Daily Rules, Proposed Rules, and Notices of the Federal Government
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).
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
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-2009-0813 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 November 26, 2012. 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 CBI) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Based upon review of the data supporting the petition, EPA is: (1) Correcting certain crop definitions to comply with current Agency policies; (2) establishing tolerance levels for certain commodities other than the proposed levels; (3) removing the proposed tolerance for plum, prune, dried; (4) modifying the crop group tolerances requested to the revised and expanded citrus fruit group 10-10, pome fruit group 11-10 and stone fruit group 12-12; and 5) revising the tolerance expression for all established commodities to be consistent with current Agency policy. The reasons for these changes are explained in Unit IV. C.
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 glufosinate ammonium including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with glufosinate ammonium follows.
EPA has evaluated the available toxicity data and considered their 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.
Technical grade glufosinate ammonium has low toxicity in the oral, dermal, inhalation studies and is not an eye or dermal irritant or a dermal sensitizer.
Subchronic toxicity studies in rats showed inhibition of glutamate synthetase and lead the Agency to conclude that the changes in brain glutamine synthetase activity are of significant concern for possible neurotoxicity and/or expression of clinical signs. Observed alterations in liver and kidney glutamate synthetase are considered an adaptive response. The primary effects in the mouse subchronic study were increased liver and kidney weights with increases in serum aspartate amino transferase and alkaline phosphatase.
Additional toxicity testing was conducted with the L-isomer of glufosinate ammonium, and degradates glufosinate propanoic acid (MPP), and 2-acetamido-4-methylphosphinico-butanoic acid (NAG). These compounds, tested in subchronic rat, mouse, and dog studies, and in developmental toxicity studies in rat and rabbit, are generally less toxic than the parent compound. However, L-isomer of glufosinate ammonium was found to be slightly more toxic than the racemic parent compound. This finding is not concern since this isomer is included in the toxicity testing of the parent compound at the levels in the technical material.
In chronic studies in the rat, inhibition of brain glutamine synthetase, increased mortality, and increased occurrence of retinal atrophy were noted, as were increased liver and kidney weights. In the mouse, increased mortality was noted, as were changes in glucose levels consistent with changes in glutathione levels. Increased mortality and electrocardiogram alterations were observed in dogs. The developmental toxicity study in the rat produced dilated renal pelvis and/or hydroureter in the fetuses at levels that produced significant increases in hyperactivity and vaginal bleeding in dams. In the rabbit, decreased fetal body weight and increased mortality were observed at 20 milligrams/kilogram/day (mg/kg/day), while in rabbit dams, decreased food consumption, body weight, and body weight gain were observed at 20 mg/kg/day. Since increased fetal mortality was observed in the presence of less severe maternal
The reproductive toxicity study in rats indicated postnatal developmental toxicity at the highest dose tested in the form of decrease in viable pups. No parental toxicity was seen at the highest dose tested. Since pup mortality was observed in the absence of parental toxicity, there is evidence of
There were indications of neurotoxicity in several studies. Of particular concern is that the developmental neurotoxicity study demonstrated alterations in brain morphometrics in the adult offspring exposed
There is no concern for immunotoxicity based on an adequate database.
There is no concern for mutagenic activity in several available studies including: Salmonella E. Coli,
Glufosinate ammonium was classified as “not likely to be a human carcinogen.” There was no evidence of a treatment-related increase in tumors in either rats or mice.
Specific information on the studies received and the nature of the adverse effects caused by glufosinate ammonium 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
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
A summary of the toxicological endpoints for glufosinate ammonium used for human risk assessment is shown in the following Table.
Such effects were identified for glufosinate ammonium for females 13 through 50 years old. In estimating acute dietary exposure assessment of glufosinate ammonium, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database DEEM-FCID
As to residue levels in food, EPA assumed tolerance level residues for all established and recommended tolerances along with default processing factors, and 100 percent crop treated (PCT) assumptions.
As to residue levels in food, EPA used anticipated residues based on average residue levels from field trial studies. The DEEM default processing factors were used for all commodities except apple juice, pear juice, grape juice, and raisins, for which factors derived from the processing studies were used in the assessment. One hundred percent crop treated values were used for all proposed new uses and some registered uses. Average PCT estimates were used in the chronic dietary analysis for crops that are currently registered for glufosinate ammonium if available.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:
• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.
• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.
• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.
The Agency estimated the average PCT for existing uses as follows: Almond: 15%; blueberry: 5%; field corn, 5%; grape, 15%; pecan, 1%; potato, 10%; soybean, 1%; walnut, 10%; canola, 25%; cotton, 5%; filbert, 10%; pistachio, 20%; and rice, 1%.
In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data
The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which glufosinate ammonium may be applied in a particular area.
Environmental fate studies indicate glufosinate ammonium is relatively stable and is very mobile. The main degradation pathway in water and soil is via microbial action, metabolizing primarily to CO
Previous analyses for glufosinate ammonium demonstrated that the maximum acute and chronic EDWCs result from surface water estimates arising from the rice use; the surface water values for rice are nearly an order of magnitude higher than any surface or ground water values for any other use of glufosinate ammonium. Therefore, a comprehensive refinement of the drinking water assessment for the rice use of glufosinate ammonium, should be protective of other uses.
The Agency estimated acute EDWCs for glufosinate ammonium and MPP using the Tier I Rice Model and Pesticide Flooded Application Model (PFAM) [version 0.70] without the index reservoir. To estimate chronic EDWCs, the acute concentrations from PFAM without the index reservoir were assumed to degrade over a 365-day period, using aerobic aquatic degradation half-lives; thus allowing calculation of average concentrations over a one-year period. This method results in chronic values approximately 76% and 3% lower than the acute values for glufosinate-ammonium and MPP, respectively.
The EDWCs for surface water are expected to be 390 parts per billion (ppb) for glufosinate and 183 ppb for MPP for acute exposures. The EDWCs for surface water are expected to be 95 ppb for glufosinate and 177 ppb for MPP for chronic exposures. The maximum chronic EDWC for rice for MPP is approximately 2X higher than the corresponding value for glufosinate: 177 and 95 ppb, respectively. Since MPP is considered less toxic than the parent compound and should not be aggregated with the parent, EPA concluded that if the EDWCs for MPP are not significantly greater than those for glufosinate, the risk assessment for the parent will be protective of any toxicity associated with exposure to MPP in drinking water. Given the estimated EDWCs for MPP concentrations are not likely to be more than twice the corresponding levels of glufosinate in drinking water, EPA concluded a quantitative risk assessment for MPP in drinking water is not needed. Accordingly, for purposes of acute and chronic dietary analyses, the recommended glufosinate EDWCs are 390 and 95 ppb, respectively.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 390 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 95 ppb was used to assess the contribution to drinking water.
Residential handler exposure is expected to be short-term. Intermediate-term exposures are not likely because of the intermittent nature of applications by homeowners. Dermal and inhalation exposures are possible for applications from mixing/loading/applying liquids with a hose-end sprayer, a backpack sprayer, and a sprinkler can and applications for manually pressurized handgun. However, only the dermal route of exposure was included in the aggregate analysis since potential dermal risks are higher than potential inhalation risks and the EPA determined it is not appropriate to aggregate the dermal and inhalation exposures since the toxicity endpoints are different.
The Agency did not quantify post-application exposures. Post-application exposure is expected to be minimal. Any exposure to children via incidental non-dietary ingestion (i.e., hand-to-mouth, object-to-mouth (turfgrass), and soil ingestion) after application to treated turf is expected to be low since
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
EPA has not found glufosinate ammonium to share a common mechanism of toxicity with any other substances, and glufosinate ammonium does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that glufosinate ammonium 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
Since increased fetal mortality was observed in the presence of less significant maternal toxicity in the rabbit developmental study, there is evidence of
i. Although all required studies for glufosinate ammonium have been submitted, the glufosinate ammonium database has a completeness issue in that the developmental neurotoxicity and the 28-day inhalation studies used for risk assessment did not demonstrate NOAELs, and LOAELs were used as endpoints. Therefore, the 10X FQPA safety factor was retained for use of a LOAEL to extrapolate a NOAEL. EPA has reduced the 10X safety factor when relying on a LOAEL in circumstances that suggest that the LOAEL is approaching a NOAEL (
ii. Although there were indications of neurotoxicity in several studies, the PODs and safety factors chosen for risk assessment are protective for these effects. The developmental neurotoxicity study showed altered brain morphometrics at the LOAEL, and this study is used in the weight-of-the evidence decision-making process for selection of an endpoint. Applying the 10X FQPA Safety Factor for the LOAEL to NOAEL extrapolation, as well as the 10X inter- and intra-species uncertainty factors, to this LOAEL will be protective against possible neurotoxicity as indicated in the laboratory animal studies.
