# 70 FR 40251: Pesticides; Procedural Regulations for Registration Review

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_05-13776

## Section

- **Citation:** 70 FR 40251
- **Heading:** Pesticides; Procedural Regulations for Registration Review
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 70 / 70 FR 40251

## Text

ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 155 [OPP-2004-0404; FRL-7718-4] RIN 2070-AD29 Pesticides; Procedural Regulations for Registration Review AGENCY:
Environmental Protection Agency (EPA).

ACTION:
Proposed rule.

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 registration. FIFRA section 3(g) specifies that EPA establish procedural regulations for conducting registration review and the goal of the regulations shall be Agency review of pesticide registrations on a 15-year cycle. This proposal describes the Agency's proposed approach to the registration review program. The proposed regulation is intended to ensure continued review of pesticides using procedures that provide for public participation and transparency in an efficient manner.

DATES:
Comments must be received on or before October 11, 2005.

ADDRESSES:
Submit your comments, identified by docket ID number OPP-2004-0404, by one of the following methods:
• Federal eRulemaking Portal : http://www.regulations.gov/ . Follow the on-line instructions for submitting comments.
• Agency Website : http://www.epa.gov/edocket/ . EDOCKET, EPA's electronic public docket and comment system, is EPA's preferred method for receiving comments. Follow the on-line instructions for submitting comments.
• E-mail : Comments may be sent by e-mail to opp-docket@epa.gov , Attention: Docket ID Number OPP-2004-0404.
• Mail : Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0404.
• Hand Delivery : Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S
rmation and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001, Attention: Docket ID Number OPP-2004-0404.
• Hand Delivery : Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID Number OPP-2004-0404. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.
Instructions : Direct your comments to docket ID number OPP-2004-0404. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.epa.gov/edocket/ , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through EDOCKET, regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov websites are “anonymous access” systems, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through EDOCKET or regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment
06C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 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 this action if you hold pesticide registrations. Pesticide users or other persons interested in the regulation of the sale, distribution, or use of pesticides may also be interested in this proposed procedural regulation. As such, the Agency is soliciting comments from the public in general. Potentially affected entities may include, but are not limited to:
• Producers of pesticide products (NAICS code 32532)
• Producers of antifoulant paints (NAICS code 32551)
• Producers of antimicrobial pesticides (NAICS code 32561)
• Producers of nitrogen stablilizer products (NAICS code 32531)
• Producers of wood preservatives (NAICS code 32519)
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in proposed § 155.40 of the regulatory text. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .
B
rmining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in proposed § 155.40 of the regulatory text. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .
B. How Can I Access Electronic Copies of this Document and Other Related Information?
In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 155 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI . Do not submit this information to EPA through EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments . When submitting comments, remember to:
i. Identify the rulemaking by docket ID number and other identifying information (subject heading, Federal Register date, and page number).
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii
. Tips for preparing your comments . When submitting comments, remember to:
i. Identify the rulemaking by docket ID number and other identifying information (subject heading, Federal Register date, and page number).
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns, and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
II. Purpose of the Proposal
With this Proposal, the Agency presents its proposed procedural regulations for the registration review program. The Agency describes:
• Statutory authority and legislative history.
• The Agency's goals for the registration review program.
• Evaluating approaches to registration review.
• Factors considered in designing the registration review program.
• Design options considered for the registration review program.
• Testing the proposed registration review decision process.
• Proposed procedures for registration review.
• Relationship of registration review to other FIFRA activities.
• Phase-in of the registration review program.
The Agency also presents the results of reviews required by statutes and other required analyses. III. Background
A. Statutory Authority
1. EPA's authority to license pesticides
the proposed registration review decision process.
• Proposed procedures for registration review.
• Relationship of registration review to other FIFRA activities.
• Phase-in of the registration review program.
The Agency also presents the results of reviews required by statutes and other required analyses. III. Background
A. Statutory Authority
1. EPA's authority to license pesticides . FIFRA section 3(a) generally requires a person to register a pesticide product with EPA before the pesticide product may be lawfully distributed or sold in the U.S. A pesticide registration is a license that allows a pesticide product to be distributed or sold for specific uses under specified terms and conditions. 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; and
(D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.
FIFRA section 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 burden to demonstrate that a pesticide product satisfies the criteria for registration is at all times on the proponents of initial or continued registration. ( Industrial Union Dept . v. American Petroleum Institute , 448 U.S. 607, 653 n. 61 (1980); Environmental Defense Fund v
de in or on any food inconsistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act.
The burden to demonstrate that a pesticide product satisfies the criteria for registration is at all times on the proponents of initial or continued registration. ( Industrial Union Dept . v. American Petroleum Institute , 448 U.S. 607, 653 n. 61 (1980); Environmental Defense Fund v. Environmental Protection Agency , 510 F.2d 1292, 1297, 1302 (D.C. Cir. 1975).
2. EPA's authority for registration review . The Food Quality Protection Act (FQPA) of 1996 amended FIFRA to add, among other things, section 3(g), “REGISTRATION REVIEW,” as follows:
(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. 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.
B. Legislative History
The Agency examined the legislative history for FIFRA section 3(g) to further its understanding of Congressional intent for this program. A discussion of registration review appears in House Committee Report 104-669, Part One (104th Congress, House of Representatives, Committee on Agriculture, July 11, 1996 to accompany H.R
e to any data required for registration review.
B. Legislative History
The Agency examined the legislative history for FIFRA section 3(g) to further its understanding of Congressional intent for this program. A discussion of registration review appears in House Committee Report 104-669, Part One (104th Congress, House of Representatives, Committee on Agriculture, July 11, 1996 to accompany H.R. 1627) which states:
The bill requires the Administrator of EPA to periodically review the registration of each pesticide. It has become apparent that the rapid development of science and the subsequent application of that knowledge in how it impacts human health and the environment is not only important but continuing to evolve. The goal of establishing ongoing scientific look-back procedures will enable the important process of registration review to be considered every 15 years during a product's market life. This creates a continuous reregistration process that both the Agency and the registrant can plan for, rather than creating the need for another complete, resource-intensive reregistration of all pesticide products at one time in the future.
IV. Agency's Goals for the Registration Review Program
A. Review Each Pesticide Every 15 Years to Assure That Each Registration is Based on Current Scientific Knowledge Regarding the Pesticide's Effects on Human Health and the Environment
The science underlying the risk-benefit assessments of pesticides is continually evolving. Research may show hazard endpoints that may not be observable with available methods. Accordingly, the Agency might adopt new methods to assess these endpoints. Models used to estimate exposures may become more accurate as the Agency refines these methods in light of additional data. Risk assessment procedures may be revised to reflect new knowledge regarding mechanism of toxicity, pharmaco-dynamics or pharmaco-kinetics
d endpoints that may not be observable with available methods. Accordingly, the Agency might adopt new methods to assess these endpoints. Models used to estimate exposures may become more accurate as the Agency refines these methods in light of additional data. Risk assessment procedures may be revised to reflect new knowledge regarding mechanism of toxicity, pharmaco-dynamics or pharmaco-kinetics. If the Agency periodically reviews the information and risk assessments for each pesticide consistent with new scientific developments, it can better ensure continued protection of human health and the environment.
B. Develop a Credible and Manageable Program to Review the Registration of All Pesticides Every 15 Years
Using a credible and manageable process, the Agency completes its review of approximately 50 chemical cases a year in the near term.
Credible--using an open and transparent process and basing its findings on sound science, the Agency reaches a regulatory decision for each pesticide in the chemical case.
Manageable--using an efficient and flexible process, the Agency produces 50 decisions per year.
C. Attributes of a Credible Program for Conducting Registration Review
1. Constructive stakeholder and public participation . To accomplish this goal, the Agency should have a reliable schedule so stakeholders and the public can decide how best to participate in the review process and to plan their own level of involvement. The Agency should make information available to stakeholders and the public early in the process, i.e., before the Agency has begun its registration review analysis. The Agency should provide opportunities for stakeholder and the public participation at several stages in the process generally at key decision points. For example, the Agency will ask for comment on draft risk assessments and proposed risk mitigation measures. Finally, broad public participation will help the Agency develop effective strategies for communicating pesticide risk to the public.
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The Agency should provide opportunities for stakeholder and the public participation at several stages in the process generally at key decision points. For example, the Agency will ask for comment on draft risk assessments and proposed risk mitigation measures. Finally, broad public participation will help the Agency develop effective strategies for communicating pesticide risk to the public.
2. Transparent decisions based on sound science . The Agency has published the standards that it uses for characterizing pesticide risk by establishing data requirements and issuing generic guidance regarding its data requirements. Data requirements are codified in 40 CFR part 158. The Agency has also issued guidelines for conducting the tests required in part 158. On a case-by-case basis, the Agency may require data not required under 40 CFR part 158.
It is the Agency's practice to publish generic guidance explaining risk assessment methods. The Agency expects to continue this practice in the future.
The Agency will continue to make decisions using its published standards, policy guidance, and risk assessment methods. The Agency will explain its reasoning when it makes exceptions.
3. Risk management decisions that protect human health and the environment . The Agency intends to use States' and Tribes' field, compliance monitoring, and enforcement experience to assess the efficacy and practicality of risk mitigation measures previously adopted to address a risk of concern. When new risks are identified, the Agency will adopt appropriate, effective, and enforceable risk mitigation measures. The Agency's registration review decisions will describe risk mitigation requirements, including time frames and procedures for assuring compliance, among other things.
4. Timely implementation of risk reduction measures . Pesticide product labels communicate and put into effect risk mitigation decisions that might be made in a pesticide's registration review
nforceable risk mitigation measures. The Agency's registration review decisions will describe risk mitigation requirements, including time frames and procedures for assuring compliance, among other things.
4. Timely implementation of risk reduction measures . Pesticide product labels communicate and put into effect risk mitigation decisions that might be made in a pesticide's registration review. In order to accomplish the Agency's goals of protecting human health and the environment, it is essential that registration review decisions be implemented as soon as practicable. The Agency intends to take prompt action to assure compliance with such requirements. Such actions might include tracking submission and initiating regulatory or enforcement action for failure to comply with requirements.
