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Determination of Health-Related and Non-Health-Related Uses
DIS/TSS-16 / June 26, 1979
REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES:
Determination of Health-Related and Non-Health-Related Uses
According to Section 3 (c) (5) of FIFRA, as amended by the Federal Pesticide Act of 1978, and the provisions of 40 CFR 162.18-2 of the Regulations for the Enforcement of FIFRA, products bearing claims for control of microorganisms which pose a threat to human health require specific efficacy data to support such claims and patterns of use; products bearing claims expressly for control of microorganisms not directly related to human health do not require supporting efficacy data.
The following criteria will be utilized to determine whether or not the labeling of an antimicrobial pesticide bears uses of human health significance:
- Products bearing claims for control of microorganisms infectious for man will be considered as directly related to human health and will require specific and complete efficacy data to support such claims and patterns of use.
- Unqualified and non-specific claims for products as sterilizers, disinfectants, or sanitizers will be considered to include or imply effectiveness against microorganisms infectious for man. Antimicrobial products recommended for use in hospital or medical environments, including sickrooms in public or private dwellings, will be similarly considered as human health-related. Such claims or recommendations must be expressly qualified or deleted in order to remove implications of human health significance.
- Algaecides, slimicides, preservatives, deodorizers, and other products expressly claiming control of microorganisms of economic or aesthetic significance not directly related to human health will not require efficacy data. However, adequate dosage recommendations and complete directions for use must be provided in labeling.
- Since elimination or significant reduction in numbers of microorganisms (sterilization, disinfection, sanitization) must be demonstrated before a product is considered acceptable for claims against microorganisms infectious for man, or for use in medical or sickroom environments, products bearing claims for effectiveness at the bacteriostatic level (inhibition of growth) will not be accepted for such situations. Bacteriostatic claims will only be permitted for products expressly recommended for control of microorganisms of economic or aesthetic significance (e.g. slime-forming bacteria, odor-causing bacteria).
- When no pesticidal purpose or function is known or shown to exist for a proposed claim or pattern of use for an antimicrobial product, registration will not be considered.
- Hospital sterilizers and disinfectants, swimming pool water disinfectants, human drinking water disinfectants and purifiers, and food contact surface sanitizers are, by their very nature, human health-related and will require efficacy data whether or not control of specific infectious microorganisms are claimed.
- Veterinary and animal premise disinfectants will require efficacy data to support claims against those microorganisms which are infectious for both man and animals. Efficacy data will not be required for those microorganisms which are solely pathogenic for animals.