Glufosinate-P; Pesticide Tolerances

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 Federal Register Office's e-CFR site at https://www.ecfr.gov/current/title-40.

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-2020-0250 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 December 30, 2024. 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-2020-0250, 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 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/where-send-comments-epa-dockets.

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 March 24, 2023 (88 FR 17778) (FRL-10579-02-OCSPP), 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 2F9021 ) by BASF Corporation Agricultural Solutions, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.473 be amended by modifying the tolerances for residues of glufosinate to include residues of L-glufosinate ammonium, glufosinate-P-ammonium [(2S)-2-amino- 4-(hydroxymethylphosphinyl) butanoic acid -monoammonium salt] as measured by the sum of glufosinate (2-amino-4-(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxy methylphosphinyl)butanoic acid equivalents in or on canola, meal at 1.1 parts per million (ppm); cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; cattle, meat byproducts at 6.0 ppm; corn, field, forage at 4.0 ppm; corn, field, grain at 0.20 ppm; corn, field, stover at 6.0 ppm; corn, sweet, forage at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.30 ppm; corn, sweet, stover at 6.0 ppm; cotton, gin byproducts at 30 ppm; cotton, seed, subgroup 20C at 15.00 ppm; egg at 0.15 ppm; goat, fat at 0.40 ppm; goat, meat at 0.15 ppm; goat, meat byproducts at 6.0 ppm; grain aspirated fractions at 25.00 ppm; hog, fat at 0.40 ppm; hog, meat at 0.15 ppm; hog, meat byproducts at 6.0 ppm; horse, fat at 0.40 ppm; horse, meat at 0.15 ppm; horse, meat byproducts at 6.0 ppm; milk at 0.15 ppm; poultry, fat at 0.15 ppm; poultry, meat at .15 ppm; poultry, meat byproducts at 0.60 ppm; rapeseed, subgroup 20A at 0.4 ppm; sheep, fat at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0 ppm; soybean at 2.0 ppm; soybean, hulls at 10.0 ppm and tolerances for indirect or inadvertent residues on barley, hay at 0.4 ppm; barley, straw at 0.4 ppm; buckwheat, fodder at 0.4 ppm; buckwheat, forage at 0.4 ppm; oat, forage at 0.4 ppm; oat, hay at 0.4 ppm; oat, straw at 0.4 ppm; rye, forage at 0.4 ppm; rye, straw at 0.4 ppm; teosinte at 0.4 ppm; triticale at 0.4 ppm; wheat, forage at 0.4 ppm; wheat, hay at 0.4 ppm; and wheat, straw at 0.4 ppm.

Also, in the Federal Register of December 21, 2020 (85 FR 82998) (FRL-10016-93), 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 0F8842 ) by Meiji Seika Pharma Co., Ltd, c/o Landis International, Inc., 3185 Madison Highway, P.O. Box 5126, Valdosta, GA 31603-5126. The petition requested to establish tolerance for residues of L- glufosinate free acid, (2S)-2-amino-4-[hydroxy(methyl)phosphinoyl]butyric acid, including its metabolites and degradates, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid (NAG), and 3-(hydroxymethylphosphinyl) propanoic acid (MPP), expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents in or on apple at 0.05 ppm; beet, sugar, molasses at 5.0 ppm; beet, sugar, roots at 0.9 ppm; beet, sugar, tops (leaves) at 1.5 ppm; bushberry subgroup 13B at 0.15 ppm; canola, meal at 1.1 ppm; canola, seed at 0.40 ppm; cattle, fat at 0.40 ppm; cattle, meat at 0.15 ppm; cattle, meat byproducts at 6.0 ppm; corn, field, forage at 4.0 ppm; corn, field, grain at 0.20 ppm; corn, field, stover at 6.0 ppm; corn, sweet, forage at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.30 ppm; corn, sweet, stover at 6.0 ppm; cotton, gin byproducts at 15 ppm; cotton, undelinted seed at 4.0 ppm; egg at 0.15 ppm; fruit, citrus, crop group 10-10 at .15 ppm; fruit, pome, crop group 11-10 at .25 ppm; fruit, stone, crop group 12-12 at 0.30 ppm; goat, fat at 0.40 ppm; goat, meat at 0.15 ppm; goat, meat byproducts at 6.0 ppm; grape at 0.05 ppm; hog, fat at 0.40 ppm; hog, meat at 0.15 ppm; hog, meat byproducts at 6.0 ppm; horse, fat at 0.40 ppm; horse, meat at 0.15 ppm; horse, meat byproducts at 6.0 ppm; milk at 0.15 ppm; nut, tree, crop group 14-12 at 0.50 ppm; olive at 0.50 ppm; potato at 0.80 ppm; potato, chips at 1.6 ppm; potato, granules/flakes at 2.0 ppm; poultry, fat at 0.15 ppm; poultry, meat at .15 ppm; poultry, meat byproducts at 0.60 ppm; sheep, fat at 0.40 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6.0 ppm; soybean at 2.0 ppm; soybean, hulls at 10.0 ppm.

These documents referenced summaries of the petitions prepared by BASF Corporation Agricultural Solutions and Meiji Seika Pharma Co., Ltd, (now known as MITSUI Chemicals Crop & Life Solutions), the petitioners, which are available in the docket, https://www.regulations.gov. One comment was received on the notice of filing for petition 0F8842. No comments were received on the notice of filing for petition 2F9021. EPA's response to this comment is discussed in Unit IV.C.

The tolerances EPA is establishing vary from what the petitioners have requested in a few ways, which are explained in greater detail in Unit IV.C. In sum, BASF Corporation Agricultural Solutions and MITSUI Chemicals Crop & Life Solutions have deleted crops from their initial request, the Agency will be establishing tolerances only on those crops as mentioned in Unit V. Moreover, in order to align with the International Organization for Standardization (ISO) recognized nomenclature, EPA is establishing tolerances for glufosinate-P, which is the current standard name for L-glufosinate free acid. Because applications of glufosinate-P-ammonium (also known as L-glufosinate-ammonium) result in residues of glufosinate-P on crops, EPA is setting the tolerance for glufosinate-P residues, which will cover any residues that remain on food from applications of pesticides with either form of the pesticide.

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 L-glufosinate, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with L-glufosinate 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.

Glufosinate is racemic mixture comprised of D- and L-stereoisomers, and the D/L form of glufosinate (also referred to as the racemic glufosinate) is currently registered as a pesticide (herbicide) in the United States. The L-isomer is the herbicidally active part of D/L-glufosinate, and the D-isomer is herbicidally inactive. The L-isomer is referred to as L-glufosinate in this document and the supporting risk assessment documents and refers to the active moiety from both L-glufosinate ammonium and L-glufosinate acid, which are two forms of the L-isomer used in pesticide formulations. As mentioned above the Agency has received applications for both L-glufosinate ammonium and L-glufosinate acid. The International Organization for Standardization (ISO) has designated L-glufosinate ammonium as glufosinate-P-ammonium and L-glufosinate free acid as glufosinate-P, so EPA is establishing tolerances using that nomenclature; however, for consistency with EPA's supporting risk assessments, this document is using the terms L-glufosinate ammonium and L-glufosinate acid.

The available in vivo and in vitro data for comparison across L-glufosinate acid and L-glufosinate ammonium, and the in vitro and in vivo DNT data for D/L-glufosinate ammonium indicate no significant differences in oral toxicities for the most sensitive endpoint ( i.e., neurotoxicity). As such, these databases are being considered together when assessing toxicity and selecting endpoints for pertinent exposures. Hence both L-glufosinate ammonium and L-glufosinate acid are considered toxicologically equivalent for oral and dermal exposure pathways. Also, L-glufosinate ammonium, when dissolved in water, dissociates to L-glufosinate acid. Therefore, the Agency considers glufosinate-P ammonium and glufosinate-P as functionally similar.

The targets identified following oral exposure to L-glufosinate were the brain and peripheral nervous system (rats, mice, and dogs), kidney (rats and mice), thyroid (rats only), and the adrenals (mice only). Neurotoxicity was observed after acute, subchronic, and chronic exposures. Adverse findings included clinical signs indicative of neurotoxicity ( i.e., tremors, clonic convulsions, inability to maintain body posture, etc.), increased motor activity, alterations in brain weight, and neuropathology of the brain, eye, and spinal cord. Kidney toxicity manifested as increased kidney weights, alterations in urinalysis parameters, and hypertrophy of the proximal tubular cells of the pars recta. Slight thyroid c-cell hyperplasia was observed in male rats, while in mice, microscopic findings of the adrenal and increased adrenal weight were noted.

Increased quantitative susceptibility was observed in the L-glufosinate rat prenatal developmental toxicity study, the L-glufosinate range-finding developmental neurotoxicity (DNT) study, and the D/L-glufosinate DNT study.

L-glufosinate is classified as “ Not Likely to be Carcinogenic to Humans ” based on a lack of treatment-related tumor response in both the L-glufosinate rat and mouse carcinogenicity studies. There is a low concern for mutagenicity for L-glufosinate.

Specific information on the studies received and the nature of the adverse effects caused by L-glufosinate 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 https://www.regulations.gov in document “L-Glufosinate. Human Health Risk Assessment for New Active Ingredient Isomer” at 21-34 in docket ID number EPA-HQ-OPP-2020-0250.

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 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

For more detailed information on the toxicological endpoints for L-glufosinate used for human risk assessment can be found in the L-Glufosinate. Human Health Risk Assessment for New Active Ingredient Isomer in docket ID number EPA-HQ-OPP-2020-0250.

C. Exposure Assessment

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to L-glufosinate, EPA considered exposure to L-glufosinate under all tolerances established for racemic glufosinate as well as the petitioned-for tolerances in this rulemaking. EPA assessed dietary exposures from L-glufosinate 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.

Such effects were identified for L-glufosinate. In conducting the acute dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software with the Food and Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses the 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA conducted an unrefined acute dietary exposure assessment for L-glufosinate assuming tolerance-level residues for L-glufosinate (scaled by 0.5X for application rate adjustment) and 100% CT assumptions for all crops and livestock commodities. The proposed uses of L-glufosinate exactly match the established uses of D/L-glufosinate in terms of crops, number of applications, retreatment intervals, and preharvest intervals; the only difference being that the use rate for L-glufosinate is one-half that of D/L-glufosinate, consistent with herbicidal activity residing primarily in the L-isomer. Since the rate of L-glufosinate is one-half that of D/L-glufosinate, the expected residues for L-glufosinate are one-half those of D/L-glufosinate.

ii. Chronic exposure. The chronic dietary exposure assessment also uses the DEEM-FCID Version 3.16 software with the 2003-2008 NHANES/WWEIA data. As to residue levels in food, EPA conducted a partially refined chronic dietary exposure assessment using anticipated residues based on average field trial residue levels for plant commodities, average calculated residues for livestock commodities, all foods scaled by 0.5X for application rate adjustment, and 100% CT.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that L-glufosinate 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.

Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

The Agency is not using percent crop treated estimates for assessing acute and chronic exposures.

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for L-glufosinate in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of L-glufosinate. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.

Determination of the residues of concern for human health in drinking water included consideration of racemic glufosinate and the degradate, 3-methylphosphinico-propionic acid (MPP). Although the chronic EDWCs for MPP are approximately 2× higher than the EDWCs for the racemic glufosinate, EPA has determined that using the EDWCs for the racemic glufosinate will be protective of effects that might occur from exposure to the degradate. This conclusion is based on a comparison of the toxicity databases for glufosinate and MPP, which indicate that glufosinate is more than twice as potent as MPP. Because the toxic effects from glufosinate and MPP are significantly different, an aggregate assessment of glufosinate and MPP is not appropriate.

Based on the Pesticides in Water Calculator (PWC; version 1.52), the estimated drinking water concentrations (EDWCs) of D/L-glufosinate are estimated to be 201 parts per billion (ppb) for acute dietary exposures and 24.4 ppb for chronic dietary exposures. Surface water simulations resulted in the highest EDWCs.

These values reflect application of D/L-glufosinate and were scaled by half to reflect the reduced application rate and expected concentrations of L-glufosinate in water. The adjusted EDWCs were incorporated in the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) into the food categories “water, direct, all sources” and “water, indirect, all sources.”

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).

L-glufosinate is not being proposed for residential uses. However, there are residential exposures to L-glufosinate as a result of the existing residential uses of the racemic glufosinate. These exposures have been assessed for L-glufosinate and are included in a short-term aggregate assessment for L-glufosinate. For this assessment, the application rate was scaled by 0.5× to reflect residues of L-glufosinate only, and the application rate was converted to acid equivalents because the PODs are likewise expressed as acid equivalents. For currently registered uses of racemic glufosinate, residential handler and post-application dermal and inhalation risks are not of concern for L-glufosinate. The scenarios that are recommended to be considered for aggregate risk assessment are high-contact lawn activities for adults and children 1 to <2 years old and golfer activities for children 6 to <11 years old and children 11 to <16 years old.

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.”

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to L-glufosinate and any other substances and L-glufosinate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA has not assumed that L-glufosinate has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/pesticide-cumulative-risk-assessment-framework.

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 (10×) 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 FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10×, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. Increased quantitative susceptibility was observed in the L-glufosinate rat prenatal developmental toxicity study, the L-glufosinate range-finding DNT study, and the D/L-glufosinate DNT study. Quantitative susceptibility was observed in the developmental rat study in which decreased fetal body weight in both sexes was observed at the highest dose tested; however, no maternal toxicity was identified. Quantitative susceptibility was observed in a L-glufosinate dose-range finding DNT study in which maternal effects were not observed up to the highest dose tested while offspring toxicity manifested as decreased pup body weight and increased total and ambulatory motor activity counts in males. The D/L-glufosinate DNT study observed alterations in brain morphometrics (a decrease in the mean length of the ventral limb of the dentate hilus), an increase in motor activity, and a decrease in body weight for the offspring at a dose level that did not elicit maternal toxicity.

