Additionally, the Agency classified permethrin as “Likely to be Carcinogenic to Humans”
by the oral route. This classification was based on two reproducible benign tumor types (lung and liver) in the mouse, equivocal evidence of carcinogenicity in Long- Evans rats, and supporting structural activity relationship information.
Risks
Dietary
- Acute, chronic non-cancer, and cancer dietary (food and drinking water) risks from permethrin were below the Agency’s level of concern (LOC).
Residential
- All non-cancer (dermal and inhalation) risks for individuals handling permethrin products in a residential setting were below the Agency’s LOC. All cancer risk estimates were also below the Agency’s LOC, except for the following scenario: mixing/loading/applying the EC formulation via sponge to horses.
- The non-cancer post-application risk estimates for adults and youth aged children exposed to an environment treated with permethrin were below the Agency’s LOC; however, the risk estimate for toddlers exposed to permethrin treated indoor surfaces (carpets) were above the Agency’s LOC. The cancer risk estimates for adults exposed to indoor surfaces treated with permethrin from directed surface sprays or total release foggers were also above the Agency’s LOC.
- The Agency considered post-application exposure to both outdoor residential misting systems and permethrin treated clothing. All scenarios were below the Agency’s non-cancer and cancer LOCs.
Aggregate Risks
- The acute aggregate risk non-cancer and cancer estimate from food and drinking water does not exceed the Agency’s LOC.
- Aggregate short-term (1-30 days) non-cancer risk estimates, which include the contribution of risk from chronic dietary sources (food + drinking water) and short-term residential sources, exceeded the Agency’s LOC for toddlers exposed to permethrin through food and drinking water, and through post-application exposure during high contact activities on lawns and indoor surfaces. The risk driver for the aggregate non-cancer risk estimate was post-application exposure to permethrin on treated indoor surfaces (carpets).
- The aggregate cancer risk estimate exceeded the Agency’s LOC for adults exposed to permethrin through food and drinking water, and through post application exposure during high contact activity on lawns and indoor surfaces. Similar to the non-cancer aggregate risk assessment, post-application exposure to treated indoor carpets was the risk driver.
- All residential/recreational exposures are expected to be short-term in duration. Therefore, no intermediate-term (1-6 months) or long-term (>6 months) aggregate risk was assessed.
- EPA believes that the appropriate way to consider the pharmaceutical use of permethrin in its risk assessment is to examine the impact that the additional nonoccupational pesticide exposures would have to a pharmaceutical patient exposed to a related (or, in some cases, the same) compound. Based on a worse case scenario assessment, EPA estimates that the permethrin exposure a patient is expected to receive from a typical single application of a 1% and 5% permethrin pharmaceutical cream, respectively, is 450 to 2300 times greater than the combined exposure from the dietary and other non-occupational sources of permethrin. FDA has reviewed these estimates and determined that pesticide exposure in patients receiving treatment with a pharmaceutical permethrin drug product would fall within the expected range of exposure following treatment with permethrin drug product alone, and would not present an increased safety risk.
.................................................. ...............
Risk/Benefit Balance Analysis
The Agency also assessed the significance of permethrin use, and conducted a risk/benefit balancing analysis. Given the significance of the use of permethrin and the mitigated nature of the risks of permethrin, the Agency believes, on balance, that the benefits of permethrin outweigh the risks. ...With regard to the treatment of fabrics,
permethrin is the only pesticide registered to pre-treat fabrics,
which the AFPMB strongly supports as a method of preventing many diseases that might afflict military personnel in the field. On other uses, such as residential uses, where there may be a potential for ecological effects due to urban runoff, the Agency intends to identify steps which can be taken to allow a greater understanding of potential ecological risk from urban uses of pyrethroid as a whole during Registration Review.
Bookmarks