[Federal Register Volume 67, Number 99 (Wednesday, May 22, 2002)]
[Rules and Regulations]
[Pages 35912-35915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12423]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0035; FRL-6836-7]


Nicotine; Tolerance Revocations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This document revokes specific tolerances for residues of 
nicotine-containing compounds used as insecticides and for the 
insecticide nicotine. The regulatory actions in this document are part 
of the Agency's reregistration program under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA), and the tolerance reassessment 
requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA) 
section 408(q), as amended by the Food Quality Protection Act (FQPA) of 
1996. By law, EPA is required by August 2002 to reassess 66% of the 
tolerances in existence on August 2, 1996, or about 6,400 tolerances. 
The regulatory actions in this document pertain to the revocation of 66 
tolerances which are counted among tolerance/exemption reassessments 
made toward the August, 2002 review deadline.

DATES: This regulation is effective August 20, 2002. Objections and 
requests for hearings, identified by docket control number OPP-2002-
0035, must be received by EPA on or before July 22, 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 IV. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-2002-0035 in 
the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Joseph Nevola, Special Review 
and Reregistration Division (7508C), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8037; 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 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 theFederal 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 control number OPP-2002-0035. 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

A. What Action is the Agency Taking?

    This final rule revokes certain FFDCA tolerances for residues of 
nicotine-containing compounds used as insecticides and for the 
insecticide nicotine in or on specified commodities listed in the 
regulatory text because nicotine is no longer registered under FIFRA 
for use on those commodities. The tolerances revoked by this final rule

[[Page 35913]]

are no longer necessary to cover residues of nicotine or nicotine-
containing compounds in or on domestically treated commodities or 
commodities treated outside but imported into the United States. 
Nicotine or nicotine-containing compounds are no longer used on those 
specified commodities within the United States, and no one commented 
that there was a need for EPA to retain the tolerances to cover 
nicotine residues in or on imported foods. EPA has historically 
expressed a concern that retention of tolerances that are not necessary 
to cover residues in or on legally treated foods has the potential to 
encourage misuse of pesticides within the United States. Thus, it is 
EPA's policy to issue a final rule revoking those tolerances for 
residues of pesticide chemicals for which there are no active 
registrations under FIFRA, unless any person commenting on the proposal 
demonstrates a need for the tolerance to cover residues in or on 
imported commodities or domestic commodities legally treated.
    In the Federal Register of January 16, 2002 (67 FR 2175) (FRL-6810-
3), EPA issued a proposed rule to revoke the tolerances listed in this 
final rule. Also, the January 16, 2002 proposal invited public comment 
for consideration and for support of tolerance retention under FFDCA 
standards. No comments were received by the Agency.
    Currently, with the exception of cucumber, lettuce, and tomato, 
there are no other active food use registrations existing for nicotine-
containing compounds or nicotine. Because no active food use 
registrations have existed since 1994 and because no comments expressed 
a need to retain these tolerances for import purposes, EPA is revoking 
62 tolerances in 40 CFR 180.167 for residues of nicotine-containing 
compounds used as insecticides in or on apples; apricots; artichokes; 
asparagus; avocados; beans; beets (with or without tops) or beet greens 
alone; blackberries; boysenberries; broccoli; brussels sprouts; 
cabbage; cauliflower; celery; cherries; citrus fruits; collards; corn; 
cranberries; currants; dewberries; eggplants; gooseberries; grapes; 
kale; kohlrabi; loganberries; melons; mushrooms; mustard greens; 
nectarines; okra; onions; parsley; parsnips (with or without tops) or 
parsnip greens alone; peaches; pears; peas; peppers; plums (fresh 
prunes); pumpkins; quinces; radishes (with or without tops) or radish 
tops; raspberries; rutabagas (with or without tops) or rutabaga tops; 
spinach; squash; strawberries; summer squash; Swiss chard; turnips 
(with or without tops) or turnip greens; and youngberries. Also, EPA is 
revoking the four tolerances in 40 CFR 180.167a for residues of the 
insecticide nicotine in eggs; poultry, fat; poultry, meat; and poultry, 
meat byproducts by removing section 180.167a in its entirety.
    Because some of the tolerances in 40 CFR 180.167 will not be 
revoked and will remain in the Code of Federal Regulations, EPA is 
revising the commodity terminology changes for the remaining tolerances 
to conform with current Agency administrative practice as follows: 
``cucumbers'' to ``cucumber'' and ``tomatoes'' to ``tomato.''

B. What is the Agency's Authority for Taking this Action?

    It is EPA's general practice to propose revocation of tolerances 
for residues of pesticide active ingredients on crop uses for which 
FIFRA registrations no longer exist. EPA has historically been 
concerned that retention of tolerances that are not necessary to cover 
residues in or on legally treated foods may encourage misuse of 
pesticides within the United States. Nonetheless, EPA will establish 
and maintain tolerances even when corresponding domestic uses are 
canceled if the tolerances, which EPA refers to as ``import 
tolerances,'' are necessary to allow importation into the United States 
of food containing such pesticide residues. However, where there are no 
imported commodities that require these import tolerances, the Agency 
believes it is appropriate to revoke tolerances for unregistered 
pesticides in order to prevent potential misuse.

