[Federal Register Volume 75, Number 71 (Wednesday, April 14, 2010)]
[Rules and Regulations]
[Pages 19272-19277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8135]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0134; FRL-8818-9]


Thifensulfuron methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
thifensulfuron methyl in or on safflower, seed. Interregional Research 
Project Number 4 (IR-4) requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective April 14, 2010. Objections and 
requests for hearings must be received on or before June 14, 2010, 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-2009-0134. 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: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; e-mail address: [email protected].

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

[[Page 19273]]

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. To 
access the OPPTS harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gov/oppts and select ``Test 
Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2009-0134 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 14, 2010. 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 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 this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0134, 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 (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL- 8407-
4), 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 
9F7523) by IR-4, 500 College Rd. East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.439 be amended by 
establishing a tolerance 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 safflower, 
seed at 0.05 parts per million (ppm). That notice referenced a summary 
of the petition prepared on behalf of IR-4 by E.I. DuPont de Nemours, 
the registrant, which is available to the public in the docket, http://www.regulations.gov There were no comments received in response to the 
notice of filing.

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 the petitioned-for 
tolerance for residues of thifensulfuron methyl on safflower seed at 
0.05ppm. EPA's assessment of exposures and risks associated with 
thifensulfuron 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.
    Thifensulfuron methyl has mild to low acute toxicity when 
administered via the oral, inhalation and dermal routes of exposure. It 
has moderate to low toxicity with respect to eye and skin irritation 
and is not a dermal sensitizer. Most findings in the submitted studies 
related to decreases in body weights, body weight gains, or organ 
weights (a reflection of the lower body weights compared with control 
weights). There were increased liver weights in male dogs and increased 
thyroid/parathyroid weights in female dogs. There were no gross or 
histopathological changes reported in any of the studies.
    In the rat developmental study, there were no maternal effects at 
the highest dose tested (HDT). The rabbit developmental study showed a 
decrease in maternal body weights at the HDT. There were no 
developmental effects at the HDT. In the 2-generation rat reproduction 
study there were no parental, reproductive or offspring effects. There 
was an increase in quantitative susceptibility in the rat developmental 
study, based on decreased mean fetal body weights, and an increase in 
the incidence of small renal papillae (only at the highest dose level).
    Thifensulfuron methyl is classified as ``not likely to be 
carcinogenic to humans,'' based on acceptable chronic/carcinogenicity 
studies in rats and mice at doses that are considered to be adequate, 
and not excessive for the determination of carcinogenic potential. The 
available mutagenicity studies in vivo and in vitro show that 
thifensulfuron methyl is neither mutagenic nor clastogenic.
    Neurotoxicity was not observed in the submitted guideline studies. 
There were

[[Page 19274]]

no acute or subchronic neurotoxicity studies available for review. 
There were also no immunotoxicity studies submitted for review. 
Immunotoxicity was observed as a decrease in spleen weight in the 
subchronic rat study. However, this effect was only noted in males, and 
only at the mid-level dose of 177 mg/kg. The lack of response at the 
high-level dose, the occurrence in a single sex, the availability of a 
clear NOAEL, and the absence of immunotoxic effects in the remainder of 
the database reduce EPA's concern for immunotoxicity.
    Specific information on the studies received and the nature of the 
adverse 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 at http://www.regulations.gov in document ``Thifensulfuron Methyl. Human Health 
Risk Assessment for the Proposed Food/Feed Use of the Herbicide 
(Associated with Regional Section 3 Registration) on Safflower,'' pp. 
9-10 in docket ID number EPA-HQ-OPP-2009-0134.

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 reference dose (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 thifensulfuron methyl 
used for human risk assessment is shown in the table of this unit.

