[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Rules and Regulations]
[Pages 5312-5317]
[FR Doc No: 2018-02344]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0629; FRL-9972-66]

Fomesafen; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fomesafen in or on the tuberous and corm vegetable subgroup 1C, the
legume vegetable group 6, and the low growing berry subgroup 13-07G
(except cranberry). Interregional Research Project Number 4 (IR-4)
requested these tolerances under the Federal Food, Drug, and Cosmetic
Act (FFDCA).

DATES: This regulation is effective February 7, 2018. Objections and
requests for hearings must be received on or before April 9, 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-2015-0629, 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. 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:<PHONE_NUMBER>; 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-2015-0629 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
April 9, 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-2015-0629, 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 October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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
5E8395) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W., Princeton, NJ 08540. The petition requested
that 40 CFR 180.433 be amended by establishing tolerances for residues
of fomesafen, 5-[2-cloro-4-(trifluoromethyl)phenoxy]-N-
(methylsulfonyl)-2-nitrobenzamide in or on the following raw
agricultural commodities: Vegetable, tuberous and corm, subgroup 1C at
0.025 parts per million (ppm); berry, low growing subgroup 13-07G
except cranberry at 0.02 ppm; and vegetable, legume group 6 at 0.05
ppm. The petition also requested to amend 40 CFR 180.433 by removing
the existing tolerances on the raw agricultural commodities bean, dry
at 0.05 ppm; bean, snap, succulent at 0.05 ppm; bean Lima, succulent at
0.05 ppm; pea, succulent at 0.025 ppm; potato at 0.025 ppm; soybean at
0.05 ppm; and soybean, vegetable succulent at 0.05 ppm. That document
referenced a summary of the petition prepared by Syngenta Crop
Protection, LLC, the registrant, which is available in the docket,
http://www.regulations.gov. Comments were received on the notice of
filing. EPA's response to these comments is discussed 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 fomesafen including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with fomesafen 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.
    The primary target organs of fomesafen are the liver and
hematological system. Generally, hyalinization of hepatocytes provided
the most sensitive toxicological endpoint (intermediate, and long term)
in mammals. In the subchronic and chronic toxicity studies in rats and
mice, food consumption, food efficiency, body weight, body weight gain,
and histopathological changes in the liver were parameters that were
most often affected. In addition, dogs, rats, and mice also showed
hematological changes (e.g., decreased erythrocyte count, hemoglobin,
or hematocrit). No progression of hematological effects was observed
beyond 90 days. Neurotoxicity (decreased motor activity) was observed
at doses above those causing liver toxicity or impacting hematological
parameters. Post-implantation loss was noted in the developmental
study, but no quantitative or qualitative evidence of increased
susceptibility was seen following in utero exposure to rats or rabbits
in developmental studies or in the reproduction study. As the etiology
of the post-implantation loss is unknown, it is considered to be both a
maternal and fetal endpoint. Fomesafen can result in suppression of
anti-SRBC IgM response; however, this immunotoxic potential was noted
only at high doses.
    Carcinogenicity was not observed in the rat chronic toxicity/
carcinogenicity study. Liver tumors were produced in the mouse
carcinogenicity study; however, the Agency determined that fomesafen
should be classified as ``Not Likely to be Carcinogenic to Humans.''
This decision was based on the weight-of-evidence which supports
activation of peroxisome proliferator-activated receptor alpha
(PPAR[alpha]) as the mode of action for fomesafen-induced
hepatocarcinogenesis in mice. Fomesafen was not considered to be
mutagenic.
    Specific information on the studies received and the nature of the
adverse effects caused by fomesafen 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 the document titled ``Fomesafen: Draft Human
Health Risk Assessment for Registration Review and for the Section 3
Registration Action on Tuberous and Corm Vegetables (Crop Group 1C),
Legume Vegetable (Crop Group 6) and Low Growing Berry (Except
Cranberry) (Crop Group 13-07G)'' on pages 36-45 in docket ID number
EPA-HQ-OPP-2015-0629.

