DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 1 of 65 SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST ( ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a). Title of the Information Collection: Data Generation for Pesticide Reregistration OMB #: 2070 0107 EPA #: 1504.05 1 ( b). Short Characterization/ Abstract This is a request to renew the existing information collection request ( ICR) for the ICR entitled: Data Generation for Pesticide Reregistration ( OMB No. 2070 0107; EPA No. 1504.05). This information collection is designed to provide the Environmental Protection Agency ( EPA, the Agency) with the necessary data for all pesticide active ingredients originally registered before November 1, 1984, to determine whether each pesticide's use poses unreasonable risks to human health or the environment. Pursuant to section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended, EPA must assess health and safety data for these active pesticide ingredients. Section 4 of FIFRA also establishes a process for the development of information needed to make reregistration decisions. Pesticide registrants seeking reregistration must generate and report the required data according to specific time tables.

This information collection activity allows EPA's Office of Pesticide Programs ( OPP) to obtain data needed by OPP scientists to assess and characterize pesticide risks, and for risk managers to determine whether and under what conditions pesticides may be reregistered and reassess existing tolerances to ensure that they meet the standards established by law. Data collected may consist of toxicology studies, residue chemistry studies, fish and wildlife studies, environmental fate studies, or other data needed to analyze the potential risks associated with pesticide chemicals and products. This collection also supports the Agency's reassessment of food tolerances associated with reregistration.

2. NEED FOR AND USE OF THE COLLECTION 2( a). Need/ Authority for the Collection EPA implements the reregistration program pursuant to the authority in section 4 of FIFRA, as amended, see Attachment A. EPA is required to collect additional information, as necessary, to determine whether active pesticide ingredients initially registered before November 1, 1984, are eligible for reregistration.

2( b). Practical Utility/ Users of the Data Under the FIFRA section 4 reregistration program, EPA examines health and safety data for pesticide active ingredients initially registered before November 1, 1984, and determines whether they are eligible for reregistration. To be eligible, a pesticide must have a substantially complete set of data, and the Agency must assess all the information/ data necessary to determine DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 2 of 65 whether products containing the pesticide present unreasonable risks to man or the environment when used in accordance with approved label directions.

In conducting the reregistration program, when the need for additional information or data arises, the Office of Pesticide Programs ( OPP) is authorized to issue a data call in notice ( DCI) pursuant to FIFRA section 3( c)( 2)( B) ( Attachment B) to obtain the data, and when necessary, the registrant may be required to certify compliance with data compensation requirements under the authority of FIFRA section 3( c)( 2)( D). Agency scientists and analysts integrate the new data received from registrants with the existing data in EPA's files. EPA reviews all relevant information to assess the potential risks associated with the use of the pesticide, to determine whether the pesticide should be reregistered. If a determination is made that a pesticide is eligible for reregistration, and the registrant submits acceptable product specific data and revised labeling, products containing the pesticide shall be reregistered within a specified time period. However, if after a review of the data, it is determined that a pesticide should not be reregistered, the Agency will take appropriate regulatory action.

To complete a pesticide's data base for reregistration, registrants have been required to generate additional information on human health and environmental effects, beyond the information that was submitted to the Agency when a pesticide was first registered. Prior to 1984, only acute testing or short term environmental testing was required for many pesticides before registration. However, by 1984, EPA had determined that data on chronic health effects and long term environmental effects ( e. g., tests for carcinogenicity or mutagenicity, or life cycle tests of organisms exposed to a pesticide) are necessary in many cases, and issued updated data requirements for registration. Any unfulfilled data requirements, or data gaps, are filled during reregistration.

In addition, all registered pesticides which may occur in food must meet the safety standard of the Federal Food Drug and Cosmetic Act ( FFDCA) as amended by the Food Quality Protection Act of 1996 ( FQPA). FQPA directs the Agency to consider aggregate exposures from dietary and other non occupational sources when assessing the risks of a pesticide. In addition to dietary exposure, such sources as drinking water and residential use must be considered. In evaluating pesticides for reregistration, EPA must make the statutory determination that pesticide residues in food or feed will result in a reasonable certainty of no harm to human health from aggregate exposure through dietary, non occupational, and drinking water routes of exposure. FQPA also directs EPA to consider the cumulative effects of pesticides that share a " common mechanism of toxicity," consider special sensitivities of infants and children, and consider possible endocrine disruptor effects.

FQPA requires the Agency to reassess all existing tolerances ( maximum limits for pesticide residues in food or feed) by 2006, to ensure that they meet the safety standard of the law. EPA was directed to give priority to the review of those pesticides that appear to pose the greatest risk to public health, and to reassess 33% of the over 9,700 tolerances requiring reassessment within three years ( by August 3, 1999), 66% within six years ( by August 3, 2002), and 100% in 10 years ( by August 3, 2006). DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 3 of 65 EPA is meeting the tolerance reassessment requirements to a great extent through the reregistration program. Schedules have been coordinated and integrated so that, in the course of making reregistration eligibility decisions, the Agency also is completing much of the tolerance reassessment. EPA also is completing tolerance reassessment through the pesticide registration program. As applications to register new food uses of existing pesticides are received, EPA must reassess the existing tolerances as well as the proposed new tolerances, to make sure there is a reasonable certainty that no harm will result to the public from aggregate exposure to residues from all uses. Finally, EPA is revoking tolerances for pesticide uses that have been canceled, many as a result of reregistration. Through these three types of tolerance reassessment decisions, the Agency is completing tolerance reassessment within the time frames mandated by the law. During the summer of 2002, for example, EPA surpassed the second portion of the FQPA goal by reassessing 66% of all food tolerances ( by August 3, 2002).

EPA expects to complete the integrated tolerance reassessment and reregistration programs within approximately the same time period, that is, in 2006 and 2008 respectively. By then, transition to the new registration review program mandated by FQPA which requires reevaluation of every existing registered pesticide with the goal of a 15 year cycle will be underway.

A record of each study submitted to OPP in support of pesticide registration or reregistration is maintained in the Agency's Pesticide Document Management System ( PDMS). The public may access the PDMS bibliography through the National Pesticides Information Retrieval System ( NPIRS). NPIRS supports searches of the PDMS database by chemical, subject, submission date, laboratory, guideline number, and document type. The public may request copies of studies that are non confidential, through a Freedom of Information Act ( FOIA) request.

2( c). Process and Program Status Section 4 of FIFRA mandates reregistration of all pesticides registered before November 1, 1984. FIFRA, as amended by FQPA in 1996, authorizes funding for the reregistration program through 2002. The Pesticide Registration Improvement Act ( PRIA) of 2003 requires all food use Reregistration Eligibility Decisions ( REDs) and non food use REDs be completed in 2006 and 2008, respectively. FIFRA structured the reregistration process into five phases with mandated deadlines for the Agency and pesticide producers or " registrants."

Phase 1, List Active Ingredients. FIFRA directs EPA to create a list of the active ingredients used in pesticides registered before November 1, 1984, and requested pesticide registrants to notify EPA of the intent to seek reregistration. In 1989, EPA created and published a list that is divided into four categories, Lists A through D.

Phase 2, Declare Intent and Identify Studies. This phase required pesticide registrants to notify EPA whether or not they intended to reregister their products; to identify and commit to providing the necessary studies, including either making a generic data exemption claim or commitment to generate or share data; and to pay the first installment of the reregistration fee. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 4 of 65 During this phase, EPA issued guidance for registrants to assist them in preparing Phase 2 and Phase 3 responses. Phase 2 was completed in 1990.

Phase 3, Summarize Studies. This phase required registrants to submit summaries and reformat acceptable studies, " flag" studies indicating adverse effects, re commit to satisfying all applicable data requirements, and pay the final installment of the reregistration fee. Phase 3 was completed in 1990.

Phase 4, EPA Review and Data Call In. During Phase 4, EPA reviewed all data submitted in Phase 2 and Phase 3 and required registrants to meet any unsatisfactory data requirements within four years. This phase was completed in 1993.

Phase 5, Reregistration Decisions. Currently, EPA is implementing Phase 5 of the Reregistration Program. In this final stage, the Agency is actively reviewing the studies submitted for each pesticide and determining whether or not the pesticide is eligible for reregistration   that is, whether the data base is substantially complete, and the pesticide does not cause unreasonable adverse effects to people or the environment when used in accordance with approved labeling. Under FFDCA, as amended by FQPA, EPA also is reassessing tolerances for any food uses, and considering whether the pesticide meets the safety standard of the new law. The Agency summarizes its resulting risk management/ regulatory decision about the pesticide in a Reregistration Eligibility Decision ( RED) document. With the RED, EPA calls in productspecific data and revised labeling. About two years later, after this additional data is received and reviewed ( and if all the active ingredients in a product are eligible), product reregistration may be completed.

EPA completed the process of calling in the generic studies required for pesticides in reregistration to fill any then existing data gaps during Phase 4. Since that time, the basic generic data set for most pesticides has been developed by their registrants and submitted to EPA. The studies submitted either are under review by Agency scientists to determine whether they are acceptable, or have been reviewed and, if found acceptable, are being used to support risk assessments, risk management conclusions, and reregistration decisions.

Although the Phase 4 data call ins are completed, other data collection and review activities for pesticides in reregistration and tolerance reassessment will continue to be necessary until these programs are concluded. The data that EPA must continue to collect and review fall into three general categories: confirmatory data, voluntary data, and product specific data.

Confirmatory Data. In completing a RED, additional generic studies sometimes are required to confirm the Agency's risk assessments, findings, or conclusions about a pesticide, and to help determine whether further use modifications will be necessary to reduce risks of concern.

Voluntary Data. FQPA, which became effective upon its enactment on August 3, 1996, requires EPA to specifically consider a number of new factors when making pesticide reregistration and other types of regulatory decisions. On January 31, 1997, EPA issued Pesticide Registration ( PR) Notice 97 1 identifying areas in which the Agency may need additional data to fully assess risks under FQPA. The notice encouraged registrants to supplement their original DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 5 of 65 reregistration submissions with additional information that may permit more accurate estimates of exposure and/ or risk. As a result of PR Notice 97 1, EPA is receiving voluntarily submitted studies for pesticides in reregistration, particularly for large volume, controversial chemicals.

Product Specific Data. After the generic data supporting a pesticide are evaluated and the RED is developed and issued, EPA's focus turns to the information and data required to make reregistration decisions at the product specific level. For every end use product covered by a RED ( that is, every product that contains an active ingredient included in the RED), the Agency requires the submission of a Confidential Statement of Formula, certain data on the product as formulated and sold ( including acute toxicity and product chemistry studies), and revised labeling. Such information and data are essential to making the final product reregistration decision.

Since a need still exists to collect the information necessary to complete the pesticide reregistration program, EPA is renewing this ICR for another three years. The renewal of this ICR will also allow for the continued use of the forms associated with this ICR; e. g., EPA Data Call In Response Form ( Attachment C); EPA Requirements Status and Registrant's Response Form ( Attachment D); Certification of Attempt to Enter into an Agreement with Registrants for Development of Data form ( EPA Form 8570 32, Attachment E); and Certification with Respect to Citation of Data ( EPA Form 8570 34, Attachment F).

Please note that this information collection program is separate from the information collection program described in the ICR entitled " Data Call in for Special Review Chemicals and Registration Review Program" ( EPA ICR # 922, OMB# 2070 0057) implemented pursuant to section 3( g) of FIFRA. The Registration Review Program involves the review of all pesticide registrations with the goal of a 15 year cycle. Similar to the FIFRA section 4 reregistration program, the Registration Review Program directs EPA to use the authority in FIFRA section 3( c)( 2)(( B) to require pesticide registrants to generate and submit data to the Agency where such data are needed to assess whether registration of an existing pesticide poses unreasonable risk to man or the environment. By the time the reregistration program, currently in its final years, is completed, the new section 3( g) Registration Review Program should be fully implemented.

3. NON DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA 3( a). Non duplication OPP has made concerted efforts to avoid duplication and promote efficiency in information collection procedures. For example, registrants were provided guidance to help them identify generic studies that had been previously submitted to the Agency but did not meet current requirements for reregistration. Rejection Rate Analyses examining studies submitted to the Agency under various scientific disciplines were developed and issued by OPP, to provide guidance to registrants. These analyses assisted registrants in developing studies that met Agency criteria and were more likely to be accepted for review when initially submitted. This guidance enabled registrants to initiate any new studies required for reregistration as soon as possible and avoid submitting deficient data. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 6 of 65 The Agency allows cost sharing agreements among manufacturers of specific pesticide chemicals to minimize the duplication of laboratory tests conducted for this collection. Data callin notices explain the statutory provisions for cost sharing agreements for FIFRA.

Finally, the information called in is specific to the needs of the federal pesticide law, negating the need for similar data by other federal agencies. The Agency maintains files on all pesticide chemicals, which includes all correspondence and information/ data submitted. Before any DCI is issued, these files are referenced to determine whether the necessary data are already on hand, thereby eliminating duplicative data requests.

3( b). Public Notice Required Prior to ICR Submission to OMB In preparing to renew this ICR, EPA will publish a notice in the Federal Register which will provide a 60 day public notice and comment period. The Agency will consider any comments on this ICR in response to that notice.

3( c). Consultations Congress intended the reregistration provisions of FIFRA to include ongoing consultations with registrants concerning data requirements for reregistration. OPP is constantly consulting with the registrants regarding data needs as new technology evolves.

The initial stage of the reregistration process allows the registrant to give feedback to the Agency's request for data. OPP is always open to communications with registrants concerning any issues they may have with the requirements for data. Additionally, registrants may request waivers of information requirements if they believe that the Agency can properly evaluate their pesticide without additional data.

3( d). Effects of Less Frequent Collection Information is collected under this activity only once and only when specific data are required.

3( e). General Guidelines The only guideline established under the Paperwork Reduction Act ( PRA) that is exceeded in this collection is the time period for retaining records. EPA requirements in 40 CFR 169.2( k) state that records containing research data relating to registered pesticides be retained for as long as the registration is valid and the producer remains in business. Registrations are valid until they are either voluntarily canceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration. Since the average period of marketability of a pesticide ranges from 15 to 30 years, the PRA guidelines specifying that data other than health, medical or tax records not be required to be retained for more than three years will be exceeded in this collection activity.

3( f). Confidentiality DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 7 of 65 In general, most health and safety data submitted by registrants under FIFRA are considered by OPP to contain no Confidential Business Information ( CBI). If, however, registrants submit data that relates to trade secrets or commercial or financial information, such information is protected from disclosure under section 10 of FIFRA. Such data submitted to this Agency are handled strictly in accordance with the provisions of the FIFRA Confidential Business Information Security Manual. This manual contains instructions relative to all contact with confidential documents, including: responsibilities of EPA employees; physical security measures; CBI copying and destruction procedures; transfer of CBI materials within EPA to contractors or other government offices; computer security; CBI typing procedures; and procedures internal to OPP. The manual dictates that all CBI must be marked or flagged as such, all CBI must be kept in secure ( double locked) areas, and all CBI intended to be destroyed must be cleared by a document control officer and shredded.

3( g). Sensitive questions No information of a sensitive or private nature is requested in conjunction with this information 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 EPA requires registrants of pesticide products to submit data to support reregistration of their product. The registrants are responsible for producing and maintaining data to support their registrations, and therefore, are the only entities affected by this collection activity. The North American Industrial Classification System ( NAICS) code for respondents to this ICR is 325320 ( Pesticide and other Agricultural Chemical Manufacturing).

4( b). Information Requested ( i) Data items, including record keeping requirements The types of data that may be requested by this ICR will depend on the information that is missing in the current set of data that is available to EPA for the pesticide chemical. However, the types of data that can be the subject of a generic data call in, or be called in as confirmatory data, or called in for product specific studies required at the end of the reregistration process, or needed to support individual end use product reregistration are categorized and listed in 40 CFR Part 158, as well as on EPA's Internet Home page and in other guidance for registering a pesticide. These categories include:

Product Chemistry Residue Chemistry Environmental Fate Toxicology Reentry Protection DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 8 of 65 Spray Drift Wildlife and Aquatic Organisms Plant Protection Nontarget Insect Product Performance Biochemical Pesticides Microbial Pesticides Additional types of data may be useful to support tolerance reassessment under FQPA. Currently, many of these studies are being submitted by pesticide registrants on a voluntary basis. Some examples of these types of studies include:

Exposure Studies Dermal Absorption/ Penetration Studies Acute and Subchronic Neurotoxicity Studies Cholinesterase Determination Biomonitoring Studies ( in Children) Food/ Milk Market Basket Surveys Monte Carlo Probabilistic Assessments/ Acute and Chronic Dietary Exposure Analyses Historical Water Monitoring Data Field Monitoring Studies and Evaluations Runoff and Drift Monitoring Studies Pesticide Removal Studies using Vegetative Filter Strips Retrospective Analyses of Surface Water Contamination Analyses of Use Patterns Research Studies of Applications and Use in Professional Markets Comparative Formulations/ Application Methods/ Resulting Crop Residue Studies Mechanistic Studies for Carcinogenicity Studies on Potential to React with DNA In addition to these types of data, other special studies could be required to support reregistration. These studies would be based on the particular characteristics of the chemical.

OPP will issue a data call in for a pesticide chemical only after it reviews the available data and determines that the information is not sufficient to satisfy the statutory requirements for reregistration. Even after OPP has completed its review and has determined that additional data must be called in, registrants may also request a waiver if they believe that OPP can properly evaluate the risks of their pesticide chemicals without additional data. OPP will review each waiver request individually.

( ii) Respondent Activities Registrants who receive a data call in notice from EPA must notify the Agency how they intend to comply with the terms of the DCI notice within 90 days of receipt of the notice. The options for complying are to voluntarily cancel their product( s), delete certain uses, DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 9 of 65 claim a generic data exemption, agree to satisfy the data requirements imposed by the notice, or request a data waiver.

Voluntary Cancellation  Registrants opting to voluntarily cancel their products containing the active ingredient that is subject to the DCI must submit a completed Data Call In Response Form. If a product is voluntarily cancelled, further sale and distribution of that product after the effective date of cancellation must be in accordance with the existing stocks provision of the individual DCI notice.

Deletion of Uses  Registrants choosing to amend their registration to delete the uses of their product to which the requirements apply must submit the Requirements Status and Registrant's Response Form, a completed application for amendment, a copy of their proposed amended labeling, and all other information required for processing the application. They must also complete a Data Call In Response Form. If registrants choose to delete the use( s) subject to the DCI notice or uses subject to specific data requirements, further sale, distribution, or use of their product after one year from the due date of their 90 day response must bear an amended label.

Generic Data Exemption  Registrants are entitled to apply for a generic data exemption from the requirement to submit or cite generic data concerning an active ingredient if the active ingredient in the product is derived exclusively from purchased, registered pesticide products containing the active ingredient. To qualify for a generic data exemption, a product must meet all of the following requirements:

a. The active ingredient( s) in the registered product must be present solely because of incorporation of another registered product which contains the subject active ingredient( s) and be purchased from a source not connected with the registrant; and,

b. Every registrant who is the ultimate source of the active ingredient( s) in the product subject to the DCI notice must be in compliance with the requirements of the notice and must remain in compliance; and c. The registrant of the product that is the subject of the DCI notice must have provided to EPA an accurate and current " Confidential Statement of Formula" for each of the products to which the Notice applies.

Registrants applying for the Generic Data Exemption must submit a completed Data Call In Response Form and all supporting documentation. Generic data exemption cannot be selected as an option for product specific data.

Registrants who are granted a Generic Data Exemption rely on the efforts of other persons to provide the Agency with the required data. If the registrant( s) who have committed to generate and submit the required data fail to take appropriate steps to meet the requirements or are no longer in compliance with the DCI notice, the Agency will consider that both registrants are not in compliance and will normally initiate proceedings to suspend the registrations of both registrants' products unless the registrant who was granted the generic data DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 10 of 65 exemption commits to submit and does submit the required data within the specified time. In such cases the Agency generally will not grant a time extension for submitting the data.

Submission of Data Required by the Notice  Registrants choosing this option must agree to either: submit the data required by the notice within the specified time frame; enter into an agreement with one or more other registrants to develop data jointly; make offers to cost share; submit an existing study that has not been submitted previously to the Agency by anyone; submit or cite data to upgrade a study classified by EPA as partially acceptable and upgradeable; or cite an existing study that EPA has classified as acceptable or an existing study that has been submitted but not reviewed by the Agency.

