Thifensulfuron Methyl; Pesticide Tolerance

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: March 21, 2007 (Volume 72, Number 54)]
[Rules and Regulations]
[Page 13179-13184]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21mr07-6]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0208; FRL-8117-1]

AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of
thifensulfuron methyl in or on rice, grain; rice, straw; sorghum,
grain, forage; sorghum, grain, grain; and sorghum, grain, stover. E. I.
DuPont de Nemours and Company 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 21, 2007. Objections and
requests for hearings must be received on or before May 21, 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-2006-0208. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. 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 Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
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) 305-5704; e-mail address: walters.vickie@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 code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
? Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
? Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
? Pesticide manufacturing (NAICS code 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

[[Page 13180]]

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.gov/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-2006-0208 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 21, 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-2006-0208, by one of the following methods:
? Federal eRulemaking Porta: 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
Bldg.), 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 40103) (FRL-8058-
8), 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
4F6889) by E.I. Dupont de Nemours and Company, Inc., Laurel Run Plaza,
P. O. Box 80038, Wilmington, DE 19880-0038. The petition requested that
40 CFR 180.439(a) be amended by establishing tolerances for residues of
the herbicide thifensulfuron methyl, (methyl-3-[[[[(4-methoxy-6-methyl-
1,3,5,-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-
thiophenecarboxylate, in or on grain sorghum (forage, grain, stover)
and rice (grain and straw) at 0.05 parts per million (ppm). That notice
referenced a summary of the petition prepared by E.I. DuPont de Nemours
and Company, Inc, the registrant, that has been included in the public
docket. A comment was received in response to the notice of filing from
B. Sachau, 15 Elm Street, Florham Park, NJ 07932. The comment and EPA's
response is discussed in Unit IV.C.4.
During the course of the review the Agency decided to update the
commodity listings to agree with current terminology. The commodities
are listed as rice, grain; rice, straw; sorghum, grain, forage;
sorghum, grain, grain; and sorghum, grain, stover.
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 thifensulfuron
methyl, (methyl-3-[[[[(4-methoxy-6-methyl-1,3,5,-triazin-2-
yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate, on rice,
grain at 0.05 part per million (ppm); rice, straw at 0.05 ppm; sorghum,
grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm and
sorghum, grain, stover 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 thifensulfuron 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
17, 2004 (69 FR 55975)(FRL-7679-4).

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

[[Page 13181]]

was achieved in the toxicology study selected. An uncertainty factor
(UF) is applied to reflect uncertainties inherent in the extrapolation
from laboratory animal data to humans and in the variations in sensitivity
among members of the human population as well as other unknowns.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. 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 thifensulfuron
miethylused for human risk assessment is shown in Table 1 of this unit:

Table 1.--Summary of Toxicological Dose and Endpoints for Thifensulfuron methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Dose Used in Risk
Assessment, Special FQPA SF and
Exposure/Scenario Interspecies and Level of Concern for Study and Toxicological
Intraspecies and any Risk Assessment Effects
Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50 years of NOAEL = 159 milligrams/ Special FQPA SF = 1x... Developmental oral
age) kilograms/day (mg/kg/ acute Population toxicity study in
day). adjusted dose (aPAD) = rats.
UF = 100............... acute Referenced dose LOAEL = 725 mg/kg/day
Acute RfD = 1.59 mg/kg/ (RfD). based on decreased
day. Special FQPA SF = 1.59 mean body weight and
mg/kg/day. increased incidence of
small renal papillae
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations) NOAEL = 7 mg/kg/day.... Special FQPA SF = 1x 90 Day Oral Toxicity in
UF = 100 Chronic RfD = chronic Population Rat
0.07 mg/kg/day. adjusted dose (cPAD) = LOAEL = 177 mg/kg/day
chronic RfD. based on decreased
Special FQPA SF = 0.07 body weight and body
mg/kg/day. weight gain in both
males and females, and
increased spleen
weights in males
----------------------------------------------------------------------------------------------------------------

1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.439) for the residues of thifensulfuron methyl,
in or on a variety of raw agricultural commodities. No tolerances for
meat, milk, poultry and egg are established. Risk assessments were
conducted by EPA to assess dietary exposures from thifensulfuron 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.
The acute dietary analysis was performed for the population
subgroup Females 13-49 only. This subgroup is the only one for which an
acute dietary endpoint was identified. In conducting the acute dietary
exposure assessment EPA used the Dietary Exposure Evaluation Model
software with the Food Commodity Intakes 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 acute
exposure assessments: Tolerance level residues and 100% crop treated
(PCT). No empirical processing factors were used. A DEEM (Version 7.81)
default processing factor was used for corn syrup. Anticipated residues
or estimates of PCT were not used.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the DEEM-FCID\TM\, which incorporates food
consumption data as reported by respondents in the USDA 1994-1996 and
1998 Nationwide 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 PCT. No
empirical processing factors were used. A DEEM (Version 7.81) default
processing factor was used for corn syrup. Anticipated residues or
estimates of PCT were not used.
iii. Cancer. Thifensulfuron methyl is classified as ``not likely to
be carcinogenic to humans'' based on acceptable chronic/carcinogenic
studies in rats and mice. Therefore, a cancer exposure assessment was
not performed.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for thifensulfuron 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 thifensulfuron 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 FQPA Index Reservior Screening Tool (FIRST) and
Screening concentration in ground water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of thifensulfuron
methyl for acute exposures are estimated to be 3.9 parts per billion
(ppb) for surface water and 0.27 ppb for ground water. The EDWCs for
chronic exposures are estimated to be 1.5 ppb for surface water and
0.27 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM-FCID). For the acute
dietary risk assessment the annual average concentration in surface
water of 3.9 ppb was used. For the chronic dietary risk assessment the
annual average concentration in surface water of 1.5 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,

