Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of halosulfuron-methyl in or on the commodities alfalfa, forage at 1.0 parts per million (ppm) and alfalfa, hay at 2.0 ppm. Gowan Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). The Agency is also correcting the tolerance expression for 40 CFR 180.479(a)(1) with this regulation. The tolerance expression is being corrected because the metabolites were inadvertently deleted from the most recent edition of 40 CFR 180.479.
This regulation is effective February 28, 2007. Objections and requests for hearings must be received on or before April 30, 2007, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPP–2006–0205. To access the electronic docket, go to
Vickie Walters, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–5704; e-mail address:
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:
• Crop production (NAICS code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.
• Pesticide manufacturing (NAICS 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather provides 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
In addition to accessing an electronic copy of this
Under section 408(g) of FFDCA, as amended by FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. 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–2006–0205 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 30, 2007.
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 that is described in
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In the
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....”
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of FFDCA and a complete description of the risk assessment process, see
Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 408(b)(2) of FFDCA, for a tolerance for residues of halosulfuron-methyl the commodities alfalfa, forage at 1.0 ppm and alfalfa, hay at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance 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. Specific information on the studies received and the nature of the toxic effects caused by halosulfuron-methyl 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
For hazards that have a threshold below which there is no appreciable risk, the dose at which the NOAEL from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the LOAEL is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify non-threshold hazards such as cancer. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk, estimates risk in terms of the probability of occurrence of additional cancer cases. More information can be found on the general principles EPA uses in risk characterization at
A summary of the toxicological endpoints for halosulfuron-methyl used for human risk assessment can be found at
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In conducting the acute dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID
The acute dietary exposure estimates are provided for females 13–50 years old only. The existing data showed no indication that halosulfuron-methyl could cause adverse effects in the general population based upon a single dose. Thus there is no concern for acute dietary exposure to the general population.
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Based on the FQPA Index Reservoir Screening Tool (FIRST) and screening concentration in ground water (SCI-GROW) models, the estimated environmental concentrations (EECs) of halosulfuron-methyl for acute exposures are estimated to be 105 parts per billion (ppb) for surface water and 0.065 ppb for ground water. The EECs for chronic exposures are estimated to be 105 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 (DEEM-FCID). For acute and chronic dietary risk assessment, the annual average concentration of 105 ppb was used to access the contribution to drinking water.
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Halosulfuron-methyl is currently registered for use on the following residential non-dietary sites: Application to commercial and residential turf and on other non-crop sites including airports, cemeteries, fallow areas, golf courses, landscaped areas, public recreation areas, residential property, roadsides, school grounds, sod or turf seed farms, sports fields, and landscaped areas with established woody ornamentals. Application may be by commercial applicator or homeowner. Residential handlers may receive short-term dermal and inhalation exposure to halosulfuron-methyl when mixing, loading, and applying the formulations. Adults and children may be exposed to halosulfuron-methyl residues through dermal contact with turf during postapplicaton activities. A residential exposure and risk assessment was previously conducted for these exposure scenarios. Combined margins of exposure (MOEs) for adults' and children's dermal exposure and toddlers' incidental exposure from all residential activities are greater than the Agency's LOC of 100, and therefore are not of concern. These risk assessments are fully discussed in Unit III.E.3. of a final rule published in the
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Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to halosulfuron-methyl and any other substances and halosulfuron-methyl does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that halosulfuron-methyl has 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at
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i. The toxicity database for halosulfuron-methyl is complete. Although EPA previously required
ii. There is no evidence of increased susceptibility of young rats in the reproduction study with halosulfuron-methyl. Although there is qualitative evidence of increased susceptibility in the prenatal developmental studies in rats and rabbits, the Agency did not identify any residual uncertainties after establishing toxicity endpoints and traditional UFs to be used in the risk assessment of halosulfuron-methyl. The degree of concern for pre and/or postnatal toxicity is low.
iii. 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. Conservative ground water and surface water modeling estimates were used in the risk assessments. Agency Residential standard operational proceedures (SOPs) are used to assess post-application exposure to children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by halosulfuron-methyl.
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Halosulfuron-methyl is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for halosulfuron-methyl.
A short-term risk assessment is required for adults because there is a residential handler exposure scenario. In addition, a short-term risk assessment is required for infants and children because there is a residential post-application exposure scenario for infants and children.
Using the exposure assumptions described in Unit III.C. for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs ranging from 2,400 to 4,400. The MOE for the U.S. population is 4,300. The most highly exposed subgroup was all infants (less than 1 year old with an MOE of 2,400. These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food and residential uses. EPA does not expect short-term aggregate exposure to exceed the Agency's LOC.
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Halosulfuron-methyl is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for halosulfuron methyl.
An intermediate-term risk assessment is required for adults because there is a residential handler exposure scenario. In addition, an intermediate-term risk assessment is required for infants and children because there is a residential post-application exposure scenario for infants and children.
As an additional protective measure, residential handler exposures were included in the intermediate-term aggregate risk assessment, although residential exposure over the intermediate-term (more than 30 days) is unlikely.
Using the exposure assumptions described is Unit III.E. for intermediate-term exposures; EPA has concluded that food and residential exposures aggregated result in aggregate MOEs ranged from 480 to 560. The MOEs for the U.S. population is 480. The most highly exposed children's subgroup was all infants (less than 1 year old) with a MOE of 560. These aggregate MOEs do not exceed the Agency's LOC for aggregate exposure to food and residential uses. EPA does not expect intermediate-term aggregate exposure to exceed the Agency's LOC.
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Adequate enforcement methodology (gas chromatography with a nitrogen specific detector) 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; e-mail address:
There are currently no established Codex, Canadian, or Mexican maximum residue levels (MRLs) for halosulfuron-methyl in or on alfalfa, forage or alfalfa, hay. International harmonization is therefore not an issue.
Therefore, the tolerance is established for residues of halosulfuron methyl, methyl 5-[(4, 6-dimethoxy-2-pyrimidinyl)amino]
This final rule establishes a tolerance under section 408(d) of FFDCA 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
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346a and 371.
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