[Federal Register Volume 63, Number 62 (Wednesday, April 1, 1998)]
[Rules and Regulations]
[Pages 15761-15763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8643]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300629; FRL-5778-9]
RIN 2070-AB78


Imidacloprid; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This rule extends a time-limited tolerance for residues of the 
insecticide imidacloprid and its metabolites in or on cucurbits at 0.2 
part per million (ppm) for an additional 1-year period, to March 31, 
1999. 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 cucurbits. 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 April 1, 1998. Objections and 
requests for hearings must be received by EPA, on or before June 1, 
1998.
ADDRESSES:  Written objections and hearing requests, identified by the 
docket control number [OPP-300629], may 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 should be identified by the 
docket control number [OPP-300629] and 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 copy of objections and hearing requests to: Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may be submitted electronically by sending electronic mail (e-
mail) to: opp [email protected]. Copies of electronic objections 
and hearing requests must be submitted as an ASCII file avoiding 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 5.1 or 6.1 file format or ASCII file format. All 
copies of electronic objections and hearing requests must be identified 
by the docket control number [OPP-300629]. No Confidential Business 
Information (CBI) should be submitted through e-mail. Copies of 
electronic objections and hearing requests on this rule may be filed 
online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Andrea Beard, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, elephone number, and e-mail address: Rm. 267, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, (703) 308-9356; e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of March 19, 1997 (62 FR 12953) (FRL-5594-2), which 
announced that on its own initiative and under section 408(e) of the 
FFDCA, 21 U.S.C. 346a(e) and (l)(6), EPA was establishing a time-
limited tolerance for the residues of imidacloprid and its metabolites 
in or on cucurbits at 0.2 ppm, with an expiration date of March 31, 
1998. 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. However, in the 
Federal Register of April 25, 1997 (62 FR 20117) (FRL-5599-5), EPA 
issued a regulation extending the expiration date for tolerances of 
indirect or inadvertent residues of imidacloprid and its metabolites on 
Vegetable cucurbits. Inadvertently, in the revision of Sec. 180.472, 
the time-limited tolerance for Vegetable cucurbits as added on March 
19, 1997 under section 18 of FIFRA, was omitted. With this regulation, 
EPA is re-establishing the time-limited tolerance and is also extending 
the expiration date from March 31, 1998 to March 31, 1999.
    EPA received a request from the California Department of Pesticide 
Regulation to extend the use of imidacloprid on cucurbits for this 
year's growing season due to the silverleaf whitefly being a recently-
introduced pest in California, which can have devastating effects on 
the cucurbit crop, and is resistant to registered alternatives. 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 cucurbits for control of silverleaf whitefly in 
cucurbits.
    EPA assessed the potential risks presented by residues of 
imidacloprid in or on cucurbits. In doing so, EPA

[[Page 15762]]

considered the new 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 new 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 March 
19, 1997 (62 FR 12953) (FRL-5594-2). 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 tolerance is extended for an additional 1-
year period. Although this tolerance will expire and is revoked on 
March 31, 1999, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on cucurbits 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.
    Any person may, by June 1, 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-300629. 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 that was 
previously extended by EPA under FFDCA section 408(d) in 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). 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 asrequired 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.

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

[[Page 15763]]

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 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: March 26, 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.


    2. In Sec. 180.472, in the table to paragraph (b), by adding an 
entry for ``Vegetable, cucurbits,'' to read as follows:


Sec. 180.472  Imidacloprid; tolerances for residues.

 * * * * *
    (b) *   *   *

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
                                                                        
                  *        *        *        *        *                 
Vegetables, cucurbits...........  0.2                 3/31/99           
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 98-8643 Filed 3-30-98; 1:15 pm]
BILLING CODE 6560-50-F