Pesticides; Procedural Regulations for Registration Review, 40251-40276 [05-13776]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 70, Number 133 (Wednesday, July 13, 2005)]
[Proposed Rules]
[Pages 40251-40276]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13776]


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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.

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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:https://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
     Agency Website:https://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 toopp-
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. 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 numberOPP-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 
https://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. Electronic files should avoid 
the use of special characters, any form of encryption, and be free of 
any defects or viruses. For additional information about EPA's public 
docket visit EDOCKET on-line or see the Federal Register of May 31, 
2002 (67 FR 38102) (FRL-7181-7).
    Docket: All documents in the docket are listed in the EDOCKET index 
at https://www.epa.gov/edocket/. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the Public Information and Records Integrity Branch (PIRIB), 
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This 
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The Docket telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Vivian Prunier, Field and External 
Affairs Division (7506C), 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 Sec.  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.

[[Page 40252]]

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (https://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at https://www.epa.gov/
fedrgstr/. A frequently updated electronic version of 40 CFR part 155 
is available at E-CFR Beta Site Two at https://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. 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. 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. 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. 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.

[[Page 40253]]

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. 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.
    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. 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. 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. The OECD's Vision

[[Page 40254]]

Document, which outlines the objectives of its harmonization program, 
specifies that individual countries will continue to conduct their own 
risk assessments, make their own regulatory decisions, and meet their 
own legal requirements. In January 2005, the EPA Acting Administrator 
and his Canadian counterpart announced their commitment to the Vision 
Document. More information about this harmonization program is 
available on the Agency's website at https://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. 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.
    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. 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. 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

[[Page 40255]]

from inadequate design, conduct, or reporting.
    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. 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. 
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. 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. 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. 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.

[[Page 40256]]

    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 avoidre-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. 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. 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: https://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. 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: https://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 
onrisk--``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.

[[Page 40257]]

    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 aFederal 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.
     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. 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. 
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:

[[Page 40258]]

     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 Sec.  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. 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.

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. 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

[[Page 40259]]

ingredient registration review cases, could support the Agency's goals 
regarding sound science. However, the Agency believes that this 
approach would not be practical and may not be appropriate. For 
example, the procedures proposed for establishing registration review 
cases, such as the proposed criteria for establishing the baseline date 
for a registration review case, would not work well for inert 
ingredients because it is often difficult to determine when registrants 
began to use an inert ingredient in registered products. Other proposed 
procedures, such as public identification of the products that belong 
in a registration review case, would not be appropriate for a 
registration review case composed of inert ingredients. Registrants 
consider the identity of the inert ingredients in their products to be 
trade secret, so the Agency must not disclose the products that belong 
in an inert ingredient registration review case. Thus, the Agency finds 
that it may not be practicable to establish a chemical case for an 
inert ingredient when it is not possible, for trade secret reasons, to 
identify products belonging to the case. The PPDC identified additional 
issues with this approach. It believes that because inert ingredients 
are ``cleared'' for use in pesticides and not registered, they are not 
subject to registration review. Accordingly, they believe it would be 
inappropriate to establish registration review cases for inert 
ingredients.
    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. 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.
    (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 Sec.  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.
    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,