[Federal Register Volume 63, Number 74 (Friday, April 17, 1998)] [Notices] [Pages 19250-19252] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-10228] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [OPP-00531; FRL-5780-8] Renewal of Pesticide Information Collection Activities; Application for New or Amended Pesticide Registration; Request for Comments AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this notice announces that EPA is planning to submit the following continuing Information Collection Request (ICR) to the Office of Management and Budget (OMB) pursuant to the procedures described in 5 CFR 1320.12: ``Application for New or Amended Pesticide Registration'' (EPA ICR No. 277.10; OMB No. 2070-0060). Before submitting the following ICR to OMB for review and reapproval, EPA is soliciting comments on specific aspects of and recent changes to activities associated with the information collection which is briefly described below. This ICR relates to section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and covers the information collection related pesticide registration. This ICR has recently undergone several changes that impact the Agency's burden estimates. An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9. Dates: Comments must be submitted on or before June 16, 1998. ADDRESSES: Submit written comments to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person, deliver comments to: Rm. 119 of Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. Comments and data may also be submitted electronically to: opp- [email protected]. Follow the instructions under Unit III. of this document. No Confidential Business Information (CBI) should be submitted through e-mail. All comments which contain information claimed as CBI must be clearly marked as such. Three sanitized copies of any comments containing information claimed as CBI must also be submitted and will be placed in the public record for this document. The public docket is available for public inspection in Rm. 119 at the Virginia address given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. Persons submitting information any portion of which they believe is entitled to treatment as CBI by EPA must assert a business confidentially claim in accordance with 40 CFR part 2 for each such portion. This claim must be made at the time that the information is submitted to EPA. If a submitter does not assert a confidentiality claim at the time of submission, EPA will consider this a waiver of any confidentiality claim and the information may be made available to the public by EPA without further notice to the submitter. FOR FURTHER INFORMATION CONTACT: Cameo Smoot, Field and External Affairs Division, Mail Code (7506C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460, Telephone: (703) 305-5454, e-mail: [email protected]. SUPPLEMENTARY INFORMATION: Electronic Availability: Internet Electronic copies of this document and the ICR are available from the EPA Home Page at the Federal Register - Environmental Documents entry for this document under ``Laws and Regulations'' (http:// www.epa.gov/fedrgstr/). Fax-on-Demand Using a faxphone call 202-401-0527 and select item 6052 for a copy of the ICR. I. Background Affected entities: Entities potentially affected by the activities covered by this ICR are individuals or entities engaged in activities related to the registration of a pesticide product. For the collection of information addressed in this notice, EPA would like to solicit comments to: 1. Evaluate whether the proposed collection of information is 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 burden of the proposed collection of information, including the validity of the methodology and assumptions used. 3. Enhance the quality, utility, and clarity of the information to be collected. 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate, automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The Agency is particularly interested in comments and information about the burden estimates, including examples that could be used to reflect the burdens imposed. II. Information Collection EPA is seeking comments on the following ICR, as well as the Agency's intention to renew the corresponding OMB approval. Expiration date: This ICR is currently scheduled to expire on May 31, 1998. However, EPA will be seeking an extension until August 1998, in order to provide adequate time for comments to be received and evaluated, and any necessary changes made to the ICR prior to its submission to OMB. Title: Application for New or Amended Pesticide Registrations. ICR numbers: EPA No. 277.10 and OMB No. 2070-0060. Abstract: In compliance with the Paperwork Reduction Act (44 U.S.C. [[Page 19251]] 3501 et seq.), this notice announces that EPA is planning to submit the following continuing ICR to the Office of Management and Budget (OMB) pursuant to the procedures described in 5 CFR 1320.12: ``Application for New or Amended Pesticide Registration'' (EPA ICR No. 277.10; OMB No. 2070-0060). EPA requires individuals or entities seeking a registration for a pesticide product to submit an application package consisting of information relating to the identity and composition of the product, and supporting data (or compensation for other's data) for the product as outlined in 40 CFR part 158. EPA bases registration decisions for pesticides on its evaluation of a battery of test data provided primarily by the 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, and product performance. If the data show that the benefits of the pesticide product outweigh the risks, then a registration is approved. All pesticides, under FIFRA, must be registered by EPA before they may be sold or distributed in U.S. commerce. Responses to this collection of information are voluntary. As part of the registration process, applicants are asked to complete and submit at least four forms which are necessary in order to register and/or amend a pesticide product registration. These forms include:EPA Form 8570-1 (``Application for Pesticide