[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Rules and Regulations]
[Pages 15387-15391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04747]



[[Page 15387]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0832; FRL-10005-85]


Cyazofamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
cyazofamid in or on multiple commodities that are identified and 
discussed later in this document. The Interregional Project Number 4 
(IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective March 18, 2020. Objections and 
requests for hearings must be received on or before May 18, 2020, 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-2018-0832, is available at 
https://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 https://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.

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-2018-0832 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 
May 18, 2020. 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-2018-0832, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 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 
https://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of May 9, 2019 (84 FR 20320) (FRL-9992-36), 
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 8E8718) 
by IR-4, Rutgers, The State University of New Jersey, 500 College Road 
East, Suite 201 W, Princeton, New Jersey 08540. The petition requested 
that 40 CFR 180.601 be amended by establishing tolerances for residues 
of the fungicide cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-
methylphenyl)-1H-imidazole-1-sulfonamide, in or on brassica, leafy 
greens, subgroup 4-16B at 15.0 parts per million (ppm); ginseng at 0.2 
ppm; kohlrabi at 1.5 ppm; leafy greens subgroup 4-16A at 10.0 ppm; and 
vegetable, brassica, head and stem, group 5-16 at 1.5 ppm. Upon the 
establishment of those tolerances, the petition requested the removal 
of existing tolerances for residues of the fungicide cyazofamid in or 
on brassica, head and stem, subgroup 5A at 1.2 ppm; brassica, leafy 
greens, subgroup 5B at 12.0 ppm; leafy greens subgroup 4A at 10 ppm; 
and turnip, greens at 12.0 ppm. That document referenced a summary of 
the petition prepared by ISK Biosciences Corporation, the registrant, 
which is available in the docket, https://www.regulations.gov. Two 
comments were received on the notice of filing. EPA's response to these 
comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition and pursuant 
to its authority in FFDCA section 408(d)(4)(A)(i), EPA is establishing 
three of the tolerances at a different level than requested. 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

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pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) of 
FFDCA requires EPA to give special consideration to exposure of infants 
and children to the pesticide chemical residue in establishing a 
tolerance and to ``ensure that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to the 
pesticide chemical residue. . . .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for cyazofamid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with cyazofamid follows.

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 
children.
    Cyazofamid belongs to a chemical class based on the cyanoimidazole 
and sulfonamide moieties. It specifically interferes with the 
cytochrome bc1 complex (ubiquinol cytochrome c oxidoreductase) in the 
mitochondrial respiratory chain of oomycetes fungi. The mechanism of 
toxicity in mammals is not clear. There were no treatment-related 
adverse effects in the acute and subchronic neurotoxicity studies. 
However, following repeated administration in more than one species, 
toxicological effects were observed primarily in the kidney. There were 
no effects observed up to the limit dose (1,000 mg/kg) in the dermal 
toxicity study. In dogs, there were no major toxicity findings.
    In the prenatal developmental toxicity study in rats, there was a 
marginal increased incidence of bent ribs observed in the high-dose 
(1,000 mg/kg/day) without any maternal effects, indicating quantitative 
susceptibility following in utero exposure.
    Cyazofamid is classified as ``not likely to be carcinogenic to 
humans'' based on the lack of evidence of carcinogenicity in both the 
rat and the mouse studies. Additionally, cyazofamid does not appear to 
be mutagenic, based on several negative in vivo and in vitro studies.
    Specific information on the studies received and the nature of the 
adverse effects caused by cyazofamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Cyazofamid. Human Health Risk 
Assessment for New Uses of Cyazofamid on Ginseng, and Greenhouse 
Cucumbers and Crop Group Conversions on Vegetable, Brassica, Head and 
Stem, Group 5-16; Brassica, Leafy Greens, Subgroup 4-16B; Leafy Greens, 
Subgroup 4-16A; and to Establish an Individual Tolerance on Kohlrabi'' 
on page 20 in docket ID number EPA-HQ-OPP-2018-0832.

