Document ID: EPA-HQ-OPP-2012-0589-0008
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Fomesafen
Posted Date: 2013-11-01T04:00Z

[Federal Register Volume 78, Number 212 (Friday, November 1, 2013)]
[Rules and Regulations]
[Pages 65565-65570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25984]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0589; FRL-9401-8]

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 multiple commodities which are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective November 1, 2013. Objections and 
requests for hearings must be received on or before December 31, 2013, 
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-2012-0589, 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), EPA West 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

[[Page 65566]]

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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; 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-2012-0589 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 
December 31, 2013. 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-2012-0589, 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 September 28, 2012 (77 FR 59578) (FRL-
9364-6) and June 5, 2013 (78 FR 33785) (FRL-9386-2), EPA issued 
documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), 
announcing the filing of pesticide petitions (PP 2E8061 and 3E8167) by 
IR-4, IR-4 Project Headquarters, 500 College Road East, Suite 201W, 
Princeton, NJ 08540. The petitions requested that 40 CFR 180.433 be 
amended by establishing tolerances for residues of the herbicide 
fomesafen, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-
2-nitrobenzamide, in or on cantaloupe; cucumber; pea, succulent; 
pumpkin; squash, summer; squash, winter; and watermelon all at 0.025 
parts per million (ppm); and soybean, vegetable, succulent at 0.05 ppm 
(2E8061); and bean, lima, succulent at 0.05 ppm (3E8167). The documents 
referenced a summary of each petition prepared by Syngenta Crop 
Protections, LLC, the registrant, which are available in the docket, 
http://www.regulations.gov. One public comment was received on the 
notice of filing for PP 3E8167. EPA's response to the comment is 
discussed in Unit IV.C.
    Based upon review of data supporting the petition, EPA corrected 
the commodity name for certain crops for which a tolerance was proposed 
as explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from 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 their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    In the subchronic and chronic fomesafen 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 and mice also showed 
hematological changes (e.g., decreased erythrocyte count, hemoglobin, 
or hematocrit).
    In the developmental studies, post-implantation loss was noted but 
no quantitative or qualitative evidence of increased susceptibility to 
fomesafen

[[Page 65567]]

was seen following in utero exposure to rat or rabbit fetuses in 
prenatal developmental studies or postnatally in rat 2-generation 
reproduction study.
    Acute neurotoxicity studies indicate fomesafen may cause 
neurotoxicity (decreased motor activity) at the same dose level as 
systemic toxicity. Although suppression of anti-sheep red blood cell 
immunoglobulin (SRBC IgM) response was noted in the immunotoxicity 
study, the selected endpoints for risk assessment are protective of 
this effect.
    Carcinogenicity was not observed in the rat chronic toxicity/
carcinogenicity study. Although liver tumors were seen in the mouse 
carcinogenicity study, EPA classified fomesafen as ``Not Likely to be 
Carcinogenic to Humans'' because the mode of action for fomesafen-
induced hepatocarcinogenesis in mice is unlikely to take place in 
humans. 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 document: ``Fomesafen Sodium: Human Health Risk 
Assessment for the Section 3 Registration Action on Cantaloupe, 
Cucumber, Pea (Succulent), Pumpkin, Summer Squash, Winter Squash, 
Watermelon, Soybean (Succulent) and Lima Bean (Succulent),'' dated July 
18, 2013 at page 27 in docket ID number EPA-HQ-OPP-2012-0589.

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://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fomesafen used for 
human risk assessment is shown in Table 1. of this unit.

   Table 1--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
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 100 mg/kg/    Acute RfD = 1 mg/kg/ Acute neurotoxicity test in the
 including infants and children).   day                   day                  rat.
                                   UFA = 10x...........  aPAD = 1 mg/kg/day.  LOAEL = 250 mg/kg/day based on
                                   UFH = 10x...........                        decreased body weight and motor
                                   FQPA SF = 1x........                        activity (horizontal and vertical
                                                                               activity and time in central
                                                                               quadrant) in males.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 0.25 mg/kg/    Chronic RfD =        Chronic toxicity/carcinogenicity
                                    day UFA = 10x         0.0025 mg/kg/day     in the rat.
                                   UFH = 10x...........  cPAD = 0.0025 mg/kg/ LOAEL = 5 mg/kg/day based on
                                   FQPA SF = 1x........   day.                 hyalinization of the liver in
                                                                               males.
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FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. 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 Dietary Exposure Evaluation Model--Food 
Consumption Intake Database (DEEM-FCID), ver. 3.16 which incorporates 
consumption data from the United States Department of Agriculture 
(USDA) 2003--2008 National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEA). Acute analysis assumed 100 
percent crop treated (PCT), DEEM 7.81 default concentration factors, 
tolerance-level residues for all existing and proposed crop uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used DEEM-FCID, ver. 3.16 which incorporates consumption 
data from USDA 2003--2008 NHANES/WWEA. As to residue levels in food, 
EPA analysis assumed 100 PCT and tolerance-level residues for all 
existing and proposed crop uses.
    iii. Cancer. Based on the data summarized in Unit III.A., 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

[[Page 65568]]

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://www.epa.gov/oppefed1/models/water/index.htm.
    Screening model Tier II Pesticide Root Zone Model/Exposure Analysis 
Modeling System (PRZM/EXAMS) was used to calculate surface water 
estimated drinking water concentrations (EDWCs). Groundwater EDWCs for 
fomesafen were calculated using Tier 1 Pesticide Root Zone Model Ground 
Water (PRZM GW). Acute exposures are estimated to be 34.8 parts per 
billion (ppb) for surface water and 51.8 ppb for ground water.
    Chronic exposures for non-cancer assessments are estimated to be 
13.1 ppb for surface water and 32.3 ppb for ground water.
    Modeled estimates of drinking water concentrations are based on 
ground water EDWCs, which were highest among surface water and ground 
water EDWCs (representing worst case), were directly entered into the 
dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
51.8 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 32.3 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).
    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 Web site at http://www.epa.gov/pesticides/cumulative.

