vinclozolin (Ronilan) Proposed Pesticide Tolerance Revocations 6/01
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Vinclozolin; Notice of Proposed Pesticide Tolerance Revocations
and Channels of Trade Provision Guidance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: This document proposes to revoke the tolerances for the
fungicide vinclozolin on strawberries, stonefruits, cucumbers, and bell
peppers. Foods legally treated with vinclozolin may continue to be
marketed under the provisions of the FFDCA. 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). By law, EPA is required to
reassess 66% of the tolerances in existence on August 2, 1996, by
August 2002, or about 6,400 tolerances. These tolerances were
established under section 408 of the Federal Food, Drug, and Cosmetic
Act (``FFDCA''), 21 U.S.C. 346a. EPA is proposing to revoke the
strawberry and stonefruit tolerances because the Agency has canceled
the pesticide registrations under Federal Insecticide, Fungicide, and
Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq., associated with
them. In addition, the registrant for vinclozolin, BASF, is no longer
supporting the tolerances on cucumbers and bell peppers, which were
established for importation purposes only.
The Food and Drug Administration (FDA) in a related document
published elsewhere in this issue of the Federal Register is announcing
the availability of a proposed guidance document presenting FDA's
policy on its planned enforcement approach for foods containing
vinclozolin residues. This guidance will assist firms in understanding
the types of showing under 408(1)(5) of the FFDCA (hereinafter referred
to as the ``channels of trade provision'') that FDA may find
satisfactory in accordance with its planned enforcement approach for
such section. EPA and FDA are cooperating on this effort. FDA will be
asking for comment on this proposed guidance and EPA also encourages
you to comment on this guidance.
DATES: Comments, identified by the docket control number must be
received on or before September 10, 2001.
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-301121 in the subject line on the first page of your
FOR FURTHER INFORMATION CONTACT: Deanna Scher, Special Review and
Registration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave.,
NW.,Washington, DC 20460; telephone number: 703-308-7043; and e-mail
I. General Information
A. Does this Action Apply to Me?
You may be affected by this action if you sell, distribute,
manufacture, or use pesticides for agricultural applications, process
food, distribute or sell food, or implement governmental pesticide
regulations. Potentially affected categories and entities may include,
but are not limited to the following:
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
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'', 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
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-301121. 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-301121 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)
3. Electronically. You may submit your comments electronically by
e-mail to: firstname.lastname@example.org, 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-301121. 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?
As discussed in Unit II, below, EPA does not believe that these
tolerances can be maintained under FFDCA. Persons believing otherwise
should submit comments to this proposed rule and any evidence as to why
the tolerances are consistent with the FFDCA safety standard. In
addition, any person may petition EPA to establish new tolerances.
Petitioners should consult EPA regulations at 40 CFR part 180 on the
necessary data and information to support tolerance petitions.
A. What Action is the Agency Taking?
After consultation with FDA, USDA and stakeholders, EPA is
proposing to revoke the tolerances for the fungicide vinclozolin on
strawberries, stonefruits, cucumbers, and bell peppers. EPA intends to
finalize this action after consideration of comments. The tolerance
revocation is proposed to be effective on the date of publication of
the final rule.
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. 346a,
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. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of the FFDCA. (21 U.S.C. 342(a)).
FFDCA section 301 prohibits, among other things, introduction or
delivery for introduction into interstate commerce of any adulterated
food. (21 U.S.C. 331(a)). For a pesticide to be sold and distributed,
the pesticide must be registered under section 3, used in accordance
with an experimental use permit under section 5, or exempted from
section 3 requirements in accordance with section 18 of FIFRA (7 U.S.C.
et seq.). Food-use pesticides not registered in the United States may
have tolerances for residues of such pesticides in or on commodities
imported into the United States, provided that EPA has determined that
the tolerance is safe under section 408.
Monitoring and enforcement of pesticide tolerances and exemptions
are carried out by the U.S. Food and Drug Administration (FDA) and the
U.S. Department of Agriculture (USDA). This includes monitoring for
pesticide residues in or on commodities imported into the United
Under FFDCA section 408(l)(2), if EPA cancels each FIFRA
registration for the use of a pesticide on a food ``due in whole or in
part to dietary risks to humans posed by residues of that pesticide
chemical on food,'' EPA is required to revoke any tolerance or
exemption in connection with the canceled use that allows residues of
the pesticide on food. This provision imposes a mandatory duty on EPA.
