Standard Interpretations - (Archived) Table of Contents|
July 19, 1990
MEMORANDUM FOR: LINDA R. ANKU REGIONAL ADMINISTRATOR FROM: PATRICIA K. CLARK DIRECTOR DESIGNATE DIRECTORATE OF COMPLIANCE PROGRAMS THROUGH: LEO CAREY, DIRECTOR OFFICE OF FIELD PROGRAMS SUBJECT: CPL 2-2.44B ClarificationsThis is in response to your May 15 memo requesting clarification of the following two issues: (1) the overall effectiveness of products registered with the EPA as effective against the human immunodeficiency virus (HIV) and (2) the length of sleeves necessary to protect dentists from exposure to blood and/or body fluids.
The attached letter and updated listings clarify the intent of the Environmental Protection Agency (EPA) in this matter. List A identifies sterilants which represent the highest level of antimicrobial activity and are intended to destroy all viruses. List B identifies disinfectants which have been documented as effective against tuberculosis bacteria and the specific viruses named on the product label. List C details products that are registered with the EPA as effective specifically against the AIDS virus. The attached February 9, 1989, Federal Register notice clarifies the EPA's labeling requirements for HIV efficacy claims.
Paragraph M.2.b. of OSHA Instruction CPL 2-2.44B describes the types of products which may be used following the initial cleanup of blood or body fluids. The intent of the disinfectant category in paragraph M.2.b.(2) is to allow the use of products registered by the EPA as being effective against HIV for cleanups in which HIV is the only infectious matter of concern (e.g., those fluids found in HIV experimental laboratories). To determine the overall effectiveness of a particular product for use in a cleanup where HBV or other bloodborne pathogens are also of concern, one must compare the listing of HIV-effective products with the other two listings to check if they overlap for the product of interest. You are correct in your assumption that a product which is only effective against HIV may very well not be effective against HBV which is much more resistant to activation than is HIV. Thus the need to compare the listings. For additional information on this subject you may wish to contact Dr. Jean Jenkins or William Campbell ofEPA's Antimicrobial Program Branch at (703) 557-7443 or 557-7470, respectively.
With regards to your second inquiry, both the OSHA Instruction CPL 2-2.44B and the proposed regulation on Occupational Exposure to Bloodborne Pathogens are performance oriented and allow for the exercise of professional judgement in determining the protective equipment which is appropriate to protect the skin from blood or body fluids. The final determination regarding the existence of a hazard (in this case exposure of the forearms to blood and body fluids) must be made in the workplace by direct OSHA compliance officer observation of the particular situation.
As a point of interest, the American Dental Association's Infection Control Guidelines states that "long sleeves and high collars that protect the user from the spatter of body fluids and which cover street clothing provide the best coverage."
May 15, 1990
MEMORANDUM FOR: PATRICIA CLARK, Director Designate Directorate of Compliance Programs FROM: LINDA R. ANKU Regional Administrator SUBJECT: CPL 2-2.44B ClarificationClarification is requested concerning CPL2-2.44B, Enforcement Procedures for Occupational Exposure to Hepatitis B and HIV. Section M.2.b.(2) states that products registered by EPA as effective against HIV may be used for cleanup of blood or body fluids. It appears that this is somewhat misleading in that such products are considered effective against HIV only. The Hepatitis B virus is considered more virulent and as such may not be inactivated by such products.
Also, clarification is requested concerning the issue of protective clothing. It is common practice for dentists to wear short sleeve shirts when performing dental procedures. Would we now require such dentists to wear long sleeve shirts or other protective garments to protect potentially exposed skin from blood or body fluids generated during dental procedures?
Please contact Jim Johnston of my staff (FTS 596-1201) if you have any
Dear Health Care Professionals:
This is in response to your recent request for information pertaining to antimicrobial pesticides that are registered by the U.S. Environmental Protection Agency (EPA) as sterilants and/or hospital disinfectants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
An important aspect of the information concerning labeling of antimicrobial pesticides is an understanding of the terminology used by the manufacturers of these products, and by EPA.
Antimicrobial pesticides identified by the term sterilizer or sterilant are intended to destroy all viruses and all living bacteria, fungi, and their spores on inanimate surfaces. Sterilization is the highest level of antimicrobial activity. Manufacturers or registrants of these types of antimicrobial pesticides are required to submit to EPA specific effectiveness data using resistant bacterial spores to support sterilization claims on their product labels. Attachment (A) is a listing of the antimicrobial pesticides currently registered by EPA as sterilizers.
Antimicrobial pesticides identified by the term disinfectant are intended to provide a lower level of activity than sterilization. Disinfectants destroy or irreversibly inactivate specific viruses, bacteria, or pathogenic fungi, but not necessarily their spores, on inanimate surfaces. Most disinfectants, even with prolonged contact times, are not effective as sterilizers. To support effectiveness as a disinfectant, specific data relative to each bacteria, pathogenic fungus or virus against which a product is claimed to be effective must be submitted to EPA by the manufacturer or registrant. To be registered as a hospital disinfectant, a product must be shown to be effective against Staphylococcus aureus, Salmonella choleraesuis, and Pseudomonas aeruginosa. However, a registrant may optionally claim effectiveness against additional microorganisms such as Mycobacterium tuberculosis, pathogenic fungi, or certain specific viruses, provided such efficacy is documented with appropriate data.
It should be noted that disinfectants bearing virucidal claims on their product labels are registered as being effective only against the specifically tested and named viruses on the label, rather than all viruses. Attachment (B) is a listing of the antimicrobial products currently registered by EPA as hospital disinfectants, and that have also been documented as effective against Mycobacterium tuberculosis and the specific viruses named on the product labels.
Also enclosed is Attachment (C), a special listing of the products registered by EPA that have been documented as effective against HIV (AIDS virus) on environmental surfaces. These lists are not intended, and therefore should not be construed, as endorsements or recommendations by EPA of specific products for any purpose. They are simply listings of registered products in certain categories of effectiveness. You may wish to contact the manufacturers or registrants for specific information concerning their products. The individual product labels should be consulted for appropriate use directions.
New and revised products are continuously being registered by the Environmental Protection Agency. Therefore, at some time in the future these listings may be updated, and again made available to the public. Thank you for your inquiry. It is hoped that this information will be of assistance to you.
Juanita Wills, Chief
Antimicrobial Program Branch
ENCLOSURES: Federal Register Vol. 54, Thursday, Feb. 9, 1989, Pages 6288 -
6290 List A - Registered Sterilants, December 1988 List B - Registered
Hospital Disinfectants that are also Tuberculocidal, Virocidal, and
Fungicidal, December 1988 List C - Registered Antimicrobial Products with
Accepted HIV-1 (Aids Virus) Effectiveness Claims, April 1990
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