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, but are not limited to those engaged in the following activities:
• 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
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-2009-1008 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 November 13, 2012. 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-2009-1008, by one of the following methods:
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Based upon review of the data supporting the petition, EPA has revised the proposed tolerances for several commodities and revised the commodity definition for tea to tea, dried. 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.D.
To control the brown marmorated stink bug, EPA is also establishing time-limited tolerances for the use of bifenthrin in or on apple, nectarine, and peach at 0.5 ppm. These tolerances expire and are revoked on December 31, 2015. The Agency is establishing the time-limited tolerances in response to an informal crisis exemption request under FIFRA section 18 on behalf of the states of Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, Virginia, and West Virginia for the emergency use of bifenthrin to control the brown marmorated stink bug on these commodities.
As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of bifenthrin in or on apple, nectarine, and peach. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and the Agency decided that the necessary tolerances under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing these tolerances without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire and are revoked on December 31, 2015, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on apple, nectarine, and peach after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.
Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions whether bifenthrin meets FIFRA's registration requirements for use in or on apple, nectarine, and peach, or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these time-limited tolerances serve as a basis for registration of bifenthrin by a State for Special Local Needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for persons in any State other than those listed to use this pesticide on these crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for bifenthrin, contact the Agency's Registration Division at the address provided under
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 assessment includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires
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 bifenthrin including exposure resulting from the tolerances, including the time-limited tolerances, established by this action. EPA's assessment of exposures and risks associated with bifenthrin 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.
Bifenthrin has a low order of acute toxicity via the dermal and inhalation routes of exposure and has moderate acute toxicity via the oral route. It is neither an eye nor skin irritant, and it is not a dermal sensitizer. Behavioral changes characteristic of Type I pyrethroids, such as muscle tremors, were noted in most of the bifenthrin experimental toxicology studies, consistent with its mode of action of delaying the inactivatation of voltage gated sodium channels. Additional effects seen in one or more toxicity studies for bifenthrin included muscle twitching, decreased grip strength, altered landing foot splay, depressed respiration, increased grooming counts, loss of muscle coordination, staggered gait, exaggerated hind limb flexion, and convulsions at high doses. Decreased body weight, body weight gains and food consumption were also noted in repeat-dosing dietary studies. Evidence of increased qualitative or quantitative susceptibility of offspring was not observed in any of the available guideline toxicity studies for bifenthrin.
Bifenthrin is classified as a “possible human carcinogen” based on an increased incidence of urinary bladder tumors in mice. However, EPA concluded that the bladder tumors may not be uncommon in mice and are not likely to be malignant. Additionally, these tumors were observed only in male mice at the highest dose tested and the incidence was of borderline significance. No evidence of carcinogenicity was observed in bifenthrin carcinogenicity studies in rats, and bifenthrin was negative in five different tests for mutagenicity but was marginally active in a forward mutation test in mouse lymphoma cells. Overall, based on the available information, there is a low concern for mutagenicity. Taking into account all of this information, the Agency has determined that quantification of risk using a non-linear approach (i.e., acute population-adjusted dose (aPAD)) will adequately account for all chronic toxicity, including carcinogenicity that could result from exposure to bifenthrin. While the Agency would typically use a chronic population-adjusted dose (cPAD) to protect for cancer concerns, use of the aPAD is protective for bifenthrin because increasing toxicity with increasing duration of exposure is not seen for bifenthrin. The no observed adverse effect level (NOAEL) observed in the mouse chronic study, in which tumors were observed, is 6.7 mg/kg/day, 2-fold higher than the points of departure (POD) used for acute risk assessment.
Specific information on the studies received and the nature of the adverse effects caused by bifenthrin as well as the dose at which the motor activity change is equal to one standard deviation (SD) from the control value (BMD
Once a pesticide's toxicological profile is determined, EPA identifies toxicological 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. Typically, 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 of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for bifenthrin used for human risk assessment is shown in Table 1. of this unit.
Additionally, the uses proposed under the section 18 emergency exemption program have use patterns that are similar to the registered use on pear. Therefore, the Agency relied on PDP data for pears, including for baby food and canned products, when assessing anticipated residues on peach, nectarine, and apple. EPA believes the use of PDP data for pears is appropriate, as bifenthrin residues are found mainly on the fruit surface and residues on peach, nectarine, and apple are expected to be similar to those found on pear.
