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/ 2008
/ November
/ Wednesday, November 26, 2008
[Federal Register: November 26, 2008 (Volume 73, Number 229)]
[Notices]
[Page 72047-72050]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no08-72]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0387; FRL-8365-9]
Intent to Suspend Certain Pesticide Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of issuance of Notice of Intent to Suspend; Suspension
Order.
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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 has issued a Notice of Intent to Suspend
pursuant to sections 3(c)(2)(B) and 4 of FIFRA. The Notice was issued
following issuance of a Section 4 Reregistration Data Requirements
Notice by the Agency and the failure of the registrant subject to the
Section 4 Reregistration Data Requirements Notice 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 1 of this
Notice further identifies the registrant to whom the Notice of Intent
to Suspend was issued, the date the 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 Notice of Intent to Suspend. Moreover, Table 2 of this Notice
identifies the basis upon which the Notice of Intent to Suspend was
issued. Finally, matters pertaining to the timing of requests for
hearing are specified in the Notice 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 Notice of Intent to Suspend was sent by
certified mail, return receipt requested, to the affected registrant at
its address of record. The Notice of Intent to Suspend described in
this Notice was received by the registrant and the products have been
suspended by operation of law. The Notice of Intent to Suspend has
become an effective suspension order.
FOR FURTHER INFORMATION CONTACT: Bonnie Adler, Special Review and
Reregistration Division, 7508P, Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-8523; fax
number: (703) 308-8005; e-mail address: adler.bonnie@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public in general. Although this
action may be of particular interest to persons who produce or use
pesticides, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the 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 a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2008-0387. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The hours of operation of this Docket Facility are
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket Facility telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under theFederal Register
listings athttp://www.epa.gov/fedrgstr.
II. 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
SUBJECT: Suspension of Registration of Pesticide Product(s)
Containing ------------------for Failure to Comply with the Section
4 Phase 5 Reregistration Eligibility Decision Data Call-In Notice
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 Phase 5 Reregistration
Eligibility Decision Data Call-In Notice imposed pursuant to section
4(g)(2)(B) and section 3(c)(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 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
[[Page 72048]]
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
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 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 Pesticide Programs
Special Review and Reregistration Division (7508P)
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 Linda S. Propst at
(703) 308-8165.
III. Registrant 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 1.--List of Products
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EPA Registration
Registrant Affected Number Active Ingredient Product Name Date Issued
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The Scotts Company 538-160 MCPA Turf Builder Plus 4/3/08*
2 W/S For Grass
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The Scotts Company 538-218 MCPA Scott's Lawn Pro 4/3/08*
Lawn Weed
Control Plus
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The Scotts Company 538-222 MCPA Scott's Lawn Pro 4/3/08*
Weed N' Feed
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* The Notice was received by The Scotts Company on April 14, 2008, as evidenced by the signed and dated U.S.
Postal Service return receipt. The Notice of Intent to Suspend has since become an effective order of
suspension as of May 14, 2008, as the registrant has neither requested a hearing nor brought its affected
registrations into compliance within the statutory time period.
IV. Basis for Issuance of Notice of Intent; Requirement List
The Scotts Company failed to submit the following required data
or information.
[[Page 72049]]
Table 2.--List of Requirements
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OPPTS Harmonized Guideline Requirement Name Test Substance Due Date
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830.1550 Product Identity and TGAI, MP, EP November 15, 2006
Composition
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830.1600 Description of TGAI, MP, EP November 15, 2006
Materials Used to
Produce the Product
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830.1620 Description of TGAI November 15, 2006
Production Process
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830.1650 Description of MP, EP November 15, 2006
Formulation Process
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830.1670 Discussion of Formation TGAI November 15, 2006
Impurities
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830.1700 Preliminary Analysis TGAI November 15, 2006
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830.1750 Certified Limits TGAI, MP, EP November 15, 2006
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830.1800 Enforcement Analytical TGAI, MP, EP November 15, 2006
Method
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830.6302 Color TGAI, MP, EP November 15, 2006
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830.6303 Physical State TGAI, MP, EP November 15, 2006
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830.6304 Odor TGAI, MP, EP November 15, 2006
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830.6313 Stability to Sunlight, TGAI November 15, 2006
Normal and Elevated
Temperatures, Metals
and Metal Ions
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830.6314 Oxidation/Reduction: MP, EP November 15, 2006
Chemical
Incompatibility
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830.6315 Flammability/Flame MP, EP November 15, 2006
Extension
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830.6316 Explodability MP, EP November 15, 2006
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830.6317 Storage Stability of MP, EP November 15, 2006
Product
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830.6319 Miscibility MP, EP November 15, 2006
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830.6320 Corrosion MP, EP November 15, 2006
Characteristics
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830.6321 Dielectric Breakdown EP November 15, 2006
Voltage
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830.7000 pH of Water Solution or TGAI, MP, EP November 15, 2006
Suspensions
830.7100 Viscosity MP, EP November 15, 2006
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830.7200 Melting Point/Melting TGAI November 15, 2006
Range (only required
if product is a solid)
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830.7220 Boiling Point/Boiling TGAI November 15, 2006
Range (only required
if product is a
liquid)
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830.7300 Density/Relative TGAI, MP, EP November 15, 2006
Density
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870.1100 Acute Oral Toxicity TGAI, MP, EP November 15, 2006
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870.1200 Acute Dermal Toxicity TGAI, MP, EP November 15, 2006
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870.1300 Acute Inhalation TGAI, MP, EP November 15, 2006
Toxicity
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870.2400 Acute Eye Irritation TGAI, MP, EP November 15, 2006
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870.2500 Acute Dermal Irritation TGAI, MP, EP November 15, 2006
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870.2600 Skin Sensitization TGAI, MP, EP November 15, 2006
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EP = End Use Product
MP = Manufacturing Product
TGAI = Technical Grade Active Ingredient
[[Page 72050]]
V. Attachment III Suspension Report-Explanatory Appendix
A discussion of the basis for the Notices of Intent to Suspend
follows.
On March 3, 2006, the Agency issued the Phase 5 Reregistration
Eligibility Decision (RED) Data Call-In Notice pursuant to sections
4(g)(2)(B) of FIFRA which required registrants of products containing
MCPA used as an active ingredient to develop and submit certain data.
The data/information was determined to be necessary to satisfy the
reregistration requirements of section 4(g) of FIFRA. Failure to comply
with the requirements of a Phase 5 Reregistration Eligibility Decision
Product Data Call-In Notice (PDCI) is a basis for suspension under
section 3(c)(2)(B) of FIFRA.
The Scotts Company (Scotts) received the MCPA RED on March 6, 2006
(as evidenced by the signed and dated U.S. Postal Service domestic
return receipt card). They did not respond to the PDCI with the
required 90-day PDCI response for any of the three products, nor with
the required 8-month responses with the required data. A letter from
Linda Propst to Sheila Kendricks of Scotts was sent on November 14,
2006, which indicated that the Agency had not received the required
data by the established due dates. It also stated that if data were not
submitted within 15 days, a Notice of Intent to Suspend would be
initiated. The return receipt for that letter was postmarked on
November 20, 2006. On March 20, 2007, a second letter from Linda Propst
to Sheila Kendricks of Scotts was sent indicating that data had still
not been received and a Notice of Intent to Suspend will be forthcoming
if data were not received in 10 days. The return receipt for that
letter was postmarked on March 27, 2007. That letter was our second and
final attempt to obtain the necessary documentation to support these
products.
Since neither the required 90-day nor 8-month responses have been
submitted for the MCPA PDCI, this Notice of Intent to Suspend is being
issued.
VI. Conclusions
EPA issued a Notice of Intent to Suspend on the date indicated and
the Notice of Intent to Suspend was received by the registrant on April
14, 2008. The Notice of Intent to Suspend became an effective
suspension order on May 14, 2008. Any further information regarding
this Notice or the suspension order may be obtained from the contact
person noted above.
List of Subjects
Environmental protection.
Dated: November 13, 2008.
Steven Bradbury
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E8-28128 Filed 11-25-08; 8:45 am]
BILLING CODE 6560-50-S
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