[Federal Register Volume 67, Number 11 (Wednesday, January 16, 2002)]
[Proposed Rules]
[Pages 2175-2179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-628]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301192; FRL-6810-3]
RIN 2070-AB78


Nicotine; Proposed Revocation of Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: This document proposes to revoke specific tolerances 
forresidues of nicotine-containing compounds used as insecticides and 
for the insecticide nicotine because nicotine is no longer registered 
for those uses in the United States. The regulatory actions proposed 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 proposed revocation of 66 nicotine tolerances which would be 
counted among tolerance/exemption reassessments made toward the August, 
2002 review deadline.

DATES: Comments, identified by docket control numberOPP-301192, must be 
received on or before March 18, 2002.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper 
receipt by EPA, it is imperative that you identify docket control 
number OPP-301192 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            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.

[[Page 2176]]

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_180/Title_40/40cfr180_00.h tml, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301192. 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-301192 in the subject line on 
the first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described in this unit. Do not submit any information electronically 
that you consider to be CBI. Electronic comments must be submitted as 
an ASCII file avoiding use of special characters and any form of 
encryption. Comments and data will also be accepted on standard disks 
in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic 
form must be identified by docket control number OPP-301192. Electronic 
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI that I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the proposed rule or 
collection activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

F. What Can I do if I Wish the Agency to Maintain a Tolerance that the 
Agency Proposes to Revoke?

    This proposed rule provides a comment period of 60 days for any 
person to state an interest in retaining a tolerance proposed for 
revocation. If EPA receives a comment within the 60-day period to that 
effect, EPA will not proceed to revoke the tolerance immediately. 
However, EPA will take steps to ensure the submission of any needed 
supporting data and will issue an order in the Federal Register under 
FFDCA section 408(f) if needed. The order would specify data needed and 
the time frames for its submission, and would require that within 90 
days some person or persons notify EPA that they will submit the data. 
If the data are not submitted as required in the order, EPA will take 
appropriate action under FFDCA.
    EPA issues a final rule after considering comments that are 
submitted in response to this proposed rule. In addition to submitting 
comments in response to this proposal, you may also submit an objection 
at the time of the final rule. If you fail to file an objection to the 
final rule within the time period specified, you will have waived the 
right to raise any issues resolved in the final rule. After the 
specified time, issues resolved in the final rule cannot be raised 
again in any subsequent proceedings.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing to revoke specific tolerances for residues of 
nicotine-containing compounds used as insecticides and for the 
insecticide nicotine in or on commodities listed in the regulatory text 
because nicotine is no longer registered under FIFRA for

[[Page 2177]]

use on those commodities. It is EPA's general practice to propose 
revocation of those tolerances for residues of pesticide active 
ingredients on crop uses for which there are no active registrations 
under FIFRA, unless any person in comments on the proposal indicates a 
need for the tolerance to cover residues in or on imported commodities 
or domestic commodities legally treated.
    Many food uses were removed from nicotine labels in 1992 and in 
1994. On April 29, 1992 a FIFRA 6(f)(1) notice of receipt of a request 
to voluntarily cancel certain nicotine registrations was published in 
the Federal Register (57 FR 18146) (FRL-4056-6), with a use deletion 
date of July 28, 1992. On October 20, 1993 another 6(f)(1) notice of a 
receipt of request to voluntarily cancel certain nicotine registrations 
was published in the Federal Register (58 FR 54148) (FRL-4647-1), with 
a cancellation date of January 28, 1994. No residue data exist to 
support the tolerances being proposed for revocation. With the 
exception of cucumber, lettuce, and tomato, there are no other active 
food use registrations existing for nicotine-containing compounds or 
nicotine. Therefore, EPA is proposing to revoke a total of 66 
tolerances, of which 62 tolerances are found in 40 CFR 180.167 and 4 
tolerances are found in Sec. 180.167a.
    Specifically, in 40 CFR 180.167 EPA is proposing to revoke 
tolerances for the following: 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. In 40 CFR 
180.167a EPA is proposing to revoke tolerances for eggs; poultry, fat; 
poultry, meat; and poultry, meat byproducts by removing Sec. 180.167a 
in its entirety. For counting purposes, the tolerances depicted above 
as with or without tops are each counted as two tolerances.
    In order to conform to current Agency practice, EPA is also 
proposing to revise the remaining tolerance commodity names in 40 CFR 
180.167 for cucumbers to cucumber and tomatoes to tomato.