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 cyazofamid used for 
human risk assessment is discussed in Unit III.B. of the final rule 
published in the Federal Register of February 3, 2016 (81 FR 5602) 
(FRL-9940-46).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyazofamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing cyazofamid tolerances in 40 CFR 
180.601. EPA assessed dietary exposures from cyazofamid 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 cyazofamid; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 2003-2008 
National Health and Nutrition Examination Survey, What We Eat in 
America, (NHANES/WWEIA). As to residue levels in food, EPA included 
tolerance-level residues for all crops, default processing factors and 
assumed that 100% of the crops were treated (100% CT) with cyazofamid.
    iii. Cancer. Based on the data cited in Unit III.A., EPA has 
concluded that cyazofamid 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. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for cyazofamid. Tolerance-level residues and/or 100% 
CT 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 cyazofamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cyazofamid. 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 Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of cyazofamid 
for chronic exposures for non-cancer assessments are estimated to be 
133.5

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ppb for surface water and 211 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 211 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).
    Cyazofamid is currently registered for the following uses that 
could result in residential exposures: Turf and ornamentals. EPA 
assumes there is no residential handler exposure because labels require 
users to wear personal protective equipment. Post application exposure 
(to turf and ornamental) from hand-to-mouth exposures was greatest to 
children 1 to less than 2 years old. 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.'' Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, EPA has not made a common mechanism of toxicity 
finding as to cyazofamid and any other substances and cyazofamid does 
not appear to produce a toxic metabolite produced by other substances. 
For the purposes of this action, therefore, EPA has not assumed that 
cyazofamid has 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 
factor.
    2. Prenatal and postnatal sensitivity. In the prenatal 
developmental toxicity study in rats, there was a marginal increased 
incidence of bent ribs observed at the high-dose (1,000 mg/kg/day) 
without any maternal effects, indicating quantitative susceptibility 
following in utero exposure. There is low concern for this effect 
because (1) bent ribs are a developmental variation rather than a 
malformation; (2) the increased incidence was only marginally increased 
over historical and concurrent controls; (3) similar effects were not 
seen in the rabbit developmental study; and (4) the effect was only 
observed at the limit dose.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for cyazofamid is complete.
    ii. There is no indication that cyazofamid is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. Although there is evidence of quantitative susceptibility in 
the developmental rat study, the concern is low because the effects 
occur at the limit dose and are well-characterized with clearly 
established no observed adverse-effect level (NOAEL)/lowest-observed 
adverse-effect level (LOAEL) values and selected endpoints address the 
observed effects.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100% CT, default processing factors and assumed tolerance-level 
residues for all crops. EPA made conservative (protective) assumptions 
in the ground and surface water modeling used to assess exposure to 
cyazofamid in drinking water. EPA used similarly conservative 
assumptions to assess post application exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by cyazofamid.

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, 
cyazofamid 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 
cyazofamid from food and water will utilize 2.0% 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 
cyazofamid 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). Cyazofamid is 
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 cyazofamid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 6,200 for 
children 1 to less than 2 years old for dietary exposure (which is 
considered a background exposure) and incidental oral (hand-to-mouth) 
exposure from contact with

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treated turf. Because EPA's level of concern for cyazofamid 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, 
cyazofamid is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term 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 
cyazofamid.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, cyazofamid 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 cyazofamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available to determine residues of 
cyazofamid and its metabolite CCIM (4-chloro-5-(4-methylphenyl)-1H-
imidazole-2-carbonitrile) in various commodities. An enforcement method 
for non-fatty commodities is available, FDA's Multiresidue Protocol D 
(without cleanup). The method completely recovers cyazofamid and its 
metabolite CCIM. In addition, the high-performance liquid 
chromatography method with ultraviolent light detection (HPLC/UV) 
method is acceptable for use as a single analyte enforcement method 
provided a confirmatory method such as the liquid chromatography method 
with tandem mass-spectrometric detection (LC/MS/MS) method is used.
    The methods 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: 
residuemethods@epa.gov.

