Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: methyl,
[Federal Register: September 20, 2002 (Volume 67, Number 183)]
[Rules and Regulations]
[Page 59182-59193]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se02-13]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0243; FRL-7200-8]
Halosulfuron-methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of halosulfuron-methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate in or on asparagus; vegetables, fruiting (except cucurbits), group; bean, dry, seed and bean, snap, succulent. Gowan Company and Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality Protection Act of 1996.
DATES: This regulation is effective September 20, 2002. Objections and requests for hearings, identified by docket ID number OPP-2002-0243, must be received on or before November 19, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP-2002-0243 in the subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins and Hoyt Jamerson, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; telephone number: (703) 305-5687 and (703) 308-9368, respectively; e-mail address: tompkins.jim@epa.gov and jamerson.hoyt@epa.gov.
SUPPLEMENTARY INFORMATION:
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General Information
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Does this Action Apply to Me?
You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:
Examples of Categories
NAICS codes
potentially affected entities
Industry
111
Crop production 112............... Animal production 311............... Food manufacturing 32532............. Pesticide manufacturing
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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have 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 Additional Information, Including Copies of this Document and Other Related Documents?
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Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet home page at http://www.epa.gov/. To access this document, on the home page select ``Laws and Regulations,'' ``Regulations and Proposed Rules,'' and then look up the entry for this document under the ``Federal Register--Environmental Documents.'' You can also go directly to theFederal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/ nara/cfr/cfrhtml--00/Title--40/40cfr180--00.html, a beta site currently under development.
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In person. The Agency has established an official record for this action under docket ID number OPP-2002-0243. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
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Background and Statutory Findings
In the Federal Register of June 3, 2002 (67 FR 38276) (FRL-7179-2), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of a pesticide petition (PP 1E6322) by Interregional Research Project Number 4(IR-4), 681 U.S. Highway 1 South, North Brunswick, New Jersey 08902-3390. In addition to the Federal Register of August 31, 2001 (66 FR 45993) (FRL-6796-1), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) 21 U.S.C. 346a, as amended by the FQPA announcing the filing of pesticide petitions 0F6169 and 1F6229) by Gowan Company, P.O. Box 5569; Yuma, AZ 85366. These notices included a summary of the petitions prepared by Gowan Company, the registrant. There were no comments received in response to these notices of filing.
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The petitions requested that 40 CFR 180.479(a) be amended by establishing tolerances for residues of the herbicide halosulfuron- methyl, methyl 5-[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyaminosulfonyl-3-chloro-1-methyl-1H-pyrazole-4-carboxylate, in or on vegetables, fruiting (except cucurbits), group at 0.05 part per million (ppm) (PP 0F6169), asparagus at 0.8 ppm (1F6229); and dry bean and succulent snap bean at 0.05 ppm (1E6322). The tolerance in or on asparagus at 0.8 ppm established by the current action will replace the time limited tolerance for asparagus established under Sec. 180.479(b) in the Federal Register of December 27, 2001 (66 FR 66778) (FRL-6816- 1).
Section 408(b)(2)(A)(i) of the 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) 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) 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 and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances in the Federal Register of November 26, 1997 (62 FR 62961) (FRL-5754-7).
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Aggregate Risk Assessment and Determination of Safety
Consistent with 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, consistent with section 408(b)(2), for a tolerance for residues of halosulfuron-methyl on asparagus at 0.8 ppm; bean, dry, seed at 0.05 ppm; bean, snap, succulent at 0.05 ppm and vegetables, fruiting (except cucurbits), group at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.
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Toxicological Profile
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 nature of the toxic effects caused by halosulfuron-methyl are discussed in Unit II.A. of the final rule on halosulfuron-methyl pesticide tolerances in the Federal Register of September 29, 2000 (65 FR 58424) (FRL-6746-2).
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Toxicological Endpoints
The dose at which no adverse effects are observed (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 lowest dose at which adverse effects of concern are identified (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. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.
