[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Proposed Rules]
[Pages 41346-41348]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-17143]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0524; FRL-9353-9]
Trinexapac-ethyl; Proposed Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to amend the existing trinexapac-ethyl
tolerance levels for wheat, forage and wheat, middlings as well as
change the commodity definition for hog, kidney. Additionally the EPA
proposes to establish tolerances for residues of trinexapac-ethyl in or
on barley, bran; sugarcane, molasses; and wheat, bran under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments must be received on or before September 11, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2010-0524 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.
FOR FURTHER INFORMATION CONTACT: Bethany Benbow, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 347-8072; email address: benbow.bethany@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.
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).
This listing is not intended to be exhaustive, but rather provides
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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. This Proposal
EPA on its own initiative, under FFDCA section 408(e), 21 U.S.C.
346a(e), is proposing to amend the existing trinexapac-ethyl tolerances
for wheat, forage from 1.5 to 1.0 parts per million (ppm) and wheat,
middlings from 6.5 to 10.5 ppm, as well as change the existing
commodity definition for ``hog, kidney'' to ``hog, meat by-products''
as these changes are needed to correct inadvertent typographical errors
listed in the final rule tolerance table for trinexapac-ethyl that was
published in the Federal Register on March 2, 2012 (77 FR 12740) (FRL-
9337-9).
Additionally, the Agency is proposing to establish tolerances for
residues of trinexapac-ethyl in or on barley, bran at 2.5 ppm;
sugarcane, molasses at 2.5 ppm; and wheat, bran at 6.0 ppm based on the
following:
The final rule for trinexapac-ethyl that was published in the
Federal Register of March 2, 2012, established tolerances for
trinexapac-ethyl residues on the raw agricultural commodities of
barley, sugarcane and wheat; however, tolerances for certain processed
commodities (barley, bran; sugarcane, molasses; and wheat, bran) were
not established in that final rule. Though these processed commodity
tolerances were not proposed in the petition submitted to the Agency by
the registrant, Syngenta Crop Protection, Inc., EPA determined they
were needed in conjunction with establishing the raw agricultural
commodity tolerances on
[[Page 41347]]
barley, sugarcane, and wheat. The data submitted by Syngenta do support
these tolerances and the tolerances were included in the Agency's last
dietary and aggregate risk assessments. EPA intended to establish these
processed tolerances as part of the March 2, 2012, rulemaking but they
were inadvertently left out. Accordingly, EPA is now proposing these
tolerances on its own initiative.
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. * *
*''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of FFDCA section 408 and a complete description
of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
Consistent with 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, consistent with FFDCA
section 408(b)(2), for these proposed tolerances for residues of
trinexapac-ethyl. EPA's assessment of exposures and risks associated
with establishing these tolerances is as follows.
In connection with the March 2, 2012 final rule for trinexapac-
ethyl that established tolerances for trinexapac-ethyl residues on the
raw agricultural commodities of barley, sugarcane and wheat, EPA
assessed not only tolerances for these raw commodities but tolerances
for the following associated processed commodities: Trinexapac-ethyl on
barley, bran at 2.5 ppm; sugarcane, molasses at 2.5 ppm; and wheat,
bran at 6.0 ppm in the dietary risk assessment. ``Trinexapac-ethyl:
Acute and Chronic Dietary Exposure and Risk Assessment for the Proposed
Uses on Cereal Grains, Sugarcane and Grasses Grown for Seed''
(September 13, 2011), this and other supporting documents for this
proposal can be accessed at www.regulations.gov under docket ID number
EPA-HQ-OPP-2010-0524. In addition, EPA assessed the risk of trinexapac-
ethyl tolerances for wheat, forage and wheat, middlings at the levels
of 1.0 ppm and 10.5 ppm, respectively, rather than at 1.5 ppm and 6.5
ppm as reported in the March 2, 2012 final rule. Despite how the risk
assessment was conducted, EPA inadvertently left the barley bran,
sugarcane molasses, and wheat bran out of the final rule and, by
mistake, established the wheat forage and wheat middlings tolerances at
the incorrect level. EPA also inadvertently established a tolerance for
``hog, kidney'' instead of using the standard Agency commodity term of
``hog, meat by-products.'' EPA is proposing to correct these errors.
