[Federal Register Volume 81, Number 31 (Wednesday, February 17, 2016)]
[Rules and Regulations]
[Pages 7982-7987]
[FR Doc No: 2016-03220]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0913; FRL-9941-69]

Fluridone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of
fluridone in or on cotton, undelinted seed. SePRO Corporation requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA).

DATES: This regulation is effective February 17, 2016. Objections and
requests for hearings must be received on or before April 18, 2016, 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-2014-0913, 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: Susan Lewis, 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_ADDRESS>
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-2014-0913 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 18, 2016. 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-2014-0913, 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 April 6, 2015 (80 FR 18327) (FRL-9924-
00), 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
4F8308) by SePRO Corporation, 11550 North Meridian Street, Suite 600,
Carmel, IN 46032. The petition requested that 40 CFR part 180 be
amended by establishing tolerances for residues of

the herbicide fluridone, 1-methyl-3-phenyl-5-(3-
(trifluoromethyl)phenyl)-4(1H)-pyridinone, in or on cotton, undelinted
seed at 0.1 parts per million (ppm). That document referenced a summary
of the petition prepared by SePRO Corporation, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

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 fluridone including exposure
resulting from the tolerance established by this action. EPA's
assessment of exposures and risks associated with fluridone 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 liver and kidneys were identified as the primary target
organs based on a multitude of organ specific effects noted across the
toxicity database. All model species exhibited indications of liver
toxicity that were often accompanied by body weight effects. Mice were
the most sensitive species examined, and dogs were the most tolerant.
Rat sensitivity was comparable (chronic exposure) to or slightly less
(subchronic exposure) than mice; however, rats were the only species to
exhibit minor kidney effects in addition to liver and body weight
toxicity. Progression of toxicity from subchronic to chronic exposures
was not observed in mice and was limited (2-fold difference) in rats.
No evidence of fetal sensitivity was observed in rats or rabbits. Body
weight effects in the F2 rat offspring during the lactation
period were suggestive of susceptibility in the young. However, this
evidence is considered equivocal because the effects were isolated to
the F2 offspring, body weight of the F2 offspring
returned to control levels after the lactation period and no subsequent
evidence of susceptibility was observed in progeny of the F2
generation. Furthermore, the offspring effects occurred at doses 2 to
4.5 times higher than the target organ and body weight toxicity noted
in adult rodents. While these effects are considered equivocal,
susceptibility will be assumed to be present in the young in the
absence of more definitive toxicity data. Behavioral anomalies,
physiological effects, and locomotor impairment consistent with
neurotoxicity were only observed following acute gavage exposure to
doses that likely exceeded linear pharmacokinetics and were at least 13
to 26 times higher than the lowest doses causing liver and kidney
effects in rodents. No signs of neurotoxicity were identified in the
rest of the toxicity database. Toxicity from repeated dose dermal
exposures was limited to irritation effects on the skin (erythema,
desquamation, epidermal fissures). No evidence of immunotoxicity,
mutagenicity, or carcinogenicity were noted in the toxicity database.
Fluridone did not demonstrate mutagenic behavior either in vitro or in
vivo nor did exposure result in an increased incidence of tumors. The
EPA concluded that fluridone should be classified as ``not likely'' to
be a human carcinogen.
    Specific information on the studies received and the nature of the
adverse effects caused by fluridone 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 Fluridone. Human Health Risk Assessment
for Registration Review and to Support the Registration of the Use on
Cotton on pages 47 thru 72 in docket ID number EPA-HQ-OPP-2014-0913.

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.
    The 2-year mouse study was used for the residential points of
departures (PODs) for short- and intermediate-term incidental oral,
dermal and inhalation exposure. The mouse chronic endpoint was
considered appropriate for short-and intermediate-term fluridone
exposures because mice were the most sensitive species and there was no
progression of toxicity from subchronic to chronic exposure.
    The guideline dermal study was not used to set endpoints for the
dermal assessment, because the study did not address concerns for the
possible sensitivity in the young observed in the 3-generation
reproduction study. The systemic NOAEL from the dermal study is 384
milligram/kilogram/day (mg/kg/day), but there is equivocal, yet
suggestive evidence of offspring toxicity at 112 mg/kg/day. The NOAEL
from the 2-year mouse cancer study is 38.5 mg/kg/day after accounting
for route-to-route extrapolation (dermal absorption factor of 39%) and
is therefore protective of the equivocal offspring effects. The chronic
mouse oral

endpoint was used for the inhalation assessment as well, because a
route-specific inhalation study was not available. Without a route
specific study, inhalation exposure was assumed to be equivalent to
oral exposure.
    A summary of the toxicological endpoints for fluridone used for
human risk assessment is shown in Table 1 of this unit.

