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Pesticides; Procedural Regulations for Registration Review
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: July 13, 2005 (Volume 70, Number 133)]
[Proposed Rules]
[Page 40251-40276]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jy05-28]
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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:http://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
? Agency Website:http://www.regulations.gov/. 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
http://www.regulations.gov/, 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 http://www.regulations.gov/. 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 (http://www.regulations.gov/), 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. 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 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. 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: 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. 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://www.regulations.gov/.
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,
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.
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
[[Page 40260]]
difficult. For example, should the criteria give greater weight to
carcinogenic potential than to potential developmental toxicity? It
would be difficult to make such judgments in an objective way.
Furthermore, applying risk criteria to generate a schedule would be
extremely resource intensive because of the effort needed to develop
criteria, see whether each pesticide in the registration review
caseload meets the criteria, and to apply a scheme for ranking
pesticides that meet the criteria. The resulting schedule might be
challenged by stakeholders who believe that particular pesticides
should be placed higher or lower on the schedule.
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.
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 Sec. 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.
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.
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.
[[Page 40261]]
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. 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 Sec. 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. 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.
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. 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 Sec. 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
[[Page 40262]]
examine some or all product labels to ascertain the uses of the pesticide.
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/. 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. 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. 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. 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?
[[Page 40263]]
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. 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. 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. 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. 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. 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
[[Page 40264]]
Agency found that it could accept the uncertainty that would occur if a
particular risk assessment were not redone. For example, in one case,
the Agency judged that the surface water exposure assessment did not
meet current risk assessment guidance and that assessment as well as
the drinking water exposure assessment should be redone. Exposure
through drinking water accounted for less than 5% of human health risk,
but aquatic species could still be exposed through pesticide residues
in surface water. Accordingly, the Agency found that the human health
risk assessment was complete, but additional work was needed to
complete the ecological risk assessment.
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. 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. Purpose of Registration Review
In proposed Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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. 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 2 years.
[[Page 40265]]
F. Early Determination That a Registration Review is Complete and
Additional Review is Not Needed
When developing triennial schedules or at other times before or
during a pesticide's registration review, the Agency may determine that
there is no reason to reconsider a previous decision that a pesticide
satisfies the standard for registration. Under proposed Sec. 155.46,
the Agency may propose that, based on its determination that a
pesticide meets the FIFRA standard for registration, no further review
will be necessary. The Agency would take comment on this proposal and
issue a decision whether the pesticide's registration review is complete.
G. Early Determination of the Need for Additional Data or Information
The Agency and the PPDC agree that the Agency should have all the
data and information it needs to conduct a registration review before
it performs any new risk assessments or other analyses. The Agency will
use a number of approaches to identify and receive data or information
that it currently does not have but which it believes would be useful
in conducting a pesticide's registration review. Stakeholders have
advised the Agency that they could provide necessary data or
information if they have advance notice and guidance as to how to
prepare and submit such material.
The Agency expects that opportunities for engaging stakeholders in
the identification of data needs and in the development of new data or
information will become apparent as the program evolves. One such
opportunity may occur when the Agency releases registration review
schedules. When describing information that it does not have but
believes may be useful, if available, in a pesticide's registration
review, the Agency would provide guidance on how to prepare and submit
such information. The Agency expects that stakeholders will participate
in ways that promote a timely and productive exchange of views
regarding the data or information needed for a pesticide's registration
review.
H. Issue FIFRA Section 3(c)(2)(B) DCI Notices
There may be times when the Agency will be able to identify a data
requirement well in advance of a pesticide's scheduled registration
review. In such cases, the Agency might issue DCI notices to require
the data to be submitted before the Agency begins the registration
review. In some cases, the Agency may find in the course of a
registration review that additional data or information are needed to
complete the review. In other cases, the Agency may find that
additional data are needed to confirm findings made in the registration
review. Accordingly, in Sec. 155.48 of the regulatory text, the
proposed regulations stipulate that the Agency may use existing
authority to issue a DCI notice to require data for use in the
pesticide's registration review at any time before, during, or after
the registration review for a particular case. This proposed rule does
not, however, impose any requirements under FIFRA section 3(c)(2)(B).
I. Establish and Maintain a Registration Review Docket
The PPDC advised, and the Agency agrees, that the public should
have the opportunity to review the types of information and issues that
the Agency may consider in its forthcoming review of a registration
review case. Under proposed Sec. 155.50 of the regulatory text, the
Agency would establish and maintain a public docket for each
registration review case. In general, the docket would contain
information to establish the current regulatory status of pesticides in
the registration review case and information to indicate what has
changed since the last registration decision on the pesticide. The
Agency may create a case overview to identify the issues it may
consider in the registration review.
The Agency would place in the docket information regarding
currently registered uses of the pesticide. Among other things, the
docket would list current registrations and tolerances, registrants of
record, and documentation underlying current registrations and
tolerances such as the most recent risk assessments and bibliography.
For pesticides subject to reregistration under FIFRA section 4, the
docket might include the RED or IRED and supporting science chapters,
an assessment of cumulative risk for pesticides with a common mechanism
of toxicity, and risk assessments supporting any new uses or other
registration actions that have occurred since the signature date of the
reregistration decision.
The Agency would assemble and place in the docket information to
address the question: ``What has changed since the last assessment''?
This might include generic changes such as new data requirements or
risk assessment methods, new statutory mandates, new regulations, court
orders, or changes in policy regarding the risks and benefits of
pesticides.
There may be changes specific to the pesticide such as pending DCI
actions, tolerance petitions, new use applications subject to the
notification requirements in FIFRA section 3(c)(4), changes in use or
usage, registration of reduced-risk alternatives under FIFRA section
3(c)(10), risk assessments conducted by other agencies or governments,
incident data, data submitted under FIFRA section 6(a)(2), new hazard
data on a structurally related chemical, or information regarding
compliance or field experience.
The Agency would also place in the docket information relating to
the registration review of individual product registrations. This
information may include copies of product labels or links to a
publically available database that contains images of product labels.
Images of product labels are already available to the public on the
Agency's website at: http://www.epa.gov/pesticides/pestlabels/.
To the extent that the Agency can identify questions or issues when
the Agency first opens the docket for a particular registration review,
the Agency intends to place in the docket questions or issues it
identified while assembling information for a pesticide's registration
review. For example, the Agency may want to know how users interpret an
ambiguous label or it might need more precise information about how a
pesticide is used in order to decide what data requirements would apply.
The Agency also intends to place in the docket any new information
pertaining to the pesticide's registration review that it receives
during the pesticide's registration review, subject to applicable
protections like those imposed for CBI.
J. Other Things That Might Happen at this Stage of a Pesticide's
Registration Review
When assembling information relating to a pesticide's regulatory
status, or at any other time during a pesticide's registration review,
the Agency may find information that suggests that the Agency might
consider taking action under other existing authorities available
outside of the pesticide's registration review. The Agency may find,
for example, evidence that a registrant may have failed to complete one
of the following actions that were taken under other authorities:
? Comply with a FIFRA section 3(c)(2)(B) notice.
? Submit data required as a condition of registration under
FIFRA section 3(c)(7).
[[Page 40266]]
? Submit amended labels as required in reregistration or as
specified in a notice of intent to cancel.
? Label a product for restricted use if this was a condition
of registration or reregistration.
? Make label changes as required in a registration decision.
In such cases, the Agency would take appropriate action under other
existing authorities in FIFRA to assure compliance with existing
requirements.
K. Invite Review and Comment on the Registration Review Docket
After the Agency has assembled the information it intends to
consider in a pesticide's registration review, it proposes in Sec.
155.50 of the regulatory text to open the docket for each registration
review case for public review and comment for a period of at least 60
days. Stakeholders may submit comments on the accuracy and completeness
of information placed in the docket. At this point, registrants could,
among other things, check to see whether the bibliography lists each of
the studies they submitted and ascertain whether anything was omitted
from the listing of regulated uses.
The comment period for the registration review case docket is the
public's opportunity to submit information that responds to the
Agency's information needs identified in a notice described above in
Unit IX.G. or in the registration review case overview described above
in Unit IX.I. Interested persons may also submit information that they
believe may pertain to the pesticide's registration review.
L. Standards for Submitting Data or Information in Support of a
Pesticide's Registration Review
Registrants may submit data or information in support of a
pesticide's registration review. Since such submissions are already
governed by existing requirements, the Agency is proposing minimum
requirements in Sec. 155.50 of the regulatory text for material
submitted in support of a pesticide's registration review. Consistent
with existing requirements, the proposed requirements for registration
review are as follows:
? Submissions must be on time.
? Submissions must be in a useable and legible form. For
example, a written English translation must accompany material not
presented in English and a written English transcription must accompany
material presented in videographic or audiographic form.
? Submitters must clearly identify the source of the data or
information.
? A person may request the Agency to review material that it
rejected in a previous review. However, the submitter must explain why
he or she believes the Agency should reconsider the data or information
in the pesticide's registration review.
In addition to the requirements proposed in this procedural
regulation, the Agency has established other procedures or guidance for
submitting data or information that may apply to the submissions
described in this unit. For example, submitters to the docket should
follow the available instructions applicable to the submission method
used which are provided in the Federal Register notice, and made
available at: http://docket.epa.gov/edkpub/do/NoticeOfUse.
Additionally, the Agency requires that scientific data submitted in
support of a pesticide's registration meet the format requirements of
40 CFR 158.32.
M. Quality of Submitted Data or Information
In order to promote efficient use of scarce resources, the Agency
would screen all submissions in order to identify data or information
it believes should be considered in the pesticide's registration
review. In particular, the Agency would look for data or information
that may materially affect the Agency's review. The Agency would
consider, among other things, whether the submitted material is
reliable, relevant, and current.
N. Examples of Information That Could Materially Affect a Pesticide's
Registration Review
The Agency expects to use information on use or usage to refine
exposure estimates. Other information might be used to assess the
adequacy of risk mitigation measures or the benefits of the pesticide.
If new and safer alternatives to a pesticide have become available,
users might provide quantitative information about the benefits of a
pesticide to justify continued registration of a pesticide with known
high risks.
The Agency believes that stakeholders might be able to provide
several different kinds of information. Registrants might have studies
that they conducted for their own needs or to support a registration in
another country. Users, especially those with interests in minor or
specialty crops, could provide specific information about use and
usage. Mosquito control districts or other public health agencies could
provide information on the role of a pesticide in controlling pests
that spread disease. Commodity groups could contribute information
about the role of a pesticide in an integrated pest management program.
Labor groups could describe the practicality and effectiveness of the
worker protection measures required for the pesticide. USDA could
provide survey information developed in the Pesticide Data Program
(PDP) and use and usage information. The Interregional Research Project
No. 4 (IR-4 Program), in partnership with State lead agencies or public
health agencies, could provide residue or other exposure information.
O. Timely Submission of Data or Information
The Agency must receive pertinent data or information early in the
registration review process to assure that any risk assessment
conducted in registration review is based on the best data and
information available. The Agency is particularly concerned that
registrants and other stakeholders might not submit relevant data or
information until the Agency releases a draft risk assessment. The
Agency could then find that it needs to redo the risk assessments to
take into account the new data or information. Such rework delays
completion of the pesticide's review and ties up scarce resources.
In conducting a pesticide's registration review, the Agency will
generally rely on the data or information that it has on hand at the
close of the comment period. If data or information that could be used
to refine a risk assessment were not submitted by the close of the
comment period described in Unit IX.K. or by some other time that the
Agency may designate, the Agency would use data and information
available (or employ appropriate assumptions) in its risk assessments.
The Agency may consider late submissions under exceptional circumstances.
P. Public Participation, Stakeholder Engagement, and Consultation with
Other Government Agencies
1. Public participation. The PPDC advised the Agency to provide
opportunities for the public to review and comment on draft documents
that the Agency prepares during the registration review process. The
PPDC recommended that the Agency model public participation procedures
for registration review on the procedures adopted for reregistration
and tolerance reassessment and that the degree of public involvement
should be commensurate with the nature and complexity of the issues in
a registration review case. In public participation procedures
published in the Federal
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Register of May 14, 2004 (69 FR 26819) the Agency would have discretion
to decide when to seek public review and comment on draft documents
prepared for reregistration or tolerance reassessment decisions. These
documents would include draft risk assessments or draft regulatory
decisions.
In proposed Sec. 155.53, the Agency would generally ask for
comments on draft risk assessments in cases where a new risk assessment
was performed. In cases where the Agency's initial screening of a
pesticide indicates that it has low use/usage, affects few if any
stakeholders or members of the public, poses low risk and/or requires
little or no risk mitigation, the Agency might not ask for comments on
draft risk assessments at this stage. In such cases, the public would
be able to review and comment on the draft risk assessment when the
Agency releases a proposed decision for the registration review case.
2. Stakeholder engagement. The Agency intends to continue its
practice, established in the reregistration and tolerance reassessment
programs, of engaging stakeholders in making decisions regarding the
continued use of existing pesticides.
Before beginning a registration review, the Agency may convene a
meeting of registrants and representatives of pesticide user groups to
discuss a pesticide's use and usage. These discussions might guide the
registrant's decisions regarding which uses to support and inform the
Agency's exposure estimates. The Agency may consult with other Federal,
State or Tribal officials at this stage. For example, the Agency may
consult with the Centers for Disease Control regarding a public health
pesticide.
The Agency may engage stakeholders in the development of risk
mitigation measures for a pesticide. The Agency might discuss risk
management options with registrants and with pesticide users, public
interest groups, or other Federal, State or Tribal officials. The
Agency might convene a closure conference for all the interested
parties where it reviews the issues and proposes a resolution that is
based upon input from the interested parties.
The Agency expects to continue to be available, as it has been
during the reregistration and tolerance reassessment programs, to meet
with any interested party regarding a pesticide's registration review.
Under proposed Sec. 155.52, the Agency would place in the docket
minutes of meetings with persons outside of government where the
primary purpose of the meeting is to discuss a forthcoming or ongoing
registration review. Under this proposal, the Agency would place
minutes of such meetings in the docket when it releases a decision. At
its discretion, the Agency may place the minutes of such meetings in
the docket sooner.
In the course of a meeting with a person outside of government, the
Agency may provide that person with a copy of a document or other
written material that the Agency has not yet released to the public.
Similarly, a person outside of government may provide the Agency a copy
of a document or other written material not previously released to the
public. Under proposed Sec. 155.52, the Agency would place a copy of
the document or other written material in the registration review
docket for the pesticide along with the minutes of the meeting where
the documents were exchanged.
The Agency will not place CBI in the docket.
3. Consultation with other governments. The Agency may consult at
any time with the Departments of Health and Human Services,
Agriculture, Interior or other Federal, State or Tribal agency
regarding a pesticide's registration review. At its discretion, the
Agency may place minutes of meetings with government officials in the
pesticide's registration review docket.
Q. Conduct a Pesticide's Registration Review
1. Assess changes since the pesticide's last review. The Agency
proposes in Sec. 155.53 of the regulatory text to review the data and
information it possesses at the close of the comment period described
in Unit IX.K. In general, it would assess any changes that have
occurred since the Agency's last registration decision on the pesticide
in order to determine the significance of such changes and whether
additional review is needed to determine whether the pesticide meets
the FIFRA standard for registration. In this review, the Agency would
take into account, among other things, changes in statutes or
regulations, policy, risk assessment procedures or methods, or data
requirements. The Agency would consider whether new data or information
on the pesticide, including data or information submitted to the
docket, warrant conducting a new risk assessment or new risk/benefit
assessment. Deciding whether existing risk assessments meet current
standards is a key task in registration review.
Under proposed Sec. 155.53, the Agency would assess any changes
that may have occurred since an individual product's last registration
decision to determine whether the significance of these changes warrant
additional review of the product's registration. Changes affecting a
pesticide's product registration might include changes in statutes or
regulations, pesticide labeling requirements or policy, or product-
specific data requirements. The Agency would also consider whether new
data or information, such as data or information about an inert
ingredient in the pesticide product or other data or information
relating to the composition, labeling or use of the pesticide product
warrant additional review of the pesticide product's registration. The
Agency would also consider whether any new data or information
submitted during the comment period described in Unit IX.K. warrant
additional review of a product's registration.
The Agency might consider an additional review of some or all of
the products in a registration review case under the following
circumstances:
? Age of the label. It has been the Agency's practice, each
time a registrant applies to amend his/her product's registration, to
review the entire product label to assure that it complies with all
requirements and conforms to applicable guidance. Accordingly, the
labels of products with recent registration actions generally conform
to current requirements and labeling policy, but the labels of products
with no recent registration activity are likely to be outdated. The
Agency might review labels that have not been updated since it
established new requirements or adopted new policies that might affect
products in a registration review case.
? Concerns about other ingredients in the product. The
Agency may examine the composition of a product to see whether any of
the inert ingredients in a product are known or suspected to have risks
of concern and to assure that the inert ingredients have appropriate
clearances for use in pesticides, including any tolerance or tolerance
exemption that might be required. If the Agency has concerns about an
inert ingredient, it may require the registrant to remove that
ingredient from the product formulation or provide data to show that
risks posed by the product are acceptable. If the Agency finds that an
inert ingredient has not been cleared for a particular use, the Agency
might require the registrant either to petition for clearance, remove
the use from the product registration, or remove the ingredient from
the product's formulation.
? Concerns about product-specific data. The Agency may assess whether
[[Page 40268]]
product-specific data submitted or cited to support a product's
registration are appropriate. If the data are not appropriate, the
Agency would require submission of new data.
2. Conduct new assessments as needed. If the Agency decides that a
new assessment is needed, the Agency would ascertain whether it can
base the new assessment on available data or information, including
data or information submitted to the docket. If a new risk assessment
can be conducted with available data or information, the Agency would
do so. If the Agency believes that additional data or information are
needed to conduct the new risk assessment, the Agency would issue DCI
notices under FIFRA section 3(c)(2)(B).
R. What Happens When the Agency Finds That it Needs Additional Data to
Complete a Registration Review?
As described in proposed Sec. 155.48 of the regulatory text, the
Agency would issue DCI notices under its existing FIFRA section
3(c)(2)(B) authority when it finds that additional data are needed to
complete a registration review. Among other things, such notices would
establish deadlines for submitting the data.
In addition to issuing a DCI notice, the Agency may issue an
interim registration review decision when it is unable to complete a
pesticide's registration review because it does not have necessary data
or information to decide whether the pesticide meets the statutory
standard for registration in FIFRA. As proposed in Sec. 155.56 of the
regulatory text, the Agency would consider issuing an interim
registration review decision when it does not have the data necessary
to complete a registration review but it does have sufficient
information to determine that new risk mitigation measures are needed.
Among other things, an interim registration review decision could
utilize existing authorities to require new risk mitigation measures,
including interim risk reduction measures that must be adopted until
the Agency receives and reviews the data required to complete the
registration review and makes a final registration review decision. The
interim registration review decision might also include schedules for
submitting data, conducting new risk assessments, and completing the
registration review. It is important to note that any requirements
discussed in the interim registration review decision document are not
imposed by this proposed rule. Instead any such requirements would be
imposed through other existing authorities.
When issuing an interim registration review decision, the Agency
would follow the same procedures it proposes in Sec. 155.58 of the
regulatory text for issuing registration review decisions. These
proposed procedures are described in Unit IX.U.
S. Deciding Whether to Conduct a New Benefits Assessment
Under proposed Sec. 155.53, the Agency might conduct a new
benefits assessment when a pesticide is known to pose high risk and
there is new information about the benefits of using this pesticide.
The new information might include the availability of reduced-risk
alternatives. When a pesticide poses a risk of concern, the Agency
would consider the economic benefits of the pesticide under FIFRA
section 2(bb). It is important to note that the safety standard in
FFDCA section 408(b) precludes consideration of benefits for pesticides
used on, in, or around food. Nonetheless, the Agency may estimate the
economic benefits of a pesticide that does not meet the FFDCA standard
in order to manage transition from the pesticide to safer alternatives.
T. Possible Outcomes of a Pesticide's Registration Review
Under proposed Sec. 155.57, the Agency would complete a
pesticide's registration review after it performs all risk assessments
or benefit assessments that it deems to be necessary to determine
whether the pesticide meets the FIFRA standard for registration. As
discussed in this unit, the Agency has identified three possible
outcomes of a pesticide's registration review: (1) The pesticide meets
the requirements for registration in FIFRA and the registration review
is complete; (2) the pesticide does not meet the requirements for
registration in FIFRA and the registration review is complete; or (3)
the pesticide meets the requirements for registration in FIFRA section
(3)(c)(7), the registration review is complete, but may be revisited
when certain new data are submitted.
1. Registration review is complete and the pesticide meets the
requirements for registration in FIFRA. Using other available
authorities, the Agency may:
? Specify label changes or other measures or remedies to
mitigate a risk of concern and establish deadlines for taking the
specified actions;
? Specify label changes to bring the product label into
conformance with regulations or applicable policy; and/or
? Require new data to confirm the findings of a risk assessment.
2. Registration review is complete and the pesticide does not meet
the requirements for registration in FIFRA. Publication of notices
specified by other existing authorities in FIFRA section 6 might
precede, accompany, or follow the issuance of the registration review
decision, as appropriate. This outcome might occur under the following
circumstances:
? If previous risk assessments showed a risk of concern
associated with uses of the pesticide, but the use remained registered
because of the high benefits associated with the use, the Agency might
conduct a new benefits assessment under FIFRA section 2(bb). The new
benefits assessment may show that decreased benefits of the pesticide
or availability of alternatives no longer justify the risks associated
with continued use of the pesticide.
? In the course of a pesticide's registration review, the
Agency may find that use of a pesticide on food does not meet the
safety standard in FFDCA section 408 and that mitigation is neither
feasible nor sufficient to ameliorate the risk.
? In the course of a pesticide's registration review, the
Agency may find that use of a pesticide poses risks of concern to
workers or non-target species. If mitigation is neither feasible nor
sufficient to ameliorate the risk, the Agency would conduct a benefits
assessment under FIFRA section 2(bb) to determine if risks of continued
use of the pesticide outweigh the benefits.
3. Registration review is complete but may be revisited when new
data are submitted; the pesticide meets the requirements of FIFRA
section (3)(c)(7).
? The Agency may conclude a registration review in some
circumstances where a general DCI that was previously issued is still
in progress. The Agency might revisit the registration review decision
if warranted.
? The Agency might use other existing authority to ask for
data to confirm a particular aspect of a risk assessment or take any of
the other actions described above in Unit IX.T.1.
U. Issuing Registration Review Decisions
Under proposed Sec. 155.58, the Agency would issue a proposed
interim registration review decision or a proposed registration review
decision. The proposed decision would, among other things, state the
Agency's proposed findings with respect to the FIFRA standard for
registration, identify proposed risk mitigation, describe any
additional data that the Agency believes are needed, specify proposed
labeling changes, and identify deadlines the
[[Page 40269]]
Agency intends to set for taking the required actions. It is important
to note that any requirements discussed in the registration review
decision document are not imposed by this proposed procedural rule.
Instead such requirements would be imposed through other existing
authorities.
The Agency would take comment on the proposed decision and on the
data or information it considered in its proposed decision.
The Agency would issue a final decision and also make available the
Agency's response to comments on the proposed decision and an
explanation of any changes to the proposed decision.
V. Implementation of Registration Review Decisions and Interim
Registration Review Decisions
Under proposed Sec. 155.58, the registration review decision or
interim registration review decision would specify actions that a
registrant must take as prescribed under other existing authorities,
and establish deadlines for completing those actions. The docket for
the pesticide's registration review would remain open until the
registrant has completed the required actions. The Agency may initiate
appropriate action under other existing authorities and procedures
prescribed under FIFRA if a registrant fails to comply as required.
