Fomesafen; Pesticide Tolerance, 25945-25951 [06-4160]
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Federal Register / Vol. 71, No. 85 / Wednesday, May 3, 2006 / Rules and Regulations
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
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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
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: April 24, 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 180.473 is amended by
adding text to paragraph (d) after the
paragraph heading to read as follows:
I
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§ 180.473 Glufosinate ammonium;
tolerances for residues.
*
*
*
*
*
(d) * * * Tolerances are established
for indirect or inadvertent residues of
the herbicide glufosinate ammonium,
butanoic acid, 2-amino-4(hydroxymethylphosphinyl)-,
monoammonium salt and its metabolite,
3-methylphosphinicopropionic acid in
or on the following raw agricultural
commodities when present therein as a
result of the application of glufosinate
ammonium to crops listed in paragraph
(a) of this section:
Commodity
Parts per
million
Barley, hay ................................
Barley, straw .............................
Buckwheat, fodder ....................
Buckwheat, forage ....................
Oat, forage ................................
Oat, hay ....................................
Oat, straw .................................
Rye, forage ...............................
Rye, straw .................................
Teosinte ....................................
Triticale .....................................
Wheat, forage ...........................
Wheat, hay ...............................
Wheat, straw .............................
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
0.40
[FR Doc. 06–4162 Filed 5–2–06; 8:45 am]
BILLING CODE 6560–50–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2006–0073; FRL–8062–6]
Fomesafen; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of fomesafen in
or on dry bean, snap bean and cotton.
Interregional Research Project No. 4 (IR4), and Syngenta Crop Protection
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 May
3, 2006. Objections and requests for
hearings must be received on or before
July 3, 2006.
ADDRESSES: To submit a written
objection or hearing request follow the
detailed instructions as provided in
Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a
docket for this action under Docket
identification (ID) number EPA–HQ–
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Federal Register / Vol. 71, No. 85 / Wednesday, May 3, 2006 / Rules and Regulations
OPP–2006–0073. All documents in the
docket are listed on the 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., confidential business information
(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.
• Important Note: OPP will be
moving to a new location the first week
of May 2006. As a result, from Friday,
April 28 to Friday, May 5, 2006, the
OPP Regulatory Public Docket will NOT
be accepting any deliveries at the
Crystal Mall #2 address and this facility
will be closed to the public. Beginning
on May 8, 2006, the OPP Regulatory
Public Docket will reopen at 8:30 a.m.
and deliveries will be accepted in Rm.
S–4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive,
Arlington, VA 22202. The mail code for
the mailing address will change to
(7502P), but will otherwise remain the
same. The OPP Regulatory Public
Docket telephone number and hours of
operation will remain the same after the
move.
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:
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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,
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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 under FOR 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 at 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 March 1,
2006 (71 FR 10508) (FRL–7763–1), EPA
issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of
pesticide petitions (PP 1E6228, 6E4653,
and 1F5068) by Interregional Research
Project No. 4 (IR-4), 681 U. S. Highway
No. 1 South, North Brunswick, NJ
08902–3390; and Syngenta Crop
Protection, Inc., P.O. Box 18300,
Greensboro, NC 27410. The petitions
requested that 40 CFR 180.433 be
amended by establishing tolerances for
residues of the herbicide sodium salt of
fomesafen, 5-[2-chloro-4(trifluoromethyl)phenoxy]-N(methylsulfonyl)-2-nitrobenzamide, in
or on the food commodities dry beans
(PP 1E6228), snap beans (PP 6E4653),
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cotton seed and cotton gin byproducts
(1F5068) at 0.025 parts per million
(ppm). That notice included a summary
of the petition prepared by IR4 and
Syngenta Crop Protection, Inc, the
registrant. There were no comments
received in response to the notice of
filing. EPA has determined that the
residue of concern is fomesafen, per se.
The tolerance expression is revised by
removing the phrase ‘‘sodium salt of’’.
Section 408(b)(2)(A)(i) of FFDCA
allows EPA to establish tolerances (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 tolerances for residues of
fomesafen on bean, dry; bean, snap,
succulent; cotton, undelinted seed and
cotton, gin byproducts at 0.025 ppm.
EPA’s assessment of exposures and risks
associated with establishing the
tolerance follows.
A. Toxicological Profile
EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
the relationship of the results of the
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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
fomesafen are discussed in Table 1 of
this unit as well as the no observed
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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
28–Day oral toxicity -- rodents (mouse)
NOAEL = 209 milligrams/kilogram/day (mg/kg/
day) for males (M) and 247 mg/kg/day for females (F)
LOAEL = 917 mg/kg/day (M) and 1247 mg/kg/
day (F) based on decreased body weights
and body weight gains, decreased food efficiency, hematology (decreased erythrocyte
count, hemoglobin, mean corpuscular volume, and mean corpuscular hemoglobin),
bile duct hyperplasia, decreased uterine size
in females, and decreased size of the seminal vesicles in males
870.3100
90–Day oral toxicity -- rodents (rat)
NOAEL = 0.5 mg/kg/day
LOAEL = 10 mg/kg/day based on hyalinization
of hepatocytes, increased eosinophilia, reduced granulation, increased liver weights in
males and females, and increases in plasma
alkaline phosphatase, alanine transaminase
and aspartate transaminase in males
870.3150
26–Week oral toxicity -- nonrodents (dog)
NOAEL = 1 mg/kg/day
LOAEL = 25 mg/kg/day based on hematology
(decreased hemoglobin and hematocrit concentrations and erythrocyte count and increased platelet count and prothrombin time
870.3200
21–Day dermal toxicity (rabbit)
NOAEL = 1,000 mg/kg/day, Highest Dose
Tested (HDT)
870.3700
Prenatal developmental -- rodents (rat)
Maternal NOAEL = 100 mg/kg/day
Maternal LOAEL = 200 mg/kg/day based on
staining of the ventral fur and significantly
decreased body weight gain (≤10%) .
Developmental NOAEL = 100 mg/kg/day
Developmental LOAEL = 200 mg/kg/day based
on postimplantation loss
870.3800
Reproduction and fertility effects (rat)
Parental/Systemic NOAEL = 12.5 mg/kg/day
Parental/Systemic LOAEL = 50 mg/kg/day
based on liver histopathology in males and
females of both generations.
Reproductive NOAEL = 50 mg/kg/day,
HDTReproductive LOAEL = Not established
Offspring NOAEL = 12.5 mg/kg/day
Offspring LOAEL = 50 mg/kg/day based on increased incidence of liver hyalinization in
males
870.4200
Carcinogenicity-mice
NOAEL = 1.5 mg/kg/day
LOAEL = 15 mg/kg/day based on the presence
of liver tumors and liver weight increases in
male and female mice
870.4300
Chronic toxicity/Carcinogenicity-rat
NOAEL = 0.25 mg/kg/day
LOAEL = 5 mg/kg/day based on hyalinization
of the liver in males
870.5100
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870.3050
Gene mutation - bacterial
Negative
870.5300
Gene mutation - mammalian
Negative
870.5375
Structural chromosomal abberations
Negative
870.5395
Other genotoxic effects
Negative
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B. Toxicological Endpoints
For hazards that have a threshold
below which there is no appreciable
risk, the dose at which 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 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. An UF of 100 is routinely
used, 10X to account for interspecies
differences and 10X for intraspecies
differences.
Three other types of safety or
uncertainty factors may be used:
‘‘Traditional uncertainty factors;’’ the
‘‘special FQPA safety factor;’’ and the
‘‘default FQPA safety factor.’’ By the
term ‘‘traditional uncertainty factor,’’
EPA is referring to those additional
uncertainty factors used prior to FQPA
passage to account for database
deficiencies. These traditional
uncertainty factors have been
incorporated by the FQPA into the
additional safety factor for the
protection of infants and children. The
term ‘‘special FQPA safety factor’’ refers
to those safety factors that are deemed
necessary for the protection of infants
and children primarily as a result of the
FQPA. The ‘‘default FQPA safety factor’’
is the additional 10X safety factor that
is mandated by the statute unless it is
decided that there are reliable data to
choose a different additional factor
(potentially a traditional uncertainty
factor or a special FQPA safety factor).
For dietary risk assessment (other
than cancer) the Agency uses the UF to
calculate an acute or chronic reference
dose (acute RfD or chronic RfD) where
the RfD is equal to the NOAEL divided
by an UF of 100 to account for
interspecies and intraspecies differences
and any traditional uncertainty factors
deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or
the default FQPA safety factor is used,
this additional factor is applied to the
RfD by dividing the RfD by such
additional factor. The acute or chronic
Population Adjusted Dose (aPAD or
cPAD) is a modification of the RfD to
accommodate this type of safety factor.
For non-dietary risk assessments
(other than cancer) the UF is used to
determine the LOC. For example, when
100 is the appropriate UF (10X to
account for interspecies differences and
10X for intraspecies differences) the
LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of
exposure (MOE) = NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology
(Q*) is the primary method currently
used by the Agency to quantify
carcinogenic risk. The Q* approach
assumes that any amount of exposure
will lead to some degree of cancer risk.
A Q* is calculated and used to estimate
risk which represents a 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 fomesafen used for human
risk assessment is shown in Table 2 of
this unit:
TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FOMESAFEN FOR USE IN HUMAN RISK ASSESSMENT
Exposure Scenario
Dose Used in Risk Assessment, Interspecies and
Intraspecies and any Traditional UF
Special FQPA SF and LOC
for Risk Assessment
Study and Toxicological Effects
An endpoint of concern for females 13–50 years of age attributable to a single dose was not identified in the
hazard database.
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
database.
Chronic Dietary
(All populations)
NOAEL= 0.25 mg/kg/day
UF = 100
Chronic RfD = 0.0025 mg/kg/
day
Cancer
(oral, dermal, inhalation)
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Acute Dietary
(Females 13–50 years of age)
In accordance with the EPA Final Guidelines for Carcinogen Risk Assessment (March 29, 2005), EPA classified fomesafen as ‘‘Not likely to be carcinogenic to humans’’. This decision was based on the weight-ofevidence which supports activation of peroxisome proliferator-activated receptor alpha (PPAR) as the
mode of action for fomesafen-induced hepatocarcinogenesis in mice. The data did not support either
mutagenesis or cytotoxicity followed by regenerative proliferation as alternative modes of action. While the
proposed mode of action for liver tumors in mice is theoretically plausible in humans, it is quantitatively
implausible and unlikely to take place in humans based on quantitative species differences in PPAR activation and toxicokinetics.
C. Exposure Assessment
1. Dietary exposure from food and
feed uses. Tolerances have been
established (40 CFR 180.433) for the
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Special FQPA SF = 1X
cPAD =
chronic RfD ÷Special FQPA
SF
= 0.0025 mg/kg/day
residues of sodium salt of fomesafen, in
or on soybeans. Risk assessments were
conducted by EPA to assess dietary
exposures from fomesafen in food as
follows:
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Chronic toxicity - rat
LOAEL = 5 mg/kg/day based on hyalinization of
the liver in males
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
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occurring as a result of a 1–day or single
exposure.
No such effects were identified in the
toxicological studies for fomesafen;
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
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
fomesafen 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
fomesafen in drinking water. 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
fomesafen.
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 concentration in
ground water (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
incorporates 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
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(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 LOC.
Since the models used are considered
to be screening tools in the risk
assessment process, the Agency uses
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 pecent Reference
dose (%RfD) or percent population
adjusted dose (%PAD).
Based on the PRZM/EXAMS and SCIGROW models, the EECs of fomesafen
for chronic exposures are estimated to
be 10.535 parts per billion (ppb) for
surface water and 1.0 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).
Fomesafen is not registered for use on
any sites that would result in residential
exposure.
4. Cumulative effects from substances
with a common mechanism of toxicity.
Section 408(b)(2)(D)(v) of the 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
fomesafen and any other substances and
fomesafen 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 fomesafen has a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see the policy statements released by
EPA’s Office of Pesticide Programs
concerning common mechanism
determinations and procedures for
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Fmt 4700
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25949
cumulating effects from substances
found to have a common mechanism on
EPA’s Web site at https://www.epa.gov/
pesticides/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 database on toxicity
and exposure unless EPA determines
based on reliable data that a different
margin of safety will be safe for infants
and children. 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 special FQPA
safety factors, as appropriate.
2. Prenatal and postnatal sensitivity.
There is no concern and/or residual
uncertainty with regard to prenatal and/
or postnatal increased susceptibility.
The requirement for an acceptable
‘‘guideline’’ developmental toxicity
study in a second species has not been
satisfied. The study in rabbits is
deficient. Individual animal data were
not reported and all fetuses were not
examined for both soft tissue and
skeletal alterations; and historical
control data were not provided.
Additionally, animals had an
intercurrent infection that confounded
interpretation of the results of the study.
Therefore, the developmental toxicity
study in the rabbit was classified
‘‘Unacceptable/Guideline’’. However, a
new developmental toxicity study in
rabbits is not required at this time
because sufficient numbers of fetuses
were available for examination in the
rabbit developmental toxicity study.
There was no increase in fetal deaths at
the highest dose tested even though the
dams suffered with an intercurrent
infection. There were no external or
internal malformation/abnormalities,
soft tissue or skeletal that could be
related to treatment with the test
material at any of the three dosage levels
tested including the highest dose level
of 40 mg/kg/day. The study does not
meet current guideline standards, but it
does provide sufficient information on
the possible effects the test material
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25950
Federal Register / Vol. 71, No. 85 / Wednesday, May 3, 2006 / Rules and Regulations
might have on the developing rabbit
fetus, especially since the maternal
animals were additionally under
considerable stress from infection.
3. Conclusion. The fomesafen toxicity
database is adequate for the risk
assessment since we are not asking for
a repeat developmental toxicity study in
rabbits at this time. In addition, there is
no evidence of increased susceptibility,
no residual uncertainty in the database,
and exposure data are complete or are
estimated based on that, reasonably
account for potential exposures.
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 dose exposure to
fomesafen was not identified in the
hazard database. Therefore there are no
acute toxicological concerns for
fomesafen.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to fomesafen from food
and drinking water will utilize 9.5% of
the cPAD for the U.S. population, 31%
of the cPAD for all infants (< 1 year old),
and 15% of the cPAD for children 1–2
years old. Fomesafen is not registered
for use on any sites that would result in
residential exposure. Therefore, the
aggregate risk is the sum of the risk from
food and water, which do not exceed
the Agency’s LOC.
3. 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 fomesafen
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(chemical derivatization followed by gas
chromatography with NitrogenPhosphorus detection) 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; email address: residuemethods@epa.gov.
sroberts on PROD1PC70 with RULES
B. International Residue Limits
No Codex Maximum residue levels
(MRLs) have been established for
residues of fomesafen. Canadian MRLs
have been established for residues of
fomesafen in or on dry beans; lima
VerDate Aug<31>2005
18:14 May 02, 2006
Jkt 208001
beans; snap beans; and soybeans at 0.05
ppm, and a Mexican MRL of 0.05 mg/
kg has been established for residues of
fomesafen in or on soybeans. Syngenta
Canada will be submitting a request to
lower the fomesafen MRLs in Canada to
match those being proposed for the
USA. Therefore the MRLs will
eventually be harmonized.