Because the pesticide product label is the primary means to communicate the safe and legal uses of any pesticide product, the Agency also intends to reduce the lag time between label approval and the commercial availability of products with new labels. The Agency plans to continue to work with stakeholders to improve distribution of updated labels to users.
5. Accountability . Registration review decisions should be documented, promptly made available for public review, and remain accessible for future reference. Schedules should be publicly available and updated regularly. The Agency should provide timely and accurate reports on the progress of individual registration reviews and of the registration review process.
6. Quality assurance and process improvements . The Agency expects to maintain the quality of its work products. The Agency expects to periodically evaluate its decision processes to improve, for example, the process used to decide the scope and depth of a pesticide's registration review. The Agency expects to evaluate the program to identify vulnerabilities in the registration review process.
7. Meaningful environmental outcomes
rovements . The Agency expects to maintain the quality of its work products. The Agency expects to periodically evaluate its decision processes to improve, for example, the process used to decide the scope and depth of a pesticide's registration review. The Agency expects to evaluate the program to identify vulnerabilities in the registration review process.
7. Meaningful environmental outcomes . Under the Government Performance and Results Act, the Agency is required to measure the effectiveness of programs such as the registration review program. To meet this requirement, the Agency will develop measures for assessing the environmental outcomes of the registration review program.
D. Attributes of a Manageable Process for Conducting Registration Review
1. Promote process efficiencies by applying the knowledge gained through experience with other programs . For example, in such programs as the reduced-risk pesticide program and the tolerance reassessment program for inert ingredients and other chemicals with low toxicity, the Agency learned to gauge the scope and depth of a pesticide chemical's review. This knowledge should be applied in the registration review process to help the Agency accurately and reliably ascertain which pesticides need intensive review.
2. Promote process efficiencies through harmonization and work-sharing with other authorities . The Agency may also be able to achieve efficiencies by harmonizing its data requirements and risk assessment methods with those used by foreign governments, international bodies, or State agencies. The Agency is involved in cooperative work with the Organization for Economic Cooperation and Development (OECD), an intergovernmental organization consisting of 30 industrialized countries in Europe, North America, Asia, and the Pacific, to harmonize pesticide data requirements, focus test guidelines on pesticide regulatory needs, and harmonize industry data submissions and governments' data review formats and content
in cooperative work with the Organization for Economic Cooperation and Development (OECD), an intergovernmental organization consisting of 30 industrialized countries in Europe, North America, Asia, and the Pacific, to harmonize pesticide data requirements, focus test guidelines on pesticide regulatory needs, and harmonize industry data submissions and governments' data review formats and content. The OECD's Vision http://www.epa.gov/oppfead1/international/harmonization.htm .
The Agency may be able to leverage its resources through other work-sharing with its State or international partners. The Agency works with its counterparts in Canada and Mexico under the North American Free Trade Agreement (NAFTA) in the NAFTA Technical Working Group on Pesticides.
Additionally, EPA and the California Department of Pesticide Regulations began in 1999 a workshare program for reviewing residue field studies and assessing dietary exposure to support minor use actions and FIFRA section 18 actions which are of interest to California agriculture. This joint program has benefitted the Federal and State regulatory agencies by shortening the processing time of key pesticide registrations.
3. Promote efficiencies through improvements in information management systems . One of the Agency's primary objective is to assemble, develop, and manage the documents needed to conduct the registration review of a pesticide. The objectives are easy access by EPA staff and availability for public review. Agency staff would have electronic access to documents that they will examine during a registration review. The public would be able to access the documents by means of the EDOCKET.
V. Evaluating Approaches to Registration Review
This unit describes the information the Agency gathered and evaluated in developing possible approaches to registration review. First, the Agency evaluated its current programs for assessing the safety of existing pesticides to see whether lessons learned from those programs would apply to registration review
he documents by means of the EDOCKET.
V. Evaluating Approaches to Registration Review
This unit describes the information the Agency gathered and evaluated in developing possible approaches to registration review. First, the Agency evaluated its current programs for assessing the safety of existing pesticides to see whether lessons learned from those programs would apply to registration review. Secondly, the Agency published an Advance Notice of Proposed Rulemaking (ANRPM) (65 FR 24585, April 26, 2000) (FRL-6488-9) to solicit public input on its preliminary interpretation of the statutory requirements and on its initial concept of registration review. In addition, the Agency consulted a stakeholder group regarding the design and implementation of the registration review program. Finally, the Agency conducted a feasibility study to test the decision process that it developed with the advice of the stakeholder group. This feasibility study also provided information the Agency used to estimate the cost of the registration review program to both the regulated community and EPA.
A. Evaluate Experience Gained from Reregistration and Tolerance Reassessment Programs
The registration review program is a brand new program to replace the tolerance reassessment program mandated by section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) and the rereregistration program mandated by FIFRA section 4. These programs will be completed in 2006 and 2008, respectively.
The 1988 amendments to FIFRA required the Agency to reregister all pesticides registered before November 1984, prescribed procedures, and established deadlines for accomplishing various activities. In contrast to the 1988 legislation, the 1996 amendment to FIFRA requiring registration review does not specify procedures or deadlines. Nonetheless, the Agency evaluated the reregistration program to see whether any of the procedures used in reregistration could be used in the new program.
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re November 1984, prescribed procedures, and established deadlines for accomplishing various activities. In contrast to the 1988 legislation, the 1996 amendment to FIFRA requiring registration review does not specify procedures or deadlines. Nonetheless, the Agency evaluated the reregistration program to see whether any of the procedures used in reregistration could be used in the new program.
1. Identification of pesticides that were subject to reregistration . FIFRA section 4(c) required the Agency to publish lists of pesticides that were subject to regregistration. To accomplish this requirement, the Agency developed criteria for deciding whether two or more structurally related active ingredients could be assigned to the same reregistration case. Over the 16-year course of reregistration, the Agency applied new information about the chemical or biological properties of active ingredients assigned to a case when deciding whether to add or remove an active ingredient from a case. The Agency proposes to use the knowledge gained in implementing FIFRA section 4(c) when it creates and maintains a list of pesticide cases that will be subject to registration review.
2. Applications for reregistration . FIFRA section 4(d) required registrants to notify the Agency whether they intended to seek reregistration for their products, and if so, to identify the data required by regulation to support the registration of the products, cite the data that the registrant would rely on to satisfy the applicable requirements, and commit to provide studies to satisfy outstanding data requirements that the registrant identified. FIFRA section 4(e) required registrants to summarize and reformat the studies that they intend to rely upon to support reregistration of their products
y regulation to support the registration of the products, cite the data that the registrant would rely on to satisfy the applicable requirements, and commit to provide studies to satisfy outstanding data requirements that the registrant identified. FIFRA section 4(e) required registrants to summarize and reformat the studies that they intend to rely upon to support reregistration of their products. In developing this proposed rule, the Agency considered whether to adopt similar procedures in registration review, but decided that reliance on the Data Call-In (DCI) authority of FIFRA section 3(c)(2)(B), as required under FIFRA section 3(g), would be sufficient.
3. Identification of outstanding data requirements (data gaps) . FIFRA section 4(f) required the Agency to review the registrants' submissions, independently identify data gaps, and issue DCI notices under FIFRA section 3(c)(2)(B) for submission of any outstanding data. The Agency's experience with these aspects of the reregistration program showed that registrants did not always correctly identify the data requirements that applied to their product registrations and that the data registrants intended to rely upon were not always adequate. The Agency identified multiple data gaps for virtually every pesticide in the reregistration program.
Because the Agency made significant effort in the reregistration and tolerance reassessment programs to ensure that data requirements were identified and satisfied with appropriate data, pesticide databases now meet or exceed the standard established in 1984. Although the Agency anticipates that it will identify data gaps for many pesticides in the registration review program, it believes that the scope of the DCI effort in this program will be smaller than that of the reregistration program. The results of an Agency's feasibility study of the proposed registration review decision process supports this expectation.
4. Quality of the submitted studies
lthough the Agency anticipates that it will identify data gaps for many pesticides in the registration review program, it believes that the scope of the DCI effort in this program will be smaller than that of the reregistration program. The results of an Agency's feasibility study of the proposed registration review decision process supports this expectation.
4. Quality of the submitted studies . In the early 1990's, the Agency frequently found that the studies submitted in response to DCI notices did not meet applicable requirements and could not be used to support a risk assessment. Because the Agency was concerned about the delay and expense that accrue when studies must be repeated, it conducted rejection analyses to determine why so many studies were inadequate. Among the outcomes of these analyses were improved guidance for the design, conduct, and reporting of studies.
The Agency believes that improvements in the guidance for designing, conducting, and reporting studies will carry forward into the registration review program. The Agency anticipates that few studies submitted in this program will suffer
5. Late submission of pertinent information . The Agency found that data and information affecting pesticide exposure and risk were frequently provided after the Agency had drafted its risk assessments. The Agency was obliged to redo the risk assessments. This problem eased somewhat after the Agency began to consult more regularly with stakeholders before conducting the review. The Agency hopes to avoid or minimize this problem in registration review by proposing procedures that would promote early submission of pertinent information.
6. Complex issues . A major challenge in the reregistration program was the number and complexity of the issues presented by many of the older pesticides subject to reregistration. Many new studies reported new hazards and raised new questions about the potential risks posed by the pesticide
registration review by proposing procedures that would promote early submission of pertinent information.
6. Complex issues . A major challenge in the reregistration program was the number and complexity of the issues presented by many of the older pesticides subject to reregistration. Many new studies reported new hazards and raised new questions about the potential risks posed by the pesticide. The Agency often required additional studies to further characterize the risks.
As a result of the work accomplished since 1984 in the registration, reregistration and tolerance reassessment programs, the Agency identified and resolved significant issues regarding human health and the environment. In the short-term, human health issues encountered in registration review are likely to be less complex than those confronted in the reregistration and tolerance reassessment programs. Overall, because scientific knowledge continuously evolves, the Agency will encounter new scientific or regulatory issues arising as the registration review program proceeds.
7. Public participation in reregistration . The Agency gained significant experience in stakeholder consultation and public participation processes during reregistration. While not required by FIFRA section 4, the Agency found value in consulting stakeholders before beginning a reregistration review. In particular, such consultation clarified use practice and usage patterns and identified uses that were no longer economically viable. As a result, the Agency was able to reduce the amount of effort and rework required to complete a reregistration eligibility decision.