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.
The Agency estimated the PCT for existing uses as follows:
Alfalfa, 1%; almond, 25%; artichoke, 30%; beans, green, 50%; broccoli, 6%; cabbage, 30%; caneberries, 45%; canola/rapeseed, 3%; cantaloupe, 60%; carrots 10%; cauliflower, 10%; celery, 1%; corn, 5%; cotton, 10%; cucumbers, 15%; dry beans and peas, 1%; grape, table, 1%; grape, wine, 5%; honeydew, 75%; hazelnut (filberts), 5%; lettuce, 15%; onion, 1%; lima bean, 35%; peanut, 5%; pea, green, 25%; pear, 4%; pecan, 5%; pepper, 20%; pistachio, 40%; potato, 5%; pumpkin, 40%; sorghum, 1%; soybean, 5%; squash, 20%; strawberry, 55%; sweet corn, 50%; tomato, 20%; walnut, 25%; watermelon, 15%; wheat, spring, 1%; and wheat, winter, 1%.
In most cases, EPA uses available data from United States 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 6-7 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 one. 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 estimated the PCT for the new uses associated with the time-limited tolerances as follows:
Apple, 10%; nectarine, 3%; and peach, 7%.
Bifenthrin is being considered for use on apple, nectarine, and peach in Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, Virginia, and West Virginia to control the brown marmorated stink bug under FIFRA section 18, which allows for the emergency use of a pesticide on a site for which it is not registered.
The Agency conservatively estimated that 100 percent of the crops in these states will be treated with bifenthrin and calculated the national PCT given the share of utilized production or grown acreage from the seven states likely to seek the use of bifenthrin.
EPA used data from 2010 USDA/NASS for apples and peaches. Data on the most recent survey years, 2007-2009, were used to derive the needed PCT estimates. The sum of the utilized production in these states was divided by the total domestic utilized production and multiplied by 100 to determine the PCT for each of the crops for each of the named years.
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
Based on the First Index Reservoir Screening Tool (FIRST), Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of bifenthrin for acute exposures are estimated to be 0.0140 parts per billion (ppb) for surface water and 0.0030 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 0.0140 ppb was used to assess the contribution to drinking water.
The Agency combines risk values resulting from separate routes of exposure when it is likely they can occur simultaneously based on the use pattern and the behavior associated with the exposed population, and if the hazard associated with the points of departure is similar across routes. A common toxicological endpoint, neurotoxicity, exists for dermal, incidental oral, and inhalation routes of exposure to bifenthrin. Therefore, these were combined for all residential exposure scenarios assessed.
Of the proposed and established uses with potential residential handler and post-application exposure, the following high-end risk estimates were selected for use in the bifenthrin short-term aggregate assessment: Combined dermal and inhalation exposures to adults from the outdoor ornamental use and combined dermal and incidental oral exposures to children from contact with treated turf.
Residential handler and post-application exposure scenarios are generally not combined. Although the potential exists for the same individual (i.e., adult) to apply a pesticide around the home and be exposed by re-entering a treated area in the same day, this is an unlikely exposure scenario. Combining these exposure scenarios would also be inappropriate because of the conservative nature of each individual assessment.
