[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Rules and Regulations]
[Pages 65546-65551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27605]



40 CFR Part 180

[EPA-HQ-OPP-2017-0587; FRL-9987-34]

Tolfenpyrad; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
tolfenpyrad in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project No. 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 21, 2018. Objections and 
requests for hearings must be received on or before February 19, 2019 
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-2017-0587, 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 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: RDFRNotices@epa.gov.


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. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to https://www.epa.gov/aboutepa/about-office-chemical-safety-and-pollution-prevention-ocspp.

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-2017-0587 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 
February 19, 2019. 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-2017-0587, 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 
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

[[Page 65547]]

II. Summary of Petitioned-For Tolerance

    In the Federal Register of January 26, 2018 (83 FR 3658) (FRL-9971-
46), 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 
7E8613) by IR-4, Rutgers, The State University of New Jersey, 500 
College Road East, Suite 201 W, Princeton, NJ 08540. The petition 
requested that 40 CFR 180.675 be amended by establishing tolerances for 
residues of the insecticide tolfenpyrad, 4-chloro-3-ethyl-1-methyl-N-
[4-(p-tolyloxy)benzyl]pyrazole-5-carboxamide), in or on Arugula at 30.0 
parts per million (ppm); Avocado at 1.5 ppm; Berry, low growing, 
subgroup 13-07G, except Cranberry and Blueberry, lowbush at 3.0 ppm; 
Bushberry, subgroup 13-07B at 7.0 ppm; Caneberry, subgroup 13-07A at 
7.0 ppm; Celtuce at 30.0 ppm; Cottonseed, subgroup 20C at 0.70 ppm; 
Florence fennel at 30.0 ppm; Fruit, small, vine climbing, except fuzzy 
kiwifruit, subgroup 13-07F at 2.0 ppm; Garden cress at 30.0 ppm; Leaf 
petiole vegetable, subgroup 22B at 30.0 ppm; Leafy greens, subgroup 4-
16A at 30.0 ppm; Onion, bulb, subgroup 3-07A at 0.09 ppm; Onion, green, 
subgroup 3-07B at 10.0 ppm; Upland cress at 30.0 ppm; Vegetable, 
fruiting, group 8-10 at 1.0 ppm; and Vegetable, tuberous and corm, 
subgroup 1C at 0.01 ppm.
    The petitioner also requested that the following established 
tolerances be removed upon establishment of the petitioned-for 
tolerances: Cotton, undelinted seed at 0.70 ppm; Grape at 2.0 ppm; 
Potato at 0.01 ppm; and Vegetable, leafy, except Brassica, group 4 at 
30.0 ppm. That document referenced a summary of the petition prepared 
by Nichino America, Inc., the registrant, which is available in the 
docket, http://www.regulations.gov. Although a comment was submitted to 
the docket for the notice of filing, the issue raised is outside the 
scope of this rulemaking.
    Based upon review of the data supporting the petition, EPA is 
establishing the petitioned-for tolerances with some variations 
consistent with its authority in FFDCA section 408(d)(4)(A). The 
reasons for these variations are explained in Unit IV.C.

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 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 tolfenpyrad including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with tolfenpyrad follows.

A. Toxicological Profile

    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 
    A variety of toxic effects were noted in the toxicology database 
for tolfenpyrad. However, the most consistent findings across species 
and studies were effects on bodyweight and bodyweight gain which were 
observed in adults of all species (rat, mice, rabbit, and dog) in the 
majority of the subchronic oral and dermal toxicity studies, and all 
chronic toxicity studies.
    Further detail of the toxicological profile for tolfenpyrad is 
discussed in Unit III.A. of the final rule published in the Federal 
Register of June 22, 2018 (83 FR 29017) (FRL-9976-21).
    Specific information on the studies received and the nature of the 
adverse effects caused by tolfenpyrad 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 http://www.regulations.gov in document ``Tolfenpyrad-Aggregate Human Health 
Risk Assessment for Section 3 New Use Requests and Crop Group Tolerance 
Conversions'' on page 31 in docket ID number EPA-HQ-OPP-2017-0587.

