[Federal Register: September 29, 2006 (Volume 71, Number 189)]
[Rules and Regulations]
[Page 57431-57436]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se06-18]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0543; FRL-8092-3]
Flufenoxuron; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
flufenoxuron in or on apple, grape, pear, orange, and livestock
commodities. BASF 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 September 29, 2006. Objections and
requests for hearings must be received on or before November 28, 2006,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0543. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., 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 in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The 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: Mark Suarez, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-0120; e-mail address: suarez.mark@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?
In addition to accessing an electronic copy of this Federal
Register document
[[Page 57432]]
through the electronic docket at http://www.regulations.gov, you may
access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr.
You may also access a frequently updated electronic version
of 40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized
Guidelines referenced in this document, go directly to the guidelines
at http://www.epa.gpo/opptsfrs/home/guidelin.htm
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the 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. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2005-0543 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 November 28, 2006.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0543, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW, Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of April 19, 2006 (71 FR 20097) (FRL-7769-
5), 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
8E4943) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research
Triangle Park, NC 27709-3528. The petition requested that 40 CFR
180.623 be amended by establishing tolerances for residues of the
insecticide flufenoxuron, 1-[4-(2-chloro-[alpha],[alpha],[alpha]-
trifluoro-p-tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea, in
or on apple at 1 parts per million (ppm), pear at 1 ppm, orange at 0.3
ppm, orange oil at 60 ppm, grape at 0.2 ppm, raisin at 0.8 ppm, meat at
0.3 ppm, cattle, meat by-products at 1.5 ppm, cattle, fat at 6 ppm,
milk at 0.6 ppm, and milk, fat at 3 ppm. That notice included a summary
of the petition prepared by BASF Corporation, the registrant. Comments
were received on the notice of filing. EPA's response to these comments
is discussed in Unit IV.C.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for tolerances for residues of flufenoxuron, in or
on apple (0.50 ppm); grape (0.70 ppm); grape, raisin (2.0 ppm); cattle,
meat (0.10 ppm); cattle, fat (4.5 ppm); cattle, meat byproducts (0.50
ppm); goat, meat (0.10 ppm); goat, fat (4.5 ppm); goat, meat byproducts
(0.50 ppm); horse, meat (0.10 ppm); horse, fat (4.5 ppm); horse, meat
byproducts (0.50 ppm); sheep, meat (0.10 ppm); sheep, fat (4.5 ppm);
sheep, meat byproducts (0.50 ppm); milk (0.20 ppm); milk, fat (4.0
ppm); orange (0.30 ppm); orange, oil (60 ppm); and pear (0.50 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 their
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 flufenoxuron as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.epa.gov/opprd001/factsheets
.
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.
[[Page 57433]]
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. More information
can be found on the general principles EPA uses in risk
characterization at http://wwwepa.gov/oppfead1/trac/science.
A summary of the toxicological endpoints for flufenoxuron used for
human risk assessment is shown in Table 1 of this unit:
Table 1.--Summary of Toxicological Dose and Endpoints for Flufenoxuron for Use in Human Risk Assessment
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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
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Acute Dietary (Females 13-50 years of An end point of concern attributed to single dose effect was not
age) identified in the database.
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Acute Dietary (General population An end point of concern attributed to single dose effect was not
including infants and children) identified in the database.
