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: April 26, 2000 (Volume 65, Number 81)]
[Proposed Rules]               
[Page 24585-24591]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap00-21]                         


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Part IV





Environmental Protection Agency





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40 CFR Part 152



Pesticides; Procedural Regulations for Registration Review; Advanced 
Notice of Proposed Rulemaking


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 152

[OPP-36195; FRL-6488-9]

RIN 2070-AD29

 
Pesticides; Procedural Regulations for Registration Review

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advanced Notice of Proposed Rulemaking.

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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 safety. FIFRA section 
3(g) specifies that EPA establish procedural regulations for conducting 
registration review and that the goal of the regulations shall be the 
Agency review of pesticide registrations on a 15-year cycle. This 
advance notice of proposed rulemaking (ANPRM) alerts stakeholders that 
EPA is beginning development of procedural regulations for registration 
review under FIFRA section 3(g). It explains EPA's preliminary 
interpretation of the authorizing legislation, presents EPA's goals in 
implementing the statutory provisions, presents the Agency's initial 
concept of how the registration review program might operate, 
identifies several issues that should be addressed in developing the 
program, and invites public comment on these and other issues relating 
to registration review.

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

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

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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

    1. Electronically. You may obtain electronic copies of this 
document from the EPA Internet Home Page at http://www.epa.gov/. To 
access this document on the Home Page select ``Laws and Regulations'' 
and then look up the entry for this document under the ``Federal 
Register--Environmental Documents.'' You can also go directly to the 
``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number [OPP-36195]. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as confidential business information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Public Information and Records Integrity 
Branch telephone number is 703-305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-36195 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 
20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Hwy., Arlington, VA. The PIRIB is open from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: ``opp-docket@epa.gov,'' or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-36195. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI by marking any part or all of that information as 
CBI. Information so marked will not be disclosed except in accordance 
with procedures set forth in 40 CFR part 2. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior

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notice. If you have any questions about CBI or the procedures for 
claiming CBI, please consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    We invite you to provide your views on the various issues we raise, 
new approaches or options we haven't considered and the potential 
impacts, including possible unintended consequences, of the Agency's 
initial concept. You may find the following suggestions helpful for 
preparing your comments:
     Explain your views as clearly as possible and provide any 
supporting data where appropriate.
     Describe any assumptions that you used.
     Make sure to submit your comments by the deadline in this 
notice.
     To ensure proper receipt by EPA, be sure to identify the 
docket control number assigned to this action in the subject line on 
the first page of your response. You may also provide the name, date, 
and Federal Register citation.

II. Purpose of the ANPRM

    With this ANPRM, the Agency presents the statutory requirement for 
pesticide registration review and alerts its stakeholders that it is 
initiating the development of rulemaking to establish procedures for a 
registration review program. Second, the Agency explains its 
preliminary interpretation of the statutory provisions and its 
preliminary ideas regarding goals and objectives for this program. 
Third, the Agency describes its preliminary ideas about how 
registration review might operate. Fourth, the Agency solicits public 
input on critical issues about registration review early in the 
planning process. Finally, EPA solicits public input to identify 
potential problems as early as possible.

III. Legal Authority

A. EPA's Authority to License Pesticide Products

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

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

    FIFRA 2(bb) defines ``unreasonable adverse effects on the 
environment'' as (1) ``any unreasonable risk to man or the environment, 
taking into account the economic, social, and environmental costs and 
benefits of the use of any pesticide, or (2) a human dietary risk from 
residues that result from a use of a pesticide in or on any food 
inconsistent with the standard under section 408 of the Federal Food 
Drug and Cosmetic Act.''
    The proponent of initial or continued registration always bears the 
burden of demonstrating that a pesticide product meets the statutory 
standard for registration.

B. EPA's Authority for Registration Review

    The FQPA amended FIFRA to add, among other things, section 3(g), 
``REGISTRATION REVIEW,'' as follows:

    (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.