Registration, Amendment, Other''). EPA Form 8570-4 (``Confidential Statement of Formula''). EPA Form 8570-27 (``Formulator's Exemption Statement''). EPA Form 8570-34 & 35 (``Certification With Respect to Citation of Data'' and Data Matrix''). Applicants may also submit additional forms, which are available upon request, that can be useful in the process of registering a pesticide: EPA Form 8570-36 (``Summary of the Physical/Chemical Properties''). EPA Form 8570-37 (``Self-Certification Statement for the Physical/Chemical Properties''). In addition, registrants of EPA-registered pesticide products at times become subject to regulations that include labeling revision requirements. A revised label is submitted as an amendment to the Agency along with the basic application form, EPA Form 8570-1, to notify EPA that revised product labeling is being submitted. This information collection request has changed since the last OMB approval. After extensive consultation with stakeholders, the Office of Pesticide Programs has streamlined several forms and created two new ones. The revised and new forms take less time to complete and reduce the volume of paper pesticide registrants send to the Agency. Burden time and cost will decrease for the industry and the Agency. The first streamlining measure created two forms from three existing ones. The revised data compensation form (EPA Form 8570-34) replaced two older forms. This new form allows pesticide registrants to indicate the data requirements they have completed and to reference existing data produced by another company. The second revised form, the data matrix (EPA Form 8570-35), replaced an older form by clarifying the instructions and providing more protection for data submitters. For consistency, both revised forms are used for registration and reregistration. In response to the President's Reinventing Government Initiative, EPA developed through a public notice and comment process a self- certification initiative. The outcome of this effort was the creation of two new forms, (EPA Forms 8570-36 and 8570-37), for the voluntary self-certification of product chemistry data for manufacturing-use and end-use products. The forms reduce industry's paperwork burden, expedite the review process, and reduce the amount of time the Agency needs to review the product chemistry for registration or reregistration of these products. Other changes in this information collection request will result in the reduction of the burden hours because certain information collection activities are no longer a part of this information collection. This new information collection request no longer includes burden hour estimates for activities conducted for the EPA Training Verification Program because this information is now collected under a separate information collection request. Additionally, information previously collected as a one-time information collection to support amended labeling requirements for termiticide products, Pesticide Regulation Notice 96-7, is no longer estimated in this information request. Burden statement: According to the Paperwork Reduction Act, ``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 needed to determine applicability; 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 and review the collection of information; and transmit or otherwise disclose the information. The information covered by this request is collected when an individual or entity applies for registration of a pesticide product. EPA makes small businesses aware of the ``Formulators's Exemption Statement'' (EPA Form 8570- 27) that allows an applicant to reduce their data submission burden when the pesticide product is comprised of an EPA-registered pesticide product by exempting the applicant from furnishing much of the data. Estimates for the annual applicant respondent burden for collection of information associated with the four categories of pesticide product applicants average: 188 hours per application for ``Type A'' antimicrobial products; 188 hours per application for new active ingredient, biochemical, new food use and new use products; 8 hours per application for ``Type B'' antimicrobial products; and 8 hours per application for amendments and notifications, etc. These estimates include the time reading the regulations, planning the necessary data collection activities, conducting tests, analyzing data, generating reports and completing other required paperwork, and storing, filing, and maintaining the data. The estimate of the number of respondents for the four categories of pesticide product applicants include: 60 applicants for ``Type A'' antimicrobial products; 200 applicants for new active ingredient, biochemical, new food use and new use products; 2,100 applicants for ``Type B'' antimicrobial products; and 10,000 applications containing amendments and notifications, etc. The total burden hours for this information collection request would decrease the annual respondent burden from 218,938 to 162,640. III. Public Record and Electronic Submissions The official record for this notice, as well as the public version, has been established for this document under docket control number ``OPP-00531'' [[Page 19252]] (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The official rulemaking record is located at the Virginia address in ``ADDRESSES'' at the beginning of this document. Electronic comments can be sent directly to EPA at: [email protected] Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comment and data will also be accepted on disks in Wordperfect 5.1/6.1 or ASCII file format. All comments and data in electronic form must be identified by the docket control number ``OPP-00531.'' Electronic comments on this notice may be filed online at many Federal Depository Libraries. List of Subjects Environmental protection and Information collection requests. Dated: April 9, 1998. Susan H. Wayland, Acting Assistant Administrator for Prevention, Pesticides and Toxic Substances. [FR Doc. 98-10228 Filed 4-16-98; 8:45 am] BILLING CODE 6560-50-F