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
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-2012-0009, by one of the following methods:
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Additionally, in the
Based upon review of the data supporting the petitions, EPA has revised the tolerances for several commodities. The reason for these changes is explained in Unit IV.D.
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 fluazinam including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with fluazinam 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.
Following subchronic and chronic exposure to fluazinam, the liver appeared to be a primary target organ in rats, dogs, and mice. Signs of liver toxicity included changes in clinical chemistry (increased serum alkaline phosphatase and aspartate aminotransferase), increased absolute and/or relative liver weights, increased incidences of gross lesions (pale, enlarged, pitted, mottled, accentuated markings), and a variety of histopathological lesions. Treatment-related effects were also observed in other organs following subchronic and chronic exposure to fluazinam, but these effects were not consistently noted in all three species or in all studies in a given species. In a subchronic inhalation toxicity study in rats, pulmonary effects were observed at the mid and high doses. These effects included dose-related increases in lung/bronchial weights and increased incidences of alveolar macrophages and peribronchiolar proliferation in both sexes.
In the developmental toxicity study in rabbits, treatment-related maternal effects (decreased food consumption and increased liver histopathology) were noted in the absence of fetal effects. In the 2-generation rat reproduction study, decreased pup weight gain was seen at the highest dose tested, in the presence of decreased food consumption and liver histopathology in parental animals. In a developmental toxicity study in rats, fetal effects included decreases in body and placental weights, increased incidences of facial/palate clefts, diaphragmatic hernias, delayed ossification in several bone types, increases in late resorptions, as well as evidence of a greenish amniotic fluid and post-implantation loss. Maternal effects, including decreases in body weight gain/food consumption and increases in water
In an acute neurotoxicity study in rats, effects included decreases in motor activity and soft stools; these effects were considered to be due to systemic toxicity and not a result of frank neurotoxicity. No signs of neurotoxicity were observed in two subchronic neurotoxicity studies in rat up to the highest dose tested. A neurotoxic lesion described as vacuolation of the white matter of the central nervous system was observed in subchronic and chronic studies in mice and dogs; however, this lesion was found to be reversible and is attributed to an impurity. Based on the level of this impurity in technical grade fluazinam, the risk assessment for the parent compound is considered protective of the effects noted. In an immunotoxicity study in mice, significant suppressions of anti-sheep red blood cell antibody-forming cell assay response were demonstrated at the highest dose tested.
In a rat carcinogenicity study, there was some evidence that fluazinam induced an increase in thyroid gland follicular cell tumors in male rats. There were statistically significant positive trends for thyroid gland follicular cell adenocarcinomas and combined follicular cell adenomas/adenocarcinomas. The incidences of thyroid gland adenomas seen at 100 ppm (3.8 mg/kg/day) and adenocarcinomas at 1,000 ppm were slightly outside their respective ranges for the historical controls. However, this increased incidence of thyroid tumors at 100 ppm was not observed in male rats in another chronic study. Further in the rat carcinogenicity study where these effects were seen, the animals in the lower dose groups were only microscopically examined for thyroid lesions if abnormalities were observed in that organ at gross necropsy and therefore, the incidences of thyroid tumors in the lower dose groups may have been somewhat misleading (too high). In one mouse carcinogenicity study, clear evidence of a treatment-related increase of hepatocellular tumors was observed in male mice; in another mouse carcinogenicity study, there was equivocal evidence that fluazinam may have induced an increase in hepatocellular tumors in male mice. There was no evidence of statistically significant tumor increases in female mice or rats in any study and no evidence of mutagenic activity in the submitted mutagenicity studies for fluazinam. EPA has classified fluazinam as having suggestive evidence of carcinogenicity. Due to the equivocal and inconsistent nature of the cancer response in the rat and mouse studies, the Agency determined that quantification of risk using a non-linear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to fluazinam.
Specific information on the studies received and the nature of the adverse effects caused by fluazinam 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 fluazinam used for human risk assessment is shown in Table 1 of this unit. To assess short-term dermal exposure, the dermal toxicity and dermal absorption studies were used to determine a refined dermal equivalent dose (RDD). To calculate a RDD,
Such effects were identified for fluazinam. In estimating acute dietary exposure, EPA used food consumption information from the 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, EPA utilized tolerance-level residues, 100 percent crop treated (PCT) for all commodities, and used DEEM default processing factors, when appropriate.
Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of fluazinam and its degradates for surface water are estimated to be 226 parts per billion (ppb) for acute exposures and 37.8 ppb for chronic exposures. For ground water, the EDWCs are estimated to be 0.404 ppb for both acute and chronic exposures.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The water concentration values of 226 ppb and 37.8 ppb were used to assess the contribution to drinking water in the acute and chronic dietary risk assessments, respectively.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
In the developmental toxicity study in rats, fetal effects (increased incidences of facial/palate clefts and other rare deformities in the fetuses) were observed in the presence of minimal maternal toxicity (decreased body weight gain and food consumption, and increased water consumption and urogenital staining). In the rat DNT study, decreases in body weight/body weight gain and a delay in completion of balano-preputial separation were observed in pups in the absence of maternal effects, suggesting increased quantitative susceptibility of the offspring.
i. The toxicity database for fluazinam is complete.
ii. There is no evidence that fluazinam results in increased susceptibility in
Additionally, while a DNT study in rat did not show evidence of neurotoxicity, the study showed evidence of increased quantitative susceptibility of offspring. Although the NOAEL for this study (2 mg/kg/day) is lower than that used for the aRfD for females 13-49 (7 mg/kg/day), the effects noted in the DNT study are considered to be postnatal effects attributable to multiple doses; therefore, the study endpoint is not appropriate for acute dietary exposures. The cRfD (0.011 mg/kg/day) is based on a lower NOAEL (1.1 mg/kg/day), and is considered to be protective of potential developmental effects. Therefore, the degree of concern is low for the observed effects and there are no residual uncertainties with regard to prenatal and/or postnatal neurotoxicity.
iii. There are no residual uncertainties identified in the exposure databases. The acute and chronic dietary food exposure assessments were performed based on 100 PCT for all commodities. Additionally, the acute assessment is based on tolerance-level residues for all commodities, and the chronic assessment is based on tolerance-level
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.
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 730 for children 6-<11 years old, 880 for youth 11-<16 years old, and 970 for adults. Because EPA's level of concern for fluazinam is a MOE of 100 or below, these MOEs are not of concern.
An adequate gas chromatography with electron capture detection (GC/ECD) method (6148-94-0170-MD-001) is available to enforce fluazinam tolerances on plant commodities. An adequate enforcement method for the determination of AMGT is also available. The method is a high performance liquid chromatography with ultraviolet detection (HPLC/UV) enforcement method entitled “Method Evaluation for the Analysis of AMGT in Grapes.”
The methods 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 a MRL for fluazinam on the commodities associated with this action.
EPA received several comments to the docket, EPA-HQ-OPP-2012-0009; however, only one of these public submissions was in response to the Notice of Filing for PP 1E7959, while the remaining comments pertained to unrelated petitions in the
Based on the data supporting the petitions, EPA revised the proposed tolerances on melon subgroup 9A from 0.08 ppm to 0.07 ppm; pepper/eggplant subgroup 8-10B from 0.10 ppm to 0.09 ppm; and soybean, hulls from 0.02 ppm to 0.05 ppm. The Agency revised these tolerance levels based on analysis of the residue field trial data using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures.
Therefore, tolerances are established for residues of fluazinam, (3-chloro-
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.