CO Risk-Based Eco.doc December 2008
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF POLLUTION PREVENTION AND TOXICS
REGULATION OF A NEW CHEMICAL SUBSTANCE
PENDING DEVELOPMENT OF INFORMATION
In the matter of: ) Premanufacture Notice Number:
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____________________ ) ____________________
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_________________________________________________________________
Consent Order and Determinations Supporting Consent Order
_________________________________________________________________
TABLE OF CONTENTS
Preamble
I. Introduction
II. Summary of Terms of the Order
III. Contents of PMN
IV. EPA's Assessment of Risk
V. EPA's Conclusions of Law
VI. Information Required to Evaluate Environmental Effects
Consent Order
I. Scope of Applicability and Exemptions
II. Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal
Pending Submission and Evaluation of Information
III. Recordkeeping
IV. Successor Liability Upon Transfer of Consent Order
V. Modification and Revocation of Consent Order
VI. Effect of Consent Order
Attachment A - Definitions
Attachment B - Notice of Transfer of Consent Order
PREAMBLE
I. INTRODUCTION
Under the authority of ?5(e) of the Toxic Substances Control Act ("TSCA") (15 U.S.C.
2604(e)), the Environmental Protection Agency ("EPA" or "the Agency") issues the attached
Order, regarding premanufacture notice ("PMN") P-_____________ for the chemical substance
___________________________ ("the PMN substance") submitted by
________________________ ("the Company"), to take effect upon expiration of the PMN
review period. The Company submitted the PMN to EPA pursuant to ?5(a)(1) of TSCA and 40
CFR Part 720.
Under ?15 of TSCA, it is unlawful for any person to fail or refuse to comply with any
provision of ?5 or any order issued under ?5. Violators may be subject to various penalties and
to both criminal and civil liability pursuant to ?16, and to specific enforcement and seizure
pursuant to ?17. In addition, chemical substances subject to an Order issued under ?5 of
TSCA, such as this one, are subject to the ?12(b) export notice requirement.
II. SUMMARY OF TERMS OF THE ORDER
The Consent Order for this PMN substance requires the Company to:
( ) submit to EPA certain toxicity testing at least 14 weeks before manufacturing or importing a
total of kilograms of the PMN substance;
( ) label the PMN substance and provide Material Safety Data Sheets ("MSDS") and worker
training in accordance with the provisions of the Hazard Communication Program section;
( ) not manufacture the PMN substance ;
( ) not process the PMN substance ;
( ) not use the PMN substance ;
( ) distribute the PMN substance only to a person who agrees to follow the same restrictions
(except the testing requirements) and to not further distribute the PMN substance until it has
been completely reacted;
( ) distribute the PMN substance only ;
( ) dispose of the PMN substance only by ;
( ) comply with the Release to Water provisions; and;
( ) maintain certain records.
III. CONTENTS OF PMN
Confidential Business Information Claims (Bracketed in the Preamble and Order):
Chemical Identity:
Specific:
Generic:
Use:
Specific:
Generic:
Maximum 12-Month Production Volume:
Test Data Submitted with PMN:
IV. EPA'S ASSESSMENT OF RISK
The following are EPA's predictions regarding the probable toxicity and environmental
releases of the PMN substance, based on the information currently available to the Agency.
Environmental Effects Summary:
[Note to Program Managers: If concern for the PMN substance is based on a chemical
category of concern, include the following reference to the New Chemicals Chemical
Category Website.]
See www.epa.gov/opptintr/newchems/pubs/chemcat.htm
Environmental Release Summary:
Manufacture
Process
Use
Consumer
# Sites
Workers
(#/site)
Exposure
(days/year)
Dermal Exposure
(mg/day)
Inhalation Exposure
(mg/day)
Drinking Water
Exposure (mg/day)
Releases
(days/year)
Release to Water
(kg/day)
Surface Water
Concentration (ppb)
Days Exceeding
Concern Level
V. EPA'S CONCLUSIONS OF LAW
The following findings constitute the basis of the Consent Order:
(a) EPA is unable to determine the potential for________________
_________________________________________________________________
from environmental release of the PMN substance. EPA therefore concludes, pursuant to ?
5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a
reasoned evaluation of the environmental effects of the PMN substance.
(b) In light of the potential risk of posed by the uncontrolled
manufacture, import, processing, distribution in commerce, use, and disposal of the PMN
substance, EPA has concluded, pursuant to ?5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled
manufacture, import, processing, distribution in commerce, use, and disposal of the PMN
substance may present an unreasonable risk of injury to the environment.
(c) In light of the estimated production volume and environmental release of the PMN
substance, EPA has further concluded, pursuant to ?5(e)(1)(A)(ii)(II) of TSCA, that the PMN
substance will be produced in substantial quantities and may reasonably be anticipated to enter
the environment in substantial quantities.
VI. INFORMATION REQUIRED TO EVALUATE ENVIRONMENTAL EFFECTS
Triggered Testing. The Order prohibits the Company from exceeding a specified
production volume unless the Company submits the information described in the Testing section
of this Order in accordance with the conditions specified in the Testing section.
Pending Testing. The following additional information would be required to evaluate the
following effects which may be caused by the PMN substance:
Information Effects Guidelines
The Order does not require submission of the above pended testing at any specified time or
production volume. However, the Order's restrictions on manufacture, import, processing,
distribution in commerce, use, and disposal of the PMN substance will remain in effect until the
Order is modified or revoked by EPA based on submission of that or other relevant information.
CONSENT ORDER
(a) Scope. The requirements of this Order apply to all commercial manufacturing, processing,
distribution in commerce, use and disposal of the chemical substance _______________ (P-__-
____)("the PMN substance") in the United States by ______________ ("the Company"), except
to the extent that those activities are exempted by paragraph (b).
(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal of the
PMN substance is exempt from the requirements of this Order (except the requirements in the
Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the
extent that (1) these activities are conducted in full compliance with all applicable requirements
of the following exemptions, and (2) such compliance is documented by appropriate
recordkeeping as required in the Recordkeeping section of this Order.
(1) Completely Reacted (Cured). The requirements of this Order do not apply to quantities
of the PMN substance after they have been completely reacted (cured) or ________. [Note to
Program Managers: If applicable to the specific PMN substance, identify a state or states in
which exposure to the PMN substance no longer presents a significant risk, e.g.,
"incorporated into a polymer matrix", "adhered onto film", or similar.]
(2) De Minimis Concentrations. The requirements of this Order do not apply to quantities
of the PMN substance that are (1) present in the work area only as a mixture and (2) at a
concentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or volume if
the PMN substance is identified as a potential carcinogen in paragraph (f) of the Hazard
Communication Program section of this Order). This exemption is not available if the Company
has reason to believe that, during intended activities, the PMN substance in the mixture may be
reconcentrated above the 1.0 or 0.1 percent level, whichever applies. If his Order contains New
Chemical Exposure Limits provisions or Release to Water provisions that, respectively, specify a
NCEL concentration ("TWA") or in-stream concentration ("N") less than the de minimis
concentration specified here, then this de minimis exemption does not apply to those provisions.
(3) Export. Until the Company begins commercial manufacture of the PMN substance for
use in the United States, the requirements of this Order do not apply to manufacture, processing or
distribution in commerce of the PMN substance solely for export in accordance with TSCA ?2(a)
and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to
manufacture the PMN substance for use in the United States, no further activity by the Company
involving the PMN substance is exempt as "solely for export" even if some amount of the PMN
substance is later exported. At that point, the requirements of this Order apply to all activities
associated with the PMN substance while in the territory of the United States. Prior to leaving
U.S. territory, even those quantities or batches of the PMN substance that are destined for export
are subject to terms of the Order, and count towards any production volume test triggers in the
Testing section of this Order.
(4) Research & Development ("R&D"). The requirements of this Order do not apply to
manufacturing, processing, distribution in commerce, use and disposal of the PMN substance in
small quantities solely for research and development in accordance with TSCA ?(h)(3), 40 CFR
720.3(cc), and 40 CFR 720.36. The requirements of this Order also do not apply to
manufacturing, processing, distribution in commerce, use and disposal of the PMN substance when
manufactured solely for non-commercial research and development per 40 CFR 720.30(i) and
TSCA ?(i).
