[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Rules and Regulations]
[Pages 22620-22625]
[FR Doc No: 2011-9849]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0102; FRL-8871-4]

Triflusulfuron-Methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
triflusulfuron-methyl in or on beet, garden, roots and beet, garden,
tops. Interregional Research Project Number 4 (IR-4) requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 22, 2011. Objections and
requests for hearings must be received on or before June 21, 2011, 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-2010-0102. All documents in the
docket are listed in the docket index available at http://www.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: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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 those
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to
provide 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 get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2010-0102 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
June 21, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0102, 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
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility'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 Facility telephone number is<PHONE_NUMBER>.

II. Summary of Petitioned-For Tolerances

    In the Federal Register of March 19, 2010 (75 FR 13277) (FRL-8813-
2), 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
9E7669) by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ
08540. The petition requested that 40 CFR 180.492 be amended by
establishing tolerances for residues of the herbicide triflusulfuron-
methyl, 2-[[[[[4-(dimethylamino)-6-(2,2,2-trifluoroethoxy)-1,3,5-
triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-methylbenzoate, in or on
beet, garden, roots at 0.01 parts per million (ppm); and beet, garden,
tops at 0.02 ppm. That notice referenced a summary of the petition
prepared on behalf of IR-4 by DuPont Crop Protection, the registrant,
which is available in the docket, http://www.regulations.gov. Comments
were received on the notice of filing. EPA's response to these comments
is discussed in Unit IV.C.
    EPA has revised the tolerance expression for all established
commodities to be consistent with current Agency policy and has made a
technical correction to the chemical name. The reasons for these
changes are explained in Unit IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    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. * *
*''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in 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 for triflusulfuron-methyl,
including exposure resulting from the tolerances established by this
action. EPA's assessment of exposures and risks associated with
triflusulfuron-methyl 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.
    Triflusulfuron-methyl is of low acute toxicity when administered
orally, dermally, or via inhalation. It is not a dermal sensitizer or
irritant, and causes only minor transient irritation to the eye. The
primary target organs identified for triflusulfuron-methyl are the
liver, testes, and red blood cells. Hematological and histopathological
changes consistent with mild hemolytic anemia were observed in the rat
and the dog. Following subchronic and/or chronic dietary exposure,
increased incidence of testicular interstitial hyperplasia was observed
in the rat, and testicular atrophy and reduced size were observed in
the dog. Liver effects including histopathology and increased weight
were observed in the dog and mouse, but not in the rat.
    No evidence of neurotoxicity was observed except for a
statistically significant increase in sciatic nerve myelin/axon
degeneration in female rats at the highest dose tested in the rat
combined chronic toxicity/carcinogenicity study. However, the incidence
was high in all dose groups, no increases were seen in the interim
sacrifice groups or in shorter-term studies, and it is commonly
observed in older rats.
    In the rat developmental toxicity study, no developmental effects
were noted, whereas maternal toxicity was observed (decreased body
weight gain, food consumption and feed efficiency). Abortions occurred
in the rabbit developmental toxicity study at a dose that also caused
significant maternal toxicity, including mortality, clinical signs,
sharply reduced food consumption and decreased weight gain. In the rat
reproductive toxicity study, decreased parental body weight/weight gain
and offspring weight during lactation were observed at the mid and high
doses. No reproductive effects were observed.
    Triflusulfuron-methyl is classified as a possible human carcinogen
(Group C) under the 1986 Cancer Guidelines, based on an increased
incidence of benign testicular interstitial cell adenomas in male rats
in the combined chronic/carcinogenicity toxicity study and evidence of
clastogenicity in some in vitro genotoxicity studies. A special
mechanistic study that evaluated hormonal changes in male rats provided
insufficient information to establish a nonlinear mode of action for
the formation of these tumors. Additionally, although a statistically
significant incidence of hepatocellular adenomas was noted in a
carcinogenicity study in mice, it was within the historical control
range and not considered as part of the weight-of-evidence for
determination of cancer classification. Because the observed tumors
were benign and found in only one species, and only at significantly
higher dose levels than the dose selected for the point of departure,
the chronic reference dose (RfD) is considered protective of potential
carcinogenicity for risk assessment purposes.
    Specific information on the studies received and the nature of the
adverse effects caused by triflusulfuron-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 at http://www.regulations.gov in document ``Triflusulfuron-methyl: Revised Human
Health Risk Assessment for Use in Garden Beet.'' at pages 34-38 in
docket ID number EPA-HQ-OPP-2010-0102.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a RfD--and a safe margin of exposure

