Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: Azoxystrobin,

[Federal Register: May 4, 2000 (Volume 65, Number 87)]

[Rules and Regulations]

[Page 25860-25864]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr04my00-7]

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.

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: giles-parker.cynthia@epa.gov.

SUPPLEMENTARY INFORMATION:

1. General Information

   1. 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

      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.

   2. 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.

2. 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).

3. 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.

4. 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.

5. 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.

6. 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.

   1. 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 tompkins.jim@epa.gov, 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: opp-docket@epa.gov. 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.

   2. 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).

7. 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).

8. 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

      * * * * * * *

      * * * * *

      [FR Doc. 00-11145Filed5-3-00; 8:45 am]

      BILLING CODE 6560-50-F