(5) Byproducts. The requirements of this Order do not apply to the PMN substance when
it is produced, without separate commercial intent, only as a "byproduct" as defined at 40 CFR
720.3(d) and in compliance with 40 CFR 720.30(g).
(6) No Separate Commercial Purpose. The requirements of this Order do not apply to the
PMN substance when it is manufactured, pursuant to any of the exemptions in 40 CFR 720.30(h),
with no commercial purpose separate from the substance, mixture, or article of which it is a part.
(7) Imported Articles. The requirements of this Order do not apply to the PMN substance
when it is imported as part of an "article" as defined at 40 CFR 720.3(c) and in compliance with 40
CFR 720.22(b)(1).
(c) Automatic Sunset. If the Company has obtained for the PMN substance a Test Market
Exemption ("TME") under TSCA ?(h)(1) and 40 CFR 720.38 or a Low Volume Exemption
("LVE") or Low Release and Exposure Exemption ("LoREX") under TSCA ?(h)(4) and 40 CFR
723.50(c)(1) and (2) respectively, any such exemption is automatically rendered null and void as
of the effective date of this Consent Order.
II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,
DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL
PENDING SUBMISSION AND EVALUATION
OF INFORMATION
PROHIBITION
The Company is prohibited from manufacturing, importing, processing, distributing in
commerce, using, or disposing of the PMN substance in the United States, for any nonexempt
commercial purpose, pending the development of information necessary for a reasoned evaluation
of the environmental effects [Note to Program Managers: Edit as appropriate.] of the
substance, and the completion of EPA's review of, and regulatory action based on, that
information, except in accordance with the conditions described in this Order.
TESTING
(a) Section 8(e) Reporting. Any information on the PMN substance which reasonably supports
the conclusion that the PMN substance presents a substantial risk of injury to health or the
environment, which is required to be reported under EPA's section 8(e) policy statement at 43
Federal Register 11110 (March 16, 1978), 68 Federal Register 33129 (June 3, 2003), and 70
Federal Register 2162 (January 12, 2005), shall reference the appropriate PMN identification
number for this substance and shall contain a statement that the substance is subject to this Consent
Order. Additional information regarding section 8(e) reporting requirements can be found in the
reporting guide referenced at 56 Federal Register 28458 (June 20, 1991).
(b) Notice of Study Scheduling. The Company shall notify, in writing, the EPA Laboratory Data
Integrity Branch (2225A), Office of Enforcement and Compliance Assurance, U.S. Environmental
Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, of the following
information within 10 days of scheduling any study required to be performed pursuant to this
Order, or within 15 days after the effective date of this Order, whichever is later:
(1) The date when the study is scheduled to commence;
(2) The name and address of the laboratory which will conduct the study;
(3) The name and telephone number of a person at the Company or the laboratory whom
EPA may contact regarding the study; and,
(4) The appropriate PMN identification number for each substance and a statement that the
substance is subject to this Consent Order.
(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be performed
pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards
at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific
community at the time the study is initiated. Before starting to conduct any such study, the
Company must obtain approval of test protocols from EPA by submitting written protocols. EPA
will respond to the Company within 4 weeks of receiving the written protocols. Published test
guidelines specified in paragraph (d) provide general guidance for development of test protocols,
but are not themselves acceptable protocols. EPA approval of a test protocol does not mean pre-
acceptance of test results.
(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or
importing the PMN substance beyond the following aggregate manufacture and import volumes
("the production limits"), unless the Company conducts the following studies on the PMN
substance and submits all final reports and underlying data in accordance with the conditions
specified in this Testing section.
Production Limit Study Guideline
Algal toxicity, Tiers I and II OPPTS 850.5400
(Static method/nominal conditions)
Aquatic invertebrate acute toxicity OPPTS 850.1010
test, freshwater daphnids
(Flow through conditions/
measured concentrations)
Fish acute toxicity OPPTS 850.1075
(Flow through conditions/
measured concentrations)
(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in
a scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of each
study; and (3) submit, in triplicate (with an additional sanitized copy, if confidential business
information is involved), the final report of each study and all underlying data ("the report and
data") to EPA no later than 14 weeks prior to exceeding the applicable production limit. The final
report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted
to EPA in accordance with the applicable "Reporting," "Data and Reporting," and "Test Report"
subparagraphs in the applicable test guidelines. However, for purposes of this Consent Order, the
word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the
submission of such information is mandatory. EPA will require the submission of raw data such as
slides and laboratory notebooks only if EPA finds, on the basis of professional judgment, that an
adequate evaluation of the study cannot take place in the absence of these items.
(f) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) of
this Testing section if notified in writing by EPA that it is unnecessary to conduct that study.
(g) Equivocal Data. If EPA finds that the data generated by a study are scientifically equivocal,
the Company may continue to manufacture and import the PMN substance beyond the applicable
production limit. To seek relief from any other restrictions of this Order, the Company may make
a second attempt to obtain unequivocal data by reconducting the study under the conditions
specified in paragraphs (b), (c), and (e)(1) and (2). The testing requirements may be modified, as
necessary to permit a reasoned evaluation of the risks presented by the PMN substance, only by
mutual consent of EPA and the Company.
(h) EPA Determination of Invalid Data.
(1) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA's receipt of a test
report and data, the Company receives written notice that EPA finds that the data generated by a
study are scientifically invalid, the Company is prohibited from further manufacture and import of
the PMN substance beyond the applicable production limit.
(2) The Company may continue to manufacture and import the PMN substance beyond the
applicable production limit only if so notified, in writing, by EPA in response to the Company's
compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii).
(i) The Company may reconduct the study in compliance with paragraphs (b), (c),
and (e)(1) and (2). If there is sufficient time to reconduct the study and submit the report and data
to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3),
the Company shall comply with subparagraph (e)(3). If there is insufficient time for the Company
to comply with subparagraph (e)(3), the Company may exceed the production limit and shall
submit the report and data in triplicate to EPA within a reasonable period of time, all as specified
by EPA in the notice described in subparagraph (h)(1). EPA will respond to the Company, in
writing, within 6 weeks of receiving the Company's report and data.
(ii) The Company may, within 4 weeks of receiving from EPA the notice described
in subparagraph (h)(1), submit to EPA a written report refuting EPA's finding. EPA will respond
to the Company, in writing, within 4 weeks of receiving the Company's report.
(i) Company Determination of Invalid Data.
(1) Except as described in subparagraph (i)(2), if the Company becomes aware that
circumstances clearly beyond the control of the Company or laboratory will prevent, or have
prevented, development of scientifically valid data under the conditions specified in paragraphs (c)
and (e), the Company remains prohibited from further manufacture and import of the PMN
substance beyond the applicable production limit.
(2) The Company may submit to EPA, within 2 weeks of first becoming aware of such
circumstances, a written statement explaining why circumstances clearly beyond the control of the
Company or laboratory will cause or have caused development of scientifically invalid data. EPA
will notify the Company of its response, in writing, within 4 weeks of receiving the Company's
report. EPA's written response may either:
(i) allow the Company to continue to manufacture and import the PMN substance
beyond the applicable production limit, or
(ii) require the Company to continue to conduct, or to reconduct, the study in
compliance with paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to conduct or
reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the
production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph
(e)(3). If there is insufficient time for the Company to comply with subparagraph (e)(3), the
Company may exceed the production limit and shall submit the report and data in triplicate to EPA
within a reasonable period of time, all as specified by EPA in the notice described in subparagraph
(i)(2). EPA will respond to the Company, in writing, within 6 weeks of receiving the Company's
report and data, as to whether the Company may continue to manufacture and import beyond the
applicable production limit.
(j) Unreasonable Risk.
