[Federal Register: March 14, 2007 (Volume 72, Number 49)]
[Rules and Regulations]
[Page 11784-11789]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14mr07-5]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0207; FRL-8117-2]
Tribenuron Methyl; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
tribenuron methyl in or on corn, field, forage; corn, field, grain;
corn, field, stover; rice, grain; rice, straw; sorghum, forage;
sorghum, grain, grain; sorghum, grain, stover; soybean, seed; and
sunflower, seed. E.I. DuPont de Nemours and Company, Inc. requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
DATES: This regulation is effective March 14, 2007. Objections and
requests for hearings must be received on or before May 14, 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-2006-0207. 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: Vickie Walters, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: 703-305-7504; e-mail address: walters.vickie@epa.gov.
SUPPLEMENTARY INFORMATION:
[[Page 11785]]
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 codes 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS codes 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS codes 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS codes 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.
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-2006-0207 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before May 14, 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-2006-0207, 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 July 14, 2006 (71 FR 40102) (FRL-8058-
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
4F6890) by E.I. DuPont de Nemours and Company, Laurel Run Plaza, P. O.
Box 80038, Wilmington, DE 19880-0038 and Interregional Research Project
No. 4 (IR-4), 681 Highway No. 1 South, North Brunswick, NJ 08902. The
petition requested that 40 CFR 180. 451 be amended by establishing a
tolerance fo residues of the herbicide tribenuron methyl (methyl 2-
[[[[(4-methoxy-6-methyl-1, 3, ,5-triazin-2-
yl)methylamino]carbonyl]amino]sulfonyl]benzoate, in or on field corn
and grain sorghum (forage, grain, and stover) rice (grain and straw);
soybean ,seed; and sunflowers at 0.05.parts per million (ppm). The
notice referenced a summary of the petition prepared by E.I. DuPont de
Nemours and Company, the registrant, that has been placed into the
public docket. A comment was received in response to this notice of
filing from B. Sachau, 15 Elm Street, Florham Park, NJ 07932. The
comment and EPA's response to this comment is discussed in Unit IV C
below.
During the course of the review the Agency noticed that the name of
the regulated chemical is incorrect and that the Petition Number for
the sunflowers tolerance was inadvertently left out of the notice. The
Agency is correcting these errors at this time. The Agency is also
updating the commodity listing to agree with current terminology.
Therefore the proposed tolerances are corrected to read: tolerances are
established for residues of the herbicide tribenuron methyl, (methyl-2-
[[[[N-(4-methoxy-6-methyl-1, 3, 5-triazin -2-
yl)methylamino]carbonyl]amino]sulfonyl]benzoate) in or on corn, field,
forage at 0.05 ppm; corn, field, grain at 0.05 ppm; corn, field, stover
at 0.05 ppm; rice, grain at 0.05 ppm; rice, straw at 0.05 ppm; sorghum,
grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm; sorghum,
grain, stover at 0.05 ppm, soybean, seed at 0.05 ppm (4F6890) and
sunflower, seed at 0.05 ppm (4E6855).
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
[[Page 11786]]
the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
III. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of and to
make a determination on aggregate exposure, consistent with section
408(b)(2) of FFDCA, for a tolerance for residues of tribenuron methyl,
(methyl-2-[[[[N-(4-methoxy-6-methyl-1, 3, 5-triazin -2-
yl)methylamino]carbonyl]amino]sulfonyl]benzoate) in or on corn, field,
forage at 0.05 ppm; corn, field, grain at 0.05 ppm; corn, field, stover
at 0.05 ppm; rice, grain at 0.05 ppm; rice; straw at 0.05 ppm; sorghum,
grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm; sorghum,
grain, stover at 0.05 ppm, soybean, seed at 0.05 ppm and sunflower,
seed at 0.05 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerances 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 tribenuron methyl 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 in Unit
III. A. of the final rule published in the Federal Register of
September 22, 2004 (69 FR 56711) (FRL-7679-5).