(MOE). For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
expected in a lifetime. For more information on the general principles
EPA uses in risk characterization and a complete description of the
risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for
triflusulfuron-methyl used for human risk assessment is shown in Table
1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Triflusulfuron-Methyl for Use in Human Health Risk
                                                   Assessment
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                                      Point of departure and
         Exposure/scenario              uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                  effects
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Acute dietary (Females 13-49 years      Not required. An appropriate endpoint for this risk assessment was not
 of age and General population,                                       identified.
 including infants and children).
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Chronic dietary (All populations)..  NOAEL= 2.44 mg/kg/day.   Chronic RfD = 0.0244    Chronic oral toxicity/
                                     UFA = 10x                 mg/kg/day.              carcinogenicity in the
                                     UFH = 10x                cPAD = 0.0244 mg/kg/     rat LOAEL = 30.6 mg/kg/
                                     FQPA SF = 1x              day.                    day based on decreased
                                                                                body weight/weight gain,
                                                                                hematological changes
                                                                                (primarily males) and
                                                                                increased interstitial
                                                                                cell hyperplasia (males).
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..        Classification: Possible Human Carcinogen (Group C, 1986 Cancer
                                       Guidelines), based on increased incidence of testicular interstitial cell
                                        adenomas in rats. The RfD is considered adequately protective of these
                                                                       effects.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor.
PAD = population adjusted dose (a = acute, c = chronic).
UFA = extrapolation from animal to human (interspecies).
UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to triflusulfuron-methyl, EPA considered exposure under the
petitioned-for tolerances as well as all existing triflusulfuron-methyl
tolerances in 40 CFR 180.492. EPA assessed dietary exposures from
triflusulfuron-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 triflusulfuron-methyl;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the food consumption data from the USDA 1994-1996
and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As
to residue levels in food, EPA utilized tolerance-level residues and
100 percent crop treated (PCT) for all commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
Cancer risk is quantified using a linear or nonlinear approach. If
sufficient information on the carcinogenic mode of action is available,
a threshold or non-linear approach is used and a cancer RfD is
calculated based on an earlier noncancer key event. If carcinogenic
mode of action data are not available, or if the mode of action data
determines a mutagenic mode of action, a default linear cancer slope
factor approach is utilized. Based on the data summarized in Unit
III.A., EPA has concluded that the use of the chronic RfD is considered
protective of potential carcinogenicity for risk assessment purposes.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for triflusulfuron-methyl. Tolerance level residues and/or 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for triflusulfuron-methyl in drinking water. These
simulation models take into account data on the physical, chemical, and
fate/transport characteristics of triflusulfuron-methyl. Further
information regarding EPA drinking water models used in pesticide
exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
triflusulfuron-methyl for chronic exposures for non-cancer assessments
are estimated to be 0.005 parts per billion (ppb) for surface water and
0.50 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 0.50 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Triflusulfuron-methyl