V. Conclusion
Therefore, the tolerance is established
for residues of fomesafen, 5-[2-chloro-4(trifluoromethyl)phenoxy]-N(methylsulfonyl)-2-nitrobenzamide, in
or on bean, dry; bean, snap, succulent;
cotton, undelinted seed and cotton, gin
byproducts at 0.025 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–2006–0073 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 July 3, 2006.
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
PO 00000
Frm 00032
Fmt 4700
Sfmt 4700
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.1., 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–2006–0073, 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.
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 a 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
E:\FR\FM\03MYR1.SGM
03MYR1
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Federal Register / Vol. 71, No. 85 / Wednesday, May 3, 2006 / Rules and Regulations
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
VerDate Aug<31>2005
18:14 May 02, 2006
Jkt 208001
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.
25951
and pests, Reporting and recordkeeping
requirements.
Dated: April 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 180.433 is revised to read
as follows:
I
§ 180.433 Fomesafen; tolerances for
residues.
(a) General. Tolerances are
established for the residues of fomesafen
5-[2-chloro-4-(trifluoromethyl)phenoxy]N-(methylsulfonyl)-2-nitrobenzamide
from the application of its sodium salt
in or on the following commodities:
Commodity
Parts per
million
Bean, dry ..................................
Bean, snap, succulent ..............
Cotton, gin byproducts .............
Cotton, undelinted seed ...........
Soybean ....................................
0.025
0.025
0.025
0.025
0.05
(b) Section 18 emergency exemptions.
[Reserved]
(c) Tolerances with regional
registrations. [Reserved]
(d) Indirect or inadvertent residues.
[Reserved]
[FR Doc. 06–4160 Filed 5–2–06; 8:45 am]
BILLING CODE 6560–50–S
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
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
PO 00000
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Fmt 4700
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2004–0398; FRL–8057–5]
Flumioxazin; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
SUMMARY: This regulation establishes
tolerances for residues of flumioxazin,
2-[7-fluoro-3,4-dihydro-3-oxo-4-(2propynyl)-2H-1,4-benzoxazin-6-yl]4,5,6,7-tetrahydro-1H-isoindole-1,3(2H)dione in or on pome fruit crop group 11,
stone fruit crop group 12 and
strawberry. 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).
E:\FR\FM\03MYR1.SGM
03MYR1
]]>Agencies
[Federal Register Volume 71, Number 85 (Wednesday, May 3, 2006)]
[Rules and Regulations]
[Pages 25945-25951]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4160]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0073; FRL-8062-6]
Fomesafen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
fomesafen in or on dry bean, snap bean and cotton. Interregional
Research Project No. 4 (IR-4), and Syngenta Crop Protection 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 May 3, 2006. Objections and
requests for hearings must be received on or before July 3, 2006.
ADDRESSES: To submit a written objection or hearing request follow the
detailed instructions as provided in Unit VI. of the SUPPLEMENTARY
INFORMATION. EPA has established a docket for this action under Docket
identification (ID) number EPA-HQ-
[[Page 25946]]
OPP-2006-0073. All documents in the docket are listed on the
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.,
confidential business information (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.
Important Note: OPP will be moving to a new location the
first week of May 2006. As a result, from Friday, April 28 to Friday,
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any
deliveries at the Crystal Mall 2 address and this facility
will be closed to the public. Beginning on May 8, 2006, the OPP
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA 22202. The mail code for the mailing
address will change to (7502P), but will otherwise remain the same. The
OPP Regulatory Public Docket telephone number and hours of operation
will remain the same after the move.
