[Federal Register Volume 65, Number 248 (Tuesday, December 26, 2000)]
[Notices]
[Pages 81700-81718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32767]



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Part V





Environmental Protection Agency





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Voluntary Children's Chemical Evaluation Program; Notice

  Federal Register / Vol. 65, No. 248 / Tuesday, December 26, 2000 / 
Notices  

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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-00274D; FRL-6758-5]


Voluntary Children's Chemical Evaluation Program

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  EPA is announcing the Voluntary Children's Chemical 
Evaluation Program (VCCEP) and asking manufacturers (including 
importers) of 23 chemicals to volunteer to sponsor their chemical(s) in 
the first tier of a pilot of this Program. Developed after considering 
various comments and concerns voiced by a number of individuals through 
a stakeholder involvement process, the VCCEP is a program designed to 
provide data to enable the public to better understand the potential 
health risks to children associated with certain chemical exposures. 
EPA has also taken steps, as described in this document, to consider 
animal welfare and to provide instructions on ways to reduce or in some 
cases eliminate animal testing, while at the same time ensuring that 
the public health is protected. The Program is also designed to ensure 
that health effects and exposure data are made available to allow EPA 
and others to evaluate the risks of these chemicals so that mitigation 
measures may be taken as appropriate.

DATES:  To be included in Tier 1 of the pilot VCCEP, EPA must receive a 
letter of commitment from a company volunteering to sponsor a 
chemical(s) between January 25, 2001 and June 25, 2001.
    Volunteering for Tier 1 means sponsors would begin to develop Tier 
1 information not later than 6 months after the end of the Tier 1 sign 
up period. The sign up period ends June 25, 2001. Sponsors may make 
separate commitments to upper tiers of the pilot program at a later 
time.

ADDRESSES:  Commitment letters may be submitted by mail or in person. 
Please follow the detailed instructions for each method as provided in 
Unit I. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by 
EPA, it is imperative that you identify docket control number OPPTS-
00274D in the subject line on the first page of your commitment letter.

FOR FURTHER INFORMATION CONTACT:   For general information contact: 
Barbara Cunningham, Acting Director, Environmental Assistance Division 
(7408), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: Ward Penberthy, Chemical Control 
Division (7405), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (202) 260-1730; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. This action may, 
however, be of special interest to those chemical manufacturers, 
importers, and processors who produce or use chemical substances that 
are covered by the Toxic Substances Control Act (TSCA), individuals or 
groups concerned with chemical testing and children's health, and 
animal welfare groups. Since other entities may also be interested, the 
Agency has not attempted to describe all the specific entities that may 
be affected by this action. If you have any questions regarding the 
applicability of this action to a particular entity, consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    To access information about the VCCEP, the previously held 
stakeholder meetings, or relevant documents, you may go directly to the 
web site at http://www.epa.gov/chemrtk/childhlt.htm.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-00274D. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as Confidential Business Information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the TSCA Nonconfidential Information Center (NCIC), 
North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, 
DC. The Center is open from noon to 4 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Center is (202) 
260-7099.

C. How and to Whom Do I Submit a Commitment Letter?

    A commitment letter to sponsor a chemical(s) may be submitted 
through the mail or in person. To ensure proper receipt by EPA, it is 
imperative that you identify docket control number OPPTS-00274D in the 
subject line on the first page of your letter.
    1. By mail. Submit your letter to: Document Control Office (7407), 
Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your letter to: OPPT Document 
Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M 
St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
DCO is (202) 260-7093.

D. What Must I Include in My Commitment Letter?

    The commitment letter must provide the name and Chemical Abstract 
Service Registry Number (CAS No.) of the chemical being sponsored, a 
commitment to start the development of the information no later than 6 
months after the end of the sign up period, and an anticipated start 
date and submission date to EPA. The commitment letter must also 
identify the entity (company or consortium of companies) sponsoring the 
chemical and provide the name, address, e-mail address, telephone, and 
fax numbers of a technical contact.

II. Background

A. What Action is the Agency Taking?

    EPA is asking manufacturers (hereinafter manufacturers include 
importers) of 23 chemicals to commit to sponsor the chemical(s) in a 
pilot of the

[[Page 81701]]

VCCEP for the purpose of making health effects, exposure, and risk 
information on these chemicals available to both EPA and the public. 
EPA is taking this action in the form of a pilot program so it can gain 
insight into how best to design and implement the VCCEP in order to 
effectively provide the Agency and the public with the means to 
understand the potential health risks to children associated with 
exposure to these and ultimately other chemicals to which children may 
be exposed. The VCCEP is a component of EPA's Chemical Right-to-Know 
initiative which committed EPA to ``....review and report on what new 
testing may be needed to assess the special impact industrial chemicals 
may have on children.''
    Volunteering to sponsor a chemical in any tier of the VCCEP pilot 
requires the companies sponsoring chemicals (hereinafter ``sponsors'') 
to make chemical-specific public commitments to make certain hazard, 
exposure, and risk assessment data and analyses publicly available. The 
information will be provided by the sponsors in a maximum of three 
tiers and will be used to make judgements about the risks to children. 
Companies, through this process, have the opportunity to sponsor 
chemicals at Tier 1 during the sign up period which will begin January 
25, 2001 and end on June 25, 2001. After the submission of Tier 1 
information and its review by a Peer Consultation Group, a third party 
contractor will compile and forward the results of the Peer 
Consultation to EPA. EPA will announce if additional information is 
needed to assess a chemical's risk to children and will indicate what 
information in Tier 2 should be provided. Companies will then be given 
an opportunity to sponsor chemicals at Tier 2. EPA plans to use the 
same process to review Tier 2 information to determine if Tier 3 
information is needed and companies will then be given an opportunity 
to sponsor chemicals at Tier 3. Detailed information on how the VCCEP 
will operate is presented in Unit III. EPA expects to modify the design 
of the VCCEP based on the results of the pilot.

B. What is the Agency's Authority for Taking this Action?

    Congress gave EPA the authority to implement TSCA for the purpose 
of protecting human health and the environment by requiring testing 
and, if necessary, restricting the use of certain chemical substances. 
The VCCEP is a voluntary program which focuses on developing data and 
assessments necessary to protect children. This document describes the 
design of the VCCEP and initiates this program in the form of a pilot. 
If some chemicals are not sponsored in the VCCEP, EPA will consider 
whether a test rule under section 4 of TSCA is appropriate.

C. What Process has EPA Used to Develop this Program?

    In initiating a chemical evaluation program, decisions need to be 
made regarding the appropriate chemicals to consider and the 
appropriate toxicology and exposure studies to conduct. To address 
these issues, EPA initiated a public stakeholder involvement process to 
bring together individuals with a broad range of interests in 
children's health issues to provide input, on an individual basis, into 
the design of a voluntary program to obtain needed data. The 
stakeholders in this process have included chemical manufacturers who 
could be required to conduct testing of chemical substances under 
section 4 of TSCA, individuals or groups concerned with chemical 
testing, children's health, and/or environmental protection, other 
Federal government agencies, and animal welfare groups. EPA held three 
public meetings to obtain individual comments and concerns from these 
stakeholders for the development of the VCCEP. These meetings were held 
September 22, 1999, November 30-December 1, 1999, and April 26-27, 
2000. EPA also considered comments submitted by stakeholders throughout 
the process (Refs. 1-29 and 35). Details of this process and summaries 
of the public meetings can be found at http://www.epa.gov/chemrtk/childhlt.htm.

D. How Were Candidate Chemicals for the VCCEP Identified?

    After considering the individual comments offered by some of the 
stakeholders during the public meetings or in comments submitted to the 
docket (Refs. 28 and 29), EPA decided to focus this program on 
chemicals which have been found to be present as contaminants in:
     Human tissues or fluids (e.g., adipose tissue, blood, 
breast milk, breath).
     Food and water children may eat and drink.
     Air children may breathe, including residential or school 
air.
    In an effort to identify chemicals to which children would have the 
highest likelihood of exposure, EPA selected chemicals which were found 
by biomonitoring data to be present in the human body (adipose tissue/
blood/breast milk/breath) and found by environmental data to be present 
in a person's environment (in food, drinking water, breast milk, air). 
If a chemical were listed in at least one biomonitoring database and at 
least one environmental database, it was identified as a candidate for 
the VCCEP.
    The biomonitoring databases EPA used in chemical identification 
are:
     National Health and Nutrition Examination Survey III 
(NHANES III).
     National Human Adipose Tissue Survey (NHATS).
     National Human Exposure Assessment Survey (NHEXAS).
     Total Exposure Assessment Methodology (TEAM).
    The environmental databases EPA used in chemical identification are 
the following:
     The Food and Drug Administration (FDA) database of 
Everything Added to Food in the United States (EAFUS).
     National Contaminant Occurrence Database (NCOD) (includes 
unregulated drinking water contaminants).
     National Human Exposure Assessment Survey (NHEXAS).
     Total Exposure Assessment Methodology (TEAM).
     EPA Office of Research and Development studies and other 
published indoor air data.
    EPA used additional criteria to remove chemicals as candidates for 
the VCCEP. Among these criteria were:
     They were not chemicals produced in or imported into the 
United States in an amount sufficient to meet TSCA Inventory Update 
Rule (IUR) reporting criteria.
     They are chemicals being phased out under the Montreal 
Protocol.
     They are chemicals whose risks to children are believed by 
EPA to be adequately managed by other ongoing programs.
    A list of the over 150 chemicals found in the biomonitoring 
databases as well as a working list of candidate chemicals for VCCEP 
can be found in Methodology for Selecting Chemicals for the Voluntary 
Children's Chemical Evaluation Program (VCCEP) Pilot (Ref. 38). 
Descriptions of the databases used for chemical selection and 
additional details regarding the selection process are also included in 
this reference.
    There was an exception to the identification process which was 
raised and discussed during the last stakeholder meeting. This 
exception relates to the identification of three polybrominated 
diphenyl ethers for the VCCEP without relying on the use of the 
databases. Polybrominated diphenyl ethers, as a class of chemicals, 
were found to be increasing in concentration in human breast milk in a 
recent Swedish study (Ref. 30). EPA used this

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study and TSCA IUR reporting, which indicates that chemicals are 
manufactured in the United States, to identify specific chemicals in 
this chemical class to include in this program (Ref. 50). Although EPA 
did not rely on the databases for the identification of these 
chemicals, it believes that the study provides biomonitoring evidence 
of exposure of the mother and also environmental evidence of the 
potential exposure via a food source of the child.
    The VCCEP candidate chemicals identified and screened by the 
criteria described in this Unit II.D. were further evaluated to select 
chemicals for the pilot as described in Unit III.A.

E. What is the Significance of a Chemical's Being Identified for the 
VCCEP?

    The identification of chemicals for the VCCEP was one of the more 
challenging aspects of the program's development. Both EPA and some 
stakeholders agreed that available data sources provided limited 
insight on children's exposure to chemicals. Consequently, to identify 
chemicals for the VCCEP, EPA used existing data sources believed to be 
especially relevant to children's chemical exposures, such as presence 
of the chemical in human tissues/blood, in food and water children eat 
and drink and in air children breathe. EPA acknowledges that the 
chemical identification process does not take into account the unique 
aspects of children's potential for exposure, based on their behaviors 
and activities. For this reason, EPA wishes to make clear what the list 
of chemicals selected for the VCCEP represents and what it does not 
represent.
    Identification for the VCCEP does not mean that the existing hazard 
and exposure data have been or will be determined to be inadequate. EPA 
has not made judgements regarding the adequacy or significance of 
existing hazard or exposure data for any of the chemicals selected for 
the pilot. While EPA recognizes that many of these chemicals are known 
to be relatively ``data rich,'' assessment of the adequacy and 
significance of hazard and exposure information will be a task of the 
sponsors participating in the voluntary program.
    Identification for the VCCEP also does not mean that EPA has made 
or will make a determination that any uses of the chemical pose 
significant risks to children's health. The level of potential risk to 
children will be determined as part of the VCCEP. The chemical 
identification process for the VCCEP did not make this determination. 
It is also important to note that for any given chemical in the VCCEP, 
EPA may ultimately determine that reasonably anticipated exposures and 
risks from expected uses do not pose any unique or other concerns for 
children's health and safety.

F. How did EPA Decide Which Tests are Necessary to Evaluate a 
Chemical's Risk to Children?

    EPA has undertaken significant technical efforts to define an 
appropriate test battery for the VCCEP over the last 2 years. The 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific 
Advisory Panel and invited members of the EPA Science Advisory Board 
(SAB) convened in late May 1999 to review the recommendations of the 
Toxicology Working Group of the 10X Task Force. The Toxicology Working 
Group had developed recommendations for a core data set necessary to 
assess the potential hazards to children following exposure to 
conventional food use pesticides (Ref. 32). These recommendations were 
prepared for consideration in developing the implementation policy for 
the Food Quality Protection Act's (FQPA) 10-fold Safety Factor. EPA's 
OPPT sought input and advice from this EPA advisory group about the 
appropriateness of using a selected subset of the 10X battery to 
address industrial chemicals to which children were likely to be 
exposed. The subset of tests which EPA proposed included the following 
types of studies:
     Acute studies (oral, dermal, or inhalation).
     Subchronic (90-day) feeding studies in rodents.
     Oncogenicity studies in two species of rodents (rats and 
mice preferred).
     Prenatal developmental toxicity studies in rodents and 
nonrodents (rats and rabbits preferred).
     2-Generation reproduction study in rodents.
     General metabolism study in rodents.
     Mutagenicity studies (in vivo and in vitro assays of gene 
mutations and structural chromosomal aberrations).
     Acute and subchronic neurotoxicity in rats.
     Immunotoxicity study in rodents.
     Developmental neurotoxicity study in rodents (usually 
rats).
    The SAP's comments were supportive with respect to the subset of 
tests which EPA proposed as the test battery for the VCCEP:

    The Panel could not conclusively determine whether the proposed 
Children's Health Testing Program (now the VCCEP) battery was 
appropriate to evaluate the potential hazards of industrial/
commercial chemicals to which children may have high potential 
exposure. In any event, the Panel concluded that the Agency should 
retain the standard toxicology protocols and add the more specific 
developmental neurotoxicity, immunotoxicity, and neurotoxicity tests 
now proposed for pesticides . . . and that it was appropriate for 
the proposed battery of tests to be viewed as a single tier of 
studies. In addition, the Panel believes that non pesticide 
(industrial/commercial) chemicals be considered in the same manner 
as pesticides with regard to their potential to impact the health of 
children . . . and that being the case, it would be prudent for the 
Agency to require the same or similar types of toxicity data on 
chemicals of industrial/commercial use as pesticides. (Ref. 33)

    These tests and the appropriate guidelines for conducting these 
tests in the VCCEP are discussed in Unit III.D.