EPA did not assess intermediate-term and chronic residential exposures because bifenthrin is acutely toxic and does not increase in potency with repeated dosing. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
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 bifenthrin, 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
The Agency has conducted a quantitative analysis of the proposed bifenthrin bed bug use and has determined that it will not contribute significantly or change the overall findings presented in the pyrethroid cumulative risk assessment. This analysis is summarized in the document: “Bifenthrin: Human Health Risk Assessment to Support Section 3 New Uses for a Bed Bug Treatment, Grass Grown for Seed, Tolerances for Imported Tea, and a Section 18 Emergency Exemption Use on Apple, Nectarine, and Peach” at pages 78-81 in docket ID number EPA-HQ-OPP-2009-1008. Further, the proposed food uses of bifenthrin 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 bifenthrin is not complete. EPA lacks additional data on immunotoxicity, inhalation toxicity, and adult-juvenile sensitivity. Recent changes to 40 CFR part 158 imposed new data requirements for immunotoxicity testing (OCSPP Guideline 870.7800) for pesticide registration. The toxicology database for bifenthrin does not show any evidence of treatment-related effects on the immune system, and the overall weight-of-evidence suggests that this chemical does not directly target the immune system. Therefore, the Agency does not believe that conducting a functional immunotoxicity study will result in a lower POD than that currently in use for overall risk assessment, and additional safety factors are not needed to account for a lack of this study. EPA is requiring an inhalation toxicity study for bifenthrin because inhalation data for other pyrethroids show the potential for the inhalation route to be more potent than the oral route. Currently, the POD for inhalation risk assessment scenarios is based on an oral toxicity study. Reliance on an oral study raises uncertainty as to whether the standard safety factors are protective of infants and children. Finally, in light of the literature studies indicating a possibility of increased sensitivity to bifenthrin in juvenile rats at high doses, EPA has also requested proposals for study protocols which could identify and quantify bifenthrin's potential juvenile sensitivity. For the reasons discussed in Unit III.D.3.ii., the uncertainty regarding the protectiveness of the intraspecies uncertainty factor raised by the literature studies and the absence of the requested data warrant application of an additional 3X for risk assessments for infants and children under six years of age.
ii. There is no evidence that bifenthrin results in increased susceptibility in
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 or residential exposure levels of pyrethroids to juveniles and these lower levels of exposure are not expected to overwhelm the ability 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 pre- and post-natal guideline studies in any pyrethroid, including bifenthrin, 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 bifenthrin databases
Further information about the reevaluation of the FQPA safety factor for pyrethroids may be found in document ID number: EPA-HQ-OPP-2011-0746-0011.
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-, intermediate-, 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.
For children 1-2 years old, the most highly exposed children's subgroup, using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that the combined short-term food, water, and residential exposures result in an aggregate MOE of 330. Because EPA's level of concern for bifenthrin is a MOE of 300 or below, this MOE is not of concern.
For adults, although the short-term dermal and inhalation risks were estimated using the same oral POD, these exposure estimates could not be directly combined for the adult short-term exposure assessment because the LOCs for dermal and inhalation routes of exposure are not the same (an MOE of < 100 defines the LOC for dermal exposure while inhalation risk is defined by an MOE of < 1,000). Accordingly an aggregate risk index (ARI) was required to estimate aggregate risk for adults. EPA identifies an ARI at or below one as a risk estimate of concern. The short-term aggregate ARI for adults is 2.0. An ARI greater than 1 indicates risks that are not of concern.
An adequate method, utilizing gas chromatography with electron capture detection (GC/ECD), is available to enforce the proposed tolerances for plant commodities.
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 not established an MRL for bifenthrin. However, Codex has proposed a 30 ppm MRL for green and black tea (fermented and dried). The United States has recommended a tolerance on tea, dried at 30 ppm in order to harmonize with the proposed Codex MRL.
EPA received one comment to the notice of filing that stated, in part, that no residue should be allowed for bifenthrin. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing
Based on the data supporting the petitions, EPA revised the proposed tolerance on grass, forage from 2.5 ppm to 4.0 ppm; and grass, hay from 4.5 ppm to 15 ppm. The Agency revised these tolerance levels based on analysis of the residue field trial data using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures. Additionally, EPA revised the proposed tolerance on tea from 25 ppm to 30 ppm, in order to harmonize with the proposed Codex MRL associated with the commodity. EPA also revised the proposed commodity definition for tea to tea, dried in order to reflect the correct 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 bifenthrin 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 bifenthrin, (2-methyl [1,1′-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylate, in or on grass, forage at 4.0 ppm; grass, hay at 15 ppm; and tea, dried at 30 ppm. This regulation additionally establishes time-limited tolerances for residues of bifenthrin in or on apple, nectarine, and peach at 0.5 ppm. Finally, this regulation removes time-limited tolerances in or on orchardgrass, forage at 2.5 ppm; and orchardgrass, hay at 4.5 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 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
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”
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 part 180 is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The revisions and addition read as follows: