Federal Register, Volume 77 Issue 247 (Wednesday, December 26, 2012)

[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Rules and Regulations]
[Pages 75859-75862]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31067]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0750; FRL-9373-5]

Pyraflufen-Ethyl; Extension of Time-Limited Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation extends already established time-limited
tolerances for residues of pyraflufen-ethyl in or on cattle, meat
byproducts; goat, meat byproducts; horse, meat byproducts; sheep, meat
byproducts; and milk. Nichino America, Inc. requested the tolerance
extensions under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 26, 2012. Objections and
requests for hearings must be received on or before February 25, 2013,
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-2012-0750, 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: Kathryn Montague, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 305-1243; email address:
montague.kathryn@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.
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 40 CFR
part 180

[[Page 75860]]

through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.''

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-2012-0750 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
February 25, 2013. 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 Confidential Business Information (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-2012-0750, 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 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
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. Summary of Petitioned-For Tolerance Extension

In the Federal Register of September 28, 2012 (77 FR 59576) (FRL-
9363-8), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2F8075 by Nichino America, Inc., 4550 New Linden Hill Road, Suite 501,
Wilmington, DE 19808. The petition requested that 40 CFR 180.585 be
amended by extending the expiration date for temporary tolerances for
residues of the herbicide, pyraflufen-ethyl, pyraflufen-ethyl, ethyl 2-
chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(4-
chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetic acid, in or on: Cattle, meat byproducts; goat, meat
byproducts; horse, meat byproducts; sheep, meat byproducts; and milk
until December 31, 2016. That document referenced a summary of the
petition prepared by Nichino America, Inc., the registrant, which is
available to the public in the docket, http://www.regulations.gov.
Comments were received on the notice of filing. EPA's response to those
comments is discussed in Unit IV.C. These tolerances expire on December
31, 2016.

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.* *
*''
Consistent with FFDCA section 408(b)(2)(D), and 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 for pyraflufen-ethyl including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with pyraflufen-
ethyl follows.
In 2008, the EPA assessed the use of pyraflufen-ethyl on pasture
and rangeland grasses. The existing cattle feeding study conducted at
the 5X dose was sufficient to establish tolerances for cattle, goat,
horse, and sheep meat byproducts and milk; however, since the OPPTS
860.1480 guidelines require that the cattle feeding study be conducted
at a 10X dose, the Agency set time-limited tolerances (Federal Register
of September 5, 2008 (73 FR 51739) until a new feeding study at the 10X
dose could be submitted for permanent tolerances to be established.
In the most recent pyraflufen-ethyl tolerance rulemaking, 76 FR
31479 (June 1, 2011) EPA assessed risk of aggregate exposure to
pyraflufen-ethyl assuming that exposure occurred in animal meat
byproducts and milk at the levels of the established time-limited
tolerances. In that action, EPA determined that aggregate risk from
exposure was safe. The dietary exposure estimates assumed 100 percent
crop treated, so EPA is confident that aggregate dietary exposure is
not underestimated and 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 pyraflufen-ethyl residues. This
action to extend time-limited tolerances for animal meat byproducts and
milk relies on the assessments supporting the June 1, 2011 rulemaking.
These assessments are posted to docket ID, EPA-HQ-OPP-2010-0426 at
http://www.regulations.gov.

IV. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (Gas Chromatography with Mass
Spectrometry (GC/MS)) 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

[[Page 75861]]

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 a MRL for pyraflufen-ethyl.

C. Response to Comments

EPA received one comment to the Notice of Filing that made a
general objection to establishing and/or extending tolerances for
pesticides. The Agency recognizes that some individuals believe that
certain pesticide chemicals should not be permitted in our food.
However, the existing legal framework provided by section 408 of the
Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may
be set when persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute. When new or amended tolerances are requested for residues
of a pesticide in food or feed, the Agency, as is required by section
408 of the FFDCA, estimates the risk of the potential exposure to these
residues. The Agency has concluded after this assessment, that there is
a reasonable certainty that no harm will result from aggregate human
exposure to pyraflufen-ethyl and that, accordingly, the pyraflufen-
ethyl temporary tolerances for cattle, goat, horse and sheep meat
byproducts, and milk are ``safe'' and can be extended.

V. Conclusion

Therefore, time-limited tolerances are extended to December 31,
2016 for residues of pyraflufen-ethyl, pyraflufen-ethyl, ethyl 2-
chloro-5-(4-chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(4-
chloro-5-difluoromethoxy-1-methyl-1H-pyrazol-3-yl)-4-
fluorophenoxyacetic acid, in or on: Cattle, meat byproducts; goat, meat
byproducts; horse, meat byproducts; sheep, meat byproducts; and milk. A
time limitation has been imposed until a cattle feeding study at the
10X dose is found acceptable to support permanent tolerances.

VI. Statutory and Executive Order Reviews

This final rule establishes tolerances 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 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 on the basis of a
petition under FFDCA section 408(d), such as the tolerance 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) (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).

VII. 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.

Dated: December 17, 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. In Sec. 180.585, revise the following entries in the table in
paragraph (a) to read as follows:

Sec. 180.585 Pyraflufen-ethyl; tolerances for residues.

(a) * * *

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Expiration/
Commodity Parts per Revocation
million date
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* * * * *
Cattle, meat byproducts....................... 0.02 12/31/16

* * * * *
Goat, meat byproducts......................... 0.02 12/31/16

* * * * *
Horse, meat byproducts........................ 0.02 12/31/16
Milk.......................................... 0.02 12/31/16

[[Page 75862]]

* * * * *
Sheep, meat byproducts........................ 0.02 12/31/16

* * * * *
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[FR Doc. 2012-31067 Filed 12-21-12; 4:15 pm]
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