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Chronic Dietary (All populations) NOAEL= 3.75 mg/kg/day.. FQPA SF = 1X........... 2-Generation
UF = 100............... cPAD = chronic RfD/FQPA Reproduction Toxicity-
Chronic RfD = 0.0375 mg/ SF = 0.0375 mg/kg/day. Rat
kg/day. LOAEL = 14.33/16.0 (M/
F) mg/kg/day based on
decreased body weights
during lactation
during days 4-21
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Oral-All Durations (Residential) NOAEL= 3.75 mg/kg/day.. LOC for MOE = 100...... 2-Generation
Reproduction Toxicity-
Rat
LOAEL = 14.33/16.0 (M/
F) mg/kg/day based on
decreased body weights
during lactation
during days 4-21
----------------------------------------------------------------------------------------------------------------
Dermal-All Durations (Occupational/ Oral study............. LOC for MOE = 100 2-Generation
Residential) NOAEL= 3.75 mg/kg/day.. (Occupational). Reproduction Toxicity-
(dermal absorption rate LOC for MOE = 100 Rat
= 100%). (Residential). LOAEL = 14.33/16.0 (M/
F) mg/kg/day based on
decreased body weights
during lactation
during days 4-21
----------------------------------------------------------------------------------------------------------------
Inhalation-All Durations Oral study............. LOC for MOE = 100 2-Generation
(Occupational/Residential) NOAEL= 3.75 mg/kg/day.. (Occupational). Reproduction Toxicity
(inhalation absorption LOC for MOE = 100 Rat
rate = 100%). (Residential). LOAEL = 14.33/16.0 (M/
F) mg/kg/day based on
decreased body weights
during lactation
during days 4-21
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation) ``Not likely to be carcinogenic to humans''
----------------------------------------------------------------------------------------------------------------
C. Exposure Assessment
1. Dietary exposure from food and feed uses. There are currently no
tolerances established (40 CFR 180) for the residues of flufenoxuron.
Risk assessments were conducted by EPA to assess dietary exposures from
flufenoxuron 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 one-day or single exposure.
No such effects were identified in the toxicological studies for
flufenoxuron; 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: Tolerance level residues and 100% crop treated were
assumed for all commodities.
iii. Cancer. Flufenoxuron is classified as ``Not Likely to be
Carcinogenic to Humans'' based on lack of evidence of carcinogenicity
in both rats and mice carcinogenicity studies and thus an exposure
assessment pertaining to cancer risk is unnecessary.
2. Dietary exposure from drinking water. There is no expectation
that residues from flufenoxuron use on imported commodities would occur
in surface or ground water sources of drinking water. No drinking water
assessment was conducted.
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).
Flufenoxuron 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 flufenoxuron and any other
substances and flufenoxuron does not appear to
[[Page 57434]]
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has not assumed that
flufenoxuron 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 website at http://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 was no evidence of
increased susceptibility for flufenoxuron in the developmental toxicity
study in rats. No adverse effects were observed in either dams or
offspring at the limit dose. Although fetal external examination data
were not provided in the study report and have been requested, their
absence does not affect the current risk assessment. Evidence of
increased susceptibility was observed in the developmental toxicity
study in rabbits. Specifically, decreased fetal weight was observed in
the absence of maternal toxicity; however, fetal effects were observed
at the limit dose, and the NOAEL, which is one order of magnitude
lower, is considered well characterized and protective of this high-
dose effect. In the 2-generation reproduction study, increased
susceptibility of offspring was observed in the form of decreased body
weight, since this effect was observed at a lower dose than the
maternal NOAEL. However, a NOAEL for this effect in offspring was also
observed, and it is considered protective of any effects at the
offspring LOAEL. Based on this analysis, there is no concern for
increased susceptibility of offspring following exposure to
flufenoxuron. If adverse effects are observed after submission of fetal
external examination data for the developmental toxicity study in rats,
this conclusion may be revised.
3. Conclusion. There is a complete toxicity database for
flufenoxuron and exposure data are complete or are estimated based on
data that reasonably account for potential exposures.
The establishment of tolerances for flufenoxuron on imported
commodities include consideration of the fact that: There are no
residual uncertainties concerning pre- and post-natal toxicity and no
neurotoxicity concerns; the chronic dietary (food + drinking water)
exposure assessment is a conservative assessment that is based on
reliable data and will not underestimate exposure/risk; there is no
potential for drinking water exposure from the proposed use on imported
commodities; there is no potential for residential exposure.
