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Notice

Intent to Suspend Certain Pesticide Registrations

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Information about this document as published in the Federal Register.

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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. 136 et seq., announces that EPA issued Notices of Intent to Suspend pursuant to section 3(c)(2)(B) of FIFRA. The Notices of Intent to Suspend were issued following issuance of Data Call-In Notices (DCI). The DCIs required registrants of products containing captan and DCPA used as an active ingredient to develop and submit certain data. These data were determined to be necessary to maintain the continued registration of affected products. Failure to comply with the data requirements of a DCI is a basis for suspension under section 3(c)(2)(B) of FIFRA. This Notice includes the text of the Notices of Intent to Suspend issued to Riverdale Chemical Company and Voluntary Purchasing Group. As required by section 6(f)(2), the Notices of Intent to Suspend were sent by certified mail, return receipt requested to each affected registrant at its address of record.

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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.

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SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you hold EPA registrations for products that contain captan or DCPA. Potentially affected entities may include, but are not limited to, pesticide registrants. Other types of entities not listed in this unit could also be affected. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in the above-mentioned Data Call-Ins and FIFRA, specifically section 3(c)(2)(B). If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0322. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/​fedrgstr/​.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/​edocket/​ to view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

II. What Action is the Agency Taking?

This Notice, pursuant to section 6(f)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., announces that EPA issued Notices of Intent to Suspend pursuant to section 3(c)(2)(B) of FIFRA to Riverdale Chemical Company and Voluntary Purchasing Group. The Notices of Intent to Suspend were issued on September 25, 2003.

III. Text of the Notice to Suspend

The text of the Notices of Intent to Suspend absent specific chemical, product, or factual information issued to Riverdale Chemical Company and Voluntary Purchasing Group follows:

United States Environmental Protection Agency

Office of Prevention, Pesticides and Toxic Substances

Washington, DC 20460

September 25, 2003

Certified Mail

Return Receipt Requested

SUBJECT: Suspension of Registration of Pesticide Product(s) Containing XXXX for Failure to Comply with the XXXX Section 4 Phase 5 Reregistration Eligibility Document Data Call-In Notice Issued XXXX

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 Start Printed Page 69402conclusion of the hearing governing the suspension of your product(s).

A request for a hearing pursuant to this Notice must: (1) include specific objections which pertain to the allowable issues which may be heard at the hearing, (2) identify the registrations for which a hearing is requested, and (3) set forth all necessary supporting facts pertaining to any of the objections which you have identified in your request for a hearing. If a hearing is requested by any person other than the registrant, that person must also state specifically why he asserts that he would be adversely affected by the suspension action described in this Notice. Three copies of the request must be submitted to:

Hearing Clerk, 1900

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460

An additional copy should be sent to the signatory listed below. The request must be received by the Hearing Clerk by the 30th day from your receipt of this Notice in order to be legally effective. The 30-day time limit is established by FIFRA and cannot be extended for any reason. Failure to meet the 30-day time limit will result in automatic suspension of your registration(s) by operation of law and, under such circumstances, the suspension of the registration for your affected product(s) will be final and effective at the close of business 30 days after your receipt of this Notice and will not be subject to further administrative review.

The Agency's Rules of Practice at 40 CFR 164.7 forbid anyone who may take part in deciding this case, at any stage of the proceeding, from discussing the merits of the proceeding ex parte with any party or with any person who has been connected with the preparation or presentation of the proceeding as an advocate or in any investigative or expert capacity, or with any of their representatives. Accordingly, the following EPA offices, and the staffs thereof, are designated as judicial staff to perform the judicial function of EPA in any administrative hearings on this Notice of Intent to Suspend: the Office of the Administrative Law Judges, the Office of the Environmental Appeals Board, the Administrator, the Deputy Administrator, and the members of the staff in the immediate offices of the Administrator and Deputy Administrator. None of the persons designated as the judicial staff shall have any ex parte communication with trial staff or any other interested person not employed by EPA on the merits of any of the issues involved in this proceeding, without fully complying with the applicable regulations.