IV. What is Registration Review?

    EPA believes that ``registration review'' would consist of the 
review of a pesticide to determine whether the pesticide continues to 
meet the statutory standard for registration under FIFRA section 
3(c)(5). During a registration review, EPA would evaluate elements of 
FIFRA 3(c)(5) including the composition, labeling and other required 
material (including studies and other data), risks and benefits of a 
pesticide, and incident data or other information relating to its use. 
FIFRA section 3(g) contemplates that EPA may determine whether or not a 
pesticide meets the statutory standard for registration in FIFRA 
section 3(c)(5). If EPA determines that a pesticide no longer meets the 
statutory standard, it should not remain registered. In this event, EPA 
may need to pursue other actions such as cancellation under other 
statutory authority.
    FIFRA section 3(g) instructs EPA to establish, by regulation, a 
procedure for accomplishing registration review. The goal of these 
regulations shall be Agency review of pesticide registrations on a 15-
year cycle. EPA believes the activities that should be addressed under 
the procedural regulations include, but are not limited to: setting 
priorities for review, establishing a mechanism for setting schedules 
for reviewing all pesticides every 15 years, and articulating the 
general approach to conducting and concluding the review.
    FIFRA section 3(g) also instructs the Agency to rely on existing 
authorities for data submission, data compensation, data exemption, or 
cancellation of registrations. Therefore, the procedural regulations 
need not be concerned with procedures for acquiring new information, 
assuring compensation for data developers, data exemption, or canceling 
a pesticide registration. Authorities and procedures for such 
activities already exist and FIFRA 3(g) did not require EPA to develop 
alterative procedures for these activities. Existing regulations such 
as those concerning good laboratory practice for data generation and 
FIFRA section 8 recordkeeping requirements would also apply.
    EPA has already issued regulations and guidelines under FIFRA 
3(c)(2)(A) to specify the kinds of information that are required to 
support a pesticide registration. EPA modifies this guidance 
periodically to reflect new developments in science areas such as 
hazard characterization and exposure assessment. Additionally, as 
explained in an October 29, 1998 Federal Register notice (63 FR 58030) 
(FRL-6041-5), EPA is in the process of issuing guidance for meeting the 
new safety standard mandated by the FQPA. Accordingly it is not 
necessary to specify such information in procedural regulations issued 
under FIFRA section 3(g)(1)(A).

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    EPA may determine that reviews accomplished under other 
authorities, e.g., section 408 of the FFDCA, could potentially 
contribute to registration reviews. In any event, EPA believes that it 
would not be necessary to specify procedures for these activities 
because authorities and procedures already exist for them.
    Finally, FIFRA section 3(g)(1)(B) stipulates that EPA retains its 
authority to undertake any other review of a pesticide under FIFRA. 
This provision means that EPA may continue to undertake any review that 
is authorized by FIFRA or EPA regulations such as reregistration or 
special review. EPA also interprets this provision to mean, among other 
things, that the Agency may continue its practice of requiring 
submission of data whenever the Agency believes that such data are 
needed to support the continued registration of a pesticide.