Additionally, the EPA evaluated the quality of the toxicology and
exposure data; and, based on these data, concluded that the FQPA SF be
reduced to 1x. The recommendation was based on the following:
i. There is no evidence of increased susceptibility in the
developmental study in rats.
ii. In the rabbit developmental study, there is evidence of
increased susceptibility; however, the effects are well characterized
and clear NOAELs and LOAELs are established. Since the effects occurred
at the limit dose, the delayed fetal growth may be considered a high
dose effect.
iii. In the 2-generation reproduction study in rat, there is
evidence for the increased susceptibility; however, the effects were
well characterized, clear NOAELs and LOAELs were established for
offspring toxicities, and the endpoints were used for risk assessment.
Therefore, there is no residual uncertainty for pre- and/or post-natal
susceptibility.
iv. The toxicological database is complete for FQPA assessment.
v. The chronic dietary food exposure assessment utilizes proposed
tolerance level residues and assumes 100% CT information for all
commodities. By using these screening-level assessments, actual
exposures/risks will not be underestimated.
E. Aggregate Risks and Determination of Safety
1. Acute risk. Because an endpoint of concern attributable to a
single dose was not identified for flufenoxuron, it is not expected to
pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
flufenoxuron from food will utilize 14% of the cPAD for the U.S.
population, 23% of the cPAD for all infants (< 1 year), and 63% of the
cPAD for children 1-2 years. There are no residential uses for
flufenoxuron that result in chronic residential exposure to
flufenoxuron. EPA does not expect the aggregate exposure to exceed 100%
of the cPAD.
3. Short-term risk, Intermediate-term risk. Flufenoxuron is not
registered for use on any sites that would result in residential or
drinking water exposure. Therefore, the aggregate risk is the sum of
the risk from food and water, which do not exceed the Agency's level of
concern.
4. Aggregate cancer risk for U.S. population. Based on lack of
evidence of carcinogenicity in both rats and mice carcinogenicity
studies, the chemical is considered as ``not likely to be carcinogenic
to humans.''
5. 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 flufenoxuron residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An adequate HPLC/ultraviolet (UV) method (SAMS 432-3) and liquid
chromatography (LC)/mass spectrometry (MS)/MS method (BASF Method 544/
0) are available for collecting data on flufenoxuron residues in/on
plant commodities. The limit of quantification (LOQ) for flufenoxuron
in/on plant commodities is 0.05 ppm for the HPLC/UV method and 0.01 ppm
for the LC/MS/MS method. Method SAMS 432-3, which is also the proposed
enforcement method for plant commodities, has been radio-validated and
undergone a successful independent laboratory validation (ILV) trial.
As a successful ILV trail has already been conducted, the method has
been forwarded to the Analytical Chemistry Branch of the Biological and
Economics Analysis Division (ACB/BEAD) for a petition method validation
(PMV) (Memo, J. Tyler, 8/10/05; DP 320112).
[[Page 57435]]
Adequate HPLC/UV methods are also available for collecting data on
flufenoxuron residues in milk (Method SAMS 486-1) and livestock tissues
(Method SAMS 457-2). The validated LOQ for flufenoxuron is 0.01 ppm in
milk, 0.3 ppm in fat, and 0.1 ppm in other tissues. Method SAMS 486-1,
which is the proposed enforcement method for milk, does not require
radio-validation (due to the similarity between the extraction
procedures in the proposed method and the extraction procedures used in
the metabolism studies) and has undergone a successful ILV. This method
has been forwarded to ACB/BEAD for a PMV trial (Memo, J. Tyler, 8/10/
05; DP 320112).
B. International Residue Limits
There are currently no established or proposed Canadian, Mexican or
Codex maximum residue limits (MRLs) for flufenoxuron.
