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): “Application for New and Amended Pesticide Registration” (EPA ICR No. 0277.13, OMB No. 2070-0060). This is a request to renew an existing ICR that is currently approved and due to expire April 30, 2002. 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-00739, must be received on or before November 19, 2001.
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-00739 in the subject line on the first page of your response.Start Further Info
FOR FURTHER INFORMATION CONTACT:
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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
I. Does this Action Apply to Me?
You may be potentially affected by this action if you are an individual or entity engaged in activities related to the registration of a pesticide product. Potentially affected categories and entities may include, but are not limited to:
|Category||NAICS codes||SIC codes||Examples of potentially affected entities|
|Pesticide and other agricultural chemical manufacturing||325320||286—Industrial organic chemicals||Individuals or entities engaged in activities related to the registration of a pesticide product.|
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?
You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet homepage at http://www.epa.gov/. On the homepage select “Laws and Regulations,” “Regulations and Proposed Rules,” 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 http://www.epa.gov/fedrgstr/.
Using a faxphone call (202) 401-0527 and select item 6090 for a copy of the ICR.
C. In Person
The Agency has established an official record for this action under docket control number OPP-00739. 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.Start Printed Page 48131
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-00739 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 Friday, 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: email@example.com, or you can submit a computer disk as described in Units III.A.1. and III.A.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-00739. 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 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 the Paperwork Reduction Act (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: Application for New and Amended Pesticide Registration.
ICR numbers: EPA ICR No. 0277.13, OMB No. 2070-0060.
ICR status: This ICR is a renewal of an existing ICR that is currently approved by OMB and is due to expire April 30, 2002.
Abstract: This data collection program is designed to provide EPA with necessary data to evaluate an application of a pesticide product as required under section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
An individual or entity wanting to obtain a registration for a pesticide product must submit an application package consisting of information relating to the identity and composition of the product, proposed labeling, and supporting data (or compensation for others' data) for the product as outlined in 40 CFR part 158. The EPA bases registration decisions for pesticides on its evaluation of a battery of test data provided primarily by applicants for registration. Required studies include testing to show whether a pesticide has the potential to cause unreasonable adverse human health or environmental effects. The Agency currently collects data on physical chemistry, acute and chronic toxicology, environmental fate, ecological effects, worker exposure, residue chemistry, environmental chemistry, and product performance. If EPA's evaluation of the data show that the statutory requirements of FIFRA are met, then a registration is approved. Under FIFRA, all pesticides must be registered by EPA before they may be sold or distributed in U.S. commerce.
Registrants of EPA-registered pesticide products at times become subject to regulations or guidance that include labeling revisions. The revised labeling is submitted as an amendment to the Agency along with the completed application form. Normally, data are not required or reviewed for revised labeling regulations or guidance; however, it is necessary that the revised labeling be reviewed and approved. This review is most often accomplished by a Product Manager (PM) or Team Leader, in one of the three regulatory divisions responsible for pesticide registration (the Registration Division, the Antimicrobial Division, and the Biopesticides and Pollution Prevention Division), who ensure that revisions are in compliance with the applicable labeling requirement or guidance.
V. What are EPA's Burden and Cost Estimates for this ICR?
Under the PRA, “burden” means the total time, effort, or financial resources Start Printed Page 48132expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal Agency. For this collection it includes the time needed 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 for this ICR is estimated to be 231,280 hours, with an annual respondent cost of $16,426,080. The following is a summary of the estimates taken from the ICR:
Respondents/affected entities: Individuals or entities engaged in activities related to the registration of a pesticide product.
Estimated total number of potential respondents: 2,100.
Frequency of response: As needed.
Estimated total/average number of responses for each respondent: 3-5.
Estimated total annual burden hours: 231,280.
Estimated total annual burden costs: $16,426,080.
VI. Are There Changes in the Estimates from the Last Approval?
The total respondent burden hour estimate under this ICR has increased from 212,640 to 231,280 hours per year, or a total net increase of 18,640 hours. The total applicant costs have increased from approximately $6.0 million to $16.4 million per year, for a total net increase of approximately $10.4 million. This increase in costs is due mainly to the update in the loaded labor hourly rates used to calculate the costs. There are no capital costs associated with this information collection activity.
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.Start List of Subjects
List of Subjects
- Environmental protection
- Reporting and recordkeeping requirements
Dated: September 6, 2001.
Susan B. Hazen,
Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances.
[FR Doc. 01-23226 Filed 9-17-01; 8:45 am]
BILLING CODE 6560-50-S