For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-\6\ or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a ``point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer= point of departure/exposures) is calculated. A summary of the toxicological endpoints for halosulfuron-methyl used for human risk assessment is shown in the following Table 1:
Table 1.--Summary Toxicological Dose and Endpoints for Halosulfuron-methyl for Use In Human Risk Assessment
Dose (mg/kg/day) UF/ Hazard Based Special Endpoint for Risk Exposure Scenario
MOE
FQPA Safety Factor
Assessment
Dietary Risk Assessments
Acute Dietary (females 13-50 years of NOAEL = 50
1x Developmental Toxicity age)
Rabbit
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UF = 300\a\
LOAEL = 150 mg/kg/day based on decreased mean litter size, increased number of resorptions (total and per dam) and increased postimplantation loss (developmental toxicity) Acute RfD = 0.17 mg/kg/ day
Acute Dietary
NOAEL = N/A
N/A No appropriate dose/ endpoint selected. general population including infants UF = N/A and children Acute RfD = N/A
Chronic Dietary
NOAEL = 10
1x Chronic Toxicity - Dog all populations
UF = 300\a\
LOAEL = 40 mg/kg/day based on decreased body weight gains in females Chronic RfD = 0.03 mg/ kg/day
Incidental Oral
NOAEL = 50
1x Developmental Toxicity- Rabbit Short-Term (1-30 Days)
UF = 300\a\
LOAEL = 150 mg/kg/day based on decreased body weight gain, food consumption, and food efficiency. (maternal toxicity) Residential Only
MOE = 300
Incidental Oral
NOAEL = 10
1x 13 Week Subchronic Toxicity - Dog Intermediate-Term (1-6 Months)
UF = 300\a\
LOAEL = 40 mg/kg/day based on decreased body weight gain and food efficiency in females Residential Only
MOE = 300
Non-Dietary Risk Assessments
Dermal
Dermal NOAEL = 100
21-Day Dermal Toxicity Study - Rat Short-Term (1-30 days)
LOAEL = 1000 mg/kg/day based on decreased body weight gain in males Residential
MOE = 300
1x
Dermal\b\
Oral NOAEL = 10
13 Week Subchronic Toxicity - Dog Intermediate-Term (1-6 Months)
LOAEL = 40 mg/kg/day based on decreased body weight gain and food efficiency in females. Residential
MOE = 300
1x
Dermal\b\
Oral NOAEL= 10
Chronic Toxicity - Dog Long-Term (>6 Months)
LOAEL = 40 mg/kg/day based on decreased body weight gains in females Residential
MOE = 300
1x
Inhalation\c\
Oral NOAEL = 50
Developmental Toxicity- Rabbit Short-Term (1-30 days)
LOAEL = 150 mg/kg/day based on decreased body weight gain, food consumption, and food efficiency. (Maternal toxicity) Residential
MOE = 300
1x
Inhalation\c\
Oral NOAEL = 10
13 Week Subchronic Toxicity - Dog Intermediate-Term (1-6 Months)
LOAEL = 40 mg/kg/day based on decreased body weight gain and food efficiency in females Residential
MOE = 300
1x
Inhalation\c\
Oral NOAEL = 10
Chronic Toxicity - Dog Long-Term (>6 Months)
LOAEL = 40 mg/kg/day based on decreased body weight gains in females Residential
MOE = 300
1x
Cancer
Classification: ``not likely to be carcinogenic to humans'' by the oral route, based on no evidence of carcinogenicity from studies in rats and mice
\*a\ = UFDB = 300 (10x for inter-species extrapolation and 10 x for intra- species variability, 3x for lack of DNT). \b\ = A 75% dermal absorption factor was used for route to route extrapolation. \c\ = Absorption via inhalation route is presumed to be equivalent to oral absorption.
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Exposure Assessment
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Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.479) for the residues of halosulfuron-methyl, in or on a variety of raw agricultural commodities. Additionally, tolerances for residues of halosulfuron-methyl and its metabolites determined as 3-chloro-1-methyl-5-sulfamoylpyrazole-4-carboxylic acid (CSA, expressed as parent equivalents) are established at 0.1 ppm on meat-by-products of cattle, goats, hogs, horses, and sheep. Risk assessments were conducted by EPA to assess dietary exposures from halosulfuron-methyl in food as follows:
i. Acute Exposure. Acute dietary 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 one day or single exposure. The Dietary Exposure Evaluation Model (DEEM\TM\) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: 100% of the crops with halosulfuron-methyl tolerances (both established and proposed) are treated and that all commodities contain tolerance level residues when consumed.
