Document ID: EPA-HQ-OPP-2011-0564-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Thifensulfuron Methyl
Posted Date: 2012-08-29T04:00Z

[Federal Register Volume 77, Number 168 (Wednesday, August 29, 2012)]
[Rules and Regulations]
[Pages 52236-52240]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21356]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0564; FRL-9360-2]

Thifensulfuron Methyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
thifensulfuron methyl in or on chicory roots and chicory 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 August 29, 2012. Objections and 
requests for hearings must be received on or before October 29, 2012, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2011-0564, is available at http://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; email address: ertman.andrew@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 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).

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2011-0564 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 
October 29, 2012. 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

[[Page 52237]]

your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0564, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statue.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7885) 
by IR-4, 500 College Rd. East, Suite 201W, Princeton, NJ 08540. The 
petition requested that 40 CFR 180.439 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 
chicory, roots at 0.01 parts per million (ppm) and chicory, tops at 
0.01 ppm. That notice referenced a summary of the petition prepared by 
E.I. du Pont de Nemours and Company, the registrant, which is available 
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 FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), 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 thifensulfuron methyl including 
exposure resulting from the tolerances established by this action. 
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).
    Neurotoxicity was not observed in any of the submitted studies, 
including the recently submitted neurotoxicity studies which are 
currently under review. Based on the lack of neurotoxicity in the 
submitted studies, a developmental neurotoxicity study (DNT) is not 
required. A decrease in spleen weight was noted only in mid-dose males 
in the subchronic rat study, and was considered a potential sign of 
immunotoxicity. However, in the recently submitted immunotoxicity study 
in female rats, dosing with thifensulfuron methyl did not affect any 
immunotoxicity parameters up to the HDT of 529 milligrams//kilograms/
day.
    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; 
there were no tumors observed in the studies, and the only adverse 
effects were decreased body weights and body weight gains. The 
available mutagenicity studies in vivo and in vitro show that 
thifensulfuron methyl is neither mutagenic nor clastogenic.
    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 the document titled ``Thifensulfuron Methyl. 
Human Health Risk Assessment for the Proposed Use of the Herbicide on 
Chicory'' on pages 30-33 in docket ID number EPA-HQ-OPP-2011-0564.

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

[[Page 52238]]

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 following Table.

   Table--Summary of Toxicological Doses and Endpoints for Thifensulfuron 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
----------------------------------------------------------------------------------------------------------------
Acute dietary......................  NOAEL = 159 mg/kg/day.  aRfD = 1.59 mg/kg/day.  Developmental oral toxicity
(Females 13-50 years of age).......  UFA = 10X.............  aPAD = 1.59 mg/kg/day.   in rats.
                                     UFH = 10X.............                          LOAEL = 725 mg/kg/day,
                                     FQPA SF = 1X..........                           based on an increased
                                                                                      incidence of small renal
                                                                                      papillae.
Chronic dietary....................  NOAEL= 4.3 mg/kg/day..  cRfD = 0.043 mg/kg/day  Carcinogenicity oral
(All populations)..................  UFA = 10X.............  cPAD = 0.043 mg/kg/day   toxicity in mice.
                                     UFH = 10X.............                          LOAEL = 128 mg/kg/day,
                                     FQPA SF = 1X..........                           based on decreased body
                                                                                      weight and body weight
                                                                                      gain.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  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 thifensulfuron methyl, EPA considered exposure under the 
petitioned-for tolerances 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.
    Such effects were identified for thifensulfuron methyl. In 
estimating acute dietary exposure, EPA used food consumption 
information from the U.S. Department of Agriculture (USDA) 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA assumed 100 percent crop 
treated (PCT) and tolerance level residues for all commodities.
    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 assumed 100 PCT and 
tolerance level residues for all commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that thifensulfuron methyl does not pose a cancer risk to 
humans. Therefore, a dietary exposure assessment for the purpose of 
assessing 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. For chronic 
exposures for non-cancer assessments the EDWCs are estimated to be 1.5 
ppb for surface water and 0.0972 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 Web site 
at http://www.epa.gov/pesticides/cumulative.

[[Page 52239]]

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 Food Quality 
Protection Act (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.
    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. Although there was evidence of increased quantitative 
susceptibility in the rat developmental study, the Agency's degree of 
concern for the increased susceptibility is low because it was only 
observed in the rat developmental toxicity study and not seen in the 
rabbit developmental or reproduction studies, and was observed at doses 
considerably higher than the doses chosen for risk assessment; in 
addition, there was a clear NOAEL for the fetal effects, and therefore 
EPA's risk assessment is protective of the potential susceptibility.
    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 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 13-49 years old, the only population subgroup of concern.
    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 1.4% of the cPAD 
for children 3-5 years old, the population group 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 short- and intermediate-term 
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 either short- and/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- and/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 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

    Adequate enforcement methodology (liquid chromatograpy/mass 
spectrometry/mass spectrometry (LC/MS/MS)) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email 
address: residuemethods@epa.gov.

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 United Nations 
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. The Codex has not 
established a MRL for thifensulfuron methyl in or on chicory roots and/
or tops.

V. Conclusion

    Therefore, tolerances are established for residues of 
thifensulfuron methyl, methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-
2-ylamino]carbonyl]amino]

[[Page 52240]]

sulfonyl]-2-thiophenecarboxylate, in or on chicory roots at 0.01 ppm 
and chicory tops at 0.01 ppm.)

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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: August 17, 2012.
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 180.439 is amended by alphabetically adding the following 
commodities to the table in paragraph (a) to read as follows:

Sec.  180.439  Thifensulfuron methyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Chicory, roots..........................................            0.01
Chicory, tops...........................................            0.01
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-21356 Filed 8-28-12; 8:45 am]
BILLING CODE 6560-50-P