[Federal Register Volume 65, Number 154 (Wednesday, August 9, 2000)]
[Rules and Regulations]
[Pages 48634-48637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20118]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301035; FRL-6736-8]
RIN 2070-AB78


Imidacloprid; Extension of Tolerances for Emergency Exemptions

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation extends time-limited tolerances for residues 
of the insecticide imidacloprid and its metabolites in or on turnip 
roots at 0.3 part per million (ppm), turnip tops at 3.5 ppm, beet roots 
at 0.3 ppm, and beet tops at 3.5 ppm for an additional 2-year period. 
These tolerances will expire and are revoked on June 30, 2002. This 
action is in response to EPA's granting of emergency exemptions under 
section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA) authorizing use of the pesticide on turnip greens and garden 
beets. Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act 
(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 FIFRA.

DATES:  This regulation is effective August 9, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301035, 
must be received by EPA on or before October 10, 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 III. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301035 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9367; 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

[[Page 48635]]

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-301035. 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 
November 29, 1996 (FRL-5575-1), which announced that on its own 
initiative under section 408 of the FFDCA, 21 U.S.C. 346a, as amended 
by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
it established time-limited tolerances for the residues of imidacloprid 
and its metabolites in or on turnip roots at 0.3 ppm, turnip tops at 
3.5 ppm, beet roots at 0.3 ppm, and beet tops at 3.5 ppm, with an 
expiration date of November 29, 1997. EPA established the tolerances 
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 FIFRA. Such tolerances can be established 
without providing notice or period for public comment. These tolerances 
were extended on December 12, 1997 (FRL-5760-9) for an additional 12-
month period to November 29, 1998. These tolerances were further 
extended on October 7, 1998, (FRL-6037-2) for an additional 18-month 
period to June 30, 2000.
    EPA received a request to extend the use of imidacloprid on turnip 
greens and garden beets for this year's growing season due to the 
continuing emergency situation in California and a new one in Arizona. 
According to the applicants, due to the lack of acceptable control with 
currently registered products, and the loss of the insecticide 
phosdrin, this pest has become a serious threat to the table beet and 
turnip green industry. Aphids can cause serious reductions due to 
contamination problems resulting from the large number of aphids 
remaining on the crop at harvest. The market will only allow 2 aphids 
or less per plant. After having reviewed the submissions, EPA concurs 
that emergency conditions exist. EPA has authorized under FIFRA section 
18 the use of imidacloprid on turnip greens for control of aphids in 
Arizona and California and for use on garden beets for control of 
aphids in California.
    EPA assessed the potential risks presented by residues of 
imidacloprid in or on turnip greens and garden beets. In doing so, EPA 
considered the safety standard in FFDCA section 408(b)(2), and decided 
that the necessary tolerances 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 rule of November 29, 1996 (FRL-5575-1). Based on that data and 
information considered, the Agency reaffirms that extension of the 
time-limited tolerances will continue to meet the requirements of 
section 408(l)(6). Therefore, the time-limited tolerances are extended 
for an additional 2-year period. EPA will publish a document in the 
Federal Register to remove the revoked tolerances from the Code of 
Federal Regulations (CFR). Although these tolerances will expire and 
are revoked on June 30, 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 turnip greens and garden beets 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 tolerances. 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-301035 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 October 
10, 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

[[Page 48636]]

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-301035, 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 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).

IV. Regulatory Assessment Requirements

    This final rule establishes time-limited tolerances 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 October 4, 1993, (58 FR 51735). 
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 May 19, 1998, (63 FR 
27655); 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 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 August 10, 
1999, (64 FR 43255). 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).

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).

[[Page 48637]]

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: July 28, 2000.

Peter Caulkins,

Acting 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.


Sec. 180.472  [Amended]

    2. In Sec. 180.472, amend the table in paragraph (b) by removing 
the date ``June 30, 2000'' for ``turnip roots,'' ``turnip tops,'' 
``beet roots,'' and ``beet tops'' and adding in its place ``June 30, 
2002.''
[FR Doc. 00-20118 Filed 8-8-00; 8:45 am]
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