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. Potentially affected entities may include, but are not limited to those engaged in the following activities:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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
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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0593, by one of the following methods:
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 and use of the OECD tolerance calculation procedures, EPA has determined that a single tolerance to cover all of the commodities within each of the crop subgroups is appropriate versus individual tolerances for each of the commodities within the crop subgroups. In addition, EPA has determined that several of the proposed tolerances for wheat commodities, including wheat bran, flour, germ, middlings, and shorts, are not required. The reason 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 flumioxazin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flumioxazin follows.
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 summary of the toxicological findings are as follows:
Flumioxazin has mild or low acute toxicity when administered orally, dermally, or by inhalation. It is not an eye or skin irritant, or a dermal sensitizer. In general, the subchronic and chronic toxicity studies demonstrated that toxic effects associated with flumioxazin include anemia as well as effects on the liver and the cardiovascular system. Developmental effects were observed in developmental rat studies but not in developmental rabbit studies. Hematologic (hematopoietic) effects of anemia were noted in rats, consisting of alterations in hemoglobin parameters. Increased renal toxicity in male rats was also reported following chronic exposure. There is no evidence of neurotoxicity or immunotoxicity in the recently submitted guideline studies. Increased quantitative susceptibility was seen in the rat developmental toxicity studies. Fetal effects were observed in the absence of maternal toxicity. In addition, both increased qualitative and quantitative susceptibility were observed in the rat reproduction study. Severe fetal effects were observed at lower doses than milder parental effects. In most of the available mutagenicity studies, flumioxazin was negative for mutagenicity; however, aberrations were seen in a chromosomal aberration assay (CHO cells). Based on the lack of evidence of carcinogenicity in mice and rats, flumioxazin is classified as “not likely to be carcinogenic to humans.”
Specific information on the studies received and the nature of the adverse effects caused by flumioxazin as well as the no-observed-adverse-effect-level
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 (U/SF) 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 flumioxazin used for human risk assessment is shown in Table 1 of this unit.
Such effects were identified for flumioxazin. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed residues are present in all commodities at the tolerance level and that 100% of commodities with tolerances are treated with flumioxazin. In addition, EPA used default concentration factors to estimate residues of flumioxazin in processed commodities. Acute dietary exposure was only estimated for females 13-49 years old based on cardiovascular effects in fetuses observed in the oral developmental and supplemental pre-natal rat studies. An endpoint of concern was not established for acute dietary assessment of the general population.
Modeled estimates of drinking water concentrations, based on the estimated environmental concentrations (EECs) for flumioxazin and its major degradates (482-HA and APF) under the use as an aquatic herbicide, were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 400 parts per billion (ppb) was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 142 ppb was used to assess the contribution to drinking water.
i. The toxicity database for flumioxazin is largely complete with the exception of an inhalation developmental study, which was recently determined necessary, in order to better assess route-specific inhalation risks. In the absence of this study, a 10x FQPA safety factor to account for database uncertainty is needed to protect the safety of infants and children to assess risks for all inhalation exposure scenarios. The toxicity profile can be characterized for all effects, including potential developmental and reproductive toxicity, immunotoxicity and neurotoxicity with the current database.
ii. There is no indication that flumioxazin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. Although increased susceptibility was seen in the rat developmental and reproductive studies, EPA's concern for these effects is low, and there are no residual uncertainties for pre- and/or postnatal toxicity because: The developmental toxicity NOAELs/LOAELs are well characterized after oral and dermal exposure; the offspring toxicity NOAEL and LOAEL are well characterized in the reproduction study and; the Points of Departure (POD) for assessing risk to developing fetuses, infants, and children have been selected either from the developmental and reproductive toxicity studies from the chronic study which established a lower POD for chronic effects than the studies in pre- and postnatal animals. Thus, the regulatory endpoints for flumioxazin are protective of the increased susceptibility seen in the developmental and reproduction studies, and there are no residual concerns for these effects.
iv. There are no residual uncertainties identified in the exposure databases. Because the acute and chronic dietary exposure estimates were based on several conservative assumptions (100% of crops treated with residues present at tolerance levels, default processing factors and screening level drinking water estimates), EPA is confident that the dietary exposure assessments do not underestimate risk to the general U.S. population and various population subgroups. Similarly, EPA does not believe that the non-dietary residential exposures are underestimated because they are based on the conservative assumptions of EPA's Draft Standard Operating Procedures (SOPs) for Residential Exposure Assessments (December 1997), and updates contained in the Science Advisory Council Policy 12 (February 2001) as well as the uses specified in the proposed labels.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and 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.
Different methodologies were used for the presentation of short-term aggregate risk for adults and children. An aggregate risk estimate (ARI) approach was required to estimate short-term adult aggregate risk because there are different LOCs for adult dermal and inhalation exposures, 100 and 1,000, respectively. For short-term child aggregate risk, the combined MOE approach was used because the endpoint of concern (decreased pup weight) and the LOC are the same. 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 ARI of 1.15 for adults and aggregate MOE of 150 for children. Because EPA's LOC for flumioxazin is an ARI of 1 or below and a MOE of 100 or below, these aggregate risk estimates are not of concern.
Adequate enforcement methodology (gas chromatography/nitrogen-phosphorus detection (GC/NPD) method, Valent Method RM30-A-1) 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:
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. There are no MRLs established by Codex, Canada, or Mexico for any of the proposed commodities in the current registration actions.
EPA has revised the requested tolerances by adjusting the tolerance values, substituting crop group tolerances for individual tolerances, and dropping unnecessary tolerances. The tolerance levels were revised based on analysis of the field trial data using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures. EPA believes they differ from the petitioner's proposed tolerances for dried pea, rapeseed subgroup 20A, and wheat grain and straw due to the petitioner having possibly used the National Technology Transfer and Advancement Act of 1995 (NAFTA) tolerance calculation procedures as opposed to the OECD procedure. In addition, EPA is setting single tolerances for the crop subgroups (6C, 20A and 20B) versus individual tolerances for each commodity within the subgroups since maximum residues of the commodities within the crop subgroups differ by less than 5X. The proposed tolerances for wheat commodities (bran, flour, germ, middlings, and shorts) are also not necessary since they are covered by the tolerance being set for wheat grain.
Therefore, tolerances are established for residues of flumioxazin, 2-[7-fluoro-3,4-dihydro-3-oxo-4-(2-propynyl)-2 H -1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1 H -isoindole-1,3(2 H)-dione, including its metabolites and degradates, in or on the commodities as set forth in the regulatory text. Compliance with the tolerance levels specified below is to be determined by measuring only flumioxazin.
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) (Pub. L. 104-4).
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of NTTAA, Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
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 amendments read as follows:
(a) * * *