29008 Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices

ACTION: Notice.

SUMMARY: In compliance with the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.), this document announces

that the following Information

Collection Request (ICR) has been

forwarded to the Office of Management

and Budget (OMB) for review and

approval: Information Collection

Request for the Underground Injection

Control Program (OMB Control No.

2040–0042; EPA ICR No. 0370.16),

expiring June 30, 1998. The ICR

describes the nature of the information

collection and its expected burden and

cost; where appropriate, it includes the

actual data collection instrument.

DATES: Comments must be submitted on

or before June 26, 1998.

FOR FURTHER INFORMATION CONTACT:

Contact Sandy Farmer at EPA by phone

at (202) 260–2740, by E-mail at

farmer.sandy@epamail.epa.gov, or

download off the Internet at http://

www.epa.gov/icr and refer to EPA ICR

No. 370.16.

SUPPLEMENTARY INFORMATION:

Title: Information Collection Request

for the Underground Injection Control

Program (OMB Control No. 2040–0042;

EPA ICR No. 370.16), expiring June 30,

1998. This is a request for extension of

a currently approved collection.

Abstract: The Underground Injection

Control (UIC) Program under the Safe

Drinking Water Act established a

Federal and State regulatory system to

protect underground sources of drinking

water from contamination by injected

fluids. Owners and operators of

underground injection wells must

obtain permits, conduct environmental

monitoring, maintain records, and

report results to EPA or the State

primacy Agency. States must report to

EPA on permittee compliance and

related information. The information is

reported using standardized forms, and

the regulations are codified at 40 CFR

parts 144 through 148. The data is used

to ensure the safety of underground

sources of drinking water. An agency

may not conduct or sponsor, and a

person is not required to respond to, a

collection of information unless it

displays a currently valid OMB control

number. The OMB control numbers for

EPA’s regulations are listed in 40 CFR

part 9 and 48 CFR Chapter 15. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. The OMB control numbers for

EPA’s regulations are listed in 40 CFR

part 9 and 48 CFR Chapter 15. The

Federal Register document required

under 5 CFR 1320.8(d), soliciting

comments on this collection of

information was published on February

19, 1998 (63 FR 8449). One comment

was received by EPA.

Burden Statement: The annual public

reporting and recordkeeping burden for

this collection of information is

estimated to average 2.59 hours per

response. Burden means the total time,

effort, or financial resources expended

by persons to generate, maintain, retain,

or disclose or provide information to or

for a Federal agency. This includes the

time needed to review instructions;

develop, acquire, install, and utilize

technology and systems for the purposes

of collecting, validating, and verifying

information, processing and

maintaining information, and disclosing

and providing information; adjust the

existing ways to comply with any

previously applicable instructions and

requirements; train personnel to be able

to respond to a collection of

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information.

Respondents/Affected Entities:

Entities potentially affected by this

action are owners and operators of

underground injection wells and their

States’ Agencies including Puerto Rico,

the U.S. Trust Territories, Indian Tribes,

and Alaska’s Native Villages.

Estimated Number of Respondents:

53,268.

Frequency of Response: Operators of

Class I, III and some Class V wells must

report monitoring results quarterly;

Class II operators report annually.

Estimated Total Annual Hour Burden:

1,135,273 hours.

Estimated Total Annualized Cost

Burden: $27,648,934.

Send comments on the Agency’s need

for this information, the accuracy of the

provided burden estimates, and any

suggested methods for minimizing

respondent burden, including through

the use of automated collection

techniques to the following addresses.

Please refer to EPA ICR No 2040–0042

and OMB Control No. 370.16 in any

correspondence.

Ms. Sandy Farmer, U.S. Environmental

Protection Agency, OPPE Regulatory

Information Division (2137), 401 M

Street, SW, Washington, DC 20460;

and

Office of Information and Regulatory

Affairs, Office of Management and

Budget, Attention: Desk Officer for

EPA, 725 17th Street, NW,

Washington, DC 20503.

Dated: May 20, 1998.

Richard T. Westlund,

Acting Director, Regulatory Information

Division.