Submission of Data Waiver Request  A registrant may request either a low volume/ minor use waiver or a waiver based on the registrant's belief that the data requirement( s) do not apply to their product. In addition to the Requirements Status and Registrant's Response Form, registrants requesting low volume/ minor use waivers must submit the following information:

a. Total company sales ( pounds and dollars) of all registered product( s) containing the active ingredient( s). If applicable to the active ingredient( s), include foreign sales for those products that are not registered in this country but are applied to sugar ( cane or beet), coffee, bananas, cocoa, and other such crops, by year for each of the past five years.

b. An estimate of the sales ( pounds and dollars) of the active ingredient( s) for each major use site, by year for each of the past five years.

c. Total direct production cost of product( s) containing the active ingredient( s) by year for the past five years, including information on raw material cost, direct labor cost, advertising, sales and marketing, and any other significant costs, listed separately.

d. Total indirect production cost ( e. g. plant overhead, amortized plant and equipment) charged to product( s) containing the active ingredient( s) by year for the past five years. Exclude all non recurring costs that were directly related to the active ingredient( s), such as costs of initial registration and any data development.

e. A list of each data requirement for which the registrant is requesting a waiver.

f. The type of waiver sought and the estimated cost to the registrant ( listed separately for each data requirement and associated test) of conducting the testing needed to fulfill each of these data requirements. g. A list of each data requirement for which the registrant is not seeking any waiver and the estimated cost ( listed separately for each data requirement and associated test) of conducting the testing needed to fulfill each of these data requirements.

h. For each of the next ten years, a year by year forecast of company sales ( pounds and dollars) of the active ingredient( s), direct production costs of product( s) containing the active ingredient( s) ( following the parameters in item c above), indirect production costs of product( s) containing the active ingredient( s) ( following the parameters in item d above), and costs of data DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 11 of 65 development pertaining to the active ingredient( s). In addition, the registrant must provide a description of the importance and unique benefits of the active ingredient( s) to users and discuss the use patterns and the effectiveness of the active ingredient( s) relative to registered alternative chemicals and non chemical control strategies. Focus on benefits unique to the active ingredient( s), providing information that is as quantitative as possible. If quantitative data is not available upon which to base estimates, then present the reasoning used to derive estimates. To assist the Agency in determining the degree of importance of the active ingredient( s) in terms of its benefits, information should be provided on any of the following factors, as applicable to the registrant's product( s):

° documentation of the usefulness of the active ingredient( s) in Integrated Pest Management; ° description of the beneficial impacts on the environment of use of the active ingredient( s), as opposed to its registered alternatives; ° information on the breakdown of the active ingredient( s) after use and on its persistence in the environment; and ° description of the product's usefulness against pest( s) of public health significance.

Failure to submit sufficient information for the Agency to make a determination regarding a request for a low volume minor use waiver will result in denial of the waiver request.

Request for Waiver of Data  A registrant may also request a waiver if they believe that a particular data requirement should not apply because the corresponding use is no longer registered or the requirement is inappropriate. In addition to the Requirements Status and Registrant's Response Form, registrants requesting a waiver of data requirements must submit a rationale explaining why the registrant believes the data requirements should not apply, as well as copies of current product labels and a current copy of the Confidential Statement of Formula for each product. If the Agency determines that a registrant does not qualify for a waiver and that the data are required for the product( s), the registrant must choose a method of meeting the requirements of the notice within the 90 day time frame provided by the notice. Within 30 days of the registrant's receipt of the Agency's written decision, the registrant must submit a revised Requirements Status and Registrant's Response Form indicating the option chosen.

A registrant responding to a DCI issued by EPA once it determines that the available information is not sufficient to satisfy the statutory requirements for reregistration should first search its internal records to identify any data or information that they may have which will satisfy the DCI. Although the Agency searches for publicly available data and information, the registrant may have unpublished data or information that might satisfy the identified data need, and may not need to generate additional data. If the registrant does not have any data or information available, they should then proceed planning the research and/ or studies necessary to generate the data required to satisfy the identified data need.

In general, the burden and cost estimates in this ICR assume that a registrant must engage in the following activities in order to comply with a DCI: DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 12 of 65 read instructions read the DCI letter to understand what data are to be submitted; or read PR Notice 97 1 to learn what voluntary data would be useful to EPA;

plan activities plan the activities necessary to comply with the DCI, or develop options to avoid having to submit data ( includes time for reviewing internal company information for existing data);

create information conduct research, administer tests, analyze data to develop studies, perform laboratory analysis, write study documents ( only if no data is available within registrant control);

gather information search for existing data that will satisfy the DCI;

compile and review assemble and evaluate data for accuracy and appropriateness for compliance with the DCI;

complete paperwork prepare necessary correspondence, documents and packages for submitting data to EPA;

maintain and file maintain the data and other information submitted to the Agency in company files.

Attachment G provides a general description of the methodology used by the Agency to estimate the potential paperwork burden and costs for respondents to comply with data call ins ( DCIs) issued by EPA.

5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a). Agency Activities The following are Agency activities necessary to conduct a DCI:

develop DCI correspondence Prepare the DCI letter identifying all data needed;

answer registrant questions respond to any questions the registrant may have regarding the DCI;

record DCI submissions record submissions in tracking system for internal review;

analyze data conduct scientific reviews of the data;

store data index data and store it in Agency files.

5( b). Collection Methodology and Management OPP has completed a major review of its information tracking systems to improve their efficiency and accuracy. This review resulted in the development of a new integrated information DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 13 of 65 system, which, when complete, will improve the quality of the Agency's databases and allows the EPA to respond more timely and accurately to queries from registrants and the public, including requests made under the FOIA.

OPP is also investigating the possibility of providing optional electronic data transfer services to the industry as a means of minimizing the burden of registration activities. The Agency's pesticide program, along with the pesticide industry, recognizes the advantages in terms of accuracy, speed, cost and personnel from electronic data transfer technologies. In addition, OPP is consulting with industry associations and other federal agencies, and participating in an Agency wide workgroup to develop electronic reporting standards intended to facilitate collection of information from industry.

OPP does not publish the studies submitted. However, it maintains records of each study in the Pesticide Document Management System ( PDMS), and provides public access to the PDMS bibliography through the National Pesticides Information Retrieval System ( NPIRS). NPIRS supports searches of the PDMS database by chemical, subject, submission date, laboratory, guideline number, and document type, and the public may request copies of studies that are non confidential by submitting a FOIA request.

5( c). Small Entity Flexibility Registrants who purchase registered pesticide products for reformulation or further manufacture obtain federal registration, but they generally do not have responsibility for supplying generic data ( unless the basic registrant does not fully support all the data requirements for their products). Therefore, they normally would need only respond to a DCI for generic data by indicating a legitimate claim to a generic data exemption. They do not incur any other information burden associated with a generic data call in. Such registrants however, are responsible for providing the data and information required by a Product Specific DCI, to support the final reregistration of their end use product( s).

5( d). Collection Schedule There is no periodic schedule for the collection. The data call ins are issued when the need for the information and/ or data is identified, and require a one time submission.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION To estimate the burden and costs for the paperwork related activities for the respondents to comply with DCIs that could be issued under this ICR, EPA used the same methodology as was previously used to estimate DCI related paperwork burden. A general description of this methodology is provided in Attachment G. In short, this methodology used the total cost of the test required by the DCI to generate estimates for the burden and cost of the paperwork related activities associated with DCIs. The following estimates represent the burden and costs for the paperwork related activities, and therefore includes the paperwork burden and costs related to the creation and gathering of the data. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 14 of 65 6( a). Estimating Respondent Burden The total burden hours for respondents to comply with this information collection activity over the next three years is estimated to be 1,566,744 hours. A three year duration of equal effort is assumed for this information collection request, so the total annual respondent burden is estimated to be 522,248 hours ( 1,566,744 ÷ 3).

The DCI burden estimate is dependent upon the type or class of chemical under review and whether there is a high, or low level ( in terms of complexity) of studies required for a particular chemical. This information collection request projects that decision documents for approximately 142 pesticide ingredients will be completed during FYs 2004 2006 and will be associated with DCIs to be issued over the next three years. As a result of the PRIA of 2003, a handful of REDs previously scheduled for FYs2007 and 2008 are being scheduled for FYs 2005 and 2006, and are included among the 142 ingredients for which DCIs are expected to be issued under this ICR renewal. Of those 142 pesticide ingredients, reregistration will account for 91 through Reregistration Eligibility Decisions ( REDs) and Interim Reregistration Eligibility Decisions ( IREDs) that will become full REDs within the renewal period, and tolerance reassessment will account for 48 through Tolerance Reassessment Decisions ( TREDs) and 3 through other documentation for ingredients with no U. S. registrations but with import tolerances. With most REDs, the Agency will probably issue data call ins ( DCIs) for product reregistration. Calculations for the burden estimates of this ICR are based only on Phase 5 activities and for reassessing existing tolerances. The type of information that the Agency may require respondents to submit or respondents may voluntarily submit to the Agency can generally be described in three categories. All three data types have been considered in estimating the respondent burden.

° Confirmatory Data  studies not previously required that EPA needs to confirm risk findings in concluding the reregistration process and issuing REDs; ° Product Specific Data  acute toxicity and product chemistry studies required for pesticides completing product reregistration; and ° Voluntary Studies  studies not required by the Agency, but submitted voluntarily by registrants to supplement studies originally submitted to show that the pesticide risks are lower than EPA might otherwise conclude.

Confirmatory data and product specific data will be called in on an as needed basis. The Agency does not know how many voluntary studies will be submitted by registrants because this information is developed and submitted at the registrants' own discretion. However, EPA examined the confirmatory, product specific and voluntary data that have been submitted for representative pesticides recently or currently in the reregistration and tolerance reassessment process and has used this information to project the estimates in this ICR.

Confirmatory data are required of registrants to fill gaps in registrant databases and to assist in the evaluation of risk findings. In estimating the burden related to confirmatory data, the Agency reviewed thirty four REDs and TREDs ( from FYs 2001 and 2002) and the list of studies requested to be submitted. An average number of confirmatory studies requested was 9.8 studies, most of which were new study requests. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 15 of 65 Voluntary data consist of studies not required by the Agency but are submitted by registrants to supplement a pesticide database. Based on a sampling of the REDs affected by FQPA tolerance reassessment, EPA recognizes that some registrants will submit voluntary data. In previous years, EPA estimated that approximately one half of the REDs will have voluntary data submittals. To account for the burden attributed to voluntarily submitted data, the Agency inventoried the data types that had been submitted for a range of chemicals. The burden was divided into ranges designated as low burden studies ( one third of all REDs) or high burden studies ( one sixth of all REDs). Of 91 REDs/ IREDs expected to be completed by FY2006, one could anticipate as many as 30 " low burden" and 15 " high burden" responses. However, a search of the Agency's OPPIN database shows that since January 1, 1996 there have been 67 extraneous data submissions received over a period of 8.25 years, with an average of about 8 extraneous data submissions per year. If this burden is attributed to 24 such submissions over the next three years, then 16 submissions are expected to be " low burden" and 8 submissions may be considered " high burden." Many of these studies submitted will probably be existing studies, e. g., studies that were found in existing literature, or studies that were slightly modified and resubmitted, or studies of lower cost. Some may be special studies such as a MONTE CARLO, or limited market basket survey, or other studies to provide the Agency with actual exposure data. The Agency averaged the burden hours related to voluntary studies as if they represented a cross section of typical data requirements.