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

    A tolerance represents the maximum level for residues of pesticide 
chemicals legally allowed in or on raw agricultural commodities and 
processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as 
amended by the FQPA of 1996, Public Law 104-170, authorizes the 
establishment of tolerances, exemptions from tolerance requirements, 
modifications in tolerances, and revocation of tolerances for residues 
of pesticide chemicals in or on raw agricultural commodities and 
processed foods (21 U.S.C. 346(a)). Without a tolerance or exemption, 
food containing pesticide residues is considered to be unsafe and 
therefore adulterated under section 402(a) of the FFDCA. If food 
containing pesticide residues is considered to be adulterated, you may 
not distribute the product in interstate commerce (21 U.S.C. 331(a) and 
342(a)). For a fooduse pesticide to be sold and distributed, the 
pesticide must not only have appropriate tolerances under the FFDCA, 
but also must be registered under FIFRA (7 U.S.C. et seq.). Fooduse 
pesticides not registered in the United States have tolerances for 
residues of pesticides in or on commodities imported into the United 
States.
    It is EPA's general practice to propose revocation of tolerances 
for residues of pesticide active ingredients on crops for which FIFRA 
registrations no longer exist and on which the pesticide may therefore 
no longer be used in the United States. 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.
    Furthermore, as a general matter, the Agency believes that 
retention of import tolerances not needed to cover any imported food 
may result in unnecessary restriction on trade of pesticides and foods. 
Under section 408 of the FFDCA, a tolerance may only be established or 
maintained if EPA determines that the tolerance is safe based on a 
number of factors, including an assessment of the aggregate exposure to 
the pesticide and of the cumulative effects of such pesticide and other 
substances that have a common mechanism of toxicity. In doing so, EPA 
must consider potential contributions to such exposure from all 
tolerances. If the cumulative risk is such that the tolerances in 
aggregate are not safe, then every one of these tolerances is 
potentially vulnerable to revocation. Furthermore, if unneeded 
tolerances are included in the aggregate and cumulative risk 
assessments, the estimated exposure to the pesticide would be inflated. 
Consequently, it may be more difficult for others to obtain needed 
tolerances or to register needed new uses. To avoid potential trade 
restrictions, the Agency is proposing to revoke tolerances for residues 
on crops uses for which FIFRA registrations no longer exist, unless 
someone expresses a need for such tolerances and commits to the data 
needed to support them. Through this proposed rule, the Agency is 
inviting individuals who need these import tolerances to identify 
themselves and the tolerances that are needed to cover imported 
commodities.
    Parties interested in retention of the tolerances should be aware 
that additional data may be needed to support retention. These parties 
should be aware that, under FFDCA section 408(f), if the Agency 
determines that additional information is reasonably required to 
support the continuation of a tolerance, EPA may require that parties 
interested in maintaining the tolerances provide the necessary 
information. If the requisite information is not submitted, EPA may 
issue an order revoking the tolerance at issue.

C. When do These Actions Become Effective?

    For this rule, the proposed actions will affect uses which have 
been canceled for many years. EPA is proposing that these actions 
become effective 90 days following publication of a final rule in the 
Federal Register. EPA is proposing to delay the effectiveness of these 
revocations for 90 days following publication of a final rule to ensure 
that all affected parties receive notice of EPA's actions. EPA believes 
that existing stocks of pesticide products labeled for the uses 
associated with the tolerances proposed for revocation have been 
exhausted. However, if EPA is presented with information that existing 
stocks would still be available and that information is verified, EPA 
will consider extending the expiration date of the tolerance. If

[[Page 2178]]

you have comments regarding existing stocks and whether the effective 
date accounts for these stocks, please submit comments as described 
under SUPPLEMENTARY INFORMATION.
    Any commodities listed in this proposal treated with the pesticides 
subject to this proposal, and in the channels of trade following the 
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as 
established by FQPA. Under this section, any residues of these 
pesticides 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 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 
January 3, 2002, EPA has reassessed over 3,830 tolerances. This 
document proposes to revoke a total of 66 tolerances of which 62 are in 
40 CFR 180.167 and 4 are in 40 CFR 180.167a. Therefore, 66 tolerance 
reassessments would be counted when the final rule is published toward 
the August, 2002 review deadline of FFDCA section 408(q), as amended by 
FQPA in 1996.

III. Are the Proposed Actions Consistent with International 
Obligations?

    The tolerance revocations in this proposal are not discriminatory 
and are designed to ensure that both domesticallyproduced and imported 
foods meet the food safety standards established by the FFDCA. The same 
food safety standards apply to domestically produced and imported 
foods.
    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. It is EPA's policy to 
harmonize U.S. tolerances with Codex MRLs to the extent possible, 
provided that the MRLs achieve the level of protection required under 
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the 
tolerance reassessment section of individual Reregistration Eligibility 
Decision documents. 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 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. Regulatory Assessment Requirements

    In this proposed rule, EPA is proposing to revoke specific 
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 
proposed rule has been exempted from review under Executive Order 12866 
due to its lack of significance, this proposed 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 proposed 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 pesticides listed in this rule, I 
certify that this action will not have a significant 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 canceled pesticides. Furthermore, for 
the pesticides named in this proposed rule, the Agency knows of no 
extraordinary circumstances that exist as to the present proposed 
revocations that would change EPA's previous analysis. Any comments 
about the Agency's determination should be submitted to EPA along with 
comments on the proposal, and will be addressed prior to issuing a 
final rule.
    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 proposed rule directly regulates growers, food

[[Page 2179]]

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.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities,Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: December 20, 2001.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR part 180 be 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 amended by removing entries from the existing 
paragraph and designating the existing paragraph as paragraph (a), and 
by adding and reserving paragraphs (b), (c), and (d), to read as 
follows:


Sec. 180.167  Nicotine-containing compounds; tolerances for residues.

    (a) General. Tolerances are established for residues ofnicotine-
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]


Sec. 180.167a  [Removed]

    3. Section 180.167a is removed.

[FR Doc. 02-628 Filed 1-15-02; 8:45 am]
BILLING CODE 6560-50-S