The Agency will continue to work with its partners in the States
and Tribes to assure that pesticides bear new labels as required and
that users comply with the directions on the pesticide label.
W. Program Evaluation
The Agency plans to periodically evaluate the registration review
process. The Agency will develop methods to analyze various aspects of
the registration review program. For example, the Agency intends to
assess the extent to which data that it required for a pesticide's
registration review affected the risk assessment.
The Agency may also assess guidance it provides to registrants and
the public regarding their participation in a pesticide's registration
review in order to improve the utility of the information that
stakeholders prepare for submission to the Agency.
The Agency might evaluate the information management systems used
to receive and store information relating to a pesticide's registration
review in order to achieve process efficiencies and improve public
access, where appropriate, to information in these systems.
As required under the Government Performance and Results Act, the
Agency will develop methods to measure the public benefits of the
program. Benefits might include public health and environmental
improvements resulting from identification, assessment, and mitigation
of previously unrecognized or poorly understood risks; increased public
confidence in the safety of pesticides; improvements in pesticide
labeling and risk communication; improved information about pesticides
for informing market choice; and improved corporate stewardship of
pesticides, as follows:
? Public health and environment--periodic review might
uncover previously unrecognized or poorly understood risks, determine
whether the appearance of new alternatives since the last review would
change the risk/benefit balance, and function as a safety net to help
assure that nothing important was overlooked.
? Economic benefits--periodic review could maintain a stable
market for pesticide users. Continued availability of a variety of
products could promote competition and reduce the price of pesticides.
? Improved stewardship--because registration review
decisions would be made through transparent procedures with public
involvement, the Agency's and stakeholders' practices and positions
would also be visible and subject to public scrutiny. The Agency
anticipates that this visibility could enhance corporate responsibility
and accountability regarding keeping a pesticide's database and product
labeling up-to-date. The Agency also anticipates that continual public
discourse regarding pesticide use might facilitate an exchange of ideas
within the pesticide user community regarding best practices. If this
were to happen, the environmental burden might decline.
? Continuous improvement of the reliability of Agency
decisions about pesticides--when a registration review decision shows
that no changes are necessary, the public is assured that the decision
to continue the registration of the pesticide is based on a finding
that the pesticide meets current standards and remains current with
evolving science.
? Conserve public resources--periodic review would limit or
nearly eliminate the need to conduct a resource-intensive comprehensive
review of all pesticides such as reregistration or tolerance reassessment.
X. Request for Comment
In the proposed process, the Agency is seeking to balance a
registrant's or pesticide user's need for specific standards against
the Agency's need for flexibility to revise these standards in light of
knowledge gained through evolving science.
The Agency proposes to inform the public of changes in statute,
regulations, data requirements, risk assessment methods, and science
policy, among other things, that the Agency will consider in its
determination whether the pesticide continues to meet the FIFRA
standard for registration. Under this proposal, the Agency would judge
whether these changes are significant enough to warrant conducting a
new risk assessment to use as a basis for determining whether the
pesticide continues to meet the FIFRA standard for registration. Under
the proposal, such determinations would be made on a case-by-case
basis, where the Agency considers what is already known about the
pesticide and evaluates whether new information, including a new risk
assessment which might be conducted using a new method or data, would
change the Agency's regulatory position on the pesticide.
The Agency recognizes it is essential that decisions about the
significance of the changes in statute, regulations, data requirements,
risk assessment methods, science policy, and other things considered in
a registration review be consistent. For example, the public should be
able to understand why a change in risk assessment procedures warrants
a new risk assessment in one case and not in another. The Agency
believes that it would not be practical to anticipate all possible
contingencies in order to establish criteria for deciding the
significance of the changes described in this unit. The Agency will
continue to rely on its internal procedures for peer and managerial
review to assure that its decisions are consistent. Additionally, the
Agency is proposing a transparent process in which the Agency would
show the information that it considered and would produce decision
documents that would explain its reasoning. The Agency is proposing an
open process in which the public has the opportunity to review and
comment on draft risk assessments and draft registration review
decisions. The public would have the opportunity to comment on the
consistency of a proposed decision. Finally, the Agency intends to
monitor and evaluate the registration review program. Such evaluations
may include assessments of the procedures used to promote and assure
consistency in its decision-making.
The Agency encourages you to comment on its approach for balancing
the registrant's or pesticide user's need
[[Page 40270]]
for specific standards with the Agency's need for flexibility to revise
these standards in light of knowledge gained through evolving science.
XI. Relationship of Registration Review to Other Pesticide Program
Activities
Registration review is intended to be a periodic review to assure
that a registered pesticide continues to meet the FIFRA standard for
registration. However, to the extent practicable, the Agency also
intends to use registration review as a context for performing other
risk assessment, benefit assessment, and risk management work. For
example, the Agency has evolving or new programs concerning existing
pesticides such as conducting assessments of pesticide risks to
threatened or endangered species, conducting endocrine disruptor
screening and testing, or assuring that certain tolerances are reviewed
every 5 years as required by FFDCA section 408(b). The Agency will
continue to use a variety of approaches to manage these requirements,
including incorporating these activities into the registration review
program.
In proposing the procedures for implementing the registration
review program, this proposed rule does not impose new requirements on
the regulated community. Instead, should the Agency determine the need
to impose requirements during a registration review, e.g., to generate
data or amend the label or registration, the Agency will utilize other
existing authorities, e.g., using FIFRA section 3(c)(2)(B) authority to
obtain needed data.
A. Relationship to Tolerance Reassessment and Reregistration
The registration review program is a brand new program that will
begin after the Agency completes tolerance reassessment in 2006. The
Agency will begin implementing the registration review program while it
completes the reregistration program. The Agency expects to complete
the last reregistration eligibility decision by September 2008.
B. Relationship of Registration Review to Existing Procedures for
Managing Emerging Risk Concerns
The Agency has a continuing obligation to respond to emerging risk
concerns. At any time, the Agency may receive new information that
suggests that the Agency should reevaluate a previous decision to
register a pesticide. After the registration review program begins, the
Agency will continue to give priority to emerging risk concerns. In
establishing the requirement to conduct registration review, FIFRA
section 3(g) states that nothing shall prohibit the Agency from
undertaking any other review under FIFRA. Among other things, this
provision means that the Agency must continue to respond to emerging
risk concerns and not defer action until a pesticide's regularly
scheduled registration review.
FIFRA section 6(a)(2) requires registrants to submit factual
information regarding a pesticide's unreasonable risk of adverse
effects on the environment. The Agency has codified in 40 CFR part 159
its criteria for identifying information that must be reported under
FIFRA section 6(a)(2) and the procedures for submitting such
information. The Agency also responds to reports from other sources,
such as other governmental agencies or academic researchers. The Agency
is continuously seeking to improve systems that capture and report
adverse events relating to pesticide risks.
When the Agency learns of new information that could significantly
change its understanding of a pesticide's risk, it uses triage systems
to evaluate the information to gauge the importance of the issue and
the need for urgent response. The process the Agency uses to assess the
significance of adverse effects information reported under FIFRA
section 6(a)(2) is one example of a triage system. When the Agency
receives a (6)(a)(2) report, it reviews the reported results of the
study and asks: ``If this study is a scientifically valid study, would
the Agency revise its regulatory position on the basis of this report''
If so, the Agency expedites a full review of the study and takes other
action as appropriate.
Although the Agency will not postpone responding to an urgent risk
concern until the pesticide's regularly scheduled registration review,
the Agency may reschedule a pesticide's registration review because of
a new risk concern. For example, if the Agency is reviewing a pesticide
because of a new risk concern, it may decide to conduct the pesticide's
registration review at the same time, even though the registration
review would occur several years ahead of schedule. Since the Agency
must expend resources to address a pesticide's urgent risk concern, it
may opt to review all other aspects of the pesticide's registration at
that time.
