Flumiclorac Pentyl; Pesticide Tolerance, 11526-11533 [06-2151]
Download as PDF
<![CDATA[
erjones on PROD1PC68 with RULES
11526
Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Rules and Regulations
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
VerDate Aug<31>2005
15:23 Mar 07, 2006
Jkt 208001
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.
forage at 4.0 ppm; alfalfa, hay at 4.0
ppm; grass, forage at 7.0 ppm; grass, hay
at 7.0 ppm; peanut, hay at 10 ppm and
onion, dry bulb at 0.10 ppm.
The additions read as follows:
§ 180.495 Spinosad; tolerances for
residues.
(a) * * *
VIII. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801et 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
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 17, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
Parts per
million
Commodity
*
*
*
*
*
Alfalfa, seed ..............................
Alfalfa, seed screenings ...........
Animal feed, nongrass, group,
18, forage ..............................
Animal feed, nongrass, group,
18, hay ..................................
*
*
*
*
Banana .....................................
Food commodities ....................
Grain, cereal, group 16, forage,
except rice .............................
Grain, cereal, group 16, hay,
except rice .............................
Grain, cereal, group, 16, stover,
except rice .............................
Grain, cereal, group, 16, straw,
except rice .............................
*
*
*
*
0.15
2.0
35.0
30.0
*
0.25
0.02
2.5
10.0
10.0
1.0
*
Grass, forage, fodder and hay,
group 17, forage ...................
Grass, forage, fodder and hay,
group 17, hay ........................
*
*
*
*
*
Onion, green .............................
*
*
*
*
*
10.0
5.0
2.0
Peanut, hay ..............................
Peppermint, tops ......................
*
*
*
*
11.0
3.5
*
Spearmint, tops ........................
*
*
*
*
*
Vegetable, bulb, group 3, except green onion ...................
*
*
*
*
*
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.495 is amended:
i. In paragragh (a), in the table, by
removing: Corn, forage at 1.0 ppm; corn,
hay at 1.0 ppm; corn stover at 1.0 ppm;
corn straw at 1.0 ppm; grass, forage,
fodder and hay, group 17 at 0.02 ppm;
sorghum, forage at 1.0 ppm; sorghum,
forage, hay at 1.0 ppm; sorghum, grain,
stover at 1.0 ppm; sorghum, straw at 1.0
ppm; wheat, forage at 1.0 ppm; wheat,
hay at 1.0 ppm and wheat, straw at 1.0
ppm; and by alphabetically adding the
commodities as set forth below.
I ii. In paragraph (b), in the table, by
removing: All commodities in
connection with the quarantine
eradication programs against exotic,
non-indigenous, fruit fly species, where
a separate higher tolerance in is not
already established at 0.02 ppm; alfalfa,
I
I
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
*
*
*
*
3.5
0.10
*
[FR Doc. 06–1939 Filed 3–7–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2005–0311; FRL–7764–1]
Flumiclorac Pentyl; Pesticide
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
E:\FR\FM\08MRR1.SGM
08MRR1
Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Rules and Regulations
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).
This regulation is effective
March 8, 2006. Objections and requests
for hearings must be received on or
before May 8, 2006.
DATES:
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
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 https://
www.regulations.gov/. Follow the online 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.
ADDRESSES:
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
erjones on PROD1PC68 with RULES
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:
VerDate Aug<31>2005
15:23 Mar 07, 2006
Jkt 208001
• 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 (https://
www.epa.gov/edocket/),you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://www.epa.gov/fedrgstr/. A
frequently updated electronic version of
40 CFR part 180 is available on E-CFR
Beta Site Two at https://
www.gpoaccess.gov/ecfr/. To access the
OPPTS Harmonized Guidelines
referenced in this document, go directly
to the guidelines athttps://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, [2chloro-4-fluoro-5-(1,3,4,5,6,7hexahydro-1,3-dioxo-2H-isoindol-2yl)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
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
11527
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 https://
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.
E:\FR\FM\08MRR1.SGM
08MRR1
11528
Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Rules and Regulations
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
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)
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--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
increasedalpha-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 µg/plate withand without metabolic activation
870.5375
Cytogenetics
Negative for chromosome aberrationup to 400 µg/
mL with metabolic activation; weak,positive response without activation
870.5395
Micronucleus - mouse
Negative at concentration up to300 µg/mL in cultured rat hepatocytes
870.5550
Unscheduled DNA Synthesis
Negative at doses up to 5,000 mg/kg
870.7485
erjones on PROD1PC68 with RULES
870.3100
Metabolism and pharmacokinetics
Rapid absorption and excretion; majormetabolic
route is deesterification to a phenoxyaceticacid
derivative followed by cleavageof the imide moiety or hydroxylationand/or sulfonation reactions
VerDate Aug<31>2005
15:23 Mar 07, 2006
Jkt 208001
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
E:\FR\FM\08MRR1.SGM
08MRR1
Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Rules and Regulations
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 nonthreshold 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
11529
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 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)
(Residential)
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
erjones on PROD1PC68 with RULES
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.
VerDate Aug<31>2005
15:23 Mar 07, 2006
Jkt 208001
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-FCIDTM), 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
PO 00000
Frm 00025
Fmt 4700
Sfmt 4700
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.
E:\FR\FM\08MRR1.SGM
08MRR1
11530
Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Rules and Regulations
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 nonoccupational, 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: Nonagricultural 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)
Average
Daily Dose
(ADD) (mg/
kg/day)
Body
Weight
NOAEL
MOE
hand to
mouth
0
15
0.0017
100
58,230
toddler
object to
mouth (turf)
0
15
0.00043
100
233,000
toddler
erjones on PROD1PC68 with RULES
toddler
soil
ingestion
0
15
0
100
1.75 E7
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
VerDate Aug<31>2005
15:23 Mar 07, 2006
Jkt 208001
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 athttps://
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
PO 00000
Frm 00026
Fmt 4700
Sfmt 4700
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
E:\FR\FM\08MRR1.SGM
08MRR1
Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Rules and Regulations
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.
11531
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.
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
TABLE 4.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO FLUMICLORAC PENTYL
NOAEL mg/
kg/day
Population
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.
erjones on PROD1PC68 with RULES
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.
VerDate Aug<31>2005
15:23 Mar 07, 2006
Jkt 208001
Average
Food +
Water Exposure mg/kg/
day
Maximum
Exposure
mg/kg/day
Level of
Concern
≤100
Residential
Exposure
mg/kg/day
Aggregate
MOE (food
and residential)
0
0.0017
46,000
1
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).
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.
V. Conclusion
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.
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
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
E:\FR\FM\08MRR1.SGM
08MRR1
erjones on PROD1PC68 with RULES
11532
Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Rules and Regulations
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 14th 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
VerDate Aug<31>2005
15:23 Mar 07, 2006
Jkt 208001
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
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
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
E:\FR\FM\08MRR1.SGM
08MRR1
Federal Register / Vol. 71, No. 45 / Wednesday, March 8, 2006 / Rules and Regulations
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).
ENVIRONMENTAL PROTECTION
AGENCY
List of Subjects in 40 CFR Part 180
AGENCY:
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:
I
PART 180—AMENDED
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.477 is amended by
revising paragraph (a) to read as follows:
I
§ 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-2Hisoindol-2-yl)phenoxy]-acetate, in or on
the raw agricultural commodities listed
below.
Parts per
million
Commodity
Corn, field, forage .....................
Corn, field, grain .......................
Corn, field, stover .....................
Cotton gin by products .............
Cotton, undelinted seed ...........
Soybean, hulls ..........................
Soybean, seed ..........................
*
*
*
*
0.01
0.01
0.01
3.0
0.2
0.02
0.01
*
[FR Doc. 06–2151 Filed 3–7–06; 8:45 am]
erjones on PROD1PC68 with RULES
BILLING CODE 6560–50–S
VerDate Aug<31>2005
15:23 Mar 07, 2006
Jkt 208001
40 CFR Parts 271 and 272
[EPA–R08–RCRA–2006–0047; FRL–8035–4]
South Dakota: Final Authorization of
State Hazardous Waste Management
Program Revision and Incorporation
by Reference of Approved State
Hazardous Waste Management
Program
Environmental Protection
Agency (EPA).
ACTION: Final rule and response to
comments.
SUMMARY: The EPA is granting final
authorization to the hazardous waste
program revisions submitted by South
Dakota. The Agency published a
Proposed Rule on September 27, 2005,
and provided for public comment. The
comment period ended on October 27,
2005. No comments were received
regarding Resource Conservation and
Recovery Act (RCRA) program issues.
There was one comment from South
Dakota State Attorney General regarding
Indian country language. No further
opportunity for comment will be
provided. This final rule also codifies
and incorporates by reference the
authorized provisions of the South
Dakota regulations in Title 40 of the
Code of Federal Regulations (CFR) part
272.
DATES: This final rule is effective on
March 8, 2006. The incorporation by
reference of authorized provisions in the
South Dakota regulations contained in
this rule is approved by the Director of
the Federal Register as of March 8, 2006,
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51.
ADDRESSES: EPA has established a
docket for this action under Docket ID
No. EPA–R08–RCRA–2006–0047. All
documents in the docket are listed on
the www.regulations.gov Web site.
Although listed in the index, some
information is not publicly available,
e.g., 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 through
www.regulations.gov or in hard copy at:
EPA Region 8, from 8 a.m. to 3 p.m., 999
18th Street, Suite 300, Denver, Colorado
80202–2466, contact: Kris Shurr, phone
number: (303) 312–6139, e-mail address:
shurr.kris@epa.gov, or SDDENR, from 9
a.m. to 5 p.m., Joe Foss Building, 523 E.
PO 00000
Frm 00029
Fmt 4700
Sfmt 4700
11533
Capitol, Pierre, South Dakota 57501–
3181, contact: Carrie Jacobson, phone
number (605) 773–3153.
FOR FURTHER INFORMATION CONTACT: Kris
Shurr, 8P–HW, U.S. EPA, Region 8, 999
18th Street, Suite 300, Denver, CO
80202–2466, phone number: (303) 312–
6139 FAX number: (303) 312–6341; email address: shurr.kris@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Authorization of Revisions to South
Dakota’s Hazardous Waste Program
and Correction
On October 25, 2004, South Dakota
submitted final complete program
revision applications seeking
authorization of their changes in
accordance with 40 CFR 271.21. We
now make a Final decision that South
Dakota’s hazardous waste program
revisions satisfy all of the requirements
necessary to qualify for Final
authorization. For a list of rules that
become effective with this Final Rule,
please see the Proposed Rule published
in the September 27, 2005 Federal
Register at 70 FR 56419. EPA is making
one correction to the Proposed Rule. In
the list of authorized provisions for
Checklists 154 through 154.6 (Column
1, page 56421), the effective date for
‘‘74:36:11:01’’ is January 2, 2005.
Response to Comments: EPA
proposed to authorize South Dakota’s
State Hazardous Waste Management
Program Revisions on September 27,
2005 (70 FR 56419). EPA received only
one comment from the State of South
Dakota, objecting to EPA’s definition of
Indian country, where the State is not
authorized to administer its program.
Specifically, the State disagreed that all
‘‘trust land’’ in South Dakota is Indian
country. However, in the comment
letter, the State of South Dakota
conveyed to EPA that ‘‘while we [the
State] continue to object and disagree on
this issue, the state will accept EPA’s
authorization of the hazardous waste
program revisions as described in EPA’s
September 27, 2005 notice in the
Federal Register.’’
EPA maintains the interpretation of
Indian country in South Dakota as
described in the September 27, 2005
Federal Register notice of proposed
rulemaking. Further explanation of this
interpretation of Indian country can be
found at 67 FR 45684 through 45686
(July 10, 2002).
II. Incorporation by Reference
In the Proposed Rule published on
September 27, 2005 (70 FR 56419), EPA
also proposed to codify EPA’s
authorization of South Dakota’s base
hazardous waste management program
E:\FR\FM\08MRR1.SGM
08MRR1
]]>Agencies
[Federal Register Volume 71, Number 45 (Wednesday, March 8, 2006)]
[Rules and Regulations]
[Pages 11526-11533]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-2151]
-----------------------------------------------------------------------
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 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 https://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 (https://www.epa.gov/edocket/),you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 180
is available on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.
To access the OPPTS Harmonized Guidelines referenced in this document,
go directly to the guidelines athttps://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 https://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 athttps://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
------------------------------------------------------------------------
* * * * *
[FR Doc. 06-2151 Filed 3-7-06; 8:45 am]
BILLING CODE 6560-50-S
