Flumiclorac Pentyl - CAS No. 87546-18-7
Valent. Pesticide Tolerance. Final Rule.
March 8, 2006. Federal Register.
Docket EPA-HQ-OPP-2005-0311

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Flumiclorac Pentyl; Pesticide Tolerance  [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]
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.

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.

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 at http://www.epa.gov/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
toxicity--rodents (rat)
NOAEL = 1,359 milligrams/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
toxicity-- nonrodents (dog)
NOAEL = 100 mg/kg/day
LOAEL = 1,000 mg/kg/day based on increased clotting time in females
870.3200 21/28-Day dermal toxicity (rat) NOAEL = 1,000 mg/kg/day (limit dose)
870.3700 Prenatal developmental-- rodents (rat) Maternal NOAEL = 1,500 mg/kg/day -HDT
Maternal LOAEL was not established
Developmental NOAEL = 1,500 mg/kg/day - HDT
Developmental LOAEL was not established
870.3800 Reproduction and fertility effects (rat) Parental/Systemic
NOAEL = 16/18mg/ kg/day (M/F)
LOAEL = 781/925mg/kg/day (M/F) based on increased kidney weight in males and females 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 decreased body weight/body weight in F2 pups
870.4100 Chronic toxicity-- dogs NOAEL = 100 mg/kg/day
LOAEL = 1,000 mg/kg/day based on decreased body weight gain in male; increased clotting time, increased globulin levels, and increased alpha-2 fraction of the serum protein electrophoresis in females
870.4200 Chronic toxicity/ Carcinogenicity-- rats NOAEL = 744.9/ 919.4 mg/kg/day(M/F) - HDT
LOAEL was not established
No evidence of carcinogenicity
870.4300 Carcinogenicity-- mice NOAEL = 731.4/ 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 with and without metabolic activation
870.5375 Cytogenetics Negative for chromosome aberration up to 400 [mu]g/mL with metabolic activation; weak, positive response without activation
870.5395 Micronucleus - mouse Negative at concentration up to 300 [mu]g/mL in cultured rat hepatocytes
870.5550 Unscheduled DNA Synthesis Negative at doses up to 5,000 mg/kg
870.7485 Metabolism and pharmacokinetics Rapid absorption and excretion; major metabolic route is deesterification to a phenoxyacetic acid derivative followed by cleavage of the imide moiety or hydroxylation and/ 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
Exposure/Scenario Dose Used in Risk
Assessment, Interspecies and Intraspecies and any Traditional UF
Special FQPA SF and Level of Concern for Risk Assessment Study and Toxicological Effects
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 including infants and children) An endpoint of concern for the general population attributable to a single dose was not identified in the hazard data base
Chronic Dietary (All populations) NOAEL= 100 mg/kg/day
UF = 100
Chronic RfD = 1.0 mg/kg/day.
Special FQPA SF = 1
cPAD = chronic RfD/
Special FQPA SF = 1.0 mg/kg/day.
Chronic dog
LOAEL = 1,000 mg/kg/day
based on decreased 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 (1 to 30 days)
inhalation (or oral) study
NOAEL = 100 mg/kg/day).
UF = 100 Chronic RfD = 1.0 mg/kg/day.
FQPA SF = 1 cPAD = 1.0 mg/kg/day 1 = 1.00 mg/kg/day
MOE = 100 (residential)
Chronic - dog
LOAEL = 1,000 mg/kg/day based on
LOAEL = mg/kg/day based 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
Resident Activity
Days After Treatment (DAT)
Body Weight
Average Daily Dose (ADD) (mg/kg/day)
toddler hand to mouth
toddler object to mouth (turf)
toddler soil ingestion
1.75 E\7\

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 at

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
NOAEL mg/kg/day
Level of Concern
Maximum Exposure mg/kg/day
Average Food + Water Exposure mg/kg/day
Residential Exposure mg/kg/day
Aggregate MOE (food and residential)
Children, 3-5 years old
< =100

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 (59 FR 22951, 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.

• Therefore, 40 CFR chapter I is amended as follows:
• 1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
• 2. Section 180.477 is amended by revising paragraph (a) to read as
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 million
Corn, field, forage
Corn, field, grain
Corn, field, stover
Cotton gin by products
Cotton, undelinted seed
Soybean, hulls
Soybean, seed

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

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