(1) EPA may notify the Company in writing that EPA finds that the data generated by a
study are scientifically valid and unequivocal and indicate that, despite the terms of this Order, the
PMN substance will or may present an unreasonable risk of injury to human health or the
environment. EPA's notice may specify that the Company undertake certain actions concerning
further testing, manufacture, import, processing, distribution, use and/or disposal of the PMN
substance to mitigate exposures to or to better characterize the risks presented by the PMN
substance. Within 2 weeks from receipt of such a notice, the Company must cease all
manufacture, import, processing, distribution, use and disposal of the PMN substance, unless
either:
(2) within 2 weeks from receipt of the notice described in subparagraph (j)(1), the
Company complies with such requirements as EPA's notice specifies; or
(3) within 4 weeks from receipt of the notice described in subparagraph (j)(1), the
Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of any
additional requirements imposed by EPA. The Company may continue to manufacture, import,
process, distribute, use and dispose of the PMN substance in accordance with the terms of this
Order pending EPA's response to the Company's written report. EPA will respond to the
Company, in writing, within 4 weeks of receiving the Company's report. Within 2 weeks of
receipt of EPA's written response, the Company shall comply with any requirements imposed by
EPA's response or cease all manufacture, import, processing, distribution, use and disposal of the
PMN substance.
(k) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing
section, the Company must continue to obey all the terms of this Consent Order until otherwise
notified in writing by EPA. The Company may, based upon submitted test data or other relevant
information, petition EPA to modify or revoke provisions of this Consent Order pursuant to Part
VI. of this Consent Order.
HAZARD COMMUNICATION PROGRAM
(a) Written Hazard Communication Program. The Company shall develop and implement a
written hazard communication program for the PMN substance in each workplace. The written
program will, at a minimum, describe how the requirements of this section for labels, MSDSs, and
other forms of warning material will be satisfied. The Company must make the written hazard
communication program available, upon request, to all employees, contractor employees, and their
designated representatives. The Company may rely on an existing hazard communication
program, including an existing program established under the Occupational Safety and Health
Administration ("OSHA") Hazard Communication Standard (29 CFR 1910.1200), to comply with
this paragraph provided that the existing hazard communication program satisfies the requirements
of this section. The written program shall include the following:
(1) A list of chemical substances known to be present in the work area which are subject to
a TSCA section 5(e) consent order signed by the Company or to a TSCA section 5(a)(2) SNUR at
40 C.F.R. Part 721, subpart E. The list must be maintained in each work area where the PMN
substance is known to be present and must use the identity provided on the MSDS for the
substance required under paragraph (c) of this section. The list may be compiled for the workplace
or for individual work areas. If the Company is required either by another Order issued under
section 5(e) of TSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, to
maintain a list of substances, the lists shall be combined with the list under this subparagraph.
(2) The methods the Company will use to inform employees of the hazards of non-routine
tasks involving the PMN substance (e.g., cleaning of reactor vessels), and the hazards associated
with the PMN substance contained in unlabeled pipes in their work area.
(3) The methods the Company will use to inform contractors of the presence of the PMN
substance in the Company's workplace and of the provisions of this Order if employees of the
contractor work in the Company's workplace and are reasonably likely to be exposed to the PMN
substance while in the Company's workplace.
(b) Labeling.
(1) The Company shall ensure that each container of the substance in the workplace is
labeled in accordance with this subparagraph (b)(1).
(i) The label shall, at a minimum, contain the following information:
(I) A statement of the health hazards(s) and precautionary measure(s), if
any, identified in paragraph (f) of this section or by the Company, for the PMN substance.
(II) The identity by which the PMN substance may be commonly
recognized.
(III) A statement of the environmental hazard(s) and precautionary
measure(s), if any, identified in paragraph (f) of this section, or by the Company, for the PMN
substance.
(IV) A statement of exposure and precautionary measure(s), if any,
identified in paragraph (f) of this section, or by the Company, for the PMN substance.
(ii) The Company may use signs, placards, process sheets, batch tickets, operating
procedures, or other such written materials in lieu of affixing labels to individual stationary process
containers, as long as the alternative method identifies the containers to which it is applicable and
conveys information specified by subparagraph (b)(1)(i) of this section. Any written materials
must be readily accessible to the employees in their work areas throughout each work shift.
(iii) The Company need not label portable containers into which the PMN
substance is transferred from labeled containers, and which are intended only for the immediate
use of the employee who performs the transfer.
(iv) The Company shall not remove or deface an existing label on containers of the
PMN substance obtained from persons outside the Company unless the container is immediately
re-labeled with the information specified in subparagraph (b)(1)(i) of this section.
(2) The Company shall ensure that each container of the substance leaving its workplace
for distribution in commerce is labeled in accordance with this subparagraph (b)(2).
(i) The label shall, at a minimum, contain the following information:
(I) The information prescribed in subparagraph (b)(1)(i) of this section.
(II) The name and address of the manufacturer or a responsible party who
can provide additional information on the substance for hazard evaluation and any appropriate
emergency procedures.
(ii) The label shall not conflict with the requirements of the Hazardous Materials
Transportation Act (18 U.S.C. 1801 et. seq.) and regulations issued under that Act by the
Department of Transportation.
(3) The label, or alternative forms of warning, shall be legible and prominently displayed.
(4) The label, or alternative forms of warning, shall be printed in English; however, the
information may be repeated in other languages.
(5) If the label or alternative form of warning is to be applied to a mixture containing the
PMN substance in combination with any other substance that is either subject to another TSCA
section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40
CFR Part 721, subpart E, or defined as a "hazardous chemical" under the OSHA Hazard
Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS,
or alternative form of warning, the measures to control worker exposure or environmental release
which the Company determines provide the greatest degree of protection. However, should these
control measures differ from the applicable measures required under this Order, the Company must
seek a determination of equivalency for such alternative control measures pursuant to 40 CFR
721.30 before prescribing them under this subparagraph (b)(5).
(6) If the Company becomes aware of any significant new information regarding the
hazards of the PMN substance or ways to protect against the hazards, this new information must be
added to the label within 3 months from the time the Company becomes aware of the new
information. If the PMN substance is not being manufactured, imported, processed, or used in the
Company's workplace, the Company must add the new information to the label before the PMN
substance is reintroduced into the workplace.
(c) Material Safety Data Sheets.
(1) The Company must obtain or develop an MSDS for the PMN substance.
(2) The MSDS shall contain, at a minimum, the following information:
(i) The identity used on the container label of the PMN substance under this
section, and, if not claimed confidential, the chemical and common name of the PMN substance.
If the chemical and common names are claimed confidential, a generic chemical name must be
used.
(ii) Physical and chemical characteristics of the substance known to the Company,
(e.g., vapor pressure, flash point).
(iii) The physical hazards of the substance known to the Company, including the
potential for fire, explosion, and reactivity.
(iv) The potential human and environmental hazards as specified in paragraph (f)
of this section.
(v) Signs and symptoms of exposure, and any medical conditions which are
expected to be aggravated by exposure to the PMN substance known to the Company.
(vi) The primary routes of exposure to the PMN substance.
(vii) Precautionary measures to control worker exposure and/or environmental
release required by this Order, or alternative control measures which EPA has determined under 40
CFR 721.30 provide substantially the same degree of protection as the identified control measures.
(viii) Any generally applicable precautions for safe handling and use of the PMN
substance which are known to the Company, including appropriate hygienic practices, protective
measures during repair and maintenance of contaminated equipment, and procedures for response
to spills and leaks.
(ix) Any generally applicable control measures which are known to the Company,
such as appropriate engineering controls, work practices, or personal protective equipment.
(x) Emergency first aid procedures known to the Company.
(xi) The date of preparation of the MSDS or of its last revision.
(xii) The name, address, and telephone number of the Company or another
responsible party who can provide additional information on the chemical substance and any
appropriate emergency procedures.
(3) If no relevant information is found or known for any given category on the MSDS, the
Company must mark the MSDS to indicate that no applicable information was found.
(4) Where multiple mixtures containing the PMN substance have similar compositions
(i.e., the chemical ingredients are essentially the same, but the specific composition varies from
mixture to mixture) and similar hazards, the Company may prepare one MSDS to apply to all of
these multiple mixtures.
(5) If the Company becomes aware of any significant new information regarding the
hazards of the PMN substance or ways to protect against the hazards, this new information must be
added to the MSDS within 3 months from the time the Company becomes aware of the new
information. If the PMN substance is not being manufactured, imported, processed, or used in the
Company's workplace, the Company must add the new information to the MSDS before the PMN
substance is reintroduced into the workplace.
