[Federal Register: December 12, 2003 (Volume 68, Number 239)]
[Notices]
[Page 69400-69405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12de03-58]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0322; FRL-7328-2]
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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[[Page 69401]]
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 Notices of Intent to Suspend pursuant
to section 3(c)(2)(B) of FIFRA. The Notices of Intent to Suspend were
issued following issuance of Data Call-In Notices (DCI). The DCIs
required registrants of products containing captan and DCPA 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. This
Notice includes the text of the Notices of Intent to Suspend issued to
Riverdale Chemical Company and Voluntary Purchasing Group. 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: 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 captan or DCPA. 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 above-mentioned Data Call-Ins and FIFRA, 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-2003-0322. 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,
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 Notices of Intent to Suspend pursuant
to section 3(c)(2)(B) of FIFRA to Riverdale Chemical Company and
Voluntary Purchasing Group. The Notices of Intent to Suspend were
issued on September 25, 2003.
III. Text of the Notice to Suspend
The text of the Notices of Intent to Suspend absent specific
chemical, product, or factual information issued to Riverdale Chemical
Company and Voluntary Purchasing Group follows:
United States Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
Washington, DC 20460
September 25, 2003
Certified Mail
Return Receipt Requested
SUBJECT: Suspension of Registration of Pesticide Product(s)
Containing ____ for Failure to Comply with the ____ Section 4 Phase
5 Reregistration Eligibility Document Data Call-In Notice Issued
____
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 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
[[Page 69402]]
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. Registrants Receiving and Affected by the Notices of Intent to
Suspend
The following is a list of products for which a Notice of Intent to
Suspend been sent:
Table A.--Product List
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EPA Registration
Registrant Affected Number Active Ingredient Product Name Date DCI Issued
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Riverdale Chemical Company 228-99 DCPA Riversale 10% 11/25/98
Dacthal Granules
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228-157 DCPA Riverdale 11/25/98
Crabgrass
Control and
Fertilizer
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228-222 DCPA Riverdale 25% 11/25/98
Dacthal Dust
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Voluntary Purchasing Group 7401-438 Captan Ferti-Lome Liquid 11/2/99
Fruit Tree Spray
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[[Page 69403]]
V. Basis for Issuance of Notice of Intent; Requirement List
The following companies failed to submit the following required
data or information:
Table B.--Requirement List
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Guideline
Company Active Ingredient Reference Number Requirement Name Due Date
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Riverdale Chemical Company DCPA --- 30-Day response 7/12/01
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--- 4-Month response 10/12/01
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61-1 Product identity 10/12/01
and composition
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61-2(a) Description of 10/12/01
starting
materials
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61-2(b) Discussion of 10/12/01
impurity
formation
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62-1 Preliminary 10/12/01
analysis
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62-2 Certification of 10/12/01
limits
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62-3 Analytical method 10/12/01
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63-2 Color 10/12/01
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63-3 Physical state 10/12/01
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63-4 Odor 10/12/01
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63-7 Density 10/12/01
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63-12 pH 10/12/01
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63-14 Oxidation/ 10/12/01
reduction
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63-15 Flammability 10/12/01
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63-16 Explodability 10/12/01
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63-17 Storage Stability 10/12/01
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63-18 Viscosity 10/12/01
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63-19 Miscibility 10/12/01
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63-20 Corrosion 10/12/01
characteristics
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81-1 Acute oral 10/12/01
toxicity
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81-2 Acute dermal 10/12/01
toxicity
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81-3 Acute inhalation 10/12/01
toxicity
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81-4 Primary eye 10/12/01
irritation
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81-5 Primary dermal 10/12/01
irritation
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81-6 Skin 10/12/01
sensitization
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Voluntary Purchasing Group Captan 830.1750 Certification of 04/12/03
limits
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830.1800 Enforcement 04/12/03
analytical
method
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830.6317 Storage stability 04/12/03
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830.6320 Corrosion 04/12/03
characteristics
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--- Revised 04/12/03
Confidential
Statements of
Formula
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[[Page 69404]]
VI. Attachment III Suspension Report-Explanatory Appendix
The Explanatory Appendix provides a discussion of the basis for the
Notice of Intent to Suspend issued herewith.
A. Captan
On November 2, 1999, the Agency issued the Phase 5 Reregistration
Eligibility Document Data Call-In Notice pursuant to sections
4(g)(2)(B) and 3(c)(2)(B) of FIFRA which required the registrants of
products containing captan used as an active ingredient to develop and
submit certain data. These data/information were determined to be
necessary to satisfy reregistration 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.
Voluntary Purchasing Group, Inc. received the Captan Reregistration
Eligibility Document (RED) on November 20, 1999, as evidenced by a U.S.
Postal Service domestic return receipt card. Therefore, the 90-day
response was due on February 20, 2000, and the 8-month response was due
on July 20, 2000. The company's 90-day response, dated April 18, 2000
was received by the Agency on April 18, 2000. The company agreed to
satisfy the data requirements by developing and submitting the data to
the Agency. It stated that the studies would be initiated within 2
weeks and it estimated that the studies would take approximately 5
months to complete.
By a letter dated February 8, 2001, the Agency informed Mr. Michael
Jackson (Brazos Associates, Inc., Agent for Voluntary Purchasing Group)
that Voluntary Purchasing Group's 8-month response was overdue. In a
letter dated March 7, 2001, Brazos Associates, Inc. requested a time
extension of an additional 4 months for submission of the product
chemistry and acute toxicity studies. Additionally, the registrant
asked for more time to submit the storage stability/corrosion data. The
rationale for the time extension requests was based on problems that
Brazos stated were being encountered with the test material and
analytical procedures employed by Stillmeadow, Inc. (Laboratory).
Brazos stated that these problems had delayed the development of
studies, particularly the storage stability and corrosion
characteristics studies. The Agency agreed to place these latter two
studies on hold until Stillmeadow resolved problems with the analytical
procedures. The registrant agreed to provide quarterly progress
reports. The 4-month time extension was granted in an Agency letter
dated March 21, 2001.
The Agency received the 8-month response on November 16, 2001.
Product specific data purporting to address product chemistry and acute
toxicity guidelines were received. In the transmittal letter dated
November 14, 2001, Brazos Associates noted that Stillmeadow was still
experiencing problems with the test material for storage stability,
corrosion characteristics, and enforcement analytical method studies.
Therefore, Brazos Associates initiated a second set of these studies
with Product Safety Labs to determine if it was a laboratory/company
problem or actual problem with the analytical methods being utilized.
On January 31, 2003, the Agency completed the review of the product
chemistry data submitted to support the reregistration of Voluntary
Purchasing Group's captan product and found remaining deficiencies in
the data that prevented the requirements from being satisfied. An
Agency letter to Brazos Associates dated March 12, 2003 outlined the
product chemistry deficiencies. Voluntary Purchasing Group was required
to submit revised Confidential Statements of Formula, and product
chemistry data for Guidelines 830.1750 Certified Limits, and 830.1800
Enforcement Analytical Method. Additionally, Voluntary Purchasing Group
was also required to notify the Agency within 30 days of their receipt
of the letter whether the storage stability and corrosion
characteristics studies have been initiated and their expected
completion dates. Brazos received the letter on behalf of Voluntary
Purchasing Group on March 17, 2003.
On July 8, 2003, Ms. Karen Jones contacted Brazos Associates to
determine if Voluntary Purchasing Group planned to submit the
outstanding product chemistry data. Mr. Jackson of Brazos Associates
indicated that Voluntary Purchasing Group did not plan to submit a
response or data. Ms. Jones informed Mr. Jackson that the Agency would
issue a Notice of Intent to Suspend (NOIS) for Voluntary Purchasing
Group's failure to respond to the Agency's letter dated March 12, 2003
and to adequately satisfy the data requirements imposed by the Captan
RED DCI.
To date, the Agency has not received required product chemistry
data for Certification of Limits, Enforcement Analytical Method, or a
Revised Confidential Statement of Formula. Additionally, the Agency has
not received the required Storage Stability and Corrosion
Characteristics product chemistry data, nor required progress reports.
Because the registrant has not supplied the required data to
support its captan product registration, this Notice of Intent to
Suspend is being issued.
B. DCPA
On November 25, 1998, the Agency issued the Phase 5 Reregistration
Eligibility Document (RED) Data Call-In Notice pursuant to sections
4(g)(2)(B) and 3(c)(2)(B) of FIFRA which required the registrants of
products containing DCPA used as an active ingredient to develop and
submit certain data. These data/information were determined to be
necessary to satisfy reregistration requirements of section 4(g).
Failure to comply with the requirements of a Phase 5 Reregistration
Eligibility Document Data Call-In Notice (DCI) is a basis for
suspension under section 3(c)(2)(B) of FIFRA.
An Agency letter dated June 4, 2001, was sent to all DCPA
registrants. The letter modified the DCI and established new time
frames for submitting the generic and product specific data required in
the DCPA RED. Riverdale Chemical Company received the letter modifying
the deadlines imposed by the DCPA RED on June 12, 2001, as evidenced by
a U.S. Postal Service Domestic return receipt card. Therefore,
Riverdale's 30-day response was due on July 12, 2001, and the 4-month
response was due on October 12, 2001.
On August 15, 2001, Ms. Venus Eagle on behalf of the Agency
contacted Mr. Sawyer, the Regulatory Affairs Manager at Riverdale
Chemical Company, to inquire why Riverdale had not responded to the
June 4, 2001 letter which Riverdale received on June 12, 2001.
Riverdale was required to respond 30 days after its receipt of the
letter, that is, by July 12, 2001. Mr. Sawyer stated that his
colleagues had not decided whether they wanted to support the DCPA end-
use products or not. Ms. Eagle stated he had in effect already had 30
additional days since the deadline of July 12, 2001 to inform the
Agency of its decision. Mr. Sawyer then responded that the Agency could
issue a NOIS in lieu of waiting for Riverdale's answer.
On September 7, 2001, three letters (dated September 6, 2001) were
received (for EPA Registration Nos. 228-99, 228-157, and 228-222)
stating that Riverdale planned to ``respond positively to the
reregistration'' of the subject products and that it ``will be sending
in the necessary documentation to continue'' the registrations.
However, by the deadline of October 12, 2001, no product specific data
had been
[[Page 69405]]
submitted for any of Riverdale's affected products. On March 11, 2002,
Ms. Eagle spoke with Mr. Sawyer about the overdue product specific
data. Mr. Sawyer responded that the samples got lost in December 2001,
and they were just starting the data. Ms. Eagle told him that the
Agency would have to issue a NOIS. Mr. Sawyer stated ``go ahead then.''
Since the required product chemistry and acute toxicity data have
not been submitted for EPA Registration Nos. 228-99, 228-157, and 228-
222, this Notice of Intent to Suspend is being issued.
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: November 6, 2003.
Richard Colbert,
Director, Agriculture Division, Office of Compliance, Office of
Enforcement and Compliance Assurance.
[FR Doc. 03-30777 Filed 12-11-03; 8:45 am]
BILLING CODE 6560-50-S