Glyphosate; Pesticide Tolerances, 25396-25401 [2013-10316]

Download as PDF 25396 Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Rules and Regulations timely notice of intent and extension request consistent with 98.234(f)(8)(ii) can automatically use best available monitoring method through June 30, 2012, for the specific parameters identified in their notification of intent and best available monitoring methods request regardless of whether the best available monitoring methods request is ultimately approved. Owners or operators that submit a notice of intent but do not follow up with a best available monitoring methods request by March 30, 2012 cannot use best available monitoring methods in 2012. For 2012, when an owner or operator has submitted a notice of intent and a subsequent best available monitoring method extension request, use of best available monitoring methods will be valid, upon approval by the Administrator, until the date indicated in the approval or until December 31, 2012, whichever is earlier. For reporting years after 2012, a new request to use best available monitoring methods must be submitted by June 30th of the year prior to the reporting year for which use of best available monitoring methods is sought. * * * * * [FR Doc. 2013–10184 Filed 4–30–13; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2012–0132; FRL–9384–3] Glyphosate; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. wreier-aviles on DSK5TPTVN1PROD with RULES AGENCY: 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). The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2012–0132, is available at https://www.regulations.gov or at the Office of Pesticide Programs ADDRESSES: VerDate Mar<15>2010 14:02 Apr 30, 2013 Jkt 229001 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 https://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: I. General Information A. 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). B. 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 https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. 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– PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 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: https:// 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/ dockets. II. 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 E:\FR\FM\01MYR1.SGM 01MYR1 Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Rules and Regulations 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 https://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. wreier-aviles on DSK5TPTVN1PROD with RULES III. 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. VerDate Mar<15>2010 14:02 Apr 30, 2013 Jkt 229001 A. 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 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 25397 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 https:// 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. B. 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 https://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). C. 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 E:\FR\FM\01MYR1.SGM 01MYR1 wreier-aviles on DSK5TPTVN1PROD with RULES 25398 Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Rules and Regulations 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 https://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. VerDate Mar<15>2010 14:02 Apr 30, 2013 Jkt 229001 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 nonoccupational, 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 shortterm 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 shortterm 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<2 years old. The incidental oral scenarios for the turf assessment (i.e., hand-to-mouth, object-to-mouth, and soil ingestion) should be considered inter-related and it is likely that they occur interspersed amongst each other across time. Combining these scenarios would be overly conservative because of the conservative nature of each individual assessment. Therefore, none of the incidental oral scenarios were combined. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at https://www.epa.gov/pesticides/ trac/science/trac6a05.pdf. 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 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 substances that have a common mechanism of toxicity.’’ EPA has not found glyphosate to share a common mechanism of toxicity with any other substances, and glyphosate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that glyphosate 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 Web site at https://www.epa.gov/pesticides/ cumulative. D. 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 Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional SF when reliable data available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. 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 (HDT); however, a 2generation 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 cRfD was set at a level well below this effect. Therefore, the endpoints selected for risk assessment are protective of the effects seen in the 3-generation rat reproduction study. 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. The toxicity database for glyphosate is complete. E:\FR\FM\01MYR1.SGM 01MYR1 Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Rules and Regulations ii. There is no indication that glyphosate is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity. iii. As discussed in Unit III.D.2., there is no evidence that glyphosate results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies. iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the surface water modeling used to assess exposure to glyphosate in drinking water. EPA used similarly conservative assumptions to assess postapplication incidental oral exposure of children. These assessments will not underestimate the exposure and risks posed by glyphosate. wreier-aviles on DSK5TPTVN1PROD with RULES E. 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, glypyhosate 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 glyphosate from food and water will utilize 13% of the cPAD for children 1–2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of glyphosate is not expected. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). VerDate Mar<15>2010 14:02 Apr 30, 2013 Jkt 229001 Glyphosate is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to glyphosate. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 2,000 for the general U.S. population and 450 for children 1–2 years old. Because EPA’s level of concern for glyphosate is a MOE of 100 or below, these MOEs are not of concern. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Glyphosate is currently registered for uses that could result in intermediateterm residential exposure to children 1– 2 years old, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to glyphosate. Using the exposure assumptions described in this unit for intermediateterm exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in an aggregate MOE of 770 for children 1–2 years old, the population subgroup of concern. Because EPA’s level of concern for glyphosate is a MOE of 100 or below, these MOEs are not of concern. 5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, glyphosate is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to glyphosate residues. IV. Other Considerations A. Analytical Enforcement Methodology Adequate enforcement methodology (high-performance liquid chromatography (HPLC)) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 25399 email address: residuemethods@epa.gov. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has established MRLs for glyphosate in or on cotton seed at 40 ppm, sunflower seed at 7 ppm, and rape seed at 20 ppm. The MRL for cotton seed is the same as the oilseed crop group tolerance and the MRL for rape seed is the same as the canola seed tolerance being established by this document. Based on the oilseed residue data, harmonization with the Codex sunflower seed tolerance is not possible. C. Revisions to Petitioned-For Tolerances The Agency has revised the petitioned-for tolerances as follows: The proposed increase in tolerance for vegetables, root and tuber, group 1, except sugar beet from 0.2 ppm to 6 ppm cannot be done at this time due to inadequate residue data. Instead, the Agency is establishing individual tolerances for carrot at 5.0 ppm and sweet potato at 3.0 ppm and modifying the existing tolerance on vegetables, root and tuber, group 1, except sugar beet at 0.20 ppm to read as ‘‘vegetables, root and tuber, group 1, except sugar beet, carrot, and sweet potato.’’ The petition requested a tolerance at 40 ppm on the oilseed group 20. In order to maintain harmonization with both Canada and Codex the Agency is establishing a tolerance on the oilseed crop group 20, except canola at 40 ppm and is maintaining the existing canola seed tolerance at 20 ppm. The petition requested that the current tolerance for vegetable, fruiting, group 8 be updated to the new vegetable, fruiting, group 8–10. Okra is part of the new crop group, however, E:\FR\FM\01MYR1.SGM 01MYR1 25400 Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Rules and Regulations and the currently established tolerance in or on crop group 8 is 0.1 ppm, whereas the okra tolerance is 0.5 ppm. Due to this difference, the Agency is updating crop group 8 to read ‘‘vegetable, fruiting, group 8–10, except okra’’ and maintaining the existing okra tolerance at 0.5 ppm. Lastly, several of the tolerance values on the crop group conversions are being revised to reflect Agency policy concerning significant figures. wreier-aviles on DSK5TPTVN1PROD with RULES V. Conclusion Therefore, tolerances are established for residues of glyphosate N(phosphonomethyl) glycine in or on the raw agricultural commodity teff, forage at 100 ppm; teff, hay at 100 ppm; oilseeds, group 20, except canola at 40 ppm; vegetable, root and tuber, group 1, except carrot, sweet potato, and sugar beet at 0.20 ppm; carrot at 5.0 ppm; sweet potato at 3.0 ppm; vegetable, bulb, group 3–07 at 0.20 ppm; vegetable, fruiting, group 8–10 (except okra) at 0.10 ppm; fruit, citrus, group 10–10 at 0.50 ppm; fruit, pome, group 11–10 at 0.20 ppm; and berry and small fruit, group 13–07 at 0.20 ppm. In addition, due to the establishment of the tolerances in this document, the following tolerances are being removed as unnecessary: Vegetables, root and tuber, crop group 1, except sugar beet; vegetable, bulb, group 3; vegetable, fruiting, group 8; fruit, citrus, group 10; fruit, pome, group 11; berry group 13; borage, seed; cotton, undelinted seed; crambe, seed; flax, meal; flax, seed; jojoba seed; lesquerella, seed; meadowfoam, seed; mustard seed; rapeseed, seed; safflower, seed; sesame, seed; sunflower, seed; cranberry; grape; juneberry; kiwifruit; lingonberry; salal; and strawberry. VI. Statutory and Executive Order Reviews This final rule establishes tolerances 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 final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This final rule does not VerDate Mar<15>2010 14:02 Apr 30, 2013 Jkt 229001 contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), 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). 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. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.). 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) (15 U.S.C. 272 note). List of Subjects in 40 CFR Part 180 VII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal Register. This action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: April 19, 2013. Daniel J. Rosenblatt, Acting Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. In § 180.364: a. Add alphabetically to the table in paragraph (a)(1) the following commodities. ■ b. Remove from the table in paragraph (a)(1), the commodities berry group 13; borage, seed; cotton, undelinted seed; crambe, seed; cranberry; flax, meal; flax, seed; fruit, citrus, group 10; fruit, pome, group 11; grape; jojoba seed; juneberry; kiwifruit; lesquerella, seed; lingonberry; meadowfoam, seed; mustard seed; rapeseed, seed; safflower, seed; salal; sesame, seed; strawberry; sunflower, seed; vegetable, bulb, group 3; vegetable, fruiting, group 8; vegetable, root and tuber, group 1, except sugar beet. The additions read as follows: ■ ■ § 180.364 Glyphosate; tolerances for residues. (a) General. (1) * * * Parts per million Commodity * * * Berry and small fruit, group 13–07 .............................. * * * * Carrot .................................. * * 5.0 * * * Fruit, citrus, group 10–10 ... Fruit, pome, group 11–10 ... * * 0.50 0.20 * * * Oilseeds, group 20, except canola .............................. * * * * * Sweet potato ....................... * * * * Teff, forage ......................... * * 100 * * * Teff, hay .............................. * * 100 E:\FR\FM\01MYR1.SGM 01MYR1 * 0.20 40 * 3.0 Federal Register / Vol. 78, No. 84 / Wednesday, May 1, 2013 / Rules and Regulations Parts per million Commodity * * * Vegetable, bulb, group 3– 07 .................................... * * * * Vegetable, fruiting, group 8–10 (except okra) .......... * Parts per million Commodity * 0.20 * * * * Vegetables, root and tuber, group 1, except carrot, sweet potato, and sugar beet ................................. * 0.10 * * * * * * * * 0.20 * * * [FR Doc. 2013–10316 Filed 4–30–13; 8:45 am] wreier-aviles on DSK5TPTVN1PROD with RULES BILLING CODE 6560–50–P VerDate Mar<15>2010 14:02 Apr 30, 2013 Jkt 229001 PO 00000 Frm 00041 Fmt 4700 Sfmt 9990 E:\FR\FM\01MYR1.SGM 01MYR1 25401

