Pesticide Tolerances: Clethodim
Federal Register: May 12, 2010 (Volume 75, Number 91)
Rules and Regulations
Page 26673-26678
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr12my10-11
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180
EPA-HQ-OPP-2009-0307; FRL-8822-7
Clethodim; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of clethodim in or on the raw agricultural commodity artichoke, globe; bushberry subgroup 13-07B; caneberry subgroup 13-07A; and peach. This regulation additionally removes the existing tolerances on lettuce leaf and spinach, as they are covered by the leafy greens subgroup 4A and removes the tolerance for flax seed at 0.50 ppm because there is one for flax seed at 0.6 ppm. 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 May 12, 2010. Objections and requests for hearings must be received on or before July 12, 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-2009-0307. 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: Andrew Ertman, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-9367; e-mail address: ertman.andrew@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 those engaged in the following activities:
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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 cite at http://www.gpoaccess.gov/ecfr.
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Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 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-2009-0307 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
July 12, 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 that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2009-0307, 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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Petition for Tolerance
In the Federal Register of June 10, 2009 (74 FR 27538) (FRL-8417- 7), 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 8E7505) by IR-4 Project Headquarters, Rutgers, The State University of
New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540.
The petition requested that 40 CFR 180.458 be amended by establishing tolerances for combined residues of the herbicide clethodim, ((E)-()-2-
1-[(3-chloro-2-propenyl)oxy imino]propyl]-5-[2-(ethylthio)propyl]-3- hydroxy-2-cyclohexen-1-one) and its metabolites containing the 5-(2-
(ethylthio)propyl]cyclohexen-3-one and the 5-[2-(ethylthio)propyl]-5- hydroxycyclohexen-3-one moieties and their sulfoxides and sulfones, expressed as clethodim, in or on the raw agricultural commodity artichoke, globe at 1.3 parts per million (ppm), bushberry subgroup 13- 07B at 3.0 ppm, caneberry subgroup 13-07A at 0.30 ppm and peach at 0.20 ppm. That notice referenced a summary of the petition prepared by
Valent U.S.A. Corporation, 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 has modified the bushberry subgroup 13-07B tolerance from 3.0 ppm to 0.20 ppm and the globe artichoke tolerance from 1.3 ppm to 1.2 ppm. The reason for these changes is explained in Unit IV.C.
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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 clethodim including exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with clethodim 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. Clethodim has a low order of acute toxicity via oral, dermal and inhalation routes of exposure. Clethodim produces mild ocular irritation and moderate skin irritation. It is not a dermal sensitizer.
The subchronic and chronic toxicity data show that clethodim produces consistent effects in the liver characterized by increased liver weights and centrilobular hepatic hypertrophy in rats, mice, and dogs.
Decreased body weight is also a consistent finding. Treatment related increase in tumor incidence is not observed in rat and mouse carcinogenicity studies. Clethodim is not genotoxic. The data demonstrate no reproductive effect in rats and no developmental effects in rabbits. No effects were seen in offspring of the 2-generation study. In the rat developmental toxicity study, reduced fetal weights and increased incidence of reduced ossification were seen in the fetuses at the maternal toxic dose level.
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The data show no increase in susceptibility in the young.
Specific information on the studies received and the nature of the adverse effects caused by clethodim 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 on pages 45-50 of the document titled ``Clethodim
Human Health Risk Assessment for Proposed Uses on Caneberry Subgroup 13-07A, Bushberry Subgroup 13-07B, Peach, and Globe Artichoke'' in docket ID number EPA-HQ-OPP-2009-0307.
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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 clethodim used for human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Clethodim for Use in Human Health Risk Assessment
Point of Departure and
Exposure/Scenario
Uncertainty/Safety
RfD, PAD, LOC for Risk Study and Toxicological
Factors
Assessment
Effects
Acute dietary
N/A
N/A
None Selected.
(All Populations)..................
There were no effects observed in oral toxicity studies including developmental toxicity studies in rats and rabbits that could be attributable to a single dose
(exposure). Therefore, a dose and endpoint were not selected for this exposure scenario.
Chronic dietary
NOAEL= 1.0 mg/kg/day
Chronic RfD = 0.01 mg/ Chronic Toxicity-Dog (1-
(All populations)................... UFA = 10x.............. kg/day
year).
UFH = 10x.............. cPAD = 0.01 mg/kg/day.. Alterations in
FQPA SF = 1x...........
hematology and clinical chemistry parameters and increased absolute and relative liver weights observed at the
LOAEL of 75 mg/kg/day.
