March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 1 of 46 SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST ( ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title of the Information Collection: Pesticide Registration Fee Waivers OMB Control No.: 2070 0167 EPA ICR No.: 2147.02 1( b) Short Characterization/ Abstract This information collection will allow the Environmental Protection Agency ( EPA) to process requests for waivers of fees under the Pesticide Registration Improvement Act of 2003 ( PRIA). The ICR covers the collection activities associated with requesting a fee waiver and involves requesters submitting a waiver request, information to demonstrate eligibility for the waiver, and certification of eligibility. Waivers are available for small businesses, for minor uses, and for actions solely associated with the Inter Regional Research Project Number 4 ( IR 4). State and federal agencies are exempt from the payment of fees. This ICR provides burden hour and labor cost estimates for both applicants for fee waivers and EPA employees who process and approve or deny waiver requests.

Through this ICR, EPA is seeking to renew for three years the OMB approval scheduled to expire on September 30, 2004, under OMB Control No. 2070 0167 ( EPA ICR No. 2147.01), which was granted by OMB on March 16, 2004 in response to EPA's emergency processing request. EPA requested emergency processing under section 3507( j) of the Paperwork Reduction Act ( PRA) ( 44 U. S. C. 3501 et seq.), as implemented in OMB regulations at 5 CFR § 1320.13, of the collection of information necessary for waiving pesticide registration fees as prescribed in the newly enacted Pesticide Registration Improvement Act of 2003 ( PRIA).

EPA sought emergency processing of the existing approval because the collection of information necessary for processing the fee waiver requests was needed prior to the expiration of the time periods established under the PRA. The collection of this information at the time the waiver is requested is necessary for the Agency to be able to waive the fees, and proceed with making a decision on the related application. The statute was enacted on January 23, 2004, with a statutory effective date of March 23, 2004, at which time the fee waiver requests can be submitted to the Agency. The statutory implementation time frame does not allow the Agency to follow the regular process for ICRs under the PRA, which includes two comment periods with 60 day and 30 day time frames. EPA asked OMB to take action on the emergency request within 2 work days of receipt, and asked that OMB approve the collection for the full 180 days permitted by the regulations.

A copy of the emergency request submitted to OMB and the related OMB action notice March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 2 of 46 approving that request has been placed in the docket identified under Docket ID Number OPP 2004 0092. 2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection Under the Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA), EPA must evaluate pesticides thoroughly before they can be marketed and used in the United States to ensure that they will not pose unreasonable adverse effects to human health and the environment. Pesticides that meet this test are granted a license or " registration" which permits their distribution, sale and use according to requirements set by EPA to protect human health and the environment.

The PRIA amended FIFRA to provide for the collection of fees in order to enhance the review of covered pesticide products. Fees collected under this program will help to reduce time frames for registration decisions; provide greater predictability and more accountability for those decisions; ensure that Food Quality Protection Act ( FQPA) deadlines are met; and result in more predictable and augmented funding for the pesticide program. The program provides stability in funding for EPA's Office of Pesticide Programs ( OPP) over five years. The program's fee schedule under PRIA will be phased out beginning on October 1, 2008, and ending on September 30, 2010. As indicated above, the PRIA also established provisions that allow these fees to be reduced or waived entirely.

A registration applicant may seek a waiver as a small business, defined by the PRIA as a business with fewer than 500 employees and on average, annual global gross revenue from pesticides of no more than $ 60 million over the most recent three year maintenance fee billing cycle. For a business entity with one or more affiliates, the gross revenue limit includes total global revenues from pesticides for the entity and all of its affiliates, including parent and subsidiary entities.

An applicant qualifying as a small businesses under the PRIA will be entitled to a waiver of fifty percent ( 50%) of its fees. In addition, all fees will be waived for small businesses with, on average, annual gross global revenues from pesticides over the most recent three year maintenance fee billing cycle, including affiliates, of no more than $ 10 million. Small business applicants requesting waivers must provide EPA with appropriate documentation demonstrating that they meet these criteria.

An applicant may also request a minor use waiver or fee reduction if the applicant can demonstrate that anticipated revenues from the uses described in the application would be insufficient to justify the imposition of the full application fee. The Agency may grant a full waiver or a partial reduction in the fee based upon its consideration of the supporting documentation provided. March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 3 of 46 In addition, the statute states that the Agency shall waive the registration service fee for an application if the Administrator determines that two criteria are met: that the application is solely associated with IR 4 tolerance petition and that the waiver is in the public interest. The Agency anticipates that most applications submitted by the IR 4 program would qualify for a waiver. In addition, under the statute, an agency of the Federal Government or a State government is exempt from fees.

The program is expected to generate in excess of $ 18 million in new registration service fees annually over five years and allows applicants for pesticide registrations submitted prior to the effective date of the Act to pay a portion of the fee voluntarily.

2( b) Practical Utility/ Users of the Data EPA is the sole intended user of the information collected. This collection of information is critical for the proper performance of Agency functions because the information collected will allow EPA to properly review a request for waivers of fees under the PRIA without delay. The actual usefulness of the information to the Agency is that the information collected will demonstrate that the applicant meets the criteria for fee waiver or reduction.

The information will be used to determine if the applicant qualifies for a fee waiver or fee reduction. Statutorily, in instances where the applicant requests a fee waiver or fee reduction, the decision review time period does not begin until either the Agency grants the waiver or until the registrant has paid the appropriate registration service fee. If the Agency does not have the information readily available ( i. e., submission by the applicant), the Agency would need to locate this information from other sources. In the meantime, the Agency, by law, cannot start working on the application. Processing of the application, therefore, will be delayed until the Agency can render a decision on the fee waiver or fee reduction request. With the submission of this data by the registrant, the Agency will be able to meet its statutory commitment to review the waiver request within 60 days and, potentially, earlier than the maximum 60 day period.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non duplication Not applicable. No other federal agency or EPA program is collecting fees for the processing of applications for pesticide registration or, therefore, information for the waiver of such fees.

3( b) Public Notice Required Prior to ICR Submission to OMB Pursuant to 5 CFR 1320.8( d), EPA published a Federal Register noticesoliciting comments on this information collection activity and EPA's intent to renew the OMB approval of this ICR. If any comments are received, they will be addressed in the ICR prior to its submission March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 4 of 46 to OMB.

3( c) Consultations The PRIA was developed over a multi year period based upon input from the pesticide industry, industry trade associations, public interest groups, and the Agency. The legislation that was introduced into Congress was based upon a consensus reached by stakeholders, informed with technical support provided by the Agency. These stakeholders included CropLife America, the Consumer Specialty Products Association, the Chemical Producers and Distributors Association, the American Chemistry Council, the Natural Resources Defense Council, and Consumers Union, among other parties. Contact information for some of the participants follows:

Ray McAllister CropLife America 202 872 3874 Phil Klein Consumer Specialty Products Assn. 202 833 7310 Warren StickleChemical Producers & 703 548 7700 Distributors Assn. Steve Goldberg BASF Corporation 973 426 3262 Julie Spagnoli Bayer 202 756 3775 Carolyn Brickey Protected Harvest cwbrickey@ aol. com Wesley Warren Natural Resources Defense Council 202 289 6868 In addition to the consultation that took place during the development of this legislation, EPA will consult with registrants on the information collection during the renewal process. Discussion with respondents will include whether the labor rate estimates in the ICR are accurate and whether the estimates of burden and methodology for arriving at the estimate are correct, whether forms should be developed, what payment methods should be considered, and alternatives to paperbased submissions, i. e., whether respondents would consider submitting the information electronically, such as through web forms and the Agency's Internet site or submitting data on disk with electronic signatures.

3( d) Effects of Less Frequent Collection As part of the initial implementation of these fee waiver provisions, the Agency anticipates that applicants will need to provide appropriate documentation demonstrating their eligibility for waivers on an application by application basis. As the Agency develops experience with the review of these waiver requests, we will seek to identify opportunities for reducing the frequency of collecting this information, provided that such a reduction will still allow the Agency to satisfy the statutory requirements of the PRIA.

