[Federal Register: December 27, 2006 (Volume 71, Number 248)]
[Rules and Regulations]
[Page 77620-77625]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de06-14]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0788; FRL-8108-8]
Fluthiacet-methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes a tolerance for combined residues
of fluthiacet-methyl in or on cotton, gin byproducts and cotton,
undelinted seed. K-I Chemical U.S.A. Inc. 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 December 27, 2006. Objections and
requests for hearings must be received on or before February 26, 2007,
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-2006-0788. 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.
[[Page 77621]]
FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration
Division (7505P), 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@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 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
.
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-2006-0788 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 February 26, 2007.
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-2006-0788, by one of the following methods:
Federal e Rule making 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 September 20, 2006 (71 FR 54987) (FRL-
8094-7), 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
7F4821) by K-I Chemical U.S.A. Inc., 11 Martine Avenue, Suite 970,
White Plains, NY 10606. The petition requested that 40 CFR 180.551 be
amended by establishing a tolerance for combined residues of the
herbicide, fluthiacet-methyl, acetic acid, [[2-chloro-4-fluoro-5-
[(tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite,
acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-,
in or on the food/feed commodities: Cotton, gin byproducts at 0.20 part
per million (ppm) and cotton, undelinted seed at 0.020 ppm. That notice
included a summary of the petition prepared by K-I Chemical U.S.A.
Inc., the registrant. There were no comments received in response to
the notice of filing.
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/
[fxsp0]EPA-PEST/1997/November/[fxsp0]Day-26/p30948.htm.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for combined residues of
fluthiacet-methyl in or on cotton, gin byproducts at 0.20 ppm and
cotton, undelinted seed at 0.020 ppm. EPA's assessment of exposures and
risks
[[Page 77622]]
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 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 fluthiacet-methyl as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in the
Federal Register of December 21, 2001 (66 FR 65839) (FRL-6806-7).
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. An UF or 100 is routinely used, 10X to account for
interspecies differences and 10X for intraspecies differences.
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://www.epa.gov/fedrgstr/EPA-PEST/[fxsp0]1997/
November/Day-26/p30948.htm.
A summary of the toxicological endpoints for fluthiacet-methyl used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of December 21, 2001 (66 FR 65839)
(FRL-6806-7).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.551) for the residues of fluthiacet-methyl, in
or on a variety of raw agricultural commodities. Risk assessments were
conducted by EPA to assess dietary exposures from fluthiacet-methyl in
food as follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
No such effects were identified in the toxicological studies for
fluthiacet-methyl; 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 were assumed and refined with
average values of current and projected percent crop treated (PCT)
estimates. Refined current PCT estimates for field corn, sweet corn and
soybeans were determined to be on average < 1% and at a maximum 1%; and
projected PCT estimates for cotton were determined to be on average 30%
and at a maximum 34%.
iii. Cancer. The Hazard Identification Assessment Review Committee
classified fluthiacet-methyl as likely to be a human carcinogen.
Chronic and cancer exposure assessement. Chronic and cancer
exposures were determined to be dietary from residues in raw
agricultural commodities derived from the use of fluthiacet-methyl for
defoliating cotton and from water. HED determined that dietary exposure
to residues of fluthiacet-methyl and it acid metabolite (CGA-300402) in
or on cotton gin byproducts at 0.20 ppm and in or on cotton undelinted
seed at 0.020 were anticipated from the proposed use-pattern. These
tolerance level exposures were used in the risk assessment. In
addition, Estimated Drinking Water Concentrations (EDWCs) were
determined by modeling (PRZM/EXAMS, Tier II) for California, the
highest found level of potential residues for chronic (0.19 [mu]g/L)
and for cancer (0.14 [mu]g)
iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of the FFDCA authorizes EPA to use available data
and information on the anticipated residue levels of pesticide residues
in food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must pursuant
to section 408(f)(1) require that data be provided 5 years after the
tolerance is established, modified, or left in effect, demonstrating
that the levels in food are not above the levels anticipated. Following
the initial data submission, EPA is authorized to require similar data
on a time frame it deems appropriate. For the present action, EPA will
issue such data call-ins for information relating to anticipated
residues as are required by FFDCA section 408(b)(2)(E) and authorized
under FFDCA section 408(f)(1). Such data call-ins will be required to
be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if the Agency can make the following findings: Condition 1,
that the data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of PCT as required
by section 408(b)(2)(F) of FFDCA, EPA may require registrants to submit
data on PCT.
The Agency used PCT information as follows: The assumptions of the
dietary exposure analysis were tolerance level residues, modified by
default processing factors and percent crop treated (PCT) data. The
resulting chronic and cancer dietary assessments were classified as
Tier 2 assessments and are considered to be partially refined.
PCT information came from EPA's refined usage analysis. Refined
current PCT estimates for field corn, sweet corn and soybeans were
determined to be on average < 1%, and at a maximum 1%. Projected PCT
estimates for cotton were
[[Page 77623]]
determined to be on average, 30%, and at a maximum 34%. Because the
estimated average PCTs for field corn, sweet corn and soybeans were
less than 1%, they were rounded up to 1% for use in the chronic and
cancer dietary assessments. The estimated average PCT for cotton was
used for both the chronic and cancer assessment. There were no data on
pop corn; therefore, 100% crop treated defaults were used. Default DEEM
7.81 processing factors were applied to corn, field, syrup and corn,
field, syrup-babyfood. EPA concluded that residues of fluthiacet-methyl
and its acid metabolite CGA-300403, were not expected to accumulate in
livestock tissues; therefore, livestock commodities were not factored
into the dietary risk assessment.
