Federal Register / Vol. 61, No. 123 / Tuesday, June 25, 1996 / Notices 32799

1The following 18 States are authorized to

implement the RCRA delisting program, including

Alabama, Colorado, Georgia, Idaho, Illinois,

Kentucky, Louisiana, Michigan, Minnesota,

Mississippi, Nebraska, North Carolina, New Jersey,

North Dakota, Oregon, South Dakota, Utah, and

Wyoming. Note that Michigan has only obtained a

‘‘partial’’ delisting authorization for wastes

involving closure or partial closure activities.

Kentucky would soon receive delisting

authorization (61 FR 18504).

SUPPLEMENTARY INFORMATION: Under

§§ 260.20 and 260.22 of the Code of

Federal Regulations, facilities may

petition the Agency to remove their

wastes from the hazardous waste

management system by excluding them

from the lists of hazardous wastes

contained in §§ 261.31 and 261.32.

Petitioners must provide sufficient

information to EPA to allow the Agency

to determine that the waste to be

excluded does not meet any of the

criteria under which the waste was

listed as a hazardous waste. In addition,

the Administrator must determine that

factors other than those for which the

waste was listed (including additional

constituents) would not warrant

retaining the waste as a hazardous

waste. The overall intent of the delisting

process is to ease the regulatory burden

on handlers of listed wastes that may

have been improperly captured by the

broad listing definitions. In addition,

the delisting process can be used to

exclude listed wastes that are

sufficiently treated so that they no

longer pose an adverse threat to human

health or the environment.

On October 10, 1995, the

Administrator formally extended the

delegation of the Federal hazardous

waste delisting authority to the Regional

Administrators [Delegation of Authority

8–19]. The Agency believes that

decentralizing the delisting authority to

the Regional Administrators would

result in more timely responses to

delisting petitions.

Under RCRA, States authorized 1 to

administer a delisting program in lieu of

the federal program also may exclude

wastes from hazardous waste

regulations. Facilities that manage their

wastes in States with delisting

authorization should petition that State

for an exclusion rather than EPA. Even

in unauthorized States, EPA encourages

petitioners to contact State authorities to

determine what procedures might be

necessary for delisting under State laws.

Regional delisting decisions will carry

the same authority as a Headquarters

delisting decision. A Regional delisting

decision will be applicable in all States

not currently authorized for delisting,

regardless of the EPA Region in which

they are located. EPA recommends that

petitioners contact relevant state and

EPA Regional Offices to determine

where the petition should be submitted.

The list of Regional delisting contacts is

provided below:

Regional Delisting Contacts

EPA Region I, Sharon Leitch, John F.

Kennedy Bldg., Mail Code CHW,

Hazardous Waste Unit, Boston, MA

02203, (617) 565–4879

EPA Region II, Ernst Jabouin, 290

Broadway, Hazardous Waste,

Facilities Branch (22nd Floor), New

York, NY 10007, (212) 637–4104

EPA Region III, David Friedman, 841

Chestnut Building, Hazardous Waste,

Management Division, Mail Code

3HW70, Philadelphia, PA 19107,

(215) 566–3395

EPA Region IV, Alan Farmer, 345

Courtland Street, NE, RCRA Branch,

Mail Code 4WD–RCRA, Atlanta, GA

30365, (404) 347–3433

EPA Region V, Judy Kleiman, 77 W

Jackson Blvd., Waste, Pesticides, and

Toxics Division, Mail Code HRP–8J,

Chicago, IL 60604, (312) 886–1482

EPA Region VI, Bill Gallagher, 1445

Ross Avenue, Oklahoma/Texas

Section, Mail STOP 6PD–0, Dallas, TX

75202, (214) 665–6775

EPA Region VII, Ken Herstowski, 726

Minnesota Avenue, Air, RCRA, and

Toxic Division, RCRA Permits and

Compliance Branch, Kansas City, KS

66101, (913) 551–7631

EPA Region VIII, Mike Gansecki, 999

18th Street, Hazardous Waste

Program, Suite #500, Mail Code 8P2–

HW, Denver, CO 80202, (303) 312–

6150

EPA Region IX, Paula Bisson, 75

Hawthorne Street, RCRA Permit

Section, Mail Code H–3–2, San

Francisco, CA 94105, (415) 744–2052

EPA Region X, Jamie Sikorski, Linda

Liu, 1200 Sixth Avenue, Office of

Waste and Chemical Management,

Mail Code WCM–126, Seattle, WA

98101, (206) 553–5153 (Sikorski),

(206) 553–1447 (Liu)

Dated: June 10, 1996.

Michael Shapiro,

Director, Office of Solid Waste.