3( e) General Guidelines This collection activity complies with the guidelines for information collections under the Paperwork Reduction Act ( PRA). The recordkeeping activities briefly described in this ICR March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 5 of 46 exceed OMB's guideline that agencies not require that records be retained for more than three years ( 5 CFR 1320.5( d)( 2)( iv)). As authorized under FIFRA section 8, EPA regulations require that applicants retain records containing research data relating to registered pesticides ( including all data submitted to EPA in support of a registration  see 40 CFR 169.2( k)) for as long as the registration is valid and the producer is in business. However, the burden related to the recordkeeping requirements is covered under another ICR ( see OMB Control No. 2070 0028, Recordkeeping Requirements for Producers of Pesticides under Section 8 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA)).

3( f) Confidentiality The information requested to document fee waiver requests is not likely to contain confidential business information ( CBI). However, data and/ or information submitted to the Agency in conjunction with service fee waiver requests may be claimed as trade secret or commercial or financial information and will be protected from disclosure under FIFRA section 10 and the associated regulation as contained in 40 CFR Part 2, Subpart B. Information claimed as CBI is protected from public disclosure unless the Administrator determines that disclosure is in the public interest. OPP routinely handles CBI data, and personnel are familiar with security procedures in accordance with provisions of the FIFRA Confidential Business Security Manual to ensure confidentiality. If any information is submitted that applicants claim as confidential, the Agency will employ the established procedures for handling such material.

3( g) Sensitive Questions No information of a sensitive or private nature is requested in conjunction with this collection activity. Further, this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB circular A 108.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents/ NAICS Codes The North American Industrial Classification System ( NAICS) codes assigned to the parties responding to this information are as follows:

° Pesticide and other agricultural chemical manufacturing ( NAICS 32532), e. g., individuals or entities engaged in activities related to the registration of a pesticide product. ° Other Basic Inorganic Chemical Manufacturing ( NAICS 32518), e. g., manufacturers of inorganic chemicals used as inert ingredients in pesticide products. ° Other Basic Organic Chemical Manufacturing ( NAICS 32519), e. g., manufacturers of organic chemicals used as inert ingredients in pesticide products. March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 6 of 46 4( b) Information Requested ( i) Data items, including record keeping requirements An applicant who seeks a small business waiver must submit a waiver request with appropriate documentation demonstrating that he meets the criteria established in the PRIA, i. e., that he has fewer than 500 employees and has no more than $ 60 million in annual global gross revenue from pesticides, averaged over the most recent three maintenance fee billing cycle, including any such revenue from affiliates. For this purpose, the applicant may be required to submit documentation regarding numbers of employees and, on behalf of itself and its affiliates, gross revenue figures, and information on revenue from pesticides over a three year period.

An applicant who seeks a minor use waiver must provide supporting documentation that anticipated revenues from the uses that are the subject of the application would be insufficient to justify imposition of the full registration fee or that the application is solely associated with a tolerance petition submitted by IR 4 and that the waiver is in the public interest.

Although there is no record keeping requirement, PRIA provides that, at any time, EPA may determine that the documentation supporting the waiver request is not accurate or based on the documentation or any other information, the waiver or reduction should not have been granted. Therefore, it is anticipated that applicants will retain copies of their submissions as well as documents demonstrating that the applicant is eligible for the waiver or reduction. There are currently no forms associated with this information collection activity.

( ii) Respondent Activities If an applicant wishes to request a fee waiver, at a minimum, it must undertake the following activities:

° Generate and submit the necessary materials to support the request.

° Indicate that a waiver is requested and that the appropriate documentation supporting the request are enclosed or have been otherwise submitted to the Agency.

5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities 1 Review and evaluate fee waiver requests. Notify applicant of decision.

2 Verify payments. Cross check payment information from Financial Management Division. March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 7 of 46 3 Store the data. Microfilm all forms, listings, telephone conversations, etc. for archiving.

5( b) Collection Methodology and Management Fee payments will be sent to the Financial Management Division in Pittsburgh, Pennsylvania. All letters, mail receipts, petitions, and other types of correspondence will be tracked electronically. The Agency is exploring the feasibility of incorporating the tracking into its current systems. If this approach is not practical, a stand alone tracking system will be developed.

Procedures for evaluating fee waiver requests will not change. Information and materials submitted to justify a fee waiver are screened for completeness by the receiving division. Economic data are sent to OPP's Biological and Economic Analysis Division for analysis. The Agency will keep applicants informed of the status of the waiver application throughout the process by telephone and by mail.

5( c) Small Entity Flexibility Small businesses may request a waiver of the registration service fee. A waiver applicant must demonstrate that it meets the criteria as outlined in the PRIA. The information that needs to be compiled in order to make this determination is information that companies routinely collect and maintain in the normal course of business.

5( d) Collection Schedule Registration service fees are required for 90 different registration categories identified by Congress, and published in the Congressional Record of September 17, 2003 ( see Attachment C). There is no set collection schedule, per se. Rather, the registration service fee is collected each time a registrant submits a registration application. The applicant must either pay a fee or request and be granted a waiver for each registration application submitted if the application is within the scope of one of the 90 fee categories.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden Since the collection of pesticide registration fees is a new requirement, the numbers provided are not reflective of any actual program values. These estimates, however, are based on the Agency's experience with other fee collection activities ( e. g., reregistration fees and maintenance fees) and reflect applicant feedback as to the amount of time it has taken to fill out a short form and undertake other related activities. March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 8 of 46 In calculating the potential respondent burden, the Agency estimated 360 responses per year for requesting fee waivers or reductions, based on 1,565 registrations per year on average for the most recent 3 years. The Agency assumes that 18.5 percent of conventional pesticides and antimicrobial registration per year and 64 percent of biopesticides will be requesting fee waivers or reductions based on pesticide industry profiles by companies' number of employees and gross revenue.

All applicants applying for waivers will want to familiarize themselves with the statutory criteria for a fee waiver. EPA assumes that every new applicant seeking a waiver of the registration service fee will want to familiarize him or herself with the criteria from the outset, thus this burden is considered a one time burden that will occur the first time the applicant submits a registration application under the PRIA. The portion of the burden covering familiarization with fee waiver submission criteria is expected to diminish in ensuing years.

6( b) Estimating Respondent Costs Annual respondent costs associated with this information collection, based on an estimate of 360 applications per year, is estimated to be $ 1,882,800 for the first year. For respondents, the value of labor per hour for management, technical, and clerical is $ 130, $ 88, and $ 40, respectively. Respondent labor rates included in the table below are rounded to the nearest dollar, based on the Gross Domestic Product as calculated by the US Department of Commerce's Bureau of Economic Analysis, and factoring in an inflation cost index of 1.056. These labor rates are fully loaded and include benefits and overhead costs. Using the Agency's burden estimate and the fully loaded labor rates, the Agency estimates the applicant costs to be approximately $ 5,230 per response.

