Availability of Reregistration Eligibility Decision Document for Comment; Receipt of Requests for Voluntary Cancellation, Cancellation Order
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: December 22, 1999 (Volume 64, Number 245)]
[Notices]
[Page 71754-71757]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22de99-84]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-34146B; FRL-6391-2]
Availability of Reregistration Eligibility Decision Document for
Comment; Receipt of Requests for Voluntary Cancellation, Cancellation
Order
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This notice announces availability and starts a 60-day public
comment period on the Reregistration Eligibility Decision (RED)
document for the pesticide active ingredient Sulfotepp. The RED
represents EPA's formal regulatory assessment of the health and
environmental data base of the subject chemical, and presents the
Agency's determination regarding which pesticidal uses are eligible for
reregistration.
The companies that hold the pesticide registrations of pesticide
products containing sulfotepp (0,0,0,0-tetraethyl dithiopyrophosphate)
have asked EPA to cancel their registrations for these products.
Pursuant to section 6(f)(1) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is announcing the Agency's receipt of
these voluntary cancellation requests from the registrants. EPA intends
to grant the requests for voluntary cancellation and intends to issue a
cancellation order at the close of the comment period for this
announcement. EPA is proposing that the voluntary cancellations shall
be effective on September 30, 2002, unless EPA determines before
September 30, 2002, that worker and bystander risks do not exceed the
Agency's level of concern. After September 30, 2002, any distribution,
sale, or use of canceled sulfotepp products will only be permitted if
such distribution, sale, or use is consistent with the terms of the
cancellation order that the Agency intends to issue.
DATES: Comments, identified by docket control number OPP-34146B, must
be received on or before February 22, 2000.
ADDRESSES: Comments may be submitted by mail, electronically, or in
person. Please follow the detailed instructions for each method as
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure
proper receipt by EPA, it is imperative that you identify docket
control number OPP-34146B in the subject line on the first page of your
response.
FOR FURTHER INFORMATION CONTACT: By mail: Robbi Farrell, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460;
telephone number:703-308-8065; and e-mail address:
farrell.roberta@epa.gov.
SUPPLEMENTARY INFORMATION:
This announcement consists of four parts. The first part contains
general information. The second part contains the announcement of the
availability of the RED. The third part addresses the registrants'
requests for voluntary cancellation of their registrations of pesticide
products containing sulfotepp. The fourth part proposes a cancellation
order, which includes requirements relating to the distribution, sale,
and use of existing stocks of canceled sulfotepp products.
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. This action may,
however, be of particular interest to those persons who are or may be
required to conduct testing of chemical substances under the Federal
Food, Drug and Cosmetic Act (FFDCA), or the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and those persons who use these
chemicals in agricultural production. You may be potentially affected
by this action if you manufacture, sell, distribute, or use sulfotepp
products. Potentially affected categories and entities may include, but
are not limited to commercial greenhouses and certified pesticide
applicators. Since other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the people
[[Page 71755]]
listed under ``FOR FURTHER INFORMATION CONTACT.''
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/.
To access the RED documents and RED fact sheets electronically, go
to the REDs table on the EPA Office of Pesticide Programs' home page,
http://www.epa.gov/REDs. For related information, see http://
www.epa.gov/pesticides.
2. In person. The Agency has established an official record for
this action under docket control number OPP-34146B. 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-34146B 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, 401 M St., SW., 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 Highway, 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: ``opp-docket@epa.gov,'' or you can submit a computer disk as
described above. Do not submit any information electronically that you
consider to be CBI. Avoid the use of special characters and any form of
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be
identified by docket control number OPP-34146B. 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 identified 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 notice 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 is the Agency's Authority for Taking these Actions?
The legal authority for these reregistration eligibility decisions
falls under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended in 1988, which directs that ``the Administrator
shall determine whether pesticides containing such active ingredient
are eligible for reregistration'' before calling in data on products
and either reregistering products or taking ``other appropriate
regulatory action.''
II. Notice of Availability of the Reregistration Eligibility
Decision
The Agency has issued a Reregistration Eligibility Decision (RED)
document for the pesticide active ingredient sulfotepp. Under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended
in 1988, EPA is conducting an accelerated reregistration program to
reevaluate existing pesticides initially registered before November
1984, to make sure they meet current scientific and regulatory
standards. The data base to support the reregistration of the chemical
listed in this document is incomplete. Due to the high risks estimated
with available information and their inability to fulfill the data
requirements needed to refine the risk assessment, the registrants
requested a voluntary cancellation of their registrations. The Agency
intends to grant the requests for voluntary cancellation. In addition,
the Agency intends to order that the registrations be canceled
effective September 30, 2002, and that any distribution, sale, or use
of canceled sulfotepp products will not be lawful after September 30,
2004. By December 1999, all sulfotepp products will bear amended labels
designed to improve worker and bystander
[[Page 71756]]
protection. This RED document describes risks of concern to the Agency,
outlines the label amendments required for all registered products, and
sets forth the timeline for cancellation and phase-out of sulfotepp and
sulfotepp products.
The reregistration program is being conducted under
Congressionally-mandated time frames, and EPA recognizes both the need
to make timely reregistration decisions and to involve the public.
