Document ID: EPA-HQ-OPP-2006-0823-0001
Agency: epa
Document Type: Rule
Title: Azoxystrobin; Pesticide Tolerances for Emergency Exemptions
Posted Date: 2006-12-20T05:00Z

[Federal Register: December 20, 2006 (Volume 71, Number 244)]
[Rules and Regulations]               
[Page 76178-76180]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20de06-15]                         

[[Page 76178]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0823; FRL-8100-9]

 
Azoxystrobin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
combined residues of azoxystrobin and its Z isomer, on rice, wild. This 
action is in response to EPA's granting of an emergency exemption under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on rice, wild. This regulation 
establishes a maximum permissible level for combined residues of 
azoxystrobin in this food commodity. The tolerance expires and is 
revoked on December 31, 2009.

DATES: This regulation is effective December 20, 2006. Objections and 
requests for hearings must be received on or before February 20, 2007, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0823. All documents in the 
docket are listed on the regulations.gov website. Although listed in 
the index, some information is not publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office 

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Building), 2777 S. Crystal Drive Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9364; e-mail address: Sec-18-Mailbox@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

 B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document 

electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 

frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. 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-2006-0823 in the 
subject line on the first page of your submission. All requests must be 
in writing, and must be mailed or delivered to the Hearing Clerk on or 
before February 20, 2007.
    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 that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2006-0823, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a, is establishing time-limited tolerances for combined 
residues of the fungicide, azoxystrobin, methyl (E)-2-(2-(6-(2-
cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate and the Z 
isomer of azoxystrobin, methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate, on rice, wild at 5.0 parts per million 
(ppm). This tolerance expires and is revoked on December 31, 2009. EPA 
will publish a document in the Federal Register to remove the revoked 
tolerance from the Code of Federal Regulations (CFR).
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical combined residues in food that will result from the 
use of a pesticide under an emergency exemption granted by EPA under 
section 18 of FIFRA. Such tolerances can be established without 
providing

[[Page 76179]]

notice or period for public comment. EPA does not intend for its 
actions on section 18 related tolerances to set binding precedents for 
the application of section 408 of the FFDCA and the new safety standard 
to other tolerances and exemptions. Section 408(e) of the FFDCA allows 
EPA to establish a tolerance or an exemption from the requirement of a 
tolerance on its own initiative, i.e., without having received any 
petition from an outside party.
    Section 408(b)(2)(A)(i) of the 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 the 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 the 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. . . 
.''
    Section 18 of the FIFRA authorizes EPA to exempt any Federal or 
State agency from any provision of FIFRA, if EPA determines that 
``emergency conditions exist which require such exemption.'' This 
provision was not amended by the Food Quality Protection Act of 1996 
(FQPA). EPA has established regulations governing such emergency 
exemptions in 40 CFR part 166.

III. Emergency Exemption for Azoxystrobin on Rice, Wild and FFDCA 
Tolerances

    The Minnesota Department of Agriculture declared a crisis exemption 
under FIFRA section 18 for the use of azoxystrobin on rice, wild for 
control of stem rot disease caused by Nakataea sigmoidea. Minnesota 
states that it appears that stem rot is widespread throughout the state 
and can cause significant damage.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by combined residues of azoxystrobin and 
its Z isomer on rice, wild. In doing so, EPA considered the safety 
standard in section 408(b)(2) of the FFDCA, and EPA decided that the 
necessary tolerance under section 408(l)(6) of the FFDCA would be 
consistent with the safety standard and with FIFRA section 18. 
Consistent with the need to move quickly on the emergency exemption in 
order to address an urgent non-routine situation and to ensure that the 
resulting food is safe and lawful, EPA is issuing this tolerance 
without notice and opportunity for public comment as provided in 
section 408(l)(6) of the FFDCA. Although this tolerance expires and is 
revoked on December 31, 2009, under section 408(l)(5) of the FFDCA, 
combined residues of the pesticide not in excess of the amount 
specified in the tolerance remaining on rice, wild after that date will 
not be unlawful, provided the pesticide is applied in a manner that was 
lawful under FIFRA, and the combined residues do not exceed a level 
that was authorized by this tolerance at the time of that application. 
EPA will take action to revoke this tolerance earlier if any experience 
with, scientific data on, or other relevant information on this 
pesticide indicate that the combined residues are not safe.
    Because this tolerance is being approved under emergency 
conditions, EPA has not made any decisions about whether azoxystrobin 
meets EPA's registration requirements for use on rice, wild or whether 
a permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that this tolerance serves as a 
basis for registration of azoxystrobin by a State for special local 
needs under FIFRA section 24(c). Nor does this tolerance serve as the 
basis for any State other than Minnesota to use this pesticide on this 
crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing FIFRA section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
for azoxystrobin, contact the Agency's Registration Division at the 
address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide combined residues. For further 
discussion of the regulatory requirements of section 408 of the FFDCA 
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.

