[Federal Register Volume 63, Number 194 (Wednesday, October 7, 1998)]
[Rules and Regulations]
[Pages 53826-53829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26903]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300743; FRL-6037-2]
RIN 2070-AB78


Imidacloprid; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule extends the time-limited tolerances for residues of 
the insecticide imidacloprid and its metabolites in or on the citrus 
fruits crop group at 1.0 part per million (ppm), dried citrus pulp at 
5.0 ppm, beet roots at 0.3 ppm, turnip roots at 0.3 ppm, and turnip 
tops 3.5 ppm for an additional 18-month period, to June 30, 2000. 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 citrus, table beets and 
turnip greens. 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 FIFRA.

DATES: This regulation becomes effective October 7, 1998. Objections

[[Page 53827]]

and requests for hearings must be received by EPA, on or before 
December 7, 1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300743], 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-300743], 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. 119, Crystal 
Mall 2 (CM #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: [email protected]. 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: Rm. 272, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703) 308-9367; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued two final rules, published in the 
Federal Register of July 9, 1997 (62 FR 36691)(FRL-5729-4), for citrus, 
and the Federal Register of December 12, 1997 (62 FR 65365)(FRL-5760-
9), for beets and turnips, which announced that on its own initiative 
under section 408(e) of the FFDCA, 21 U.S.C. 346a(e) and (l)(6), it 
established time-limited tolerances for the residues of imidacloprid 
and its metabolites in or on the citrus fruits crop group at 1.0 part 
per million (ppm), dried citrus pulp at 5.0 ppm, beet roots at 0.3 ppm, 
turnip roots at 0.3 ppm, and turnip tops 3.5 ppm, with an expiration 
date of December 31, 1998 for citrus and November 29, 1998 for beets 
and turnips. 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 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 citrus 
for this year growing season due to the continuing emergency situation 
in Florida. The brown citrus aphid (BrCA) is a potentially devastating 
pest that was first introduced into southern Florida in the Fall of 
1995 and as of January 24, 1997, has been detected in 15 counties in 
the southern portion of the state. Today, BrCA is found throughout 
Florida's citrus belt. The BrCA has the potential to become a major 
economic pest to citrus nurseries and young citrus groves by impacting 
citrus production in two ways. First, the BrCA, similar to the citrus 
leaf miner, has the ability to stunt the growth of young trees by 
feeding on the newly developing foliage, causing leaf distortion and/or 
premature leaf drop. These effects on foliage can reduce the trees' 
photosynthetic ability which can lead to defoliation. The second, and 
larger, concern for Florida citrus growers is that the BrCA is a 
transmitter of citrus tristeza virus (CTV).
    The citrus leafminer (CLM) has spread throughout the state to all 
commercial citrus production areas since its initial discovery in May 
1993, and has since become established as a major economic pest to 
citrus nurseries and young citrus groves. CLM has the ability to stop 
growth of young trees, by feeding on the newly developing foliage, 
causing eventual premature leaf drop. When the new growth twigs are 
attacked, it then also threatens the crop for the following year as 
well. After having reviewed the submission, EPA concurs that emergency 
conditions exist for this state. EPA has authorized under FIFRA section 
18 the use of imidacloprid on citrus for control of [the brown citrus 
aphid and citrus leafminer in Florida.
    EPA also received a request to extend the use of imidacloprid on 
table beets and turnips for this year growing season due to the 
continuing emergency situation in California. According to the 
applicant, due to the lack of acceptable control with currently 
registered products, and the loss of the insecticide Phosdrin, this 
pest became a serious threat to the table beet and turnip green 
industry in 1996. 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 submission, EPA concurs 
that emergency conditions exist for this state. EPA has authorized 
under FIFRA section 18 the use of imidacloprid on table beets and 
turnips for control of aphids in California.
    EPA assessed the potential risks presented by residues of 
imidacloprid in or on citrus, beet roots, turnip roots and turnip tops. 
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 rule published in the Federal Register of 
July 9, 1997 (62 FR 36691), for citrus, and December 12, 1997 (62 FR 
65365), for beets and turnips. 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). 
Therefore, the time-limited tolerances are extended for an additional 
18-month period. Although these tolerances will expire and be revoked 
on June 30, 2000, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on citrus, beet roots, turnip roots, 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 FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. 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.

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    Any person may, by December 7, 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:
[email protected].


    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-300743]. 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

A. Certain Acts and Executive Orders

    This final rule extends a time-limited tolerance that was 
previously established by EPA under FFDCA section 408 (l)(6). 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). In addition, 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).
    Since this extension of an existing time-limited tolerance does 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 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.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local, or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide to OMB, in a separately 
identified section of the preamble to the rule, a description of the 
extent of EPA's prior consultation with representatives of affected 
tribal governments, a summary of the nature of their concerns, and a 
statement supporting the need to issue the

[[Page 53829]]

regulation. In addition, Executive Order 13084 requires EPA to develop 
an effective process permitting elected officials and other 
representatives of Indian tribal governments ``to provide meaningful 
and timely input in the development of regulatory policies on matters 
that significantly or uniquely affect their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

IV. 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 the rule in the Federal Register. This 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: September 29, 1998.

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. 346a and 371.

Sec. 180.472  [Amended]

    2. In Sec. 180.472, by amending paragraph (b) by changing for the 
commodities ``beet roots,'' ``beet tops,'' ``turnip roots,'' and 
``turnip tops'' the date ``11/29/98'' to read ``6/30/00'' and by 
changing for the commodities ``citrus fruits crop group'' and ``dried 
citrus pulp'' the date ``12/31/98'' to read ``6/30/00''.

[FR Doc. 98-26903 Filed 10-6-98; 8:45 am]
BILLING CODE 6560-50-F