Document ID: EPA-HQ-OPP-2015-0629-0006
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fomesafen
Posted Date: 2018-02-07T05:00Z

[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Rules and Regulations]
[Pages 5312-5317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 (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: [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

[[Page 5313]]

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

[[Page 5314]]

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
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
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).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)    Classification: The Agency has classified Fomesafen as ``Not Likely to be
                                                              Carcinogenic to Humans''
----------------------------------------------------------------------------------------------------------------
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

[[Page 5315]]

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

[[Page 5316]]

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: (410) 305-2905; email address: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food 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

[[Page 5317]]

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