Public participation is also critical for achieving transparency of the decisions made in the reregistration program. Under procedures adopted in 1998 and formalized in a notice published in the Federal Register of May 14, 2004 (69 FR 26819) (FRL-7357-9), the Agency provided an opportunity to review draft preliminary risk assessments
rk required to complete a reregistration eligibility decision.
Public participation is also critical for achieving transparency of the decisions made in the reregistration program. Under procedures adopted in 1998 and formalized in a notice published in the Federal Register of May 14, 2004 (69 FR 26819) (FRL-7357-9), the Agency provided an opportunity to review draft preliminary risk assessments. When the Agency released the refined risk assessment, it also provided a document explaining how it had responded to the comments. The Agency also invited public comment on draft risk management decisions.
The Agency has modified its public participation procedures for reregistration so that it can tailor public participation in accordance to the complexity of the issues and the degree of stakeholder interest in the pesticide. Although the public participation process adds to the time frame for making reregistration decisions particularly in complex or controversial cases, the process leads to better decisions and more efficient use of Agency resources. In addition, the public benefits from the transparency and openness of the decision process. For these reasons, the Agency proposes to include ample opportunities for public participation in the registration review process.
8. Reregistration Eligibility Decision Document . The Agency found that a highly structured decision document did not always provide flexibility in addressing the range of issues presented by the diverse pesticides that were reviewed in reregistration. In particular, the reregistration report format and the process used to create such reports did not provide flexibility for expediting review of pesticides that pose low hazard and risk. The Agency proposes to incorporate such flexibility in the registration review process and in registration review decision documents.
9. Scheduling reregistration decisions
that were reviewed in reregistration. In particular, the reregistration report format and the process used to create such reports did not provide flexibility for expediting review of pesticides that pose low hazard and risk. The Agency proposes to incorporate such flexibility in the registration review process and in registration review decision documents.
9. Scheduling reregistration decisions . For much of the reregistration program, the Agency did not have published procedures for scheduling completion of Reregistration Eligibility Decisions (REDs). FIFRA section 4(c)(1) provided general guidance for prioritizing reregistration reviews which the Agency accomplished early in the reregistration process when it published lists A, B, C, and D within the mandated time frames. However, the Agency appeared not to have criteria for setting priorities for reviewing pesticides within each list. Later, FFDCA section 408(q) established a 10-year time frame for reassessing tolerances and exemptions. This section generally instructed the Agency to give priority to reviewing tolerances or exemptions that appear to pose the greatest risk to public health. Initially, the Agency did not have schedules for conducting tolerance reassessments.
The Agency now has a priority ranking for reregistration and tolerance reassessment and publishes schedules well in advance. These scheduling procedures provide stakeholders ample opportunity to share information, data, and concerns to aid the Agency in making well-informed and balanced decisions.
The Agency proposes to use chronologically based criteria to establish priority of review and to provide advance notice of registration review schedules. The Agency's experience in reregistration and tolerance reassessment shows that adopting these practices will help the Agency meet its objective of having a predictable and reliable schedule.
10. Implementing reregistration decisions . FIFRA section 4(g)(2) specifies procedures for reregistering individual pesticide products
review and to provide advance notice of registration review schedules. The Agency's experience in reregistration and tolerance reassessment shows that adopting these practices will help the Agency meet its objective of having a predictable and reliable schedule.
10. Implementing reregistration decisions . FIFRA section 4(g)(2) specifies procedures for reregistering individual pesticide products. A criticism of this aspect of the program is the lag time between issuance of a RED and the appearance, at the retail level, of products with labeling that put into effect the risk mitigation measures identified in the RED. This issue is significant because the pesticide label is the Agency's chief means of communicating risk management procedures to pesticide users. Because one of the objectives for the registration review program is to ensure timely implementation of risk reduction measures, it is important to develop a process for timely submission and review of pesticide product labels.
B. Advance Notice of Proposed Rulemaking (ANPRM)
The Agency published an ANPRM in the Federal Register of April 26, 2000 (65 FR 24585) that presented the statutory requirement for registration review and alerted its stakeholders that the Agency was initiating the development of rulemaking to establish procedures for a registration review program. The Agency explained its preliminary interpretation of the statutory provisions and its preliminary ideas regarding goals, objectives, and how registration review might operate. Soliciting public input on critical issues about registration review early in the planning process helped the Agency to identify potential problems as early as possible.
C. Summary of Comments on the ANPRM
The Agency received eight comments on the ANPRM, primarily from pesticide manufacturers or other persons with commercial interest in the sale or use of pesticides. These comments are available for review in the public docket for the ANPRM under docket control number OPP-36195
ning process helped the Agency to identify potential problems as early as possible.
C. Summary of Comments on the ANPRM
The Agency received eight comments on the ANPRM, primarily from pesticide manufacturers or other persons with commercial interest in the sale or use of pesticides. These comments are available for review in the public docket for the ANPRM under docket control number OPP-36195. The Agency has placed a summary of these comments and EPA's response to the issues discussed in these comments in the docket for this proposed rule.
The four issues that stimulated the most discussion were:
1. Standard for registration under FIFRA . Some commenters asserted that compliance with data requirements in 40 CFR part 158 would be sufficient to satisfy the FIFRA requirements for registration. Other commenters advocated that the Agency use a checklist approach to see whether a pesticide continued to meet the FIFRA standard for registration. Commenters agreed that the Agency should use existing data and data reviews and avoid re-review where possible.
2. Predictable schedules . Industry commenters generally stated that they sought predictable schedules and advocated using the date of the last comprehensive review as the basis for scheduling a pesticide's registration review. Most asserted that the risk-based priority system described in the ANPRM would not produce a predictable schedule because priority-setting would require too many resources and schedules that rank pesticides by perceived risk would be contentious. Commenters advised the Agency to handle emerging risks such as actions based on information on adverse effects that must be reported under FIFRA section 6(a)(2) information outside of the registration review process.
3. Public participation . Most commenters wanted to be able to participate throughout the registration review process. However, some commenters want to limit public participation in various ways
vised the Agency to handle emerging risks such as actions based on information on adverse effects that must be reported under FIFRA section 6(a)(2) information outside of the registration review process.
3. Public participation . Most commenters wanted to be able to participate throughout the registration review process. However, some commenters want to limit public participation in various ways. Other commenters acknowledged the value of public participation but cautioned that it could slow down decision-making.
4. Registrant's role in registration review . In general, commenters asserted that the Agency should not expect registrants to provide studies or other information unless the Agency specifically requires it.
D. Stakeholder Consultation
After reviewing the issues raised in the comments to the ANPRM, the Agency reconsidered its initial approach to the design of the registration review process. Before issuing a proposed rule, however, the Agency decided to consult with stakeholders to gain additional views on the design of the registration review process. The Agency chose to present its revised approach to the registration review process at a public meeting of the Pesticide Program Dialogue Committee (PPDC) held in Arlington, VA in April 2003.
The PPDC is an advisory committee established in 1995 under the Federal Advisory Committee Act. Its charter was renewed in November 2001 and 2004. This Committee provides a forum for a diverse group of stakeholders to discuss and provide advice to the pesticide program on various pesticide regulatory, policy, and program implementation issues. Topics of discussion at past meetings have included, among other things, implementation of the FQPA.
Membership to the PPDC includes environmental and public interest groups, pesticide manufacturers and trade associations, user and commodity groups, public health and academic institutions, Federal and State agencies, and the general public
e regulatory, policy, and program implementation issues. Topics of discussion at past meetings have included, among other things, implementation of the FQPA.
Membership to the PPDC includes environmental and public interest groups, pesticide manufacturers and trade associations, user and commodity groups, public health and academic institutions, Federal and State agencies, and the general public. The PPDC meets two to three times a year and all meetings are open to the public. Background materials along with a summary of each meeting held to date are kept in a public docket at the Docket facility identified under ADDRESSES . Meeting summaries for the PPDC are also available electronically at the following internet address: http://www.epa.gov/oppfead1/cb/ppdc/ .
In response to the Agency's April 2003 request for stakeholder input into the design of the registration review program, the PPDC agreed to form a workgroup to develop recommendations for the Agency.
In June 2003, the PPDC chartered the PPDC Registration Review Workgroup. The workgroup was composed of 23 members representing a broad and balanced range of interests who were drawn from the PPDC membership and other stakeholders who were not currently serving on the PPDC. Its mission was to develop an assessment of key registration review issues as a basis for the full PPDC to provide EPA advice and recommendations on issues and topics related to developing the Agency's registration review program.
The workgroup held several public meetings and teleconferences during the summer and fall of 2003. At the PPDC meeting in October 2003, the PPDC Registration Review Workgroup presented its recommendations on three topics. The PPDC endorsed these recommendations and asked the workgroup to continue to meet and to present additional recommendations at the spring 2004 PPDC meeting. The PPDC Registration Review Workgroup resumed its deliberations in January 2004. The PPDC endorsed a second set of recommendations at the April 2004 PPDC meeting
C Registration Review Workgroup presented its recommendations on three topics. The PPDC endorsed these recommendations and asked the workgroup to continue to meet and to present additional recommendations at the spring 2004 PPDC meeting. The PPDC Registration Review Workgroup resumed its deliberations in January 2004. The PPDC endorsed a second set of recommendations at the April 2004 PPDC meeting. Meeting minutes and background information for the workgroup's activities in 2003, including a copy of the October 2003 presentation to the PPDC, may be found in Docket OPP-2003-0252; meeting minutes and background information for the workgroup's activities in 2004, including a copy of the April 2004 presentation, may be found in Docket OPP-2004-0014. You may access these dockets electronically at the following internet address: http://docket.epa.gov/edkpub/index.jsp .
E. Summary of PPDC Recommendations
The PPDC considered a number of procedural and implementation issues, as follows:
1. How should pesticides be scheduled for registration review ? The PPDC took into consideration that approximately 1,200 active ingredients and 15,000 products would be subject to registration review and that new pesticides will be added in the future.
