July 7, 2017 Office of Pesticide Programs Environmental Protection Agency 1200 Pennsylvania Ave. NW. Washington, DC 20460-0001 Re: Registration Review: Draft Human Health and/or Ecological Risk Assessments for pyrethrins and pyrethroids. (Docket # EPA-HQ-OPP-2010-0384, EPA-HQ-OPP-2010-0684, EPA-HQ-OPP-2012-0167, EPA-HQ-OPP-2009-0842, EPA-HQ-OPP-2011-0539, EPA-HQ- OPP-2009-0637, EPA-HQ-OPP-2009-0301, EPA-HQ-OPP-2007-0804, EPA-HQ-OPP-2010- 0422, EPA-HQ-OPP-2016-0031, EPA-HQ-OPP-2010-0479, EPA-HQ-OPP-2011-0692, EPA- HQ-OPP-2010-0480, EPA-HQ-OPP-2015-0752, EPA-HQ-OPP-2011-0039, EPA-HQ-OPP- 2011-1009, EPA-HQ-OPP-2011-0885, EPA-HQ-OPP-2010-0915, EPA-HQ-OPP-2012-0501, EPA-HQ-OPP-2011-0907) Please accept the following comments on behalf of the Center for Biological Diversity, Center for Environmental Health, Friends of the Earth, Center for Food Safety, Beyond Pesticides, Boulder Innovative Technologies, Inc, Beyond Toxics and Doan Family Farms in response to the Environmental Protection Agency’s (“EPA”) receipt of an application for products containing a new active ingredient under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). Introduction Pyrethrins and their synthetic analogs pyrethroids are a class of pesticides that target insects’ peripheral and central nervous systems. 1 These chemicals are some of the most widely used pesticides in the United States, both in agricultural and residential settings.2 Dependency on pyrethroids has increased over the past twenty years, propelled by interest in replacing organophosphate insecticides.3 Today, pyrethroids and pyrethrins are so heavily used that their environmental concentrations exceed regulatory thresholds.4 1 T.G.E. Davies et al., DDT, Pyrethrins, Pyrethroids and Insect Sodium Channels, 59 LIFE 151, 155 (2007). 2 Muhammad M. Hossain, et al., Hippocampal ER Stress and Learning Deficits Following Repeated Pyrethroid Exposure, 143 TOXICOLOGICAL SCIENCES 220, 220 (2015). 3 Holly A Rogers, et al., Bifenthrin Causes Trophic Cascade and Altered Insect Emergence in Mesocosms: Implications for Small Streams, 50 ENVTL. SCI. & TECH. 11,974, 11,974 (2016). 4 Rogers, et al., supra note 3, at 11,974. Until recently, pyrethroids were believed to have limited toxicity in humans; this belief was based on the assumption that pyrethrins and pyrethroids are rapidly metabolized in the human body. But current studies and scientific investigations cast serious doubt on that assumption. For example, one recent pharmacokinetic study on the pyrethroid deltamethrin indicates that its peak concentration in the human brain is two times higher than that in rats.5 Additionally, mammalian studies showed that repeated exposure to low levels of a pyrethroid insecticide caused learning deficiencies and physiological effects associated with neurodegeneration and Alzheimer’s and Parkinson’s diseases, among others.6 Additionally, one study revealed higher incidences of autism spectrum disorders and developmental delay amongst children whose mothers were living within 1.5 kilometers of sites of pyrethroid applications during the third trimester of pregnancy.7 Not only do pyrethroids present serious risks to human health, but they also present risks to wildlife resources and ecosystems. A study by U.S. Geological Survey scientists found that commonly used pyrethroids have the potential to “alter aquatic and terrestrial ecosystem function at the regional scale.”8 More specifically, the study concluded that pyrethroid contamination in freshwater streams resulted in “less abundant and less diverse macroinvertebrate communities.”9 Additionally, the study revealed that pyrethroid contamination in aquatic ecosystems “propagate across life stages and generations of intervertebrates, trophic levels in aquatic food webs, and ecosystem boundaries to riparian food webs.”10 In the current preliminary risk assessment of eight pyrethroids and pyrethrins,11 the EPA states: “This assessment concludes that the down-the-drain, non-agricultural outdoor, agricultural, and adulticide use patterns of synthetic pyrethroids and pyrethrins may result in multiple exceedances of acute and chronic LOCs for freshwater and estuarine/marine fish, and for freshwater and estuarine/marine invertebrates, resulting in a potential reduction in survival, growth and reproduction to non-target aquatic animals.”12 Further, “As an additional line of evidence, a review of the OPP Incident Data System (IDS) which now incorporates the Ecological Incident Information System (EIIS) database was conducted. The IDS and EIIS databases contained numerous aquatic and pollinator incidents for the pyrethroids and pyrethrins. The number of reports listed in the EIIS database is believed to be only a small fraction of the total incidents involving non-target organism mortality and damage caused by pesticides. These incidents appear to support the findings of the PRA.”13 5 Stephen J. Godin, et al., Physiologically Based Pharmacokinetic Modeling of Deltamethrin: Development of a Rat and Human Diffusion-Limited Model, 115 Toxicological Sciences 330, 338 (2010). 