[Federal Register Volume 65, Number 87 (Thursday, May 4, 2000)]
[Rules and Regulations]
[Pages 25860-25864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-11145]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300995; FRL-6554-9]
RIN 2070-AB78


Azoxystrobin: Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  This regulation increases 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

[[Page 25861]]

on pistachios from 0.01 part per million (ppm) to 0.02 ppm and in or on 
tree nuts from 0.01 ppm to 0.02 ppm. A final rule establishing 
tolerances of azoxystrobin and its Z isomer in or on pistachios at 0.01 
ppm and in or on tree nuts at 0.01 ppm was published in the Federal 
Register of March 17, 1999. These were the tolerances that Zeneca Ag 
Products had originally proposed in pesticide petition number 7F4864. 
Immediately following publication of this final rule, EPA received 
telephone comments from two parties indicating that they believed that 
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, concluded that the 
commenters were correct in their concerns, and published a proposed 
rule in the Federal Register of January 5, 2000, that made the proposal 
to increase the tolerances for azoxystrobin and its Z isomer in or on 
pistachios and in or on tree nuts to 0.02 ppm. No comments concerning 
the proposed rule were received.

DATES:  This regulation is effective May 4, 2000. Objections and 
requests for hearings, identified by docket control number OPP-300995, 
must be received by EPA on or before July 3, 2000.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION: To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300995 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Cynthia Giles-Parker, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW.,Washington, DC 20460; telephone number: (703) 305-7740; and 
e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:   

I. General Information

A. Does this Action Apply to Me?

    You may be 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
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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-300995. 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 1921 Jefferson Davis Hwy., Arlington, 
VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of March 17, 1999 (64 FR 113106) (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), 21 U.S.C. 346a as amended 
by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
announcing the establishment of tolerances for azoxystrobin and its Z 
isomer on several commodities, including pistachios at 0.01 ppm and 
tree nuts at 0.01 ppm, as had been proposed by Zeneca Ag Products, 1800 
Concord Pike, Wilmington, DE 19897 in tolerance petition number 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 publication of the rule. In 
both cases, the parties believed that 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 use directions on the label were 
accurately followed. EPA agreed to revisit the tolerances assigned to 
these commodities. If the commenter's comments were substantiated, a 
reassessment of the risk from the use of azoxystrobin would also be 
necessary. The Agency has concluded that the commenters' 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. There was 
a negligible increase in the risk calculated for the use of 
azoxystrobin as a result of the increases in these two tolerances. 
Therefore, in the Federal Register of January 5, 2000 (65 FR 425) (FRL-
6393-1), a proposed rule was issued, pursuant to section 
408(b)(2)(A)(ii) of the FFDCA as amended by the FQPA, announcing the 
Agency's intention to increase the tolerances for azoxystrobin and its 
Z isomer in or on pistachio nuts to 0.02 ppm and in or on tree nuts to 
0.02 ppm. There were no comments received in response to the proposed 
rule.

[[Page 25862]]

    The proposed rule requested that 40 CFR 180.507 be amended by 
increasing the tolerances of the fungicide, azoxystrobin and its Z 
isomer, in or on pistachio nuts to 0.02 ppm and in or on tree nuts to 
0.02 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish or 
leave in effect 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 November 26, 1997 (62 FR 62961) (FRL-5754-7).

III. 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 azoxystrobin and its Z isomer in or on 
pistachios at 0.02 parts per million (ppm) and in or on tree nuts at 
0.02 ppm. EPA's assessment of the dietary exposures and risks 
associated with increasing the subject tolerances for azoxystrobin and 
its Z isomer from 0.01 ppm to 0.02 ppm was performed in essentially 
exactly the same way as was the azoxystrobin risk assessment contained 
in the azoxystrobin final rule that was published in the Federal 
Register of March 17, 1999, except that where tolerance-level residues 
were used in the analyses, in the first analysis a tolerance value for 
azoxystrobin and its Z isomer of 0.01 ppm was used for pistachios and 
the same value was used for tree nuts, while in the second analysis, a 
tolerance value for azoxystrobin and its Z isomer of 0.02 ppm was used 
for pistachios and a tolerance value for azoxystrobin and its Z isomer 
of 0.02 ppm was used for tree nuts. The exposure/risk reassessment lead 
to no change in the toxicological profile or toxicological endpoints 
compared to those in the azoxystrobin final rule published on March 17, 
1999. The increases in the exposure and risk estimates in the second 
analysis, compared to those presented in the first analysis, were so 
small (generally at the fourth decimal place) that the risk assessment 
values (rounded) that are reported in the March 17, 1999 final rule 
were not changed. Stated another way, the risk increase resulting from 
this final rule will be negligible.

IV. Other Considerations

    No change in the discussions of metabolism in plants and animals, 
analytical enforcement methodology, magnitude of residues, and 
international residue limits, compared to the discussions of those 
topics in the final rule dated March 17, 1999, that established 
azoxystrobin tolerances on a number of commodities, including 
pistachios and tree nuts, is needed.

V. Conclusion

    Therefore, tolerances for the residues of azoxystrobin and its Z 
isomer in or on pistachios are increased from 0.01 ppm to 0.02 ppm and 
in or on tree nuts are increased from 0.01 ppm to 0.02 ppm.

VI. Objections and Hearing Requests

    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. EPA procedural regulations 
which govern the submission of objections and requests for hearings 
appear in 40 CFR part 178. Although the procedures in those regulations 
require some modification to reflect the amendments made to the FFDCA 
by the FQPA of 1996, EPA will continue to use those procedures, with 
appropriate adjustments, until the necessary modifications can be made. 
The new section 408(g) provides essentially the same process for 
persons to ``object'' to a regulation for an exemption from the 
requirement of a tolerance issued by EPA under new section 408(d), as 
was provided in the old FFDCA sections 408 and 409. However, the period 
for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300995 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 July 3, 
2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential 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. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania 
Ave., NW., Washington, DC 20460. You may also deliver your request to 
the Office of the Hearing Clerk in Rm. M3708, Waterside Mall, 401 M 
St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open 
from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The telephone number for the Office of the Hearing Clerk is (202) 260-
4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact

[[Page 25863]]

James Tompkins by phone at (703) 305-5697, by e-mail at 
[email protected], or by mailing a request for information to Mr. 
Tompkins at Registration Division (7505C), Office of Pesticide 
Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 
Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 
1200 Pennsylvania Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-300995, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. In person or by courier, bring a copy to the 
location of the PIRIB described in Unit I.B.2. You may also send an 
electronic copy of your request via e-mail to: [email protected]. 
Please use an ASCII file format and avoid the use of special characters 
and any form of encryption. Copies of electronic objections and hearing 
requests will also be accepted on disks in WordPerfect 6.1/8.0 file 
format or ASCII file format. Do not include any CBI in your electronic 
copy. You may also submit an electronic copy of your request at many 
Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule increases two tolerances under FFDCA section 408(d) 
in response to comments received following publication of a final rule 
that was itself a 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). 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 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). 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. 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 FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    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: April 27, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is 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, by revising the entries for pistachios and tree 
nuts to the table in paragraph (a)(1) to read as follows:


Sec. 180.507  Azoxystrobin; tolerances for residues.

    (a) General. (1) * * *

[[Page 25864]]



 
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
 
                     *    *    *    *    *    *    *
Pistachios................................                          0.02
 
                     *    *    *    *    *    *    *
Tree nuts.................................                          0.02
 
                     *    *    *    *    *    *    *
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[FR Doc. 00-11145 Filed 5-3-00; 8:45 am]
BILLING CODE 6560-50-F