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

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

A. Keeping a Registration Up-to-Date

    EPA has identified several aspects involved in keeping a pesticide 
registration up-to-date. These include receipt of new data; changes in 
data requirements and associated test guidelines (or protocols); 
changes in risk assessment methods; new information gained through use 
and practical experience with a pesticide; and changes in labeling 
policy.
    1. Availability of new data. At any time, registrants or other 
persons may submit new studies on a pesticide. These studies may be 
undertaken in response to an Agency request or upon the data 
generator's own initiative. FIFRA section 6(a)(2) requires submission 
of certain kinds of data, as specified in 40 CFR part 159.
    2. Changes in data requirements and test guidelines. From time to 
time, EPA changes data requirements or testing guidelines to reflect 
advances in the science of hazard characterization or exposure 
assessment. When changes are significant, EPA may require registrants 
to submit new testing to EPA to support registration. New testing may 
be necessary to evaluate an aspect of toxicity or exposure that was not 
previously considered, to replace particular studies that are no longer 
adequate as a result of advances in test design or protocols, or for 
many other possible reasons.
    3. Changes in risk assessment methodologies. EPA continually seeks 
to improve its risk assessment methodologies. Currently, the Agency is 
reviewing a number of risk assessment methodologies as part of its 
implementation of the FQPA. Undoubtedly, there will be further changes 
as science and policy advance.
    4. Use and practical experience with a pesticide. EPA evaluates 
whether practical experience from using a pesticide changes our 
understanding of the risks and benefits of the pesticide. EPA has 
established registrant reporting requirements for risk/benefit 
information (see 40 CFR part 159) and has a process for quickly 
assessing the safety implications of such information. The EPA will 
also maintain incident databases, sponsor a toll free telephone service 
that gathers information related to pesticide incident, and obtain 
incident related information from poison control centers. In addition, 
EPA is considering the establishment of a Pesticide Field Data Plan for 
capturing key information about pesticide use or misuse. Under this 
plan, States would standardize their procedures for collecting and 
reporting information from State pesticide compliance and enforcement 
records. EPA would analyze information from thousands of federally-
funded investigations and inspections for trends and patterns of 
problems related to pesticide use or misuse. EPA may eventually be able 
to use these analyses to shape or confirm regulatory decisions.
    5. Changes in labeling policy. From time to time, EPA publishes 
guidance on the format and content of pesticide product labels. EPA 
would, as part of registration review, evaluate existing labeling to 
determine whether it needs to be changed to reflect current policies 
and regulations pertaining to matters such as restrictions in use, 
requirements for protective clothing, and other precautionary label 
language associated with reducing exposure and environmental risk. 
Additionally, EPA may assess alternative ways to communicate risk 
management information to pesticide users.

B. Incorporate Lessons Learned from Reregistration

    FIFRA section 4, established by the 1988 amendments to FIFRA, 
instructed EPA to review the human health and environmental effects of 
all pesticide active ingredients originally registered before November 
1, 1984, in order to determine whether they are eligible for 
reregistration. To be ``eligible,'' an older pesticide must have a 
substantially complete data base, and must be found not to cause 
unreasonable risks to man or the environment when used in accordance 
with its approved labeling. As of August 1, 1999, of 612 reregistration 
cases (composed of a pesticide active ingredient or group of related 
pesticide active ingredients), 415 cases have completed reregistration 
(including 231 cases where registrants requested voluntary cancellation 
of all registrations of the pesticide). That leaves 197 cases awaiting 
reregistration decisions.
    The Agency's experience with the reregistration program offers 
insights into the construction of an efficient registration review 
program. Chief among these are the importance of effective organization 
of large quantities of data for review, the efficient conduct of the 
review of these data, and the need for flexibility in defining the 
scope of the review for each pesticide. In addition, public 
participation at critical junctures helps ensure that the Agency 
develops practical risk mitigation measures where needed, and that 
stakeholders better understand the bases for decisions. To the extent 
possible, EPA plans to:
    1. Review first those pesticide registrations for which EPA 
believes registration review will produce the greatest human health and 
environmental benefits.
    2. Establish methods and approaches for ensuring that it has all 
necessary

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data to make good regulatory decisions on schedule.
    3. Standardize data submission by adopting guidance for data 
submitters such as the guidance developed by the Organization for 
Economic Cooperation and Development (OECD). Standard submission 
formats could expedite EPA's review and promote sharing the work of 
pesticide evaluation with other governments.
    4. Review related pesticides simultaneously. This would allow 
effective use of review resources and promote more practical and 
comprehensive risk mitigation measures.
    5. Tailor the level and nature of the review to the specific facts 
and concerns of each case.
    6. Build on the results of prior review efforts such as 
reregistration and tolerance reassessment and on updates such as 
evaluations of applications for registration of new uses. EPA would 
avoid re-reviewing data to the fullest extent possible.
    7. Adopt, or use to the extent practicable, state and foreign 
governments' reviews of pesticide studies. For several years, EPA has 
been developing experience in sharing the work of pesticide evaluation 
with North American Free Trade Agreement (NAFTA) partners. We intend to 
build on this experience by developing work share relationships with 
additional countries through OECD initiatives.
    8. Standardize its approach to documenting data reviews by adapting 
OECD guidance for development of government monographs. Standard 
formats would promote sharing work between countries and can enhance 
understanding of EPA reviews.
    9. Seek stakeholder views and input through an open process that 
offers the public and the regulated community clearly defined, time-
limited, opportunities for input to various aspects of the review 
process for an individual pesticide.