(6) The Company must ensure that persons receiving the PMN substance from the
Company are provided an appropriate MSDS with their initial shipment and with the first shipment
after an MSDS is revised. The Company may either provide the MSDS with the shipped
containers or send it to the person prior to or at the time of shipment.
(7) The Company must maintain a copy of the MSDS in its workplace, and must ensure
that it is readily accessible during each work shift to employees when they are in their work areas.
(8) The MSDS may be kept in any form, including as operating procedures, and may be
designed to cover groups of substances in a work area where it may be more appropriate to address
the potential hazards of a process rather than individual substances. However, in all cases, the
required information must be provided for the PMN substance and must be readily accessible
during each work shift to employees when they are in their work areas.
(9) The MSDS must be printed in English; however, the information may be repeated in
other languages.
(d) Employee Information and Training. The Company must ensure that employees are provided
with information and training on the PMN substance. This information and training must be
provided at the time of each employee's initial assignment to a work area containing the PMN
substance and whenever the PMN substance is introduced into the employee's work area for the
first time.
(1) The information provided to employees under this paragraph shall include:
(i) The requirements of this section.
(ii) Any operations in the work area where the PMN substance is present.
(iii) The location and availability of the written hazard communication program
required under paragraph (a) of this section, including the list of substances required by
subparagraph (a)(1) of this section and MSDSs required by paragraph (c) of this section.
(2) The training provided to employees shall include:
(i) Methods and observations that may be used to detect the presence or release of
the PMN substance in or from an employee's work area (such as exposure monitoring conducted
by the Company, continuous monitoring devices, visual appearance, or odor of the substance when
being released).
(ii) The potential human health and environmental hazards of the PMN substance
as specified in paragraph (f) of this section.
(iii) The measures employees can take to protect themselves and the environment
from the PMN substance, including specific procedures the Company has implemented to protect
employees and the environment from exposure to the PMN substance, including appropriate work
practices, emergency procedures, personal protective equipment, engineering controls, and other
measures to control worker exposure and/or environmental release required under this Order, or
alternative control measures which EPA has determined under 40 CFR 721.30 provide the same
degree of protection as the specified control measures.
(iv) The requirements of the hazard communication program developed by the
Company under this section, including an explanation of the labeling system and the MSDS
required by this section and guidance on obtaining and using appropriate hazard information.
(e) Existing Hazard Communication Program. The Company need not take additional actions if
existing programs and procedures satisfy the requirements of this section.
(f) Environmental Hazard and Precautionary Statements. The following environmental hazard
and precautionary statements shall appear on each label as specified in paragraph (b) and the
MSDS as specified in paragraph (c) of this section:
(1) Environmental hazard statements. This substance may be:
(i) toxic to fish.
(ii) toxic to aquatic organisms.
(2) Environmental hazard precautionary statements. Notice to users:
(i) disposal restrictions apply.
(ii) spill clean-up restrictions apply.
(iii) do not release to water.
(3) The human and environmental hazard and precautionary statement on the label
prepared pursuant to paragraph (b) of this section must be followed by the statement: "See the
MSDS for details."
MANUFACTURING
(a)(1) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import
of the PMN substance by any other person.
(2) Sunset Following SNUR. Subparagraph (a)(1) shall expire 75 days after promulgation
of a final significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2)
of TSCA unless the Company is notified on or before that day of an action in a Federal Court
seeking judicial review of the SNUR. If the Company is so notified, subparagraph (a)(1) shall not
expire until EPA notifies the Company in writing that all Federal Court actions involving the
SNUR have been resolved and the validity of the SNUR affirmed.
(3) Notice of SNUR. When EPA promulgates a final SNUR for the PMN substance and
subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Company shall notify each
person whom it causes, encourages or suggests to manufacture or import the PMN substance of the
existence of the SNUR.
(b) The Company shall not manufacture the PMN substance:
(1) In non-enclosed processes;
(2) In the United States;
(3) Beyond an aggregate manufacture and importation volume of ;
(4) Beyond an annual manufacture and importation volume of ;
(5) In the form of a powder;
(6) In the form of a solid;
(7) In the form of a liquid;
(8) In the form of a gas; or
(9) Other: .
PROCESSING
(a) The Company shall not process the PMN substance:
(1) In non-enclosed processes;
(2) Beyond the site of manufacture or import;
(3) In the form of a powder;
(4) In the form of a solid;
(5) In the form of a liquid;
(6) In the form of a gas; or
(7) Other: .
USE
(a) The Company shall not use the PMN substance:
(1) In non-enclosed processes;
(2) Beyond the site of manufacture or import;
(3) Other than as an intermediate;
(4) Other than as a site-limited intermediate;
(5) As an intermediate where the concentration of the PMN substance in the product
intended for distribution in commerce exceeds percent;
(6) Other than as described in the PMN;
(7) For non-industrial applications;
(8) For commercial applications;
(9) For non-commercial applications;
(10) In consumer products;
(11) In the form of a powder;
(12) In the form of a solid;
(13) In the form of a liquid;
(14) In the form of a gas;
(15) Involving an application method that generates a vapor, mist, or aerosol;
(16) Involving an application method that generates a dust; or
(17) Other: .
DISTRIBUTION
(a) Export Notice Requirement. Prior to the date of distribution, the Company shall notify in
writing any person to whom it distributes the PMN substance that, due to the issuance of this
Consent Order under section 5(e) of TSCA, the PMN substance is subject to the export notification
requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in
the form in which it appears in this Consent Order, the following information: (1) the PMN
number, and (2) either (A) the specific chemical identity of the PMN substance, or (B) if the
specific chemical identity is confidential, the generic chemical identity.
(b) Distribution Requirements. (i) Except after the PMN has been completely reacted (or
________), [Note to Program Managers: If applicable to the specific PMN substance, identify
a state or states in which exposure to the PMN substance no longer presents a significant
risk, e.g., "incorporated into a polymer matrix", "adhered onto film", or similar.] or as
provided in paragraph (b), the Company shall distribute the PMN substance outside the Company,
other than for disposal, only to a person who has agreed in writing prior to the date of distribution,
to:
(1) Notify in writing any person to whom it distributes the PMN substance that, due to the
issuance of this Consent Order under section 5(e) of TSCA, the PMN substance is subject to the
export notification requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D. Such
notice shall contain, in the form in which it appears in this Consent Order, the following
information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN
substance, or (B) if the specific chemical identity is confidential, the generic chemical identity.
(2) Not further distribute the PMN substance to any other person, other than for disposal,
until after the PMN substance has been completely reacted (cured) or _________. [Note to
Program Managers: If applicable to the specific PMN substance, identify a state or states in
which exposure to the PMN substance no longer presents a significant risk, e.g.,
"incorporated into a polymer matrix", "adhered onto film", or similar.]
(3) Comply with the same requirements and restrictions, if any, required of the Company
in the Protection in the Workplace and the New Chemical Exposure Limit sections of this Order,
or _______.
(4) Comply with the same requirements and restrictions, if any, required of the Company
in the Hazard Communication Program section of this Order, or______.
(5) Comply with the same environmental release restrictions, if any, required of the
Company in the Disposal and Release to Water sections of this Order, or _______.
(6) Not process the PMN substance:
(i) In non-enclosed processes;
(ii) At a site not in that person's control;
(iii) Except as described in the PMN;
(iv) In the form of a powder;
(v) In the form of a solid;
(vi) In the form of a liquid;
(vii) In the form of a gas; or
(viii) Other:____________.
(7) Not use the PMN substance:
(i) At a site not under the person's control;
(ii) In non-enclosed processes;
(iii) Other than as an intermediate;
(iv) Other than as a site-limited intermediate; or
(v) As an intermediate where the concentration of the PMN substance in the
product intended for distribution in commerce exceeds ____percent;
(vi) Other than as described in the PMN;
(vii) For non-industrial applications;
(viii) For commercial use;
(ix) For non-commercial use;
(x) In consumer products;
(xi) In the form of a powder;
(xii) In the form of a solid;
(xiii) In the form of a liquid;
(xiv) In the form of a gas;
(xv) Involving an application method that generates a vapor, mist, or aerosol;
(xvi) Involving an application method that generates a dust; or
(xvii) Other: ____________.
