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Standard Interpretations
04/01/1997 - Disinfectants claiming efficacy against the Hepatitis B virus.
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• Standard Number: 1910.1030

OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov.


April 1, 1997

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

Dear Mr. Bach:

This is in response to your letter of December 10, 1996. You have requested a clarification of the Occupational Safety and Health Administrations (OSHA) position on disinfectants claiming efficacy against the Hepatitis B virus. You have asked if the products with the EPA approval meet the requirements of the Bloodborne Pathogens Standard without a registered tuberculocidal claim.

A review of the initial intent of the Bloodborne Pathogens Standard that specifically deals with the cleaning of contaminated work surfaces, i.e., 1910.1030(d)(4)(ii)(A), reveals that OSHA intended to provide a performance-based provision that would allow for future development of "appropriate disinfectant" products. OSHA has reviewed the information on the disinfectants and has reconsidered its position on EPA-registered disinfectants that are labeled as effective against HBV and HIV. OSHA's current stance is that EPA-registered disinfectants for HIV and HBV meet the requirement in the standard and are "appropriate" disinfectants to clean contaminated surfaces, provided such surfaces have not become contaminated with agent(s) or volumes of or concentrations of agent(s) for which higher level disinfection is recommended.

It is important to emphasize the EPA-approved label section titled "SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATION AGAINST HIV-1 AND HBV Of SURFACES\OBJECTS SOILED WITH BLOOD\BODY FLUIDS." On the labels that OSHA has seen, these instructions require:
  1. personal protection devices for the worker performing the task;
  2. that all the blood must be cleaned thoroughly before applying the disinfectant;
  3. that the disposal of the infectious waste is in accordance with federal, state, or local regulations;
  4. that the surface is left wet with the disinfectant for 30 seconds for HIV-1 and 10 minutes for HBV.

OSHA would expect all such disinfectants to be used in accordance with their EPA-approved label instructions.

We thank you for your interest in workplace safety and health. Should you have further questions, please call [the Office of Health Enforcement at 202 693-2190].

Sincerely,


John B. Miles, Jr., Director
[Directorate of Enforcement Programs]

[Corrected 2/10/2005]

December 10, 1996

Mr. Charles Adkins, Director
[Directorate of Science, Technology, and Medicine]
U.S. Dept. of Labor
Occupational Safety and Health Administration
Washington, D.C. 20210

Dear Mr Adkins:

This letter is requesting clarification of OSHA's position regarding disinfectants claiming efficacy against Hepatitis B virus under the OSHA Occupational Exposure to Bloodborne Pathogens Standard (CFR 1910.1030).

Within the past six to twelve months there have been products appearing on the market for professional maintenance use claiming efficacy against Hepatitis B virus. This particular organism is claimed as part of an EPA registration package for a hospital disinfectant. Being a disinfectant utilizing a quaternary ammonium active, these products do not claim efficacy against Mycobacterium tuberculosis which, under the Standard, is considered a significant marker organism indicating the potency of the product.

In order to answer specific user questions, could you please provide OSHA's opinion as to these products' ability to meet the requirements of the Bloodborne Pathogens Standard without a registered tuberculocidal claim.

Thank you for your time.

Sincerely,


Thomas H. Bach
Technical Service Manager

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