
[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Rules and Regulations]
[Pages 59558-59561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23986]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0758; FRL-9363-3]


Sulfentrazone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
sulfentrazone in or on succulent soybeans. Interregional Research 
Project Number 4 (IR-4) requested this tolerance under the Federal 
Food, Drug, and Cosmetic Act (FFDCA). In addition, this regulation 
corrects an incorrect commodity definition in the table. The term 
``Berry, low growing, group 13-07'' is being revised to its correct 
term ``Berry and small fruit, group 13-07.''

DATES: This regulation is effective September 28, 2012. Objections and 
requests for hearings must be received on or before November 27, 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-2011-0758, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., 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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     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-2011-0758 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 
November 27, 2012. Addresses for mail and hand delivery of objections

[[Page 59559]]

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 (excluding 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 the non-CBI copy 
of your objection or hearing request, identified by docket ID number 
EPA-HQ-OPP-2011-0758, 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 statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (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.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-for Tolerance

    In the Federal Register of July 25, 2012 (77 FR 43562) (FRL-9353-
6), 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 2E8020) 
by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 08540. The 
petition requested that 40 CFR 180.498 be amended by establishing 
tolerances for residues of the herbicide sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-
triazol-1-yl]phenyl]-methanesulfonamide) and its metabolites 3-
hydroxymethylsulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-
dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl] methanesulfonamide), in or on soybean, vegetable, succulent 
(Edamame) at 0.15 ppm. That notice referenced a summary of the petition 
prepared by FMC, 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 sulfentrazone including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with sulfentrazone 
follows.
    In the Federal Register of July 12, 2012 (77 FR 41081) (FRL-9353-
8), EPA published a final rule establishing tolerances for residues of 
herbicide sulfentrazone in Sec.  180.498(a)(2) in or on rhubarb; turnip 
roots; turnip tops; sunflower subgroup 20B; citrus fruit group 10-10; 
low growing berry group 13-07; tree nut group 14; pistachio; and Sec.  
180.498 (c) tolerances with regional registrations for wheat forage; 
wheat hay; wheat grain; wheat straw; and cowpea, succulent. The human 
health risk assessment used to support this final rule 
(``Sulfentrazone: Human-Health Risk Assessment for the Establishment of 
Sulfentrazone Tolerances in/on: Rhubarb, Turnip Roots and Tops, 
Sunflower Subgroup 20B, Succulent Cowpea, Succulent Lima Bean, 
Succulent Vegetable Soybean, Wheat (Spring), Citrus Fruit Group 10-10, 
Low-Growing Berry Group 13-07, Tree Nut Group 14, Pistachios, and Crop 
Group 18 Nongrass Animal Feeds''), assumed that sulfentrazone would be 
used on succulent soybeans. Therefore the aggregate risks for 
sulfentrazone for this action are not changed from those discussed in 
the July 12, 2012 Federal Register.
    EPA concluded the following: That the acute dietary exposure from 
food and water to sulfentrazone will occupy 3.2% of the acute 
population adjusted dose (aPAD) for females 13-49 years old, the 
population group receiving the greatest exposure; that chronic exposure 
to sulfentrazone from food and water will utilize 4.2% of the chronic 
population adjusted dose (cPAD) for children 1-2 years old, the 
population group receiving the greatest exposure; and that the combined 
short-term food, water, and residential exposures result in an 
aggregate margin of exposure (MOE) of 280 for children 1-2 years old, 
and an aggregate risk index (ARI) of 3.9 for the general U.S. 
population and adult males. Because EPA's level of concern for 
sulfentrazone is an MOE of 100 or below and/or an ARI of 1 or below, 
this MOE and ARI are not of concern. Based on the lack of evidence of 
carcinogenicity in two adequate rodent carcinogenicity studies, 
sulfentrazone is not expected to pose a cancer risk to humans.
    Therefore, EPA concluded that there is a reasonable certainty that 
no harm will result to the general population and to infants and 
children from aggregate exposure to sulfentrazone residues. Refer to 
the July 12, 2012 Federal Register document, available at http://www.regulations.gov, for a detailed discussion of the aggregate risk 
assessments and determination of safety. EPA relies upon those risk 
assessments and the findings made in the Federal Register document in 
support of this action.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography (GC)) is 
available to enforce the tolerance expression. The method has been 
forwarded for inclusion in the Pesticides Analytical Manual, Volume II. 
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

[[Page 59560]]

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 sulfentrazone on succulent 
soybean.

V. Conclusion

    Therefore, a tolerance is established for residues of 
sulfentrazone, (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl] methanesulfonamide) and its 
metabolites 3-hydroxy methylsulfentrazone (N-[2,4-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl] phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl] methanesulfonamide), in Sec.  180.498(a)(2) in or on 
vegetable, soybean, succulent at 0.15 ppm.
    Also, EPA is amending the table in Sec.  180.498(a)(2) to correct 
the description therein of Crop Group 13-07. Under EPA crop group 
regulations, Crop Group 13-07 is designated as the ``Berry and Small 
Fruit Crop Group,'' 40 CFR 180.41(c)(18). Consistent with this 
regulation, the petitioner requested the ``berry and small fruit group 
13-07'' and provided the appropriate residue field trial data to 
support a tolerance on this group. EPA published appropriate notice of 
this request in the Federal Register, correctly describing the 
requested tolerance as being for the ``berry and small fruit group 13-
07,'' in the Federal Register of July 6, 2011 (76 FR 39358) (FRL-8875-
6). EPA also correctly identified in the final rule that petitioners 
had requested a ``berry and small fruit group 13-07'' and tolerance and 
EPA disclaimed any intent to modify this proposed tolerance, (77 FR 
41082, 41086). Nonetheless, EPA mistakenly directed that paragraph 
(a)(2) be amended to establish a tolerance for ``low growing berry 
group 13-07.'' EPA is amending paragraph (a)(2) to revise ``low growing 
berry group 13-07'' with the correct regulatory term, ``berry and small 
fruit group 13-07,'' consistent with the petition's request and the 
Federal Register notice of the petition and EPA's disposition of the 
petition in the final rule published in the Federal Register of July 
12, 2012.

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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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: September 21, 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 180.498 is amended by revising the entry for ``Berry, low 
growing, group 13-07'' to read as ``Berry and small fruit, group 13-
07'' and by adding alphabetically the entry ``Vegetable, soybean, 
succulent'' to paragraph (a)(2) to read as follows:


Sec.  180.498  Sulfentrazone; tolerances for residues.

    (a) * * *
    (2) * * *

[[Page 59561]]



------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
 
                                * * * * *
Berry and small fruit, group 13-07........  0.15
 
                                * * * * *
Vegetable, soybean, succulent.............  0.15
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-23986 Filed 9-27-12; 8:45 am]
BILLING CODE 6560-50-P