The acute dietary exposure estimates are provided for females 13-50 years old only. No appropriate endpoint attributable to a single exposure was identified for the general U.S. population including infants, children and adult males. This assessment concludes that the acute dietary exposure estimates are below the Agency's level of concern (]g/Lb x 2.47E-8 A/cm\2\ (11.2) \2\ Daily Dose = [Dislodgeable Foliar Residue x Absorption Factor (1 for short-term, 0.75 for intermediate-term) x 0.001 mg/ug x Dermal Transfer Coefficient x Exposure Time (2 hrs/day)]/Body weight
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\3\ Dermal MOE = Dermal NOAEL/Daily Dose; where short-term NOAEL = 100 mg/kg/day, and intermediate-term NOAEL = 10 mg/kg/day
Table 6.--Postapplication Oral Hand-to-Mouth Exposure and Risk for Children from Treated Lawns
Fraction of ai
Dislodgeable
Short-term/
Daily Dose\2\ (mg/kg/day)
Oral MOE\3\ Appl. Rate (lb ai/A)
Retained on the Saliva Extraction Foliar Residue\1\ Hand Surface Area Intermediate-term Body Weight (kg) ------------------------------------------------------------------------------- Foliage
Factor
(ug/cm\2\)
(cm\2\/event) Freq. (events/hr)
Short-term Intermediate-term Short-term Intermediate-term
0.062
0.05
50%
0.035
20
20/9.5
15
0.00093
0.00044
54,000
23,000
\1\ Dislodgeable Foliar Residue\Postapplication day\ (ug/cm\2\)=Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That Dissipates Daily, 0.10)\Postapplication day\ x 4.54E+8 []g/lb x 24.7E-9 A/cm\2\ (11.2138) \2\ Daily Dose = (Dislodgeable Foliar Residue (ug/cm\2\) x Hand Surface Area (cm\2\/event) x Extraction factor x Frequency (events/hr) x 0.001 mg/ug x Exposure time (2 hrs/day)]/[Body Weight (kg)] \3\ Oral MOE = Oral NOAEL/Daily Dose; where Short-term NOAEL = 50 mg/kg/day, and Intermediate-term NOAEL = 10 mg/kg/day
Table 7.--Postapplication Oral Object-to-Mouth (Turfgrass) Exposure and Risk for Children from Treated Lawns
Fraction of
Oral MOE\3\ ai Retained Grass Ingestion Rate Body Weight Daily Dose\2\ (mg/------------------------------------- Application Rate (lb ai/A)
on the Residue\1\ (cm\2\/day)
(kg)
kg/day) Foliage ug/cm\2\)
Short-term Intermediate-term
0.062
0.20
0.031
25
15
0.00023
220,000
43,000
\1\ Grass residue\Postapplication day\ (ug/cm\2\) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That Dissipates Daily)\Postapplication day\ x 4.54E+8 []g/lb x 24.7E-9 A/cm\2\ \2\ Daily Dose = [Grass reside (ug/cm\2\) x Ingestion rate (cm\2\/day) x 0.001 mg/ug] / [Body Weight (kg)]] \3\ Oral MOE = Oral NOAEL/Daily Dose; where Short-term NOAEL = 50 mg/kg/day, and Intermediate-term NOAEL = 10 mg/kg/day
Table 8.--Postapplication Incidental Soil Ingestion Exposure and Risk for Children from Treated Lawns
Fraction of ai Soil
Daily
Oral MOE\3\ Appl. Rate (lb ai/A)
Retained in the Residue\1\ Ingestion Rate Body Weight Dose\2\ (mg/------------------------------------- Soil
(ug/g)
(mg/day)
(kg) kg/day)
Short-term Intermediate-term
0.062
1
0.47
100
15 3.1E-06
16,000,000
3,200,000
\1\ Soil residue \Postapplication day\ (ug/cm\2\) = Application rate (lb ai/A) x Fraction of ai Retained on the Foliage x (1- Fraction of Residue That Dissipates Daily) \Postapplication day\ x 4.54E+8 []g/lb x 24.7E-9 A/cm\2\ x 0.67 cm\3\/g soil \2\ Daily Dose = [Soil reside (ug/g) x Ingestion rate (mg/day) x 0.000001 g/ug] / [Body Weight (kg)]] \3\ Oral MOE = Oral NOAEL/Daily Dose; where Short-term NOAEL = 50 mg/kg/day, and Intermediate-term NOAEL = 10 mg/kg/day
Both short-term and intermediate-term MOEs for each scenario are above the target MOE of 300, and are not of concern.
When a common effect (i.e., decreased body weight gain) is observed in those studies selected for the endpoints for all routes of exposure; MOEs are to be combined where appropriate. Aggregate residential risk was assessed for adults and children (Tables 9 and 10). For children, short-term and intermediate-term aggregate risk was assessed based on postapplication dermal and oral exposure. For adults, short-term aggregate residential risk was assessed based on exposure through application (handler) and postapplication dermal exposure. Intermediate aggregate risk for adults was not assessed because the application of halosulfuron-methyl is not expected to occur for more than 30 days. The Total MOEs resulting from the combined MOEs for both adults and children, are also above the target MOE of 300, and are not of concern.
