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. 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).
This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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
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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0759, by one of the following methods:
Based upon review of the data supporting the petition, EPA has revised the proposed tolerance levels for several commodities. Due to insufficient data, EPA is not establishing the citrus group 10-10 tolerance. The reasons for these changes are explained in Unit IV.D.
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 buprofezin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with buprofezin 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.
Buprofezin has low acute toxicity via the oral, dermal and inhalation routes of exposure. It is not an eye or skin irritant; nor is it a dermal sensitizer. In subchronic toxicity studies, the primary effects of concern in the rat were increased microscopic lesions in male and female liver and thyroid, increased liver weights in males and females, and increased thyroid weight in males. In chronic studies in the rat, an increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males was reported. Increased relative liver weights were reported in female dogs. Buprofezin was not carcinogenic to male and female rats. In the mouse, increased absolute liver weights in males and females, along with an increased incidence of hepatocellular adenomas and hepatocellular adenomas plus carcinomas in females were reported. The increase in carcinomas was not statistically significant when analyzed separately. Based on the increased incidence of combined benign and malignant liver tumors in female mice only, no evidence of carcinogenicity in rats, and no evidence of genotoxicity in submitted guideline studies using
Developmental and reproductive toxicity studies do not indicate concern for increased susceptibility in offspring. Toxicity in the offspring was found at dose levels that were also toxic to the parent and the effects observed in the offspring were not more severe, qualitatively, than the effects observed in the parent. No neurotoxic effects were observed at any dose in a subchronic neurotoxicity study in rats at the highest dietary doses of 5,000 ppm. An immunotoxicity study did not demonstrate immunotoxic effects by buprofezin. A special study is required to generate specific data on the thyroid to protect the developing nervous
Specific information on the studies received and the nature of the adverse effects caused by buprofezin 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 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 buprofezin used for human risk assessment is shown in the Table of this unit.
Such effects were identified for buprofezin in the population subgroup females age 13-49. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed tolerance level residues for buprofezin and estimated residue levels of the BF4 Conjugate, a metabolite of concern, based on buprofezin metabolism data. The BF4 Conjugate is not detectable by data collection methods and thus is not included in the tolerance level. Given the potential for the buprofezin metabolites BF9 and BF12 to concentrate to a greater degree than buprofezin in processed commodities, Dietary Exposure Evaluation Model (DEEM) (Version 7.81) default processing factors were retained for all commodities, except for tomato paste and puree, which were reduced based on empirical data. Total residues of concern in meat and milk were based on feeding study data. EPA also assumed 100 percent crop treated (PCT) for all commodities.
The cRfD was based on an endpoint of toxicity from a rat combined chronic/oncogenicity study. The NOAEL in this study was 1.0 mg/kg/day based on increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid of males at 8.7 mg/kg/day. Buprofezin was not carcinogenic in rats. Administration of buprofezin in the diet was associated with increased incidence of liver tumors in female mice only at the mid- and high-doses but not at the low dose of 1.82 mg/kg/day which was considered to be the NOAEL for the females. Because the positive evidence of cancer was limited to one sex of one species (female mice), there was no evidence of mutagenicity, and no carcinogenic effects in rats, EPA concluded that the weight-of-the-evidence indicated that the carcinogenic findings in female mice are a threshold effect. The NOAEL of 1 mg/kg/day from the rat study on which the cRfD is based on is lower than the NOAEL for liver tumors of 1.82 mg/kg/day from the mouse. Therefore, the cRfD would be protective of potential carcinogenic effects from exposure to buprofezin.
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:
Almond 1%; Cantaloupes 5%; Cotton 1%; Grapefruit 1%; Honeydew 2.5%: Lemons 2.5%; Lettuce (head and leaf) 1%; Oranges 2.5%; Pears 15%; Pistachio 5%; Pumpkins 1%; Squash (summer) 1%; Tomatoes 2.5%; Watermelons 2.5%.
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%.
Buprofezin has only been registered for use on some commodities since late 2009. Therefore, PCT estimates based on actual usage data were not deemed sufficient indicators of potential usage on these recently registered crops. In 2009 the EPA used PCT estimates for these commodities based on the market leader approach and has determined these are still appropriate estimates to be used in risk assessment. The Agency estimated the PCT for the uses registered in 2009 as follows:
Spinach 30%; Celery 18%; Broccoli 55%; Cabbage 40%, Celery 18%, Chinese Broccoli 55%; Brussel Sprouts 61%; Cauliflower 48%; Kohlrabi 5%; Apple 5%; Apricot 51%; Cherry 72%; Nectarine 51%; Peach 13%; Plum 37%; Grape 15%; Strawberry 39%;
For additional information regarding the PCT estimates for these commodities refer to the final rule published in the
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 buprofezin may be applied in a particular area.
Based on the 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 buprofezin for acute exposures are estimated to be 58.2 parts per billion (ppb) for surface water and 0.09 ppb for ground water. The EDWCs for chronic exposures are estimated to be 18.6 ppb for surface water and 0.09 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 58.2 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration value of 18.6 ppb was used to assess the contribution to drinking water.
