Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 73749 

Average Burden Per Response: 1 hour. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access the HHS Web 

site address at http://www.hhs.gov/ 

oirm/infocollect/pending/ or e-mail your 

request, including your address, phone 

number, OMB number, and OS 

document identifier, to 

naomi.cook@hhs.gov, or call the Reports 

Clearance Office on (202) 690–6162. 

Written comments and 

recommendations for the proposed 

information collections must be mailed 

within 30 days of this notice directly to 

the Desk Officer at the address below: 

OMB Desk Officer: Katherine Astrich, 

OMB Human Resources and Housing 

Branch, Attention: (OMB 4040–0004), 

New Executive Office Building, Room 

10235, Washington, DC 20503. 

Date: December 2, 2005. 

Robert E. Polson, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E5–7252 Filed 12–12–05; 8:45 am] 

BILLING CODE 4157–17–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Toxic Substances and 

Disease Registry 

[ATSDR–215] 

Update on the Status of the Superfund 

Substance-Specific Applied Research 

Program 

Editorial Note: FR Doc. 05–23361 was 

originally published at page 71506 in the 

issue of Tuesday, November 29, 2005. The 

corrected document is republished below in 

its entirety, due to printing errors. 

AGENCY: Agency for Toxic Substances 

and Disease Registry (ATSDR), U.S. 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: This Notice provides the 

status of ATSDR’s Superfund-mandated 

Substance-Specific Applied Research 

Program (SSARP) which was last 

updated in a Federal Register notice in 

2002 (67 FR 4836). Authorized by the 

Comprehensive Environmental 

Response, Compensation, and Liability 

Act of 1980 (CERCLA, also known as the 

Superfund statute), 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 

frequently found at waste sites 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). 

The 38 substances, each of which is 

found on ATSDR’s Priority List of 

Hazardous Substances (68 FR 63098, 

November 7, 2003), are aldrin/dieldrin, 

arsenic, benzene, beryllium, cadmium, 

carbon tetrachloride, chloroethane, 

chloroform, chromium, cyanide, p,p’- 

DDT,DDE,DDD, di(2-ethylhexyl) 

phthalate, lead, mercury, methylene 

chloride, nickel, polychlorinated 

biphenyl compounds (PCBs), polycyclic 

aromatic hydrocarbons (PAHs—

includes 15 substances), selenium, 

tetrachloroethylene, toluene, 

trichloroethylene, vinyl chloride, and 

zinc. 

On July 30, 1997, priority data needs 

for 12 additional hazardous substances 

frequently found at waste sites were 

determined and announced in the 

Federal Register (62 FR 40820). The 12 

substances, each of which is included in 

ATSDR’s Priority List of Hazardous 

Substances, are chlordane, 1,2-dibromo3-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, and toxaphene. 

More recently, priority data needs for 

10 additional hazardous substances 

frequently found at waste sites were 

determined and announced in the 

Federal Register (68 FR 22704). The ten 

substances, each of which is included in 

ATSDR’s Priority List of Hazardous 

Substances, are asbestos, benzidine, 

chlorinated dibenzo-p-dioxins, 1,2- 

dibromoethane, 1,2-dichloroethane, 1,1- 

dichloroethene, ethylbenzene, 

pentachlorophenol, 1,1,2,2- 

tetrachloroethane, and total xylenes. 

Currently, the priority data needs for 

acrolein and barium are being identified 

and will be reported in a future Federal 

Register notice. 

To date, 270 priority data needs have 

been identified for the 60 hazardous 

substances, and 86 priority data needs 

have been filled (Table 1). ATSDR fills 

these research needs through U.S. 

Environmental Protection Agency (EPA) 

regulatory mechanisms (test rules), 

private-sector voluntarism, and the 

direct use of CERCLA funds. Additional 

priority data needs are being addressed 

through collaboration with the National 

Toxicology Program (NTP), by ATSDR’s 

Great Lakes Human Health Effects 

Research Program, and other Agency 

programs. Priority data needs 

documents describing ATSDR’s 

rationale for prioritizing research needs 

for each substance are available. See 

ADDRESSES section of this 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 

identified in this Notice by indicating 

their interest through submission of a 

letter of intent to ATSDR (see 

ADDRESSES section of this Notice). A TriAgency Superfund Applied Research 

Committee (TASARC) composed of 

scientists from ATSDR, National 

Institute of Environmental Health 

Sciences (NIEHS)/NTP, and the EPA, 

will review all proposed voluntary 

research studies. 

DATES: ATSDR provides updates on the 

status of its Substance-Specific Applied 

Research Program approximately every 

three years or sooner, as needed. ATSDR 

considers the voluntary research effort 

to be important to the continuing 

implementation of the SSARP. 

Therefore, the Agency strongly 

encourages private-sector organizations 

to volunteer at any time to conduct 

research to fill data needs until ATSDR 

announces that other research 

mechanisms are in place to address 

those specific data needs. 

ADDRESSES: Private-sector organizations 

interested in volunteering to conduct 

research can write to Yee-Wan Stevens, 

M.S., Applied Toxicology Branch, 

Division of Toxicology and 

Environmental Medicine, ATSDR, 1600 

Clifton Road, NE., Mailstop F–32, 

Atlanta, Georgia 30333, e-mail: 

YStevens@cdc.gov. Information about 

pertinent ongoing or completed research 

that may fill priority data needs cited in 

this Notice should be similarly 

addressed. 

Other Requirements: Projects that 

involve the collection of information 

from ten or more individuals and 

funded by cooperative agreement will 

be subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act. 

FOR FURTHER INFORMATION CONTACT: YeeWan Stevens, M.S., Applied Toxicology 

Branch, Division of Toxicology and 

Environmental Medicine, ATSDR, 1600 

Clifton Road, NE., Mailstop F–32, 

Atlanta, Georgia 30333, telephone: (770) 

488–3325, fax: (770) 488–4178. 

SUPPLEMENTARY INFORMATION: 

Background 

CERCLA as amended by SARA [42 

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

jointly with the EPA, develop and 

73750 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

prioritize a list of hazardous substances 

found at National Priorities List (NPL) 

sites, (2) prepare toxicological profiles 

for these substances, and (3) assure the 

initiation of a research program, in 

conjunction with NTP, to address 

identified data needs associated with 

the substances. Before starting such a 

program, ATSDR will consider 

recommendations of the InterAgency 

Testing Committee on the type of 

research that should be done. This 

committee was established under 

section 4(e) of the Toxic Substances 

Control Act of 1976 [15 U.S.C. 

2604(e)](TSCA). 

The major goals of the ATSDR SSARP 

are (1) to address the substance-specific 

information needs of the public and 

scientific community, and (2) to supply 

information necessary to improve the 

database used to conduct 

comprehensive public health 

assessments of populations living near 

hazardous waste sites. We anticipate 

that the information will help to 

establish linkages between levels of 

contaminants in the environment and 

levels in human tissue and organs 

associated with adverse health effects. 

Once such links have been established, 

strategies to mitigate potentially harmful 

exposures can be developed. This 

program will also provide data that can 

be generalized to other substances or 

areas of science, including risk 

assessment of chemicals, thus creating a 

scientific information base for 

addressing a broader range of data 

needs. 

ATSDR encourages the use of in vitro 

assessment methods and other 

innovative tools for filling priority data 

needs. For example, the Agency believes 

that physiologically based 

pharmacokinetic (PBPK) modeling 

could serve as a valuable tool in 

predicting across route similarities (or 

differences) in toxicological responses 

to hazardous substances. Therefore, on 

a case-by-case basis, a priority data need 

can be filled using existing data and 

modeling. In addition, ATSDR is a 

member of NTP’s InterAgency 

Coordinating Committee on the 

Validation of Alternative Methods 

(ICCVAM) and supports development, 

validation, and acceptance of alternative 

toxicological test methods that reduce, 

refine, and replace the use of animals, 

as appropriate. 

CERCLA section 104(i)(5)(D) 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 

substance in question,’’ as required in 

TSCA and the Federal Insecticide, 

Fungicide, and Rodenticide Act of 1972 

[7 U.S.C. 136 et seq.] (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 the regulatory 

mechanisms referenced (TSCA/FIFRA), 

private-sector voluntarism, and the 

direct use of CERCLA funds. 

The TASARC, composed of scientists 

from ATSDR, NIEHS/NTP, and EPA, has 

been set up to: 

(1) Advise ATSDR on the assignment 

of priorities for mechanisms to address 

data needs, 

(2) Coordinate knowledge of research 

activities to avoid duplication of 

research in other programs and under 

other authorities, 

(3) Advise ATSDR on issues of 

science related to substance-specific 

data needs, and 

(4) Maintain a scheduled forum that 

provides an overall review of the 

ATSDR SSARP. 

TASARC has met 12 times since the 

initiation of the SSARP. It has guided 

referral of priority data needs to EPA 

and the associated development of test 

rules through TSCA. In addition, it has 

endorsed the proposals of several 

private-sector organizations to conduct 

voluntary research. Furthermore, 

TASARC has become a forum for other 

federal agencies to bring forth their 

research agendas. For example, it has 

coordinated research efforts on 

hazardous pollutants with the Office of 

Air and Radiation, EPA. TASARC has 

developed testing guidelines for 

immunotoxicity; and has endorsed the 

use of decision-support methodologies 

such as physiologically based 

pharmacokinetic (PBPK) modeling and 

benchmark-dose modeling, where 

appropriate. 

Additional priority data needs are 

being addressed through collaborative 

research efforts with NTP, by ATSDR’s 

Great Lakes Human Health Effects 

Research Program, and other Agency 

programs. 

Criteria for Evaluating Status of 

Priority Data Needs 

To update the activities covered 

under the SSARP, criteria for evaluating 

the status of the priority data needs 

were developed. Based on these criteria 

and the review of the current literature, 

a priority data need can be filled, or 

unchanged. 

The criteria for evaluating the status 

of the priority data needs are described 

below. 

