97-32550. Imidacloprid; Tolerance Extension for Emergency Exemptions

[Federal Register Volume 62, Number 239 (Friday, December 12, 1997)]
[Rules and Regulations]
[Pages 65365-65367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32550]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300594; FRL-5760-9]
RIN 2070-AB78


Imidacloprid; Tolerance Extension for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule extends a time-limited tolerance for residues of the 
insecticide imidacloprid and its metabolites in or on beet and turnip 
roots at 0.3 part per million (ppm) beet and turnip tops at 3.5 ppm for 
an additional 1-year period, to November 29, 1998. This action is in 
response to EPA's granting of an emergency exemption under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of the pesticide on table beets and turnip greens. 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 FIFRA.

EFFECTIVE DATE: This regulation becomes effective December 12, 1997. 
Objections and requests for hearings must be received by EPA, on or 
before February 10, 1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300447], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300594], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 1132, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [e-mail]. Follow the instructions in 
Unit II. of this preamble. No Confidential Business Information (CBI) 
should be submitted through e-mail.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703)-308-9367; e-mail: 
[e-mail].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of November 29, 1996 (61 FR 60622) (FRL-5575-1), which 
announced that on its own initiative and under section 408(e) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and 
(l)(6), it established a time-limited tolerance for the residues of 
imidacloprid and its metabolites in or on beet and turnip roots at 0.3 
ppm and beet and turnip tops at 3.5 ppm, with an expiration date of 
November 29, 1997. 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 FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    EPA received a request to extend the use of imidacloprid on table 
beets and turnip greens for this year growing season due to the lack of 
acceptable control with currently registered products and the loss of 
the insecticide Phosdrin. Under moderate to severe infestation 
conditions, the aphids are expected to cause serious reductions

[[Page 65366]]

due to contamination problems at harvest, primarily due to the large 
number of aphids remaining on the crop. The overall threshold that the 
market will allow is two aphids or less per plant. After having 
reviewed the submission, EPA concurs that emergency conditions exist 
for this state. EPA has authorized under section 18 of FIFRA the use of 
imidacloprid on table beets and turnip greens for control of aphids in 
California.
    EPA assessed the potential risks presented by residues of 
imidacloprid in or on beet and turnip roots and beet and turnip tops. 
In doing so, EPA considered the new safety standard in section 
408(b)(2) of the FFDCA, and decided that the necessary tolerance under 
FFDCA section 408(l)(6) of the FFDCA would be consistent with the new 
safety standard and with section 18 of FIFRA. The data and other 
relevant material have been evaluated and discussed in the final rule 
published in the Federal Register of November 29, 1997. Based on that 
data and information considered, the Agency reaffirms that extension of 
the time-limited tolerance will continue to meet the requirements of 
section 408(l)(6) of the FFDCA. Therefore, the time-limited tolerance 
is extended for an additional 1-year period. Although this tolerance 
will expire and is revoked on November 29, 1998, under section 
408(l)(5) of the FFDCA, residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on beet and turnip 
roots and beet and turnip tops 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 this tolerance earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.

I. Objections and Hearing Requests

     The new section 408(g) of the FFDCA provides essentially the same 
process for persons to ``object'' to a tolerance regulation issued by 
EPA under new section 408(e) and (l)(6) of the FFDCA as was provided in 
the old section 408 and in section 409 of the FFDCA. However, the 
period for filing objections is 60 days, rather than 30 days. EPA 
currently has procedural regulations which govern the submission of 
objections and hearing requests. These regulations will require some 
modification to reflect the new law. However, until those modifications 
can be made, EPA will continue to use those procedural regulations with 
appropriate adjustments to reflect the new law.
    Any person may, by February 10, 1998, file written objections to 
any aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is 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 in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). 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.

II. Public Record and Electronic Submissions

    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.
    Electronic comments may be sent directly to EPA at:
[e-mail].


    Electronic objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Objections and hearing requests will also be accepted on 
disks in WordPerfect 5.1/6.1 or ASCII file format. All copies of 
objections and hearing requests in electronic form must be identified 
by the docket control number [OPP-300594]. No CBI should be submitted 
through e-mail. Electronic copies of objections and hearing requests on 
this rule may be filed online at many Federal Depository Libraries.

III. Regulatory Assessment Requirements

    This final rule extends a time-limited tolerance under section 
408(l)(6) of the FFDCA. 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) (Pub. L. 104-4). Nor does it require any 
prior consultation as specified by Executive Order 12875, entitled 
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 
1993), or 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 in accordance with Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997).
    In addition, since these tolerances and exemptions that are 
established under section 408(l)(6) of the FFDCA, 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. Nevertheless, the Agency has 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

[[Page 65367]]

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.

IV. Submission to Congress and the General Accounting Office

    Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business 
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in 
today's Federal Register. This 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: November 26, 1997.

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. 346a and 371.

Sec. 180.472  [Amended]

    2. In Sec. 180.472, by amending paragraph (a) in the table, for the 
commodities ``beet roots,'' ``beet tops,'' ``turnip roots,'' and 
``turnip tops'' by removing ``November 29, 1997'' and adding in its 
place ``November 29, 1998''.

[FR Doc. 97-32550 Filed 12-11-97; 8:45 am]
BILLING CODE 6560-50-F