Application for New and Amended Pesticide Registration; Renewal of Pesticide Information Collection Activities and Request for Comments, 6860-6863 [05-2511]

Download as PDF 6860 Federal Register / Vol. 70, No. 26 / Wednesday, February 9, 2005 / Notices Abstract: TSCA section 8(c) requires companies that manufacture, process, or distribute chemicals to maintain records of significant adverse reactions to health or the environment alleged to have been caused by such chemicals. Since section 8(c) includes no automatic reporting provision, EPA can obtain and use the information contained in company files only by inspecting those files or requiring reporting of records that relate to specific substances of concern. Therefore, under certain conditions, and using the provisions found in 40 CFR part 717, EPA may require companies to report such allegations to the Agency. EPA uses such information on a casespecific basis to corroborate suspected adverse health or environmental effects of chemicals already under review by EPA. The information is also useful to identify trends of adverse effects across the industry that may not be apparent to any one chemical company. Responses to the collection of information are mandatory (see 40 CFR part 717). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2. III. What are EPA’s Burden and Cost Estimates for this ICR? Under 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 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 collection of information is estimated to range between 0.25 hour and 8.0 hours per response. The following is a summary of the estimates taken from the ICR: Respondents/affected entities: Companies that manufacture, process, VerDate jul<14>2003 16:49 Feb 08, 2005 Jkt 205001 import, or distribute in commerce chemical substances or mixtures. Estimated total number of potential respondents: 13,445. Frequency of response: On occasion. Estimated total/average number of responses for each respondent: 1. Estimated total annual burden hours: 24,548 hours. Estimated total annual burden costs: $1,232,417. IV. Are There Changes in the Estimates from the Last Approval? There is a decrease of 5,391 hours (from 29,939 hours to 24,548 hours) in the total estimated respondent burden compared with that identified in the ICR most recently approved by OMB. This decrease is based on several factors. Most importantly, while the number of firms rose since the last ICR (12,287 to 13,445), the number of employees fell (from 1,000,000+ to 909,562). Since the allegation rate is based on the number of employees, this results in a decrease in total allegations (7,397 to 6,050), and thus a reduction in burden. There is also a small reduction in burden associated with reviewing Federal Register notices. Based on experience over the life of the rule, the average annual number of notices the Agency is expected to issue fell from an estimated 0.11 in the most recent ICR to 0.1 notice per year estimated in this renewal. An additional small reduction is attributable to reduced industry reporting requirements, which have fallen from an estimated 1.75 reports per year (31 reports total/18 years of the rule), to 1.5 reports per year, over the 21 years of the rule (31 reports/21 years). V. 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 technical person listed under FOR FURTHER INFORMATION CONTACT. List of Subjects Environmental protection, Reporting and recordkeeping requirements. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Dated: February 1, 2005. Susan B. Hazen, Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. 05–2510 Filed 2–8–05; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [OPP–2004–0419; FRL–7694–2] Application for New and Amended Pesticide Registration; Renewal of Pesticide Information Collection Activities and Request for Comments Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: 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. 0277.14, OMB Control No. 2070–0060). This is a request to renew an existing ICR that is currently approved and due to expire October 31, 2005. 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. DATES: Written comments, identified by the docket identification (ID) number OPP–2004–0419, must be received on or before April 11, 2005. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/courier. Follow the detailed instructions as provided in Unit III. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Cameo G. Smoot, Field and External Affairs Division (7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (703) 305– 5454; fax number: (703) 305–5884; email address: smoot.cameo@epa.gov. SUPPLEMENTARY 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 entities may include, but are not limited to: E:\FR\FM\09FEN1.SGM 09FEN1 Federal Register / Vol. 70, No. 26 / Wednesday, February 9, 2005 / Notices • Pesticide and other agricultural chemical manufacturing (NAICS 325320), e.g., individuals or entities engaged in activities related to the registration of a pesticide product. This listing 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 above could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the data requirements of 40 CFR part 158. If you have any 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 Copies of this Document and Other Related Information? A. Docket EPA has established an official public docket for this action under docket ID number OPP–2004–0419. 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, 1801 S. Bell St., 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. B. Electronic Access You may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https:// 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 https://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents VerDate jul<14>2003 16:49 Feb 08, 2005 Jkt 205001 of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select ‘‘search,’’ then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA’s electronic public docket. EPA’s policy is that copyrighted material will not be placed in EPA’s electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA’s electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA’s electronic public docket. 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 II.A. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA’s electronic public docket. For public commenters, it is important to note that EPA’s policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA’s electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA’s electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA’s electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA’s electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA’s electronic public docket along with a brief description written by the docket staff. PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 6861 III. How Can I Respond to this Action? A. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked ‘‘late.’’ EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit III.B. Do not use EPA Dockets or e-mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA’s policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA’s electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA’s electronic public docket to submit comments to EPA electronically is EPA’s preferred method for receiving comments. Go directly to EPA Dockets at https://www.epa.gov/edocket/, and follow the online instructions for submitting comments. Once in the system, select ‘‘search,’’ and then key in docket ID number OPP–2004–0419. The system is an ‘‘anonymous access’’ system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment. ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, Attention: Docket ID Number OPP– 2004–0419. In contrast to EPA’s electronic public docket, EPA’s e-mail E:\FR\FM\09FEN1.SGM 09FEN1 6862 Federal Register / Vol. 70, No. 26 / Wednesday, February 9, 2005 / Notices system is not an ‘‘anonymous access’’ system. If you send an e-mail comment directly to the docket without going through EPA’s electronic public docket, EPA’s e-mail system automatically captures your e-mail address. E-mail addresses that are automatically captured by EPA’s e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA’s electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit III.A. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001, Attention: Docket ID Number OPP–2004–0419. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID Number OPP–2004–0419. Such deliveries are only accepted during the docket’s normal hours of operation as identified in Unit II.A. B. How Should I Submit CBI to the Agency? Do not submit information that you consider to be CBI electronically through EPA’s electronic public docket or by e-mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is 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 docket and EPA’s electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA’s VerDate jul<14>2003 16:49 Feb 08, 2005 Jkt 205001 electronic public docket 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 ID 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 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. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 ICR numbers: EPA ICR No. 0277.14, OMB Control 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 October 31, 2005. 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 FIFRA. Under FIFRA, all pesticides must be registered by EPA before they may be sold or distributed in U.S. commerce. Respondents must comply with this collection of information in order to obtain or maintain a benefit (i.e., pesticide registration). An individual or entity seeking to register a new pesticide or to amend an existing pesticide registration 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. 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 (EPA Form 8570–1). 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. E:\FR\FM\09FEN1.SGM 09FEN1 Federal Register / Vol. 70, No. 26 / Wednesday, February 9, 2005 / Notices 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 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 152,974 hours at an estimated annual cost of $15,811,872. The following is a summary of the estimates taken from the ICR: Respondents/affected entities: Not applicable. 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: 152,974. Estimated total annual burden costs: $15,811,872. VI. Are There Changes in the Estimates from the Last Approval? The burden hours for the registrant are based on response activities that have not changed since the last ICR approval, nor has the aggregate number of responses changed. The only changes are the respondent costs as reflected by the increase in labor costs adjusted to 2004 dollars, an increase of $1,603,798 (from $14,208,074 to $15,811,872). 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 VerDate jul<14>2003 16:49 Feb 08, 2005 Jkt 205001 questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT. List of Subjects Environmental protection, Reporting and recordkeeping requirements. Dated: February 1, 2005. Susan B. Hazen, Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. 05–2511 Filed 2–8–05; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [FRL–7870–7] Investigator Initiated Grants: Request for Applications U.S. Environmental Protection Agency. ACTION: Notice of Requests for Applications. AGENCY: SUMMARY: This notice provides information on the availability of fiscal year 2005 investigator initiated grants program announcements, in which the areas of research interest, eligibility and submission requirements, evaluation criteria, and implementation schedules are set forth. Grants will be competitively awarded following peer review. Receipt dates vary depending on the specific research areas within the solicitations. DATES: In its Requests for Applications (RFA) the U.S. Environmental Protection Agency invites research applications in the following areas of special interest to its mission: (1) Early Indicators of Environmentally-Induced Disease, (2) Computational Toxicology: Environmental Bioinformatics Research Center, (3) Environmental Behavior & Decisionmaking: Benefits of Information Disclosure/Provision, (4) Impact of Climate Change and Variability on Human Health, (5) Climate Change and Public Health Decision Making, (6) Exposure Measurement Tools for Endocrine Disrupting Chemicals in Mixtures, (7) Continuous Measurement Methods for Particulate Matter, (8) Development and Evaluation of Innovative Approaches for the Quantitative Assessment of Pathogens in Drinking Water, (9) Novel Biologically-based Public Health Indicators, (10) Allergenicity of Genetically Modified foods, (11) SUPPLEMENTARY INFORMATION: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 6863 Valuation for Environmental Policy, (12) Implications of Tropospheric Air Pollution for Surface UV Exposures, (13) Nonlinear Responses to Global Change in Linked Aquatic and Terrestrial Ecosystems, (14) Ecology and Oceanology of Hazardous Algal Blooms (with NOAA, NSF, ONR and NASA), (15) Development of Predictive Toxicogenomics Approaches with Computational Toxicology, (16) Market Mechanisms and Incentives: Methods for New Markets; Experimental Markets, (17) Lifestyle and Cultural Practices of Tribal Populations and Risks from Toxic Substances in the Environment, (18) Integration of Biomarkers and PBPK & PBPD Modeling, (19) STAR Graduate Fellowships, (20) GRO Graduate & Undergraduate Fellowships. CONTACTS: (1) Early Indicators of Environmentally-Induced Disease, email: fields.nigel@epa.gov, telephone: 202–343–9767; (2) Computational Toxicology: Environmental Bioinformatics Research Center, e-mail: mustra.david@epa.gov, telephone: 202– 343–9616; (3) Environmental Behavior & Decisionmaking: Benefits of Information Disclosure/Provision, e-mail: clark.matthew@epa.gov, telephone: 202–343–9807; (4) Impact of Climate Change and Variability on Human Health, e-mail: winner.darrell@epa.gov, telephone: 202–343–9748; (5) Climate Change and Public Health Decision Making, e-mail: winner.darrell@epa.gov, telephone: 202–343–9748; (6) Exposure Measurement Tools for Endocrine Disrupting Chemicals in Mixtures, email: laessig.susan@epa.gov, telephone: 202–343–9617; (7) Continuous Measurement Methods for Particulate Matter, e-mail: winner.darrell@epa.gov, telephone: 202–343–9748; (8) Development and Evaluation of Innovative Approaches for the Quantitative Assessment of Pathogens in Drinking Water, e-mail: nolthelms.cynthia@epa.gov, telephone: 202– 343–9693; (9) Novel Biologically-based Public Health Indicators, e-mail: turner.vivian@epa.gov, telephone: 202– 343–9697; (10) Allergenicity of Genetically Modified Foods, e-mail: turner.vivian@epa.gov, telephone: 202– 343–9697; (11) Valuation for Environmental Policy, e-mail: wheeler.william@epa.gov, telephone: 202–564–6842; (12) Implications of Tropospheric Air Pollution for Surface UV Exposures, e-mail: winner.darrell@epa.gov, telephone: 202–343–9748; (13) Nonlinear Responses to Global Change in Linked Aquatic and Terrestrial Ecosystems, email: smith.bernicel@epa.gov, telephone: 202–343–9766; (14) Ecology E:\FR\FM\09FEN1.SGM 09FEN1