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 under FOR 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 at 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 March 1, 2006 (71 FR 10508) (FRL-7763-
1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP
1E6228, 6E4653, and 1F5068) by Interregional Research Project No. 4
(IR-4), 681 U. S. Highway No. 1 South, North Brunswick, NJ 08902-3390;
and Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, NC
27410. The petitions requested that 40 CFR 180.433 be amended by
establishing tolerances for residues of the herbicide sodium salt of
fomesafen, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-
2-nitrobenzamide, in or on the food commodities dry beans (PP 1E6228),
snap beans (PP 6E4653), cotton seed and cotton gin byproducts (1F5068)
at 0.025 parts per million (ppm). That notice included a summary of the
petition prepared by IR4 and Syngenta Crop Protection, Inc, the
registrant. There were no comments received in response to the notice
of filing. EPA has determined that the residue of concern is fomesafen,
per se. The tolerance expression is revised by removing the phrase
``sodium salt of''.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish tolerances
(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 tolerances for residues of fomesafen on bean,
dry; bean, snap, succulent; cotton, undelinted seed and cotton, gin
byproducts at 0.025 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the
[[Page 25947]]
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 fomesafen 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
------------------------------------------------------------------------
870.3050 28-Day oral NOAEL = 209
toxicity -- milligrams/
rodents (mouse) kilogram/day (mg/
kg/day) for males
(M) and 247 mg/kg/
day for females
(F)
LOAEL = 917 mg/kg/
day (M) and 1247
mg/kg/day (F)
based on
decreased body
weights and body
weight gains,
decreased food
efficiency,
hematology
(decreased
erythrocyte
count,
hemoglobin, mean
corpuscular
volume, and mean
corpuscular
hemoglobin), bile
duct hyperplasia,
decreased uterine
size in females,
and decreased
size of the
seminal vesicles
in males
------------------------------------------------------------------------
870.3100 90-Day oral NOAEL = 0.5 mg/kg/
toxicity -- day
rodents (rat) LOAEL = 10 mg/kg/
day based on
hyalinization of
hepatocytes,
increased
eosinophilia,
reduced
granulation,
increased liver
weights in males
and females, and
increases in
plasma alkaline
phosphatase,
alanine
transaminase and
aspartate
transaminase in
males
------------------------------------------------------------------------
870.3150 26-Week oral NOAEL = 1 mg/kg/
toxicity -- day
nonrodents (dog) LOAEL = 25 mg/kg/
day based on
hematology
(decreased
hemoglobin and
hematocrit
concentrations
and erythrocyte
count and
increased
platelet count
and prothrombin
time
------------------------------------------------------------------------
870.3200 21-Day dermal NOAEL = 1,000 mg/
toxicity (rabbit) kg/day, Highest
Dose Tested (HDT)
------------------------------------------------------------------------
870.3700 Prenatal Maternal NOAEL =
developmental -- 100 mg/kg/day
rodents (rat) Maternal LOAEL =
200 mg/kg/day
based on staining
of the ventral
fur and
significantly
decreased body
weight gain
(>10%) .
Developmental
NOAEL = 100 mg/kg/
day
Developmental
LOAEL = 200 mg/kg/
day based on
postimplantation
loss
------------------------------------------------------------------------
870.3800 Reproduction and Parental/Systemic
fertility effects NOAEL = 12.5 mg/
(rat) kg/day
Parental/Systemic
LOAEL = 50 mg/kg/
day based on
liver
histopathology in
males and females
of both
generations.
Reproductive NOAEL
= 50 mg/kg/day,
HDTReproductive
LOAEL = Not
established
Offspring NOAEL =
12.5 mg/kg/day
Offspring LOAEL =
50 mg/kg/day
based on
increased
incidence of
liver
hyalinization in
males
------------------------------------------------------------------------
870.4200 Carcinogenicity- NOAEL = 1.5 mg/kg/
mice day
LOAEL = 15 mg/kg/
day based on the
presence of liver
tumors and liver
weight increases
in male and
female mice
------------------------------------------------------------------------
870.4300 Chronic toxicity/ NOAEL = 0.25 mg/kg/
Carcinogenicity- day
rat LOAEL = 5 mg/kg/
day based on
hyalinization of
the liver in
males
------------------------------------------------------------------------
870.5100 Gene mutation - Negative
bacterial
------------------------------------------------------------------------
870.5300 Gene mutation - Negative
mammalian
------------------------------------------------------------------------
870.5375 Structural Negative
chromosomal
abberations
------------------------------------------------------------------------
870.5395 Other genotoxic Negative
effects
------------------------------------------------------------------------
[[Page 25948]]
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the dose at which 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 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. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intraspecies differences.