[FR Doc. 96–15887 Filed 6–24–96; 8:45 am]

BILLING CODE 6560–50–P

[FRL–5526–6]

Proposed Process for Reevaluating

Cancer Assessments

AGENCY: U.S. Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: On April 23, 1996, EPA

issued a proposal to revise its 1986

Guidelines for Cancer Risk Assessment

(61 FR 17960). Today, EPA is proposing

a process for using the new guidelines

to reevaluate cancer hazard and doseresponse assessments developed using

the 1986 guidelines.

EPA is inviting public comment on its

proposal to identify, prioritize and

select agents for reevaluation. This

proposal outlines opportunities for

public involvement in the reevaluation

process, and requests comment on the

proposed process. The new process

would take effect when the Proposed

Guidelines are issued as final.

In addition, this notice also discusses

the use of the Proposed Guidelines in

ongoing or new cancer assessments.

DATES: Comments on this proposal must

be submitted on or before September 23,

1996.

ADDRESSES: This notice contains the full

proposed process for reevaluating

cancer assessments.

Submitting Comments: Comments on

the proposed process should be

submitted to: U.S. Environmental

Protection Agency, Air and Radiation

Docket and Information Center (6102),

Attn: File CAN–96–01, Waterside Mall,

401 M St. SW, Washington, DC 20460.

Please submit one unbound original

with pages numbered consecutively,

and three copies. For attachments,

provide an index, number pages

consecutively, provide comment on

how the attachments relate to the main

comment(s), and submit an unbound

original and three copies. Please

identify all comments and attachments

with the file number CAN–96–01.

Mailed comments must be postmarked

by the date indicated. Comments may be

also submitted electronically by sending

electronic mail (e-mail) to: A-and-RDocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect 5.1

file format or ASCII file format. All

comments in electronic form must also

be identified by the file number CAN–

96–01. No Confidential Business

Information (CBI) should be submitted

through e-mail.

The docket and information center is

open for public inspection and copying

between 8:00 a.m. and 5:30 p.m.,

weekdays, at the Air and Radiation

Docket and Information Center (6102),

Room M–1500, 401 M St. SW,

Washington, DC 20460. The docket and

information center is located on the

ground floor of Waterside Mall. The file

index, materials and comments are

available for review in the information
32800 Federal Register / Vol. 61, No. 123 / Tuesday, June 25, 1996 / Notices

center or copies may be mailed on

request from the Air and Radiation

Docket and Information Center by

calling (202) 260–7548 or –7549. The

FAX number for the Center is (202) 260–

4400. A reasonable fee may be charged

for copying information materials.

Please note that all technical

comments received in response to this

notice will be placed in the public

record. For that reason, commentors

should not submit personal information

such as medical data or home addresses,

confidential business information or

information protected by copyright. Due

to limited resources, acknowledgments

will not be sent.

Requesting Copies of Proposed

Guidelines

To obtain a copy of the Proposed

Guidelines for Carcinogen Risk

Assessment (61 FR 17960), interested

parties should consult the April 23

Federal Register notice or contact ORD

Publications, Technology Transfer and

Support Division, National Risk

Management Research Laboratory, U.S.

Environmental Protection Agency, 26

W. Martin Luther King Drive,

Cincinnati, OH 45268; telephone: 513–

569–7566. Please provide your name,

mailing address, document title

(Proposed Guidelines for Carcinogen

Risk Assessment), and EPA number

(EPA/600/P–92/003C).

FOR FURTHER INFORMATION ON TODAY’S

NOTICE CONTACT: Jennifer OrmeZavaleta, Office of Water, Telephone

Number (202) 260–7571.

Proposed Implementation Strategy for

Reevaluating Existing Assessments

Using the Final Revised Guidelines

Background

EPA has applied the 1986 Guidelines

for Carcinogen Risk Assessment to

hundreds of environmental agents. The

results of many of these cancer hazard

and dose-response assessments

(hereafter referred to as assessments)

can be found on EPA’s Agency-wide

Integrated Risk Information System

(IRIS) database. Other assessments are

maintained separately within individual

EPA programs (e.g., certain pesticides).

Information on IRIS and the other

assessments are used as guidance to

support Agency decisions.

Once the Proposed Guidelines are

finalized, EPA will continue to rely on

existing assessments as they are still

viewed as scientifically acceptable

based on the 1986 Guidelines. However,

EPA recognizes that under some

circumstances, it will be appropriate to

reassess an existing assessment taking

into account new risk assessment

methods, principles and data. As EPA’s

current compendium of cancer

assessments is the product of many

years of analysis, it is reasonable to

assume that revisiting all existing

assessments could require comparable

amounts of time and resources.