G. Why does the VCCEP Need Exposure Assessments?

    Although the biomonitoring data used in chemical selection 
(discussed in Unit II.D. and III.B.) provide strong qualitative 
evidence that human exposure to the VCCEP chemicals has occurred, not 
all of the data were obtained recently and there are questions 
regarding the quality of some of the data, causing some to question 
their relevance. Although EPA believes the biomonitoring data are still 
relevant, more information would be valuable to assure a full 
understanding of current exposure patterns and levels, especially as 
they relate to children. The VCCEP will provide sponsors the 
opportunity to submit exposure data that reflect current exposures. 
Submission of exposure information to EPA is included as a component in 
Tier 1, Tier 2, and Tier 3 of the VCCEP, as described in Unit III.H., 
III.J., III.K., and III.L.
    An equally important reason for collecting exposure data in the 
VCCEP is its need in risk assessment. To assess risk, exposure data are 
needed as much as hazard data. Hazard data may indicate a chemical's 
potential to cause adverse health effects, but exposure data are needed 
to put those data in context. A chemical may test as potentially 
hazardous, but if there is no or very low exposure to the chemical, 
there may be a low risk of the chemical causing adverse health effects. 
Likewise, exposure data which indicate low or no exposure can support 
an argument that additional hazard data may not be necessary, thus 
avoiding unnecessary expenditures of testing resources. The VCCEP 
includes this principle in its design by requiring the consideration of 
exposure, hazard, and risk data before deciding whether data from the 
next tier of information are needed.

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III. The VCCEP

A. How Were VCCEP Candidate Chemicals Further Culled to Identify 
Chemicals for the VCCEP Pilot?

    The names of the 23 chemicals identified for the VCCEP pilot 
program are listed in Table 1 of this unit in CAS No. order. These 
chemicals were identified using the criteria discussed in Unit II.D. 
Table 1 of this unit indicates the specific databases which were the 
source of the biomonitoring data and the environmental monitoring data 
which together supported the selection of a chemical.
     An additional factor which influenced which candidate chemicals 
were selected for the pilot program was the availability of hazard 
data. For reasons discussed in Unit III.C., EPA wanted to select 
chemicals for the pilot which have available Tier 1 hazard data. To 
identify such chemicals, EPA used two primary indications of data 
availability:
    1. Data were available from the Organization for Economic 
Cooperation and Development (OECD) Screening Information Data Set 
(SIDS) Program, and
    2. Chemicals with commitments in the High Production Volume (HPV) 
Challenge Program that had early start years, i.e., 2000 or 2001.
    Table 1 of this unit indicates which chemicals have early start 
years in the HPV Challenge Program and which chemicals have available 
or soon to be available SIDS data.
    In the final selection for the VCCEP pilot, several chemicals 
otherwise meeting the hazard data availability selection criterion were 
not included in the pilot.
     Several chemicals were deferred because the only 
biomonitoring data supporting their selection were from NHATS or the 
only environmental data supporting their selection were from EAFUS. 
This is because several stakeholders questioned whether these data sets 
were appropriate for this chemical selection application.
     Several phthalate esters are included in the working list 
of candidate chemicals for VCCEP presented in the Methodology for 
Selecting Chemicals for the Voluntary Children's Chemical Evaluation 
(VCCEP) Program Pilot (Ref. 38). EPA is aware that phthalates are used 
in a wide variety of products, including some that present 
opportunities for exposure to children, which has been an important 
consideration in the selection of candidate substances for the VCCEP. 
EPA also is aware that several phthalates are currently the subjects of 
assessments being performed by other government agencies, including 
some assessments that are specifically addressing potential exposures 
and hazards to children. These other assessments include:
    1. The National Toxicology Program (NTP) Center for the Evaluation 
of Risks to Human Reproduction (CERHR) which is preparing detailed 
assessments of the scientific evidence for whether a given exposure or 
exposure circumstance may pose a hazard to reproduction and the health 
and welfare of children for seven phthalates--dibutyl phthalate (DBP), 
butylbenzyl phthalate (BBP), di-n-hexyl phthalate (DnHP), di-n-octyl 
phthalate (DnOP), di(2-.ethylhexyl) phthalate (DEHP), diisononyl 
phthalate (DINP), and diisodecyl phthalate (DIDP). A separate 
assessment is being prepared for each phthalate by an expert panel 
chosen specifically for the phthalates. Each assessment will be an 
evaluation of the scientific evidence for whether adverse reproductive/
developmental health effects are associated with exposures to the 
phthalate and will include the expert panel's conclusions about 
knowledge gaps for the phthalate. (Ref. 53). Additional information is 
available on web site http://ntp-server.niehs.nih.gov/htdocs/liason/CERHRPhthalatesAnnct.html.
    2. The Consumer Product Safety Commission (CPSC) has convened a 
Chronic Hazard Advisory Panel (CHAP) to evaluate the existing 
information regarding whether chronic hazards (cancer, birth defects, 
and gene mutations) may be posed by DINP and the implications of these 
hazards on risks to children. The CHAP expert panel will evaluate 
available hazard and exposure information, including data generated by 
the CPSC in its testing laboratory on the amount of DINP that is likely 
to come out of a toy when chewed or mouthed by a young child. (Ref. 
54).
    3. The FDA is preparing a risk assessment of DEHP in medical 
devices, including medical devices that result in exposure to infants 
and newborn babies. (Ref. 55).
    Additional information is available on web site http://www.fda.gov/cdrh/present/DEHP_GHTF.pdf.
    In addition, risk assessments of DBP, BBP, DEHP, DINP, and DIDP are 
being conducted by scientists in the European Union (EU).
    Most of these assessments are close to being complete. It would be 
neither practical nor efficient to attempt to repeat all of the work of 
these other assessments under the VCCEP program, but EPA believes the 
outcome of these assessments will provide helpful information for 
deciding whether the risks of phthalates to children have been 
adequately characterized, and which, if any, of the phthalates are 
appropriate for inclusion in the VCCEP. In some cases, the work of 
these other bodies may facilitate review of phthalates under the VCCEP. 
In other cases, EPA may determine that in light of these hazard and 
risk assessments, further review under the VCCEP is either unnecessary 
or a low priority. Accordingly, EPA is not deciding whether to include 
phthalates in the VCCEP Pilot at this time. Instead, EPA will 
reevaluate the phthalates in approximately 6-9 months, after many of 
the assessments have been completed. The producers of phthalates have 
agreed to provide the assessments to EPA once they are completed, and 
to include in that submission their assessment of the extent to which 
further evaluation under the VCCEP is or is not necessary. EPA will 
review these materials when they are received to determine which 
phthalates, if any, the Agency believes are appropriate for further 
evaluation under the VCCEP at that time. The materials submitted by the 
producers will be made publicly available and EPA will invite input 
from other stakeholders before making its decisions.
     Styrene was deferred from the pilot program because of 
ongoing assessments which are well advanced and substantially 
equivalent to the VCCEP in that they address potential exposures and 
hazards to children. The assessments underway are listed below:
    1. The Styrene Information and Research Center (SIRC), which is 
composed of styrene manufacturers and users, has sponsored 
toxicological research covering nearly all the health endpoints to be 
addressed by the VCCEP and has funded additional 2-generation 
reproduction and developmental neurotoxicity testing (Ref. 23).
    2. The Center for Risk Analysis at the Harvard School of Public 
Health has created a risk assessment panel on styrene. The panel is 
undertaking an exposure assessment and an independent hazard analysis 
of styrene and is expected to include an evaluation of risks to 
children's health in its review (Ref. 23). The SIRC was asked to submit 
exposure data to support the assessment being conducted at Harvard 
(Ref. 23) which is expected to be available to EPA by July 2001.
    3. EPA's Integrated Risk Information System (IRIS) program is 
currently conducting an assessment of available hazard data on styrene 
which will address all of the health endpoints included in the VCCEP. 
The IRIS assessment will address children as a

[[Page 81704]]

subpopulation in its review and may include both short-term and long-
term health values for children in the IRIS summary document which EPA 
will issue for styrene (Ref. 23).
    EPA believes these assessments will provide helpful information for 
whether the risks of styrene to children have been adequately 
characterized. EPA may determine after receipt of these hazard, 
exposure, and risk assessments, that further review under the VCCEP is 
either unnecessary or a low priority. As with the case with phthalates, 
materials submitted by the producers will be made publicly available 
and EPA will invite input from other stakeholders before making its 
decision.
     Additional details on how chemicals were selected for the pilot 
are provided in the document Methodology for Selecting Chemicals for 
the Voluntary Children's Chemical Evaluation Program (VCCEP) Pilot 
(Ref. 38).

                                                                       Table 1.--Chemicals Identified for the VCCEP Pilot
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Chemicals found in human biological samples                    Chemicals found in human
                                                     HPV Chall.                      ------------------------------------------------------------------------             environment
            CAS No.               Chemical name      Commit. \1\         SIDS\2\                                                                             -----------------------------------
                                                                                           NHANES            NHEXAS             TEAMS        Human milk \3\         NCOD           Indoor air
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
67-64-1.......................  Acetone.........    ..............  Y...............  Y...............    ..............    ..............    ..............    ..............  Y
71-43-2.......................  Benzene.........    ..............  Y...............  Y...............  Y...............  Y...............    ..............  Y...............  Y
75-35-4.......................  Vinylidenechlori  Y...............    ..............    ..............    ..............  Y...............    ..............  Y...............  Y
                                 de.
78-93-3.......................  Methyl ethyl        ..............  Y...............  Y...............    ..............    ..............    ..............    ..............  Y
                                 ketone.
79-01-6.......................  Trichloroethylen    ..............  Y...............  Y...............    ..............  Y...............    ..............  Y...............  Y
                                 e.
80-56-8.......................  -Pinene  Y...............    ..............    ..............    ..............  Y...............    ..............    ..............  Y
95-47-5.......................  o-Xylene........  Y...............    ..............  Y...............    ..............  Y...............    ..............  Y...............  Y
100-41-4......................  Ethylbenzene....    ..............  Y...............  Y...............    ..............  Y...............    ..............  Y...............  Y
106-46-7......................  p-Dichloroben       ..............  Y...............  Y...............    ..............  Y...............    ..............  Y...............  Y
                                 zene.
106-93-4......................  Ethylene          Y...............    ..............    ..............    ..............  Y...............    ..............  Y...............  Y
                                 dibromide.
107-06-2......................  Ethylene          Y...............    ..............    ..............    ..............  Y...............    ..............  Y...............  Y
                                 dichloride.
108-38-5......................  m-Xylene........  Y...............    ..............    ..............    ..............  Y...............    ..............  Y...............  Y
108-88-3......................  Toluene.........    ..............  Y...............  Y...............    ..............  Y...............    ..............  Y...............  Y
108-90-7......................  Chlorobenzene...  Y...............    ..............  Y...............    ..............  Y...............    ..............  Y...............  Y
112-40-3......................  n-Dodecane......  Y...............    ..............    ..............    ..............  Y...............    ..............    ..............  Y
123-91-1......................  p-Dioxane.......    ..............  Y...............    ..............    ..............  Y...............    ..............    ..............  Y
124-18-5......................  Decane..........    ..............  Y...............    ..............    ..............  Y...............    ..............    ..............  Y
127-18-4......................  Tetrachloroethyl    ..............  Y...............  Y...............  Y...............  Y...............    ..............  Y...............  Y
                                 ene.
541-73-1......................  m-                Y...............    ..............    ..............    ..............  Y...............    ..............  Y...............  Y
                                 Dichlorobenzene.
1120-21-4.....................  Undecane........    ..............  Y...............    ..............    ..............  Y...............    ..............    ..............  Y
1163-19-5.....................  Decabromodipheny    ..............  Y...............    ..............    ..............    ..............  Y...............    ..............
                                 lether.
32534-81-9....................  Pentabromodiphen    ..............  Y...............    ..............    ..............    ..............  Y...............    ..............
                                 yl ether.
32536-52-0....................  Octabromodipheny    ..............  Y...............    ..............    ..............    ..............  Y...............    ..............
                                 l ether.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ HPV Challenge commitment with early start year (2000 or 2001).
\2\ SIDS Screening Information Assessment Report is available.
\3\ The chemicals in this column were chemicals identified in Ref. 30 that were also reported to the TSCA IUR

    EPA is aware of recent ongoing discussions between the Agency for 
Toxic Substances and Disease Registry (ATSDR) and the Halogenated 
Solvents Industries Association (HSIA) regarding the voluntary testing 
of two chemicals relevant to the VCCEP pilot, i.e., trichloroethylene 
(CAS No. 79-01-6) and tetrachloroethylene (CAS No. 127-18-4). These 
chemicals have been the subject of discussions relating to priority 
data needs identified by ATSDR as part of a proceeding under the 
Emergency Planning and Community Right-to-Know Act (EPCRA) section 110 
and are also likely to be included in a test rule proposal being 
developed under TSCA section 4 at ATSDR's request. EPA understands that 
ATSDR and HSIA may soon come to agreement on arrangements to meet some 
of ATSDR's priority hazard data needs for these two pilot chemicals. 
While the testing being discussed would meet some of the hazard data 
needs of the VCCEP, it would not address exposure information needs and 
there appear to be several important deficiencies with regards to 
higher tier toxicity end points. In the event that ATSDR and HSIA can 
conclude their voluntary testing arrangement in the near future, EPA 
believes that a workable course of action in this case may be to use 
the ATSDR-HSIA work as input to Tier 1 hazard information. If this 
occurs, the delivery date for Tier 1 information and assessments 
prepared by VCCEP pilot sponsors could be adjusted to take account of 
the timing elements in the ATSDR-HSIA agreement. In the event that 
ATSDR and HSIA are unable to conclude a voluntary testing arrangement 
in the near future, EPA will consider the chemicals open for 
sponsorship under the Pilot as described in this notice.
    Although only o-xylene and m-xylene are listed in Table 1 of this 
unit as pilot chemicals, the sponsors of these chemicals may want to 
consider addressing p-xylene (CAS No. 106-42-3) and mixed xylenes (CAS 
No. 1330-20-7) as they proceed in the VCCEP pilot. These two xylenes 
were deferred from the pilot because they are not been sponsored in the 
HPV Challenge Program and there is no Tier 1 data available from the 
OECD SIDS program. EPA believes these 4 chemicals may present the 
potential for a group approach.

B. Has EPA Completed Any Evaluations that Demonstrate the Relevance of 
the Biomonitoring Data Sets?

    EPA considers the biomonitoring data as strong evidence of exposure 
and as providing a strong rationale for identifying a chemical for this 
program. EPA has evaluated the biomonitoring data not only for the 
detection of a chemical by the monitoring program, but also the 
detection frequency and concentration of the chemical in the tested 
biological medium. Examples of these data for the VCCEP pilot chemicals 
are presented in Table 2 of

[[Page 81705]]

this unit. The information in Table 2 is intended to be illustrative 
rather than complete. Many of the listed chemicals were also found in 
other human monitoring studies, some of which report the frequency of 
occurrence and some of which do not. The blood levels shown in Table 2 
are from NHANES III; the breath data are from TEAM studies; and the 
breast milk data are from a recent Swedish study (Ref. 30). A number of 
the candidate chemicals were also studied in NHEXAS, but these data are 
not included in Table 2 because all of the chemicals found in NHEXAS 
were also reported in NHANES III.
    With the possible exception of the Swedish breast milk study, all 
of the monitoring programs from which these data were drawn were 
relatively large, broad-scale studies. The blood data were derived from 
a subset of the national scale NHANES III population and were used to 
establish reference ranges for the chemicals studied. NHEXAS involved 
surveys in EPA Region 5 (Illinois, Indiana, Michigan, Minnesota, Ohio, 
and Wisconsin), in the State of Arizona, and in the Baltimore 
Metropolitan Area. TEAM studies were done in communities in California, 
New Jersey, North Carolina, and North Dakota. Because of the size and 
scope of these programs, the detection of a chemical at even a 
relatively low frequency may indicate exposure to a large population. 
The significance of the reported concentrations is difficult to 
interpret without information about the exposure events that led to a 
chemical's occurrence in that tissue and a detailed knowledge of that 
chemical's metabolic fate. At present, the reported data are best used 
simply as a qualitative indicator that exposure has occurred.
     The first substance in Table 2 of this unit does not exactly match 
the corresponding entries on the pilot chemical list. However, EPA 
believes that the TEAM data on the mixture of meta and para isomers of 
dichlorobenzene are relevant to the listing of m-dichlorobenzene and p-
dichlorobenzene as individual isomers. Likewise, the NHANES III data on 
mixed meta and para isomers of xylene are relevant to the listing of m-
xylene in the pilot chemical list. Also, the listing of polybrominated 
diphenyl ethers in Table 2 of this unit and the data from the Swedish 
study (Ref. 30) is relevant to three entries on the pilot chemical list 
(decabromodiphenyl ether, pentabromodiphenyl ether, and 
octabromodiphenyl ether).

       Table 2.--Frequency of Detection and Concentration of Select VCCEP Pilot Chemicals in Certain Human
                                              Biomonitoring Studies
----------------------------------------------------------------------------------------------------------------
                                                                               Detection
             CAS No.                 Chemical name          Medium             frequency         Concentration
----------------------------------------------------------------------------------------------------------------
                                  m,p-                breath............  91% of 49.........  GM\1\= 1.81 g/m\3\
                                  m,p-Xylene........  blood.............  75% of   med\2\= 0.19 ppb
                                                                           649.
                                  Polybrominated      milk..............    ................  mean = 4 ng/g
                                   diphenylethers.
67-64-1.........................  Acetone...........  blood.............  75% of   med = 1,800 ppb
                                                                           1062.
71-43-2.........................  Benzene...........  blood.............  75% of   med = 0.06 ppb
                                                                           883.
75-35-4.........................  Vinylidene          breath............  95% of 49.........  WAGM\3\ = 6.6
                                   chloride.                                                   g/m\3\
78-93-3.........................  Methyl ethyl        blood.............  75% of   med = 5.4 ppb
                                   ketone.                                 1101.
79-01-6.........................  Trichloroethylene.  blood.............  13% of 677........
80-56-8.........................  -Pinene..  breath............  92% of 110........  GM = 0.94 g/m\3\
95-47-6.........................  o-Xylene..........  blood.............  75% of   med = 0.11 ppb
                                                                           711.
100-41-4........................  Ethylbenzene......  blood.............  75% of   med = 0.06 ppb
                                                                           631.
106-46-7........................  p-Dichlorobenzene.  blood.............  75% of   med = 0.33 ppb
                                                                           1037.
106-93-4........................  Ethylene dibromide  breath............  3% of 300.........  GM = 0.4 g/m\3\
107-06-2........................  Ethylene            breath............  (frequency data     WAGM = 0.19 g/m\3\
108-88-3........................  Toluene...........  blood.............  75% of   med = 0.28 ppb
                                                                           804.
108-90-7........................  Chlorobenzene.....  blood.............  21% of 1024.......
112-40-3........................  n-Dodecane........  breath............  30% of 110........  GM = 0.19 g/m\3\
123-91-1........................  p-Dioxane.........  breath............  8% of 110.........  GM = 0.05 g/m\3\
124-18-5........................  Decane............  breath............  53% of 110........  GM = 0.27 g/m\3\
127-18-4........................  Tetrachloroethylen  blood.............  75% of   med = 0.06 ppb
                                   e.                                      590.
1120-21-4.......................  Undecane..........  breath............  56% of 110........  GM = 0.28 g/m\3\
----------------------------------------------------------------------------------------------------------------
 \1\ GM = geometric mean.
 \2\ Med = median.
 \3\ WAGM = weighted average geometric mean.

C. Why Have a Pilot of the VCCEP?

    EPA is running a pilot of the VCCEP so it can gain insight into how 
best to design and implement the VCCEP in order to effectively provide 
the Agency and the public with the means to understand the potential 
health risks to children associated with exposure to these and 
ultimately other chemicals to which children may be exposed. EPA 
intends the pilot to be the means of identifying efficiencies which can 
be applied to the subsequent implementation of the VCCEP.
    Another purpose for running the pilot is the opportunity it will 
offer to test the performance of the Peer Consultation Process. Peer 
Consultation as it will apply to the VCCEP pilot is described in Unit 
III.P. through III.U. A number of stakeholders expressed concern that 
Peer Consultation may be a lengthy process and require a high 
commitment of time from those asked to participate. To expedite 
experience in determining how well the planned Peer Consultation 
Process works and what efficiencies might be introduced to expedite its 
work, EPA believes that chemicals which will present Tier 2 and Tier 3 
assessment issues at an early point in time would be the most 
appropriate chemicals to include in the pilot. In selecting the 
chemicals for the pilot, EPA considered several indications of data 
availability to identify chemicals which already have extensive 
available hazard data (or nearly complete hazard data) . Screening 
level hazard data were considered available if Screening Information 
Data Set (SIDS) SIDS Initial Assessment Report (SIAR) had been 
prepared, or if the chemical is in the evaluation phase. Chemicals in 
the HPV Challenge Program with testing which is to begin in the years 
2000 or 2001 were also included in the VCCEP pilot.
    The pilot program will be evaluated at its completion as discussed 
in Unit III.W. The evaluation will consider what

[[Page 81706]]

modifications might be made which would make the VCCEP run more 
efficiently and the recommendations coming out of the pilot program 
evaluation will be used to improve the subsequent implementation of the 
VCCEP.

D. What Toxicity Studies Will Be Collected by the VCCEP and Will the 
Studies Be Divided into Tiers?

    The toxicity studies EPA would collect for the VCCEP are the 
studies listed in Unit II.F. These are the studies EPA believes are 
appropriate to be included in a core toxicology data set to evaluate 
the toxicity of chemicals to which children have a significant 
potential for exposure. These are also the studies the SAP agreed with 
EPA regarding their inclusion in such a program. The SAP supported the 
application of this battery of tests as a single tier (Ref. 33). 
However, during stakeholder discussions, EPA frequently heard comments 
from various individuals that several of the studies in the test 
battery should be initiated only after lower level (e.g., HPV Challenge 
Program) tests and exposure information indicate additional cause for 
concern. In order to meet the needs of as many of the stakeholders as 
possible and to ensure the participation of industry sponsors in a 
voluntary program, testing tiers have been incorporated in the VCCEP. 
Also, many of the chemicals selected for this voluntary program are 
sponsored in the HPV Challenge Program and the health effects studies 
conducted in that Program will satisfy the Tier 1 test requirements of 
the VCCEP, thereby allowing a resource-saving integration of the VCCEP 
and the HPV Challenge Program. Table 3 of this unit indicates how the 
test battery will be divided among three tiers and lists the 
appropriate guideline for conducting each test.

                  Table 3.--Three Tiers of VCCEP Tests
------------------------------------------------------------------------
              Tier                       Test           Test Guideline
------------------------------------------------------------------------
1\1\                             Acute oral toxicity  OECD 425 or ASTM
                                  (up/down) OR         E1163-98
                                 Acute inhalation     OECD 403 or 40 CFR
                                  toxicity             799.9130
                                ----------------------------------------
                                 In vitro gene        OECD 471,
                                  mutation:            870.5100, or 40
                                  Bacterial reverse    CFR 799.9510
                                  mutation assay
                                ----------------------------------------
                                 Combined repeated    OECD 422
                                  dose toxicity with
                                  reproductive and
                                  developmental
                                  toxicity screens
                                  OR
                                 Repeated dose oral   OECD 407
                                  toxicity AND
                                 Reproductive         OECD 415/421
                                  toxicity (1-
                                  generation)
                                ----------------------------------------
                                 In vitro             OECD 473,
                                  chromosomal          870.5375, or 40
                                  aberrations OR       CFR 799.9537
                                 In vivo chromosomal  OECD 475,
                                  aberrations OR       870.5385, or 40
                                                       CFR 799.9538
                                 In vivo mammalian    OECD 474,
                                  erythrocyte          870.5395, or 40
                                  micronucleus         CFR 799.9539
------------------------------------------------------------------------
2                                90-Day subchronic    870.3100 (oral),
                                  toxicity in          870.3250
                                  rodents              (dermal),
                                                       870.3465
                                                       (inhalation), or
                                                       40 CFR 799.9346
                                                       (inhalation)
                                ----------------------------------------
                                 Reproduction and     870.3800 or 40 CFR
                                  fertility effects    799.9380
                                ----------------------------------------
                                 Prenatal             870.3700 or 40 CFR
                                  developmental        799.9370
                                  toxicity (two
                                  species)
                                ----------------------------------------
                                 In vivo mammalian    OECD 475,
                                  bone marrow          870.5385, or 40
                                  chromosomal          CFR 799.9538
                                  aberrations, OR
                                 In vivo mammalian    OECD 474,
                                  erythrocyte          870.5395, or 40
                                  micronucleus         CFR 799.9539
                                  (triggered off
                                  results from in
                                  vitro mammalian
                                  chromosomal
                                  aberration test if
                                  conducted in Tier
                                  1)
                                ----------------------------------------
                                 Immunotoxicity       870.7800 or 40 CFR
                                                       799.9780
                                ----------------------------------------
                                 Metabolism and       870.7485 or 40 CFR
                                  pharmacokinetics     799.9748
------------------------------------------------------------------------
3                                Carcinogenicity OR   870.4200 or 40 CFR
                                                       799.9420
                                 chronic toxicity/    870.4300
                                  carcinogenicity
                                ----------------------------------------
                                 Neurotoxicity        870.6200 or 40 CFR
                                  screening battery    799.9620
                                ----------------------------------------
                                 Developmental        870.6300 or 40 CFR
                                  neurotoxicity        799.9630
------------------------------------------------------------------------
\1\ The tests and test guidelines in Tier 1 are the same as those in the
  HPV Challenge Program. For example, under the HPV Challenge Program,
  EPA encourages persons required to conduct testing for chromosomal
  damage to use the in vitro Mammalian Chromosome Aberration Test to
  generate the needed data unless known chemical properties (e.g.,
  physical/chemical properties, chemical class characteristics) preclude
  its use. As another example, if not superseded by a higher tier study,
  EPA recommends the use of the Combined Repeated Dose Toxicity Study
  with the Reproduction/Developmental Toxicity Screening Test. See HPV
  Challenge Program web site at http://www.epa.gov/chemrtk/.

