[Federal Register: September 17, 2003 (Volume 68, Number 180)]
[Notices]
[Page 54444-54449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se03-63]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0277; FRL-7319-8]
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. 136et
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 bensulide, boric acid and
its salts, and/or methyl nonyl ketone used as an active ingredient to
develop and submit certain data. These data were
[[Page 54445]]
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
Care Flex One-Year Guarantee Company, The Scotts Company, and Voluntary
Purchasing Group. As required by section 6(f)(2), the Notice of Intent
to Suspend was 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 bensulide, boric acid and its
salts, and/or methyl nonyl ketone. 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-2003-0277. 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 athttp://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 Care Flex One-Year Guarantee Company,
The Scotts Company, and the Voluntary Purchasing Group. The Notices of
Intent to Suspend were issued on July 23, 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 Care Flex One-Year
Guarantee Company, The Scotts Company, and Voluntary Purchasing Group
follows:
United States Environmental Protection Agency
Office of Prevention, Pesticides and Toxic Substances
Washington, DC 20460
November 27, 2002
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 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
[[Page 54446]]
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 Notice of Intent to Suspend
The following is a list of products for which a letter of
notification has been sent:
Table A.--Product List
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EPA Registration Date DCI
Registrant Affected Number Active Ingredient Name of Product Issued
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Care-Flex One-Year Guarantee 66680-1 Boric acid and its Care-Flea Home 2/16/94
Company sodium salts Treatment
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The Scotts Company 538-164 Bensulide Proturf Goosegrass/ 7/11/00
Crabgrass Control
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Voluntary Purchasing Group 7401-439 Methyl nonyl ketone Fert-Pro Dog-Gon and 2/28/96
Cat Repellent
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V. Basis for Issuance of Notice of Intent; Requirement List
The following companies failed to submit the following required
data or information:
[[Page 54447]]
Table B.--Requirement List
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Guideline
Registant Affected Active Ingredient Requirement Name Reference Number Due Date
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Care-Flex One-Year Guarantee Boric acid and its 90-Day response --- 06/11/94
Company sodium salts
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Confidential --- 11/11/94
Statement of
Formula
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8-Month response --- 11/11/94
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Product identity 61-1 11/11/94
and composition
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Description 61-2(a) 11/11/94
starting
materials,
production &
formulation
process
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Discussion of 61-2(b) 11/11/94
formation of
impurities
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Preliminary 62-1 11/11/94
analysis
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Certification of 62-2 11/11/94
limits
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Analytical method 62-3 11/11/94
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Color 63-2 11/11/94
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Physical state 63-3 11/11/94
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Odor 63-4 11/11/94
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Density 63-7 11/11/94
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PH 63-12 11/11/94
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Oxidizing or 63-14 11/11/94
reducing action
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Explodability 63-16 11/11/94
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Storage stability 63-17 11/11/94
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Viscosity 63-18 11/11/94
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Corrosion 63-20 11/11/94
characteristics
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Acute oral toxicity- 81-1 11/11/94
rat
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Acute dermal 81-2 11/11/94
toxicity-rabbit/
rat
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Acute inhalation- 81-3 11/11/94
toxicity-rat
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Primary eye 81-4 11/11/94
irritation-rabbit
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Primary dermal 81-5 11/11/94
irritation
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Dermal 81-6 11/11/94
sensitization
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Treatments 95-2,3 11/11/94
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Manmade premises 95-10 11/11/94
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Premises treatment 95-11 11/11/94
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Treatments 95-12 11/11/94
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Stored products 95-13 11/11/94
treatment
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The Scotts Company Bensulide Product identity 158.155 12/30/01
and composition
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Description of 158.160 12/30/01
starting materials
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[[Page 54448]]
Description of 158.162 12/30/01
production process
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Description of 158.165 12/30/01
formulation
process
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Discussion of 158.167 12/30/01
impurity formation
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Preliminary 158.170 12/30/01
analysis
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Certification of 158.175 12/30/01
limits
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Enforcement 158.180 12/30/01
analytical method
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Color 63-2 12/30/01
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Physical state 63-3 12/30/01
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Odor 63-4 12/30/01
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Density 63-7 12/30/01
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pH 63-12 12/30/01
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Oxidation/reduction 63-14 12/30/01
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Flammability 63-15 12/30/01
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Explodability 63-16 12/30/01
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Storage stability 63-17 12/30/01
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Viscosity 63-18 12/30/01
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Miscibility 63-19 12/30/01
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Corrosion 63-20 12/30/01
characteristics
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Dielectric 63-21 12/30/01
breakdown voltage
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Acute oral toxicity 81-1 06/30/01
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Acute dermal 81.2 06/30/01
toxicity
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Acute inhalation 81-3 06/30/01
toxicity
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Primary eye 81-4 06/30/01
irritation
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Primary dermal 81-5 06/30/01
irritation
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Skin sensitization 81-6 06/30/01
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Voluntary Purchasing Group Methyl nonyl ketone Storage stability 63-17 (830-6317) 8/28/00
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Corrosion 63[dash]20 (830- 8/28/00
characteristics 6320)
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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. Bensulide
On July 11, 2000, the Agency issued the Phase 5
ReregistrationEligibility Document Data Call-In Notice pursuant to
sections 4(g)(2)(B)and 3(c)(2)(B) of FIFRA which required the
registrants of productscontaining bensulide used as an active
ingredient to develop and submitcertain data. These data/information
were determined to be necessary tosatisfy reregistration
requirements of section 4(g). Failure to complywith the requirements
of a Phase 5 Reregistration Eligibility DocumentData Call-In Notice
is a basis for suspension under section 3(c)(2)(B) ofFIFRA.
The Scotts Company (Scotts) received the Bensulide
ReregistrationEligibility Document (RED) on July 20, 2000, as
evidenced by a U.S. PostalService domestic return receipt card.
Therefore, the 90-day response wasdue on October 20, 2000, and the
8-month response was due on March 20,2001.
In its 90-day response, dated October 30, 2000 (received by
theAgency on November 2, 2000), Scotts requested a time extension to
submittheir product-specific data. For the acute toxicity date, the
companyrequested a time extension until June 30, 2001, and for the
productchemistry data, it requested an extension until December 30,
2001. TheAgency in a letter dated December 18, 2000 granted Scotts
time extensionrequests.
To date, no product chemistry or acute toxicity data have
beensubmitted to the Agency for EPA Registration No. 538-164.Because
Scott has failed to submit the
[[Page 54449]]
required data, this Notice ofIntent to Suspend is being issued.
B. Boric Acid and its Sodium Salts
On February 16, 1994, the Agency issued the Phase 5
ReregistrationEligibility Document Data Call-In Notice pursuant to
sections 4(g)(2)(B)and 3(c)(2)(B) of FIFRA which required the
registrants of productscontaining boric acid and its sodium salts
used as an active ingredient todevelop and submit certain data.
These data/information were determinedto be necessary to satisfy
reregistration requirements of section 4(g).Failure to comply with
the requirements of a Phase 5 ReregistrationEligibility Document
Data Call-In Notice is a basis for suspension undersection
3(c)(2)(B) of FIFRA.
Care-Flex One-Year Guarantee Company received the Boric Acid and
ItsSodium Salts Reregistration Eligibility Document (RED) on March
11, 1994,as evidenced by a U.S. Postal Service green card. The
Agency has notreceived either the 90-day response or the 8-month
response to the Boric Acid and Its Sodium Salts RED for the product
EPA Registration Number66680-1. The 90-day response was due on June
11, 1994, and the 8-month response was due on November 11, 1994. The
Agency has sent two follow-up letters to the registrant dated April
22, 2002 and August 19, 2002,respectively, and those letters were
received by the registrant on April27, 2002, and August 23, 2002,
respectively, as evidenced by the U.S.Postal Service green cards. To
date, the registrant has not responded.
Because Care-Flex One-Year Guarantee Company has not submitted
the requiredDCI/RED responses and data, the Agency is issuing this
Notice of Intent toSuspend.
C. Methyl Nonyl Ketone
On February 28, 1996, the Agency issued the Phase 5
ReregistrationEligibility Document Data Call-In Notice pursuant to
sections 4(g)(2)(B)and 3(c)(2)(B) of FIFRA which required the
registrants of productscontaining Methyl Nonyl Ketone used as an
active ingredient to develop andsubmit certain data. These data/
information were determined to benecessary to satisfy reregistration
requirements of section 4(g). Failureto comply with the requirements
of a Phase 5 Reregistration EligibilityDocument Data Call-In Notice
is a basis for suspension under section3(c)(2)(B) of FIFRA.
Voluntary Purchasing Group received the Methyl Nonyl
KetoneReregistration Eligibility Document Data Call-In Notice (RED)
on March 9,1996, as evidenced by a U.S. Postal Service Domestic
return receipt card.The 90-day response was received on June 26,
1996.
The Agency completed its review of the product chemistry data
onFebruary 28, 2002. The data requirements for Guideline 63-17
(StorageStability) and Guideline 63-20 (Corrosion Characteristics)
were notsatisfied. The interim report submitted by Voluntary
Purchasing Groupby letter dated February 18, 2002 related to an
unacceptable study and thedata requirements remain unsatisfied. In
an Agency letter dated March 6,2002 to Michael Jackson (consultant
for Voluntary Purchasing Group) a timeextension was granted since a
new study had been reportedly initiated inDecember 2001, according
to information provided to the Agency by Mr.Jackson. The new
deadline for submission of the storage stability andcorrosion
characteristics data was January 2003. Subsequently, theAgency sent
a letter dated January 15, 2003, as no data addressing thesetwo
outstanding requirements had been received as of that date.
Thatletter, which was received by Mr. Jackson on January 21, 2003
(asevidenced by a U.S. Postal Service domestic return receipt card),
informedhim and his client that a Notice of Intent to Suspend would
beinitiated if the outstanding data were not received by January 31,
2003.
To date, the Agency has not received the required data.
Becausethe required data have not been received, the Agency is
issuing thisNotice of Intent to Suspend.
VII. 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. 136et seq.
List of Subjects
Environmental protection.
Dated: September 4, 2003.
Richard Colbert,
Director, Agriculture Division, Office of Compliance, Office of
Enforcement and Compliance Assurance.
[FR Doc. 03-23754 Filed 9-16-03; 8:45 am]
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