The PPDC recommended that the administrative procedures for scheduling registration review should not be subjective, resource intensive, or time-consuming. There should be a predictable schedule generally based on a date 15 years from the date of registration, reregistration, or other major risk assessment. Specific criteria for departure from scheduling should be established by regulation. The Agency should publish a comprehensive schedule in the Federal Register and on the Agency website with regular updates.
The PPDC considered whether scheduling procedures could be based on risk--“worst first”--but concluded that scheduling procedures based on this criterion would be resource intensive and time-consuming.
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ia for departure from scheduling should be established by regulation. The Agency should publish a comprehensive schedule in the Federal Register and on the Agency website with regular updates.
The PPDC considered whether scheduling procedures could be based on risk--“worst first”--but concluded that scheduling procedures based on this criterion would be resource intensive and time-consuming.
2. Should there be different levels of review ? The PPDC recommended that the degree of assessment not be a “one-size-fits-all” process. The workgroup took into consideration that: (a) Not all chemicals pose the same risks; (b) the scope of the program mandates efficient use of resources; and (c) changes in data requirements, database, adverse effects data, science policies, and use and usage profiles could affect the scope or depth of a pesticide's registration review.
The PPDC developed a flow chart for the registration review process that identified points in the review process where the Agency could determine whether further review was needed. Specifically, the process should focus on identifying what has changed since the last review and determining whether existing risk assessments could be used as the basis of a risk-benefit analysis.
The PPDC recommended that the registration review process allow for a streamlined review for pesticides judged to be low risk and for pesticides with a stable regulatory history and science. Pesticides with major complex issues should receive a more comprehensive assessment.
3. How can meaningful public participation be accomplished ? The PPDC took into consideration that a pesticide's registration review would benefit from early participation by all stakeholders. It noted that stakeholders need a predictable schedule to prepare and participate in registration review and an understandable process where opportunities and expectations for public participation are clear
3. How can meaningful public participation be accomplished ? The PPDC took into consideration that a pesticide's registration review would benefit from early participation by all stakeholders. It noted that stakeholders need a predictable schedule to prepare and participate in registration review and an understandable process where opportunities and expectations for public participation are clear.
The PPDC recommended that the Agency seek stakeholder input regarding use profiles, risk assessments, benefit assessments, risk/benefit analyses, and risk mitigation measures and that stakeholder participation should be commensurate with the level of review. The PPDC recommended that the Agency use modern electronic technology to facilitate stakeholder access to information and asked the Agency to establish and maintain an electronic docket for each pesticide that would include comprehensive information about the pesticide, including history, status, public comments, and all previous regulatory decisions.
4. How does registration review relate to other pesticide program activities ? Because registration review does not supercede or replace EPA's other authorities under FIFRA, the PPDC recommended that EPA manage risk issues as they arise rather than relying exclusively on registration review for resolving these issues. To the extent possible, registration review should be a safety net to help assure that no risk-related issues have been overlooked.
5. How should EPA initiate a pesticide's registration review ? The PPDC found that there is no need for a registrant to submit an application for registration review because payment of annual maintenance fees attests to a registrant's willingness to support a pesticide through the registration review process. The PPDC advised the Agency to publish a Federal Register notice to initiate a pesticide's registration review. The notice would announce the public availability of the documents that the Agency intends to review in its assessment of the pesticide
review because payment of annual maintenance fees attests to a registrant's willingness to support a pesticide through the registration review process. The PPDC advised the Agency to publish a Federal Register notice to initiate a pesticide's registration review. The notice would announce the public availability of the documents that the Agency intends to review in its assessment of the pesticide. During the comment period, registrants and other persons could submit additional information for the Agency to consider during registration review.
6. How should EPA encourage early submission of test data and other information to support a pesticide's registration review ? Before the Agency begins its assessment, registrants and other stakeholders should be allowed to comment on the information that the Agency had placed in the registration review docket for the pesticide. At this point, stakeholders could submit data and other information that would be pertinent to the review. However, the PPDC noted that registrants need a clear understanding of the Agency's requirements, guidelines, and issues of concern to assess what additional information would be useful. The Agency should explain how the data will be used. When necessary, the Agency should issue DCI notices under FIFRA section 3(c)(2)(B). The Agency should support stakeholder efforts to provide information by providing a framework for communicating information needs and by creating an electronic listserve for use by stakeholders who wish to participate in the registration review.
7. What is a registration review decision ? The PPDC identified seven potential outcomes of a registration review:
• Registration review concluded—no changes in current registration are needed.
• Registration review concluded—risk mitigation or other action required.
• Registration review concluded—confirmatory data requested.
• Registration review cannot be concluded until additional data are submitted
egistration review decision ? The PPDC identified seven potential outcomes of a registration review:
• Registration review concluded—no changes in current registration are needed.
• Registration review concluded—risk mitigation or other action required.
• Registration review concluded—confirmatory data requested.
• Registration review cannot be concluded until additional data are submitted.
• Registration review concluded, but there is ongoing generic DCI or other action—registration review decision may be revisited if necessary.
• Registration review concluded—active ingredient voluntarily canceled.
• Registration review concluded—FIFRA section 6 cancellation or suspension action.
F. Feasibility Study
The Agency conducted a feasibility study to test certain aspects of the registration review decision process that the PPDC recommended. The Agency randomly selected 30 pesticides from among the likely candidates for review in the first 5 years of the program. The Agency assembled data that it would consider in a registration review and then simulated the review and decision process described in the proposed procedures. A detailed description of this study is presented in the economic analysis for this proposed regulation. A copy of the economic analysis is available in the public docket for this proposed regulation. Unit VIII. of this preamble describes how the Agency used the study to learn how the proposed registration review decision process might work and to identify aspects of the proposed process that need further development.
VI. Factors Considered in Designing a Registration Review Decision Process
A. Pesticides Subject to Registration Review Should Have Already Met the Data Requirements for Registration Established in 1984
Registration decisions made since 1984 and reregistration decisions made since 1988 are based on data requirements and risk assessment methods that were current at that time
ther development.
VI. Factors Considered in Designing a Registration Review Decision Process
A. Pesticides Subject to Registration Review Should Have Already Met the Data Requirements for Registration Established in 1984
Registration decisions made since 1984 and reregistration decisions made since 1988 are based on data requirements and risk assessment methods that were current at that time. In addition, by August 2006, the Agency will complete tolerance reassessment to assure that pesticides with food uses meet the requirements of FFDCA section 408 with respect to human health risks from aggregate and cumulative exposures. In general, the Agency believes it will not be necessary to redo reviews of studies because it has already determined that studies supporting current registrations meet requirements established in 1984.
B. FQPA Requirements Have Transformed Pesticide Risk Assessment into a Dynamic and Iterative Process
Before FQPA, EPA considered the incremental dietary risk posed by each new use and generally did not reexamine risk from existing uses. When establishing a tolerance for a new food use, the Agency now must conduct a new assessment of aggregate non-occupational exposures and assess cumulative risk, if necessary, using the most recent procedures for conducting such assessments. This assessment would update the non-occupational human health risk assessment performed during tolerance reassessment and would provide the Agency another opportunity to evaluate previously approved uses. Accordingly, the non-occupational human health risk assessments for some pesticides may be updated during the 15-year registration review cycle as a result of the review of any applications for new uses.
C. Emerging Serious and Urgent Risk Issues Will Be Identified, Characterized, and Managed as They Arise and Generally in Processes Other than Registration Review
It is the Agency's practice to investigate reports of pesticide incidents or findings of adverse effects as expeditiously as possible
ng the 15-year registration review cycle as a result of the review of any applications for new uses.
C. Emerging Serious and Urgent Risk Issues Will Be Identified, Characterized, and Managed as They Arise and Generally in Processes Other than Registration Review
It is the Agency's practice to investigate reports of pesticide incidents or findings of adverse effects as expeditiously as possible. The Agency intends to continue this practice.
VII. Design Options for Registration Review
This unit describes and evaluates options for various aspects of a registration review program. The program aspects discussed in this unit are:
• What should be the unit of review?
• How should the Agency account for inert ingredients in registration review?
• How should the Agency schedule pesticides for review?
• What event should be used as the basis for developing a chronological schedule?
• What approach should the Agency use in conducting the review?
• What is the optimal way to assemble the materials that the Agency will consider in its review?
• How should review of individual product registrations be managed in registration review?
• How should the Agency communicate the results of the registration review?
A. What Should Be the Unit of Review?
The statute requires the Agency to review “the registrations of pesticides,” but did not further describe in FIFRA section 3(g) the unit of review. Accordingly, the Agency must determine the unit of review for the purpose of this program. The Agency has identified the following three options: (1) Individual pesticide products; (2) individual active or inert ingredients; or (3) registration review cases composed of chemically related active ingredients and the products that contain one or more of these ingredients. For the reasons discussed in this unit, the Agency is proposing to use the third option and review registration review cases in the registration review program. This is reflected in proposed § 155.42 of the regulatory text.
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ive or inert ingredients; or (3) registration review cases composed of chemically related active ingredients and the products that contain one or more of these ingredients. For the reasons discussed in this unit, the Agency is proposing to use the third option and review registration review cases in the registration review program. This is reflected in proposed § 155.42 of the regulatory text.
1. Review each product separately . Under longstanding practice, EPA bases its decision to register a product on its assessment of the hazard characteristics of the active ingredient in the product (and its metabolites and degradates) and the risk posed by potential exposures to these substances that would result from the proposed uses of the product. The Agency also considers the possible benefits from the proposed uses of the pesticide. The Agency makes its registration decisions on a pesticide chemical and then applies this decision to a pesticide product.
Under this option, the Agency would conduct a risk assessment on each individual product. Such an assessment would not be a complete assessment of the exposure to the active ingredient(s) in the product because it does not consider exposures from other products that contain the same active ingredient(s). Accordingly, this approach might not be scientifically sound and might not meet FIFRA requirements.
2. Review of pesticide ingredients . The Agency currently makes decisions on ingredients and applies them to products. Comments on the ANPRM agreed that the unit of review should be a pesticide ingredient. Congress intended that EPA review a pesticide's registration in light of advances in science (i.e., data and other information relating to hazard, exposure, and risk). Because “science” is generally developed on a generic basis, the Agency believes conducting registration review on ingredients would be consistent with Congressional intent
d that the unit of review should be a pesticide ingredient. Congress intended that EPA review a pesticide's registration in light of advances in science (i.e., data and other information relating to hazard, exposure, and risk). Because “science” is generally developed on a generic basis, the Agency believes conducting registration review on ingredients would be consistent with Congressional intent. However, a product that contains multiple active ingredients could belong in two or more cases and could undergo registration review more than once in a 15-year cycle. The Agency believes that the statute does not preclude the Agency from reviewing a pesticide product more than once in a 15-year cycle.