iii. Although there is evidence that glufosinate ammonium results in increased qualitative or quantitative susceptibility in the developmental neurotoxicity study (rats), a prenatal developmental study (rabbits), and in the 2-generation reproduction study (rats), the PODs selected for risk assessment are protective for these effects because they are either based on clear NOAELs for the effects in young animals or they are based on a LOAEL adjusted by a 10X safety factor to account for the lack of a NOAEL in that study.
iv. There are no residual uncertainties identified in the exposure databases. The acute dietary food exposure assessment was performed based on 100 PCT and tolerance-level residues. The chronic dietary exposure analysis was performed using anticipated residues from field trial data, processing factors, and PCT information. With limited monitoring data available, upper-bound assumptions were used to determine exposure through drinking water sources. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to glufosinate ammonium in drinking water. These assessments will not underestimate the exposure and risks posed by glufosinate ammonium.
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.
Glufosinate ammonium 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 glufosinate ammonium.
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 1,800 for the general population for mixer/loader/applicators. Because EPA's level of concern for glufosinate ammonium is an MOE of 1,000 or below, these MOEs are not of concern.
An intermediate-term adverse effect was identified; however, glufosinate ammonium is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for glufosinate ammonium.
Two analytical methods have been validated by EPA for enforcement of the currently established tolerances: (1) Method HRAV-5A for the determination of glufosinate ammonium and glufosinate propanoic acid in/on apple, grape, almond, soybean seed, corn grain, and corn forage, and (2) Method BK/01/99 for determination of glufosinate ammonium,
Based on the similarity in the two methods and the results from the petition method validations (PMVs), EPA concludes that method BK/01/99 is a suitable method for enforcement of sweet corn, stone fruit, pome fruit, citrus fruit, and olive tolerances.
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:
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 MRLs for glufosinate ammonium in or on olives and sweet corn commodities. However, for glufosinate ammonium in or on citrus fruit, pome fruit, and stone fruit, Codex has set MRLs of 0.1, 0.05, and 0.05 ppm, respectively. EPA is establishing tolerances in this action for citrus fruit, pome fruit, and stone fruit, at 0.15, 0.25, and 0.25 ppm, respectively. EPA cannot harmonize these tolerance values with the Codex MRLs because the lower MRLs could be exceeded with the uses petitioned-for in this action.
EPA modified/revised certain IR-4 proposed tolerances for glufosinate ammonium residues. Higher tolerance levels were established for citrus, pome fruit, stone fruit, and olives because EPA concluded that it was appropriate to sum the full level of quantification (LOQ) for each of the three residues of concern in situations where < LOQ residue levels were found. Sweet corn tolerances were amended based on results from the Organization for Economic Co-operation and Development (OECD) tolerance calculation procedures the corn, sweet, K+CWHR tolerance proposed at 0.2 ppm will be established at 0.30 ppm, corn, sweet, forage tolerance proposed at 4.0 ppm will be established at 1.5 ppm. A separate prune tolerance was established as residues in this processed commodity are covered by the stone fruit group tolerance.
Additionally, EPA was petitioned for tolerances on citrus fruit group 10, pome fruit group 11, and stone fruit group 12. In the
Finally, EPA has revised the tolerance expression to clarify (1) that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of glufosinate ammonium not specifically mentioned; and (2) that compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.
Therefore, tolerances are established for residues of glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl) monoammonium salt) and its metabolites, 2-(acetylamino)-4-(hydroxymethyl phosphinyl) butanoic acid, and 3-(hydroxymethylphosphinyl) propanoic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents in or on 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; fruit, citrus, group 10-10 at 0.15 ppm; fruit, pome, group 11-10 at 0.25 ppm; fruit, stone, group 12-12 at 0.25 ppm; and olive at 0.15 ppm.
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
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
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
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).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
The revised and added text reads as follows: