Glyphosate; Pesticide Tolerances
Federal Register, Volume 78 Issue 84 (Wednesday, May 1, 2013)
Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)
Rules and Regulations
Pages 25396-25401
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2013-10316
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ENVIRONMENTAL PROTECTION AGENCY
EPA-HQ-OPP-2012-0132; FRL-9384-3
Glyphosate; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of glyphosate in or on multiple commodities which are identified and discussed later in this document. 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 1, 2013. Objections and requests for hearings must be received on or before July 1, 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-2012-0132, 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: Andrew Ertman, Registration Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-9367; email 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. 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 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-2012-0132 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 1, 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-2012-0132, 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.html.
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 Tolerance
In the Federal Register of May 2, 2012 (77 FR 25954) (FRL-9346-1), 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 2E7979) by IR-4, 500 College Rd. East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.364 be amended by establishing tolerances for residues of the herbicide glyphosate N-(phosphonomethyl) glycine in or on the raw agricultural commodity teff, forage and teff, hay at 100 parts per million (ppm) and oilseed crops, group 20 at 40 ppm. The petition also requested amendments to the tolerances in 40 CFR 180.364 as follows: Vegetable, root and tuber, group 1, except sugar beet, from 0.2 ppm to 6.0 ppm; vegetable, bulb, group 3 at 0.2 ppm to
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vegetable, bulb, group 3-07 at 0.2 ppm; okra at 0.5 ppm; vegetable, fruiting, group 8 at 0.1 ppm to vegetable, fruiting, group 8-10 at 0.1 ppm; fruit, citrus, group 10 at 0.5 ppm to fruit, citrus, group 10-10 at 0.5 ppm; fruit, pome, group 11 at 0.2 ppm to fruit, pome, group 11-
10 at 0.2 ppm; cranberry, grape, juneberry, kiwifruit, lingonberry, salal, strawberry, and berry group 13 at 0.2 ppm to berry and small fruit, group 13-07 at 0.2 ppm. That document referenced a summary of the petition prepared by Monsanto, the registrant, which is available in the docket at 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 levels at which tolerances are being established for some commodities as well as the crops for which tolerances are being established. 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 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 glyphosate including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with glyphosate 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.
A chronic feeding/carcinogenicity study in rats found no systemic effects in any of the parameters examined (body weight, food consumption, clinical signs, mortality, clinical pathology, organ weights, and histopathology). A second chronic feeding/carcinogenicity study in rats tested at higher dietary levels, and a lowest-observed-
adverse-effect level (LOAEL) was identified at 20,000 ppm (approximately 940 milligram/kilogram/day (mg/kg/day)) based on decreased body-weight gains in females and increased incidence of cataracts and lens abnormalities, decreased urinary pH, increased absolute liver weight, and increased relative liver weight/brain weight in males. No evidence of carcinogenicity was found in mice or rats. In a chronic toxicity study in dogs, no systemic effects were found in all examined parameters.
There is no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure in developmental studies. A focal tubular dilation of the kidneys was observed in an older 3-generation reproductive study on rats at the 30-
mg/kg/day level (highest dose tested (HDT)); however, a 2-generation reproductive study on rats did not observe the same effect at the 1,500 mg/kg/day level (HDT), nor were any adverse reproductive effects observed at any dose level. A clear NOAEL was established and the chronic reference dose (cRfD) was set at a level well below this effect. Neurotoxicity has not been observed in any of the acute, subchronic, chronic, developmental, or reproductive studies performed with glyphosate.
Neurotoxicity screening battery tests and an immunotoxicity study have been submitted to the Agency. Given the timing of the submission of these studies, the Agency has conducted preliminary reviews of these studies. The preliminary reviews show no effects up to the HDT for both the acute and subchronic durations for the neurotoxicity studies and no effects up to the HDT in the immunotoxicity study. EPA does not believe that further review will result in different conclusions concerning the neurotoxic or immunotoxic potential of glyphosate.
Specific information on the studies received and the nature of the adverse effects caused by glyphosate as well as the NOAEL and the LOAEL from the toxicity studies can be found at http://www.regulations.gov in the document entitled ``Glyphosate. Section 3 Registration Concerning the Application of Glyphosate to Carrots, Sweet Potato, Teff, and Oilseeds (Crop Group (CG) 20) and to Update the CG Definitions for Bulb Vegetable (CG 3-07), Fruiting Vegetable (CG 8-10), Citrus Fruit (CG 10-
10), Pome Fruit (CG 11-10), and Berry (CG 13-07). Human-Health Risk Assessment'' on pp. 26-28 in docket ID number EPA-HQ-OPP-2012-0132.
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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 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 glyphosate used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of April 8, 2011 (76 FR 19701) (FRL-
8866-8).
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Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary exposure to glyphosate, EPA considered exposure under the petitioned-
for tolerances as well as all existing
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glyphosate tolerances in 40 CFR 180.364. EPA assessed dietary exposures from glyphosate 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 glyphosate; therefore, a quantitative acute dietary exposure assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, EPA assumed tolerance level residues and 100 percent crop treated (PCT) for both proposed and existing commodities.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that glyphosate 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 percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for glyphosate. Tolerance level residues and/or 100 PCT were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used both a screening level water exposure model (surface water) as well as monitoring data (ground water) in the dietary exposure analysis and risk assessment for glyphosate in drinking water. The simulation model takes into account data on the physical, chemical, and fate/transport characteristics of glyphosate. 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 Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and monitoring data from the National Water-Quality Assessment Program (NAWQA), the estimated drinking water concentrations (EDWCs) of glyphosate for chronic exposures are estimated to be 8.11 parts per billion (ppb) for surface water and 2.03 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 of value 8.11 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).
Glyphosate is currently registered for the following uses that could result in residential exposures: Turf (including golf courses and residential lawns) and for aquatic application. EPA assessed residential exposure using the following assumptions:
Based on the registered residential use patterns, there is a potential for short-term dermal and inhalation exposures to homeowners who mix and apply products containing glyphosate (residential handlers). However, since short- and intermediate-term dermal or inhalation endpoints were not selected, a quantitative exposure risk assessment was not completed.
Based on the registered use patterns, children 1-2 years old may have short-term post-application incidental oral exposures from hand-
to-mouth behavior on treated lawns and swimmers (adults and children 3-
6 years old) may have short-term post-application incidental oral exposures from aquatic uses. Based on the soil half-life for glyphosate, intermediate-term soil ingestion was also considered for children 1
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