Voluntary Children's Chemical Evaluation Program

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: December 26, 2000 (Volume 65, Number 248)]
[Notices]
[Page 81699-81718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de00-122]

[[Page 81699]]

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Part V

Environmental Protection Agency

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Voluntary Children's Chemical Evaluation Program; Notice

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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: TSCA-Hotline@epa.gov.
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:
penberthy.ward@epa.gov.

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

[[Page 81709]]

[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

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