VI. EPA's Initial Thinking on How Registration Review Might Operate

    EPA has developed an initial concept for registration review, which 
is presented in this document. It is intended to stimulate thought 
about and comment on all aspects of developing procedures to implement 
registration review. EPA believes that the conceptual model presented 
in this Unit meets the statutory requirements and Agency goals and 
objectives for the registration review program for all pesticides.
    EPA intends for registration review to be implemented within the 
next 5 years. EPA expects that the reregistration program will be 
completed by then, and the registration review program will become the 
Agency's primary review program for all pesticide registrations. We 
anticipate that the registration review program will incorporate the 
application of the FQPA safety standard and, as appropriate, the use of 
reviews conducted under other authorities and programs such as 
reregistration, tolerance assessment and reassessment, and our proposed 
endocrine disrupter screening program.

VII. EPA's Initial Conceptual Model

    This conceptual model has five steps. EPA expects that each 
pesticide would start registration review at step one and proceed step-
wise through the process. At key points in the conceptual model, EPA 
may decide to omit one or more steps in the registration review of a 
pesticide. Registrants who are responsible for generating generic data 
on an active ingredient would likely be involved in all five steps of 
the process described in this preliminary model. Registrants who are 
generally not responsible for generating generic data would likely 
participate in fewer steps.

A. Step 1: Plan and Schedule Candidates for Review

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

B. Step 2: Publish Schedule, Define Initial Scope and Level of Review, 
and Issue Needed Data Call-Ins and Requests for Applications for 
Scheduled Candidates

    The second step would also consist of two principle tasks: (1) 
publication in the Federal Register of the list of review candidates 
and the tentative schedule for review; and (2) case-specific 
determinations of the level and scope of review and the development of 
needed data call-in notices.
    EPA believes that the schedule for registration review candidates 
should be announced at least 5 years in advance of the review to 
provide time for generating and submitting new data. In addition to 
publishing a Federal Register notice listing the registration review 
candidates, EPA could publish the listing in the Code of Federal 
Regulations (CFR), make the list available as part of a registration 
review docket, and/or maintain a list electronically on the OPP 
Internet Home Page.
    In making case-specific determinations about the level and scope of 
review appropriate to any given pesticide, EPA might conduct a 
preliminary analysis of the completeness of the data base; the 
potential significance of any real-world monitoring and field data 
collected since the last regulatory action; the need to revise the risk 
assessment using updated methodologies; and any applicable labeling 
policy changes. This analysis would provide an initial characterization 
of the level and type of risks possibly posed by the pesticide, 
critical data needs, and an early assessment of the appropriate level 
and scope of review (e.g., whether tolerances should be reassessed). 
EPA might then publish a pesticide-specific notice in the Federal 
Register describing the preliminary analysis, the initial assessment of 
data needs, and the proposed level and scope of review. EPA would 
invite comment on these issues. After analysis of comments received, 
EPA would issue notices to registrants to call-in any needed data and 
establish a deadline for submitting applications for registration 
review.
    EPA expects that the deadline set for the submission of an 
application for registration review will depend in large part on the 
scope, level, and focus of registration review for the pesticide and 
the type of data that are being called in.
    The case-specific determination of the level and scope of review 
may show that the pesticide meets the requirements of FIFRA section 
3(c)(5) and that no additional data or review are needed. In

[[Page 24590]]

such cases, EPA would issue a preliminary determination, as described 
in Step 4 below.

