Source: https://www.global-regulation.com/law/united-states/31500/deltamethrin%253b-pesticide-tolerances.html
Timestamp: 2018-11-14 22:26:42
Document Index: 425301935

Matched Legal Cases: ['art 178', 'art 178', 'art 178', 'art 2', '§ 180', '§ 180']

Deltamethrin; Pesticide Tolerances (United States)
Link to law: https://www.federalregister.gov/articles/text/raw_text/201/506/861.txt
This regulation establishes tolerances for residues of the insecticide deltamethrin in or on all food and feed commodities from use of deltamethrin as a wide-area mosquito adulticide. Bayer CropScience requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective March 27, 2015. Objections and requests for hearings must be received on or before May 26, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION ).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0209, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov .
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0209 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before May 26, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0209, by one of the following methods:
In the Federal Register of January 28, 2015 (80 FR 4527) (FRL-9921-60), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP [3F8210]) by Bayer CropScience, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.435 be amended by establishing a tolerance for residues of the insecticide deltamethrin, (1R,3R)-R-cyano(3-phenoxyphenyl)methyl 3-(2,2-dibromoethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on food and feed commodities at 0.05 parts per million (ppm) from use as a wide-area mosquito adulticide. That document referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to the comment is discussed in Unit IV.C.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Deltamethrin, a Type II pyrethroid, targets the nervous system by disrupting the voltage-gated sodium channels, resulting in neurotoxicity. Neurotoxicity was observed throughout the toxicity database, and effects were seen across species, sexes, exposure duration, and routes of administration. Clinical signs characteristic of Type II pyrethroids, such as increased salivation, altered mobility/gait, and tremors were the most common effects observed. Increased sensitivity to external stimuli, abnormal vocalization, and decreased fore- and hind-limb grip strength were also commonly observed in the database.
Deltamethrin is rapidly absorbed following an oral dose, and effects are typically observed within two to five hours after dosing. For pyrethroids, as a class, the combination of rapid absorption, metabolism, and elimination precludes accumulation and increased potency following repeated dosing. This is also true of deltamethrin. No observed adverse effect levels (NOAELs) for the acute and chronic studies are similar, and the acute endpoint is protective of the endpoints from repeat dosing studies.
A dermal risk assessment was not conducted based on the lack of effects in a 21-day dermal study and low potential for dermal absorption for deltamethrin. These findings are consistent with the toxicology profile of many pyrethroids.
The Agency is making best use of the extensive scientific knowledge about the mode of action/adverse outcome pathway (MOA/AOP) on pyrethroids in the risk assessments for this class of pesticides. A significant portion of the scientific literature on pyrethroids utilizes deltamethrin as the test chemical. In the on-going work by the Council for the Advancement of Pyrethroid Human Risk Assessment (CAPHRA), deltamethrin is one of two sentinel pyrethroids being used to develop the initial, extensive database of in vitro and in vivo toxicology studies and highly refined physiologically-based pharmacokinetic (PBPK) models. Pharmacokinetics (PK) can be defined as what the body does to the chemical. The underlying PK of pyrethroids is an important determination of their toxicity because the concentration of pyrethroid at the sodium channel relates to the extent of toxicity; greater pyrethroid concentration translates as increased neurotoxicity. Age-dependent PK differences have been identified for several pyrethroids ( i.e., there are differences in the ability of adults and juveniles to metabolize pyrethroids). The enzymes that metabolize and detoxify pyrethroids are present in rats and humans at birth, and as a result, both juveniles and adults are able to tolerate low doses of pyrethroids when the internal dose, or the amount of pyrethroid at the sodium channel, is low. However, the activity of these enzymes increases with age, conveying in adults a greater capacity to detoxify pyrethroids compared to juveniles and the PK contribution to the FQPA Safety Factor will be 1X for adults and children >6 years old, and 3X for children <6 years old.
