Daily Rules, Proposed Rules, and Notices of the Federal Government
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
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-2009-0644 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 January 28, 2013. 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-2009-0644, by one of the following methods:
Based upon review of the data supporting the petition, EPA has revised the proposed tolerances for several commodities. The Agency has also revised the tolerance expression for all established commodities to be consistent with current Agency policy. The reasons for these changes are explained in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * * .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for fenpropathrin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fenpropathrin follows.
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.
Fenpropathrin is a member of the pyrethroid class of insecticides. Pyrethroids have historically been classified into two groups—Type I and Type II, based on chemical structure and toxicological effects. Type I pyrethroids induce in rats a syndrome consisting of aggressive sparring, altered sensitivity to external stimuli, hyperthermia, and fine tremors, progressing to whole-body tremors, and prostration (T-syndrome). Type II pyrethroids, which contain an alpha-cyano moiety, produce in rats a syndrome that includes pawing, burrowing, salivation, hypothermia, and coarse tremors leading to choreoathetosis (CS-syndrome). Fenpropathrin is a mixed type pyrethroid because the biochemical responses and resulting clinical signs of neurotoxicity are intermediate between those of Type I and Type II pyrethroids. The adverse outcome pathway shared by pyrethroids involves the ability to interact with voltage-gated sodium channels in the central and peripheral nervous systems, leading to changes in neuron firing and, ultimately, neurotoxicity.
Fenpropathrin exhibits high acute toxicity via the oral and dermal routes, but low toxicity via the inhalation route of exposure. Fenpropathrin is a mild eye irritant, but does not cause dermal irritation or skin sensitization. Toxicological effects characteristic of Type I pyrethroids were seen in most of the experimental toxicology studies including the acute, subchronic, and developmental neurotoxicity studies, subchronic studies in the rat and dog, the chronic carcinogenicity study in the rat, the developmental studies in the rat and rabbit, and in the 3-generation reproduction study in rats. Tremors were the most common indication of neurotoxicity; however, ataxia, increased sensitivity (e.g., heightened response) to external stimuli, convulsions, and increased auditory startle response were also observed.
In developmental toxicity studies in rats and rabbits, maternal toxicity included neurological effects such as ataxia, sensitivity to external stimuli, tremors in the rat, and flicking of forepaws in the rabbit. Developmental effects were limited to incomplete or asymmetrical ossification of sternebrae at the maternally toxic dose in the rat. There were no developmental effects in the rabbit. There were no indications of immunotoxicity in any of the guideline studies, including the immunotoxicity study in rats. In a 3-generation reproduction study in the rat, maternal and offspring effects were observed at the mid- and high-dose. At the high dose, maternal effects included increased deaths and clinical signs of toxicity (tremors, muscle twitches, and increased sensitivity) during lactation. Pup deaths were noted at this level. At the mid-dose, minimal signs of treatment-related effects were observed for both adults and pups, reducing concern for quantitative or qualitative sensitivity.
There was no evidence of carcinogenicity in either the rat or mouse long-term dietary studies, nor was there any mutagenic activity in bacteria or cultured mammalian cells. Fenpropathrin has been classified as “not likely to be carcinogenic to humans.”
Specific information on the studies received and the nature of the adverse effects caused by fenpropathrin 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
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin
Residue distributions were used for the commodities that made the most significant contributions to the risk estimates. Distributions of USDA's PDP monitoring data from 2007 through 2010 were used for broccoli (translated to Chinese mustard cabbage and cauliflower), watermelon, squash, oranges (translated to tangerines), apples, apple juice, pears, blueberries (translated to huckleberries), grapes, grape juice, and strawberries. Distributions of field trial data were used for cherries, peaches, plums, grapefruit, raspberries, blackberries, apricots, cabbage, papaya, olives, tomatoes, cucumbers, Brussels sprouts, and guava. Tolerance-level residues were assumed for all other commodities having existing or proposed tolerances. Dietary Exposure Evaluation Model (DEEM) default processing factors were used for those commodities for which they were available. In some cases, empirical processing factors were used.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency estimated the PCT for existing uses as follows:
Apples, 15%; apricots, 2.5%; blueberries, 2.5%; broccoli, 2.5%; Brussels sprouts, 10%; cabbage, 2.5%; cauliflower, 2.5%; cherries, 5%; cotton, 2.5%; cucumbers, 2.5%; grapefruit, 35%; grapes, 10%; nectarines, 2.5%; oranges, 35%; peaches, 2.5%; pears, 10%; plums, 2.5%; prune plums, 2.5%; squash, 2.5%; strawberries, 50%; tangerines, 15%; tomatoes, 10%; and watermelons, 2.5%.
In most cases, EPA uses available data from U.S. Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6 to 7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than 1. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which fenpropathrin may be applied in a particular area.
Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fenpropathrin for acute exposures are estimated to be 10.3 parts per billion (ppb) for surface water and 0.005 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 10.3 ppb was used to assess the contribution to drinking water.
The Agency is required to consider the cumulative risks of chemicals sharing a common mechanism of toxicity. The Agency has determined that the pyrethroids and pyrethrins, including fenpropathrin, share a common mechanism of toxicity. The members of this group share the ability to interact with voltage-gated sodium channels, ultimately leading to neurotoxicity. The cumulative risk assessment for the pyrethroids/pyrethrins was published in the November 9, 2011 issue of the
The Agency has conducted a quantitative analysis of the proposed tolerances for fenpropathrin and has determined that it will not contribute significantly or change the overall findings presented in the pyrethroid cumulative risk assessment. In the cumulative assessment for pyrethroids, residential exposures were the greatest contributor to the total exposure. As there are no residential uses for fenpropathrin, the proposed new uses will have no impact on the residential component of the cumulative risk estimates.
Dietary exposures make a minor contribution to the total pyrethroid exposure. The dietary exposure assessment performed in support of the pyrethroid cumulative assessment was much more highly refined than that performed for the single chemical, fenpropathrin. In addition, for the fenpropathrin risk assessment, the most sensitive apical endpoint in the fenpropathrin database was selected to derive the POD. Additionally, the POD selected for fenpropathrin is specific to fenpropathrin, whereas the POD selected for the cumulative assessment was based on common mechanism of action data that are appropriate for all 20 pyrethroids included in the cumulative assessment. The proposed food uses of fenpropathrin will not contribute significantly or change the overall findings in the pyrethroid cumulative risk assessment, as the dietary risks are a minor component of total pyrethroid cumulative risk. For information regarding EPA's efforts to evaluate the risk of exposure to pyrethroids, refer to
There are several
i. The toxicity database for fenpropathrin is not complete. While the database is considered to be complete with respect to the guideline toxicity studies for fenpropathrin, EPA lacks additional data to address the potential for juvenile sensitivity to all pyrethroids. In light of the literature studies indicating a possibility of increased sensitivity to fenpropathrin in juvenile rats at high doses, EPA has requested proposals for study protocols which could identify and quantify fenpropathrin's potential juvenile sensitivity. The reasons discussed in Unit III.D.3.ii, and the uncertainty regarding the protectiveness of the intraspecies uncertainty factor raised by the literature studies warrant application of an additional 3X for risk assessments for infants and children less than 6 years of age.
ii. There is no evidence that fenpropathrin results in increased susceptibility in
No evidence of increased quantitative or qualitative susceptibility was seen in the pyrethroid scientific literature related to pharmacodynamics (the effect of pyrethroids at the target tissue) both with regard to interspecies differences between rats and humans and to differences between juveniles and adults. Specifically, there are
In light of the high dose literature studies showing juvenile sensitivity to pyrethroids and the absence of the requested data on juvenile sensitivity to pyrethroids, EPA is retaining a 3X additional safety factor as estimated by pharmacokinetic modeling. For several reasons, EPA concludes there are reliable data showing that a 3X factor is protective of the safety of infants and children. First, the high doses that produced juvenile sensitivity in the literature studies are well above normal dietary exposure levels of pyrethroids to juveniles and these lower levels of exposure are not expected to overwhelm the ability to metabolize pyrethroids as occurred with the high doses used in the literature studies. This is confirmed by the lack of a finding of increased sensitivity in prenatal and postnatal guideline studies in any pyrethroid, including fenpropathrin, despite the relatively high doses used in those studies. Second, the portions of both the inter- and intraspecies uncertainty factors that account for potential pharmacodynamic differences (generally considered to be approximately 3X for each factor) are likely to overstate the risk of inter- and intraspecies pharmacodynamic differences given the data showing similarities in pharmacodynamics between juveniles and adults and between humans and rats. Finally, as indicated, pharmacokinetic modeling only predicts a 3X difference between juveniles and adults.
iii. There are no residual uncertainties identified in the exposure databases. Although the acute dietary exposure estimates are refined, as described in Unit III.C.1.i., the exposure estimates will not underestimate risk for the established and proposed uses of fenpropathrin. The residue levels used are based on distributions of residues from field trial data, monitoring data reflecting actual residues found in the food supply, and tolerance-level residues for several commodities; the use of estimated PCT information; and, when appropriate, processing factors measured in processing studies or default high-end factors representing the maximum concentration of residue into a processed commodity. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to fenpropathrin in drinking water. These assessments will not underestimate the exposure and risks posed by fenpropathrin.
Further information about the reevaluation of the FQPA SF for
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
An adequate enforcement methodology utilizing gas chromatography with electron capture detection (GC/ECD, Residue Method Number RM-22-4) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has established MRLs for fenpropathrin in or on tea, green and black at 2.0 ppm. Using the Organization for Economic Cooperation and Development (OECD) MRL calculation procedures, the recommended U.S. tolerance for tea, dried would be 3.0 ppm. However, for the purposes of harmonization of the U.S. tolerance with the established Codex MRL, EPA is recommending the tolerance of 2.0 ppm for tea, dried. The Agency considers this tolerance level to be adequate because the highest field trial value noted for tea, dried was 1.38 ppm.
Based on the data supporting the petitions, EPA revised the proposed tolerances on acerola, feijoa, guava, jaboticaba, passionfruit, startfruit and wax jambu from 1.5 ppm to 3.0 ppm; longan, lychee, pulasan, rambutan, and Spanish lime from 3.0 ppm to 7.0 ppm; and atemoya, birba, cherimoya, custard apple, ilama, soursop, and sugar apple, from 1.0 ppm to 1.5 ppm. The Agency revised these tolerance levels based on analysis of the residue field trial data using the OECD tolerance calculation procedures. EPA also revised the proposed commodity definition for tea to tea, dried in order to reflect the Agency's commodity nomenclature.
Finally, the Agency has revised the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of fenpropathrin not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.
Therefore, tolerances are established for residues of fenpropathrin, alpha-cyano-3-phenoxy-benzyl 2,2,3,3-tetramethylcyclopropanecarboxylate, in or on acerola, feijoa, guava, jaboticaba, passionfruit, starfruit and wax jambu at 3.0 ppm; longan, lychee, pulasan, rambutan and Spanish lime, at 7.0 ppm; atemoya, biriba, cherimoya, custard apple, ilama, soursop and sugar apple, at 1.5 ppm; and tea, dried at 2.0 ppm.
This final rule establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.