[[Page 13182]]

indoor pest control, termiticides, and flea and tick control on pets).
Thifensulfuron 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 thifensulfuron methyl and
any other substances and thifensulfuron 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
thifensulfuron 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 evidence in the
developmental study in rabbits and two generation reproduction study in
rats of increased quantitative or qualitative susceptibility of the
offspring after in utero or post-natal exposure to thifensulfuron
methyl. The acceptable developmental toxicity in rats revealed
increased quantitative susceptibility of the fetus after in utero
exposure. Nonetheless there are no residual uncertainties for pre and
post natal toxicity because the fetal toxicity seen in the
developmental rat study has been well-characterized and the NOAEL
relied upon to calculate the chronic RfD is more than an order of
magnitude lower than the NOAEL from the developmental rat study.
3. Conclusion. EPA has 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 database for thifensulfuron methyl is complete.
Although the impact of thifensulfuron methyl on the nervous system has
not been specifically evaluated in neurotoxicity studies, available
toxicology studies in four species (rat, mouse, dog, and rabbit) do not
indicate a neurotoxic mode of action for this chemical and there are no
concerns from potential developmental neurotoxicity. Therefore, a
developmental neurotoxicity is not required for thifensulfuron methyl.
ii. As discussed in above Unit III.D.2., there are no concerns or
residual uncertainties for pre and/post natal toxicity.
iii. There are no residual uncertainties identified in the exposure
databases. The dietary food assessments were performed based on 100 PCT
and tolerance level residues. Conservative ground water and surface
water modeling estimates were used in the risk assessments. These
assessments will not underestimate the exposure and risks posed by
thifensulfuron methyl.

E. Aggregate Risks and Determination of Safety

1. Acute risk. The acute aggregate risk assessment is provided for
females 13-50 years old only. The existing data showed no indication
that thifensulfuron methyl could cause adverse effects in the general
population based upon a single dose. Thus there is no concern for acute
dietary exposure to the general population. Using the exposure
assumptions discussed in Unit III.C. for acute exposure, the acute
dietary exposure from food and water to thifensulfuron methyl will
occupy 0.03% of the aPAD at the 95% percentile of exposure for females
13 years and older. EPA does not expect the aggregate exposure to
exceed 100% of the aPAD,
2. Chronic risk. Using the exposure assumptions described in Unit
III.C. for chronic exposure, EPA has concluded that exposure to
thifensulfuron methyl from food and water will utilize < 1 % of the cPAD
for the U.S. population, < 1% of the cPAD for all infants less than 1
year old, and < 1% of the cPAD for children 3-5 years old. There are no
residential uses for thifensulfuron methyl that result in chronic
residential exposure to thifensulfuron 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).
Thifensulfuron 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 LOC.
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).
Thifensulfuron 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 LOC.
5. Aggregate cancer risk for U.S. population. Thifensulfuron methyl
is classified ``as not likely to be a human carcinogen.'' Therefore,
EPA does not expect thifensulfuron methyl will pose a cancer risk to humans.
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 thifensulfuron methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (including high performance liquid
chromatography (HPLC) with photo-conductivity detection and liquid
chromatography with detection via electrospray mass spectroscopy) are
available to enforce the tolerance

[[Page 13183]]

expression. These methods 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 established or proposed Codex Maximum Residue Levels
(MRLs) for residues of thifensulfuron methyl. Canadian and Mexican MRLs
have been established for residues of thifensulfuron methyl for several
crops. However no MRLs have been established for sorghum, grain,
forage; sorghum, grain, grain; sorghum, grain, stover; rice, grain; or
rice, straw.

C. Response to Comments

A comment for thifensulfuron methyl was received from Ms. B.
Sachau, 15 Elm Street, Florham Park, NJ 07932. Ms. Sachau stated that
any residue of this product in food was dangerous and questioned the
availability of testing for this chemical in combination with thousands
of other chemicals used in America today.
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 at the effects caused by 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 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 evidence that
supported a revision of Agency conclusions.
Based on the Agency risk assessments discussed in Unit III.E. of
this document the Agency has concluded that there is a reasonable
certainty that no harm will result to the general population and to
infants and children from aggregate exposure to thifensulfuron
residues. Ms. Sachau did not submit any scientific evidence that
supported a revision of Agency conclusions.

V. Conclusion

Therefore, the tolerances are established for residues of
thifensulfuron methyl, (methyl-3-[[[[(4-methoxy-6-methyl-1,3,5,-
triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate,on
rice, grain at 0.05 part per million (ppm); rice, straw at 0.05 ppm;
sorghum, grain, forage at 0.05 ppm; sorghum, grain, grain at 0.05 ppm
and sorghum, grain, stover 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 (59 FR 22951,
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

[[Page 13184]]

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.

? Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

? 1. The authority citation for part 180 continues to read as follows:

Authority: 21 U.S.C. 321(q), 346a and 371.

? 2. Section 180.439 is amended by alphabetically adding commodities to
the table in paragraph (a) to read as follows:

Sec. 180.439 Thifensulfuron methyl; Tolerances for residues.

(a) * * *

------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Rice, grain......................................... 0.05
Rice, straw......................................... 0.05
Sorghum, grain, forage............................... 0.05
Sorghum, grain, grain................................ 0.05
Sorghum, grain, stover............................... 0.05
* * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. E7-4762 Filed 3-20-07; 8:45 am]
BILLING CODE 6560-50-S

Notices For
2009
2008
2007
2006
2005
2004
2003
2002
2001
2000
1999
1998
1997
1996
1995
1994

Thifensulfuron Methyl; Pesticide Tolerance

Local Navigation