk, thereby requiring a closer examination of the conditions of manufacturing, processing, distribution, use, and disposal during a full 90 - day PMN review. This level of analysis would be necessary to make an appropriate determination about risk.
In 1982, when the Risk Analysis and Evaluation of PMN Regulatory Decisions for Polymers was performed for the original polymer rule, the Agency determined that high MW (MW) polymers containing small amounts of low MW species were not considered an unreasonable risk to humans or the environment. Extensive discussion on this topic can be found in the 1982 proposed polymer exemption rule and the preamble to the final rule promulgated in 1984. The Agency has assumed that monomers would be of greater concern than oligomers, and that oligomers would be of greater concern than polymers based on the probability that the monomer would be more readily absorbed and, on a weight basis, be more reactive than the resulting oligomer or polymer.
In the 1982 proposal, the Agency proposed to allow polymers with MW greater than 20,000 to be manufactured without any premanufacture review by EPA but determined in the final rule that an abbreviated review period was necessary due to concerns for unreacted monomers and low MW species. The Agency is now proposing a modified version of this option, based on the review and hazard assessment of PMN polymers received over the last 7 years. The Agency now believes that it has sufficient experience with high MW polymers such that a ``no unreasonable risk'' finding may be made for certain of these substances.
As part of its risk assessment and in determining which type of polymer would be the most appropriate subject of an exemption at that time, EPA analyzed its existing database of polymers which had been submitted as full PMNs. Of the 266 polymer PMNs received by the Agency between March 17 and December 31, 1981, 7 were subject to preliminary review and none received formal Agency regulation under section 5(e) or section 5(f) of TSCA. These 266 polymers constitute a significant percentage of the 553 PMNs received during this period. In addition, of the 13 polymer PMNs that would have been eligible for review under the then proposed exemption, 11 were dropped by the Agency after abbreviated review on the basis of chemical/physical property data.
Over the past 13 years, the Agency has reviewed approximately 10,000 polymers in the New Chemicals Program. (Approximately 50 percent of all PMNs are polymers.) Of these 10,000, the majority of the polymers that would have qualified for the proposed polymer exemption rule have consistently been characterized as posing low concern for both adverse health and environmental effects by the Agency. The characteristics of a significant number of polymers are such that they are either not absorbed by biological systems or do not interact with biological systems. Furthermore, these polymers do not degrade to toxic species in the environment. However, based on data received by the Agency and referenced above, there is a second category of polymers which may pose a risk which the Agency believes can nonetheless be controlled through the use of process changes, engineering controls or use of personal protective equipment.
As a class, the Agency considers polymers to be among the safest chemical substances known. Based on over 13 years experience with the review and evaluation of new polymers, the Agency has established specific criteria which define low-risk polymeric substances. For example, the low MW species, reactive functional group, and the cationic limitations serve as such criteria. Many of these proposed criteria are outgrowths of the criteria used to determine eligibility under the current polymer exemption that has been in effect since 1984. Further, the Agency uses these identical criteria to identify low-risk polymers in its PMN review process.
The current polymer exemption, which uses the same types of criteria as the proposed exemption criteria to determine eligibility, requires a 21 - day review period. The Agency believes that this review period for polymers that meet the proposed exemption criteria is unnecessary based on EPA's finding that polymers which meet these exemption criteria put a sufficient bound on risk so that EPA review would not result in any additional protection. As a result, the Agency can then refocus its limited resources from this category of low risk concerns to those chemicals which, by comparison, may pose a considerable risk to society. Of the 1,371 polymers reviewed under the existing polymer exemption, only 1 polymer raised a concern of unreasonable risk based on ecotoxicity concern for significant releases; however, the case was dropped from review after receipt of algal test results which mitigated the Agency's concerns.
To further characterize the risk of the polymers that would be eligible for the proposed polymer exemption, the database of TSCA section 8(e)/FYI submissions was reviewed. Section 8(e) of TSCA requires that information on chemical substances which present a substantial risk of injury to human health or the environment be submitted to the Agency. A review of approximately 1,300 section 8(e) submissions revealed that, while polymers were the subject of 72 submissions, only 4 of the chemical substances identified in these 8(e) submissions would have been eligible for today's proposed polymer exemption (assuming the proposed worker protection provisions were not taken into consideration). The remaining 68 would be excluded from the proposed exemption due to MW considerations, restricted constituents and/or an excess amount below the MW of 500 or 1,000.
As discussed in Unit II of this preamble, the data received by the Agency on the six referenced submissions indicate that inhalation of respirable particles of certain of these polymers resulted in irreversible lung damage to experimental animals. In response to these new data, the Agency convened a Workshop to analyze the data to characterize the toxicity and chemical structures which may be responsible for the reported toxicity. The proceedings of the workshop are available in the Public Docket at OPPTS - 50594.
Based on the small size of this data set and the uncertainty of the cause of identified effects, the Agency is not willing at this time to draw any broad scientific conclusions for a class of compounds that numbers well over the 30,000 currently listed on the TSCA Inventory. As discussed in Unit II of this preamble, the Agency is proposing to exclude from the exemption, polymers having MW of 10,000 daltons or greater that are water-absorbing in response to TSCA section 8(e) data received by EPA. In addition, under the proposal, procedural safeguards to control inhalation exposure would be imposed on water-insoluble polymers having MW of 10,000 or greater if there is a potential for inhalation exposure to respirable particles. Chemicals other than these polymers which cause similar effects are generally insoluble particles of inorganic materials, such as titanium dioxide, which have no obvious chemical similarity to the subject polymers. However, if there is a potential for inhalation exposure to any respirable particles of water-insoluble polymers of MW greater than or equal to 10,000 daltons, the Agency believes it cannot make an affirmative finding that the activities associated with eligible polymers will not present an unreasonable risk of injury to human health and the environment unless respiratory protection or other workplace controls are used.