During the first year of the program, the Agency estimates that, in many cases, fee waiver requests will be submitted separately from registration applications. The estimates of respondent costs for the first year, therefore, include postage costs of $ 10 per response, for a total cost of $ 3,600 per year. In subsequent years, however, the Agency estimates that as registrants become more familiar with the process of submitting fee waiver requests, they will be submitted at the same time as registration applications, so mailing cost estimates for subsequent years will be correspondingly lower. March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 9 of 46 TABLE 1: FIRST YEAR RESPONDENT BURDEN AND COST ESTIMATES Burden Hours ( per year) Total COLLECTION ACTIVITY Mgmt. $ 130/ hr Tech. $ 88/ hr Cler. $ 40/ hr Hours Costs 1 Read regulation and plan activities 10 10 $ 1,300 2 Generate materials for waiver request for submission to EPA 40 40 $ 3,520 3 Store/ maintain/ submit and produce information 10 1 $ 400 4 Mailing costs $ 10 Totals 10 40 10 60 $ 5,230 FIRST YEAR BURDEN:

( line 1) 10 Hours x 360 responses = 3,600 Hours ( line 2) 40 Hours x 360 responses = 14,400 Hours ( line 3) 10 Hours x 360 responses = 3,600 Hours TOTAL 1st YEAR BURDEN = 21,600 Hours FIRST YEAR COSTS:

( line 1) 10 hours x $ 130 ( mgmt.) x 360 responses = $ 468,000 ( line 2) 40 hours x $ 88 ( mgmt.) x 360 responses = $ 1,267,200 ( line 3) 10 hours x $ 40 ( tech.) x 360 responses = $ 144,000 ( line 4) $ 10 x 360 responses = $ 3,600 TOTAL 1st YEAR COSTS = $ 1,882,800 March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 10 of 46 TABLE 2: SUBSEQUENT ANNUAL RESPONDENT BURDEN AND COST ESTIMATES Burden Hours ( per year) Total COLLECTION ACTIVITY Mgmt. $ 130/ hr Tech. $ 88/ hr Cler. $ 40/ hr Hours Costs 1 Read regulation and plan activities 2 2 $ 260 2 Generate materials for waiver request for submission to EPA 40 40 $ 3,520 3 Store/ maintain/ submit information 10 10 $ 400 4 Mailing costs $ 5 Totals 2 40 10 52 $ 4,185 SUBSEQUENT YEAR RESPONDENT BURDEN:

( line 1) 2 Hours x 360 responses = 720 Hours ( line 2) 40 Hours x 360 responses = 14,400 Hours ( line 3) 10 Hours x 360 responses = 3,600 Hours TOTAL ANNUAL RESPONDENT BURDEN = 18,720 Hours SUBSEQUENT YEAR RESPONDENT BURDEN COSTS:

( line 1) 2 hours x $ 130 ( mgmt.) x 360 responses = $ 93,600 ( line 2) 40 hours x $ 88 ( mgmt.) x 360 responses = $ 1,267,200 ( line 3) 10 hours x $ 40 ( tech.) x 360 responses = $ 144,000 ( line 4) $ 5 x 360 responses = $ 1,800 TOTAL ANNUAL RESPONDENT BURDEN COSTS = $ 1,506,600 March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 11 of 46 6( c) Estimating Agency Burden and Cost The Agency's burden consists of reviewing, evaluating, and notifying applicants of the Agency's decision to grant or deny fee waiver requests; entering data into tracking systems; verifying fee payment; and storing/ maintaining this information. The table below estimates EPA's burden for performing these activities.

The Agency cost covered by this ICR is associated solely with the processing of fee waiver requests and is estimated to be $ 1,093,042 per year. The labor rates are based on Office of Personnel Management salary tables for federal employees for 2003 and are rounded to the nearest dollar and include benefits and overhead costs, as well as locality pay for the Washington, DC Baltimore area. For purposes of this estimate we have used an average grade of GS 14, Step 5 with an hourly rate of $ 130. For technical staff, we used an average grade of GS 12, Step 4 with an hourly rate of $ 88. For clerical staff, an average grade of GS 7, Step 5 with an hourly rate of $ 40 was used. March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 12 of 46 TABLE 3: ANNUAL AGENCY BURDEN AND COST ESTIMATES Burden Hours/ pe r year Total COLLECTION ACTIVITY Mgmt. $ 96/ hr Tech $ 70 Cler. $ 33 Hours Costs 1 Review submitted waiver request and notify requestor of decision 1 40 2 43 $ 2,962 2 Enter data into tracking systems 0.5 0.5 $ 17 3 Verify payment 0.5 0.5 $ 17 4 Store/ maintain/ submit information 1 1 $ 33 TOTAL 1 40 4 45 $ 3,029 ANNUAL AGENCY BURDEN:

( line 1) 43 Hours x 360 responses = 15,480 Hours ( line 2) 0.5 Hours x 360 responses = 180 Hours ( line 3) 0.5 Hours x 360 responses = 180 Hours ( line 4) 1 Hours x 360 responses = 360 Hours TOTAL ANNUAL AGENCY BURDEN = 16,200 Hours ANNUAL COSTS:

( line 1) ( 1 hours x $ 96 ( mgmt.) ) + ( 40 hours x $ 70 ( Tech.) ) + ( 2 hours x $ 33 ( Tech.) ) = $ 2,962 $ 2,962 x 360 responses = $ 1,066,320 ( line 2) 0.5 hours x $ 33 ( Cler.) x 360 responses = $ 5,940 ( line 3) 0.5 hours x $ 33 ( Cler.) x 360 responses = $ 5,940 ( line 4) 1 hours x $ 33 ( Cler.) x 360 responses = $ 11,880 TOTAL ANNUAL AGENCY COSTS = $ 1,093,042 March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 13 of 46 6( d). Bottom Line Hours And Costs / Master Table Hours Costs Respondent Burden/ Cost Estimates First Year 21,600 $ 1,882,800 Subsequent Years 18,720 $ 1,506,600 Agency Burden/ Cost Estimates 16,200 $ 1,093.042 6( e) Reasons for Change in Burden ( no discussion needed  this is a new ICR)

6( f) Burden Statement The public reporting burden for this collection of information is estimated to average 60 hours per response in the first year and 52 hours per response in subsequent years. According to 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 read the new regulation, review instructions, plan activities, assemble pertinent materials, and transmit or otherwise disclose the information. 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 PRA unless the Agency displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after initial display in the final rule, are listed in 40 CFR part 9. Since the collection activity in this ICR are contained in the PRIA and not a current regulation, the OMB control number for this collection activity will appear in the FR document related to this ICR ( e. g., attachment B).

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OPP 2004 0092, which is available for public viewing at the OPP Docket in the Public Information and Records Integrity Branch, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4: 00 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305 5805. March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 14 of 46 ATTACHMENTS TO THE SUPPORTING STATEMENT:

[ NOTE: Unless otherwise noted, an electronic copy of the attachment is available in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID No.: OPP 2004 0092. Search the docket index for the document by the title provided below. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.]

Attachment A  Pesticide Registration Improvement Act of 2003 electronic copy available at: www. epa. gov/ pesticides/ fifra. pdf Attachment B  Federal Register Document entitled: Pesticide Registration Fee Waivers; New Information Collection Activities and Request for Comments ( 69 FR 15322)  published March 25, 2004. Electronic copy available at http:// a257. g. akamaitech. net/ 7/ 257/ 2422/ 14mar20010800/ edocket. access. gpo. gov/ 2004/ pdf/ 04 6 699. pdf Attachment C  Categories of Registration Requiring Fees under the PRIA March 15, 2004 DRAFT FOR PUBLIC COMMENT Page 15 of 46 Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 16 of 46 To amend the Federal Insecticide, Fungicide, and Rodenticide Act to provide for the enhanced review of covered pesticide products, to authorize fees for certain pesticide products, and to extend and improve the collection of maintenance fees.

IN THE SENATE OF THE UNITED STATES September 25, 2003 A BILL To amend the Federal Insecticide, Fungicide, and Rodenticide Act to provide for the enhanced review of covered pesticide products, to authorize fees for certain pesticide products, and to extend and improve the collection of maintenance fees.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. PESTICIDE REGISTRATION. ( a) SHORT TITLE This Act may be cited as the   Pesticide Registration Improvement Act of 2003'.

