
[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Rules and Regulations]
[Pages 66715-66720]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27066]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0756; FRL-9366-8]


Fluridone; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of fluridone in or on cotton. This action is in response to 
EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing 
use of the pesticide on cotton. This regulation establishes a maximum 
permissible level for residues of fluridone in or on cotton 
commodities. The time-limited tolerances expire on December 31, 2014.

DATES: This regulation is effective November 7, 2012. Objections and 
requests for hearings must be received on or before January 7, 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-2012-0756, 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 Docket is (703) 305-
5805. Please review the visitor instructions and additional

[[Page 66716]]

information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Debra Rate, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0309; email address: rate.debra@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:
    [emsp14]Crop production (NAICS code 111).
    [emsp14]Animal production (NAICS code 112).
    [emsp14]Food manufacturing (NAICS code 311).
    [emsp14]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 40 CFR 
part 180 through the Government Printing Office's e-CFR site at: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 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-
2012-0756 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 January 7, 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-2012-0756, 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.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for residues of fluridone, 1-
methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-pyridinone, its 
metabolites and degradates, in or on cotton, undelinted seed at 0.1 
parts per million (ppm). These time-limited tolerances expire on 
December 31, 2014.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under FIFRA 
section 18. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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 * * 
*.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Fluridone on Cotton and FFDCA Tolerances

    This is the first section 18 request received for the use of 
fluridone on cotton. Since the introduction of glyphosate resistant 
cotton in 1997, twenty-one weed species have developed resistance to 
glyphosate. Glyphosate-resistant palmer amaranth is the most serious of 
these species across all the major agronomic crops in the southern U.S. 
Glyphosate-resistant palmer amaranth was confirmed in Arkansas in 2006. 
Since 2006, it has become the most severe weed problem that Arkansas 
cotton producers face. Greater than 95% of Arkansas cotton and 80% of 
soybean contain the glyphosate tolerant gene and thus glyphosate is the 
base herbicide for weed control. A significant economic loss is 
expected to occur on nearly 25% of acres grown or about 160,000 acres.
    After having reviewed the Arkansas emergency exemption application, 
EPA determined that an emergency condition exists for this State, and 
that the criteria for approval of an emergency exemption are met. EPA 
has authorized a specific exemption under FIFRA section 18 for the use 
of fluridone on cotton for control of glyphosate-resistant palmer 
amaranth in Arkansas.
    As part of its evaluation of the emergency exemption application, 
EPA

[[Page 66717]]

assessed the potential risks presented by residues of fluridone in or 
on cotton. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing this tolerance without notice and opportunity for public 
comment as provided in FFDCA section 408(l)(6). Although these time-
limited tolerances expire on December 31, 2014, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on cotton, undelinted seed 
after that date will not be unlawful, provided the pesticide was 
applied in a manner that was lawful under FIFRA, and the residues do 
not exceed a level that was authorized by these time-limited tolerances 
at the time of that application. EPA will take action to revoke these 
time-limited tolerances earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
fluridone meets FIFRA's registration requirements for use on cotton or 
whether permanent tolerances for this use would be appropriate. Under 
these circumstances, EPA does not believe that this time-limited 
tolerance decision serves as a basis for registration of fluridone by a 
State for special local needs under FIFRA section 24(c). Nor does this 
tolerance by itself serve as the authority for persons in any State 
other than Arkansas to use this pesticide on the applicable crops under 
FIFRA section 18 absent the issuance of an emergency exemption 
applicable within that State. For additional information regarding the 
emergency exemption for fluridone, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. 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 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 expected as a result of this emergency exemption request and 
the time-limited tolerances for residues of fluridone on cotton, 
undelinted seed at 0.1 ppm. EPA's assessment of exposures and risks 
associated with establishing time-limited tolerances follows.

A. 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 non-threshold 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 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 (females 13-49       NOAEL = 125 mg/kg/    aRfD = 1.25 mg/kg/   Developmental toxicity--rabbit.
 years of age).                     day.                  day.                LOAEL = 300 mg/kg/day based on
                                   UFA = 10x...........  aPAD = 1.25 mg/kg/    increased incidences of
                                   UFH = 10x...........   day..                abortions.
                                   FQPA SF = 1X........
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Chronic dietary (All populations)  NOAEL = 15 mg/kg/day  cRfD = 0.15 mg/kg/   2 yr. cancer study in mice.
                                   UFA = 10x...........   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 heptocellular hyperplasia.

[[Page 66718]]