[FR Doc. 98–13990 Filed 5–26–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6102–7]

Science Advisory Board,

Environmental Health Committee;

Notification of Public Meeting, June 9–

10, 1998

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: Pursuant to the Federal

Advisory Committee Act, Pub. L. 92–

463, notification is hereby given that the

Environmental Health Committee (EHC)

(henceforth, the ‘‘Committee’’) of the

Science Advisory Board (SAB) will meet

on Tuesday June 9 and Wednesday June

10, 1998, beginning no earlier than 8:30

am and ending no later than 5:00 pm on

each day. The meeting will be held in

the Main Auditorium, U.S. EPA,

Environmental Research Center, Route

54 and Alexander Drive, Research

Triangle Park, North Carolina 27711.

The meeting is open to the public,

however, due to limited space, seating

will be on a first-come basis.

The purpose of the meeting is for the

Committee to review: (a) Case studies on

the application of the Inhalation

Reference Concentrations (RfC)

Methods; and (b) the Acute Reference

Exposure Methodology (ARE). Both the

RfC Methods and the ARE Methods

were developed by the U.S. EPA Office

of Research and Development (ORD),

National Center for Environmental

Assessment (NCEA).

Charge for the RfC Methods Case

Studies Review

The Methodology document provides

the general conceptual framework for

evaluation of inhalation toxicity, as well

as the specifics and operational

procedures for this evaluation. The

procedures of the methodology will

continue to develop as the state-ofscience changes. The general charge to

the Committee is to conduct a review on

the utility of the conceptual framework

through examination of case studies of

chemicals across various types of agents

(particle versus gas category) and data

base (human versus laboratory animal;

incomplete or comprehensively

complete). The Committee is also

charged to comment on specific aspects
Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices 29009

of this framework, notably, consistency

in the conceptual approach regarding:

hazard identification; designation of

effect levels; choice of critical effect;

choice of principal study; duration and

dosimetry adjustment; response

modeling; application of UF; and

characterization of uncertainty

(confidence statements).

The Committee has also been asked to

comment on the level of documentation

used to support RfC estimates. In

addition, the Committee has been asked

to respond to the following specific

questions: (a) Overall, are the concepts

and applications of the RfC

methodology clearly articulated in the

documentation provided for the case

studies? Do the decisions and choices in

these files attain the Agency’s goal of

being ‘‘transparent, clear, and

reasonable’’? If not, what are specific

examples within these files that could

be instituted to better attain this goal?;

(b) In derivation of the RfC in the

specific case studies, (1) are the study

summaries presented in sufficient detail

for reader evaluation?, (2) are the

designations of the critical effect and

effects levels (NOAEL/LOAEL/BMC)

based on rationales that are clear and

reasonable?, (3) of the studies presented

in either the IRIS Summary or

Toxicological Review of each chemical,

has the Principal study/ies been

selected in a consistent and rational

manner? Does this choice reflect

consideration on the current knowledge

of potential human response?, (4) have

the underlying assumptions of the

duration and dosimetry adjustments

been presented clearly?, (5) are the

rationales presented for use of

uncertainty factors clear, reasonable and

consistent?, (6) do the confidence

statements reflect the strengths and

limitations (e.g., relevancy to humans,

comprehensiveness of the data base) of

the RfC assessment in a manner

consistent with the Agency’s goals?; and

(c) In the IRIS Summaries for the

specific cases, numerous studies are

included under the heading

‘‘Supporting/Additional Studies’’ that

are meant to provide further support for

designation of the critical effect (e.g.,

mechanistic data, human data) or for the

effect level chosen in the Principal

study, or to establish the completeness

of the data base. Is the depth of

presentation in this section sufficiently

comprehensive to provide information

supportive of the decisions made in the

assessment (such as uncertainty factors

and confidence levels)?

