Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Flumiclorac pentyl,
[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Rules and Regulations]
[Page 11526-11533]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr06-7]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0311; FRL-7764-1]
Flumiclorac Pentyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of flumiclorac pentyl in or on undelinted cottonseed and cotton gin byproducts. Valent U.S.A. Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective March 8, 2006. Objections and requests for hearings must be received on or before May 8, 2006.
ADDRESSES: To submit a written objection or hearing request follow the detailed instructions as provided in Unit VI. of theSUPPLEMENTARY INFORMATION. EPA has established a docket for this action under Docket identification (ID) number EPA-HQ-OPP-2005-0311. All documents in the docket are listed on the http://www.regulations.gov web site. (EDOCKET, EPA's
electronic public docket and comment system was replaced on November 25, 2005, by an enhanced Federal-wide electronic docket management and comment system located at http://www.regulations.gov/. Follow the on-
line instructions.) Although listed in the index, some information is not publicly available, i.e., 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 either electronically in EDOCKET or in hard copy at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305- 5805.
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460- 0001; telephone number: (703) 305-6224; e-mail address:miller.joanne@epamail.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 not limited to:
Crop production (NAICS 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS 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 underFOR FURTHER INFORMATION CONTACT.
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How Can I Access Electronic Copies of this Document and Other Related Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/),you may
access this Federal Register document electronically through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines athttp://www.epa. gpo/opptsfrs/home/
guidelin. htm/.
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Background and Statutory Findings
In the Federal Register of November 30, 2005 (70 FR 71844) (FRL- 7747-3), 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 3F6767) by Valent U.S.A. Corporation, 1600 Riviera Ave., Suite 200, Walnut Creek, CA 94596-8025. The petition requested that 40 CFR 180.477 be amended by establishing tolerances for residues of the herbicide, flumiclorac pentyl, [2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro-1,3- dioxo-2H-isoindol-2-yl)phenoxy]-acetate, in or on cotton undelinted seed at 0.1 parts per million (ppm) and cotton gin by products at 2.0 ppm. That notice included a summary of the petition prepared by Valent U.S.A. Corporation, the registrant. The Notice of Availability of the Flumiclorac Pentyl Tolerance Reassessment (TRED) was published in the Federal Register on October 19, 2005 (70 FR 60824) (FRL-7740-4). The flumiclorac pentyl TRED stated that the residues should be expressed as flumiclorac pentyl, per se, and that the tolerances for cotton undelinted seed be increased to 0.2 ppm, and that cotton gin by products be increased to 3.0 ppm. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .''
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 the FFDCA and a complete description of the risk assessment process, see http://www. epa.gov/
fedrgstr/ EPA-PEST/1997/ November/ Day-26/p30948.htm.
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Aggregate Risk Assessment and Determination of Safety
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 flumiclorac pentyl on cotton undelinted seed at 0.2 ppm and cotton gin by products at 3.0 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. Specific information on the studies received and the nature of the toxic effects caused by flumiclorac pentyl are discussed in Table 1 of this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.
Table 1.--Subchronic, Chronic, and Other Toxicity
Guideline No.
