24586 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 152

[OPP–36195; FRL–6488–9]

RIN 2070–AD29

Pesticides; Procedural Regulations for

Registration Review

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Advanced Notice of Proposed

Rulemaking.

SUMMARY: The Food Quality Protection

Act (FQPA) of 1996 amended the

Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA) to require

periodic review of pesticide

registrations to ensure that over time

they continue to meet statutory

standards for safety. FIFRA section 3(g)

specifies that EPA establish procedural

regulations for conducting registration

review and that the goal of the

regulations shall be the Agency review

of pesticide registrations on a 15–year

cycle. This advance notice of proposed

rulemaking (ANPRM) alerts

stakeholders that EPA is beginning

development of procedural regulations

for registration review under FIFRA

section 3(g). It explains EPA’s

preliminary interpretation of the

authorizing legislation, presents EPA’s

goals in implementing the statutory

provisions, presents the Agency’s initial

concept of how the registration review

program might operate, identifies

several 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

Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Proposed Rules 24587

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).

24588 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Proposed Rules

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

Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Proposed Rules 24589

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

24590 Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Proposed Rules

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 productspecific 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 nonconventional 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

Federal Register / Vol. 65, No. 81 / Wednesday, April 26, 2000 / Proposed Rules 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