(ii) Disposal Exemption. Except for the ?2(b) export notice requirement in paragraph
(b)(i)(1) above, the distribution requirements in (b)(i) do not apply when the Company distributes
the PMN substance for disposal only. [Note to Program Managers: Delete this paragraph (ii) if
the Consent Order contains disposal restrictions.]
(c) Temporary Transport and Storage. Notwithstanding paragraph (b), the Company may
distribute the PMN substance outside the Company for temporary transport and storage in sealed
containers (labeled in accordance with paragraph (b)(2) of the Hazard Communication Program
section of this Order) provided the following two conditions are met:
(1) Subsequent to any such exempt temporary transport or storage of sealed containers, the
PMN substance may be distributed only to the Company or a person who has given the Company
the written agreement required by paragraph (b).
(2) Any human exposure or environmental release resulting from opening the sealed
containers and removing or washing out the PMN substance may occur only while the PMN
substance is in the possession and control of the Company or a person who has given the Company
the written agreement required by paragraph (b).
(d) Recipient Non-Compliance. If, at any time after commencing distribution in commerce of the
PMN substance, the Company obtains knowledge that a recipient of the substance has failed to
comply with any of the conditions specified in paragraph (b) of this Distribution section or, after
paragraph (b)(2) expires in accordance with subparagraph (e)(1), has engaged in a significant new
use of the PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a
significant new use notice to EPA, the Company shall cease supplying the substance to that
recipient, unless the Company is able to document each of the following:
(1) That the Company has, within 5 working days, notified the recipient in writing that the
recipient has failed to comply with any of the conditions specified in paragraph (b) of this
Distribution section, or has engaged in a significant new use of the PMN substance without
submitting a significant new use notice to EPA.
(2) That, within 15 working days of notifying the recipient of the noncompliance, the
Company received from the recipient, in writing, a statement of assurance that the recipient is
aware of the terms of paragraph (b) of this Distribution section and will comply with those terms,
or is aware of the terms of the significant new use rule for the PMN substance and will not engage
in a significant new use without submitting a significant new use notice to EPA.
(3) If, after receiving a statement of assurance from a recipient under subparagraph (d)(2)
of this Distribution section, the Company obtains knowledge that the recipient has failed to comply
with any of the conditions specified in paragraph (b) of this Distribution section, or has engaged in
a significant new use of the PMN substance without submitting a significant new use notice to
EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA of
the failure to comply, and shall resume supplying the PMN substance to that recipient only upon
written notification from the Agency.
(d) Sunset Following SNUR. (1) Paragraph (b)(2) of this Distribution section shall expire 75
days after promulgation of a final SNUR for the PMN substance under section 5(a)(2) of TSCA,
unless the Company is notified on or before that day of an action in a Federal Court seeking
judicial review of the SNUR. If the Company is so notified, paragraph (b)(2) of this Distribution
section shall not expire until EPA notifies the Company in writing that all Federal Court actions
involving the SNUR have been resolved and the validity of the SNUR affirmed.
(2) When EPA promulgates a final SNUR for the PMN substance and paragraph (b)(2) of this
Distribution section expires in accordance with subparagraph (e)(1), the Company shall notify each
person to whom it distributes the PMN substance of the existence of the SNUR. Such notification
must be in writing and must specifically include all limitations contained in the SNUR which are
defined as significant new uses, and which would invoke significant new use notification to EPA
for the PMN substance. Such notice must also reference the publication of the SNUR for this
PMN substance in either the Federal Register or the Code of Federal Regulations. After
promulgation of a SNUR and expiration of subparagraph (b)(2), such notice may substitute for the
written agreement required in the introductory clause of paragraph (b); so that, if the Company
provides such notice to the persons to whom it distributes the PMN substance, then the Company
is not required to obtain from such persons the written agreement specified in paragraph (b).
DISPOSAL
(a) The Company shall dispose of the PMN substance and any waste stream containing the PMN
substance only as follows. This provision does not supersede or preempt any applicable federal,
state, and local laws and regulations if those laws are more stringent than the requirements below.
(1) The PMN substance must be disposed of only by:
(i) incineration;
(ii) landfill;
(iii) deep well injection;
(iv) other:
(2) Waste streams from manufacture must be disposed of only by:
(i) incineration;
(ii) landfill;
(iii) deep well injection;
(iv) other:
(3) Waste streams from processing must be disposed of only by:
(i) incineration;
(ii) landfill;
(iii) deep well injection;
(iv) other:
(4) Waste streams from use must be disposed of only by:
(i) incineration;
(ii) landfill;
(iii) deep well injection;
(iv) other:
(5) The Company shall not dispose of or release the PMN substance into the environment.
RELEASE TO WATER
(a) This provision does not supersede or preempt any applicable federal, state, and local laws and
regulations. (Those other laws may be more stringent than the requirements below.) The
Company is prohibited from any predictable or purposeful release of the PMN substance, or any
waste stream from (manufacturing/processing/use) containing the PMN
substance:
(1) Into the waters of the United States;
(2) Into the waters of the United States without application of one or more of the following
specified treatment technologies either by the discharger or, in the case of a release through
publicly-owned treatment works, by a combination of treatment by the discharger and the publicly-
owned treatment works:
(i) Chemical precipitation and settling;
(ii) Biological treatment (activated sludge or equivalent) plus clarification;
(iii) Stream stripping;
(iv) Resin or activated carbon adsorption;
(v) Chemical destruction or conversion;
(vi) Primary wastewater treatment;
(3) Into the waters of the United States without primary wastewater treatment, and
secondary wastewater treatment as defined in 40 CFR Part 133.
(4)(i) Into the waters of the United States if the quotient from the formula:
number of kilograms/day/site released
-------------------------------------------------x 1000 = N parts per billion
receiving stream flow (million liters/day)
exceeds , when calculated using the methods described in 40 CFR 721.91. However, 40
CFR 721.91(a)(4) does not apply. Instead, if the waste stream containing the PMN substance will
be treated using , then the amount of PMN substance reasonably likely to be removed
from the waste stream by such treatment may be subtracted in calculating the number of kilograms
released. No more than percent removal efficiency may be attributed to such treatment. [Note
to Program Managers: Use this language, starting from "However, 40 CFR 721.91(a)(4) does
not..." only when EPA has received and reviewed removal rate data..]
(ii) In lieu of calculating the quotient in subparagraph (4)(i), monitoring or alternative
calculations may be used to predict the surface water concentration expected to result from the
intended release of the substance, if the monitoring procedures or calculations have been approved
for such purpose by EPA. EPA will review and act on a written request to approve monitoring
procedures or alternative calculations within 90 days after such a request is received. The Agency
will inform the Company of the disposition of such requests in writing and, where a request is
denied, will explain the reasons therefore.
