DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 1 of 55 SUPPORTING STATEMENT FOR AN INFORMATION COLLECTION REQUEST ( ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a). Title of the Information Collection: Data Call Ins for the Special Review and Registration Review Programs ICR Numbers: OMB Control No. 2070 0057; EPA ICR No. 0922.07 1( b). Short Characterization/ Abstract This is a request to renew the existing information collection request ( ICR) entitled: Data Call Ins for the Special Review and Registration Review Programs ( OMB No. 2070 0057; EPA No. 0922.07). This information collection will enable the Environmental Protection Agency ( EPA) to collect the necessary data to assess whether the continued registration of an existing pesticide causes an unreasonable adverse effect on human health or the environment. The Special Review process is set in motion when EPA has reason to believe that the use of a pesticide may result in unreasonable adverse effects to human health or the environment. The goal of this process is to reduce the risks posed by a pesticide to an acceptable level while taking into consideration the benefits provided by the use of the pesticide. The Agency is authorized to use section 3( c)( 2)( B) of the Federal Insecticide, Fungicide and Rodenticide Act ( FIFRA) to require pesticide registrants to generate and submit data to the Agency where such data is needed to assess whether registration of an existing pesticide poses unreasonable risk to human health or the environment.

This ICR also includes the information collection related to the Registration Review Program. The Food Quality Protection Act of 1996 ( FQPA), which amended the two primary statutes regulating pesticides, i. e., the Federal Food, Drug and Cosmetic Act ( FFDCA) and FIFRA, established the Registration Review Program. Under FIFRA § 3( g), EPA must now periodically review all pesticide registrations. The goal of the regulations is Agency review of pesticide registrations on a 15 year cycle. In doing so, the Agency is authorized to use FIFRA § 3( c)( 2)( B) to require pesticide registrants to generate and submit data to the Agency where such data is needed to assess whether registration of an existing pesticide poses unreasonable risk to human health or the environment.

EPA's Office of Pesticide Programs ( OPP), under the Assistant Administrator for Prevention, Pesticides and Toxic Substances, uses this ICR to obtain the data needed by OPP scientists to assess whether certain pesticides should continue to be registered. After identifying a specific data need for a particular chemical, either as part of Special Review or as part of Registration Review, the Agency will first search for available information ( i. e., EPA databases for information that may have been submitted to EPA under another ICR, voluntarily, or submitted by another respondent; information that has otherwise published in the literature; or information that is otherwise publicly available). Only if the needed data is not found will EPA require the submission or generation of the specific data needed. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 2 of 55 The information collected under this ICR may consist of toxicology studies, fish and wildlife studies, environmental fate studies, chemistry studies or other data needed to analyze the potential risks and benefits associated with pesticide chemicals.

Since the information collection activities related to the Registration Review Program are very similar to those related to the Special Review Program, EPA has continued to include both programs in this ICR. Both collections derive their authority and procedures from FIFRA § 3( c)( 2)( B) and are part of ongoing processes. Both collections are based, in part, on concerns about potential hazard.

Please note that the information collection activities contained in this ICR are separate from those described in the ICR entitled " Data Generation for Reregistration" [ OMB Control # 2070 0107; EPA ICR # 1504], which involves the collection of information necessary to reregister pesticides which were registered before 1984 in accordance with FIFRA § 4. The reregistration program is expected to be completed by 2006 for food use pesticide ingredients and 2008 for non food use pesticide ingredients.

2. NEED FOR AND USE OF THE COLLECTION 2( a). Need/ Authority for the Collection FIFRA sections 3( a) and 12( a)( 1) require a person to register a pesticide product with the EPA before the pesticide product may be lawfully sold or distributed in the United States. A pesticide registration is a license that allows a pesticide product to be sold and distributed for specific uses under specified terms and conditions such as use instructions and precautions. A pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA § 3( c)( 5), which is as follows:

( A) Its composition is such as to warrant the proposed claims for it. ( B) Its labeling and other material required to be submitted comply with the requirements of this Act. ( C) It will perform its intended function without unreasonable adverse effects on the environment. ( D) When used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.

FIFRA § 2( bb) defines " unreasonable adverse effects on the environment'' as ( 1) " any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or ( 2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food Drug and Cosmetic Act.''

The proponent of initial or continued registration always bears the burden of demonstrating that a pesticide product meets the statutory standard for registration. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 3 of 55 The authority for the information collection activities contained in this ICR can be found in FIFRA § 3( c)( 2)( B), which allows EPA to require pesticide registrants to generate and submit data to the Agency when data is needed to assess whether the existing pesticide registration poses an unreasonable risk to human health or the environment. A copy of this section is provided in Attachment A.

Whenever EPA has reason to believe that the use of a registered pesticide may result in unreasonable adverse effects to people or the environment, the Agency initiates a Special Review of the registration for that pesticide to determine whether it must take any action under FIFRA § 6( b) to cancel or change the registration of that pesticide. Special Review is an intensive and systematic examination process that offers opportunities for interested parties to comment and present evidence on the risks and benefits of a pesticide. EPA uses the authority under FIFRA § 3( c)( 2)( B) to request additional information from the registrant that is necessary for its review.

FIFRA § 3( g) now requires EPA to periodically assess the registration of each pesticide and assess all information/ data necessary to determine whether the intended use( s) of the pesticide presents unreasonable adverse effects on human health or the environment. Continued registration of some pesticides may require that the Agency obtain additional information under FIFRA § 3( c)( 2)( B) necessary to complete the Registration Review.

2( b). Practical Utility/ Users of the Data OPP will use the information/ data obtained from registrants to assess whether unreasonable adverse effects are associated with the use of the chemical in the pesticide products. Agency scientists and analysts integrate the new data received from registrants with the existing data in EPA's files. The information is then reviewed to assess the potential risks and benefits associated with the use of the pesticide. If it is determined that regulatory actions are needed, the Agency will act accordingly.

A record of each study submitted is maintained in the Agency's Pesticide Document Management System ( PDMS), and public access to the PDMS bibliography may be made 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 non confidential studies through the Freedom of Information Act ( FOIA).

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a). Non duplication The information collected under this program is collected by no other federal agency or any other office within EPA. As described above, this information is required for EPA's evaluation of the health and environmental effects and economic benefits associated with the use of pesticides. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 4 of 55 In addition, prior to requesting any information under these programs, the Agency must review existing records for the availability of the information that it is considering requesting. EPA also provides for public comment and may modify its DCI requirements if warranted by information provided by registrants or the public. Registrants may respond to the DCI by requesting waivers of data requirements if they believe that OPP can properly evaluate their pesticide without additional data.

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 Before a particular DCI is issued under either program, the procedures for both programs provide several opportunities for consultations with the affected registrants, as well as with the public and other interested parties.

In the initial stage of a Special Review, EPA announces its intent to conduct such a review and require additional studies. Registrants and other interested parties have the opportunity to comment on the Agency's intent. Generally, the Agency consults with registrants before a data call in notice is issued to discuss the Agency's need for particular information and the protocol to be used to conduct the study. EPA is always open to communications with registrants concerning any issue they may have with the requirements for data. As mentioned, registrants may request waivers of data requirements if they believe that the Agency can properly evaluate their pesticide without additional data.

For Registration Review, EPA will document the reasons for requiring additional studies in a Pre DCI Analysis. EPA will announce the availability of this document in a FR notice and may also hold a public meeting to discuss the findings of the Pre DCI analysis. Registrants and other interested parties may submit additional information or comments at this time. The Agency may modify its DCI requirements if warranted by information provided by registrants or the public. Also, registrants may respond to the DCI by requesting waivers of data requirements if they believe that OPP can properly evaluate their pesticide without additional data. As indicated previously, EPA published an advanced notice of proposed rulemaking in 2000, will propose rulemaking in 2005 and take public comment on the establishment of procedural regulations for conducting registration reviews, and complete final rulemaking in 2006. In the meantime, EPA will follow this basic public process for any necessary registration reviews.

In preparing the previous ICR, the Agency discussed with industry stakeholders the incorporation of the burden related to the new Registration Review program, along with the methodology used to estimate the burden and costs.

In addition, EPA will consult with registrants on the information collection during the renewal process. Discussion with respondents will include whether the labor rate estimates in the DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 5 of 55 ICR are accurate and whether the estimates of burden and methodology for arriving at the estimate are correct, and alternatives to paper based submissions, i. e., whether respondents would consider submitting the information electronically, such as through web forms and the Agency's Internet site or submitting data on disk with electronic signatures, if that option were available.

3( d). Effects of Less Frequent Collection Information is collected under this ICR only when the Agency has identified a need for the specific data, and only on a one time basis.

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. Pursuant to FIFRA § 8, EPA recordkeeping requirements in 40 CFR 169.2( k) state that records containing research data relating to registered pesticides be retained 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.

The forms associated with this ICR are also used for other information collection activities that are approved under separate OMB Control numbers, e. g., 2070 0107, 2070 0060, and 2070 0122. The Agency recently completed a review of these forms, which included stakeholder input, and has determined that the elements on these forms are not expected to change when the Agency makes them available electronically. In accordance with OMB's guidance regarding the inclusion of the expiration date on forms, EPA requests permission to omit the current expiration date on future forms.

3( f). Confidentiality Most health and safety data submitted by registrants under FIFRA is 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 intended to be destroyed must be cleared by a document control officer and shredded.