C. Step 3: Registrants Submit Applications for Review

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

D. Step 4: EPA Conducts the Review and Issues It for Public Comment

    The fourth step would be to conduct the registration review. This 
review could include evaluation of all new data and data reviews done 
by other regulatory officials, review and evaluation of the 
registrant's risk assessments and public comments (including data) 
submitted in Step 3, revision of the Agency's risk assessments (where 
necessary), review of pesticide labeling for conformance to current 
policy, and development of proposed risk mitigation measures. At this 
step in the process, EPA envisions making a preliminary determination 
whether the pesticide continues to meet the statutory standard for 
registration under FIFRA section 3(c)(5). EPA would announce the 
availability of the preliminary determination for public review and 
comment.
    If EPA preliminarily determines that the pesticide no longer meets 
the standard for registration under FIFRA section 3(c)(5), EPA would 
immediately collect and review any benefits information which it 
believed it needed. If it appears that there would be a significant 
change in the existing registration, EPA would seek public input on 
proposed risk management action before taking such action.

E. Step 5: Consider Comments, Issue Final Review, and Review 
Registrant's Proposed Labels

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

VIII. Issues for Public Comment

    Although EPA is soliciting your comments on all aspects of the 
discussion presented in this document regarding registration review, 
EPA is particularly interested in receiving your comments on the 
following topics. You may submit comments on any other issue related to 
registration review, including your own views on what registration 
review procedures should look like.
    1. EPA's interpretation of the requirements in FIFRA section 3(g). 
Do you agree with EPA's interpretation of the statutory mandate for 
registration review as set forth in Unit IV? If not, why? How would you 
interpret FIFRA section 3(g)?
    2. Interpretation of ``Review of a Pesticide's Registration every 
15 years.'' EPA recognizes that there may be various interpretations of 
``review of a pesticide's registration every 15 years.'' This term 
could be interpreted to mean that EPA would complete a registration 
review of each pesticide within 15 years of the pesticide's 
registration or reregistration. This term could also be interpreted to 
mean that the Agency would complete registration reviews of all 
pesticides within a 15-year period that could begin when EPA's 
procedural regulations for registration review go into effect.
    3. Commencement of a 15-year registration review cycle. The Agency 
believes that the effective date of the procedural regulations for 
registration review could be a possible starting date of the 15-year 
period for completing registration review, but recognizes that another 
date or series of dates may also be possible starting dates for 
registration review.Do you have any suggestions for designing a system 
of staggered scheduling for registration reviews?
    4. Goals and objectives for the registration review program. Do you 
agree with the goals that EPA has identified? What changes do you 
suggest?
    5. Relationship of registration review to other mandates. A key 
design issue is how registration review fits in with other activities 
such as the implementation of the new FQPA safety standard, 
reregistration, registration of new uses, and tolerance assessment or 
reassessment, and endocrine disrupter screening and testing. In what 
way could EPA integrate these activities to promote the efficiency of 
registration review?
    6. Non-conventional pesticides. Do the Agency's proposed goals, 
objectives and procedures for registration review work for all 
pesticides, including non-conventional pesticides such as antimicrobial 
or biological pesticides? How should the Agency's concepts be modified 
to accommodate any special issues pertaining to the registration review 
of non-conventional pesticides?
    7. Criteria for setting priorities and scheduling compounds for 
review. In selecting candidates for Registration Review, should the 
relative risk, length of time since its last review, relationship to a 
high priority initiative (for example, EPA's current initiative on 
persistent bioaccumulative toxics), or other similar programmatic 
activities (e.g., tolerance reassessment schedule) be considered? What 
additional factors should the agency consider in selecting and 
prioritizing pesticides for Registration Review?
    8. Process for announcing schedules for registration review. Should 
the agency announce its registration review

[[Page 24591]]

