[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Rules and Regulations]
[Pages 66721-66723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27191]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0455; FRL-9364-8]


Metconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation amends the tolerance for residues of 
metconazole in or on corn, sweet, stover. BASF Corporation requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective November 7, 2012. Objections and 
requests for hearings must be received on or before January 7, 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-2012-0455, 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: Tamue L. Gibson, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-9096; 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://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-2012-0455 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 
January 7, 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-2012-0455, 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

    In the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-
9), 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 
1F7937) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. The petition requested that the tolerance 
in the 40 CFR 180.617 be amended by increasing the established 
tolerance for residues of the fungicide metconazole, 5-[(4-
chlorophenyl)-methyl]-2, 2-dimethyl-1-(1H-1, 2, 4-triazol-1-ylmethyl) 
cyclopentanol, measured as the sum of cis- and trans- isomers, in or on 
corn, sweet, stover from 4.5 parts per million (ppm) to 25.0 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.
    Based upon review of the data supporting the petition, EPA has 
modified the proposed tolerance level by increasing the tolerance for 
residues of corn, sweet, stover to 30 ppm. The reason for this change 
is explained in Unit IV.C.

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

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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 metconazole including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with metconazole follows.
    EPA's analysis of the impact of the proposed increase of the corn 
stover tolerance will have a minimal impact on exposure of livestock to 
metconazole and will not change the safety determination EPA made for 
metconazole in tolerance rulemaking published in the Federal Register 
of August 17, 2011 (76 FR 50898) (FRL-8882-7) and the initial 
establishment of the corn stover tolerance published in the Federal 
Register of May 7, 2009, 74 FR 21260, FRL-8408-6. In the aggregate risk 
assessment supporting those actions, EPA included exposure from 
previously established tolerances for corn and corn by-products, 
including corn stover (See Metconazole: Human Health Assessment for 
Proposed Uses on Tuberous and Corm Vegetables Subgroup 1C and Bushberry 
Subgroup 13-07B, EPA Docket Number EPA-HQ-OPP-2010-0621). In that risk 
assessment, metconazole exposure to humans due to the presence of 
metconazole in animal livestock feed items was calculated based on the 
tolerance levels in livestock commodities consumed by humans (e.g., 
meat and milk). Tolerance levels in livestock commodities are driven by 
the tolerance levels in livestock feed items, taking into account the 
makeup of the livestock diet. EPA's analysis of the impact of raising 
the corn stover tolerance shows that there will be no increase in the 
maximum reasonably balanced dietary burden for beef cattle, swine, or 
poultry but a small increase for diary cattle. There is no increase for 
beef cattle, swine, or poultry because sweet corn stover is only a 
significant feed item in dairy cattle. Although there is an increase in 
the estimated dietary burden of metaconazole for dairy cattle 
associated with the proposed increase in the corn stover tolerance, the 
increase is relatively small (less than 15 percent) and, based on data 
from a cattle feeding study with metaconazole, EPA has determined that 
the small increase in dietary burden to dairy cattle will not result in 
metaconazole residues in food commodities from dairy cattle that exceed 
existing tolerances. Thus, despite the increase in the corn stover 
tolerance, the aggregate risk assessment underlying the 2009 and 2011 
metconazole rulemakings, which assumed residue levels in food 
commodities from dairy cattle at existing tolerances levels, remains an 
accurate estimate of metconazole risk.
    In the August 17, 2011 and May 7, 2009 Federal Register actions, 
EPA concluded that there is reasonably certainty that no harm will 
result to the general population and to infants and children from 
aggregate exposure to metconazole residues. That conclusion was based 
on the findings that metconazole did not pose either an acute or cancer 
risk and that chronic exposure to metconazole from food and water falls 
well below the safe exposure level for all population groups, including 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Refer to the August 17, 2011 (76 FR 50898) (FRL-8882-7), 
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 documents in support of this 
action.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate high performance liquid chromatography with tandem mass 
spectrometry (Method D0604, entitled ``The Determination of Residues of 
BAS 555 F and its Metabolites in Corn and Cotton Matrices Using LC/MS/
MS''), with the German multi-residue method DFG S19 as a confirmatory 
method, is adequate as an enforcement method. Method D0604 determines 
metconazole (cis--and transisomers), 1,2,4-triazole (T), 
triazolyalanine (TA), and triazolylacetic acid (TAA). DFG S19 uses gas 
chromatography/nitrogen phosphorus detection (GC/NPD) or gas 
chromatography/mass spectrometric detection (GC/MS). The methods 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 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 metconazole on corn, sweet, 
stover.

C. Revisions to Petitioned-For Tolerances

    Based on the analysis of the residue field trial data on field corn 
stover and using the Organization for Economic Cooperation and 
Development (OECD) tolerance calculation procedures, the tolerance for 
sweet corn stover was increased.

V. Conclusion

    Therefore, tolerances are established for residues of metconazole, 
5-[(4-chlorophenyl)-methyl]-2, 2-dimethyl-1-(1H-1, 2, 4-triazol-1-
ylmethyl) cyclopentanol, measured as the sum of cis- and transisomers, 
in or on corn, sweet, stover at 30.0 ppm.

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

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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: October 26, 2012.
Daniel J. Rosenblatt,
Acting 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.  180.617, revise the following entry in the table in 
paragraph (a) to read as follows:


Sec.  180.617  Metconazole; tolerance for residues.

    (a) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
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                                * * * * *
Corn, sweet, stover.........................................        30.0
 
                                * * * * *
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[FR Doc. 2012-27191 Filed 11-6-12; 8:45 am]
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