4. Mitigation of potential risks. In order to mitigate potential risks if the potential for inhalation exposure exists, the Agency has determined that: (a) By requiring manufacturers and importers to notify persons in its employ of the potential inhalation toxicity of respirable particles; (b) by requiring exposed workers to use respirators in accordance with applicable OSHA and National Institute for Occupational Safety and Health (NIOSH) requirements, or, in the alternative, by maintaining a specified workplace inhalation exposure level; (c) by requiring subsequent risk notification to processors and industrial users; (d) inclusion of strong revocation procedures; and (e) by the exclusions and terms of the exemption itself, the ``no unreasonable risk'' finding can in fact be made on a classwide basis for purposes of this exemption. These provisions are more fully described in Unit II of this preamble. The Agency believes that the exclusions and conditions are sufficient to mitigate risk, particularly when compared to the benefits, in toto, of encouraging further development of comparatively lower risk classes of chemicals with significant consumer exposure, such as polymers.
Because of the safeguards in the proposed rule, the requirement that the information provided in submissions are binding on the submitter, and the restricted nature of the exemption categories, EPA believes that risks are not likely to be any greater than if PMNs are filed and reviewed by EPA. Furthermore, the new polymers provide benefits to industry and to the public, which comprise an important element in the finding of no unreasonable risk.
In addition to the exclusions described in the proposed rule, the Agency in 723.250(e)(2) is proposing the adoption of notification requirements which are similar to provisions in the R&D exemption at 720.36(c) if there is potential inhalation exposure to respirable particles of high MW water-insoluble polymers. These would include notification of risks related to inhalation concerns raised by section 8(e) data, by the manufacturer of the exempt polymer [see 40 CFR 720.36 and 720.78]. The rule would require manufacturers to evaluate information which would lead the manufacturer to believe there is a potential risk of inhalation exposure to the substance based on respirable particulates, and would require the manufacturer to notify employees and persons to whom the polymer is distributed of any risk identified during the review. Such notification would help to address the concerns raised by the section 8(e) data which indicated irreversible lung damage in experimental animals.
At the present time, a 2 - year chronic inhalation bioassay would be recommended to fully evaluate the potential for lung toxicity from exposure to high MW polymers. The Agency encourages manufacturers and importers to develop and conduct appropriate toxicity testing to determine the lung toxicity from inhalation exposure to respirable polymer dusts. The docket for the proposed rule details the concerns for inhalation toxicity and raises awareness regarding the potential inhalation risks associated with certain polymers. The Agency is attempting to address the concerns raised by the section 8(e) data regarding inhalation toxicity in the proposed rule and in the PMN program. If EPA determines in the future that concerns for these polymers are mitigated or modified, it will consider revising the exemption to either delete or modify the workplace control limitations currently in the proposed rule, as appropriate, and consistent with its statutory mandate to make a ``no unreasonable risk'' finding.
The Agency believes that notification through labeling; notice where actual exposure is expected to occur; individual written notice or use of any other method which adequately informs persons of potential inhalation risk which EPA has reason to believe may be associated with the substance; will mitigate risk to potentially exposed populations, thereby enabling EPA to make the necessary no unreasonable risk finding.
Despite the low risk generally associated with the types of polymers that would qualify for this exemption, EPA recognizes that as the scientific community, and EPA, gain a better understanding of these substances and the potential risks associated with them, new risks may be identified. Although EPA does not currently have any information indicating that any particular polymers or categories of polymers that meet the proposed criteria for this exemption may present an unreasonable risk, it is possible that in the future EPA will obtain such information. To minimize any potential risks posed by this exemption, EPA is proposing a provision in this polymer exemption rule that would enable EPA to revoke exemptions where EPA obtains information indicating that a particular polymer or category of polymers may present an unreasonable risk of injury to health or the environment.
The Agency has proposed revocation language in the polymer exemption which would allow EPA to revoke the exemption for an exempted polymer and require a full PMN review, should the Agency obtain new information that identifies a hazard that results in a ``may present'' an unreasonable risk finding. Such a determination could be based on any new information, or when the body of toxicity data permits a sound scientific judgment regarding the mechanisms of lung toxicity or the structural guidelines for the toxicity referenced above.
If a polymer were eligible for the proposed polymer exemption, the polymer would not be listed on the Inventory, thereby precluding manufacture by any one other than the company submitting the exemption notice. Furthermore, based on information received on the substance itself, or analog data, the exemption status could be revoked at any time if information becomes available which results in a finding that the polymer may present an unreasonable risk to human health or the environment.
5. Benefits. The following discussion describes the benefits of this proposal in a qualitative manner; for a more quantitative approach, see the economic analysis discussion in Unit IV.B of this preamble. It is reasonable to assume that a newly developed polymer will either possess a new function or serve an existing function more efficiently or less expensively. The reduction in delay for that polymer to be introduced into commerce is a benefit to both manufacturers and the general public, who will have access to the substance in a more timely manner.
A consideration of which benefits to analyze would encompass more than the costs associated with or from having to submit the polymer as a full PMN. Rather, any benefit analysis undertaken by the Agency would include a consideration of the broader benefits of reduction of costs to society by providing a less burdensome alternative for polymer manufacturers, including a reduction in the burden associated with both full PMN and current polymer exemption requirements. EPA's unreasonable risk determination may be based on the effects from provision of the substances on society beyond those benefits attributable to the substance itself.
Some of the costs directly attributable to the substance include the preparation of the PMN or polymer exemption form as well as the delay in the commercial market introduction of the new chemical substance. On the other hand, there are broad societal benefits which are not directly attributable to any one chemical substance or category of substances. Such benefits would include a reduction in Agency review resources being dedicated to a category of compounds determined to be of low risk, and a concomitant shift in concentration of those resources to substances of greater known concern. While factors such as these are not of the type that EPA would take into account when making an individual control decision on a new chemical substance, they have a significant effect on society which is directly linked to EPA's exercise of its exemption authority, and are appropriately considered in a section 5(h)(4) unreasonable risk finding for a category of substances. The costs of reporting requirements will also be lessened due to the limited informational requirements imposed under the proposed polymer exemption. These savings are detailed in the Regulatory Impact Analysis report which is available in the public docket for this rulemaking (docket control number OPPTS - 50594).