( b) REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES Section 3( h) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. 136a( h)) is amended   ( 1) in paragraph ( 2)( F), by striking   90 to 180 days' and inserting   120 days'; and ( 2) in paragraph ( 3)

( A) in subparagraph ( D)( vi), by striking   240 days' and inserting   120 days'; and ( B) in subparagraph ( F), by adding at the end the following:

 ( iv) LIMITATION Notwithstanding clause ( ii), the failure of the Administrator to notify an applicant for an amendment to a registration for an antimicrobial pesticide shall not be judicially reviewable in a Federal or State court if the amendment requires scientific review of data within    ( I) the time period specified in subparagraph ( D)( vi), in the absence of a final regulation under subparagraph ( B); or  ( II) the time period specified in paragraph ( 2)( F), if adopted in a final regulation under subparagraph ( B).'. Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 17 of 46 ( c) MAINTENANCE FEES

( 1) AMOUNTS FOR REGISTRANTS Section 4( i)( 5) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. 136a 1( i)( 5)) is amended

( A) in subparagraph ( A)

( i) by striking  ( A) Subject' and inserting the following:

 ( A) IN GENERAL Subject'; and ( ii) by striking   of' and all that follows through   additional registration' and inserting   for each registration';

( B) in subparagraph ( D)

( i) by striking  ( D) The' and inserting the following:

 ( D) MAXIMUM AMOUNT OF FEES FOR REGISTRANTS The';

( ii) in clause ( i), by striking   shall be $ 55,000; and' and inserting   shall be

 ( I) for fiscal year 2004, $ 84,000;

 ( II) for each of fiscal years 2005 and 2006, $ 87,000;

 ( III) for fiscal year 2007, $ 68,000; and  ( IV) for fiscal year 2008, $ 55,000; and'; and ( iii) in clause ( ii), by striking   shall be $ 95,000.' and inserting   shall be

 ( I) for fiscal year 2004, $ 145,000;

 ( II) for each of fiscal years 2005 and 2006, $ 151,000;

 ( III) for fiscal year 2007, $ 117,000; and  ( IV) for fiscal year 2008, $ 95,000.'; and Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 18 of 46 ( C) in subparagraph ( E)

( i) by striking  ( E)( i) For' and inserting the following:

 ( E) MAXIMUM AMOUNT OF FEES FOR SMALL BUSINESSES

 ( i) IN GENERAL For';

( ii) by indenting the margins of subclauses ( I) and ( II) of clause ( i) appropriately; and ( iii) in clause ( i)

( I) subclause ( I), by striking   shall be $ 38,500; and' and inserting   shall be     ( aa) for fiscal year 2004, $ 59,000;

 ( bb) for each of fiscal years 2005 and 2006, $ 61,000;

 ( cc) for fiscal year 2007, $ 48,000; and  ( dd) for fiscal year 2008, $ 38,500; and'; and ( II) in subclause ( II), by striking   shall be $ 66,500.' and inserting   shall be     ( aa) for fiscal year 2004, $ 102,000;

 ( bb) for each of fiscal years 2005 and 2006, $ 106,000;

 ( cc) for fiscal year 2007, $ 82,000; and  ( dd) for fiscal year 2008, $ 66,500.'.

( 2) TOTAL AMOUNT OF FEES Section 4( i)( 5)( C) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. 136( a) 1( i)( 5)( C)) is amended   ( A) by striking  ( C)( i) The' and inserting the following:

 ( C) TOTAL AMOUNT OF FEES The'; and Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 19 of 46 ( B) by striking   aggregate amount' and all that follows through clause ( ii) and inserting   aggregate amount of    ( i) for fiscal year 2004, $ 26,000,000;

 ( ii) for fiscal year 2005, $ 27,000,000;

 ( iii) for fiscal year 2006, $ 27,000,000;

 ( iv) for fiscal year 2007, $ 21,000,000; and  ( v) for fiscal year 2008, $ 15,000,000.'.

( 3) DEFINITION OF SMALL BUSINESS Section 4( i)( 5)( E)( ii) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. 136a 1( i)( 5)( E)( ii)) is amended   ( A) by redesignating subclauses ( I) and ( II) as items ( aa) and ( bb), respectively, and indenting the margins appropriately;

( B) by striking  ( ii) For purposes of' and inserting the following:

 ( ii) DEFINITION OF SMALL BUSINESS

 ( I) IN GENERAL In'; ( C) in item ( aa) ( as so redesignated), by striking   150' and inserting   500';

( D) in item ( bb) ( as so redesignated), by striking   gross revenue from chemicals that did not exceed $ 40,000,000.' and inserting   global gross revenue from pesticides that did not exceed $ 60,000,000.'; and ( E) by adding at the end the following:

 ( II) AFFILIATES

 ( aa) IN GENERAL In the case of a business entity with 1 or more affiliates, the gross revenue limit under subclause ( I)( bb) shall apply to the gross revenue for the entity and all of the affiliates of the entity, including parents and subsidiaries, if applicable.

 ( bb) AFFILIATED PERSONS For the purpose of item ( aa), persons are affiliates of each other Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 20 of 46 if, directly or indirectly, either person controls or has the power to control the other person, or a third person controls or has the power to control both persons.

 ( cc) INDICIA OF CONTROL For the purpose of item ( aa), indicia of control include interlocking management or ownership, identity of interests among family members, shared facilities and equipment, and common use of employees.'.

( 4) EXTENSION OF AUTHORITY FOR COLLECTING MAINTENANCE FEES Section 4( i)( 5)( H) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. 136a 1( i)( 5)( H)) is amended by striking   2003' and inserting   2008'. ( 5) REREGISTRATION AND OTHER ACTIVITIES Section 4( g)( 2) of the Federal Insecticide, Fungicide and Rodenticide Act ( 7 U. S. C. 136a 1( g)( 2)) is amended   ( A) by striking subparagraph ( A) and inserting the following:

 ( A) IN GENERAL The Administrator shall make a determination as to eligibility for reregistration    ( i) for all active ingredients subject to reregistration under this section for which tolerances or exemptions from tolerances are required under the Federal Food, Drug, and Cosmetic Act ( 21 U. S. C. 301 et seq.), not later than the last date for tolerance reassessment established under section 408( q)( 1)( C) of that Act ( 21 U. S. C. 346a( q)( 1)( C)); and  ( ii) for all other active ingredients subject to reregistration under this section, not later than October 3, 2008.';

( B) in subparagraph ( B)

( i) by striking  ( B) Before' and inserting the following:

 ( B) PRODUCT SPECIFIC DATA

 ( i) IN GENERAL Before';

( ii) by striking   The Administrator' and inserting the following:

 ( ii) TIMING

 ( I) IN GENERAL Subject to subclause ( II), the Administrator'; and Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 21 of 46 ( iii) by adding at the end the following:

 ( II) EXTRAORDINARY CIRCUMSTANCES In the case of extraordinary circumstances, the Administrator may provide such a longer period, of not more than 2 additional years, for submission of data to the Administrator under this subparagraph.'; and ( C) in subparagraph ( D)

( i) by striking  ( D) If' and inserting the following:

 ( D) DETERMINATION TO NOT REREGISTER

 ( i) IN GENERAL If'; and ( ii) by adding at the end the following:

 ( ii) TIMING FOR REGULATORY ACTION Regulatory action under clause ( i) shall be completed as expeditiously as possible.'.

( d) OTHER FEES

( 1) IN GENERAL Section 4( i)( 6) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. 136a 1( i)( 6)) is amended   ( A) by striking   During' and inserting   Except as provided in section 33, during'; and ( B) by striking   2003' and inserting   2010'.

( 2) TOLERANCE FEES Notwithstanding section 408( m)( 1) of the Federal Food, Drug, and Cosmetic Act ( 21 U. S. C. 346a( m)( 1)), the Administrator of the Environmental Protection Agency shall not collect any tolerance fees under that section during the period beginning on the effective date of this section and ending on September 30, 2008.

( e) EXPEDITED PROCESSING OF SIMILAR APPLICATIONS Section 4( k)( 3) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. 136a 1( k)( 3)) is amended   ( 1) in the paragraph heading, by striking   EXPEDITED' and inserting   REVIEW OF INERT INGREDIENTS; EXPEDITED'; and Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 22 of 46 ( 2) in subparagraph ( A)

( A) by striking   1997' and all that follows through   of the maintenance fees' and inserting   2004 through 2006, approximately $ 3,300,000, and for each of fiscal years 2007 and 2008, between 1/ 8 and 1/ 7 , of the maintenance fees';

( B) by redesignating clauses ( i), ( ii), and ( iii) as subclauses ( I), ( II) and ( III), respectively, and indenting appropriately; and ( C) by striking   resources to assure the expedited processing and review of any application that' and inserting   resources    ( i) to review and evaluate new inert ingredients; and  ( ii) to ensure the expedited processing and review of any application that'.