Generally, product specific data is comprised of toxicity and product chemistry data. EPA estimated the respondent burden for product specific DCIs by developing a typical reregistration case with a typical number of batches and estimating the number and type of studies required. Calculations estimate the average burden hour and dollar costs associated with preparing and submitting those studies. The number of responses per RED varies greatly from 1 to more than 100, but due to the efforts to pool resources, complete industry responses should average 3 responses per RED. Due to the citation of data on similar products and the citation of existing data previously submitted to the Agency, the number of studies called in under the DCI typically differs significantly from the number of new studies actually generated in response to the DCI. The Agency previously determined that for the Acute Toxicity, a sample of approximately 95 reviews from five randomly selected chemicals were evaluated. This evaluation was performed to determine the number of new studies generated in response to the DCI. Based on this evaluation, it was determined that approximately 18% of the Acute Toxicity data requirements are newly generated in response to the DCI. Among the six Acute Toxicity requirements ( acute oral, acute dermal, acute inhalation, acute eye irritation, acute dermal irritation and dermal sensitization), the Acute eye irritation ( 870.2400), and Acute dermal irritation ( 870.2500) studies may account for as much as 50% of the new data produced ( in equal proportions). The other 50% of the new data is equally distributed between the remaining four study requirements.

For the Product Chemistry, the percent of new data produced in response to the DCI is based on Product Chemistry reviewer estimates from previous reviews. This process established that approximately 10% of the Product Chemistry data requirements are newly generated in response to the DCI. Among the Product Chemistry Requirements, typically the Storage Stability ( 830.6317), Corrosion Characteristics ( 830.6320), Viscosity ( 830.7100) and Analytical Methods ( 830.1800) guidelines may account for up to 90% of the new data produced ( in equal proportions). The remaining new data is equally distributed between the Flammability DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 16 of 65 ( 830.6315), pH ( 830.7000), Density ( 830.7300), and various requirements for technical/ pure active ingredients including Preliminary analysis ( 830.1700), Water solubility ( 830.7840 or 830.7860), and Vapor pressure ( 830.7950) for a total of about 10 guidelines. Ideally, the remaining product chemistry requirements have already been generated at registration since the information is inherent to the production process [ e. g. Product identity and composition ( 830.1550), Description of formulation process ( 830.1650)].

In developing these estimates, EPA assumed that: studies were submitted by registrants ( not by grower groups, other agencies, etc.); studies had not been requested under a previous Data Call In; studies were not a request to resubmit because the original study submitted was not complete or did not meet the data submission requirements; and studies submitted that are based on preexisting data and can be found in published, peer reviewed literature were not included.

The following tables illustrate the respondent paperwork burden hours and costs for voluntary, confirmatory and product specific tests. Followed by the agency's burden hours and costs associated with this collection activity, a presentation of the total burden and costs for this ICR, an explanation of the changes in the burden estimate since the last ICR approval, and the burden statement for this ICR. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 17 of 65 Table 1. Respondent Burden for DCIs Involving Confirmatory Studies a Collection Activities Burden Hours Total Mgmt. $ 130/ hr Tech. $ 88/ hr Cler. $ 40/ hr Hours Costs 1. Read and discuss test requirements 12 0 0 12 $ 1,560 2. Discuss test and protocol with Agency 6 6 0 12 $ 1,308 3. Plan activities 24 6 0 30 $ 3,648 4. Create information 18 299 36 353 $ 30,092 5. Gather information 0 30 0 30 $ 2,640 6. Process, compile, review information for accuracy 35 48 0 83 $ 8,774 7. Complete written forms 0 0 12 12 $ 480 8. Record, disclose, display information 11 0 24 35 $ 2,390 9. Store, file, or maintain information 11 0 18 29 $ 2,150 Total Burden 117 389 90 596 $ 53,042 No change in burden hour distribution since the last ICR. Update in the cost per labor hour.

Estimated Total Annual Respondent Burden & Costs for DCIs Involving Confirmatory Studies: Burden: 596 hours per response x approximately 446 responses = 276,544 burden hours. Costs: $ 53,042 per response x approximately 446 responses = $ 24,611,488 It is assumed that for 142 RED/ IRED/ TRED/ etc. pesticide ingredients there will be an average of 9.8 confirmatory studies, which will result in a maximum annual total of 1,392 responses ( 142 x 9.8) over the three year period of the ICR. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 18 of 65 Table 2. A. Respondent Burden for Submissions of Voluntary Low Burden Studies Collection Activities Burden Hours Total Mgmt. $ 130/ hr Tech. $ 88/ hr Cler. $ 40/ hr Hours Costs 1. Read and discuss test requirements 12 0 0 12 $ 1,560 2. Discuss test and protocol with Agency 6 6 0 12 $ 1,308 3. Plan activities 24 6 0 30 $ 3,648 4. Create information 18 299 36 353 $ 30,092 5. Gather information 0 30 0 30 $ 2,640 6. Process, compile, review information for accuracy 35 48 0 83 $ 8,774 7. Complete written forms 0 0 12 12 $ 480 8. Record, disclose, display information 11 0 24 35 $ 2,390 9. Store, file, or maintain information 11 0 18 29 $ 2,150 Total per Respondent Burden 117 389 90 596 $ 53,042 Estimated Total Annual Respondent Burden & Costs for DCIs Involving Voluntary Low Burden: Burden: 596 hours x 5.3 responses = 3,179 hours Costs: $ 53,042 x 5.3 responses = $ 282,890 It is assumed that over three years there will be no more than 24 extraneous data submissions of which sixteen responses ( 0.67 x 24) will include voluntary low burden studies. The hourly burden is assumed to be 10% of the 1996 ICR's list C& D chemicals burden hour estimate generated for the 1996 ICR and reviewed in 2000, and updated such that the $/ per hour for each labor category is based upon the accepted fully loaded labor rate for each of the three labor categories.

Table 2. B. Respondent Burden for Submission of Voluntary High Burden Studies Collection Activities Burden Hours Total Mgmt. $ 130/ hr Tech. $ 88/ hr Cler. $ 40/ hr Hours Costs 1. Read and discuss test requirements 72 0 0 72 $ 9,360 2. Discuss test and protocol with Agency 36 36 0 72 $ 7,848 3. Plan activities 144 36 0 180 $ 21,888 DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 19 of 65 4. Create information 108 1,791 215 2,114 $ 180,248 5. Gather information 0 179 0 179 $ 15,752 6. Process, compile, review information for accuracy 215 287 0 502 $ 53,206 7. Complete written forms 0 0 72 72 $ 2,880 8. Record, disclose, display information 72 0 144 216 $ 15,120 9. Store, file, or maintain information 72 0 108 180 $ 13,680 Total Burden 719 2,329 539 3,587 $ 319,982 Estimated Total Annual Respondent Burden for DCIs Involving Voluntary High Burden: Burden: 3,587 hours x 3 responses = 9,565 hours Costs: $ 319,982 x 3 responses = $ 853,285 It is assumed that over three years there will be no more than 24 extraneous data submissions of which eight responses ( 0.33 x 24) will include voluntary high burden studies. The hourly burden is assumed to be 10% of the 1996 ICR's list C& D chemicals burden hour estimate generated for the 1996 ICR and reviewed in 2000, and updated such that the $/ per hour for each labor category is based upon the accepted fully loaded labor rate for each of the three labor categories. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 20 of 65 Table 3. Respondent Burden Estimates for Product Specific DCI Activities a Collection Activities Burden Hours Total Mgmt. $ 130/ hr Tech. $ 88/ hr Cler. $ 40/ hr Hours Costs 1. Read and discuss test requirements 51 0 0 51 $ 6,630 2. Discuss test and protocol with Agency 26 26 0 52 $ 5,668 3. Plan activities 102 26 0 128 $ 15,548 4. Create information 77 1,280 154 1,511 $ 128,810 5. Gather information 0 128 0 128 $ 11,264 6. Process, compile, review information for accuracy 154 204 0 358 $ 37,972 7. Complete written forms 0 0 51 51 $ 2,040 8. Record, disclose, display information 51 0 102 153 $ 10,710 9. Store, file, or maintain information 51 0 77 128 $ 9,710 Total Burden 512 1,664 384 2,560 $ 228,352 Estimated Total Annual Respondent Burden for Product Specific DCI Activities: Burden: 2,560 hours x 91 responses = 232,960 hours. Costs: $ 228,352 x 91 responses = $ 20,780,932 It is assumed that only REDs will require product DCIs and that for 91 RED/ IRED pesticide ingredients there will be, due to the efforts to pool resources, an average of 3 responses per RED ( the same as expected in the previous ICR) and there will be a total of 273 ( 91 x 3) responses.

6( b). Estimating Respondent Costs The total annual cost to all respondents to comply with the DCIs potentially issued under this ICR is estimated to be $ 46,528,595, with the total respondent costs over three years estimated to be $ 139,585,575.

Respondent costs are based on managerial, technical and clerical burden hours estimated at $ 130, $ 88, and $ 40 per hour, respectively. EPA has calculated the estimated labor rates for respondents to the requirements of this ICR factoring in an inflation cost index of 1.056 based on the Gross Domestic Product. These labor rates are fully loaded and include benefits and overhead costs. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 21 of 65 These estimates are representative of the expected costs per chemical based on an average cost using sample DCIs, and the estimated number of respondents for each DCI based on the type of DCI as discussed above. Some respondents will spend less effort and others with several chemicals or products will have more complicated requirements and spend more time than the average estimated. Other respondents may experience much less burden, e. g., if they already have data that was otherwise unavailable to EPA, or if they request and receive a waiver.

6( c). Estimating Agency Burden and Cost In the previous ICR, the Agency estimated it would spend 99,135 hours at a cost of $ 6,003,810 per year to perform the duties and activities as required to support DCIs issued for 10 REDs annually. Of that total, the Agency estimated 4,975 hours or $ 300,184 would be spent performing paperwork and record keeping activities. The Agency's labor burden included developing DCI correspondence, communication with registrants, and documenting and storing the evaluation of the data submissions. However, in this ICR, the Agency is increasing its annual burden estimate to reflect an increase in REDs/ IREDs/ TREDs/ etc. by 4.73 fold ( from 10 to 47.3) annually.

Agency labor rates are $ 96, $ 70, and $ 33 per hour for management, technical, and clerical staff, respectively. These rates are based on Office of Personnel Management salary tables for federal employees for the years 1999 through 2001 and include benefits and overhead costs, as well as locality pay for the Washington, DC Baltimore area. The details of the calculations are given below.