scheduling priority in the Federal Register? The Agency anticipates 
announcing tentative schedules 5 years in advance of the initiation of 
the review. Because review priorities or time estimates for preparing 
for a review may change after a review schedule has been announced, 
should EPA publish updated schedules, and if so, how frequently?
    9. Scope and depth of registration review. Should all pesticides 
undergo the same level of review or should the review be tailored to 
the level of risk posed, exposure potential, severity of hazard, level 
of benefits, degree of uncertainty, length of time since its last 
review, completeness of database and related factors?
    10. Submission of applications for registration review by 
registrants. The Agency is considering requiring a registrant to submit 
an application for registration review of its pesticides. The 
application could follow a standard format and content and include any 
required data, risk mitigation proposal if applicable, information on 
use and usage and related information. Registrants may also include 
proposed risk assessments as part of their submissions. Do you believe 
this requirement will be cost effective and contribute to the overall 
efficiency of the registration review program? Should EPA require, 
encourage, or discourage the preparation of proposed risk assessments 
by registrants?
    11. Potential penalties for submission of incomplete applications. 
If an application for registration review is ``material required to be 
submitted,'' the product registration would be subject to cancellation 
if the registrant fails to comply with the requirement. If a registrant 
fails to submit required data as specified in the data call-in notice 
requiring the data, the product registration would be subject to 
suspension. What could the Agency do to promote compliance with a 
requirement to submit a registration review application? If submission 
of an application for registration review were not mandatory, what 
should the Agency do if a registrant fails to submit a registration 
review application or submits an incomplete application?
    12. Incentives and opportunities for registrant participation in 
registration review. EPA believes that the public may benefit when a 
registrant takes the initiative to identify and provide data needed for 
refining a risk assessment. What can be done to encourage and promote 
voluntary compliance and registrants taking the initiative?
    13. Maximize work sharing opportunities. In order to avoid 
duplication of effort, EPA wishes to use existing reviews wherever 
possible, provided that these reviews are based on current scientific 
standards. In addition to its own recent reviews, EPA could use data 
reviews prepared by state or foreign governments that have participated 
in harmonization efforts. Are there any reasons why harmonized data 
reviews should not be used in registration review?
    14. Public participation. EPA envisions public participation at 
several critical junctures of the registration review process. How can 
the public have access to sufficient information to participate 
meaningfully? At which junctures in the process would public input be 
most valuable? Is a public meeting on the registrant's data and 
associated analyses a good way to involve stakeholders in the 
registration review process? If not, how can the agency best involve 
stakeholders? Would making information available to the public 
substantially affect any stakeholder's interests? How can efficiencies 
be achieved?
    15. Role of the Internet in involving outside stakeholders. EPA 
intends to publish notices in the Federal Register and maintain a 
docket for registration review actions, but wants to expand its 
outreach efforts. Is the Internet an effective supplement to the 
published notice and is it an equitable way of meaningfully involving 
stakeholders in the registration review program? What other 
opportunities using electronic and Internet technology should the 
Agency consider?
    16. Participation of small entities in the rulemaking process. What 
can be done to ensure that the rulemaking process is accessible to 
small entities and that the Agency identifies issues of concern to 
small entities regarding procedures for registration review?

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

    The Office of Management and Budget (OMB) has determined that this 
advanced notice of proposed rulemaking is not a ``significant 
regulatory action'' subject to review by OMB under Executive Order 
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
1993). Nevertheless, the Agency provided OMB with an opportunity to 
review a draft of this advanced notice of proposed rulemaking, and did 
not receive any comments that resulted in changes to this document.
    This advanced notice of proposed rulemaking does not impose any 
requirements. Instead, it seeks comments and suggestions on possible 
approaches that the Agency should consider in developing a procedural 
rulemaking to implement the registration review requirements contained 
in FIFRA section 3(g). As such, the various other regulatory assessment 
requirements that apply when an agency imposes requirements do not 
apply to this advance notice of proposed rulemaking.
    As a part of your comments on this document, you may include any 
comments or information that you have regarding these requirements. In 
particular, any comments or information that would facilitate the 
Agency's assessment of the potential impact of a procedural rule on 
small entities pursuant to the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.); the Agency's consideration of voluntary consensus 
standards pursuant to section 12(d) of the National Technology Transfer 
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) 
(15 U.S.C. 272 note); and the Agency's consideration of environmental 
health or safety effects on children pursuant to Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). The Agency will consider 
such comments during the development of the procedural rulemaking as it 
takes appropriate steps to address any applicable requirements.

List of Subjects

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

    Dated: April 19, 2000.
Carol M. Browner,
Administrator.
[FR Doc. 00-10433 Filed 4-25-00; 8:45 am]
BILLING CODE 6560-50-F
Pesticides; Procedural Regulations for Registration Review

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