Document ID: EPA-HQ-OPP-2017-0035-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Clopyralid
Posted Date: 2018-05-23T04:00Z

[Federal Register Volume 83, Number 100 (Wednesday, May 23, 2018)]
[Rules and Regulations]
[Pages 23819-23825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10693]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0035; FRL-9977-13]

Clopyralid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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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previously established tolerances that are superseded by this final 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).

[[Page 23820]]

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].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. 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).

B. 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.

C. 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.

II. 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.

III. 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

[[Page 23821]]

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.

A. Toxicological Profile

    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.

B. 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
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
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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
                                                                                          epithelial hyperplasia
                                                                                          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..............   = <100.                  (oral)--rat.
                                       UFH = 10x..............                           Maternal LOAEL = 250 mg/
                                       FQPA SF = 1x...........                            kg/day, based on
                                                                                          mortality.

[[Page 23822]]

 
Inhalation short-term (1 to 30 days).  Inhalation (or oral)     Residential LOC for MOE  Developmental Toxicity
                                        study NOAEL = 75 mg/kg/  = <100.                  (oral)--rat.
                                        day (inhalation                                  Maternal LOAEL = 250 mg/
                                        absorption rate =                                 kg/day, based on
                                        100%).                                            mortality.
                                       UFA = 10x..............
                                       UFH = 10x..............
                                       FQPA SF = 1x...........
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)                     ``Not likely to be carcinogenic to humans.''
 routes.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to clopyralid, EPA considered exposure under the petitioned-
for tolerances as well as all existing clopyralid tolerances in 40 CFR 
180.431. EPA assessed dietary exposures from clopyralid in food as 
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    No such effects were identified in the toxicological studies for 
clopyralid; therefore, a quantitative acute dietary exposure assessment 
is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID) which incorporates 
consumption data from the United States Department of Agriculture's 
(USDA) National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA) conducted from 2003 to 2008. As to residue 
levels in food, the chronic dietary exposure assessment was based on 
tolerance-level residues, and assumed that 100 percent (PCT) of all 
crops were treated.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that clopyralid does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for clopyralid. Tolerance level residues and 100 PCT were assumed for 
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for clopyralid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of clopyralid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Water Calculator Version 1.52 (PWC) model, 
the estimated drinking water concentrations (EDWCs) of clopyralid for 
chronic exposures for non-cancer assessments are estimated to be 5.43 
parts per billion (ppb) for surface water and 38.1 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 value of 38.1 ppb was used to 
assess the contribution from drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Clopyralid is currently registered for the following uses that 
could result in residential exposures: Weed control on lawns, turf and 
ornamentals in residential and public areas. EPA assessed residential 
exposure using the following assumptions: Residential handler exposures 
are not expected since the residential uses require that handlers wear 
specific clothing (e.g., long-sleeved shirt and long pants; shoes plus 
socks) and/or personal protective equipment (e.g., gloves). As a 
result, a residential handler assessment was not conducted. Short-term 
post-application exposure is anticipated for children from incidental 
oral contact with treated turf (hand-to-mouth, object-to-mouth and soil 
ingestion). Post-application dermal exposure is also anticipated from 
residential use of clopyralid. However, systemic toxicity via the 
dermal route of exposure is not expected 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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    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.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of

[[Page 23823]]

safety for infants and children in the case of threshold effects to 
account for prenatal and postnatal toxicity and the completeness of the 
database on toxicity and exposure unless EPA determines based on 
reliable data that a different margin of safety will be safe for 
infants and children. This additional margin of safety is commonly 
referred to as the FQPA Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional safety factor when reliable data available to EPA support 
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased qualitative or quantitative sensitivity/susceptibility in the 
developing or young animal. In the rat developmental toxicity study, no 
developmental toxicity was observed at a maternally toxic dose. In the 
rat 2-generation reproductive toxicity study, decreased pup weight 
(post-natal day 28), and increased relative liver weights were observed 
at the parental LOAEL. Hydrocephalus and decreased mean fetal weight 
were observed in the rabbit developmental study, but at a dose that 
also caused significant maternal toxicity, including mortality; 
therefore, quantitative or qualitative developmental susceptibility was 
not observed for clopyralid.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
Food Quality Protection Act Safety Factor Safety Factor (FQPA SF) were 
reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for clopyralid is considered complete and 
no additional studies are required at this time.
    ii. There are no clinical or micropathological indications of 
neurotoxicity in the available subchronic and chronic studies in 
multiple species. Hydrocephalus was observed in fetuses in the rabbit 
developmental study, but only at a high dose that resulted in 
significant maternal toxicity, including mortality. There is no need 
for a developmental neurotoxicity study or additional uncertainty 
factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that clopyralid results in increased 
susceptibility in utero in rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the dietary 
and residential exposure databases. EPA conducted the chronic dietary 
food exposure assessment based on 100 PCT, tolerance-level residues of 
clopyralid, and default processing factors, where applicable. 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 post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by clopyralid.

E. Aggregate Risks and Determination of Safety

    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.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
clopyralid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
clopyralid from food and water will utilize 26% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
clopyralid is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Several 
clopyralid products are currently registered for uses that could result 
in short-term residential exposure and the Agency has determined that 
it is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to clopyralid.
    Using the exposure assumptions described in this unit for short-
term exposures and data results from a most recent previous EPA 
assessment of residential exposure, the Agency combined food, water, 
and short-term residential exposures result in aggregate MOEs of 1600 
for children. Because EPA's level of concern (LOC) for clopyralid is an 
MOE of 100 or below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
clopyralid is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk 
aggregate risk is assessed based on intermediate- term residential 
exposure plus chronic dietary exposure. Because there is no 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess intermediate-term 
risk), no further assessment of intermediate-term risk is necessary, 
and EPA relies on the chronic dietary risk assessment for evaluating 
intermediate-term risk for clopyralid.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, clopyralid is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to clopyralid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The Pesticide Analytical Manual Volume II (PAM II) lists a method 
utilizing gas chromatography with electron capture detection (GC/ECD) 
for determination of clopyralid residues in plant commodities (Method I 
or Method ACR 75.6).
    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: 
[email protected].

B. 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

[[Page 23824]]

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.

C. 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.

D. 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).

V. Conclusion

    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.

VI. 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).

VII. 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.

[[Page 23825]]

    Dated: April 30, 2018.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Amend the table in Sec.  180.431(a) as follows:
0
a. 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''.
0
b. 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) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
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
 
                                * * * * *
Kohlrabi....................................................         2.0
 
                                * * * * *
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]
 BILLING CODE 6560-50-P