[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Rules and Regulations]
[Pages 60917-60919]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24646]



40 CFR Part 180

[EPA-HQ-OPP-2010-0524; FRL-9363-4]
RIN 2070-ZA16

Trinexapac-ethyl; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
trinexapac-ethyl in or on multiple commodities and modifies existing 
tolerance levels and commodity definitions for trinexapac-ethyl, which 
are identified and discussed later in this document. EPA proposed these 
tolerances and noted amendments under the Federal Food, Drug, and 
Cosmetic Act (FFDCA) in order to correct inadvertent errors in the 
final rule tolerance table for trinexapac-ethyl that published in the 
Federal Register on March 2, 2012.

DATES: This regulation is effective October 5, 2012. Objections and 
requests for hearings must be received on or before December 4, 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-2010-0524, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., 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: 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: [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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     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 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-2010-0524 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 
December 4, 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 (excluding 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 the non-CBI copy 
of your objection or hearing request, identified by docket ID number 
EPA-HQ-OPP-2010-0524, by one of the following methods:

[[Page 60918]]

     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), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
     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

    In the Federal Register of July 13, 2012 (77 FR 41346) (FRL-9353-
9), EPA issued a proposed rule pursuant to FFDCA section 408(e), 21 
U.S.C. 346a (d)(3). The Agency-initiated rule proposed that 40 CFR 
180.662 be amended by establishing tolerances for 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 rule also proposed amending 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 changing the existing 
commodity definition for ``hog, kidney'' to ``hog, meat by-products'' 
in order to correct inadvertent errors 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). The proposed rule included 
a summary of the exposure assessment prepared by the Agency and 
explained the basis for EPA's conclusion that there is a reasonable 
certainty that no harm will result to the general population or to 
infants and children, as a result of aggregate exposure to trinexapac-
ethyl residues. A comment was received in response to the proposed 
rule. EPA's response to that comment is discussed below in Unit III.

III. Response to Comment

    An anonymous citizen objected to the presence of any pesticide 
residues on food. The Agency understands the commenter's concerns and 
recognizes that some individuals believe that pesticides should be 
banned completely. However, the existing legal framework provided by 
section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) 
contemplates that tolerances greater than zero may be set when persons 
seeking such tolerances or exemptions have demonstrated that the 
pesticide meets the safety standard imposed by that statute. This 
citizen's comment appears to be directed at the underlying statute and 
not EPA's implementation of it; the citizen has made no contention that 
EPA has acted in violation of the statutory framework.

 IV. Conclusion

    Given that EPA received no meaningful comment on its proposal and 
based on the information, analysis, and conclusions in the July 13, 
2012 proposal (77 FR 41346) (FRL-9353-9), tolerances are established, 
as 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. In 
addition, as proposed, the tolerance level for wheat, forage is revised 
from 1.5 to 1.0 ppm, the tolerance level for wheat, middlings is 
revised from 6.5 to 10.5 ppm and the commodity definition, ``hog, 
kidney'' is revised to ``hog, meat by-products.''

V. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
on EPA's own initiative. 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).
    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 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.
    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) (2 U.S.C. 1501 et seq.).
    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) (15 U.S.C. 272 note).

VI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
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 
the rule in the Federal Register. This action 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.

[[Page 60919]]

    Dated: September 25, 2012.
Daniel J. Rosenblatt,
Acting 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. In Sec.  180.662, the table in paragraph (a) is amended by:
i. Alphabetically adding the following commodities: ``Barley, bran'', 
``Sugarcane, molasses'', and ``Wheat, bran''.
ii. Removing the entry for ``Hog, kidney'' and adding in alphabetical 
order an entry for ``Hog, meat by-products''.
iii. Revising the entries for ``Wheat, forage'' and ``Wheat, 

    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.............................................            6.0
Wheat, forage...........................................            1.0
                                * * * * *
Wheat, middlings........................................           10.5
                                * * * * *

* * * * *
[FR Doc. 2012-24646 Filed 10-4-12; 8:45 am]