Agencies

[Federal Register Volume 70, Number 26 (Wednesday, February 9, 2005)]
[Notices]
[Pages 6860-6863]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2511]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2004-0419; FRL-7694-2]


Application for New and Amended Pesticide Registration; Renewal 
of Pesticide Information Collection Activities and Request for Comments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: 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. 
0277.14, OMB Control No. 2070-0060). This is a request to renew an 
existing ICR that is currently approved and due to expire October 31, 
2005. 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.

DATES: Written comments, identified by the docket identification (ID) 
number OPP-2004-0419, must be received on or before April 11, 2005.

ADDRESSES: Comments may be submitted electronically, by mail, or 
through hand delivery/courier. Follow the detailed instructions as 
provided in Unit III. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Cameo G. Smoot, Field and External 
Affairs Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5454; fax number: (703) 305-5884; e-
mail address: smoot.cameo@epa.gov.

SUPPLEMENTARY 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 entities may include, but 
are not limited to:

[[Page 6861]]

     Pesticide and other agricultural chemical manufacturing 
(NAICS 325320), e.g., individuals or entities engaged in activities 
related to the registration of a pesticide product.
    This listing 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 above could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in section 3 of the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the 
data requirements of 40 CFR part 158. If you have any 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 Copies of this Document and Other Related 
Information?

A. Docket

    EPA has established an official public docket for this action under 
docket ID number OPP-2004-0419. 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, 1801 S. Bell St., 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.

B. Electronic Access

    You may access this Federal Register document electronically 
through the EPA Internet under the ``Federal Register'' listings at 
https://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 https://www.epa.gov/edocket/ to submit or 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. Once in the system, select ``search,'' 
then key in the appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets. 
Information claimed as CBI and other information whose disclosure is 
restricted by statute, which is not included in the official public 
docket, will not be available for public viewing in EPA's electronic 
public docket. EPA's policy is that copyrighted material will not be 
placed in EPA's electronic public docket but will be available only in 
printed, paper form in the official public docket. To the extent 
feasible, publicly available docket materials will be made available in 
EPA's electronic public docket. When a document is selected from the 
index list in EPA Dockets, the system will identify whether the 
document is available for viewing in EPA's electronic public docket. 
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 II.A. EPA intends to work 
towards providing electronic access to all of the publicly available 
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is 
that public comments, whether submitted electronically or in paper, 
will be made available for public viewing in EPA's electronic public 
docket as EPA receives them and without change, unless the comment 
contains copyrighted material, CBI, or other information whose 
disclosure is restricted by statute. When EPA identifies a comment 
containing copyrighted material, EPA will provide a reference to that 
material in the version of the comment that is placed in EPA's 
electronic public docket. The entire printed comment, including the 
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or 
delivered to the docket will be transferred to EPA's electronic public 
docket. Public comments that are mailed or delivered to the docket will 
be scanned and placed in EPA's electronic public docket. Where 
practical, physical objects will be photographed, and the photograph 
will be placed in EPA's electronic public docket along with a brief 
description written by the docket staff.