General Criteria 

A priority data need is filled: 

• If it has been referred to one of the 

implementation mechanisms and 

research has been initiated (Exception: 

priority data needs referred to EPA [i.e., 

included in the EPA/ATSDR test rule] 

and/or ATSDR Voluntary Research 

Program remain as priority data needs 

until the studies have been completed, 

peer reviewed and accepted by ATSDR), 

OR 

• If an updated ATSDR toxicological 

profile contains relevant new studies, or 

if other relevant, peer-reviewed, and 

publicly available new studies (not 

included in the toxicological profile) 

have been identified since the 

finalization of the priority data needs 

document; and based on such studies, it 

is generally agreed that a priority data 

need has been filled. 

Furthermore, in the event a priority 

data need is considered filled, it does 

not necessarily mean that the study has 

been completed and that ATSDR has 

accepted the data. It does, however, 

indicate that the Agency no longer 

considers it a priority to initiate 

additional studies at this time. 

A priority data need remains 

unchanged: 

• If no mechanism or information has 

been identified to address the priority 

data need, or 

• If the priority data need is included 

in the ATSDR/EPA test rule under 

development and/or ATSDR Voluntary 

Research Program, or it is associated 

with a pilot substance in EPA’s 

Voluntary Children’s Chemical 

Evaluation Program. 

Specific Criteria 

Examples of specific criteria for two 

categories of priority data needs are 

described below. 

• Epidemiologic studies—A priority 

data need is filled if multiple new 

studies assessing key health end points 

are available in ATSDR’s updated 

toxicological profile and/or ongoing 

studies have been identified, e.g., 

human health studies supported by 

ATSDR’s Great Lakes Human Health 

Effects Research Program or the 

Minority Health Professions Foundation 

Research Program. In some cases, 

ATSDR indicates that it will continue to 

evaluate new data as they become 

available to determine whether 

additional studies are needed. 

• Exposure levels in humans (adults 

and/or children)—A priority data need 

is filled if (a) there are current and 

adequate biomonitoring data for 

exposed populations associated with 

health effects (from published or 

ongoing studies), or (b) there are 

reference range data (e.g., the Centers for 

Disease Control and Prevention’s Third 

Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 73751 

National Report on Human Exposure to 

Environmental Chemicals, with data 

from a random sample of participants 

from the National Health and Nutrition 

Examination Survey [NHANES] ) or 

generally agreed upon background 

population levels. In the latter case, 

ATSDR acknowledges that reference 

concentration data can support 

exposure and health assessments at 

waste sites, but the Agency also 

continues to recognize the importance 

of collecting additional data on 

uniquely exposed populations at waste 

sites. It should be noted that for some 

of the chemicals listed in the National 

Report, the measurements are reported 

as below the limit of detection (LOD) for 

those chemicals. However, the LODs for 

all the chemicals monitored are 

available in the Report, and therefore, 

these data can be considered as 

estimates of background exposure 

levels. 

In updating the SSARP, the status of 

the priority data needs may change as 

new information becomes available. 

Further, during the literature review, 

new studies may be identified 

suggesting other effects of concern, such 

as those related to endocrine disruptors 

and children’s health, which were not 

included in the original list of priority 

data needs. In such cases, additional 

priority data needs may be added to the 

research agenda. For example, in 

addressing issues relating to children’s 

health, ATSDR considers it a priority to 

obtain data on exposure levels in 

children; therefore, when such 

information is available, it is used to fill 

this additional priority data need (e.g., 

cadmium, chlordane, chlorinated 

dibenzo-p-dioxins, DDT, lead, and 

pentachlorophenol, see Table 1). 

In contrast, the Agency may consider 

a previously identified priority data 

need to no longer be a priority to fill at 

this time and thus be deleted from the 

list of priority data needs. However, it 

remains a data need for the Agency. For 

example, as a result of reevaluation of 

the database for di-n-butyl phthalate, 

two of its previously identified priority 

data needs, i.e., immunotoxicity and 

neurotoxicty studies via oral exposure 

are no longer considered to be priority 

data needs. This is due to the fact that 

the immune system does not appear to 

be a target for di-n-butyl phthalate 

toxicity and that additional neurotoxicty 

studies do not seem necessary because 

of the lack of effects seen in long-term 

neurotoxicty studies. In addition, under 

the Agency’s Voluntary Research 

Program, the Halogenated Solvents 

Industry Alliance, Inc. (HSIA) proposed 

to fill a trichloroethylene priority data 

need (dose-response data for 

intermediate-duration, oral exposure) by 

conducting PBPK modeling to obtain 

the data for oral exposure using existing 

inhalation data. However, ATSDR is 

concerned that, based on the existing 

data for this exposure duration, it is not 

clear if the most sensitive end point for 

oral exposure is the same as that for 

inhalation exposure. Therefore, the 

Agency believes it is prudent not to 

consider it a priority to conduct a PBPK 

study to obtain the oral data at this time 

pending evaluation of additional 

information. This is reflected in Table 1 

from which this priority data need has 

been deleted. 

Update of Activities in the SSARP 

An update of the activities associated 

with the mechanisms for implementing 

the ATSDR Substance-Specific Applied 

Research Program (SSARP) is discussed 

below. 

A. TSCA/FIFRA 

In developing and implementing the 

SSARP, ATSDR, NIEHS/NTP, and EPA 

have identified a subset of priority data 

needs for substances of mutual interest 

to the federal programs. These priority 

data needs are being addressed through 

a program of toxicological testing under 

TSCA according to established 

procedures and guidelines. On several 

occasions when ATSDR identified 

priority data needs for oral exposure, 

other agencies needed inhalation data. 

In response, ATSDR considers proposals 

to conduct inhalation studies in 

conjunction with physiologically based 

pharmacokinetic (PBPK) studies in lieu 

of oral studies. ATSDR expects that 

inhalation data derived from these 

studies can be used with PBPK 

modeling to address its oral toxicity 

priority data needs. Currently, an EPA/ 

ATSDR test rule, under development, 

includes eight ATSDR substances, i.e., 

benzene, chloroethane, cyanide 

(hydrogen cyanide and sodium 

cyanide), methylene chloride, 

tetrachloroethylene, toluene and 

trichloroethylene, and addresses 13 

ATSDR priority data needs (Table 2). 

The test rule is presently undergoing 

ATSDR and EPA final review and is 

anticipated to be available for public 

comment in Spring 2006. 

At least seven metals included in the 

ATSDR’s SSARP (arsenic, beryllium, 

chromium, manganese, mercury, nickel, 

and selenium, associated with 21 

priority data needs) (Table 2) have been 

forwarded to EPA through TASARC for 

toxicity testing. The EPA is currently 

developing a risk assessment framework 

for metals. Once the framework has 

been adopted, the EPA will solicit 

testing proposals for these metals and 

pursue appropriate testing mechanisms 

at a later date. 

B. Private-Sector Voluntarism 

As part of the Substance-Specific 

Applied Research Program (SSARP), 

ATSDR announced a set of proposed 

procedures for conducting voluntary 

research in the Federal Register (57 FR 

4758) on February 7, 1992. Revisions 

based on public comments were 

published on November 16, 1992 (57 FR 

54160). Private-sector organizations are 

encouraged to volunteer to conduct 

research to fill specific priority data 

needs at no expense to ATSDR. All 

study protocols and final reports are 

subjected to ATSDR’s external peer 

review, and ATSDR accepts the study 

results based on the peer reviewers’

recommendation and the industry 

groups’ satisfactory response to the 

reviewers’ comments. 

To date, ATSDR has established 

memoranda of understanding with four 

industry groups. Through the voluntary 

research efforts of these organizations, at 

least 15 research needs (12 priority data 

needs and 3 data needs) for methylene 

chloride, tetrachloroethylene 

(perchloroethylene), trichloroethylene, 

polychlorinated biphenyl compounds 

[PCBs], and vinyl chloride have been or 

are being filled (Table 2). 

Industry groups which conducted 

studies under the Voluntary Research 

Program include: The American 

Chemistry Council (ACC) [formerly the 

Chemical Manufacturers Association 

(CMA)] ATSDR accepted the ACC 

studies ‘‘Vinyl chloride: Combined 

inhalation two-generation reproduction 

and developmental toxicity study in CD 

rats.’’

General Electric Company (GE) 

GE conducted studies on 

polychlorinated biphenyls including 

‘‘An assessment of the chronic toxicity 

and oncogenicity of Aroclors 1016, 

1242, 1254, and 1260 administered in 

diet to rats,’’ ‘‘PCB congener analyses,’’

and ‘‘Metabolite detection as a tool for 

determining naturally occurring aerobic 

PCB biodegradation.’’ Although these 

studies do not specifically address 

ATSDR’s priority data needs for PCBs, 

they do address other Agency research 

needs for these substances. 

Halogenated Solvents Industry Alliance, 

Inc. (HSIA) 

To date, ATSDR has entered into five 

MOUs with HSIA to conduct studies to 

fill priority data needs for methylene 

chloride, tetrachloroethylene and 

trichloroethylene. In addition, in 2002, 

HSIA signed a letter of agreement with 

ATSDR stating that HSIA volunteers to 

73752 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

conduct studies to fill ATSDR’s 

remaining priority data needs for 

tetrachloroethylene (perchloroethylene) 

and trichloroethylene. These studies are 

being done in conjunction with the 

EPA/ATSDR test rule and EPA’s 

Voluntary Children’s Chemical 

Evaluation Program. In some cases, 

HSIA first conducted a study via 

inhalation which was followed by route 

extrapolation via PBPK modeling to 

obtain data for oral exposure. This is 

because, for specific chemicals, EPA 

requires inhalation data while ATSDR 

has determined that ingestion of 

contaminated environmental media is 

the primary exposure route at hazardous 

waste sites. 

HSIA studies accepted by ATSDR 

include: Addressing priority data needs 

for methylene chloride with 

physiologically based pharmacokinetic 

modeling’’ which evaluates acute- and 

subchronic-duration toxicity and 

developmental toxicity via oral 

exposure. 