The Agency believes that the three conditions listed in Unit
IV.C.1. have been met. With respect to Condition 1, PCT estimates are
derived from Federal and private market survey data, which are reliable
and have a valid basis. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions 2 and 3, regional consumption information and
consumption information for significant subpopulations are taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which fluthiacet-
methyl may be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for fluthiacet-methyl 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 fluthiacet-methyl. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/[fxsp0]oppefed/models/water/index.htm.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System and Sreening Concentrations in Groundwater models, the estimated
environmental concentrations (EECs) of fluthiacet-methyl for acute
exposures are estimated to be between 0.23 and 1.0 parts per billion
(ppb) for surface water and 0.08 ppb for ground water. The EECs for
chronic and cancer exposures are estimated to be 0.19 and 0.l4,
respectively.
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). Fluthiacet-methyl 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 fluthiacet-methyl and any
other substances and fluthiacet-methyl 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 fluthiacet-methyl
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 data base on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There is no quantitative or
qualitative evidence or increased susceptibility of rat and rabbit
fetuses to in utero exposure to fluthiacet-methyl in developmental
toxicity studies. There is no quantitative or qualitative evidence of
increased susceptibility to fluthiacet-methyl following prenatal/
postnatal exposure to a 2-generation reproduction study.
3. Conclusion. EPA concluded based on reliable data that it would
be safe to remove the additional 10X safety factor for the protection
of infants and children. This conclusion was based on the following
findings:
i. There is no quantitative or qualitative evidence of increased
susceptibility to fluthiacet-methyl following prenatal/postnatal
exposure;
ii. There is no concern for developmental neurotoxicity resulting
from exposure to fluthiacet-methyl. A developmental neurotoxicity study
is not required;
iii. The toxicological data base is complete for FQPA assessment;
iv. The chronic dietary food exposure assessment utilizes tolerance
level residues and 34% of cotton and 1% corn and soybean crop treated
information for all commodities. By using these screening-level residue
values and conservative percent crop treated assessment, actual
exposures/risks will not be underestimated; and
v. The dietary drinking water assessment utilizes water
concentration values generated by model and associated modeling
parameters that are designed to provide conservative, health
protective, high-end estimates of water concentrations that will not
likely be exceeded.
E. Aggregate Risks and Determination of Safety
1. Acute risk. An effect of concern attributable to a single
exposure (dose)
[[Page 77624]]
was not identified from the oral toxicity studies including the
developmental toxicity studies in rat and rabbits. No acute risk is
expected from exposure to fluthiacet-methyl.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fluthiacet-methyl from food will utilize < 1% of the cPAD for the U.S.
population, 1.4% of the cPAD for all infant < 1 year old. There are no
residential uses for fluthiacet-methyl that results in chronic
residential exposure to fluthiacet-methyl.
3. Short-term risk. Fluthiacet-methyl 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 level of concern.
4. Aggregate cancer risk for U.S. population. The overall cancer
dietary risk for the U.S. population is 7.51 x 10-7, based
on dietary (food and drinking water exposures).
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 fluthiacet-methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/mass
spectrometry method which uses negative ion chemical ionization (GC/
NCI-MS) is available to enforce the tolerance expression. The method
may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian or Mexican maximum residue limits
established for fluthiacet-methyl on corn, cotton and soybean
commodities or on meat and milk commodities.
V. Conclusion
Therefore, the tolerance is established for combined residues of
Fluthiacet-methyl, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-
oxo-1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]-methyl ester, and its acid metabolite,
acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-1H,3H-
[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-,
in or on cotton, gin byproducts at 0.20 ppm and cotton, undelinted seed
at 0.020 ppm.
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 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
[[Page 77625]]
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: December 19, 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 180.551 is amended by redesignating existing paragraph (a)
as (a)(1), and adding paragraph (a)(2) to read as follows.
Sec. 180.551 Fluthiacet-methyl; tolerances for residues.
(a) General. (1) * * *
(2) A tolerance is established for the combined residues of the
herbicide fluthiacet-methyland its acid metabolite: acetic acid, [[2-
chloro-4-fluoro-5-[tetrahydro-3-oxo-1H,3H-[1,3,4]thiadiazolo[3,4-
[alpha]]pyridazin-1-ylidene)amino]phenyl]thio]-methyl ester, and its
acid metabolite, acetic acid, [[2-chloro-4-fluoro-5-[(tetrahydro-3-oxo-
1H,3H-[1,3,4]thiadiazolo[3,4-[alpha]]pyridazin-1-
ylidene)amino]phenyl]thio]- , in or on the following food commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cotton, gin byproducts..................................... 0.20
Cotton undelinted seed..................................... 0.020
------------------------------------------------------------------------
* * * * *
[FR Doc. E6-22126 Filed 12-26-06; 8:45 am]
BILLING CODE 6560-50-S