Clopyralid; Pesticide Tolerances
Federal Register, Volume 83 Issue 100 (Wednesday, May 23, 2018)
Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)
Rules and Regulations
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2018-10693
ENVIRONMENTAL PROTECTION AGENCY
Clopyralid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of clopyralid in or on multiple commodities which are identified and discussed later in this document. In addition, it removes certain previously established tolerances that are superseded by this final rule. Interregional Research Project Number 4 (IR-4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May 23, 2018. Objections and requests for hearings must be received on or before July 23, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0035, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: email protected.
Does this action apply to me?
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).
How can I get electronic access to other related information?
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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
How can I file an objection or hearing request?
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-2017-0035 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 July 23, 2018. 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-2017-0035, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
Summary of Petitioned-For Tolerance
In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9961-
14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8528) by IR-4 Project Headquarters, 500 College Road East, Suite 201W, Princeton, New Jersey 08540. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the herbicide, clopyralid, (3,6-dichloro-2-pyridinecarboxylic acid), in or on berry, low growing, subgroup 13-07G at 4.0 parts per million (ppm); berry, low growing, except strawberry, subgroup 13-07H at 4.0 ppm; brassica, leafy greens, subgroup 4-16B at 5.0 ppm; fruit, pome, group 11-10 at 0.05 ppm; fruit, stone, group 12-12 at 0.5 ppm; radish, roots at 0.3 ppm; stalk and stem vegetable subgroup 22A at 1.0 ppm; vegetable, brassica, head and stem, group 5-16 at 2.0 ppm; and vegetable, leaves of root and tuber, group 2 at 5.0 ppm. Additionally, upon establishment of the above new tolerances, the petitioner requests to amend 40 CFR 180.431 by removing the established tolerances for clopyralid in or on apple at 0.05 ppm, asparagus at 1.0 ppm, beet, garden, tops at 3.0 ppm, beet, sugar, tops at 3.0 ppm, brassica, head and stem, subgroup 5A at 2.0 ppm, brassica, leafy greens, subgroup 5B at 5.0 ppm, canola, seed at 3.0 ppm, cranberry at 4.0 ppm, fruit, stone, group 12 at 0.5 ppm, strawberry at 4.0 ppm, and turnip, greens at 4.0 ppm. That document referenced a summary of the petition prepared by Dow AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to that comment is discussed in Unit IV.C.
Consistent with the authority in FFDCA 408(d)(4)(A)(i), EPA is issuing tolerances that vary from what the petitioner sought. The reasons for these changes are explained in Unit IV.D.
Aggregate Risk Assessment and Determination of Safety
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 their 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 dermal, oral, and inhalation routes of exposure. It is not a dermal irritant or sensitizer, but it is a severe eye irritant in its acid form.
Toxicity was observed in the mouse after subchronic and chronic exposure and the rat and dog after chronic exposure, but consistent target organs were not identified. In dogs, reductions in red blood cell parameters, increased liver weight, and vacuolated adrenal cortical cells were observed, with skin lesions and clinical chemistry changes at the highest dose. In rats, stomach lesions were observed at the lowest-observed-adverse-effects level (LOAEL), and decreased body weight was observed at the high dose. In mice, the only observed effects were decreased body weight/body weight gain. No systemic toxicity was seen in a rabbit 21-day dermal toxicity study. The available toxicology studies did not indicate the potential for neurotoxicity, immunotoxicity or reproductive toxicity.
The available database does not show evidence of increased qualitative or quantitative pre- and/or post-natal susceptibility in the available developmental or 2-generation reproduction toxicity studies. No developmental toxicity was observed in the rat at doses that caused maternal mortality. In the developmental study in the rabbit, decreased fetal body weight and hydrocephalus were observed, but only at a dose that caused significant maternal toxicity, including mortality, clinical signs of toxicity, and gastric mucosal lesions. Reproductive toxicity was not observed in the rat, but mean pup weights (day 28) were reduced, and relative pup liver weights were increased at doses that caused parental toxicity (decreased body weight/weight gain and food consumption; gastric lesions).
There were no direct clinical or histopathological indications of neurotoxicity in the available studies at doses up to or exceeding the limit dose. Hydrocephalus was observed in the young in the rabbit developmental study, but only in the presence of significant maternal toxicity, including a high rate of mortality.
Clopyralid is classified as ``not likely to be carcinogenic to humans,'' based on the lack of treatment-related tumors in the rat and mouse carcinogenicity studies, and negative results of the genotoxicity assays.
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 (NOAEL) and LOAEL from the toxicity studies can be found at http://www.regulations.gov in document SUBJECT: Clopyralid. Aggregate Human Health Risk Assessment to Support Proposed New Uses on Pome Fruit Group 11-10 and Radish Roots, Along with Various Crop Group/
Subgroup Conversions and Expansions at pages 31-35 in docket ID number EPA-HQ-OPP-2017-0035.
Toxicological Points of Departure/Levels of Concern
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 the NOAEL and the LOAEL are identified. 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for clopyralid used for human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Clopyralid for Use in Human Health Risk Assessment
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
Chronic dietary (All populations) NOAEL= 15 mg/kg/day Chronic RfD = 0.15 mg/ 2-Year Combined Chronic
UFA = 10x.............. kg/day. Toxicity-
UFH = 10x.............. cPAD = 0.15 mg/kg/day.. Carcinogenicity
FQPA SF = 1x........... (oral)--rat.
