
[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]
BILLING CODE 6560-50-P


