propargite (Omite, Comite) Notice of Receipt of Request to Delete Uses 7/96
ENVIRONMENTAL PROTECTION AGENCY
[OPP-64029; FRL 5367-4]
Propargite; Voluntary Deletion of Ten uses in Response to EPA's
Concerns of Risk from Dietary Exposure to the U.S. Population
AGENCY: Environmental Protection Agency (EPA).
Action: Notice of Receipt of Request to Delete Uses.
SUMMARY: This notice, issued pursuant to section 6(f)(1) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136d(f)(1), announces EPA's receipt of a request from Uniroyal Chemical
Company to delete 10 uses from its propargite labels. EPA invites
public comment on the proposed use deletions.
DATES: Public comment on the use deletions will be accepted until July
ADDRESSES: By mail, submit comments to Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, 401 M St., SW., Washington, DC 20460. In person,
deliver comments to Room 1132, Crystal Mall #2, 1921 Jefferson Davis
Highway, Arlington, VA.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: firstname.lastname@example.org. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by docket
number [OPP-64029]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic comments on this notice may be
filed online at many Federal Depository libraries. Additional
information on electronic submissions can be found below in this
FOR FURTHER INFORMATION CONTACT: By mail: Jeff Morris, Special Review
Branch, Special Review and Reregistration Division (7508W), U.S.
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Special Review Branch, 3rd floor,
2800 Crystal Drive, Arlington, VA, (703) 308-8029; e-mail:
I. Background Information
EPA determined that long-term exposure to propargite (trade names
Omite, Ornamite, and Comite), a pesticide registered in 1969 for the
control of mites on a number of agricultural commodities and ornamental
plants, posed an unacceptable dietary cancer risk to persons who
consumed propargite-treated foods. EPA classifies propargite as a
B<INF>2 (probable) human carcinogen. EPA's risk assessment estimates
overall dietary risk to the U.S. general public from exposure to all
propargite uses (including the 10 uses that Uniroyal has now deleted
from its labels) at 1.6 x 10<SUP>-5 This was based on an intensive
dietary assessment that includes exposure estimates based on actual
residues found in foods. The commodities with the largest contributions
to the overall risk are apples at 9.2 x 10<SUP>-6, and peaches at 2.5 x
10<SUP>-6. Accordingly, based on the foregoing information as well as
information on the benefits of propargite use, EPA determined that
continued use of propargite products would cause unreasonable adverse
effects. However, based on a voluntary agreement reached with Uniroyal,
which includes the deletion of the apple and peach uses, EPA believes
the overall dietary risk has been reduced to a level that EPA considers
II. Uniroyal Request to Amend Registrations
EPA discussed its risk findings with Uniroyal Chemical Company, the
sole propargite registrant, and Uniroyal responded by agreeing in an
April 5, 1996 letter to EPA to amend propargite product labels with EPA
registration numbers 400-82, 400-83, 400-89, 400-104, 400-154, 400-426,
and 400-427 to delete the following uses: apples, apricots,
cranberries, figs, green beans, lima beans, peaches, pears, plums
(including plums grown for prune production), and strawberries. These
proposed use deletions are the subject of the Notice. Uniroyal further
requested that its propargite registrations be immediately amended to
incorporate a number of new terms and conditions. These amended terms
and conditions (reproduced in section IV below) were accepted by EPA
and made immediately effective as of April 5, 1996.
III. Deletions Pursuant to Voluntary Requests, and Opportunity for
Under section 6(f)(1) of FIFRA, a registrant may request at any
time that EPA amend a pesticide registration to delete one or more uses
(7 U.S.C. 136d(f)(1)). EPA must publish in the Federal Register a
notice of receipt of the request and allow public comment. In
accordance with FIFRA section 6(f)(1)(C)(ii), Uniroyal has requested
that the 90-day comment period for the proposed deletions be waived.
However, the Administrator has determined that a 60-day comment period
is appropriate for the proposed action. Accordingly, persons wishing to
comment may do so by July 2, 1996. In addition, because propargite is
undergoing reregistration, any comments received in response to this
notice will be considered in EPA's determination of propargite's
eligibility for reregistration.