EPA has not found buprofezin to share a common mechanism of toxicity with any other substances, and buprofezin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that buprofezin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
i. The toxicity database for buprofezin is complete except for submission of the thyroid toxicity study that will inform the Agency's understanding of buprofezin's chronic effects. A chronic POD of 1.0 mg/kg/day (NOAEL) was selected for the general population from a 2-year chronic feeding study in rats based on increased incidence of follicular cell hyperplasia and hypertrophy in the thyroid in males at the LOAEL of 8.7 mg/kg/day. A UF 300× (10× for intraspecies variation; 3× for interspecies extrapolation—reduced from 10× based on demonstrated evidence that rats are more susceptible to thyroid effects than humans; 10× for protection of infants and children) was applied to the dose to obtain a cPAD. The 10× FQPA Safety Factor was retained due to uncertainty caused by the lack of a thyroid assay in young rats. In rat chronic, subchronic, and reproductive toxicity studies effects such as thyroid enlargement and follicular cell hyperplasia were seen in adult animals. However, hormone levels, thyroid organ weights, and histopathology were not evaluated for pups in any reproductive studies. To assess the potential toxic characteristics to thyroid structure or hormone homeostasis during development, the Agency is requiring a developmental thyroid study.
ii. There is no indication that buprofezin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that buprofezin results in increased susceptibility to
iv. There are no residual uncertainties identified in the exposure databases. The acute dietary food exposure assessment was performed based on 100 PCT and a conservative estimate of total residues of concern for buprofezin. The chronic dietary food exposure assessment was performed based, in part on, average field trial residues, average USDA PDP residues, and PCT were used where available. Nonetheless, the chronic exposure assessment is conservative and is likely to overestimate risks based on a number of factors including, use of 100 PCT assumptions for several crops for which data were unavailable, use of a conservative factor to account for the BF4 Conjugate, use of default processing factors, and use of drinking water exposure estimates for application of buprofezin to coffee, which is grown in limited areas of the U.S. (e.g., Puerto Rico, Hawaii). Likewise, EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to buprofezin in drinking water. These assessments will not underestimate the exposure and risks posed by buprofezin.
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.
Adequate gas chromatography with nitrogen phosphorus detection (GC/NPD) and a GC/mass spectrometry (MS) method for confirmation of buprofezin residues in plant commodities is available to enforce the tolerance. These methods are available in the Pesticide Analytical Manual (PAM) Volumes I & II for enforcement of buprofezin tolerances.
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 tolerance level being established by this action for tree nut group 14 is harmonized with the Codex MRL for almond. There is an established Codex MRL of 2.0 ppm in/on pepper and 1.0 ppm in/on tomato. The petitioner proposed a tolerance of 3.0 ppm for the Fruiting vegetable group 8-10, which contains both peppers and tomatoes. EPA cannot harmonize the U.S. tolerance on tomatoes with the tomato MRL because the residue field trial data submitted to support the fruiting vegetable group 8-10 tolerance reported residues higher than the 1.0 ppm level established by Codex for tomato. However, the residue field trial data was consistent with a tolerance of 2.0 ppm for the fruiting vegetable group 8-10, so EPA was able to harmonize with the Codex MRL for peppers. For pome fruit, the Codex MRLs and the U.S. tolerances are harmonized for “fruit, pome (except pear and pear, Asian) at 3.0 ppm and pear and pear, Asian at 6.0 ppm. There are currently no established Codex MRLs for buprofezin in/on the remainder of the tolerances being established.
EPA received two comments to the notice of filings PP 1E7908 and 1F7905, which said that toxic chemicals should not be allowed on food that Americans eat. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.
The tolerance for fruit, citrus, group 10-10 is not being established at this time due to a lack of residue chemistry data. Based on the data supporting the petition, EPA has revised the proposed tolerance on Brassica, leafy greens, subgroup 5B and turnip greens from 55 ppm to 60 ppm. The Agency revised these tolerance levels based on analysis of the residue field trial data using the Organization for Economic Co-operation and Development (OECD) tolerance calculation procedures.
Additionally, the Agency revised the proposed tolerance in or on vegetables, fruiting, group 8-10 from 3.0 to 2.0 to harmonize with the Codex MRL on pepper and will establish separate tolerances for fruit, pome, group 11-10 (except pear and pear, Asian) at 3.0 ppm and pear and pear, Asian oriental at 6.0 ppm to harmonize with Codex. A tolerance is not needed for pistachio since there is already a pistachio tolerance in § 180.511. Finally, the Agency is correcting language for established commodities that are spelled incorrectly—Llama should be Ilama and Loganberry should be Logan.
Therefore, tolerances are established for residues of buprofezin 2-[(1,1-dimethylethyl)imino]tetrahydro-3(1-methylethyl)-5-phenyl-4
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” (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) (Public Law 104-4).
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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
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.
The revisions and additions read as follows:
(a) * * *