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 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks.
    A summary of the toxicological endpoints for tolfenpyrad used for 
human risk assessment is discussed in Unit III B. of the final rule 
published in the Federal Register of June 22, 2018 (83 FR 29020) (FRL-

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to tolfenpyrad, EPA considered exposure under the petitioned-
for tolerances as well as all existing tolfenpyrad tolerances in 40 CFR 
180.675. EPA assessed dietary exposures from tolfenpyrad in food as 
    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.
    Such effects were identified for tolfenpyrad. In estimating acute 
dietary exposure, EPA used the Dietary

[[Page 65548]]

Exposure Evaluation Model DEEM-FCIDTM (Ver. 3.16). This 
model uses food consumption data from the 2003-2008 United States 
Department of Agriculture's (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA used tolerance-level residues for all foods 
and assumed 100% crop treated (PCT) for all current and proposed crops. 
The assessment was refined with the application of empirical processing 
factors where available. Where empirical processing factors were not 
available or were not translated, default processing factors were used. 
Additional refinements include a factor to account for the reduction in 
residues when wrapper leaves are removed (head lettuce, radicchio, 
cabbage, Chinese Napa cabbage, and Brussels sprouts). Empirical 
processing factors were available for processed commodities of apple, 
orange, cottonseed, grape, plum, potato and tomato, and were translated 
to other processed commodities where appropriate. Where empirical 
processing factors were not available or were not translated, default 
processing factors were used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the DEEM-FCIDTM (Ver. 3.16). This model 
uses food consumption data from the 2003-2008 USDA's NHANES/WWEIA. As 
to residue levels in food, EPA assumed 100% PCT and average residue 
levels from crop field trials as well as the refinements described 
above for the acute assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that tolfenpyrad 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 percent crop treated (PCT) information. 
Although EPA did not use any percent crop treated estimates for this 
action, the Agency relied on average residue information. Section 
408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such Data Call-Ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for tolfenpyrad in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of tolfenpyrad. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
tolfenpyrad for acute exposures are estimated to be 26.9 parts per 
billion (ppb) for surface water and 11.0 ppb for ground water. Chronic 
exposures for non-cancer assessments are estimated to be 12.2 ppb for 
surface water and 11.0 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 26.9 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration value of 12.2 ppb was used to 
assess the contribution to 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).
    Tolfenpyrad is not registered for any specific use patterns that 
would result in residential exposure. Further information regarding EPA 
standard assumptions and generic inputs for residential exposures may 
be found at https://www.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 tolfenpyrad to share a common mechanism of 
toxicity with any other substances, and tolfenpyrad does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
tolfenpyrad 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 website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 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 
    2. Prenatal and postnatal sensitivity. Although there is evidence 
of increased qualitative susceptibility in the young in the 
developmental immunotoxicity study (DIT) in rats, there is low concern, 
and there are no residual uncertainties regarding increased 
quantitative or qualitative pre- and/or postnatal susceptibility for 
tolfenpyrad. When the DIT study is considered along with the 
reproduction study, the offspring toxicity in the DIT study was 
observed at the same dose as comparable maternal toxicity (moribundity/
mortality) was observed in the reproduction study. Therefore, EPA does 
not consider the isolated incident in the DIT a true indicator of 
qualitative susceptibility. Additionally, the effects observed in the 
DIT study are well characterized, a clear NOAEL was identified, and the 
endpoints chosen for risk assessment are protective of potential 
offspring effects.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 

[[Page 65549]]

were reduced to 1X. That decision is based on the following findings:
    i. The toxicity database for tolfenpyrad is complete.
    ii. There is no indication that tolfenpyrad is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. While there was evidence of qualitative susceptibility in one 
study, the Agency's concern for the susceptibility is low because it 
was not observed in other studies with tolfenpyrad; offspring effects 
consistently occurred at or above the dose associated with significant 
maternal toxicity; there was a clear NOAEL/LOAEL; and endpoints and 
doses selected for risk assessment are protective of the 
    iv. There are no residual uncertainties with regard to the exposure 
assessment. The acute dietary exposure assessment is based on high-end 
health protective residue levels (that account for parent and 
metabolites of concern), processing factors, and percent crop treated 
assumptions (100%). The chronic dietary assessment incorporates some 
refinement in that average residue values were used. For both the acute 
and chronic dietary exposure, actual exposures to tolfenpyrad will 
likely be lower than the estimated exposures. Furthermore, 
conservative, upper-bound assumptions were used to estimate exposure 
through drinking water, such that these exposures have not been 
underestimated. No residential exposures are expected. These 
assessments will not underestimate the exposure and risks posed by 