III. RECORDKEEPING
(a) Records. The Company shall maintain the following records until 5 years after the date they
are created and shall make them available for inspection and copying by EPA in accordance with
section 11 of TSCA:
(1) Exemptions. Records documenting that the PMN substance did in fact qualify for any
one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records
must satisfy all the statutory and regulatory recordkeeping requirements applicable to the
exemption being claimed by the Company. Any amounts or batches of the PMN substance
eligible for the Export exemption in Section I, Paragraph (b)(3) of this Order are exempt from all
the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the
date of their creation, copies of the export label and export notice to EPA, required by TSCA
sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches of the PMN substance
eligible for the Research and Development exemption in Section I, Paragraph (b)(4) of this Order
are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for
5 years from the date of their creation, the records required by 40 CFR 720.78(b). For any
amounts or batches of the PMN substance claimed to be eligible for any other exemption described
in Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating
qualification for that exemption as well as the records specified in paragraphs (2) and (3) below,
but is exempt from the other recordkeeping requirements in this Recordkeeping section;
(2) Records documenting the manufacture and importation volume of the PMN substance
and the corresponding dates of manufacture and import;
(3) Records documenting the names and addresses (including shipment destination
address, if different) of all persons outside the site of manufacture or import to whom the Company
directly sells or transfers the PMN substance, the date of each sale or transfer, and the quantity of
the substance sold or transferred on such date;
(4) Records documenting the address of all sites of manufacture, import, processing, and
use;
(5) Records documenting establishment and implementation of the hazard communication
program required by the Hazard Communication Program section of this Order;
(6) Copies of labels required under the Hazard Communication Program section of this
Order;
(7) Copies of Material Safety Data Sheets required by the Hazard Communication
Program section of this Order;
(8) Records documenting compliance with any applicable manufacturing, processing, use,
and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections of
this Order, including distributees' written agreement to comply with the Distribution section of this
Order;
(9) Records documenting compliance with any applicable disposal requirements under the
Disposal section of this Order, including method of disposal, location of disposal sites, dates of
disposal, and volume of PMN substance disposed. Where the estimated disposal volume is not
known to the Company and is not reasonably ascertainable by the Company, the Company must
maintain other records which demonstrate establishment and implementation of a program that
ensures compliance with any applicable disposal requirements;
(10) Records documenting establishment and implementation of procedures that ensure
compliance with any applicable water discharge limitation in the Release to Water section of this
Order;
(11) Copies of any Transfer Documents and notices required by the Successor Liability
section of this Order, if applicable; and,
(12) The Company shall keep a copy of this Order at each of its sites where the PMN
substance is manufactured or imported.
(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities
of the Company and its Contract Manufacturer, if applicable, and not to activities of the
Company's customers.
(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part
1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this "collection of
information" unless this Order displays a currently valid control number from the Office of
Management and Budget ("OMB"), and EPA so informs the Company. The "collection of
information" required in this TSCA ?(e) Consent Order has been approved under currently valid
OMB Control Number 2070-0012.
IV. REQUESTS FOR PRE-INSPECTION INFORMATION
(a) EPA's Request for Information. Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA
may occasionally conduct on-site compliance inspections of Company facilities and conveyances
associated with the PMN substance. To facilitate such inspections, EPA personnel may contact the
Company in advance to request information pertinent to the scheduling and conduct of such
inspections. Such requests may be written or oral. The types of information that EPA may request
include, but are not limited to, the following:
(i) Expected dates and times when the PMN substance will be in production within the
subsequent 12 months;
(ii) Current workshift schedules for workers who are involved in activities associated with
the PMN substance and may reasonably be exposed to the PMN substance;
(iii) Current job titles or categories for workers who are involved in activities associated
with the PMN substance and may reasonably be exposed to the PMN substance;
(iv) Existing exposure monitoring data for workers who are involved in activities
associated with the PMN substance and may reasonably be exposed to the PMN substance;
(v) Records required by the Recordkeeping section of this Order; and/or
(vi) Any other information reasonably related to determining compliance with this Order
or conducting an inspection for that purpose.
(b) Company's Response. The Company shall respond to such requests within a reasonable
period of time, but in no event later than 30 days after receiving EPA's request. When requested
in writing by EPA, the Company's response shall be in writing. To the extent the information is
known to or reasonably ascertainable to the Company at the time of the request, the Company's
response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers
to all of EPA's requests.
(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the
Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with ?4 of
TSCA and 40 CFR Part 2.
V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER
(a) Scope. This section sets forth the procedures by which the Company's rights and obligations
under this Order may be transferred when the Company transfers its interests in the PMN
substance, including the right to manufacture the PMN substance, to another person outside the
Company (the "Successor in Interest").
(b) Relation of Transfer Date to Notice of Commencement ("NOC").
(1) Before NOC. If the transfer from the Company to the Successor in Interest is effective
before EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN
substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a
new PMN to EPA and comply fully with Section 5(a)(1) of TSCA and 40 CFR part 720 before
commencing manufacture or import of the PMN substance.
(2) After NOC. If the transfer from the Company to the Successor in Interest is effective
after EPA receives a NOC, the Successor in Interest shall comply with the terms of this Order and
shall not be required to submit a new PMN to EPA.
(c) Definitions. The following definitions apply to this Successor Liability section of the Order:
(1) "Successor in Interest" means a person outside the Company who has acquired the
Company's full interest in the rights to manufacture the PMN substance, including all ownership
rights and legal liabilities, through a transfer document signed by the Company, as transferor, and
the Successor in Interest, as transferee. The term excludes persons who acquire less than the full
interest of the Company in the PMN substance, such as a licensee who has acquired a limited
license to the patent or manufacturing rights associated with the PMN substance. A Successor in
Interest must be incorporated, licensed, or doing business in the United States in accordance with
40 CFR 720.22(a)(3).
(2) "Transfer Document" means the legal instrument(s) used to convey the interests in the
PMN substance, including the right to manufacture the PMN substance, from the Company to the
Successor in Interest.
(d) Notices.
(1) Notice to Successor in Interest. On or before the effective date of the transfer, the
Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent
Order and the "Notice of Transfer" document which is incorporated by reference as Attachment B
to this Order.
(2) Notice to EPA. Within 10 business days of the effective date of the transfer, the
Company shall, by registered mail, submit the fully executed Notice of Transfer document to:
U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania
Avenue, N.W., Washington, D.C. 20460.
(3) Transfer Document. Copies of the Transfer Document must be maintained by the
Successor in Interest at its principal place of business, and at all sites where the PMN substance is
manufactured or imported. Copies of the Transfer Document must also be made available for
inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must
contain provisions which expressly transfer liability for the PMN substance under the terms of this
Order from the Company to the Successor in Interest.
(e) Liability.
(1) The Company shall be liable for compliance with the requirements of this Order until
the effective date of the transfer described above.
(2) The Successor in Interest shall be liable for compliance with the requirements of this
Order effective as of the date of transfer.
(3) Nothing in this section shall be construed to prohibit the Agency from taking
enforcement action against the Company after the effective date of the transfer for actions taken, or
omissions made, during the time in which the Company manufactured, processed, used, distributed
in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order.
(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing section
of this Consent Order requires the Company to submit test data to EPA at a specified production
volume ("test trigger"), the aggregate volume of the PMN substance manufactured and imported
by the Company up to the date of transfer shall count towards the test trigger applicable to the
Successor in Interest.
VI. MODIFICATION AND REVOCATION OF CONSENT ORDER
The Company may petition EPA at any time, based upon new information on the
environmental effects or environmental release of the PMN substance, to modify or revoke
substantive provisions of this Order. The exposures and risks identified by EPA during its review
of the PMN substance and the information EPA determined to be necessary to evaluate those
exposures and risks are described in the preamble to this Order. However, in determining whether
to amend or revoke this Order, EPA will consider all relevant information available at the time the
Agency makes that determination, including, where appropriate, any reassessment of the test data
or other information that supports the findings in this Order, an examination of new test data or
other information or analysis, and any other relevant information.
EPA will issue a modification or revocation if EPA determines that the activities proposed
therein will not present an unreasonable risk of injury to health or the environment and will not
result in significant or substantial human exposure or substantial environmental release in the
absence of data sufficient to permit a reasoned evaluation of the health or environmental effects of
the PMN substance.
In addition, the Company may petition EPA at any time to make other modifications to the
language of this Order. EPA will issue such a modification if EPA determines that the
modification is useful, appropriate, and consistent with the structure and intent of this Order as
issued.
VII. EFFECT OF CONSENT ORDER
By consenting to the entry of this Order, the Company waives its rights to file objections to
this Order pursuant to section 5(e)(1)(C) of TSCA, to receive service of this Order no later than 45
days before the end of the review period pursuant to section 5(e)(1)(B) of TSCA, and to challenge
the validity of this Order in any subsequent action. Consenting to the entry of this Order, and
agreeing to be bound by its terms, does not constitute an admission by the Company as to the facts
or conclusions underlying the Agency's determinations in this proceeding. This waiver does not
affect any other rights that the Company may have under TSCA.