Charge for the Acute Reference

Exposure Methods Review

The Committee has been asked to

respond to the following Charge

questions for the Acute Reference

Exposure Methodology review: (a) The

ARE methodology recommends three

approaches for deriving ARE values and

describes the types and amount of data

that should be used to support each

approach. Are these approaches

appropriate for deriving acute exposure

values? Are the recommendations for

types and amount of data appropriate?;

(b) The ARE methodology recommends

using dosimetric adjustments to derive

human equivalent concentrations from

animal exposures. The ARE

methodology departs from the RfC

methodology by recommending default

dosimetric adjustment factors of one for

all categories of gases. For particulates,

the same adjustments used for

developing RfCs are recommended.

Does the documentation provide

sufficient rationale for these

recommendations? If not, please

comment on the elements that are

lacking. Are the recommended

dosimetric adjustments applicable to

acute exposure scenarios? If not, please

recommend dosimetric adjustments that

are more applicable to acute exposures;

(c) The categorical regression option of

the ARE methodology involves

assigning ordinal severity categories to

effect data from toxicity studies that use

a variety of species, exposure

concentrations and exposure durations.

Regression analysis is then used to

relate the severity of response to

exposure concentration and duration for

the entire array of data. For determining

the severity category of acute health

effects, the ARE methodology document

recommends using toxicological

judgment rather than a well-defined

scheme as schemes are unlikely to be

applicable to a variety of toxic

endpoints. Is the expert system for

categorizing severity sufficient? If not,

how can it be improved?; (d) The ARE

methodology recommends using severe

effect data, including lethality, for the

categorical regression approach, but

advises against using lethality and other

nonsensitive endpoints when using NoObserved-Adverse-Effect Level (NOAEL)

and benchmark concentration

approaches. The categorical regression

model uses severe effect data to

determine the slopes of the probability

curves for each severity, the intercepts

for the curves and the distance between

the various severity curves. Is the

guidance offered for including lethal

and severe effect data for ARE

derivation sufficient? Can the

Committee suggest ways in which

severe effect data could be better

utilized?; (e) CatReg software allows

individual data and data reported as

group information to be combined in a

single analysis. The CatReg Software

User Manual offers three alternatives for

placing group and individual data on

‘‘equal footing’’: the use of a scaling

factor, g; converting individual data to

group data; and estimating individual

responses from group information. No

alternative is described as preferred.

Does the Committee have an opinion as

to which alternative may be preferable?;

(f) In categorical regression, the rules of

probability constrain the probability

curves for the various severities to be

parallel. Although parallelism is a

mathematical constraint, it implies the

biological interpretation that similar

mechanisms of action and kinetics are

active in all severity categories. Does the

Committee view this as a limitation to

the categorical regression approach? If

so, how should the use of categorical

regression be constrained?; and (g) Of

the approaches recommended for ARE

derivation, categorical regression is the

only approach for which duration

extrapolation is not required. The

NOAEL and benchmark dose/

concentration methods (BMC)

approaches can only be applied to

exposure durations for which data are

available. AREs for other exposure

durations must be derived by duration

extrapolations. AREs for other exposure

durations must be derived by duration

extrapolations. For extrapolation from

short duration values to longer

durations, a concentration x time

adjustment is recommended. For

extrapolations from long durations to

shorter durations, use of the same

concentration identified at the longer

duration is recommended. These are

conservative duration adjustments. Are

these duration adjustments appropriate

for the approaches to which they are

applied? Can the Committee suggest

other adjustments that may be more

appropriate?

Background for RfC Methods Case

Studies Review

The Clean Air Act Amendments

(CAAA) of 1990 require sources to

demonstrate negligible risk and lack of

residual risk (after implementation of

control technology) based on health risk

estimates. Inhalation Reference

Concentrations (RfCs) are developed as

dose-response estimates for noncancer

effects. The RfC is an estimate (with

uncertainty spanning perhaps an order

of magnitude) of a daily inhalation

exposure to the human population

(including sensitive subgroups) that is
29010 Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices

likely to be without an appreciable risk

of deleterious noncancer effects during

a lifetime. It is anticipated that RfCs will

be used for CAAA regulatory activities

as a part of the determination of

negligible and residual risk for

noncancer health effects of air toxics.

Additionally, Regional, State and local

air pollution control offices utilize RfC

values in risk management programs.