2. You may also avoid suspension if, within 30 days of your receipt of this Notice, the Agency determines that you have taken appropriate steps to comply with the section 3(c)(2)(B) Data Call-In Notice. In order to avoid suspension under this option, you must satisfactorily comply with Attachment II, Requirement List, for each product by submitting all required supporting data/information described in Attachment II and in the Explanatory Appendix (Attachment III) to the following address (preferably by certified mail):

Office of Compliance (2225A)

Agriculture Division

U.S. Environmental Protection Agency

1200 Pennsylvania Avenue, NW

Washington, DC 20460

For you to avoid automatic suspension under this Notice, the Agency must also determine within the applicable 30-day period that you have satisfied the requirements that are the bases of this Notice and so notify you in writing. You should submit the necessary data/information as quickly as possible for there to be any chance the Agency will be able to make the necessary determination in time to avoid suspension of your product(s).

The suspension of the registration(s) of your company's product(s) pursuant to this Notice will be rescinded when the Agency determines you have complied fully with the requirements which were the bases of this Notice. Such compliance may only be achieved by submission of the data/information described in the attachments to the signatory below.

Your product will remain suspended, however, until the Agency determines you are in compliance with the requirements which are the bases of this Notice and so informs you in writing.

After the suspension becomes final and effective, the registrant subject to this Notice, including all supplemental registrants of product(s) listed in Attachment I, may not legally distribute, sell, use, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person, the product(s) listed in Attachment I.

Persons other than the registrant subject to this Notice, as defined in the preceding sentence, may continue to distribute, sell, use, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person, the product(s) listed in Attachment I.

Nothing in this Notice authorizes any person to distribute, sell, use, offer for sale, hold for sale, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver, to any person, the product(s) listed in Attachment I in any manner which would have been unlawful prior to the suspension.

If the registration(s) for your product(s) listed in Attachment I are currently suspended as a result of failure to comply with another section 3(c)(2)(B) Data Call-In Notice or Section 4 Data Requirements Notice, this Notice, when it becomes a final and effective order of suspension, will be in addition to any existing suspension, i.e., all requirements which are the bases of the suspension must be satisfied before the registration will be reinstated.

You are reminded that it is your responsibility as the basic registrant to notify all supplementary registered distributors of your basic registered product that this suspension action also applies to their supplementary registered products and that you may be held liable for violations committed by your distributors.

If you have any questions about the requirements and procedures set forth in this suspension notice or in the subject section 3(c)(2)(B) Data Call-In Notice, please contact Frances Liem at (202) 564-2365.

Sincerely yours,

Director, Agriculture Division, Office of Compliance.

Attachment I Suspension Report - Product List

Attachment II Suspension Report - Requirement List

Attachment III Suspension Report - Explanatory Appendix

IV. Registrants Receiving and Affected by the Notices of Intent to Suspend

The following is a list of products for which a Notice of Intent to Suspend been sent:

Table A.—Product List

Registrant AffectedEPA Registration NumberActive IngredientProduct NameDate DCI Issued
Riverdale Chemical Company228-99DCPARiversale 10% Dacthal Granules11/25/98
228-157DCPARiverdale Crabgrass Control and Fertilizer11/25/98
228-222DCPARiverdale 25% Dacthal Dust11/25/98
Voluntary Purchasing Group7401-438CaptanFerti-Lome Liquid Fruit Tree Spray11/2/99
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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:

Table B.—Requirement List

CompanyActive IngredientGuideline Reference NumberRequirement NameDue Date
Riverdale Chemical CompanyDCPA---30-Day response7/12/01
---4-Month response10/12/01
61-1Product identity and composition10/12/01
61-2(a)Description of starting materials10/12/01
61-2(b)Discussion of impurity formation10/12/01
62-1Preliminary analysis10/12/01
62-2Certification of limits10/12/01
62-3Analytical method10/12/01
63-2Color10/12/01
63-3Physical state10/12/01
63-4Odor10/12/01
63-7Density10/12/01
63-12pH10/12/01
63-14Oxidation/reduction10/12/01
63-15Flammability10/12/01
63-16Explodability10/12/01
63-17Storage Stability10/12/01
63-18Viscosity10/12/01
63-19Miscibility10/12/01
63-20Corrosion characteristics10/12/01
81-1Acute oral toxicity10/12/01
81-2Acute dermal toxicity10/12/01
81-3Acute inhalation toxicity10/12/01
81-4Primary eye irritation10/12/01
81-5Primary dermal irritation10/12/01
81-6Skin sensitization10/12/01
Voluntary Purchasing GroupCaptan830.1750Certification of limits04/12/03
830.1800Enforcement analytical method04/12/03
830.6317Storage stability04/12/03
830.6320Corrosion characteristics04/12/03
---Revised Confidential Statements of Formula04/12/03
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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. Captan

On November 2, 1999, the Agency issued the Phase 5 Reregistration Eligibility Document Data Call-In Notice pursuant to sections 4(g)(2)(B) and 3(c)(2)(B) of FIFRA which required the registrants of products containing captan used as an active ingredient to develop and submit certain data. These data/information were determined to be necessary to satisfy reregistration requirements of section 4(g). Failure to comply with the requirements of a Phase 5 Reregistration Eligibility Document Data Call-In Notice is a basis for suspension under section 3(c)(2)(B) of FIFRA.

Voluntary Purchasing Group, Inc. received the Captan Reregistration Eligibility Document (RED) on November 20, 1999, as evidenced by a U.S. Postal Service domestic return receipt card. Therefore, the 90-day response was due on February 20, 2000, and the 8-month response was due on July 20, 2000. The company's 90-day response, dated April 18, 2000 was received by the Agency on April 18, 2000. The company agreed to satisfy the data requirements by developing and submitting the data to the Agency. It stated that the studies would be initiated within 2 weeks and it estimated that the studies would take approximately 5 months to complete.

By a letter dated February 8, 2001, the Agency informed Mr. Michael Jackson (Brazos Associates, Inc., Agent for Voluntary Purchasing Group) that Voluntary Purchasing Group's 8-month response was overdue. In a letter dated March 7, 2001, Brazos Associates, Inc. requested a time extension of an additional 4 months for submission of the product chemistry and acute toxicity studies. Additionally, the registrant asked for more time to submit the storage stability/corrosion data. The rationale for the time extension requests was based on problems that Brazos stated were being encountered with the test material and analytical procedures employed by Stillmeadow, Inc. (Laboratory). Brazos stated that these problems had delayed the development of studies, particularly the storage stability and corrosion characteristics studies. The Agency agreed to place these latter two studies on hold until Stillmeadow resolved problems with the analytical procedures. The registrant agreed to provide quarterly progress reports. The 4-month time extension was granted in an Agency letter dated March 21, 2001.

The Agency received the 8-month response on November 16, 2001. Product specific data purporting to address product chemistry and acute toxicity guidelines were received. In the transmittal letter dated November 14, 2001, Brazos Associates noted that Stillmeadow was still experiencing problems with the test material for storage stability, corrosion characteristics, and enforcement analytical method studies. Therefore, Brazos Associates initiated a second set of these studies with Product Safety Labs to determine if it was a laboratory/company problem or actual problem with the analytical methods being utilized.

On January 31, 2003, the Agency completed the review of the product chemistry data submitted to support the reregistration of Voluntary Purchasing Group's captan product and found remaining deficiencies in the data that prevented the requirements from being satisfied. An Agency letter to Brazos Associates dated March 12, 2003 outlined the product chemistry deficiencies. Voluntary Purchasing Group was required to submit revised Confidential Statements of Formula, and product chemistry data for Guidelines 830.1750 Certified Limits, and 830.1800 Enforcement Analytical Method. Additionally, Voluntary Purchasing Group was also required to notify the Agency within 30 days of their receipt of the letter whether the storage stability and corrosion characteristics studies have been initiated and their expected completion dates. Brazos received the letter on behalf of Voluntary Purchasing Group on March 17, 2003.