Table 9.--Adult's Aggregate Exposure and Risk Estimates from Residential Lawns
Acres PHED Unit Short-term Adult's Scenario
Exposure Route
Rate (lb ai/ Treated Exposure Daily Dose Short-term Total Short- acre) (acres/day) (mg/lb ai) (mg/kg/day) MOE
term MOE
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Mix/load and broadcast application of dermal
0.062
0.5
30 0.0043 21,000
5,200 liquid formulation (garden hose-end sprayer) inhalation
0.062
0.5
0.016 0.0000071 7,000,000
5,200
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Postapplication exposure
dermal
0.062
N/A
N/A
0.014
7,000
5,200
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Table 10.--Children's Aggregate Exposure and Risk Estimates from Residential Lawns
Children's Short-Term Intermediate
Total TTR/GR/SR0(ug/cm\2\ or g)\1\
ScenariosExposure PDR\0-norm\ PDR\0-norm\ Short-Term Intermediate-Term Total Short- Intermedite- Route
(mg/kg/day) (mg/kg/day) MOE
MOE
Term MOE term MOE
(1) Dermal contact
0.035
0.024
0.0090
4,200
1,100
3,800
1,000 (2) Hand-to-mouth
0.035
0.00093 0.00044 54,000
23,000
3,800
1,000 (3) Mouth grass
0.14
0.00023 0.00023 220,000
43,000
3,800
1,000 (4) Soil ingestion
0.047
3.1E-6
3.1E-6 16,000,000
3,2000,000
3,800
1,000
\1\ TTR=turf transferable residue on the ``0''; GR=gras residue on the day ``0''; SR0=soil residue on the day ``0.'' \2\ PDR 0-norm= potential doe rate on day ``0.''
Halosulfuron-methyl may be used on turf at recreational use sites, and, therefore may result in postapplication exposure to adults and children involved in recreational activities. Exposures to adults and children from the use of halosulfuron-methyl at recreational use sites are assumed to be the same as those assessed for residential use sites, and therefore, a separate recreational exposure assessment was not included. Refer to section 4.4 of this risk assessment for details on assumptions, input variables and risk estimates for residential use sites. Residential turf exposure assessment results in what are considered upper bound risk estimates. Therefore, it is not expected that the upper bound residential exposure scenario would occur on the same day as an upper bound recreational exposure scenario. Exposure from these two exposure scenarios are not aggregated. Rather, the residential risk estimate should serve as an upper bound for both residential and recreational exposure.
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Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.''
EPA does not have, at this time, available data to determine whether halosulfuron-methyl has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, 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 final rule for Bifenthrin Pesticide Tolerances in the Federal Register of November 26, 1997 (62 FR 62961) (FRL-5754-7).
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Safety Factor for Infants and Children
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In general. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.
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Prenatal and postnatal sensitivity. 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 uncertainty factors to be used in the risk assessment of halosulfuron-methyl.
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Conclusion. There is a complete toxicity data base for halosulfuron-methyl except for a developmental neurotoxicity study and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that, based on reliable data, an additional database uncertainty factor of 3X is necessary to protect the safety of infants and children in assessing halosulfuron-methyl exposures and risks. This factor is necessary to address a data deficiency for the developmental neurotoxicity study. The additional uncertainty factor of 3X is incorporated into the numerical expression for the acute and chronic RfD and PAD (aPAD and cPAD) and applied to all dietary and residential (non-dietary) exposure scenarios. For residential assessments, an MOE of 300 (10X for interspecies extrapolation, 10X for intraspecies variation, and the additional database uncertainty factor of 3X) is required.
No Special FQPA Safety Factor is necessary to protect the safety of infants and children in assessing halosulfuron-methyl exposure and risks because:
i. 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 uncertainty factors to be used in the risk assessment of halosulfuron-methyl.
ii. There are no residual uncertainties identified in the exposure databases. The dietary (food and drinking water) exposure assessments will not underestimate the exposure (postapplication exposure to children as well as incidental oral exposure to toddlers) and risks posed by halosulfuron-methyl.
Recently, EPA has received objections to a tolerance it established for residues of halosulfuron-methyl in or on the melon subgroup (66 FR 66786, December 26, 2001) and an emergency exemption for asparagus (66 FR 66778, December 27, 2001). The objections were filedby the Natural Resources Defense Council (NRDC) and raised several issues regarding aggregate exposure estimates and the additional safety factor for the protection of infants and children. NRDC's objections raise complex legal, scientific, policy, and factual matters and EPA has initiated a public comment period on them in the Federal Register of June 19, 2002 (67 FR 41628) (FRL-7167-7), which ends on September 17, 2002. Although that proceeding remains ongoing, prior to
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acting on this current tolerance action, EPA reviewed the halosulfuron- specific objections raised by NRDC and has addressed them below.