( f) PESTICIDE REGISTRATION SERVICE FEES The Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. 136a et seq.) is amended   ( 1) by redesignating sections 33 and 34 ( 7 U. S. C. 136x, 136y) as sections 34 and 35, respectively; and ( 2) by inserting after section 32 ( 7 U. S. C. 136w 7) the following:

  SEC. 33. PESTICIDE REGISTRATION SERVICE FEES.  ( a) DEFINITION OF COSTS In this section, the term   costs', when used with respect to review and decisionmaking pertaining to an application for which registration service fees are paid under this section, means    ( 1) costs to the extent that    ( A) officers and employees provide direct support for the review and decisionmaking for covered pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses;

 ( B) persons and organizations under contract with the Administrator engage in the review of the applications, and corresponding risk and benefits information and assessments; and  ( C) advisory committees and other accredited persons or organizations, on the request of the Administrator, engage in the peer review of risk or benefits information associated with covered Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 23 of 46 pesticide applications;

 ( 2) costs of management of information, and the acquisition, maintenance, and repair of computer and telecommunication resources ( including software), used to support review of pesticide applications, associated tolerances, and corresponding risk and benefits information and analyses; and  ( 3) costs of collecting registration service fees under subsections ( b) and ( c) and reporting, auditing, and accounting under this section.

 ( b) FEES

 ( 1) IN GENERAL Effective beginning in fiscal year 2004, the Administrator shall assess and collect covered pesticide registration service fees in accordance with this section.

 ( 2) COVERED PESTICIDE REGISTRATION APPLICATIONS  ( A) IN GENERAL An application for the registration of a pesticide covered by this Act that is received by the Administrator on or after October 1, 2003, shall be subject to a registration service fee under this section.

 ( B) EXISTING APPLICATIONS

 ( i) IN GENERAL Subject to clause ( ii), an application for the registration of a pesticide that was submitted to the Administrator before October 1, 2003, and is pending on the date of enactment of the Pesticide Registration Improvement Act of 2003, shall be subject to a service fee under this section if the application is for the registration of a new active ingredient that is not listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environmental Protection Agency.

 ( ii) TOLERANCE OR EXEMPTION FEES The amount of any fee otherwise payable for an application described in clause ( i) under this section shall be reduced by the amount of any fees paid to support the related petition for a pesticide tolerance or exemption under the Federal Food, Drug, and Cosmetic Act ( 21 U. S. C. 301 et seq.).

 ( C) DOCUMENTATION An application subject to a registration service fee under this section shall be submitted with documentation certifying    ( i) payment of the registration service fee; or Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 24 of 46  ( ii) a request for a waiver from or reduction of the registration service fee.

 ( 3) SCHEDULE OF COVERED APPLICATIONS AND REGISTRATION SERVICE FEES

 ( A) IN GENERAL Not later than 30 days after the effective date of the Pesticide Registration Improvement Act of 2003, the Administrator shall publish in the Federal Register a schedule of covered pesticide registration applications and corresponding registration service fees.

 ( B) REPORT Subject to paragraph ( 6), the schedule shall be the same as the applicable schedule appearing in the Congressional Record on pages S11631 through S11633, dated September 17, 2003.

 ( 4) PENDING PESTICIDE REGISTRATION APPLICATIONS

 ( A) IN GENERAL An applicant that submitted a registration application to the Administrator before October 1, 2003, but that is not required to pay a registration service fee under paragraph ( 2)( B), may, on a voluntary basis, pay a registration service fee in accordance with paragraph ( 2)( B).

 ( B) VOLUNTARY FEE The Administrator may not compel payment of a registration service fee for an application described in subparagraph ( A).  ( C) DOCUMENTATION An application for which a voluntary registration service fee is paid under this paragraph shall be submitted with documentation certifying  ( i) payment of the registration service fee; or  ( ii) a request for a waiver from or reduction of the registration service fee.

 ( 5) RESUBMISSION OF PESTICIDE REGISTRATION APPLICATIONS If a pesticide registration application is submitted by a person that paid the fee for the application under paragraph ( 2), is determined by the Administrator to be complete, and is not approved or is withdrawn ( without a waiver or refund), the submission of the same pesticide registration application by the same person ( or a licensee, assignee, or successor of the person) shall not be subject to a fee under paragraph ( 2).  ( 6) FEE ADJUSTMENT Effective for a covered pesticide registration application received on or after October 1, 2005, the Administrator shall    ( A) increase by 5 percent the service fee payable for the application under paragraph ( 3); and  ( B) publish in the Federal Register the revised registration service fee schedule. Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 25 of 46  ( 7) WAIVERS AND REDUCTIONS

 ( A) IN GENERAL An applicant for a covered pesticide registration may request the Administrator to waive or reduce the amount of a registration service fee payable under this section under the circumstances described in subparagraphs ( D) through ( G).

 ( B) DOCUMENTATION  ( i) IN GENERAL A request for a waiver from or reduction of the registration service fee shall be accompanied by appropriate documentation demonstrating the basis for the waiver or reduction.  ( ii) CERTIFICATION The applicant shall provide to the Administrator a written certification, signed by a responsible officer, that the documentation submitted to support the waiver or reduction request is accurate.  ( iii) INACCURATE DOCUMENTATION An application shall be subject to the applicable registration service fee payable under paragraph ( 3) if, at any time, the Administrator determines that  ( I) the documentation supporting the waiver or reduction request is not accurate; or  ( II) based on the documentation or any other information, the waiver or reduction should not have been granted or should not be granted.

 ( C) DETERMINATION TO GRANT OR DENY REQUEST As soon as practicable, but not later than 60 days, after the date on which the Administrator receives a request for a waiver or reduction of a registration service fee under this paragraph, the Administrator shall    ( i) determine whether to grant or deny the request; and  ( ii) notify the applicant of the determination.

 ( D) MINOR USES

 ( i) IN GENERAL The Administrator may waive or reduce a registration service fee for an application for minor uses for a pesticide.  ( ii) SUPPORTING DOCUMENTATION An applicant requesting a waiver under this subparagraph shall provide supporting documentation that demonstrates, to the satisfaction of the Administrator, that anticipated revenues from the uses that are the subject of the application would be insufficient to justify imposition of the full application fee.

 ( E) IR 4 WAIVER The Administrator shall waive the registration service fee for an application if the Administrator determines that   Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 26 of 46  ( i) the application is solely associated with a tolerance petition submitted in connection with the Inter Regional Project Number 4 ( IR 4) as described in section 2 of Public Law 89 106 ( 7 U. S. C. 450i( e)); and  ( ii) the waiver is in the public interest.

 ( F) SMALL BUSINESSES

 ( i) IN GENERAL The Administrator shall waive 50 percent of the registration service fees payable by an entity for a covered pesticide registration application under this section if the entity is a small business ( as defined in section 4( i)( 5)( E)( ii)) at the time of application.  ( ii) WAIVER OF FEES The Administrator shall waive all of the registration service fees payable by an entity under this section if the entity  ( I) is a small business ( as defined in section 4( i)( 5)( E)( ii)) at the time of application; and  ( II) has average annual global gross revenues described in section 4( i)( 5)( E)( ii)( I)( bb) that does not exceed $ 10,000,000, at the time of application.  ( iii) FORMATION FOR WAIVER The Administrator shall not grant a waiver under this subparagraph if the Administrator determines that the entity submitting the application has been formed or manipulated primarily for the purpose of qualifying for the waiver.  ( iv) DOCUMENTATION An entity requesting a waiver under this subparagraph shall provide to the Administrator  ( I) documentation demonstrating that the entity is a small business ( as defined in section 4( i)( 5)( E)( ii)) at the time of application; and  ( II) if the entity is requesting a waiver of all registration service fees payable under this section, documentation demonstrating that the entity has an average annual global gross revenues described in section 4( i)( 5)( E)( ii)( I)( bb) that does not exceed $ 10,000,000, at the time of application.

 ( G) FEDERAL AND STATE AGENCY EXEMPTIONS An agency of the Federal Government or a State government shall be exempt from covered registration service fees under this section.

