[Federal Register: February 28, 2003 (Volume 68, Number 40)]
[Notices]
[Page 9656-9660]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28fe03-89]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0040; FRL-7292-1]
Intent to Suspend Certain Pesticide Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of issuance of notice 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 that EPA issued a Notice of Intent to Suspend pursuant
to section 3(c)(2)(B) of FIFRA and that the Notice of Intent to Suspend
has since become an effective suspension order. The Notice of Intent to
Suspend was issued following issuance of the 1991 Thiram Data Call-In
Notice (DCI). The DCI required registrants of products containing
thiram used as an active ingredient to
[[Page 9657]]
develop and submit certain data. These data were determined to be
necessary to maintain the continued registration of affected products.
Failure to comply with the data requirements of a DCI is a basis for
suspension under section 3(c)(2)(B) of FIFRA. Prochimie International,
Inc. holds the registration of a technical thiram product (EPA
Registration Number 8236-2) and is therefore subject to the
requirements of the 1991 DCI. Prochimie's technical thiram product is
currently registered only for nonresidential turf use. This Notice
includes the text of the Notice of Intent to Suspend which was issued
to Prochimie on November 27, 2002. The text identifies the registrant
involved, the active ingredient involved, the EPA Registration Number,
the name of the affected product, and the basis upon which the Notice
of Intent to Suspend was issued. As required by section 6(f)(2), the
Notice of Intent to Suspend was sent by certified mail, return receipt
requested to Prochimie, Inc. at its address of record. The Notice of
Intent to Suspend was received on December 4, 2002, by the registrant
and became an effective suspension order on January 4, 2003.
Dates: The Notice of Intent to Suspend became an effective suspension
order January 4, 2003.
FOR FURTHER INFORMATION CONTACT: Harold Day, Agriculture Division,
2225A, Office of Enforcement and Compliance Assurance, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: 202-564-4133; fax number: 202-564-0029; e-mail
address: day.harold@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you hold EPA
registrations for products that contain thiram. Potentially affected
entities may include, but are not limited to pesticide registrants.
Other types of entities not listed in this unit could also be affected.
To determine whether you or your business may be affected by this
action, you should carefully examine the applicability provisions in
the 1991 Thiram Data Call-In and FIFRA regulations, specifically
section 3(c)(2)(B). If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0040. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to view public comments,
use EPA Dockets at http://www.epa.gov/edocket/ to view public comments,
access the index listing of the contents of the official public docket,
and to access those documents in the public docket that are available
electronically. Although not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.1.
Once in the system, select ``search,'' then key in the appropriate
docket ID number.
II. What Action is the Agency Taking?
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 that EPA issued a Notice of Intent to Suspend pursuant
to section 3(c)(2)(B) of FIFRA to Prochimie International, Inc. The
Notice of Intent to Suspend was issued on November 27, 2002, and was
received on December 4, 2002, by the registrant, Prochimie
International, Inc., as evidenced by the U.S. Postal Service return
receipt. No request for a hearing was received within the required
statutory time frame and the Notice of Intent to Suspend became an
effective suspension order on January 4, 2003, which was 30 days
following the date of receipt of the Notice of Intent to Suspend by the
registrant.
III. Text of the Notice to Suspend
The text of the Notice of Intent to Suspend issued to Prochimie
International, Inc. follows:
United States Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
Washington, DC 20460
November 27, 2002
Certified Mail
Return Receipt Requested
Ms. Mary Ann Roston
Prochimie International, Inc.
5 Waterside Crossing
Windsor, CT 06095
SUBJECT: Suspension of Registration of Pesticide Product(s)
Containing Thiram for Failure to Comply with the Thiram Data Call-In
Notice Dated September 16, 1991.
Dear Sir/Madam:
This letter gives you notice that the pesticide product
registration(s) 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 section 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 3(c)(2)(B) Data Call-In
Notice. The specific basis for issuance of this Notice is stated in
the Explanatory Appendix (Attachment III) to this Notice. The
affected product(s) and the requirement(s) 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
[[Page 9658]]
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, any allegations of
errors or unfairness in any proceedings before an arbitrator, 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
product(s).
