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Data Acquisition for Registration; Renewal of Pesticide Information Collection Activities and Request for Comments

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Environmental Protection Agency (EPA).




In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this notice announces that EPA is seeking public comment on the following Information Collection Request (ICR): “Data Acquisition for Registration (EPA ICR No. 1503.03, OMB No. 2070-0122).” This is a request to renew an existing ICR that is currently approved and due to expire December 31, 2000. The ICR describes the nature of the information collection activity and its expected burden and costs. Before submitting this ICR to the Office of Management and Budget (OMB) for review and approval under the PRA, EPA is soliciting comments on specific aspects of the collection.


Written comments, identified by the docket control number OPP-00667, must be received on or before October 2, 2000.


Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit III. of the “SUPPLEMENTARY INFORMATION.” To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00667 in the subject line on the first page of your response.

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By mail: Nancy Vogel, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-6475; fax number: (703) 305-5884; e-mail address:

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I. Does this Action Apply to Me?

You may be potentially affected by this action if you are a pesticide registrant with a product registered under section 3 or section 24(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Potentially affected categories and entities may include, but are not limited to:

CategoryNAICS codesSIC codesExamples of potentially affected entities
Pesticide and other agricultural chemical manufacturing325320286—Industrial organic chemicalsPesticide registrants
287—Agricultural chemicals

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this table could also be affected. The North American Industrial Classification System (NAICS) codes and the Standard Industrial Classification (SIC) codes are provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under “FOR FURTHER INFORMATION CONTACT.”

II. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

A. Electronically

You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at​. On the Home Page select “Laws and Regulations” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at​fedrgstr/​.

B. Fax-on-Demand

Using a faxphone call (202) 401-0527 and select item 6082 for a copy of the ICR.

C. In Person

The Agency has established an official record for this action under docket control number OPP-00667. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

III. How Can I Respond to this Action?

A. How and to Whom Do I Submit the Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP-00667 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Start Printed Page 47492Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

3. Electronically. You may submit your comments and/or data electronically by e-mail to: “,” or you can submit a computer disk as described in Units III.A.1. and 2. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP-00667. Electronic comments may also be filed online at many Federal Depository Libraries.

B. How Should I Handle CBI that I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under “FOR FURTHER INFORMATION CONTACT.”

C. What Should I Consider when I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Offer alternative ways to improve the collection activity.

7. Make sure to submit your comments by the deadline in this notice.

8. To ensure proper receipt by EPA, be sure to identify the docket control number and administrative record number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

D. What Information is EPA Particularly Interested in?

Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits comments and information to enable it to:

1. Evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.

2. Evaluate the accuracy of the Agency's estimates of the burdens of the proposed collections of information.

3. Enhance the quality, utility, and clarity of the information to be collected.

4. Minimize the burden of the collections of information on those who are to respond, including through the use of appropriate automated or electronic collection technologies or other forms of information technology, e.g., permitting electronic submission of responses.

IV. What Information Collection Activity or ICR Does this Action Apply to?

EPA is seeking comments on the following ICR:

Title: Data Acquisition for Registration

ICR numbers: EPA ICR No. 1503.03, OMB No. 2070-0122

ICR status: This a renewal of an existing ICR that is currently approved by OMB and is due to expire December 31, 2000. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information that is subject to the approval under the PRA, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's information collections appear on the collection instruments or instructions, in the Federal Register notices for related rulemakings and ICR notices, and, if the collection is contained in a regulation, in a table of OMB approval numbers in 40 CFR part 9.

Abstract: The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136) requires the EPA to register pesticides prior to distribution and sale within the United States. FIFRA also requires applicants for pesticide registration to provide EPA with the data needed to assess whether the registration of a pesticide would cause unreasonable adverse effects on human health or the environment, and grants EPA the authority to require registrants to provide additional data to maintain an existing registration.

Sometimes additional data are necessary for the Agency's Office of Pesticide Programs (OPP) to evaluate whether a current registration should be maintained. One common trigger for the requirement of additional data is the EPA's program to reduce the use of pesticide inert ingredients of toxicological concern, which may lead to additional data needed to support continued use of these ingredients in registered pesticides. When the need for additional data arises, OPP issues to affected registrants a Data Call-In notice (DCI) under the authority of FIFRA section 3(c)(2)(B). In addition, data supporting pesticide inert ingredients may be called-in based on OPP's policy statement on inert ingredients in pesticide products (52 FR 13305, April 22, 1987, and November 22, 1989, 54 FR 48314).

Registrants of products containing inert ingredients of toxicological concern (List 1, chemicals for which data already exist that demonstrate a defined toxicological effect) will be subject to a DCI. Since these inert ingredients have demonstrated certain toxic effects, OPP requires the submission of data equivalent to 40 CFR part 158 data requirements for active ingredients. The full complement of 40 CFR part 158 data requirements includes the submission of all applicable studies in the areas of product chemistry, residue chemistry, environmental fate, toxicology, wildlife and aquatic organisms, plant protection, and nontarget insects.

List 2 inert ingredients, which are potentially toxic may be subject to a lesser set of data. In these cases, after review of available studies, the data that will be required to be submitted will focus on the effects of concern that led to listing on List 2. The results of this testing will determine whether to elevate the inert ingredient to List 1.

V. What are EPA's Burden and Cost Estimates for this ICR?

Under the PRA, “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection it includes the time Start Printed Page 47493needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The ICR provides a detailed explanation of this estimate, which is only briefly summarized in this notice. The annual public burden is estimated to be 91,196 hours. The following is a summary of the estimates taken from the ICR:

Respondents/affected entities: Nine

Frequency of response: Once annually

Estimated total/average number of responses for each respondent: One

Estimated total annual burden hours: 91,196

Estimated total annual burden costs: $7,571,569

VI. Are There Changes in the Estimates from the Last Approval?

The total annual burden hours and cost estimated for respondents have decreased from 208.132 to 91,196 due to a decrease in number of respondents and the associated cost from $16,011,809 to $7,571,569. While there was an increase in the number of responses from 5 to 6 for List 2 inert ingredients, the number of respondents for special studies decreased from 23 to respondents to one. Meeting the new FQPA standard has increased the burden hours for additional studies by 9%. Cost increases occurred in the estimated hourly rates for management, technical, and clerical reflect more current values from $114.2 to $123, $76.91 to $83, and from $34.96 to $38 respectively.

VII. What is the Next Step in the Process for this ICR?

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person listed under “FOR FURTHER INFORMATION CONTACT.”

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List of Subjects

  • Environmental protection
  • Reporting and recordkeeping requirements
  • Inert ingredients
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Dated: July 18, 2000.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances.

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[FR Doc. 00-19348 Filed 8-1-00; 8:45 am]