

[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Rules and Regulations]               
[Page 11526-11533]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr06-7]                         

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0311; FRL-7764-1]

 
Flumiclorac Pentyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

[[Page 11527]]

SUMMARY: This regulation establishes tolerances for residues of 
flumiclorac pentyl in or on undelinted cottonseed and cotton gin 
byproducts. Valent U.S.A. Corporation requested this tolerance under 
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the 
Food Quality Protection Act of 1996 (FQPA).

DATES: This regulation is effective March 8, 2006. Objections and 
requests for hearings must be received on or before May 8, 2006.

ADDRESSES:  To submit a written objection or hearing request follow the 
detailed instructions as provided in Unit VI. of theSUPPLEMENTARY 
INFORMATION. EPA has established a docket for this action under Docket 
identification (ID) number EPA-HQ-OPP-2005-0311. All documents in the 
docket are listed on the http://www.regulations.gov web site. (EDOCKET, EPA's 

electronic public docket and comment system was replaced on November 
25, 2005, by an enhanced Federal-wide electronic docket management and 
comment system located at http://www.regulations.gov/. Follow the on-

line instructions.) Although listed in the index, some information is 
not publicly available, i.e., CBI or other information whose disclosure 
is restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either electronically in EDOCKET or in hard copy at the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket 
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The docket telephone number is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT:  Joanne I. Miller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460-
0001; telephone number: (703) 305-6224; e-mail 
address:miller.joanne@epamail.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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers; 
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and 
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural 
workers; commercial applicators; farmers; greenhouse, nursery, and 
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket/),you may 

access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180 

is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/. 

To access the OPPTS Harmonized Guidelines referenced in this document, 
go directly to the guidelines athttp://www.epa. gpo/opptsfrs/home/

guidelin. htm/.

II. Background and Statutory Findings

    In the Federal Register of November 30, 2005 (70 FR 71844) (FRL-
7747-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
3F6767) by Valent U.S.A. Corporation, 1600 Riviera Ave., Suite 200, 
Walnut Creek, CA 94596-8025. The petition requested that 40 CFR 180.477 
be amended by establishing tolerances for residues of the herbicide, 
flumiclorac pentyl, [2-chloro-4-fluoro-5-(1,3,4,5,6,7-hexahydro-1,3-
dioxo-2H-isoindol-2-yl)phenoxy]-acetate, in or on cotton undelinted 
seed at 0.1 parts per million (ppm) and cotton gin by products at 2.0 
ppm. That notice included a summary of the petition prepared by Valent 
U.S.A. Corporation, the registrant. The Notice of Availability of the 
Flumiclorac Pentyl Tolerance Reassessment (TRED) was published in the 
Federal Register on October 19, 2005 (70 FR 60824) (FRL-7740-4). The 
flumiclorac pentyl TRED stated that the residues should be expressed as 
flumiclorac pentyl, per se, and that the tolerances for cotton 
undelinted seed be increased to 0.2 ppm, and that cotton gin by 
products be increased to 3.0 ppm. One comment was received on the 
notice of filing. EPA's response to this comment is discussed in Unit 
IV.C.
    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. . . 
.''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www. epa.gov/

fedrgstr/ EPA-PEST/1997/ November/ Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section 
408(b)(2) of FFDCA, for a tolerance for residues of flumiclorac pentyl 
on cotton undelinted seed at 0.2 ppm and cotton gin by products at 3.0 
ppm. EPA's assessment of exposures and risks associated with 
establishing the tolerance follows.

[[Page 11528]]

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. Specific information on the studies received and the nature 
of the toxic effects caused by flumiclorac pentyl are discussed in 
Table 1 of this unit as well as the no observed adverse effect level 
(NOAEL) and the lowest observed adverse effect level (LOAEL) from the 
toxicity studies reviewed.