In reference to NRDC`s statements that the Agency erred by not retaining the additional 10X children's safety factor in light of the data gap for developmental neurotoxicity study, the Agency re-reviewed its determination that a different safety factor, 3X, would be safe for infants and children. Taking into account the lack of the developmental neurotoxicity study, EPA concluded that an additional traditional Database Uncertainty Factor of 3X is needed for all dietary and residential (non-dietary) exposure scenarios until the data are received and evaluated. An uncertainty factor of 3X (as opposed to a higher value) was viewed to be adequate because the doses selected for dietary and non-dietary risk assessments would address the concerns for the alterations of the fetal nervous system seen in the developmental toxicity study in rats and provide a large margin of safety in regard to any uncertainty arising from the lack of a developmental neurotoxicity study. The NOAEL of 50 mg/kg/day (used for acute dietary, short-term incidental oral and inhalation risk assessments) and the NOAEL of 10 mg/kg/day (used for chronic dietary and intermediate-term incidental oral, dermal and inhalation risk assessments) are 5X and 25X lower, respectively, than the NOAEL of 250 mg/kg/day in the rat developmental study where alterations of the fetal nervous system were seen at 750 mg/kg/day (LOAEL). It was these alterations of the fetal nervous system seen at 750 mg/kg/day in the rat developmental study that caused EPA to require submission of a developmental neurotoxicity study. Thus, in combination with the 3X database uncertainty factor, the doses selected for risk assessment provide a 15X (acute) and 75X (chronic) margin of safety with regard to observed developmental neurotoxic effects. Consequently, based on the available data, use of a 3X factor instead of a 10X factor will provide an adequate margin of safety for the protection of infants and children.
NRDC also claimed that there were several other data gaps necessitating retention of the additional 10X safety factor for the protection of infants and children. NRDC claimed that no cancer risk assessment or short-term or intermediate-term residential risk assessments had been conducted. NRDC's allegations in this regard are contradicted by the Federal Register notice establishing the halosulfuron-methyl tolerances. EPA did assess the cancer risk posed by halosulfuron-methyl and concluded that ``no cancer risk is expected from exposure to halosulfuron-methyl.'' (66 FR 66333, 66338, December 26, 2001). This conclusion was based on EPA's qualitative conclusion that halosulfuron-methyl is not likely to be a human carcinogen. Id. Having concluded that, as a qualitative matter, halosulfuron-methyl is not likely to be a human carcinogen EPA did not perform a quantitative cancer risk assessment, as such risk assessment would not be scientifically justified. EPA's statement earlier in the Federal Register notice regarding not conducting a cancer risk assessment referred to the fact that a quantitative assessment was unnecessary. Id. at 66336. Short-term and intermediate-term risk residential risk assessments were performed and considered by the Agency. Id. at 66337- 66338.
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Aggregate Risks and Determination of Safety
To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure). This allowable exposure through drinking water is used to calculate a DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by USEPA Office of Water are used to calculate DWLOCs 21/70 kg (adult male), 2L/60 kg (adult female ), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and groundwater are less than the calculated DWLOCs, the Office of Pesticide Programs (OPP) concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.
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Acute risk. Using the exposure assumptions discussed in Unit III.C., Exposure Assessment, for acute exposure, the acute dietary exposure from food to halosulfuron-methyl will occupy 2, 1921 Jefferson Davis Hwy, Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.
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Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
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Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its
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inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket ID number OPP-2002-0243, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.
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When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).
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Regulatory Assessment Requirements
This final rule establishes a tolerance 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 rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or 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). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). 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). 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 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure ``meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' ``Policies that have federalism implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any ``tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure ``meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' ``Policies that have tribal implications'' is defined in the Executive order to include regulations that have ``substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.
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Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: September 12, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
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The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346(a) and 371.
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Section 180.479 is amended as follows:
i. By revising the section heading and alphabetically adding the following
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commodities to the table in paragraph (a)(2).
ii. The text of paragraph (b) is removed and reserved.
Sec. 180.479 Halosulfuron-methyl; tolerances for residues.
(
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General. * * *
(2) * * *
Parts per Commodity
million
* * * * * Asparagus..................................................
0.8 Bean, dry, seed............................................
0.05 Bean, snap, succulent......................................
0.05 * * * * * Vegetables, fruiting (except cucurbits), group.............
0.05
(b) Section 18 emergency exemptions. [Reserved] * * * * *
[FR Doc. 02-23995Filed9-19-02; 8:45 am]
BILLING CODE 6560-50-S
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