The inhalation RfC methodology was

developed according to the oral

reference dose (RfD) paradigm with an

added emphasis on portal-of-entry

considerations of comparative toxicity

and inhalation dosimetry for particles

and gases. Extrapolation modeling was

added in which factors are derived for

adjustment of exposure concentrations

that account for dosimetric differences

between experimental animal species

and humans. The methodology is

considered to be a ‘‘living’’ document.

Previous versions have undergone

external peer review, including an

expert peer review in October 1987 and

a Science Advisory Board review in

1990 (EPA-SAB-EC–91–008). The

current version of the methodology

(Methods for Derivation of Inhalation

Reference Concentrations and

Application of Inhalation Dosimetry,

EPA/600/8–90/066F, October 1994)

represents the Agency’s response to

comments made at the 1990 SAB review

including revisions to allow flexibility

in the methods employed for dosimetry

adjustments that reflect the state-of-thescience such as substitution of

‘‘optimal’’ approaches (e.g., PB-PK)

when validated models are available.

The current version of the Methodology

and a category scheme for gases was

reviewed by two additional external

workgroups in August and September

1993. Revisions are already underway in

the dosimetry adjustments to allow for

contemporary mechanistic data to

inform the choice of alternative dose

metrics across noncancer and cancer

toxicities where appropriate.

At its review of the inhalation

methodology, the SAB requested the

opportunity to review case studies using

the methods to demonstrate the

application of the dosimetric

adjustments and to illustrate the

methodology applied to chemicals

representative of the typical range of

data available including those with

human occupational or clinical

information and those with databases

considered to be insufficient for

quantitative dose-response estimation

(‘‘not-verifiable’’). The review requested

by the SAB is not intended to be a

review of the RfC methods themselves

but rather one of the conceptual

framework of the approach as applied to

representative data. The accompanying

documents and related references

(Jarabek, 1994; 1995a,b) provide

definitions of uncertainty factors and

details on the RfC derivation

procedures. Case studies will be

presented in one of four groups: (1)

Particle case studies, (2) category 1 gas

case studies, (3) category 3 gas case

studies, and (4) not-verifiable case

studies.

Another concern that had been voiced

in a 1990 EHC report to the Agency

(EPA–SAB–EHC–90–005) regarding the

RfD Methodology was the reliance on

the NOAEL/LOAEL approach for

designation of the effect levels used in

the derivation. Since that time, the

Agency has advocated the use of the

benchmark dose/concentration (BMD/C)

approach as preferred or at least

complimentary to the NOAEL/LOAEL

approach (The Use of the Benchmark

Dose Approach in Health Risk

Assessment, EPA/630/R–94/007,

February 1995) when the data allow.

Some of the case studies to be reviewed

(MDI, phosphoric acid, antimony

trioxide, carbon disulfide) present BMC

analyses.

Background documentation

describing the derivation of the RfC for

each of the chemical files has been

provided. In some cases this is

embodied by the IRIS Summary (i.e., online IRIS file) alone. The newer files

(1997 and 1998) are accompanied by a

Toxicological Review from which the

actual on-line IRIS assessments are

derived in addition to the summary

sheet. The complete IRIS file for the

compounds reviewed (and any other

compound on IRIS) is available at http:/

/www.epa.gov/iris. The differences in

level of documentation reflect changes

made during a pilot program of the

Integrated Risk Information System

(IRIS) process which will be described

at the meeting and is reviewed in Mills

and Foureman (1998).

Background for Acute Reference

Exposure Methods Review

Risk assessment for acute inhalation

exposures has been hampered by the

lack of acute toxicity values on which

to base an evaluation of exposure. In an

effort to provide toxicity values for

acute noncancer risk assessment for

inhalation exposures, the U.S. EPA

National Center for Environmental

Assessment has developed a

methodology for Agency use to perform

dose-response assessments for

noncancer effects due to acute

inhalation exposures. The methodology

describes how to derive chemicalspecific acute exposure benchmarks

called acute reference exposures (AREs).