 
Incidental oral short-term (1-30   NOAEL = 15 mg/kg/day  LOC for MOE = 100..  2 yr. cancer study in mice (same
 days) and intermediate-term (1-6  UFA = 10x...........                        as above).
 months) oral, dermal, and         UFH = 10x...........
 inhalation exposures.
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)  Fluridone is classified as ``not likely'' to be a human carcinogen, based on
                                    the lack of evidence of carcinogenicity in mice and rats. 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).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fluridone, EPA considered exposure under the time-limited 
tolerances established by this action 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. Such effects were identified for fluridone. In 
estimating acute dietary exposure for the subpopulation, females 13-49 
years, EPA used food consumption information from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). As to residue 
levels in food, EPA used tolerance level residues, DEEM (Ver. 7.81) 
default processing factors (as necessary) and 100 percent crop treated 
(PCT) for all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used tolerance level 
residues, DEEM (Ver. 7.81) default processing factors (as necessary) 
and 100 PCT for all commodities.
    iii. Cancer. Based on the data summarized in Unit IV.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 or PCT information in the dietary assessment for 
fluridone. 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 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://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of fluridone for acute 
exposures are estimated to be 9.6 parts per billion (ppb) for surface 
water and 0.67 ppb for ground water. EDWCs of fluridone for chronic 
exposures for non-cancer assessments are estimated to be 2.5 ppb for 
surface water and 0.67 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 9.6 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 2.5 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, swimming in treated water, and flea and tick control on 
pets).
    Fluridone is currently registered for one use that could result in 
residential handler and residential post-application exposures: 
Consumer use to control aquatic weeds in ponds. EPA assessed 
residential exposure using the following assumptions: Residents or 
consumers may experience short-term (1-30 days) skin contact or 
inhalation exposures. These exposures are assessed through residential 
handler scenarios. Post-application exposures of children and adults 
through contact with treated swimming ponds are also anticipated. These 
exposures are expected to be short- and intermediate-term (1-6 months) 
in duration through dermal, ingestion, aural, buccal/sublingual, and 
nasal/orbital exposure. All residential handler and post-application 
scenarios from the uses of fluridone have been assessed and no risks of 
concern have been identified (MOE <=100). The scenarios for residential 
handler and post-application exposure (combined dermal and inhalation) 
resulted in MOEs of 1,800 and 23,000, respectively.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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

[[Page 66719]]

http://www.epa.gov/pesticides/cumulative.

C. 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 SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Based on the results in the 
developmental toxicity studies in rats and rabbits and in a three-
generation reproduction study, no increased sensitivity of fetuses or 
pups (as compared to adults) was demonstrated for fluridone. There are 
no concerns or residual uncertainties for prenatal/postnatal toxicity 
following exposure to fluridone.
    3. Conclusion. EPA has determined that reliable data show that 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 except for the 
lack of an immunotoxicity study and a neurotoxicity battery (i.e., 
acute and subchronic neurotoxicity) that meets the new data 
requirements in 40 CFR part 158 for conventional pesticide 
registration. However, the existing toxicology database for fluridone 
does not show any evidence of treatment-related effects on either the 
nervous or the immune system. In addition, fluridone does not belong to 
any class of compounds (e.g., the organotins, heavy metals, or 
halogenated aromatic hydrocarbons) that would be expected to be 
immunotoxic. Based on the currently available data for fluridone, the 
Agency expects that findings from the additional studies will not 
result in a lower point of departure POD than that currently in use for 
overall risk assessment, and therefore, a database uncertainty factor 
is not needed to account for the lack of these studies.
    ii. There is no indication that fluridone is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that fluridone 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.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessment utilized 100 PCT and 
tolerance-level residues (established or recommended). 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 post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by fluridone.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. An adverse effect resulting from a single oral exposure 
was identified for only the subpopulation females 13-49 years. Using 
the exposure assumptions described in this unit for acute exposure, EPA 
has concluded that acute exposure to fluridone from food and water will 
utilize less than 1% of the aPAD for females 13-49 years. Therefore, 
fluridone is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
fluridone from food and water will utilize 4% of the cPAD for children 
1-2 years, the population group receiving the greatest exposure. Based 
on the explanation in the unit regarding residential use patterns, 
chronic residential exposure to residues of fluridone is not expected.
    3. Short-and Intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short-term residential exposure 
or intermediate-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- and intermediate-term residential exposure, and the Agency has 
determined that it is appropriate to aggregate chronic exposure through 
food and water with short- and intermediate-term residential exposures 
to fluridone.
    Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded the combined 
short-term food, water, and residential exposures and the intermediate-
term food, water, and residential exposures each result in aggregate 
MOEs of 290 (liquids for pouring applications + swimming exposure) to 
340 (liquids for garden hose end sprayer + swimming exposure). Because 
EPA's level of concern for fluridone is a MOE of 100 or below, these 
MOEs are not of concern.
    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.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies (enzyme-linked immunosorbant 
assay (ELISA), high performance liquid chromatography with ultraviolet 
detection (HLPC/UV), and liquid chromatography with tandem mass 
spectroscopy (LC-MSMS)) are available to enforce the tolerance 
expression. 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).

[[Page 66720]]

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 an 
MRL for fluridone.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
fluridone, 1-methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-4(1H)-
pyridinone, including its metabolites and degradates, in or on cotton, 
undelinted seed at 0.1 ppm. This tolerance expires on December 31, 
2014.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA sections 408(e) 
and 408(l)(6). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), 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 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).

VIII. 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 26, 2012.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 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, revise paragraph (b) to read as follows:


Sec.  [emsp14]180.420  Fluridone; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
herbicide fluridone, 1-methyl-3-phenyl-5-(3-(trifluoromethyl)phenyl)-
4(1H)-pyridinone, including its metabolites and degradates in or on the 
specified agricultural commodities, resulting from use of the pesticide 
pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) section 18 emergency exemptions. Compliance with the tolerance 
levels specified below is to be determined by measuring only fluridone. 
The tolerances expire on the date specified in the table.

------------------------------------------------------------------------
                                                Parts per    Expiration
                  Commodity                      million        date
------------------------------------------------------------------------
Cotton, undelinted seed.....................          0.1      12/31/14
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-27066 Filed 11-6-12; 8:45 am]
BILLING CODE 6560-50-P


