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• Standard Number: 1910.1030

June 27, 1997

Mr. Thomas H. Bach
Reckitt & Colman Inc.
225 Summit Avenue
Montvale, New Jersey 07645-1575

Dear Mr. Bach:

This is in response to your second letter dated May 5 concerning the Occupational Safety and Health Administration's (OSHA) position on U.S. Environmental Protection Agency-approved disinfectants. Your concern is that the inclusion of additional products that have different kill claims will provide the employer with choices for cleaning blood spills, and that this is not in keeping with universal precautions.

The newly EPA-approved quaternary ammonium (quats) products do not bear a label with kill claims for all the blood borne pathogens regulated by OSHA. The employer must choose the appropriate disinfectant in any situation based on the information available. Quaternary ammonium [products] are not an appropriate disinfectant for all bloodborne pathogens. The universal precaution concept is central to employee protection, and nothing in the latest decision to include EPA-approved HIV/HBV disinfectants among "appropriate" disinfectants suggest that OSHA is changing the requirement to practice universal precautions.

I hope this is responsive to your needs and all your questions have been addressed. This office has received a number of letters and telephone calls concerning the same subject you raised. In the near future, this issue and our methods of communicating this information to the public will be reviewed. If you have further questions, please call Wanda Bissell of my staff at (202) 219-8036 ext. 36.

Sincerely,



Stephen Mallinger, Acting Director
Office of Health Compliance Assistance




May 5, 1997

Ms. Wanda Bissell
Compliance Programs
U.S. Dept of Labor
Occupational Safety and Health Administration
Washington D C. 20210

Dear Ms Bissell:

This letter is requesting further clarification and consideration to your response to my request for OSHA's position on disinfectants claiming efficacy against the Hepatitis B virus. (Copy of A[pril] 1, 1997 letter attached)

Although the second paragraph of the attached letter states that a disinfectant that provides efficacy against HBV and HIV would be considered an "appropriate" disinfectant, it qualifies appropriate, provided such surfaces have not become contaminated with agent(s) or volumes or concentrations of agent(s) for which higher level disinfection is recommended. According to accepted practice of Universal Precautions all patients and blood or body fluid spills are to be treated equally assuming that they are contaminated and any resulting spill of blood or OPIM be removed (cleaned) from the surface for ultimate decontamination of the surface rendering it organism free. The attached response indicates that a qualification of the level of contamination must be made first prior to using a disinfectant that is only effective against HBV. This appears to contradict the purpose of the Bloodborne Pathogens standard.

Based on review of the available products claiming HBV efficacy, none currently make the added claim of efficacy against Mycobacterium tuberculosis. This is typical of many disinfectants that utilize quaternary ammonium compounds as the active ingredient. Tuberculosis efficacy in addition to hospital disinfection is an indicator of a disinfectant formula's ability to penetrate the lipid sheath that surrounds the organism. Typically, a disinfectant's strength is reinforced when TB is included in its list of claims. HBV efficacy is indicative of performance against lipophilic viruses which are represented by efficacy claims against Herpes Simplex, Influenza, Vaccina, and Human Immunodeficiency Virus (HIV- 1). The indicator of a disinfectants strength should rest with the most difficult organism to inactivate, tuberculosis.

A hospital disinfectant product that claims efficacy against both TB and HBV would provide user confidence of infection control compliance. However, tuberculosis efficacy, due to its unique properties and difficulty to kill may be a more significant benchmark to assure workplace safety and health.

Thank you for taking the time to consider this additional information.

Sincerely,



Thomas H. Bach
Technical Service Manager


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