‘‘Methylene chloride: 28 day 

inhalation toxicity study in the rat to 

assess potential immunotoxicity.’’

‘‘Immunotoxic potential of orally 

administered dichloromethane from 

immunotoxicty studies conducted by 

the inhalation route.’’ (PBPK modeling) 

‘‘Trichloroethylene: Inhalation 

developmental toxicity study in CD 

rats.’’ HSIA will conduct PBPK 

modeling to obtain data for oral 

exposure based on the inhalation data. 

‘‘Trichloroethylene (TCE): 

Immunotoxicity potential in CD rats 

following a 4-week vapor inhalation 

exposure.’’ The final report of the study 

is undergoing ATSDR’s external peer 

review. Pending ATSDR’s acceptance of 

the inhalation study, HSIA will conduct 

PBPK modeling to obtain data for oral 

exposure based on the inhalation data. 

‘‘Perchloroethylene: Study of effects 

on embryo-fetal development in CD rats 

by inhalation administration.’’ HSIA 

will conduct PBPK modeling to obtain 

data for oral exposure based on the 

inhalation data. 

Electric Power Research Institute, Inc. 

(EPRI) 

In addition to the substance-specific 

MOUs described above, ATSDR also 

signed an MOU with EPRI to conduct a 

study ‘‘Validation of test methods for 

assessing neurodevelopment in 

children.’’ In this particular case, 

ATSDR and three other federal agencies 

(the Food and Drug Administration, 

EPA, and NIEHS) were also funding 

partners. 

C. CERCLA-Funded Research (Minority 

Health Professions Foundation Research 

Program) 

During FY 1992, ATSDR announced a 

$4 million cooperative agreement 

program with the Minority Health 

Professions Foundation (MHPF) to 

support substance-specific 

investigations. A not-for-profit Internal 

Revenue Code 501(c)(3) organization, 

the MHPF comprises 11 minority health 

professions schools at historically black 

colleges and universities. The MHPF 

mission is to research health problems 

that disproportionately affect poor and 

minority citizens. The purpose of the 

cooperative agreement was to address 

substance-specific data needs for 

priority hazardous substances identified 

by ATSDR. In addition, the agreement 

strengthened the environmental health 

research opportunities for scientists and 

students at MHPF member institutions 

and enhanced existing disciplinary 

capacities to conduct research in 

toxicology and environmental health. 

The MHPF published a report, 

‘‘Environmental Health and Toxicology 

Research Program: Meeting 

Environmental Health Challenges 

Through Research, Education, and 

Service,’’ that describes the research 

findings and other successes from the 

first 5 years of the program. 

In the first five year project period 

that concluded during FY 1997, nine 

priority data needs for 21 priority 

hazardous substances and 22 other 

research needs for these and other 

substances were addressed. Research 

initiated in the second 5-year project 

period included studies to address 10 

additional priority data needs for 

chlordane, di-n-butyl phthalate, lead, 

manganese, the polycylic aromatic 

hydrocarbons (PAHs), zinc, and eight 

other research needs. To date, 14 

priority data needs have been filled 

through this cooperative agreement 

(Table 1). 

During 2003, ATSDR announced a 

new five year cooperative agreement 

program with the MHPF. The purpose of 

the program is to apply findings from 

the previous ten year environmental 

health and Toxicology Research 

Program and to improve public health 

and environmental medicine in lowincome and minority communities. The 

new program builds on earlier efforts 

and expands the Program’s public 

environmental health impact on affected 

communities. Activities across the 

following four research and 

environmental public health focus areas 

were funded to initiate this new 

program: substance-specific toxicology 

research, environmental exposure 

assessment, community-based 

environmental health education, and 

environmental health education for 

primary-care providers. No additional 

priority data needs are being addressed 

under this new program. 

To date, Program research findings 

and other activities have resulted in the 

publication of more than 50 

manuscripts in peer-reviewed journals. 

The institutions which have received 

awards and their respective studies are 

listed in Table 2. 

D. National Toxicology Program (NTP) 

Section 104(i)(5) of CERCLA directs 

the administrator of ATSDR (in 

consultation with the administrator of 

EPA and agencies and programs of the 

Public Health Service) to assess whether 

adequate information on the health 

effects of priority hazardous substances 

found at NPL sites is available. Where 

adequate information is not available, 

ATSDR, in cooperation with the 

National Toxicology Program (NTP), is 

required to assure the initiation of a 

program of research designed to 

determine these health effects (and 

techniques for developing methods to 

determine such health effects). 

ATSDR continues to collaborate with 

NTP to address priority data needs of 

mutual interest. Chemicals for which 

NTP has conducted studies (or is in the 

process of conducting studies) to fill 

ATSDR’s priority data needs include 

carbon tetrachloride, 1,1- 

dichloroethene, di-n-butyl phthalate, 

disulfoton, and heptachlor (Table 2). 

E. Great Lakes Human Health Effects 

Research Program 

Some of the priority data needs 

identified in the SSARP have been 

independently identified as research 

needs through the ATSDR Great Lakes 

Human Health Effects Research 

Program, a separate research program. 

In support of the Great Lakes Critical 

Programs Act of 1990, ATSDR 

announced in Fiscal Year 1992 the 

availability of $2 million for a grant 

program to conduct research on the 

potential for short- and long-term 

adverse health effects from consumption 

of contaminated fish from the Great 

Lakes basin. Research undertaken 

through this program is intended to 

build on and amplify the results of past 

and ongoing fish consumption research 

in the Great Lakes basin. The ATSDRsupported research projects focus on 

known high-risk populations to define 

further the human health consequences 

of exposure to persistent toxic 

substances (PTSs) identified in the Great 

Lakes basin. These at-risk populations 

include sport anglers; African 

Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 73753 

Americans, Asians and other nonEnglish speaking populations; pregnant 

women; fetuses, nursing infants, and 

children of mothers who consume 

contaminated Great Lakes sport fish; the 

elderly, and the urban poor. To date, the 

research activities of the ATSDR Great 

Lakes Human Health Effects Research 

Program have resulted in 70 

publications in peer-reviewed journals. 

Currently, 14 priority data needs for 

24 priority hazardous substances 

(including 15 PAHs) identified in the 

SSARP are being addressed through this 

program. The institutions which have 

received awards and their respective 

studies are listed in Table 2. 

F. Other ATSDR Programs 

In its role as a public health agency 

addressing environmental health, 

ATSDR may collect human data to 

validate substance-specific exposure 

and toxicity findings. The need for 

additional information on levels of 

contaminants in humans has been 

identified, and remains as a priority 

data need for 59 of the 60 priority 

substances (Table 1). In some cases, 

ATSDR anticipates obtaining this 

information through exposure and 

health effects studies, and through 

establishing and using substancespecific subregistries of people within 

the Agency’s National Exposure Registry 

who have potentially been exposed to 

these substances. Regarding the priority 

data need for exposure subregistries, the 

list of the 60 priority hazardous 

substances in the SSARP was forwarded 

to ATSDR’s Division of Health Studies 

for consideration as potential candidates 

for subregistries of exposed persons, 

based on criteria described in its 1994 

document, ‘‘National Exposure Registry: 

Policies and Procedures Manual 

(Revised),’’ Agency for Toxic Substances 

and Disease Registry, Public Health 

Service, U.S. Department of Health and 

Human Services, Atlanta, Georgia, NTIS 

Publication No. PB95–154571. 

Currently, ATSDR has established 

exposure subregistries for benzene, 

dioxin, 1,1,1-trichloroethane (not 

included in the SSARP), 

trichloroethylene, and tremolite 

asbestos. 

G. Conclusion 

The results of the research conducted 

via the SSARP are expected to provide 

information necessary to improve the 

database used to conduct 

comprehensive public health 

assessments of populations living near 

hazardous waste sites. The information 

will enable the Agency to establish 

linkages between levels of contaminants 

in the environment and levels in human 

tissue and organs associated with 

adverse health effects, ultimately 

helping to determine methods for 

interdicting exposure and mitigating 

toxicity. This program will also provide 

data that can be generalized to other 

substances or areas of science, including 

risk assessment of chemicals, thus 

creating a scientific information base for 

addressing a broader range of data 

needs. The Agency plans to provide an 

update on the status of this research 

program approximately every three 

years or sooner, as needed. 

Dated: November 17, 2005. 

Kenneth Rose, 

Acting Director, Office of Policy, Planning, 

and Evaluation, National Center for 

Environmental Health/Agency for Toxic 

Substances and Disease Registry. 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

Aldrin/Dieldrin ................................ 1A ......... Dose-response data in animals 

for intermediate-duration oral 

exposure.

.................. Filled ........ An MRL was derived in the 2000 

updated ATSDR toxicological 

profile. 

1B ......... Bioavailability from soil.

1C ........ Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

.................. .................. This priority data need, previously 

addressed in a study in the 

Great Lakes Research Program, is no longer investigated 

in that study. 

1D ........ Potential candidate for subregistry of exposed persons.ATSDR.

Arsenic .......................................... 2A ......... Comparative toxicokinetic studies 

to determine if an appropriate 

animal species can be identified.

EPA.

2B ......... Half-lives in surface water, 

groundwater.

EPA.

2C ........ Bioavailability from soil ................ EPA.

2D ........ Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

G. Lakes .. Filled ........ In addition to the data from the 

Great Lakes Research Program, background level data 

are available in ATSDR’s 1993 

toxicological profile, and at 

least seven ATSDR studies 

that evaluated urine arsenic 

levels and potential adverse 

health effects are available. 

Also, additional studies are 

available in ATSDR’s 2000 updated toxicological profile. 

73754 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

Asbestos ....................................... 3A ......... Epidemiologic studies of individuals occupationally exposed to 

asbestos levels lower than 

those experienced before the 

institution of current occupational standards governing the 

use of asbestos, but higher 

than current levels in the general population. These studies 

should be performed in conjunction with the 

immunotoxicity studies.

3B ......... Immunotoxicity studies of individuals occupationally exposed to 

asbestos.

