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



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.


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: 
[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 40 CFR 
part 180

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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 
     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-
fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(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 

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: 
[email protected].

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-
fluorophenoxyacetate and its acid metabolite, E-1, 2-chloro-5-(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:


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.  180.585, revise the following entries in the table in 
paragraph (a) to read as follows:

Sec.  180.585  Pyraflufen-ethyl; tolerances for residues.

    (a) * * *

                   Commodity                     Parts per    Revocation
                                                  million        date
                                * * * * *
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
                                * * * * *

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