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
of concern are identified is sometimes used for risk assessment if no
NOAEL was achieved in the toxicology study selected. An uncertainty
factor (UF) is applied to reflect uncertainties inherent in the
extrapolation from laboratory animal data to humans and in the
variations in sensitivity among members of the human population as well
as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, and 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/pesticides/health/human.htm.
A summary of the toxicological endpoints for tribenuron methyl used
for human risk assessment is discussed in Unit III.B. of the final rule
published in the Federal Register of September 22, 2004 (69 FR 56711)
(FRL-7679-5).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.451) for the residues of tribenuron methyl, in
or on a variety of raw agricultural commodities. No tolerances for meat
product, eggs, or milk are established. Risk assessments were conducted
by EPA to assess dietary exposures from tribenuron 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 effect attributable to a
single dose was observed in any studies in the toxicology database for
tribenuron methyl. As a result, no acute dietary endpoint was
identified and no acute risk assessment was performed.
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 Intakes 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 (CT). No
empirical processing factors were used. A DEEM (Version 7.81) default
processing factor was used for corn syrup. Anticipated residues or
estimates of percent crop treated (PCT) were not used.
iii. Cancer. Tribenuron methyl is classified as a Group C (possible
human carcinogen) because of the increased incidence of mammary gland
adenocarcinomas in female Sprague-Dawley rats. Tribenuron methyl was
not shown to be mutagenic in any tests conducted. EPA considers the
chronic risk assessment to be protective of any potential risk of
carcinogenicity. Further discussion is found in Unit III.C. of the
final rule published in the Federal Register of September 22, 2004, 69
FR 56711 (FRL-7679-5).
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for tribenuron 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 tribenuron methyl. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed/models/water/index.htm.
Based on the first index reservoir screening tool (FIRST) and
screening concentration in ground water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of tribenuron methyl
for acute exposures are estimated to be 4.1 parts per billion (ppb) for
surface water and 6.8 ppb for ground water. The EDWCs for chronic
exposures are estimated to be 2.7 ppb for surface water and 6.8 ppb for
ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID). For the chronic
dietary risk assessment the higher ground water value of 6.8 ppb was
used.
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)Tribenuron 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
[[Page 11787]]
based on a common mechanism of toxicity, EPA has not made a common
mechanism of toxicity finding as to tribenuron methyl and any other
substances and tribenuron 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 tribenuron 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. Developmental and
reproductive toxicity studies in rats and rabbits indicated no
increased susceptibility (quantitative or qualitative) following in
utero or prenatal and/or postnatal exposure to tribenuron methyl.
3. Conclusion. EPA determined that reliable data show that it would
be safe for infants and children to reduce the FQPA safety factor to
1X. That decision is based on the following findings.
i. The toxicity data base for tribenuron methyl is complete. The
impact of tribenuron methyl on the nervous system has been specially
evaluated in neurotoxicity studies. There was no evidence of
neurotoxicity or neuropathology seen in the acute, subchronic, chronic
or reproductive studies. Therefore, a developmental neurotoxicity study
is required for tribenuron methyl.
ii. The available data from the developmental and reproductive
toxicity studies do not indicate a potential susceptibility of infants
and children to tribenuron methyl.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food assessments were performed based on 100% CT
and tolerance level residues. Conservative ground water estimates were
used in the risk assessment. This assessment will not underestimate the
exposure and risks posed by tribenuron methyl.
E. Aggregate Risks and Determination of Safety
1. Acute risk. No toxic effect attributable to a single dose was
observed in any studies in the toxicology database. As a result, no
acute risk is expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
tribenuron methyl from food and water will utilize 4.7% of the cPAD for
the U.S. population, 9.8% of the cPAD for all infants (< 1 year old),
and 9.1% of the cPAD for children 3-5 years old. There are no
residential uses for tribenuron methyl that result in chronic
residential exposure to tribenuron methyl. EPA does not expect the
aggregate exposure to exceed 100% of the cPAD.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level).
Tribenuron 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 does not exceed the Agency's
level of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Tribenuron 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 does not exceed the Agency's
level of concern.