Agencies

[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

40 CFR Part 180

[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 https://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 https://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: 

I. General Information

A. 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).

B. 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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. 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: https://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 https://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. 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

[[Page 25397]]

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 https://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.

III. 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.

A. 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 https://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.

B. 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 https://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).

C. 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

[[Page 25398]]

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 https://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<2 years old. The incidental oral scenarios for the turf 
assessment (i.e., hand-to-mouth, object-to-mouth, and soil ingestion) 
should be considered inter-related and it is likely that they occur 
interspersed amongst each other across time. Combining these scenarios 
would be overly conservative because of the conservative nature of each 
individual assessment. Therefore, none of the incidental oral scenarios 
were combined.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at https://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 glyphosate to share a common mechanism of 
toxicity with any other substances, and glyphosate does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
glyphosate 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 Web site at https://
www.epa.gov/pesticides/cumulative.

D. 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 Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. 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 (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 cRfD was set at a level well below this effect. Therefore, the 
endpoints selected for risk assessment are protective of the effects 
seen in the 3-generation rat reproduction study.
    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. The toxicity database for glyphosate is complete.

[[Page 25399]]

    ii. There is no indication that glyphosate is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. As discussed in Unit III.D.2., there is no evidence that 
glyphosate results in increased susceptibility in in utero rats or 
rabbits in the prenatal developmental studies.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the surface water modeling used to assess 
exposure to glyphosate in drinking water. EPA used similarly 
conservative assumptions to assess post-application incidental oral 
exposure of children. These assessments will not underestimate the 
exposure and risks posed by glyphosate.

E. 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, 
glypyhosate 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 
glyphosate from food and water will utilize 13% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
glyphosate is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Glyphosate is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to glyphosate.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 2,000 for the 
general U.S. population and 450 for children 1-2 years old. Because 
EPA's level of concern for glyphosate is a MOE of 100 or below, these 
MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Glyphosate is currently registered for uses that could result in 
intermediate-term residential exposure to children 1-2 years old, and 
the Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with intermediate-term residential 
exposures to glyphosate.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in an 
aggregate MOE of 770 for children 1-2 years old, the population 
subgroup of concern. Because EPA's level of concern for glyphosate is a 
MOE of 100 or below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, glyphosate is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population or to infants and children from aggregate 
exposure to glyphosate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography (HPLC)) is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has established MRLs for glyphosate in or on cotton seed 
at 40 ppm, sunflower seed at 7 ppm, and rape seed at 20 ppm. The MRL 
for cotton seed is the same as the oilseed crop group tolerance and the 
MRL for rape seed is the same as the canola seed tolerance being 
established by this document. Based on the oilseed residue data, 
harmonization with the Codex sunflower seed tolerance is not possible.