            Table 1.--Subchronic, Chronic, and Other Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type      Results Assessment
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 1,359
                                   toxicity--rodents   milligrams/
                                   (rat)               kilogram/day (mg/
                                                       kg/day)males (M)
                                                       and 1,574 mg/kg/
                                                       day females (F) -
                                                       Highest Dose
                                                       Tested(HTD)
                                                      LOAEL was not
                                                       established
------------------------------------------------------------------------
870.3150                          90-Day oral         NOAEL = 100 mg/kg/
                                   toxicity--          day
                                   nonrodents (dog)   LOAEL = 1,000 mg/
                                                       kg/day based on
                                                       increased
                                                       clotting time in
                                                       females
------------------------------------------------------------------------
870.3200                          21/28-Day dermal    NOAEL = 1,000 mg/
                                   toxicity (rat)      kg/day (limit
                                                       dose)
------------------------------------------------------------------------
870.3700                          Prenatal            Maternal NOAEL =
                                   developmental--     1,500 mg/kg/day -
                                   rodents (rat)       HDT
                                                      Maternal LOAEL was
                                                       not established
                                                      Developmental
                                                       NOAEL = 1,500 mg/
                                                       kg/day - HDT
                                                      Developmental
                                                       LOAEL was not
                                                       established
------------------------------------------------------------------------
870.3800                          Reproduction and    Parental/Systemic
                                   fertility effects   NOAEL = 16/18mg/
                                   (rat)               kg/day (M/F)
                                                      Parental/Systemic
                                                       LOAEL = 781/925mg/
                                                       kg/day (M/F)
                                                       based on
                                                       increased kidney
                                                       weight in males
                                                       andfemales and
                                                       nephropathy in
                                                       males
                                                      Reproductive NOAEL
                                                       = 1610/1869 mg/kg/
                                                       day (M/F) - HDT
                                                      Reproductive LOAEL
                                                       was not
                                                       established
                                                      Offspring NOAEL =
                                                       781/925mg/kg/day
                                                       (M/F)
                                                      Offspring LOAEL =
                                                       1610/1869mg/kg/
                                                       day (M/F) based
                                                       on decreasedbody
                                                       weight/body
                                                       weight in F2 pups
------------------------------------------------------------------------
870.4100                          Chronic toxicity--  NOAEL = 100 mg/kg/
                                   dogs                day
                                                      LOAEL = 1,000 mg/
                                                       kg/day based on
                                                       decreased body
                                                       weight gain in
                                                       male; increased
                                                       clotting time,
                                                       increased
                                                       globulin levels,
                                                       and
                                                       increasedalpha-2
                                                       fraction of the
                                                       serum protein
                                                       electrophoresis
                                                       in females
------------------------------------------------------------------------
870.4200                          Chronic toxicity/   NOAEL = 744.9/
                                   Carcinogenicity--   919.4 mg/kg/day(M/
                                   rats                F) - HDT
                                                      LOAEL was not
                                                       established
                                                      No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.4300                          Carcinogenicity--   NOAEL = 731.4/
                                   mice                850.2 mg/kg/day(M/
                                                       F) - HDT
                                                      LOAEL was not
                                                       established
                                                      No evidence of
                                                       carcinogenicity
------------------------------------------------------------------------
870.5100                          Gene mutation       Negative up to
                                                       5,000 [mu]g/plate
                                                       withand without
                                                       metabolic
                                                       activation
------------------------------------------------------------------------
870.5375                          Cytogenetics        Negative for
                                                       chromosome
                                                       aberrationup to
                                                       400 [mu]g/mL with
                                                       metabolic
                                                       activation;
                                                       weak,positive
                                                       response without
                                                       activation
------------------------------------------------------------------------
870.5395                          Micronucleus -      Negative at
                                   mouse               concentration up
                                                       to300 [mu]g/mL in
                                                       cultured rat
                                                       hepatocytes
------------------------------------------------------------------------
870.5550                          Unscheduled DNA     Negative at doses
                                   Synthesis           up to 5,000 mg/kg
------------------------------------------------------------------------
870.7485                          Metabolism and      Rapid absorption
                                   pharmacokinetics    and excretion;
                                                       majormetabolic
                                                       route is
                                                       deesterification
                                                       to a
                                                       phenoxyaceticacid
                                                       derivative
                                                       followed by
                                                       cleavageof the
                                                       imide moiety or
                                                       hydroxylationand/
                                                       or sulfonation
                                                       reactions
------------------------------------------------------------------------


[[Page 11529]]