3C ........ Development of human and rat 

lung retention models to aid in 

extrapolating between rat and 

human data.

3D ........ Improved analytical methods for 

screening samples and determining the chemical structure 

of asbestos fibers. Also, techniques are needed to normalize studies in which different analytical methods were 

employed.

3E ......... Exposure levels, fiber size distribution, and asbestos fiber 

type in areas with natural geologic deposits of friable asbestos and at hazardous waste 

sites. Also, techniques for estimating air levels of asbestos 

from soil concentrations and 

activity scenarios.

3F ......... Exposure levels in humans living 

near hazardous waste sites 

and in other populations, such 

as humans living in areas with 

naturally high levels of friable 

asbestos.

3G ........ Potential candidate for subregistry of exposed persons.ATSDR .... Filled ........ ATSDR established registry to 

follow the health of people who 

were exposed to asbestos in 

Libby, Montana. The name of 

the registry is the Tremolite Asbestos Registry (TAR). 

Benzene ........................................ 4A ........ Dose-response data in animals 

for acute- and intermediate-duration oral exposure. The subchronic study should include an 

extended reproductive organ 

histopathology.

EPA ......... .................. Reproductive toxicity study is the 

only component of this PDN 

that is included in the EPA/ 

ATSDR test rule. 

4B ......... Prenatal developmental toxicity 

study via oral exposure.

EPA ......... .................. Previously planned study in the 

MHPF Research Program to 

address this priority data need 

was canceled. 

4C ........ Neurotoxicology battery of tests 

via oral exposure.

EPA.

4D ........ Epidemiologic studies on the 

health effects of benzene (Special emphasis end points include immunotoxicity).

.................. Filled ........ Based on an evaluation of the 

data in ATSDR’s 1997 updated 

toxicological profile. ATSDR 

will continue to evaluate new 

data as they become available 

to determine if additional studies are needed. 

Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 73755 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

4E ......... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

.................. Filled ........ Reference range concentrations 

are available (Ashley et al. 

1992, 1994; Needham et al. 

1995), and at least one ATSDR 

study that evaluated blood benzene levels and potential adverse health effects is available. ATSDR acknowledges 

that reference concentration 

data can support exposure and 

health assessments at waste 

sites, but the Agency also continues to recognize the importance of collecting additional 

data on uniquely exposed populations at waste sites. 

Benzidine ...................................... 5A ......... Dose-response data for acuteand intermediate-duration exposure via the oral route (the 

study of intermediate-duration 

exposure should include evaluation of reproductive and endocrine organ histopathology, 

lymphoid tissues 

histopathology as well as examination of relevant blood 

components, and nervous system histopathology).

5B ......... Exposure levels in humans living 

near hazardous waste sites.

5C ........ Exposure levels in children.

5D ........ Potential candidate for subregistry of exposed persons.ATSDR.

Beryllium ....................................... 6A ......... Dose-response data in animals 

for acute- and intermediate-duration inhalation exposures. 

The subchronic study should 

include extended reproductive 

organ histopathology.

EPA.

6B ......... Prenatal developmental toxicity 

study via inhalation exposure.

EPA.

6C ........ Environmental fate in air; factors 

affecting bioavailability in air.

EPA.

6D ........ Analytical methods to determine 

environmental speciation.

.................. Filled ........ Based on an evaluation of the 

data in ATSDR’s 2000 updated 

toxicological profile. 

6E ......... Immunotoxicology battery of tests 

following oral exposure.

EPA.

6F ......... Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations, such as exposed workers.

.................. Filled ........ Reference range concentrations 

in urine are available (Paschal 

et al. 1998, CDC 2005). 

ATSDR acknowledges that reference concentration data can 

support exposure and health 

assessments at waste sites, 

but the Agency also continues 

to recognize the importance of 

collecting additional data on 

uniquely exposed populations 

at waste sites. 

6G ........ Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in urine are available (CDC 

2005). 

6H ........ Potential candidate for subregistry of exposed persons.ATSDR.

Cadmium ....................................... 7A ......... Analytical methods for biological 

tissues and fluids and environmental media.

.................. Filled ........ Based on an evaluation of the 

data in ATSDR’s 1999 updated 

toxicological profile. 

73756 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

7B ......... Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations, such as exposed workers.

G. Lakes .. Filled ........ In addition to the data from the 

Great Lakes Research Program, reference range concentrations in blood and urine 

are available (CDC 2005), and 

at least nine ATSDR studies 

that evaluated blood and urine 

cadmium levels and potential 

adverse health effects are 

available. 

7C ........ Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in blood and urine are available 

(CDC 2005). 

Carbon tetrachloride ..................... 8A ......... Dose-response data in animals 

for chronic oral exposure. The 

study should include extended 

reproductive organ and nervous tissue histopathology.

8B ......... Immunotoxicology battery of tests 

via oral exposure.

NTP ......... Filled ........ NTP dose-finding study and one 

study in ATSDR’s 1994 updated toxicological profile addressed the priority data need. 

8C ........ Half-life in soil .............................. .................. Filled ........ One study in ATSDR’s 1994 updated toxicological profile provided information on half-life in 

soil. 

8D ........ Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

.................. Filled ........ Reference range concentrations 

in blood are available (Ashley 

et al. 1992, 1994; Needham et 

al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the 

Agency also continues to recognize the importance of collecting additional data on 

uniquely exposed populations 

at waste sites. 

8E ......... Potential candidate for subregistry of exposed persons.ATSDR.

Chlordane ..................................... 9A ......... Oral multigenerational studies to 

evaluate reproductive toxicity.

MHPF ...... Filled ........ Availability of studies in the 

MHPF Research Program. 

9B ......... Bioavailability studies following 

ingestion of contaminated 

media.

9C ........ Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations potentially exposed to 

chlordane.

.................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). ATSDR acknowledges 

that reference concentration 

data can support exposure and 

health assessments at waste 

sites, but the Agency also continues to recognize the importance of collecting additional 

data on uniquely exposed populations at waste sites. 

9D ........ Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). 

9E ......... Potential candidate for subregistry of exposed persons.ATSDR.

Chlorinated dibenzo-p-dioxins 

(CDDs).

10A ...... Studies via oral exposure designed to assess childhood 

susceptibility.

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TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

10B ....... Comparative toxicokinetic studies 

examining the relative absorption of CDDs across exposure 

routes and the relative contribution of each exposure 

route to total body burdens.

10C ...... Exposure levels in humans 

(adults) living near hazardous 

waste sites.

.................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). ATSDR acknowledges 

that reference concentration 

data can support exposure and 

health assessments at waste 

sites, but the Agency also continues to recognize the importance of collecting additional 

data on uniquely exposed populations at waste sites. 

10D ...... Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). 

Chloroethane ................................ 11A ....... Dose-response data in animals 

for acute- and intermediate-duration oral exposures. The subchronic study should include an 

evaluation of immune and 

nervous system tissues, and 

extended reproductive organ 

histopathology.

EPA.

11B ....... Dose-response data in animals 

for chronic inhalation exposures. The study should include an evaluation of nervous 

system tissues.

EPA.

11C ...... Potential candidate for subregistry of exposed persons.ATSDR.

Chloroform .................................... 12A ....... Dose-response data in animals 

for intermediate-duration oral 

exposure.

.................. Filled ........ An MRL was derived in ATSDR’s 

1997 updated toxicological profile. 

12B ....... Epidemiologic studies on the 

health effects of chloroform 

(Special emphasis end points 

include cancer, neurotoxicity, 

reproductive and developmental toxicity, hepatotoxicity, 

and renal toxicity).

.................. Filled ........ Based on an evaluation of the 

data in ATSDR’s 1997 updated 

toxicological profile. ATSDR 

will continue to evaluate new 

data as they become available 

to determined if additional studies are needed. 

12C ...... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

.................. Filled ........ Reference range concentrations 

in blood are available (Ashley 

et al. 1992, 1994; and Needham et al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the 

Agency also continues to recognize the importance of collecting additional data on 

uniquely exposed populations 

at waste sites. 

12D ...... Potential candidate for subregistry of exposed persons.ATSDR.

Chromium ..................................... 13A ...... Dose-response data in animals 

for acute-duration exposure to 

chromium (VI) and (III) via oral 

exposure and for intermediateduration exposure to chromium 

(VI) via oral exposure.

EPA.

13B ....... Multigeneration reproductive toxicity study via oral exposure to 

chromium (III) and (VI).

EPA.

73758 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

13C ...... Immunotoxicology battery of tests 

following oral exposure to chromium (III) and (VI).

EPA.

13D ...... Prenatal developmental toxicity 

study via oral exposure to 

chromium (III) and (VI).

EPA.

13E ....... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

G. Lakes .. Filled ........ In addition to the data from the 

Great Lakes Research Program, reference range concentrations in urine are available (Paschal et al. 1998). 

Also, at least two ATSDR studies that evaluated urine chromium levels and potential adverse health effects are available. 

Cyanide ......................................... 14A ....... Dose-response data in animals 

for acute- and intermediate-duration exposures via inhalation. 

The subchronic study should 

include extended reproductive 

organ histopathology and evaluation of neurobehavioral and 

neuropathological end points.

EPA.

14B ....... Prenatal developmental toxicity 

study via oral exposure.

EPA.

14C ...... Evaluation of the environmental 

fate of cyanide in soil.

.................. Filled ........ A study addressing the priority 

data need was submitted by industry to EPA in response to 

EPA’s solicitation for proposals 

for test rule making. Scientists 

from EPA and ATSDR reviewed the study and considered that this research need is 

no longer a priority. 

14D ...... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

14E ....... Potential candidate for subregistry of exposed persons.ATSDR.

1,2-dibromo-3-chloropropane ....... 15A ...... Dose-response data in animals 

for acute-duration exposure via 

the oral route (including reproductive organ histopathology).

15B ....... Dose-response data in animals 

for chronic-duration exposure 

via the oral route (including reproductive organ 

histopathology).

15C ...... Prenatal developmental toxicity 

study via oral exposure.

