[Federal Register Volume 73, Number 157 (Wednesday, August 13, 2008)]
[Rules and Regulations]
[Pages 47072-47075]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18457]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0564; FRL-8374-4]


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 barley, hay; oat, forage; oat, hay; 
wheat, forage, and wheat, hay. E.I. DuPont de Nemours and Company 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective August 13, 2008. Objections and 
requests for hearings must be received on or before October 14, 2008, 
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-2007-0564. To access the 
electronic docket, go to http://www.regulations.gov, and search for the 
docket ID number. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. All 
documents in the docket are listed in the docket index available in 
regulations.gov. Although listed in the index, some information is not 
publicly available, e.g., Confidential Business Information (CBI) or 
other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Vickie Walters, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number:

[[Page 47073]]

(703) 305-5704; 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 affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0564 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before October 14, 2008.
    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-2007-0564, 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'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 September 19, 2007 (72 FR 53577) (FRL-
8144-3), 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 
7F7219) by E.I. DuPont de Nemours and Company, DuPont Crop Protection, 
P.O. Box 80038, Wilmington, DE 19880-0038. The petition requested that 
40 CFR 180.439(a) be amended by establishing tolerances for residues of 
the herbicide, thifensulfuron methyl, methyl-3-[[[[(4-methoxy-6-methyl-
1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-
thiophenecarboxylate, in or on barley, hay at 0.7 part per million 
(ppm), oat, forage at 0.2 ppm; oat, hay at 2.0 ppm; wheat, forage at 
1.0 ppm; and wheat, hay at 0.8 ppm. That notice referenced a summary of 
the petition prepared by E. I. DuPont de Nemours and Company, 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.
    Thifensulfuron methyl currently has tolerances for grain and straw 
from barley, oats, and wheat. No tolerances have been established for 
hay and forage of these commodities because thifensulfuron methyl's 
registration under the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA), U.S.C. 136 et seq., restricts the feeding of hay and 
forage from treated barley, oats, and wheat to livestock. DuPont has 
applied to EPA to lift the feeding restriction in its FIFRA 
registration and this petition for hay and forage was filed in 
conjunction with that requested change.
    Based upon review of the field trial data supporting the petition, 
EPA is revising the tolerance levels for pending commodities as 
follows: barley, hay at 0.8 ppm; oat, hay at 0.05 ppm; wheat, forage at 
2.5 ppm; and wheat, hay at 0.7 ppm.

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 
tolerances for residues of thifensulfuron methyl, methyl-3-[[[[(4-
methoxy-6-methyl-1,3,5-triazin-2-yl)amino]carbonyl]amino]sulfonyl]-2-
thiophenecarboxylate, on barley, hay at 0.8 ppm; oat, forage at 0.2 
ppm; oat, hay at 0.05 ppm; wheat, forage at 2.5 ppm and wheat, hay at 
0.7 ppm.
    EPA has previously concluded that aggregate exposure to 
thifensulfuron methyl on the grain and straw of barley, oats, and wheat 
as well as other

[[Page 47074]]

commodities is safe. (72FR13179 (March 21, 2007)). Establishment of the 
requested thifensulfuron methyl tolerances on hay and forage of barley, 
oats, and hay will not change the exposure or risk estimates from this 
prior tolerance action because:
    1. The requested change in FIFRA registration for thifensulfuron 
methyl is only for the lifting of the feeding restriction on treated 
barley, oats, and wheat. There are no requested changes, such as to 
application rates that could affect residue levels on human food items. 
No changes in existing tolerances are necessary.
    2. The Agency has determined that there will not be finite residues 
of thifensulfuron methyl in animal commodities as a result of animals 
consuming thifensulfuron methyl-treated barley, oats or wheat.
    3. Since thifensulfuron methyl is not being registered on any 
additional crops and the application rates to the registered crops are 
not increasing, there is no change in estimated drinking water 
estimates.
    4. No residential uses are being proposed.
    The toxicological profile, endpoints and current risk assessments 
are discussed in the final rule published in the Federal Register of 
March 21, 2007 (72FR13179)(FRL-8117-1) which established tolerances for 
residues of thifensulfuron methyl in rice, grain at 0.05 ppm; rice, 
straw at 0.05 ppm; sorghum, grain, forage at 0.05 ppm; sorghum, grain, 
grain at 0.05 ppm; and sorghum, grain, stover at 0.05 ppm. These 
previous risk assessments and the reasons that the current action does 
not change that risk assessment are discussed in the document entitled 
``Ingredient: Thifensulfuron Methyl Title: Label Amendments and 
Petition for Tolerances on Wheat Forage and Hay, Oat Forage and Hay, 
and Barley, Hay.'' This document can be found at http://www.regulations.gov. in docket EPA-HQ-OPP-2007-0564 and is identified 
as document 004. Based on risk assessments and the findings presented 
in the Federal Register notice above, EPA concludes that there is a 
reasonable certainty that no harm will result to the general population 
and to infants and children from aggregate exposure to thifensulfuron 
methyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology ((liquid chromatography/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; e-mail 
address: [email protected].

B. International Residue Limits

    There are no established or proposed Codex Maximum residue limits 
(MRLs) for residues of thifensulfuron methyl. Canada and Mexico have 
established MRLs for thifensulfuron methyl on several plant 
commodities. However, no Canadian or Mexican MRLs for thifensulfuron 
methyl have been proposed or established for barley, hay; oat, forage; 
oat, hay; wheat, forage; or wheat, hay.

V. Conclusion

    Therefore, tolerances are established for residues of 
thifensulfuron methyl, methyl-3-[[[[(4-methoxy-6-methyl-1,3,5-triazin-
2-yl)amino]carbonyl]amino]sulfonyl]-2-thiophenecarboxylate, on barley, 
hay at 0.8 ppm; oat, forage at 0.2 ppm; oat, hay at 0.05 ppm; wheat, 
forage at 2.5 ppm and wheat, hay at 0.7 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, 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) (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.



[[Page 47075]]


    Dated: July 31, 2008.
Donald R. Stubbs,
Acting 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. 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) * * *

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Barley, hay                                                          0.8
                                * * * * *
Oat, forage                                                          0.2
                                * * * * *
Oat, hay                                                            0.05
                                * * * * *
Wheat, forage                                                        2.5
                                * * * * *
Wheat, hay                                                           0.7
                                * * * * *
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[FR Doc. E8-18457 Filed 8-12-08; 8:45 am]
BILLING CODE 6560-50-S