LOAEL = 150 mg/kg/day,
based on increased
and thickening of the
limiting ridge of the
stomach in both sexes.
Incidental oral short-term (1 to 30 NOAEL= 75 mg/kg/day.... Residential LOC for MOE Developmental Toxicity
days). UFA = 10x.............. = email protected.
International Residue Limits
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 MRLs for clopyralid residues on any commodities for which tolerances are established in this rule.
Response to Comments
One comment to the Notice of Filing was received from an anonymous commenter that stated, in part, that no clopyralid (pesticide) residue should be allowed on food crops.
EPA's Response: The Agency recognizes that some individuals believe that pesticides should not be allowed on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) 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 commenter's statements appear to be directed at the underlying statute and not EPA's implementation of it; the commenter has made no contention that EPA has acted in violation of the statutory framework.
Revisions to Petitioned-For Tolerances
EPA is establishing individual tolerances in kohlrabi and broccoli, chinese as they were part of subgroup 5A, but not included in expansion crop group 5-16 for which a tolerance is being established by this action.
EPA is not establishing the petitioned-for tolerance for Berry, low growing, except strawberry, subgroup 13-07H because it is not necessary. All commodities in subgroup 13-07H, plus strawberry, are included in subgroup 13-07G.
In accordance with its standard practice to provide greater precision about the levels of residues that are permitted by a tolerance, EPA is adding an additional significant figure to the petitioned-for tolerance values for the following commodities: Fruit, stone, group 12-12 from 0.5 to 0.50 ppm and radish, roots from 0.3 to 0.30. This is to avoid the situation where residues may be higher than the tolerance level, but as a result of rounding would be considered non-violative (for example, radish, roots proposed at 0.3 ppm was established at 0.30 ppm, to avoid an observed hypothetical tolerance at 0.34 ppm being rounded to 0.3 ppm).
Therefore, tolerances are established for residues of clopyralid, (3,6-dichloro-2-pyridinecarboxylic acid), in or on Berry, low growing, subgroup 13-07G at 4.0 ppm; Brassica, leafy greens, subgroup 4-16B at 5.0 ppm; broccoli, Chinese at 2.0 ppm; fruit, pome, group 11-10 at 0.05 ppm; fruit, stone, group 12-12 at 0.50 ppm; kohlrabi at 2.0 ppm; radish, roots at 0.30 ppm; stalk and stem vegetable subgroup 22A at 1.0 ppm; vegetable, Brassica, head and stem, group 5-16 at 2.0 ppm; and vegetable, leaves of root and tuber, group 2 at 5.0 ppm. In addition, established tolerances in or on ``apple''; ``asparagus''; ``beet, garden, tops''; ``beet, sugar, tops''; ``Brassica, head and stem, subgroup 5A''; ``Brassica, leafy greens, subgroup 5B''; ``canola, seed''; ``cranberry''; ``fruit, stone, group 12''; ``strawberry''; and ``turnip, greens'' are removed as they are superseded by this final tolerance rule.
Statutory and Executive Order Reviews
This action 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 action has been exempted from review under Executive Order 12866, this action 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); Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994).
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 et seq.), do not apply.
This action 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
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 (NTTAA) (15 U.S.C. 272 note).
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Dated: April 30, 2018.
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
Amend the table in Sec. 180.431(a) as follows:
Add alphabetically the entries for ``Berry, low growing, subgroup 13-07G'';``Brassica, leafy greens, subgroup 4-16B''; ``Broccoli, Chinese''; ``Fruit, pome, group 11-10''; ``Fruit, stone, group 12-12''; ``Kohlrabi''; ``Radish, roots''; ``Stalk and stem vegetable subgroup 22A''; ``Vegetable, Brassica, head and stem, group 5-16''; and ``Vegetable, leaves of root and tuber, group 2''.
Remove the entries for ``Apple''; ``Asparagus''; ``Beet, garden, tops''; ``Beet, sugar, tops''; ``Brassica, head and stem, subgroup 5A''; ``Brassica, leafy greens, subgroup 5B''; ``Canola, seed''; ``Cranberry''; ``Fruit, stone, group 12''; ``Strawberry''; and ``Turnip, greens''.
The additions read as follows:
Sec. 180.431 Clopyralid; Tolerances for residues.
(a) * * *
* * * * *
Berry, low growing, subgroup 13-07G......................... 4.0
Brassica, leafy greens, subgroup 4-16B...................... 5.0
* * * * *
Broccoli, Chinese........................................... 2.0
* * * * *
Fruit, pome, group 11-10.................................... 0.05
Fruit, stone, group 12-12................................... 0.50
* * * * *
* * * * *
Radish, roots............................................... 0.30
* * * * *
Stalk and stem vegetable subgroup 22A....................... 1.0
* * * * *
Vegetable, Brassica, head and stem, group 5-16.............. 2.0
Vegetable, leaves of root and tuber, group 2................ 5.0
* * * * *
* * * * *
FR Doc. 2018-10693 Filed 5-22-18; 8:45 am
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