C. Managing New Data Needs
New data needs may arise from new statutory requirements, such as
the screening and testing program for endocrine disruptor effects
mandated in FFDCA section 408(p); new regulations, such as amendments
to 40 CFR part 158; or changes in science policy. This proposed rule
does not change the authority or existing process for identifying new
data needs. The Agency will continue to use a variety of approaches,
including registration review, to address an identified need for new
data requirements for existing pesticides. The following are some of
the approaches the Agency might use to manage DCIs issued under
existing FIFRA section 3(c)(2)(B) authority.
? Special DCI projects. The Agency may respond to a new data
requirement by issuing DCI notices to registrants of all affected
pesticides simultaneously, without regard to the registration review
schedule. The Agency might use this approach when a data requirement
applies to a class of pesticides, i.e., pesticides with particular
chemical characteristics or use pattern, and the Agency urgently needs
the data to address a risk concern.
? Pipeline DCIs. The Agency might issue DCI notices for new
data requirements 2 or 3 years before a pesticide's scheduled
registration review so that the data would be required to be submitted
in time for the registration review. This approach is particularly
useful when a new data requirement applies to virtually all pesticides
and is so new and different that it generally cannot be satisfied by
previously submitted data. For instance, this approach might be used to
obtain endocrine disruptor screening and testing data required under
FFDCA section 408(p).
? Conditional registration of new uses. When the Agency
identifies a data gap in the course of reviewing an application for a
new use, it may make approval of the new use conditional on the receipt
of data to satisfy the data requirement. These data would then be
available when the Agency conducts a registration review of the pesticide.
? Call-in the data as part of a regularly scheduled
registration review. Identifying a data gap generally requires a lot of
resources. In most situations, the Agency must conduct a review to
determine whether a data requirement applies, and if so, whether it can
be satisfied with existing data and who should be required to provide
the data. It may be more efficient to conduct such an analysis in the
context of a regularly scheduled registration review.
D. Relationship to Reviews of Applications for Registration of New Uses
The Agency will not delay registration of a new use of a pesticide
while conducting the registration review of the
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pesticide. It will consider, however, whether reviewing the new use and
the existing uses together would be an efficient use of resources and
produce a better decision. When beginning a pesticide's registration
review, the Agency would note any pending applications for registering
a significant new use. If an application for registering a new use
arrives during the pesticide's registration review, the Agency would
post this information in the pesticide's registration review docket.
The Agency would, to the extent practicable, include the application
for the new use in its registration review considerations.
E. Relationship to Special Review
The Agency expects any current special reviews to be resolved
through the reregistration program. As a matter of policy, the Agency
does not use special review procedures in 40 CFR part 154 when it
receives new information regarding an urgent and serious risk. In such
cases, the Agency uses procedures under FIFRA section 6 to resolve the
risk concern as expeditiously as possible.
The PPDC suggested that a decision to initiate a special review
might be an outcome of a pesticide's registration review. The PPDC
believed that special review may be appropriate in cases where further
study, possibly including developing new scientific approaches, is
needed to resolve questions raised about the pesticide.
If a pesticide presents an issue that is too complex to be resolved
in the time frame allocated for a pesticide's registration review, the
Agency might issue an interim registration review decision, with a plan
for addressing the unresolved issues. The plan could include a schedule
for developing a scientifically sound approach for resolving the issue
and require periodic reports on progress toward resolution. Because the
proposed registration review procedures would provide an open and
transparent process for resolving the issue, the Agency believes that
may not be necessary to use special review procedures to complete the
review.
F. Managing Potential Risks of Substitute Pesticides
In managing the potential risks identified in a pesticide's
registration review, one or more of a pesticide's uses might be
voluntarily canceled or amended. In addition, the Agency might take
action under FIFRA section 6 procedures to cancel a use that poses
risks of concern. In either case, there is a possibility that a
pesticide posing greater risks could replace the canceled use. Shifting
the market to a potentially more harmful pesticide could be an
unintended consequence of registration review.
The Agency believes that shifting the market to a potentially more
harmful pesticide is less likely to occur under the proposed approach
for scheduling registration review than under other scheduling
approaches. The Agency proposes to review the oldest pesticides first,
i.e., pesticides with the earliest dates of reregistration or post-1984
registration. The pesticides that could be substitutes for these older
pesticides are pesticides that the Agency has reviewed more recently
through registration or reregistration, based on more recent data
requirements and using more recent risk assessment methodology.
Additionally, many of the pesticides registered since 1996 are reduced-
risk pesticides. The risks of the potential substitutes are, therefore,
well characterized and appropriately managed.
As science advances, the Agency may modify its data requirements to
add new tests that measure hazard endpoints that may not be captured by
current test methods. As discussed in Unit IX.H., the Agency proposes
to require submission of such studies during registration review, when
necessary to conduct a pesticide's review. A pesticide registrant may
choose to cancel a pesticide use rather than conduct the required
testing. Or the new test may show that a use must be canceled or
amended to mitigate a new risk concern. In either event, it is possible
that the market might shift to a pesticide that has not been tested for
the new hazard endpoint. However, as the Agency gains experience with
the new test method, it may acquire information that it could use to
set priorities for testing and conduct a special DCI project to require
testing of high priority pesticides. This activity could reduce the
tendency of the market to shift to an untested pesticide.
The Agency has several approaches for minimizing the likelihood of
a market shift to a more risky or untested pesticide, as follows.
1. Assessing risks of substitutes. When the Agency is considering
canceling a use under FIFRA section 6, it must assess the benefits of
the use to determine whether the risks and benefits of the pesticide
warrant cancellation. This assessment generally entails identifying
pesticides that could substitute for the canceled use. When analyzing
benefits under FIFRA section 6, the Agency checks to see whether any of
the substitutes pose higher risks than the pesticide being considered
for cancellation.
Although the Agency does not analyze benefits when a registrant
requests voluntary cancellation of a pesticide, the Agency provides the
public an opportunity to comment on the proposed cancellation under
FIFRA section 6(f). Under the proposed procedures for registration
review, the Agency would also provide an opportunity for the public to
comment on any Agency proposal to place restrictions on the use of a
pesticide. Users or other stakeholders may describe any concerns they
might have regarding the availability of substitutes if the Agency
cancels or places restrictions on a use.
Depending on the seriousness of the potential risk posed by a
substitute pesticide, the Agency could take action as follows:
? Issue a FIFRA section 3(c)(2)(B) DCI notice requiring data
to characterize the potential risk of the substitute pesticide;
? Advance the registration review schedule for the
substitute pesticide; or
? Manage the risk posed by the substitute pesticide
generally in a process outside of registration review.
2. Group pesticides by chemical class or use cluster. When
feasible, the Agency may group pesticides for registration review by
chemical class allowing all the chemicals in that class to be reviewed
together and making it possible to address any risks posed by
pesticides in that class at the same time. This would be most useful
when pesticides in a chemical class are used interchangeably. This
procedure would reduce concerns regarding unreviewed substitutes.
When feasible, the Agency may group pesticides by use cluster. For
example, in the reregistration program, the Agency grouped soil
fumigants, wood preservatives, and rodenticides. Since pesticides in a
use cluster may be used interchangeably, such a procedure would reduce
concerns regarding unreviewed substitutes.
The Agency believes the chronological approach to scheduling
registration review cases is even-handed and practicable for managing
the program's expected workload. However, EPA also realizes that
relying exclusively on such an approach may not work in all cases. When
necessary, the Agency may elect to take cases out of the original,
chronological sequence for risk concerns or other factors. While doing
so would be the exception, rather than the rule, there may arise
circumstances that in the judgement of the Agency warrant changes to
the schedule and require additional
[[Page 40272]]
analysis, including an evaluation of risks to substitute pesticides.
Nonetheless, the Agency does not anticipate doing an extensive
alternatives assessment as a regular feature of registration review
because doing so would disrupt the regular scheduling of registration
review that the Agency, industry, and other stakeholders rely upon to
plan for a pesticide's registration review.
XII. Phase-in of Registration Review Program
The Agency plans to begin the registration review program in
September 2006. To the extent possible, the Agency expects to prepare
for transition to this program while completing the procedural rule.