On July 8, 2003, Ms. Karen Jones contacted Brazos Associates to determine if Voluntary Purchasing Group planned to submit the outstanding product chemistry data. Mr. Jackson of Brazos Associates indicated that Voluntary Purchasing Group did not plan to submit a response or data. Ms. Jones informed Mr. Jackson that the Agency would issue a Notice of Intent to Suspend (NOIS) for Voluntary Purchasing Group's failure to respond to the Agency's letter dated March 12, 2003 and to adequately satisfy the data requirements imposed by the Captan RED DCI.

To date, the Agency has not received required product chemistry data for Certification of Limits, Enforcement Analytical Method, or a Revised Confidential Statement of Formula. Additionally, the Agency has not received the required Storage Stability and Corrosion Characteristics product chemistry data, nor required progress reports.

Because the registrant has not supplied the required data to support its captan product registration, this Notice of Intent to Suspend is being issued.

B. DCPA

On November 25, 1998, the Agency issued the Phase 5 Reregistration Eligibility Document (RED) Data Call-In Notice pursuant to sections 4(g)(2)(B) and 3(c)(2)(B) of FIFRA which required the registrants of products containing DCPA used as an active ingredient to develop and submit certain data. These data/information were determined to be necessary to satisfy reregistration requirements of section 4(g). Failure to comply with the requirements of a Phase 5 Reregistration Eligibility Document Data Call-In Notice (DCI) is a basis for suspension under section 3(c)(2)(B) of FIFRA.

An Agency letter dated June 4, 2001, was sent to all DCPA registrants. The letter modified the DCI and established new time frames for submitting the generic and product specific data required in the DCPA RED. Riverdale Chemical Company received the letter modifying the deadlines imposed by the DCPA RED on June 12, 2001, as evidenced by a U.S. Postal Service Domestic return receipt card. Therefore, Riverdale's 30-day response was due on July 12, 2001, and the 4-month response was due on October 12, 2001.

On August 15, 2001, Ms. Venus Eagle on behalf of the Agency contacted Mr. Sawyer, the Regulatory Affairs Manager at Riverdale Chemical Company, to inquire why Riverdale had not responded to the June 4, 2001 letter which Riverdale received on June 12, 2001. Riverdale was required to respond 30 days after its receipt of the letter, that is, by July 12, 2001. Mr. Sawyer stated that his colleagues had not decided whether they wanted to support the DCPA end-use products or not. Ms. Eagle stated he had in effect already had 30 additional days since the deadline of July 12, 2001 to inform the Agency of its decision. Mr. Sawyer then responded that the Agency could issue a NOIS in lieu of waiting for Riverdale's answer.

On September 7, 2001, three letters (dated September 6, 2001) were received (for EPA Registration Nos. 228-99, 228-157, and 228-222) stating that Riverdale planned to “respond positively to the reregistration” of the subject products and that it “will be sending in the necessary documentation to continue” the registrations. However, by the deadline of October 12, 2001, no product specific data had been Start Printed Page 69405submitted for any of Riverdale's affected products. On March 11, 2002, Ms. Eagle spoke with Mr. Sawyer about the overdue product specific data. Mr. Sawyer responded that the samples got lost in December 2001, and they were just starting the data. Ms. Eagle told him that the Agency would have to issue a NOIS. Mr. Sawyer stated “go ahead then.”

Since the required product chemistry and acute toxicity data have not been submitted for EPA Registration Nos. 228-99, 228-157, and 228-222, this Notice of Intent to Suspend is being issued.

V. What is the Agency's Authority for Taking this Action?

The Agency's authority for taking this action is section 6(f)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq.

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List of Subjects

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Dated: November 6, 2003.

Richard Colbert,

Director, Agriculture Division, Office of Compliance, Office of Enforcement and Compliance Assurance.

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[FR Doc. 03-30777 Filed 12-11-03; 8:45 am]

BILLING CODE 6560-50-S