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the dose at which no adverse effects are observed 
(the NOAEL) from the toxicology study identified as appropriate for use 
in risk assessment is used to estimate the toxicological level of 
concern (LOC). However, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) is sometimes used for risk 
assessment if no NOAEL was achieved in the toxicology study selected. 
An uncertainty factor (UF) is applied to reflect uncertainties inherent 
in the extrapolation from laboratory animal data to humans and in the 
variations in sensitivity among members of the human population as well 
as other unknowns.
    The linear default risk methodology (Q*) is the primary method 
currently used by the Agency to quantify non-threshold hazards such as 
cancer. The Q* approach assumes that any amount of exposure will lead 
to some degree of cancer risk, estimates risk in terms of the 
probability of occurrence of additional cancer cases (e.g., risk). An 
example of how such a probability risk is expressed would be to 
describe the risk as one in one hundred thousand (1 X 10-5), 
one in a million (1 X 10-6), or one in ten million (1 X 
10-7). Under certain specific circumstances, MOE 
calculations will be used for the carcinogenic risk assessment. In this 
non-linear approach, a ``point of departure'' is identified below which 
carcinogenic effects are not expected. The point of departure is 
typically a NOAEL based on an endpoint related to cancer effects though 
it may be a different value derived from the dose response curve. To 
estimate risk, a ratio of the point of departure to exposure 
(MOEcancer = point of departure/exposures) is calculated.
    A summary of the toxicological endpoints for flumiclorac pentyl 
used for human risk assessment is shown in Table 2 of this unit:

  Table 2.--Summary of Toxicological Dose and Endpoints for flumiclorac pentyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary (females 13-49)            An endpoint of concern for the females 13 -49 attributable to a single
                                                    dose was not identified in the hazard data base.
----------------------------------------------------------------------------------------------------------------
Acute Dietary (General population         An endpoint of concern for the general population attributable to a
 including infants and children)                 single dose was not identified in the hazard data base
----------------------------------------------------------------------------------------------------------------
Chronic Dietary (All populations)      NOAEL= 100 mg/kg/day     Special FQPA SF = 1      Chronic dog
                                       UF = 100...............  cPAD = chronic RfD/      LOAEL = 1,000 mg/kg/day
                                       Chronic RfD = 1.0 mg/kg/  Special FQPA SF = 1.0    based on decreased
                                        day.                     mg/kg/day.               body weight gain
                                                                                          (males), increased
                                                                                          clotting time (males
                                                                                          and females), and
                                                                                          increased globulin
                                                                                          levels and increased
                                                                                          alpha-2 fraction of
                                                                                          the serum protein
                                                                                          electrophoresis
                                                                                          (females)
----------------------------------------------------------------------------------------------------------------
Short-Term Incidental Oral Exposure    inhalation (or oral)     FQPA SF = 1 cPAD = 1.0   Chronic - dog
 (1 to 30 days)                         study                    mg/kg/day 1 = 1.00 mg/  LOAEL = 1,000 mg/kg/day
(Residential)........................  NOAEL = 100 mg/kg/day).   kg/day                   based on
                                       UF = 100 Chronic RfD =   MOE = 100 (residential)  LOAEL = mg/kg/day based
                                        1.0 mg/kg/day.                                    on decreased body
                                                                                          weight gain (males),
                                                                                          increased clotting
                                                                                          time (males and
                                                                                          females), and
                                                                                          increased globulin
                                                                                          levels and increased
                                                                                          alpha-2 fraction of
                                                                                          the serum protein
                                                                                          electrophoresis
                                                                                          (females)
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)                No evidence of carcinogenicity in the hazard data base
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.477) for the residues of flumiclorac pentyl, in 
or on field corn and soybeans. Risk assessments were conducted by EPA 
to assess dietary exposures from flumiclorac pentyl 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.
    No such effects were identified in the toxicological studies for 
flumiclorac pentyl; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model software with 
the Food Commodity Intake Database (DEEM-FCID\TM\), which incorporates 
food consumption data as reported by respondents in the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII), and accumulated exposure to the chemical for each commodity. 
The following assumptions were made for the chronic exposure 
assessments: For the chronic analyses, tolerance-level residues were 
assumed for all food commodities with current or proposed flumiclorac 
pentyl tolerances, and it was assumed that all of the crops included in 
the analysis were treated. Percent Crop Treated (PCT) and/or 
anticipated residues were not used in the chronic risk assessment.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring exposure data to complete a comprehensive dietary 
exposure analysis and risk assessment for flumiclorac pentyl in 
drinking water.