3. Review of chemical cases that include one or more structurally similar pesticide ingredients and the products that contain these ingredients . Under FIFRA section 4, the Agency established reregistration cases that contain either a single active ingredient or two or more structurally related active ingredients. In the reregistration program, the Agency uses data on one member of the case to support other members of the case. Significant resource savings are achieved when chemically related pesticide ingredients are grouped in the same chemical case and are reviewed together. Decisions made on the active ingredients would apply to products in the case. The Agency finds that because FIFRA section 3(g) does not stipulate the unit of review, the Agency may continue its current practice of forming cases consisting of one or more active ingredients and the products that contain these ingredients. The Agency believes that this unit of review is consistent with Congressional intent that a pesticide be reviewed in light of advances in science, which are developed generically. As stated in Unit III.A., a product that contains multiple active ingredients could belong in two or more cases and could undergo registration review more than once in a 15-year cycle.
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that contain these ingredients. The Agency believes that this unit of review is consistent with Congressional intent that a pesticide be reviewed in light of advances in science, which are developed generically. As stated in Unit III.A., a product that contains multiple active ingredients could belong in two or more cases and could undergo registration review more than once in a 15-year cycle.
B. How to Account for Inert Ingredients in Registration Review?
When the Agency evaluates an application to register a pesticide product, it examines the product's composition and product-specific toxicity data as part of its consideration of the potential risks posed by the product. Accordingly, the Agency believes that a review of a pesticide's registration must include a consideration of the inert ingredients as well as the active ingredients in the product.
Options for managing the review of inert ingredients include:
1. Option 1--Establish registration review cases for inert ingredients . Such cases would be composed of one or more inert ingredients and the products that contain the ingredient(s). The Agency would conduct either a comprehensive review of each inert ingredient, as is being done for active ingredients in reregistration or tailor the scope and depth of the review, as is being proposed for the registration review of active ingredients.
2. Option 2--Review individual inert ingredients in a process that is separate from registration review . During registration review, examine product composition to assure that any inert ingredient used in the product has been cleared for use in pesticides, and, if the pesticide is used on foods, to assure that a tolerance or tolerance exemption for the chemical has been established and reassessed.
The Agency may establish a program for periodically reevaluating inert clearances, tolerances, or tolerance exemptions. If the Agency does so, it would be able to use this new information in the registration review program
cleared for use in pesticides, and, if the pesticide is used on foods, to assure that a tolerance or tolerance exemption for the chemical has been established and reassessed.
The Agency may establish a program for periodically reevaluating inert clearances, tolerances, or tolerance exemptions. If the Agency does so, it would be able to use this new information in the registration review program. During a pesticide's registration review, the Agency would review the composition of a product and then check to see whether there are issues of concern associated with any of the inert ingredients in the product.
3. Option 3--Focus on product hazards rather than reviewing individual inert ingredients . After making findings on the active ingredients, base an assessment of the safety of end-use products upon a review of the product's acute toxicity data without separately considering each inert ingredient in the product.
The Agency proposes to adopt option 2. It would not establish registration review cases for inert ingredients as would be done under option 1. Safety of inert ingredients will continue to be evaluated in a separate process. During registration review, the Agency will check to see whether there are any issues concerning the inert ingredients in a product that is undergoing registration review. This approach would produce product assessments that reflect current knowledge about the ingredients in the product. Additionally, the PPDC registration review workgroup endorsed this approach.
The Agency believes that option 1, conducting a registration review of inert
The Agency believes that option 3, basing a product's registration review on acute toxicity data rather than on a review of individual inert ingredients, might not meet Agency goals relating to efficient use of resources and sound science. Review of product-specific acute data is unlikely to provide insight into potential hazards posed by chronic or repeated exposure to the inert ingredients in a pesticide product
es that option 3, basing a product's registration review on acute toxicity data rather than on a review of individual inert ingredients, might not meet Agency goals relating to efficient use of resources and sound science. Review of product-specific acute data is unlikely to provide insight into potential hazards posed by chronic or repeated exposure to the inert ingredients in a pesticide product. Because such a review may not provide new understanding of the potential hazards posed by a product, the review would not be an appropriate use of Agency resources.
C. Approaches for Scheduling Registration Review Cases for Review
The Agency believes that an optimal scheduling approach would enable the Agency to meet the following goals:
• Achieve a 15-year review cycle with a predictable and reliable registration review schedule (emphasized in ANPRM comments).
• Set schedules for review that promote protection of human health and the environment.
• Promote efficient use of resources to develop and implement the schedule and provide flexibility for managing the registration review caseload.
• Be perceived as fair and objective. For example, avoid stigmatizing a pesticide by alleging that concern for the pesticide's potential risk warrants scheduling its registration review early in the registration review cycle (emphasized in ANPRM comments).
The Agency has evaluated three basic approaches to scheduling registration reviews:
(1) Chronological. Commenters on the ANPRM and PPDC Registration Review Workgroup recommended scheduling registration review based on the date of the last comprehensive review.
(2) Risk-based “worst first.” Under the Agency's “initial concept” published in the 2000 ANPRM, registration reviews would be scheduled on the basis of known or suspected risk.
aches to scheduling registration reviews:
(1) Chronological. Commenters on the ANPRM and PPDC Registration Review Workgroup recommended scheduling registration review based on the date of the last comprehensive review.
(2) Risk-based “worst first.” Under the Agency's “initial concept” published in the 2000 ANPRM, registration reviews would be scheduled on the basis of known or suspected risk.
(3) Random. Use randomizing procedures to develop a schedule for registration review.
Under the proposed procedures, any of these approaches could be modified to address the need to revise a pesticide's registration review schedule to balance workload (both EPA's and industry's), group related cases together, or to achieve process efficiencies, among other things.
Because FIFRA does not prescribe any approach to scheduling registration review, all of the scheduling approaches would be consistent with FIFRA section 3(g), as long as they are implemented in a way that strives to attain the 15-year review goal. For the reasons given in this unit, the Agency proposes to base its schedule on option 1. This is reflected in proposed § 155.44 of the regulatory text.
1. Chronological, based on date of registration or reregistration . This approach has the advantage that after initial effort to ascertain registration or reregistration dates, this schedule could be constructed and maintained with minimal resources. Because the criteria for scheduling are objective, a chronological listing of pesticides would not stigmatize any pesticide. The Agency would be in a better position to achieve the 15-year review of each pesticide's registration with this scheduling scheme than with a risk-based scheduling scheme because, in any given year, this approach is likely to produce a mix of heavy and light registration review cases
criteria for scheduling are objective, a chronological listing of pesticides would not stigmatize any pesticide. The Agency would be in a better position to achieve the 15-year review of each pesticide's registration with this scheduling scheme than with a risk-based scheduling scheme because, in any given year, this approach is likely to produce a mix of heavy and light registration review cases.
The date of a pesticide's registration or reregistration may be a general indicator of potential risk in that older pesticides could potentially have data gaps, outdated risk assessments, and unrecognized risks. Previously unrecognized risks from older pesticides could be identified earlier in a registration review program using this scheduling scheme than one which uses a scheduling scheme based exclusively on risk potential. The Agency's feasibility study described in Unit VIII. showed that older pesticides often lacked assessments that have become routine in the last 8 years or so, such as ecological, occupational, and residential risk assessments. Accordingly, the Agency believes that the date of the last comprehensive review is a reasonable indicator for potential risk.
As discussed in Unit VI.A., the Agency will have performed a comprehensive review on all pesticides that will undergo registration review and will have determined that all pesticides meet, at a minimum, standards established in 1984. In the last 5 years or so, the Agency used its most up-to-date methods to evaluate high risk pesticides. The Agency made regulatory judgments about the acceptability or reasonableness of the risks posed by these pesticides. The public health or environmental benefit of reviewing these pesticides early in registration review would be marginal because the Agency's understanding of the risks or the societal benefits of the pesticides probably would not change much since the Agency's last evaluation of the pesticides
de regulatory judgments about the acceptability or reasonableness of the risks posed by these pesticides. The public health or environmental benefit of reviewing these pesticides early in registration review would be marginal because the Agency's understanding of the risks or the societal benefits of the pesticides probably would not change much since the Agency's last evaluation of the pesticides.
However, without appropriate modification, a strictly chronological approach lacks flexibility to group related pesticides or balance the workload. Moreover, because risk factors such as hazard or exposure are not included in a chronological schedule, registration review of pesticides with known or suspected risks might occur later than registration review of pesticides that pose less risk.
In proposing this approach, the Agency recognizes that, in order to protect human health and the environment, it must rely on other procedures for identifying, assessing, and managing new risks from existing pesticides.
2. Risk-based, relying on exposure, hazard, or other recognized expression of risk . This approach has the advantage of early review of pesticides that are recognized to have greater potential to pose risks of concern. Additionally, pesticides with similar risks are likely to be scheduled for review at approximately the same time. Grouping such pesticides for review would promote efficient use of resources.
However, identifying and describing the risk criteria to be used in prioritizing pesticides could be controversial and
As risk-based priorities change over time, the schedule would need to be modified repeatedly to advance some cases and defer others. Because the schedule would be “front-loaded” with the most difficult and time-consuming cases, the Agency would be less likely to stay on schedule and meet the statute's goal of reviewing each pesticide's registration every 15 years
cides could be controversial and
As risk-based priorities change over time, the schedule would need to be modified repeatedly to advance some cases and defer others. Because the schedule would be “front-loaded” with the most difficult and time-consuming cases, the Agency would be less likely to stay on schedule and meet the statute's goal of reviewing each pesticide's registration every 15 years.
As described in Unit VIII.B., the feasibility study showed that older pesticides often lacked assessments that have subsequently become routine. When the Agency performs such assessments during a pesticide's registration review, it may find risks that it had not recognized before. Under the risk-based approach for scheduling registration review, the Agency might not review an older pesticide until later in the cycle and, as a result, the Agency would discover any unrecognized risk associated with the pesticide later than it might have under another approach.