Table 4. Annual Agency Burden Estimates a Collection Activities Burden Hours Total Mgmt. $ 96/ hr Tech. $ 70/ hr Cler. $ 33/ hr Hours Costs a. Develop DCI correspondence 2,838 28,380 2,838 34,056 $ 2,352,702 b. Answer DCI questions from registrants 355 14,190 0 14,545 $ 1,027,356 c. Review, evaluate data submission 710 413,21 0 413,92 $ 28,993,00 d. Record DCI submissions 0 0 5,676 5,676 $ 187,308 e. Store data 0 0 710 710 $ 23,414 Total Annual Agency Burden 3,902 455,78 3 9,224 468,90 9 $ 32,583,78 8 a No change in hour burden distribution among labor types since the last ICR. Update in the total number of hours ( 4.73 fold increase) and cost per labor hour. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 22 of 65 6( d). Bottom Line Hours and Cost Tables As indicated previously, EPA will only issue a DCI for a pesticide chemical after it reviews the available data and determines that the available information is not sufficient to satisfy the statutory requirements for reregistration. In addition to the submissions in response to DCIs issued by EPA, this ICR includes estimated burden and costs for voluntary submissions. The total estimate represents the activities that are currently estimated to occur over the next three years. Since the Agency assumes that these activities involve an equal level of effort over this period, the estimated annual burden and costs is derived from a simple division of the total burden and costs by 3. The following table provides the total burden and costs for Respondents, the annual burden and costs for Respondents, and the total burden and costs for the Agency:

Table 5. Bottom Line Hours And Costs / Master Table Collection Activity Burden Hours Costs DCI Involving Confirmatory Studies 276,544 $ 24,611,488 Voluntary Low Burden Studies 3,179 $ 282,890 Voluntary High Burden Studies 9,565 $ 853,285 Product Specific DCIs 232,960 $ 20,780,932 Total Annual Respondent Burden and Costs 522,248 $ 46,528,595 Total Annual Agency Burden 468,909 $ 32,583,788 The terms of clearance outlined by OMB when this ICR was approved in 2001 required that EPA not issue any DCI unless it had first been approved by relevant high level management in the Office of Pesticide Programs and approved by OMB. In the approval request, EPA was to estimate the respondent burden and costs related to specific DCIs before they were issued, including the total cost for performing the required study( s), and the associated paperwork related burden and costs. OMB would then review the information collection activities associated with each individual DCI to ensure that the collection of information was the least burdensome necessary for the proper performance of the agency's functions and that the collection of information was not duplicative of information otherwise accessible to the agency. If OMB raised no questions during the review period, EPA could issue the DCIs.

EPA has complied with these terms of clearance by submitting requests to OMB for approval of DCIs for a total of 35 chemicals. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 23 of 65 6( e). Reasons for Change In Burden The following program changes have affected the calculations in this ICR:

1) The number of REDs/ TREDs to be completed over the next three years will increase dramatically as less complex and less controversial chemicals are reviewed and therefore the number of DCIs will increase proportionally. 2) Calculating the number of responses to confirmatory studies will increase not only to reflect the increase in REDs/ TREDs expected to be completed, but also to correct a calculation error in the previous ICR. While in the previous ICR, 30 food use REDs with an average of 9.35 confirmatory studies would result in 281 ( 30 x 9.35) responses, only 30 responses were estimated. The previous ICR was associated mainly with controversial pesticide active ingredients, such as organophosphates. For controversial pesticide active ingredients, a number of registrants may choose not to support the active ingredient's reregistration and not respond to the generic DCI for economic reasons, resulting in the need to issue fewer DCIs. Nevertheless, the previous ICR appears to have greatly underestimated the number of responses expected for confirmatory studies, possibly by failing to multiply the number of REDs by the number of studies per RED. In this ICR, EPA has calculated that the number of responses will be greater for DCIs involving confirmatory studies because of the increased number of non controversial REDs/ TREDs that are to be completed over a three year period ( from 30 to 142). Also, the Agency is adjusting a slight increase in the average of such studies per RED ( from 9.35 to 9.8) based on more recent REDs ( from 2001 and 2002) and applying that full number per RED/ TRED. Therefore, in this ICR the Agency estimates there will be 1,392 ( 142 x 9.8) responses involving confirmatory studies. This analysis assumes one registrant will generate the test data for a given chemical; if a consortium takes responsibility for the data, the burden and cost will be distributed across members of the consortium.

3) EPA has continued to include the burden and costs related to the voluntary submission of data for food use RED/ TRED active ingredients. However, the number of responses is expected to be fewer than anticipated in the previous ICR ( which used one half the RED number) because the 91 REDs/ IREDs to be completed in FYs2004 2006 and associated with this ICR are mostly less controversial chemicals than those, such as organophosphate chemicals, that were associated with the previous ICR. In fact, a recent search in OPP's OPPIN database for extraneous data submissions received by the Agency since January 1, 1996 showed an average of only 8 submissions per year. Over a three year period, twenty four such data submissions are expected. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 24 of 65 The following adjustment related changes have affected the calculations in this ICR:

1) Given that the reregistration program is in phase 5, and considering that the Agency expects to complete all remaining food use REDs by the end of FY2006, EPA has adjusted the number of ( RED/ IRED/ TRED plus AIs with import tolerance) responses expected for the next three years to 142. In the previous ICR, the Agency had expected that for 30 food use REDs there would be an average of 9.35 studies per RED, but only a total of 30 responses for DCIs involving confirmatory studies over three years. In this ICR, the Agency expects to adjust the number of REDs, IREDs, TREDs, etc. to 142 completions through the end of FY2006. Also, the Agency recently reviewed REDs and TREDs ( from 2001 and 2002) and determined an average of 9.8 confirmatory studies. Therefore, a maximum of 1,392 responses ( 142 x 9.8) is expected for confirmatory studies.

2) The Agency is adjusting PDCI responses based on the number of REDs expected to be completed for FYs 2004 2006, and for which the Agency expects to issue PDCIs over the next three years. EPA has reviewed thirty four REDs/ TREDs ( from 2001 and 2002). TREDs are issued regarding FQPA tolerance reassessment, not reregistration of an active ingredient and its products. TREDs are completed to reassess tolerances in cases where either a RED was completed prior to FQPA, registration was completed post 1984 and no RED is required, or for import tolerances concerning ingredients without active U. S. registrations. Generally, TREDs do not require a product DCI. Therefore, the Agency adjusted the number of expected responses to PDCIs. It is assumed that for 91 RED chemicals there will be, due to the efforts to pool resources, an average of 3 responses per RED ( the same as was estimated in the previous ICR). For 91 REDs with 3 responses per RED, there will be a total of 273 ( 91 x 3) responses to PDCIs.

3) EPA has updated the hourly rates used to calculate costs.

4) In comparing the estimated total burden between these ICRs, an increase in the burden is evident. In the previous ICR, the total burden came to 272,175 hours, or 90,725 hours annually, compared to the total burden for this ICR of 1,566,744 hours, or 522,248 hours annually. This increase of about 5.76 fold in burden hours includes an overall increase of 4.73 fold in the number of REDs, IREDs, and TREDs, etc. which the Agency expects to complete during FYs 2004 2006 and for which the Agency expects to generate DCIs over the next three years. The discrepancy in increases likely reflects two factors: ( a) the underestimation in the previous ICR regarding the number of responses ( 281 likely vs 30 estimated) for DCIs involving confirmatory studies and therefore the total number of hours involving confirmatory studies ( 167,476 vs 17,880 estimated), which would have increased the annual burden hours to about 140,590, and ( b) the fact that the DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 25 of 65 previous ICR was associated only with RED chemicals and this ICR is associated with a mix of chemicals of which about two thirds concern REDs and one third concern TREDs, and TREDs generally do not need PDCIs and their associated paperwork burden costs.

The program changes and adjustments related to the phase 5 reregistration activities and tolerance reassessment activities have offset the anticipated pre FQPA respondent burden reductions, resulting in the net increase. It is also important to point out that the burden and cost estimates in this ICR are intended to represent potential burden and costs. As such, some respondents that receive DCIs may have paperwork burden hours and costs greater than the average estimates, while the costs for others may be lower than the average estimates.

6( f). Burden Statement The total burden hours for respondents to comply with this information collection activity over the next three years is estimated to be 1,566,744 hours. A three year duration of equal effort is assumed for this information collection request, so the total annual respondent burden is estimated to be 522,248 hours.

According to the Paperwork Reduction Act, " burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection, it is the time reading the regulations, planning the necessary data collection activities, conducting tests, analyzing data, generating reports and completing other required paperwork, and storing, filing, and maintaining the data. The agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection appear at the beginning and the end of this document. In addition OMB control numbers for EPA's regulations, after initial display in the final rule, are listed in 40 CFR part 9.

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 0110, 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.

An electronic version of the public docket for this ICR renewal is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the 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 docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 26 of 65 Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID No. OPP 2004 0110 and OMB Control No. 2070 0107 in any correspondence. DRAFT FOR PUBLIC COMMENT April 13, 2004 Page 27 of 65 ATTACHMENTS TO THE SUPPORTING STATEMENT ATTACHMENT A: FIFRA section 4  also available electronically at http:// www. epa. gov/ oppfead1/ fqpa/

ATTACHMENT B: FIFRA section 3( c)( 2)( B) also available electronically at http:// www. epa. gov/ oppfead1/ fqpa/ and click on " LAWS," then click on the available PDF file for FIFRA.

ATTACHMENT C: Data Call In Response Form ATTACHMENT D: Requirements Status and Registrant's Response Form ATTACHMENT E: Certification of Attempt to Enter into an Agreement with Registrants for Development of Data ( EPA Form 8570 32)  also available electronically at http:// www. epa. gov/ opprd001/ forms/

ATTACHMENT F: Certification with Respect to Citation of Data ( EPA Form 8570 34)  also available electronically at http:// www. epa. gov/ opprd001/ forms/

ATTACHMENT G: Estimating the Potential Paperwork Burden and Cost for DCIs.

ATTACHMENT H: ICR for Reregistration Program: List of RED/ IRED, TRED, and Import Tolerance Pesticide Candidates Estimated To Have DCI Needs Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 28 of 65 Sec. 4. [ 136a 1] Reregistration of Registered Pesticides.

( a) General Rule. The Administrator shall reregister, in accordance with this section, each registered pesticide containing any active ingredient contained in any pesticide first registered before November 1, 1984, except for any pesticide as to which the Administrator has determined, after November 1, 1984, and before the effective date of this section, that   ( 1) there are no outstanding data requirements; and ( 2) the requirements of section 3( c)( 5) of this title have been satisfied.