   Table 1--Summary of Toxicological Doses and Endpoints for Fluridone 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
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Acute dietary (All populations)..  NOAEL = 125 mg/kg/    Acute RfD = 1.25 mg/ Acute Neurotoxicity--Rat.
                                    day.                  kg/day.             LOAEL = 650 mg/kg/day based on
                                   UFA = 10x...........  aPAD = 1.25 mg/kg/    decreased ambulatory counts and
                                   UFH = 10x...........   day.                 the prevalence of functional
                                   FQPA SF = 1x........                        observational battery (FOB)
                                                                               anomalies in males and females.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL= 15 mg/kg/day.  Chronic RfD = 0.15   2-year cancer study--Mouse.
                                    UFA = 10x..........   mg/kg/day.          LOAEL = 50 mg/kg/day based on
                                   UFH = 10x...........  cPAD = 0.15 mg/kg/    increased alkaline phosphatase
                                   FQPA SF = 1x........   day.                 activity and increased incidence
                                                                               of hepatocellular hyperplasia.
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Incidental oral short-term (1 to   NOAEL= 15 mg/kg/day.  LOC for MOE = 100..  2-year cancer study--Mouse.
 30 days) and intermediate-term.    UFA = 10x..........                       LOAEL = 50 mg/kg/day based on
                                   UFH = 10x...........                        increased alkaline phosphatase
                                   FQPA SF = 1x........                        activity and increased incidence
                                                                               of hepatocellular hyperplasia.
----------------------------------------------------------------------------------------------------------------
Dermal short-term (1 to 30 days)   Oral study NOAEL =    LOC for MOE = 100..  2-year cancer study--Mouse.
 and intermediate-term (1 to 6      15 mg/kg/day                              LOAEL = 50 mg/kg/day based on
 months).                           (dermal absorption                         increased alkaline phosphatase
                                    rate = 39%).                               activity and increased incidence
                                   UFA = 10x...........                        of hepatocellular hyperplasia.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Oral study NOAEL= 15  LOC for MOE = 100..  2-year cancer study--Mouse.
 days) and intermediate-term (1     mg/kg/day                                 LOAEL = 50 mg/kg/day based on
 to 6 months).                      (inhalation                                increased alkaline phosphatase
                                    absorption rate =                          activity and increased incidence
                                    100%).                                     of hepatocellular hyperplasia.
                                   UFA = 10x...........
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Fluridone is classified as ``not likely'' to be a human carcinogen.
                                    Quantitative cancer risk assessment is not required.
----------------------------------------------------------------------------------------------------------------
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 fluridone, EPA considered exposure under the petitioned-for
tolerances as well as all existing fluridone tolerances in 40 CFR
180.420. EPA assessed dietary exposures from fluridone 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 fluridone. In estimating acute dietary exposure, EPA used food
consumption information from the United States Department of
Agriculture (USDA) National Health and Nutrition Examination Survey,
What We Eat in America, (NHANES/WWEIA). This dietary survey was
conducted from 2003 to 2008. 100 percent crop treated (PCT), tolerance
residues, and default processing factors were assumed for this
assessment.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA. This dietary survey was conducted from 2003 to 2008. 100 PCT,
tolerance residues, and default processing factors were assumed.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fluridone 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 and/or PCT information in the dietary assessment
for fluridone. Tolerance-level residues and/or 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 fluridone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/