A. Developing Procedures for Establishing Registration Review Cases
This proposal describes procedures for establishing registration
review cases and assigning baseline dates for each registration review
case. The Agency may use the proposed procedures to create a
preliminary list of registration review cases. The purpose of this
project would be to develop internal processes for creating a list of
registration review cases. The Agency may release this list for public
review and comment.
B. Feasibility Studies to Test the Proposed Registration Review Process
As described elsewhere in this preamble, the Agency conducted a
feasibility study to test the registration review decision process.
This project also produced data to support development of the economic
assessment that accompanies this proposed rule.
The Agency may conduct other projects to examine other aspects of
the registration review process. For example, the Agency might conduct
a feasibility study to see how early consultation might affect the
outcome of the registration review decision process.
C. Data Call-In Projects
The Agency may issue DCI notices under existing FIFRA section
3(c)(2)(B) authority to obtain data it believes to be necessary to
support the registration of certain pesticides. After the registration
review procedural regulations go into effect, such pesticides might become
candidates for registration review in the early years of the program.
XIII. FIFRA Review Requirements
In accordance with FIFRA section 25(a), this proposal was submitted
to the FIFRA Science Advisory Panel (SAP), the Secretary of Agriculture
(USDA), and appropriate Congressional Committees. The SAP has waived
its review of this proposal, and no comments were received from any of
the Congressional Committees or USDA.
XIV. Statutory and Executive Order Reviews
A. Executive Order 12866
Pursuant to Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has designated this proposed rule as a ``significant
regulatory action'' under section 3(f) of the Executive Order because
it may raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order. This action was therefore submitted to OMB for
review under this Executive Order, and any changes to this document
made at the suggestion of OMB have been documented in the public docket
for this rulemaking.
EPA has prepared an economic analysis of the potential impacts of
the registration review procedures, if implemented as proposed. In
addition to the requirements contained in this proposed rule, the
Agency analyzed other potential actions that could occur during a
registration review using other existing authorities that are not
proposed or otherwise changed in this proposed rule. The Agency's
analysis, therefore, considers the potential impact of the registration
review process, which includes the costs of a registrant's
participation in the public review components of the process described
in this proposed rule and other potential requirements imposed by
existing authorities such as data generation under FIFRA section
3(c)(2)(B). This analysis is contained in a document entitled Economic
Analysis of the Proposed Procedural Regulations for the Registration
Review of Pesticides. A copy of this Economic Analysis is available in
the public docket for this action and is briefly summarized here.
The proposed rule does not require registrants to take specific
action as part of the review of a pesticide registration; however, the
Agency's analysis assumes that registrants will engage in their own
evaluation of information provided by the Agency and other
stakeholders, and participate in the public process described in this
proposed rule. The Agency estimates such industry costs to be around
$1.2 million annually.
The Agency recognizes that under other existing authorities a
registrant may also need to submit data that they have or generate data
as necessary to support the registration. As such, the analysis also
considers the potential cost to industry from other anticipated
activities under existing authorities that may occur during the
registration review process, although such activities are not proposed
requirements in this rulemaking. These activities include potential
data submission or generation activities related to DCIs, including the
paperwork burden, and other activities that might occur under other
existing authorities.
Considering these other potential activities, the analysis shows an
estimated total annual cost to industry of about $50 million, with the
estimates for potential data generation activities accounting for
approximately 70% of these costs. The Agency estimates about 68
companies will be impacted each year; thus, per-company costs for the
entire registration review process are likely to average less than
$750,000 each year, even though some companies may have multiple
chemicals under review during the year. Out of the universe of 2,000
small businesses estimated to hold pesticide registrations, the Agency
estimates that only about 30 small businesses might be involved in a
registration review each year. Assuming the same level of participation
and potential need to generate data, the estimated average cost of the
registration review process is estimated to be less than 2% of the
gross sales for small businesses.
B. Paperwork Reduction Act
The information collection activities associated with the
registration review program are already approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act, 44
U.S.C. 3501 et seq. That Information Collection Request (ICR) document
has been assigned EPA ICR number 0922.07, and OMB control number 2070-
0057. Although this action does not impose any new information
collection requirements that would require additional approval by OMB,
the Agency expects the approved burden estimate to increase with the
full implementation of the registration review process. A copy of the
OMB approved ICR has been placed in the public docket for this proposed
rule, and the Agency's estimated burden increase is presented in the
economic analysis that has been prepared for this proposed rule.
Under the currently approved ICR, the Agency estimated the annual
respondent burden for information collection activities associated with
the registration review program to average
[[Page 40273]]
63,780 hours, with an estimated total annual respondent cost of
$5,769,960. As detailed in the Economic Analysis prepared for this
proposed rule, the annual respondent burden for information collection
activities associated with the registration review program is estimated
to increase to an average 120,000 hours, with an estimated total annual
respondent cost of $10,800,000. The increase in the annual burden and
costs for the information collection activities associated with the
registration review program (revised as appropriate) will be
incorporated into the existing ICR when the final rule is promulgated.
Under the PRA, ``burden'' means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
or disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of information; and transmit or otherwise disclose the
information.
An agency may not conduct or sponsor, and a person is not required
to respond to an ICR unless it displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in 40 CFR, after
appearing in the preamble of the final rule, are listed in 40 CFR part
9 and included on any related collection instrument (e.g., on the form
or survey).
Submit any comments on the Agency's need for this information, the
accuracy of the provided burden estimates, and any suggested methods
for minimizing respondent burden, including the use of automated
collection techniques, along with your comments on the proposed rule as
instructed under ADDRESSES. The Agency will consider any comments
related to the information collection requirements contained in this
proposal as it develops the final rule. Any changes to the burden
estimate for the ICR will be effectuated with the final rule.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., the Agency hereby certifies that this proposal
will not have a significant adverse economic impact on a substantial
number of small entities. This proposed rule defines the procedures
that EPA will follow to implement the statutory registration review
provision. It does not impose any new requirements on the regulated
community.
This proposal does not have direct adverse impacts on small
businesses, small non-profit organizations, or small local governments.
For purposes of assessing the impacts of today's proposed rule on small
entities, small entity is defined as: (1) A small business as defined
by the Small Business Administration's (SBA) regulations at 13 CFR
121.201, which for the pesticide industry consists of businesses with
fewer than 500 to 1,000 employees (range is based on NAICS sector
variations); (2) a small governmental jurisdiction that is a government
of a city, county, town, school district or special district with a
population of less than 50,000; and (3) a small organization that is
any not-for-profit enterprise which is independently owned and operated
and is not dominant in its field. The regulated community does not
include any small governmental jurisdictions or small not-for-profit
organizations.
D. Unfunded Mandates Reform Act
Under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA)
(Public Law 104-4), EPA has determined that this action does not
contain a Federal mandate that may result in expenditures of $100
million or more for State, local, and Tribal governments, in the
aggregate, or the private sector in any 1 year. As described in Unit
XIV.A., this proposed rule is not expected to result in such
expenditures. In addition, this action will not impact small
governments, or local or Tribal governments. Accordingly, this proposed
rule is not subject to the requirements of sections 202, 203, 204, and
205 of UMRA.
E. Executive Order 13132
Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999), EPA has determined that this proposed rule
does not have ``federalism implications,'' because it will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in the Order. Thus, Executive Order 13132 does not apply to
this proposed rule.
F. Executive Order 13175
As required by Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (59 FR 22951, November 6,
2000), EPA has determined that this proposed rule does not have Tribal
implications because it will not have any affect on Tribal governments,
on the relationship between the Federal government and the Indian
tribes, or on the distribution of power and responsibilities between
the Federal government and Indian tribes, as specified in the Order.
Thus, Executive Order 13175 does not apply to this proposed rule.
G. Executive Order 13211
This proposed rule is not subject to Executive Order 13211,
entitledActions Concerning Regulations that Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001) because it is
not designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866 (see Unit XIV.A.), nor is it likely to
have any significant adverse effect on the supply, distribution, or use
of energy.