( b) Reregistration Phases. Reregistrations of pesticides under this section shall be carried out in the following phases:

( 1) The first phase shall include the listing under subsection ( c) of the active ingredients of the pesticides that will be reregistered.

( 2) The second phase shall include the submission to the Administrator under subsection ( d) of notices by registrants respecting their intention to seek reregistration, identification by registrants of missing and inadequate data for such pesticides, and commitments by registrants to replace such missing or inadequate data within the applicable time period.

( 3) The third phase shall include submission to the Administrator by registrants of the information required under subsection ( e).

( 4) The fourth phase shall include an independent, initial review by the Administrator under subsection ( f) of submissions under phases two and three, identification of outstanding data requirements, and the issuance, as necessary, of requests for additional data.

( 5) The fifth phase shall include the review by the Administrator under subsection ( g) of data submitted for reregistration and appropriate regulatory action by the Administrator.

( c) Phase One.

( 1) Priority for Reregistration. For purposes of the reregistration of the pesticides described in subsection ( a), the Administrator shall list the active ingredients of pesticides and shall give priority to, among others, active ingredients ( other than active ingredients for which registration standards have been issued before the effective date of this section) that   ( A) are in use on or in food or feed and may result in postharvest residues;

( B) may result in residues of potential toxicological concern in potable ground water, edible fish, or shellfish; Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 29 of 65 ( C) have been determined by the Administrator before the effective date of this section to have significant outstanding data requirements; or ( D) are used on crops, including in greenhouses and nurseries, where worker exposure is most likely to occur.

( 2) Reregistration Lists. For purposes of reregistration under this section, the Administrator shall by order   ( A) not later than 70 days after the effective date of this section, list pesticide active ingredients for which registration standards have been issued before such effective date;

( B) not later than four months after such effective date, list the first 150 pesticide active ingredients, as determined under paragraph ( 1);

( C) not later than seven months after such effective date, list the second 150 pesticide active ingredients, as determined under paragraph ( 1); and ( D) not later than ten months after such effective date, list the remainder of the pesticide active ingredients, as determined under paragraph ( 1).

Each list shall be published in the Federal Register.

( 3) Judicial Review. The content of a list issued by the Administrator under paragraph ( 2) shall not be subject to judicial review.

( 4) Notice to Registrants. On the publication of a list of pesticide active ingredients under paragraph ( 2), the Administrator shall send by certified mail to the registrants of the pesticides containing such active ingredients a notice of the time by which the registrants are to notify the Administrator under subsection ( d) whether the registrants intend to seek or not to seek reregistration of such pesticides.

( d) Phase Two.

( 1) In General. The registrant of a pesticide that contains an active ingredient listed under subparagraph ( B), ( C), or ( D) of subsection ( c)( 2) shall submit to the Administrator, within the time period prescribed by paragraph ( 4), the notice described in paragraph ( 2) and any information, commitment, or offer described in paragraph ( 3).

( 2) Notice of Intent to Seek or Not to Seek Reregistration.

( A) The registrant of a pesticide containing an active ingredient listed under subparagraph ( B), ( C), or ( D) of subsection ( c)( 2) shall notify the Administrator by certified mail whether the registrant intends to seek or does not intend to seek reregistration of the pesticide. Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 30 of 65 ( B) If a registrant submits a notice under subparagraph ( A) of an intention not to seek reregistration of a pesticide, the Administrator shall publish a notice in the Federal Register stating that such a notice has been submitted.

( 3) Missing or Inadequate Data. Each registrant of a pesticide that contains an active ingredient listed under subparagraph ( B), ( C), or ( D) of subsection ( c)( 2) and for which the registrant submitted a notice under paragraph ( 2) of an intention to seek reregistration of such pesticide shall submit to the Administrator   ( A) in accordance with regulations issued by the Administrator under section 3, an identification of   ( i) all data that are required by regulation to support the registration of the pesticide with respect to such active ingredient;

( ii) data that were submitted by the registrant previously in support of the registration of the pesticide that are inadequate to meet such regulations; and ( iii) data identified under clause ( i) that have not been submitted to the Administrator; and ( B) either

( i) a commitment to replace the data identified under subparagraph ( A)( ii) and submit the data identified under subparagraph ( A)( iii) within the applicable time period prescribed by paragraph ( 4)( B); or ( ii) an offer to share in the cost to be incurred by a person who has made a commitment under clause ( i) to replace or submit the data and an offer to submit to arbitration as described by section 3( c)( 2)( B) with regard to such cost sharing.

For purposes of a submission by a registrant under subparagraph ( A)( ii), data are inadequate if the data are derived from a study with respect to which the registrant is unable to make the certification prescribed by subsection ( e)( 1)( G) that the registrant possesses or has access to the raw data used in or generated by such study. For purposes of a submission by a registrant under such subparagraph, data shall be considered to be inadequate if the data are derived from a study submitted before January 1, 1970, unless it is demonstrated to the satisfaction of the Administrator that such data should be considered to support the registration of the pesticide that is to be reregistered.

( 4) Time Periods.   ( A) A submission under paragraph ( 2) or ( 3) shall be made   Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 31 of 65 ( i) in the case of a pesticide containing an active ingredient listed under subsection ( c)( 2)( B), not later than three months after the date of publication of the listing of such active ingredient;

( ii) in the case of a pesticide containing an active ingredient listed under subsection ( c)( 2)( C), not later than 3 three months after the date of publication of the listing of such active ingredient; and ( iii) in the case of a pesticide containing an active ingredient listed under subsection ( c)( 2)( D), not later than three months after the date of publication of the listing of such active ingredient.

On application, the Administrator may extend a time period prescribed by this subparagraph if the Administrator determines that factors beyond the control of the registrant prevent the registrant from complying with such period.

( B) A registrant shall submit data in accordance with a commitment entered into under paragraph ( 3)( B) within a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than two years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period. Upon application of a registrant, the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under this section for the other uses of the pesticide established as of the date of enactment of the Food Quality Protection Act of 1996 if   ( i) the data to support other uses of the pesticide on a food are being provided;

( ii) the registrant, in submitting a request for such an extension provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;

( iii) the Administrator has determined that such extension will not significantly delay the Administrator's schedule for issuing a reregistration eligibility determination required under this section; and ( iv) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause ( iv) of section 3( c)( 2)( B) or other provisions of this section, as appropriate, regarding the continued registration of the affected products with the minor use and Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 32 of 65 shall inform the public of such action. Notwithstanding the provisions of this subparagraph, the Administrator may take action to modify or revoke the extension under this subparagraph if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide written notice to the registrant revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the Administrator for submission of the data.

( 5) Cancellation and Removal.

( A) If the registrant of a pesticide does not submit a notice under paragraph ( 2) or ( 3) within the time prescribed by paragraph ( 4)( A), the Administrator shall issue a notice of intent to cancel the registration of such registrant for such pesticide and shall publish the notice in the Federal Register and allow 60 days for the submission of comments on the notice. On expiration of such 60 days, the Administrator, by order and without a hearing, may cancel the registration or take such other action, including extension of applicable time periods, as may be necessary to enable reregistration of such pesticide by another person.

( B)( i) If

( I) no registrant of a pesticide containing an active ingredient listed under subsection ( c)( 2) notifies the Administrator under paragraph ( 2) that the registrant intends to seek reregistration of any pesticide containing that active ingredient;

( II) no such registrant complies with paragraph ( 3)( A); or ( III) no such registrant makes a commitment under paragraph ( 3)( B) to replace or submit all data described in clauses ( ii) and ( iii) of paragraph ( 3)( A);

the Administrator shall publish in the Federal Register a notice of intent to remove the active ingredient from the list established under subsection ( c)( 2) and a notice of intent to cancel the registrations of all pesticides containing such active ingredient and shall provide 60 days for comment on such notice.

( ii) After the 60 day period has expired, the Administrator, by order, may cancel any such registration without hearing, except that the Administrator shall not cancel a registration under this subparagraph if

( I) during the comment period a person acquires the rights of the registrant in that registration;

( II) during the comment period that person furnishes a notice of intent to reregister the pesticide in accordance with paragraph ( 2); and Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 33 of 65 ( III) not later than 120 days after the publication of the notice under this subparagraph, that person has complied with paragraph ( 3) and the fee prescribed by subsection ( i)( 1) of this section has been paid.

( 6) Suspensions and Penalties. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by section 3( c)( 2)( B)( iv) if the Administrator determines that ( A) progress is insufficient to ensure the submission of the data required for such pesticide under a commitment made under paragraph ( 3)( B) within the time period prescribed by paragraph ( 4)( B) or ( B) the registrant has not submitted such data to the Administrator within such time period. If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this paragraph in regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food Quality Protection Act of 1996, for the submission of data under this section for the supported uses identified pursuant to this paragraph unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On such a determination the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 6( f)( 1). If the Administrator grants an extension under this paragraph, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with section 3( c)( 2)( B)( iv) of this title regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 6( f)( 2) of this title. Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the temporary extension under this paragraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.

( e) Phase Three.

( 1) Information about Studies. Each registrant of a pesticide that contains an active ingredient listed under subparagraph ( B), ( C), or ( D) of subsection ( c)( 2) who has submitted a notice under subsection ( d)( 2) of an intent to seek the reregistration of such pesticide shall submit, in accordance with the guidelines issued under paragraph ( 4), to the Administrator   Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 34 of 65 ( A) a summary of each study concerning the active ingredient previously submitted by the registrant in support of the registration of a pesticide containing such active ingredient and considered by the registrant to be adequate to meet the requirements of section 3 and the regulations issued under such section;

( B) a summary of each study concerning the active ingredient previously submitted by the registrant in support of the registration of a pesticide containing such active ingredient that may not comply with the requirements of section 3 and the regulations issued under such section but which the registrant asserts should be deemed to comply with such requirements and regulations;

( C) a reformat of the data from each study summarized under subparagraph ( A) or ( B) by the registrant concerning chronic dosing, oncogenicity, reproductive effects, mutagenicity, neurotoxicity, teratogenicity, or residue chemistry of the active ingredient that were submitted to the Administrator before January 1, 1982;

( D) where data described in subparagraph ( C) are not required for the active ingredient by regulations issued under section 3, a reformat of acute and subchronic dosing data submitted by the registrant to the Administrator before January 1, 1982, that the registrant considers to be adequate to meet the requirements of section 3 and the regulations issued under such section;

( E) an identification of data that are required to be submitted to the Administrator under section 6( a)( 2), indicating an adverse effect of the pesticide;

( F) an identification of any other information available that in the view of the registrant supports the registration;

( G) a certification that the registrant or the Administrator possesses or has access to the raw data used in or generated by the studies that the registrant summarized under subparagraph ( A) or ( B);

( H) either

( i) a commitment to submit data to fill each outstanding data requirement identified by the registrant; or ( ii) an offer to share in the cost of developing such data to be incurred by a person who has made a commitment under clause ( i) to submit such data, and an offer to submit to arbitration as described by section 3( c)( 2)( B) and ( I) evidence of compliance with section 3( c)( 1)( D)( ii) and regulations issued thereunder with regard to previously submitted data as if the registrant were now seeking the original registration of the pesticide.

