40820 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Notices

Health effects study NTIS document

Number

Sympton and Disease Prevalence With Biomarkers Health Study, Cornhusker Army Ammunition Plant, Hall County, Nebraska, ATSDR/HS–96–72.PB96–187760

Disease and Sympton Prevalence Survey, Tucson International Airport Site, Tucson, Arizona, ATSDR/HS–96–71 ................ PB96–199484

Evaluation of Developmental Disabilities in Relation to Environmental Exposures in Groton, Massachusetts, ATSDR/HS–

97–75.

PB97–137715

Adult Environmental Neurobehavioral Test Battery, ATSDR/HS–95–58 .................................................................................... PB96–109012

Standardized Assessment of Birth Defects and Reproductive Disorders in Environmental Health Field Studies, ATSDR/HS–

96–73.

PB96–199609

Pediatric Environmental Neurobehavioral Test Battery, ATSDR/HS–96–74 ............................................................................... PB96–207352

National Exposure Registry, Trichloroethylene (TCE) Subregistry, TCE Baseline, CD–ROM Series: TCE, Volume: Baseline,

No. 1.

PB95–501987

In accordance with 42 CFR 90.11,

copies of these final publications have

been distributed, as appropriate, to the

Environmental Protection Agency; the

applicable State and local government

agencies; the affected local

communities; and parties potentially

responsible for their release, if their

identity is readily available to ATSDR.

Additional final reports will be

announced semiannually in the Federal

Register as they become available.

Dated: July 24, 1997.

Georgi Jones,

Director, Office of Policy and External Affairs,

Agency for Toxic Substances and Disease

Registry.

[FR Doc. 97–20013 Filed 7–29–97; 8:45 am]

BILLING CODE 4163–70–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Toxic Substances and

Disease Registry

[ATSDR–124]

Announcement of Final Priority Data

Needs for 12 Priority Hazardous

Substances and Call for Voluntary

Research Proposals

AGENCY: Agency for Toxic Substances

and Disease Registry (ATSDR), U.S.

Department of Health and Human

Services (HHS).

ACTION: Announcement of final priority

data needs and ongoing call for

Voluntary Research Proposals.

SUMMARY: This notice announces the

final priority data needs for 12 priority

hazardous substances (see attached

Table 1) as part of the continuing

development and implementation of the

ATSDR Substance-Specific Applied

Research Program (SSARP). The notice

also serves as a continuous call for

voluntary research proposals. The

SSARP is authorized by the

Comprehensive Environmental

Response, Compensation, and Liability

Act of 1980 (Superfund) or CERCLA, as

amended by the Superfund

Amendments and Reauthorization Act

of 1986 (SARA) (42 U.S.C. 9604(i)). This

research program was initiated on

October 17, 1991. At that time, a list of

priority data needs for 38 priority

hazardous substances was announced in

the Federal Register (56 FR 52178). The

list was subsequently revised based on

public comments and published in final

form on November 16, 1992 (57 FR

54150).

Twelve substances constitute the

second list of hazardous substances for

which priority data needs are identified

by ATSDR. In developing this list,

ATSDR solicited input from the

Environmental Protection Agency (EPA)

and the National Institute of

Environmental Health Sciences

(NIEHS). The 12 substances, which are

included in the ATSDR Priority List of

Hazardous Substances established by

ATSDR and EPA (59 FR 9486, February

28, 1994), are:

*Chlordane

*1,2-dibromo-3-chloropropane

*Di-n-butyl phthalate

*Disulfoton

*Endrin (includes endrin aldehyde)

*Endosulfan (alpha-, beta-, and

endosulfan sulfate)

*Heptachlor (includes heptachlor

epoxide)

*Hexachlorobutadiene

*Hexachlorocyclohexane (alpha-, beta-,

delta-, and gamma-)

*Manganese

*Methoxychlor

*Toxaphene.

The priority data needs for these 12

substances were initially announced by

ATSDR in the Federal Register on April

1, 1996 (61 FR 14430). The public was

invited to comment on the priority data

needs during a 90-day period. ATSDR

received comments from industry

groups concerning substance-specific

priority data needs. The agency

responded to these comments and has

finalized the ‘‘Priority Data Needs’’

documents for these 12 hazardous

substances. Both the agency’s responses

and the revised ‘‘Priority Data Needs’’

documents are available for public

inspection at ATSDR (see ADDRESSES

section).

