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 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-2011-0569 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 19, 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 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-2011-0569, 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 petition, EPA has determined that the proposed tolerance on rapeseed subgroup 20A, except gold of pleasure, forage is not necessary. Additionally, EPA has determined that several established tolerances should be removed. Finally, the Agency determined that the proposed tolerance on rapeseed subgroup 20A, except gold of pleasure, meal should be established as a tolerance on rapeseed, meal. 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 clopyralid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with clopyralid 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.
Clopyralid has low acute toxicity via the oral, dermal, and inhalation routes of exposure. It is not a dermal irritant or sensitizer, but it is a severe eye irritant in its acid form. No consistent mammalian target organ was identified in the clopyralid toxicological studies submitted to the Agency. Effects were noted in various organs and systems in different species, including increases in liver weight, changes in clinical chemistry and blood cell parameters, skin lesions, and decreases in body weight gain.
In subchronic mouse studies, decreased body weights were observed in males and females. Following chronic exposure, effects in dogs included reductions in red blood cell parameters, increased liver weight (males), and vacuolated adrenal cortical cells (females). Additionally, skin lesions and clinical chemistry changes (decreased serum glucose, protein, and albumin) were observed at the highest dose tested. In the rat, epithelial hyperplasia, thickening of the limiting ridge of the stomach, and decreased body weight were observed following chronic exposure. There were no clinical indications of neurotoxicity or immunotoxicity in the subchronic or chronic toxicity studies.
No developmental toxicity was observed in the rat at doses that caused maternal mortality and decreased body weight gains. In the rabbit developmental toxicity study, decreased fetal body weights and hydrocephalus were observed at a dose that caused severe maternal toxicity including a high rate of mortality, clinical signs of toxicity, decreased body weight gains, and gastric mucosal lesions. Reproductive toxicity was not observed in the rat, but mean pup weight reductions and relative liver weight increases were observed at doses that caused parental toxicity (decreased body weight/weight gain and food consumption and gastric lesions).
There was no evidence of carcinogenic potential in the rat and mouse 2-year carcinogenicity studies. Further, there were no positive findings for mutagenicity or clastogenicity observed in a battery of mutagenicity studies (including bacterial reverse gene mutation,
Specific information on the studies received and the nature of the adverse effects caused by clopyralid 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 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 clopyralid used for human risk assessment is shown in Table 1 of this unit. EPA notes that in the last final rule for clopyralid, published in the
Based on the First Index Reservoir Screening Tool (FIRST) model, the estimated drinking water concentration (EDWC) of clopyralid for chronic exposures is estimated to be 11.9 parts per billion (ppb) for surface water. The Agency also considered available monitoring data from the United States Geological Survey (USGS) National Water Quality Assessment Data Warehouse (
For chronic dietary risk assessment, the water concentration of value 11.9 ppb was used to assess the contribution to drinking water.
Clopyralid is currently registered for use on lawns, turf, and ornamentals in residential and public areas, which could result in residential exposures. EPA assessed residential exposure using the following assumptions: Short-term inhalation exposure for adult residential handlers and short-term postapplication exposure for children from incidental oral contact with treated turf (hand-to-mouth, object-to-mouth and soil ingestion). Although dermal exposure is anticipated from residential use of clopyralid, risks via the dermal route of exposure are not of concern for clopyralid; therefore, dermal risks were not quantitatively assessed for residential exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at
EPA has not found clopyralid to share a common mechanism of toxicity with any other substances, and clopyralid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that clopyralid 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 clopyralid is complete. EPA has waived the requirement of a 28-day inhalation toxicity study in rats (OCSPP Guideline 870.3465) based on the low volatility and low acute inhalation toxicity for clopyralid, as well as the selection of conservative and adequately protective points of departure from oral studies for clopyralid. As the 28-day inhalation toxicity study was not required, oral studies were considered for use with route-to-route extrapolation for the short-term adult handler inhalation exposure assessment. For short-term inhalation exposure, the maternal toxicity NOAEL of 75 mg/kg/day from the rat developmental toxicity study was selected based on mortality, decreased maternal body weight gain, and decreased food consumption at the LOAEL of 250 mg/kg/day. This study was chosen because it was of the appropriate duration and route, and it provided the most sensitive NOAEL. This endpoint is protective of potential pre- and postnatal toxicity because developmental toxicity in the rabbit was only seen in the presence of significant maternal toxicity (maternal/developmental NOAEL = 250 mg/kg/day), and developmental toxicity in the rat was not observed up to a maternally toxic dose. As such, it is considered to be a conservative endpoint for this exposure scenario.
ii. In the rabbit developmental toxicity study, neuropathology (hydrocephalus) was observed at the highest dose tested. However, the concern for this effect is considered low because it occurred at a dose that caused severe maternal toxicity, including a
iii. There is no evidence that clopyralid results in increased susceptibility in
iv. There are no residual uncertainties identified in the exposure databases. The chronic dietary food exposure assessment was 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 clopyralid in drinking water. EPA used similarly conservative assumptions to assess postapplication incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by clopyralid.
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 5,300 for the general population and 1,700 for children 1-2 years old. Because EPA's level of concern for clopyralid is a MOE of 100 or below, these MOEs are not of concern.
The following adequate enforcement methodology is available in
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 clopyralid in or on the commodities associated with these petitions.
Based on the data supporting the petitions, EPA has determined that the proposed tolerance on rapeseed subgroup 20A, except gold of pleasure, forage at 3.0 ppm is not necessary because the commodity is not a significant livestock feed item. Additionally, the Agency has determined that the established tolerances in or on crambe, seed; flax, seed; mustard, seed; and rapeseed, seed should be removed because they are superseded by inclusion in rapeseed, subgroup 20A, except gold of pleasure at 3.0 ppm. EPA is also removing the established tolerance on mustard greens, as it is superseded by inclusion in brassica, leafy greens, subgroup 5B. Finally, the Agency determined that the proposed tolerance on rapeseed subgroup 20A, except gold of pleasure, meal at 6.0 ppm should be established on rapeseed, meal at 6.0 ppm. The EPA may establish an individual tolerance on a processed commodity that is a member of rapeseed subgroup 20A. However, the Agency will not establish a subgroup tolerance for processed foods prepared from crops covered by a group tolerance, as outlined in 40 CFR 180.40, paragraph (f). Therefore, a separate tolerance for the processed commodity is appropriate.
Therefore, tolerances are established for residues of clopyralid, (3,6-dichloro-
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) (Public Law 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 the National Technology Transfer and Advancement Act of 1995 (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.
(a) * * *