A registrant who submits a certification under subparagraph ( G) that is false shall be considered to have violated this Act and shall be subject to the penalties prescribed by section 14. Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides 1Indentation of the following sentences of this subparagraph is so in original ( as added by sec. 201( c)( 2) of P. L. 104 170). Probably should be indented the same as flush matter of this subparagraph.

Page 35 of 65 ( 2) Time Periods.

( A) The information required by paragraph ( 1) shall be submitted to the Administrator   ( i) in the case of a pesticide containing an active ingredient listed under subsection ( c)( 2)( B), not later than 12 months after the date of publication of the listing of such active ingredient;

( ii) in the case of a pesticide containing an active ingredient listed under subsection ( c)( 2)( C), not later than 12 months after the date of publication of the listing of such active ingredient; and ( iii) in the case of a pesticide containing an active ingredient listed under subsection ( c)( 2)( D), not later than 12 months after the date of publication of the listing of such active ingredient.

( B) A registrant shall submit data in accordance with a commitment entered into under paragraph ( 1)( H) within a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment under such paragraph. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than two years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period. Upon application of a registrant, the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under this section for the other uses of the pesticide established as of the date of enactment of the Food Quality Protection Act of 1996 if   ( i) the data to support other uses of the pesticide on a food are being provided;

( ii) the registrant, in submitting a request for such an extension provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;

( iii) the Administrator has determined that such extension will not significantly delay the Administrator's schedule for issuing a reregistration eligibility determination required under this section; and ( iv) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment1. If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 36 of 65 production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause ( iv) of section 3( c)( 2)( B) or other provisions of this section, as appropriate, regarding the continued registration of the affected products with the minor use and shall inform the public of such action.

Notwithstanding the provisions of this subparagraph, the Administrator may take action to modify or revoke the extension under this subparagraph if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide written notice to the registrant revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the Administrator for submission of the data.

( 3) Cancellation.

( A) If the registrant of a pesticide fails to submit the information required by paragraph ( 1) within the time prescribed by paragraph ( 2), the Administrator, by order and without hearing, shall cancel the registration of such pesticide. If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this subparagraph in regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food Quality Protection Act of 1996 for the submission of data under this section for the supported uses identified pursuant to this subparagraph unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 6( f)( 1).

If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with section 3( c)( 2)( B)( iv) regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 6( f)( 2).

Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the temporary extension under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 37 of 65 In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.

( B)( i) If the registrant of a pesticide submits the information required by paragraph ( 1) within the time prescribed by paragraph ( 2) and such information does not conform to the guidelines for submissions established by the Administrator, the Administrator shall determine whether the registrant made a good faith attempt to conform its submission to such guidelines.

( ii) If the Administrator determines that the registrant made a good faith attempt to conform its submission to such guidelines, the Administrator shall provide the registrant a reasonable period of time to make any necessary changes or corrections.

( iii)( I) If the Administrator determines that the registrant did not make a good faith attempt to conform its submission to such guidelines, the Administrator may issue a notice of intent to cancel the registration. Such a notice shall be sent to the registrant by certified mail.

( II) The registration shall be canceled without a hearing or further notice at the end of 30 days after receipt by the registrant of the notice unless during that time a request for a hearing is made by the registrant.

( III) If a hearing is requested, a hearing shall be conducted under section 6( d), except that the only matter for resolution at the hearing shall be whether the registrant made a good faith attempt to conform its submission to such guidelines. The hearing shall be held and a determination made within 75 days after receipt of a request for hearing.

( 4) Guidelines.

( A) Not later than one year after the effective date of this section, the Administrator, by order, shall issue guidelines to be followed by registrants in   ( i) summarizing studies;

( ii) reformatting studies;

( iii) identifying adverse information; and ( iv) identifying studies that have been submitted previously that may not meet the requirements of section 3 or regulations issued under such section, under paragraph ( 1).

( B) Guidelines issued under subparagraph ( A) shall not be subject to judicial review.

( 5) Monitoring. The Administrator shall monitor the progress of registrants in acquiring and submitting the data required under paragraph ( 1). Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 38 of 65 ( f) Phase Four.

( 1) Independent Review and Identification of Outstanding Data Requirements.

( A) The Administrator shall review the submissions of all registrants of pesticides containing a particular active ingredient under subsections ( d)( 3) and ( e)( 1) to determine if such submissions identified all the data that are missing or inadequate for such active ingredient. To assist the review of the Administrator under this subparagraph, the Administrator may require a registrant seeking reregistration to submit complete copies of studies summarized under subsection ( e)( 1).

( B) The Administrator shall independently identify and publish in the Federal Register the outstanding data requirements for each active ingredient that is listed under subparagraph ( B), ( C), or ( D) of subsection ( c)( 2) and that is contained in a pesticide to be reregistered under this section. The Administrator, at the same time, shall issue a notice under section 3( c)( 2)( B) for the submission of the additional data that are required to meet such requirements.

( 2) Time Periods.

( A) The Administrator shall take the action required by paragraph ( 1)

( i) in the case of a pesticide containing an active ingredient listed under subsection ( c)( 2)( B), not later than 18 months after the date of the listing of such active ingredient;

( ii) in the case of a pesticide containing an active ingredient listed under subsection ( c)( 2)( C), not later than 24 months after the date of the listing of such active ingredient; and ( iii) in the case of a pesticide containing an active ingredient listed under subsection ( c)( 2)( D), not later than three months after the date of the listing of such active ingredient.

( B) If the Administrator issues a notice to a registrant under paragraph ( 1)( B) for the submission of additional data, the registrant shall submit such data within a reasonable period of time, as determined by the Administrator, but not to exceed 48 months after the issuance of such notice. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 two years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period.

Upon application of a registrant, the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under this section for the other uses of the pesticide established as of the date of enactment of the Food Quality Protection Act of 1996 if   ( i) the data to support other uses of the pesticide on a food are being provided; Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 39 of 65 ( ii) the registrant, in submitting a request for such an extension provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;

( iii) the Administrator has determined that such extension will not significantly delay the Administrator's schedule for issuing a reregistration eligibility determination required under this section; and ( iv) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with clause ( iv) of section 3( c)( 2)( B) or other provisions of this section, as appropriate, regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this subparagraph, the Administrator may take action to modify or revoke the extension under this subparagraph if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide written notice to the registrant revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the Administrator for submission of the data.

( 3) Suspensions and Penalties. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by section 3( c)( 2)( B)( iv) if the Administrator determines that ( A) tests necessary to fill an outstanding data requirement for such pesticide have not been initiated within one year after the issuance of a notice under paragraph ( 1)( B), or ( B) progress is insufficient to ensure submission of the data referred to in clause ( A) within the time period prescribed by paragraph ( 2)( B) or the required data have not been submitted to the Administrator within such time period. If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this paragraph in regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food Quality Protection Act of 1996, for the submission of data under this section for the supported uses identified pursuant to this paragraph unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On such a determination the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 40 of 65 registration pursuant to section 6( f)( 1). If the Administrator grants an extension under this paragraph, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with section 3( c)( 2)( B)( iv) regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 6( f)( 2). Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the temporary extension under this paragraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.

( g) Phase Five.

( 1) Data Review. The Administrator shall conduct a thorough examination of all data submitted under this section concerning an active ingredient listed under subsection ( c)( 2) of this section and of all other available data found by the Administrator to be relevant.

( 2) Reregistration and Other Actions   ( A) Within one year after the submission of all data concerning an active ingredient of a pesticide under subsection ( f), the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration. For extraordinary circumstances, the Administrator may extend such period for not more than 1 additional year.

( B) Before reregistering a pesticide, the Administrator shall obtain any needed product specific data regarding the pesticide by use of section 3( c)( 2)( B) and shall review such data within 90 days after its submission. The Administrator shall require that data under this subparagraph be submitted to the Administrator not later than 8 months after a determination of eligibility under subparagraph ( A) has been made for each active ingredient of the pesticide, unless the Administrator determines that a longer period is required for the generation of the data.

( C) After conducting the review required by paragraph ( 1) for each active ingredient of a pesticide and the review required by subparagraph ( B) of this paragraph, the Administrator shall determine whether to reregister a pesticide by determining whether such pesticide meets the requirements of section 3( c)( 5). If the Administrator determines that a pesticide is eligible to be reregistered, the Administrator shall reregister such pesticide within 6 months after the submission of the data concerning such pesticide under subparagraph ( B).

( D) If after conducting a review under paragraph ( 1) or subparagraph ( B) of this paragraph the Administrator determines that a pesticide should not be reregistered, the Administrator shall take appropriate regulatory action. Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 41 of 65 ( E) As soon as the Administrator has sufficient information with respect to the dietary risk of a particular active ingredient, but in any event no later than the time the Administrator makes a determination under subparagraph ( C) or ( D) with respect to pesticides containing a particular active ingredient, the Administrator shall   ( i) reassess each associated tolerance and exemption from the requirement for a tolerance issued under section 408 of the Federal Food, Drug, and Cosmetic Act ( 21 U. S. C. 346a);

( ii) determine whether such tolerance or exemption meets the requirements of that Act;

( iii) determine whether additional tolerances or exemptions should be issued;

( iv) publish in the Federal Register a notice setting forth the determinations made under this subparagraph; and ( v) commence promptly such proceedings under this Act and section 408 of the Federal Food, Drug, and Cosmetic Act as are warranted by such determinations.

( h) Compensation of Data Submitter. If data that are submitted by a registrant under subsection ( d), ( e), ( f), or ( g) of this section are used to support the application of another person under section 136a of this title, the registrant who submitted such data shall be entitled to compensation for the use of such data as prescribed by section 136a( c)( 1)( D) \ 2\ of this title. In determining the amount of such compensation, the fees paid by the registrant under this section shall be taken into account.

( i) Fees.

( 1) Initial Fee for Food or Feed Use Pesticide Active Ingredients.   The registrants of pesticides that contain an active ingredient that is listed under subparagraph ( B), ( C), or ( D) of subsection ( c)( 2) of this section and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $ 50,000 on submission of information under paragraphs ( 2) and ( 3) of subsection ( d) of this section for such ingredient.

