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-2011-0906 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 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-2011-0906, by one of the following methods:
Based upon review of the data supporting the petition, EPA has revised the proposed tolerance levels for several commodities. The Agency has also determined that the time-limited tolerance on basil, fresh should be
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 cyazofamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyazofamid 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.
Cyazofamid has a low order of acute toxicity via the oral, dermal, and inhalation routes of exposure. It produces minimal but reversible eye irritation, is a slight dermal irritant, and is a weak dermal sensitizer. In subchronic toxicity studies in rats, the kidney appeared to be the primary target organ, with kidney effects including an increased number of basophilic kidney tubules and mild increases in urinary volume, pH, and protein. However, no adverse kidney effects were noted in chronic toxicity studies in rats. There were no toxicity findings up to the limit dose in a subchronic toxicity study in dogs; in the chronic dog toxicity study, increased cysts in parathyroids were observed in males at the limit dose for chronic toxicity testing.
There were no maternal or developmental effects observed in the prenatal developmental toxicity study in rabbits and no maternal, reproductive, or offspring effects in the 2-generation reproductive toxicity study in rats. There was evidence of increased susceptibility following
There was no evidence of neurotoxicity or evidence of biologically relevant structural effects on the immune system in any study in the exposure database for cyazofamid. Skin lesions, which may be due to a systemic allergy, were observed in male mice in a carcinogenicity study. There was no evidence of carcinogenicity in the rat or mouse carcinogenicity studies and no evidence that cyazofamid is mutagenic in several
Specific information on the studies received and the nature of the adverse effects caused by cyazofamid 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 cyazofamid used for human risk assessment is shown in Table 1 of this unit. EPA notes that the last final rule for cyazofamid, published in the
In estimating acute dietary exposure for females 13 to 49 years old, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994 to 1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed tolerance-level residues, DEEM
The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for cyazofamid and its degradates in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of cyazofamid and its degradates. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) model for surface water and the Screening Concentration in Ground Water (SCI-GROW) model for ground water, the estimated drinking water concentrations (EDWCs) of CTCA for acute exposures are estimated to be 136 parts per billion (ppb) for surface water and 2.18 ppb for ground water. Chronic exposures for noncancer assessments are estimated to be 133 ppb for surface water and 2.18 ppb for ground water.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 136 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 133 ppb was used to assess the contribution to drinking water.
Cyazofamid is currently registered for use on turf at golf courses, sod farms, seed farms, college and professional sports fields, residential and commercial lawns, and on ornamental plants in landscapes and those grown in commercial greenhouses and nurseries. EPA assessed residential exposure using the following assumptions: For adult handlers, short-term dermal and inhalation exposures from mixing, loading, and applying cyazofamid in residential areas; for adults, short-term postapplication dermal exposure from contact with treated turf and ornamentals; and for children, short-term postapplication incidental oral exposure to treated turf, including hand-to-mouth activity, object-to-mouth activity, and soil ingestion. No POD was identified for dermal exposures to treated turf for children, since no toxicity was seen in the 28-day dermal toxicity study at the highest dose tested (1,000 milligrams/kilograms/day (mg/kg/day)); therefore, dermal postapplication exposure scenarios were not assessed for children. Based on the residential use profile, adult handler and adult and child postapplication exposures to cyazofamid are expected to be short-term only. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
EPA has not found cyazofamid to share a common mechanism of toxicity with any other substances, and cyazofamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyazofamid 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 cyazofamid is complete except for immunotoxicity and subchronic neurotoxicity testing. Recent changes to 40 CFR part 158 imposed new data requirements for immunotoxicity testing (OCSPP Test Guideline 870.7800) and subchronic neurotoxicity testing (OCSPP Test Guideline 870.6200) for pesticide registration. However, the available data for cyazofamid do not show potential for immunotoxicity. Further, there is no evidence of neurotoxicity in any study in the toxicity database for cyazofamid. EPA does not believe that conducting neurotoxicity and immunotoxicity studies will result in a NOAEL lower than the regulatory dose for risk assessment. Consequently, the EPA believes the existing data are sufficient for endpoint selection for exposure/risk assessment scenarios and for evaluation
ii. There is no indication that cyazofamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.
iii. Although there is evidence of increased quantitative susceptibility in the prenatal developmental study in rats, the Agency determined that concern is low because the developmental effect (increased bent ribs) is well identified with a clear NOAEL and LOAEL. In addition, other considerations indicating a low concern include the following: Increased bent ribs are considered a reversible variation rather than a malformation; the effect was noted only at the limit dose of 1,000 mg/kg/day and this endpoint was used to establish the RfD for females 13-49; and the overall toxicity profile indicates that cyazofamid is not a very toxic compound. Therefore, there are no residual concerns regarding developmental effects in the young.
iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to cyazofamid in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by cyazofamid.
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 2,200 for children 1-2 years old and 390 for adults. Because EPA's level of concern for cyazofamid is a MOE of 100 or below, these MOEs are not of concern.
An adequate analytical methodology is available to enforce the proposed tolerances. Cyazofamid and the metabolite CCIM are completely recovered (>80% recovery) using the Food and Drug Administration's (FDA) Multi-Residue Protocol D (without cleanup). In addition, a high performance liquid chromatography/ultraviolet detector (HPLC/UV) method is available for use as a single analyte confirmatory method.
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 a MRL for cyazofamid.
EPA received comments from a private citizen to the notice of filing for cyazofamid, PP# 1E7929, objecting to the establishment of tolerances associated with the petition. In addition, the commenter noted several adverse effects seen in animal toxicology studies
EPA has found, however, that there is a reasonable certainty of no harm to humans after considering these toxicological studies and the exposure levels of humans to cyazofamid. The Agency understands the commenter's concerns and recognizes that some individuals believe that certain pesticide chemicals should not be permitted in our food. However, the existing legal framework provided by FFDCA section 408 states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.
Based on the data supporting the petition, EPA revised the proposed tolerances on several commodities, as follows: Basil, dried leaves from 80 ppm to 90 ppm; bean, succulent from 0.4 ppm to 0.5 ppm; bean, succulent shelled from 0.07 ppm to 0.08 ppm; leafy greens subgroup 4A from 9.0 ppm to 10 ppm; and vegetable, fruiting, group 8-10 from 0.40 ppm to 0.9 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. Additionally, the Agency has determined that the time-limited tolerance on basil, fresh at 12 ppm should be removed, as it will be superseded by the permanent tolerance on basil, fresh leaves.
Therefore, tolerances are established for residues of cyazofamid, 4-chloro-2-cyano-
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 additions read as follows:
(a) * * *