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
1200 Pennsylvania Avenue, NW
Washington, DC 20460
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 of the Administrative Law
Judges, the Office of the Environmental Appeals Board, 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 3(c)(2)(B) Data Call-In
Notice. 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 Division
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
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 registration(s) for your product(s) listed in Attachment
I are currently suspended as a result of failure to comply with
another section 3(c)(2)(B) Data Call-In Notice or Section 4 Data
Requirements 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
3(c)(2)(B) Data Call-In Notice, please contact Frances Liem at (202)
564-2365.
Sincerely yours,
Director, Agriculture Division, Office of Compliance.
Attachment I Suspension Report - Product List
Attachment II Suspension Report - Requirement List
Attachment III Suspension Report - Explanatory Appendix
IV. Registrant Receiving and Affected by Notice of Intent to Suspend
Prochimie International, Inc. was sent a letter of notification for
the following product.
Table A.--Product List
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EPA Registration Number Product Name
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8236-2 Thiram Technical
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V. Basis for Issuance of Notice of Intent; Requirement List
Prochimie International, Inc. failed to submit the following
required data or information.
[[Page 9659]]
Table B.--Requirement List
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Guideline Reference Number Requirement Name Due Date
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71-4(b) Avian reproduction- 9/16/93
duck
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72-3(a) Estuarine/marine 9/16/92
toxicity-fish
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72-3(b) Estuarine/marine 9/16/92
toxicity-mollusk
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72-3(c) Estuarine/marine 9/16/92
toxicity-shrimp
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82-2 21-Day dermal 9/16/93
toxicity rabbit/
rat
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83-4 2-Generation 9/16/95
reproduction-rat
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85-1 General metabolism 9/16/93
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122-2 Aquatic plant 9/16/92
growth
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161-1 Hydrolysis 12/16/91
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161-2 Photodegradation-w 12/16/91
ater
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162-1 Aerobic soil 9/16/93
metabolism
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163-1 Leaching/ 9/16/92
adsorption/
desorption
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164-1 Terrestrial field 9/16/93
dissipation
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165-4 Bioaccumulation in 9/16/92
fish
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VI. 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 16, 1991, EPA issued a Data Call-In (``1991 DCI'')
to all registrants of products containing thiram under the authority
of FIFRA section 3(c)(2)(B). The 1991 DCI required registrants of
products containing thiram used as an active ingredient to develop
and submit certain data. These data were determined to be necessary
to maintain the continued registration of affected products. Failure
to comply with the data requirements of a DCI is a basis for
suspension under section 3(c)(2)(B) of FIFRA. Prochimie holds the
registration of a technical thiram product (EPA Registration Number
8236-2) and is therefore subject to the requirements of the 1991
DCI. Prochimie's technical thiram product is currently registered
only for nonresidential turf use. The following describes
Prochimie's noncompliance with the 1991 DCI and FIFRA section
3(c)(2)(B) for failing to meet certain data requirements in the 1991
DCI applicable to products registered for nonresidential turf use.
These data requirements are identified in Appendix II to this
Notice.
In its required 90-day response to the 1991 DCI, Prochimie
indicated that it elected Option 2 provided in the 1991 DCI as the
method for complying with the DCI. In a letter dated June 6, 2001,
Prochimie emphasized that it selected only Option 2 for complying
with the 1991 DCI and did not select Option 3 (i.e., an offer to
pay). Selection of Option 2 indicates that the registrant has
entered into a cost share agreement with one or more registrants to
jointly develop data required under the 1991 DCI. To qualify for
Option 2, the 1991 DCI requires that the registrant provide the name
of the party who would be submitting the data. In addition, the
registrant must provide documentary evidence that a cost share
agreement has been formed. Such evidence can be a letter offering to
cost share and a letter accepting such offer, or a written statement
by the parties that an agreement exists. Prochimie's 90-day response
indicated that it was a member of Thiram Task Force I and that Task
Force I would be submitting the data required by the 1991 DCI.
In a letter dated April 20, 1992, EPA notified Prochimie that
its 90-day response was insufficient, because there were data
requirements in the 1991 DCI that Task Force I had not committed to
satisfy. In response, Prochimie provided EPA with a letter dated
April 28, 1992, in which Prochimie informed Mr. Jerome C. Rockwell,
the chairman of both Thiram Task Force I and Thiram Task Force II,
that Prochimie ``will participate and cost share in the Thiram Task
Force [emphasis added] submitting information for the EPA Thiram
Data Call-In requirements regarding turf use of Thiram only.'' In
subsequent correspondence with the Agency, Prochimie stated that,
although not a member of Task Force II, Prochimie had agreed to
participate in all Task Force II studies necessary to support
nonresidential turf use of thiram.
However, Prochimie has not provided any evidence, nor does the
Agency have any other indication, that Thiram Task Forces I and II,
either individually or jointly, have generated or committed to
generate all studies necessary to satisfy the 1991 DCI requirements
for nonresidential turf use. Task Force I was formed in 1985, by a
consortium of registrants of products containing thiram, including
Prochimie, for the purpose of acquiring or developing data required
by a previous DCI issued in 1984 (``1984 DCI''). Although the 1991
DCI restated some of the data requirements contained in the 1984 DCI
that were still outstanding, it required additional data that were
not included in the 1984 DCI. Prior to its dissolution on July 31,
1992, Task Force I did not commit to satisfying any of the new data
requirements in the 1991 DCI that were not imposed earlier by the
1984 DCI. Similarly, Thiram Task Force II was established in May
1989 for the development of data necessary to support primarily food
use of thiram, which does not include nonresidential turf use. To
date, there are data requirements applicable to nonresidential turf
use under the 1991 DCI which neither Task Force I nor Task Force II
have satisfied or committed to satisfy. Prochimie has not
independently submitted studies or provided evidence that it has
agreed to cost share with any other party for developing data to
satisfy these data requirements or selected any other option to
address such data requirements. Accordingly, Prochimie is in
noncompliance with these requirements. These data requirements are
identified in Appendix II to this Notice and are as follows: EPA
Guideline Nos. 72-3(a), 72-3(b), and 72-3(c), 82-2, and 165-4.
Furthermore, Prochimie failed to submit evidence required by the
1991 DCI that a cost share agreement had been reached between Task
Force II and Prochimie. As mentioned above, Prochimie's April 28,
1992 letter to Mr. Rockwell stated that Prochimie ``will participate
and cost share in the Thiram Task Force [emphasis added] submitting
information for the EPA Thiram Data Call-In requirements regarding
turf use of Thiram only.'' Because Mr. Rockwell was the chairman of
both Task Force I and Task Force II, it is not clear whether
Prochimie's letter
[[Page 9660]]
intended to restate its commitment to cost share with Task Force I
or to make an offer to cost share with Task Force II. In any case,
Prochimie's letter at most shows that Prochimie made an offer to
cost share, which was an option it emphasized that it had not
selected. Prochimie did not provide any evidence that it had
selected the option of offer to pay or that any such offer had been
accepted. In order to support the option Prochimie selected to
address the data requirements, it must provide evidence that any
such offer had been accepted. Prochimie did not do that. Although
Prochimie paid Task Force II for the use of several specific studies
which are not involved in this Notice, those payments do not provide
any evidence that a cost share agreement has been reached with
respect to any other studies required by the 1991 DCI for
nonresidential turf use that Task Force II submitted or has
committed to submit. In fact, Mr. Rockwell, the chairman of Task
Force II, stated in an affidavit dated May 2, 2000, that ``No
written offer-to-pay or any offer to jointly develop any data as
required by and identified in the 1991 DCI has ever been received by
Thiram Task Force II. . .from Prochimie.'' Since Task Force II does
not believe that it has ever received an offer to cost share from
Prochimie, it is unlikely that a cost share agreement has been
reached between Prochimie and Task Force II. Without adequate proof
of such an agreement, Prochimie may not claim an ownership interest
in Task Force II's data for which Prochimie has not paid and hence
may not claim that such data satisfies Prochimie's obligations.
Consequently, the Agency considers that Prochimie is in
noncompliance with certain data requirements for nonresidential turf
use imposed by the 1991 DCI irrespective of Task Force II's actions
to address those data requirements. Those data requirements are
identified in Appendix II to this Notice and are as follows: EPA
Guideline Nos. 71-4(b), 83-4, 85-1, and 122-2.
Moreover, prior to its dissolution, Task Force I failed to
satisfy certain 1984 DCI data requirements for nonresidential turf
use that were also imposed by the 1991 DCI. Because Prochimie was a
member of Task Force I and has not independently submitted data or
otherwise addressed these requirements, Prochimie is in
noncompliance with these requirements. These data requirements are
identified in Appendix II to this Notice and are as follows: EPA
Guideline Nos. 161-1, 161-2, 162-1, 163-1, and 164-1.
In a letter dated December 21, 1998, EPA informed Prochimie that
the data required under the 1991 DCI were long overdue and that
Prochimie had satisfied only those data requirements that had been
satisfied by Task Force I prior to its dissolution. In a letter
dated January 12, 1999, Prochimie informed EPA that ``Prochimie cost
shared/co-owned several studies submitted by Task Force II.''
However, Prochimie did not provide the evidence required by the 1991
DCI that Prochimie and Task Force II have agreed to cost share in
the development of any other data required by the 1991 DCI for
nonresidential turf use. Prochimie's letter also restated
Prochimie's commitment to satisfy certain data requirements that
neither Task Forces committed to fulfill. However, Prochimie did not
submit any studies or proof required by the 1991 DCI of a cost share
agreement with any party obligated to satisfy these data
requirements.
In a letter dated June 29, 1999, Prochimie requested data
waivers (or determination of nonapplicability or no need for
additional data) for, among others, the following data requirements:
Guideline Nos. 82-2, 83-4, 122-2, 161-1, 161-2, 163-1, and 164-1,
and 165-4. After careful consideration of Prochimie's requests, EPA
denied the request for waiver of the above mentioned data
requirements in letters dated May 21, 2001 and August 31, 2001.
In a letter dated August 31, 2001, EPA informed Prochimie of its
failure to demonstrate that it had taken appropriate steps to secure
data required by the 1991 DCI. In an attachment to the letter, EPA
identified all of the data requirements for nonresidential turf use
under the 1991 DCI and the names of the parties who submitted
studies for those requirements. As shown in that attachment, UCB
Chemicals Corporation, Inc. (``UCB''), not Task Force I or II,
satisfied a number of data requirements under the 1991 DCI for
nonresidential turf use. The letter notified Prochimie of the
Agency's intent to issue a Notice of Intent to Suspend Prochimie's
technical thiram registration unless, within 30 calendar days of its
receipt of the letter, EPA received from Prochimie certain required
data or proof of an agreement or offer to cost share with UCB. In
its October 4, 2001 response, Prochimie did not provide any of the
data/information that the Agency required, but instead requested a
re-evaluation of the Agency's determination not to waive certain
environmental fate studies, clarification of applicable existing
data, and a determination of data requirements applicable to the
nonresidential turf use.
To date, Prochimie has failed to take appropriate steps to
secure certain data required by the 1991 DCI applicable to
nonresidential turf use and remains in noncompliance with those data
requirements, which are set forth in Appendix II to this Notice.
Accordingly, the Agency is issuing this Notice of Intent to Suspend.
V. What is the Agency's Authority for Taking this Action?
The Agency's authority for taking this action is section 6(f)(2) of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7
U.S.C. 136 et seq.
List of Subjects
Environmental protection.
Dated: February 4, 2003.
Richard Colbert,
Director, Agriculture Division, Office of Compliance, Office of
Enforcement and Compliance Assurance.
[FR Doc. 03-4776 Filed 2-27-03; 8:45 am]
BILLING CODE 6560-50-S