In March 2, 2012 rule and the risk assessment underlying the rule,
EPA concluded that all risk estimates were below EPA's level of
concern. The acute dietary exposure estimate for females 13 to 49 years
old will only utilize 2% of the acute population adjusted dose (aPAD),
which is well below the Agency's level of concern (100% of the aPAD).
Chronic exposure to trinexapac-ethyl from food and water will utilize
6% of the chronic population adjusted dose (cPAD) for children 1 to 2
years old, the population group receiving the greatest exposure.
Further, trinexapac-ethyl is currently registered for uses that could
result in short- and intermediate-term residential exposures for
adults, and the Agency has determined the combined food, water, and
adult post-application dermal exposures result in aggregate MOEs of 761
for liquid products and 601 for granular products. These MOEs are above
the EPA's level of concern for trinexapac-ethyl, a MOE of 100 or below.
Finally, based on the lack of evidence of carcinogenicity in two
adequate rodent carcinogenicity studies, trinexapac-ethyl is not
expected to pose a cancer risk to humans.
Therefore, since aggregate risk and exposure estimates do not
change as a result of these tolerance proposals, 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
trinexapac-ethyl residues. Refer to the March 2, 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 (Method GRM020.01A, which utilizes
high performance liquid chromatography with triple-quadruple mass
spectrometry) 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:
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 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 MRLs for trinexapac-ethyl in or on
commodities associated with this action.
V. Conclusion
Tolerances are proposed for residues of trinexapac-ethyl in or on
barley, bran at 2.5 ppm; sugarcane, molasses at 2.5 ppm; and wheat,
bran at 6.0 ppm. The EPA is also proposing to amend the existing
trinexapac-ethyl tolerances for wheat, forage from 1.5 to 1.0 ppm and
wheat, middlings from 6.5 to 10.5 ppm, as well as change the existing
commodity definition for ``hog, kidney'' to ``hog, meat by-products''.
[[Page 41348]]
VI. Statutory and Executive Order Reviews
This proposed rule establishes a tolerance 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 proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed 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). This proposed rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., or 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). 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); or OMB review
or any Agency action under Executive Order 13045, entitled ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). 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). Pursuant to the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby
certifies that these proposed tolerances will not have significant
negative economic impact on a substantial number of small entities.
Establishing an a pesticide tolerance or an exemption from the
requirement of a pesticide tolerance is, in effect, the removal of a
regulatory restriction on pesticide residues in food and thus such an
action will not have any negative economic impact on any entities,
including small entities. In addition, the Agency has determined that
this action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This proposed rule directly regulates
growers, food processors, food handlers, and food retailers, not
States. This action does not alter the relationships or distribution of
power and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this proposed rule does not have any
``tribal implications'' as described in Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: July 5, 2012.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.662 the table in paragraph (a) is amended by:
i. Revising the entry for ``Hog, Kidney'' to read ``Hog, meat-
byproducts'',
ii. Revising the tolerance levels for ``Wheat, forage'' and
``Wheat, middlings'', and
iii. Alphabetically adding ``Barley, bran''; ``Sugarcane,
molasses''; and ``Wheat, bran process''.
The amendments read as follows:
Sec. 180.662 Trinexapac-ethyl; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, bran............................................... 2.5
* * * * *
Hog, meat by-products...................................... 0.03
* * * * *
Sugarcane, molasses........................................ 2.5
Wheat, bran process........................................ 6.0
Wheat, forage.............................................. 1.0
* * * * *
Wheat, middlings........................................... 10.5
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-17143 Filed 7-12-12; 8:45 am]
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