These priority data needs will be

addressed by the mechanisms described

in the Implementation of SubstanceSpecific Applied Research Program

section of this Federal Register notice.

This notice also serves as a

continuous call for voluntary research

proposals. Private-sector organizations

may volunteer to conduct research to

address specific priority data needs in

this notice by indicating their interest

through submission of a research

proposal to ATSDR (see ADDRESSES

section). A Tri-Agency Superfund

Applied Research Committee (TASARC)

comprised of scientists from ATSDR,

the National Toxicology Program (NTP),

and EPA will review all proposals. The

‘‘Priority Data Needs’’ documents are

available by writing to ATSDR (see

ADDRESSES section).

DATES: ATSDR considers the voluntary

research effort to be of significant

importance to the continuing

development of the Substance-Specific

Applied Research Program, and believes

this effort should be an open and

continuous one. Therefore, privatesector organizations are encouraged to

volunteer to conduct research to address

identified data needs, beginning with

the publication of this notice and until

that time when ATSDR announces that

research has been initiated for a specific

data need.

ADDRESSES: Private-sector organizations

interested in volunteering to conduct

research to address identified data

needs should announce their intention

by writing to Dr. William Cibulas,

Research Implementation Branch,

Division of Toxicology, Agency for

Toxic Substances and Disease Registry,

1600 Clifton Road, NE., Mailstop E–29,

Atlanta, Georgia 30333. Requests for the

final ‘‘Priority Data Needs’’ documents

and ATSDR’s response to public

comments should be addressed

similarly.
Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Notices 40821

These documents are available for

public inspection at the Agency for

Toxic Substances and Disease Registry,

Building 4, Suite 2400, Executive Park

Drive, Atlanta, Georgia (not a mailing

address), from 8 a.m. until 4:30 p.m.,

Monday through Friday, except for legal

holidays.

FOR FURTHER INFORMATION CONTACT:

Dr. William Cibulas, Chief, Research

Implementation Branch, Division of

Toxicology, Agency for Toxic

Substances and Disease Registry, 1600

Clifton Road, NE., Mailstop E–29,

Atlanta, Georgia 30333, telephone 404–

639–6306.

SUPPLEMENTARY INFORMATION:

Background

The Comprehensive Environmental

Response, Compensation, and Liability

Act of 1980 (Superfund) or CERCLA (42

U.S.C. 9604 (i)), as amended by the

Superfund Amendments and

Reauthorization Act of 1986 (SARA) (42

U.S.C. 9604(i)), requires that ATSDR: (1)

Develop jointly with EPA a list of

hazardous substances found at National

Priorities List (NPL) sites (in order of

priority), (2) prepare toxicological

profiles of these substances, and (3)

assure the initiation of a research

program to address identified priority

data needs associated with the

substances.

The Substance-Specified Applied

Research Program (SSARP) was initiated

on October 17, 1991. At that time, a list

of priority data needs for 38 priority

hazardous substances was announced in

the Federal Register (56 FR 52178). The

list was subsequently revised based on

public comments and published in final

form on November 16, 1992 (57 FR

54150).

Twelve substances constitute the

second list of hazardous substances for

which priority data needs are identified

by ATSDR. The priority data needs for

these 12 substances were initially

announced by ATSDR in the Federal

Register on April 1, 1996 (61 FR 14430).

The exposure and toxicity priority data

needs in this notice have been identified

from information gaps via a ‘‘Decision

Guide’’ that was published in the

Federal Register on September 11, 1989

(54 FR 37618). The priority data needs

represent essential information to

improve the database to conduct public

health assessments. Research to address

these data needs will help determine the

types or levels of exposure that may

present significant risks of adverse

health effects in people exposed to the

subject substances.

The priority data needs identified in

this notice reflect the opinion of

ATSDR, in consultation with other

Federal programs, of the research

needed pursuant to ATSDR’s authority

under CERCLA. They do not represent

the priority data needs for any other

program.

Consistent with Section 104(i)(12) of

CERCLA as amended (42 U.S.C.

9604(i)(12)), nothing in this research

program shall be construed to delay or

otherwise affect or impair the authority

of the President, the Administrator of

ATSDR, or the Administrator of EPA, to

exercise any authority regarding any

other provision of law, including the

Toxic Substances Control Act of 1976

(TSCA) and the Federal Insecticide,

Fungicide, and Rodenticide Act of 1972

(FIFRA), or the response and abatement

authorities of CERCLA.