3( g). Sensitive questions DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 6 of 55 No information of a sensitive or private nature is requested in conjunction with this information collection activity. Further, the information collection activity under this ICR 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 Respondents to the information collection activities related to the Special Review and the Registration Review Program consist of pesticide Registrants identified by the North American Industrial Classification System ( NAICS) code 325320 ( Pesticide and Other Agricultural Chemical Manufacturing).

4( b). Information Requested ( i) Data Items, Including Record Keeping Requirements Considering the potential variation in the specific need identified for the individual pesticide under review, the specific data items that may be collected for the individual pesticides under this ICR are also likely to vary from pesticide to pesticide. However, based on the specific need identified for the pesticide, the Agency may request one or more of the following of types of data:

Product Chemistry Residue Chemistry Environmental Fate Toxicology Reentry Protection Spray Drift Wildlife and Aquatic Organisms Plant Protection Nontarget Insect Product Performance Biochemical Pesticides Microbial Pesticides These categories, which are defined in greater detail in 40 CFR Part 158, basically consist of that information and/ or data that is necessary to determine whether the intended use( s) of the pesticide presents unreasonable adverse effects on human health or the environment. In addition to the categories identified above, the Agency may also require that a special study be conducted to provide critical information about the risks and benefits of the pesticide in support of its continued registration. These special studies would be based on the particular characteristics of the chemical, and the Agency's need for such information to make the required statutory finding.

OPP will issue a data call in ( DCI) for a pesticide chemical only after it reviews the available data and determines that the information is not sufficient to satisfy the statutory DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 7 of 55 requirements for continued registration. Even after OPP has completed its review and has determined that additional data must be called in, registrants are given the opportunity to 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.

The following forms are associated with this ICR, but may also be used and referenced under other information collection activities and the related ICRs involving DCIs:

1) Data Call in Response Form ( See Attachment B)

2) Requirements Status and Registrant's Response Form ( See Attachment C)

3) EPA Form 8570 32: Certification of Attempt to Enter into an Agreement with Registrants for Development of Data ( See Attachment D)

4) EPA Form 8570 34: Certification with Respect to Citation of Data ( See Attachment E)

Although the Registration Review program is new, FIFRA section 3( g) also instructs the Agency to rely on existing authorities for data submission, data compensation, data exemption, or cancellation of registrations. Therefore, the procedures for acquiring new information or granting data exemptions under the Registration Review program already exist, and there are no additions, deletions or changes to the universe of potential data items collected since the last OMB clearance. The same type of data items may be collected under the Special Review and the Registration Review Programs. However, since the collection activities under both programs are limited to specific pesticides and specifically identified needs for those pesticides, the collection activities under both programs will not be duplicative.

( ii) Respondent Activities A pesticide registrant whose chemicals are under Special Review or Registration Review will engage in the following activities under this ICR.

read instructions read the DCI letter to understand what data are to be submitted plan activities plan the activities necessary to comply with the DCI, or develop options to avoid having to submit data ( e. g., exemption/ waiver)

create information conduct research, administer tests, analyze data to develop studies, perform laboratory analysis, write study documents 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 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 8 of 55 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, 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. If a generic data exemption is claimed, the registrant is not required to complete the Requirements Status and Registrant's Response Form. 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 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 9 of 55 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 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 you ( 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. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 10 of 55 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 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 your 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 request for a waiver.

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.

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

develop DCI correspondence prepare the DCI letter identifying all the data needed answer registrants' questions respond to any questions the registrant may have regarding the DCI DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 11 of 55 review data submissions review data submissions for completeness and appropriateness record DCI submissions record submissions in tracking system for internal review analyze data conduct scientific reviews of data store data index data and store it in Agency files 5( b). Collection Methodology and Management When the need for additional information/ data for a particular pesticide is identified under Special Review or in the Registration Review process, OPP will issue a data call in ( DCI) to obtain the necessary data from the Registrant( s) of that pesticide.

A pesticide will undergo Special Review when the Agency has reason to believe that the use of the pesticide may result in unreasonable adverse effects to people or the environment. In accordance with FIFRA § 3( g)( 1)( A), a pesticide must undergo Registration Review every 15 years. As a result, the initiation of Special Review is triggered by the availability of information to EPA which calls into question the existing registration of a particular pesticide, while the initiation of Registration Review is triggered by the date of the original registration ( i. e., prior to 1984).

When a Special Review is initiated, the Agency notifies the registrant( s) for the pesticide in question, and, after reviewing the available information to identify the data that is missing but necessary for evaluating the continued registration of the pesticide in question, the Agency publishes a document that presents its review and findings. Comments from the registrant, public and other interested parties are considered, and a DCI is issued to gather any missing but necessary data. After considering the data submitted in response to the DCI, the Agency issues a Special Review Decision Document which describes the Agency's review, findings, and decisions regarding the registration of the pesticide in question, which are then implemented with appropriate registration actions.

The method for scheduling the registration review of pesticides will be established in the procedural regulations that are currently still under development with broad participation from the regulated community and other stakeholders. In general, the scheduling of the registration reviews for the individual chemicals will be based on the goal of a 15 year review pursuant to FIFRA § 3( g). On April 26, 2000, EPA issued an advance notice of proposed rulemaking that sought initial public comment of the basic procedural framework that the Agency is considering for carrying out the mandated registration reviews ( 65 FR 24586) ( see Attachment F). While in that document, the Agency stated an intent for registration review to be implemented in 2005, the procedural final rulemaking to implement the program will not be completed until 2006. In the meantime, the Agency will only issue DCIs for specific information that is necessary to meet new statutory requirements ( e. g., FFDCA § 408( p) requires EPA to screen all pesticides for estrogenic activity).

The effective and efficient management of the Information collected pursuant to this ICR is a critical component of these programs. As indicated in section 2( b) of this ICR, a record of each study submitted in response to a DCI issued under this ICR is maintained in the Agency's DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 12 of 55 PDMS. This information may then be easily accessed by EPA personnel involved in reviewing the data as part of a Special Review or Registration Review. In addition, this information may be subsequently accessed by EPA personnel whenever necessary as part of any other Agency activities that require the pesticide specific information in question, i. e., the information submitted to EPA becomes part of the Agency's " available information" that is first consulted whenever necessary to make decisions under FIFRA or FFDCA.

OPP continues to revise its information tracking systems to improve efficiency and accuracy. The Office of Pesticide Programs Information System has improved the quality of the Agency's databases and will allow the EPA to respond more timely and accurately to queries, including requests made under FOIA.

OPP is 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 Agencywide workgroup to develop electronic reporting standards intended to facilitate the submission and use of information about pesticides.

Although the Agency does not publish the submitted information, and public access to the PDMS bibliography is made 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 nonconfidential studies through FOIA.

5( c). Small Entity Flexibility Small businesses are generally exempt from the generation of data on purchased active ingredients. Most small entities are formulators and not basic manufacturers. Thus, they do not have the responsibility for supplying basic data on a chemical unless the manufacturer decides not to support the registration. Formulators need only respond to a data call in for basic data by indicating a legitimate claim for exemption. They do not incur any other information burden associated with the call in.

5( d). Collection Schedule There is not a collection schedule per se. DCIs are issued when the need is identified. The time frame in which the respondents must then submit the requested material is specifically established for each DCI based on the individual circumstances surrounding the particular DCI and applicable review. EPA usually works with respondents to ensure that sufficient time is built into the individual DCIs to allow for respondents to gather and submit the requested information.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 13 of 55 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 potential burden and costs related to the creation/ gathering, submission, and recordkeeping of the data requested pursuant to a DCI issued under this ICR. The Agency has estimated the annual and total potential burden and costs during the three year approval period.

The annual respondent burden hour and cost estimate for this ICR ( both the Special Review and Registration Review programs) is estimated to be 64,699 hours, with a cost of $ 5,851,894. Therefore, the total respondent burden hour and cost estimate for this ICR over three years is estimated to be 194,097 hours, with a cost of $ 17,555,682.

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.

The following includes a breakdown of the annual and total potential burden hours and costs by respondent and by the annual and total number of responses.

6( a). Estimating Respondent Burden As illustrated in Table 1A, the average annual burden for Special Review is estimated to be 919 hours per response with one annual response expected, for a total annual burden of 919 hours. In this ICR, the average number of burden hours per response for Special Review is the same as in the previous ICR; i. e., 919 hours. This annual burden estimate is based on the following assumptions: ( a) that the Agency would issue 1 DCI under the Special Review program ( aka Special Review DCIs) in any given 12 month period, and ( b) that for each Special Review DCI issued, there would be 1 response. Over a three year ICR approval period, three responses would be expected and the total respondent burden for Special Review related activities is estimated to be 2,757 hours.

The potential number of Special Review DCIs required, the type of data, and the number of respondents affected are quite variable. The burden estimates for the Special Review DCIs for this ICR renewal were calculated using information from Special Review DCIs conducted during the previous approval period. Review of this information resulted in the Agency's estimates that 1 Special Review DCIs would be required per year affecting approximately 1 respondent per DCI for a total of 3 responses. Because of the variability inherent in each Special Review DCI, the estimates serve as a proxy for what the actual burdens are likely to be. Although the Agency estimated that an average of 1 respondent per Special Review DCI is expected because the DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 14 of 55 majority of the Special Review DCIs have only affected 1 or 2 respondents, some previous Special Review DCIs have, on occasion, exceeded this.

