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-2011-0985 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 January 14, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0985, by one of the following methods:
Based upon review of the data supporting the petition and/or current Agency policies, EPA has revised/modified the petitioned-for flonicamid residue tolerance level in certain commodities and revised the tolerance expression for flonicamid residues. EPA is also revising the existing crop group tolerance on “Vegetable, cucurbit, group 9” to exclude cucumbers. 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 flonicamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flonicamid 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
Flonicamid has low acute toxicity via the oral, inhalation and dermal routes of exposure. Flonicamid is nonirritating to the eye and skin and is not a dermal sensitizer. Its metabolites, TFNA, TFNA-AM, TFNG, TFNG-AM, and TFNA-OH, also demonstrated low toxicity in acute oral toxicity studies. In the 28-day dermal study with flonicamid technical no dermal or systemic toxicity was seen at the limit dose. In oral studies using rats and dogs, the kidney and liver are the target organs for flonicamid toxicity. Increased kidney weight and hyaline droplet deposition were observed as well as liver centrilobular hypertrophy in the rat 28-day oral range-finding, 90-day oral, developmental, and reproductive studies. The 90-day dog study showed kidney tubular vacuolation as well as increased adrenal weights, increased reticulocytes and decreased thymus weights. Increased reticulocyte count was noted in both the subchronic and chronic dog studies.
In rats, developmental effects including increased incidence of cervical ribs were observed at maternally toxic (liver and kidney gross and histopathological effects) dose levels. In rabbits, developmental effects were not observed at any dose level including maternally toxic doses. Offspring effects (decreased body weight and delayed sexual maturation) in the multi-generation study were seen only in the presence of parental toxicity (kidney effects in males, blood effects in females). Thus, there is no evidence that flonicamid results in increased susceptibility (qualitative or quantitative) in
There are no concerns for flonicamid neurotoxicity. Although clinical signs suggesting potential neurotoxic effects (e.g., decreased motor activity, tremors) were seen in the acute and subchronic neurotoxicity studies; other effects in these studies (e.g., increased mortality, and significant decreases in food consumption and body weight) indicated that the clinical signs were a result of the animals being in an extreme condition or otherwise compromised and in a state of general malaise. Also, these types of effects were not observed in the other subchronic or chronic studies in mice, rats or dogs. Thus, there is not clear evidence of neurotoxicity. Lastly, clear no-observed-adverse-effect-levels (NOAELs) and lowest-observed-adverse-effect-levels (LOAELs) were defined for the clinical signs, which are above the levels currently used for risk assessment purposes. Preliminary results of a 28-day oral (dietary) immunotoxicity study of technical flonicamid in female CD-1 mice suggest that flonicamid is not an immuno-suppressant, either structurally or functionally up to and including dose levels exceeding the Limit Dose.
Although there is some limited evidence suggesting that flonicamid has apotential for carcinogenic effects, EPA determined that quantification of risk using a non-linear approach (i.e., using a chronic reference dose (cRfD)) adequately accounts for all chronic toxicity, including carcinogenicity that could result from exposure to flonicamid. The following considerations support that determination. First, mutagenicity studies were negative for the parent chemical, flonicamid, and its metabolites, TFNA, TFNA-AM, TFNG, TFNG-AM, and TFNA-OH. Second, although flonicamid is carcinogenic in CD-1 mice, based on increased incidences of lung tumors associated with Clara cell activation, this tumor type is associated with species and strain sensitivity and is not directly correlated with cancer risks in humans. Third, nasal cavity tumors seen in male Wistar rats were linked to incisor inflammation and not considered to be treatment related. These tumor findings were confounded by the lack of a dose-response and the biological significance is questionable.
Specific information on the studies received and the nature of the adverse effects caused by flonicamid as well as the NOAEL and the 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 flonicamid used for human risk assessment is shown in Table 1 of this unit.
iv. Anticipated residue and
The drinking water assessment was conducted using a parent only and total toxic residues of flonicamid (flonicamid TTR) approach. Total toxic residues include TFNA, TFNA-AM, TFNA-OH, TFNG, and TFNG-AM.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of total toxic residues of flonicamid for chronic exposures for non-cancer assessments are estimated to be 1.9 parts per billion (ppb) for surface water and 0.00132 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 1.9 ppb was used to assess the contribution to drinking water.
Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
EPA has not found flonicamid to share a common mechanism of toxicity with any other substances, and flonicamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that flonicamid 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
i. The toxicity database for flonicamid is complete except for an immunotoxicity study and a subchronic inhalation study. Existing data are sufficient for endpoint selection for exposure/risk assessment scenarios, and for evaluation of the requirements under the FQPA. Except for decreased thymus weights in the subchronic dog study,there are no other indications in the available studies that organs associated with immune function are affected by flonicamid, and preliminary results of the above-mentioned immunotoxicity study suggested that flonicamid is not an immunosuppressant. EPA does not believe that the final results of the immunotoxicity study will result in a dose less than the point of departure already used in this risk assessment and an additional database uncertainty factor for potential immunotoxicity does not need to be applied.
A subchronic 28-day inhalation study is required and is outstanding at this time. In the absence of a route specific inhalation study, EPA has retained a 10X FQPA SF to assess risks for inhalation exposure scenarios. However, residential inhalation exposures are not expected.
ii. The available data base includes acute and subchronic neurotoxicity studies. As discussed in Unit III.A., EPA has concluded that the clinical signs observed in those studies were not the result of a neurotoxic mechanism and that therefore a developmental neurotoxicity study is not required.
iii. There was no evidence for quantitative or qualitative susceptibility following oral exposures to rats
iv. There are no residual uncertainties identified in the exposure databases. An unrefined conservative chronic dietary exposure assessment for food and drinking water was conducted, assuming tolerance level residues for all existing and proposed commodities and 100 PCT of registered and proposed crops treated. The drinking water assessment utilized water concentration values generated by models and associated modeling parameters which are designed to produce conservative, health protective, high-end estimates of water concentrations which are not likely to be exceeded. The dietary (food and drinking water) exposure assessment does not underestimate the potential exposure for infants, children, or women of child bearing age.
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.
Adequate enforcement methods are available to enforce the tolerances for flonicamid and the major metabolites in plants and livestock. The proposed method for plants uses Liquid Chromatography with Tandem Mass Spectrometry (LC/MS/MS) (FMC No. P-3561M) to determine the residues of flonicamid and its major metabolites, TFNA-AM, TFNA, and TFNG.
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
There are no Codex MRLs established on the proposed crops.
Based on results from the Organization for Economic Cooperation and Development (OECD) spreadsheet tolerance calculation procedures, EPA modified certain IR-4 proposed tolerances for flonicamid residues. EPA increased the proposed tolerance from 1.4 to 1.5 ppm for Berry, low growing, subgroup 13-07G and from 1.3 to1.5 ppm for cucumber. Because there is an existing crop group tolerance for “Vegetable, cucurbit, group 9” that applies to cucumbers, EPA, for the sake of clarity, is revising that existing crop group tolerance to exclude cucumbers.
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 flonicamid 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 the residues of flonicamid,
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 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
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 added and revised text read as follows:
(a) * * * (1) Tolerances are established for the residues of the insecticide flonicamid, including its metabolites and degradates, in or on the commodities in thetable below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of flonicamid,
(2) Tolerances are established for the residues of the insecticide flonicamid, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of flonicamid,