[Federal Register Volume 65, Number 246 (Thursday, December 21, 2000)]
[Rules and Regulations]
[Pages 80333-80336]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32572]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301092; FRL-6760-7]
RIN 2070-AB78


Avermectin; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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[[Page 80334]]

SUMMARY: This regulation re-establishes time-limited tolerances for the 
combined residues of the insecticide and miticide avermectin a mixture 
of avermectins containing greater than or equal to 80% avermectin 
B1a (5-O-demethyl avermectin A1) and less than or 
equal to 20% avermectin B1b (5-O-demethyl-25-de(1-
methylpropyl)-25-(1-methylethyl) avermectin A1)) and its 
delta-8,9-isomer in or on avocado and spinach for an additional 2-year 
period. These tolerances will expire and are revoked on December 31, 
2002. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act 
requires EPA to establish a time-limited tolerance or exemption from 
the requirement for a tolerance for pesticide chemical residues in food 
that will result from the use of a pesticide under an emergency 
exemption granted by EPA under section 18 of the Federal Insecticide, 
Fungicide, and Rodenticide Act.

DATES: This regulation is effective December 21, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301092, 
must be received by EPA on or before February 20, 2001.

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 III. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301092 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Dan Rosenblatt, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9375; 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
------------------------------------------------------------------------
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,'' ``Regulations and Proposed Rules,'' 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-301092. 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

    EPA issued a final rule, published in the Federal Register of 
August 19, 1997 (62 FR 44089) (FRL-5737-1), which announced that on its 
own initiative under section 408 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) it established a 
time-limited tolerance for the combined residues of avermectin and its 
delta-8,9-isomer in or on spinach at 0.05 ppm, with an expiration date 
of July 31, 1998. In the Federal Register of August 7, 1998 (63 FR 
42246) (FRL-6021-2), this time-limited tolerance was subsequently 
extended to be effective through January 31, 2000. EPA established the 
tolerance because 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 residues in food that will 
result from the use of a pesticide under an emergency exemption granted 
by EPA under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA). Such tolerances can be established without 
providing notice or period for public comment. In a separate rule, 
published in the Federal Register of April 7, 1999 (64 FR 16843) (FRL-
6070-6), EPA established a time-limited tolerance for the combined 
residues of avermectin and its delta-8,9-isomer in or on avocado at 
0.02 ppm, with an expiration date of September 20, 2000.
    EPA received requests to extend the use of avermectin on avocado 
and spinach for this year's growing seasons for these crops. After 
having reviewed the submissions, EPA concurs that emergency conditions 
still exist this year. The nature of the emergency with regard to 
avocado production involves the continued threat and yield losses posed 
by thrips. With regard to spinach, this exemption application is 
submitted in order to respond to the damage posed by leafminers to this 
crop.
    EPA has assessed the potential risks presented by residues of 
avermectin in or on avocado and spinach. In doing so, EPA considered 
the safety standard in FFDCA section 408(b)(2), and decided that the 
necessary tolerance under FFDCA section 408(l)(6) would be consistent 
with the safety standard and with FIFRA section 18. The data and other 
relevant material have been evaluated and discussed in the final rules 
of August 19, 1997 (62 FR 44089) (FRL-5737-1), for spinach and April 7, 
1999 (64 FR 16843) (FRL-6070-6) for avocado. Based on that data and 
information considered, the Agency reaffirms that the re-establishment 
of the

[[Page 80335]]

time-limited tolerances will continue to meet the requirements of 
section 408(l)(6). Therefore, the time-limited tolerances are re-
established for an additional 2-year period. EPA will publish a 
document in the Federal Register to remove the revoked tolerance from 
the Code of Federal Regulations (CFR). Although this tolerance will 
expire and is revoked on December 31, 2002, under FFDCA section 
408(l)(5), residues of the pesticide not in excess of the amounts 
specified in the tolerances remaining in or on avocado and spinach 
after that date will not be unlawful, provided the pesticide is applied 
in a manner that was lawful under FIFRA and the application occurred 
prior to the revocation of the tolerance. EPA will take action to 
revoke these tolerances earlier if any experience with, scientific data 
on, or other relevant information on this pesticide indicate that the 
residues are not safe.

III. 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. The 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-301092 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, 2001.
    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, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, 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 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, 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, 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 III.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-301092, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 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 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).

IV. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. 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

[[Page 80336]]

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 FIFRA section 18 
petition under FFDCA section 408, such as the tolerances 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 pre-emption provisions 
of FFDCA section 408(n)(4).

V. 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: December 12, 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), 346(a) and 371.


Sec. 180.449   [Amended]

    2. In Sec. 180.449, amend the table in paragraph (b), by revising 
the expiration/revocation date for Avocado from ``9/20/00'' to read 
``12/31/02'' and for Spinach from ``1/31/00'' to read ``1/31/02''.

[FR Doc. 00-32572 Filed 12-20-00; 8:45 am]
BILLING CODE 6560-50-S