[[Page 11530]]

 Because the Agency does not have comprehensive monitoring data, 
drinking water concentration estimates are made by reliance on 
simulation or modeling taking into account data on the physical 
characteristics of flumiclorac pentyl.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) to estimate pesticide concentrations in surface 
water and Screening Concentrations in Groundwater (SCI-GROW), which 
predicts pesticide concentrations in ground water. In general, EPA will 
use GENEEC (a Tier 1 model) before using PRZM/EXAMS (a Tier 2 model) 
for a screening-level assessment for surface water. The GENEEC model is 
a subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a screen for sorting out pesticides for which it is 
unlikely that drinking water concentrations would exceed human health 
levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs), which are the model estimates of a 
pesticide's concentration in water. EECs derived from these models are 
used to quantify drinking water exposure and risk as a %Reference dose 
or %Population adjusted dose.
    Based on the FIRST and SCI-GROW models, the EECs of flumiclorac 
pentyl for chronic exposures are estimated to be 0.24 parts per billion 
(ppb) for surface water and 0.002 ppb for ground 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).
    Flumiclorac pentyl is currently registered for use on the following 
residential non-dietary sites: Non-agricultural settings which include 
golf course, parks, recreation areas as well as schools. The risk 
assessment was conducted using the following residential exposure 
assumptions: The short-term incidental oral exposures was assessed for 
toddlers, the most sensitive population possibly exposed to 
flumiclorac-pentyl from residential use. Residential Exposure 
Assessments for the exposure scenarios described in Table 3 which are 
the most likely to result in highest possible exposure by toddlers to 
the herbicide.

        Table 3.--Short-Term Residential Exposure Estimates and MOEs for Flumiclorac-pentyl Treated Turf
----------------------------------------------------------------------------------------------------------------
                                                                             Average
                                                  Days After                Daily Dose
             Resident                 Activity    Treatment   Body Weight   (ADD) (mg/     NOAEL         MOE
                                                    (DAT)                    kg/day)
----------------------------------------------------------------------------------------------------------------
toddler                                 hand to            0           15       0.0017          100       58,230
                                          mouth
----------------------------------------------------------------------------------------------------------------
toddler                               object to            0           15      0.00043          100      233,000
                                          mouth
                                         (turf)
----------------------------------------------------------------------------------------------------------------
toddler                                    soil            0           15            0          100    1.75 E\7\
                                      ingestion
----------------------------------------------------------------------------------------------------------------

    All MOEs, including the total toddler ingestion MOE, are well above 
100 and therefore exposures to toddlers from flumiclorac-pentyl are not 
of concern.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to flumiclorac pentyl and any 
other substances and flumiclorac pentyl does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that flumiclorac 
pentyl has a commonmechanism 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 the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's website athttp://www. epa.gov/ pesticidesca/

cumulative/.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional tenfold 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 data base on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
MOE analysis or through using uncertainty (safety) factors in 
calculating a dose level that poses no appreciable risk to humans. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional safety 
factor value based on the use of traditional uncertainty factors and/or

[[Page 11531]]

special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of 
increased susceptibility of rats or rabbits to in utero and/or 
postnatal exposure to flumiclorac pentyl. There is no concern for 
neurotoxicity.
    3. Conclusion. There is a complete toxicity data base for 
flumiclorac pentyl, there is no evidence of increased susceptibility of 
rats or rabbits to in utero and/or postnatal exposure to flumiclorac 
pentyl, and exposure data are complete or are estimated based on data 
that reasonably accounts for potential exposures. The dietary food 
exposure assessment utilizes tolerance level residues and 100% crop 
treated (CT) information for all commodities. By using these screening-
level assumptions, chronic exposures/risks will not be underestimated. 
The dietary drinking water assessment utilizes values generated by 
models and associated modeling parameters which are designed to provide 
conservative, health protective, high-end estimates of water 
concentrations. Accordingly, the additional 10X factor for the 
protection of infants and children is removed.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An endpoint of concern attributable to a single 
exposure was not identified in the hazard data base and therefore no 
acute risk is expected from exposure to flumiclorac pentyl.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
flumiclorac pentyl from food and drinking water will utilize < 0.01% of 
the cPAD for the U.S. population, < 0.01% of the cPAD for the most 
highly exposed population subgroup, Children 3-5 years old. Based the 
use pattern, chronic residential exposure to residues of flumiclorac 
pentyl is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Flumiclorac pentyl is currently registered for use that could 
result in short-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic food and water and short-
term exposures for flumiclorac pentyl.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, drinking water and 
residential exposures aggregated result in aggregate MOE of 46,000 for 
Children 3-5 years old. This aggregate MOE does not exceed the Agency's 
level of concern for aggregate exposure to food and residential uses.