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 MRLs for cyazofamid in or on Brassica 
(cole or cabbage) vegetables, head cabbage, and flowerhead Brassicas at 
1.5 ppm; leaves of Brassicaceae at 15 ppm; and leafy vegetables (except 
Brassica leafy vegetables) at 10 ppm. The U.S. tolerances being 
established are harmonized with these Codex MRLs, specifically 
vegetable, brassica, head and stem, group 5-16 at 1.5 ppm; kohlrabi at 
1.5 ppm; brassica leafy greens, subgroup 4-16B at 15 ppm; and leafy 
greens subgroup 4-16A at 10 ppm. There is no Codex MRL for ginseng.

C. Response to Comments

    EPA received two comments to the Notice of Filing, generally 
opposed to any cyazofamid residues on leafy greens. Although the Agency 
recognizes that some individuals believe that pesticides should be 
banned on agricultural crops, the existing legal framework provided by 
section 408 of the 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. These 
comments appear to be directed at the underlying statute and not EPA's 
implementation of it; the comments provide no information relevant the 
Agency's safety determination.

D. Revisions to Petitioned-For Tolerances

    EPA is establishing tolerances for Brassica, leafy greens, subgroup 
4-16B and Leafy greens subgroup 4-16A at different levels than 
requested to be consistent with the Organisation for Economic 
Cooperation and Development (OECD) rounding class practice. For 
ginseng, the petitioner's proposed tolerance was adjusted because 
storage stability data indicated a decline in residues of CCIM. 
Organization for Economic Cooperation and Development (OECD) 
statistical calculation procedures applied to the corrected residue 
data provided a different value (0.3 ppm) than the proposed value (0.2 
ppm). Therefore, EPA is establishing the tolerance for ginseng at 0.3 
ppm.

V. Conclusion

    Therefore, tolerances are established for residues of cyazofamid, 
4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-
sulfonamide, in or on Brassica, leafy greens, subgroup 4-16B at 15 ppm; 
Ginseng at 0.3 ppm; Kohlrabi at 1.5 ppm; Leafy greens subgroup 4-16A at 
10 ppm; and Vegetable, brassica, head and stem, group 5-16 at 1.5 ppm. 
Additionally, EPA is removing the established tolerances for Brassica, 
head and stem, subgroup 5A at 1.2 ppm; Brassica, leafy greens, subgroup 
5B at 12.0 ppm; Leafy greens subgroup 4A at 10 ppm; and Turnip, greens 
at 12.0 ppm. Finally, as a housekeeping measure, EPA is removing the 
expired exemption in paragraph (b) Section 18 emergency exemptions for 
Basil, dried at 144 ppm, as it expired on December 31, 2014.

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

[[Page 15391]]

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: March 2, 2020.
Michael Goodis,
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. In Sec.  180.601:
0
a. In the table in paragraph (a):
0
i. Remove the entries: Brassica, head and stem, subgroup 5A; and 
Brassica, leafy greens, subgroup 5B;
0
ii. Add alphabetically the entries: Brassica, leafy greens, subgroup 4-
16B; Ginseng; and Kohlrabi;
0
iii. Remove the entry Leafy greens subgroup 4A;
0
iv. Add alphabetically the entry Leafy greens subgroup 4-16A;
0
v. Remove the entry Turnip, greens; and
0
vi. Add alphabetically the entry Vegetable, brassica, head and stem, 
group 5-16; and
0
b. Remove and reserve paragraph (b).
    The additions and revision read as follows:


Sec.  180.601  Cyazofamid; tolerances for residues.

    (a) * * *

                         Table to Paragraph (a)
------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Brassica, leafy greens, subgroup 4-16B......................          15
 
                                * * * * *
Ginseng.....................................................         0.3
 
                                * * * * *
Kohlrabi....................................................         1.5
Leafy greens subgroup 4-16A.................................          10
Vegetable, brassica, head and stem, group 5-16..............         1.5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-04747 Filed 3-17-20; 8:45 am]
BILLING CODE 6560-50-P