In the Special Review Program, EPA focuses on specific hazards or uses of a pesticide. Special Reviews are not intended to be comprehensive evaluations of the pesticide; DCIs address specific hazard or exposure concerns that are at issue. The Agency believes that it has sufficient experience with administering DCIs to make reasonable estimates of the information burden that will be generated.

Special Review DCI's, like Registration Review DCI's, may request data on more than one pesticide, and may involve two or more respondents who join together to provide the needed data.

It is important to note that 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 so the per respondent burden would be less. In addition, in recent years, the Agency has not typically issued 1 Special Review DCI each year over a three year period.

Table 1A: Average Annual Burden/ Cost Estimates for Special Review DCIs per Respondent BURDEN HOURS ( per year) TOTALS COLLECTION ACTIVITIES Mgmt. $ 130/ hr Tech. $ 88/ hr Cler. $ 40/ hr Hrs Cost 1) Read and discuss test requirements 18 0 0 18 $ 2,340 2) Discuss test and protocol with Agency 9 9 0 18 $ 1,962 3) Plan activities 0 0 0 0 $ 0 4) Create information 37 9 0 46 $ 5,602 5) Gather information 28 460 0 488 $ 44,120 6) Process, compile, review information for accuracy 0 46 0 46 $ 4,048 7) Complete written forms 55 74 55 184 $ 15,862 8) Record, disclose, display information 0 0 18 18 $ 720 9) Store, file, or maintain information 36 0 65 166 $ 7,280 TOTAL 183 ( 20%) 598 ( 65%) 138 ( 15%) 919 $ 81,934 Special Review Total Respondent Burden and Cost Per Year During Three Year Period: Hours: 1 response X 919 = 919 hours Costs: 1 response X $ 81,934 = $ 81,934 Special Review Total Respondent Burden and Cost Over Three Years: Hours: 3 responses X 919 = 2,757 hours Costs: 3 responses X $ 81,934 = $ 245,802 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 15 of 55 As illustrated in Table 1B, the average annual burden for Registration Review is estimated to be 1,063 hours per response with 60 responses expected annually, for a total annual burden of 63,780 hours ( 1,063 x 60). In this ICR, the average number of burden hours per response for Registration Review is the same as in the previous ICR; i. e., 1,063 hours. This annual burden estimate is based on the following two assumptions: ( a) that the Agency would issue at least 40 DCIs under the Registration Review program ( aka Registration Review DCIs) in any given 12 month period, and ( b) that for each Registration Review DCI issued, there would be at least 1.5 responses on average per DCI. Over a three year ICR approval period, 180 responses would be expected and the total respondent burden for Registration Review related activities is estimated to be 191,340 hours.

In the Reregistration Program, EPA examined the entire data base supporting all uses of the pesticide. Pesticides on Reregistration " List A" had been reviewed in the 1980' s and generally had more complete data bases than other pesticides in the Reregistration Program.

In the Registration Review Program, EPA will, among other things, update the databases of pesticides to obtain data that were not required when the pesticide was registered or reregistered, but which are now required and determined necessary. The Agency believes that it has sufficient experience with administering DCIs to make reasonable estimates of the information burden that will be generated by Registration Review DCIs.

The potential number of Registration Review DCIs that will be issued, the type of data, and the number of respondents affected will be quite variable. As indicated in the advance notice related to the procedural regulations that are under development, EPA is considering providing an advance notice in scheduling the registration reviews. Once the procedural rule is issued, the schedule of registration reviews will enable the Agency to provide a better estimate of the potential number of Registration Review DCIs in any given 12 month period, along with the related burden.

In the meantime, since the Registration Review DCIs expected during the three year approval period for this ICR are expected only to involve a request for specific information that is necessary to meet new statutory requirements, EPA estimates that it might issue up to 40 Registration Review DCIs per year. This is the same estimate the Agency used in the previous ICR. The Agency continues to estimate that, on average, there will be 1.5 responses per DCI for a total of 60 responses per year. As with Special Review DCI's, Registration Review DCI's may request data on more than one pesticide, and may involve two or more respondents who join together to provide the needed data. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 16 of 55 Table 1B: Annual Respondent Burden/ Cost Estimates for Registration Review DCIs BURDEN HOURS ( per year) TOTALS COLLECTION ACTIVITIES Mgmt. $ 130/ hr Tech. $ 88/ hr Cler. $ 40/ hr Hrs Cost 1) Read and discuss test requirements 22 0 0 22 $ 2,860 2) Discuss test and protocol with Agency 11 11 0 22 $ 2,398 3) Plan activities 44 11 0 55 $ 6,688 4) Create information 33 544 33 610 $ 53,482 5) Gather information 0 54 0 54 $ 4,752 6) Process, compile, review information for accuracy 65 87 0 152 $ 16,106 7) Complete written forms 0 0 22 22 $ 880 8) Record, disclose, display information 22 0 44 66 $ 4,620 9) Store, file, or maintain information 22 0 38 60 $ 4,380 TOTAL 219 707 137 1,063 $ 96,166 Registration Review Total Respondent Burden and Cost Per Year During Three Year Period: Hours: 60 responses X 1,063 = 63,780 hours Costs: 60 responses X $ 96,166 = $ 5,769,960 Registration Review Total Respondent Burden and Cost Over Three Years: Hours: 180 responses X 1,063 = 191,340 hours Costs: 180 responses X $ 96,166 = $ 17,309,880 6( b). Estimating Respondent Costs Annual Total: For Special Review DCIs, the total annual respondent cost is estimated to be $ 81,934 ($ 81,934 per response x 1 response). For Registration Review, the total annual respondent cost is estimated to be $ 5,769,960 ($ 96,166 per response x 60 responses). The annual totals of both Special Review and Registration Review, when added together, will be $ 5,851,894. See Tables 1A, 1B, and 3.

Three year ICR approval total: For Special Review DCIs, the total respondent cost is estimated to be $ 245,802 ($ 81,934 per response x 3 responses). For Registration Review, the total respondent cost is estimated to be $ 17,309,880 ($ 96,166 per response x 180 responses). The totals of both Special Review and Registration Review, when added together, will be $ 17,555, 682. See last row of Table 3.

The methodology for estimating the total potential cost associated with the paperwork activities related to the studies conducted to respond to a DCI are discussed in more detail in Attachment G. The labor costs were derived using previous cost information for individual Special Review DCIs conducted during the previous approved period. Based on the cost information, the Agency assumed an average total test cost of $ 500,000 per Special Review DCI. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 17 of 55 This cost was the basis for calculating the value of labor per hour for management, technical, and clerical, which is $ 130, $ 88, and $ 40, respectively. These hourly rate include overhead and benefits and were used to calculate the potential costs ( Tables 1A and 1B provide the details on the calculations of these costs). 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.

6( c). Estimating Agency Burden and Cost As illustrated in Table 2A, the average annual Agency cost for Special Review is estimated to be 1,348 hours and $ 91,404 per response with one annual response, for a total annual burden of 1,348 ( 1,348 x 1) hours and cost of $ 91,404. In this ICR, the average number of Agency burden hours per response for Special Review is the same as in the previous ICR; i. e., 1,348 hours. Over a three year ICR approval period, 3 responses are expected and the total Agency burden hour and cost is estimated at 4,044 ( 1,348 x 3) hours, with a cost of $ 274,212.

As illustrated in Table 2B, the average annual Agency cost for Registration Review is estimated to be 760 hours and $ 47,376 per response with 60 annual responses, for a total annual burden of 45,600 hours ( 760 x 60) and cost of $ 2,842,560. In this ICR, the average number of Agency burden hours per response for Registration Review is the same as in the previous ICR; i. e., 760 hours. Over a three year ICR approval period, 180 responses are expected and the total Agency burden hour and cost is estimated at 136,800 ( 760 x 180) hours, with a cost of $ 8,527,680.

The hourly rates for Agency staff are $ 96, $ 70, and $ 33 per hour for management, technical, and clerical staff, respectively. Agency labor 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.

Annual Total: The total annual burden for the Agency to administer Special Review and Registration Review DCI responses is estimated to be 46,948 hours and cost $ 2,933,964. See Table 4.

Three year ICR approval total: Over the three year approval for this ICR, the total burden for the Agency to administer all Special Review and Registration DCI responses is estimated to be 140,844 hours and cost $ 8,801,892. See the last row of Table 4.