3. Random assignment . The sole advantage of this approach is that the criteria are completely objective and incontrovertible. This scheduling approach would require the least resources. The schedule would be predictable and easily ascertainable. However, because no indicators of potential risk would be taken into account when developing a schedule, the public would not receive the public health or environmental protection benefits associated with the other approaches.
D. Establish a Baseline Date for Each Registration Review Case
Since the Agency is proposing to schedule registration review on a chronological basis, it must decide what event or events should be used to establish a baseline date for each registration review case. The options include: (1) Registration date of oldest product in the case or date of reregistration whichever is later; or (2) date of latest registration action
for Each Registration Review Case
Since the Agency is proposing to schedule registration review on a chronological basis, it must decide what event or events should be used to establish a baseline date for each registration review case. The options include: (1) Registration date of oldest product in the case or date of reregistration whichever is later; or (2) date of latest registration action.
Option 1 would list in chronological order pesticides registered or reregistered after the November 1984 effective date of the Agency's data requirements for pesticides. Under this option, the Agency would give priority to pesticides with the oldest post-1984 data.
Under option 2, the Agency would use the date of the most recent approval of a new use as the basis for scheduling the review. The disadvantage of this approach is that the review of the new use would have focused on the exposures that would result from the proposed new use and might or might not have led to a comprehensive review of the pesticide. Although aggregate exposure from all dietary and non-occupational exposures might have been assessed in the review of the new use, occupational or ecological risks from earlier registration actions might not have been considered.
The Agency believes that registration review schedules should generally provide for reviewing the oldest decisions first to see whether the pesticide continues to meet current standards for registration. The Agency proposes to use the earliest post-1984 registration or reregistration decision as the initial basis for scheduling registration reviews. The Agency proposes to use the date of the latest registration review as the basis for scheduling subsequent registration reviews. This is reflected in proposed § 155.42 of the regulatory text
icide continues to meet current standards for registration. The Agency proposes to use the earliest post-1984 registration or reregistration decision as the initial basis for scheduling registration reviews. The Agency proposes to use the date of the latest registration review as the basis for scheduling subsequent registration reviews. This is reflected in proposed § 155.42 of the regulatory text.
For the purpose of registration review procedures, the Agency must decide which event constitutes “reregistration.” The options include: (1) Signature date of the Registration Eligibility Decision (RED) or Interim Registration Eligibility Decision (IRED); (2) date of issuance of DCI notices for product-specific data and labels specified in the RED; and (3) date of approval of submitted labels. The Agency prefers the signature date of the RED or IRED because this is the date of the latest comprehensive risk assessment of the pesticide. Other events in the reregistration process might not be useful as a baseline date. For example, the date of the DCI notice for product-specific data is significant for compliance purposes and the label approval date signifies the completion of regulatory action in the reregistration process.
The Agency must also decide what should be the baseline date for reregistration cases for which REDs or IREDs have not been completed by the time the registration review program begins. The Agency could use either the date of initial registration or the projected date of the registration eligibility decision as a baseline date or it could wait until reregistration is completed before establishing a baseline date. The Agency believes it is simpler and more practical to wait until it issues a reregistration decision before establishing a baseline date for such cases. Consequently, the initial list of registration review cases would not include baseline dates for such cases.
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tion eligibility decision as a baseline date or it could wait until reregistration is completed before establishing a baseline date. The Agency believes it is simpler and more practical to wait until it issues a reregistration decision before establishing a baseline date for such cases. Consequently, the initial list of registration review cases would not include baseline dates for such cases.
E. Approaches for Conducting a Pesticide's Registration Review
The Agency has identified three approaches for conducting a pesticide's registration review: (1) A comprehensive approach modeled on reregistration; (2) a checklist approach suggested in comments on the ANPRM; and (3) a tailored approach where the scope and depth of the review are tailored to the circumstances of the registration review case. Variations of a tailored approach to registration review were presented in the Agency's initial concept described in the ANPRM, the revised concept that the Agency presented to the PPDC in 2003, and the approach recommended by the PPDC.
In evaluating these approaches, the Agency finds that the comprehensive approach and the checklist approach do not satisfy the Agency's policy objectives. The underlying assumption in the comprehensive approach is that existing risk assessments and the studies upon which they are based do not meet current standards. The studies must be reviewed again and replaced if necessary and the risk assessments must be redone. This process would redo the work performed in registration and reregistration without significantly adding value. Accordingly, this approach would not satisfy the objective of avoiding unnecessary rework. Because a comprehensive review is likely to be resource-intensive and time-consuming, the Agency would not be able to complete reviews within a 15-year cycle. Under the comprehensive approach, the Agency also would not be able to provide review decisions and impose data requirements on a predictable schedule
Accordingly, this approach would not satisfy the objective of avoiding unnecessary rework. Because a comprehensive review is likely to be resource-intensive and time-consuming, the Agency would not be able to complete reviews within a 15-year cycle. Under the comprehensive approach, the Agency also would not be able to provide review decisions and impose data requirements on a predictable schedule.
The checklist approach also would not meet the Agency's objectives for a registration review process. Because this approach does not address the adequacy of existing risk assessments, it might not reveal risks that could be discovered if new risk assessments were performed. This approach would not address deficiencies in previously accepted data or changes in policy or assessment methods. In successive 15-year cycles, the original risk assessments would fall further behind the standards of the day.
Also, this approach does not include an assessment of new information that could affect the risk assessment. Accordingly, a decision based on such a review would not be based on sound science. Furthermore, under this approach, the Agency might not review new use or usage or other information on benefits that could affect the risk/benefit assessment for the pesticide.
As a practical matter, it would be extremely difficult for the Agency to develop a core assessment scheme, as suggested in comments on the ANPRM, that would apply to all pesticide products. The Agency has always made case-by-case decisions on pesticides and expects to continue to do so. For these reasons, the Agency believes that a checklist approach might not meet the requirements of FIFRA section 3(g).
The tailored approach differs from the other approaches in that scope and depth of the review would be commensurate with the complexity of the issues presented by the pesticide. The scope/depth decision and any accompanying DCI notice that might be needed is a critical output of the registration review process
ieves that a checklist approach might not meet the requirements of FIFRA section 3(g).
The tailored approach differs from the other approaches in that scope and depth of the review would be commensurate with the complexity of the issues presented by the pesticide. The scope/depth decision and any accompanying DCI notice that might be needed is a critical output of the registration review process. By using a tailored approach, the Agency believes it will be able to make such decisions on approximately 1/15th of the total registration review workload each year. As a result of registration activity that will continue to occur during the 15-year registration review cycle, the Agency will receive new data and conduct new risk assessments for many pesticides. The Agency expects that the scope/depth decision that the Agency would make as part of registration review is likely to show that very little additional work would be needed to complete the registration review for such pesticides, at least in regard to non-occupational human health assessments.
The Agency finds that an approach that tailors the scope and depth of a pesticide's review according to the circumstances of each case is more likely to meet the Agency's goals than the alternative approaches. Accordingly, in § 155.53 of the regulatory text, the Agency is proposing this approach for the conduct of registration review.
F. What is the Optimal Way to Assemble the Materials That the Agency Will Consider in its Review?
For example, should the Agency require registrants to submit registration review applications that include or cite material for the Agency's consideration? Alternatively, should the Agency identify and assemble the material it will consider in its review? Or should the Agency and stakeholders work together to prepare for a pesticide's registration review?
1. One option for assembling material to be considered in a pesticide's registration review would be to adopt procedures used in reregistration
de or cite material for the Agency's consideration? Alternatively, should the Agency identify and assemble the material it will consider in its review? Or should the Agency and stakeholders work together to prepare for a pesticide's registration review?
1. One option for assembling material to be considered in a pesticide's registration review would be to adopt procedures used in reregistration . As discussed in Unit V.A.2., FIFRA section 4(d) required registrants to notify the Agency whether they intended to seek reregistration for their products, identify the data required by regulation to support the registration of the products, and the studies that satisfy the applicable requirements, and commit to provide studies to satisfy data gaps that they identified. In addition to the notification requirements in FIFRA section 4(d), FIFRA section 4(e) required registrants to summarize and reformat previously submitted studies that they intended to rely upon to support reregistration of their products.
In the ANPRM, the Agency raised the possibility of requiring registrants to submit a registration review application. The registration review application could indicate which uses the registrant intends to support, identify applicable data requirements, and cite the studies used to satisfy these requirements. The registration review application could include additional information and data on the pesticide that has not already been submitted. The Agency hypothesized that requiring registrants to assemble information needed in the review could save the Agency's resources.
Comments to the ANPRM did not object to the idea of requiring registration review applications. In fact, several comments supported the idea and made suggestions regarding the required contents of a registration review application.
However, the PPDC believed that a requirement to submit registration review applications would be burdensome to registrants
eview could save the Agency's resources.
Comments to the ANPRM did not object to the idea of requiring registration review applications. In fact, several comments supported the idea and made suggestions regarding the required contents of a registration review application.
However, the PPDC believed that a requirement to submit registration review applications would be burdensome to registrants. Members of the PPDC stated their belief that registrants should not be required to identify data and other information they have already submitted and that the Agency has already accepted to support a pesticide's registration.
The Agency believes that administering a registration review application process could be quite resource intensive. The Agency would have to identify who is required to submit an application, notify them of the requirement, verify receipt of such notification, track submissions, and process submitted registration review applications. Additionally, the Agency would have to follow-up when a registrant fails to submit an application as required.
The Agency has considered the burden that requiring a registration review application would impose on registrants and the costs the Agency would incur to process such applications and finds that these costs outweigh the possible benefits of such a requirement. Accordingly, the Agency will not propose to require registration review applications.
2. The Agency might decide to base the scope/depth decision on a review of the material it has on hand . This may be sufficient in some cases, particularly for pesticides that pose minimal risk and for which there appears to be no information that would cause the Agency to reconsider its previous registration decision. However, the feasibility study showed that in many cases, early input from registrants or other stakeholders could help clarify the Agency's understanding use practices. Accordingly the Agency will not propose to forgo public participation at this stage of registration review.