Pharmacodynamics (PD) can be defined as the changes that chemicals cause to the body, in this case, how pyrethroids interact with the sodium channels. In contrast to the age-related PK differences identified for pyrethroids, pharmacodynamic contributions to pyrethroid toxicity are not age-dependent. The occurrence and ontogeny of voltage-gated sodium channels in humans are not well characterized compared to those in the rat. The available data indicate that the rat is a highly-sensitive model and extrapolations from the rat would be protective of human health. Based on the comparable function and distribution of sodium channels between the species, the rat is an appropriate surrogate for the evaluation of human PD. Based on the body of data, the Agency concludes that juvenile rats are not more sensitive than adults with respect to pyrethroid PD, and the PD contribution to the FQPA SF will be 1X.
The Wolansky et al. acute oral study (2006), in which decreased motor activity was observed, provides the most robust data set for extrapolating risk from exposure to deltamethrin. The dose used for risk assessment was determined using a benchmark dose (BMD) analysis using one standard deviation from the control group as the benchmark response (BMR) as suggested for continuous endpoints in the Agency's BMD guidance (USEPA 2012). The Wolansky acute study, endpoint, and dose were used for all dietary (acute), non-occupational (incidental oral and inhalation), and occupational exposure (inhalation) scenarios because it was the most robust data set for extrapolating risk from deltamethrin, and there is a lack of increased hazard from repeated/chronic exposure to deltamethrin.
Specific information on the studies received and the nature of the adverse effects caused by deltamethrin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Deltamethrin. Human Health Risk Assessment for the Proposed Use of Deltamethrin as a Mosquito Adulticide over Agricultural Crops at [page 55] in docket ID number EPA-HQ-OPP-20[14]-[0209].
A summary of the toxicological endpoints for deltamethrin used for human risk assessment is discussed in Unit III.B of the final rule published in the Federal Register of [November 7, 2014] ([79] FR [66294]) (FRL-9918-24).
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to deltamethrin, EPA considered exposure under the petitioned-for tolerance as well as all existing deltamethrin tolerances in 40 CFR 180.435. Acute and chronic dietary (food and drinking water) exposure assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). Specific information on the dietary exposure assessment can be found at http://www.regulations.gov in document Deltamethrin. Acute and Chronic Dietary (Food and Drinking Water) Exposure and Risk Assessment for the Proposed Use of Deltamethrin as a Wide Area Mosquito Adulticide over Agricultural Crops in docket ID number EPA-HQ-OPP-20[14]-[0209].
i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for deltamethrin. As to residue levels in food, EPA used tolerance-level residues for most commodities and Pesticide Data Program (PDP) monitoring data for a number of commodities. Maximum percent crop treated (%CT) estimates were used for some commodities. To account for the mosquito adulticide use, the maximum residue value from the mosquito adulticide trials was multiplied by the %CT estimate for the adulticide use (1%) for those commodities that would only have a residue as a result of the mosquito adulticide use. However, if the commodity could have residues from both the agricultural and mosquitocide uses, residue values from the adulticide trials were included in a distribution considering the 1% CT estimate (depending on whether the commodities were blended, nonblended, or partially blended). Default processing factors were used for some processed commodities and empirical factors were used for others.
ii. Chronic exposure. As to residue levels in food, EPA [used tolerance-level residues for most commodities. The average PDP value was used for cereal grains and milk. The average mosquito adulticide residue value multiplied by the 1% CT estimate was used to account for the mosquito adulticide uses. Since deltamethrin is registered for use in food handling establishments (FHEs), one-half the FHE tolerance was used to account for the FHE uses. The FHE tolerance is based on the LOQ, and one-half the tolerance was used as a refinement in the dietary assessment. For the commodities for which one-half the FHE tolerance was used, the assumption was made that there was a 4.65% chance that a food item consumed by a person contained deltamethrin residues as a result of treatment at some point in an FHE. Default processing factors were used for some processed commodities and empirical factors were used for others.
iv. Anticipated residue and percent crop treated (PCT) information.