Once EPA cancels a FIFRA use due in part to dietary risks, EPA must
revoke the associated tolerances and exemptions. Under section
408(l)(5), foods lawfully treated prior to the last legal use date may
in most cases continue to be marketed.
C. Why is this Action being Proposed?
1. Strawberries and stonefruits. During a 1998 review of the
vinclozolin toxicology data base, it was determined that an additional
tenfold margin of safety, as specified in the Food Quality Protection
Act, was required to protect the safety of infants and children. Based
on EPA's assessment of the acute dietary risk posed by vinclozolin, the
use of the additional tenfold margin of safety rendered aggregate risk
to vinclozolin under existing use patterns unacceptable. BASF
Corporation, the sole registrant for vinclozolin, requested amendment
of its registrations to terminate the use of vinclozolin on
strawberries and stonefruits in June 1998 in response to potential
Agency action to revoke tolerances and cancel registrations due to
unacceptable dietary risk. On July 30, 1998, EPA published a notice in
the Federal Register (63 FR 40710-40712) (FRL-6020-9) announcing the
cancellation of the FIFRA registered uses for the pesticide vinclozolin
on strawberries and stonefruits. That notice informed the public of how
it could comment on the request for cancellation. One comment was
received in response to the proposal, submitted on behalf of the
California Strawberry Commission. This
comment was fully addressed in a subsequent FR Notice (63 FR 59557-
59558) (FRL-6041-7) published on November 4, 1998 which announced the
approval, with one minor change, of the proposed existing stocks
provision for products containing vinclozolin. Under limitations on the
use of existing stocks, the application of the pesticide vinclozolin on
strawberries and stonefruit became unlawful after January 30, 2000.
Although the use cancellations on strawberries and stonefruits were
requested by the vinclozolin registrant, the cancellations closely
followed, and in EPA's view, were precipitated by, EPA's determination
that aggregate exposure to vinclozolin exceeded the safety standard
under the FQPA. Thus, the cancellation action was ``due in whole or
part to dietary risks to humans posed by residues of that pesticide
chemical on food.''
2. Cucumbers and bell peppers. Additional dietary and aggregate
risk concerns were identified last year when vinclozolin was
reevaluated for the purposes of reregistration. Acute dietary risk from
vinclozolin in food was above the Agency's level of concern and
potential exposure from surface and ground water sources exceeded the
Agency's level of concern for cancer dietary risk from vinclozolin-
derived 3,5-DCA (see vinclozolin RED, http://www.epa.gov/REDs/). On May
31, 2000, BASF submitted a risk mitigation proposal designed to address
dietary and aggregate risk concerns identified during the
reregistration process for vinclozolin. BASF requested a phase out of
all domestic food uses of vinclozolin except for use on canola (65 FR
56894, September 20, 2000) (FRL-6744-2). The proposal also involved the
cancellation of all import tolerances except for wine grapes;
specifically, the import tolerances for cucumbers and bell peppers.
Vinclozolin is not registered for use on bell peppers and cucumbers in
the United States. BASF requested that EPA revoke the established
import tolerances for bell peppers and cucumbers not before January 1,
2001. These mitigation measures allowed the Agency to determine that
the use of vinclozolin, with the amendments proposed by the registrant,
would meet the safety standard of the Food Quality Protection Act
D. When do These Actions Become Effective?
Under FFDCA section 408(l)(2), revocations required by that
provision must take place no later than 180 days after the date such
cancellation takes effect or the date on which the use of the canceled
pesticide becomes unlawful under the terms of the cancellation,
whichever is later. EPA approved BASF's label amendments deleting
strawberries and stone fruits in September, 1998; however, use of
vinclozolin on strawberries and stonefruits did not become unlawful
until January 30, 2000, the last date for use of existing stocks.
Since vinclozolin is not registered for use on bell peppers and
cucumbers in the United States, imported cucumbers and bell peppers are
the only foods that will be affected by this proposal. FFDCA 408(l)(2)
does not apply to these commodities because there are no associated
EPA intends to finalize this action as quickly as possible after
consideration of comments. The tolerance revocation is proposed to be
effective on the date of final publication.