The Agency's labor burden includes developing DCI correspondence, communication with registrants, and documenting and storing the evaluation of the data submissions. The value of labor per hour for management, technical, and clerical is $ 96, $ 70, and $ 33 ( revised from the previous ICR's rates of $ 84, $ 61, and $ 29), respectively. Burden cost estimates have been calculated based on the General Schedule ( GS) hourly rates for three levels of Agency personnel as follows:

Management = Branch Chief ( GS 15) DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 18 of 55 Technical = Section Head ( GS 14) & Staff Scientists ( GS 9 13). Average Grade used is equal to GS 12 Clerical = Secretary ( GS 6)

Table 2A: Annual Agency Burden/ Cost Estimates for Special Review DCIs Collection Activities Burden Hours Total Mgmt. $ 96/ hr Tech. $ 70/ hr Cler. $ 33/ hr Hours Cost Develop DCI correspondence needed 32 160 60 252 $ 16,252 Answer registrants' questions regarding the DCI 4 160 0 164 $ 11,584 Review and analyze data submissions 4 880 0 884 $ 61,984 Record DCI submissions 0 0 40 40 $ 1,320 Store Data 0 0 8 8 $ 264 TOTAL 40 1,200 108 1,348 $ 91,404 Annual Agency Burden and Cost for Special Review DCIs: Hours: 1 response X 1,348 = 1,348 hours Cost: 1 response X $ 91,404 = $ 91,404 Total Agency Burden and Cost for Special Review DCIs: Hours: 3 responses X 1,348 = 4,044 hours Cost: 3 responses X $ 91,404 = $ 274,212 Table 2B: Annual Agency Burden/ Cost Estimates for Registration Review DCIs Collection Activities Burden Hours Total Mgmt. $ 96/ hr Tech. $ 70/ hr Cler. $ 33/ hr Hours Cost Develop DCI correspondence needed 64 320 120 504 $ 32,504 Answer registrants' questions regarding the DCI 4 160 0 164 $ 11,584 Review and analyze data submissions 4 0 0 4 $ 384 Record DCI submissions 0 0 80 80 $ 2,640 Store Data 0 0 8 8 $ 264 TOTAL 72 480 208 760 $ 47,376 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 19 of 55 Annual Agency Burden and Cost for Registration Review DCIs: Hours: 60 responses X 760 = 45,600 hours Cost: 60 responses X $ 47,376 = $ 2,842,560 Total Agency Burden and Cost for Registration Review DCIs: Hours: 180 responses X 760 = 136,800 hours Cost: 180 responses X $ 47,376 = $ 8,527,680 6( d). Bottom Line Burden Hours and Cost Tables The total Respondent burden and costs are illustrated in Table 3, while the total Agency burden and costs are illustrated in Table 4.

Table 3: Annual and Total Respondent Burden/ Cost Estimates Over Three Years Per Response Number of Responses Totals Hours Cost Hours Cost Special Review 919 $ 81,934 1 919 $ 81,934 Registration Review 1,063 $ 96,166 60 63,780 $ 5,769,960 TOTAL ANNUAL BURDEN 1,982 $ 178,100 61 64,699 $ 5,851,894 TOTAL BURDEN 5,946 $ 534,300 183 194,097 $ 17,555,682 Table 4: Annual and Total Agency Burden/ Cost Estimates Over Three Years Per Response Number of Responses Totals Hours Costs Hours Cost Special Review 1,348 $ 91,404 1 1,348 $ 91,404 Registration Review 760 $ 47,376 60 45,600 $ 2,842,560 TOTAL ANNUAL BURDEN 2,108 $ 138,780 61 46,948 $ 2,933,964 TOTAL BURDEN 6,324 $ 416,340 183 140,844 $ 8,801,892 6( e). Reasons for Change in Burden This ICR renewal request will result in a net decrease in the annual respondent burden of 6,433 hours, i. e., from 7,352 hours to 919 hours, for Special Review when compared with the previous ICR. The Agency has adjusted the annual number of Special Review DCIs that may be issued ( from 2 to 1), and the total estimated number of respondents affected ( from 4 to 1). Based on experience, and the Agency's existing work plan, EPA believes that a more accurate estimate involves the prediction of up to 1 Special Review DCI being issued each year, with each DCI affecting 1 respondent, for a total estimate of 3 responses over a three year period. This DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 20 of 55 adjustment resulted in a decrease in annual burden of hours due to a reduction in total annual responses from 8 ( 2 x 4) to 1 ( 1 x 1).

Also, EPA has updated the hourly labor rates used to calculate costs for the respondent to $ 130, $ 88, and $ 40 ( up from $ 123, $ 83, and $ 38 in the previous ICR) for management, technical, and clerical work, respectively. In addition, EPA has updated the hourly labor rates used to calculate costs for the Agency to $ 96, $ 70, and $ 33 ( from $ 84, $ 61, and $ 29) for management, technical, and clerical work, respectively.

6( f). Burden Statement The annual respondent burden for the information collection activities under OMB Control Number 2070 0057 ( EPA ICR # 922.07) is estimated to average 919 hours for Special Review DCIs and 63,780 hours for Registration Review DCIs. The annual respondent burden under this ICR is 64,699 hours. This estimate includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to respond to a collection of information; search existing data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

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, on the forms approved under this ICR, and in the list of OMB control numbers for EPA's regulations in 40 CFR 9.1 ( see Attachment H for additional information about 40 CFR 9.1).

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 0111, 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 Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID No. OPP 2004 0111 and OMB Control No. 2070 0057 in any correspondence. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 21 of 55 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 22 of 55 ATTACHMENTS TO THE SUPPORTING STATEMENT Attachment A  FIFRA, sections 3( c)( 2)( B), 3( c)( 2)( D) and 3( g) ( 7 U. S. C. 136a). Available electronically at http:// www. epa. gov/ oppfead1/ fqpa/ and click on " LAWS," then click on the available PDF file for FIFRA.

Attachment B  Data Call In Response Form.

Attachment C  Requirement Status and Registrants' Response Form.

Attachment D  EPA Form 8570 32  Certification of Attempt to Enter into an Agreement with Registrants for Development of Data  available electronically at http:// www. epa. gov/ opprd001/ forms/

Attachment E  EPA Form 8570 34  Certification with Respect to Citation of Data. Available electronically at http:// www. epa. gov/ opprd001/ forms/

Attachment F  Pesticides; Procedural Regulations for Registration Review; Advanced Notice of Proposed Rulemaking ( 65 FR 24585, April 26, 2000). Available electronically at http:// frwebgate. access. gpo. gov/ cgi bin/ getdoc. cgi? dbname= 2000_ register& docid= 00 10433 file d Attachment G  Estimating the Potential Paperwork Burden and Cost for DCIs. An electronic copy of this attachment follows in the electronic file for this ICR.

Attachment H  Display Related to OMB Control # 2070 0057  Listings of Related Regulations in 40 CFR 9.1. An electronic copy of this attachment follows in the electronic file for this ICR. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 23 of 55 Attachment A Federal Insecticide, Fungicide, and Rodenticide Act Section 3( c)( 2)( B)

( 2) 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.

( 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 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 24 of 55 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.

( iv) Notwithstanding any other provision of this Act, if the Administrator determines that a registrant, within the time required by the Administrator, has failed to take appropriate steps to secure the data required under this subparagraph, to participate in a procedure for reaching agreement concerning a joint data development arrangement under this subparagraph or in an arbitration proceeding as required by this subparagraph, or to comply with the terms of an agreement or arbitration decision concerning a joint data development arrangement under this subparagraph, the Administrator may issue a notice of intent to suspend such registrant's registration of the pesticide for which additional data is required. The Administrator may include in the notice of intent to suspend such provisions as the Administrator deems appropriate concerning the continued sale and use of existing stocks of such pesticide. Any suspension proposed under this subparagraph shall become final and effective at the end of thirty days from receipt by the registrant of the notice of intent to suspend, unless during that time a request for hearing is made by a person adversely affected by the notice or the registrant has satisfied the Administrator that the registrant has complied fully with the requirements that served as a basis for the notice of intent to suspend. If a hearing is requested, a hearing shall be conducted under section 6( d) of this Act. The only matters for resolution at that hearing shall be whether the registrant has failed to take the action that served as the basis for the notice of intent to suspend the registration of the pesticide for which additional data is required, and whether the Administrator's determination with respect to the disposition of existing stocks is consistent with this Act. If a hearing is held, a decision after completion of such hearing shall be final. Notwithstanding any other provision of this Act, a hearing shall be held and a determination made within seventy five days after receipt of a request for such hearing. Any registration suspended under this subparagraph shall be reinstated by the Administrator if the Administrator determines that the registrant has complied fully with the requirements that served as a basis for the suspension of the registration.

( v) Any data submitted under this subparagraph shall be subject to the provisions of paragraph ( 1)( D). Whenever such data are submitted jointly by two or more registrants, an agent shall be agreed on at the time of the joint submission to handle any subsequent data compensation matters for the joint submitters of such data. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 25 of 55 ( vi) Upon request 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 section 4 for the other uses of the pesticide established as of the date of enactment of the Food Quality Protection Act of 1996, if B ( 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 section 4; 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 clause, 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) 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 clause, the Administrator may take action to modify or revoke the extension under this clause 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, in writing to the registrant, a notice revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date established by the Administrator for the submission of the data.

( vii) 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 nonfat 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 nonfat uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this clause in regard to such unsupported minor use until the final deadline established as the date of enactment of the Food Quality Protection Act of 1996, for the submission of data under section 4 for the supported uses identified pursuant to this clause 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 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 clause, 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 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 26 of 55 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 this subparagraph 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 the provisions of this clause, 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 effects 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.

( viii) ( I) If data required to support registration of a pesticide under subparagraph ( A) is requested by a Federal or State regulatory authority, the Administrator shall, to the extent practicable, coordinate data requirements, test protocols, timetables, and standards of review and reduce burdens and redundancy cause to the registrant by multiple requirements on the registrant.

( II) The Administrator may enter into a cooperative agreement with a State to carry out subclause ( I).