 Table --Summary of Toxicological Doses and Endpoints for Thifensulfuron methyl for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of Departure and
          Exposure/Scenario               Uncertainty/Safety     RfD, PAD, LOC for Risk  Study and Toxicological
                                               Factors                 Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute dietary                          NOAEL = 159 milligrams/  Acute RfD = 1.59 mg/kg/  Developmental Oral
 (Females 13 - 50 years of age)......   kilograms/day (mg/kg/    day                      Toxicity-Rat.
                                        day)                    aPAD = 1.59 mg/kg/day..  LOAEL = 725 mg/kg/day
                                       UFA = 10x..............                            based on decreased
                                       UFH = 10x..............                            mean body weight and
                                       FQPA SF = 1x...........                            increased incidence of
                                                                                          small renal papillae
----------------------------------------------------------------------------------------------------------------
Acute dietary                          Not applicable.                                   There were no single
(General population including infants                                                     dose effects
 and children).                                                                           appropriate for acute
                                                                                          exposure assessment
                                                                                          for the general
                                                                                          population.
----------------------------------------------------------------------------------------------------------------
Chronic dietary                        NOAEL= 4.3 mg/kg/day     Chronic RfD = 0.043 mg/  Carcinogenicity oral
(All populations)....................  UFA =10x...............   kg/day                   toxicity in mice.
                                       UFH = 10x..............  cPAD = 0.043mg/kg/day..  LOAEL = 128 mg/kg/day
                                       FQPA SF 1x.............                            based on decreased
                                                                                          body weight and body
                                                                                          weight gain.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral)                            Not likely to be a human carcinogen, based on the lack of evidence of
                                                           carcinogenicity in rats and mice.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD =
  reference dose. MOE = margin of exposure. LOC = level of concern.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to thifensulfuron methyl, EPA considered exposure under the 
petitioned-for tolerance as well as all existing thifensulfuron methyl 
tolerances in 40 CFR 180.439. EPA assessed 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. No such effect was 
identified for thifensulfuron methyl for the general population. 
However, EPA identified potential acute effects (decreased mean body 
weight, and increased incidence of small renal papillae) from pre-natal 
exposure and thus is assessing exposure and risk for the population 
subgroup, females 13 - 49 years old.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA used tolerance-
level residues, DEEM default processing factors for all processed 
commodities and assumed 100 percent crop treated (PCT) for all 
commodities covered by existing or proposed tolerances.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used tolerance-level 
residues, DEEM default processing factors for all processed commodities 
and assumed 100 PCT for all commodities covered by existing or proposed 
tolerances.

[[Page 19275]]

    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
classified thifensulfuron methyl as ``not likely to be carcinogenic to 
humans''. Therefore, a quantitative exposure assessment to evaluate 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
thifensulfuron methyl. Tolerance level residues and 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 thifensulfuron methyl in drinking water. These 
simulation models take into account data on the physical, chemical, and 
fate/transport characteristics of thifensulfuron 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 First Index Reservoir 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 4.429 parts per billion 
(ppb) for surface water and 0.0972 ppb for ground water and for chronic 
exposures for non-cancer assessments are estimated to be 1.5 ppb for 
surface water and .0972 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 4.429 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 1.5 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). Thifensulfuron 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 thifensulfuron methyl to share a common mechanism 
of toxicity with 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 assumed 
that thifensulfuron 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 website 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 prenatal and postnatal 
toxicology database for thifensulfuron methyl includes rat and rabbit 
prenatal developmental toxicity studies and a 2-generation reproduction 
toxicity study in rats. There was evidence of increased quantitative 
susceptibility in the rat developmental toxicity study. At the HDT, 
decreased mean fetal weights, and an increase in incidence of small 
renal papillae were observed in the absence of maternal toxicity. There 
was no indication of pre- or post-natal susceptibility in the rabbit 
developmental or rat reproduction studies.
    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 thifensulfuron methyl is complete 
except for immunotoxicity, acute neurotoxicity and subchronic 
neurotoxicity testing. Recent changes to 40 CFR part 158 make acute and 
subchronic neurotoxicity testing (OPPTS Guideline 870.6200) and 
immunotoxicity testing (OPPTS Guideline 870.7800) required 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.
    Neurotoxicity was not observed in any of the studies up to the HDT, 
nor is there any expectation of neurotoxicity based on the mechanism of 
action. Furthermore, the toxicity database for thifensulfuron methyl 
does not indicate that the immune system is the primary target organ. 
Immunotoxicity was observed as a decrease in spleen weight in the 
subchronic rat study. However, this effect was only noted in males, and 
only at the mid-level dose of 177 mg/kg. The lack of response in the 
high-level dose, the occurrence in a single sex, the availability of a 
clear NOAEL, and the absence of immunotoxic effects in the remainder of 
the database reduces EPA's concern for immunotoxicity. The overall 
weight of evidence suggests that thifensulfuron methyl does not 
directly target the immune system, and this finding (decrease in spleen 
weight) may be due to secondary effects of a primary toxicity. 
Therefore, the Agency does not believe that conducting the acute and 
subchronic neurotoxicity, and the immunotoxicity studies will result in 
a lower point of departure than the currently selected endpoints for 
overall risk assessment, and therefore, a database uncertainty factor 
is not needed to account for the lack of these studies.
    ii. There is no indication that thifensulfuron methyl is a 
neurotoxic chemical and there is no need for a developmental 
neurotoxicity study or additional UFs to account for neurotoxicity.
    iii. There is evidence that thifensulfuron methyl results in 
increased susceptibility in in utero rats in the prenatal developmental 
studies and in young rats in the 2-generation reproduction study; 
therefore, a degree of concern analysis was performed to determine the 
level of concern for the effects observed when considered in the 
context of all available toxicity data and to identify any residual 
concerns after establishing toxicity endpoints and traditional UF's to 
be used in the thifensulfuron methyl risk assessment. In considering 
the overall toxicity profile and the endpoints and doses selected for 
the thifensulfuron methyl risk assessment, EPA characterized the degree 
of concern for the susceptibility observed in the rat developmental and