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 1× for all exposure scenarios for glufosinate-P. That decision is based on the following findings:

i. The toxicity database for L-glufosinate is complete, as a result of bridging data between the racemic glufosinate, L-glufosinate, and L-glufosinate ammonium databases.

ii. Evidence of neurotoxicity was observed in the L-glufosinate database in both adults and early life stages. However, the concern is low because all selected endpoints are based on, and protective of, the most sensitive neurotoxic effects in the database, as indicated by the following: (1) the 17% increase in motor activity observed in females in the 28-day range-finding subchronic rat study occurred at a dose level that is approximately 13×-80× higher than the selected PODs; (2) the decreased brain weight and vacuolation of the cerebrum in the chronic mouse study occurred at dose levels approximately 11×-67× higher than the selected PODs; (3) the neuropathology observed in the subchronic neurotoxicity study occurred at a dose level approximately 29×-174× higher than the selected PODs; (4) the increased total and ambulatory motor activity counts in the range-finding DNT study occurred at a dose level approximately 27× higher than the selected PODs; and (5) the brain morphometric changes and increased motor activity observed in the offspring in the D/L-glufosinate DNT occurred at a dose level approximately 42× higher than the selected PODs for all relevant exposure scenarios.

iii. As discussed in Unit III.D.2. above, increased quantitative susceptibility was observed in the L-glufosinate rat prenatal developmental toxicity study, the L-glufosinate range-finding DNT study, and the D/L-glufosinate ammonium DNT study. However, the concern for the increased susceptibility is low, as clear NOAELs have been identified for those studies and all selected PODs are protective of the effects seen in those studies.

iv. There are no residual uncertainties identified in the exposure databases.

The dietary food exposure assessments were performed based on 100% CT and conservative residue estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to L-glufosinate in drinking water. These assessments will not underestimate the exposure and risks posed by L-glufosinate.

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 aggregate 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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure to L-glufosinate from food and water will occupy 26% of the aPAD with the females 13 to 49 years old population subgroup. For all the other population subgroups, the most highly exposed population subgroup is all infants (<1 year old) at 4.7% of the aPAD.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to L-glufosinate from food and water will utilize 12% of the cPAD for children (1-2 years old), the population group receiving the highest exposure.

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). 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 1,100 for adults, 2,600 for children (11 to <16 years old), 1,700 for children (6 to <11 years old) and 230 for children (1 to <2 years old), which are above the LOC (100) and 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).

An intermediate-term adverse effect was identified; however, L-glufosinate is not registered for any use patterns that would result in intermediate-term residential exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD, no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for L-glufosinate.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, L-glufosinate 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 L-glufosinate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Two analytical methods have been validated by the Analytical Chemistry Branch (ACB) for enforcement of the currently established tolerances of D/L-glufosinate: (1) method HRAV-5A was validated by ACB for the determination of glufosinate and MPP in/on apple, grape, almond, soybean seed, corn grain, and corn forage and (2) method BK/01/99 was validated by ACB for determination of glufosinate, N-acetyl-glufosinate (NAG), and MPP in/on canola seed and sugar beet root.

Based on the results from the petition method validations (PMVs) and the ability of the methods to detect both the D- and L- isomers of glufosinate, EPA concludes that adequate enforcement methods are available for L-glufosinate.

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 not established a MRL for L-glufosinate.

C. Response to Comments

The Agency did receive one comment raising concerns that there are studies indicating that L-glufosinate is harmful and toxic to health of humans even in small doses. The commentor was also concerned over the use of L-glufosinate on corn, cotton and soybean which are staples of American diet. The commentor emphasized the role of EPA in reasonably assessing its analysis of pesticide tolerances, safety, and awareness of disproportionate effects of agricultural production, and its firm commitment to environmental justice.

Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the FFDCA authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that these glufosinate-P tolerances are safe. The commenter provided no information supporting a conclusion that glufosinate-P is not safe, nor did the commenter provide any basis for concluding that the tolerances would have a disproportionate effect on any population.