In addition, if the exemption is used to its greatest advantage, more than 31 percent of the resources allocated to the PMN burden could be shifted from this category of low concern to those chemicals which are considered to pose a considerably greater risk to society by comparison. Finally, manufacturers of these polymeric substances will be given greater flexibility provided they meet the terms of the criteria of the exemption.
In view of the expansive and continually increasing use of polymers in commerce, encouraging industry to expand the use of low hazard polymers can result in significant benefits to society. In general, such low hazard polymers function as replacements for heavy metals, many of which can cause detrimental human health effects to multiple organ systems as well as permanently contaminating the ecosystem with subsequent damage to the flora and fauna. The benefit of encouraging low hazard chemical substances in place of known hazards touch on all aspects of human activity and the environment including less hazardous work place environments, safer products available for the consumer, and materials that will not decompose to toxic products in the disposal sites. Such benefits outweigh risks which may be associated with inhalation of an as yet undefined subset of polymers, taking into consideration the exposure controls included in this proposal.
6. Risk/benefit balance. Determining the presence or absence of an unreasonable risk requires balancing of the benefits and risks posed by a regulatory action. EPA has determined that the risks are low based on the inherent properties of this class of substances; the additional safeguards built into the eligibility criteria; and the exposure controls included to mitigate any risks. EPA, of course recognizes its authority to revoke any exemption when and if information becomes available to it which would warrant such action.
EPA believes that the benefits of this proposed action are quite significant. Promoting the development of this category of polymeric substances by reducing the regulatory burden in both reporting requirements and in eliminating the delay of these products into commerce will have clear benefits to society. The added benefit of concentrating limited resources on substances which have a greater potential to present significant risks rather than a category such as polymers which have a minimal potential for significant risk is difficult to quantify, but is considered substantial nonetheless.
Given the above analysis, EPA concludes that the polymers covered by the proposed revision of the polymer exemption rule will not present an unreasonable risk of injury to human health or the environment.
V. Comments Containing Confidential Business Information
Any person who submits comments claimed as confidential business information must mark the comments as ``confidential,'' ``trade secret,'' or other appropriate designation. Comments not claimed as confidential at the time of submission will be placed in the public file. Any comments marked as confidential will be treated in accordance with the procedures in 40 CFR part 2. Any party submitting comments claimed to be confidential must prepare and submit a nonconfidential public version in triplicate of the comments that EPA can place in the public file.
VI. Rulemaking Record
EPA has established a record for this rulemaking (docket control number OPPTS - 50594). The record includes basic information considered by the Agency in developing this proposed rule. A public version of the record without any confidential information is available in the TSCA Public Docket Office from 8 a.m. to 12 noon and 1 p.m. to 4 p.m., Monday through Friday, except legal holidays. The TSCA Public Docket Office is located at EPA Headquarters in Rm. NE - G004, 401 M St., SW., Washington, DC.
VII. Other Regulatory Requirements
A. Executive Order 12291
Under Executive Order 12291, EPA must judge whether a rule is ``major'' and therefore requires a Regulatory Impact Analysis. EPA has determined that this rule would not be a ``major'' rule because it would not have an effect on the economy of $100 million or more, and it would not have a significant effect on competition, costs, or prices.
This proposed regulation was submitted to the Office of Management and Budget (OMB) for review as required by Executive Order 12291.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), EPA has determined that this rule would not have a significant impact on a substantial number of small businesses. EPA has not determined whether parties affected by this rule would likely be small businesses. However, EPA believes that the number of small businesses affected by this rule would not be substantial, even if all of the polymer exception notice submitters were small firms. They will have reduced burdens compared to the PMN process and the existing exemption.
C. Paperwork Reduction Act
The information collection requirements in this rule have been approved under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3502 et. seq. and have been assigned OMB control number 2070 - 0012.
The public reporting burden for this collection of information is estimated to vary from 10 to 14 hours per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. The public reporting burden for a PMN submission is estimated to vary from 95 to 110 hours; the burden for the 1984 polymer exemption is estimated to vary from 29.5 to 40 hours.
Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: Chief, Information Policy Branch, PM - 223, U.S. Environmental Protection Agency, 401 M. St., SW., Washington, DC 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503, marked ``Attention: Desk Officer for EPA.''
List of Subjects in 40 CFR Part 723
Chemicals, Environmental protection, Hazardous materials, Premanufacture notification, Reporting and recordkeeping requirements.
Dated: January 19, 1993.
William K. Reilly,
Administrator.
Therefore, 40 CFR chapter I, subchapter R, part 723 is proposed to be amended as follows:
PART 723-[AMENDED]
1. The authority citation for part 723 would continue to read as follows:
Authority: 15 U.S.C. 2604
2. By revising 723.250 to read as follows:
723.250 Polymers.
(a) Purpose and scope. (1) This section grants an exemption from certain of the premanufacture notice requirements of section 5(a)(1)(A) of the Toxic Substances Control Act (15 U.S.C. 2604(a)(1)(A)) for the manufacture of certain polymers.
(2) To manufacture a new chemical substance under the terms of this section, a manufacturer must:
(i) Determine that the substance meets the definition of polymer in paragraph (b) of this section.
(ii) Determine that the substance is not specifically excluded by paragraph (d) of this section.
(iii) Ensure that the substance meets the exemption criteria of paragraph (e) of this section.
(iv) Submit a notice as required under paragraph (f) of this section.
(v) Comply with the recordkeeping requirements of paragraph (l) of this section.
(b) Definitions. In addition to the definitions under section 3 of the Act, 15 U.S.C. 2602, the following definitions apply to this part.
Act means the Toxic Substances Control Act (115 U.S.C. 2601 et seq.).
Biopolymer means a polymer directly produced by living or once-living cells or cellular components.
Category of chemical substances has the same meaning as in section 26(c)(2) of the Act (15 U.S.C. 2625).