_________________ _____________________________________
Date Jim Willis, Director
Chemical Control Division
Office of Pollution Prevention and Toxics
_________________ _____________________________________
Date Name:
Title:
Company:
ATTACHMENT A
DEFINITIONS
[Note: The attached Order may not contain some of the terms defined below.]
"Chemical name" means the scientific designation of a chemical substance in accordance
with the nomenclature system developed by the International Union of Pure and Applied
Chemistry or the Chemical Abstracts Service's rules of nomenclature, or a name which will clearly
identify a chemical substance for the purpose of conducting a hazard evaluation.
"Chemical protective clothing" means items of clothing that provide a protective barrier to
prevent dermal contact with chemical substances of concern. Examples can include, but are not
limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants.
"Company" means the person or persons subject to this Order.
"Commercial use" means the use of a chemical substance or any mixture containing the
chemical substance in a commercial enterprise providing saleable goods or a service to consumers
(e.g., a commercial dry cleaning establishment or painting contractor).
"Common name" means any designation or identification such as code name, code number,
trade name, brand name, or generic chemical name used to identify a chemical substance other
than by its chemical name.
"Consumer" means a private individual who uses a chemical substance or any product
containing the chemical substance in or around a permanent or temporary household or residence,
during recreation, or for any personal use or enjoyment.
"Consumer product" means a chemical substance that is directly, or as part of a mixture,
sold or made available to consumers for their use in or around a permanent or temporary
household or residence, in or around a school, or in recreation.
"Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage
tank, or the like that contains a hazardous chemical. For purposes of this section, pipes or piping
systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be
containers.
"Contract Manufacturer" means a person, outside the Company, who is authorized to
manufacture and import the PMN substance under the conditions specified in Part II. of this
Consent Order and in the Consent Order for Contract Manufacturer.
"Identity" means any chemical or common name used to identify a chemical substance or a
mixture containing that substance.
"Immediate use." A chemical substance is for the "immediate use" of a person if it is under
the control of, and used only by, the person who transferred it from a labeled container and will
only be used by that person within the work shift in which it is transferred from the labeled
container.
"Impervious." Chemical protective clothing is "impervious" to a chemical substance if the
substance causes no chemical or mechanical degradation, permeation, or penetration of the
chemical protective clothing under the conditions of, and the duration of, exposure.
"Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a
chemical substance, regardless of physical state or concentration, through all intended operations
of manufacture, including the cleaning of equipment.
"MSDS" means material safety data sheet, the written listing of data for the chemical
substance.
"NIOSH" means the National Institute for Occupational Safety and Health of the U.S.
Department of Health and Human Services.
"Non-enclosed process" means any equipment system (such as an open-top reactor, storage
tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise
used where significant direct contact of the bulk chemical substance and the workplace air may
occur.
"Non-industrial use" means use other than at a facility where chemical substances or
mixtures are manufactured, imported, or processed.
"PMN substance" means the chemical substance described in the Premanufacture notice
submitted by the Company relevant to this Order.
"Personal protective equipment" means any chemical protective clothing or device placed
on the body to prevent contact with, and exposure to, an identified chemical substance or
substances in the work area. Examples include, but are not limited to, chemical protective
clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and
various types of respirators. Barrier creams are not included in this definition.
"Process stream" means all reasonably anticipated transfer, flow, or disposal of a chemical
substance, regardless of physical state or concentration, through all intended operations of
processing, including the cleaning of equipment.
"Scientifically invalid" means any significant departure from the EPA-approved protocol
or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency
approval that prevents a reasoned evaluation of the health or environmental effects of the PMN
substance.
"Scientifically equivocal data" means data which, although developed in apparent
conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are
inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of
the potential risk of injury to human health or the environment of the PMN substance.
"Sealed container" means a closed container that is physically and chemically suitable for
long-term containment of the PMN substance, and from which there will be no human exposure to,
nor environmental release of, the PMN substance during transport and storage.
"Use stream" means all reasonably anticipated transfer, flow, or disposal of a chemical
substance, regardless of physical state or concentration, through all intended operations of
industrial, commercial, or consumer use.
"Waters of the United States" has the meaning set forth in 40 CFR 122.2.
"Work area" means a room or defined space in a workplace where the PMN substance is
manufactured, processed, or used and where employees are present.
"Workplace" means an establishment at one geographic location containing one or more
work areas.
ATTACHMENT B
NOTICE OF TRANSFER
OF
TOXIC SUBSTANCES CONTROL ACT
SECTION 5(e) CONSENT ORDER
___________________________ _________________
Company (Transferor) PMN Number
1. Transfer of Manufacture Rights. Effective on _______________, the Company did sell or
otherwise transfer to ________________________________, ("Successor in Interest") the rights
and liabilities associated with manufacture of the above-referenced chemical substance, which was
the subject of a premanufacture notice ("PMN") and is governed by a Consent Order issued by the
U.S. Environmental Protection Agency ("EPA") under the authority of ?(e) of the Toxic
Substances Control Act ("TSCA," 15 U.S.C. ?604(e)).
2. Assumption of Liability. The Successor in Interest hereby certifies that, as of the effective date
of transfer, all actions or omissions governed by the applicable Consent Order limiting
manufacture, processing, use, distribution in commerce and disposal of the PMN substance, shall
be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is
incorporated, licensed, or doing business in the United States in accordance with 40 CFR
720.22(a)(3).
3. Confidential Business Information. The Successor in Interest hereby:
___ reasserts,
___ relinquishes, or
___ modifies
all Confidential Business Information ("CBI") claims made by the Company, pursuant to Section
14 of TSCA and 40 CFR part 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is
indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is
indicated, such modification shall be explained in detail in an attachment to this Notice of
Transfer. Information which has been previously disclosed to the public (e.g., a chemical identity
that was not claimed as CBI by the original submitter) would not subsequently be eligible for
confidential treatment under this Notice of Transfer.
TOXIC SUBSTANCES CONTROL ACT
SECTION 5(e) CONSENT ORDER
NOTICE OF TRANSFER
(continued)
___________________________________ _____________________
Company (Transferor) PMN Number
___________________________________ _____________________
Signature of Authorized Official Date
___________________________________
Printed Name of Authorized Official
___________________________________
Title of Authorized Official
___________________________________
Successor in Interest
___________________________________ _____________________
Signature of Authorized Official Date
___________________________________
Printed Name of Authorized Official
___________________________________
Title of Authorized Official
___________________________________
Address
___________________________________
City, State, Zip Code
TOXIC SUBSTANCES CONTROL ACT
SECTION 5(e) CONSENT ORDER
NOTICE OF TRANSFER
(continued)
___________________________________
Successor's Technical Contact
___________________________________
Address
___________________________________
City, State, Zip Code
___________________________________
Phone
[DELETE INAPPLICABLE ENTRIES; LETTER REMAINING ENTRIES WITH
LOWER CASE LETTERS]
[DELETE THOSE ACTIVITY RESTRICTIONS WHICH ARE NOT DEPENDENT
UPON THE PENDING TESTING. FOR EXAMPLE, IF THE PENDING TESTING IS
FOR ECOTOXICITY, THEN THE ONLY ACTIVITY RESTRICTIONS WHICH WILL
REMAIN IN EFFECT PENDING THAT TESTING AND SHOULD BE LISTED HERE
ARE THE DISPOSAL RESTRICTIONS.]
[INCLUDE PARAGRAPHS (a), (b) and (c) IN ALL ORDERS. INCLUDE THE ENTIRE
TESTING SECTION IN ANY ORDERS WITH TRIGGERED TESTING. THE
CORRESPONDING SNUR CITATION FOR TRIGGERED TESTING IS THE
PRODUCTION VOLUME LIMIT AT 721.80(P) FOR NON-CBI PRODUCTION
VOLUMES AND 721.80(q) FOR CBI VOLUMES. IN ADDITION, FOR THE SNUR, YOU
MUST SPECIFY THE SNUR PRODUCTION VOLUME LIMIT. FOR TIERED
TESTING, THE SNUR VOLUME LIMIT SHOULD BE THE LOWEST PRODUCTION
VOLUME IN PARAGRAPH (d) OF THE CONSENT ORDER TESTING SECTION.]
