Fluroxypyr; Pesticide Tolerances
Federal Register, Volume 78 Issue 11 (Wednesday, January 16, 2013)
Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)
Rules and Regulations
Pages 3328-3333
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2013-00562
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ENVIRONMENTAL PROTECTION AGENCY
EPA-HQ-OPP-2011-0962; FRL-9371-1
Fluroxypyr; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of fluroxypyr in or on rice bran and rice grain. Dow AgroSciences LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective January 16, 2013. Objections and requests for hearings must be received on or before March 18, 2013, 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: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2011-0962, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Bethany Benbow, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-8072; email address: benbow.bethany@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. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection
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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-2011-0962 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 March 18, 2013. 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 (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0962, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
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Summary of Petitioned-for Tolerances
In the Federal Register of December 30, 2011 (76 FR 82238) (FRL-
9331-1), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 1F7928) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268. The petition requested that 40 CFR 180.535 be amended by establishing tolerances for residues of the herbicide, fluroxypyr 1-MHE and its acid metabolite, fluroxypyr, in or on rice at 1.5 parts per million (ppm) and rice bran at 3.0 ppm. That document referenced a summary of the petition prepared by Dow AgroSciences LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.
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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 FFDCA section 408(b)(2)(D), and the factors specified in FFDCA 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 for fluroxypyr including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluroxypyr 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 active ingredient used in formulating end-use herbicide products is fluroxypyr 1-methylheptyl ester. However, since the ester form has been shown to rapidly hydrolyze to the acid form, the residues of fluroxypyr 1-methylheptyl ester along with its fluroxypyr acid metabolite (free and conjugated), are collectively expressed as ``fluroxypyr'' and are therefore regulated together for tolerance enforcement. In terms of toxicity, the ester and acid forms are considered the same.
Fluroxypyr has low acute toxicity by the oral and dermal routes of exposure and moderate to mild acute toxicity by the inhalation route of exposure, based on lethality studies. Fluroxypyr is not a dermal sensitizer, nor is it irritating to the skin; however, it is a mild eye irritant.
The kidney is the target organ for fluroxypyr following oral exposure to rats, mice, and dogs. In the rat, increased kidney weight, nephrotoxicity, and death were observed in both sexes in the 90-day feeding study, and increased kidney weight and microscopic kidney lesions were observed in both sexes in the chronic study. Increased kidney weight was also observed in maternal rats in the developmental toxicity study, and kidney effects (deaths due to renal failure; increased kidney weight, and microscopic kidney lesions) were observed in both sexes in the 2-generation reproduction study in rats. Although microscopic kidney lesions were observed in dogs in the 28-day feeding study, no kidney effects or other treatment related toxicity were seen in the chronic feeding study in dogs at the same doses used in the 28-
day study. Microscopic kidney lesions were observed in mice following long-term exposure.
There was no evidence of increased susceptibility (quantitative/
qualitative) following in utero exposure in rats and rabbits, or following pre and/or postnatal exposure in rats. Neither developmental toxicity nor reproductive toxicity was observed in rats. In rabbits, developmental toxicity was not observed following exposure to dose levels that resulted in maternal death; however, abortions were observed in rabbits following exposure to fluroxypyr at the limit dose. There was no evidence of neurotoxicity or neuropathology in any of the studies. An immunotoxicity study in rats found no indication of immunotoxicity. Fluroxypyr is classified ``not likely to be carcinogenic to humans'' due to lack of evidence to suggest carcinogenicity in the database, and there is no concern for its mutagenicity potential.
Specific information on the studies received and the nature of the adverse effects caused by fluroxypyr as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``Fluroxypyr. Human Health Risk Assessment to Support Proposed New
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Use on Rice,'' p. 15 in docket ID number EPA-HQ-OPP-2011-0962.
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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 fluroxypyr used for human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Fluroxypyr for Use in Human Health Risk Assessment
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Point of departure
Exposure/scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
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Acute dietary (All populations).. No adverse effects were identified following a single oral dose and there are
no developmental concerns noted in the database.
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Chronic dietary (All populations) NOAEL = 100 mg/kg/ Chronic RfD = 1 mg/ Chronic/Carcinogenicity-Rat LOAEL
day. kg/day. = 500 mg/kg/day, based on kidney
UFA = 10x........... cPAD = 1 mg/kg/day. effects (increased kidney
UFH = 10x........... weights, alterations in clinical
FQPA SF = 1x........ chemistry parameters indicative
of impaired renal functions, and
increase in severity of chronic
progressive glomerulonephropathy
in both sexes).
Incidental oral (Short- and NOAEL = 100 mg/kg/ LOC for MOE = 100.. Chronic/Carcinogenicity-Rat LOAEL
Intermediate term). day. = 500 mg/kg/day, based on kidney
UFA = 10x........... effects (increased kidney
UFH = 10x........... weights, alterations in clinical
FQPA SF = 1x........ chemistry parameters indicative
of impaired renal functions, and
increase in severity of chronic
progressive glomerulonephropathy
in both sexes).
Inhalation (all durations)....... Inhalation (or oral) LOC for MOE = 100.. Chronic/Carcinogenicity-Rat LOAEL
study NOAEL = 100 = 500 mg/kg/day, based on kidney
mg/kg/day effects (increased kidney
(inhalation and weights, alterations in clinical
oral toxicity chemistry parameters indicative
assumed to be of impaired renal functions, and
equivalent). increase in severity of chronic
UFA = 10x........... progressive glomerulonephropathy
UFH = 10x........... in both sexes).
FQPA SF = 1x........
Cancer (Oral).................... Classified as a ``Not Likely'' human carcinogen.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
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Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to fluroxypyr, EPA considered exposure under the petitioned-
for tolerances as well as all existing fluroxypyr tolerances in 40 CFR 180.535. EPA assessed dietary exposures from fluroxypyr 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 fluroxypyr; 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 U.S. Department of Agriculture's National Health and Nutrition Examination Survey, ``What We Eat in America'' (NHANES/WWEIA) dietary survey conducted in 2003-2008. As to residue levels in food, EPA assumed tolerance-level residues with 100 percent crop treated (PCT) for all existing and proposed crop uses and default processing factors for processed commodities.
iii. Cancer. EPA has concluded that fluroxypyr does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.
iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for fluroxypyr. Tolerance level residues and 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for fluroxypyr in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of fluroxypyr. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at
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http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the Tier 1 Rice Model and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fluroxypyr for acute and chronic exposures are both estimated to be 540 parts per billion (ppb) for surface water and 0.055 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute and chronic dietary risk assessment, the water concentration value of 540 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).
Fluroxypyr is currently registered for the following uses that could result in residential exposures: Residential turfgrass, golf courses, parks and sports fields. EPA assessed residential exposure using the following assumptions: Residential handler exposure is expected to be short-term. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Since there are no toxicity findings for the short-term dermal route of exposure up to the limit dose, only inhalation exposure was assessed for residential handlers of fluroxypyr. The following exposure scenarios were assessed for residential handlers: Loading and applying liquids with manually pressurized hand-wands, hose-end sprayers, and backpack applicators.
For residential post-application exposure and risk estimates, EPA assumed that young children 1 to
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