is not registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of 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.'' EPA has not
found triflusulfuron-methyl to share a common mechanism of toxicity
with any other substances, and triflusulfuron-methyl does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
triflusulfuron-methyl does not have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. The triflusulfuron-methyl
toxicity database is adequate to evaluate potential increased
susceptibility of infants and children, and includes developmental
toxicity studies in rat and rabbit and a 2-generation toxicity study in
rat. No developmental effects were seen in the rat developmental
toxicity study. In the rabbit developmental toxicity study, abortions
were observed at a dose that also caused significant maternal toxicity,
including mortality, clinical signs, sharply reduced food consumption
and decreased weight gain. In the rat 2-generation reproductive
toxicity study, decreased parental body weight/weight gain and F1 pup
weight during lactation were observed at the mid and high doses. No
reproductive effects were observed.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for triflusulfuron-methyl is complete
except for immunotoxicity testing. Recent changes to 40 CFR part 158
require immunotoxicity testing (OPPTS Guideline 870.7800) for pesticide
registration. However, the existing data are sufficient for endpoint
selection for exposure/risk assessment scenarios, and for evaluation of
the requirements under the FQPA. There was no evidence of direct
immunotoxicity in the available studies. Hemolytic anemia, an effect
associated with exposure to some sulfonylurea compounds, was observed
for triflusulfuron-methyl. Immune-mediated hemolysis following binding
to red blood cells has been reported for sulfonylurea drugs such as
chlorpromamide, although it is not clear that the hemolytic anemia
observed with triflusulfuron-methyl is related to the immune system.
However, the hemolytic effects seen in the studies were of low concern
because the effects were sporadic and marginal (< 10% below controls)
and a large margin of safety for the effects was provided by the
selection of the PODs. In the rat, significant hematological
alterations and regenerative changes were observed at doses >= 100-fold
above the selected PODs. Effects in the dog were seen at doses >= 15-
fold higher. The Agency does not believe that an immunotoxicity study
will provide a POD lower than that currently used for risk assessment;
therefore, an additional UF is not needed to account for the lack of
this study.
    ii. Although a statistically significant increase in sciatic nerve
myelin/axon degeneration in high dose female rats was observed in the
triflusulfuron-methyl rat combined chronic toxicity/carcinogenicity
study, the incidence was high in all dose groups, no increases were
seen in the interim sacrifice groups or in shorter-term studies, and
the lesion is commonly observed in older rats. Therefore, EPA did not
consider this finding to be evidence of frank neurotoxicity, and there
is no need for a developmental neurotoxicity study or additional UFs to
account for neurotoxicity.
    iii. There is no evidence that triflusulfuron-methyl results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground water and surface water modeling
used to assess exposure to triflusulfuron-methyl in drinking water.
These assessments will not underestimate the exposure and risks posed
by triflusulfuron-methyl.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
triflusulfuron-methyl is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
triflusulfuron-methyl from food and water will utilize < 1% of the cPAD
for children 3-5 years old, the population group receiving the greatest
exposure. There are no residential uses for triflusulfuron-methyl.
Therefore, the chronic aggregate risk estimates are equivalent to the
chronic dietary (food + water) risk estimates.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however,
triflusulfuron-methyl is not registered for any use patterns that would
result in short- or intermediate-term residential exposure. Short- and
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there
is no short- or intermediate-term residential exposure and chronic
dietary exposure has already been assessed under the appropriately
protective cPAD (which is at least as protective as the POD used to
assess short- and intermediate-term risk), no further assessment of
short- and intermediate-

term risk is necessary, and EPA relies on the chronic dietary risk
assessment for evaluating short- and intermediate-term risk for
triflusulfuron-methyl.
    4. Aggregate cancer risk for U.S. population. Based on the
discussion in Unit III.C.iii., the chronic dietary risk assessment is
protective of any potential cancer effects.
    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, or to infants and children from aggregate
exposure to triflusulfuron-methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a high-performance liquid
chromatography with ultraviolet detection (HPLC-UV) method (Method AMR
1930-91), 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:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    There are currently no Codex MRLs established for residues of
triflusulfuron-methyl in or on commodities associated with this
petition. However, this action was a work share agreement with Canada's
Pesticide Management Regulatory Agency (PMRA). While the tolerance for
beet, garden, roots at 0.01 ppm is harmonized with PMRA, the tolerance
for beet, garden, tops at 0.02 ppm is not harmonized with PMRA's MRL of
0.01 ppm for that commodity. Based on the submitted residue data,
garden beet tops had residue levels equal to 0.01 ppm; given the level
of uncertainty for quantification around the limit of quantitation
(0.01 ppm), EPA has determined that a tolerance for beet, garden, tops
at 0.02 ppm is appropriate.

C. Response to Comments

    EPA received one comment to the Notice of Filing that made a
general objection to the presence of any pesticide residues on crops
and stated that EPA should set no pesticide tolerance greater than
zero. The Agency understands the commenter's concerns and recognizes
that some individuals believe that pesticides should be banned
completely. However, the existing legal framework provided by section
408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) states that
tolerances may be set when persons seeking such tolerances or
exemptions have demonstrated that the pesticide meets the safety
standard imposed by that statute. This citizen's comment appears to be
directed at the underlying statute and not EPA's implementation of it;
the citizen has made no contention that EPA has acted in violation of
the statutory framework.

D. Revisions to Petitioned-For Tolerances

    EPA has revised the tolerance expression to clarify: (1) That, as
provided in FFDCA section 408(a)(3), the tolerance covers metabolites
and degradates of triflusulfuron-methyl not specifically mentioned; and
(2) that compliance with the specified tolerance levels is to be
determined by measuring only the specific compounds mentioned in the
tolerance expression. Additionally, EPA has revised the chemical name
from triflusulfuron methyl to triflusulfuron-methyl in order to reflect
the preferred common name of the chemical.

V. Conclusion

    Therefore, tolerances are established for residues of
triflusulfuron-methyl, (methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-
trifluoroethoxy)-1,3,5-triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-
methylbenzoate), in or on beet, garden, roots at 0.01 ppm; and beet,
garden, tops at 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). 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., 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).
    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.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal governments, on the relationship between the national government
and the States or Tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 15, 2011.
 Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    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 180.492 is amended by revising the section heading and
paragraph (a) introductory text and alphabetically adding the following
commodities to the table in paragraph (a) to read as follows:

Sec.  180.492  Triflusulfuron-methyl; tolerances for residues.

    (a) General. Tolerances are established for residues of
triflusulfuron-methyl, including its metabolites and degradates, in or
on the commodities listed in the table below. Compliance with the
tolerance levels specified below is to be determined by measuring only
triflusulfuron-methyl (methyl 2-[[[[[4-(dimethylamino)-6-(2,2,2-
trifluoroethoxy)-1,3,5-triazin-2-yl]amino]carbonyl]amino]sulfonyl]-3-
methylbenzoate) in or on the following commodities:

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Beet, garden, roots........................................         0.01
Beet, garden, tops.........................................         0.02

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-9849 Filed 4-21-11; 8:45 am]
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[Federal Register: August 9, 2007 (Volume 72, Number 153)]
[Proposed Rules]
[Page 44817]
[DOCID:fr09au07-34]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2007-0619; FRL-8450-6]

Approval and Promulgation of Implementation Plans; State of
Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA proposes to approve the State Implementation Plan (SIP)
revision submitted by the state of Missouri for the purpose of
including the Kansas City 8-hour ozone maintenance plan into the SIP.
Section 110(a)(1) of the Clean Air Act requires that areas which were
maintenance areas for the 1-hour ozone standard and attainment for the
8-hour ozone standard develop a plan showing how the state will
maintain the ozone standard for the area. The maintenance plan includes
an emissions inventory demonstration, a plan for how the states will
track progress on reducing emissions, a commitment to continue ozone
monitoring, and a contingency plan that will ensure that a violation of
the 8-hour ozone standard is promptly addressed.

DATES: Comments on this proposed action must be received in writing by
September 10, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2007-0619 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Amy Algoe-Eakin, Environmental Protection Agency, Air
Planning and Development Branch, 901 North 5th Street, Kansas City,
Kansas 66101.
    4. Hand Delivery or Courier. Deliver your comments to: Amy Algoe-
Eakin, Environmental Protection Agency, Air Planning and Development
Branch, 901 North 5th Street, Kansas City, Kansas 66101. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8 to 4:30, excluding legal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Amy Algoe-Eakin at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the direct final rule. If no relevant adverse comments are
received in response to this action, no further activity is
contemplated in relation to this action. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed action. EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. Please note that if EPA receives
adverse comment on part of this rule and if that part can be severed
from the remainder of the rule, EPA may adopt as final those parts of
the rule that are not the subject of an adverse comment. For additional
information, see the direct final rule which is located in the rules
section of this Federal Register.

    Dated: July 27, 2007.
John B. Askew,
Regional Administrator, Region 7.
[FR Doc. E7-15258 Filed 8-8-07; 8:45 am]

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