    Consistent with section 408(b)(2)(D) of the FFDCA, 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 
azoxystrobin and to make a determination on aggregate exposure, 
consistent with section 408(b)(2) of the FFDCA, for time-limited 
tolerances for combined residues of azoxystrobin and its Z isomer on 
rice, wild at 5.0 ppm. On August 23, 2006 the Agency published in the 
Federal Register a final rule (71 FR 49358) (FRL-8086-9) establishing 
tolerances for combined residues of azoxystrobin, 2-[7-fluoro-3,4-
dihydro-3-oxo-4-(2-propynyl)-2H-1,4-benzoxazin-6-yl]-4,5,6,7-
tetrahydro-1H-isoindole-1,3(2H)-dione in or on vegetable, foliage of 
legume, group 7; vegetable, fruiting, group 8 (except tomato); pea and 
bean, succulent shelled, subgroup 6B; pea and bean, dried shelled, 
except soybean, subgroup 6C; citrus, dried pulp; citrus, oil; and 
fruit, citrus, Group 10. When the Agency conducted the risk assessments 
in support of those tolerance actions, the Agency also assessed the use 
of azoxystrobin on wild rice under section 18 of FIFRA. Therefore, 
establishing the rice, wild tolerance will not change the most recent 
estimated aggregate risks resulting from use of azoxystrobin, as 
discussed in the August 23, 2006 Federal Register. Refer to the August 
23, 2006 Federal Register document 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 
document in support of this action.
     Based on the risk assessments discussed in the final rule 
published in the Federal Register of August 23, 2006, EPA 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 azoxystrobin combined residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography-nitrogen 
phosphorus detection) 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; e-mail address:  
residuemethods@epa.gov.

B. International Residue Limits

    There are no Codex, Canadian or Mexican maximum residue limits 
established for azoxystrobin on rice, wild.

[[Page 76180]]

VI. Conclusion

    Therefore, tolerances are established for combined residues of 
azoxystrobin, methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate and the Z isomer of azoxystrobin, 
methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
methoxyacrylate, on rice, wild at 5.0 ppm.

VII. Statutory and Executive Order Reviews

    This final rule establishes a time-limited tolerance under section 
408 of the FFDCA. 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 rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, this rule is not subject 
to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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., or impose any enforceable duty or 
contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a FIFRA 
section 18 exemption under section 408 of the FFDCA, 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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers, and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of the 
FFDCA. For these same reasons, the Agency has determined that this rule 
does not have any ``tribal implications'' as described in Executive 
Order 13175, entitled Consultation and Coordination with Indian Tribal 
Governments (65 FR 67249, November 6, 2000). Executive Order 13175, 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' is defined in the Executive order to include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the Federal Government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
Federal Government and Indian tribes.'' This rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this rule.

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. 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 this final rule in the Federal Register. This final 
rule 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 6, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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. Section 180.507 is amended by alphabetically adding the commodity 
``Rice, wild'' to the table in paragraph (b) to read as follows:

Sec.  180.507  Azoxystrobin; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    revocation
                                                  million        date
------------------------------------------------------------------------
                                * * * * *
Rice, wild....................................          5.0     12/31/09
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E6-21498 Filed 12-19-06; 8:45 am]

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