The Agency estimated the PCT for existing uses as follows: For acute dietary: 2.5% for apples, cantaloupes, carrots, soybeans, tomatoes, and watermelons; and 5% for cucumbers and pears. For chronic dietary: 1% for apples, cantaloupes, carrots, cotton, potatoes (some food forms), pumpkins, radishes, squash, tomatoes, turnips, and watermelon; 2.5% for cucumbers, leeks, onions, pears, and sunflowers; 4.65% (commodities with residues resulting only from the FHE use) for: Almonds, pistachios, potatoes (some food forms), soybeans, sweet corn, and walnuts; 5% for canola and peppers; and 40% for globe artichokes.
In the acute and chronic assessments, the mosquito adulticide %CT estimate of 1% was used to modify the mosquito adulticide use residue value. Residues from the mosquito adulticide use were included for all commodities with the exception of livestock commodities because the livestock commodities tolerances are very conservative, and any residues in livestock feed items resulting from the mosquito adulticide use will not increase the established tolerance levels.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for deltamethrin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of deltamethrin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .
The estimated drinking water concentration (EDWC) of deltamethrin for acute and chronic exposures is estimated to be 0.200 parts per billion (ppb) for both surface water and ground water. The FIRST Model was used to determine the surface water concentration, and the SCI-GROW Model was used to determine the groundwater concentration. The acute surface water EDWC and the groundwater EDWC were equivalent because, in both cases, the value was limited by the solubility of deltamethrin.
3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g. , for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).
Deltamethrin is currently registered for the following uses that could result in residential exposures: Residential outdoor and indoor sites, turf, paint additives, and pet products.
There are no residential handler exposure scenarios associated with the proposed mosquito control use as applications are to be made by Federal, State, Tribal or local Government Officials or the U.S. Military. However, there is potential for residential post-application exposure resulting from mosquito control use. Post-application inhalation exposures and incidental oral (hand-to-mouth) contact with residues deposited on lawn/turf from ULV truck fogger applications were included in the quantitative risk assessment. To calculate post-application exposure from ULV truck fogger applications, EPA used the 2012 Residential SOPs for Outdoor Fogging/Misting Systems, with minimal modification to the well-mixed box (WMB) model. The WMB model allows for the estimation of inhalation exposure in the breathing zones of adults and children residing in areas being treated by ground application of deltamethrin.
EPA also assessed handler and post-application exposures for existing residential uses of deltamethrin ( i.e. , indoor, outdoor, pet, and paint additive). A quantitative dermal assessment for residential handlers was not conducted since no systemic toxicity associated with dermal exposure to deltamethrin was observed. MOEs were calculated for the inhalation route of exposure only. Adult post-application exposures from the existing uses were not quantitatively assessed since inhalation exposures are typically negligible in outdoor settings. Post-application inhalation exposure for adults and children is anticipated to be negligible for representative residential registered uses; therefore, a quantitative post-application inhalation exposure assessment was not performed. EPA assessed post-application incidental oral exposures to children for representative indoor/outdoor and pet incidental oral scenarios including hand-to-mouth, object-to-mouth, soil ingestion, and episodic granule ingestion scenarios.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf .
The Agency has determined that the pyrethroids and pyrethrins share a common mechanism of toxicity: the ability to interact with voltage-gated sodium channels ultimately leading to neurotoxicity. The cumulative risk assessment (CRA) for the pyrethroids/pyrethrins (published on 11/9/2011 and available at http://www.regulations.gov ; EPA-HQ-OPP-2011-0746) did not identify cumulative risks of concern, allowing the Agency to consider new uses for pyrethroids. Deltamethrin was included in the pyrethroid/pyrethrin CRA.
Dietary exposures make a minor contribution to the total pyrethroid exposure. The dietary exposure assessment performed in support of the pyrethroid CRA was much more highly refined than that performed for deltamethrin alone. Additionally, the PODs selected for deltamethrin are specific to deltamethrin, whereas the PODs selected for the cumulative assessment were based on common mechanism of action data that are appropriate for all 20 pyrethroids included in the CRA. Dietary exposure to deltamethrin residues resulting from the proposed wide-area mosquito adulticide use will contribute very little to the dietary exposure to deltamethrin alone and will have an insignificant impact on the cumulative risk assessment. No dietary, residential, or aggregate risk estimates of concern have been identified in the single chemical assessment.