III. How Can I Respond to this Action?

A. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand 
delivery/courier. To ensure proper receipt by EPA, identify the 
appropriate docket ID number in the subject line on the first page of 
your comment. Please ensure that your comments are submitted within the 
specified comment period. Comments received after the close of the 
comment period will be marked ``late.'' EPA is not required to consider 
these late comments. If you wish to submit CBI or information that is 
otherwise protected by statute, please follow the instructions in Unit 
III.B. Do not use EPA Dockets or e-mail to submit CBI or information 
protected by statute.
    1. Electronically. If you submit an electronic comment as 
prescribed in this unit, EPA recommends that you include your name, 
mailing address, and an e-mail address or other contact information in 
the body of your comment. Also include this contact information on the 
outside of any disk or CD ROM you submit, and in any cover letter 
accompanying the disk or CD ROM. This ensures that you can be 
identified as the submitter of the comment and allows EPA to contact 
you in case EPA cannot read your comment due to technical difficulties 
or needs further information on the substance of your comment. EPA's 
policy is that EPA will not edit your comment, and any identifying or 
contact information provided in the body of a comment will be included 
as part of the comment that is placed in the official public docket, 
and made available in EPA's electronic public docket. If EPA cannot 
read your comment due to technical difficulties and cannot contact you 
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to 
submit comments to EPA electronically is EPA's preferred method for 
receiving comments. Go directly to EPA Dockets at https://www.epa.gov/
edocket/, and follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2004-0419. The system is an ``anonymous access'' system, which 
means EPA will not know your identity, e-mail address, or other contact 
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov, 
Attention: Docket ID Number OPP-2004-0419. In contrast to EPA's 
electronic public docket, EPA's e-mail

[[Page 6862]]

system is not an ``anonymous access'' system. If you send an e-mail 
comment directly to the docket without going through EPA's electronic 
public docket, EPA's e-mail system automatically captures your e-mail 
address. E-mail addresses that are automatically captured by EPA's e-
mail system are included as part of the comment that is placed in the 
official public docket, and made available in EPA's electronic public 
docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM 
that you mail to the mailing address identified in Unit III.A. These 
electronic submissions will be accepted in WordPerfect or ASCII file 
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records 
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0419.
    3. By hand delivery or courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Office of Pesticide 
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall 
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID 
Number OPP-2004-0419. Such deliveries are only accepted during the 
docket's normal hours of operation as identified in Unit II.A.

B. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI 
electronically through EPA's electronic public docket or by e-mail. You 
may claim information that you submit to EPA as CBI by marking any part 
or all of that information as CBI (if you submit CBI on disk or CD ROM, 
mark the outside of the disk or CD ROM as CBI and then identify 
electronically within the disk or CD ROM the specific information that 
is 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 docket and EPA's electronic public docket. If you submit 
the copy that does not contain CBI on disk or CD ROM, mark the outside 
of the disk or CD ROM clearly that it does not contain CBI. Information 
not marked as CBI will be included in the public docket and EPA's 
electronic public docket 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 
ID 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 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. 0277.14, OMB Control 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 October 31, 2005.
    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 FIFRA. Under FIFRA, all pesticides must 
be registered by EPA before they may be sold or distributed in U.S. 
commerce. Respondents must comply with this collection of information 
in order to obtain or maintain a benefit (i.e., pesticide 
registration).
    An individual or entity seeking to register a new pesticide or to 
amend an existing pesticide registration 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.
    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 (EPA Form 8570-1). 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.

[[Page 6863]]

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 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 152,974 hours at an estimated annual cost 
of $15,811,872. The following is a summary of the estimates taken from 
the ICR:
    Respondents/affected entities: Not applicable.
    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: 152,974.
    Estimated total annual burden costs: $15,811,872.

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

    The burden hours for the registrant are based on response 
activities that have not changed since the last ICR approval, nor has 
the aggregate number of responses changed. The only changes are the 
respondent costs as reflected by the increase in labor costs adjusted 
to 2004 dollars, an increase of $1,603,798 (from $14,208,074 to 
$15,811,872).

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.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.


    Dated: February 1, 2005.
Susan B. Hazen,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.
[FR Doc. 05-2511 Filed 2-8-05; 8:45 am]
BILLING CODE 6560-50-S
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