Therefore, it would not be practicable to

reassess all these existing assessments

and balance our commitment to assess

new agents as well. Given these

circumstances, EPA is proposing a

process for applying the revised Cancer

Guidelines that moves the Agency

forward with new assessments, while

also addressing reassessments of some

environmental agents.

Proposed Reassessment Process

EPA proposes the following process to

involve the public in the identification,

prioritization and selection of candidate

environmental agents for reevaluation.

The intent is to ensure that agents that

warrant reevaluation are given the

highest priority.

EPA envisions the following process:

(1) EPA publishes an annual notice in

the Federal Register requesting

candidates for reevaluation,

(2) Candidates are submitted,

(3) Candidates are reviewed and

prioritized within the Agency,

(4) Candidates selected are published

in a Federal Register notice. Submitters

are notified on the status of their

submission.

(5) Reassessment is initiated in the

next fiscal year. The reassessment is

reviewed in accordance with EPA’s Peer

Review Policy and placed on IRIS.

In selecting candidates for

reevaluation, EPA will consider the

following:

(1) whether application of the new

guidelines will appreciably change the

existing cancer assessment,

(2) completeness and validity of the

scientific information,

(3) EPA priorities,

(4) Resources.

Discussion

On an annual basis, EPA will publish

in the Federal Register a list of agents

for which EPA plans to initiate cancer

hazard and dose response assessments

in the following year. A rationale will be

given. This list may include

reassessments as well as new

assessments to meet Agency needs,

focusing on evidence that application of

the new guidelines is expected to

change the assessment.

Call for Candidates and Screening

Criterion

In addition, the above notice will ask

the public for candidates for

reassessment. For all nominations, EPA

will ask the public to provide evidence

that application of the revised

guidelines is likely to appreciably

change the existing cancer assessment.

This requirement represents the

criterion that the Agency will use to

screen candidates for reassessment.

Along with this nomination, EPA will

encourage the public to propose a

revised cancer assessment which

applies the revised guidelines; this

could greatly facilitate the review for

selection. If an interested party is not

able to provide a revised assessment,

then the nomination should be

accompanied by a justification

explaining the importance of reassessing

that agent. Candidates for reassessment

will be accepted during a 90-day period.

Prioritization and Peer Review

An Agency screening team will

review all nominations. The team will

first determine if the above criterion is

met. Then, the screening team will

prioritize the submissions based on

completeness and quality of the

supporting information and consistency

with Agency priorities. It is the intent of

the Agency to involve peer review of the

scientific validity and relative ranking

of the candidates proposed for

reassessment. The peer review can assist

EPA in the final prioritization of

requests for reevaluation. A number of

peer review mechanisms can be used,

including the Science Advisory Board,

an annually constituted expert panel

specifically charged with reviewing the

ranking of chemicals, targeted mail

reviews to expert independent

reviewers, or other peer review

mechanisms.

(a) Completeness and scientific

validity of the supporting information:

The screening team will consider the

extent to which a request for

reevaluation is supported by a complete

reassessment or justification. A

complete, high-quality reassessment

should address all the principles of the

new Guidelines.

EPA expects that commentors may be

interested in submitting candidates

based on minor changes, e.g., change in

interspecies scaling factor. Revising risk

assessments based on minor changes

may or may not be consistent with

Agency priorities. Thus, commentors

are encouraged to apply all elements of

the Guidelines in their supporting

materials.

(b) Agency priorities: Following

review of the screening criterion and

supporting scientific information, the

Agency screening team will weigh the

list of candidates according to the

following Agency priorities:
Federal Register / Vol. 61, No. 123 / Tuesday, June 25, 1996 / Notices 32801

Degree of public health protection,

Protecting the maximum number of

people including sensitive subgroups,

Addressing the public interest,

Addressing multimedia exposure,

Addressing agents where there is

scientific controversy,

Addressing the potential to change a

regulation.

Prioritization of candidates will be

case-by-case depending on issues

identified above. The screening team

may give higher priority to those agents

for which public health protection is of

concern to ensure that those agents with

the potentially highest risk are

addressed first. Other factors such as

potential for widespread exposure,

particularly to sensitive members of the

population, may also place an agent

higher on the list.

Selection and Notification

Once the candidate list has been

prioritized, the Agency will evaluate the

availability of resources for final

selection of candidates for reassessment.

The Agency must balance resource

needs for new assessments as well as

reassessments in making this decision.

Resources include the availability of

staff time as well as resources for

conducting peer reviews.