These estimates, applicable to single

continuous exposures for up to 24

hours, will have wide applicability in

assessing potential health risks due to

short-term exposures to airborne

chemicals in the environment. As they

are developed and reviewed, AREs will

be available to the public in chemicalspecific files found in U.S. EPA’s

Integrated Risk Information System

(IRIS) database.

The methodology document, Methods

for Exposure-Response Analysis for

Acute Inhalation Exposure to

Chemicals, Development of Acute

Reference Exposure, has undergone both

internal and external peer review and

was revised accordingly. The

supplementary documents, CatReg

Software Documentation and CatReg

Software User Manual, were developed

subsequent to the external peer review

and have undergone internal peer

review and revision.

For Further Information

Copies of the review document and

any background materials for the review

(with the exception of the SAB reports)

are not available from the SAB. Copies

of SAB prepared reports mentioned in

this FR Notice may be obtained from the

SAB’s Committee Evaluation and

Support Staff at (202) 260–4126, or via

fax at (202) 260–1889. Please provide

the SAB report number when making a

request.

Requests for individual copies of the

background material for the RfC

Methods Case Studies review should be

directed to Ms. Annie Jarabek by

telephone (919) 541–4847, by fax (919)

541–1818 or via Email at:

jarabek.annie@epa.gov. Technical

questions about the RfC Methods Case

Studies review should also be directed

to Ms. Annie Jarabek, National Center

for Environmental Assessment-RTP,

Mail Drop 52, U.S. EPA, Research

Triangle Park, NC 27711.

Requests for individual copies of the

background material for the Acute

Reference Exposure review should be

directed to Dr. Judy Strickland by

telephone (919) 541–4930, by fax (919)

541–0245 or via Email at:

strickland.judy@epa.gov. Technical

questions about the Acute Reference

Exposure Methods should also be

directed to Dr. Judy Strickland, National

Center for Environmental AssessmentRTP, Mail Drop 52, U.S. EPA, Research

Triangle Park, NC 27711.

Members of the public desiring

additional information about the

meeting, including an agenda, should

contact Ms. Mary Winston, Committee

Operations Staff, Science Advisory

Board (1400), U.S. EPA, 401 M Street,
Federal Register / Vol. 63, No. 101 /Wednesday, May 27, 1998 / Notices 29011

SW, Washington DC 20460, by

telephone (202) 260–4126; fax (202)

260–7118; or via Email at:

winston.mary@epa.gov

Anyone wishing to make an oral

presentation at the meeting must contact

Ms. Roslyn Edson, Acting Designated

Federal Officer for the EHC, in writing,

no later than 5:00 p.m. Eastern Time on

June 4, 1998, by fax (202) 260–7118, or

via Email at: edson.roslyn@epa.gov The

request should identify the name of the

individual who will make the

presentation and an outline of the issues

to be addressed. At least 35 copies of

any written comments to the Committee

are to be given to Ms. Edson no later

than the time of the presentation for

distribution to the Committee and the

interested public. For questions

concerning the review, Ms. Edson can

be contacted at (202) 260–3823.

Providing Oral or Written Comments at

SAB Meetings

The Science Advisory Board expects

that public statements presented at its

meetings will not repeat previously

submitted oral or written statements. In

general, each individual or group

making an oral presentation will be

limited to a total time of ten minutes.

This time may be reduced at the

discretion of the SAB, depending on

meeting circumstances. Oral

presentations at teleconferences will

normally be limited to three minutes per

speaker or organization. Written

comments (at least 35 copies) received

in the SAB Staff Office sufficiently prior

to a meeting date, may be mailed to the

relevant SAB committee or

subcommittee prior to its meeting;

comments received too close to the

meeting date will normally be provided

to the committee at its meeting. Written

comments, which may be of any length,

may be provided to the relevant

committee or subcommittee up until the

time of the meeting.

Individuals requiring special

accommodation, including wheelchair

access, should contact Ms. Edson at

least five business days prior to the

meeting so that appropriate

arrangements can be made.

Dated: May 15, 1998.

Donald G. Barnes,

Staff Director, Science Advisory Board.