Cationic polymer means a polymer that contains a net positively charged atom(s) or associated groups of atoms covalently linked to its polymer molecule.
Chemical substance, Director, EPA, importer, impurity, Inventory, known to or reasonably ascertainable, manufacture, manufacturer, mixture, new chemical, person, possession or control, process and test data have the same meanings as in 720.3 of this chapter.
Internal monomer unit means a monomer unit that is covalently bonded to at least two other monomer units. Internal monomer units of polymer molecules are chemically derived from monomer molecules that have formed covalent bonds between two or more other monomer molecules.
Monomer means a chemical substance that has the capacity to form chemical bonds between two or more other molecules.
Monomer Unit means the reacted form of the monomer in a polymer bonded to two or more other molecules.
Number-average molecular weight means the arithmetic average (mean) of the molecular weight of all molecules in a polymer.
Polyester means a chemical substance that meets the definition of polymer and whose polymer molecules contain at least two carboxylic acid ester linkages, at least one of which links internal monomer units together.
Polymer means a chemical substance consisting of molecules characterized by the sequence of one or more types of monomer units and comprising a simple weight majority of molecules containing at least 3 monomer units which are covalently bound to at least one other monomer unit or other reactant and which consists of less than a simple weight majority of molecules of the same molecular weight. Such molecules must be distributed over a range of molecular weights wherein differences in the molecular weight are primarily attributable to differences in the number of monomer units.
Polymer molecule means a molecule which includes at least 3 covalently bound monomer units, at least two of which are internal monomer units.
Reactant means a chemical substance that is used intentionally in the manufacture of a polymer to become chemically a part of the polymer composition.
Reactive functional group means an atom or associated group of atoms in a chemical substance that is intended or can reasonably be anticipated to undergo facile chemical reaction.
Reasonably anticipated means that a knowledgeable person would expect a given physical or chemical composition or characteristic to occur based on such factors as the nature of the precursors used to manufacture the polymer, the type of reaction, the type of manufacturing process, the products produced in polymerization, the intended uses of the substance, or associated use conditions.
(c) Applicability. This section applies to manufacturers of new chemical substances that otherwise must submit a premanufacture notice to EPA under 720.22 of this chapter. New substances are eligible for exemption under this section if they meet the definition of ``polymer'' in paragraph (b) of this section, and the criteria in paragraph (e) of this section, and if they are not excluded from the exemption under paragraph (d) of this section.
(d) Polymers that cannot be manufactured under this section-- (1) Cationic polymers. A polymer cannot be manufactured under this section if the polymer is a cationic polymer as defined under paragraph (b) of this section or if the polymer is reasonably anticipated to become a cationic polymer in a natural aquatic environment (e.g., rivers, lakes) unless:
(i) The polymer is a solid material that is not soluble or dispersible in water and will be used only in the solid phase (for example, polymers that will be used as ion exchange beads), or
(ii) The combined functional group equivalent weight of cationic groups in the polymer is equal to or greater than 5,000.
(2) Elemental limitations. (i) A polymer manufactured under this section must contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.
(ii) A polymer cannot be manufactured under this section if it contains as an integral part of its composition, except as impurities, any elements other than the following:
(A) The elements listed in paragraph (d)(2)(i) of this section.
(B) Sodium, magnesium, aluminum, potassium, calcium, chlorine, bromine, and iodine as the monatomic counterions Na+, Mg+2, Al+3, K+, Ca+2, Cl-, Br-, or I-.
(C) Fluorine, chlorine, bromine, and iodine covalently bound to carbon.
(D) Less than 0.20 weight percent of any combination of the atomic elements lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin, and zirconium.
(3) Polymers which degrade, decompose, or depolymerize. A polymer cannot be manufactured under this section if the polymer is designed or is reasonably anticipated to substantially degrade, decompose, or depolymerize.
(4) Polymers manufactured or imported from monomers and reactants not on the TSCA Chemical Substance Inventory. A polymer cannot be manufactured under this section if the polymer being manufactured or imported comprises monomers and/or other reactants not already included on the TSCA Chemical Substance Inventory.
(5) Water absorbing polymers with number average molecular weight (MW) 10,000 and greater. A polymer cannot be manufactured under this section if the polymer being manufactured or imported is considered a water absorbing polymer and has a number average MW greater than or equal to 10,000. A water-absorbing polymer is a polymeric substance that, either in whole or in part, increases its volume when in contact with water. A polymer that is partially water soluble and partially water-absorbing shall be considered water-absorbing for the purposes of this section.
(e) Exemption criteria. To be manufactured under this section, the polymer must meet one of the following criteria:
(1) Polymers with number average MW greater than or equal to 1,000 and less than 10,000 (and oligomer content less than 10 percent below MW 500 and less than 25 percent below MW 1,000). (i) The polymer must have a number average MW greater than or equal to 1,000 and less than 10,000 and contain less than 10 percent oligomeric material below MW 500 and less than 25 percent oligomeric material below MW 1,000.
(ii) A polymer cannot be manufactured under this paragraph if the polymer contains reactive functional groups that are intended or reasonably anticipated to undergo further reaction unless it meets one of the following criteria:
(A) The polymer contains no or only the following reactive functional groups: carboxylic acid groups, aliphatic hydroxyl groups, unconjugated olefinic groups that are considered ``ordinary'', butenedioic acid groups, those conjugated olefinic groups contained in naturally-occurring fats, oils, and carboxylic acids, blocked isocyanates (including ketoxime-blocked isocyanates), thiols, unconjugated nitrile groups, and halogens (except that reactive halogen-containing groups such as benzylic or allylic halides would not be included).
(B) The polymer has a combined reactive group equivalent weight greater than or equal to 1,000 for the following reactive functional groups: acid halides; acid anhydrides; aldehydes, hemiacetals; methylolamides, - amines or, - ureas; C2 alkoxysilanes; allyl ethers; conjugated olefins; cyanates; epoxides; imines; or unsubstituted positions ortho or para to phenolic hydroxyl.
