Pesticide registration, cancellation, etc.: Breen Laboratories et al.,
[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]
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.
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:
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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.
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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.
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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
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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.
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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
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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
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
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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
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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)
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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))
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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)
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Attachment III Suspension Report--Explanatory Appendix
A discussion of the basis for the Notices of Intent to Suspend follows:
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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.
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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
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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.
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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.
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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
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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.
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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. 00-24782Filed9-28-00; 8:45 am]
BILLING CODE 6560-50-F