5. Aggregate cancer risk for U.S. population. The Agency considers
the chronic risk assessment, making use of the cPAD, to be protective
of any aggregate cancer risk. See Unit III. E.2. Therefore, the
aggregate risk is not expected to exceed the Agency's level of concern.
6. 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 tribenuron methyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (including high performance liquid
chromatography (HPLC) with photo-conductivity and liquid chromatography
with detection via electrospray mass spectroscopy (LC/MS)) are
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 Mexican or Codex Maximum Residue Levels (MRLs) have been
established for tribenuron methyl. Canadian MRLs have been established
for tribenuron methyl on certain crops; however, no MRLs have been
established for corn, field, forage; corn, field, grain; corn, field,
stover; rice, grain; rice, straw; sorghum, grain, forage; sorghum,
grain, grain; sorghum, grain, stover; soybean, seed; or sunflower,
seed, therefore no questions of compatibility exist for these
commodities.
C. Response to Comments
A comment was received from Ms. B. Sachau in response to the notice
of filing. Ms. Sachau stated that the chemical should not be
manufactured or sold. Ms. Sachau based her conclusion on the following:
eye irritation potential, effects on the liver and kidney, and its
carcinogenic potential. Ms. Sachau also questioned the availability of
testing for this chemical in combination with other chemicals in use
today.
The effects on the kidney and liver were the basis of the chronic
reference dose (cRfD) and cPAD used for the chronic dietary risk
assessment. As discussed in Unit III. E.2, EPA does not expect the
aggregate exposure to exceed 100% of the cPAD which does not exceed the
Agency's level of concern. After review of available data, the Agency
considers the chronic risk
[[Page 11788]]
assessment, making use of the cPAD, to be protective of any aggregate
cancer risk. Ms. Sachau did not submit any scientific information to
support a revision of Agency conclusions.
EPA generally does not require companies to conduct studies to
evaluate the potential for synergistic effects from exposure to
combinations of chemical exposure. Such testing rarely shows any kind
of interaction (synergistic or antagonistic), and there are a nearly
infinite number of possible combinations, making the cost of
indiscriminate testing prohibitively high.
Because synergism does not occur often, the scientific community
believes that exposure to multiple chemicals is best assessed by
looking the effects caused by exposure to each chemical individually.
The only exception to that is when people are exposed to multiple
chemicals that share a common mechanism of toxicity. Then the effects
of exposure to multiple chemicals are expected to be additive, adjusted
for the relative toxicity of the different chemicals. This is done
through Agency cumulative risk assessments, which are discussed in Unit
III.C.4. of this document. Ms. Sachau did not submit any scientific
information to support a revision of Agency conclusions.
V. Conclusion
Therefore, the tolerances are established for residues of
tribenuron methyl, (methyl-2-[[[[N-(4-methoxy-6-methyl-1, 3, 5-triazin
-2-yl)methylamino]carbonyl]amino]sulfonyl]benzoate) in or on corn,
field, forage at 0.05 ppm; corn, field, grain at 0.05 ppm; corn, field,
stover at 0.05 ppm; rice, grain at 0.05 ppm; rice; straw at 0.05 ppm;
sorghum, grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm;
sorghum, grain, stover at 0.05 ppm, soybean, seed at 0.05 ppm and
sunflower, seed at 0.05 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 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: March 5, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
[[Page 11789]]
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 180.451 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:
Sec. 180.451 Tribenuron methyl; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Corn, field, forage............................ 0.05
Corn, field, grain............................. 0.05
Corn, field, stover............................ 0.05
* * * * *
Rice, grain.................................... 0.05
Rice, straw.................................... 0.05
Sorghum, grain, forage......................... 0.05
Sorghum, grain, grain.......................... 0.05
Sorghum, grain, stover......................... 0.05
Soybean, seed.................................. 0.05
Sunflower, seed................................ 0.05
* * * * *
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* * * * *
[FR Doc. E7-4645 Filed 3-13-07; 8:45 am]
BILLING CODE 6560-50-S