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 http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
    A summary of the toxicological endpoints for fomesafen used for
human risk assessment is shown in the Table of this unit.

    Table--Summary of Toxicological Doses and Endpoints for Fomesafen for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (Females 13-49        No toxic effects of fomesafen attributable to a single dose and specific to
 years of age).                                   females of ages 13-49 were found in the database.
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Acute dietary (General population  NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Acute neurotoxicity test in rats.
 including infants and children).   day.                  day.                LOAEL = 250 mg/kg/day based on
                                   UFA = 10x...........  aPAD = 1 mg/kg/day.   decreased motor activity
                                   UFH = 10x...........                        (horizontal and vertical activity
                                   FQPA SF = 1x........                        and time in central quadrant) in
                                                                               males.
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Chronic dietary (All populations)  NOAEL = 1 mg/kg/day.  Chronic RfD = 0.01   Subchronic toxicity in the dog.
                                   UFA = 10x...........   mg/kg/day.          LOAEL = 25 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.01 mg/kg/    hematology (decreased hemoglobin
                                   FQPA SF = 1x........   day..                and hematocrit concentrations and
                                                                               erythrocyte count and increased
                                                                               platelet count and prothrombin
                                                                               time).
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Cancer (Oral, dermal, inhalation)    Classification: The Agency has classified Fomesafen as ``Not Likely to be
                                                              Carcinogenic to Humans''
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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 fomesafen, EPA considered exposure under the petitioned-for
tolerances as well as all existing fomesafen tolerances in 40 CFR
180.433. EPA assessed dietary exposures from fomesafen 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.
    Such effects were identified for fomesafen. In estimating acute
dietary exposure, EPA used 2003-2008 food consumption data from the
U.S. Department of Agriculture's (USDA's) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA). As to
residue levels in food, EPA assumed tolerance level residues and 100
percent crop treated (PCT).
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used 2003-2008 food consumption data from the USDA's
NHANES/WWEIA. As to residue levels in food, EPA assumed tolerance level
residues and 100 PCT.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fomesafen 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 or PCT information in the dietary assessment for
fomesafen. 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 fomesafen in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fomesafen. 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 in Water Calculator (PWC) model (Version
1.52) the estimated drinking water concentrations (EDWCs) of fomesafen
for acute exposures are estimated to be 168 parts per billion (ppb) and
for chronic exposures are estimated to be 125 ppb. These modeled
estimates of drinking water concentrations were directly entered into
the dietary exposure model.
    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).
    Fomesafen is not registered for any specific use patterns that
would result in residential exposure.
    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 fomesafen to share a common mechanism of toxicity
with any other substances, and fomesafen does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fomesafen 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 http://www2.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 Food Quality
Protection Act Safety Factor (FQPA 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 is no evidence of
increased susceptibility of rat fetuses to in utero exposure to
fomesafen. Post-implantation loss was observed in the rat developmental
toxicity study. However, as the etiology of the effect is unknown, it
is considered to be a part of both a maternal and fetal effect. The 2-
generation reproduction study in rats did not show evidence of
increased susceptibility to fomesafen. Although the developmental
toxicity study in rabbits was classified as unacceptable due to
mortality from bacterial infections, there was adequate information to
show that there was no evidence of increased susceptibility of rabbit
fetuses due to the treatment with fomesafen.
    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 toxicology database for fomesafen is complete and sufficient
for assessing potential susceptibility to infants and children.
Although the developmental toxicity study in rabbits was classified
unacceptable due to mortality from bacterial infections, there was no
evidence of increased susceptibility of rabbit fetuses due to the
treatment with fomesafen. Therefore, the lack of an acceptable
developmental toxicity study in non-rodents is not considered a data
gap.
    ii. There is no need for a developmental neurotoxicity study or a
need to retain the FQPA SF to account for the lack of such study.
Decreased motor activity (horizontal and vertical activity and time in
central quadrant) was observed in male rats in the acute neurotoxicity
screening battery. In the subchronic neurotoxicity test, neither
general systemic toxicity nor neurotoxicity was observed at the highest
dose tested. All points of departure used in the risk assessment are
protective of potential neurotoxicity.
    iii. There is no evidence that fomesafen results in increased
susceptibility in in utero rats in the prenatal developmental studies
or in young rats in the 2-generation reproduction study. Although the
developmental toxicity study in rabbits was classified as unacceptable
due to mortality from bacterial infections, there was adequate
information to show that there was no evidence of increased
susceptibility of rabbit fetuses due to the treatment with fomesafen.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to fomesafen in drinking water. These assessments
will not underestimate the exposure and risks posed by fomesafen.