( III) Not later than 1 year after the date of enactment of this clause, the Administrator shall develop a process to identify and assist in alleviating future disparities between Federal and State data requirements.

( C) Simplified Procedures. Within nine months after the date of enactment of this subparagraph, the Administrator shall, by regulation, prescribe simplified procedures for the registration of pesticides, which shall include the provisions of subparagraph ( D) of this paragraph.

( D) Exemption. No applicant for registration of a pesticide who proposes to purchase a registered pesticide from another producer in order to formulate such purchased pesticide into the pesticide that is the subject of the application shall be required to B ( i) submit or cite data pertaining to such purchased product; or ( ii) offer to pay reasonable compensation otherwise required by paragraph ( 1)( D) of this subsection for the use of any such data.

( E) Minor Use Waiver. In handling the registration of a pesticide for a minor use, the Administrator may waive otherwise applicable data requirements if the Administrator determines that the absence of such data will not prevent the Administrator from determining

( i) the incremental risk presented by the minor use of the pesticide; and ( ii) that such risk, if any, would not be an unreasonable adverse effect on the environment. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 27 of 55 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 28 of 55 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 29 of 55 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 30 of 55 DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 31 of 55 ATTACHMENT F [ Federal Register: April 26, 2000 ( Volume 65, Number 81)]

[ Proposed Rules]

[ Page 24585 24591]

Part IV Environmental Protection Agency

40 CFR Part 152 Pesticides; Procedural Regulations for Registration Review; Advanced Notice of Proposed Rulemaking

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 152 [ OPP 36195; FRL 6488 9]

RIN 2070 AD29 Pesticides; Procedural Regulations for Registration Review AGENCY: Environmental Protection Agency ( EPA).

ACTION: Advanced Notice of Proposed Rulemaking.

SUMMARY: The Food Quality Protection Act ( FQPA) of 1996 amended the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) to require periodic review of pesticide registrations to ensure that over time they continue to meet statutory standards for safety. FIFRA section 3( g) specifies that EPA establish procedural regulations for conducting registration review and that the goal of the regulations shall be the Agency review of pesticide registrations on a 15 year cycle. This advance notice of proposed rulemaking ( ANPRM) alerts stakeholders that EPA is beginning development of procedural regulations for registration review under FIFRA section 3( g). It explains EPA's preliminary interpretation of the authorizing legislation, presents EPA's goals in implementing the statutory provisions, presents the Agency's initial concept of how the registration review program might operate, identifies several DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 32 of 55 issues that should be addressed in developing the program, and invites public comment on these and other issues relating to registration review.

DATES: Comments, identified by the docket control number [ OPP 36195], must be received on or before June 26, 2000.

ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP 36195 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: Vivian Prunier, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703 308 9341; fax number: 703 305 5884; e mail address: prunier. vivian@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by the planned rulemaking described in this document if you hold pesticide registrations or may hold pesticide registrations in the future. Pesticide users or other persons interested in the regulation of the sale, distribution, or use of pesticides may also be interested in these planned procedural rules. As such, the Agency is soliciting comments from the public in general. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document from the EPA Internet Home Page at http:// www. epa. gov/. To access this document on the Home Page select    Laws and Regulations'' and then look up the entry for this document under the    Federal Register B Environmental Documents.'' You can also go directly to the    Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 33 of 55 2. In person. The Agency has established an official record for this action under docket control number [ OPP 36195]. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as confidential business information ( CBI).

This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Highway,

Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The Public Information and Records Integrity Branch telephone number is 703 305 5805.

C. How and to Whom Do I Submit Comments?

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, it is imperative that you identify docket control number OPP 36195 in the subject line on the first page of your response.

1. By mail. Submit your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Information Resources and Services Division ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305 5805.

3. Electronically. You may submit your comments electronically by e mail to:    opp docket@ epa. gov,'' or you can submit a computer disk as described above. Do not submit any information electronically that you consider to be CBI. Avoid the use of special characters and any form of encryption. Electronic submissions will be accepted in WordPerfect 6.1/ 8.0 or ASCII file format. All comments in electronic form must be identified by docket control number OPP 36195. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency? DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 34 of 55 Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views on the various issues we raise, new approaches or options we haven't considered and the potential impacts, including possible unintended consequences, of the Agency's initial concept. You may find the following suggestions helpful for preparing your comments:

Explain your views as clearly as possible and provide any supporting data where appropriate.

Describe any assumptions that you used.

Make sure to submit your comments by the deadline in this notice.

To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Purpose of the ANPRM With this ANPRM, the Agency presents the statutory requirement for pesticide registration review and alerts its stakeholders that it is initiating the development of rulemaking to establish procedures for a registration review program. Second, the Agency explains its preliminary interpretation of the statutory provisions and its preliminary ideas regarding goals and objectives for this program. Third,

the Agency describes its preliminary ideas about how registration review might operate. Fourth, the Agency solicits public input on critical issues about registration review early in the planning process. Finally, EPA solicits public input to identify potential problems as early as possible. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 35 of 55 III. Legal Authority A. EPA's Authority to License Pesticide Products FIFRA sections 3( a) and 12( a)( 1) require a person to register a pesticide product with the EPA before the pesticide product may be lawfully sold or distributed in the United States. A pesticide registration is a license that allows a pesticide product to be sold and distributed for specific uses under specified terms and conditions such as use instructions and precautions. A pesticide product may be registered or remain registered only if it meets the statutory standard for registration given in FIFRA section 3( c)( 5), as follows:

( A) Its composition is such as to warrant the proposed claims for it.

( B) Its labeling and other material required to be submitted comply with the requirements of this Act.

( C) It will perform its intended function without unreasonable adverse effects on the environment.

( D) When used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.

FIFRA 2( bb) defines    unreasonable adverse effects on the environment'' as ( 1)    any unreasonable risk to man or the environment,

taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or ( 2) a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal Food Drug and Cosmetic Act.''

The proponent of initial or continued registration always bears the burden of demonstrating that a pesticide product meets the statutory standard for registration.

B. EPA's Authority for Registration Review The FQPA amended FIFRA to add, among other things, section 3( g),    REGISTRATION REVIEW,'' as follows: DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 36 of 55 ( 1)( A) GENERAL RULE. The registrations of pesticides are to be periodically reviewed. The Administrator shall by regulation establish a procedure for accomplishing the periodic review of registrations. The goal of these regulations shall be a review of a pesticide's registration every 15 years. No registration shall be canceled as a result of the registration review process unless the Administrator follows the procedures and substantive requirements of section 6.

( B) LIMITATION. Nothing in this subsection shall prohibit the Administrator from undertaking any other review of a pesticide pursuant to this Act.

( 2)( A) DATA. The Administrator shall use the authority in subsection ( c)( 2)( B) to require the submission of data when such data are necessary for a registration review.

( B) DATA SUBMISSION, COMPENSATION, AND EXEMPTION. B For purposes of this subsection, the provisions of subsections ( c)( 1), ( c)( 2)( B), and ( c)( 2)( D) shall be utilized for and be applicable to any data required for registration review.

IV. What is Registration Review?

EPA believes that    registration review'' would consist of the review of a pesticide to determine whether the pesticide continues to meet the statutory standard for registration under FIFRA section 3( c)( 5). During a registration review, EPA would evaluate elements of FIFRA 3( c)( 5) including the composition, labeling and other required material ( including studies and other data), risks and benefits of a pesticide, and incident data or other information relating to its use. FIFRA section 3( g) contemplates that EPA may determine whether or not a pesticide meets the statutory standard for registration in FIFRA section 3( c)( 5). If EPA determines that a pesticide no longer meets the statutory standard, it should not remain registered. In this event, EPA may need to pursue other actions such as cancellation under other statutory authority.

FIFRA section 3( g) instructs EPA to establish, by regulation, a procedure for accomplishing registration review. The goal of these regulations shall be Agency review of pesticide registrations on a 15 year cycle. EPA believes the activities that should be addressed under the procedural regulations include, but are not limited to: setting priorities for review, establishing a mechanism for setting schedules for reviewing all pesticides every 15 years, and articulating the general approach to conducting and concluding the review. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 37 of 55 FIFRA section 3( g) also instructs the Agency to rely on existing authorities for data submission, data compensation, data exemption, or cancellation of registrations. Therefore, the procedural regulations need not be concerned with procedures for acquiring new information,

assuring compensation for data developers, data exemption, or canceling a pesticide registration. Authorities and procedures for such activities already exist and FIFRA 3( g) did not require EPA to develop alterative procedures for these activities. Existing regulations such as those concerning good laboratory practice for data generation and FIFRA section 8 recordkeeping requirements would also apply. EPA has already issued regulations and guidelines under FIFRA 3( c)( 2)( A) to specify the kinds of information that are required to support a pesticide registration. EPA modifies this guidance periodically to reflect new developments in science areas such as hazard characterization and exposure assessment. Additionally, as explained in an October 29, 1998 Federal Register notice ( 63 FR 58030)

( FRL 6041 5), EPA is in the process of issuing guidance for meeting the new safety standard mandated by the FQPA. Accordingly it is not necessary to specify such information in procedural regulations issued under FIFRA section 3( g)( 1)( A).

EPA may determine that reviews accomplished under other authorities, e. g., section 408 of the FFDCA, could potentially contribute to registration reviews. In any event, EPA believes that it would not be necessary to specify procedures for these activities because authorities and procedures already exist for them.