Three other types of safety or uncertainty factors may be used:
``Traditional uncertainty factors;'' the ``special FQPA safety
factor;'' and the ``default FQPA safety factor.'' By the term
``traditional uncertainty factor,'' EPA is referring to those
additional uncertainty factors used prior to FQPA passage to account
for database deficiencies. These traditional uncertainty factors have
been incorporated by the FQPA into the additional safety factor for the
protection of infants and children. The term ``special FQPA safety
factor'' refers to those safety factors that are deemed necessary for
the protection of infants and children primarily as a result of the
FQPA. The ``default FQPA safety factor'' is the additional 10X safety
factor that is mandated by the statute unless it is decided that there
are reliable data to choose a different additional factor (potentially
a traditional uncertainty factor or a special FQPA safety factor).
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by an UF of
100 to account for interspecies and intraspecies differences and any
traditional uncertainty factors deemed appropriate (RfD = NOAEL/UF).
Where a special FQPA safety factor or the default FQPA safety factor is
used, this additional factor is applied to the RfD by dividing the RfD
by such additional factor. The acute or chronic Population Adjusted
Dose (aPAD or cPAD) is a modification of the RfD to accommodate this
type of safety factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the LOC. For example, when 100 is the appropriate UF (10X
to account for interspecies differences and 10X for intraspecies
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and
compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a 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 fomesafen used for
human risk assessment is shown in Table 2 of this unit:
Table 2.--Summary of Toxicological Dose and Endpoints for Fomesafen for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment,
Exposure Scenario Interspecies and Special FQPA SF and LOC Study and Toxicological
Intraspecies and any for Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary An endpoint of concern for females 13-50 years of age attributable to a
(Females 13-50 years of age)......... single dose was not identified in the hazard database.
----------------------------------------------------------------------------------------------------------------
Acute Dietary An endpoint of concern for the general population attributable to a
(General population including infants single dose was not identified in the hazard database.
and children).
----------------------------------------------------------------------------------------------------------------
Chronic Dietary NOAEL= 0.25 mg/kg/day Special FQPA SF = 1X Chronic toxicity - rat
(All populations).................... UF = 100............... cPAD =................. LOAEL = 5 mg/kg/day
Chronic RfD = 0.0025 mg/ chronic RfD /Special based on hyalinization
kg/day. FQPA SF. of the liver in males
= 0.0025 mg/kg/day.....
----------------------------------------------------------------------------------------------------------------
Cancer In accordance with the EPA Final Guidelines for Carcinogen Risk
(oral, dermal, inhalation)........... Assessment (March 29, 2005), EPA classified fomesafen as ``Not likely to
be carcinogenic to humans''. This decision was based on the weight-of-
evidence which supports activation of peroxisome proliferator-activated
receptor alpha (PPAR) as the mode of action for fomesafen-induced
hepatocarcinogenesis in mice. The data did not support either
mutagenesis or cytotoxicity followed by regenerative proliferation as
alternative modes of action. While the proposed mode of action for liver
tumors in mice is theoretically plausible in humans, it is
quantitatively implausible and unlikely to take place in humans based on
quantitative species differences in PPAR activation and toxicokinetics.
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.433) for the residues of sodium salt of
fomesafen, in or on soybeans. Risk assessments were conducted by EPA to
assess dietary exposures from fomesafen 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
[[Page 25949]]
occurring as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
fomesafen; 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 fomesafen
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 fomesafen in drinking water.
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 fomesafen.
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 concentration in ground water (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 incorporates 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
LOC.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency uses 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 pecent Reference dose
(%RfD) or percent population adjusted dose (%PAD).
Based on the PRZM/EXAMS and SCI-GROW models, the EECs of fomesafen
for chronic exposures are estimated to be 10.535 parts per billion
(ppb) for surface water and 1.0 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).
Fomesafen is not registered for use on any sites that would result
in residential exposure.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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 fomesafen and any other
substances and fomesafen 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 fomesafen has a common
mechanism of toxicity with other substances. For information regarding
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
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 Web site at https://www.epa.gov/pesticides/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 database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. 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
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no concern and/or
residual uncertainty with regard to prenatal and/or postnatal increased
susceptibility. The requirement for an acceptable ``guideline''
developmental toxicity study in a second species has not been
satisfied. The study in rabbits is deficient. Individual animal data
were not reported and all fetuses were not examined for both soft
tissue and skeletal alterations; and historical control data were not
provided. Additionally, animals had an intercurrent infection that
confounded interpretation of the results of the study. Therefore, the
developmental toxicity study in the rabbit was classified
``Unacceptable/Guideline''. However, a new developmental toxicity study
in rabbits is not required at this time because sufficient numbers of
fetuses were available for examination in the rabbit developmental
toxicity study. There was no increase in fetal deaths at the highest
dose tested even though the dams suffered with an intercurrent
infection. There were no external or internal malformation/
abnormalities, soft tissue or skeletal that could be related to
treatment with the test material at any of the three dosage levels
tested including the highest dose level of 40 mg/kg/day. The study does
not meet current guideline standards, but it does provide sufficient
information on the possible effects the test material
[[Page 25950]]
might have on the developing rabbit fetus, especially since the
maternal animals were additionally under considerable stress from
infection.
3. Conclusion. The fomesafen toxicity database is adequate for the
risk assessment since we are not asking for a repeat developmental
toxicity study in rabbits at this time. In addition, there is no
evidence of increased susceptibility, no residual uncertainty in the
database, and exposure data are complete or are estimated based on
that, reasonably account for potential exposures. 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 dose
exposure to fomesafen was not identified in the hazard database.
Therefore there are no acute toxicological concerns for fomesafen.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to fomesafen
from food and drinking water will utilize 9.5% of the cPAD for the U.S.
population, 31% of the cPAD for all infants (< 1 year old), and 15% of
the cPAD for children 1-2 years old. Fomesafen is not registered for
use on any sites that would result in residential exposure. Therefore,
the aggregate risk is the sum of the risk from food and water, which do
not exceed the Agency's LOC.
3. 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 fomesafen residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (chemical derivatization followed
by gas chromatography with Nitrogen-Phosphorus detection) 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
No Codex Maximum residue levels (MRLs) have been established for
residues of fomesafen. Canadian MRLs have been established for residues
of fomesafen in or on dry beans; lima beans; snap beans; and soybeans
at 0.05 ppm, and a Mexican MRL of 0.05 mg/kg has been established for
residues of fomesafen in or on soybeans. Syngenta Canada will be
submitting a request to lower the fomesafen MRLs in Canada to match
those being proposed for the USA. Therefore the MRLs will eventually be
harmonized.
V. Conclusion
Therefore, the tolerance is established for residues of fomesafen,
5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-
nitrobenzamide, in or on bean, dry; bean, snap, succulent; cotton,
undelinted seed and cotton, gin byproducts at 0.025 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-2006-0073 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 July 3,
2006.
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.1.,
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-2006-0073, 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.
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 a 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
[[Page 25951]]
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 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: April 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 180.433 is revised to read as follows:
Sec. 180.433 Fomesafen; tolerances for residues.
(a) General. Tolerances are established for the residues of
fomesafen 5-[2-chloro-4-(trifluoromethyl)phenoxy]-N-(methylsulfonyl)-2-
nitrobenzamide from the application of its sodium salt in or on the
following commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Bean, dry.................................................. 0.025
Bean, snap, succulent...................................... 0.025
Cotton, gin byproducts..................................... 0.025
Cotton, undelinted seed.................................... 0.025
Soybean.................................................... 0.05
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 06-4160 Filed 5-2-06; 8:45 am]
BILLING CODE 6560-50-S