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 fomesafen will occupy 2.9% of the aPAD for all infants less than 1-
years old, 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
fomesafen from food and water will utilize 70% of the cPAD for all
infants less than 1 year old, the population group receiving the
greatest exposure. There are no residential uses for fomesafen.
    3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
    Both short- and intermediate-term adverse effects were identified;
however, fomesafen is not registered for any use patterns that would
result in either short- or intermediate-term residential exposure.
Short- and intermediate-term risk is assessed based on short- and
intermediate-term residential exposure plus chronic dietary exposure.
Because there is no short- or 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 either short- or intermediate-term risk), no further
assessment of short- or intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating short- and
intermediate-term risk for fomesafen.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fomesafen 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 fomesafen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate residue analytical methods are available for the purpose
of fomesafen tolerance enforcement for plant commodities. A high
performance liquid chromatography method with tandem mass spectrometry
detection (LC/MS/MS) method (GRM045.01A) has

previously been submitted as an enforcement method. The method uses
extraction procedures similar to previous methods, SPE cleanup
procedures, and the final determination step by LC/MS/MS for analysis
of fomesafen residues. The validated limit of quantitation (LOQ) of the
method is 0.02 ppm.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; 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 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 any MRLs for fomesafen.

C. Response to Comments

    Two comments were received in response to the notice of filing. The
first was related to a different chemical, azoxystrobin, and is
therefore not relevant to this action. The second was from the Center
for Biological Diversity and centered primarily around impacts on
endangered and threatened species. This comment is not relevant to the
Agency's evaluation of safety of the fomesafen tolerances under section
408 of the FFDCA, which requires the Agency to evaluate the potential
harms to human health, not effects on the environment.

V. Conclusion

    Therefore, tolerances are established for residues of fomesafen,
including its metabolites and degradates, in or on the following
commodities: Berry, low growing, subgroup 13-07G, except cranberry at
0.02 ppm; vegetable, legume, group 6 at 0.05 ppm; and vegetable,
tuberous and corm, subgroup 1C at 0.025 ppm. In addition, the following
existing tolerances are removed as unnecessary since they are
superseded by the newly established tolerances: Bean, dry at 0.05 ppm;
bean, lima, succulent at 0.05 ppm; bean, snap, succulent at 0.05 ppm;
pea, succulent at 0.025 ppm; potato at 0.025 ppm; soybean at 0.05 ppm;
and soybean, vegetable, succulent at 0.05 ppm.

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); 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 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.

    Dated: January 25, 2018.
Michael L. 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.  180.433, amend the table in paragraph (a) by:
0
i. Removing the commodities ``Bean, dry''; ``Bean, lima, succulent'';
and ``Bean, snap, succulent'';
0
ii. Adding alphabetically the commodity ``Berry, low growing, subgroup
13-07G, except cranberry'';
0
iii. Removing the commodities ``Pea, succulent''; ``Potato'';
``Soybean''; and ``Soybean, vegetable, succulent''; and

0
iv. Adding alphabetically the commodities ``Vegetable, legume, group
6'' and ``Vegetable, tuberous and corm, subgroup 1C''.
    The additions read as follows:

Sec.  180.433  Fomesafen; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Berry, low growing, subgroup 13-07G, except cranberry......         0.02

                                * * * * *
Vegetable, legume, group 6.................................         0.05
Vegetable, tuberous and corm, subgroup 1C..................        0.025

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2018-02344 Filed 2-6-18; 8:45 am]
BILLING CODE 6560-50-P