    For chemicals which are in both the HPV Challenge Program and the 
VCCEP, sponsors should consider conducting appropriate upper tier VCCEP 
test(s) instead of the screening studies (such as OECD 422 or OECD 407 
and 415/421 studies) included in the HPV Challenge Program to avoid 
conducting the lower tier studies unnecessarily. For example, if a 
chemical which was included in the HPV Challenge Program as well as the 
VCCEP lacked repeated dose testing data, it would be prudent for the 
sponsor to conduct a 90-day subchronic study to meet the needs of the 
VCCEP versus the recommended studies under the HPV Challenge program 
(OECD 422 or 407). Similarly, although the OECD 422 and 415/421 
evaluate certain developmental and reproductive endpoints, they do not 
provide as full

[[Page 81707]]

an evaluation of those endpoints as would the Tier 2 VCCEP tests, i.e., 
the prenatal developmental toxicity test and the 2-generation 
reproduction and fertility effects test, respectively.
    For most tests listed in Table 3, the sponsor may choose among 
several alternative guidelines developed for different programs 
including the OECD, OPPTS, TSCA, and the American Society for Testing 
and Materials (ASTM). All but four of the TSCA test guidelines were 
published in the July 1, 1999, edition of the Code of Federal 
Regulations (CFR) at 40 CFR part 799 (Ref. 46). Revisions of the other 
four TSCA guidelines (40 CFR 799.9130, 799.9537, 799.9630, and 
799.9748) will be published shortly in the Federal Register and should 
appear in the July 1, 2001 edition of the CFR. The published TSCA 
guidelines (Ref. 46) as well as the OECD, OPPTS, and ASTM guidelines 
(Refs. 47-49) are available for review in the public docket for this 
notice, OPPTS-00274D. Copies of the guidelines can also be obtained 
from other sources. OECD test guidelines are available on the Internet 
at http://www.oecd.org/ehs/guide/index.htm followed by the selection of 
a specific guideline number. The OPPTS test guidelines in the 870 
series are available in hard copy from the Government Printing Office 
at telephone number (202) 512-0132 and on the Internet in PDF format at 
http://www.epa.gov/opptsfrs/home/guidelin.htm/. followed by selections 
for ``870--Health Effects Test Guidelines'' and ``Final Guidelines.'' 
The TSCA test guidelines are available on the Internet at http://www.epa.gov/docs/epacfr40/chapt-I.info/subch-R/ followed by selections 
``Part 799'' and ``Subpart H.'' The ASTM guideline E1163-98 can be 
purchased online at address http://www.ASTM.org followed by selections 
``ASTM Store'' and ``Search for individual standards,'' and entering 
and selecting ``E1163-98.'' The ASTM test guideline E1163-98 can also 
be ordered from ASTM, 100 Barr Harbor Dr., West Conshohocken, PA 19428.
    During the course of the VCCEP pilot, some of the guidelines listed 
in Table 3 may be revised by the entity which developed them, i.e., 
OECD, ASTM, or EPA. If revisions are made, the sponsor may conduct 
testing according to the guideline in effect on the date the sponsor 
made a commitment to provide that information or when the relevant test 
is initiated. Whenever practical, EPA encourages sponsors to use the 
most up to date guideline.
    EPA believes that many of the chemicals selected for the VCCEP and 
its pilot may have been relatively well tested and therefore a 
significant amount of both lower and upper tier test data may already 
exist. Existing upper tier test data will be integrated into the 
program by having them submitted with Tier 1 information; this is 
consistent with the approach in the HPV Challenge Program. A possible 
outcome may be that the existing data may be sufficient such that no 
further hazard data development is needed at this time.
    There may be instances when children have relevant exposures to 
VCCEP chemicals by multiple routes. EPA believes that needed 
information should be available on all relevant routes of exposure. In 
some instances, however, physiologically based pharmacokinetics (PBPK) 
testing and modeling may enable route-to-route extrapolation and be a 
possible alternative to multiple route testing. Ultimately, EPA plans 
to rely heavily on the reports of the third party contractor as 
described in Units III.P. through III.U. for compiling all scientific 
issues related to multiple route testing.

E. What Animal Welfare Considerations Have Been Made in the VCCEP?

    In designing the VCCEP, EPA has taken several steps to reduce 
animal testing without unduly compromising the goal of protecting 
children from chemical hazards. EPA is committed to avoiding 
duplicative testing, and to reducing, refining, and replacing animal 
testing when valid alternatives exist. In the United States, EPA works 
within the framework of the Interagency Coordinating Committee for the 
Validation of Alternative Methods (ICCVAM), and, internationally, with 
OECD to ensure the scientific acceptability of alternative test 
methods. All test methods must be scientifically validated to 
demonstrate their accuracy before they can be accepted for regulatory 
and international data sharing purposes. Without such safeguards, tests 
may need to be repeated, resulting in the use of additional animals. If 
relevant alternative test methods become validated during the 
implementation of the VCCEP or its pilot, EPA will consider their 
immediate implementation in the program. In an effort to avoid 
duplication of similar tests, Tier 1 of the VCCEP includes testing 
endpoints which will be satisfied by tests already designated in the 
HPV Challenge Program.
    A key step in reducing the number of animals used for testing is to 
ensure maximum use of existing data and to combine tests where 
feasible. To ensure the maximum use of existing data, industry and 
others are encouraged to search for existing relevant and adequate data 
and to share sources of such information. Sponsors will, as part of 
this program, commit to identifying and assessing the adequacy of 
existing data. To facilitate this effort, EPA has developed guidance 
under the HPV Challenge Program and will develop additional guidance 
for this effort as needed. EPA encourages chemical sponsors to combine 
tests where possible to conserve resources and reduce the number of 
animals required for testing. An example of two tests which can be 
combined are the tests for subchronic toxicity and immunotoxicity. 
Sponsors are also encouraged to consider development of PBPK approaches 
to evaluate route-to-route extrapolation of test data which also may 
reduce the need for certain testing.
    An important step EPA has taken to address animal welfare concerns 
was to use chemical selection criteria for the VCCEP pilot which 
clearly demonstrate that actual exposures to humans are likely to be 
occurring and for which there is a compelling need for children's 
health effects data, exposure data, and risk information to be made 
publicly available. The resulting list of chemicals selected for this 
pilot program and listed in Table 1 are known to be relatively well 
characterized. As such, EPA was in a position to focus less on test 
data development and structure the pilot VCCEP around data evaluation 
and emphasize the importance of gathering exposure data to support an 
assessment of the risks of chemicals to children.
    The tiered testing design of the pilot program is another feature 
of the program that is responsive to animal welfare concerns. In the 
VCCEP pilot, the Tier 2 and Tier 3 testing will be limited to chemicals 
for which there is a clear need; i.e., Tier 2 and Tier 3 tests will not 
automatically be required. The need for testing will be considered as 
part of an overall assessment directed to judging whether the potential 
hazards, exposures and risks to children have been adequately 
evaluated. This will be done by EPA in this program and the Agency will 
be assisted by a deliberative, science-based Peer Consultation process 
that is intended to ensure that the hazard and exposure information 
developed via this program will inform the public on a chemical's 
potential health effects, exposure and risks to children. The Peer 
Consultation process will also serve as a forum for all stakeholders to 
provide input on the available hazard and exposure information for each 
chemical and the need for any additional information.

[[Page 81708]]

F. What is the Sequence of Events that Comprise the VCCEP Pilot?

    A flow chart (Figure 1) depicts the sequence of events that 
comprise the VCCEP pilot. Each event is briefly described in Unit 
III.F.1. through III.F.15. and more fully described in the subsequent 
sections of Unit III.
    1. Chemical selection. After receiving feedback on the Framework 
Document (Ref. 31) from various individuals at the April 26-27, 2000, 
Stakeholder meeting and considering the written comments submitted to 
the docket and other communications, EPA identified candidate chemicals 
for the VCCEP and the pilot program. These chemicals are those judged 
by EPA to present, given the data at hand, the relatively greatest 
potential for exposures that may impact children. This notice initiates 
the voluntary program by identifying the test battery, outlining the 
program, and soliciting Tier 1 sponsorship of the pilot chemicals by 
their manufacturers and importers.
    2. Tier 1 commitment. To sponsor a chemical at Tier 1, a company 
(or consortium) would send a letter to EPA indicating their commitment 
to handling a chemical under the VCCEP pilot as described in Unit I.C. 
and D. and Unit IV.B. Tier 1 commitments are requested between January 
25, 2001 and June 25, 2001.
    3. Submission of Tier 1 data. Sponsors (or consortium) would 
subsequently submit to EPA a Tier 1 Hazard Assessment described in 
Units III.H. and III.I., a Tier I Exposure Assessment as described in 
Units III.H., III.J., and III.K., and a Tier 1 Risk Assessment as 
described in Units III.H. and III.M. A Data Needs Assessment which 
would describe additional hazard testing and/or exposure data needed to 
fully evaluate the risks of a chemical to children and, where relevant, 
prospective parents would also be submitted to EPA as described in 
Units III.H., III.N., and III.O.
    4. Peer Consultation regarding Tier 2 data needs. At EPA's request, 
the third party contractor would periodically convene a Peer 
Consultation to evaluate the Tier 1 information with emphasis on the 
Data Needs Assessment. The Peer Consultation would evaluate whether 
Tier 1 data needs were met by the sponsor's submission and whether the 
Tier 1 submission fully characterized the chemical's potential risk to 
children and whether there are remaining Tier 2 data needs. A possible 
conclusion of the Peer Consultation is that no more work is needed. 
Results and comments from the Peer Consultation Process will be 
compiled by the third party contractor and submitted to EPA.
    5. EPA review of Peer Consultation results. EPA would review the 
sponsor's submission and the third party contractor report and announce 
the Tier 2 Data Needs Decision. The sponsor will be informed by mail 
and the public by the VCCEP web site. If EPA's approach differs 
substantially from that indicated by the third party report, sponsors 
and other stakeholders will have 60 days to comment on EPA's 
determination regarding Tier 2 data needs. EPA, following consideration 
of comments, will mail its final decision on Tier 2 data needs to the 
sponsor and announce it on the VCCEP web site.
    6. Tier 2 commitment. The sponsor would have a period of 4 months 
after the issuance of EPA's final Tier 2 Data Needs Decision to commit 
to Tier 2 of the pilot program. This commitment would be made by letter 
to the Agency as described in Units I.C., I.D., and IV.C.
    7. Development and submission of Tier 2 data. The sponsor will 
develop and submit to EPA Tier 2 hazard and exposure data in the form 
of a revised Hazard Assessment, revised Exposure Assessment, and 
revised Risk Assessment. The sponsor will also submit a Data Needs 
Assessment which addresses the need for Tier 3 information. The time 
allowed for this effort would be based on the time needed to conduct 
specific tests or exposure studies for each chemical using the guidance 
provided in Unit III.V., Table 4.
    8. Peer Consultation regarding Tier 3 data needs. At EPA's request, 
the third party contractor would periodically convene a Peer 
Consultation to review the Tier 2 information with emphasis on the Data 
Needs Assessment. The Peer Consultation would evaluate whether Tier 2 
data needs were met by the sponsor's submission and whether the Tier 2 
submission fully characterized the chemical's potential risk to 
children and whether there are remaining Tier 3 data needs. A possible 
conclusion of the Peer Consultation is that no more work is needed. The 
results and comments from the Peer Consultation Process will be 
compiled by a third party contractor and submitted to EPA.
    9. EPA review of Peer Consultation results. EPA would review the 
sponsor's submission and the third party contractor report and announce 
the Tier 3 Data Needs Decision. The sponsor will be informed by mail 
and the public by the VCCEP web site. If EPA's approach differs 
substantially from that indicated by the third party report, sponsors 
and other stakeholders will have 60 days to comment on EPA's decision 
regarding Tier 3 data needs. EPA, following consideration of comments, 
will mail its final decision on Tier 3 data needs to the sponsor and 
announce it on the VCCEP web site.
    10. Tier 3 commitment. Sponsors would have a period of 4 months 
after the issuance of EPA's Tier 3 Data Needs Decision to commit to 
Tier 3 of the pilot program. This commitment would be made by letter to 
the Agency as described in Units I.C., I.D., and IV.D.
    11. Development and submission of Tier 3 data. The sponsor will 
develop and submit Tier 3 hazard and exposure data to EPA in the form 
of a revised Hazard Assessment, revised Exposure Assessment, and 
revised Risk Assessment. The time allowed for this effort would be 
based on the time needed to conduct specific tests or exposure studies 
for each chemical using the guidance provided in Unit III.V., Table 4.
    12. Peer Consultation of Tier 3 data. At EPA's request, the third 
party contractor would periodically convene a Peer Consultation to 
review the Tier 3 information. The Peer Consultation would evaluate 
whether Tier 3 data needs were met by the sponsor's submission and 
whether the Tier 3 submission fully characterized the chemical's 
potential risk to children. The results and comments from the Peer 
Consultation Process will be compiled by the third party contractor and 
submitted to EPA.
    13. EPA review of Peer Consultation results. EPA would review the 
sponsor's submission and the third party contractor report and 
determine if the risk to children has been adequately evaluated. The 
sponsor will be informed by mail and the public by the VCCEP web site. 
If EPA's evaluation identifies additional information needs, sponsors 
and other stakeholders will have 60 days to comment on EPA's decision. 
EPA, following consideration of comments, will mail its final 
evaluation to the sponsor and announce it on the VCCEP web site.
    14. Risk communication. Risk communication in the VCCEP and its 
pilot is the dissemination of information collected and developed by 
this program and is further described in Unit III.X.
    15. Risk reduction. Risk reduction in the VCCEP and its pilot is 
the follow up action necessary to reduce any identified risk and is 
further described in Unit III.Y.
BILLING CODE 6560-50-S

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[GRAPHIC] [TIFF OMITTED] TN26DE00.010

BILLING CODE 6560-50-C

G. Does a Sponsor Make a Separate Commitment for Each Tier?

    For the pilot program, which will address 23 chemicals as explained 
in Unit III.A., the sponsor will be given the opportunity to commit to 
one tier at a time. After the completion of the pilot program, EPA will 
evaluate this aspect of the program and consider whether the multiple 
commitment procedure and other aspects of the program can be 
simplified.

[[Page 81710]]

H. What Information Must Be Submitted for Each Tier Committed To?

    Four types of assessments must be submitted when a company/
consortia commits to sponsor a chemical: A Hazard Assessment, an 
Exposure Assessment, a Risk Assessment, and a Data Needs Assessment. 
The Hazard, Exposure, and Risk Assessments, which should be consistent 
with applicable Agency guidelines (Refs. 34 and 41-44), would be 
submitted at the completion of each of the three tiers while a Data 
Needs Assessment would only be submitted with Tier 1 and Tier 2 
submissions. The Data Needs Assessment submitted with Tier 1 
submissions will address the need for Tier 2 data. Similarly, the Data 
Needs Assessment submitted with Tier 2 submissions will address the 
need for Tier 3 data. EPA, after reviewing both the sponsor's 
submission and the report of the third party summarizing the results 
and comments from the Peer Consultation (described in Units III.P. 
through III.U.), will announce what data are needed in Tier 2 and Tier 
3.
    The amount of information in the Hazard, Exposure, and Risk 
Assessments will increase with each successive tier because, as data 
are developed with each tier, those data will be used to expand and 
revise the relevant assessment developed for the previous tier. For 
example, the Hazard Assessment developed for Tier 2 will contain hazard 
information on the Tier 2 tests and all the information from the Tier 1 
Hazard Assessment, which should be appropriately revised to reflect any 
new insights provided by the Tier 2 tests. Likewise, the hazard data 
developed from Tier 3 tests will be considered along with the Tier 2 
Hazard Assessment, which will be expanded or revised to produce the 
Tier 3 Hazard Assessment. Similarly, higher tier Exposure Assessments 
will build upon Exposure Assessments developed for lower tiers. As 
Hazard and Exposure Assessments are expanded and revised for each tier 
so must the Risk Assessments be expanded and revised since they are 
based on the integration of hazard and exposure data. Because risk 
assessments define risk in terms of hazard and exposure, additional 
description of the risk or ``risk characterization'' should be provided 
to identify the adequacy/limitations/or deficiencies of the hazard and 
exposure data.
    The Data Needs Assessments, which the sponsor will provide with 
Tiers 1 and Tier 2 submissions, will indicate whether the Tier 1 and 
Tier 2 Risk Assessments would benefit by additional hazard or exposure 
data which could be provided by the next tier. These Data Needs 
Assessments should be influenced by any known limitations or 
deficiencies of the hazard or exposure data as noted by the risk 
characterization. The Data Needs Assessment will be used by the Peer 
Consultation Group when considering whether the risks to children have 
been adequately assessed and characterized.

I. What Will a Hazard Assessment Contain for Each Tier?

    The Tier 1 Hazard Assessment should consist, in part, of summaries 
of the Tier 1 studies listed in Table 3 in Unit III.D. Sponsors need to 
determine whether available information already adequately describes a 
given endpoint and submit summaries of this information. EPA guidance 
for determining data adequacy has already been provided in the HPV 
Challenge Program (web site address: http://www.epa.gov/chemrtk). The 
summaries should follow the guidance for Robust Summaries also provided 
by the HPV Challenge Program on the same web site. A Robust Summary 
must include an objective, discussion of methods, results, and 
conclusions. From a practical standpoint, it is not reasonable to 
attempt to create an electronic version of full study reports. Instead 
electronic summaries of full study reports should be prepared that 
contain the appropriate technical information for that particular 
endpoint. Guidance on what technical information, on an endpoint-by-
endpoint basis, is necessary to adequately describe an experiment or 
study is also provided on the HPV Challenge Program web site. Robust 
Summaries should provide sufficient information to allow a technically 
qualified person to make an independent assessment of a given study 
report without having to go back to the full study report. If there are 
existing studies which are equivalent or relevant to any of the upper 
tier tests listed in Table 3 in Unit III.D., Robust Summaries of these 
studies should also be submitted with the Tier I Hazard Assessment. Any 
additional information, such as mechanistic information or SAR, that 
may influence decisions on further testing needs should also be 
included.
    For a Tier 2 commitment, the sponsor should develop a Hazard 
Assessment that includes summaries of those Tier 2 studies listed in 
Table 3 in Unit III.D., which EPA has announced in its Data Needs 
Decision. In addition to the new hazard data developed for Tier 2, the 
Tier 2 Hazard Assessment should also contain all the information from 
the Tier 1 Hazard Assessment, which should be revised as appropriate to 
reflect new insights provided by the new hazard data developed for Tier 
2.
    For a Tier 3 commitment, the sponsor should develop a Hazard 
Assessment that includes summaries of those Tier 3 studies listed in 
Table 3 in Unit III.D., which EPA has announced in its Data Needs 
Decision. In addition to the new hazard data developed for Tier 3, the 
Tier 3 Hazard Assessment should also contain all the information from 
the Tier 2 Hazard Assessment, which should be revised as appropriate to 
reflect new insights provided by the new hazard data developed for Tier 
3.

J. What Will an Exposure Assessment Contain?

    An Exposure Assessment should contain information to answer the 
following questions for a particular chemical:
     Who and how many people are exposed?
     What are the sources of exposure, i.e., environmental 
releases, consumer products, etc.?
     Does the exposure occur through breathing air, drinking 
water, eating food, contact with skin, or any other routes?
     How intense is the exposure, i.e., what is the potential 
dose level?
     How often and for how long does exposure occur, that is, 
what is its frequency and duration?
    The populations of concern to this program are children and, in 
certain situations, prospective parents. Exposures that can affect 
children are those which occur prior to conception (to either parent), 
during prenatal development, and postnatally to the age of sexual 
maturation which is completed around 18-21 years of age (Ref. 33). 
Although adult exposures are not intended to be a major focus of this 
program, certain risks to children cannot be assessed without 
evaluating parental exposures. Specifically, prospective parents' 
exposure is relevant to an evaluation of risks due to fertility and 
reproductive effects, as well as developmental effects from in utero 
exposures. Children can be exposed to chemicals through food and 
drinking water, through indoor and outdoor air, through ingestion of 
dust and soil, and through direct contact with products they use and 
products used in their immediate vicinity. Prospective parents can be 
exposed to chemicals through these pathways as well as through 
occupational activities.
    The information in a complete Exposure Assessment should be 
representative and encompass

[[Page 81711]]

manufacturing, processing, and use. If existing data are submitted, 
they may include non-TSCA uses, but if new data are developed they 
should focus on exposure data from TSCA uses. Following are the 
specific types of information which should be submitted in an Exposure 
Assessment:
     Identification of all potential manufacturing and 
processing activities associated with the chemical that can lead to 
exposure to children or, where relevant, prospective parents. It is 
appropriate to evaluate a prospective parent's exposure if it is 
relevant to determining the need for higher tier developmental and 
reproductive toxicity studies.
     Identification of all potential uses (industrial, 
commercial, consumer) of the chemical and activities associated with 
these uses that may lead to exposure to children or, if appropriate, 
prospective parents.
     Measures or estimates of exposure to children (including 
significant subpopulations) or, where relevant, prospective parents.
     Measures or estimates of environmental releases from all 
activities and exposures resulting from these releases.
     Identification of relevant activity patterns, age ranges 
and subpopulations associated with activities that can lead to 
exposures.
     Physical/chemical properties and environmental fate 
characteristics.
     Review and analysis of relevant existing environmental and 
biological monitoring data.
     Documentation of all measured data, scenarios, 
assumptions, and estimation techniques.
    Exposure Assessments should be developed using EPA's Exposure 
Assessment Guidelines (Ref. 34) as well as other existing exposure 
assessment procedures and guidance. EPA's National Center for 
Environmental Assessment (NCEA) is preparing a document entitled Child-
Specific Exposure Factors Handbook which consolidates all child 
exposure factors and related data in one document. A draft copy (Ref. 
39) is available on the NCEA website (http://www.epa.gov/ncea/csefh2.htm) and the final document should be available in the near 
future. The exposure information that is provided for the VCCEP must be 
transparent and must address the completeness of the assessment, i.e., 
how complete is the assessment in terms of addressing sources, 
populations, pathways, and routes of exposure to children. It is 
desirable for the exposure information from different sponsors to be 
provided in a consistent manner. EPA will work with stakeholders to 
develop a template that sponsors can use to provide exposure 
information. We anticipate the template will provide a format for 
reporting the results of exposure studies, e.g., exposure ``robust 
summaries.'' The template will also include sections that address the 
completeness of the assessment, the overall results and conclusions, 
the data gaps, and the need for further data and assessment. EPA 
encourages collaboration among sponsor companies and when necessary, 
between sponsor and non-sponsor companies, in order to ensure that 
exposure information encompasses all relevant activities, including 
activities outside the immediate knowledge and control of the sponsor 
companies.
    Sponsors will bear a special responsibility in defining and 
describing the essential exposure issues associated with each chemical 
included in the program. Because the biomonitoring data used in 
selecting chemicals for this program are a strong indicator of human 
exposure, arguments to discontinue testing based on conclusions of no 
or low exposure must be supported by convincing analysis and thorough 
documentation. Refuting the biomonitoring data used for candidate 
chemical identification does not constitute exposure assessment and 
will not be considered a sufficient assessment. Similarly, complete 
reliance on the biomonitoring data for an exposure assessment, given 
the quality concerns raised by stakeholders, would be insufficient.
    There may be certain cases, however, where evaluation of hazard 
data alone may appear warranted. In these cases, the sponsor should 
explain why exposure data have not been included, and should understand 
that the Peer Consultation Group and EPA may, in the absence of 
exposure data, conclude that upper tier testing and exposure data 
development are warranted.

K. What Should the Tier 1 Exposure Assessment Contain?

    At a minimum, the Tier 1 Exposure Assessment should contain 
screening level (or, if available, better) information on exposure from 
manufacturing supplemented with relevant screening level data on 
downstream processing and use activities and specific information on 
children's exposures, if available. A screening level exposure 
assessment should generate conservative, quantitative estimates of 
exposure. The screening approach generally involves using readily 
available measured data, existing release and exposure estimates and 
other exposure-related information. Where actual measures of exposure 
are not available, the use of models may be necessary. For example, a 
screening-level model for ambient air exposure which uses the 
assumption that the exposed populations live near the chemical release 
locations is often used in EPA screening level assessments. An 
appropriately conservative screening level assessment can also help to 
rule out certain exposure concerns and set priorities for more detailed 
evaluation of the remaining concerns.

L. What Should Tier 2 and 3 Exposure Assessments Contain?

    Tier 2 Exposure Assessments will be more advanced assessments that 
develop more accurate estimates of exposure and will generally focus on 
the higher priority exposures identified in the Tier 1 screening 
assessment. An advanced Exposure Assessment should quantify central 
tendency (e.g. median, geometric mean) and high end (i.e., greater than 
90\th\ percentile) exposures. Representative, well designed monitoring 
studies of known quality are the ideal. Higher tier exposure models may 
also be used in advanced assessments when appropriate measured data are 
unavailable. When higher tier models are used, every effort should be 
made to obtain accurate input data. For example, a higher tier model 
for ambient air exposure may use facility-specific parameters for 
emission rates, such as stack height and the exact size and location of 
the exposed population. Tier 2 assessments should also more 
specifically address exposures relevant to Tier 2 health testing 
endpoints. Similarly, Tier 3 Exposure Assessments would further develop 
Tier 1 and 2 exposure data and more specifically address exposures 
relevant to Tier 3 health testing endpoints.

M. What Will a Risk Assessment Contain?

    The Risk Assessment should follow the guidance provided in EPA's 
risk assessment (Refs. 41-44) and exposure assessment guidelines (Refs. 
34 and 39) which can be found at http://www.epa.gov/ncea. The Risk 
Assessment must integrate the Hazard and Exposure Assessments, and 
characterize the risks to children and, where relevant, prospective 
parents by indicating the adequacy, limitations, and/or deficiencies of 
the existing data for this purpose. Guidance for characterizing risk 
will be provided in EPA's Risk Characterization Handbook (Ref. 45) 
which should be available in the near future, at which time it will be 
on web site http://www.epa.gov/ORD/

[[Page 81712]]

spc/2riskchr.htm. The risk characterization should summarize key 
aspects of the following components of the risk assessment:
     Qualitative conclusions about the likelihood that the 
chemicals may pose a specific hazard to children or, where relevant, 
prospective parents, the nature of the observed effects, under what 
conditions (route, dose levels, time, and duration) of exposure these 
effects may occur, and whether the health effects-related data are 
sufficient and relevant to use in a risk assessment.
     A discussion of the dose-response patterns of the effects, 
the relationship among various endpoints and toxicities, the rationale 
behind the determination of the No Observed Adverse Effect Level 
(NOAEL), Lowest Observed Adverse Effect Level (LOAEL), and/or benchmark 
dose, the underlying assumptions, and the implications of using 
alternative assumptions.
     Descriptions of the sources and pathways of exposure, 
estimates of the range of human exposure (e.g., central tendency, high 
end), the route, duration, and pattern of exposure, relevant PK 
aspects, and the size and characteristics of the population exposed. 
The strengths and weaknesses of the risk assessment.
     The areas of uncertainty and the potential impact on the 
assessment.
     The potential impact of missing or inadequate hazard or 
exposure information.
    For a Tier 1 commitment, the sponsor will develop a Risk Assessment 
which integrates Tier 1 Hazard and Exposure Assessments and 
characterizes the risk based on the quality and extent of those data. 
As noted earlier, the Hazard Assessment development for Tier 1 will 
include existing data from Tier 1 and higher tiers.
    The Tier 2 Risk Assessment will integrate the Hazard and Exposure 
Assessments developed for Tier 2 and characterize the risk based on the 
quality and extent of those data. As noted earlier, the Hazard and 
Exposure Assessments developed for Tier 2 include the new data 
developed for Tier 2 and all the information in the relevant Tier 1 
assessments which may be revised based on new insights provided by the 
data developed for Tier 2.
    The Tier 3 Risk Assessment will integrate hazard and exposure 
assessments developed for Tier 3, and characterize the risk based on 
the quality and extent of those data. As noted earlier, the Hazard and 
Exposure Assessments developed for Tier 3 include the new data 
developed for Tier 3 and all the information in the relevant Tier 2 
assessments which may have been revised based on new insights provided 
by the data developed for Tier 3.

N. What Will a Data Needs Assessment Contain?

    A Data Needs Assessment identifies the additional hazard and/or 
exposure information needed to adequately assess the potential risks to 
children and, where relevant, prospective parents. The sponsor should 
be familiar with current requirements of test guidelines listed in 
Table 3 and consider to what degree the available hazard information 
covers current data needs. In situations where adequate data may be 
lacking for a particular hazard endpoint, the sponsor should consider 
what impact these limitations may have on the ability to adequately 
evaluate the potential hazards. The sponsor should consider to what 
degree the potential exposures to children from environmental releases 
and uses of the chemical have been accounted for and addressed. In 
situations where there are gaps in the evaluation of exposure, the 
sponsor should consider the impacts that these limitations, along with 
limitations in the hazard data, may impose on the ability to evaluate 
the risks to children. The sponsor should consider what hazard and 
exposure information could be provided by the next tier (e.g., Tier 2) 
and use a weight-of-the-evidence evaluation of Tier 1 hazard and 
exposure information to develop recommendations regarding needed work. 
The sponsor should provide the scientific rationale for any needed work 
in these areas in the next tier. The sponsor should also provide the 
scientific rationale for any hazard studies that are not recommended 
within that tier.
    In meeting a Tier 1 commitment, the sponsor will develop an 
assessment of the need for Tier 2 hazard and exposure information. In 
meeting a Tier 2 commitment, the sponsor will develop an assessment of 
the need for Tier 3 hazard and exposure information. A Data Needs 
Assessment will not be required to be submitted with Tier 3 
information.

O. What Will Be Considered when Preparing and Evaluating the Data Needs 
Assessment?

    To evaluate what Tier 2 or Tier 3 information is needed, the 
Hazard, Exposure, and Risk Assessments from the previous tier will be 
considered. The need to conduct Tier 2 or Tier 3 toxicity tests and 
exposure studies for a specific chemical would be based on a judgement 
that the potential hazards, exposures, and risks to children and, where 
relevant, prospective parents have not been adequately evaluated by the 
lower tier assessments. The starting point for this judgement would be 
based on a weight-of-the-evidence evaluation of the Tier 1 hazard and 
exposure data prepared by the sponsor addressing the chemical's 
potential for hazards, exposures and risks to children and, where 
relevant, prospective parents. Of primary importance in this judgment 
is the risk characterization which notes any known limitations or 
deficiencies of the hazard and exposure data. If there is existing 
upper tier data, they will also be included in the evaluation. If the 
Tier 1 data are believed to adequately evaluate a chemical's potential 
hazard, exposure, and risk to children and, where relevant, prospective 
parents, Tier 2 hazard and exposure studies would not be pursued. 
Similarly, if the Tier 1 and Tier 2 data are believed to adequately 
evaluate a chemical's potential risks to children and, where relevant, 
prospective parents, Tier 3 hazard and exposure studies would not be 
pursued.

P. What is Peer Consultation and Why is it Included in VCCEP?

    For the VCCEP, the purpose of the Peer Consultation Process is to 
provide a forum for scientists and relevant experts from various 
stakeholder groups to exchange views on the sponsor's Assessments and 
in particular on the recommended data needs and to provide these views 
to a third party contractor. The Peer Consultation Group will be asked 
to discuss whether the potential hazards, exposures, and risks to 
children have been adequately evaluated and to provide scientific input 
on the hazard and exposure data needs. It is not intended to be a 
consensus based process, but should identify areas of agreement, 
disagreement, and the supporting scientific rationale. An independent 
third party contractor will compile the results and comments from the 
Peer Consultation and submit a report to EPA.
    After considering the sponsor's submission and the report of the 
third party contractor, EPA will announce what data from the next tier 
are needed. If EPA's approach differs substantially from that indicated 
by the third party report, EPA will provide a supporting rationale 
indicating the basis for its approach. Stakeholders will have 60 days 
to comment. EPA will consider these comments and then issue a final 
decision.

[[Page 81713]]

Q. How Does Peer Consultation Differ from Peer Review?

    The key distinctions between peer consultation and peer review are 
the independence of the peer reviewers and their level of involvement. 
The goal of formal peer review is to obtain an independent, third-party 
review of a product. In contrast, peer consultation provides an 
opportunity to solicit input and comments from stakeholders on a 
scientific document. Depending on the nature of the peer consultation, 
this input could involve an interaction during the development of an 
evolving work product. Alternatively, it may involve solicitation of 
comments on a draft document. EPA's Science Policy Council has 
published the Peer Review Handbook (Ref. 51) that provides guidance on 
formal external peer review and informal peer consultation.

R. Who Prepares the Peer Consultation Documentation and What Must It 
Contain?

    The sponsor is responsible for preparing the documentation for 
review by the Peer Consultation. A separate Peer Consultation Document 
will be prepared for each tier and should consist of four sections. The 
first section should provide the Hazard Assessment and robust summaries 
of all available hazard information (e.g., Tier 1 plus any available 
Tier 2 and Tier 3 data) including relevant toxicology studies as well 
as any additional information (i.e., mechanistic data, SAR) that may 
influence decisions on data needs. The second section is the Exposure 
Assessment which provides and characterizes the relevant exposure 
information available on the chemical. The third section is the Risk 
Assessment which indicates the potential health risk of exposure to the 
chemical for children and, if appropriate, prospective parents based on 
available hazard and exposure data, and also indicates whether the risk 
has been adequately evaluated. Finally, the last section is the Data 
Needs Assessment which summarizes the hazard and exposure data needs, 
as appropriate, with respect to achieving an adequate set of data for 
risk assessment. The sponsor should provide the scientific rationale 
for any needed work in these areas in the next tier. The sponsor should 
also provide the scientific rationale for any hazard studies that are 
not recommended within that tier. In a similar manner, the sponsor 
should provide the scientific rationale for the recommendations related 
to meeting exposure information needs in the next tier. It is 
recognized that this section may also include a recommendation of low 
priority for further work, which should also be supported by a 
scientific rationale. For each tier to which the sponsor has made a 
commitment, the sponsor will submit three hard copies and an electronic 
copy of a Peer Consultation Document to EPA. EPA will make the document 
available to the public and the third party contractor.

S. Who Will Participate in the Peer Consultation Group?

    Because the goal of the Peer Consultation Process is to contribute 
to the review of a scientific work product, it should not be conducted 
as a mechanical evaluation step. To ensure this outcome, the Peer 
Consultation Group should be comprised of scientific experts with 
extensive and broad experience in toxicity testing and exposure 
evaluations, such that members will have sufficient technical expertise 
to make meaningful contributions to science-based evaluations. The 
membership of the Peer Consultation Group will likely vary somewhat for 
each chemical reviewed. To ensure consistency among reviews, there will 
be a balanced ``core'' group that consists of scientists from 
interested stakeholder groups, including EPA scientists and scientists 
representing industry, academia, children's health, public health, 
environmental, and animal welfare organizations. This group will be 
involved in the review of all chemicals. In addition, there should be a 
group of experts that will be invited to participate on a case-by-case 
basis to provide additional expertise relevant to a specific chemical 
or issue. This could include experts in specific toxicology 
disciplines, experts in exposure, or experts in a specific chemical. 
The Peer Consultation Group for a specific chemical is therefore likely 
to be composed of the core group and invited experts.

T. How Will the Peer Consultation be Conducted?

    An external, third party scientific organization will be contracted 
to be responsible for arranging the Peer Consultation meetings, 
inviting experts, and facilitating the meetings. Stakeholders will be 
given an opportunity to suggest appropriate invited experts, but the 
selection will be made by the third party. The third party will also be 
responsible for addressing potential conflicts of interest in the 
membership of the Peer Consultation.
    The sponsor will provide three hard copies and one electronic copy 
of the Peer Consultation Document to EPA. EPA will make the Document 
available to the third party contractor and to the public in the TSCA 
NCIC docket and announce its availability on the VCCEP web site. The 
third party contractor will be responsible for distributing the 
Document to the Peer Consultation Group. The sponsor will present the 
Assessments and recommendations in the Peer Consultation Document to 
the Peer Consultation Group and participate in the Group's 
deliberations to the extent of answering any questions about the 
Assessments and offering clarifications. The focus of the meetings will 
be the Data Needs Assessment section of the Document.
    The Peer Consultation Group should review the Assessments prepared 
by the sponsor with particular emphasis on the sponsor's recommendation 
for developing additional data. The Peer Consultation Group should take 
a weight-of-evidence approach that considers all the available toxicity 
and exposure information. A weight-of-evidence evaluation can include, 
but not be limited to, consideration of the quality of the data, the 
resolving power of the studies, the number and types of endpoints 
examined, the relevance of the dose levels, route, timing, and duration 
of exposures, the appropriateness of dose selection, the replication of 
effects, statistical and/or biological significance of effects, the 
adequacy of the exposure information, and the relevance of the exposure 
scenario to the toxicology endpoints of concern. Sound scientific 
judgment is the foundation for the weight-of-evidence evaluation.
    The results of the Peer Consultation Process should be the 
individual opinions of the members of the Peer Consultation Group 
regarding necessary follow up toxicity testing and/or exposure 
information within the context of the tiered evaluation framework. If 
specific toxicity studies are indicated, they should be chosen from the 
next tier of studies within the overall framework and should allow 
flexibility, if possible, to pursue either additional toxicity testing 
and/or exposure evaluation, allowing sponsors to select the option 
which will most quickly, directly, and cost-effectively reduce 
uncertainty and allow the creation of a risk assessment. If the 
opinions of the Peer Consultation Group are that no additional work is 
needed based on low priority of current concern, that would also be 
acceptable.
    Peer Consultation meetings and deliberations will be open to the 
public. Interested parties who are not part of the Peer Consultation 
Group will have the opportunity to provide written and/or oral comments 
and information at the

[[Page 81714]]

appropriate time during the Peer Consultation meeting. EPA will ensure 
that the public and interested stakeholders are adequately notified of 
upcoming Peer Consultation meetings. If stakeholders express an 
interest, EPA will consider conducting these Peer Consultation meetings 
at locations other than Washington, DC. Meeting announcements will 
include information on the meeting agenda and meeting location.
    At the end of the meeting, the results of the Peer Consultation 
will be compiled by the third party contractor and distributed to the 
Peer Consultation group to check for accuracy. The third party 
contractor will then submit this report, which will include a summary 
of significant written and verbal comments from outside parties and any 
third party comments, to the sponsor and EPA. EPA will place the report 
in the public record in the TSCA NCIC docket.
    EPA will use the third party report in forming its decision 
regarding additional data needs. EPA will mail its Data Needs Decision 
to the sponsor and announce it on the VCCEP web site. If EPA's approach 
differs substantially from that presented in the third party contractor 
report, EPA will provide a supporting rationale which indicates the 
basis for its decision. Stakeholders will have 60 days to comment on 
the decision; all comments will be placed in the public docket. EPA 
will consider the stakeholders' comments and then make a final decision 
which will be mailed to the sponsor and announced on the VCCEP web 
site.

U. What Guidance is Provided for the Peer Consultation Process?

    The third party contractor will provide the members of the Peer 
Consultation Group with a series of documents that will provide Agency 
guidance. This will include EPA's TSCA (Ref. 46) and OPPTS test 
guidelines (Ref. 47), OECD test guidelines (Ref. 48), ASTM guideline 
(Ref. 49), EPA's exposure assessment guidelines (Refs. 34 and 39), 
EPA's risk assessment guidelines (Refs. 41-44), EPA's Risk 
Characterization Handbook (Ref. 45), EPA's Peer Review Handbook (Ref. 
51), and this Federal Register notice. The report entitled 
Retrospective Validation of Tiered Toxicity Testing Triggers (Ref. 2, 
Attachment D) prepared by the Chemical Manufacturers Association (CMA), 
now known as the American Chemistry Council (ACC), may also provide 
information to assist in the evaluation.
    The Peer Consultation Group will assess the sponsor's prepared 
Assessments for technical adequacy, proper documentation, and 
satisfaction of established specifications. The Peer Consultation Group 
should also determine if the Assessments adequately present 
assumptions, calculations, supporting documentation, extrapolations, 
alternative interpretations, methodology, acceptance criteria, as well 
as other conclusions.

V. What Time Will be Allowed to Complete Each Tier?

    After the sponsor has made a commitment to a particular tier, EPA 
believes there is a certain amount of time which is sufficient to 
collect information, conduct testing, obtain exposure information, and 
prepare a report. The amount of time necessary will depend on the 
nature of the toxicology and exposure information that is being 
developed. For toxicology studies, the amount of time that may be 
needed is presented in Table 4 of this unit. These times assume that 
tests within the same tier will be run concurrently. The time allowed 
to submit the information for a particular tier will be determined by 
consideration of the test in that tier requiring the greatest number of 
months to complete and the estimated time demands for any exposure 
studies. An additional 4 months of time may be requested by the sponsor 
to prepare one or more of the following: The Exposure Assessment, Risk 
Assessment, and Data Needs Assessment.

   Table 4.--Time Allowed to Conduct Toxicology Test and Prepare Final
                                 Report
------------------------------------------------------------------------
                   Test                                Months
------------------------------------------------------------------------
Acute oral toxicity (up/down) OR            18
Acute inhalation toxicity
------------------------------------------------------------------------
In vitro gene mutation: Bacterial reverse   18
 mutation assay
------------------------------------------------------------------------
In vitro chromosomal aberrations            18
------------------------------------------------------------------------
90-Day subchronic in rodents                18
------------------------------------------------------------------------
Reproduction and fertility effects          29
------------------------------------------------------------------------
Prenatal developmental toxicity (two        12
 species)
------------------------------------------------------------------------
In vivo mammalian bone marrow chromosomal   16
 aberrations, OR
In vivo mammalian erythrocyte micronucleus
------------------------------------------------------------------------
Immunotoxicity                              12\1\
------------------------------------------------------------------------
Metabolism and pharmacokinetics             12
------------------------------------------------------------------------
Carcinogenicity OR                          60
Chronic toxicity/carcinogenicity
------------------------------------------------------------------------
Neurotoxicity screening battery             21
------------------------------------------------------------------------
Developmental neurotoxicity                 21
------------------------------------------------------------------------
\1\ If the test for immunotoxicity is run as a satellite of another
  study, the final report would be due on the reporting date of the
  other study.

W. How Will the VCCEP Pilot Program be Evaluated?

    Evaluation of the pilot program is critical to the success of the 
VCCEP. The evaluation will consider what modifications might be made 
which would make the VCCEP run more efficiently. One efficiency that 
might be introduced into the program is requesting the sponsor to 
commit to more than one tier at a time. Experience gained from the 
pilot may indicate whether it is best to run the program with 
commitments at each tier, e.g. three commitments, or to run the program 
with two commitments, i.e., to Tier 1 and to Tiers 2/3. The evaluation 
of the pilot program will also look at the time frames allowed for 
sponsor commitment which for the pilot is 6 months to commit to Tier 1, 
4 months to commit to Tier 2, and 4 months to commit to Tier 3. At this 
time, EPA expects to evaluate the pilot at 3 and 6 years after its 
initiation.
    A key feature in the evaluation of the pilot program will be an 
objective evaluation of the performance of the Peer Consultation 
Process and its results. The evaluation will be organized and conducted 
by EPA, but representatives of the third party contractor and 
stakeholders will be consulted.
    Questions to address in evaluating the Peer Consultation Process 
should include, but not necessarily be limited to, the following:
     Has the Peer Consultation Process been open and 
transparent?
     Has the Peer Consultation Process been efficient? If not, 
what improvements could be made?
     Does the evaluative process provide a scientifically 
rigorous and effective means for developing results and comments from 
Peer Consultation and for assisting EPA in developing decisions?
     Has the Peer Consultation Group adequately considered both 
toxicology and exposure information in developing its results?

[[Page 81715]]

     Have the communications related to the Peer Consultation 
Process, activities and outcomes been effective and have they 
facilitated public understanding and use of the information generated 
from this process?
    EPA believes that the VCCEP pilot presents a unique opportunity for 
EPA, the chemical industry, and other stakeholders to demonstrate that 
they can jointly manage, participate in, and generate results in an in-
depth hazard, exposure, and risk assessment program. While the focus of 
this pilot is on chemicals that may have potential health effects on 
children, EPA believes that the process to be evaluated in the pilot 
may have broader applications in the future. For example, it may 
present a mechanism to follow up on chemicals that are of concern based 
on information developed in the HPV Challenge Program. In the event 
that there is little participation in the pilot or if the activities 
under the pilot are unnecessarily drawn out and resource inefficient, 
EPA will evaluate whether its TSCA chemicals programs should revert to 
a more conventional regulatory approach, especially with regard to test 
rules under TSCA section 4 or other regulatory actions.

X. How Will the Data Resulting from the VCCEP and its Pilot be Provided 
to the Public?

    Because the chemicals selected for the VCCEP are believed to have 
widespread potential for exposures to both children and prospective 
parents, EPA believes that the availability of the information that 
will be developed as a result of this program is vitally important so 
that government, industry, and the public can understand potential 
chemical hazards, exposures, and risks posed to the nation's children.
    EPA will announce on the VCCEP web site the public availability in 
the TSCA NCIC of the Hazard Assessments, Exposure Assessments, Risk 
Assessments, and Data Needs Assessments developed for this program. It 
will similarly provide access to EPA's communications with sponsors and 
the reports of the third party contractor who will compile the results 
and comments from the Peer Consultation. Stakeholders will also be 
involved in contributing to follow up communication of risk information 
developed by this program.

Y. How Will the Information Submitted for the VCCEP and its Pilot be 
Used by EPA?

    When data and other information generated from this program become 
available, EPA will utilize a risk-based, scientifically sound process 
to make decisions on the need for further information gathering or risk 
reduction action. All stakeholders to this process will be involved in 
contributing to follow up actions that result from information 
developed by this program. The sponsor and other stakeholders will be 
provided adequate notice and a reasonable opportunity to comment should 
EPA perceive the need to initiate risk reduction actions based on that 
data.

IV. Volunteering for the VCCEP Pilot

A. What are My Legal Obligations If I Volunteer for the VCCEP or its 
Pilot?

    If a company volunteers to sponsor a chemical in the VCCEP or its 
pilot it has made a voluntary commitment to develop hazard and exposure 
data on a specific chemical in the program consistent with EPA's 
Chemical Right-to-Know Initiative. Commitments are not enforceable 
agreements or contracts. Sponsors may withdraw their sponsorship of a 
chemical at any time with the understanding that EPA may then exercise 
its authority to require testing under TSCA where appropriate. Where a 
chemical is currently being sponsored under VCCEP or its pilot, the 
Agency will take this into consideration when considering taking 
actions under TSCA section 4.

B. How do I Volunteer to Sponsor My Chemical at Tier 1 of the Pilot?

    To sponsor a chemical at Tier 1, a company (or consortium) would 
forward a letter to EPA indicating their commitment to handling the 
chemical under the VCCEP pilot. This commitment letter should be 
submitted between January 25, 2001 and June 25, 2001. The commitment 
letter must identify the chemical by name and CAS No., include a 
technical contact per Unit I.D. (and member companies for consortia), 
commit to starting development of Tier 1 hazard and exposure data 
described in Units III.H., III.I., III.J., and III.K. within 6 months 
after the end of the sign up period, and include the anticipated start 
date and submission date to EPA of Tier 1 information.
    For purposes of the VCCEP, Tier 1 includes the hazard endpoints 
found in the HPV Challenge as well as any existing Tier 2 or Tier 3 
hazard data. Sponsors are encouraged to begin efforts under the VCCEP 
within 6 months after the end of the sign up period, but may opt to 
delay the start year for developing Tier 1 hazard and exposure data to 
be consistent with the commitment made to the HPV Challenge Program. 
Also, new testing of individual chemicals (i.e., those HPV chemicals 
not proposed for testing in a category) shall be deferred until 
November 2001 (Ref. 40). In these cases, Tier 1 data (as described 
above) should be provided in January of the start year.
    Sponsors or consortia making a Tier 1 commitment for a specific 
chemical would agree to:
    1. Sponsor the chemical in Tier 1.
    2. Develop a Hazard Assessment of Tier 1 (existing and new studies 
as needed) studies and existing higher tier hazard studies, as 
described in Units III.H. and III.I.
    3. Develop an Exposure Assessment, Risk Assessment, and a Data 
Needs Assessment as described in Units III.H., III.J., III.K., III.M., 
III.N., and III.O.
    4. Prepare a Peer Consultation Document as described in Unit III.R. 
and provide three hard copies and an electronic copy to EPA. EPA will 
make the Document available to the public and the third party 
contractor.
    5. Make a good faith effort to start and finish all work in a 
timely manner and within the time period specified.
    6. Make all hazard and exposure data developed for this program 
publicly available.
    7. Judge existing hazard studies not conducted per Good Laboratory 
Practices (GLPs) guidelines based on their merits.
    8. Generate any new hazard data using GLPs and test guidelines in 
Table 3 of Unit III.D.
    9. Develop exposure data that is representative of known exposure 
scenarios and is of known quality.
    10. Cooperate with other potential sponsors in facilitating the 
formation of consortia.

C. How do I Volunteer to Sponsor My Chemical at Tier 2 of the Pilot?

    To sponsor a chemical at Tier 2, a company (or consortium) would 
forward a letter to EPA indicating their commitment to handling the 
chemical under Tier 2 of the VCCEP pilot. The commitment letter must 
identify the chemical by name and CAS No., include a technical contact 
per Unit I.D. (and member companies for consortia), commit to starting 
development of Tier 2 hazard and exposure data described in Units 
III.H., III.I., III.J, and III.L. no later than 6 months after the end 
of the sign up period, and include the anticipated start date and 
submission date to EPA of Tier 2 information. Tier 2 commitments should 
be made by sponsor companies within 4 months of the issuance of EPA's 
Tier 2 Data Needs Decision.

[[Page 81716]]

    Sponsors or consortia making a Tier 2 commitment for a specific 
chemical would agree to comply with the guidance in Unit IV.B.4. 
through 10. as well as the following:
    1. Sponsor the chemical in Tier 2.
    2. Develop a Hazard Assessment of Tier 2 (existing and new studies 
as needed) studies and existing higher tier hazard studies, as 
described in Units III.H. and III.I.
    3. Develop an Exposure Assessment, Risk Assessment, and a Data 
Needs Assessment as described in Units III.H., III.J., III.L., III.M., 
III.N., and III.O.

D. How do I Volunteer to Sponsor My Chemical at Tier 3 of the Pilot?

    To sponsor a chemical at Tier 3, a company (or consortium) would 
forward a letter to EPA indicating their commitment to handling the 
chemical under Tier 3 of the VCCEP pilot. The commitment letter must 
identify the chemical by name and CAS No., include a technical contact 
per Unit I.D. (and member companies for consortia), commit to starting 
development of Tier 3 hazard and exposure data described in Units 
III.H., III.I., III.J., and III.L. no later than 6 months after the end 
of the sign up period, and include the anticipated start date and 
submission date to EPA of Tier 3 information. Tier 3 commitments should 
be made by sponsors within 4 months of the issuance of EPA's Tier 3 
Data Needs Decision.
    Sponsors or consortia making a Tier 3 commitment for a specific 
chemical would agree to comply with the guidance in Unit IV.B.4. 
through 10. as well as the following:
    1. Sponsor the chemical in Tier 3.
    2. Develop a Hazard Assessment of Tier 3 (existing and new studies 
as needed) studies, as described in Units III.H. and III.I.
    3. Develop an Exposure Assessment and Risk Assessment as described 
in Units III.H., III.J., III.L., and III.M.

V. Identification of Manufacturers and Importers of Pilot VCCEP 
Chemicals

    When CBI is not an issue, EPA will assist in identifying the 
manufacturers and importers. A list of VCCEP pilot chemicals and non-
CBI manufacturers and importers who reported to the 1998 IUR is 
included in Ref. 36. Similar information is available from the HPV 
Challenge Program web site on manufacturers and importers of HPV 
chemicals reporting under the 1990 and 1994 IURs. EPA encourages all 
companies that manufacture or import a selected chemical to share the 
responsibility of supporting this program.

VI. Tracking VCCEP Pilot Sponsor Commitments and Performance

    Public confidence in the successful outcome of this voluntary 
program and ongoing participation by the sponsors are both enhanced by 
the public's ability to follow the program's progress as it occurs. EPA 
will maintain a database on its web site which will list the sponsor 
commitments. Information in the tracking database will include:
     CAS No. and name of the chemical.
     Sponsors and any consortia involved.
     Expected and actual start date and submission date to EPA 
for Tier 1 information.
     Third party contractor report on the results and comments 
from Peer Consultations and EPA's Data Needs Decisions for Tier 2 and 
Tier 3.
     Status of Tier 2 and Tier 3 commitments.
     Expected and actual start date and submission date to EPA 
for Tier 2 and Tier 3 information.

VII. Schedule for the VCCEP Pilot

    The schedule goals for the VCCEP pilot are as follows:
     Receive Tier 1 commitments to the VCCEP pilot between 
January 25, 2001 and June 25, 2001.
     Sponsors initiate any needed studies within 6 months after 
the end of the sign up period.
     Sponsors complete needed studies within the time period 
specified in Table 4 of Unit III.V., unless they have requested an 
extension of up to 4 months to prepare one or more of the following 
assessments: Exposure Assessment, Risk Assessment, and Data Needs 
Assessment.
     Make all Tier 1 Assessments publicly available within 1 
month of receipt by EPA.
     Peer Consultation reviews Tier 1 Assessments, third party 
contractor compiles results and comments, and sends report to EPA.
     EPA announces the Tier 2 Data Needs Decision.
         1. 60-Day comment period if Decision differs substantially 
from what is presented in the third party contractor's report.
         2. EPA announces the final Tier 2 Data Needs Decision.
     Receive Tier 2 commitments within 4 months of the final 
Tier 2 Data Needs Decision.
     Sponsors initiate any needed studies within 6 months after 
the end of the sign up period.
     Sponsors complete needed studies within the time period 
specified in Table 4 of Unit III.V., unless they have requested an 
extension of up to 4 months to prepare one or more of the following 
assessments: Exposure Assessment, Risk Assessment, and Data Needs 
Assessment.
     Make all needed Tier 2 Assessments publicly available 
within 1 month of receipt by EPA.
     Peer Consultation reviews Tier 2 Assessments, third party 
contractor compiles results and comments, and sends report to EPA.
     EPA announces the Tier 3 Data Needs Decision.
         1. 60-Day comment period if Decision differs substantially 
from what is presented in the third party contractor's report.
         2. EPA announces the final Tier 3 Data Needs Decision.
     Receive Tier 3 commitments within 4 months of the final 
Tier 3 Data Needs Decision.
     Sponsors initiate any needed studies within 6 months after 
the end of the sign up period.
     Sponsors complete needed studies within the time period 
specified in Table 4 of Unit III.V., unless they have requested an 
extension of up to 4 months to prepare one or more of the following 
assessments: Exposure Assessment, Risk Assessment, and Data Needs 
Assessment.
     Make all needed Tier 3 Assessments publicly available 
within 1 month of receipt by EPA.
     Peer Consultation reviews Tier 3 Assessments, third party 
contractor compiles results and comments, and sends report to EPA.
     EPA announces its evaluation of Tier 3 data.
         1. 60-Day comment period if EPA identifies additional 
information needs.
         2. EPA announces the final evaluation of Tier 3 data.
     Evaluation of pilot program.
     Initiate any necessary Risk Reduction and Risk 
Communication after review of final Risk Assessment.

VIII. References

    The following references are available for inspection in the TSCA 
NCIC under docket control number OPPTS-00274D.
    1. Amvac Chemical Corporation. Comments on the Framework Document 
for the VCCEP. May 30, 2000.
    2. CMA. Comments on the Framework Document for the VCCEP. May 30, 
2000.
    3. CMA, Chemstar, Acetone Panel. Comments on the Framework Document 
for the VCCEP. May 30, 2000.
    4. CMA, Chemstar, Brominated Flame Retardant Industry Panel. 
Comments on the Framework Document for the VCCEP. May 30, 2000.

[[Page 81717]]

    5. CMA, Chemstar, Cumene Panel. Comments on the Framework Document 
for the VCCEP. May 30, 2000.
    6. CMA, Chemstar, Isophorone Task Group. Comments on the Framework 
Document for the VCCEP. May 30, 2000.
    7. CMA, Chemstar, Ketones Panel. Comments on the Framework Document 
for the VCCEP. May 30, 2000.
    8. CMA, Chemstar, Naphthalene Panel. Comments on the Framework 
Document for the VCCEP. May 30, 2000.
    9. CMA, Chemstar, Phthalate Esters Panel. Comments on the Framework 
Document for the VCCEP. May 30, 2000.
    10. CMA, Chemstar, Vinyl Chloride Health Committee. Comments on the 
Framework Document for the VCCEP. May 30, 2000.
    11. Chemical Specialties Manufacturers Association (CSMA). Comments 
on the Framework Document for the VCCEP. June 1, 2000.
    12. Doris Day Animal League. Comments on the Framework Document for 
the VCCEP. May 26, 2000.
    13. Dow. Comments on the Framework Document for the VCCEP. May 23, 
2000.
    14. Halogenated Solvents Industries Association (HSIA). Comments on 
the Framework Document for the VCCEP. May 30, 2000.
    15. HSIA. Comments on the Framework Document for the VCCEP. Filed 
electronically. May 30, 2000.
    16. Humane Society of the United States. Comments on the Framework 
Document for the VCCEP. May 30, 2000.
    17. King and Spalding. Comments on the Framework Document for the 
VCCEP. May 30, 2000.
    18. The National Treasure Employees Union (NTEU). Comments on the 
Framework Document for the VCCEP. May 26, 2000.
    19. Physicians Committee for Responsible Medicine (PCRM). Comments 
on the Framework Document for the VCCEP. Filed electronically. June 8, 
2000.
    20. PCRM. Comments on the Framework Document for the VCCEP. Filed 
electronically. May 30, 2000.
    21. People for the Ethical Treatment of Animals (PETA). Comments on 
the Framework Document for the VCCEP. May 30, 2000.
    22. Silicones Environmental Health and Safety Council (SEHSC). 
Comments on the Framework Document for the VCCEP. May 30, 2000.
    23. Styrene Information and Research Center (SIRC). Comments on the 
Framework Document for the VCCEP. May 31, 2000.
    24. Synthetic Organic Chemical Manufacturers Association (SOCMA). 
Comments on the Framework Document for the VCCEP. May 30, 2000.
    25. The Dow Chemical Company. Comments on the Framework Document 
for the VCCEP. May 26, 2000.
    26. People for the Ethical Treatment of Animals (PETA). Comments on 
the Framework Document for the VCCEP. December 10, 1999.
    27. Physicians Committee for Responsible Medicine (PCRM). Comments 
on the Framework Document for the VCCEP. January 6, 2000.
    28. CMA. Letter with 3 attachments from Sandra Tirey to James 
Aidala and Susan Wayland, USEPA, Office of Prevention, Pesticides and 
Toxics, Washington, DC. September 21, 1999.
    29. American Public Health Association (APHA), Children's 
Environmental Health Network, Environmental Defense, National 
Environmental Trust, Physicians for Social Responsibility. Comments on 
the Environmental Protection Agency's Framework for a Voluntary 
Children's Chemical Evaluation Program. April 12, 2000.
    30. Noren K., Meironte D. Contaminants in Swedish human milk. 
Decreasing levels of organochlorine and increasing levels of 
organobromine compounds. Organohalogen Compounds 38:1-4. 1998.
    31. USEPA. Framework for a Voluntary Children's Chemical Evaluation 
Program. April 12, 2000.
    32. USEPA. Toxicology Data Requirements for Assessing Risks of 
Pesticide Exposure to Children's Health. Report of the Toxicology 
Working Group of the 10X Task Force. April 28, 1999. (Web site address: 
http:// www.epa.gov/pesticides/SAP/1999).
    33. USEPA. FIFRA Scientific Advisory Panel Meeting, May 25-27, 
1999; May 25, 1999. SAP Report No. 99-03.
    34. USEPA. Guidelines for Exposure Assessment. Federal Register 
(FRL-4129-5) (57 FR 22888, May 29, 1992).
    35. Novigen Sciences, Inc. Washington, DC. Frequency of detection 
and levels of organochlorine compounds in biomonitoring samples 
collected by NHANES, NHEXAS, NHATS, and TEAM. Prepared for Chlorine 
Chemistry Council. May 4, 2000.
    36. USEPA. Non-CBI companies which manufacture or import chemicals 
in the VCCEP pilot. August 2000.
    37. USEPA. Supporting data for Tables 1, 2, and 3. August 24, 2000.
    38. USEPA. Methodology for Selecting Chemicals for the Voluntary 
Children's Chemical Evaluation Program (VCCEP) Pilot. December 5, 2000.
    39. USEPA, NCEA. Child-Specific Exposure Factors Handbook. NCEA-W-
0853. June 2000. External Review Draft.
    40. USEPA. Letter from Susan H. Wayland to companies participating 
in the HPV Challenge Program. October 14, 1999.
    41. USEPA. Guidelines for Neurotoxicity Risk Assessment. Federal 
Register (FRL-6011-3) (63 FR 26925-26954, May 14, 1998).
    42. USEPA. Guidelines for Carcinogen Risk Assessment. EPA/600/P-92/
003C. April 1996. Federal Register (FRL-5460-3) (61 FR 17960-18011, 
April 23, 1996).
    43. USEPA. Guidelines for Developmental Toxicity Risk Assessment. 
Federal Register (FRL-4038-3) (56 FR 63798, December 5, 1991).
    44. USEPA. Guidelines for Reproductive Toxicity Risk Assessment. 
Federal Register (FRL-5630-6) (61 FR 56273, October 31, 1996).
    45. USEPA, Science Policy Council. Risk Characterization Handbook. 
In preparation.
    46. USEPA. Toxic Substances Control Act Test Guidelines. 40 CFR 
part 799. pp. 280-312, 319-344. July 1, 2000.
    47. USEPA. OPPTS Test Guidelines. 870 Series.
    48. OECD. OECD Test Guidelines.
    49. ASTM. ASTM Test Guideline E1163-98.
    50. USEPA. Letter from Doyoung Lee to Henry Lau, Charles Auer, Ward 
Penberthy, Neil Patel, and James Darr. Candidate Chemicals for 
Children's Testing Program. April 12, 2000.
    51. USEPA. Science Policy Council, Office of Research and 
Development. Peer Review Handbook. EPA 100-B-98-001. January 1998.
    52. USEPA. TSCA Existing Chemical Test Rules, Consent Orders, Test 
Rule Exemptions, and Voluntary Test Data Submissions. EPA ICR #1139.06.
    53. NTP, CERHR. Review of Phthalates. July 14, 2000.
    54. CPSC. Notice of meeting of Chronic Hazard Advisory Panel on 
Diisononyl Phthalate (DINP). Federal Register (65 FR 49231, August 11, 
2000).
    55. FDA. Center for Devices and Radiological Health. PVC and DEHP. 
Presentation by Dr. David W. Feigal to the 8\th\ GHTF Conference, 
Ottawa, Canada. September 20, 2000.

IX. Regulatory Assessment Requirement

    Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., an Agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information that is

[[Page 81718]]

subject to approval under the PRA, unless it displays a currently valid 
OMB control number. The OMB control numbers for EPA's regulations, 
after appearing in the preamble of the notice, are listed in 40 CFR 
part 9, and included on the related collection instrument. The 
information collection activities related to the submission of 
commitment letters and submission of data on health effects have been 
approved under OMB control number 2070-0033 (EPA ICR No. 1139) (Ref. 
52). EPA will develop a new ICR to cover the submission of exposure and 
risk information for the chemicals in the VCCEP. The availability of 
the new ICR will be announced in the Federal Register and there will be 
an opportunity for public comment. Upon OMB approval of the new ICR, 
EPA will send a letter to the sponsors or issue a Federal Register 
notice reminding them of the due date for the Tier 1 information and 
will include the ICR number and OMB control number covering the data 
collection.
    The collection of commitment letters and health effects information 
discussed in this notice is approved by OMB and the total burden hours 
currently approved for the information collection activities for a 
voluntary chemical evaluation program specifically accounts for the 
Agency's burden estimate for 22 chemicals during the OMB approved 
information collection period. EPA believes that if several chemicals 
are addressed as a group instead of individually, as discussed in Unit 
III.A. for o-xylene and m-xylene, that the burden estimate for a group 
should be that for a single chemical. EPA therefore believes that the 
existing approval includes a sufficient burden hour allocation to cover 
the burden related to the 23 chemicals in the pilot of this voluntary 
program.
    The voluntary testing program involves the submission by the 
sponsor of one commitment letter per year and one long term report 
(referred to in this program as the Peer Consultation Document) per 
chemical or group per year. EPA estimates that the information 
collection activities related to commitment letters and health effects 
evaluation/testing discussed in the Peer Consultation Document would 
result in total burden hours of approximately 39,768 (Ref. 52, 
Attachment 7) . The average burden is estimated to be 68.36 hours per 
response (Ref. 52).
    As defined by the PRA and 5 CFR 1320.3(b), ``burden'' means the 
total time, effort, or financial resources expended by persons to 
generate, maintain, retain, or disclose or provide information to or 
for a Federal agency. This includes the time needed to review 
instructions; develop, acquire, install, and utilize technology and 
systems for the purposes of collecting, validating, and verifying 
information, processing and maintaining information, and disclosing and 
providing information; adjust the existing ways to comply with any 
previously applicable instructions and requirements; train personnel to 
be able to respond to a collection of information; search data sources; 
complete and review the collection of information; and transmit or 
otherwise disclose the information.

List of Subjects

    Environmental protection, Chemicals, Children, Hazardous 
substances, Health and safety.


    Dated: December 15, 2000.

Susan H. Wayland,

Acting Assistant Administrator for Prevention, Pesticides and Toxics.

[FR Doc. 00-32767 Filed 12-22-00; 8:45 am]
BILLING CODE 6560-50-S