Public Comments on Permethrin Reregistration Eligibility Decision Needed
by September 26, 2006
(Beyond Pesticides, July 14, 2006) EPA has completed its Reregistration Eligibility Decision (RED) for the pesticide permethrin, and has concluded that products containing permethrin are eligible for reregistration provided that risk mitigation measures outlined in the RED, such as increased buffer zones for certain applications, changes in labeling, and discontinuing the indoor residential use of direct broadcast and crack and crevice permethrin sprays, are adopted and necessary changes to the registration and product labels are addressed. EPA also reassessed permethrin tolerances in food and in feed and determined that current tolerances met the safety standards established by the Food Quality Protection Act (FQPA). EPA has opened a public comment period, announced in the Federal Register (June 28, 2006) ending on September 26, 2006.
Permethrin is a synthetic pyrethroid insecticide and was first registered in 1979. It is a broad spectrum synthetic insecticide, and is registered for use on numerous food/feed crops, livestock and livestock housing, modes of transportation, structures, buildings, public health mosquito abatement programs, numerous indoor and outdoor residential spaces, pets, and clothing. Besides permethrin, other synthetic pyrethroids include allethrin, cypermethrin, deltamethrin, and resmethrin. EPA is not currently following a cumulative risk approach for the pyrethroids.
Permethrin is a possible carcinogen and a suspected endocrine disruptor. Endocrine disruptors interfere with normal hormone function and can contribute to breast and testicular cancer, birth defects, learning disorders, and other problems. Animal studies indicate that small amounts of permethrin may cause immunotoxicity, or corruption of the immune system. Additionally, permethrin has been linked to neurotoxic effects, including Gulf War syndrome and Parkinson’s disease.
The full permethrin
RED can be downloaded from: http://www.epa.gov/oppsrrd1/REDs/permethrin_red.pdf.
TAKE ACTION! It is key that people make themselves heard by sending in comments to EPA during the public comment period, which ends September 26, 2006. Tell EPA that the permethrin RED does not go far enough in providing adequate protection to children and the public. Use the following talking points to draft your comments:
1. EPA does not have adequate data to eliminate the 10X FQPA safety factor.
EPA has reduced the 10X safety factor to 1X for permethrin. However, EPA does not have adequate data to abandon the 10X safety factor assigned by the Food Quality Protection Act (FQPA) to protect infants and children. Congress overwhelmingly passed FQPA to address, among other concerns, the particular hazards faced by children from exposure to pesticides. Children are not little adults, and their bodies are unlikely to respond in the same manner as adults. In the case of permethrin, many levels of concern are already exceeded or close to being exceeded for various exposure scenarios for both adults and children. If EPA would retain the 10X safety factor, most uses would have to be cancelled or severely restricted.
2. EPA does not adequately take into account risks from permethrin-impregnated clothing. Based on comments sent to the agency about permethrin-impregnated clothing losing efficacy after washing, EPA “is requiring product specific efficacy data for all permethrin impregnated fabric products, and wash-off data to support the efficacy claims.” However, EPA ignores numerous comments about the underestimated risks of permethrin-impregnated clothing. In the RED, EPA uses a generic model that considers the clothing residue concentration, surface area of the skin that is in contact with the fabric, the transfer factor, and body weight to assess exposure risk. Actual exposure may be much greater, however, because real world conditions, such as rainy weather, sweating and other factors, could increase the transfer factor. Despite acknowledging that permethrin-impregnated clothing are a source of dermal and oral exposure to permethrin, EPA does not require health warnings to be put on the clothing label, nor does the label caution against improper uses, such as prolonged exposure to the clothes. Additionally, the label of Buzz Off clothing recommends to “use in conjunction with an insect repellent..." However, use of permethrin-impregnated clothing in conjunction with DEET, one of the most commonly used insect repellents, creates numerous health problems, yet this aggregate risk is not taken into account in the RED.
3. EPA does not take into account the possible endocrine-disrupting effects of permethrin. The RED states, “In the available toxicity studies on permethrin, there was no toxicologically significant evidence endocrine disruptor effects.” However, permethrin was classified as a suspected endocrine disruptor at the 1997 Illinois EPA Endocrine Disruptors Strategy Meeting. Permethrin binds to receptors for androgen (a male sex hormone) and testosterone in cells from human males. In a long-term feeding study of mice, permethrin was shown to cause reduced testes weights. In another study, researchers found that permethrin had significant estrogenic potency as it inhibited the binding of estradiol to the estrogen receptor.
4. Synergistic effects between common pesticide exposure combinations must be considered. EPA does not take into account synergistic effects with other chemicals when registering pesticides. However, studies show that many pesticides have dangerous synergistic effects when exposure is combined with pesticides and pharmaceuticals, including permethrin combined with DEET. Because of the threat of West Nile virus and other mosquito-borne illnesses, DEET use is recommended by the Centers for Disease Control and Prevention (CDC), and many individuals wear DEET while outside during mosquito season. Permethrin is widely used by communities for mosquito control, as well as on lawns and gardens, in clothing and for myriad of other uses discussed in the RED. Therefore, the combined exposure to both DEET and permethrin is likely. According to the literature, the use of DEET in combination with permethrin likely facilitates enhanced dermal absorption of permethrin. Additionally, studies done by Duke University researcher Mohammed Abou-Donia suggest that DEET in conjunction with permethrin may be linked to Gulf War Syndrome, which affects thousands of veterans. However, the RED takes into account only permethrin use, which is not a realistic exposure scenario.
5. EPA fails to consider the health and ecological impacts of permethrin formulated with piperonyl butoxide (PBO). Permethrin is commonly formulated with the synergist piperonyl butoxide (PBO), which is added to increase the potency of the permethrin product. Because of the frequency with which these chemicals are formulated together, EPA should evaluate the combined impact for all health and ecological endpoints. PBO inhibits important liver enzymes responsible for breakdown of some toxins, including the active ingredients of pesticides. In addition to its effect on humans, the impact of permethrin combined with PBO to aquatic organisms must be considered.
6. Permethrin is highly toxic to bees and other beneficial insects. The RED states that permethrin is highly toxic to bees and other beneficial insects. The continued use permethrin is likely to reduce and eliminate important insect populations. Pollinators provide an essential ecological function in both agricultural and wild land ecosystems. Protection of pollinators should be the highest priority of the EPA, as without them crops would not produce harvests and wild plant communities would decline.
7. EPA does not adequately mitigate the effect of permethrin on asthmatics. In the RED, EPA states, “Although it is a relatively safe product, it can aggravate asthma or lead to asthma like symptoms.” Asthma rates in the US have reached epidemic levels, particular in young children, who are most vulnerable. Nearly 1 in 8 school-aged children have asthma, and the rate is rising. Synthetic pyrethroids have been shown to be respiratory allergens and use of them may result in asthma-like symptoms, especially in children with a history of asthma or allergies. Numerous cases of people exposed to synthetic pyrethroids have reported symptoms of irritation of the throat and respiratory tract, shortness of breath, coughing, and other asthmatic symptoms. Despite acknowledging the potential impact of permethrin on asthmatics and describing incidents involving asthma and permethrin, EPA fails to take into account the special vulnerability of asthmatics in its analysis.
comments, identified by docket identification (ID) number EPA-HQ-OPP-2004-0385,
by one of the following methods:
• Electronically: Federal eRulemaking Portal (http://www.regulations.gov) Follow the on-line instructions for submitting comments.
• Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW. Washington, DC 20460-0001.
• Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. The Docket telephone number is (703) 305-5805.
EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov.