Pesticide Tolerances:
Federal Register: August 4, 2010 (Volume 75, Number 149)
Rules and Regulations
Page 46847-46854
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr04au10-7
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180
EPA-HQ-OPP-2009-0797; FRL-8835-8
Halosulfuron-methyl; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of halosulfuron-methyl in or on multiple commodities which are identified and discussed later in this document. Additionally, this regulation removes the existing tolerance on bean, snap, succulent at 0.05 parts per million (ppm) in that it is superseded by this action establishing a tolerance at 0.05 ppm on pea and bean, succulent shelled, subgroup 6B. The Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective August 4, 2010. Objections and requests for hearings must be received on or before October 4, 2010, and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2009-0797. All documents in the docket are listed in the docket index available at http:// www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-7610; e-mail address: jackson.sidney@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does this Action Apply to Me?
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
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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 FOR FURTHER
INFORMATION CONTACT.
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How Can I Get Electronic Access to Other Related Information?
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 http://www.gpoaccess.gov/ecfr.
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How Can I File an Objection or Hearing Request?
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-2009-0797 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
October 4, 2010. 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 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-2009-0797, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.
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Summary of Petitioned-For Tolerance
In the Federal Register of Wednesday, January 6, 2010 (75 FR 864)
(FRL-8801-5), EPA issued a notice pursuant to section 408(d)(3) of
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9E7577) by IR-4 Project Headquarters, 500 College Road
East, Suite 201 W, Princeton, NJ 08549. The petition requested that 40
CFR 180.479 be amended by establishing tolerances for residues of the herbicide halosulfuron-methyl, methyl 3-chloro-5-[(4,6-dimethoxy-2- pyrimidinyl)amino]carbonyl]amino]sulfonyl]-1-methyl-1 H-pyrazole-4- carboxylate, and its metabolites and degradates (compliance with the tolerance level specified is to be determined by measuring only those halosulfuron-methyl residues convertible to 3-chloro-1-methyl-5- sulfamoylpyrazole-4-carboxylic acid, expressed as the stoichiometric equivalent of halosulfuron-methyl) in or on pea and bean, succulent shelled, subgroup 6B; pea and bean, dried shelled, except soybean, subgroup 6C; vegetables, tuberous and corm, subgroup 1C; bushberry, subgroup 13-07B; apple; rhubarb; and okra at 0.05 ppm That notice referenced a summary of the petition prepared by Gowan Company, the registrant, which is available in the docket, http:// www.regulations.gov. There were no comments received in response to the notice of filing.
Based upon review of the data supporting the petition, EPA is not taking action at this time on the petitioned-for tolerance for pea and bean, dried shelled, except soybean, subgroup 6C due to insufficient field trial data to support this use. Additionally, the Agency is revoking the existing tolerance on bean, snap, succulent at 0.05 ppm in order to eliminate redundancy with the 0.05 ppm tolerance on pea and bean, succulent shelled, subgroup 6B established by this action. EPA is also revising the tolerance expressions for halosurfuron-methyl for new uses in this regulation and for existing plant and livestock commodities to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. The reasons for these changes are explained in Unit IV.D.
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Aggregate Risk Assessment and Determination of Safety
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 section 408(b)(2)(D) of FFDCA, and the factors specified in 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 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.
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Toxicological Profile
EPA has evaluated the available toxicity data and considered their 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.
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Halosulfuron-methyl has low acute toxicity by oral, dermal, and inhalation routes of exposure. It is not a dermal sensitizer nor is it an eye or skin irritant. The toxicity mode of action in mammals is undetermined. However, available data show that the dog is the most sensitive animal 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-term and long-term oral and dermal studies. Both acute and subchronic neurotoxicity studies showed no neurotoxic effects.
There was no quantitative evidence for increased susceptibility following pre- and/or post-natal exposure. However, there was qualitative evidence for increased susceptibility. In the rat developmental toxicity study, 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. In the rabbit study, increases in resorptions and post-implantation losses and a decrease in mean litter size were seen in the presence of decreases in body weight and food consumption in maternal animals. Thus, in both species, the developmental effect was considered to be qualitatively more severe than maternal effects.
Halosulfuron-methyl is classified as ``not likely to be carcinogenic to humans'' based on a lack of evidence for carcinogenicity in mice and rats following long-term dietary administration. Halosulfuron-methyl is negative for mutagenicity in a battery of genotoxicity studies. There is no evidence of immunotoxicity in the available studies for halosulfuron-methyl. Acute and subchronic neurotoxicity studies showed no evidence of neurotoxicity.
Specific information on the studies received and the nature of the adverse 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 http:// www.regulations.gov in document: ``Halosulfuron-Methyl: Human Health
Risk Assessment for IR-4 Proposed Uses on Crop Group 6B Succulent
Shelled Pea and Bean Subgroup, Crop Group 1C Tuberous and Corm
Vegetables Subgroup, Crop Group 6C Dried Shelled Pea and Bean (Except
Soybean), Subgroup 13-07B Bushberry, Okra, Apples, and Rhubarb, dated
April 5, 2010,'' p. 13 in docket ID number EPA-HQ-OPP-2009-0797-0005.
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Toxicological Points of Departure/Levels of Concern
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 http://www.epa.gov/ pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for halosulfuron-methyl used for human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for for Use in Human Health Risk Assessment
Point of Departure and
Exposure/Scenario
Uncertainty/FQPA Safety RfD, PAD, LOC for Risk Study and Toxicological
Factors
Assessment
Effects
Acute dietary
NOAEL = 50 milligrams/ Acute RfD = 0.5 mg/kg/ Developmental Toxicity
(Females 13-49 years of age)........ kilograms/day (mg/kg/ day
Rabbit day)
aPAD = 0.5 mg/kg/day... LOAEL = 150 mg/kg/day
UFA = 10x..............
based on decreased
UFH = 10x..............
mean litter size,
FQPA SF = 1x...........
increased number of resorptions and increased post- implantations loss.
Acute dietary
N/A
N/A
No adverse effect
(General population including infants
attributable to a and children).
single dose was identified and no dose/ endpoint was selected.
Chronic dietary
NOAEL= 10 mg/kg/day UFA Chronic RfD = 0.1 mg/kg/ Chronic Toxicity - Dog
(All populations).................... = 10x
day
LOAEL = 40 mg/kg/day
UFH = 10x.............. cPAD = 0.1 mg/kg/day... based on decreased
FQPA SF = 1x...........
body weight gains in females.
Incidental oral short-term
NOAEL= 50 mg/kg/day UFA Residential LOC for MOE Developmental Toxicity
(1 to 30 days)....................... = 10x
= 100.
Rabbit
UFH = 10x..............
LOAEL = 150 mg/kg/day
FQPA SF = 1x...........
based on decreased body weight gain, food consumption, and food efficiency (maternal toxicity).
Incidental oral intermediate-term
NOAEL= 10 mg/kg/day
Residential LOC for MOE 13 week Subchronic
(1 to 6 months)...................... UFA= 10x
= 100
toxicity - Dog
UFH= 10x...............
LOAEL = 40 mg/kg/day
FQPA SF = 1x...........
based on on decreased body weight gains and food efficiency along with hematological and clinical chemistry changes.
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Dermal short-term
Dermal study NOAEL =
Residential LOC for MOE 21-Day Dermal Toxicity
(1 to 30 days)....................... 100mg/kg/day
= 100
Study - Rat
UFA = 10x..............
LOAEL = 1,000 mg/kg/day
UFH = 10x..............
based on decreased
FQPA SF = 1x...........
body weight gain in males.
Dermal intermediate-term
Dermal study NOAEL= 10 Residential LOC for MOE 13 Week Subchronic
(1 to 6 months)...................... mg/kg/day (dermal
= 100
Toxicity - Dog absorption rate = 75%)
LOAEL = 40 mg/kg/day
UFA = 10x..............
based on decreased
UFH = 10x..............
body weight gains and
FQPA SF = 1x...........
food efficiency along with hematological and clinical chemistry changes.
Inhalation short-term
Inhalation study NOAEL Residential LOC for MOE Developmental Toxicity
(1 to 30 days)....................... = 50 mg/kg/day
= 100
Rabbit
(inhalation absorption
LOAEL = 150 mg/kg/day rate = 100%)
based on decreased
UFA = 10x..............
body weight gain, food
UFH = 10x..............
consumption, and food
FQPA SF = 1x...........
efficiency (maternal toxicity).
Inhalation Intermediate-term
Inhalation (or oral)
Residential LOC for MOE 13 week Subchronic
(1 to 6 months)...................... study NOAEL = 10 mg/kg/ = 100
Toxicity - Dog day (inhalation
LOAEL = 40 mg/kg/day absorption rate =
based on based on 100%)
decreased body weight
UFA = 10x..............
gains and food
UFH = 10x..............
efficiency along with
FQPA SF = 1x...........
hematological and clinical chemistry changes.