                Table 4.--Aggregate Risk Assessment for Short-Term Exposure to flumiclorac pentyl
----------------------------------------------------------------------------------------------------------------
                                                                            Average
                                                               Maximum       Food +    Residential    Aggregate
            Population             NOAEL mg/kg/   Level of   Exposure mg/    Water     Exposure mg/   MOE (food
                                       day        Concern       kg/day    Exposure mg/    kg/day         and
                                                                             kg/day                 residential)
----------------------------------------------------------------------------------------------------------------
Children, 3-5 years old                    100        < =100            1            0       0.0017        46,000
----------------------------------------------------------------------------------------------------------------

    4. 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, and to infants and children from aggregate 
exposure to flumiclorac pentyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas-liquid chromatography with 
thermionic-specific detector) is 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; e-mail address: 
residuemethods@epa.gov.


B. International Residue Limits

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits for flumiclorac pentyl.

C. Response to Comments

    Public comments were received from B. Sachau who objected to the 
proposed tolerances because of the amounts of pesticides already 
consumed and carried by the American population. She further indicated 
that testing conducted on animals have absolutely no validity and are 
cruel to the test animals. B. Sachau's comments contained no scientific 
data or evidence to rebut the Agency's conclusion that there is a 
reasonable certainty that no harm will result from aggregate exposure 
to flumiclorac pentyl, including all anticipated dietary exposures and 
all other exposures for which there is reliable information. EPA has 
responded to B. Sachau's generalized comments on numerous previous 
occasions, January 7, 2005 (70 FR 1349, 1354) (FRL-7691-4); October 29, 
2004 (69 FR 63083, 63096) (FRL-7681-9).

V. Conclusion

    Therefore, the tolerance is established for residues of flumiclorac 
pentyl on cotton undelinted seed at 0.2 ppm and cotton gin by products 
at 3.0 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of FFDCA, as amended by FQPA, any person may 
file an objection to any aspect of this regulation and may also request 
a hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. Although the procedures in those regulations require 
some modification to reflect the amendments made to FFDCA by FQPA, EPA 
will continue to use those procedures, with appropriate adjustments, 
until the necessary modifications can be made. The new section 408(g) 
of FFDCA provides essentially the same process for persons to 
``object'' to a regulation for an exemption from the requirement of a 
tolerance issued by EPA under new section 408(d) of FFDCA, as was 
provided in the old sections 408 and 409 of FFDCA. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2005-0311 in the subject line on 
the first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before May 8, 
2006.

[[Page 11532]]

    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issue(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900L), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. You may also deliver your request to the 
Office of the Hearing Clerk in Suite 350, 1099 14\th\ St., NW., 
Washington, DC 20005. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 564-6255.
    2. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in ADDRESSES. Mail your 
copies, identified by docket ID number EPA-HQ-OPP-2005-0311, to: Public 
Information and Records Integrity Branch, Information Technology and 
Resources Management Division (7502C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. In person or by courier, bring a copy to the 
location of the PIRIB described in ADDRESSES. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. 
Do not include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is reasonable possibility 
that available evidence identified by the requestor would, if 
established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issue(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA 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 rule has been 
exempted from review under Executive Order 12866 due to its lack of 
significance, this rule is not subject to Executive Order 13211, 
Actions Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001). 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., or impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 
104-4). 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); or OMB review or any Agency action under Executive 
Order 13045, entitled Protection of Children from Environmental Health 
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must

[[Page 11533]]

submit a rule report, which includes a copy of the rule, to each House 
of the Congress and to the Comptroller General of the United States. 
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 
this final rule in the Federal Register. This final rule 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 27, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.477 is amended by revising paragraph (a) to read as 
follows:


Sec.  180.477  Flumiclorac pentyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
herbicide flumiclorac pentyl, [2-chloro-4-fluoro-5-(1,3,4,5,6,7-
hexahydro-1,3-dioxo-2H-isoindol-2-yl)phenoxy]-acetate, in or on the raw 
agricultural commodities listed below.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Corn, field, forage........................................         0.01
Corn, field, grain.........................................         0.01
Corn, field, stover........................................         0.01
Cotton gin by products.....................................          3.0
Cotton, undelinted seed....................................          0.2
Soybean, hulls.............................................         0.02
Soybean, seed..............................................         0.01
------------------------------------------------------------------------

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[FR Doc. 06-2151 Filed 3-7-06; 8:45 am]

BILLING CODE 6560-50-S