(C) If any reactive functional groups not included in paragraph (e)(1)(ii)(A) or (B) of this section are present, the combined reactive group equivalent weight, including any groups listed in paragraph (e)(1)(ii)(B), must be greater than or equal to 5,000.
(2) Polymers with number average MW greater than or equal to 10,000 (and oligomer content less than 2 percent below MW 500 and less than 5 percent below MW 1,000). The polymer must have a number average MW greater than or equal to 10,000 and contain less than 2 percent oligomeric material below MW 500 and less than 5 percent oligomeric material below MW 1000. In addition, for all water insoluble polymers greater than or equal to 10,000 MW to be manufactured under the terms of this section, the manufacturer must:
(i) Notify persons in its employ of the following if there is a potential for their inhalation exposure to any respirable particulates of the substance as identified under paragraph (e)(2)(ii) of this section:
(A) The potential for harmful lung effects upon inhalation of respirable particulates of the substance.
(B) The requirements of paragraph (e)(2)(iv) of this section. The notification must be in accordance with paragraph (e)(2)(iii) of this section.
(ii) Evaluate the potential for inhalation exposure to any respirable particulates of this substance.
(iii) Notify each person in its employ that may be potentially exposed to any respirable particulates of this substance by means of a container labeling system, conspicuous placement of notices in areas where exposure may occur, written notification, or any other form of notification which adequately informs persons of the potential inhalation exposure as determined under paragraph (e)(2)(ii) of this section, the potential for harmful lung effects upon inhalation of respirable particulates of the substance, and the requirements of paragraph (e)(2)(iv) of this section.
(iv) Provide to, and require to wear, each person in its employ that may be potentially exposed to any respirable particulates of the substance the following respiratory protection:
(A) At a minimum, a Category 21C or 23C respirator equipped with a high efficiency filter, selected in accordance with the National Institute for Occupational Safety and Health (NIOSH) Respirator Decision Logic (DHHS/NIOSH Publication No. 87 - 108 or current version) and used in accordance with 29 CFR 1910.134 and 30 CFR part 11. Respirators shall be selected such that employee exposure to respirable dust, mist, or aerosol of this substance via inhalation does not exceed 0.5 mg/m3 in any 8 - hour work shift of a 40 - hour work week.
(B) Employees are not required to wear respirators if alternate controls in the workplace are provided so that inhalation exposure to respirable dust, mist, or aerosol of the new chemical substance in the workplace during manufacture, processing, and use does not exceed 0.5 mg/m3 in any 8 - hour work shift of a 40 - hour work week. Process changes, work practices, good housekeeping, and maintenance practices can effectively reduce exposure to airborne respirable polymer materials. Examples of process changes that can reduce exposure include using the substance in solution, in pellet form, or as a wet cake. Application methods other than spray applications that can reduce airborne respirable exposures include roller coating, dip coating, etc. Good housekeeping may include such practices as wet mopping or vacuuming spills instead of dry sweeping and the repair of leaks as soon as possible.
(v) Provide in writing to processors and industrial users to whom it directly distributes the polymer a notice of potential inhalation exposure to any respirable particulates of the substance if such a determination is made in accordance with paragraph (e)(2)(ii) of this section and the potential for harmful lung effects upon inhalation of respirable particulates of the substance. The manufacturer must also inform processors and industrial users of respirator or alternate workplace controls specified in paragraph (e)(2)(iv) of this section so that inhalation exposure to respirable dust, mist, or aerosol of the new substance in the workplace during processing or use does not exceed 0.5 mg/m3 in any 8 - hour work shift of a 40 - hour work week. The manufacturer may notify processors and industrial users by means of a container labeling system, written notification, material safety data sheet, or any other method that adequately informs them of inhalation exposure potential to any respirable particulates of the substance, the potential for harmful lung effects upon exposure to respirable particulates of the substance, and the use of respirator or alternate workplace controls. If the manufacturer learns that a customer is processing or using the substance in violation of prescribed respirator or alternate workplace controls, the manufacturer must cease distribution of the substance to the customer immediately. The manufacturer must also report this action to EPA within 15 working days of receipt of this information under paragraph (i) of this section.
(3) Polyester polymers. The polymer is a polyester as defined in paragraph (b) of this section and is manufactured solely from one or more of the reactants in the following Table 1:
Table 1.-- List of Reactants From Which Polyester May be Made
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
Reactant CAS No.
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
Monobasic Acids and Natural Oils
Benzoic acid.............................. 65 - 85 - 0
Coconut oil............................... \1\8001 - 31 - 8
Corn oil.................................. \1\8001 - 30 - 7
Cottonseed oil............................ \1\8001 - 29 - 4
Dodecanoic acid........................... 143 - 07 - 7
Fatty acids, coco......................... \1\61788 - 47 - 4
Fatty acids, linseed oil.................. \1\68424 - 45 - 3
Fatty acids, safflower oil................
Fatty acids, soya......................... \1\68308 - 53 - 2
Fatty acids, sunflower oil................ \1\84625 - 38 - 7
Fatty acids, tall-oil..................... \1\61790 - 12 - 3
Fatty acids, tall-oil, conjugated.........
Fatty acids, vegetable oil................ \1\61788 - 66 - 7
Heptanoic acid............................ 111 - 14 - 8
Hexanoic acid............................. 142 - 62 - 1
Hexanoic acid, 3,3,5-trimethyl-........... 3302 - 10 - 1
Linseed oil............................... \1\8001 - 26 - 1
Nonanoic acid............................. 112 - 05 - 0
Oils, Cannabis............................
Oils, anchovy.............................
Oils, babassu palm........................
Oils, herring............................. \1\68153 - 06 - 0
Oils, menhaden............................ \1\8002 - 50 - 4
Oils, oiticica............................ \1\8016 - 35 - 1
Oils, palm kernel......................... \1\8023 - 79 - 8
Oils, perilla............................. \1\68132 - 21 - 8
Oils, walnut.............................. \1\8024 - 09 - 7
Oils, sardine.............................