Finally, FIFRA section 3( g)( 1)( B) stipulates that EPA retains its authority to undertake any other review of a pesticide under FIFRA. This provision means that EPA may continue to undertake any review that is authorized by FIFRA or EPA regulations such as reregistration or special review. EPA also interprets this provision to mean, among other things, that the Agency may continue its practice of requiring submission of data whenever the Agency believes that such data are needed to support the continued registration of a pesticide.

V. What are EPA's Goals for Registration Review?

EPA's ultimate goal for registration review is to ensure continued protection of human health and the environment throughout the    life'' of each pesticide's registration. To achieve this goal, EPA will periodically review all pesticide registrations to assure that they continue to meet the FIFRA statutory standard for registration based on the science, policies, and regulations current at the time of the review. EPA will conduct this review efficiently and effectively by building on existing knowledge about the pesticide. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 38 of 55 EPA will evaluate any new test data, monitoring data, and field information. EPA will consider the effects of any changes in data requirements, risk assessment methodologies and labeling policies. If the risk assessment changes for any of these reasons, EPA may need to change the regulatory requirements pertaining to the registration. In some cases, EPA may find significant new risks that were not considered when the pesticide was registered or reregistered. This could trigger further review of risks or benefits. In such cases, EPA may determine that the pesticide does not meet the statutory standard for registration under FIFRA section 3( c)( 5) and therefore should not remain registered. In other cases, EPA may find that originally it had overestimated risks and it may be possible to ease regulatory restrictions.

A. Keeping a Registration Up to Date EPA has identified several aspects involved in keeping a pesticide registration up to date. These include receipt of new data;

changes in data requirements and associated test guidelines ( or protocols); changes in risk assessment methods; new information gained through use and practical experience with a pesticide; and changes in labeling policy.

1. Availability of new data. At any time, registrants or other persons may submit new studies on a pesticide. These studies may be undertaken in response to an Agency request or upon the data generator's own initiative. FIFRA section 6( a)( 2) requires submission of certain kinds of data, as specified in 40 CFR part 159.

2. Changes in data requirements and test guidelines. From time to time, EPA changes data requirements or testing guidelines to reflect advances in the science of hazard characterization or exposure assessment. When changes are significant, EPA may require registrants to submit new testing to EPA to support registration. New testing may be necessary to evaluate an aspect of toxicity or exposure that was not previously considered, to replace particular studies that are no longer adequate as a result of advances in test design or protocols, or for many other possible reasons.

3. Changes in risk assessment methodologies. EPA continually seeks to improve its risk assessment methodologies. Currently, the Agency is reviewing a number of risk assessment methodologies as part of its implementation of the FQPA. Undoubtedly, there will be further changes as science and policy advance.

4. Use and practical experience with a pesticide. EPA evaluates whether practical experience from using a pesticide changes our understanding of the risks and benefits of the pesticide. EPA has established registrant reporting requirements for risk/ benefit information ( see 40 CFR part 159) and has a process for quickly assessing the safety implications of such information. The EPA will DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 39 of 55 also maintain incident databases, sponsor a toll free telephone service that gathers information related to pesticide incident, and obtain incident related information from poison control centers. In addition, EPA is considering the establishment of a Pesticide Field Data Plan for capturing key information about pesticide use or misuse. Under this plan, States would standardize their procedures for collecting and reporting information from State pesticide compliance and enforcement records. EPA would analyze information from thousands of federally funded investigations and inspections for trends and patterns of problems related to pesticide use or misuse.

EPA may eventually be able to use these analyses to shape or confirm regulatory decisions.

5. Changes in labeling policy. From time to time, EPA publishes guidance on the format and content of pesticide product labels.

EPA would, as part of registration review, evaluate existing labeling to determine whether it needs to be changed to reflect current policies and regulations pertaining to matters such as restrictions in use, requirements for protective clothing, and other precautionary label language associated with reducing exposure and environmental risk. Additionally, EPA may assess alternative ways to communicate risk management information to pesticide users.

B. Incorporate Lessons Learned from Reregistration FIFRA section 4, established by the 1988 amendments to FIFRA, instructed EPA to review the human health and environmental effects of all pesticide active ingredients originally registered before November 1, 1984, in order to determine whether they are eligible for reregistration. To be    eligible,'' an older pesticide must have a substantially complete data base, and must be found not to cause unreasonable risks to man or the environment when used in accordance with its approved labeling. As of August 1, 1999, of 612 reregistration cases ( composed of a pesticide active ingredient or group of related pesticide active ingredients), 415 cases have completed reregistration ( including 231 cases where registrants requested voluntary cancellation of all registrations of the pesticide).

That leaves 197 cases awaiting reregistration decisions.

The Agency's experience with the reregistration program offers insights into the construction of an efficient registration review program. Chief among these are the importance of effective organization of large quantities of data for review, the efficient conduct of the review of these data, and the need for flexibility in defining the scope of the review for each pesticide. In addition, public participation at critical junctures helps ensure that the Agency develops practical risk mitigation measures where needed, and that stakeholders better understand the bases for decisions. To the extent possible, EPA plans to:

1. Review first those pesticide registrations for which EPA believes registration review will produce the greatest human health and environmental benefits. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 40 of 55 2. Establish methods and approaches for ensuring that it has all necessary data to make good regulatory decisions on schedule.

3. Standardize data submission by adopting guidance for data submitters such as the guidance developed by the Organization for Economic Cooperation and Development ( OECD). Standard submission formats could expedite EPA's review and promote sharing the work of pesticide evaluation with other governments.

4. Review related pesticides simultaneously. This would allow effective use of review resources and promote more practical and comprehensive risk mitigation measures.

5. Tailor the level and nature of the review to the specific facts and concerns of each case.

6. Build on the results of prior review efforts such as reregistration and tolerance reassessment and on updates such as evaluations of applications for registration of new uses. EPA would avoid re reviewing data to the fullest extent possible.

7. Adopt, or use to the extent practicable, state and foreign governments' reviews of pesticide studies. For several years, EPA has been developing experience in sharing the work of pesticide evaluation with North American Free Trade Agreement ( NAFTA)

partners. We intend to build on this experience by developing work share relationships with additional countries through OECD initiatives.

8. Standardize its approach to documenting data reviews by adapting OECD guidance for development of government monographs.

Standard formats would promote sharing work between countries and can enhance understanding of EPA reviews.

9. Seek stakeholder views and input through an open process that offers the public and the regulated community clearly defined,

time limited, opportunities for input to various aspects of the review process for an individual pesticide.

VI. EPA's Initial Thinking on How Registration Review Might Operate EPA has developed an initial concept for registration review, which is presented in this document. It is intended to stimulate thought about and comment on all aspects of developing procedures to implement registration review. EPA believes that the conceptual model presented in this Unit meets the statutory requirements and Agency goals and objectives for the registration review program for all pesticides. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 41 of 55 EPA intends for registration review to be implemented within the next 5 years. EPA expects that the reregistration program will be completed by then, and the registration review program will become the Agency's primary review program for all pesticide registrations. We anticipate that the registration review program will incorporate the application of the FQPA safety standard and, as appropriate, the use of reviews conducted under other authorities and programs such as reregistration, tolerance assessment and reassessment, and our proposed endocrine disrupter screening program. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 42 of 55 VII. EPA's Initial Conceptual Model This conceptual model has five steps. EPA expects that each pesticide would start registration review at step one and proceed stepwise through the process. At key points in the conceptual model, EPA may decide to omit one or more steps in the registration review of a pesticide. Registrants who are responsible for generating generic data on an active ingredient would likely be involved in all five steps of the process described in this preliminary model. Registrants who are generally not responsible for generating generic data would likely participate in fewer steps.

A. Step 1: Plan and Schedule Candidates for Review The first step in EPA's conceptual model of a Registration Review Program would be planning and scheduling of pesticides for review. This step might consist of two tasks: ( 1) Assembling the historic record; and ( 2) selecting and prioritizing candidates.

EPA would assemble the historic record for a pesticide, including prior reviews and associated documentation ( for example, a Registration Eligibility Document ( RED) if the pesticide had been evaluated in the reregistration program); use and enforcement history, including information on compliance with Good Laboratory Practice regulations and other FIFRA requirements. The selection and priority of candidates for review would depend on a number of factors such as: ( 1) The relative importance of benefits to human health and the environment which might accrue by completing the review of a particular pesticide; ( 2) whether the pesticide is part of a class or group that should be considered together; ( 3) state of the data base relative to current guideline requirements; ( 4) length of time since last comprehensive review; ( 5) incident data, existence of information required to be submitted under FIFRA section 6( a)( 2); ( 6) any compliance issues; and ( 7) the pesticide's status in the reregistration and tolerance reassessment programs.

B. Step 2: Publish Schedule, Define Initial Scope and Level of Review, and Issue Needed Data Call Ins and Requests for Applications for Scheduled Candidates The second step would also consist of two principle tasks: ( 1) publication in the Federal Register of the list of review candidates and the tentative schedule for review; and ( 2) case specific determinations of the level and scope of review and the development of needed data call in notices.

EPA believes that the schedule for registration review candidates should be announced at least 5 years in advance of the review to provide time for generating and submitting new data. In addition to publishing a Federal Register notice listing the registration review DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 43 of 55 candidates, EPA could publish the listing in the Code of Federal Regulations ( CFR), make the list available as part of a registration review docket, and/ or maintain a list electronically on the OPP Internet Home Page.

