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
• 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-2010-0458 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 February 4, 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-2010-0458, 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 tolerance levels for several commodities. 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 picoxystrobin, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with picoxystrobin 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.
The most consistently observed effects of picoxystrobin exposure across species, genders, and treatment durations were decreased body weight, body weight gain and food consumption, and diarrhea. The effects on body weight and food consumption were consistent with the commonly observed findings for compounds which disrupt mitochondria respiration system and the resulting disruption of energy production. Similar to some other strobilurins, picoxystrobin causes intestinal disturbance as indicated by increased incidence of diarrhea or duodenum mucosal thickening. These intestinal effects appeared to be related to the irritating action on the mucus membranes as demonstrated by the severe eye irritation effect seen in the primary eye irritation study on picoxystrobin.
Picoxystrobin caused changes in behavioral effects in both the acute and subchronic neurotoxicity studies with no neuropathological findings. The effects observed with acute exposure
In the rat and rabbit developmental toxicity studies, developmental toxicity was expressed as skeletal variations at doses causing maternal toxicity (i.e. diarrhea, decreased body weight, body weight gain, food consumption, and clinical signs of toxicity). In the reproduction study, parental/systemic toxicity manifested as decreased body weight and body weight gain in both the parents and offspring; no reproductive toxicity was seen.
Picoxystrobin induced a treatment-related increase in testicular interstitial cell benign tumors only in the high dose male rats. No tumors were seen in females; no treatment related-increase in any type of tumor incidence was seen in male and female mice at doses that were considered to be adequate for the assessment of carcinogenicity of picoxystrobin. There is no mutagenic concern. Based on these data, EPA has concluded that quantification of cancer risk based on a non-linear approach (i.e., reference dose (RfD) will adequately account for all chronic toxicity, including carcinogenicity, that which could result from exposure to picoxystrobin. Specific information on the studies received and the nature of the adverse effects caused by picoxystrobin 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
Such effects were identified for picoxystrobin. In estimating acute dietary exposure for the general population, including infants and children, EPA used food consumption information from the U.S. Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA's assumption of this dietary assessment included total highest field trial total residues (parent and metabolite) for all proposed crops. In addition, 100 percent crop treated (PCT) was assumed. Dietary Exposure Evaluation Model (DEEM) version 7.81 default processing factors were assumed except for where tolerances were established for processed commodities or when processing studies showed no concentration. A separate tolerance was set for wheat bran, wheat germ, barley bran and corn oil. Tolerance levels were used for livestock commodities.
The drinking water assessment used a total toxic residue approach to include parent and the major environmental degradates: Compound 2, Compound 3, Compound 7, and Compound 8. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System and Screening Concentration in Ground Water models, the estimated drinking water concentrations of picoxystrobin for:
• Acute exposures are estimated to be 7.95 parts per billion (ppb) for surface water and 0.041 ppb for ground water.
• Chronic exposures for non-cancer assessments are estimated to be 2.41 ppb for surface water and 0.041 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 7.95 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 2.41 ppb was used to assess the contribution to drinking water.
EPA has not found picoxystrobin to share a common mechanism of toxicity with any other substances, and picoxystrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that picoxystrobin 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. Although all required toxicity studies for picoxystrobin have been submitted, the acute neurotoxicity study used for acute dietary risk assessment did not demonstrate a NOAEL, and a LOAEL was used as an endpoint. Therefore, the 10X FQPA safety factor was retained for use of a LOAEL to extrapolate a NOAEL.
ii. There is no indication that picoxystrobin 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 picoxystrobin results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT, total highest field trial total residues for acute exposures, total highest average field trial total residues for chronic exposures, and tolerance levels for livestock commodities. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to picoxystrobin in drinking water. These assessments will not underestimate the exposure and risks posed by picoxystrobin.
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 enforcement methodology, (a liquid chromatography tandem mass spectrometry method (LC/MS/MS), 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. No Codex MRLs have been established for picoxystrobin.
The Agency has revised several of the commodity definitions and modified the levels for which tolerances are being established as follows: Vegetable, legume, dried shelled, except soybean, (group 6C) at 0.1 ppm is revised to pea and bean, dried shelled, except soybean, subgroup 6C at 0.06 ppm; soybean forage at 0.08 ppm is revised to soybean, forage at 1.0 ppm; soybean hay at 2.5 ppm is revised to soybean, hay at 3.0 ppm; soybean hulls at 10 ppm is revised to soybean, hulls at 0.2 ppm; canola, seed at 0.05 ppm is revised to rapeseed subgroup 20A at 0.08 ppm; barley, grain which was proposed as crop group 15 at 0.2 ppm is revised to barley, grain at 0.3 ppm. Tolerance for soybeans oil was proposed at 0.8 ppm, but EPA has determined that a tolerance is not needed. These tolerances have been revised based on the use of the
Based on the corn processing study, the proposed tolerance for cereal grain oil at 1.5 ppm is revised to corn, field, refined oil at 0.07 ppm.
The proposed tolerance for cereal (wheat), aspirated grain fractions at 4.5 ppm is being established as grain, aspirated grain fractions at 10 ppm; soybean, aspirated grain fractions at 3.2 ppm is revised to grain, aspirated grain fractions at 10 ppm as well.
Though not proposed, the Agency has determined it was appropriate to establish tolerances for wheat, bran at 0.06 ppm; wheat, germ at 0.09 ppm; and barely, bran at 0.5 ppm.
EPA also revised livestock tolerances as follows, based on the calculated dietary burden to account for the transfer of residues to livestock matrices (tissues and milk): Cattle, fat from 0.05
Therefore, tolerances are established for residues of picoxystrobin, methyl (αE)-α-(methoxymethylene)-2-[[[6-(trifluoromethyl)-2-pyridinyl]oxy]methyl]benzeneacetate in or on barley, bran at 0.5 ppm; barley, grain at 0.3 ppm; rapeseed subgroup 20A at 0.08 ppm; cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts, at 0.01 ppm; corn, field, refined oil at 0.07 ppm; goat, fat at 0.01 ppm; goat, meat at 0.01 ppm; goat meat byproduct, at 0.01 ppm; grain, aspirated grain fractions at 10 ppm; grain, cereal, group 15, except rice and barely at 0.04 ppm; grain, cereal, forage, fodder, and straw, group 16, hay at 5.0 ppm; grain, cereal, forage, fodder, and straw, group 16, forage at 15 ppm; grain, cereal, forage, fodder, and straw group 16, stover at 10 ppm; grain, cereal, forage, fodder, and straw, group 16, straw at 2 ppm; hog, fat at 0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts, at 0.01 ppm; horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts, at 0.01 ppm; milk at 0.01 ppm; pea and bean, dried shelled, except soybean, subgroup 6C at 0.06 ppm; eggs at 0.01 ppm; poultry, fat at 0.01 ppm; poultry, meat at 0.01 ppm; poultry, meat byproducts at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, meat byproducts, at 0.01 ppm; soybean, forage at 1 ppm; soybean, hay at 3 ppm; soybean, hulls at 0.2 ppm; soybean, seed at 0.05 ppm; vegetable, foliage of legume, except soybean, subgroup 7A at 40 ppm; wheat, bran at 0.06 ppm; and wheat, germ at 0.09 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” (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.