Safflower oil............................. \1\8001 - 23 - 8
Soybean oil............................... \1\8001 - 22 - 7
Sunflower oil............................. \1\8001 - 21 - 6
Tung oil.................................. \1\8001 - 20 - 5
Di and Tri Basic Acids:.....................
1,2-Benzenedicarboxylic acid.............. 88 - 99 - 3
1,3-Benzenedicarboxylic acid.............. 121 - 91 - 5
1,4-Benzenedicarboxylic acid.............. 100 - 21 - 0
1,2,4-Benzenetricarboxylic acid........... 528 - 44 - 9
Butanedioic acid.......................... 110 - 15 - 6
2-Butenedioic acid (E).................... 110 - 17 - 8
Decanedioic acid.......................... 111 - 20 - 6
Hexanedioic acid.......................... 124 - 04 - 9
Nonanedioic acid.......................... 123 - 99 - 9
Polyols
1,3-Butanediol............................ 107 - 88 - 0
1,4-Butanediol............................ 110 - 63 - 4
1,4-Cyclohexanedimethanol................. 105 - 08 - 8
1,2-Ethanediol............................ 107 - 21 - 1
1,6-Hexanediol............................ 629 - 11 - 8
1,3-Pentanediol, 2,2,4-trimethyl-......... 144 - 19 - 4
1,2-Propanediol,.......................... 57 - 55 - 6
1,3-Propanediol, 2,2-bis(hydroxymethyl)-.. 115 - 77 - 5
1,3-Propanediol, 2,2-dimethyl-............ 126 - 30 - 7
1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- 77 - 99 - 6
.
1,3-Propanediol, 2-(hydroxymethyl)-2- 77 - 85 - 0
methyl-.
1,2,3-Propanetriol........................ 56 - 81 - 5
1,2,3-Propanetriol, homopolymer........... 25618 - 55 - 7
2-Propen-1-ol, polymer with ethenylbenzene 25119 - 62 - 4
Modifiers
Acetic acid, 2,2'-oxybis-................. 110 - 99 - 6
1-Butanol................................. \2\71 - 36 - 3
Cyclohexanol.............................. 108 - 93 - 0
Cyclohexanol, 4,4-(1-methylethylidene)bis- 80 - 04 - 6
Ethanol, 2-(2-butoxyethoxy)-.............. 112 - 34 - 5
1-Hexanol................................. 111 - 27 - 3
Methanol, hydrolysis products with \1\72318 - 84 - 4
trichlorohexylsilane and
trichlorophenylsilane.
1-Phenanthrenemethanol, tetradecahydro- 13393 - 93 - 6
1,4a-dimethyl-7- (1-methylethyl)-.
Phenol, 4,4'-(1- 25036 - 25 - 3
methylethylidene)bis, polymer with 2,2'-
[(1-methylethylidene)bis(4,1-
phenyleneoxymethylene)] bis[oxirane].
Siloxanes and Silicones, di-Me, di-Ph, \1\68440 - 65 - 3
polymers with Ph silsesquioxanes, methoxy-
terminated.
Siloxanes and Silicones, di-Me, methoxy \1\68957 - 04 - 0
Ph, polymers with Ph silsesquioxanes,
methoxy-terminated.
Siloxanes and Silicones, Me Ph, methoxy \1\68957 - 08 - 2
Ph, polymers with Ph silsesquioxanes,
methoxy- and Ph-terminated.
Silsesquioxanes, Ph Pr.................... \1\68037 - 90 - 1
ÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄÄ
\1\ Chemical substance of unknown or variable composition, complex reaction
products, and biological materials (UVCB). The CAS Registry Numbers for UVCB
substances are not used in CHEMICAL ABSTRACTS and its indexes.
\2\ These substances may not be used in a substance manufactured from fumaric
or maleic acid because of potential risks associated with esters, which may
be formed by reaction of these reactants.
(f) Exemption notice. An exemption notice must be submitted to EPA no later than 30 days after commencement of manufacture for commercial purposes.
(1) Notice form. The information set forth in paragraph (f)(2) of this section must be submitted on EPA Form No.7710-?? (Form number to be assigned) as identified below.
(2) Contents of exemption notice. For substances exempt under paragraph (e) of this section the notice must include to the extent known to or reasonably ascertainable by the manufacturer:
(i) Manufacturer's name. This includes the name and address of the manufacturer and the name and telephone number of a technical contact in the United States.
(ii) Type of exemption. A designation on page 1 of the notice, of whether the manufacturer is claiming an exemption under paragraph (e)(1), (e)(2), or (e)(3) of this section.
(iii) Site of manufacture. The name and street address of the site of first manufacture or import.
(iv) Chemical identity information. (A) The identity by specific chemical name and CAS Registry Number (or EPA assigned Accession Number) of each ``reactant'', as that term is defined in paragraph (b) of this section, used at greater than two weight percent in the manufacture of the polymer. The manufacturer may determine whether a reactant is used at greater than two weight percent according to either the weight of the reactant charged to the reaction vessel or the weight of the chemically combined (incorporated) reactant in the polymer. Manufacturers who choose the ``incorporated'' method must maintain analytical data to demonstrate compliance with this paragraph.
(B) A representative structural diagram, as complete as can be known, of the polymer.
(C) The currently correct Chemical Abstracts (CA) Index name for the polymeric substance or the CA preferred name (whichever is appropriate based on Chemical Abstract Service (CAS) 9th Collective Index nomenclature rules and conventions).
(D) The currently correct CAS Registry Number (CASRN) for the polymeric substance if a CASRN already exists for the substance in the CAS Registry File.
(v) Generic chemical identity. If the chemical identity provided under this section is claimed as confidential information under paragraph (h) of this section, the notice must provide a non-confidential description of this information which is only as generic as necessary to protect the confidentiality of the information.
(vi) Test data and other data. Test data on the polymer in the possession or control of the manufacturer, a description of other data concerning the health and environmental effects of the polymer that are known to or reasonably ascertainable by the manufacturer, and a description of data on related chemicals, as required in 720.50 of this chapter. (Identify as an attachment to the notice.)