3
which there appears to be no information that would cause the Agency to reconsider its previous registration decision. However, the feasibility study showed that in many cases, early input from registrants or other stakeholders could help clarify the Agency's understanding use practices. Accordingly the Agency will not propose to forgo public participation at this stage of registration review.
3. In comments on the ANPRM and in public meetings, stakeholders expressed their need to participate in the registration review process before the Agency makes a scope/depth decision . The Agency agrees that stakeholder input early in the process could improve the quality of the scope/depth decision and improve the efficiency of the review process. The Agency might also use submitted information when it conducts any new risk assessment that might be needed.
The PPDC has developed a number of recommendations as to how to manage various aspects of stakeholder participation at this stage--assembly of information for the registration review--such as:
• Advance notice of schedules so stakeholders can plan.
• Early consultation to clarify pesticide use and usage patterns.
• Early determination by Agency of data or information that might be useful in refining exposure assessments.
• Early determination of outstanding data requirements so that DCI notices can be sent out and studies required to be submitted in time for use in the registration review.
The Agency is proposing in § 155.50 of the regulatory text to provide opportunity for stakeholder participation in the information assembly stage of the process.
G. Managing the Registration Review of Individual Products
Consideration of individual products could occur at various stages of registration review. Before initiating a registration review, the Agency would
There are approximately 15,000 registered pesticide products subject to registration review
de opportunity for stakeholder participation in the information assembly stage of the process.
G. Managing the Registration Review of Individual Products
Consideration of individual products could occur at various stages of registration review. Before initiating a registration review, the Agency would
There are approximately 15,000 registered pesticide products subject to registration review. However, the Agency does not believe it is practical to conduct a comprehensive review of the composition, labeling, and product-specific data for each product. Clearly, it is necessary to assure that specific product labeling is consistent with the risk assessment regarding use directions and precautionary statements. Because pesticides undergoing registration review were registered or reregistered after 1984, the Agency expects that many pesticide products currently display up-to-date labels. As a result of reregistration, the current generation of product labels conform to labeling policy and are adequately supported by appropriate product-specific data. As discussed in Unit VII.B., the Agency would review a product's composition to confirm that the inert ingredients in the product have appropriate clearances for use in the product. The Agency might conduct a detailed review of a product if there are circumstances, such as a product registration that had not been amended in many years, that indicate that a review might be warranted.
The Agency expects to involve stakeholders in its decision regarding the scope and depth of product review in registration review. As described in Unit IX.I., the Agency will establish a docket for information that it intends to consider in a pesticide's registration review. This information may include product labels. Images of product labels are already available to the public on the Agency's website at: http://www.epa.gov/pesticides/pestlabels/
cision regarding the scope and depth of product review in registration review. As described in Unit IX.I., the Agency will establish a docket for information that it intends to consider in a pesticide's registration review. This information may include product labels. Images of product labels are already available to the public on the Agency's website at: http://www.epa.gov/pesticides/pestlabels/ . When commenting on the information in a pesticide's docket, stakeholders may advise the Agency of any issues that they have identified regarding the registration of products in the case, based on their own assessment of the information in the docket, and describe what they believe should be the scope and depth of the Agency's review of the products in the case.
H. Communicating the Results of a Registration Review
FIFRA section 3(g) does not specify how the Agency should communicate the results of a registration review to pesticide registrants or the public. The options range from publication of a comprehensive review document, modeled on the RED used in the reregistration program, to private communication with individual registrants, as is the current practice when the Agency reviews applications for registration actions. In order to satisfy its objectives for an open and transparent registration review process, the Agency believes that it should release to the public the results of the review of each registration review case and that the public should have the opportunity to comment on the Agency's draft conclusions before a decision regarding a pesticide's registration review becomes final.
VIII. Feasibility Study: Testing the Proposed Registration Review Decision Process
A. Design and Conduct of the Feasibility Study
The Agency conducted a feasibility study to test certain aspects of the decision process described in this regulation. A detailed description of this study is presented in the economic analysis for this proposed rule which is available in the public docket for this proposed regulation
tudy: Testing the Proposed Registration Review Decision Process
A. Design and Conduct of the Feasibility Study
The Agency conducted a feasibility study to test certain aspects of the decision process described in this regulation. A detailed description of this study is presented in the economic analysis for this proposed rule which is available in the public docket for this proposed regulation. The following discussion describes how the Agency conducted the feasibility study.
1. Draft a preliminary list of registration review cases . Using the criteria described in the proposed regulation, the Agency drafted a preliminary list of registration review cases and provisionally assigned baseline dates for each case.
2. Selection of cases for the feasibility study . The Agency randomly selected 30 cases from among the cases that, under the proposed scheduling procedures, would be scheduled for registration review in the first few years of the program. The proportions of conventional pesticides, biopesticides, and antimicrobial pesticides in the sample were roughly the same as the proportion of these categories of pesticides in the pesticide program.
3. Assess the regulatory status of the pesticide —a. Assemble information regarding: Current registrations and tolerances, including product labels; decision memos, reregistration eligibility decisions or tolerance reassessment decisions; pending registration actions; bibliography of submitted data; incident information or data submitted under FIFRA section 6(a)(2); and latest risk assessments for the pesticide.
b. Consult with others within the Office of Pesticide Programs (OPP) who review or regulate the pesticide. Because of time and resource constraints, OPP staff was unable to consult with other EPA program offices or other agencies. Under the proposed process, the Agency would consult with other EPA program offices and other agencies.
c
ion 6(a)(2); and latest risk assessments for the pesticide.
b. Consult with others within the Office of Pesticide Programs (OPP) who review or regulate the pesticide. Because of time and resource constraints, OPP staff was unable to consult with other EPA program offices or other agencies. Under the proposed process, the Agency would consult with other EPA program offices and other agencies.
c. Develop a summary of the information on the regulatory status of the pesticide, including a brief discussion of the risks or other issues identified.
d. Under the proposed registration review process, the Agency would establish a docket for the information on the regulatory status of the pesticide and ask for comment on it. At this stage in the proposed registration review process, the Agency might ask stakeholders to comment on specific issues, such as the use of the pesticide, that the Agency might have identified. The Agency did not seek stakeholder input in the feasibility study. Accordingly, the feasibility study was limited to data available in the Agency's files.
4. Determine whether the existing risk assessments meet current standards . Ask: What do we know and what do we need to know, and what would be the value of the new information?
a. Clarify the uses of the pesticide, using information on product labels without attempts at detailed interpretation. Determine whether there is a risk assessment to support each use of the pesticide. Account for the data requirements for all the uses. Determine whether there are any on-going studies required under a DCI or conditional registration.
b. Identify the changes in requirements, risk assessment methods, science policy, and regulatory policy that have occurred since the last regulatory decision
ation. Determine whether there is a risk assessment to support each use of the pesticide. Account for the data requirements for all the uses. Determine whether there are any on-going studies required under a DCI or conditional registration.
b. Identify the changes in requirements, risk assessment methods, science policy, and regulatory policy that have occurred since the last regulatory decision. For the feasibility study, the Agency identified changes since the publication of 40 CFR part 158 data requirements for pesticide registration in 1984, including: Introduction of a new paradigm for ecological risk assessment, 1993; introduction of short-term and intermediate-term human health risk assessments, 1995; worker protection standards in 40 CFR part 170, 1995; science policy changes arising from the passage of FQPA in 1996; EPA begins joint regulation of indirect food additives with FDA, 1996; introduction of probabilistic dietary risk assessments, 1998; and “counterpart” regulations regarding endangered species risk assessment, 2004.
c. In evaluating the risk assessment, consider the following factors, among other things: Are any existing data waivers still appropriate? Has the Agency established new data requirements for these uses? Has the Agency adopted new risk assessment methodology? Is there new information that suggests that the risk assessment should be revised?
d. In deciding whether to conduct a new risk assessment, consider the following factors, among other things: Is it likely that data from other sources--open literature, other government agencies--could address the uncertainties? Are new data or a new risk assessment likely to change a regulatory endpoint?
e. In the feasibility study, the Agency did not review new studies or conduct new risk assessments. Nor did it attempt to locate additional data or information by conducting searches of the open literature or consulting with other government agencies.
5
ure, other government agencies--could address the uncertainties? Are new data or a new risk assessment likely to change a regulatory endpoint?
e. In the feasibility study, the Agency did not review new studies or conduct new risk assessments. Nor did it attempt to locate additional data or information by conducting searches of the open literature or consulting with other government agencies.
5. Prepare a document summarizing the findings of each review conducted under the feasibility study.
B. Lessons Learned in the Feasibility Study
The Agency evaluated the results of the feasibility study to improve its understanding of how the registration review process might work. Some of the findings are described in this unit. The Agency anticipates that the registration review decision process would continue to evolve as the Agency implements the program and gains experience in conducting registration reviews. Accordingly, the feasibility study illustrates the kinds of issues that might occur in registration review but by no means identifies all the issues that could arise.
1. Case formation . To develop a list of candidates for the feasibility study, the Agency applied the procedures it is proposing for forming registration review cases, thereby testing the assumptions that it made in developing these procedures. Before releasing a draft list of registration review cases, the Agency will continue to refine the information that it will use to generate such a list.
2. Consultation with stakeholders . The feasibility study demonstrated the usefulness of early consultation with stakeholders. Such consultation would help resolve issues such as questions regarding formulation of the pesticide, ambiguous label language, and use and usage of the pesticide. Examples include:
a. In one case, an ambiguous statement on a product label implied that a pesticide could be used either indoors or outdoors. There were insufficient data to support the outdoor use
rly consultation with stakeholders. Such consultation would help resolve issues such as questions regarding formulation of the pesticide, ambiguous label language, and use and usage of the pesticide. Examples include:
a. In one case, an ambiguous statement on a product label implied that a pesticide could be used either indoors or outdoors. There were insufficient data to support the outdoor use. In another case, an ambiguous statement on the label implied that the pesticide might have residential exposures. Consultation with the registrants and other stakeholders could help to clarify whether the registrants intended the pesticides to be used outdoors or in the home and whether users actually used or intended to use the pesticides in these ways.
b. A pesticide was registered for greenhouse and shadehouse uses. When the shadehouse use was registered (or reregistered), the Agency considered use of a pesticide in a shadehouse to be an indoor use. Since then, the Agency has reclassified shadehouse use as an outdoor use. Much additional data would be required to support this outdoor use. Consultation with the registrant could help to clarify whether the registrant intends to support the outdoor use of the pesticide.