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. The pre- and postnatal 
database for fomesafen includes a prenatal developmental toxicity study 
in rabbits, two prenatal developmental toxicity studies in rats, and a 
2-generation reproduction toxicity study in rats. The rabbit 
developmental study was classified as unacceptable because of bacterial 
infection in the colony; however, the study provided information to 
assess potential developmental toxicity in rabbits. There was no 
significant difference between the treated and control animals for 
developmental abnormalities in the rabbit study. In the two rat 
developmental studies (considered together), developmental effects 
(postimplantation loss) occurred at the same dose causing maternal 
toxicity (staining of the ventral fur and significantly decreased body 
weight gain (>10%)). In the rat reproduction study, offspring effects 
(increased incidence of liver hyalinization in males) occurred at the 
same dose causing parental effects (liver histopathology in males and 
females of both generations).
    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 fomesafen is complete. The 
developmental toxicity study in rabbits, classified unacceptable due to 
mortality from bacterial infections, showed 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 was not considered a data gap.
    ii. There is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity. In an acute neurotoxicity 
screening battery in rats, decreased motor activity (horizontal and 
vertical activity and time in central quadrant) was observed at the 
same dose that resulted in general systemic toxicity. 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 any potential neurotoxicity.
    iii. There is no evidence that fomesafen results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. The 2-generation reproduction study in rats did not show 
evidence of increased susceptibility to fomesafen.
    iv. There are no residual uncertainties identified in the exposure 
databases. Tolerance level residues and 100 PCT were assumed for all 
food commodities. 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 < 1% of the aPAD for all population subgroups, 
including all infants (< 1 year 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

[[Page 65569]]

food and water will utilize 77% of the cPAD for all infants (< 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- or intermediate-term 
residential exposure plus chronic exposure from food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, fomesafen 
is not registered for any use patterns that would result in short- and 
intermediate-term residential 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 short-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 data 
summarized in Unit III.A., 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 enforcement methodology (high performance liquid 
chromatography method with tandem mass spectrometry detection (LC/MS/
MS) method (GRM045.01A) is available to enforce the tolerance 
expression. 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: 
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.
    Codex has not established maximum residue limits (MRLs) for 
residues of fomesafen.

C. Response to Comments

    The Agency received an anonymous public comment objecting to the 
proposed fomesafen tolerance on lima bean because of the amounts of 
pesticides already consumed and carried by the American population.
    The Agency understands the commenter's concerns and recognizes that 
some individuals believe that pesticides should be banned completely. 
However, under the existing legal framework provided by section 408 of 
the FFDCA, EPA is authorized to establish pesticide tolerances or 
exemptions where persons seeking such tolerances or exemptions have 
demonstrated that the pesticide meets the safety standard imposed by 
that statute.

D. Revisions to Petitioned-For Tolerances

    Petitioned-for tolerance levels in or on commodities were 
unchanged, however, the commodity name of certain proposed crops was 
changed to comply with current EPA commodity definitions, as follows: 
Winter, squash changed to squash, winter; vegetable, soybean, succulent 
to soybean, vegetable, succulent; and lima, bean to bean, lima, 
succulent.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide 
fomesafen, including its metabolites and degradates, in or on 
cantaloupe; cucumber; pea, succulent; pumpkin; squash, summer; squash, 
winter; and watermelon all at 0.025 ppm; soybean, vegetable, succulent 
at 0.05 ppm; and bean, lima, succulent at 0.05 ppm.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
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). This final rule does not contain 
any information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require

[[Page 65570]]

Agency consideration of voluntary consensus standards pursuant to 
section 12(d) of the National Technology Transfer and Advancement Act 
of 1995 (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: October 17, 2013.
Lois Rossi,
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, add alphabetically the following commodities to 
the table in paragraph (a) to read as follows:

Sec.  180.433  Fomesafen; tolerance for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Bean, lima, succulent......................................         0.05
 
                                * * * * *
Cantaloupe.................................................        0.025
 
                                * * * * *
Cucumber...................................................        0.025
Pea, succulent.............................................        0.025
 
                                * * * * *
Pumpkin....................................................        0.025
 
                                * * * * *
Soybean, vegetable, succulent..............................         0.05
Squash, summer.............................................        0.025
Squash, winter.............................................        0.025
 
                                * * * * *
Watermelon.................................................        0.025
------------------------------------------------------------------------

* * * * *
[FR Doc. 2013-25984 Filed 10-31-13; 8:45 am]
BILLING CODE 6560-50-P