(vii) Date of first manufacture or import. The date of first manufacture or import of the substance under the terms of this exemption.
(viii) Certification. A certification that:
(A) The notice includes all test data and other data required.
(B) The person submitting the notice manufactured or imported the polymer for a commercial purpose other than for research and development.
(C) All information provided in the notice is complete and truthful as of the date of submission.
(D) The new chemical substance meets the definition of a polymer, is not specifically excluded from the exemption, and meets the conditions of the exemption. (Certification on page 1 of exemption form, plus the statement required by paragraph (f)(2)(viii)(D) of this section.)
(E) The person submitting the notice for a water insoluble polymer with a number average MW of 10,000 or greater (and oligomer content less than 2 percent below MW 500 and less than 5 percent below MW 1,000) is aware of the potential for harmful lung effects upon inhalation of respirable particulates of certain high molecular weight polymers as described in this chapter and has complied with paragraph (e)(2) of this section.
(F) The person submitting the notice is providing a correct chemical identification of this substance using Chemical Abstract Services (CAS) nomenclature as required under paragraph (f)(2)(iv) of this section.
(G) The Company named in Part 1 of the form has remitted the fee specified at 40 CFR 700.45(b) or, the Company named in Part 1 of the form is a small business concern under 40 CFR 700.43 and has remitted a fee of $100 in accordance with 40 CFR 700.45(b).
(ix) List of attachments. The notice must include a list of attachments submitted with the notice.
(g) Notice procedures. The following sections of 40 CFR part 720 of this chapter apply to the handling of notices under this section.
(1) Section 720.25 Determining whether a chemical substance is on the Inventory.
(2) Section 720.40 General. (Notice Form, paragraphs (g) and (h).
(3) Section 720.57 Imports.
(4) Section 720.70 Notice in the Federal Register.
(5) Section 720.80 General Provisions.
(6) Section 720.90 Data from health and safety studies.
(7) Section 720.95 Public file.
(h) Confidentiality. (1) If the manufacturer submits to EPA under this section information which it claims as confidential business information, the manufacturer must clearly identify the information at the time of submission to EPA in the manner prescribed on the notice form or by bracketing, and stamping ``CONFIDENTIAL'' any attachment. Any information so identified will be treated in accordance with the procedures in part 2 of this chapter. Any information not claimed confidential at the time of submission may be made available to the public without further notice. A submitter may assert a claim of confidentiality for the chemical identity only if the submitter believes that public disclosure of the fact that anyone manufactures or imports the new chemical substance for commercial purposes would reveal confidential business information.
(2)(i) Any person who asserts a claim of confidentiality for chemical identity under this paragraph must provide a generic name that is only as generic as necessary to protect the confidential chemical identity of the particular chemical substance. The name should reveal the specific chemical identity to the maximum extent possible.
(ii) The generic name provided by the submitter will be subject to EPA review and approval in accordance with the procedures specified in 720.85(b)(6) of this chapter. The generic name provided by the submitter or an alternative selected by the EPA under these procedures will be placed on a public list of substances exempt under this section.
(3) If any information is claimed confidential, the manufacturer must submit a second copy of the notice except that all information claimed as confidential in the first copy must be deleted. EPA will place the second copy in the public file.
(i) Additional information. If the manufacturer of a new chemical substance under the terms of this exemption obtains test data or other information indicating that the new chemical substance may not qualify for the exemption, the manufacturer must submit these data or information to EPA within 15 working days of receipt of the information.
(j) Notification of receipt of notice. EPA will file for publication with the Office of the Federal Register, a notice of receipt by means of paragraph (g)(4) of this section. This notice does not constitute a finding by EPA that the notice, as submitted, is in compliance with this section. EPA will consider a person to have submitted the notice on the date the notice is received by the Document Control Officer for the Office of Pollution Prevention and Toxics. The exemption notice must be ``postmarked'' or hand-delivered by the 30th day after manufacture has commenced under the terms of this exemption.
(k) Exemptions granted under superseded regulations. Manufacturers holding exemptions granted under the superseded requirements of this section shall either continue to comply with those requirements or submit a new exemption notice pursuant to this section. If an exemption holder continues to follow the superseded regulations, the Notice of Commencement requirements apply and the exempt polymer will continue to be listed on the Inventory with exclusion criteria, exemption category restrictions, and residual monomer and low molecular weight species content limitations.
(l) Recordkeeping. (1) A manufacturer of a new polymer under paragraphs (e)(1), (e)(2), or (e)(3) of this section, must retain the records described in this paragraph at the manufacturing site for a period of 5 years from the final date of manufacture.
(2) The records must include the following to demonstrate compliance with the terms of this section:
(i) A copy of the exemption notice.
(ii) Documentation of any other information provided in the limited premanufacture notice, including:
(A) Information to demonstrate that the new polymer is not specifically excluded from the exemption.
(B) Information to demonstrate that the new polymer meets the exemption criteria in paragraphs (e)(1), (e)(2), or (e)(3) of this section including:
(1) Detailed batch records including reaction conditions (i.e., temperature, time, etc.) and amount of materials charged to the reactor and appropriate analytical test results for the first batch of the polymer manufactured for distribution in commerce and the initial batch manufactured for distribution in commerce immediately following any change in the polymer manufacturing process that may alter the eligibility of the polymer to meet the criteria at paragraphs (e)(1), (e)(2) or (e)(3) of this section as certified in the exemption notice.
(2) An explanation of the submitter's determination that the polymer is exempt under this section. Sufficient written explanation may include conclusions based on: Analytical data, analogies to other similar engineering or chemical processes, or extrapolations from R&D information on the polymer. A new written explanation must be made each time there is a change in manufacturing process that may alter the eligibility of the polymer to meet the criteria at paragraphs (e)(1), (e)(2), or (e)(3) of this section.