H. Executive Order 13045
Executive Order 13045, entitledProtection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997) does not apply to this proposed rule because this action is not
designated as an ``economically significant'' regulatory action as
defined by Executive Order 12866 (see Unit XIV.A.), nor does it
establish an environmental standard, or otherwise have a
disproportionate effect on children.
I. National Technology Transfer and Advancement Act
Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), 15 U.S.C. 272 note) directs EPA to use voluntary
consensus standards in its regulatory activities unless to do so would
be inconsistent with applicable law or impractical. Voluntary consensus
standards are technical standards (e.g., materials specifications, test
methods, sampling procedures) that are developed or adopted by
voluntary consensus standards bodies. This proposed rule does not
impose any technical standards that would require EPA to consider any
voluntary consensus standards.
J. Executive Order 12898
This proposed rule does not have an adverse impact on the environmental
[[Page 40274]]
and health conditions in low-income and minority communities.
Therefore, under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), the Agency does not need
to consider environmental justice-related issues.
List of Subjects in 40 CFR Part 155
Environmental protection, Administrative practice and procedure,
Pesticides and pests.
Dated: July 6, 2005.
Stephen L. Johnson,
Administrator.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
PART 155--[AMENDED]
1. The authority citation for part 155 will continue to read as
follows:
Authority: FIFRA 136a.
2. By adding a new subpart C to read as follows:
Subpart C--Registration Review Procedures
Sec.
155.40 General.
155.42 Registration review cases.
155.44 Establish schedules for registration review.
155.46 Deciding that a registration review is complete and
additional review is not needed.
155.48 Data Call-In before, during, or after a registration review.
155.50 Initiate a pesticide's registration review.
155.52 Stakeholder engagement.
155.53 Conduct a pesticide's registration review.
155.56 Interim registration review decision.
155.57 Registration review decision.
155.58 Procedures for issuing a decision on a registration review case.
Subpart C--Registration Review Procedures
Sec. 155.40 General.
(a) Purpose. These regulations establish procedures for the
registration review program required in FIFRA section 3(g).
Registration review is the periodic review of a pesticide's
registration to ensure that each pesticide registration continues to
satisfy the FIFRA standard for registration. The goal of the
registration review procedures is review of each pesticide's
registration every 15 years.
(1) Among other things, FIFRA requires that a pesticide generally
will not cause unreasonable adverse effects on the environment.
Registration review is intended to ensure that each pesticide's
registration is based on current scientific and other knowledge
regarding the pesticide, including its effects on human health and the
environment.
(2) If a product fails to satisfy the FIFRA standard for
registration, the product's registration may be subject to cancellation
or other remedies under FIFRA.
(b) Applicability. This subpart applies to every pesticide product
registered under FIFRA section 3 as well as all pesticide products
registered under FIFRA section 24(c). It does not apply to products
whose sale or distribution is authorized under FIFRA section 5 or
section 18.
(c) Limitations. (1) At any time, the Agency may undertake any
other review of a pesticide under FIFRA, irrespective of the pesticide's
past, ongoing, scheduled, or not yet scheduled registration review.
(2) When the Agency determines that new data or information are
necessary for a pesticide's registration review, it will require such
data under FIFRA section 3(c)(2)(B).
Sec. 155.42 Registration review cases.
(a) Establishing registration review cases. A registration review
case will be composed of one or more active ingredients and all the
products containing such ingredient(s). The Agency may group related
active ingredients into a registration review case when the active
ingredients are so closely related in chemical structure and
toxicological profile as to allow common use of some or all required
data for hazard assessment.
(1) Existing pesticides. The Agency will assign each pesticide
registered on or before the effective date of this regulation to a
registration review case.
(2) New pesticides. The Agency will assign each pesticide
registered after the effective date of this regulation to an existing
registration review case or to a new registration review case.
(3) A pesticide product that contains multiple active ingredients
will belong to the registration review cases for each of its active
ingredients.
(b) Modifying registration review cases. New data or information
may suggest that a registration review case should be modified. The
Agency may modify a registration review case in the following ways:
(1) Add a new active ingredient to a registration review case. The
Agency may determine that a new active ingredient is chemically and
toxicologically similar to active ingredients in an existing
registration review case and should be grouped with the ingredients in
the existing registration review case.
(2) Split a registration review case into two or more registration
review cases. For example, new data or information may suggest that
active ingredients in a registration review case are not as similar as
previously believed and that they belong in two or more separate
registration review cases.
(3) Move an ingredient from one registration review case to
another. For example, new data or information might suggest that an
ingredient should not be grouped with the other ingredients in the
registration review case and that it belongs in a different
registration review case.
(4) Merge two or more registration review cases into a single
registration review case. For example, new data or information might
suggest that the active ingredients in two or more registration review
cases should be grouped together for registration review.
(5) Delete an active ingredient from a registration review case.
For example, the Agency will remove the ingredient from the case if the
registrations of all products containing an active ingredient in a
registration review case are canceled.
(c) Closing a registration review case. The Agency will close a
registration review case if all products in the case are canceled.
(d) Establishing a baseline date for a registration review case.
For the purpose of scheduling registration reviews, the Agency will
establish a baseline date for each registration review case. In
general, the baseline date will be the date of initial registration of
the pesticide or the date of reregistration, whichever is later. For
purposes of these procedures, the date of reregistration is the date on
which the Reregistration Eligibility Decision or Interim Reregistration
Decision was signed, whichever date the Agency determines to be more
appropriate.
(1) The Agency generally will not change the baseline date for a
registration review case when it modifies a case by adding or deleting
ingredients or products.
(2) When the Agency splits a registration review case into two or
more cases, the new case(s) generally will have the baseline date of
the original registration review case.
(3) When the Agency merges two or more registration review cases
into a single case, the Agency generally will use the earliest baseline
date as the baseline date for the new case.
[[Page 40275]]
(e) Announcing registration review cases and baseline dates. The
Agency will maintain a list of registration review cases, including
baseline dates, on its website.
Sec. 155.44 Establish schedules for registration review.
The Agency will develop schedules for registration review that are
generally based on the baseline date of the registration review case or
on the date of the latest registration review of the registration
review case. As indicated in Sec. 155.40, the Agency may change the
schedule of a pesticide's registration review if circumstances warrant.
The Agency may also take into account other factors, such as achieving
process efficiencies by reviewing related cases together, when
developing schedules for registration review. The Agency will maintain
schedules on its website.
Sec. 155.46 Deciding that a registration review is complete and
additional review is not needed.
The Agency may determine that there is no need to reconsider a
previous decision that a pesticide satisfies the standard of
registration in FIFRA. In such cases, the Agency may propose that,
based on its determination that a pesticide meets the FIFRA standard
for registration, no further review will be necessary. In such
circumstances, the Agency will publish a notice in the Federal Register
announcing the availability of the proposed decision and provide a
comment period of at least 60 calendar days. The Agency will publish a
notice in the Federal Register announcing the availability of a final
version of the decision, an explanation of any changes to the proposed
decision, and its response to any comments.
Sec. 155.48 Data Call-In before, during, or after a registration review.
The Agency may issue a Data Call-In notice under FIFRA section
3(c)(2)(B) at any time before, during, or after a pesticide's
registration review if the Agency believes that the data are needed to
conduct the registration review. The provisions in FIFRA section
3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the submission,
compensation, and exemption of data required to conduct a registration
review.
Sec. 155.50 Initiate a pesticide's registration review.
The Agency will initiate a pesticide's registration review by
establishing a docket for each registration review case and opening it
for public review.
(a) Establish a registration review docket for each registration
review case. The Agency will establish a docket which it will maintain
for the registration review of the pesticide. The Agency will place in
this docket information that will assist the public in understanding
the types of information and issues that the Agency may consider in the
course of the registration review. The Agency will consider including,
among other pieces of information:
(1) An overview of registration review case status;
(2) A list of current registrations and registrants, any Federal
Register notice regarding pending registration actions, and current or
pending tolerances;
(3) Risk assessment documents;
(4) Bibliographies concerning current registrations;
(5) Summaries of incident data; and
(6) Any other pertinent data or information.