3. Determine whether the existing risk assessments meet current standards —a. Determine whether there is a risk assessment to support each use of the pesticide. In some cases, the Agency found that there was no assessment of occupational or residential exposures or ecological risk posed by one or more uses of the pesticide. In order to conduct a registration review, the Agency would need additional data to assess the risk posed by such uses.
b. Evaluate the risk assessment to see whether the methods used to perform the risk assessment meet current standards. As expected, the Agency found that human health risk assessments were generally acceptable and complete for pesticides for which tolerance reassessments had been completed. In such cases, there generally was no need for further analysis
ata to assess the risk posed by such uses.
b. Evaluate the risk assessment to see whether the methods used to perform the risk assessment meet current standards. As expected, the Agency found that human health risk assessments were generally acceptable and complete for pesticides for which tolerance reassessments had been completed. In such cases, there generally was no need for further analysis. In other cases, the Agency found that a new risk assessment method had supplanted the method used in the existing risk assessment. In these cases, the Agency performed further analysis to determine whether it would need additional data to conduct a new assessment.
c. Check whether there are incident reports or data submitted under FIFRA section 6(a)(2). In one case, incident reports underscored the Agency's concern that a metabolite or degradate of the pesticide may be more toxic than the parent. The Agency would require additional data to characterize the effects of the metabolite or degradate.
In several cases, the Agency found that studies had been submitted under FIFRA section 6(a)(2) but were judged as not needing expedited review and had not yet been reviewed. Such studies would be reviewed in registration review to confirm the Agency's finding, made when the studies were submitted, that the results of the study do not warrant revision of the Agency's regulatory decision.
d. Account for the data requirements for all the uses. In some cases, the Agency had received studies that had been required in a RED or a conditional registration but had not yet reviewed them. In other cases, the Agency identified new data gaps. New data gaps might occur under a number of circumstances, such as:
• The Agency previously determined that a particular study was not needed in order to register or reregister a use, but now finds that the study is required. This might happen because the Agency has developed a new method for assessing the risk posed by a particular use
them. In other cases, the Agency identified new data gaps. New data gaps might occur under a number of circumstances, such as:
• The Agency previously determined that a particular study was not needed in order to register or reregister a use, but now finds that the study is required. This might happen because the Agency has developed a new method for assessing the risk posed by a particular use. The data are needed to perform the new assessment and the Agency finds that it must conduct a risk assessment using the new method.
• The Agency finds that, because of changes in risk assessment methodology, a study that was adequate for use in an earlier risk assessment is inadequate for use in a new risk assessment.
• After registering or reregistering a particular use, the Agency reclassified the use into a different use category. The Agency requires more data to support uses in the new category than it does for uses in the former category.
e. Determine whether there are any on-going studies that the Agency required under a DCI or registration action. In some cases, the Agency found that studies needed to conduct a risk assessment were already required to support an application for registration of a new use or as a condition for registration under FIFRA section 3(c)(7). Where appropriate, the Agency would use such studies to support a review of existing uses as well as the new use or conditionally registered use.
f. Determine whether there are other potential sources of information that could address uncertainties identified in the review. Alternative sources of information might exist elsewhere in the Agency (i.e., outside of the Office of Pesticide Programs), other Federal agencies or the open literature. In the feasibility study, the Agency did not consult the open literature or anyone outside of the Office of Pesticide Programs.
g. Assess the value that would be provided by the new data or risk assessment
tified in the review. Alternative sources of information might exist elsewhere in the Agency (i.e., outside of the Office of Pesticide Programs), other Federal agencies or the open literature. In the feasibility study, the Agency did not consult the open literature or anyone outside of the Office of Pesticide Programs.
g. Assess the value that would be provided by the new data or risk assessment. To conduct this phase of a registration review assessment, the Agency would consider the significance of a data gap or outdated risk assessment in the context of everything else it knows about the pesticide. In many cases, the Agency found that the missing information was essential and that without this information, it would not be able to determine whether the pesticide continued to meet the requirements of registration in FIFRA section 3(c)(5). In other cases, the
4. Case studies . A summary of the results of the feasibility study was presented to the PPDC in 2004 and is available on the Agency's website at http://www.epa.gov/oppfead1/cb/ppdc/regisreview/regreview-update.pdf . Three case studies illustrate the effects of changes in requirements, risk assessment methods, and science or regulatory policy on risk assessments conducted before these changes occurred.
a. Case 1 . This herbicide was registered for cereal crop uses in the late 1980's. Since then no new uses have been granted. The tolerances for this pesticide were reevaluated in accordance with FQPA. The environmental fate and effects of this pesticide were reviewed at the time of initial registration. The feasibility study showed that the dietary risk assessment performed for the FQPA tolerance reassessment is still acceptable. The occupational risk assessment would need to be updated, but no new data would be required for this assessment. Because of changes in ecological risk assessment methods since the late 1980's, a new ecological risk assessment would need to be performed.
b. Case 2
on. The feasibility study showed that the dietary risk assessment performed for the FQPA tolerance reassessment is still acceptable. The occupational risk assessment would need to be updated, but no new data would be required for this assessment. Because of changes in ecological risk assessment methods since the late 1980's, a new ecological risk assessment would need to be performed.
b. Case 2 . This biological insect control agent is a pheromone registered in the 1970's and reregistered in the 1990's. It is always used in a trap at low rates and is not applied directly to food or feed. Although there have been many changes in requirements, risk assessment methods, and policy since this pesticide was reregistered, none of these changes affect the validity of the existing risk assessments for this pesticide and no additional data are needed.
c. Case 3 . This antimicrobial pesticide was registered in the mid-1980's and a RED was issued in the mid-1990's, before the passage of FQPA. It is used as an indirect food additive and has indoor residential uses such as use in cleaning products and as a disinfectant in ventilation systems, industrial uses, and outdoor uses. Because antimicrobial pesticides used as indirect food additives must now meet the safety standard of FQPA, a new dietary risk assessment would be required. FQPA dietary risk assessments assess aggregate risk from food, drinking water, and residential exposures. No new toxicity data would be required for this assessment, but residential exposure data would be needed. Worker exposure data would be needed for a new occupational risk assessment. Additional environmental fate data would be needed to support a drinking water exposure assessment and ecological risk assessment. Ecological effects data would be needed to support an ecological risk assessment.
IX. Proposed Procedures for Registration Review
A
sessment, but residential exposure data would be needed. Worker exposure data would be needed for a new occupational risk assessment. Additional environmental fate data would be needed to support a drinking water exposure assessment and ecological risk assessment. Ecological effects data would be needed to support an ecological risk assessment.
IX. Proposed Procedures for Registration Review
A. Purpose of Registration Review
In proposed § 155.40 of the regulatory text, the Agency states that the purpose of a pesticide's periodic registration review is to ensure that each pesticide's registration continues to satisfy the statutory standard for registration in FIFRA.
B. Establish Registration Review Cases
In § 155.42 of the regulatory text, the Agency proposes to establish registration review cases that contain one or more active ingredients and the products that contain those active ingredients. The Agency proposes to continue the reregistration program practice of grouping related active ingredients into cases (e.g., 2,4-D and its salts & esters), where the active ingredients in each case are so closely related in chemical structure and toxicological profile as to allow common use of some or all of the same required data for hazard assessment.
As noted in proposed § 155.42 of the regulatory text, from time to time, the Agency may modify a case by adding or deleting an active ingredient and its associated products, split a case into two different cases, or merge a case with another case.
The Agency would close a registration review case when all the products in the case have been canceled.
C. Establish Baseline Date for Each Case
The Agency proposes in § 155.42 of the regulatory text to use the earliest post-1984 registration or reregistration decision as the point of departure for scheduling registration reviews. The Agency will use the signature date of a pesticide's RED or IRED as the baseline date for a registration review case for a pesticide that was subject to reregistration
. Establish Baseline Date for Each Case
The Agency proposes in § 155.42 of the regulatory text to use the earliest post-1984 registration or reregistration decision as the point of departure for scheduling registration reviews. The Agency will use the signature date of a pesticide's RED or IRED as the baseline date for a registration review case for a pesticide that was subject to reregistration. If a pesticide's RED or IRED has not been completed by the time the registration review program begins, the Agency proposes to wait until it issues a reregistration decision before establishing a baseline date for such cases.
Once the Agency has assigned a baseline date to a case, it generally would not change this date when it modifies a case by adding or deleting ingredients or products to the case. When a registration review case is split into two or more cases, the new cases generally would keep the baseline date of the original registration review case. When two or more cases are merged, the Agency generally would use the baseline date of the case that had the earliest baseline date as the baseline date for the new case.
D. Maintaining Lists of Registration Review Cases
As provided in § 155.42 of the regulatory text, the Agency would maintain a list of registration review cases on its website.
E. Apply Scheduling Criteria to Create Schedules
Under § 155.44 of the regulatory text, the Agency proposes to base registration review schedules on baseline dates or, for subsequent registration reviews, the date of the latest registration review decision, and other factors. When developing schedules, the Agency would consider clustering cases belonging to the same chemical class to promote efficiency of review for the Agency and provide a “level playing field” for industry.
The Agency may take other factors into consideration when developing schedules for registration review
gistration reviews, the date of the latest registration review decision, and other factors. When developing schedules, the Agency would consider clustering cases belonging to the same chemical class to promote efficiency of review for the Agency and provide a “level playing field” for industry.
The Agency may take other factors into consideration when developing schedules for registration review. For example, the Agency's economic analysis of this proposed regulation suggested that a small business may be unduly burdened if it holds registrations in two or more registration review cases that are scheduled to undergo registration review in the same year. In such cases, the Agency may take into account when developing a schedule the potential burdens imposed on a small business (i.e., a business that meets criteria established by the Small Business Administration).
The Agency proposes to maintain registration review schedules on its website. The Agency expects to maintain schedules that list registration review cases scheduled for review in the current year and subsequent

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_05-13776. Check the current official text before relying on it. Not legal advice.