EPA believes the deletions proposed by Uniroyal in conjunction with
the new terms and conditions described below will, in the short term,
substantially reduce the risk of unreasonable adverse effects from
continued use of products containing propargite. EPA further believes
that for most of the uses proposed for deletion there are adequate
alternative products and pest control practices available as
substitutes for propargite products. For these uses and those for which
alternatives are not available, EPA has determined that potential
economic loses are outweighed by the risks posed by continued use. It
is EPA's intention to uphold Uniroyal's request for deletion of the
specified uses unless during the comment period convincing information
is received that demonstrates that approval of Uniroyal's request is
inappropriate. Based on the large and persuasive record already
assembled regarding the risks and benefits of propargite, the Agency
believes its proposed decision to accept Uniroyal's deletions is well
IV. New Terms and Conditions for Propargite Products
As indicated above, in addition to requesting deletion of certain
propargite uses, Uniroyal by letter dated April 5, 1996, also requested
that all of its propargite registrations be immediately amended by the
addition of the terms and conditions described below. The Agency
approved this request, effective April 5, 1996:
(1) Uniroyal will not sell or distribute any propargite products
labeled for the deleted uses unless and until such uses are restored in
accordance with the provisions set forth below. However, for a period
of 21 days following the April 5, 1996 letter, Uniroyal may sell and
distribute propargite products labeled for the deleted uses if Uniroyal
stickers such products in accordance with paragraph (2) below, at the
purchaser's premises before such products are resold or used by the
(2) Uniroyal will sticker all propargite products in its warehouses
and in possession of distributors and dealers. These stickers will
notify buyers to use new labels that will be provided by Uniroyal and
will accompany the purchased propargite products. Uniroyal will
distribute new labels with the ten uses deleted. Uniroyal will use its
best efforts to have existing stocks in the possession of growers
stickered and will take back product and credit growers who return to
Uniroyal product labeled for the deleted uses.
(3) Uniroyal will not seek restoration of the deleted uses until it
submits a completed prolonged cell proliferation study or other new
scientific data demonstrating a carcinogenic mechanism.
(4) Uniroyal will not seek State Local Needs registrations under
FIFRA section 24(c) or emergency exemptions under FIFRA section 18 for
any of the deleted uses, until EPA issues a final determination on any
application by Uniroyal to restore the deleted uses submitted in
accordance with paragraph (i) below.
(5) Uniroyal will not challenge revocation of tolerances and food
additive regulations for any of the deleted uses.
(6) Uniroyal will not provide encouragement or assistance to
persons or organizations seeking to challenge the voluntary use
deletions requested herein or the associated tolerance or food additive
regulation revocation actions.
(7) Uniroyal will not provide encouragement or assistance to
persons or organizations seeking to restore the deleted uses, or
seeking FIFRA section 24(c) registrations or FIFRA section 18 emergency
exemptions for the deleted uses, until Uniroyal submits an application
to restore the deleted uses in accordance with paragraph (i) below.
(8) In taking these actions to voluntarily delete certain uses and
amend the terms and conditions of its propargite registrations,
Uniroyal does not intend to create any rights for third parties.
(9) Uniroyal requests that the 90-day comment period under FIFRA
section 6(f) be waived. Uniroyal consents to a 30-day comment period
under FIFRA section 6(f). In an April 5, 1996 letter to Uniroyal's
representative, EPA accepted the above amendments to the terms and
conditions of propargite registrations and agreed to the following:
(i) After two years from April 5, 1996, if Uniroyal submits an
application to restore any of the deleted uses, EPA will review the
application and any supporting data within 120 days of submission of
all materials to EPA. Upon completion of its review and during the 120-
day review period, EPA will either grant the application or announce a
preliminary decision to deny the application. If EPA announces a
preliminary decision to deny the application, Uniroyal may request that
EPA submit the scientific questions that are the subject of the denial
to the Scientific Advisory Panel (SAP). EPA will schedule a prompt SAP
review. EPA will consider the report of the SAP in making a final
determination whether to grant Uniroyal's application. EPA will issue a
final determination on the application within 90 days after receiving
the SAP report.
(ii) EPA intends to commence proceedings to revoke tolerances for
the deleted uses. If EPA commences proceedings to revoke tolerances for
the deleted uses, it will propose effective dates for the revocations
that provide the time needed for appropriate and orderly movement of
crops already legally treated with propargite through the channels of
commerce. Force Majeure: It is understood that if circumstances beyond
EPA's control (such as an Act of God, war, or the like) interfere with
EPA's ability to meet one or more of the deadlines set forth in
paragraphs (i) or (ii) above, EPA will use its best efforts to complete
such undertaking as expeditiously as possible.