In making case specific determinations about the level and scope of review appropriate to any given pesticide, EPA might conduct a preliminary analysis of the completeness of the data base; the potential significance of any real world monitoring and field data collected since the last regulatory action; the need to revise the risk assessment using updated methodologies; and any applicable labeling policy changes. This analysis would provide an initial characterization of the level and type of risks possibly posed by the pesticide, critical data needs, and an early assessment of the appropriate level and scope of review ( e. g., whether tolerances should be reassessed). EPA might then publish a pesticide specific notice in the Federal Register describing the preliminary analysis, the initial assessment of data needs, and the proposed level and scope of review. EPA would invite comment on these issues. After analysis of comments received, EPA would issue notices to registrants to call in any needed data and establish a deadline for submitting applications for registration review.

EPA expects that the deadline set for the submission of an application for registration review will depend in large part on the scope,

level, and focus of registration review for the pesticide and the type of data that are being called in. The case specific determination of the level and scope of review may show that the pesticide meets the requirements of FIFRA section 3( c)( 5) and that no additional data or review are needed. In such cases, EPA would issue a preliminary determination, as described in Step 4 below.

C. Step 3: Registrants Submit Applications for Review The third step would be the registrant's submission of an application for registration review. EPA envisions that the registrant's application for registration review would contain all required data and all needed use and usage information and any relevant data reviews conducted by regulatory officials in the states or other countries. The format for the submission could be modeled after the OECD data submission guidelines noted earlier in this document. The application might also include the registrant's opinion of which hazard, exposure or risk assessments should be updated ( possibly including an evaluation of monitoring data and their impact on the assessment), the registrant's assessment of the pesticide's risks, and the registrant's risk mitigation proposals, including proposed label changes. Finally, if the registrant is considering changes in the pesticide registration that would result in changes in tolerances for the pesticide, a tolerance petition might be needed, along with the appropriate tolerance petition processing fees. The tolerance petition processing fees would be based on the new tolerance fee schedule, which EPA proposed to establish as required by FQPA ( 64 FR 31039, June 9, 1999) ( FRL 6028 2). DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 44 of 55 EPA would screen the application for completeness, identify issues and questions, and decide whether any issues or questions warrant public discussion before proceeding with the review. EPA does not anticipate routinely soliciting public input at this stage in the process and EPA expects that most pesticides will move to Step 4 without a public meeting. However, in those cases where, for example, the registrant's application potentially raises significant risk related issues or where the registrant is proposing risk mitigation measures which would potentially be of interest to certain stakeholders  such as protective clothing requirements,

establishment of buffer zones, or voluntary cancellation of minor uses, EPA would expect to hold a public meeting before progressing to Step 4.

D. Step 4: EPA Conducts the Review and Issues It for Public Comment The fourth step would be to conduct the registration review. This review could include evaluation of all new data and data reviews done by other regulatory officials, review and evaluation of the registrant's risk assessments and public comments ( including data)

submitted in Step 3, revision of the Agency's risk assessments ( where necessary), review of pesticide labeling for conformance to current policy, and development of proposed risk mitigation measures. At this step in the process, EPA envisions making a preliminary determination whether the pesticide continues to meet the statutory standard for registration under FIFRA section 3( c)( 5).

EPA would announce the availability of the preliminary determination for public review and comment.

If EPA preliminarily determines that the pesticide no longer meets the standard for registration under FIFRA section 3( c)( 5), EPA would immediately collect and review any benefits information which it believed it needed. If it appears that there would be a significant change in the existing registration, EPA would seek public input on proposed risk management action before taking such action.

E. Step 5: Consider Comments, Issue Final Review, and Review Registrant's Proposed Labels In the final step EPA would evaluate public comments on its updated risk assessment and proposed regulatory position and issue its final review. EPA would request submission of product specific data or new labels if the registration review shows that they are needed. In cases where EPA decides that the registration appears to no longer meet the requirements for registration under FIFRA section 3( c)( 5), EPA would undertake appropriate regulatory action, including, if necessary, cancellation action under FIFRA section 6.

VIII. Issues for Public Comment DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 45 of 55 Although EPA is soliciting your comments on all aspects of the discussion presented in this document regarding registration review, EPA is particularly interested in receiving your comments on the following topics. You may submit comments on any other issue related to registration review, including your own views on what registration review procedures should look like.

1. EPA's interpretation of the requirements in FIFRA section 3( g). Do you agree with EPA's interpretation of the statutory mandate for registration review as set forth in Unit IV? If not, why? How would you interpret FIFRA section 3( g)?

2. Interpretation of    Review of a Pesticide's Registration every 15 years.'' EPA recognizes that there may be various interpretations of    review of a pesticide's registration every 15 years.'' This term could be interpreted to mean that EPA would complete a registration review of each pesticide within 15 years of the pesticide's registration or reregistration. This term could also be interpreted to mean that the Agency would complete registration reviews of all pesticides within a 15 year period that could begin when EPA's procedural regulations for registration review go into effect.

3. Commencement of a 15 year registration review cycle. The Agency believes that the effective date of the procedural regulations for registration review could be a possible starting date of the 15 year period for completing registration review, but recognizes that another date or series of dates may also be possible starting dates for registration review. Do you have any suggestions for designing a system of staggered scheduling for registration reviews?

4. Goals and objectives for the registration review program. Do you agree with the goals that EPA has identified? What changes do you suggest?

5. Relationship of registration review to other mandates. A key design issue is how registration review fits in with other activities such as the implementation of the new FQPA safety standard,

reregistration, registration of new uses, and tolerance assessment or reassessment, and endocrine disrupter screening and testing. In what way could EPA integrate these activities to promote the efficiency of registration review?

6. Non conventional pesticides. Do the Agency's proposed goals, objectives and procedures for registration review work for all pesticides, including non conventional pesticides such as antimicrobial or biological pesticides? How should the Agency's concepts be modified to accommodate any special issues pertaining to the registration review of non conventional pesticides? DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 46 of 55 7. Criteria for setting priorities and scheduling compounds for review. In selecting candidates for Registration Review, should the relative risk, length of time since its last review, relationship to a high priority initiative ( for example, EPA's current initiative on persistent bioaccumulative toxics), or other similar programmatic activities ( e. g., tolerance reassessment schedule) be considered?

What additional factors should the agency consider in selecting and prioritizing pesticides for Registration Review?

8. Process for announcing schedules for registration review. Should the agency announce its registration review scheduling priority in the Federal Register? The Agency anticipates announcing tentative schedules 5 years in advance of the initiation of the review.

Because review priorities or time estimates for preparing for a review may change after a review schedule has been announced, should EPA publish updated schedules, and if so, how frequently?

9. Scope and depth of registration review. Should all pesticides undergo the same level of review or should the review be tailored to the level of risk posed, exposure potential, severity of hazard, level of benefits, degree of uncertainty, length of time since its last review, completeness of database and related factors?

10. Submission of applications for registration review by registrants. The Agency is considering requiring a registrant to submit an application for registration review of its pesticides. The application could follow a standard format and content and include any required data, risk mitigation proposal if applicable, information on use and usage and related information. Registrants may also include proposed risk assessments as part of their submissions. Do you believe this requirement will be cost effective and contribute to the overall efficiency of the registration review program? Should EPA require, encourage, or discourage the preparation of proposed risk assessments by registrants?

11. Potential penalties for submission of incomplete applications. If an application for registration review is    material required to be submitted,'' the product registration would be subject to cancellation if the registrant fails to comply with the requirement. If a registrant fails to submit required data as specified in the data call in notice requiring the data, the product registration would be subject to suspension. What could the Agency do to promote compliance with a requirement to submit a registration review application? If submission of an application for registration review were not mandatory, what should the Agency do if a registrant fails to submit a registration review application or submits an incomplete application?

12. Incentives and opportunities for registrant participation in registration review. EPA believes that the public may benefit when a registrant takes the initiative to identify and provide data needed for refining a risk assessment. What can be done to encourage and promote voluntary compliance and registrants taking the initiative? DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 47 of 55 13. Maximize work sharing opportunities. In order to avoid duplication of effort, EPA wishes to use existing reviews wherever possible, provided that these reviews are based on current scientific standards. In addition to its own recent reviews, EPA could use data reviews prepared by state or foreign governments that have participated in harmonization efforts. Are there any reasons why harmonized data reviews should not be used in registration review?

14. Public participation. EPA envisions public participation at several critical junctures of the registration review process. How can the public have access to sufficient information to participate meaningfully? At which junctures in the process would public input be most valuable? Is a public meeting on the registrant's data and associated analyses a good way to involve stakeholders in the registration review process? If not, how can the agency best involve stakeholders? Would making information available to the public substantially affect any stakeholder's interests? How can efficiencies be achieved?

15. Role of the Internet in involving outside stakeholders. EPA intends to publish notices in the Federal Register and maintain a docket for registration review actions, but wants to expand its outreach efforts. Is the Internet an effective supplement to the published notice and is it an equitable way of meaningfully involving stakeholders in the registration review program? What other opportunities using electronic and Internet technology should the Agency consider?