E. Will Food Treated Prior to the Last Lawful Date of Application Be
Permitted to Clear the Channels of Trade?
Any commodities listed in the regulatory text of this document that
are treated with vinclozolin, and that are in the channels of trade
following the tolerance revocations, shall be subject to FFDCA section
408(l)(5), as established by the FQPA. Under this section, any residue
of vinclozolin in or on such commodities shall not render the
commodities 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. The channels of
trade provision allows for the orderly marketing of foods that may
currently contain legal residues resulting from lawful applications of
Use of vinclozolin on strawberries and stonefruits became unlawful
under FIFRA on January 30, 2000, the last date on which use of existing
stocks was permitted. Because application of vinclozolin outside the
United States after January 30, 2000 is essentially unregulated by
FIFRA, EPA considers commodities with residues resulting from
application outside the United States after that date to be outside the
scope of the channels of trade provision in section 408(l)(5).
Therefore, residues on both domestic and foreign commodities treated
subsequent to January 30, 2000 would not be 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 thus, would not be covered or subject to the
channels of trade provision.
FDA is announcing, elsewhere in this issue of Federal Register, the
availability of a proposed guidance document on how it plans to
administer FFDCA section 408(l)(5) for both domestic and imported
commodities. FDA will invite comment on this draft guidance before
issuing any final guidance. EPA encourages all interested parties to
commnet on FDA's draft guidance.
Considering the perishable nature of cucumbers and bell peppers,
FDA estimates that they will either be consumed as fresh produce or
will be further processed within three months of the effective date of
the tolerance revocations. FDA's guidance indicates its intent to
exercise enforcement discretion following the effective date of the
revocation of the associated tolerances in order to: (1) Allow fresh
bell peppers and cucumbers which bear residues of vinclozolin and which
were imported prior to the effective date of tolerance revocation, to
reach the ultimate consumer or be sold for further processing and (2)
permit bell peppers and cucumbers bearing residues of vinclozolin which
were processed abroad no later than three months after the tolerance
revocations, to be subsequently imported into the U.S., thus granting
equal treatment to foreign and domestic processors. EPA believes that
allowing bell peppers or cucumbers to remain in domestic commerce
during this three month period, or permitting processed bell peppers or
cucumbers processed abroad during that 3 month period to be imported
into the U.S., will not significantly impact the dietary risk
contribution to the general population or any population subgroup.
Exposure to residues is expected to be very low due to the fact that
the majority of cucumbers and bell peppers consumed in the U.S. are
grown domestically and of the fraction which are imported into the
United States, EPA estimates that 1% or less have been treated with
F. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required to reassess 66% or about 6,400 of the
tolerances in existence on August 2, 1996, by August 2002. EPA is also
required to assess the remaining tolerances by August, 2006. As of
October 15, 2000, EPA has reassessed over 3,550 tolerances. This
document proposes to revoke 4 vinclozolin tolerances; however, the
reassessments were previously counted in 1997 when all vinclozolin
were reassessed in order to make a decision on a new tolerance
petition. Consequently, no further vinclozolin reassessments, including
these 4 revocations, count towards the August, 2002 review deadline of
FFDCA section 408(q).
III. Are The Proposed Actions Consistent with International
The tolerance revocations in this proposal are not discriminatory
and are designed to ensure that both domestically-produced 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. The U.S. 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:/
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). 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 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).
Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether revocations of tolerances
for previously canceled uses 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, 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
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
proposed 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 proposed 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 proposed rule.''
List of Subjects in 40 CFR Part 180
Environmental protection, pesticides and pest.
Dated: June 19, 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), 346a and 371.
2. Section 180.380 is amended by removing from the table in
paragraph (a) the entries for ``cucumbers'', ``peppers (bell)'',
``stonefruits, except plums/fresh prunes'' and ``strawberries'', and by
adding paragraph (e) to read as follows.
Sec. 180.380 Vinclozolin; tolerances for residues.
* * * * *
(e) Revoked tolerances subject to the channel of trade provisions.
The following table lists commodities with residues of vinclozolin
resulting from lawful use are subject to the channels of trade
provisions of section 408(1)(5) of the FFDCA:
Peppers (bell)............................................... 3.0
Stonefruits, except plums/fresh prunes....................... 25.0
[FR Doc. 01-16955 Filed 7-9-01; 8:45 am]