In the fourth quarter of each fiscal

year, EPA will publish in the Federal

Register a list of agents that have been

selected for reevaluation. Those who

submitted comments will be notified in

writing. If a chemical is not selected for

reassessment in the upcoming cycle,

EPA will explain its reasons for not

including the requester’s candidate and

invite the requester to resubmit its

request during the next cycle (with any

updated supporting information, if

desired or necessary). A decision to not

include a chemical in any given cycle

does not mean that the Agency does not

consider reassessment of the chemical

to be appropriate, and it certainly does

not mean that the Agency will not

reassess the chemical in some later

cycle. The decision merely means that

given Agency resources for the

performance of reassessments in the

upcoming cycle and the other

candidates presented, the Agency will

not be able to reassess the requestor’s

candidate in the next cycle. For

purposes of judicial review, the Agency

does not consider this prioritization

decision to be a final Agency action on

a request to reassess a chemical.

Once an assessment (including

reevaluations) has been completed by

EPA, it will undergo peer review in

accordance with the Agency’s Peer

Review Policy. Consistent with previous

practices for conducting assessments,

EPA may also consult with other

Federal agencies. The final

reassessment, reflecting Agency

consensus and peer review, will be

summarized in IRIS.

The Office of Pesticide Programs is

conducting new or updated cancer

assessments on certain pesticides

according to timetables established for

its reregistration, registration and

special review programs. A list of

potential candidate chemicals to be

evaluated in reregistration during FY97

was published for comment in the

Federal Register on May 15, 1996. The

comment period for that notice ends

July 15, 1996. Therefore, requests to

reevaluate previous assessments

associated with the listed pesticides are

not necessary under the process

outlined above.

Issues for Comment

EPA requests comments on the

proposed process for reevaluating

existing cancer hazard and dose

response assessments. Specifically, EPA

seeks public opinion on four topics.

(1) The screening criterion.

(2) The relative importance of the

different prioritization factors in

determining where an agent falls on the

list. Other factors that can usefully be

considered.

(3) The utility and appropriateness of

the peer review mechanism(s) suggested

for peer review of the ranking of

chemicals for reevaluation. Please note

that peer review of each completed EPA

assessment (both new and reevaluated)

will proceed as outlined above.

(4) Other relevant issues pertaining to

this proposed process.

Interim Use of the Proposed Guidelines

Pending Finalization in New

Assessments

EPA will continue in most

circumstances to rely on the assessment

information currently available on IRIS

as guidance for use in regulatory and

non-regulatory decisions. Existing

assessments which applied the 1986

Guidelines continue to be scientifically

acceptable.

At the same time, the Agency’s 1986

Guidelines for Carcinogen Risk

Assessment provide for use of data on

mode(s)/mechanism(s) of action and

biologically-based models whenever

such information is available. The 1986

Guidelines state that they are intended

to accommodate new knowledge and

methods regarding cancer assessment as

they emerge. Accordingly, EPA has used

new approaches to cancer assessment

for agents (such as in EPA’s pending

reevaluation of dioxin risks) when there

has been sufficient scientific foundation

to support the new approaches.

Thus, pending publication of the final

revised guidelines and in keeping with

advancing knowledge on cancer

assessment, the principles and

approaches of the Proposed Guidelines

will be applied in part or in whole, on

a case-by-case basis for new assessments

as data warrant. Such use of the

Proposed Guidelines will allow EPA to

gain more experience before they are

finalized. The assessment will state the

rationale for applying the Proposed

Guidelines. When the Guidelines are

adopted by the Agency as final, they

will provide guidance for all new cancer

hazard and dose-response assessments.

EPA will continue to use appropriate

peer review processes during this time.

In summary, EPA recognizes the

possible need to reevaluate cancer

assessments developed using the 1986

Guidelines for Carcinogen Risk

Assessment. In addition, EPA must also

address new chemicals to meet Agency

priorities. Thus, EPA is proposing a

process that will enable it to move

forward in conducting new assessments

while also reevaluating existing

assessments using the new guidelines.

Dated: June 17, 1996.

Henry L. Longest,

Acting Assistant Administrator for Research

and Development.

[FR Doc. 96–16128 Filed 6–24–96; 8:45 am]

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS

COMMISSION

FCC To Hold Open Commission

Meeting Thursday, June 27, 1996

The Federal Communications

Commission will hold an Open Meeting

on the subjects listed below on

Thursday, June 27, 1996, which is

scheduled to commence at 9:30 a.m., in

Room 856, at 1919 M Street, NW.,

Washington, DC.

Item No., Bureau, Subject

1—Wireless Telecommunications—

Title: Amendment of the

Commission’s Rules to Permit

Flexible Service Offerings in the

Commercial Mobile Radio Services,

WT Docket No. 96–6). Summary: The

Commission will consider action to

allow commercial mobile radio

service providers more flexibility to

provide fixed wireless services.

2—Wireless Telecommunications—

Title: Interconnection and Resale

Obligations Pertaining to Commercial