6 Hossain, et al., supra note 2, at 223. 7 Janie F. Shelton, et al. Neurodevelopmental Disorders and Prenatal Residential Proximity to Agricultural Pesticides: The CHARGE Study, 122 CHILDREN’S HEALTH 1103, 1107 (2014). 8 Rogers, et al., supra note 3, at 11,974. 9 Id. at 11,979. 10 Rogers, et al., supra note 3, at 11,980. 11 EPA. 2016. Preliminary Comparative Environmental Fate and Ecological Risk Assessment for the Registration Review of Eight Synthetic Pyrethroids and the Pyrethrins. Document ID EPA-HQ-OPP-2010-0384-0045. 12 Id. at 2-3. 13 Id. at 3. 2 These findings are highly significant for multiple reasons. The first is that it demonstrates the power these chemicals have at altering and destroying ecosystems where they are used heaviest. The other is that, despite various mitigation measures that have been put in place over the last 20-30 years, the harm these chemicals are causing are still so abundant. This is a cautionary tale of what happens when an agency assumes that weak mitigation measures will somehow solve the problem of pesticide overuse. It is clear from this preliminary ecological risk assessment that that EPA will not be able to uphold its obligations under FIFRA with again requiring small tweaks to label language that are more or less meaningless. More appropriate changes will be significant buffers from water sources, lower maximum application rates and the cancelling of certain uses. For non-agricultural uses things such as cancelling some products that contain the most toxic, and persistent pyrethroids will likely be necessary. Below we have addressed concerns that we have with the current ERA and human health risk assessments. We address each section individually and then give general comments on how the analysis should be strengthened. Part I. Assessing Pyrethroid Releases to Publicly Owned Treatment Works In the current assessment of the down-the-drain uses of pyrethroids, the EPA has concluded that “…the use of bifenthrin, cypermethrin, cyfluthrins, deltamethrin, esfenvalerate, cyhalothrins, and permethrin, plus the pyrethrins, in accordance with registered labels, results for acute and/or chronic risk Levels of Concern (LOCs) exceedances for freshwater and estuarine/marine invertebrates, from the indoor down-the-drain exposure to POTWs which in turn result in releases to bodies of water. Additionally, it results in acute risk LOC exceedances for freshwater fish for bifenthrin, lambda- cyhalothrin, cypermethrin and esfenvalerate, plus chronic risk LOC exceedances to freshwater fish for bifenthrin.”14 We agree with the EPA that, based on the best available science, the urban uses of most pyrethroids that result in down-the-drain disposal may be harming certain aquatic vertebrates and invertebrates in urban bodies of water. This is a significant finding and it adds to our knowledge of how persistent and toxic chemicals with this mode of action (MOA) can be to aquatic wildlife. On an acute basis, pyrethroids are characterized as very highly toxic to fish and invertebrates. The EPA has clearly identified the exposure pathway coming from publicly owned treatment works (POTWs) and has done a lot of analysis in trying to quantify that exposure pathway. There is obviously a lot of uncertainty involved in trying to estimate exposure from this exposure scenario. While there were certain measures that were taken to attempt to be conservative (i.e. 14 EPA. 2016. Preliminary Comparative Environmental Fate and Ecological Risk Assessment for the Registration Review of Eight Synthetic Pyrethroids and the Pyrethrins. Document ID EPA-HQ-OPP-2010-0384- 0045. Pg 8. 3 assuming that the analyzed indoor uses would result in down-the-drain (DtD) exposure at every use, and assuming no degradation or sorption to organic matter), we ultimately believe that risk has been severely underestimated and that this should be clearly communicated to the risk manager who reviews this document for the following reasons: 1) It is troubling to us that the Office of Pesticide Programs has decided not to analyze certain uses and exposure sources by simply stating “that’s someone else’s job.” The most notable example being the use of permethrin as a pediculicide for the treatment of head lice and scabies. The EPA maintains that the Food and Drug Administration (FDA) is responsible for products containing permethrin used for pharmaceutical purposes. While it is the FDA’s job to ensure that those products are safe