[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Pages 78738-78740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30575]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2013-0071; FRL-9904-04]


Pendimethalin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the current tolerance for combined 
residues of pendimethalin and its metabolite, expressed as 
pendimethalin equivalents in or on almond, hulls. BASF Corporation, 26 
Davis Drive, Research Triangle Park, NC 27709 requested this tolerance 
under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 27, 2013. Objections and 
requests for hearings must be received on or before February 25, 2014, 
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-2013-0071, 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: [email protected].

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 EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

[[Page 78739]]

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-2013-0071 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, 2014. 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-2013-0071, 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.html.
    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

    In the Federal Register of February 27, 2013 (78 FR 13295) (FRL-
9380-2), 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 
2F8133) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709. The petition requested that 40 CFR 180.361 be amended by 
establishing a tolerance for the combined residues of the herbicide 
pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6- dinitrobenzenamine, 
and its 3,5-dinitrobenzyl alcohol metabolite (CL202347), in or on 
almond, hulls at 6.0 parts per million (ppm). That document referenced 
a summary of the petition prepared by BASF Corporation, the registrant, 
which is available in the docket, http://www.regulations.gov. There 
were no comments received in response to the notice of filing.

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 pendimethalin including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with pendimethalin 
follows.
    The toxicity database for pendimethalin is complete. On August 29, 
2012, the Agency published a final rule (77 FR 52240) (FRL-9360-5) 
establishing tolerances for combined residues of pendimethalin and its 
metabolite in or on various commodities. In the risk assessment 
supporting that action, EPA assessed the toxicity of pendimethalin. 
Since that assessment, EPA's hazard characterization of pendimethalin 
has not changed, and no additional data were needed to assess an 
increase in the tolerance of pendimethalin on almond hulls (see 
``Pendimethalin: Human Health Risk Assessment to Support an Amended Use 
on Almonds''; in docket ID number EPA-HQ-OPP-2013-0071).
    In the 2012 assessment, EPA assessed the dietary risk from residues 
of pendimethalin on almond hulls, which are an animal feed item. Based 
on that assessment, EPA concluded that there is no reasonable 
expectation of finite residues in meat, milk, poultry, and eggs. 
Because EPA expects residues of pendimethalin on almond hulls to be 
higher under this revised tolerance, EPA recalculated the ruminant 
reasonable dietary burden with the new tolerance levels for almond 
hulls and concluded that there would be no increase in the ruminant 
dietary burden. Furthermore, the increase in tolerance on almond hulls 
will not impact the residential exposure and risk assessments that the 
Agency conducted in 2012. As there is no change to the residential and 
dietary risk assessments, a new aggregated risk assessment was not 
needed.
    Therefore, based on the findings of the 2013 risk assessment and 
the 2012 final rule and risk assessment, the Agency concludes that 
there is a reasonable certainty that no harm will result to the general 
population, or to infants and children, from aggregate exposure to 
pendimethalin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    PAM Volume II lists four Gas Chromatography/Electron Capture 
Detector (GC/ECD), methods for the determination of pendimethalin and 
its 3,5-dinitrobenzyl alcohol metabolite in plant commodities. Methods 
I and III determine residues of the parent, whereas Methods II and IV 
determine residues of the 3,5-dinitrobenzyl alcohol metabolite.

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

[[Page 78740]]

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 almond hulls for 
pendimethalin.

C. Revisions to Petitioned-For Tolerances

    Although the petitioner requested that EPA establish a new 
tolerance for residues of pendimethalin on almond hulls, there is 
already a tolerance for almond hulls at 0.4 ppm. Therefore, EPA is 
simply revising that existing tolerance, rather than establishing a new 
tolerance.

V. Conclusion

    Therefore, 40 CFR 180.361 is amended by revising the established 
tolerance for the combined residues of the herbicide pendimethalin and 
its metabolite, in or on almond, hulls from 0.4 ppm to 6.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule modifies 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 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 16, 2013.
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.  180.361, in the table in paragraph (a), revise the 
tolerance level for ``Almond, hulls'' to read as follows:


Sec.  180.361  Pendimethalin; tolerances for residues.(a) * * *

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                                                              Parts per
                         Commodity                             million
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                                * * * * *
Almond, hulls..............................................          6.0
 
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[FR Doc. 2013-30575 Filed 12-26-13; 8:45 am]
BILLING CODE 6560-50-P