In developing this research program,

ATSDR has worked with other Federal

programs to determine common

substance-specific data needs, as well as

mechanisms to implement research that

may include authorities under TSCA

and FIFRA, private-sector voluntarism,

or the direct use of CERCLA funds.

When deciding the type of research

that should be done, ARSDR considers

the recommendations of the Interagency

Testing Committee (ITC) established

under Section 4(e) of TSCA. Federally

funded projects that collection

information from 10 or more

respondents and are funded by

cooperative agreement are subject to

review by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act. If the proposed project

involves research on human subjects,

the applicants must comply with

Department of Health and Human

Services’ regulations (45 CFR Part 46)

regarding the protection of human

subjects. Assurance must be provided

that the project will be subject to initial

and continuing review by the

appropriate institutional review

committees. Overall, data generated

from this research program will lend

support to others involved in human

health assessments involving these 12

substances (and related ones) by

providing additional scientific

information for the risk assessment

process.

Implementation of Substance-Specified

Applied Research Program

In Section 104(i)(5)(D), CERCLA states

that it is the sense of Congress that the

costs for conducting this research

program be borne by the manufacturers

and processors of the hazardous

substances under TSCA and by

registrants under FIFRA, or by cost

recovery from responsible parties under

CERCLA. To execute this statutory

intent, ATSDR developed a plan

whereby parts of the SSARP are being

conducted via regulatory mechanisms

(TSCA/FIFRA), private-sector

voluntarism, and the direct use of

CERCLA funds.

CERCLA also requires that ATSDR

consider recommendations of the ITC

on the types of research to be done.

ATSDR actively participates on this

committee; however, none of the

proposed 12 substances are now on the

ITC priority testing list.

The mechanisms for implementing

the SSARP are discussed below. The

status of the SSARP in addressing

priority data needs of the first set of 38

priority hazardous substances via these

mechanisms was described in a Federal

Register notice on April 1, 1996 (61 FR

14420).

A. TSCA/FIFRA

In developing and implementing the

SSARP, ATSDR and EPA established

procedures to identify priority data

needs of mutual interest to Federal

programs. Generally, this begins before

or during the finalization of the priority

data needs. These data needs will be

addressed through a program of

toxicologic testing under TSCA or

FIFRA. This part of the research will be

conducted according to established

TSCA/FIFRA procedures and

guidelines. Generally, this testing will

fulfill more than one Federal program’s

need.

Currently, in collaboration with EPA,

the ATSDR test rule for seven organic

chemicals (benzene, trichloroethylyene,

tetrachloroethylene, cyanide, toluene,

methylene chloride, and chloroethane)

is being developed. In addition, the

Metals Testing Task Force, consisting of

scientists from ATSDR, EPA, and

NIEHS, met last February and

established a draft list of priority metals

(including all of ATSDR’s priority

metals) for testing. A draft survey for

soliciting testing needs of other

government agencies was also

developed. A second meeting of the

Task Force to help set priorities for

testing needs is scheduled for early fall.

B. Private-Sector Voluntarism

As part of the SSARP, on February 7,

1992, ATSDR announced a set of

proposed procedures for conducting

voluntary research (56 FR 4758).

Revisions based on public comments

were published on November 16, 1992

(57 FR 54160). ATSDR strongly

encourages private-sector organizations

to propose research to address data

needs at any time until ATSDR

announces that research has already

been initiated for a specific data need
40822 Federal Register / Vol. 62, No. 146 / Wednesday, July 30, 1997 / Notices

(e.g., via EPA test rule development).

Private-sector organizations may

volunteer to conduct research to address

specific priority data needs identified in

this notice by indicating their interest

through submission of a research

proposal.

The research proposal should be a

brief statement (1–2 pages) that

identifies the priority data need(s) to be

addressed and the methods to be used.

The TASARC will review these

proposals. Based on the review

committee’s recommendations, ATSDR

will determine which specific voluntary

research projects will be pursued (and

how) with the volunteer organizations.

ATSDR will only enter into those

voluntary research projects that lead to

high quality, peer-reviewed scientific

work. Additional details regarding the

process for voluntary research are in the

Federal Register notices cited in this

section.