[FR Doc. 98–13993 Filed 5–26–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

[FRL–6102–5]

Changes to the May 8, 1998 Federal

Register Notice Regarding Salt River

Municipal Solid Waste Landfill

Tentative Approval; Address

Correction to Public Hearing Location;

Date Changes to Public Hearing and

Public Comment Period

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice; correction.

SUMMARY: EPA’s tentative approval of an

alternative liner system design and use

of an alternative daily cover material for

the Salt River Municipal Solid Waste

Landfill was published in the May 8,

1998, Federal Register (63 FR 25476–

25479). The following information is an

update to the May 8, 1998, Federal

Register document.

Address Correction: the address for

the public hearing was incorrect and

printed as 1005 E. Osborne Road. The

correct address is 10005 Osborne Road.

Public Hearing Date: has been

rescheduled from June 10, 1998, to July

29, 1998.

Public Comment Period: has been

extended from June 10, 1998, to August

5, 1998.

Please note that public hearing is

scheduled for July 29, 1998, from 5–7

pm at Salt River Pima-Maricopa Indian

Reservation, Community Development

Conference Room, 10005 E. Osborne

Road, Scottsdale, Arizona 85256. For

further information, contact Steve

Parker at (602) 850–8024. At the

hearing, EPA may limit oral testimony

to five minutes per speaker, depending

on the number of commentors. The

hearing may adjourn earlier than 7:00

pm if all of the speakers deliver their

comments before that hour.

Representatives of the Salt River PimaMaricopa Indian Community and the

Salt River MSWLF will be present at the

public hearing.

Copies of the Salt River PimaMaricopa Indian Community’s

applications for site-specific flexibility

are available for inspection and copying

at: Salt River Pima-Maricopa Indian

Reservation Administration Building,

10005 E. Osborne Road, Scottsdale,

Arizona 85256. Contact: Lonita Jim,

Tribal Secretary (602) 850–8000, or the

US EPA Region 9 Library, 75 Hawthorne

Street 13th Floor, San Francisco,

California, 94105, telephone (415) 744–

1510, from 9 am to 5 pm Monday

through Friday.

All comments on the Salt River PimaMaricopa Indian Community’s

applications for approval of site-specific

flexibility must be received by August 5,

1998. Written comments should be sent

to Ms. Susanna Trujillo, Mail Code

WST–7, US EPA Region 9, 75

Hawthorne Street, San Francisco,

California 94105.

Dated: May 15, 1998.

Lawrence J. Bowerman,

Acting Director, Waste Management Division.

[FR Doc. 98–13991 Filed 5–26–98; 8:45 am]

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS

COMMISSION

Notice of Public Information

Collection(s) Being Reviewed by the

Federal Communications Commission

May 19, 1998.

SUMMARY: The Federal Communications

Commission, as part of its continuing

effort to reduce paperwork burden

invites the general public and other

Federal agencies to take this

opportunity to comment on the

following information collection(s), as

required by the Paperwork Reduction

Act of 1995, Public Law 104–13. An

agency may not conduct or sponsor a

collection of information unless it

displays a currently valid control

number. No person shall be subject to

any penalty for failing to comply with

a collection of information subject to the

Paperwork Reduction Act (PRA) that

does not display a valid control number.

Comments are requested concerning (a)

whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Commission, including whether the

information shall have practical utility;

(b) the accuracy of the Commission’s

burden estimate; (c) ways to enhance

the quality, utility, and clarity of the

information collected; and (d) ways to

minimize the burden of the collection of

information on the respondents,

including the use of automated

collection techniques or other forms of

information technology.

DATES: Written comments should be

submitted on or before July 27, 1998. If

you anticipate that you will be

submitting comments, but find it

difficult to do so within the period of

time allowed by this notice, you should

advise the contact listed below as soon

as possible.

ADDRESSES: Direct all comments to Judy

Boley, Federal Communications

Commission, Room 234, 1919 M St.,

N.W., Washington, DC 20554 or via

internet to jboley@fcc.gov.

FOR FURTHER INFORMATION CONTACT: For

additional information or copies of the