Announcement of Final Priority Data Needs for 12 Priority Hazardous Substances and Call for Voluntary Research Proposals

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.

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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 Substance-Specific 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, private-sector 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.

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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

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(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

ATSDR-sponsored 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 substance-specific 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.

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[FR Doc. 97-20012 Filed 7-29-97; 8:45 am]

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