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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to tolfenpyrad will occupy 63% of the aPAD for children 1-2 years of 
age, the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
tolfenpyrad from food and water will utilize 97% of the cPAD for 
children 1-2 years of age, the population group receiving the greatest 
exposure. There are no residential uses for tolfenpyrad.
    3. Short-and Intermediate-term risk. Short- and intermediate-term 
aggregate exposures take into account short- and intermediate-term 
residential exposures plus chronic exposures to food and water 
(considered to be background exposure levels). Short- and intermediate-
term adverse effects were identified; however, tolfenpyrad is not 
registered for any use patterns that would result in short- or 
intermediate-term residential exposures. Short- and intermediate-term 
risks are assessed based on short- and intermediate-term residential 
exposure plus chronic dietary exposure. Because there are no short- or 
intermediate-term residential exposures 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 short- and 
intermediate-term risk), no further assessment of short- and 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for tolfenpyrad.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, tolfenpyrad is not expected to pose a cancer risk to humans.
    5. 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 tolfenpyrad residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies utilizing high-performance 
liquid chromatography method with tandem mass spectrometry detection 
(LC/MS/MS) is available for enforcement of tolfenpyrad residue 
tolerances in/on plant commodities (Morse Laboratories Analytical 
Method #Meth-183, Revision #2). For livestock, a method described in 
PTRL West Study No. 1841W is available. The livestock method adequately 
determines residues of tolfenpyrad and its metabolites, PT-CA, OH-PT-
CA, and PCA in milk, bovine meat, kidney, liver and fat. Residues are 
determined by LC/MS/MS analysis. These methods are adequate to enforce 
the tolerance expression.
    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: 

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 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 established an MRL for tolfenpyrad on potato at 0.01 
ppm. Due to crop group conversions, the established potato tolerance 
will be covered by Vegetable, tuberous and corm, subgroup 1C. 
Therefore, the Codex MRL for potato is harmonized with the U.S. 
tolerance for Vegetable, tuberous and corm, subgroup 1C at 0.01 ppm.

C. Revisions to Petitioned-For Tolerances

    The petitioner requested tolerances for residues of tolfenpyrad and 
cited the International Union of Pure and Applied Chemistry (IUPAC) 
name for the chemical. The residue definition for tolfenpyrad 
tolerances currently established under 40 CFR 180.675 complies with the 
Agency's Guidance on Tolerance Expressions, except that the IUPAC 
chemical name is listed rather than the Chemical Abstracts Service 
(CAS) chemical name. The Agency's practice is to use the CAS name; 
therefore, the tolerance expression is being revised. This change also 
results in harmonization of the chemical name expression with that used 
by the Pest Management Regulatory Agency (PMRA).

[[Page 65550]]

    EPA reviewed the current residue data and tolerance conversion 
proposals and is establishing some the proposed tolerance levels for 
residues of tolfenpyrad in accordance with the Agency's rounding 
practice. In addition, using the highest overall average residue level 
from the greenhouse tomato decline trial (at a post-harvest interval 
(PHI) of 5 days instead of a PHI of 1 day), the Agency is establishing 
a tolerance for Vegetable, fruiting, group 8-10 at 1.5 ppm instead of 
1.0 ppm.
    While the petitioner requested individual tolerances for arugula, 
garden cress, and upland cress, individual tolerances are not necessary 
since these commodities are included in Brassica, leafy greens, 
subgroup 4-16B.
    Finally, the Agency is establishing a tolerance for the requested 
commodity Florence fennel as a tolerance for Fennel, Florence, fresh 
leaves and stalk to conform to the Agency's preferred vocabulary for 
this commodity.

V. Conclusion

    Therefore, tolerances are established for residues of tolfenpyrad, 
pyrazole-5-carboxamide), including its metabolites and degradates, in 
or on Avocado at 1.5 ppm; Berry, low growing, subgroup 13-07G, except 
cranberry and lowbush blueberry at 3.0 ppm; Bushberry subgroup 13-07B 
at 7.0 ppm; Caneberry subgroup 13-07A at 7.0 ppm; Celtuce at 30 ppm; 
Cottonseed subgroup 20C at 0.70 ppm; Fennel, Florence, fresh leaves and 
stalk at 30 ppm; Fruit, small, vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F at 2.0 ppm; Leaf petiole vegetable subgroup 22B at 30 
ppm; Leafy greens subgroup 4-16A at 30 ppm; Onion, bulb, subgroup 3-07A 
at 0.09 ppm; Onion, green, subgroup 3-07B at 10 ppm; Vegetable, 
fruiting, group 8-10 at 1.5 ppm; and Vegetable, tuberous and corm, 
subgroup 1C at 0.01 ppm. In addition, EPA is removing the following 
tolerances from paragraph (a) as they are superseded by the new 
tolerances being established in this rulemaking Cotton, undelinted seed 
at 0.70 ppm; Grape at 2.0 ppm; Potato at 0.01 ppm; and Vegetable, leafy 
except Brassica, group 4 at 30.0 ppm. EPA is also removing the time-
limited tolerance for onion, dry bulb at 0.09 ppm in Sec.  180.675(b) 
as it is no longer needed with the establishment of a new permanent 
tolerance for onion, bulb subgroup 3-07A in paragraph (a)(1).