(C) If applicable, analytical data to demonstrate that the first batch of new polymer manufactured for commercial purposes under the exemption, and the initial batch manufactured subsequent to a change in manufacturing process that may alter the eligibility of the polymer to meet the criteria at paragraphs (e)(1) or (e)(2) of this section, meets the number-average MW exemption criteria in paragraphs (e)(1) or (e)(2) of this section. The analytical tests may include gel permeation chromatography (GPC). vapor pressure osmometry (VPO), or other such tests which will demonstrate that the polymer meets the number-average MW criterion.
(D) If applicable, analytical data to demonstrate that the first batch of new polymer manufactured for commercial purposes under the terms of the exemption, and the initial batch manufactured subsequent to a change in manufacturing process that may alter the eligibility of the polymer to meet the criteria in paragraphs (e)(1) or (e)(2) of this section, meets the low MW content criteria in paragraphs (e)(1) or (e)(2) of this section.
(E) If applicable, analytical data required in paragraph (f)(2)(iv)(A) of this section to make an ``as incorporated'' basis determination for reporting reactants used at greater than 2 weight percent in the manufacture of the polymer.
(iii) Documentation of the nature and method of notification under paragraph (e)(2)(i) of this section including copies of any labels or written notices used.
(iv) If notification is required under paragraph (e)(2)(v) of this section, the names and addresses of any persons other than the manufacturer or importer to whom the substance is distributed and copies of the written notification required under that paragraph.
(v) Records that demonstrate compliance with the requirements of paragraph (e)(2) of this section. Records must demonstrate use of the required respirators under paragraph (e)(2) of this section or information to demonstrate that sufficient workplace controls are in place such that inhalation exposure does not exceed 0.5 mg/m3 in any 8 - hour work shift of a 40 - hour work week. Records of any additional results of personal exposure monitoring and any additional information related to worker's occupational exposure which the manufacturer may possess must also be maintained and made available to EPA if requested.
(3) The manufacturer must submit the records listed in paragraph (l)(2) of this section to EPA upon written request by EPA. The manufacturer must provide these records within 15 working days of receipt of this request. In addition, any person who manufactures a new chemical substance under the terms of this section, upon request of EPA, must permit such person at all reasonable times to have access to and to copy these records.
(m) Submission of information. Information submitted to EPA under this section must be sent in writing to: Document Control Officer (TS - 790), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
(n) Compliance. (1) Failure to comply with any provision of this section is a violation of section 15 of the Act (15 U.S.C. 2614).
(2) A person who manufactures or imports a new chemical substance and fails to comply with paragraph (f) of this section is in violation of section 15 of the Act.
(3) Using for commercial purposes a chemical substance or mixture which a person knew or had reason to know was manufactured, processed, or distributed in commerce in violation of section 5 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614).
(4) Failure or refusal to establish and maintain records or to permit access to or copying of records, as required by this section and section 11 of the Act, is a violation of section 15 of the Act (15 U.S.C. 2614).
(5) Failure or refusal to permit entry or inspection as required by section 11 of the Act is a violation of section 15 of the Act (15 U.S.C. 2614).
(6) Violators may be subject to the civil and criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each violation. Persons who submit materially misleading or false information in connection with the requirements of any provision of this section may be subject to penalties calculated as if they never filed their notices.
(7) EPA may seek to enjoin the manufacture or processing of a chemical substance in violation of this section or act to seize any chemical substance manufactured or processed in violation of this section or take other actions under the authority of section 7 of the Act (15 U.S.C. 2606) or section 17 of the Act (15 U.S.C. 2616).
(o) Inspections. EPA will conduct inspections under section 11 of the Act to assure compliance with section 5 and this section, to verify that information submitted to EPA under this section is true and correct, and to audit data submitted to EPA under this section.
(p) Revocation of exemption. (1) If at any time after an exemption application has been received under the terms of this section, EPA obtains information (through a TSCA section 8(e) report or through any other source) indicating to EPA that a particular polymer (or category of polymers that includes such polymer) or a reasonably anticipated metabolite or environmental transformation product of the substance may present an unreasonable risk of injury to human health or the environment, EPA shall notify the manufacturer of that polymer, by certified mail, that its exemption under this section will be revoked. The criteria for revocation of the exemption are that the polymer substance or a reasonably anticipated metabolite or environmental transformation product of the substance:
(i) May cause significant chronic effects, including carcinogenic, developmental or reproductive effects, under anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal of the substance.
(ii) May cause significant acute effects (lethal or sublethal) under anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal of the new substance.
(iii) May cause significant environmental effects under anticipated conditions of manufacture, processing, distribution in commerce, use, or disposal of the substance.
(2) The manufacturer may continue to manufacture, process, distribute in commerce, and use the substance after receiving the notice under paragraph (p)(1) of this section if the manufacturer was manufacturing, processing, distributing in commerce, or using the substance at the time of the notification and if the manufacturer submits written objections to EPA within 15 days of receipt of the notification. Such written objections must state the reasons why the manufacturer believes that the polymer will not present an unreasonable risk of injury to health or the environment. Manufacturers not manufacturing, processing, distributing in commerce, or using the substance at the time of the notification may not begin manufacture until EPA makes its final determination under paragraph (p)(3) of this section.
(3) EPA will consider any objections submitted under paragraph (p)(2) of this section and will make a final determination on whether to revoke the exemption. EPA will notify the manufacturer of the final determination by certified mail within 15 days of receipt of the objections submitted under paragraph (p)(2) of this section.
(4) Within 24 hours of receipt of a final determination from EPA that an exemption is revoked, the manufacturer of the substance for which the exemption was revoked shall cease all manufacturing, processing, distribution in commerce, and use of that substance. The manufacturer may not resume manufacture, processing, distribution in commerce, or use until it submits a premanufacture notice under section 5(a)(1) of the Act and part 720 of this chapter and the notice review period has ended.
(5) Action under this paragraph does not preclude action under any other applicable sections of the Act.
[FR Doc. 93 - 2776 Filed 2 - 5 - 93; 8:45 am]
BILLING CODE 6560 - 50 - F
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