 ( 8) REFUNDS

 ( A) EARLY WITHDRAWALS If, during the first 60 days after the beginning of the applicable decision time review period under subsection ( f)( 3), a covered pesticide registration application is withdrawn by the applicant, the Administrator shall refund all but 10 percent of the total registration service fee payable under paragraph ( 3) for the application.

 ( B) WITHDRAWALS AFTER THE FIRST 60 DAYS OF DECISION REVIEW TIME Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 27 of 46 PERIOD  ( i) IN GENERAL If a covered pesticide registration application is withdrawn after the first 60 days of the applicable decision time review period, the Administrator shall determine what portion, if any, of the total registration service fee payable under paragraph ( 3) for the application may be refunded based on the proportion of the work completed at the time of withdrawal.  ( ii) TIMING The Administrator shall  ( I) make the determination described in clause ( i) not later than 90 days after the date the application is withdrawn; and  ( II) provide any refund as soon as practicable after the determination.

 ( C) DISCRETIONARY REFUNDS  ( i) IN GENERAL In the case of a pesticide registration application that has been filed with the Administrator and has not been withdrawn by the applicant, but for which the Administrator has not yet made a final determination, the Administrator may refund a portion of a covered registration service fee if the Administrator determines that the refund is justified.  ( ii) BASIS The Administrator may provide a refund for an application under this subparagraph  ( I) on the basis that, in reviewing the application, the Administrator has considered data submitted in support of another pesticide registration application; or  ( II) on the basis that the Administrator completed portions of the review of the application before the effective date of this section.

 ( D) CREDITED FEES In determining whether to grant a refund under this paragraph, the Administrator shall take into account any portion of the registration service fees credited under paragraph ( 2) or ( 4).  ( c) PESTICIDE REGISTRATION FUND  ( 1) ESTABLISHMENT There is established in the Treasury of the United States a Pesticide Registration Fund to be used in carrying out this section ( referred to in this section as the   Fund'), consisting of  ( A) such amounts as are deposited in the Fund under paragraph ( 2);  ( B) any interest earned on investment of amounts in the Fund under paragraph ( 4); and  ( C) any proceeds from the sale or redemption of investments held in the Fund.  ( 2) DEPOSITS IN FUND Subject to paragraph ( 4), the Administrator shall deposit fees collected under this section in the Fund.  ( 3) EXPENDITURES FROM FUND  ( A) IN GENERAL Subject to subparagraphs ( B) and ( C) and paragraph ( 4), the Administrator may make expenditures from the Fund  ( i) to cover the costs associated with the review and decisionmaking pertaining to all applications for which registration service fees have been paid under this section; and Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 28 of 46  ( ii) to otherwise carry out this section.

 ( B) WORKER PROTECTION For each of fiscal years 2004 through 2008, the Administrator shall use approximately 1/ 17 of the amount in the Fund ( but not more than $ 1,000,000, and not less than $ 750,000, for any fiscal year) to enhance current scientific and regulatory activities related to worker protection.

 ( C) NEW INERT INGREDIENTS For each of fiscal years 2004 and 2005, the Administrator shall use approximately 1/ 34 of the amount in the Fund ( but not to exceed $ 500,000 for any fiscal year) for the review and evaluation of new inert ingredients.  ( 4) COLLECTIONS AND APPROPRIATIONS ACTS The fees authorized by this section and amounts deposited in the Fund  ( A) shall be collected and made available for obligation only to the extent provided in advance in appropriations Acts; and  ( B) shall be available without fiscal year limitation.  ( 5) UNUSED FUNDS Amounts in the Fund not currently needed to carry out this section shall be  ( A) maintained readily available or on deposit;  ( B) invested in obligations of the United States or guaranteed by the United States; or  ( C) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds.  ( d) ASSESSMENT OF FEES  ( 1) DEFINITION OF COVERED FUNCTIONS In this subsection, the term   covered functions' means functions of the Office of Pesticide Programs of the Environmental Protection Agency, as identified in key programs and projects of the final operating plan for the Environmental Protection Agency submitted as part of the budget process for fiscal year 2002, regardless of any subsequent transfer of 1 or more of the functions to another office or agency or the subsequent transfer of a new function to the Office of Pesticide Programs.  ( 2) MINIMUM AMOUNT OF APPROPRIATIONS Registration service fees may not be assessed for a fiscal year under this section unless the amount of appropriations for salaries, contracts, and expenses for the functions ( as in existence in fiscal year 2002) of the Office of Pesticide Programs of the Environmental Protection Agency for the fiscal year ( excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for covered functions for fiscal year 2002 ( excluding the amount of any fees appropriated for the fiscal year).  ( 3) USE OF FEES Registration service fees authorized by this section shall be available, in the aggregate, only to defray increases in the costs associated with the review and decisionmaking for the review of pesticide registration applications and associated tolerances ( including increases in the number of full time equivalent positions in the Environmental Protection Agency engaged in Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 29 of 46 those activities) over the costs for fiscal year 2002, excluding costs paid from fees appropriated for the fiscal year.  ( 4) COMPLIANCE The requirements of paragraph ( 2) shall have been considered to have been met for any fiscal year if the amount of appropriations for salaries, contracts, and expenses for the functions ( as in existence in fiscal year 2002) of the Office of Pesticide Programs of the Environmental Protection Agency for the fiscal year ( excluding the amount of any fees appropriated for the fiscal year) is not more than 3 percent below the amount of appropriations for covered functions for fiscal year 2002 ( excluding the amount of any fees appropriated for the fiscal year).  ( 5) SUBSEQUENT AUTHORITY If the Administrator does not assess registration service fees under subsection ( b) during any portion of a fiscal year as the result of paragraph ( 2) and is subsequently permitted to assess the fees under subsection ( b) during the fiscal year, the Administrator shall assess and collect the fees, without any modification in rate, at any time during the fiscal year, notwithstanding any provisions of subsection ( b) relating to the date fees are to be paid.  ( e) REFORMS TO REDUCE DECISION TIME REVIEW PERIODS To the maximum extent practicable consistent with the degrees of risk presented by pesticides and the type of review appropriate to evaluate risks, the Administrator shall identify and evaluate reforms to the pesticide registration process under this Act with the goal of reducing decision review periods in effect on the effective date of the Pesticide Registration Improvement Act of 2003 for pesticide registration actions for covered pesticide registration applications ( including reduced risk applications).  ( f) DECISION TIME REVIEW PERIODS  ( 1) IN GENERAL Not later than 30 days after the effective date of the Pesticide Registration Improvement Act of 2003, the Administrator shall publish in the Federal Register a schedule of decision review periods for covered pesticide registration actions and corresponding registration service fees under this Act.  ( 2) REPORT The schedule shall be the same as the applicable schedule appearing in the Congressional Record on pages S11631 through S11633, dated September 17, 2003.  ( 3) APPLICATIONS SUBJECT TO DECISION TIME REVIEW PERIODS The decision time review periods specified in paragraph ( 1) shall apply to  ( A) covered pesticide registration applications subject to registration service fees under subsection ( b)( 2);  ( B) covered pesticide registration applications for which an applicant has voluntarily paid registration service fees under subsection ( b)( 4); and  ( C) covered pesticide registration applications listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environmental Protection Agency.  ( 4) START OF DECISION TIME REVIEW PERIOD Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 30 of 46  ( A) IN GENERAL Except as provided in subparagraphs ( C) and ( D), in the case of a pesticide registration application accompanied by the registration service fee required under this section, the decision time review period begins 21 days after the date on which the Administrator receives the covered pesticide registration application.  ( B) COMPLETENESS OF APPLICATION In conducting an initial screening of an application, the Administrator shall determine  ( i) whether  ( I) the applicable registration service fee has been paid; or  ( II) the application contains a waiver or refund request; and  ( ii) whether the application  ( I) contains all necessary forms, data, draft labeling, and, documentation certifying payment of any registration service fee required under this section; or  ( II) establishes a basis for any requested waiver or reduction.  ( C) APPLICATIONS WITH WAIVER OR REDUCTION REQUESTS  ( i) IN GENERAL In the case of an application submitted with a request for a waiver or reduction of registration service fees under subsection ( b)( 7), the decision time review period shall be determined in accordance with this subparagraph.  ( ii) REQUEST GRANTED WITH NO ADDITIONAL FEES REQUIRED If the Administrator grants the waiver or reduction request and no additional fee is required, the decision time review period begins on the earlier of  ( I) the date on which the Administrator grants the request; or  ( II) the date that is 60 days after the date of receipt of the application.  ( iii) REQUEST GRANTED WITH ADDITIONAL FEES REQUIRED If the Administrator grants the waiver or reduction request, in whole or in part, but an additional registration service fee is required, the decision time review period begins on the date on which the Administrator receives certification of payment of the applicable registration service fee.  ( iv) REQUEST DENIED If the Administrator denies the waiver or reduction request, the decision time review period begins on the date on which the Administrator receives certification of payment of the applicable registration service fee.  ( D) PENDING APPLICATIONS  ( i) IN GENERAL The start of the decision time review period for applications described in clause ( ii) shall be the date on which the Administrator receives certification of payment of the applicable registration service fee.  ( ii) APPLICATIONS Clause ( i) applies to  ( I) covered pesticide registration applications for which voluntary fees have been paid under subsection ( b)( 4); and  ( II) covered pesticide registration applications received on or after the effective date of the Pesticide Registration Improvement Act of 2003 but submitted without the applicable registration service fee required under this section due to the inability of the Administrator to assess fees Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 31 of 46 under subsection ( d)( 1).  ( E) 2003 WORK PLAN In the case of a covered pesticide registration application listed in the Registration Division 2003 Work Plan of the Office of Pesticide Programs of the Environmental Protection Agency, the decision time review period begins November 1, 2003.  ( 5) EXTENSION OF DECISION TIME REVIEW PERIOD The Administrator and the applicant may mutually agree in writing to extend a decision time review period under this subsection.  ( g) JUDICIAL REVIEW  ( 1) IN GENERAL Any applicant adversely affected by the failure of the Administrator to make a determination on the application of the applicant for registration of a new active ingredient or new use for which a registration service fee is paid under this section may obtain judicial review of the failure solely under this section.  ( 2) SCOPE  ( A) IN GENERAL In an action brought under this subsection, the only issue on review is whether the Administrator failed to make a determination on the application specified in paragraph ( 1) by the end of the applicable decision time review period required under subsection ( f) for the application.  ( B) OTHER ACTIONS No other action authorized or required under this section shall be judicially reviewable by a Federal or State court.  ( 3) TIMING  ( A) IN GENERAL A person may not obtain judicial review of the failure of the Administrator to make a determination on the application specified in paragraph ( 1) before the expiration of the 2 year period that begins on the date on which the decision time review period for the application ends.  ( B) MEETING WITH ADMINISTRATOR To be eligible to seek judicial review under this subsection, a person seeking the review shall first request in writing, at least 120 days before filing the complaint for judicial review, a decision review meeting with the Administrator.  ( 4) REMEDIES The Administrator may not be required or permitted to refund any portion of a registration service fee paid in response to a complaint that the Administrator has failed to make a determination on the covered pesticide registration application specified in paragraph ( 1) by the end of the applicable decision review period.  ( h) ACCOUNTING The Administrator shall  ( 1) provide an annual accounting of the registration service fees paid to the Administrator and disbursed from the Fund, by providing financial statements in accordance with  ( A) the Chief Financial Officers Act of 1990 ( Public Law 101 576; 104 Stat. 2838) and amendments made by that Act; and  ( B) the Government Management Reform Act of 1994 ( Public Law 103 356; 108 Stat. 3410) and amendments made by that Act;  ( 2) provide an accounting describing expenditures from the Fund authorized under subsection Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 32 of 46 ( c); and  ( 3) provide an annual accounting describing collections and expenditures authorized under subsection ( d).  ( i) AUDITING  ( 1) FINANCIAL STATEMENTS OF AGENCIES For the purpose of section 3515( c) of title 31, United States Code, the Fund shall be considered a component of an executive agency.  ( 2) COMPONENTS The annual audit required under sections 3515( b) and 3521 of that title of the financial statements of activities under this section shall include an analysis of  ( A) the fees collected under subsection ( b) and disbursed;  ( B) compliance with subsection ( f);  ( C) the amount appropriated to meet the requirements of subsection ( d)( 1); and  ( D) the reasonableness of the allocation of the overhead allocation of costs associated with the review and decisionmaking pertaining to applications under this section.

