[Federal Register Volume 67, Number 162 (Wednesday, August 21, 2002)]
[Rules and Regulations]
[Pages 54108-54111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20990]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0150; FRL-7188-4]


Imidacloprid; Re-Establishment of Tolerance for Emergency 
Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation re-establishes time-limited tolerances for 
combined residues of the insecticide imidacloprid (1-[6-chloro-3-
pyridinyl) methyl]-N-nitro-2-imidazolidinimine) and its metabolites 
containing the 6-chloropyridinyl moiety, all expressed as 1-[(6-chloro-
3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine, in or on turnip, roots 
at 0.3 parts per million (ppm); turnip, tops at 3.5 ppm; beet, garden, 
roots at 0.3 ppm; and beet, garden, tops for an additional 2-year 
period. These tolerances will expire and are revoked on June 30, 2004. 
This action is in response to EPA's granting of an emergency exemption 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizing use of the pesticide on turnips and garden 
beets. 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.

DATES: This regulation is effective August 21, 2002. Objections and 
requests for hearings, identified by docket ID number OPP-2002-0150, 
must be received on or before October 21, 2002.

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 ID number OPP-2002-0150 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; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 54109]]

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 Potentially
             Categories                 NAICS       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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket ID number OPP-2002-0150. 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 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 time-limited 
tolerances for the combined residues of the insecticide imidacloprid 
(1-[6-chloro-3-pyridinyl) methyl]-N-nitro-2-imidazolidinimine) and its 
metabolites containing the 6-chloropyridinyl moiety, all expressed as 
1-[(6-chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine, 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.
    These tolerances were subsequently extended on in Federal Register 
documents published on December 12, 1997 (extended to Novemer 29, 
1998), October 7, 1998 (extended to June 30, 2000), and August 9, 2000 
(extended to June 30, 2002). The extension that was published on August 
9, 2000 amended Sec. 180.472(b) by extending the expirations dates of 
turnip roots; turnip tops; beet roots; and beet tops. However; these 
changes have never been reflected in the tolerance table in 
Sec. 180.472(b) because the time-limited tolerances for these 
commodities were originally listed in the tolerance table for 
Sec. 180.472(a). This document will re-establish the tolerances using 
the correct commodity terms from the Food and Feed Commodity Vocabulary 
database, correctly place them in the table to Sec. 180.472(b), and 
remove the commodities turnip roots, turnip tops, beet roots and beet 
tops from the table in Sec. 180.472(a).
    Recently, EPA has received an objection to a tolerance it 
established for imidacloprid on a different food commodity. The 
objection was filed by the Natural Resources Defense Council (NRDC) and 
raised several issues regarding aggregate exposure estimates and the 
additional safety factor for the protection of infants and children. 
Although this objection concerns separate rulemaking proceedings under 
the FFDCA, EPA has considered whether it is appropriate to re-establish 
the emergency exemption tolerances for imidacloprid while the objection 
is still pending.
    Factors taken into account by EPA included how close the Agency is 
to concluding the proceedings on the objection, the nature of the 
current action, whether NRDC's objection raised frivolous issues, and 
the extent to which the issues raised by NRDC had already been 
considered by EPA. Although NRDC's objection is not frivolous, the 
other factors all support extending these tolerances at this time. 
First, the objections proceeding is not near to conclusion. NRDC's 
objections raise complex legal, scientific, policy, and factual matters 
and EPA has just initiated a 60 day public comment period on them. (See 
67 FR 41628, June 19, 2002, FRL-7167-7) Second, the nature of the 
current actions are extremely time-sensitive as they address emergency 
situations. Third, the issues raised by NRDC are not new matters but 
questions that have been the subject of considerable study by EPA and 
comment by stakeholders. Accordingly, EPA is proceeding with re-
establishing the tolerances for imidacloprid.
    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 turnips 
and garden beets for this year's growing season due to a continuation 
of the emergencies in California and Arizona. After having reviewed the 
submission, EPA concurs that emergency conditions exist. EPA has 
authorized under FIFRA section 18 the use of imidacloprid on turnips 
and garden beets for control of aphids in Arizona and California, 
respectively.
    EPA assessed the potential risks presented by residues of 
imidacloprid in or on turnip roots, turnip tops, garden beet roots, and 
garden beet tops. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2), and decided that the necessary tolerances 
under FFDCA section

[[Page 54110]]

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 
November 29, 1996 (FRL-5575-1). Based on that data and information 
considered, the Agency reaffirms that re-establishment of the 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 tolerances from the Code of 
Federal Regulations (CFR). Although these tolerances will expire and 
are revoked on June 30, 2004, 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, roots; turnip, tops; beet, 
garden, roots; and beet, garden, 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 
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 ID number OPP-2002-0150 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 
21, 2002.
    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 ID number OPP-2002-0150, 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 re-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 (58 FR 51735, October 4, 1993). 
Because this rule has been exempted from review under Executive Order 
12866 due to its lack of significance, this rule is not subject to

[[Page 54111]]

Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001). 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 special considerations under Executive Order 12898, 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994); 
or 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 preemption provisions 
of FFDCA section 408(n)(4). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications'' is defined in the Executive 
order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
Government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal Government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

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: August 11, 2002.
Debra Edwards,
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), 346(a) and 371.

    2. In Sec. 180.472, amend the table in paragraph (a) by removing 
the entries for the commodities turnip tops; turnip roots; beet tops; 
and beet roots and amend the table in paragraph (b) by adding 
alphabetically the following entries:


Sec. 180.472  Imidacloprid; tolerances for residues.

* * * * *
    (b) *  *  *

------------------------------------------------------------------------
                                                            Expiration/
                  Commodity                    Parts per    Revocation
                                                million        Date
------------------------------------------------------------------------
Beet, garden, roots;.........................        0.3        06/30/04
Beet, garden, tops;..........................        3.5        06/30/04
                  *        *        *        *        *
Turnip, roots;...............................        0.3        06/30/04
Turnip, tops;................................        3.5        06/30/04
                  *        *        *        *        *
------------------------------------------------------------------------

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[FR Doc. 02-20990 Filed 8-20-02; 8:45 am]
BILLING CODE 6560-50-S