Cancer
Classification: ``Not likely to be Carcinogenic to Humans'' based on
(Oral, dermal, inhalation)..........
feeding studies in rats and mice.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern.
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Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to clethodim, EPA considered exposure under the petitioned-for tolerances as well as all existing clethodim tolerances in 40 CFR 180.458. EPA assessed dietary exposures from clethodim 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 clethodim; therefore, a quantitative acute dietary exposure assessment is unnecessary. ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. The chronic dietary (food and drinking water) exposure assessment is partially refined, i.e., based on the assumption of tolerance-level residues for most commodities and average percent crop treated information for some crops. An anticipated residue (AR) value was used for succulent snap bean. iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that clethodim is classified as ``Not Likely to be
Carcinogenic to Humans.'' Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary. iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to section 408(f)(1) of FFDCA that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by section 408(b)(2)(E) of FFDCA and authorized under section 408(f)(1) of FFDCA. Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
Condition a: The data used are reliable and provide a valid basis to show what percentage of the food
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derived from such crop is likely to contain the pesticide residue.
Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit data on PCT.
The Agency estimated the percent crop treated for existing uses as follows:
Beets 1%, Broccoli 10%, Cabbage 1%, Cantaloupes 1%, Carrots 10%,
Celery 5%, Cotton 1%, Cucumbers 1%, Dry beans 5%, Lettuce 1%, Onions 10%, Peanuts 5%, Potatoes 5%, Pumpkins 5%, Soybeans 5%, Squash 5%,
Strawberries 1%, Sugar beets 45%, Sunflowers 20%, Sweet potatoes 1%,
Tomatoes 1%, Watermelons 5%.
In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys, and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.
The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which clethodim may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for clethodim in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of clethodim. 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) and
Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of clethodim for chronic exposures for non-cancer assessments are 13.0 ppb for surface water and 9.8 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 13.0 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).
Clethodim is not registered for any specific use patterns that would result in residential exposure. 4. 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.''
EPA has not found clethodim to share a common mechanism of toxicity with any other substances, and clethodim does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that clethodim does not have 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 EPA's website at http://www.epa.gov/pesticides/ cumulative.
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Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) 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 database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility of fetuses as compared to maternal animals following in utero and/or postnatal exposure to clethodim in the developmental toxicity studies in rats or rabbits, and no increased sensitivity in pups as compared to adults in the 2-generation rat reproduction toxicity study. There are no residual uncertainties concerning prenatal and postnatal toxicity and no neurotoxicity concerns. 3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following findings: i. Except for the new requirements of an immunotoxicity study and an acute and subchronic neurotoxicity battery, the available toxicity database for clethodim is sufficient and the exposure data are complete or are estimated based on data that reasonably account for potential exposures. In the absence of the immunotoxicity and acute and subchronic neurotoxicity studies, the available toxicity data for clethodim have been thoroughly examined for any information which suggests a potential for neurotoxicity or immunotoxicity.
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The analysis did not reveal such information and the Agency does not believe that conducting these studies will result in a NOAEL less than the currently selected NOAELs for risk assessment. Therefore, a database uncertainty factor (UFdb) is not needed to account for the lack of these studies. ii. There is no evidence of susceptibility following in utero and/ or postnatal exposure in the developmental toxicity studies in rats or rabbits, and in the 2-generation rat reproduction study. There are no residual uncertainties concerning prenatal and postnatal toxicity. iii. There is no evidence that clethodim is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. iv. There are no residual uncertainties identified in the exposure data base. The chronic dietary food exposure assessment utilized tolerance level residues for most commodities and incorporated average
PCT data for some commodities. There is no potential for residential exposure. The dietary (food and drinking water) exposure assessment will not underestimate the potential exposure for infants, children, and/or women of childbearing age.
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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. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, clethodim is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to clethodim from food and drinking water will utilize 79% of the cPAD for all infants )-2-[1-[(3-chloro-2- propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2- cyclohexen-1-one] and its metabolites containing the 5-(2- ethylthiopropyl)cyclohexen-3-one and 5-(2-ethylthiopropyl)-5- hydroxycyclohexen-3-one moieties and their sulphoxides and sulphones, expressed as clethodim tolerance residues for the following commodities:
Commodity
Parts per million
* * * * *
Artichoke, globe.....................................
1.2
* * * * *
Bushberry subgroup 13-07B............................
0.20
Caneberry subgroup 13-07A............................
0.30
* * * * *
Peach................................................
0.20
* * * * *
* * * * *
FR Doc. 2010-11301 Filed 5-11-10; 8:45 am
BILLING CODE 6560-50-S
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