[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-19987]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Flutriafol; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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].
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
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
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,
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
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;
telephone number: (410) 305-2905; email address:
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.
Therefore, time-limited tolerances are established for residues of
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: August 3, 2012.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.629 is amended by revising paragraph (b) to read as
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
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
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
* * * * *
[FR Doc. 2012-19987 Filed 8-14-12; 8:45 am]
BILLING CODE 6560-50-P