( 2) Final Fee for Food or Feed Use Pesticide Active Ingredients   ( A) The registrants of pesticides that contain an active ingredient that is listed under subparagraph ( B), ( C), or ( D) of subsection ( c)( 2) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $ 100,000

( i) on submission of information for such ingredient under subsection ( e)( 1) if data are reformatted under subsection ( e)( 1)( C); or ( ii) on submission of data for such ingredient under subsection ( e)( 2)( B) if data are not reformatted under subsection ( e)( 1)( C). Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 42 of 65 ( B) The registrants of pesticides that contain an active ingredient that is listed under subsection ( c)( 2)( A) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $ 150,000 at such time as the Administrator shall prescribe.

( 3) Fees for Other Pesticide Active Ingredients.

( A) The registrants of pesticides that contain an active ingredient that is listed under subparagraph ( B), ( C), or ( D) of subsection ( c)( 2) and that is not an active ingredient of any pesticide registered for a major food or feed use shall collectively pay fees in amounts determined by the Administrator. Such fees may not be less than one half of, nor greater than, the fees required by paragraphs ( 1) and ( 2). A registrant shall pay such fees at the times corresponding to the times fees prescribed by paragraphs ( 1) and ( 2) are to be paid.

( B) The registrants of pesticides that contain an active ingredient that is listed under subsection ( c)( 2)( A) and that is not an active ingredient of any pesticide that is registered for a major food or feed use shall collectively pay a fee of not more than $ 100,000 and not less than $ 50,000 at such time as the Administrator shall prescribe.

( 4) Reduction or Waiver of Fees for Minor Use and Other Pesticides.

( A) An active ingredient that is contained only in pesticides that are registered solely for agricultural or nonagricultural minor uses, or a pesticide the value or volume of use of which is small, shall be exempt from the fees prescribed by paragraph ( 3).

( B) The Administrator shall exempt any public health pesticide from the payment of the fee prescribed under paragraph ( 3) if, in consultation with the Secretary of Health and Human Services, the Administrator determines, based on information supplied by the registrant, that the economic return to the registrant from sales of the pesticide does not support the registration or reregistration of the pesticide.

( C) An antimicrobial active ingredient, the production level of which does not exceed 1,000,000 pounds per year, shall be exempt from the fees prescribed by paragraph ( 3). For purposes of this subparagraph, the term " antimicrobial active ingredient" means any active ingredient that is contained only in pesticides that are not registered for any food or feed use and that are   ( i) sanitizers intended to reduce the number of living bacteria or viable virus particles on inanimate surface or in water or air;

( ii) bacteriostats intended to inhibit the growth of bacteria in the presence of moisture;

( iii) disinfectants intended to destroy or irreversibly inactivate bacteria, fungi, or viruses on surfaces or inanimate objects; Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 43 of 65 ( iv) sterilizers intended to destroy viruses and all living bacteria, fungi, and their spores on inanimate surfaces; or ( v) fungicides or fungistats.

( D)( i) Notwithstanding any other provision of this subsection, in the case of a small business registrant of a pesticide, the registrant shall pay a fee for the reregistration of each active ingredient of the pesticide that does not exceed an amount determined in accordance with this subparagraph.

( ii) If during the 3 year period prior to reregistration the average annual gross revenue of the registrant from pesticides containing such active ingredient is   ( I) less than $ 5,000,000, the registrant shall pay 0.5 percent of such revenue;

( II) $ 5,000,000 or more but less than $ 10,000,000, the registrant shall pay 1 percent of such revenue; or ( III) $ 10,000,000 or more, the registrant shall pay 1.5 percent of such revenue, but not more than $ 150,000.

( iii) For the purpose of this subparagraph, a small business registrant is a corporation, partnership, or unincorporated business that   ( I) has 150 or fewer employees; and ( II) during the 3 year period prior to reregistration, had an average annual gross revenue from chemicals that did not exceed $ 40,000,000.

( 5) Maintenance Fee.

( A) Subject to other provisions of this paragraph, each registrant of a pesticide shall pay an annual fee by January 15 of each year of   ( i) $ 650 for the first registration; and ( ii) $ 1,300 for each additional registration, except that no fee shall be charged for more than 200 registrations held by any registrant.

( B) In the case of a pesticide that is registered for a minor agricultural use, the Administrator may reduce or waive the payment of the fee imposed under this paragraph if the Administrator determines that the fee would significantly reduce the availability of the pesticide for the use. Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 44 of 65 ( C)( i) The amount of each fee prescribed under subparagraph ( A) shall be adjusted by the Administrator to a level that will result in the collection under this paragraph of, to the extent practicable, an aggregate amount of $ 14,000,000 each fiscal year.

( ii) in each of the fiscal years 1998, 1999, and 2000, the Administrator is authorized to collect up to an additional $ 2,000,000 in a manner consistent with subsection ( k)( 5) and the recommendations of the Inspector General of the Environmental Protection Agency. The total fees that may be collected under this clause shall not exceed $ 6,000,000.

( D) The maximum annual fee payable under this paragraph by   ( i) a registrant holding not more than 50 pesticide registrations shall be $ 55,000; and ( ii) a registrant holding over 50 registrations shall be $ 95,000.

( E)( i) For a small business, the maximum annual fee payable under this paragraph by

( I) a registrant holding not more than 50 pesticide registrations shall be $ 38,500; and ( II) a registrant holding over 50 pesticide registrations shall be $ 66,500.

( ii) For purposes of clause ( i), the term " small business" means a corporation, partnership, or unincorporated business that   ( I) has 150 or fewer employees; and ( II) during the 3 year period prior to the most recent maintenance fee billing cycle, had an average annual gross revenue from chemicals that did not exceed $ 40,000,000.

( F) The Administrator shall exempt any public health pesticide from the payment of the fee prescribed under paragraph ( 3) if, in consultation with the Secretary of Health and Human Services, the Administrator determines, based on information supplied with the registrant, that the economic return to the registrant from sales of the pesticide does not support the registration or reregistration of the pesticide.

( G) If any fee prescribed by this paragraph with respect to the registration of a pesticide is not paid by a registrant by the time prescribed, the Administrator, by order and without hearing, may cancel the registration.

( H) The authority provided under this paragraph shall terminate on September 30, 2001.

( 6) Other Fees. During the period beginning on October 25, 1988, and ending on September 30, 2001, the Administrator may not levy any other fees for the registration of a pesticide under this Act except as provided in paragraphs ( 1) through ( 5). Attachment A  Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) Section 4  Reregistration of Registered Pesticides Page 45 of 65 ( 7) Apportionment.

( A) If two or more registrants are required to pay any fee prescribed by paragraph ( 1), ( 2), or ( 3) with respect to a particular active ingredient, the fees for such active ingredient shall be apportioned among such registrants on the basis of the market share in United States sales of the active ingredient for the 3 calendar years preceding the date of payment of such fee, except that   ( i) small business registrants that produce the active ingredient shall pay fees in accordance with paragraph ( 4)( C); and ( ii) registrants who have no market share but who choose to reregister a pesticide containing such active ingredient shall pay the lesser of   ( I) 15 percent of the reregistration fee; or ( II) a proportionate amount of such fee based on the lowest percentage market share held by any registrant active in the marketplace. In no event shall registrants who have no market share but who choose to reregister a pesticide containing such active ingredient collectively pay more than 25 percent of the total active ingredient reregistration fee.

( B) The Administrator, by order, may require any registrant to submit such reports as the Administrator determines to be necessary to allow the Administrator to determine and apportion fees under this subsection or to determine the registrant's eligibility for a reduction or waiver of a fee, or to determine the volume usage for public health pesticides.

( C) If any such report is not submitted by a registrant after receiving notice of such report requirement, or if any fee prescribed by this subsection ( other than paragraph ( 5)) for an active ingredient is not paid by a registrant to the Administrator by the time prescribed under this subsection, the Administrator, by order and without hearing, may cancel each registration held by such registrant of a pesticide containing the active ingredient with respect to which the fee is imposed. The Administrator shall reapportion the fee among the remaining registrants and notify the registrants that the registrants are required to pay to the Administrator any unpaid balance of the fee within 30 days after receipt of such notice.

( j) Exemption of Certain Registrants.   The requirements of subsections ( d), ( e), ( f), and ( i) of this section ( other than subsection ( i)( 5) of this section) regarding data concerning an active ingredient and fees for review of such data shall not apply to any person who is the registrant of a pesticide to the extent that, under section 3( c)( 2)( D), the person would not be required to submit or cite such data to obtain an initial registration of such pesticide. Page 46 of 65 ATTACHMENT B  FIFRA Section 3( c)( 2)( B)

Data in Support of Registration.

( A) In General. The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise such guidelines from time to time. If thereafter the Administrator requires any additional kind of information under subparagraph ( B) of this paragraph, the Administrator shall permit sufficient time for applicants to obtain such additional information. The Administrator, in establishing standards for data requirements for the registration of pesticides with respect to minor uses, shall make such standards commensurate with the anticipated extent of use, pattern of use, the public health and agricultural need for such minor use, and the level and degree of potential beneficial or adverse effects on man and the environment.

The Administrator shall not require a person to submit, in relation to a registration or reregistration of a pesticide for minor agricultural use under this Act, any field residue data from a geographic area where the pesticide will not be registered for such use. In the development of these standards, the Administrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impact of the cost of meeting the requirements on the incentives for any potential registrant to undertake the development of the required data. Except as provided by section 10, within 30 days after the Administrator registers a pesticide under this Act the Administrator shall make available to the public the data called for in the registration statement together with such other scientific information as the Administrator deems relevant to the Administrator's decision.

( B) Additional Data.( i) If the Administrator determines that additional data are required to maintain in effect an existing registration of a pesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates and provide a list of such registrants to any interested person.

( ii) Each registrant of such pesticide shall provide evidence within ninety days after receipt of notification that it is taking appropriate steps to secure the additional data that are required.

Two or more registrants may agree to develop jointly, or to share in the cost of developing, such data if they agree and advise the Administrator of their intent within ninety days after notification.

Any registrant who agrees to share in the cost of producing the data shall be entitled to examine and rely upon such data in support of maintenance of such registration. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause ( iv) if a registrant fails to comply with this clause. Page 47 of 65 ( iii) If, at the end of sixty days after advising the Administrator of their agreement to develop jointly, or share in the cost of developing, data, the registrants have not further agreed on the terms of the data development arrangement or on a procedure for reaching such agreement, any of such registrants may initiate binding arbitration proceedings by requesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct. All parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by clause ( iv) if a registrant fails to comply with this clause.