Cancer
Classification: not likely to be carcinogenic to humansby the oral route, based on no evidence of carcinogenicity from studies in rats and mice.
A 75% dermal absorption factor should be used in route-to-route extrapolation for the intermediate term dermal exposure risk. Absorption via the inhalation route is presumed to be equivalent to oral absorption.NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level. UF = uncertainty factor. UFA = extrapolation from animal to human (inter-species). UFH = potential variation in sensitivity among members of the human population (intra-species). FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. N/A = not applicable.
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Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to halosulfuron-methyl, EPA considered exposure under the petitioned-for tolerances as well as all existing halosulfuron-methyl tolerances in 40 CFR 180.479. EPA assessed dietary exposures from halosulfuron-methyl in food as follows: i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.
Such effects were identified for halosulfuron-methyl including decreased mean litter size, increased number of resorptions (total and per dam) and increased post-implantation loss (developmental toxicity) were identified for the population subgroup females 13 to 49 years old
(the only population subgroup with a toxicological endpoint attributable to a single dose of halosulfuron-methyl). 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 and 100 percent crop treated (PCT) for all existing and recommended new uses of halosulfuron-methyl. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed tolerance- level residues and 100 PCT for all existing and recommended new uses of halosulfuron-methyl iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that halosulfuron-methyl does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and PCT information EPA did not use anticipated residue and/or PCT information in the dietary assessment for halosulfuron-methyl. Tolerance level residues and 100 PCT were assumed for all food commodities. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for halosulfuron-methyl in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of halosulfuron-methyl. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/ index.htm.
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
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(EDWCs) of halosulfuron-methyl are Tier I EDWCs based on a maximum annual application rate of 0.125 lb active ingredient (ai)/acre(A) for rice.
Acute exposures and chronic exposures for non-cancer assessments are estimated to be 59.2 parts per billion (ppb) based on FIRST model for surface water and 0.065 ppb bases on SCI-GROW model results for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.
For acute and chronic dietary risk assessment, the water concentration value of 59.2 ppb was used to assess the contribution to drinking water. 3. From non-dietary exposure. The term ``residential exposure'' is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).
Halosulfuron-methyl is currently registered for the following uses that could result in residential exposures: Ornamentals, and commercial and residential turfgrass. EPA assessed residential exposure using the following assumptions: Residential handlers may receive short-term dermal and inhalation exposures to halosulfuron-methyl when mixing, loading and applying halosulfuron-methyl products. Adults and children may be exposed to halosulfuron-methyl residues through dermal contact with turf during postapplication activities. In addition, toddlers may receive short- and intermediate-term oral exposure from incidental ingestion during postapplication activities.
Halosulfuron-methyl exposure data for handler activities were not submitted to EPA in support of registered lawn uses. EPA's Draft
Standard Operating Procedures (SOPs) for Residential Exposure
Assessments, and Recommended Revisions were used as the basis for the residential handler exposure calculations. The handler exposure data used in this assessment are from the Outdoor Residential Exposure Task
Force (ORETF).
For residential exposure from lawn use, the Agency evaluated the combined exposure and risk estimates to adults from halsulfuron-methyl under scenarios including: i. Mix/load and broadcast application of liquid formulation (garden hose-end sprayer) for both dermal and inhalation routes, and ii. Post-application exposure by dermal route.
For residential postapplication exposure, the following scenarios resulting from lawn treatment were assessed: a. Adult and children 3 to DB) for database uncertainty is not needed to account for the lack of this study because the available data do not suggest that this chemical affects the immune system. 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 qualitative evidence of increased susceptibility in the prenatal developmental studies in
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rats and rabbits, as discussed in this unit, there are no residual uncertainties after establishing toxicity endpoints and the degree of concern for pre-and/or post-natal toxicity is low. 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, and conservative (protective) assumptions in the ground water and surface water modeling were used to assess exposure to halosulfuron-methyl in drinking water. Similarly conservative assumptions were also used 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.
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Aggregate Risks and Determination of Safety
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. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to halosulfuron-methyl will occupy less than 1% of the aPAD for the population subgroup of concern, females 13-49 years old, the only population group where there are acute toxicology concerns. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to halosulfuron-methyl from food and water will utilize 5% of the cPAD for all infants less than 1 year old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of halosulfuron-methyl is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Halosulfuron- methyl is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to halosulfuron-methyl.
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 short-term aggregate MOEs ranging from 2,800 to 4,800. The MOE for the U.S. population is 4,700. The most highly exposed subgroup is all infants (
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