[721.72(a)]
[CHECK]
[CHECK]
[CHECK]
[721.72(b)]
[CHECK]
[721.72(c)]
[CHECK]
[721.72(d)]
[CITE THE APPROPRIATE LANGUAGE FROM THE FOLLOWING; DELETE THE
REST AND RELETTER/NUMBER AS APPROPRIATE]
[721.72(g)(3)(i)]
[721.72(g)(3)(ii)]
[721.72(g)(4)(i)]
[721.72(g)(4)(ii)]
[721.72(g)(4)(iii)]
[ALL ORDERS:]
[721.72(g)(5)]
[INCLUDE PARAGRAPH (a) IN ALL ORDERS. THERE IS NO CORRESPONDING
SNUR PROVISION FOR PARAGRAPH (a).]
[MAKE SURE PUNCTUATION IS CORRECT IN FOLLOWING SECTIONS]
[721.80(b)]
[721.80(f)]
[INSERT VOLUME IN SNUR] [non-CBI] [721.80(p)]
[CBI] [721.80(q)]
[INSERT VOLUME [non-CBI][721.80(s)]
IN SNUR] [CBI] [721.80(t)]
[721.80(w)(1)]
[721.80(w)(2)]
[721.80(w)(3)]
[721.80(w)(4)]
[721.80(c)]
[721.80(e)]
[721.80(x)(1)]
[721.80(x)(2)]
[721.80(x)(3)]
[721.80(x)(4)]
[721.80(a)]
[721.80(d)]
[721.80(g)]
[721.80(h)]
[721.80(i)]
[721.80(j)]
[721.80(l)]
[721.80(m)]
[721.80(n)]
[721.80(o)]
[721.80(v)(1)]
[721.80(v)(2)]
[721.80(v)(3)]
[721.80(v)(4)]
[721.80(y)(1)]
[721.80(y)(2)]
[721.80(k)]
[ALWAYS INCLUDE SUBPARAGRAPH (a)(1) UNLESS THERE IS A GOOD REASON
NOT TO INCLUDE IT! THERE ARE NO CORRESPONDING SNUR CITATIONS FOR
THE PROVISIONS IN THIS DISTRIBUTION SECTION.]
[ALWAYS INCLUDE SUBPARAGRAPH (b)(2) UNLESS THERE IS A GOOD REASON NOT TO
INCLUDE IT! THERE ARE NO CORRESPONDING SNUR CITATIONS FOR THE PROVISIONS IN
THIS DISTRIBUTION SECTION.]
[OR SPECIFY APPROPRIATE PROVISIONS, IF IT IS INAPPROPRIATE FOR ALL OF THE
DISTRIBUTION PROVISIONS TO TERMINATE WHEN THE SNUR BECOMES EFFECTIVE]
[OR SPECIFY APPROPRIATE PROVISIONS, IF IT IS INAPPROPRIATE FOR ALL OF THE
DISTRIBUTION PROVISIONS TO TERMINATE WHEN THE SNUR BECOMES EFFECTIVE]
[OR SPECIFY APPROPRIATE PROVISIONS, IF IT IS INAPPROPRIATE FOR ALL OF THE
DISTRIBUTION PROVISIONS TO TERMINATE WHEN THE SNUR BECOMES EFFECTIVE]
[INCLUDE A PROVISION FROM THE DISPOSAL AND/OR RELEASE TO WATER
SECTIONS IN ALL RISK-BASED ORDERS WITH ECOTOX RISK OR HUMAN
HEALTH RISK FROM DRINKING WATER EXPOSURE.]
[721.85(a), (b), & (c)(1)]
[721.85(a), (b), & (c)(2)]
[721.85(a), (b), & (c)(3)]
[721.85(a)(1)]
[721.85(a)(2)]
[721.85(a)(3)]
[721.85(b)(1)]
[721.85(b)(2)]
[721.85(b)(3)]
[721.85(c)(1)]
[721.85(c)(2)]
[721.85(c)(3)]
[721.85(d)]
[INCLUDE A PROVISION FROM THE DISPOSAL AND/OR RELEASE TO WATER
SECTIONS IN ALL RISK-BASED ORDERS WITH ECOTOX OR HUMAN HEALTH
RISK FROM DRINKING WATER EXPOSURE.]
[TO COMPLETE THE BLANK SPACE IN THE FOLLOWING SNUR CITATIONS IN
THIS RELEASE TO WATER SECTION, E.G. 721.90(__)(1), INSERT "a" IN THE BLANK
FOR RELEASES FROM MANUFACTURING, "b" FOR PROCESSING, AND "c" FOR
USE.]
[721.90(__)(1)]
[721.90(__)(2)(i)]
[721.90(__)(2)(ii)]
[721.90(__)(2)(iii)]
[721.90(__)(2)(iv)]
[721.90(__)(2)(v)]
[721.90(__)(2)(vi)]
[721.90(__)(3)]
[721.90(__)(4)].
When appropriate and EETD/EAB concurs, you may add the following language to the Order and
SNUR:
However, contrary to 40 CFR 721.91(a)(4), if the waste stream containing the PMN substance will
be treated using _______________________________,
then the amount of PMN substance reasonably likely to be removed from the waste stream by such
treatment may be subtracted in calculating the number of kilograms released. No more than _____
percent removal efficiency may be attributed to such treatment.
To convert this comment language to regular text: place the cursor after the comment, then press
Ctrl-F5, 4, and 3.
[721.90(__)(4)]
[INCLUDE THOSE Record-keeping PROVISIONS WHICH CORRESPOND TO THE
SUBSTANTIVE REQUIREMENTS IN THE BODY OF THE CONSENT ORDER.
SUBPARAGRAPH (a)(1), PRODUCTION VOLUME, SHOULD BE INCLUDED IN ALL
ORDERS WITH TESTING TRIGGERS AND/OR DISPOSAL OR RELEASE TO WATER
RESTRICTIONS.]
[721.125(a) & (b)]
[721.125(c)]
[721.125(f)]
[721.125(g)]
[721.125(h)]
[DELETE THOSE ACTIVITIES FOR WHICH THERE ARE NO CORRESPONDING
SUBSTANTIVE REQUIREMENTS IN THE BODY OF THE ORDER]
[721.125(i)]
[721.125(j)]
[721.125(k)]
[ALL ORDERS]
[ALL RBH ORDERS WITH PROTECTIVE EQUIPMENT REQ'TS]
[ALL ORDERS]
[RBH OR RBE ORDERS WITH USE OR DISTRIBUTION SECTIONS CITING THIS WORD]
[ALL ORDERS]
[RBH OR RBE ORDERS WITH USE OR DISTRIBUTION SECTIONS CITING THIS WORD]
[RBH OR RBE ORDERS WITH USE OR DISTRIBUTION SECTIONS CITING THIS PHRASE]
[ALL ORDERS]
[ALL ORDERS WITH CONTRACT MANUFACTURER PROVISIONS]
[ALL ORDERS]
[ALL ORDERS]
[RBH ORDERS WITH DERMAL PROTECTION REQ'TS]
[RBH OR RBE ORDERS WITH DISPOSAL RESTRICTIONS]
[ALL ORDERS]
[RBH ORDERS W/ RESPIRATOR REQ'TS]
[RBH AND RBE ORDERS WITH MANUFACTURING, USE, OR DISTRIBUTION REQUIREMENTS
CITING THIS PHRASE]
[RBH AND RBE ORDERS WITH MANUFACTURING, USE, OR DISTRIBUTION REQUIREMENTS
CITING THIS PHRASE]
[ALL ORDERS]
[RBH ORDERS WITH PERSONAL PROTECTIVE EQUIPMENT REQ'TS]
[RBH AND RBE ORDERS WITH DISPOSAL RESTRICTIONS]
[ALL ORDERS WITH TESTING TRIGGERS]
[ALL ORDERS WITH TESTING TRIGGERS]
[RBH AND RBE ORDERS WITH DISPOSAL RESTRICTIONS]
[RBH AND RBE ORDERS W/ RELEASE TO WATER PROVISIONS]
[ALL ORDERS]
[ALL ORDERS]
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