15D ...... Immunotoxicology testing battery 

via oral exposure.

.................. .................. Previously planned study in the 

MHPF Research Program to 

address this priority data need 

was canceled. 

15E ....... Neurotoxicology testing battery 

via oral exposure.

.................. .................. Previously planned study in the 

MHPF Research Program to 

address this priority data need 

was canceled. 

15F ....... Exposure levels in humans living 

near hazardous waste sites 

and other exposed populations, 

such as exposed workers.

15G ...... Potential candidate for subregistry of exposed persons.ATSDR.

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TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

1,2-Dibromoethane ....................... 16A ...... Dose-response data in animals 

for acute- and intermediate-duration exposure by the oral 

route (the study of intermediate-duration exposure 

should include evaluation of 

neuropathology and observation for overt signs of 

neurotoxicity).

16B ....... Multigeneration reproductive toxicity studies via oral exposure.

16C ...... Developmental toxicity studies via 

oral exposure.

16D ...... Immunotoxicity battery studies via 

oral exposure.

16E ....... Exposure levels in humans living 

near hazardous waste sites 

and in other populations, such 

as workers exposed to 1, 2- 

dibromoethane.

16F ....... Exposure levels in children.

16G ...... Potential candidate for subregistry of exposed persons.ATSDR.

1,2-Dichloroethane ........................ 17A ....... Dose-response data in animals 

for acute-duration (14-day) exposure by the inhalation route, 

including a comparison of 

young and adult animals.

17B ....... Dose-response data in animals 

for acute-duration (14-day) exposure by the oral route, including a comparison of young 

and adult animals.

17C ...... Dose-response data in animals 

for intermediate-duration exposure by the inhalation route 

(the study should be performed 

in conjunction with the 

neurotoxicology battery of 

tests).

17D ...... Neurotoxicology battery of tests 

following inhalation exposure.

17E ....... Neurotoxicology battery of tests 

following oral exposure.

17F ....... Dose-response data in animals 

for chronic-duration exposure 

by the oral route.

17G ...... Prenatal developmental toxicity 

data for inhalation exposure 

(assessment of developmental 

cardiotoxicity and neurotoxicity).

17H ...... Prenatal developmental toxicity 

data for oral exposure (assessment of developmental 

cardiotoxicity and neurotoxicity).

17I ........ Additional analyses and studies 

for comparative toxicokinetics 

across species, ages, routes, 

and durations.

17J ....... Children’s susceptibility.

17K ....... Exposure levels in humans living 

near hazardous waste sites.

17L ....... Exposure levels in children.

17M ...... Potential candidate for subregistry of exposed persons.ATSDR.

1,1-Dichloroethene ........................ 18A ....... Dose-response data in animals 

for acute-duration exposure by 

the inhalation route.

NTP ......... Filled ........ Availability of ongoing NTP study. 

73760 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

18B ....... Dose-response data in animals 

for chronic-duration exposure 

by the inhalation route.

NTP ......... Filled ........ Availability of ongoing NTP study. 

18C ...... Dose-response data in animals 

for acute- and intermediate-duration exposure by the oral 

route.

18D ...... Carcinogenicity studies in two 

species following inhalation exposure.

18E ....... Reproductive toxicity studies assessing male and female end 

points following inhalation exposure.

18F ....... Prenatal developmental toxicity 

studies following oral exposure.

18G ...... Immunotoxicology battery of tests 

following oral exposure.

18H ...... Battery of neurobehavioral tests 

following inhalation exposure.

18I ........ Children’s susceptibility.

18J ....... Exposure levels in humans living 

near hazardous waste sites.

18K ....... Exposure levels in children.

18L ....... Potential candidate for subregistry of exposed persons.ATSDR.

DDT ............................................... 19A ....... Dose-response data in animals 

for chronic-duration oral exposure.

19B ....... Comparative toxicokinetic study 

(across routes/species).

19C ...... Bioavailability and bioaccumulation from soil.

19D ...... Epidemiologic studies on the 

health effects of DDT, DDD, 

and DDE (Special emphasis 

end points include 

immunotoxicity, and reproductive and developmental toxicity).

G. Lakes .. Filled ........ In addition to the data from the 

Great Lakes Research Program, multiple studies in 

ATSDR’s 2000 updated toxicological profile are available. 

19E ....... Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations, such as exposed workers.

G. Lakes .. Filled ........ In addition to the data from the 

Great Lakes Research Program, reference range concentrations in serum are available (CDC 2005). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the 

Agency also continues to recognize the importance of collecting additional data on 

uniquely exposed populations 

at waste sites. 

19F ....... Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). 

19G ...... Potential candidate for subregistry of exposed persons.ATSDR.

Di (2-ethylhexyl) phthalate ............ 20A ....... Epidemiologic studies on the 

health effects of DEHP (Special emphasis end points include cancer).

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TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

20B ....... Dose-response data in animals 

for acute- and intermediate-duration oral exposures. The subchronic study should include an 

extended histopathologic evaluation of the immunologic and 

neurologic systems.

.................. .................. This research need remains as a 

priority data need because the 

previously developed MRL for 

acute-duration (1993 toxicological profile) was withdrawn. However, a new MRL 

for intermediate-duration was 

derived in ATSDR’s 2002 updated Toxicological Profile. 

Therefore, this priority data 

need is considered partially 

filled because additional adequate acute-duration data for 

deriving an MRL are still lacking. 

20C ...... Multigeneration reproductive toxicity study via oral exposure................... .................. This research need is reassigned 

as a priority data need based 

on an evaluation of the data in 

ATSDR’s 2002 updated toxicological profile. Also, the NTP 

Center for the Evaluation of 

Risks to Human Reproduction 

Expert Panel Report (October 

2000) has identified critical 

data needs for reproductive 

toxicity. 

20D ...... Comparative toxicokinetic studies 

(Studies designed to examine 

how primates metabolize and 

distribute DEHP as compared 

with rodents via oral exposure).

.................. Filled ........ The existing database provides 

adequate information to fill this 

priority data need based on 

ATSDR’s reevaluation of the 

published data. 

20E ....... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

20F ....... Potential candidate for subregistry of exposed persons.ATSDR.

Di-n-butyl phthalate ....................... 21A ....... Dose-response data in animals 

for acute-duration exposure via 

the oral route.

NTP ......... Filled ........ Availability of an NTP study. 

21B ....... Dose-response data in animals 

for chronic-duration exposure 

via the oral route.

21C ...... Carcinogenicity studies via oral 

exposure.

21D ...... In vivo genotoxicity studies .......... MHPF ...... Filled ........ Availability of a study in the 

MHPF Research Program. 

21E ....... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

21F ....... Environmental fate of di-n-butyl 

phthalate in environmental 

media.

21G ...... Bioavailability in contaminated 

environmental media near hazardous waste sites.

21H ...... Potential candidate for subregistry of exposed persons.ATSDR.

Disulfoton ...................................... 22A ...... Immunotoxicology testing battery 

following oral exposure.

NTP ......... Filled ........ Availability of ongoing NTP study. 

22B ....... Exposure levels of disulfoton in 

tissues/fluids for populations 

living near hazardous waste 

sites and other populations, 

such as exposed workers.

22C ...... Disulfoton should be considered 

as a potential candidate for a 

subregistry of exposed persons.

ATSDR.

73762 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

Endosulfan (a, b, and sulfate) ...... 23A ...... Acute-duration oral exposure 

studies.

23B ....... Data on sensitive neurologic end 

point following oral exposure.

23C ...... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

23D ...... Data on the bioavailability of 

endosulfan from soil.

23E ....... Potential candidate for subregistry of exposed persons.ATSDR.

Endrin/endrin aldehyde ................. 24A ....... Dose-response animal data for 

acute oral exposure to endrin.

24B ....... Multigeneration reproductive toxicity studies via oral exposure 

to endrin.

24C ...... Accurately describe the 

toxicokinetics of endrin and its 

degradation products and identify the animal species to be 

used as the most appropriate 

model for human exposure.

24D ...... Exposure levels for endrin and its 

degradation products in humans living near hazardous 

waste sites.

24E ....... Accurately describe the environmental fate of endrin, including 

environmental breakdown products and rates, media halflives, and chemical and physical properties of the breakdown products that help predict 

mobility and volatility.

24F ....... Potential candidate for subregistry of exposed persons.ATSDR.

Ethylbenzene ................................ 25A ...... Dose-response data for acute-duration exposure by the inhalation route.

25B ....... Dose-response data for chronicduration exposure by the inhalation route.

25C ...... Dose-response data for acuteand intermediate-duration exposure by the oral route; the 

study of intermediate-duration 

exposure should include an 

evaluation of clinical signs of 

neurotoxicity and 

histopathology of reproductive 

organs, endocrine glands, and 

nervous system.

25D ...... Multigeneration toxicity study examining reproductive end 

points and indicators of endocrine disruption following inhalation exposure.

25E ....... Prenatal developmental study 

with continued assessment of 

offspring during postnatal development following oral exposure.

25F ....... Studies for comparative 

toxicokinetics.

25G ...... Exposure levels in humans living 

near hazardous waste sites.

25H ...... Exposure levels in children.

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Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

25I ........ Potential candidate for subregistry of exposed persons.ATSDR.

Heptachlor/heptachlor epoxide ..... 26A ...... Dose-response animal data for 

acute- and intermediate-duration oral exposures, including 

immunopathology.

26B ....... Multigeneration reproductive toxicity studies via the oral route 

of exposure.

NTP ......... Filled ........ Availability of publication ‘‘The effects of perinatal/juvenile heptachlor exposure on adult immune and reproductive system 

function in rats’’ by Smialowicz 

et al. (2001), Toxicological 

Sciences 61:164–175. 

26C ...... Prenatal developmental toxicity 

studies via the oral route of exposure.

.................. Filled ........ Based on ATSDR’s review of the 

literature, i.e., Smialowicz et al. 

(2001), Toxicological Sciences 

61:164–175 and Moser et al. 