Therefore, EPA is issuing this RED as a final document with a 60-day
comment period. The 60-day public comment period is intended to provide
an opportunity for public input and a mechanism for initiating any
necessary amendments to the RED. All comments will be carefully
considered by the Agency. If any comment significantly affects a RED,
EPA will amend the RED by publishing the amendment in the Federal
Register.
III. Receipt of Requests for Voluntary Cancellation
In a memorandum of agreement (``Agreement'') effective September
30, 1999, EPA and all registrants of products containing sulfotepp
agreed to take several steps to reduce the risks associated with the
use of sulfotepp. Based on the limited data available, EPA estimated
that risks of dermal and inhalation exposure to workers and bystanders
were very high. Practical, effective options for mitigation were
limited, and the registrants were unable to provide the data needed to
refine the risk assessment. EPA reached this agreement with the
registrants to reduce those risks. As part of the Agreement, the
registrants, among other things, agreed to amend the labels of their
end-use products to reduce applicator risk and to cap production of
sulfotepp. The registrants also requested to voluntarily cancel their
sulfotepp registrations. As a result, EPA agreed not to initiate any
suspension or cancellation proceedings under sections 3 or 6 of FIFRA
to achieve the risk reduction measures set forth in the Agreement.
Prior to the effective date of the Agreement, each registrant
submitted to EPA, pursuant to section 6(f) of FIFRA, a request for
voluntary cancellation of all existing registrations held by the
registrant of pesticide products containing sulfotepp. The
registrations for which cancellations have been requested are
identified in the table below. In the Agreement, the registrants
conditioned their requests for voluntary cancellation on the following:
(1) The cancellations shall be effective on September 30, 2002; (2) the
cancellations shall not become effective if EPA determines prior to
September 30, 2002, that worker and bystander risks do not exceed the
Agency's level of concern based on the submission of new data deemed
acceptable by the Agency; and (3) any resulting cancellation order will
include the terms set forth in the Agreement.
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Company Reg. No Product SLNs
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Fuller System Inc............. 1327-38 Fulex Dithio N/A
Smoke Fumigant
............................ 1327-39 Sulfotepp N/A
Technical
Plant Products Corporation.... 8241-10 Plantfume 103 CA89005900
............................ 8241-11 Sulfotepp N/A
Technical
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Section 6(f)(1)(C) of FIFRA requires that EPA provide a 180-day
comment period on a request for voluntary termination of any minor
agricultural use before granting the request, unless (1) the
registrants request a waiver of the comment period, or (2) the
Administrator determines that continued use of the pesticide would pose
an unreasonable adverse effect on the environment. As part of the
Agreement, the registrants requested that the Administrator waive any
applicable public comment period under section 6(f) before taking
action on their requests to cancel the registrations of the products
identified in the table above. In light of this request, EPA is
granting the request to waive the 180-day comment period but is
nonetheless providing a 60-day public comment period before taking
action on the requested cancellations. This 60-day comment period will
coincide with that provided for comments on the RED document as
discussed in Unit II of this Notice. EPA intends to grant the requested
cancellations at the close of the comment period for this announcement.
The requested cancellations shall be effective on September 30, 2002,
unless EPA determines before that date that worker and bystander risks
do not exceed the Agency's level of concern.
IV. Proposed Cancellation Order
The registrants have requested voluntary cancellation of the
registrations of the sulfotepp products identified in the table above.
Pursuant to section 6(f) of FIFRA, EPA intends to grant the requests
for voluntary cancellation and intends to order that the registrations
of the pesticide products identified in the table be canceled on
September 30, 2002. This announcement proposes the provisions for that
cancellation order, including requirements for existing stocks. For
purposes of the cancellation order that the Agency intends to issue at
the close of the comment period for this announcement, the term
``existing stocks'' will be defined, pursuant to EPA's existing stocks
policy (56 FR 29362, Wednesday, June 26, 1991), as those stocks of a
registered pesticide product which are currently in the United States
and which have been packaged, labeled, and released for shipment prior
to the effective date of the cancellation. Any distribution, sale, or
use of existing stocks of the canceled sulfotepp products after
September 30, 2002, that is not consistent with the terms of the
cancellation order that the Agency intends to issue will be considered
a violation of section 12(a)(2)(K) of FIFRA and/or section 12(a)(1)(A)
of FIFRA.
A. Existing Stocks Provisions
1. Distribution or sale by registrants. The distribution or sale of
existing stocks by registrants will not be lawful under FIFRA after
September 30, 2004, except for the purpose of shipping such stocks for
export consistent with the requirements of section 17 of FIFRA or for
proper disposal.
2. Distribution or sale by other persons. The distribution or sale
of existing stocks by persons other than registrants will not be lawful
under FIFRA after September 30, 2004, except for the purpose of
shipping such stocks for export consistent with the requirements of
section 17 of FIFRA or for proper disposal.
3. Use of existing stocks. The use of existing stocks will not be
lawful under FIFRA after September 30, 2004. Any
[[Page 71757]]
use of existing stocks of canceled product prior to October 1, 2004,
must be in accordance with either the directions for use contained in
the Agreement or the existing labeling of that product.
List of Subjects
Environmental protection, pesticides and pests, Memorandum of
agreement.
Dated: December 15, 1999.
Lois Rossi,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. 99-33160 Filed 12-21-99; 8:45 am]
BILLING CODE 6560-50-F
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