C. Revisions to Petitioned-For Tolerances

    The Agency has revised the petitioned-for tolerances as follows:
    The proposed increase in tolerance for vegetables, root and tuber, 
group 1, except sugar beet from 0.2 ppm to 6 ppm cannot be done at this 
time due to inadequate residue data. Instead, the Agency is 
establishing individual tolerances for carrot at 5.0 ppm and sweet 
potato at 3.0 ppm and modifying the existing tolerance on vegetables, 
root and tuber, group 1, except sugar beet at 0.20 ppm to read as 
``vegetables, root and tuber, group 1, except sugar beet, carrot, and 
sweet potato.''
    The petition requested a tolerance at 40 ppm on the oilseed group 
20. In order to maintain harmonization with both Canada and Codex the 
Agency is establishing a tolerance on the oilseed crop group 20, except 
canola at 40 ppm and is maintaining the existing canola seed tolerance 
at 20 ppm.
    The petition requested that the current tolerance for vegetable, 
fruiting, group 8 be updated to the new vegetable, fruiting, group 8-
10. Okra is part of the new crop group, however,

[[Page 25400]]

and the currently established tolerance in or on crop group 8 is 0.1 
ppm, whereas the okra tolerance is 0.5 ppm. Due to this difference, the 
Agency is updating crop group 8 to read ``vegetable, fruiting, group 8-
10, except okra'' and maintaining the existing okra tolerance at 0.5 
ppm.
    Lastly, several of the tolerance values on the crop group 
conversions are being revised to reflect Agency policy concerning 
significant figures.

V. Conclusion

    Therefore, tolerances are established for residues of glyphosate N-
(phosphonomethyl) glycine in or on the raw agricultural commodity teff, 
forage at 100 ppm; teff, hay at 100 ppm; oilseeds, group 20, except 
canola at 40 ppm; vegetable, root and tuber, group 1, except carrot, 
sweet potato, and sugar beet at 0.20 ppm; carrot at 5.0 ppm; sweet 
potato at 3.0 ppm; vegetable, bulb, group 3-07 at 0.20 ppm; vegetable, 
fruiting, group 8-10 (except okra) at 0.10 ppm; fruit, citrus, group 
10-10 at 0.50 ppm; fruit, pome, group 11-10 at 0.20 ppm; and berry and 
small fruit, group 13-07 at 0.20 ppm.
    In addition, due to the establishment of the tolerances in this 
document, the following tolerances are being removed as unnecessary: 
Vegetables, root and tuber, crop group 1, except sugar beet; vegetable, 
bulb, group 3; vegetable, fruiting, group 8; fruit, citrus, group 10; 
fruit, pome, group 11; berry group 13; borage, seed; cotton, undelinted 
seed; crambe, seed; flax, meal; flax, seed; jojoba seed; lesquerella, 
seed; meadowfoam, seed; mustard seed; rapeseed, seed; safflower, seed; 
sesame, seed; sunflower, seed; cranberry; grape; juneberry; kiwifruit; 
lingonberry; salal; and strawberry.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). 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.), 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).
    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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: April 19, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.364:

0
a. Add alphabetically to the table in paragraph (a)(1) the following 
commodities.
0
b. Remove from the table in paragraph (a)(1), the commodities berry 
group 13; borage, seed; cotton, undelinted seed; crambe, seed; 
cranberry; flax, meal; flax, seed; fruit, citrus, group 10; fruit, 
pome, group 11; grape; jojoba seed; juneberry; kiwifruit; lesquerella, 
seed; lingonberry; meadowfoam, seed; mustard seed; rapeseed, seed; 
safflower, seed; salal; sesame, seed; strawberry; sunflower, seed; 
vegetable, bulb, group 3; vegetable, fruiting, group 8; vegetable, root 
and tuber, group 1, except sugar beet.
    The additions read as follows:


Sec.  180.364  Glyphosate; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Berry and small fruit, group 13-07......................            0.20
 
                                * * * * *
Carrot..................................................            5.0
 
                                * * * * *
Fruit, citrus, group 10-10..............................            0.50
Fruit, pome, group 11-10................................            0.20
 
                                * * * * *
Oilseeds, group 20, except canola.......................           40
 
                                * * * * *
Sweet potato............................................            3.0
 
                                * * * * *
Teff, forage............................................          100
 
                                * * * * *
Teff, hay...............................................          100
 

[[Page 25401]]

 
                                * * * * *
Vegetable, bulb, group 3-07.............................            0.20
 
                                * * * * *
Vegetable, fruiting, group 8-10 (except okra)...........            0.10
 
                                * * * * *
Vegetables, root and tuber, group 1, except carrot,                 0.20
 sweet potato, and sugar beet...........................
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2013-10316 Filed 4-30-13; 8:45 am]
BILLING CODE 6560-50-P