(2001) Toxicological Sciences 

60 (2):315–326. 

26D ...... Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations, such as exposed workers.

.................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). ATSDR acknowledges 

that reference concentration 

data can support exposure and 

health assessments at waste 

sites, but the Agency also continues to recognize the importance of collecting additional 

data on uniquely exposed populations at waste sites. 

26E ....... Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). 

26F ....... Bioavailability from contaminated 

air, water, and soil and bioaccumulation potential.

26G ...... Potential candidate for subregistry of exposed persons.ATSDR.

Hexachlorobutadiene .................... 27A ...... Dose-response data in animals 

for acute-duration exposure via 

the oral route.

27B ....... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

27C ...... Environmental fate studies that 

determine the extent to which 

hexachlorobutadiene volatilizes 

from soil, and studies that determine the reactions and rates 

which drive degradation in soil.

27D ...... Bioavailability studies in soil and 

plants.

27E ....... Potential candidate for subregistry of exposed persons.ATSDR.

Hexachlorocyclohexane (a, b and 

g).

28A ...... Dose-response data for chronicduration oral exposure................... Filled ........ An MRL was derived in ATSDR’s 

1999 updated toxicological profile. 

28B ....... Mechanistic studies on the 

neurotoxicity, hepatotoxicity, reproductive toxicity, and 

immunotoxicity of 

hexachlorocyclohexane.

73764 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

28C ...... Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations, such as exposed workers.

.................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). ATSDR acknowledges 

that reference concentration 

data can support exposure and 

health assessments at waste 

sites, but the Agency also continues to recognize the importance of collecting additional 

data on uniquely exposed populations at waste sites. 

28D ...... Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). 

28E ....... Potential candidate for subregistry of exposed persons.ATSDR.

Lead .............................................. 29A ...... Mechanistic studies on the neurotoxic effects of lead.MHPF ...... Filled ........ Multiple studies (at least 13 publications from the MHPF Research Program + numerous 

studies in ATSDR’s 1999 updated toxicological profile) are 

available. 

29B ....... Analytical methods for tissue levels.MHPF ...... Filled ........ A publication from the MHPF Research Program and numerous 

studies in ATSDR’s 1999 toxicological profile are available. 

29C ...... Exposure levels in humans 

(adults) near hazardous waste 

sites and other populations, 

such as exposed workers.

MHPF ......

G. Lakes 

Filled ........ In addition to the data from Great 

Lakes Research Program and 

MHPF Research Program, reference range concentrations in 

blood and urine are available 

(CDC 2005; Paschal et al. 

1998), and at least 19 ATSDR 

studies that evaluated blood 

lead levels and potential adverse health effects are available. 

29D ...... Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in blood and urine are available 

(CDC 2005). 

Manganese ................................... 30A ....... Dose-response data for acuteand intermediate-duration oral 

exposures (the subchronic 

study should include reproductive histopathology and an 

evaluation of immunologic parameters including manganese 

effects on plaque-forming cells 

(SRBC), surface markers 

(D4:D8 ratio), and delayed 

hypersensitivity reactions).

MHPF ......

EPA 

Filled ........ Availability of studies in the 

MHPF Research Program. 

30B ....... Toxicokinetic studies on animals 

to investigate uptake and absorption, relative uptake of differing manganese compounds, 

metabolism of manganese, and 

interaction of manganese with 

other substances following oral 

exposure.

MHPF ......

EPA .........

Filled ........ Availability of studies in the 

MHPF Research Program. 

30C ...... Epidemiological studies on the 

health effects of manganese 

(Special emphasis end points 

include neurologic, reproductive, developmental, 

immunologic, and cancer).

.................. Filled ........ Based on an evaluation of the 

data in ATSDR’s 2000 updated 

toxicological profile. ATSDR 

will continue to evaluate new 

data as they become available 

to determine if additional studies are needed. 

Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 73765 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

30D ...... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

30E ....... Relative bioavailability of different 

manganese compounds and 

bioavailability of manganese 

from soil.

EPA. 

Mercury ......................................... 31A ...... Multigeneration reproductive toxicity study via oral exposure.MHPF ...... Filled ........ Availability of publications from 

the MHPF Research Program. 

31B ....... Dose-response data in animals 

from chronic-duration oral exposure.

.................. Filled ........ An MRL was derived in ATSDR’s 

1999 updated toxicological profile. 

31C ...... Immunotoxicology battery of tests 

via oral exposure.

EPA. 

31D ...... Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations, such as exposed workers.

G. Lakes .. Filled ........ In addition to the data from the 

Great Lakes Research Program, background levels data 

are available in ATSDR’s 1997 

updated toxicological profile, 

and multiple ATSDR studies 

that evaluated blood, urine, 

hair mercury levels and potential adverse health effects are 

available. Also, reference 

range concentrations in blood 

and urine are available (CDC 

2005). 

31E ....... Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in blood and urine are available 

(CDC 2005). 

31F ....... Potential candidate for subregistry of exposed persons.ATSDR. 

Methoxychlor ................................. 32A ...... Evaluate neurologic effects after 

long-term, low-level oral exposure.

.................. Filled ........ Based on an evaluation of the 

data in ATSDR’s 2000 updated 

toxicological profile. 

32B ....... Exposure levels of methoxychlor 

and primary metabolites in humans living near hazardous 

waste sites and those individuals with the potential to ingest 

it.

32C ...... Evaluate the fate, transport, and 

levels of the degradation products of methoxychlor in soil.

32D ...... Potential candidate for subregistry of exposed persons.ATSDR. 

Methylene chloride ........................ 33A ...... Dose-response data in animals 

for acute- and intermediate-duration oral exposure. The subchronic study should include 

extended reproductive organ 

histopathology, 

neuropathology, and 

immunopathology.

EPA .........

Vol Res 

Filled ........ ATSDR accepted HSIA’s toxicity 

study for acute- and intermediate-duration exposure duration in February 1997. Also, 

ATSDR accepted HSIA’s 

immunotoxicity study via inhalation in November 2000 and 

the oral data obtained via 

PBPK modeling conducted by 

HSIA based on the 

immunotoxicity data from the 

inhalation study. Neurotoxicity 

screening battery testing remains in the ATSDR/EPA test 

rule under development. 

33B ....... Prenatal developmental toxicity 

study via the oral route.

Vol Res .... Filled ........ ATSDR accepted HSIA’s study in 

February 1997. 

73766 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

33C ...... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

.................. Filled ........ Reference range concentrations 

in blood are available (Ashley 

et al. 1992, 1994; Needham et 

al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the 

Agency also continues to recognize the importance of collecting additional data on 

uniquely exposed populations 

at waste sites. 

33D ...... Potential candidate for subregistry of exposed persons.ATSDR. 

Nickel ............................................ 34A ...... Epidemilogic studies on the 

health effects of nickel (Special 

emphasis end points include 

reproductive toxicity).

.................. Filled ........ Based on at least two relevant 

studies in ATSDR’s 1997 updated toxicological profile. 

ATSDR will continue to evaluate new data as they become 

available to determine if additional studies are needed. 

34B ....... Prenatal development toxicity 

study via the oral route.

EPA ......... Filled ........ In ATSDR’s 1997 updated toxicological profile, a study confirming the results of two previous studies is available. 

34C ...... Dose-response data in animals 

for acute- and intermediate-duration oral exposures.

EPA. 

34D ...... Neurotoxicology battery of tests 

via oral exposure.

EPA. 

34E ....... Bioavailability of nickel from soil .. EPA. 

34F ....... Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations, such as exposed workers.

G. Lakes .. Filled ........ Based on availability of the data 

from the Great Lakes Research 

Program and an evaluation of 

ATSDR’s 1997 updated toxicological profile. 

34G ...... Potential candidate for subregistry of exposed persons.ATSDR. 

Pentachlorophenol ........................ 35A ....... Comparative toxicokinetic studies.

35B ....... Exposure levels in humans 

(adults) living near hazardous 

waste sites.

.................. Filled ........ Reference range concentrations 

in urine are available (CDC 

2005). ATSDR acknowledges 

that reference concentration 

data can support exposure and 

health assessments at waste 

sites, but the Agency also continues to recognize the importance of collecting additional 

data on uniquely exposed populations at waste sites. 

35C ...... Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in urine are available (CDC 

2005). 

35D ...... Potential candidate for subregistry of exposed persons.ATSDR. 

Polychlorinated biphenyls (PCBs) 36A ....... Dose-response data in animals 

for acute- and intermediate-duration oral exposure.

G. Lakes .. .................. Although an MRL for intermediate-exposure duration was 

derived in ATSDR’s 2000 updated toxicological profile, an 

MRL for acute-exposure duration is still lacking. 

36B ....... Biodegradation of PCBs in water; 

bioavailability of PCBs in air, 

water, and soil.

Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 73767 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

36C ...... Dose-response data in animals 

for acute- and intermediate-duration inhalation exposures. 

The subchronic study should 

include extended reproductive 

organ histopathology.

36D ...... Epidemiologic studies on the 

health effects of PCBs (Special 

emphasis end points include 

immunotoxicity, gastrointestinal 

toxicity, liver toxicity, kidney 

toxicity, thyroid toxicity, and reproductive/developmental toxicity).

G. Lakes .. Filled ........ In addition to the data from the 

Great Lakes Research Program, multiple studies in 

ATSDR’s 2000 updated toxicological profile are available. 

36E ....... Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations, such as exposed workers.

G. Lakes .. Filled ........ In addition to the data from the 

Great Lakes Research Program, background levels data 

are available (ATSDR’s 1997 

updated toxicological profile, 

Needham et al. 1996, and 

CDC 2005). Also, multiple 

ATSDR studies that evaluated 

blood and breast milk PCB levels and potential adverse 

health effects are available. 

36F ....... Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in serum are available (CDC 

2005). 

36G ...... Potential candidate for subregistry of exposed persons.ATSDR. 

36H 5 .... Chronic toxicity and oncogenicity 

via oral exposure.

Vol Res .... Filled ........ ATSDR accepted the final report 

of the GE study in October 

1997. 

36I 5 ...... Aerobic PCB biodegradation in 

sediment.

Vol Res .... Filled ........ ATSDR accepted the final report 

of the GE study in July 1999. 

36J 5 ..... PCB congener analysis ............... Vol Res ....

G. Lakes 

Filled ........ ATSDR accepted the final report 

of the GE study in October 

1997. Also, data from the 

Great Lakes Research Program are available. 

Polycyclic aromatic hydrocarbons 

(PAHs) (Includes 15 substances).

37A ...... Dose-response data in animals 

for intermediate-duration oral 

exposures. The subchronic 

study should include extended 

reproductive organ 

histopathology and 

immunopathology.

MHPF ...... Filled ........ MRLs for four PAHs were derived 

in ATSDR’s 1995 updated toxicological profile. A publication 

from the MHPF Research Program addressing this priority 

data need is available. 

37B ....... Prenatal developmental toxicity 

study via inhalation or oral exposure.

MHPF ...... Filled ........ Data from the MHPF Research 

Program including a publication 

are available. 

37C ...... Mechanistic studies on PAHs, on 

how mixtures of PAHs can influence the ultimate activation 

of PAHs, and on how PAHs affect rapidly proliferating tissues.

MHPF ...... Filled ........ In addition to publications from 

the MHPF Research Program, 

studies are available in 

ATSDR’s 1995 updated toxicological profile. 

37D ...... Dose-response data in animals 

for acute- and intermediate-duration inhalation exposures. 

The subchronic study should 

include extended reproductive 

organ histopathology and 

immunopathology.

MHPF ...... Filled ........ Data from the MHPF Research 

Program including one publication are available. 

37E ....... Epidemiologic studies on the 

health effects of PAHs (Special 

emphasis end points include 

cancer, dermal, 

hemolymphatic, and hepatic 

toxicity).

.................. Filled ........ Multiple studies in ATSDR’s 1995 

updated toxicological profile 

are available. ATSDR will continue to evaluate new data as 

they become available to determine if additional studies are 

needed. 

73768 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

37F ....... Exposure levels in humans 

(adults) living near hazardous 

waste sites and other populations, such as exposed workers.

G. Lakes .. Filled ........ Based on data from the Great 

Lakes Research Program and 

an evaluation of the ATSDR 

1995 updated toxicological profile. Also, reference range concentrations in urine are available (CDC 2005). The Agency 

continues to recognize the importance of collecting additional 

data on uniquely exposed populations at waste sites. 

37G ...... Exposure levels in children .......... .................. Filled ........ Reference range concentrations 

in urine are available (CDC 

2005). 

37H ...... Potential candidate for subregistry of exposed persons.ATSDR. 

Selenium ....................................... 38A ....... Dose-response data in animals 

for acute-duration oral exposure.

EPA. 

38B ....... Immunotoxicology battery of tests 

via oral exposure.

EPA. 

38C ...... Epidemiologic studies on the 

health effects of selenium 

(Special emphasis end points 

include cancer, reproductive 

and developmental toxicity, 

hepatotoxicity, and adverse 

skin effects).

.................. Filled ........ Based on an evaluation of 

ATSDR’s 2001 updated toxicological profile. ATSDR will 

continue to evaluate new data 

as they become available to 

determine if additional studies 

are needed. 

38D ...... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

G. Lakes .. Filled ........ In addition to the data from the 

Great Lakes Research Program, reference range concentrations in serum are available (NHANES III). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the 

Agency also continues to recognize the importance of collecting additional data on 

uniquely exposed populations 

at waste sites. 

38E ....... Potential candidate for subregistry of exposed persons.ATSDR.

1,1,2,2-Tetrachloroethane ............. 39A ...... Prenatal developmental toxicity 

study by the oral route.

39B ....... Immunotoxicity battery following 

oral exposure.

39C ...... Mammalian in vivo genotoxicity 

assays.

39D ...... Exposure levels in humans living 

near hazardous waste sites.

39E ....... Exposure levels in children.

39F ....... Potential candidate for subregistry of exposed persons.ATSDR.

Tetrachloroethylene ...................... 40A ...... Dose-response data in animals 

for acute-duration oral exposure, including neuropathology 

and demeanor, and 

immunopathology.

.................. Filled ........ An MRL was derived in the 

ATSDR 1997 updated toxicological profile. 

Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 73769 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

40B ....... Multigeneration reproductive toxicity study via oral exposure.Vol Res .... .................. HSIA’s inhalation study was accepted by ATSDR and included 

in ATSDR’s 1997 updated toxicological profile. However, 

ATSDR has identified ingestion 

of contaminated environmental 

media to be the primary exposure route for this chemical at 

waste sites. HSIA will obtain 

the oral data from the inhalation study by conducting PBPK 

modeling. 

40C ...... Dose-response data in animals 

for intermediate-duration oral 

exposure, including 

neuropathology, and 

immunopathology.

EPA. ........

Vol Res 

HSIA will obtain oral data for intermediate-duration toxicity and 

neurotoxicity by PBPK modeling based on existing inhalation data. Also, it will conduct 

an inhalation immunotoxicity 

study, followed by PBPK modeling to obtain oral data. 

40D ...... Prenatal developmental toxicity 

study via oral exposure.

Vol Res .... .................. HSIA’s developmental toxicity 

study via inhalation was accepted by ATSDR. However, 

ATSDR has identified ingestion 

of contaminated environmental 

media to be the primary exposure route for this chemical at 

waste sites. HSIA will obtain 

the oral data from the inhalation study by conducting PBPK 

modeling. 

40E ....... Developmental neurotoxicity 

study via oral exposure.

EPA 

Vol Res.

40F ....... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

.................. Filled ........ Reference range concentrations 

in blood are available (Ashley 

et al. 1992, 1994; Needham et 

al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the 

Agency also continues to recognize the importance of collecting additional data on 

uniquely exposed populations 

at waste sites. 

40G ...... Potential candidate for subregistry of exposed persons.ATSDR.

Toluene ......................................... 41A ....... Dose-response data in animals 

for acute- and intermediate-duration oral exposures. The subchronic study should include an 

extended histopathologic evaluation of the immune system.

.................. Filled ........ Availability of MRLs for acuteand intermediate-exposure durations in ATSDR’s 2000 updated toxicological profile. 

41B ....... Comparative toxicokinetic studies 

(Characterization of absorption, 

distribution, and excretion via 

oral exposure).

.................. Filled ........ Based on evaluation of the data 

in ATSDR’s 2000 updated toxicological profile. 

41C ...... Neurotoxicology battery of tests 

via oral exposure.

EPA .........

MHPF 

A publication for acute exposure 

but not longer term exposure is 

available in the MHPF Research Program. Also, this priority data need is included in 

the EPA/ATSDR test rule. 

41D ...... Mechanism of toluene-induced 

neurotoxicity.

.................. Filled ........ Multiple studies in ATSDR’s 1994 

and 2000 updated toxicological 

profiles are available. 

73770 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

41E ....... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

.................. Filled ........ Reference range concentrations 

in blood are available (Ashley 

et al. 1992, 1994; Needham et 

al. 1995), and additional data 

in ATSDR’s 2000 updated toxicological profile are available. 

ATSDR acknowledges that reference concentration data can 

support exposure and health 

assessments at waste sites, 

but the Agency also continues 

to recognize the importance of 

collecting additional data on 

uniquely exposed populations 

at waste sites. 

41F ....... Potential candidate for subregistry of exposed persons.ATSDR.

Toxaphene .................................... 42A ....... Identify the long-term health consequences of exposure to environmental toxaphene via oral 

exposure.

42B ....... Conduct additional 

immunotoxicity studies for 

chronic-duration via oral route 

of exposure.

42C ...... Conduct additional neurotoxicity 

studies for chronic-duration via 

oral route of exposure.

42D ...... Exposure levels in humans living 

in areas near hazardous waste 

sites with toxaphene and in 

those individuals with the potential to ingest it.

42E ....... Potential candidate for subregistry of exposed persons.ATSDR.

Trichloroethylene .......................... 43A ...... Dose-response data in animals 

for acute-duration oral exposure.

.................. Filled ........ An MRL was derived in ATSDR’s 

1997 updated toxicological profile. 

43B ....... Neurotoxicology battery of tests 

via the oral route.

EPA 

MHPF ......

Vol Res 

.................. A publication for acute exposure 

but not longer term exposure is 

available in the MHPF Research Program. Also, this priority data need is included in 

the EPA/ATSDR test rule and 

ATSDR’s Voluntary Research 

Program. 

43C ...... Immunotoxicology battery of tests 

via oral route.

Vol Res .... .................. HSIA has completed an inhalation immunotoxicity study which 

is undergoing ATSDR peer review. HSIA will obtain oral data 

via PBPK modeling based on 

the inhalation data. 

43D ...... Prenatal developmental toxicity 

study via oral exposure.

Vol Res .... .................. ATSDR has accepted HSIA’s 

final report for an inhalation developmental toxicity study. 

HSIA will use PBPK modeling 

to obtain data for oral exposure 

based on the results of its inhalation study. 

43E ....... Developmental neurotoxicity 

study via oral exposure.

EPA 

Vol Res 

43F ....... Epidemiologic studies on the 

health effects of trichloroethylene (Special emphasis 

end points include cancer, 

hepatotoxicity, renal toxicity, 

developmental toxicity, and 

neurotoxicity).

.................. Filled ........ Based on evaluation of the data 

in ATSDR’s 1997 updated toxicological profile. ATSDR will 

continue to evaluate new data 

as they become available to 

determine if additional studies 

are needed. 

Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 73771 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

43G ...... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

.................. Filled ........ Reference range concentrations 

in blood are available (Ashley 

et al. 1992, 1994; Needham et 

al. 1995). ATSDR acknowledges that reference concentration data can support exposure and health assessments at waste sites, but the 

Agency also continues to recognize the importance of collecting additional data on 

uniquely exposed populations 

at waste sites. 

Vinyl chloride ................................ 44A ...... Dose-response data in animals 

for acute-duration inhalation 

exposure.

.................. Filled ........ An MRL was derived in ATSDR’s 

1997 updated toxicological profile. 

44B ....... Multigeneration reproductive toxicity study via inhalation.Vol Res .... Filled ........ ATSDR accepted the final report 

of ACC’s study in November 

2000. 

44C ...... Dose-response data in animals 

for chronic-duration inhalation 

exposure.

44D ...... Mitigation of vinyl chloride-induced toxicity.

44E ....... Prenatal developmental toxicity 

study via inhalation.

Vol Res .... Filled ........ ATSDR accepted the final report 

of ACC’s study in November 

2000. 

44F ....... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

44G ...... Potential candidate for subregistry of exposed persons.ATSDR. 

Xylenes ......................................... 45A ...... Dose-response data for chronicduration exposure by the oral 

route. This study should be 

done in conjunction with the 

neurotoxicology battery of tests.

45B ....... Neurotoxicology battery of tests 

following oral exposure.

45C ...... Two-generation reproductive 

study following oral exposure.

45D ...... Developmental toxicity study that 

includes neurodevelopmental 

end points following oral exposure.

45E ....... Exposure levels in humans living 

near hazardous waste sites.

45F ....... Exposure levels in children.

45G ...... Potential candidate for subregistry of exposed persons.ATSDR. 

Zinc ............................................... 46A ...... Dose-response data in animals 

for acute- and intermediate-duration oral exposures. The subchronic study should include an 

extended histopathologic evaluation of the immunologic and 

neurologic systems.

MHPF ...... Filled ........ Availability of ongoing studies in 

the MHPF Research Program. 

46B ....... Multigeneration reproductive toxicity study via oral exposure.MHPF ...... Filled ........ Availability of ongoing studies in 

the MHPF Research Program. 

46C ...... Carcinogenicity testing (2-year 

bioassay) via oral exposure.

46D ...... Exposure levels in humans living 

near hazardous waste sites 

and other populations, such as 

exposed workers.

.................. .................. This priority data need, previously 

anticipated to be addressed 

under the voluntary research 

program, is not being investigated under any of the 

ATSDR research programs. 

73772 Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 

TABLE 1.—ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS FOR 60 PRIORITY HAZARDOUS SUBSTANCES—

Continued 

Substances PDN ID 1 PDN description Program 2 Status 

change 3 Comments 4

46E ....... Potential candidate for subregistry of exposed persons.ATSDR. 

1Priority data need identification number. 

2Programs addressing priority data needs. ATSDR = ATSDR’s Division of Health Studies; EPA = U.S. Environmental Protection Agency; G. 

Lakes = Great Lakes Human Health Effects Research Program; MHPF = Minority Health Professions Foundation; NTP = National Toxicology 

Program; Vol Res = Voluntary research. 3PDN can be filled or remain unchanged based on reevaluation of the database using criteria developed by ATSDR. 4ACC = American Chemistry Council; Ashley et al. 1992 = Ashley DL, Bonin MA, Cardinali FL, et al. Anal Chem (1992) 64:1021–29; Ashley et 

al. 1994 = Ashley DL, Bonin MA, Cardinali FL et al., Clin Chem (1994) 40/7:1401–4; ATSDR studies = Studies conducted by ATSDR’s Division 

of Health Studies; GE = General Electric Company; HSIA = Halogenated Solvents Industry Alliance, Inc.; MHPF = Minority Health Professions 

Foundation; MRL = Minimal Risk Level; CDC 2005 = The third National Report on Human Exposure to Environmental Chemicals, prepared by 

the National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA; Needham et al. 1995 = Needham LL, Hill 

RH Jr, Ashley DL, Pirkle JL, and Sampson EJ. Environ Health Perspect 103(Suppl 3):89–94; Needham et al. 1996 = Needham LL, Patterson DG 

Jr, Burse VW, Paschal DC, Turner WE, and Hill VW Jr. Toxicol Ind Health 12:507–513; NHANES III = The Third National Health and Nutrition 

Examination Survey, conducted by the National Center for Health Statistics, Centers for Disease Control and Prevention, Atlanta, GA; NTP = National Toxicology Program; Paschal et al. 1998 = Paschal DC, Ting BC, Morrow JC, et al. Environ Res, Section A 76: 53–59; PBPK modeling = 

physiologically based pharmacokinetic modeling; Toxicological profile = ATSDR’s toxicological profiles for the Agency’s priority hazardous substances. 5 Not a priority data need. 

TABLE 2.—GROUPS WHICH ARE ADDRESSING/HAVE ADDRESSED ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS

(PDNS) 

Program Firm, institution, agency, or consortium Substance PDN ID 

Voluntarism .......................................... American Chemistry Council ............... Vinyl chloride ....................................... 44B, 44E 

General Electric Company .................. PCBs ................................................... 36H*, 36I*, 36J*

Halogenated Solvents Industry Alliance, Inc.Methylene chloride .............................. 33A, 33B 

Tetrachloroethylene ............................. 40B, 40C, 40D, 40E 

Trichloroethylene ................................. 43B, 43C, 43D, 43E 

Minority Health Professions Foundation.Florida A & M University ..................... Lead ..................................................... 29A 

The King/Drew Medical Center of the 

Charles R. Drew University of Medicine and Science.

Lead ..................................................... 29B, 29C 

Meharry Medical College .................... PAHs ................................................... 37A, 37B, 37C, 37D 

Morehouse School of Medicine ........... Lead ..................................................... 29C 

Texas Southern University .................. Di-n-butyl phthalate ............................. 21D 

Lead ..................................................... 29A 

Toluene ................................................ 41C 

Trichloroethylene ................................. 43B 

Tuskegee University ............................ Chlordane ............................................ 9A 

Mercury ................................................ 31A 

Zinc ...................................................... 46A, 46B 

Xavier University ................................. Manganese .......................................... 30A, 30B 

Zinc ...................................................... 46A 

Great Lakes Human Health Effects 

Research Program.

Michigan State University .................... DDT/DDE ............................................. 19D, 19E 

Lead ..................................................... 29C 

Mercury ................................................ 31D 

PCBs ................................................... 36D, 36E, 36J*

Selenium .............................................. 38D 

New York State Health Department .... DDT/DDE ............................................. 19E 

Lead ..................................................... 29C 

Mercury ................................................ 31D 

PCBs ................................................... 36D, 36E, 36J*

State University of New York at Albany.PCBs ................................................... 36E 

State University of New York at Buffalo.DDT/DDE ............................................. 19D, 19E 

Lead ..................................................... 29C 

Mercury ................................................ 31D 

PCBs ................................................... 36D, 36E, 36J*

State University of New York at 

Oswego.

DDT/DDE ............................................. 19D, 19E 

Lead ..................................................... 29C 

Mercury ................................................ 31D 

PCBs ................................................... 36D, 36E, 36J*

University of Illinois at Chicago ........... DDT/DDE ............................................. 19D, 19E 

Federal Register / Vol. 70, No. 238 / Tuesday, December 13, 2005 / Notices 73773 

TABLE 2.—GROUPS WHICH ARE ADDRESSING/HAVE ADDRESSED ATSDR’S SUBSTANCE-SPECIFIC PRIORITY DATA NEEDS

(PDNS)—Continued 

Program Firm, institution, agency, or consortium Substance PDN ID 

Lead ..................................................... 29C 

Mercury ................................................ 31D 

PCBs ................................................... 36D, 36E, 36J*

University of Illinois at Urbana-Champaign.DDT/DDE ............................................. 19D, 19E 

Lead ..................................................... 29C 

Mercury ................................................ 31D 

PCBs ................................................... 36D, 36E, 36J*

University of Wisconsin-Milwaukee ..... DDT/DDE ............................................. 19D, 19E 

Lead ..................................................... 29C 

Mercury ................................................ 31D 

PCBs ................................................... 36A, 36D, 36E, 36J*

Selenium .............................................. 38D 

Wisconsin Department of Health and 

Social Services—5 State Consortium.

Arsenic ................................................. 2D 

Cadmium ............................................. 7B 

Chromium ............................................ 13E 

DDT/DDE ............................................. 19D, 19E 

Lead ..................................................... 29C 

Mercury ................................................ 31D 

Nickel ................................................... 34F 

PAHs ................................................... 37F 

PCBs ................................................... 36D, 36E, 36J*

Environmental Protection Agency 

TSCA/FIFRA.

EPA/ATSDR Test Rule ....................... Benzene .............................................. 4A, 4B, 4C 

Chloroethane ....................................... 11A, 11B 

Cyanide (hydrogen cyanide and sodium cyanide).14A, 14B 

Methylene chloride .............................. 33A 

Tetrachloroethylene ............................. 40C, 40E 

Toluene ................................................ 41C 

Trichloroethylene ................................. 43B, 43E 

Metals Testing Task Force (TASARC) Arsenic ................................................. 2A, 2B, 2C 

Beryllium .............................................. 6A, 6B, 6C, 6E 

Chromium ............................................ 13A, 13B, 13C, 13D 

Manganese .......................................... 30A, 30B, 30E 

Mercury ................................................ 31C 

Nickel ................................................... 34B, 34C, 34D, 34E 

Selenium .............................................. 38A, 38B 

National Toxicology Program .............. National Institute of Environmental 

Health Sciences.

Carbon tetrachloride ............................ 8B 

1,1-dichloroethene ............................... 18A, 18B 

Di-n-butyl phthalate ............................. 21A 

Disulfoton ............................................. 22A 

Heptachlor ........................................... 26B 

* Not priority data needs. 

Editorial Note: FR Doc. 05–23361 was 

originally published at page 71506 in the 

issue of Tuesday, November 29, 2005. The 

corrected document is republished in its 

entirety, due to printing errors. 

[FR Doc. R5–23361 Filed 12–12–05; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–06–0556] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–4766 or send 

comments to Seleda Perryman, CDC 

Assistant Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c)