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-2011-0781 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 1, 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-2011-0781, by one of the following methods:
Based upon review of the data supporting the petition, EPA has revised the proposed tolerance levels, determined that established tolerances for certain livestock commodities should be increased and multiple new livestock commodity tolerances should be established. 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
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 halosulfuron-methyl including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with halosulfuron-methyl 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.
Halosulfuron-methyl has a low acute toxicity via the oral, dermal, and inhalation routes of exposure. Halosulfuron-methyl is a non-irritant for skin and eyes and is not a dermal sensitizer.
With repeated dosing, halosulfuron-methyl produces non-specific effects, which are frequently characterized by reduced body weight/body weight gain in the test animals. The available data show that the dog is the most sensitive mammalian species. In the dog, decreased body weight was seen in the chronic oral toxicity study and decreased body weight gain was observed in females in the subchronic oral toxicity study. In the rat and mouse, there was a decrease in body weight gains at high dose levels in short- and long-term oral and dermal studies.
In the prenatal developmental toxicity study in rats, increases in resorptions, soft tissue (dilation of the lateral ventricles) and skeletal variations, and decreases in body weights were seen in the fetuses compared to clinical signs and decreases in body weights and food consumption in the maternal animals at similar dose level.
In the rabbit developmental toxicity study, increases in resorptions and post-implantation losses and decrease in mean litter size was seen in the presence of decreases in body weight and food consumption in maternal animals were observed. However, a clear no-observed-adverse-effect-level (NOAEL) for these effects was established in both rat and rabbit developmental toxicity studies.
Halosulfuron-methyl did not produce reproductive effects. No neurotoxic effects were observed in the acute or subchronic neurotoxicity studies. Halosulfuron-methyl is classified as “not likely to be carcinogenic to humans” because in both rat and mouse carcinogenicity studies halosulfuron-methyl does not cause; compound-related increases in tumor incidence. It is negative for mutagenicity in a battery of genotoxicity studies. Specific information on the studies received and the nature of the adverse effects caused by halosulfuron-methyl as well as the 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 (LOC) 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 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
Based on the Tier 1 Rice Model and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of halosulfuron-methyl for acute and chronic exposures are estimated to be 59.2 parts per billion (ppb) for surface water and 0.065 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both acute and chronic dietary risk assessments, the water concentration value of 59.2 ppb was used to assess the contribution to drinking water.
i. The toxicity database for halosulfuron-methyl is complete except for an immunotoxicity study. In accordance with 40 CFR part 158, Toxicology Data Requirements, an immunotoxicity study is required for halosulfuron-methyl. In the absence of specific immunotoxicity studies, EPA has evaluated the available halosulfuron-methyl toxicity data to determine whether an additional uncertainty factor is needed to account for potential immunotoxicity. The toxicology database for halosulfuron-methyl does not show any evidence of biologically relevant effects on the immune system following exposure to this chemical. The overall weight of evidence suggests that this chemical does not directly target the immune system. Based on these considerations, EPA does not believe that conducting immunotoxicity testing will result in a POD lower than those already selected for halosulfuron-methyl risk assessment, and an additional database uncertainty factor is not needed to account for the lack of this study.
ii. There is no indication that halosulfuron-methyl is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. Although there is evidence of increased qualitative susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to halosulfuron-methyl in drinking water. EPA used similarly conservative assumptions to assess post application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by halosulfuron-methyl.
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
Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1,800 for adults and 840 for children. For adults, potential pathways of exposure include oral (background) and dermal (post-application primary) routes, while for children, potential pathways of exposure include oral (background) and incidental oral and dermal (primary) routes. Because EPA's level of concern for halosulfuron-methyl is a MOE of 100 or below, these MOEs are not of concern.
Adequate enforcement methodologies are available to enforce the tolerance expression: A gas chromatography with nitrogen phosphorus detection; GC/NPD method for crop commodities and a gas chromotagraphy with electron capture detection (GC/ECD) method for livestock commodities. The methods 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. There are no Maximum Residue Limits (MRLs) established by Codex, Canada, or Mexico for any crop or livestock commodities for halosulfuron-methyl.
An anonymous citizen objected to the presence of any pesticide residues on food. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned completely. However, the existing legal framework provided by section 408 of the FFDCA contemplates that tolerances greater than zero 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.
EPA has revised the requested tolerances by increasing the tolerance values for millet, proso, forage and grass, forage, fodder, and hay, group 17, forage and reducing the tolerance values for millet, proso, hay and grass, forage, fodder, and hay, group 17, hay. Differences in proposed and recommended tolerances may be attributed to the petitioner having used the North American Free Trade Agreement (NAFTA) tolerance calculation procedures for determining the tolerance and EPA's use of the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures. Recently, EPA has adopted use of the OECD tolerance calculation procedures to increase international harmonization of tolerance levels. For grass hay, the petitioner used values below the level of quantitation (LOQ) in the tolerance calculation whereas EPA used LOQ values. In addition, already established tolerances for cattle, goat, horse, and sheep meat byproducts are being increased and multiple new livestock commodity tolerances are being established. Livestock tolerances are derived from reevaluation of the dairy/beef cattle diet with new feed items (millet and grass).
Therefore, tolerances are established for residues of halosulfuron-methyl, including its metabolites and degradates, as set forth in the regulatory text.
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 chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The revised and added text read as follows:
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