In the cumulative assessment, residential exposure was the greatest contributor to the total exposure. In order to determine if the registered deltamethrin indoor and turf uses will significantly contribute to, or change the overall findings in the pyrethroid CRA, the Agency performed a quantitative exposure and risk assessment. This assessment used the deltamethrin relative potency factor (RPF) as well as the same exposure algorithms and inputs that were used in the 2011 pyrethroid CRA. In all cases, the estimated deltamethrin MOEs using the RPF method were higher ( i.e. , less of a risk concern) than those used in the 2011 pyrethroid CRA. Thus, the Agency continues to support the previous assessment, and concludes that the registered deltamethrin uses will not significantly contribute to the overall findings in the 2011 pyrethroid CRA, and the registered deltamethrin indoor and turf uses will have no impact on the residential component of the cumulative risk estimates.
For information regarding EPA's efforts to evaluate the risk of exposure to this class of chemicals, refer to: ^ http://www.epa.gov/oppsrrd1/reevaluation/pyrethroids-pyrethrins.html.
2. Prenatal and postnatal sensitivity. There were no indications of fetal toxicity in any of the guideline studies. Evidence of increased juvenile qualitative sensitivity was observed in the DNT and 2-generation reproduction studies at doses that were considered to be relatively high ( i.e., near lethal doses). However, at doses near the point of departure, no effects on parental animals or offspring were observed in either the DNT or 2-generation reproduction study and, therefore, there is no susceptibility at these doses.
3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 3X for infants and children <6 years old; and to 1X for children >6 years old, women of child bearing age and all adult populations. That decision is based on the following findings:
i. The database of experimental toxicology studies available for deltamethrin is largely complete including developmental toxicity studies in rats and rabbits, a reproduction study in rats, and acute neurotoxicity (ACN), subchronic neurotoxicity (SCN), and developmental neurotoxicity (DNT) studies. The database provides a robust characterization profile for children 6 years old and older, as well as for adults. In addition to the standard guideline studies, numerous studies from the scientific literature that describe the pharmacodynamic and pharmacokinetic profile of the pyrethroids in general have been considered in this assessment. Many of these studies were conducted with deltamethrin. A 28- or 90-day inhalation study is not available, but the Agency determined the study is not required for deltamethrin.
iii. There were no indications of fetal toxicity in any of the guideline studies in the database, including developmental studies in the rat and rabbit, a developmental neurotoxicity study in rats, and a 2-generation reproduction study in rats. There was evidence of increased juvenile qualitative susceptibility at high doses observed in both the DNT and 2-generation reproduction studies. These observations are consistent with the findings of juvenile sensitivity in the literature for deltamethrin. However, the observations of increased sensitivity were at doses that were considered to be relatively high ( i.e. , near lethal doses), whereas at doses near the point of departure, no effects on parental animals or offspring were observed in either the developmental neurotoxicity (DNT) or 2-generation reproduction study and, therefore, there is no susceptibility at these doses. The Agency has retained a 3X uncertainty factor to protect for exposures of children <6 years of age based on increased quantitative susceptibility seen in studies on pyrethroid pharmacokinetics (primarily conducted with deltamethrin) and the increased quantitative juvenile susceptibility observed in high dose guideline and literature studies with deltamethrin and other pyrethroids. The Agency has no residual uncertainties regarding age-related sensitivity for women of child bearing age as well as for all adult populations and children ≥6 years of age, based on the absence of pre-natal sensitivity observed in 76 guideline studies for 24 pyrethroids and the scientific literature. Additionally, no evidence of increased quantitative or qualitative susceptibility was seen in the pyrethroid scientific literature related to pharmacodynamics.