Study Type Results Assessment
870.3100
90-Day oral
NOAEL = 1,359 toxicity--rodents milligrams/ (rat)
kilogram/day (mg/ kg/day)males (M) and 1,574 mg/kg/ day females (F) - Highest Dose Tested(HTD) LOAEL was not established
870.3150
90-Day oral
NOAEL = 100 mg/kg/ toxicity--
day nonrodents (dog) LOAEL = 1,000 mg/ kg/day based on increased clotting time in females
870.3200
21/28-Day dermal NOAEL = 1,000 mg/ toxicity (rat) kg/day (limit dose)
870.3700
Prenatal
Maternal NOAEL = developmental-- 1,500 mg/kg/day - rodents (rat) HDT Maternal LOAEL was not established Developmental NOAEL = 1,500 mg/ kg/day - HDT Developmental LOAEL was not established
870.3800
Reproduction and Parental/Systemic fertility effects NOAEL = 16/18mg/ (rat)
kg/day (M/F) Parental/Systemic LOAEL = 781/925mg/ kg/day (M/F) based on increased kidney weight in males andfemales and nephropathy in males Reproductive NOAEL = 1610/1869 mg/kg/ day (M/F) - HDT Reproductive LOAEL was not established Offspring NOAEL = 781/925mg/kg/day (M/F) Offspring LOAEL = 1610/1869mg/kg/ day (M/F) based on decreasedbody weight/body weight in F2 pups
870.4100
Chronic toxicity-- NOAEL = 100 mg/kg/ dogs
day LOAEL = 1,000 mg/ kg/day based on decreased body weight gain in male; increased clotting time, increased globulin levels, and increasedalpha-2 fraction of the serum protein electrophoresis in females
870.4200
Chronic toxicity/ NOAEL = 744.9/ Carcinogenicity-- 919.4 mg/kg/day(M/ rats
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- HDT LOAEL was not established No evidence of carcinogenicity
870.4300
Carcinogenicity-- NOAEL = 731.4/ mice
850.2 mg/kg/day(M/ F) - HDT LOAEL was not established No evidence of carcinogenicity
870.5100
Gene mutation Negative up to 5,000 [mu]g/plate withand without metabolic activation
870.5375
Cytogenetics
Negative for chromosome aberrationup to 400 [mu]g/mL with metabolic activation; weak,positive response without activation
870.5395
Micronucleus - Negative at mouse
concentration up to300 [mu]g/mL in cultured rat hepatocytes
870.5550
Unscheduled DNA Negative at doses Synthesis
up to 5,000 mg/kg
870.7485
Metabolism and Rapid absorption pharmacokinetics and excretion; majormetabolic route is deesterification to a phenoxyaceticacid derivative followed by cleavageof the imide moiety or hydroxylationand/ or sulfonation reactions
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Toxicological Endpoints
For hazards that have a threshold below which there is no appreciable risk, 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.
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 (e.g., risk). An example of how such a probability risk is expressed would be to describe the risk as one in one hundred thousand (1 X 10-5), one in a million (1 X 10-6), or one in ten million (1 X 10-7). 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 flumiclorac pentyl used for human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for flumiclorac pentyl for Use in Human Risk Assessment
Dose Used in Risk Assessment,
Special FQPA SF and Exposure/Scenario
Interspecies and Level of Concern for Study and Toxicological Intraspecies and any Risk Assessment
Effects Traditional UF
Acute Dietary (females 13-49)
An endpoint of concern for the females 13 -49 attributable to a single dose was not identified in the hazard data base.
Acute Dietary (General population
An endpoint of concern for the general population attributable to a including infants and children)
single dose was not identified in the hazard data base
Chronic Dietary (All populations) NOAEL= 100 mg/kg/day Special FQPA SF = 1 Chronic dog UF = 100............... cPAD = chronic RfD/ LOAEL = 1,000 mg/kg/day Chronic RfD = 1.0 mg/kg/ Special FQPA SF = 1.0 based on decreased day.
mg/kg/day.
body weight gain (males), increased clotting time (males and females), and increased globulin levels and increased alpha-2 fraction of the serum protein electrophoresis (females)
Short-Term Incidental Oral Exposure inhalation (or oral) FQPA SF = 1 cPAD = 1.0 Chronic - dog (1 to 30 days)
study
mg/kg/day 1 = 1.00 mg/ LOAEL = 1,000 mg/kg/day (Residential)........................ NOAEL = 100 mg/kg/day). kg/day
based on UF = 100 Chronic RfD = MOE = 100 (residential) LOAEL = mg/kg/day based 1.0 mg/kg/day.
on decreased body weight gain (males), increased clotting time (males and females), and increased globulin levels and increased alpha-2 fraction of the serum protein electrophoresis (females)
Cancer (oral, dermal, inhalation)
No evidence of carcinogenicity in the hazard data base
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Exposure Assessment
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Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.477) for the residues of flumiclorac pentyl, in or on field corn and soybeans. Risk assessments were conducted by EPA to assess dietary exposures from flumiclorac pentyl 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.