transport characteristics of fluridone. 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 First Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of fluridone for acute exposures
are estimated to be 24 parts per billion (ppb) for surface water and 34
ppb for ground water. For chronic exposures they are estimated to be 21
ppb for surface water and 32 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 34 ppb was used to assess
the contribution to drinking water. For chronic dietary risk
assessment, the water concentration of value 32 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).
    Fluridone is currently registered for the following uses that could
result in residential exposures: From use on ponds (including a
homeowner use), lakes, reservoirs, and rivers. EPA assessed residential
exposure using the following assumptions: Adult applicators may be
exposed (dermal and inhalation) while applying the pesticide to
residential ponds. Residential handler exposure is expected to be
short-term in duration only. Intermediate-term and chronic exposures
are not likely because of the intermittent nature of applications by
homeowners. There is also potential for residential post-application
exposure (dermal, inhalation and incidental ingestion) for adults and
children (3 to <6 years old) swimming in treated water. Residential
post-application exposure is expected to be short term in duration
only.
    Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found fluridone to share a common mechanism of toxicity
with any other substances, and fluridone does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fluridone 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://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 was no evidence of
qualitative susceptibility in fetuses in the rat and rabbit
developmental study. Equivocal susceptibility was observed in the young
from the F2 population in the reproductive study during the
lactation phase (based decreased body weight); however, body weight of
the F2 offspring returned to control levels after the
lactation period and no evidence of susceptibility was observed in the
F3 offspring.
    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 fluridone is complete. Though EPA
relied on an oral study to assess inhalation exposures, a subchronic
inhalation study is not required based on a weight-of-evidence (WOE)
approach that considered the physical/chemical properties of fluridone
including low vapor pressure, low acute inhalation toxicity, and the
large short- and intermediate-term inhalation MOEs calculated.
    ii. The combination of behavioral anomalies and impaired
physiological and locomotor function in the acute neurotoxicity (ACN)
study were suggestive of neurotoxicity following high dose acute
exposure. However, the concern for neurotoxicity is low because the
adverse effects in the ACN study were only seen at relatively high
gavage doses (650-2000 mg/kg/day); there were no corresponding
neurohistopathological findings; there were no indications of
neurotoxicity in the rest of the toxicity database; and the endpoints
selected for risk assessment are protective of these adverse effects.
    iii. There is no evidence that fluridone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies. There was equivocal susceptibility observed in
the young from the F2 population in the reproductive study
during the lactation phase (decreased body weight); however, body
weight of the F2 offspring returned to control levels after
the lactation period, and no evidence of susceptibility was observed in
the F3 offspring. The PODs selected to assess risk are
protective of the equivocal susceptibility in young animals.
    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 fluridone in drinking water. EPA used similarly
conservative assumptions to assess postapplication exposure of children
as well as incidental oral exposure of toddlers. These assessments will
not underestimate the exposure and risks posed by fluridone.

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 fluridone will occupy 1.3% of the aPAD for children 1-2 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
fluridone from food and water will utilize 5.5% of the cPAD for
children 1-2 years old the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
fluridone is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Fluridone is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to fluridone. Using the exposure
assumptions described in this unit for short-term exposures, EPA has
concluded the combined short-term food, water, and residential
exposures result in aggregate MOEs of 1,500 for adults and 1,600 for
children. Because EPA's level of concern for fluridone is a MOE of 100
or below, these MOEs are not of concern.
    4. Intermediate-term risk. An intermediate-term adverse effect was
identified; however, fluridone is not registered for any use patterns
that would result in intermediate-term residential exposure.
Intermediate-term risk is assessed based on intermediate-term
residential exposure plus chronic dietary exposure. Because there is no
intermediate-term residential exposure and chronic dietary exposure has
already been assessed under the appropriately protective cPAD (which is
at least as protective as the POD used to assess intermediate-term
risk), no further assessment of intermediate-term risk is necessary,
and EPA relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for fluridone.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fluridone is not expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to fluridone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology [high performance liquid
chromatography (HPLC) method (originally submitted as method AM-AA-CA-
RO52-AA-755)] is available in the Pesticide Analytical Manual (PAM)
Volume II for residues of fluridone in plant commodities, including
cotton.

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 a MRL for fluridone in cotton.

V. Conclusion

    Therefore, a tolerance is established for residues of fluridone, 1-
methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-pyridinone, in or
on cotton, undelinted seed at 0.1 ppm. Additionally, the tolerances for
cotton, undelinted seed at 0.1 ppm in paragraphs (b) and (d) are
removed, since they are superseded by this action.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). 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: February 8, 2016.
Susan Lewis,
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.  180.420, is amended:
0
i. By alphabetically adding ``cotton, undelinted seed'' to the table in
paragraph (a)(2);
0
ii. By removing and reserving the text of paragraph (b);
0
iii. By removing ``cotton, undelinted seed'' from the table in
paragraph (d).
    The addition reads as follows:

Sec.  180.420  Fluridone; tolerances for residues.

    (a) * * *
    (2) * * *

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

                                * * * * *
Cotton, undelinted seed.................................             0.1

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

    (b) Section 18 emergency exemptions. [Reserved].
* * * * *
[FR Doc. 2016-03220 Filed 2-16-16; 8:45 am]
 BILLING CODE 6560-50-P