TECHNICAL BULLETIN

     Registration Requirements for Surface Disinfectants



  Situation:

  A recent advertising campaign by Germiphene (refer to Appendix A and B), two flyers

  have been circulated at dental conventions and to dental offices titled: “Read the Label

  Don’t be Fooled� and “We Kill Fungi Do You?�



  This document has been prepared and third party reviewed to bring facts and clarity to

  the questions resulting from the published misinformation by Germiphene. This

  misinformation has caused many of you to contact us for clarification and we thank you

  for doing so, otherwise we may not have been aware this document existed.



  Virox Statement:

  To be clear, Virox feels that credible companies represent their products based on their

  merits, not by creating negative information on other products. That said, the details in

  this document will show:



     1. OPTIM 33 TB “is� in fact fungicidal (refer to Reference list to download report)

        and has a registered claim with Health Canada. The decision was made not to

        include it on the OPTIM 33 TB label.

     2. Fungi is not a suggested target pathogen per the Dental Association Guidelines.

     3. Health Canada regulations preclude the addition of claims at varied contact times.



  Please take the time to learn more by reading on.







  Registration Requirements for Health Canada:

  In Canada, the registration of disinfectants for use on surfaces or medical devices falls

  under the jurisdiction of the Therapeutic Products Programme and the associated

  Disinfectant Drugs Guideline for submission and registration of disinfectants. To be

sold in Canada as a disinfectant for use in the Healthcare Market (hospitals, long-term-

care, dental offices, doctors offices, etc) a product must identify itself with a Drug

Identification Number (DIN). Registrations and approvals for use as a disinfectant

received from outside of Canada that do not include a DIN are not approved for sale or

use in Canada. Additionally, testing conducted by non-accredited laboratories or the use

of methods that are not approved by Health Canada for registration of a disinfectant are

not relevant to the registration of the product and should not be viewed as scientifically

sound. In fact, unauthorized claims can result in serious action taken from Health Canada

to a would be offender.



For background purposes the following sections provide definitions and requirements for

registration in Canada under the Disinfectant Drugs Guideline:



Section 2, Subsection 1: Definition of a Disinfectant



        “A disinfectant is an antimicrobial agent capable of destroying pathogenic and

potentially pathogenic microorganisms on inanimate surfaces, and includes germicide,

bactericide, fungicide, virucide, tuberculocide, sporicide, sterilant, etc. The term

“disinfectant�, as used in the guideline, is considered to include gaseous or liquid

sterilants, germicides, bactericides, fungicides or combinations of these.�



Section 4, Subsection 4: Intended Use:



This section describes the Intended Use for the product that is considered to be necessary

to clearly communicate the purpose of the product.



        �4.4.1: Claims, states that the label must clearly identify the purpose of the

product (e.g. as a disinfectant, germicide, bactericide, virucide, fungicide, etc. or a

combination of these), so that the user will clearly the understand its intended uses and

limitations.�



Section 4, Subsection 5: Directions for Use:



         “Directions for use must provide explicit information relevant to the effective use

of the disinfectant. It is not considered to be acceptable to indicate different dilution

levels for use against specific microorganisms or groups of microorganisms, since a user

is unable to readily determine which microorganisms are present on a target surface.

For example, it is not considered acceptable to make reference to a 5-minute contact time

for efficacy against vegetative bacteria and a 10-minute contact time for efficacy against

fungi.�



APPENDIX II: Evaluation Criteria



The table from Appendix II of the Disinfectant Drug Guideline has been included in

Appendix C as a reference for testing requirements and specifications for registration as

well as definitions of the various classes of disinfectant products.

As defined in the table, there are three classifications of Disinfectants:



         High Level Disinfectant for use on Semi-critical devices that requires submission

of testing proving Sporicidal and Tuberculocidal efficacy.



      Intermediate Level Disinfectant with requirements of testing proving

Tuberculocidal efficacy.



       Low Level Disinfectant for use on environmental surfaces and non-critical

devices with the required testing proving Bactericidal efficacy against Salmonella,

Staphylococcus and Pseudomonas.



A product can further be classified as a Fungicide, Virucide, or Tuberculocide upon

submission of appropriate efficacy testing. It is not however, required that all products

be tested against all organisms. Products targeted for specified markets can choose to

test for targeted organisms relevant to that market.





Relevance of Cleaning and Disinfection:

With respect to risk of transmission from environmental surfaces, appropriate cleaning

and disinfection is important to help limit the transmission of organisms, however, no

data conclusively links infection of patients or healthcare workers to environmental

transmission. Cleaning and maintenance prevent the build-up of soil, dust or other

foreign material that can harbour pathogens and support their growth so best practices

would dictate that appropriate disinfection of environmental surfaces be routinely

performed to reduce microbial contamination or cross-infection from inanimate surfaces.



Many human pathogens can remain viable on porous and non-porous inanimate objects

for extended periods. The frequency of cleaning and disinfecting the environment will

vary depending on the type of surface, number of people or amount of activity in an area

as well as the risk to patients. For example, clinics such as dental offices or hemodialysis

units require cleaning and disinfection of the patient care area between patients while

patient rooms, common areas or bathrooms require cleaning and/or disinfection on a

daily basis. Soiled hands or soiled patient care equipment have a greater potential as

vehicles for transmission of infection showing the need for strict hand hygiene and

frequent cleaning and disinfection of share patient care equipment.





