nicotine Proposed Revocation of Tolerances 12/01
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
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
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:
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:
Categories NAICS Potentially
Industry 111 Crop production
112 Animal production
311 Food 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
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.html, a beta site currently
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@example.com, 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
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
7. Make sure to submit your comments by the deadline in this
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
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.
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
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
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
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
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
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
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
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
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
Dated: December 20, 2001.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
1. The authority citation for part 180 continues to read as
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
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
Commodity Parts per million
(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]