[Federal Register Volume 76, Number 188 (Wednesday, September 28, 2011)]
[Rules and Regulations]
[Pages 59906-59908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-24517]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0849; FRL-8889-1]


Fluazifop-P-butyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes and increases tolerances for 
residues of fluazifop-P-butyl in or on cotton, gin byproducts; cotton, 
refined oil; and cotton, undelinted seed. Syngenta Crop Protection 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective September 28, 2011. Objections and 
requests for hearings must be received on or before November 28, 2011, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0849. 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: Kathryn V. Montague, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-1243; 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 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-2010-0849 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 28, 2011. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0849, 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. Summary of Petitioned-for Tolerance

    In the Federal Register of December 15, 2010 (75 FR 78240) (FRL-
8853-1), 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 
0F7768) by Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC 
27419. The petition requested that 40 CFR 180.411 be amended by 
establishing tolerances for residues of the herbicide, fluazifop-P-
butyl, butyl(R)-2-[4-[[5-(trifluoromethyl)-2- 
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of 
the resolved isomer of fluazifop, (R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on 
cotton, undelinted seed at 0.9 ppm; and cotton, gin byproducts at 0.8 
ppm. That notice referenced a summary of the petition prepared by 
Syngenta Crop Protection, the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.
    Based upon review of the data supporting the petition EPA has made 
changes to the requested tolerances. First, EPA is raising the proposed 
cotton, gin byproducts tolerance from 0.8 ppm to 1.5 ppm; second, 
raising the established cotton, refined oil tolerance from 0.2 ppm to 
1.3 ppm; and finally,

[[Page 59907]]

raising the proposed cotton, undelinted seed tolerance from 0.9 ppm to 
1.0 ppm. EPA also retains the current tolerance expression for 
fluazifop-P-butyl that was established in 40 CFR 180.411 paragraph (a) 
in the Federal Register of February 2, 2011 (76 FR 5696) (FRL-8861-1). 
The reason for these changes are explained in Unit IV.C.

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. * * 
*''
    In the Federal Register of February 2, 2011 EPA issued a final rule 
establishing a tolerance for residues of fluazifop-P-butyl in or on 
banana; beet, sugar; citrus, fruit, group 10; grape and potato. EPA has 
determined that establishing revised tolerances for cotton commodities 
will not significantly change the risk assessments the Agency relied on 
to support the February 2, 2011, tolerance action, as explained in this 
unit.
    Cotton commodities (undelinted seed, gin byproducts, meal, and 
hulls) may be used as roughage or protein concentrate feedstuffs in the 
diets of livestock. When the Agency conducted the risk assessment in 
support of the February 2, 2011 tolerance action, it considered 
secondary residues of fluazifop-P-butyl in livestock commodities from 
consumption of fluazifop-P-butyl treated feed. In calculating livestock 
dietary burdens for fluazifop-P-butyl, EPA assumed that 100% of feed 
items consumed by livestock are treated with fluazifop-P-butyl. EPA 
also assumed residues were present in the roughage and protein 
concentrate components of livestock diets at the tolerance level for 
soybean feedstuffs of 2.5 parts per million (ppm) which is greater than 
the tolerances being established for cotton feedstuffs. Therefore, the 
Agency has determined that the establishment of a tolerance on the feed 
commodity cotton, gin byproducts at 1.5 ppm and raising the cotton, 
undelinted seed tolerance from 0.1 ppm to 1.0 ppm will not increase 
residues of fluazifop-P-butyl in livestock feed commodities above those 
calculated in the previous risk assessment conducted for the February 
2, 2011 tolerance action.
    The only human food item affected by this action is cotton, refined 
oil. This commodity was included in the most recent acute and chronic 
dietary exposure assessment for the February 2, 2011 tolerance action 
at the level of 0.2 ppm using the food consumption data from the USDA 
1994-1996 and 1998 Continuing Surveys of Food Intake by Individuals 
(CSFII). EPA conducted additional calculations using the increased 
level of 1.3 ppm for cotton, refined oil to determine if any increase 
in dietary exposure results. For both acute and chronic analyses, 
identical results were obtained to three significant figures. EPA 
typically reports dietary exposures as a percentage of the population 
adjusted dose (PAD) to just two significant figures. Therefore, EPA 
concludes that no significant increase in human dietary exposure 
resulting from the establishment of the revised cotton tolerances.
    Based on these considerations, EPA has determined that establishing 
the tolerance for fluazifop-P-butyl in cotton, gin byproducts at 1.5 
ppm, raising the established cotton, refined oil from 0.2 ppm to 1.3 
ppm and raising the cotton, undelinted seed tolerance from 0.1 ppm to 
1.0 ppm will not affect the estimated livestock dietary burden and will 
not change the estimated aggregate risks resulting from use of 
fluazifop-P-butyl, as discussed in the February 2, 2011 Federal 
Register. Refer to the Federal Register document, available at http://www.regulations.gov, for a detailed discussion of the aggregate risk 
assessment and determination of safety.
    Therefore, based on this information and the findings in the final 
rule published in the Federal Register of February 2, 2011, 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 fluazifop-P-butyl residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (High Performance Liquid 
Chromatography/Ultra-Violet Spectrometry (HPLC/UV)) is available to 
enforce the tolerance expression. The method is available in Pesticide 
Analytical Methods (PAM), Volume II or 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

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for fluazifop-P-butyl.

C. Revisions to Petitioned-for Tolerances

    EPA has revised the proposed tolerances levels. Based on the 
submitted cotton undelinted seed and gin byproducts data, EPA 
calculated that the cotton, gin byproducts tolerance should be 1.5 ppm; 
cotton, refined oil tolerance should be 1.3 ppm, and cotton, undelinted 
seed tolerance should be 1.0 ppm.
    Also, EPA is retaining the current tolerance expression for 
fluazifop-P-butyl. The current tolerance expression makes clear that 
the tolerances cover residues of the herbicide fluazifop-P-butyl, 
including its metabolites and degradates, but that compliance with the 
tolerance levels is to be determined by measuring only the sum of 
fluazifop-P-butyl, butyl(R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of 
the resolved isomer of fluazifop, (R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid, calculated as the stoichiometric 
equivalent of fluazifop, in or on the commodity.

[[Page 59908]]

V. Conclusion

    Therefore, tolerances are established for residues of fluazifop-P-
butyl, butyl(R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoate, and the free and conjugated forms of 
the resolved isomer of fluazifop, (R)-2-[4-[[5-(trifluoromethyl)-2-
pyridinyl]oxy]phenoxy]propanoic acid, expressed as fluazifop, in or on 
cotton, gin byproducts; cotton, refined oil; and cotton, undelinted 
seed at 1.5 ppm, 1.3 ppm and 1.0 ppm, respectively.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4). This action does not involve 
any technical standards that would require Agency consideration of 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

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

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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


0
2. Section 180.411, paragraph (a), the table is amended by:
0
i. Revising the entries for ``cotton, refined oil'' and ``cotton, 
undelinted seed''; and
0
ii. Adding the entry for ``cotton, gin byproducts'' to the table in 
paragraph (a)
0
iii. The amendments read as follows:


Sec.  180.411  Fluazifop-P-butyl; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Cotton, gin byproducts.....................................          1.5
Cotton, refined oil........................................          1.3
Cotton, undelinted seed....................................          1.0
 
                                * * * * *
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[FR Doc. 2011-24517 Filed 9-27-11; 8:45 am]
BILLING CODE 6560-50-P