Relevance of Claims:

Vegetative bacteria (MRSA, VRE, E. coli, etc), Viruses (Norovirus, Hepatitis strains,

Rhinovirus, RSV, etc) and Spores (C. difficile) account for greater than 90% of all

Nosocomial infections. In general, risk factors for acquiring a nosocomial infection

include receipt of antimicrobial agents, chemotherapy, and the presence of indwelling

devices such as catheters or invasive procedures such as hemodialysis. Most of these

factors are very common in hospitalized patients; especially in high-risk areas such has

ICUs or oncology wards. The risk of nosocomial infections to healthy individuals in

clinical offices such as doctor or dental offices is minimal and not well documented.



As greater than 90% of the nosocomial infections are related to bacterial or viral

microorganisms, environmental surface cleaning and disinfection using a Hospital Grade

Disinfectant of Low Level Disinfectant is sufficient and generally recommended by

existing Infection Control Guidelines.





AHP as a Disinfectant:

AHP is commercially available in a number of formulations as a DIN registered. The

formulations available are targeted to meet the needs of the markets the products are

designed for use in. For example, in the Industrial and Institutional Market which covers

Environmental Services in Healthcare and Education facilities the primary formulation is

available in a concentrate for use as a Low Level Disinfectant with claims against

vegetative bacteria including MRSA and VRE as well as virucidal claims against both

enveloped viruses such as Hepatits B or HIV and non-enveloped viruses such as

norovirus or rhinovirus. In the Dental market, the AHP-formulation carries vegetative

bacteria claims, enveloped and non-enveloped virucidal claims and tuberculocidal claims

and is defined by Health Canada as an Intermediate Level Disinfectant. The additional

of the Tuberculocidal claim is relevant due to the aerosolization of body fluids during

exam and surgical procedures in a dental office. Lastly, for the Foot Care, Medical Spa

and Professional Beauty Market a registered Intermediate Level Disinfectant is available

that carries vegetative bacteria claims, enveloped and non-enveloped virucidal claims.

tuberculocidal claims as well as a fungicidal claim. The addition of the fungicidal claim

is relevant due to the potential transmission of athlete’s foot and other fungal infections

common to nails of hands and feet.



Accelerated Hydrogen Peroxide (AHP) solutions have found the balance between safety

and efficacy. AHP solutions are formulated by a synergy between Hydrogen Peroxide,

Surface Acting Agents (surfactants/detergents), wetting agents (a substance that reduces

the surface tension of a liquid, causing the liquid to spread across or penetrate more easily

the surface of a solid) and chelating agents (a substance that helps the hardness of water).

The ingredients are all listed on the EPA and Health Canada Inerts lists or the FDA

Generally Regarded as Safe (GRAS) list. Additionally, where possible the chemicals

used to manufacture AHP have CFR 21 (Code of Federal Regulations) clearance as a

direct or indirect food additive.



This due diligence is also in part why AHP has an unsurpassed health and safety profile.

In the RTU / Use Dilution form AHP has been proven to be non-toxic, not an eye irritant,

or skin irritant (all data is on file and available upon request). Recent Acute Inhalation

Toxicity and Acute Oral Toxicity testing on a new AHP formula have shown a LC50

greater that 2.59 mg/L and LD50 greater than 5000 mg/kg respectively. As a result, the

formulation has been classified as a Category IV product that does not require

precautionary labeling. Additionally, AHP solutions are Volatile Organic Compounds

(VOC) free, fragrance free and dye free for the specific reason that it is often these

constituents in chemical products that are found to cause significant health risks.



The due diligence in choosing chemicals that have undergone stringent toxicity testing

and have been proven to be safe and sustainable alternative to legacy chemicals thereby

allowing AHP to be registered as Canada’s FIRST EcoLogo registered disinfectant.







References:



   1. Health Canada. Therapeutic Products Programme Guidelines: Disinfectant Drugs.

       Fall 1999

   2. Infection Control Guidelines: Hand Washing, Cleaning, Disinfection and

       Sterilization in Health Care, Health Canada. Dec 1998, Vol 24S8

   3. Routine Practices and Additional Precautions for Preventing the Transmission of

       Infection in Health Care, Health Canada. July 1999, Vol 25S4

   4. Guidelines for Environmental Infection Control in Healthcare Facilities, CDC.

       MMWR June 2003, Vol 52, No RR-10

   5. Best Practices for Cleaning, Disinfection and Sterilization in All Health Care

       Settings, PIDAC, March 2006

   6. Mayhall CG. Hospital Epidemiology and Infection Control, 3rd Ed. Philadelphia.

       Lippincott Williams & Wilkins, 2004:1473-1522

   7. Rutala WA. APIC Guideline for Selection and Use of Disinfectants AJIC

       1990:17(2) 99-117

   8. Rutala WA & Weber DJ. The benefits of surface disinfection. AJIC 2004;32(4)

       226-229

   9. Guidelines for Infection Control in Dental Health-Care Settings, MMWR (CDC),

       2003:52 No RR-17

   10. Infection Control in the Dental Office, Royal College of Dental Surgeons of

       Ontario, January 2002

   11. Assessment of the Mycobactericidal and Fungicidal Activities of OPTIM 33TB,

       CREM November 2003, http://www.viroxtech.com/pdf/Optim33TB_SAS.pdf

Appendix A

Appendix B

Appendix C