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.
July 11, 1989
MEMORANDUM FOR: ALL REGIONAL ADMINISTRATORS FROM: PATRICIA K. CLARK, ACTING DIRECTOR DIRECTORATE OF COMPLIANCE PROGRAMS THRU: LEO CAREY, DIRECTOR DIRECTORATE OF FIELD PROGRAMS SUBJECT: Update to OSHA Instruction CPL 2-2.44A
Due to the recent clarification (Federal Register. Vol. 54, No. 26; February 9, 1989) issued by the Environmental Protection Agency (EPA) on its labeling policy for antimicrobial pesticide products, it has become necessary to update OSHA Instruction CPL 2-2.44A. EPA's FR publication expanded the listing of the approved products claiming to be effective against the human immunodeficiency virus (AIDS virus) on environmental surfaces. This new information will be incorporated into the next change to CPL 2-2.44A.
Attached for your information is a letter from EPA's Office of pesticides and Toxic Substances that provides the above-mentioned information on the antimicrobial pesticides that are registered by EPA as sterilants and/or hospital disinfectants under FIFRA. Attachments A through C list products registered by EPA as sterilizers and hospital disinfectants; attachment C provides a special listing of products that have been documented as effective against HIV (AIDS) virus on environmental surfaces.
Should you require any additional information concerning one of the listed products or any other chemical germicide, contact the EPA directly.
The address and telephone number are:
U.S. Environmental Protection Agency
Branch Registration Division (TS-767C)
Office of Pesticide Programs
401 M Street, S.W.
Washington, D.C. 20460
Telephone: (703) 557-7470
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 produce 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
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
Dear Health Care Professional:
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.