[Federal Register Volume 65, Number 3 (Wednesday, January 5, 2000)]
[Proposed Rules]
[Pages 425-427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-75]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300951; FRL-6393-1]
RIN 2070-AB78


Azoxystrobin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to revise the tolerances for residues 
of azoxystrobin (methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate) and its Z isomer (methyl(Z)-2-(2-(6-
(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) in or on 
pistachios at 0.02 part per million (ppm) and tree nuts at 0.02 ppm. A 
final rule establishing tolerances for residues of azoxystrobin and its 
Z isomer in or on pistachios at 0.01 ppm and tree nuts at 0.01 ppm was 
published in the Federal Register of March 17, 1999 (64 FR 13106). 
These were the tolerances that Zeneca Ag Products had originally 
proposed, in pesticide petition (PP) 7F4864. Immediately following 
completion of this final rule, EPA received telephone comments from two 
parties indicating that they believed the pistachio and tree nuts 
tolerances were too low, considering the data submitted in support of 
the tolerances and the use directions on the label, and might lead to 
adulterated commodities even when the label use directions were 
accurately followed. EPA agreed to revisit the tolerances assigned to 
these commodities, has concluded that the commentors are correct in 
their concerns, and here proposes to increase the tolerances for 
residues of azoxystrobin and its Z isomer in or on pistachios to 0.02 
ppm and in or on tree nuts to 0.02 ppm.

DATES: Comments, identified by docket control number OPP-300951, must 
be received by EPA on or before March 6, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the ``SUPPLEMENTARY INFORMATION.'' To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-300951 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia L. Giles-Parker, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
telephone number: (703) 305-7740; and e-mail address: giles-
[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. 
Potentially affected categories and entities may include, but are not 
limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         Potentially
                                                      Affected  Entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------


    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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under ``FOR FURTHER INFORMATION 
CONTACT.''

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300951. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall 2 (CM #2), 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday

[[Page 426]]

through Friday, excluding legal holidays. The PIRIB telephone number is 
(703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-300951 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall 2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-300951. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person listed under ``FOR FURTHER INFORMATION 
CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule or 
collection activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

    In the Federal Register of March 17, 1999 (64 FR 13106) (FRL-6064-
6), EPA issued a final rule pursuant to section 408(b)(2)(A)(i) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food 
Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing 
the establishment of tolerances for residues of azoxystrobin and its Z 
isomer on several commodities, including pistachio nuts at 0.01 ppm and 
tree nuts at 0.01 ppm, as had been proposed by Zeneca Ag Products in 
tolerance petition number (PP) 7F4864. This final rule included a 
detailed discussion of the risk assessment and of residue and other 
considerations that lay behind EPA's decision to establish the 
tolerances. Telephone comments were received from two parties in 
California immediately after completion of the rule. In both cases the 
parties believed that the pistachios and tree nuts tolerances were too 
low, considering the data submitted in support of the tolerances and 
the use directions on the label, and might lead to adulterated 
commodities even when the use directions on the label were accurately 
followed. EPA agreed to revisit the tolerances assigned to these 
commodities. If the commentor's comments were substantiated, a 
reassessment of the risk from the use of azoxystrobin would also be 
necessary. The Agency has concluded that the commentors' concerns are 
justified and that the appropriate tolerances for these commodities are 
0.02 ppm in or on pistachios and 0.02 ppm in or on tree nuts.
    This document proposes to amend 40 CFR 180.507 by increasing the 
tolerances for combined residues of the fungicide azoxystrobin and its 
Z isomer, in or on pistachios at 0.02 ppm and tree nuts at 0.02 ppm.

B. What is the Agency's Authority for Taking this Action?

    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) 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) 
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....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

C. Aggregate Risk Assessment and Determination of Safety

    Consistent with 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, consistent with section 
408(b)(2), for a tolerance for

[[Page 427]]

combined residues of azoxystrobin and its Z isomer in or on pistachios 
at 0.02 ppm and in or on tree nuts at 0.02 ppm. EPA's assessment of the 
dietary exposures and risks associated with establishing the tolerances 
were published in 64 FR 13106 (March 17, 1999), the final rule that 
established the initial tolerances for residues of azoxystrobin in or 
on pistachios at 0.01 ppm and in or on tree nuts at 0.01 ppm. In that 
rule the Agency concluded that there was a reasonable certainty that no 
harm would result from the establishment of azoxystrobin tolerances for 
several other commodities. A reassessment of the risk associated with 
increasing the azoxystrobin tolerances for pistachios and tree nuts to 
0.02 ppm demonstrated that the calculated risk increases were so small 
(generally at the fourth decimal place) that the risk assessment values 
(rounded) reported in 64 FR 13106 (March 17, 1999) were not changed. 
That is, the risk increase resulting from this proposed rule will be 
negligible. Accordingly, EPA concludes that modifying these tolerances 
as described will be safe for the general population, including infants 
and children. EPA reaffirms its specific risk findings set forth in the 
March 1999 azoxystrobin tolerance action.

D. International Residue Limits

    There are no Codex, Canadian or Mexican Maximum Residue Limits 
(MRL) established for azoxystrobin for pistachios or tree nuts. Thus, 
harmonization is not an issue.

III. Regulatory Assessment Requirements

    This proposed rule seeks to establish a tolerance under FFDCA 
section 408(e). 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). 
This action 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 prior consultation 
as specified by Executive Order 13084, entitled Consultation and 
Coordination with Indian Tribal Governments (63 FR 27655, May 19,1998); 
special considerations as required by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or require 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). Pursuant to the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a generic matter, 
that there is no adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance actions published on May 
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration. 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 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 FFDCA section 408(n)(4).

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, 1999.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I shall be amended as 
follows:

PART 180--[AMENDED]

    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. 180.507, the table to paragraph (a)(1), by revising the 
entries for pistachios and tree nuts to read as follows:


Sec. 180.507  Azoxystrobin; tolerances for residues.

    (a) General. (1)    *    *    *

 
------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
 
                          *    *    *    *    *
Pistachios.....................................                     0.02
 
                          *    *    *    *    *
Tree nuts......................................                     0.02
 
                          *    *    *    *    *
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*    *    *    *    *

[FR Doc. 00-75 Filed 1-4-00; 8:45 am]
BILLING CODE 6560-50-F