(b) Public review of the registration review case docket. The
Agency will publish a notice in the Federal Register announcing the
availability for public review of the information described in
paragraph (a) of this section and requesting that interested persons
identify within 60 calendar days of publication any additional
information they believe the Agency should consider in the course of
the registration review.
(c) Submission of data and other information. The Agency may
identify, either in the notice published under paragraph (b) of this
section, or at any other time, data or information that it does not
have but which may be useful, if available, for consideration in the
registration review. Any person may submit data or information in
response to such identification. In order to be considered during a
pesticide's registration review, the submitted data or information must
meet the requirements listed below.
(1) In order to guarantee that the Agency will consider data or
information in the conduct of a registration review, interested persons
must submit the data or information within 60 calendar days of
publication of the notice described in paragraph (b) of this section or
by some other time that the Agency may designate. The Agency may, at
its discretion, consider data or information submitted at a later date.
(2) The data or information must be presented in a legible and
useable form. For example, an English translation must accompany any
material that is not in English, and a written transcript must
accompany any information submitted as an audiographic or videographic
record. Written material may be submitted in paper or electronic form.
(3) Submitters must clearly identify the source of any submitted
data or information.
(4) Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should reconsider
the data or information in the pesticide's registration review.
Sec. 155.52 Stakeholder engagement.
In addition to the public participation opportunities described in
Sec. 155.50 and Sec. 155.53(c), the Agency may meet with stakeholders
regarding a forthcoming or ongoing registration review. For example,
before conducting a pesticide's registration review, the Agency may
consult with registrants or pesticide users regarding the use and usage
of the pesticide. The Agency may consult with registrants, pesticide
users, or public interest groups during a pesticide's registration
review with regard to developing risk management options for a
pesticide. The Agency may informally consult with officials of Federal,
State or Tribal agencies regarding a forthcoming or ongoing
registration review.
(a) Meetings with persons outside of government. The Agency will
place in the docket minutes of meetings with persons outside of
government where the primary purpose of the meeting is to discuss a
forthcoming or ongoing registration review. The Agency will place
minutes of such meetings in the docket when it takes action under Sec.
155.58. At its discretion, the Agency may place minutes of such
meetings in the docket sooner.
(b) Exchange of documents or other written material. In the course
of a meeting with a person outside of government, the Agency or that
person may provide the other with a copy of a document or other written
material that has not yet been released to the public. The Agency will
place a copy of any such document or other written material in the
docket along with the minutes of the meeting where the materials were
exchanged.
(c) Confidential business information. The Agency will not place
confidential business information in the docket.
Sec. 155.53 Conduct a pesticide's registration review.
The Agency will review data and information described in Sec.
155.51 or submitted in response to a Data Call-In notice that it
believes should be considered in the pesticide's registration review.
(a) Assess changes since a pesticide's last review. The Agency will
assess any
[[Page 40276]]
changes that may have occurred since the Agency's last registration
decision in order to determine the significance of such changes and
whether the pesticide still satisfies the FIFRA standard for
registration. The Agency will consider whether to conduct a new risk
assessment to take into account, among other things, any changes in
statutes or regulations, policy, risk assessment procedures or methods,
or data requirements. The Agency will consider whether any new data or
information on the pesticide, including any data or information
submitted under Sec. 155.50 or in response to a Data Call-In notice,
warrant conducting a new risk assessment or a new risk/benefit
assessment. The Agency will also consider whether any new data or
information regarding an individual pesticide product, including any
data or information submitted under Sec. 155.50 or in response to a
Data Call-In notice, such as data or information about an inert
ingredient in the pesticide product or other information or data
relating to the composition, labeling, or use of the pesticide product,
warrant additional review of a pesticide product's registration.
(b) Conduct new assessments as needed. (1) Active ingredient(s) in
the registration review case. If the Agency finds that a new assessment
of the pesticide is needed, it will determine whether it can base the
new assessment on available data or information, including data or
information submitted under Sec. 155.50 or in response to a Data Call-
In notice. If sufficient data or information are available, the Agency
will conduct the new risk assessment or risk/benefit assessment. If the
Agency determines that additional data or information are needed to
conduct the review, the Agency will issue a Data Call-In notice under
FIFRA section 3(c)(2)(B).
(2) Individual product registrations. If the Agency finds that
additional review of an individual product's registration is needed, it
will review the pesticide product label, confidential statement of
formula, product-specific data, or other pertinent data or information,
as appropriate, to determine whether the registration of the individual
product meets the FIFRA standard for registraton. If the Agency
determines that additional data or information are needed to conduct
the review, the Agency will issue a Data Call-In notice under FIFRA
section 3(c)(2)(B).
(c) Public participation during a pesticide's registration review.
The Agency will generally make available for public review and comment
a draft risk assessment for a pesticide if a new risk assessment has
been conducted. The Agency will publish a notice in the Federal
Register announcing the availability of the draft risk assessment and
provide a comment period of at least 30 calendar days. The Agency will
publish a notice in theFederal Register announcing the availability of
a revised risk assessment, an explanation of any changes to the
proposed document, and its response to comments.
(1) The Agency might not ask for comments on a draft risk
assessment in cases where the Agency's initial screening of a pesticide
indicates that it has low use/usage, affects few if any stakeholders or
members of the public, poses low risk, and/or requires little or no
risk mitigation. In such cases, the Agency will make a draft risk
assessment available for public review and comment when it issues a
proposed decision on the registration review case.
(2) If the Agency finds that it is not necessary to conduct a new
risk assessment, it will issue a proposed decision on the registration
review case as described in Sec. 155.58.
Sec. 155.56 Interim registration review decision.
The Agency may issue, when it determines it to be appropriate, an
interim registration review decision before completing a registration
review. Among other things, the interim registration decision may
require new risk mitigation measures, impose interim risk mitigation
measures, identify data or information required to complete the review,
and include schedules for submitting the required data, conducting the
new risk assessment and completing the registration review. A FIFRA
section 3(c)(2)(B) notice requiring the needed data or information may
precede, accompany, or follow issuance of the interim registration
decision. The Agency will follow procedures in Sec. 155.58 when
issuing an interim registration review decision.
Sec. 155.57 Registration review decision.
A registration review decision is the Agency's determination
whether a pesticide meets, or does not meet, the standard for
registration in FIFRA.
Sec. 155.58 Procedures for issuing a decision on a registration
review case.
(a) The Agency will publish a notice in the Federal Register
announcing the availability of a proposed registration review decision
or a proposed interim registration review decision. At that time, the
Agency will place in the pesticide's registration review docket the
Agency's proposed registration review decision and the bases for the
decision. There will be a comment period of at least 60 calendar days
on the proposed decision.
(b) In its proposed decision, the Agency will, among other things:
(1) State its proposed findings with respect to the FIFRA standard
for registration and describe the basis for such proposed findings.
(2) Identify proposed risk mitigation measures or other remedies as
needed and describe the basis for such proposed requirements.
(3) State whether it believes that additional data are needed and,
if so, describe what is needed. A FIFRA section 3(c)(2)(B) notice
requiring such data may precede, accompany, or follow issuance of a
proposed or final decision on the registration review case or a
proposed or final interim decision on a registration review case.
(4) Specify proposed labeling changes.
(5) Identify deadlines that it intends to set for completing any
required actions.
(c) After considering any comments on the proposed decision, the
Agency will issue a registration review decision or interim
registration review decision. This decision will include an explanation
of any changes to the proposed decision and the Agency's response to
significant comments. The Agency will publish a notice in the Federal
Register announcing the availability of a registration review decision
or interim registration review decision. The registration review case
docket will remain open until all actions required in the final
decision on the registration review case have been completed.
(d) If the registrant fails to take the action required in a
registration review decision or interim registration review decision,
the Agency may take appropriate action under FIFRA.
[FR Doc. 05-13776 Filed 7-12-05; 8:45 am]
BILLING CODE 6560-50-S