C. When Do These Actions Become Effective?

    These actions become effective 90 days following publication of 
this final rule in the Federal Register. EPA has delayed the 
effectiveness of these revocations for 90 days following publication of 
this final rule to ensure that all affected parties receive notice of 
EPA's actions. Consequently, the effective date is August 20, 2002. For 
this final rule, tolerances that were revoked because registered uses 
did not exist concerned uses which have been canceled for many years. 
Therefore, commodities containing these pesticide residues should have 
cleared the channels of trade.
    Any commodities listed in the regulatory text of this document that 
are treated with the pesticide subject to this final rule, and that are 
in the channels of trade following the tolerance revocations, shall be 
subject to FFDCA section 408(1)(5), as established by the FQPA. Under 
this section, any residue of this pesticide in or on such food shall 
not render the food adulterated so long as it is shown to the 
satisfaction of FDA that, (1) the residue is present as the result of 
an application or use of the pesticide at a time and in a manner that 
was lawful under FIFRA, and (2) the residue does not exceed the level 
that was authorized at the time of the application or use to be present 
on the food under a tolerance or exemption from a tolerance. Evidence 
to show that food was lawfully treated may include records that verify 
the dates that the pesticide was applied to such food.

D. What is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2002 to reassess 66% or about 
6,400 of the tolerances in existence on August 2, 1996. EPA is also 
required to assess the remaining tolerances by August, 2006. As of May 
1, 2002, EPA has reassessed over 4,140 tolerances. For counting 
purposes, the tolerances depicted as ``with or without tops'' were each 
counted as two tolerances. In this rule, EPA is revoking 66 tolerances 
which count as reassessments toward the August, 2002 review deadline of 
FFDCA section 408(q), as amended by FQPA in 1996.

III. Are There Any International Trade Issues Raised by this Final 
Action?

    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. When possible, EPA seeks 
to harmonize U.S. tolerances with Codex MRLs. EPA may establish a 
tolerance that is different from a Codex MRL; however, FFDCA section 
408(b)(4) requires that EPA explain in a Federal Register document the 
reasons for departing from the Codex level. EPA's effort to harmonize 
with Codex MRLs is summarized in the tolerance reassessment section of 
individual REDs. EPA has developed guidance concerning submissions for 
import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). This 
guidance will be made available to interested persons. Electronic 
copies are available on the internet at http://www.epa.gov/. On the 
Home Page select ``Laws and Regulations,'' then select ``Regulations 
and Proposed Rules'' and

[[Page 35914]]

then look up the entry for this document under ``Federal Register--
Environmental Documents.'' You can also go directly to the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr/.

IV. Objections and Hearing Requests

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-2002-0035 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 July 22, 
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. Objection/hearing 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 IV.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-2002-0035, 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).

V. Regulatory Assessment Requirements

    This final rule will revoke tolerances established under FFDCA 
section 408. The Office of Management and Budget (OMB) has exempted 
this type of action (i.e., a tolerance revocation for which 
extraordinary circumstances do not exist) from review under Executive 
Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 
October 4, 1993). Because this final rule has been exempted from review 
under Executive Order 12866 due to its lack of significance, this final 
rule is not subject to 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 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 OMB review or any other 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). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.), the Agency previously assessed whether revocations of 
tolerances might significantly impact a substantial number of small 
entities and concluded that, as a general matter, these actions do not 
impose a significant economic impact on a substantial number of small 
entities. This analysis was published on December 17, 1997 (62 FR 
66020), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration. Taking into account this analysis, and 
available information concerning the pesticide listed in this rule, I 
certify that this action will not have a significant

[[Page 35915]]

economic impact on a substantial number of small entities. 
Specifically, as per the 1997 notice, EPA has reviewed its available 
data on imports and foreign pesticide usage and concludes that there is 
a reasonable international supply of food not treated with nicotine-
containing compounds used as insecticides or the insecticide nicotine. 
Furthermore, the Agency knows of no extraordinary circumstances that 
exist as to the present revocations that would change EPA's previous 
analysis.
    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.

VI. 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: May 2, 2002.
Joseph J. Merenda,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 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. Section 180.167 is revised to read as follows:


 180.167  Nicotine-containing compounds; tolerances for 
residues.

    (a) General. Tolerances are established for residues of nicotine- 
containing compounds used as insecticides in or on the following raw 
agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cucumber.............................................                2.0
Lettuce..............................................                2.0
Tomato...............................................                2.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]


 180.167a  [Removed]

    3. Section 180.167a is removed.
[FR Doc. 02-12423 Filed 5-21-02; 8:45 am]
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