No such effects were identified in the toxicological studies for flumiclorac pentyl; therefore, a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 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 chronic exposure assessments: For the chronic analyses, tolerance-level residues were assumed for all food commodities with current or proposed flumiclorac pentyl tolerances, and it was assumed that all of the crops included in the analysis were treated. Percent Crop Treated (PCT) and/or anticipated residues were not used in the chronic risk assessment.
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Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for flumiclorac pentyl in drinking water.
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Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of flumiclorac pentyl.
The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and Screening Concentrations in Groundwater (SCI-GROW), which predicts pesticide concentrations in ground water. In general, EPA will use GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.
None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a screen for sorting out pesticides for which it is unlikely that drinking water concentrations would exceed human health levels of concern.
Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs), which are the model estimates of a pesticide's concentration in water. EECs derived from these models are used to quantify drinking water exposure and risk as a %Reference dose or %Population adjusted dose.
Based on the FIRST and SCI-GROW models, the EECs of flumiclorac pentyl for chronic exposures are estimated to be 0.24 parts per billion (ppb) for surface water and 0.002 ppb for ground water.
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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).
Flumiclorac pentyl is currently registered for use on the following residential non-dietary sites: Non-agricultural settings which include golf course, parks, recreation areas as well as schools. The risk assessment was conducted using the following residential exposure assumptions: The short-term incidental oral exposures was assessed for toddlers, the most sensitive population possibly exposed to flumiclorac-pentyl from residential use. Residential Exposure Assessments for the exposure scenarios described in Table 3 which are the most likely to result in highest possible exposure by toddlers to the herbicide.
Table 3.--Short-Term Residential Exposure Estimates and MOEs for Flumiclorac-pentyl Treated Turf
Average Days After
Daily Dose Resident
Activity Treatment Body Weight (ADD) (mg/ NOAEL
MOE (DAT)
kg/day)
toddler
hand to
0
15 0.0017
100 58,230 mouth
toddler
object to
0
15 0.00043
100 233,000 mouth (turf)
toddler
soil
0
15
0
100 1.75 E\7\ ingestion
All MOEs, including the total toddler ingestion MOE, are well above 100 and therefore exposures to toddlers from flumiclorac-pentyl are not of concern.
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Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
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 flumiclorac pentyl and any other substances and flumiclorac pentyl 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 flumiclorac pentyl has a commonmechanism 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 athttp://www. epa.gov/ pesticidesca/
cumulative/.
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Safety Factor for Infants and Children
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In general. Section 408 of FFDCA 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 based on reliable data 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. In applying this provision, EPA either retains the default value of 10X when reliable data do not support the choice of a different factor, or, if reliable data are available, EPA uses a different additional safety factor value based on the use of traditional uncertainty factors and/or
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special FQPA safety factors, as appropriate.
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Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to flumiclorac pentyl. There is no concern for neurotoxicity.
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Conclusion. There is a complete toxicity data base for flumiclorac pentyl, there is no evidence of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to flumiclorac pentyl, and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The dietary food exposure assessment utilizes tolerance level residues and 100% crop treated (CT) information for all commodities. By using these screening- level assumptions, chronic exposures/risks will not be underestimated. The dietary drinking water assessment utilizes values generated by models and associated modeling parameters which are designed to provide conservative, health protective, high-end estimates of water concentrations. Accordingly, the additional 10X factor for the protection of infants and children is removed.
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Aggregate Risks and Determination of Safety
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Acute risk. An endpoint of concern attributable to a single exposure was not identified in the hazard data base and therefore no acute risk is expected from exposure to flumiclorac pentyl.
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Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to flumiclorac pentyl from food and drinking water will utilize
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