V. Public Comment Procedures
EPA invites interested persons to submit written comments,
information, or data in response to this notice. In addition, EPA
desires comment on related actions concerning tolerances for the
proposed deleted uses. It is EPA's intention to propose revocation of
the tolerances associated with these uses. It has generally been the
practice of EPA in similar instances to establish an effective date for
each revocation that takes into consideration the time needed for
legally treated food to pass through the channels of commerce. It is
useful for the Agency to have accurate information regarding the length
of time required for each affected commodity to move through commerce.
Thus, EPA requests public comments on this matter. This issue will also
be available for comment as part of any propargite revocation actions
proposed by EPA. Comments must be submitted by July 2, 1996. Comments
must bear a notation indicating the document control number. Three
copies of the comments should be submitted to either location listed
under ``ADDRESSES'' at the beginning of this notice.
Information submitted as a comment concerning this notice may be
claimed confidential by marking any or all that information as
Confidential Business Information (CBI). EPA will not disclose
information so marked, except in accordance with procedures set forth
in 40 CFR part 2. A second copy of such comments, with the CBI deleted,
also must be submitted for inclusion in the public record. EPA may
publicly disclose without prior notice information not marked
A record has been established for this notice under docket number
[OPP-64029] (including comments and data submitted electronically as
described below). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 1132 of the Public Response and Program
Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, Crystal Mall #2,
1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at: opp-
email@example.com. Electronic comments must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption. The official record for this notice, as
well as the public version, as described above will be kept in paper
form. Accordingly, EPA will transfer all comments received
electronically into printed, paper form as they are received and will
place the paper copies in the official record, which will also include
all comments submitted directly in writing. The official rulemaking
record is the paper record maintained at the address in ``ADDRESSES''
at the beginning of this notice.
VI. Existing Stocks
For the purposes of this notice, existing stocks are defined as
those stocks of the propargite products with the EPA registration
numbers 400-82, 400-83, 400-89, 400-104, 400-154, 400-426, and 400-427
that are labeled with any of the ten uses subject to deletion by this
notice and were packaged, labeled, and/or released for shipment prior
to April 26, 1996.
EPA has an established policy for determinations concerning the
sale, distribution, and use of existing stocks of pesticides where the
registration has been amended, cancelled, or suspended under FIFRA
sections 3, 4, or 6 dated June 26, 1991, (56 FR 29362). That policy
states that in cases where EPA has identified a significant risk
concern and the registration has been amended, EPA will make existing
stocks determinations on a case-by-case basis. In most cases EPA will
not permit the continued sale, distribution, or use of a product
labeled with deleted uses unless it can be demonstrated that the
benefits exceed the risks. EPA reserves the right to amend this
existing stocks provision, should conditions warrant such amendment.
EPA has determined that the limited continued sale and use of
existing stocks of propargite products labeled for the deleted uses
permitted under paragraphs (1) and (2) of the terms and conditions
contained in section IV of this notice, will not cause unreasonable
adverse effects. Under these provisions, Uniroyal will not sell or
distribute any propargite products containing the deleted uses. In
addition, Uniroyal will relabel stocks at the distributor and retailer
levels to reflect the deletion of the ten uses. Uniroyal will also
accept return of products from users. Accordingly, EPA believes very
little product labeled for use on the proposed deleted crops will be
used during the 1996 growing season.
VII. Proposed Use Deletion/Cancellation Order
The following Use Deletion/Cancellation Order and Approval of
Uniroyal's request for deletion of uses will take effect on August 1,
1996 unless before that date EPA publishes a notice in the Federal
Register modifying this proposed order.
EPA approves Uniroyal's request for deletion of the apple, apricot,
cranberry, fig, green bean, lima bean, peach, pear, plum, and
strawberry uses from the propargite products with EPA registration
numbers 400-82, 400-83, 400-89, 400-104, 400-154, 400-426, and 400-427,
effective August 1, 1996 notice. All propargite products containing
instructions for use on apples, apricots, cranberries, figs, green
beans, lima beans, peaches, pears, plums, or strawberries are
cancelled, effective August 1, 1996 notice.
List of Subjects
Environmental protection, Agricultural commodities, Pesticides and
Dated: April 26, 1996.
Daniel M. Barolo,
Director, Office of Pesticide Programs.
[FR Doc. 96-10910 Filed 5-2-96; 8:45 am]
BILLING CODE 6560-50-F