D. Revisions to Petitioned-For Tolerances

The Agency is establishing a tolerance for residues of glufosinate-P, including its metabolites and degradates, that result from applications of glufosinate-P or glufosinate-P-ammonium, with compliance to be determined by measuring the sum of glufosinate (2-amino-4-(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents. BASF Corporation had petitioned for expression of L-glufosinate-ammonium, glufosinate-P-ammonium [(2S)-2-amino-4-(hydroxymethylphosphinyl) butanoic acid -monoammonium salt] as measured by the sum of glufosinate (2-amino-4-(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid, and MITSUI Chemicals Crop & Life Solutions, Inc. had petitioned for expression of L-glufosinate free acid, (2S)-2-amino-4-[hydroxy(methyl)phosphinoyl]butyric acid, including its metabolites and degradates, 2-(acetylamino)-4-(hydroxymethylphosphinyl) butanoic acid (NAG), and 3-(hydroxymethylphosphinyl) propanoic acid (MPP), expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents. As discussed in Unit III.A, glufosinate-P-ammonium (also referred to as L-glufosinate ammonium) is the ammonium salt of glufosinate-P (also referred to as L-glufosinate acid). Since the glufosinate-P-ammonium breaks down into residues of glufosinate-P, EPA is establishing the tolerances for residues of glufosinate-P including its metabolites and degradates, that may result from applications of either form of glufosinate-P.

In addition, the petitioners have withdrawn their requests to establish tolerances on the following crops, so EPA is not establishing tolerances on those crops at this time: apple; beet, sugar, molasses; beet, sugar, roots; beet, sugar, tops (leaves); bushberry subgroup 13-07B; fruit, citrus, crop group 10-10; fruit, pome, crop group 11-10; fruit, stone, crop group 12-12; grape; nut, tree, crop group 14-12; olive; potato; potato, chips; and potato, granules/flakes.

Finally, EPA has applied its policy on OECD Rounding Classes to the petitioned-for tolerances to establish tolerances without trailing zeros after the decimal place.

V. Conclusion

Therefore, tolerances are established for residues of glufosinate-P including its metabolites and degradates in or on canola, meal at 1.1 parts per million (ppm); cattle, fat at 0.4 ppm; cattle, meat at 0.15 ppm; cattle, meat byproducts at 6 ppm; corn, field, forage at 4 ppm; corn, field, grain at 0.2 ppm; corn, field, stover at 6 ppm; corn, sweet, forage at 1.5 ppm; corn, sweet, kernels plus cob with husks removed at 0.3 ppm; corn, sweet, stover at 6 ppm; cotton, gin byproducts at 30 ppm; cotton, seed, subgroup 20C at 15 ppm; egg at 0.15 ppm; goat, fat at 0.4 ppm; goat, meat at 0.15 ppm; goat, meat byproducts at 6 ppm; grain aspirated fractions at 25 ppm; hog, fat at 0.4 ppm; hog, meat at 0.15 ppm; hog, meat byproducts at 6 ppm; horse, fat at 0.4 ppm; horse, meat at 0.15 ppm; horse, meat byproducts at 6 ppm; milk at 0.15 ppm; poultry, fat at 0.15 ppm; poultry, meat at 0.15 ppm; poultry, meat byproducts at 0.6 ppm; rapeseed, subgroup 20A at 0.4 ppm; sheep, fat at 0.4 ppm; sheep, meat at 0.15 ppm; sheep, meat byproducts at 6 ppm; soybean at 2 ppm; soybean, hulls at 10 ppm.

In addition, tolerances are established for indirect or inadvertent residues of glufosinate-P including its metabolites and degradates in or on barley, hay at 0.4 ppm; barley, straw at 0.4 ppm; buckwheat, fodder at 0.4 ppm; buckwheat, forage at 0.4 ppm; oat, forage at 0.4 ppm; oat, hay at 0.4 ppm; oat, straw at 0.4 ppm; rye, forage at 0.4 ppm; rye, straw at 0.4 ppm; teosinte at 0.4 ppm; triticale at 0.4 ppm; wheat, forage at 0.4 ppm; wheat, hay at 0.4ppm; and wheat, straw at 0.4 ppm.

VI. Statutory and Executive Order Reviews

This action 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 action has been exempted from review under Executive Order 12866, this action 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 action 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 tolerances 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 action 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (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 (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).

Therefore, for the reasons stated in the preamble, 40 CFR chapter I is amended as follows:

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

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

2. Revise and republish § 180.473 to read as follows:

(a) General. (1) Tolerances are established for residues of glufosinate, including its metabolites and degradates, in or on the commodities in table 1 to paragraph (a)(1). Compliance with the tolerance levels specified in table 1 to paragraph (a)(1) is to be determined by measuring the sum of glufosinate (2-amino-4-(hydroxymethylphosphinyl)butanoic acid) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents.