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Intent to Suspend Certain Pesticide Registrations
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: September 29, 2000 (Volume 65, Number 190)]
[Notices]
[Page 58540-58546]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29se00-87]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-60057; FRL-6589-4]
Intent to Suspend Certain Pesticide Registrations
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of issuance of Notices of Intent to Suspend.
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SUMMARY: This Notice, pursuant to section 6(f)(2) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq., announces that EPA has issued Notices of Intent to Suspend
pursuant to sections 3(c)(2)(B) and 4 of FIFRA. The Notices were issued
following issuance of Section 4 Reregistration Requirements Notices by
the Agency and the failure of registrants subject to the Section 4
Reregistration Requirements Notices to take appropriate steps to secure
the data required to be submitted to the Agency. This Notice includes
the text of a Notice of Intent to Suspend, absent specific chemical,
product, or factual information. Table A of this Notice further
identifies the registrants to whom the Notices of Intent to Suspend
were issued, the date each Notice of Intent to Suspend was issued, the
active ingredient(s) involved, and the EPA registration numbers and
names of the registered product(s) which are affected by the Notices of
Intent to Suspend. Moreover, Table B of this Notice identifies the
basis upon which the Notices of Intent to Suspend were issued. Finally,
matters pertaining to the timing of requests for hearing are specified
in the Notices of Intent to Suspend and are governed by the deadlines
specified in section 3(c)(2)(B). As required by section 6(f)(2), the
Notices of Intent to Suspend were sent by certified mail, return
receipt requested, to each affected registrant at its address of
record.
FOR FURTHER INFORMATION CONTACT: Harold Day, Office of Compliance
(2225A), Agriculture and Ecosystem Division, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460, (202) 564-
4133.
SUPPLEMENTARY INFORMATION:
I. 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.
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 Aliphatic Alcohols, C1-C5, Benomyl, Bromacil, and Ortho-
Benzyl-Para-Chlorophenol for Failure to Comply with the Section 4
Phase 5 Reregistration Eligibility Document Data Call-In Notice
Dear Sir/Madam:
This letter gives you notice that the pesticide product
registrations listed in Attachment I will be suspended 30 days from
your receipt of this letter unless you take steps within that time to
prevent this Notice from automatically becoming a final and effective
order of suspension. The Agency's authority for suspending the
registrations of your products is sections 3(c)(2)(B) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). Upon becoming a
final and effective order of suspension, any violation of the order
will be an unlawful act under section 12(a)(2)(J) of FIFRA.
You are receiving this Notice of Intent to Suspend because you have
failed to comply with the terms of the Phase 5 Reregistration
Eligibility Document Data Call-In Notice imposed pursuant to section
4(g)(2)(b) and section (3)(2)(B) of FIFRA.
The specific basis for issuance of this Notice is stated in the
Explanatory Appendix (Attachment III) to this Notice. The affected
products and the requirements which you failed to satisfy are listed
and described in the following three attachments:
Attachment I Suspension Report--Product List
Attachment II Suspension Report--Requirement List
Attachment III Suspension Report--Explanatory Appendix
The suspension of the registration of each product listed in
Attachment I will become final unless at least one of the following
actions is completed.
1. You may avoid suspension under this Notice if you or another
person adversely affected by this Notice properly request a hearing
within 30 days of your receipt of this Notice. If you request a
hearing, it will be conducted in accordance with the requirements of
section 6(d) of FIFRA and the Agency's procedural regulations in 40 CFR
part 164.
Section 3(c)(2)(B), however, provides that the only allowable
issues which may be addressed at the hearing are whether you have
failed to take the actions which are the bases of this Notice and
whether the Agency's decision regarding the disposition of existing
stocks is consistent with FIFRA. Therefore, no substantive allegation
or legal argument concerning other issues, including but not limited to
the Agency's original decision to require the submission of data or
other information, the need for or utility of any of the required data
or other information or deadlines imposed, and the risks and benefits
associated with continued registration of the affected product, may be
considered in the proceeding. The Administrative Law Judge shall by
order dismiss any objections which have no bearing on the allowable
issues which may be considered in the proceeding.
Section 3(c)(2)(B)(iv) of FIFRA provides that any hearing must be
held and a determination issued within 75 days after receipt of a
hearing request. This 75-day period may not be extended unless all
parties in the proceeding stipulate to such an extension. If a hearing
is properly requested, the Agency will issue a final order at the
conclusion of the hearing governing the suspension of your products.
A request for a hearing pursuant to this Notice must (1) include
specific objections which pertain to the allowable issues which may be
heard at the hearing, (2) identify the registrations for which a
hearing is requested, and (3) set forth all necessary supporting facts
pertaining to any of the objections which you have identified in your
request for a hearing. If a hearing is requested by any person other
than the registrant, that person must also state
[[Page 58541]]
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 Ave., 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 Judicial Officer,
the Administrator, the Deputy Administrator, and the members of the
staff in the immediate offices of the Administrator and Deputy
Administrator. None of the persons designated as the judicial staff
shall have any ex parte communication with trial staff or any other
interested person not employed by EPA on the merits of any of the
issues involved in this proceeding, without fully complying with the
applicable regulations.
2. You may also avoid suspension if, within 30 days of your receipt
of this Notice, the Agency determines that you have taken appropriate
steps to comply with the Section 4 Phase 5 Reregistration Eligibility
Document Data Call-In Notice requirements. In order to avoid suspension
under this option, you must satisfactorily comply with Attachment II,
Requirement List, for each product by submitting all required
supporting data/information described in Attachment II and in the
Explanatory Appendix (Attachment III) to the following address
(preferably by certified mail):
Office of Compliance (2225A), Agriculture and Ecosystems Division, U.S.
Environmental Protection Agency, 1200 Pennsylvania Ave., 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 registrations of your products listed in Attachment I are
currently suspended as a result of failure to comply with another
Section 4 Data Requirements Notice or Section 3(c)(2)(B) Data Call-In
Notice, this Notice, when it becomes a final and effective order of
suspension, will be in addition to any existing suspension, i.e., all
requirements which are the bases of the suspension must be satisfied
before the registration will be reinstated.
You are reminded that it is your responsibility as the basic
registrant to notify all supplementary registered distributors of your
basic registered product that this suspension action also applies to
their supplementary registered products and that you may be held liable
for violations committed by your distributors. If you have any
questions about the requirements and procedures set forth in this
suspension notice or in the subject Section 4 Data Requirements Notice,
please contact Francisca Liem at (202) 564-2365.
Sincerely yours,
Director, Agriculture and Ecosystems Division, Office of Compliance
Attachments:
Attachment I--Product List
Attachment II--Requirement List
Attachment III--Explanatory Appendix
III. Registrants Receiving and Affected by Notices of Intent to
Suspend; Date of Issuance; Active Ingredient and Products Affected
The following is a list of products for which a letter of
notification has been sent:
Table A-List of Products
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EPA Registration
Registrant Affected Number Active Ingredient Name of Product Date Issued
----------------------------------------------------------------------------------------------------------------
Breen Laboratories 00028300003 Aliphatic Alcohols, Solu Styril Germicide 3/1/99
C1-C5 Solution
----------------------------------------------------------------------------------------------------------------
Haag Laboratories Inc. 00231100004 Ortho-Benzyl-Para- Gld Germicidal Liquid 3/6/00
Chlorophenol Detergent
----------------------------------------------------------------------------------------------------------------
[[Page 58542]]
Hi-Yield Chemical Company 03491100027 Benomyl Hi-Yield Benomyl 4/15/98
Systemic Fungicide
----------------------------------------------------------------------------------------------------------------
KC Laboratories 06316300001 Ortho-Benzyl-Para- Phenosol 3/6/00
Chlorophenol
----------------------------------------------------------------------------------------------------------------
06316300002 Ortho-Benzyl-Para- Microcide 3/6/00
Chlorophenol
----------------------------------------------------------------------------------------------------------------
Russall Products Co. Inc. 03489200004 Bromacil Russall Weed Killer 3/6/00
#1
----------------------------------------------------------------------------------------------------------------
Voluntary Purchasing Group, Inc. 00740100225 Benomyl Ferti Lome Systemic 4/15/98
Fungicide With
Benomyl
00740100407 American Brand 4/15/98
Benomyl Systemic
Fungicide
----------------------------------------------------------------------------------------------------------------
IV. Basis for Issuance of Notice of Intent; Requirement List
The following companies failed to submit the following required
data or information:
Table B-List of Requirements
----------------------------------------------------------------------------------------------------------------
Original
Registrant Affected Active Ingredient Requirement Name Due-Date
----------------------------------------------------------------------------------------------------------------
Breen Laboratories Aliphatic Alcohols, C1-C5 90-Day Response 6/22/98
Chemical Identity 6/22/98
(Guideline Reference No:
61-1)
Beginning Material and 6/22/98
Manufacturing Process
(Guideline Reference No:
61-2(a))
Preliminary Analysis of 6/22/98
Product Samples (Guideline
Reference No: 62-1)
Certification of Ingredient 6/22/98
Limits (Guideline
Reference No: 62-2)
Analytical Method to Verify 6/22/98
Certified Limits
(Guideline Reference No:
62-3)
pH (Guideline Reference No: 6/22/98
63-12)
Oxidizing/Reducing Action 6/22/98
(Guideline Reference No:
63-14)
Viscosity (Guideline 6/22/98
Reference No: 63-18)
Color (Guideline Reference 6/22/98
No: 63-2)
Corrosion Characteristics 6/22/98
(Guideline Reference No:
63-20)
Physical State (Guideline 6/22/98
Reference No: 63-3)
Density, Bulk Density, or 6/22/98
Specific Gravity
(Guideline Reference No:
63-7)
Odor (Guideline Reference 6/22/98
No: 63-4)
Discussion of Impurities 6/22/98
(Guideline Reference No:
61-2(b))
Flammability (Guideline 6/22/98
Reference No: 63-15)
Explodability (Guideline 6/22/98
Reference No: 63-16)
Storage Stability 6/22/98
(Guideline Reference No:
63-17)
Miscibility (Guideline 6/22/98
Reference No: 63-19)
Dielectric Breakdown 6/22/98
Voltage (Guideline
Reference No: 63-21)
Products for Use on Hard 6/22/98
Surfaces (Guideline
Reference No: 91-2)
Products Requiring 6/22/98
Confirmatory Data
(Guideline Reference No:
91-3)
Products for Use on Fabrics 6/22/98
and Textiles (Guideline
Reference No: 91-4)
Air Sanitizers (Guideline 6/22/98
Reference No: 91-5)
Products for Control of 6/22/98
Microbial Pests (Guideline
Reference No: 91-7)
Products for Treating Water 6/22/98
Systems (Guideline
Reference No: 91-8)
----------------------------------------------------------------------------------------------------------------
Haag Laboratories Inc. Ortho-Benzyl-Para- Chemical Identity 7/13/97
Chlorophenol (Guideline Reference No:
61-1)
Beginning Material and 7/13/97
Manufacturing Process
(Guideline Reference No:
61-2(a)).
Discussion of Impurities 7/13/97
(Guideline Reference No:
61-2(b))
Preliminary Analysis of 7/13/97
Product Samples (Guideline
Reference No: 62-1)
Certification of Ingredient 7/13/97
Limits (Guideline
Reference No: 62-2)
Analytical Method to Verify 7/13/97
Certified Limits
(Guideline Reference No:
62-3)
pH (Guideline Reference No: 7/13/97
63-12)
[[Page 58543]]
Stability (Guideline 7/13/97
Reference No: 63-13)
Flammability (Guideline 7/13/97
Reference No: 63-15)
Storage Stability 7/13/97
(Guideline Reference No:
63-17)
Viscosity (Guideline 7/13/97
Reference No: 63-18)
Color (Guideline Reference 7/13/97
No: 63-2)
Corrosion Characteristics 7/13/97
(Guideline Reference No:
63-20)
Physical State (Guideline 7/13/97
Reference No: 63-3)
Odor (Guideline Reference 7/13/97
No: 63-4)
Density, Bulk Density, or 7/13/97
Specific Gravity
(Guideline Reference No:
63-7)
Acute Oral Toxicity--Rat 7/13/97
(Guideline Reference No:
81-1)
Acute Dermal Toxicity-- 7/13/97
Rabbit/Rat (Guideline
Reference No: 81-2)
Acute Inhalation Toxicity-- 7/13/97
Rat (Guideline Reference
No: 81-3)
Primary Eye Irritation-- 7/13/97
Rabbit (Guideline
Reference No: 81-4)
Primary Dermal Irritation 7/13/97
(Guideline Reference No:
81-5)
Dermal Sensitization 7/13/97
(Guideline Reference No:
81-6)
Confidential Statement of 7/13/97
Formula (CSF) Form
----------------------------------------------------------------------------------------------------------------
Hi-Yield Chemical Company Benomyl Dislodgeable Foliar 6/16/94
Residue: Crop (Guideline
Reference No: 132-1)
Dermal Passive Dosimetry 6/16/94
Exposure (Guideline
Reference No: 133-3)
Worker Reentry Exposure 6/16/94
(WRE); Crop-Grapes; Site-
CA (Guideline Reference
No: 133-3)
Inhalation Passive 6/16/94
Dosimetry Exposure
(Guideline Reference No:
133-4)
Inhalation Exposure: Mixer/ 6/16/94
Loader/Applicator
(Guideline Reference No:
232)
----------------------------------------------------------------------------------------------------------------
KC Laboratories Benomyl Chemical Identity 7/13/97
(Guideline Reference No:
61-1)
Beginning Material and 7/13/97
Manufacturing Process
(Guideline Reference No:
61-2(a))
Discussion of Impurities 7/13/97
(Guideline Reference No:
61-2(b))
Preliminary Analysis of 7/13/97
Product Samples (Guideline
Reference No: 62-1)
Certification of Ingredient 7/13/97
Limits (Guideline
Reference No: 62-2)
Analytical Method to Verify 7/13/97
Certified Limits
(Guideline Reference No:
62-3)
Color (Guideline Reference 7/13/97
No: 63-2)
Physical State (Guideline 7/13/97
Reference No: 63-3)
Odor (Guideline Reference 7/13/97
No: 63-4)
Density, Bulk Density, or 7/13/97
Specific Gravity
(Guideline Reference No:
63-7)
pH (Guideline Reference No: 7/13/97
63-12)
Stability (Guideline 7/13/97
Reference No: 63-13)
Oxidizing/Reducing Action 7/13/97
(Guideline Reference No:
63-14)
Flammability (Guideline 7/13/97
Reference No: 63-15)
Explodability (Guideline 7/13/97
Reference No: 63-16)
Storage Stability 7/13/97
(Guideline Reference No:
63-17)
Viscosity (Guideline 7/13/97
Reference No: 63-18)
Miscibility (Guideline 7/13/97
Reference No: 63-19)
Corrosion Characteristics 7/13/97
(Guideline Reference No:
63-20)
Dielectric Breakdown 7/13/97
Voltage (Guideline
Reference No: 63-21)
Acute Oral Toxicity--Rat 7/13/97
(Guideline Reference No:
81-1)
Acute Dermal Toxicity-- 7/13/97
Rabbit/Rat (Guideline
Reference No: 81-2)
Acute Inhalation Toxicity-- 7/13/97
Rat (Guideline Reference
No: 81-3)
Primary Eye Irritation-- 7/13/97
Rabbit (Guideline
Reference No: 81-4)
Primary Dermal Irritation 7/13/97
(Guideline Reference No:
81-5)
Dermal Sensitization 7/13/97
(Guideline Reference No:
81-6)
Products for Use on Hard 7/13/97
Surfaces (Guideline
Reference No: 91-2)
Products for Control of 7/13/97
Microbial Pests (Guideline
Reference No: 91-7)
Confidential Statement of 7/13/97
Formula (CSF) Form
8-Month Response 7/13/97
----------------------------------------------------------------------------------------------------------------
Russall Products Co. Inc. Bromacil Chemical Identity 9/9/97
(Guideline Reference No:
61-1)
Beginning Material and 9/9/97
Manufacturing Process
(Guideline Reference No:
61-2(a))
[[Page 58544]]
Discussion of Impurities 9/9/97
(Guideline Reference No:
61-2(b))
Preliminary Analysis of 9/9/97
Product Samples (Guideline
Reference No: 62-1)
Certification of Ingredient 9/9/97
Limits (Guideline
Reference No: 62-2)
Analytical Method to Verify 9/9/97
Certified Limits
(Guideline Reference No:
62-3)
Physical State (Guideline 9/9/97
Reference No: 63-3)
Density, Bulk Density, or 9/9/97
Specific Gravity
(Guideline Reference No:
63-7)
Oxidizing/Reducing Action 9/9/97
(Guideline Reference No:
63-14)
Flammability (Guideline 9/9/97
Reference No: 63-15)
Explodability (Guideline 9/9/97
Reference No: 63-16)
Storage Stability 9/9/97
(Guideline Reference No:
63-17)
Miscibility (Guideline 9/9/97
Reference No: 63-19)
Corrosion Characteristics 9/9/97
(Guideline Reference No:
63-20)
Dielectric Breakdown 9/9/97
Voltage (Guideline
Reference No: 63-21)
Acute Oral Toxicity--Rat 9/9/97
(Guideline Reference No:
81-1)
Acute Dermal Toxicity-- 9/9/97
Rabbit/Rat (Guideline
Reference No: 81-2)
Acute Inhalation Toxicity-- 9/9/97
Rat (Guideline Reference
No: 81-3)
Primary Eye Irritation-- 9/9/97
Rabbit (Guideline
Reference No: 81-4)
Primary Dermal Irritation 9/9/97
(Guideline Reference No:
81-5)
Dermal Sensitization 9/9/97
(Guideline Reference No:
81-6)
Confidential Statement of 9/9/97
Formula (CSF) Form
90-Day Response 9/9/97
8-Month Response 9/9/97
----------------------------------------------------------------------------------------------------------------
Voluntary Purchasing Group, Inc. Benomyl Dislodgeable Foliar 6/16/94
Residue: Crop (Guideline
Reference No: 132-1)
Dermal Passive Dosimetry 6/16/94
Exposure (Guideline
Reference No: 133-3)
Worker Reentry Exposure 6/16/94
(WRE); Crop-Grapes; Site-
CA (Guideline Reference
No: 133-3)
Inhalation Passive 6/16/94
Dosimetry Exposure
(Guideline Reference No:
133-4)
Dermal Exposure: Mixer/ 6/16/94
Loader/Applicator
(Guideline Reference No:
231)
Inhalation Exposure: Mixer/ 6/16/94
Loader/Applicator
(Guideline Reference No:
232)
----------------------------------------------------------------------------------------------------------------
V. Attachment III Suspension Report--Explanatory Appendix
A discussion of the basis for the Notices of Intent to Suspend
follows:
A. Aliphatic Alcohols, C1-C5
On August 17, 1995, the Agency issued an Aliphatic Alcohols
Reregistration Eligibility Document Data Call-In Notice imposed
pursuant to section 4(g)(2)(b) and (3)(c)(2)(B) of FIFRA which required
registrants of products containing aliphatic alcohols to develop and
submit certain data. These data/information were determined to be
necessary to satisfy reregistration data requirements of section 4(g).
Failure to comply with the requirements of a Phase 5 Reregistration
Eligibility Document Data Call-In Notice is a basis for suspension
under section 3(c)(2)(B) of FIFRA.
The Aliphatic Alcohols Phase 5 Reregistration Eligibility Document
Data Call-In Notice, dated August 17, 1995, required each affected
registrant to submit data/information to the Agency to address each of
the data requirements. Those data/information were required to be
received by the Agency within 8 months of the registrant's receipt of
the Notice. While you have submitted some of the required data, the 90-
day response as well as the product chemistry and efficacy studies have
not been submitted to date. By a June 11, 1998 letter, the Agency gave
Breen Laboratories 10 days from Breen's receipt of the letter to submit
the outstanding data or the Agency might begin the registration
suspension process. Because you have not responded to that letter or
numerous phone calls to submit adequate information and the 90-day
response listed in Attachment I, the Agency is issuing this Notice of
Intent to Suspend.
B. Benomyl
On June 16, 1992, EPA issued a Data Call-In Notice the under
authority of FIFRA section 3(c)(2)(B) which required registrants of
products containing benomyl used as an active ingredient to develop and
submit data. These data/information were determined to be necessary to
maintain the continued registration of affected products. Failure to
comply with the requirements of a Data Call-In Notice is a basis for
suspension under section (3)(c)(2)(B) of FIFRA.
The Benomyl Data Call-In Notice dated June 16, 1992, required each
affected registrant to submit materials relating to the election of the
options to address each of the data requirements. That submission was
required to be received by the Agency within 90 days of the
registrant's receipt of the Notice. On July 1, 1992, the Agency
received your response in which you claimed a Generic Data Exemption
(GDE).
On May 24, 1995, E.I. DuPont de Nemours & Company, submitted a
request to amend their benomyl registrations to delete uses on turf and
lawn grasses. The Agency approved this
[[Page 58545]]
request and published a notice to this effect in the September 13, 1995
Federal Register. These use deletions became effective on December 12,
1995. DuPont's current benomyl registrations and labels do not include
any uses of benomyl on turf and lawn grasses. Since the basic
manufacturer of benomyl, E.I. DuPont de Nemours and Company, has
deleted from their benomyl registrations all uses on turf and lawn
grasses, the responsibility for generating the necessary data to
support these uses shifted to remaining end-use registrants.
On December 2, 1996, you were sent and received a letter in
reference to your GDE which you sought in your response to the Benomyl
Data Call-In issued in 1992. In this letter you were informed that the
basic registrant, E.I. DuPont de Nemours, was no longer supporting the
use of benomyl on turf and lawn grasses and had deleted all turf and
lawn grass uses from its registrations and labels. Pursuant to FIFRA
section 3(c)(2)(B), your GDE for your affected products was revoked.
The letter also gave you some options, including submitting data
specified in the Data Call-In. The letter required you to inform the
Agency of your election of one of these options within 30 days of your
reciept of the Agency's letter. You received the Agency's December 2,
1996 letter on December 9, 1996, as evidenced by a return receipt green
card. The Agency has not received from you the required election of
options, nor the required data or amendments to delete the affected
uses from your registrations and labels.
Because the Agency has not received a response from you, as a
benomyl end-use registrant, to undertake the required testing, or any
other appropriate response, the Agency is initiating this Notice of
Intent to Suspend the benomyl registrations described in Attachment II.
This action is required under FIFRA in these circumstances.
C. Bromacil
The Bromacil Registration Eligibility Document Data Call-In Notice
for bromacil was issued May 22, 1997. The 90-day responses were due on
September 9, 1997, and the 8-month responses were due on January 17,
1998. An Agency letter dated October 23, 1997, was mailed to Russall
Products Company requiring within 20 days of receipt of the letter
submission of the overdue 90-day response for Russall's bromacil
product registration. The letter was received on October 28, 1997, as
evidenced by the U.S. Postal Service return receipt. The Agency has not
received a 90-day response either from Russall. Likewise, an Agency
letter dated February 10, 1998, was mailed certified mail return
receipt requested to Russall stating that both the 90-day and 8-month
responses were overdue. The letter required Russall to submit the 90-
day and 8-month responses within 20 days of reciept of the letter.
Russall received the February 10, 1998 letter on February 18, 1998, as
evidenced by a U.S. Postal Service return receipt. The Agency has not
received any 8-month responses.
On October 5, 1998, Karen Jones, of EPA's Special Review and
Reregistration Division/Product Reregistration Branch, spoke with
Martin Derise, the contact person for Russall Products Company,
regarding Russall's overdue 90-day and 8-month responses to the
Bromacil Data Call-In. During this phone conversation, Mr. Derise
informed Ms. Jones that Dr. J.B. Ruck & Associates is the consultant
handling the reregistration of their bromacil product. On several
occasions during the last year, Dr. Ruck indicated Russall Products
plans to voluntarily cancel the bromacil product. The Agency has not
received the voluntary cancellation.
On October 19, 1999, the Agency sent another letter to Dr. Ruck (a
courtesy copy of the letter was also sent to Mr. Derise via certified
mail) requesting that the voluntary cancellation or the 90-day and 8
month responses be submitted within 20 days of receipt of the letter.
In the same letter, the Agency also notified Russall Products Company
that failure to submit a response would result in a Notice of Intent to
Suspend for Russall's Bromacil product registration. Dr. Ruck received
the October 19, 1999 letter on October 22, 1999, and Mr. Derise
received the letter on October 22, 1999.
To date, the Agency has not received either the voluntary
cancellation or the 90-day or 8-month responses. Based on the 1997
Bromacil Data Call-In, Russall Products Company is not in compliance;
therefore, the Agency is issuing this Notice of Intent to Suspend.
D. Ortho-Benzyl-Para-Chlorophenol
Haag Laboratories, Inc.
On November 15, 1996, EPA issued the Phase 5 Registration
Eligibility Document Data Call-In Notice imposed pursuant to sections
4(g)(2)(B) and 3(c)(2)(B) of FIFRA which required the registrants of
products containing 2-benzyl-4-chlorophenol used as the active
ingredient to develop and submit certain data. These data/information
were determined to be necessary to satisfy reregistration data
requirements of section 4(g). Failure to comply with the requirements
of a Phase 5 Reregistration Eligibility Document Data Call-In Notice is
a basis for suspension under section 3(c)(2)(B) of FIFRA.
The 2-Benzyl-4-chlorophenol Phase 5 Registration Eligibility
Document Data Call-In Notice dated November 15, 1996, required each
affected registrant to submit data/information to the Agency to address
each of the data requirements. Those data/information were required to
be received by the Agency within 8 months of the registrant's receipt
of the Notice. You received the Data Call-In Notice on November 18,
1996, as evidenced by the U.S. Postal Service return receipt.
The Agency received on February 25, 1997, your 90-day response to
the 2-benzyl-4-chlorophenol RED for the product, EPA registration
Number 2311-4. The response which included the ``Requirements Status
and Registrant's Response'' form dated February 18, 1997, indicated
Haag Laboratories, Inc.'s commitment to generate and submit data by the
specified due dates, for all product chemistry, acute toxicity, and
efficacy data requirements with the exception of certain waivers which
were requested for Product Chemistry Guidelines 63-14, Oxidizing or
Reducing Action; 63-16, Explodability; 63-19, Miscibility; and 63-21,
Dialectric Breakdown Voltage. The Agency approved the product chemistry
waiver requests and so informed you.
In a facsimile dated March 20, 1997, Haag Laboratories, Inc.
submitted a cover letter citing MRID 265974 and Northview Laboratories,
Inc.'s ``Report of Analysis,'' in support of the efficacy data
requirement for Guideline 91-2, AOAC Tuberculocidal Activity study.
The 8-month response to the 2-benzyl-4-chlorophenol RED was due to
the Agency on July 13, 1997. No additional data have been provided to
date to address other product-specific data requirements. In an Agency
letter dated April 26, 1999, Haag Laboratories, Inc. was given 30 days
to submit the required responses and required data. You received that
letter on April 29, 1999. The Agency has not received the remaining
required product-specific data (8-month responses).
Since Haag Laboratories, Inc. has not provided the required 8-month
responses, including the data required to meet those requirements
listed in Attachment II within the required time, the Agency is issuing
this Notice of Intent to Suspend.
Ortho-Benzyl-Para-Chlorophenol
KC Laboratories
On November 15, 1996, EPA issued the Phase 5 Registration
Eligibility Document Data Call-In-Notice imposed
[[Page 58546]]
pursuant to sections 4(g)(2)(B) and 3(c)(2)(B) of FIFRA which required
the registrants of the products containing 2-benzyl-4-chlorophenol used
as the active ingredient to develop and submit certain data. These
data/information were determined to be necessary to satisfy
reregistration data requirements of section 4(g). Failure to comply
with the requirements of a Phase 5 Reregistration Eligibility Document
Data Call-In-Notice is a basis for suspension under section 3(c)(2)(B)
of FIFRA. You received this notice on November 18, 1996, as evidenced
by the U.S. Postal Service return receipt.
The Agency received on February 21, 1997, the 90-day response to
the 2-Benzyl-4-chlorophenol Data Call-In for EPA Registration Number
63163-1. The response which included the ``Requirements Status and
Registrant's Response'' form dated February 12, 1997, indicated KC
Laboratories' commitment to generate and submit all product chemistry,
acute toxicity and efficacy data required by the 2-benzyl-4-
chlorophenol, RED, Product Specific Data Call-In Notice by dates
required by the Notice.
The 8-month response including all the required data set forth in
the 2-Benzyl-4-chlorophenol Data Call-In was required to be submitted
to the Agency by July 13, 1997. In an Agency letter dated April 27,
1999, KC Laboratories was given 30 days from its receipt of the letter
to submit the 8-month response and required data. KC Laboratories
received this letter on May 3, 1999, as evidenced by the U.S. Postal
Service return receipt. To date, the Agency has not received the
product specific data (8-month response).
To date October 1, 1999, the Agency has not received the required
8-month response. Based on the 1996 2-Benzyl-4-chlorophenol Data Call-
In, KC Laboratories is not in compliance; therefore, the Agency is
issuing this Notice of Intent to Suspend.
VI. Conclusions
EPA has issued Notices of Intent to Suspend on the dates indicated.
Any further information regarding these Notices may be obtained from
the contact person noted above.
List of Subjects
Environmental protection.
Dated: September 18, 2000.
Richard Colbert,
Director, Agriculture and Ecosystems Division, Office of Compliance.
[FR Doc. 00-24782 Filed 9-28-00; 8:45 am]
BILLING CODE 6560-50-F