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) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997), nor is it considered a 
regulatory action under 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 tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 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.

    Dated: December 10, 2018.
Michael Goodis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. In Sec.  180.675:
 a. Revise the introductory text of paragraph (a)(1);
 b. In the table to paragraph (a)(1):
i. Add alphabetically the entries ``Avocado''; ``Berry, low growing, 
subgroup 13-07G, except cranberry and lowbush blueberry''; ``Bushberry, 
subgroup 13-07B''; ``Caneberry, subgroup 13-07A''; ``Celtuce''; 
``Cottonseed, subgroup 20C''; ``Fennel, Florence, fresh leaves and 
stalk''; ``Fruit, small, vine climbing, except fuzzy kiwifruit, 
subgroup 13-07F''; ``Leaf petiole vegetable subgroup 22B''; ``Leafy 
greens, subgroup 4-16A''; ``Onion, bulb, subgroup 3-07A''; ``Onion, 
green, subgroup 3-07B''; and ``Vegetable, tuberous and corm, subgroup 
ii. Revise the entry for ``Vegetable, fruiting, group 8-10'';
iii. Remove the entries ``Cotton, undelinted seed''; ``Grape''; 

[[Page 65551]]

and ``Vegetable, leafy except Brassica, group 4'';
c. Revise the introductory text of paragraph (a)(2);
d. Revise paragraph (b).
    The additions and revisions read as follows:

Sec.  180.675   Tolfenpyrad; tolerances for residues.

    (a) General. (1) Tolerances are established for residues of the 
insecticide tolfenpyrad, including its metabolites and degradates, in 
or on the commodities in the table below. Compliance with the tolerance 
levels specified below is to be determined by measuring only 
tolfenpyrad (4-chloro-3-ethyl-1-methyl-N-[[4-(4-
methylphenoxy)phenyl]methyl]-1H-pyrazole-5-carboxamide) in or on the 

                                                             Parts per
                        Commodity                             million
                              * * * * * * *
Avocado.................................................             1.5
Berry, low growing, subgroup 13-07G, except cranberry                3.0
 and lowbush blueberry..................................
                              * * * * * * *
Bushberry, subgroup 13-07B..............................             7.0
Caneberry, subgroup 13-07A..............................             7.0
Celtuce.................................................              30
                              * * * * * * *
Cottonseed, subgroup 20C................................            0.70
Fennel, Florence, fresh leaves and stalk................              30
                              * * * * * * *
Fruit, small, vine climbing, except fuzzy kiwifruit,                 2.0
 subgroup 13-07F........................................
                              * * * * * * *
Leaf petiole vegetable subgroup 22B.....................              30
Leafy greens, subgroup 4-16A............................              30
                              * * * * * * *
Onion, bulb, subgroup 3-07A.............................            0.09
Onion, green, subgroup 3-07B............................              10
                              * * * * * * *
Vegetable, fruiting, group 8-10.........................             1.5
Vegetable, tuberous and corm, subgroup 1C...............            0.01

    (2) Tolerances are established for residues of the insecticide 
tolfenpyrad, including its metabolites and degradates, in or on the 
commodities in the following table. Compliance with the tolerance 
levels specified below is to be determined by measuring only the sum of 
tolfenpyrad, 4-chloro-3-ethyl-1-methyl-N-[[4-(4-
methylphenoxy)phenyl]methyl]-1H-pyrazole-5-carboxamide, and its 
metabolite 4-[4-[(4-chloro-3-ethyl-1-methylpyrazol-5-yl)carbonylamino-
methyl]phenoxy]-benzoic acid, calculated as the stoichiometric 
equivalent of tolfenpyrad.
* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. 2018-27605 Filed 12-20-18; 8:45 am]