C. Response to Comments
A private citizen responded to PP 8E4943. Comments were received on
April 19, 2006 objecting to the allowance of any residues of
flufenoxuron on food commodities. One comment was received from a
private citizen who opposed the authorization to sell to any pesticide
that leaves a residue on food. The Agency has received this same
comment from this commenter on numerous previous occasions and rejects
it for the reasons previously stated. (January 7, 2005, 70 FR 1349,
1354; FRL-7691-4).
V. Conclusion
Therefore, the tolerances are established for residues of
flufenoxuron, 1-[4-(2-chloro-[alpha],[alpha],[alpha]-trifluoro-p-
tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea, in or on apple
(0.50 ppm); grape (0.70 ppm); grape, raisin (2.0 ppm); cattle, meat
(0.10 ppm); cattle, fat (4.5 ppm); cattle, meat byproducts (0.50 ppm);
goat, meat (0.10 ppm); goat, fat (4.5 ppm); goat, meat byproducts (0.50
ppm); horse, meat (0.10 ppm); horse, fat (4.5 ppm); horse, meat
byproducts (0.50 ppm); sheep, meat (0.10 ppm); sheep, fat (4.5 ppm);
sheep, meat byproducts (0.50 ppm); milk (0.20 ppm); milk, fat (4.0
ppm); orange (0.30 ppm); orange, oil (60 ppm); and pear (0.50 ppm).
The petitioner is to provide an amended analytical method, as the
current method is not adequate for tolerance enforcement in/on plant
commodities because confirmatory HPLC/UV analysis is not sufficiently
distinct from the primary analytical method. The petitioner should
revise the method to include a confirmatory analysis using LC/MS/MS,
which has been shown to adequately detect and quantify flufenoxuron in
BASF Method 544/0. In addition, although a successful ILV trial was
conducted on HPLC/UV method SAMS 458- 1 using fat samples, this method
is distinct from SAMS 457-2 and is only for the analysis of fat.
Therefore, a separate ILV trial should be conducted on Method SAMS 457-
2 using samples of liver and muscle. Any proposed HPLC/UV method must
also be revised to include directions for a confirmatory analysis using
an analytical method that is distinct from the primary analytical
method. In addition, radio-labeled method validation data are required
for the proposed enforcement method using tissue samples from the goat
metabolism study to ensure that the method will adequately extract
endogenous flufenoxuron residues.
VI. 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
[[Page 57436]]
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
VII. 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: August 20, 2006.
James Jones,
Director, 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 180.623 is added to read as follows:
Sec. 180.623 Flufenoxuron; tolerances for residues.
(a) General. Tolerances are established for residues of the
insecticide, flufenoxuron, 1-[4-(2-chloro-[alpha],[alpha],[alpha]-
trifluoro-p-tolyloxy)-2-fluorophenyl]-3-(2,6-difluorobenzoyl)urea, in
or on the following food commodities.
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Apple\1\............................................. 0.50
Cattle, fat\1\....................................... 4.5
Cattle, meat\1\...................................... 0.10
Cattle, meat byproducts\1\........................... 0.50
Goat, fat\1\......................................... 4.5
Goat, meat\1\........................................ 0.10
Goat, meat byproducts\1\............................. 0.50
Grape\1\............................................. 0.70
Grape, raisin\1\..................................... 2.0
Horse, fat\1\........................................ 4.5
Horse, meat\1\....................................... 0.10
Horse, meat byproducts\1\............................ 0.50
Milk................................................. 0.20
Milk, fat\1\......................................... 4.0
Orange\1\............................................ 0.30
Orange, oil\1\....................................... 60
Pear\1\.............................................. 0.50
Sheep, fat\1\........................................ 4.5
Sheep, meat\1\....................................... 0.10
Sheep, meat byproducts\1\............................ 0.50
------------------------------------------------------------------------
\1\There are no U.S. registrations as of September 30, 2006.
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional restrictions. [Reserved]
(b) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-15931 Filed 9-28-06; 8:45 am]
BILLING CODE 6560-50-S