[[Page 19276]]

2-generation reproductive studies as low and determined that there are 
no residual uncertainties for prenatal and/or postnatal toxicity 
because:
    a. The only missing toxicity data for thifensulfuron methyl are the 
newly required neurotoxicity and immunotoxicity studies; however, no 
additional UF is needed in the absence of these studies because there 
is no evidence to indicate that thifensulfuron methyl targets the 
nervous system or the immune system. Further, EPA has concluded a 
developmental neurotoxicity study is not required.
    b. There are clear NOAELs and LOAELs for the developmental and 
offspring effects noted in the rat developmental toxicity and in the 2-
generation reproduction toxicity studies and the doses and endpoints 
have been selected from these studies for risk assessment for the 
relevant exposed populations, ie., pregnant females and children.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on conservative assumptions, including 100 PCT and tolerance-level 
residues. EPA made conservative (protective) assumptions in the ground 
and surface water modeling used to assess exposure to thifensulfuron 
methyl in drinking water. These assessments will not underestimate the 
exposure and risks posed by thifensulfuron 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. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to thifensulfuron methyl will occupy less than 1% of the aPAD for 
females (ages 13 - 49), the population subgroup receiving the greatest 
exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
thifensulfuron methyl from food and water will utilize 1% of the cPAD 
for children (ages 3 - 5), the population subgroup receiving the 
greatest exposure. There are no residential uses for thifensulfuron 
methyl.
    3. Short and intermediate-term risk. Short and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    A short and intermediate-term adverse effect was identified; 
however, thifensulfuron 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 
point of departure used to assess short and intermediate-term risk), no 
further assessment of short or intermediate-term risk is necessary, and 
EPA relies on the chronic dietary risk assessment for evaluating short 
and intermediate-term risk for thifensulfuron methyl.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, thifensulfuron methyl is not expected to pose a cancer risk to 
humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to thifensulfuron methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    The following adequate enforcement methodology is available to 
enforce the tolerance expression: Two High Pressure Liquid 
Chromatography (HPLC) photo-conductivity detection methods. The 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: 
[email protected].

B. International Residue Limits

    There are no CODEX, Canadian or Mexican maximum residue limits 
(MRLs) established for residues of thifensulfuron methyl on safflower.

C. Revisions to Petitioned-For Tolerances

    EPA revised the tolerance expression in paragraph (a) to clarify:
     1. That, as provided in FFDCA section 408(a)(3), the tolerance 
covers metabolites and degradates of thifensulfuron 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.

V. Conclusion

    Therefore, a tolerance is established for residues of 
thifensulfuron methyl (methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-
2-yl) amino] carbonyl] amino] sulfonyl]-2-thiophenecarboxylate), in or 
on safflower, seed at 0.05 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

[[Page 19277]]

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) (Public Law 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 1, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. In Sec.  180.439, revise paragraph (a) introductory text and 
paragraph (c) to read as follows:


Sec.  180.439  Thifensulfuron methyl; tolerances for residues.

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

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Safflower, seed......................................               0.05
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-8135 Filed 4-13-10; 8:45 am]
BILLING CODE 6560-50-S