 ( 3) INSPECTOR GENERAL The Inspector General of the Environmental Protection Agency shall    ( A) conduct the annual audit required under this subsection; and  ( B) report the findings and recommendations of the audit to the Administrator and to the appropriate committees of Congress.

 ( j) PERSONNEL LEVELS All full time equivalent positions supported by fees authorized and collected under this section shall not be counted against the Agency wide personnel level goals of the Environmental Protection Agency.

 ( k) REPORTS

 ( 1) IN GENERAL Not later than March 1, 2005, and each March 1 thereafter through March 1, 2009, the Administrator shall publish an annual report describing actions taken under this section.

 ( 2) CONTENTS The report shall include    ( A) a review of the progress made in carrying out each requirement of subsections ( e) and ( f), including    ( i) the number of applications reviewed, including the decision times for each application specified in subsection ( f); Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 33 of 46  ( ii) the number of actions pending in each category of actions described in subsection ( f)( 3), as well as the number of inert ingredients;

 ( iii) to the extent determined appropriate by the Administrator and consistent with the authorities of the Administrator and limitations on delegation of functions by the Administrator, recommendations for    ( I) expanding the use of self certification in all appropriate areas of the registration process;

 ( II) providing for accreditation of outside reviewers and the use of outside reviewers to conduct the review of major portions of applications; and  ( III) reviewing the scope of use of the notification process to cover broader categories of registration actions; and  ( iv) the use of performance based contracts, other contracts, and procurement to ensure that    ( I) the goals of this Act for the timely review of applications for registration are met; and  ( II) the registration program is administered in the most productive and cost effective manner practicable;

 ( B) a description of the staffing and resources relating to the costs associated with the review and decisionmaking pertaining to applications;

and  ( C) a review of the progress in meeting the timeline requirements of section 4( g).

 ( 3) METHOD The Administrator shall publish a report required by this subsection by such method as the Administrator determines to be the most effective for efficiently disseminating the report, including publication of the report on the Internet site of the Environmental Protection Agency.

 ( l) SAVINGS CLAUSE Nothing in this section affects any other duties, obligations, or authorities established by any other section of this Act, including the right to judicial review of duties, obligations, or authorities established by any other section of this Act.

 ( m) TERMINATION OF EFFECTIVENESS Attachment A Pesticide Registration Improvement Act of 2003 108th CONGRESS, 1st Session S. 1664 Page 34 of 46  ( 1) IN GENERAL Except as provided in paragraph ( 2), the authority provided by this section terminates on September 30, 2008.

 ( 2) PHASE OUT  ( A) FISCAL YEAR 2009 During fiscal year 2009, the requirement to pay and collect registration service fees applies, except that the level of registration service fees payable under this section shall be reduced 40 percent below the level in effect on September 30, 2008.

 ( B) FISCAL YEAR 2010 During fiscal year 2010, the requirement to pay and collect registration service fees applies, except that the level of registration service fees payable under this section shall be reduced 70 percent below the level in effect on September 30, 2008.

 ( C) SEPTEMBER 30, 2010 Effective September 30, 2010, the requirement to pay and collect registration service fees terminates.

 ( D) DECISION REVIEW PERIODS

 ( i) PENDING APPLICATIONS In the case of an application received under this section before September 30, 2008, the application shall be reviewed in accordance with subsection ( f).

 ( ii) NEW APPLICATIONS In the case of an application received under this section on or after September 30, 2008, subsection ( f) shall not apply to the application.'.

