[Federal Register Volume 63, Number 44 (Friday, March 6, 1998)]
[Notices]
[Pages 11237-11240]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-5855]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-60053; FRL-5770-5]
Intent To Suspend Certain Pesticide Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of issuance of notices of intent to suspend.
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SUMMARY: This Notice, pursuant to section 6(f)(2) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq., announces
[[Page 11238]]
that EPA has issued Notices of Intent to Suspend pursuant to sections
3(c)(2)(B) and 4 of FIFRA. The Notices were issued following issuance
of Section 4 Reregistration Requirements Notices by the Agency and the
failure of registrants subject to the Section 4 Reregistration
Requirements Notices to take appropriate steps to secure the data
required to be submitted to the Agency. This Notice includes the text
of a Notice of Intent to Suspend, absent specific chemical, product, or
factual information. Table A of this Notice further identifies the
registrants to whom the Notices of Intent to Suspend were issued, the
date each Notice of Intent to Suspend was issued, the active
ingredient(s) involved, and the EPA registration numbers and names of
the registered product(s) which are affected by the Notices of Intent
to Suspend. Moreover, Table B of this Notice identifies the basis upon
which the Notices of Intent to Suspend were issued. Finally, matters
pertaining to the timing of requests for hearing are specified in the
Notices of Intent to Suspend and are governed by the deadlines
specified in section 3(c)(2)(B). As required by section 6(f)(2), the
Notices of Intent to Suspend were sent by certified mail, return
receipt requested, to each affected registrant at its address of
record.
FOR FURTHER INFORMATION CONTACT: Francisca Liem, Office of Compliance
(2225A), Agriculture and Ecosystem Division, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460, (202) 564-2365.
SUPPLEMENTARY INFORMATION:
I. Text of a Notice of Intent to Suspend
The text of a Notice of Intent to Suspend, absent specific
chemical, product, or factual information, follows:
United States Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
Washington, DC 20460
Certified Mail
Return Receipt Requested
Fairfax Biological Laboratories
P.O. Box 300, Electronic Road
Clinton Corners, NY 12514
SUBJECT: Suspension of Registration of Pesticide Product(s)
Containing Bacillus popillae and Bacillus lentimorbus for Failure to
Comply with the Bacillus popillae and Bacillus lentimorbus Section 4
Phase 5 Reregistration Eligibility Document Data Call-In Notice
Dated September 30, 1992
Dear Sir/Madam:
This letter gives you notice that the pesticide product
registrations listed in Attachment I will be suspended 30 days from
your receipt of this letter unless you take steps within that time to
prevent this Notice from automatically becoming a final and effective
order of suspension. The Agency's authority for suspending the
registrations of your products is sections 3(c)(2)(B) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Upon becoming a
final and effective order of suspension, any violation of the order
will be an unlawful act under section 12(a)(2)(J) of FIFRA.
You are receiving this Notice of Intent to Suspend because you have
failed to comply with the terms of the Phase 5 Reregistration
Eligibility Document Data Call-In Notice imposed pursuant to section
4(g)(2)(b) and section (3)(2)(B) of FIFRA.
The specific basis for issuance of this Notice is stated in the
Explanatory Appendix (Attachment III) to this Notice. The affected
products and the requirements which you failed to satisfy are listed
and described in the following three attachments:
Attachment I Suspension Report - Product List
Attachment II Suspension Report - Requirement List
Attachment III Suspension Report - Explanatory Appendix
The suspension of the registration of each product listed in
Attachment I will become final unless at least one of the following
actions is completed.
1. You may avoid suspension under this Notice if you or another
person adversely affected by this Notice properly request a hearing
within 30 days of your receipt of this Notice. If you request a
hearing, it will be conducted in accordance with the requirements of
section 6(d) of FIFRA and the Agency's procedural regulations in 40 CFR
part 164.
Section 3(c)(2)(B), however, provides that the only allowable
issues which may be addressed at the hearing are whether you have
failed to take the actions which are the bases of this Notice and
whether the Agency's decision regarding the disposition of existing
stocks is consistent with FIFRA. Therefore, no substantive allegation
or legal argument concerning other issues, including but not limited to
the Agency's original decision to require the submission of data or
other information, the need for or utility of any of the required data
or other information or deadlines imposed, and the risks and benefits
associated with continued registration of the affected product, may be
considered in the proceeding. The Administrative Law Judge shall by
order dismiss any objections which have no bearing on the allowable
issues which may be considered in the proceeding.
Section 3(c)(2)(B)(iv) of FIFRA provides that any hearing must be
held and a determination issued within 75 days after receipt of a
hearing request. This 75-day period may not be extended unless all
parties in the proceeding stipulate to such an extension. If a hearing
is properly requested, the Agency will issue a final order at the
conclusion of the hearing governing the suspension of your products.
A request for a hearing pursuant to this Notice must (1) include
specific objections which pertain to the allowable issues which may be
heard at the hearing, (2) identify the registrations for which a
hearing is requested, and (3) set forth all necessary supporting facts
pertaining to any of the objections which you have identified in your
request for a hearing. If a hearing is requested by any person other
than the registrant, that person must also state specifically why he
asserts that he would be adversely affected by the suspension action
described in this Notice. Three copies of the request must be submitted
to: Hearing Clerk, 1900, U.S. Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460, and an additional copy should be sent
to the signatory listed below. The request must be received by the
Hearing Clerk by the 30th day from your receipt of this Notice in order
to be legally effective. The 30-day time limit is established by FIFRA
and cannot be extended for any reason. Failure to meet the 30-day time
limit will result in automatic suspension of your registration(s) by
operation of law and, under such circumstances, the suspension of the
registration for your affected product(s) will be final and effective
at the close of business 30 days after your receipt of this Notice and
will not be subject to further administrative review.
The Agency's Rules of Practice at 40 CFR 164.7 forbid anyone who
may take part in deciding this case, at any stage of the proceeding,
from discussing the merits of the proceeding ex parte with any party or
with any person who has been connected with the preparation or
presentation of the proceeding as an advocate or in any investigative
or expert capacity, or with any of their representatives. Accordingly,
the following EPA offices, and the staffs thereof, are designated as
judicial staff to perform the judicial function of EPA in any
administrative hearings on this Notice of Intent to Suspend: The Office
[[Page 11239]]
of the Administrative Law Judges, the Office of the Judicial Officer,
the Administrator, the Deputy Administrator, and the members of the
staff in the immediate offices of the Administrator and Deputy
Administrator. None of the persons designated as the judicial staff
shall have any ex parte communication with trial staff or any other
interested person not employed by EPA on the merits of any of the
issues involved in this proceeding, without fully complying with the
applicable regulations.
2. You may also avoid suspension if, within 30 days of your receipt
of this Notice, the Agency determines that you have taken appropriate
steps to comply with the Section 4 Phase 5 Reregistration Eligibility
Document Data Call-In Notice requirements. In order to avoid suspension
under this option, you must satisfactorily comply with Attachment II,
Requirement List, for each product by submitting all required
supporting data/information described in Attachment II and in the
Explanatory Appendix (Attachment III) to the following address
(preferably by certified mail):
Office of Compliance (2225A), Agriculture and Ecosystems Division, U.S.
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
For you to avoid automatic suspension under this Notice, the Agency
must also determine within the applicable 30-day period that you have
satisfied the requirements that are the bases of this Notice and so
notify you in writing. You should submit the necessary data/information
as quickly as possible for there to be any chance the Agency will be
able to make the necessary determination in time to avoid suspension of
your product(s).
The suspension of the registration(s) of your company's product(s)
pursuant to this Notice will be rescinded when the Agency determines
you have complied fully with the requirements which were the bases of
this Notice. Such compliance may only be achieved by submission of the
data/information described in the attachments to the signatory below.
Your product will remain suspended, however, until the Agency
determines you are in compliance with the requirements which are the
bases of this Notice and so informs you in writing.
After the suspension becomes final and effective, the registrant
subject to this Notice, including all supplemental registrants of
product(s) listed in Attachment I, may not legally distribute, sell,
use, offer for sale, hold for sale, ship, deliver for shipment, or
receive and (having so received) deliver or offer to deliver, to any
person, the product(s) listed in Attachment I.
Persons other than the registrant subject to this Notice, as
defined in the preceding sentence, may continue to distribute, sell,
use, offer for sale, hold for sale, ship, deliver for shipment, or
receive and (having so received) deliver or offer to deliver, to any
person, the product(s) listed in Attachment I.
Nothing in this Notice authorizes any person to distribute, sell,
use, offer for sale, hold for sale, ship, deliver for shipment, or
receive and (having so received) deliver or offer to deliver, to any
person, the product(s) listed in Attachment I in any manner which would
have been unlawful prior to the suspension.
If the registrations of your products listed in Attachment I are
currently suspended as a result of failure to comply with another
Section 4 Data Requirements Notice or Section 3(c)(2)(B) Data Call-In
Notice, this Notice, when it becomes a final and effective order of
suspension, will be in addition to any existing suspension, i.e., all
requirements which are the bases of the suspension must be satisfied
before the registration will be reinstated.
You are reminded that it is your responsibility as the basic
registrant to notify all supplementary registered distributors of your
basic registered product that this suspension action also applies to
their supplementary registered products and that you may be held liable
for violations committed by your distributors. If you have any
questions about the requirements and procedures set forth in this
suspension notice or in the subject section 4 Data Requirements Notice,
please contact Francisca Liem at (202) 564-2365.
Sincerely yours,
Director, Agriculture and Ecosystems Division, Office of Compliance
Attachments:
Attachment I - Product List
Attachment II - Requirement List
Attachment III - Explanatory Appendix
II. Registrants Receiving and Affected by Notices of Intent to
Suspend; Date of Issuance; Active Ingredient and Products Affected
The following is a list of products for which a letter of
notification has been sent:
Table A.--List of Products
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EPA Registration
Registrant Affected Number Active Ingredient Name of Product Date Issued
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Fairfax Biological Laboratories 403-9 Bacillus popillae Doom Milky Disease 2/6/98
and Bacillus Powder
lentimorbus
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III. Basis for Issuance of Notice of Intent; Requirement List
The following companies failed to submit the following required
data or information:
[[Page 11240]]
Table B.--List of Requirements
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Guideline Original
Active Ingredient Registrant Affected Requirement Name Reference Number Due Date
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Bacillus popillae and Bacillus Fairfax Biological 90-Day Response ** 12/20/92
lentimorbus Laboratories Acute Pulmonary 152-30 10/20/93
Toxicity/ 152-32 10/20/93
Pathogenicity 154-16 10/20/93
Acute Intravenous 154-23 10/20/93
Toxicity/
Pathogenicity
Avian Oral Toxicity/
Pathogenicity
Non-Target Insects
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IV. Attachment III Suspension Report--Explanatory Appendix
This Explanatory Appendix provides a discussion of the basis for
the Notice of Intent to Suspend issued herewith.
On September 30, 1992, EPA issued the Phase 5 Reregistration
Eligibility Document Data Call-In Notice imposed pursuant to section
4(g)(2)(B) of FIFRA which required registrants of products containing
Bacillus popillae and Bacillus lentimorbus used as the active
ingredients to develop and submit certain data. These data/information
were determined to be necessary to satisfy reregistration data
requirements of section 4(g). Failure to comply with the requirements
of a Phase 5 Reregistration Eligibility Document Data Call-In Notice is
a basis for suspension under section 3(c)(2)(B) of FIFRA.
The Bacillus popillae and Bacillus lentimorbus Phase 5
Reregistration Eligibility Document Data Call-In Notice dated September
30, 1992 required each affected registrant to submit data/information
to the Agency to address each of the data requirements. Those data/
information were required to be received by the Agency within 8 months
of the registrant's receipt of the Notice. Fairfax Biological
Laboratories was sent the original 1992 Data Call-In. According to a
U.S. Postal Service return receipt, you received the original Data
Call-In Notice on October 10, 1992. You subsequently failed to respond
within 90 days of receipt as required, and failed to submit the
required data within 8 months as required. Repeated attempts to contact
the company via telephone were unsuccessful. Fairfax was sent a letter
on March 25, 1996, with a May 1, 1996 deadline for response to the Data
Call-In and its requirements. You received the letter on April 2, 1996,
as evidenced by the U.S. Postal Service return receipt. The Agency
received no response.
Because you have failed to submit appropriate or adequate data/
information within the time provided for the data/information
requirements listed in Attachment II and have yet to provide the
required response to date, the Agency is issuing this Notice of Intent
to Suspend.
V. Conclusions
EPA has issued Notices of Intent to Suspend on the dates indicated.
Any further information regarding these Notices may be obtained from
the contact person noted above.
List of Subjects
Environmental protection.
Dated: February 18, 1998.
Elaine G. Stanley,
Director, Office of Compliance.
[FR Doc. 98-5855 Filed 3-5-98; 8:45 am]
BILLING CODE 6560-50-F