Recently, the first research study

conducted under ATSDR’s voluntary

research program was completed. The

study, conducted by the Halogenated

Solvents Industry Alliance, Inc. (HSIA),

addressed three priority data needs for

methylene chloride using

physiologicially-based parhmacokinetic

(PBPK) modeling. HSIA has also

proposed to conduct an immunotoxicity

assessment for methylene chloride via

inhalation exposure, and to obtain the

oral immunotoxicity data via PBPK

modeling. HSIA and ATSDR are

continuing to discuss voluntary research

efforts for trichloroethylene and

tetrachloroethylene.

Presently, ATSDR has three

memorandums of understanding with

private-sector organizations: HSIA, to

conduct studies on methylene chloride;

the Chemical Manufacturers

Association, to conduct research on

vinyl chloride; and the General Electric

Company (GE), to conduct studies on

polychlorinated biphenyl compounds.

The final report of GE’s study on an

assessment of the chronic toxicity and

oncogenicity of Aroclor–1016, Aroclor–

1242, Aroclor–1254, and Aroclor–1260

administered in diet to rats was recently

reviewed by ATSDR’s peer reviewers.

ATSDR will accept the report pending

GE’s satisfactory response to the

review’s comments.

C. CERCLA

Those priority data needs that are not

addressed by TSCA/FIFRA or initial

voluntarism will be considered for

funding by ATSDR through its CERCLA

budget. A large part of this research

program is envisioned to be unique to

CERCLA, for example, research on

substances not regulated by other

programs or research needs specific to

public health assessments. Current

examples of the direct use of CERCLA

funds include interagency agreements

with other Federal agencies and

cooperative agreements and grants with

academic institutions.

Mechanisms to address these priority

data may include a second call for

voluntarism. Again, scientific peer

review of study protocols and results

would occur for all research conducted

under this auspice.

Substance-Specific Priority Data Needs

The final priority data needs are

identified in Table 1. Unique

identification numbers (25A through

36H) are assigned to the priority data

needs for this list of 12 priority

hazardous substances; the initial list of

38 substances has identification

numbers 1A through 24C (59 FR 11434,

March 10, 1994).

As previously stated, ATSDR believes

that part of this research will be most

appropriately conducted using CERCLA

data and resources. Toward this end,

ATSDR has identified particular data

needs that may be implemented by

ATSDR programs. These priority data

needs fall into both the exposure and

toxicity data needs categories.

A major exposure priority data need

for all 12 substances will be to collect,

evaluate, and interpret data from

contaminated environmental media

around hazardous waste sites. However,

a substantial amount of this information

has already been collected through

individual State programs and EPA’s

CERCLA activities. ATSDR scientists

will, therefore, evaluate the extant

information from these programs to

better characterize the need for

additional site-specific information.

ATSDR’s role as a public health

agency addressing environmental health

is, when appropriate, to collect human

data to validate substance-specific

exposure and toxicity findings. ATSDR

will obtain this information by

conducting exposure and health effects

studies, and by establishing and using

substance-specific subregistries of

people enrolled in the agency’s National

Exposure Registry who are potentially

exposed to these substances. When a

subregistry or a human exposure study

is identified as a priority data need, the

responsible ATSDR program will

determine its feasibility, which depends

on identifying appropriate populations

and funding. These priority data needs

may be reclassified following

considerations of feasibility. Any

reclassification will be published in the

Federal Register.

ATSDR acknowledges that the

conduct of human studies to determine

possible links between exposure to

hazardous substances and human health

effects may be accomplished other than

by ATSDR’s or under other ATSDRsponsored projects. We encourage

private-sector organizations and other

governmental programs to use ATSDR’s

priority data needs to plan their

research activities, including identifying

appropriate populations and conducting

studies to answer specific human health

questions.

The results of the research conducted

via this ATSDR Substance-Specific

Applied Research Program will be used

for public health assessment purposes

and to reassess ATSDR’s substancespecific priority data needs. ATSDR

intends to reevaluate the priority data

needs for hazardous substances every

three years.

Dated: July 24, 1997.

Georgi Jones,

Director, Office of Policy and External Affairs,

Agency for Toxic Substances and Disease

Registry.

BILLING CODE 4163–70–U
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[FR Doc. 97–20012 Filed 7–29–97; 8:45 am]

BILLING CODE 4163–70–C