( g) CONFORMING AMENDMENTS The table of contents in section 1( b) of the Federal Insecticide, Fungicide, and Rodenticide Act ( 7 U. S. C. prec. 136) is amended ( 1) by striking the item relating to section 4( k)( 3) and inserting the following:  ( 3) Review of inert ingredients; expedited processing of similar applications.'; and ( 2) by striking the items relating to sections 30 and 31 and inserting the following:   Sec. 30. Minimum requirements for training of maintenance applicators and service technicians.   Sec. 31. Environmental Protection Agency minor use program.   Sec. 32. Department of Agriculture minor use program.  ( a) In general.  ( b)( 1) Minor use pesticide data.  ( 2) Minor Use Pesticide Data Revolving Fund.

  Sec. 33. Pesticide registration service fees.  ( a) Definition of costs. Page 35 of 46  ( b) Fees.  ( 1) In general.  ( 2) Covered pesticide registration applications.  ( 3) Schedule of covered applications and registration service fees.  ( 4) Pending pesticide registration applications.  ( 5) Resubmission of pesticide registration applications.  ( 6) Fee adjustment.  ( 7) Waivers and reductions.  ( 8) Refunds.  ( c) Pesticide Registration Fund.  ( 1) Establishment.  ( 2) Transfers to Fund.  ( 3) Expenditures from Fund.  ( 4) Collections and appropriations Acts.  ( 5) Unused funds.  ( d) Assessment of fees.  ( 1) Definition of covered functions.  ( 2) Minimum amount of appropriations.  ( 3) Use of fees.  ( 4) Compliance.  ( 5) Subsequent authority.  ( e) Reforms to reduce decision time review periods.  ( f) Decision time review periods.  ( 1) In general.  ( 2) Report.  ( 3) Applications subject to decision time review periods.  ( 4) Start of decision time review period.  ( 5) Extension of decision time review period.  ( g) Judicial review.  ( 1) In general.  ( 2) Scope.  ( 3) Timing.  ( 4) Remedies.  ( h) Accounting.  ( i) Auditing.  ( 1) Financial statements of agencies.  ( 2) Components.  ( 3) Inspector General.  ( j) Personnel levels.  ( k) Reports.  ( 1) In general.  ( 2) Contents.  ( l) Savings clause.  ( m) Termination of effectiveness.  ( 1) In general. Page 36 of 46  ( 2) Phase out.   Sec. 34. Severability.   Sec. 35. Authorization for appropriations.'.

( h) EFFECTIVE DATE This section and the amendments made by this section take effect on October 1, 2003. Page 37 of 46 Attachment B  Federal Register Document entitled: Pesticide Registration Fee Waivers; New Information Collection Activities and Request for Comments ( 69 FR 15322)  published March 25, 2004.

[ Federal Register: March 25, 2004 ( Volume 69, Number 58)] [ Notices] [ Page 15322 15325] From the Federal Register Online via GPO Access [ wais. access. gpo. gov] [ DOCID: fr25mr04 63]

ENVIRONMENTAL PROTECTION AGENCY [ OPP 2004 0092; FRL 7351 8]

Pesticide Registration Fee Waivers; New 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 document announces that EPA is seeking public comment on the following Information Collection Request ( ICR): Pesticide Registration Fee Waivers ( EPA ICR No. 2147.02, OMB Control No. 2070 0167). This is a request to renew an existing collection activity approved under the emergency processing procedures in section 3507( j) of the PRA, as implemented in OMB regulations at 5 CFR 1320.13, through September 30, 2004. 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 ID number OPP 2004 0092, must be received on or before May 24, 2004.

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: Nancy Vogel, 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 6475; fax number: ( 703) 305 5884; e mail address: vogel. nancy@ epa. gov. Page 38 of 46 SUPPLEMENTARY INFORMATION:

I. Does this Action Apply to Me?

You may be potentially affected by this action if you register pesticide products for food or feed uses, or submit petitions for pesticide tolerances. Additionally, this action may be of interest to agricultural producers, food manufacturers, or other pesticide manufacturers. Potentially affected categories and entities may include, but are not limited to:

Crop production ( NAICS 111), e. g., Establishments growing crops mainly for food and fiber.

Animal production ( NAICS 112), e. g., Establishments primarily engaged in keeping, grazing, breeding, or feeding animals.

Food processing ( NAICS 311), e. g., Establishments engaged in transforming livestock and agricultural products into products for intermediate or final consumption.

Pesticide and other agricultural chemical manufacturing ( NAICS 325320), e. g., Pesticide registrants who sell and distribute pesticide products to the general public in the United States.

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 the Information Collection Request document. 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 identification ( ID) number OPP 2004 0092. 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.

B. Electronic Access Page 39 of 46 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 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    OPP 2004 0092.'' 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. Page 40 of 46 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 http:// 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 0092. 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 0092. In contrast to EPA's electronic public docket, EPA's e mail 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 0092. 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, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP 2004 0092. 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? Page 41 of 46 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. Page 42 of 46 IV. What Information Collection Activity or ICR Does This Action Apply To?

EPA is seeking comments on the following ICR: Title: Pesticide Registration Fee Waivers.

ICR numbers: EPA ICR No. 2147.02, OMB Control No. 2070 0167. ICR status: This ICR is a renewal of an existing ICR that is currently approved by OMB and is due to expire on September 30, 2004.

Abstract: OMB approved the information collection activities described in this ICR under OMB Control No. 2070 0167 on March 16, 2004 in response to EPA's emergency processing request. EPA requested emergency processing under section 3507( j) of the PRA ( 44 U. S. C. 3501 et seq.), as implemented in OMB regulations at 5 CFR 1320.13, of the collection of information necessary for waiving pesticide registration fees as prescribed in the newly enacted Pesticide Registration Improvement Act of 2003 ( PRIA). A copy of the emergency request submitted to OMB ( EPA ICR No. 2147.01) and the related OMB action notice approving that request has been placed in the docket identified under Docket ID Number OPP 2004 0092.

EPA sought emergency processing of the existing approval because the collection of information necessary for processing the fee waiver requests was needed prior to the expiration of the time periods established under the PRA. The collection of this information at the time the waiver is requested is necessary for the Agency to be able to waive the fees, and proceed with making a decision on the related application. The statute was enacted on January 23, 2004, with a statutory effective date of March 23, 2004, at which time the fee waiver requests can be submitted to the Agency. The statutory implementation time frame does not allow the Agency to follow the regular process for ICRs under the PRA, which includes two comment periods with 60 day and 30 day time frames. EPA asked OMB to take action on the emergency request within 2 work days of receipt, and asked that OMB approve the collection for the full 180 days permitted by the regulations.

The collection activities covered by this ICR will allow the Agency to process requests for waivers of fees under the PRIA by ensuring that those requesting the waivers provide EPA with appropriate documentation demonstrating that they meet the waiver criteria established in the PRIA. The ICR covers the collection activities associated with requesting a fee waiver and involves requesters submitting a waiver request, information to demonstrate eligibility for the waiver, and certification of eligibility. Waivers are available for small businesses, for minor uses, and for actions solely associated with the Inter Regional Research Project Number 4 ( IR 4). State and Federal Agencies are exempt from the payment of fees.

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 Page 43 of 46 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 21,600 hours for the first year of implementation, and 18,720 hours in subsequent years. The following is a summary of the estimates taken from the ICR:

Respondents/ affected entities: Applicants for pesticide registration actions.

Estimated total number of potential respondents: 360 annually.

Frequency of response: On occasion.

Estimated total/ average number of responses for each respondent: 1.

Estimated total annual burden hours: 21,600 hours.

Estimated total annual burden costs: $ 1,879,200.

VI. Does the Proposed Renewal ICR Include Any Changes Over the Emergency Approval?

The burden and costs estimates are the same, but the detailed description is new.

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: March 18, 2004.

/ signed/ Susan B. Hazen, Acting Assistant Administrator, Office of Prevention, Pesticides and Page 44 of 46 Toxic Substances. [ FR Doc. 04 6699 Filed 3 24 04; 8: 45 am]

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