[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Rules and Regulations]
[Pages 48899-48902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19987]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0324; FRL-9349-6]


Flutriafol; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of flutriafol in or on cotton, undelinted seed; cotton, meal; 
cotton, refined oil; and cotton gin byproducts. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on cotton. This regulation establishes 
a maximum permissible level for residues of flutriafol in or on cotton 
commodities. The time-limited tolerances expire on December 31, 2014.

DATES: This regulation is effective August 15, 2012. Objections and 
requests for hearings must be received on or before October 15, 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-2012-0324, is available either 
electronically through http://www.regulations.gov or in hard copy 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: Debra Rate, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 306-0309; email 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:
     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 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 section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(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-
2012-0324 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 15, 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 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2012-0324, 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), 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.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for combined residues of 
flutriafol, its metabolites and degradates, in or on cotton, undelinted 
seed at 0.35 parts per million (ppm); cotton, meal at 0.5 ppm; cotton, 
refined oil at 0.5 ppm; and cotton gin byproducts at 0.50 ppm. These 
time-limited tolerances expire on December 31, 2014.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    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

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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 * * * .''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Flutriafol on Cotton and FFDCA Tolerances

    This is the first section 18 request received for the use of 
flutriafol on cotton. Texas had the worst one-year, 2011, drought since 
1895 (Huber, 2011). Under the drought conditions cotton root rot fungus 
flourished on stressed cotton plants to reduce yields and produce more 
fungal inoculums that will remain viable for 5-8 years in the soil. The 
submitted information showed that in 2011, cotton growers suffered 30-
66 percent yield losses in fields infested with cotton root rot. Fields 
infested with cotton root rot disease last year are expected to have 
even heavier losses this year unless the pest is effectively mitigated.
    In Texas, approximately 12% of 2.4 million acres of cotton are 
infested with the root rot fungus. In 2012, yield losses are expected 
to be like 2011 or higher without the use of flutriafol. The severe 
drought condition of 2011 was a non-routine event that stressed cotton 
plants. The drought stressed cotton is more susceptible to the root rot 
fungus which causes high yield losses and build-up of fungal inoculums 
in soil. The drought condition and elevated pest pressure are likely to 
continue to cause severe yield losses in the 2012 growing season 
resulting in significant economic losses.
    After having reviewed the submission, EPA determined that an 
emergency condition exists for this State, and that the criteria for 
approval of an emergency exemption are met. EPA has authorized a 
specific exemption under FIFRA section 18 for the use of flutriafol on 
cotton for control of cotton root rot, caused by the fungus 
Phymatotrichum omnivorum in Texas.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of flutriafol in 
or on cotton. In doing so, EPA considered the safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerances under 
FFDCA section 408(l)(6) would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing these tolerances without advance notice and opportunity for 
public comment as provided in FFDCA section 408(l)(6). Although these 
time-limited tolerances expire on December 31, 2014, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on cotton, 
undelinted seed; cotton, meal; cotton, refined oil and cotton, gin 
byproducts after that date will not be unlawful, provided the pesticide 
was applied in a manner that was lawful under FIFRA, and the residues 
do not exceed a level that was authorized by these time-limited 
tolerances at the time of that application. EPA will take action to 
revoke these time-limited tolerances earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
flutriafol meets FIFRA's registration requirements for use on cotton or 
whether permanent tolerances for this use would be appropriate. Under 
these circumstances, EPA does not believe that this time-limited 
tolerance decision serves as a basis for registration of flutriafol by 
a State for special local needs under FIFRA section 24(c). Nor do these 
tolerances by themselves serve as the authority for persons in any 
State other than Texas to use this pesticide on cotton absent the 
issuance of an emergency exemption applicable within that State. For 
additional information regarding the emergency exemption for 
flutriafol, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 of the FFDCA and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    Consistent with 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 expected as a result of this emergency exemption request and 
the time-limited tolerances for combined residues of flutriafol, its 
metabolites and degradates, in or on cotton, undelinted seed at 0.35 
ppm; cotton, meal at 0.5 ppm; cotton, refined oil at 0.5 ppm and 
cotton, gin byproducts at 0.5 ppm.
    On November 9, 2011, the Agency published a final rule (76 FR 
69643) (FRL-9325-6) establishing tolerances for residues of flutriafol, 
(()-[alpha]-(2-fluorophenyl)-[alpha]-(4-fluorophenyl)-1H-
1,2,4-triazole-1-ethanol, in or on multiple commodities. Since the 
publication of that final rule, the Agency has conducted risk 
assessments evaluating the use of flutriafol on cotton under section 18 
of FIFRA. These new risk assessments have not identified any changes to 
the hazard data, hazard characterization or end-points relied upon in 
the November 9, 2011, tolerance rule. The additional exposures and 
risks associated with residues resulting from the section 18 use on 
cotton are negligible and do not significantly change the previous 
acute and chronic aggregate risk. Therefore, establishing the time-
limited tolerances on the cotton commodities will not change the most 
recent aggregate risks resulting from the use of flutriafol, as 
discussed in the November 9, 2011 Federal Register. Refer to the 
November 9, 2011 Federal Register document for a detailed discussion of 
the aggregate risk assessments and determination of safety.
    Based on the risk assessments and findings discussed in the final 
rule published in the Federal Register of November 9, 2011, as well as 
recent documents in the current docket, 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 
flutriafol residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    An adequate enforcement methodology (gas chromatography/Nitrogen/
Phosphorus detector (NPD) for tolerances and method ICIA AM00306 for 
ruminant liver) 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;

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telephone number: (410) 305-2905; email 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 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, Canada, and Mexico have not established MRLs for 
flutriafol in or on cotton commodities.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
flutriafol, [()-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1 H -1,2,4-triazole-1-ethanol], including its metabolites 
and degradates, in or on cotton, undelinted seed at 0.35 ppm; cotton, 
meal at 0.5 ppm; cotton, refined oil at 0.5 ppm; and cotton, gin 
byproducts at 0.5 ppm. These tolerances expire on December 31, 2014.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA sections 408(e) 
and 408(l)(6). 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 in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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).

VIII. 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 3, 2012.
Lois Rossi,
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 180.629 is amended by revising paragraph (b) to read as 
follows:


Sec.  [emsp14]180.629  Flutriafol; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
flutriafol, [()-[alpha]-(2-fluorophenyl)-[alpha]-(4-
fluorophenyl)-1 H -1,2,4-triazole-1-ethanol], including its metabolites 
and degradates in or on the specified agricultural commodities, 
resulting from use of the pesticide pursuant to FIFRA section 18 
emergency exemptions. The tolerances expire on the date specified in 
the table.

------------------------------------------------------------------------
                                             Parts per      Expiration
                Commodity                     million          date
------------------------------------------------------------------------
Cotton, gin byproducts..................            0.5         12/31/14
Cotton, meal............................            0.5         12/31/14
Cotton, refined oil.....................            0.5         12/31/14
Cotton, undelinted seed.................            0.35        12/31/14
------------------------------------------------------------------------


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[FR Doc. 2012-19987 Filed 8-14-12; 8:45 am]
BILLING CODE 6560-50-P