1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to deltamethrin will occupy 81% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 2,500 for the general U.S. population and of 520 for children 1-2 years old, the population group receiving the greatest exposure. Because EPA's level of concern for deltamethrin is an MOE of 300 or below, these MOEs are not of concern.
Adequate enforcement methodology utilizing gas chromatography with electron capture detection (GC/ECD), is available for enforcing tolerances for residues of deltamethrin in plant commodities, as described in Pesticide Analytical Manual (PAM) Volume II, Section 180.422. Another GC/ECD method (Method HRAV-22) is available for enforcing tolerances in livestock commodities. Adequate confirmatory method validation data have been submitted for these methods, along with adequate independent laboratory validation (ILV) trials.
Multiresidue methods data for cis -deltamethrin and trans -deltamethrin were previously sent to FDA. Cis -deltamethrin is completely recovered through Methods 302 and 303, and partially recovered through Method 304. Trans -Deltamethrin is partially recovered through Method 303, but not recovered through Method 304.
Harmonization of MRLs is not an issue for the proposed use of deltamethrin as a wide area mosquitocide since established tolerance levels are not changing.
An anonymous citizen objected to the approval of the requested tolerance for deltamethrin. The commenter expressed concerns about the neurotoxicity of the chemical and made unsubstantiated claims that together with all other approved toxic chemicals, use of deltamethrin could lead to many deaths and injuries and that the Agency is harming the American people. Under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) EPA is authorized to establish pesticide tolerances where the safety standard imposed by that statute is met. When new or amended tolerances for residues of a pesticide in food or feed are requested, the Agency evaluates whether there is a reasonable certainty of no harm from aggregate exposure to the pesticide chemical residue. The risk assessment conducted by the Agency considers the potential risks from dietary exposure and other non-occupational exposures. The Agency also considers the available information regarding cumulative toxicological effects of the pesticide residues and other substances that share a common mechanism of toxicity with the subject pesticide. Such an assessment has been conducted for deltamethrin. Deltamethrin is a Type II pyrethroid, and as with other pyrethroids, deltamethrin causes neurotoxicity. These effects are well characterized and adequately assessed by the body of data available to the Agency. The Agency is confident that it has chosen endpoints, points of departure, and uncertainty factors, that have a strong scientific foundation and that are protective for all human populations. As a result, EPA concludes that the tolerances for deltamethrin are safe.
Therefore, tolerances are established for residues of deltamethrin, (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylic acid (S)-alpha-cyano-3-phenoxybenzyl ester and its major metabolites, trans -deltamethrin (S)- alpha -cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate and alpha -R-deltamethrin[(R)- alpha -cyano-m-phenoxybenzyl-(1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate in or on all food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) from use as a wide-area mosquito adulticide at 0.05 ppm.
Currently, a tolerance of 0.05 ppm is established for residues of deltamethrin in or on all food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments. The tolerance level does not need to be increased for the proposed use as a mosquito adulticide; however, EPA is revising 40 CFR 180.435 to clarify the tolerance. In addition, EPA is removing subparagraphs (a)(2)(i), (ii), (A) and (B) as they contain language that is more appropriately enforced under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as use directions on the label.
2. In § 180.435, paragraph (a)(2) is revised to read as:
§ 180.435
(2) A tolerance of 0.05 ppm is established for residues of the insecticide deltamethrin, including its metabolites and degradates, in or on all food/feed items (other than those covered by a higher tolerance as a result of use on growing crops) when deltamethrin is used in food/feed handling establishments or as a wide-area mosquito adulticide. Compliance with the tolerance levels specified is to be determined by measuring only deltamethrin, (1 R ,3 R )-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylic acid ( S )- alpha -cyano-3-phenoxybenzyl ester, and its major metabolites, trans -deltamethrin, ( S )- alpha -cyano- m -phenoxybenzyl(1 R ,3 S )-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate, and alpha-R -deltamethrin, ( R )- alpha -cyano- m -phenoxybenzyl-(1 R ,3 R )-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate, in or on the commodity.
[FR Doc. 2015-06861 Filed 3-26-15; 8:45 am]