16. Participation of small entities in the rulemaking process. What can be done to ensure that the rulemaking process is accessible to small entities and that the Agency identifies issues of concern to small entities regarding procedures for registration review?

IX. Do Any of the Regulatory Assessment Requirements Apply to this Action?

The Office of Management and Budget ( OMB) has determined that this advanced notice of proposed rulemaking is not a    significant regulatory action'' subject to review by OMB under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4,

1993). Nevertheless, the Agency provided OMB with an opportunity to review a draft of this advanced notice of proposed rulemaking, and did not receive any comments that resulted in changes to this document.

This advanced notice of proposed rulemaking does not impose any requirements. Instead, it seeks comments and suggestions on possible approaches that the Agency should consider in developing a procedural rulemaking to implement the registration review requirements contained DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 48 of 55 in FIFRA section 3( g). As such, the various other regulatory assessment requirements that apply when an agency imposes requirements do not apply to this advance notice of proposed rulemaking.

As a part of your comments on this document, you may include any comments or information that you have regarding these requirements. In particular, any comments or information that would facilitate the Agency's assessment of the potential impact of a procedural rule on small entities pursuant to the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.); the Agency's consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104 113, section 12( d) ( 15 U. S. C. 272 note); and the Agency's consideration of environmental health or safety effects on children pursuant to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). The Agency will consider such comments during the development of the procedural rulemaking as it takes appropriate steps to address any applicable requirements.

List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping.

Dated: April 19, 2000.

Carol M. Browner,

Administrator.

[ FR Doc. 00 10433 Filed 4 25 00; 8: 45 am]

BILLING CODE 6560 50 F DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 49 of 55 ATTACHMENT G Estimating the Potential Paperwork Burden and Cost for DCIs The following is 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. In general, the ICRs provided an estimate of the potential paperwork burden and costs related to a typical or general DCI based on sample DCIs derived from previously issued DCIs. Prior to issuing a specific DCI, pursuant to the terms of clearance for the ICRs, EPA calculated the paperwork burden and costs related to the specific DCI using the general method described here.

The estimates represent the burden associated with completing multi year studies and submitting the study results to EPA in response to a DCI. A portion of the total cost for a study conducted in response to a DCI may be attributed to the paperwork related requirements that EPA imposes on the pesticide registrants. The potential number of DCIs that might be issued in any year, the type of data requested, and the number of respondents potentially affected by a particular DCI vary, and remain unknown until the Agency identifies the need for the information. To help estimate potential burden under these circumstances, EPA reviewed previously issued DCIs to develop sample DCIs that are used to generate burden and cost estimates for the anticipated testing that would be requested by EPA, from which EPA also calculates the paperwork burden and costs.

1. What activities are included in the estimated paperwork burden and cost for DCIs?

Under the Paperwork Reduction Act ( PRA) , 44 USC 3501 et seq., and the implementing regulations at 5 CFR 1320 et seq.,

" 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. This typically includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

In the case of DCIs, a responding registrant may be required to engage in one or more of the following paperwork related activities: DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 50 of 55 1) Read DCI & test requirements ( includes review of records for previously unavailable data & requesting exemptions or waivers)

2) Discuss test and protocol with Agency, submit exemption/ waiver request 3) Plan activities necessary to respond to DCI 4) Create & gather information ( conduct tests)

5) Process, compile, review information for accuracy 6) Complete written forms 7) Submit information to EPA 8) Store, file, or maintain information OPP 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. Although the Agency is responsible for identifying available data, the registrant may have data that is not generally available. In such a case, the registrant may respond to a DCI by simply submitting such data to EPA. In addition, 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. For purposes of estimating the potential paperwork burden and costs, EPA assumes that registrants do not have any such data, and that registrants will not request any waivers. Since such activities are likely to be few, the estimates provided will cover these activities and will generally result in an overestimate of the total burden and costs if these activities occur for any specific DCI.

2. How did EPA estimate the potential Respondent paperwork burden?

In general, the estimates for the total burden and costs associated with a Pesticide Registrant responding to a DCI are derived from the total costs for doing the tests that might be required based on the sample DCIs. The average potential test costs were derived using cost information for individual DCIs previously issued by the Agency. Based on the cost information available, the Agency calculates an average total test cost for the sample DCIs. These costs then form the basis for calculating the labor costs from which the burden hours are derived.

Although the Agency also anticipates that multiple respondents for a given chemical will often establish consortiums to share in the burden of generating the data and that the burden and cost will be distributed proportionately across the participating members.

However, for purposes of this ICR, EPA estimates are on a per Registrant basis, without considering this possibility for sharing the burden. The Agency did not make any adjustments to consider reductions related to such cost sharing. DRAFT FOR PUBLIC COMMENT April 12, 2004 Page 51 of 55 The total annual respondent paperwork burden for this ICR is estimated to be 64,699 hours. The total annual burden hours estimate is for no more than 61 responses ( 1 for Special Review and 60 for Registration Review) to comply with planned data call ins ( DCIs). The average annual paperwork burden is estimated to be 919 hours ( 919 hours per response x 1 response per year) for Special Review and 63,780 hours ( 1,063 hours per response x 60 responses per year) for Registration Review. The 919 hours per Special Review response and 1,063 hours per Registration Review response are the same as given in the previous ICR. Tables 1A and 1B present the expected labor mix required and breakdown of the per respondent collection activities based on the Special Review DCIs, taken from the existing ICR. An overview of these respondent burden hour estimates is presented in Table 3, along with cost estimates. The scope of the existing ICR is focused primarily on the anticipated burden necessary to comply with Agency DCIs in support of the Special Review Program to collect and evaluate information regarding pesticides suspected of presenting risks to human health or the environment and the Registration Program to collect and evaluate information regarding review of a pesticide's registration on a 15 year cycle.

Two types of burdens on respondents were considered in deriving the burden estimates for the existing ICR: Administrative Burden and Technical Burden. The respondents' Administrative Burden is defined as the time spent communicating and working with the Agency throughout the Special Review process to develop and agree upon data requirements such as the protocol, the field site, and data presentations. In addition, the Administrative Burden includes the time for registrants to draft and summarize the results of studies completed by an individual respondent or by a consortium of respondents for one chemical. The Administrative Burden is also intended to include time spent overseeing any contractor activities employed by the respondent. The Technical Burden represents the labor needed to actually derive the data, which involves designing the test, performing it, analyzing and compiling test data and summarizing the results.

Estimates for the total hours associated with both types of respondent burdens are derived from the total test costs. The Agency anticipates that multiple respondents for a given chemical will establish consortiums to share in the burden of generating the data and that the burden and cost will be distributed proportionately across the participating members.

To derive the Administrative Burden, the Agency estimated the amount of administrative labor cost as a percentage of the total test costs. The Agency assumed that respondents would expend approximately two percent of the total cost for Administrative DRAFT FOR PUBLIC COMMENT April 12, 2004 1This percentage represents an estimate obtained from expert opinion, industry sources, and proprietary data.

2This estimate was derived from a survey of the test data cost estimates by DPRA, Inc.; subcontract with W. R. Landis Associates,

Inc. 3The hourly rates are based on EPA's 1993 RIA supporting the proposed plant pesticide rule ( published in the Federal Register, of March 28, 1994, indexed to 1996 dollars.

4 Same as Footnote 2. Page 52 of 55 Burden. 1 The Agency assumed that the value of this time is divided proportionally among management ( 20%), technical staff ( 65%)

and clerical ( 15%). 2 The value of labor per hour for management, technical, and clerical is $ 130, $ 88, and $ 40, respectively. 3 The hourly rate includes overhead and benefits. The combination of the proportional distribution of cost across the labor mix and the hourly rate for the labor categories are then used to determine the total burden hours from the total labor cost estimate.

To derive the Technical Burden, the Agency assumes that one third of the total test cost represents labor. 4 Management,

technical, and clerical comprise the labor staff. The same proportional labor rate approximations and hourly rates are used to calculate the distribution of hours across the labor mix from the total labor cost estimate. The technical burden related to the paperwork activities, i. e., the labor burden, is included in the burden and cost estimates for this ICR. Not included is the portion of the test costs associated with the non paperwork related activities that anyone would typically undertake as part of conducting any study, and which are not related to any requirement imposed by EPA as part of the DC, e. g., daily care and feeding of test animals,

cleaning of cages, etc.

3. Estimating the Respondent Paperwork Cost The total annual respondent paperwork cost for this ICR is estimated to be $ 5,851,894. Over a three year ICR approval period for this ICR, the total respondent cost is estimated to be $ 17,555,682. Tables 1A and 1B present the expected labor mix required and a breakdown of the collection activities per respondent as provided in the existing ICR. An overview of these cost estimates is presented in Table 3, along with burden hour estimates.

Tables 1A and 1B show that for Special Review and Registration Review, the distributions of respondent burden hours of management, technical, and clerical sources among the various collection activities are the same as given in the previous ICR. DRAFT FOR PUBLIC COMMENT April 12, 2004 5Same as Footnote 1.

6Same as Footnote 2.

7Ibid. 8Same as Footnote 3. Page 53 of 55 Therefore, the respondent burden totals of 919 hours per Special Review response and 1,063 hours per Registration Review response are also the same as that found in the previous ICR. Using these burden hours with updated labor rates, the Agency derived the cost burdens for a Special Review response and a Registration Review response in this ICR.