PMEP Home Page --> Pesticide Active Ingredient Information --> Insecticides and Miticides --> mevinphos (Phosdrin) to propargite (Omite) --> propargite (Omite, Comite) --> propargite (Omite, Comite) Notice of Receipt of Request to Delete Uses 7/96

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 
2, 1996.

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: opp-docket@epamail.epa.gov. 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 
document.

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: 
morris.jeff@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

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 
negligible.

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 
Public Comment

    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
 supported.

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 
purchaser.
    (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 
confidential.
    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-
docket@epamail.epa.gov. 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 
pests.

    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