Document ID: EPA-HQ-OPPT-2008-0816-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-24T05:00Z

Supporting Statement for a Request for OMB Review under

	the Paperwork Reduction Act

	

1	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title and Number of the Information Collection    

Title:	Voluntary Children’s Chemical Evaluation Program (VCCEP)

EPA ICR No.:   2055.03	OMB Control No.:   2070-0165

1(b)	Short Characterization

The Voluntary Children’s Chemical Evaluation Program (VCCEP) is a
voluntary program designed to provide the Environmental Protection
Agency (EPA) with information under the Toxic Substances Control Act
(TSCA) on health effects, exposure, risk, and additional data needed to
evaluate the risks of chemicals to which children have a high likelihood
of exposure.  This is the second renewal of the Information Collection
Request (ICR) that covers the activities related to the pilot of VCCEP,
which with this renewal will also cover new, non-pilot chemicals to be
added to and evaluated in VCCEP.  EPA decided to run a pilot of the
VCCEP so it could evaluate the program and, if necessary, make changes
to increase the efficiency of the program’s implementation and
influence how chemicals should be handled in VCCEP in the future.  Of
particular interest was the Peer Consultation Process that was being
used for the first time in such a program.  

EPA conducted an interim evaluation of the pilot in 2006 – 2007. 
Possible program changes considered by EPA as a result of the interim
evaluation were discussed with stakeholders at a public meeting in 2008
before any changes were implemented.  In 2008, EPA modified VCCEP by
adopting four program changes: 1) EPA may include tests from both Tier 2
and 3 in a single Data Needs Decision and request sponsorship of both
tiers in a single commitment, 2) the sponsor may be responsible for
paying the organization that manages the Peer Consultation process, 3)
the sponsor may revise its Peer Consultation Document because of
comments at the Peer Consultation before that document is used by EPA to
prepare its Data Needs Decision, and 4) an additional source of future
VCCEP chemicals will be high production volume chemicals with
children’s issues referred for further evaluation from the Chemical
Assessment and Management Program (ChAMP).  

This ICR covers the pilot chemicals and the new chemicals to be added to
VCCEP.   Specifically, this ICR covers the commitment letters,
activities, VCCEP-related comments/information, data, chemical
assessments, and revised chemical assessments to be requested by EPA so
that the objectives of VCCEP as that program is described in the
December 26, 2000, Federal Register Notice (65 FR 81700) (see Attachment
1), and as modified by the 2008 program changes, can be met.  

The VCCEP was developed by EPA’s Office of Pollution Prevention and
Toxics (OPPT) after considering various comments and concerns voiced by
a number of parties through an extensive stakeholder involvement process
that included individuals from the chemical industry, various government
agencies, child health groups, environmental groups, animal welfare
groups, and the general public.  Through the VCCEP and commitments by
chemical sponsors, EPA will obtain data on chemicals to which children
are likely to be exposed.  Participation in the VCCEP and submission of
data are voluntary.  Industry has the opportunity to make a separate
commitment for each of three tiers and each commitment is initiated by a
letter to EPA identifying the chemical and tier of information that a
company is volunteering to sponsor.  However, because of certain 2008
program changes, some sponsors will be asked to commit to sponsor both
upper tiers together instead of separately.  Sponsors then collect or
develop data that provide information on health effects, exposure, risk,
and additional data needs of the sponsored chemicals.  EPA will use a
publicly conducted Peer Consultation Process to help assess whether the
submitted data are adequate to fully characterize the risk to children
and, if not, what additional data are needed.

The VCCEP is also designed to ensure that health effects, exposure, and
risk information collected on chemicals are made publicly available to
allow EPA and others to pursue any necessary risk management or
regulatory action with respect to a chemical, to help the public
understand the risks posed to children by exposure to certain chemicals,
and to facilitate the public’s involvement in environmental
decision-making.  EPA makes the collected data publicly available on the
VCCEP website at http://www.epa.gov/oppt/vccep/index.htm.

The data that a sponsor commits to develop under the VCCEP need to be
collected only once for each specified chemical.  As such, only one of
the entities that manufacture or import the specified chemical, or a
consortium formed by these entities, will develop the specified data and
report the results to EPA.

EPA has established an official docket under Docket ID OPPTS-00274 for
all activities conducted under the VCCEP.  The official docket consists
of the documents referenced in the notice announcing the VCCEP (65 FR
81700, December 26, 2000), letters of commitment to sponsor a chemical,
the Peer Consultation Documents (containing hazard, exposure, risk, and
data needs assessments for each chemical assessed), the report on the
results of the Peer Consultation meeting prepared by the organization
that manages the Peer Consultation process, EPA’s Data Needs
Decisions, any public comments received during an applicable comment
period, and other information related to the Stakeholder Involvement
Process, including information claimed as Confidential Business
Information (CBI).  Although a part of the official docket, the public
docket does not include CBI or other information whose disclosure is
restricted by statute.  The official public docket is the collection of
materials that is available for public viewing at the EPA Public Reading
Room, Room B102, EPA West Building, 1301 Constitution Avenue, N.W.,
Washington, D.C., from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays (202-566-0280).

2	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

Section 2(b)(1) of TSCA, states that it is the policy of the United
States that adequate data should be developed with respect to the effect
of chemical substances and mixtures on health and the environment and
that the development of such data should be the responsibility of those
who manufacture [which is defined by statute to include import] and
those who process such chemical substances and mixtures [.]  To
implement this policy, EPA may rely on TSCA section 4(a), which
authorizes EPA to require manufacturers and processors of chemical
substances and mixtures to conduct testing if certain findings for
hazard and/or exposure are made by EPA.  With the VCCEP, however, EPA is
working with manufacturers and other stakeholders to voluntarily develop
needed data.

In general, chemicals were selected for the VCCEP pilot if there were
data indicating that exposure to the general population had occurred and
that the chemicals are present in the environment.  The biomonitoring
data sets used for selection of the VCCEP pilot chemicals included
samples from human blood, breast milk, and exhaled breath.  Presence in
the environment was established by monitoring data indicating presence
in indoor air or presence in drinking water as an unregulated
contaminant.

Chemicals were screened from the VCCEP pilot if they were being
adequately addressed by another risk management program, were being
phased out, or were not manufactured in or imported into the United
States.  Other chemicals were deferred because of ongoing assessments
that are similar in scope to the VCCEP.

New chemicals are expected to be added to VCCEP from the Chemical
Assessment and Management Program (ChAMP) when chemicals are identified
by that program as possibly being of concern for children due to
possible health risks and potential exposure.

2(b)	Use/Users of the Data

The information collected through the VCCEP will provide critical
information on health effects, exposure, risk, and data needs that will
enable EPA and others to properly assess and manage health risks to
children that may be posed by exposure to TSCA chemicals evaluated by
VCCEP.  This information will also be made publicly available to help
the public understand the risks posed by exposure to certain chemicals
and to facilitate the public’s involvement in environmental
decision-making.

Data collected under the VCCEP, along with a report of a Peer
Consultation’s discussion of the data, will be used by EPA scientists
to determine whether the health risk to children from exposure to any of
the VCCEP chemicals has been adequately characterized.  In determining
whether exposure to a VCCEP chemical poses a risk  to children’s
health and whether data from the next VCCEP Tier are needed, the EPA
scientists will rely on the opinions of the scientific experts at the
Peer Consultation and public comment processes.  If EPA’s Data Needs
Decision differs substantially from the approach indicated by the report
of the Peer Consultation meeting, EPA will provide a supporting
rationale indicating the basis for its approach.  Concurrence on the
Data Needs Decision will be obtained from other EPA Offices before the
decision is final.  EPA has provided guidance to the chemical sponsors
that explain how to develop an acceptable assessment document, and how
to assess risk to children.  The Peer Consultation Group will use
accepted scientific standards when reviewing the assessment documents
provided by the sponsor.  EPA also intends to apply the accepted
scientific standards and principles, as is currently done in making risk
determinations under other TSCA programs.

If the hazard, exposure, and risk data submitted by the sponsor indicate
that potentially unreasonable risks to children may exist, the data will
be used by EPA and the manufacturer to determine the appropriate action
necessary to avoid or mitigate the risks.  Such information, considered
in conjunction with exposure data, can be used for risk management,
hazard communication and right-to-know purposes, and product labels. 
EPA may also use the assessments to identify chemicals that may not
warrant additional regulation or concern, or should otherwise be treated
as a low priority for further consideration.  For example, six of the
first thirteen Peer Consultations conducted under the VCCEP resulted in
recommendations that no further data were needed to characterize risks
to children. 

Data may also be used by other Federal agencies such as the Consumer
Product Safety Commission (CPSC), the Occupational Safety and Health
Administration (OSHA), and the National Institute for Occupational
Safety and Health (NIOSH).

Additionally, data developed for chemicals used or produced in
particular work sites will be useful in developing comprehensive safety
and health programs at those facilities.  Local, state and county
governments rely on the Agency’s ability to set health and
environmental standards, as do other national governments.  The
paperwork related requirements imposed on the sponsors as part of the
VCCEP allow EPA to ensure that the necessary data will be developed,
that the results meet basic scientific standards of acceptability and
adequacy, and that the testing is progressing on schedule.  To date, EPA
has used collected data from other test programs to perform the
necessary assessments that support such activities as the development of
water quality criteria, hazardous waste listings, chemical advisories,
and reduction of workplace exposures.

3	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)	Non-Duplication

3(a)(1) Testing and assessments 

Prior to announcing the VCCEP, EPA held three public meeting with
stakeholders (industry, other government agencies, children’s health
groups, environmental groups and animal welfare groups) to discuss the
appropriate test battery to evaluate chemicals of concern for
children’s health. This was done to ensure that only the tests that
could contribute to the understanding of a chemical’s effect on
children’s health would be conducted under the VCCEP.  The stakeholder
involvement process and recommendations from the EPA Science Advisory
Panel (SAP) identified such a test battery.  The stakeholder involvement
process also identified a tiering process that would stage when the
sponsor would be asked to submit the data specified by the test battery.

Under the VCCEP, the sponsor(s) will only be asked to submit the data
specified by the test battery in accordance with a tiering process that
allows the sponsor(s) to make a separate commitment for each tier, or,
due to the 2008 program changes, to Tier 1 and Tier 2/3.  Before
conducting any new testing, it is the VCCEP sponsor’s responsibility
to review available data and existing studies so duplication of testing
can be avoided.  Because a sponsor’s use of adequate, existing data to
evaluate a chemical under the VCCEP will provide a substantial cost
savings over developing data through new testing, EPA believes the data
developed as a result of the VCCEP will not be duplicative.  EPA also
believes that duplication of the required assessments (hazard, exposure,
risk, and data needs) will not occur in implementing the VCCEP, because
only one submission is necessary for each chemical.  As a result, each
chemical is sponsored by either a single company or a single consortium
of companies, usually consisting of the manufacturers of the chemical in
question.  In addition, information regarding the voluntary commitments
under the VCCEP will be posted on the EPA website, where they will be
available to the public (see http://www.epa.gov/oppt/vccep/).

3(a)(2)  Exemptions

Exemptions are not required or necessary for this program because
participation in the program is voluntary.  

3(a)(3) Equivalence information

Equivalence information will provide verification that a chemical tested
is the same as the chemical in the VCCEP.  Often this information is CBI
and only the manufacturer or processor of the chemical has this
information.  As such, the collection of this information under the
VCCEP is not duplicative.

3(b)	Public Notice Required Prior to ICR Submission to OMB

  SEQ CHAPTER \h \r 1 Prior to submission to OMB, this ICR will be made
available to the public for comment through a Federal Register notice. 
The public will have 60 days to provide comments.  Any comments received
will be given consideration when completing the supporting statement
that is submitted to OMB.

3(c)	Consultations

A number of issues applicable to the implementation of the VCCEP,
including the time allowed for completing testing, what constitutes
confidential information, how EPA should provide guidance for submission
of equivalence data, and how the Agency will provide standards for
development of test data, were developed over the past 25 years as part
of the Agency’s overall TSCA chemical testing program and involved an
extensive public process involving both notice and comment rulemakings
and many public meetings.

In developing the details of the VCCEP, EPA considered advice from the
SAP and individual input from the stakeholders concerning the
appropriate test battery for this program.  EPA also considered
stakeholder comments in a public meeting setting on the need for
exposure and risk assessments in addition to the hazard assessment.  The
initial interest in exposure and risk assessments came from industry
representatives at the meetings.  EPA described what each assessment
should contain in a document provided prior to or at each public
meeting.  Hazard assessments were to follow the format of robust
summaries.  The format for an Exposure Assessment was discussed and
developed at a workshop with EPA and industry participation.  Risk
assessments were to be an integration of the information in the hazard
and exposure assessments.  Guidance documents were also identified to
guide the sponsor in developing information for the assessments.  The
submission of all the assessments in a single document for review by a
Peer Consultation was also discussed at the public meetings.  EPA also
considered input on how the Peer Consultation should be run and how the
pilot program should be evaluated.  Five years after the initiation of
the pilot, EPA evaluated the pilot program to consider what
modifications might be made that would make the VCCEP run more
efficiently.  Stakeholders, the organization that manages the Peer
Consultation process and the general public were consulted in this
evaluation.

Additionally,   SEQ CHAPTER \h \r 1 under 5 CFR 1320.8(d)(1), OMB
requires agencies to consult with potential ICR respondents and data
users about specific aspects of ICRs before submitting an original or
renewal ICR OMB for review and approval.  In accordance with this
regulation, EPA will pursue additional consultations with interested
parties during the development of the renewal of this collection.

3(d)	Effects of Less Frequent Collection

As designed, this program minimizes overall burden by utilizing a
tiering process for submissions and by allowing companies to jointly
sponsor a chemical, limiting submissions per chemical to the minimum,
i.e., only one response per chemical per tier (or per two tiers if a
commitment is made to Tier2/3).  The VCCEP requires the sponsor to
submit a letter notifying EPA that it is volunteering to sponsor a
particular chemical and include the anticipated start date and
completion date for any testing conducted under the tier(s) of the
program committed to.  A sponsor may commit to three separate tiers or
two separate tiers (Tier 1 and Tier 2/3, per 2008 program changes), and
the sponsor for each tier may vary.  The sponsor is required to submit
all four assessments (hazard, exposure, risk, and data needs) in a
single document.  EPA believes this is the absolute minimum frequency
for collecting the information under such a chemical evaluation program.

3(e)	Compliance with General OMB Guidelines

The data retention requirements for test rules and consent orders
exceeds one of OMB’s general guidelines contained in 5 CFR
1320.5(d)(2).  Documentation records, raw data, and specimens pertaining
to a test rule or consent order study are required by Good Laboratory
Practice Standards (GLPS) to be retained for ten years from the
effective date of the applicable test rule or publication date of the
consent order (40 CFR 792).  This requirement is necessary to permit
sufficient time to review results, perform appropriate risk assessments
and, when necessary, to institute appropriate regulatory control
responses.  Long-term studies may take five years from the effective
date of the final test rule or consent order to perform and submit to
the Agency; assessment of study results may require an additional one to
two years of internal and external peer review; institution of
regulatory controls and legal challenges may require an additional two
to three years before final resolution of issues.  All studies, both
short and long-term, are relevant to assessing the potential risk of the
chemical and therefore must be retained during the ten year period.  In
those regulatory cases where the Agency’s action may be challenged, it
is imperative that all records, raw data, and specimens be available to
support the Agency’s decision.

These same considerations apply to the data generated for the VCCEP. 
The time necessary to develop the data required by the VCCEP should
closely reflect the time needs previously calculated for a test rule and
consent order because the VCCEP, test rules, and consent orders follow
the same guidance concerning time allowed per test.  However, in the
VCCEP, additional time is needed to develop exposure, risk, and data
needs assessments at each tier.  The notice announcing the VCCEP
specified that four months could be requested for this purpose.  The
four months would be in addition to the time necessary to develop the
health effects data.  If four months is requested at each of three
tiers, an additional 12 months would be added to the time requirement
for the program (8 months if a Data Needs Decision addresses Tier 2/3
data needs in the same decision).  Also, the VCCEP is a tiered testing
program and, for some pilot chemicals, Tier 3 testing might not begin
until eight years into the program.

Additional time may be necessary for review in the VCCEP compared to
what is necessary for test rules and consent orders.  The VCCEP has
features not present in most test rules and consent orders, namely a
Peer Consultation (approximately two months), the report of the
organization that manages the Peer Consultation process (approx. 2
months), EPA’s announcement of its Data Needs Decision (approx. 6
months), and 4 months for the sponsor to commit to the next tier of
testing.  This additional time of 14 months would be required for both
Tier 1 and Tier 2, while Tier 3 would require only 4 additional months
since it does not have a Data Needs Decision.  Therefore, the VCCEP may
require an additional 32 months to implement, but a significant amount
of this time may be matched by the test rule/consent order review time
that requires a complete review of studies in house, the development of
an exposure assessment in house, and the development of an EPA risk
assessment document.  A final consideration that would add to the VCCEP
implementation time is the likelihood of scheduling problems in
arranging the Peer Consultation meetings due to the time demands on the
scientific experts whose participation will be needed.

For the above reasons, the records retention time for the VCCEP pilot
will be 10 years from the date that the studies/information are
submitted to EPA.  Ten years is also the records retention time
specified by GLP.  Thus, the Paperwork Reduction Act (PRA) guidelines
specifying that data other than health, medical, or tax records not be
required to be retained for more than three years will be exceeded in
this program.

3(f)	Confidentiality

EPA expects that information submitted to EPA in response to the VCCEP
is, in most cases, non-confidential.  If respondents wish to claim
information submitted in response to the VCCEP as CBI, they may do so. 
Respondents may claim all or part of a document confidential if there is
a legitimate need to do so as described in 40 CFR part 2.  These claims
will be handled according to the EPA procedures described in 40 CFR Part
2 and the TSCA Confidential Business Information Security Manual, which
call for careful protection of confidential business information.  EPA
will disclose information that is covered by a claim of confidentiality
only to the extent permitted by, and in accordance with, the procedures
in TSCA section 14 and 40 CFR part 2.

	3(g)	Sensitive Questions

The information requested does not include information of a sensitive
nature other than CBI, which is discussed above in Unit 3(f).

4	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents/NAICS Codes

Respondents affected by the collection activity include but are not
limited to:              

Type of Entity	

NAICS	

Examples of Potentially Affected Entities

Chemical Manufacturers and Importers	

325,

32552

32551

313

42272	

Persons who manufacture (defined by statute to include import) one or
more of the subject chemical substances.

The North American Industrial Classification System (NAICS) codes have
been provided to indicate which entities might be affected by this
information collection activity.  This listing is not intended to be
exhaustive and other types of entities not listed in this table could
also be affected.

4(b)	Information Requested

Data Items

The VCCEP is a voluntary initiative under which manufacturers and
importers of chemicals to which children have a high likelihood of
exposure agree to submit available data, develop data, and/or conduct
any needed testing for the chemicals they manufacture or import. 
Although the data submissions are voluntary, EPA believes that the
development and/or submission of such data represent costs and burdens
not captured in existing information collections. 

In general, Sponsors will be asked to submit a letter of commitment to
sponsor a chemical in a specific tier or tiers; submit a Peer
Consultation Document for each commitment which will contain four
assessments; and retain the required records related to the assessments
for ten years after the date they are submitted to EPA.

Following is a list of information that the Sponsor will submit:

1. Letter of commitment for each chemical and tier(s) sponsored.

2. Peer Consultation Document for each chemical and tier(s) sponsored. 
Each 

    Peer Consultation Document will contain four assessments:

Hazard Assessment.

Exposure Assessment.

Risk Assessment.

Data Needs Assessment.

EPA has specified four assessments as necessary to address unanswered
questions about the effects on children from exposure to a chemical
substance.  The four assessments will address hazard, exposure, risk,
and data needs.  The scope of testing/data development for each chemical
is limited to the tier(s) for which a commitment to sponsor has been
received, and to the tests/data specified for that tier(s).  However, if
there are existing studies, even though they address an endpoint in an
upper tier not yet committed to, the sponsor is expected to include that
study in the relevant assessment prepared for the lower tier.  The
assessments are to be submitted in a single document, the Peer
Consultation Document, and prepared for each tier(s) to which a company
or consortium commits.

The Hazard Assessment to be prepared by the sponsor is to be based
primarily on toxicity tests specified for the tier(s) committed to, but
should also include existing toxicity studies even though they address
endpoints in an upper tier not yet committed to.  The three tiers of
toxicity tests specified by the VCCEP are listed in Table 1.

Table 1.--Three Tiers of VCCEP Tests

Tier	

Test	

Test Guideline

   11

	

Acute oral toxicity (up/down) OR 

Acute inhalation toxicity	

OECD 425 or ASTM E1163-98

OECD 403 or 40 CFR 799.9130

	

In vitro gene mutation: Bacterial reverse mutation assay	

OECD 471, 870.5100, or 40 CFR 799.9510

	

Combined repeated dose toxicity with reproductive and developmental
toxicity screens OR

Repeated dose oral toxicity AND 

Reproductive toxicity (1-generation)	

OECD 422

OECD 407

OECD 415/421

	

In vitro chromosomal aberrations OR

In vivo chromosomal aberrations OR

In vivo mammalian erythrocyte micronucleus	

OECD 473, 870.5375, or 40 CFR 799.9537

OECD 475, 870.5385, or 40 CFR 799.9538

OECD 474, 870.5395, or 40 CFR 799.9539

   2	

90-day subchronic toxicity in rodents	

870.3100 (oral), or

870.3250 (dermal), or

870.3465 (inhalation) or 40 CFR 799.9346 (inhalation)

	

Reproduction and fertility effects	

870.3800 or 40 CFR 799.9380

	

Prenatal developmental toxicity (two species)	

870.3700 or 40 CFR 799.9370

	

In vivo mammalian bone marrow chromosomal aberrations, OR

In vivo mammalian erythrocyte micronucleus

Triggered off results from in vitro mammalian chromosomal aberration
test if conducted in Tier 1)	

OECD 475, 870.5385, or 40 CFR 799.9538

OECD 474, 870.5395, or 40 CFR 799.9539

	

Immunotoxicity	

870.7800 or 40 CFR 799.9780

	

Metabolism and pharmacokinetics	

 870.7485 or 40 CFR 799.9748

   3	

Carcinogenicity OR

chronic toxicity/carcinogenicity	

870.4200 or 40 CFR 799.9420

870.4300

	

Neurotoxicity screening battery	

870.6200 or 40 CFR 799.9620

	

Developmental neurotoxicity	

870.6300 or 40 CFR 799.9630

The various guidelines that are appropriate to use when conducting each
test are the TSCA guidelines in 40 CFR part 799, the Organization for
Economic Cooperation and Development (OECD) guidelines, the American
Society for Testing and Materials (ASTM) International guideline, or the
OPPTS harmonized guidelines in the 870 series (Health Effects Test
Guidelines).  The OPPTS harmonized test guidelines have been developed
for use in the testing of pesticides and toxic substances, and the
development of test data that must be submitted to the Agency for review
under Federal regulations.  Initiated several years ago, the purpose of
harmonizing the guidelines into a single set of OPPTS guidelines is to
minimize variations among the testing procedures that must be performed
to meet the Agency’s data requirements for submissions under the Toxic
Substances Control Act (TSCA) (15 U.S.C. 2601) and the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136-136y). 
In establishing the harmonized guidelines, the Agency considers
available guidelines, including those that might have been developed by
EPA for pesticides or toxic substances, as well as those developed by
OECD.  Today, the harmonized guidelines may also be newly developed
through a cooperative process reflecting all three organizations, as
well as others in the scientific community.  In general, the process for
developing the OPPTS harmonized test guidelines is scientifically
rigorous and includes both peer review and public comment opportunities.
 To access copies of the OPPTS harmonized guidelines, go to
http://www.epa.gov/opptsfrs/home/guidelin.htm.

The Exposure Assessment to be prepared by the sponsor 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 that occur prior to conception (to either or both parents), during
prenatal development, and post-natally to the age of sexual maturation,
which is completed around 18-21 years of age.  Although adult exposures
are not intended to be a major focus of the VCCEP, 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 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. 
The specific content of a particular exposure assessment is dependent
upon the specific chemical involved and the information available at the
time that the assessment is performed.  For example, if during Tier 1 it
is determined that the chemical in question is only used in industrial
settings and using a closed process, it is unlikely that the exposure
assessment would need to consider all of the factors that could be
included in a complete exposure assessment as listed below.  When a
question arises about the content of a particular exposure assessment,
the sponsor will be able to consult with EPA and other participants
before proceeding.  To assist the sponsors in preparing a complete
Exposure Assessment, the Agency has also made several detailed guidance
documents available to sponsors that are also used by EPA staff and
others to prepare the exposure assessments that are submitted to or
otherwise used by the Agency in decision-making.  These documents can be
found under Guidance Documents at
http://www.epa.gov/oppt/vccep/pubs/submit.htm#F.

Although the guidance documents cited above provide more specific detail
about what to include in an Exposure Assessment, the following is a list
of the specific types of information that the Agency has told sponsors
that they should submit in an Exposure Assessment (see also the
discussion that begins on 65 FR 81710):

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 as well as other existing exposure assessment
procedures and guidance.  EPA’s National Center for Environmental
Assessment (NCEA) has prepared a document entitled Child-Specific
Exposure Factors Handbook that consolidates all child exposure factors
and related data in one document.  After considering public comment, the
final Handbook was issued on September 1, 2002 (Child-specific Exposure
Factors Handbook (Interim Report), USEPA EPA-600-P-00-002B, 01 Sep 2002)
and is easily accessible under Guidance Documents at
http://www.epa.gov/oppt/vccep/pubs/submit.htm#F.

The exposure information that is provided for the VCCEP should be
transparent and should 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
important to note that given the tier structure of the VCCEP, the
Exposure Assessment may need to be amended when the chemical proceeds to
the next tier.  As is always the case, the specific content of a
particular exposure assessment is dependent upon the specific chemical
involved and the information available to the Sponsor at the time that
the assessment is being performed.  For example, if during Tier 1 it is
determined that the chemical in question is only used in industrial
settings and using a closed process, it is unlikely that the exposure
assessment would need to consider all of the factors listed.  When a
question arises, the Sponsor will be able to consult with EPA and other
participants before proceeding.

In determining the adequacy of existing data under Tier 1, EPA and the
Sponsors agreed to use the same approach contained in the guidance
provided for the HPV Challenge Program, a copy of which is available at
http://www.epa.gov/chemrtk/pubs/general/datadfin.htm.  This document
provides basic guidance for accepting or rejecting data used to describe
the basic hazard of a chemical, but the approach presented is also
generally used for determining whether available data are adequate to
describe the potential health effects of a chemical.  Basically, the
approach used has two steps.  In Step 1, established criteria should be
used to assess overall scientific integrity of the information. Any data
or information that do not meet the Step 1 criteria are to be rejected
from further consideration.  In Step 2, a more rigorous evaluation of
existing data that have passed Step 1 occurs (existing data generated
via OECD or equivalent guidelines can enter directly into Step 2
evaluation).  The specific criteria are test specific and described in
detail in the guidance document referenced above.

In determining whether a chemical will proceed to Tier 2 or to Tier 2/3,
the Agency will review all of the assessments submitted by the Sponsor,
along with the Peer Consultation report, and prepare a Data Needs
Decision at the completion of Tier 2.  If Tier 2 data are submitted, a
Data Needs Decision must also be submitted at the completion of Tier 2. 
For the most part, the Agency’s Data Needs Decision is expected to
mirror the general opinion of the Peer Consultation report.  As
described in the December 2000 Federal Register Notice describing the
VCCEP, the Agency considers the following factors when making a Data
Needs Decision under the VCCEP (see also the discussion that begins on
65 FR 81712):

(1)  EPA will utilize a risk-based, scientifically sound process to make
decisions on the need for further information gathering or risk
reduction action (65 FR 81715).

(2) When the risk characterization is adequate to characterize the
relative level of risk to children and, where relevant, prospective
parents, additional studies or data from the next tier will not be
pursued (65 FR 81712).

(3) In making a data needs decision, EPA will use a weight-of-evidence
approach to evaluate both the hazard and exposure data prepared by the
sponsor (65 FR 81712).

(4) An appropriately conservative screening level assessment can help
rule out certain exposures (65 FR 81711).

(5) If specific toxicity studies are indicated, they should be chosen
from the next tier(s) 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 that will most quickly, directly, and cost-effectively reduce
uncertainty (65 FR 81713).  And,

(6) Other factors may also be considered, as appropriate.  See also the
discussion that begins on 65 FR 81712.

4(c)	Respondent (Sponsor) Activities

Sponsors of VCCEP chemicals and pilot VCCEP chemicals may undertake a
number of activities during the effective period of this ICR.  The
actual number and type of activities a sponsor will undertake will
depend on the tier(s) committed to, the amount of currently available
data on the health effects, exposure, and risk to children for the
subject chemical(s), and EPA’s decision on the need for additional
data on the chemical(s).  The maximum number and type of activities that
a Sponsor of a VCCEP chemical or pilot VCCEP chemical can be anticipated
to undertake per tier commitment are listed below for all three tiers,
even though many of the VCCEP chemicals may not complete all three tiers
of evaluation during the effective period of this ICR, and the majority
of the pilot VCCEP chemicals have completed most of their evaluation
under VCCEP.

Tier 1:

Review notice announcing the VCCEP.

Submit Letter of Commitment to EPA volunteering to sponsor a chemical in
Tier 

	1.

Conduct file search for relevant existing data on toxicity and exposure.
 If existing

	 data are found:

- Prepare summaries of existing data.

- Add summaries to Hazard and Exposure Assessments.

Plan necessary activities, e.g., consortia, arrange for conduct of
studies, etc.

Prepare Hazard Assessment, Exposure Assessment, Risk Assessment and Data

	Needs Assessment for Tier 1 for each chemical committed to.

Prepare Peer Consultation Document for Tier 1.

Review Peer Consultation Document for CBI.

Submit the Peer Consultation Document for Tier 1 to the organization
that 

	manages the Peer Consultation process.

Present the assessments to the Peer Consultation Group at the public
meeting.

	Revise Peer Consultation Document if so advised by the Peer
Consultation 

	Group and in accordance with its comments. Resubmit the Peer
Consultation 

Document to the organization that manages the Peer Consultation process
and three copies and one electronic copy to EPA.

Maintain test data records and Peer Consultation Documents for ten
years.

Tier 2:

Submit Letter of Commitment to EPA volunteering to sponsor a chemical in
Tier

	2.

Conduct file search for any new existing data on toxicity and exposure. 
If existing 

	data are found:

- Prepare summaries of existing data.

- Add summaries to Hazard and Exposure Assessments.

Plan necessary activities, e.g., consortia, arrange for conduct of
studies, etc.

Prepare Hazard Assessment, Exposure Assessment, Risk Assessment and Data

	Needs Assessment for Tier 2 for each chemical committed to.

Prepare Peer Consultation Document for Tier 2 for each chemical
committed to.

Review Peer Consultation Document for CBI.

Submit the Peer Consultation Document for Tier 2 to the organization
that 

	manages the Peer Consultation process.

Present the assessments to the Peer Consultation Group at the public
meeting.

Revise Peer Consultation Document if so advised by the Peer Consultation

	Group and in accordance with its comments. Resubmit the Peer
Consultation

	Document to the organization that manages the Peer Consultation process
and 

	three copies and one electronic copy to EPA.

Maintain test data records and Peer Consultation Documents for ten
years.

Tier 2/3 or Tier 3:

Submit Letter of Commitment to EPA volunteering to sponsor a chemical in
Tier 

	2/3 or Tier 3.

Conduct file search for any new existing data on toxicity and exposure. 
If existing 

	data are found:

- Prepare summaries of existing data.

- Add summaries to Hazard and Exposure Assessments.

Plan necessary activities, e.g., consortia, arrange for conduct of
studies, etc.

Prepare Hazard Assessment, Exposure Assessment and Risk Assessment for 

	Tier 2/3 or Tier 3 for each chemical committed to.

Prepare Peer Consultation Document for Tier 2/3 or Tier 3 for each
chemical 

	committed to.

Review Peer Consultation Document for CBI.

Submit the Peer Consultation Document to the organization that manages
the 

	Peer Consultation process.

Present the assessments to the Peer Consultation Group at the public
meeting.

Revise Peer Consultation Document if so advised by the Peer Consultation

Group and in accordance with its comments. Resubmit the Peer
Consultation Document to the organization that manages the Peer
Consultation process and three copies and one electronic copy to EPA.

Maintain test data records and Peer Consultation Documents for ten
years.

Additional information describing the products of the above activities
is provided below:

Letter of Commitment: A company wishing to volunteer to sponsor its
chemical in the VCCEP must send a letter to EPA committing to do so by
the deadline specified by EPA.  The letter must identify the company,
technical contact (name, address, e-mail address, telephone, and fax
number), the chemical name and its CAS number, the tier committed to,
the anticipated start date, and the anticipated submission date to EPA. 
Letters of commitment for Tier 1 have been received for 20 chemicals;
letters of commitment for Tier 2 have been received for two chemicals
(decabromodiphenyl ether and benzene).  Letters of commitment are due 4
months after the announcement of EPA’s Data Needs Decision.

Hazard Assessment: A separate Hazard Assessment is to be prepared for
each tier for each chemical to which a sponsor commits.  The Hazard
Assessment should be a robust summary of the studies conducted for a
particular tier and also any existing relevant studies, even though they
may address an endpoint in an upper tier not committed to.  A robust
summary is to 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.  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.  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 that 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 2/3 or Tier 3 commitment, the sponsor should develop a Hazard
Assessment that includes summaries of those Tier 2/3 or Tier 3 studies
that EPA has announced in its Data Needs Decision.  In addition to the
new hazard data developed for Tier 2/3 or Tier 3, the Tier 2/3 or Tier 3
Hazard Assessment should also contain all the information from the
previous Hazard Assessment(s), which should be revised as appropriate to
reflect new insights provided by the new hazard data developed for Tier
2/3 or Tier 3.

Exposure Assessment:  The Exposure Assessment should be a robust summary
of existing exposure information and any exposure studies conducted by
the sponsor.  The Exposure Assessment for Tier 1 should consist
primarily of 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 that 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.  A Tier 2 Exposure Assessment 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 90th 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.

Risk Assessment: The Risk Assessment should integrate information
presented in the Hazard Assessment and the Exposure Assessment for the
purpose of characterizing the risk to children’s health from exposure
to the chemical in question.

Data Needs Assessment: The Data Needs Assessment is the sponsor’s
opinion of what additional studies or data are needed from the next tier
of the VCCEP so that a thorough assessment of the risk to children from
exposure to a chemical can be developed.

Peer Consultation Document: The Peer Consultation Document is the
compilation of the Hazard Assessment, Exposure Assessment, Risk
Assessment, and Data Needs Assessment into a single document that will
be submitted to the organization that manages the Peer Consultation. 
Revisions addressing comments of the Peer Consultation Group will be
submitted to the organization that manages the Peer Consultation process
and to EPA (two copies and one electronic copy).  EPA will put one copy
in the TSCA Nonconfidential Information Center (NCIC) docket.

Data Needs Decision: The Data Needs Decision is prepared by EPA and is a
decision concerning which tests in the next tier(s) of the VCCEP are
needed.  EPA makes this decision after reviewing the report of the Peer
Consultation (prepared by the organization that manages the Peer
Consultation process), and expects to rely on the opinions in the
report. If EPA’s Data Needs Decision differs substantially from the
approach indicated by the Peer Consultation report, EPA will provide a
supporting rationale indicating the basis for its approach. Concurrence
on the Data Needs Decision will be obtained from other EPA Offices
before issued as a final decision. 

As a voluntary program, it is not necessary for anyone to request an
exemption under the VCCEP.  However, companies may submit relevant
information that indicates that specific chemicals included in the VCCEP
because of production volume are not currently produced in substantial
quantities and, therefore, testing of these chemicals is not necessary. 
Based on a review of the information submitted, EPA may remove a
chemical that is no longer HPV from the list of children’s health
chemicals.  This ICR does not separately account for submitting such
production information, although it could reasonably be submitted in
lieu of a commitment letter.  Mid production volume (25,000 lbs to less
than one million lbs) chemicals referred to VCCEP from ChAMP because of
children’s issues do not need substantial production to be included
and evaluated in VCCEP.

4(d)	Respondent (Sponsor) Activities from 2002 - 2009.

During the seven years from October 2002 through July 2009, the sponsors
have completed or EPA expects they will complete the following
activities:

- By July 2008, the sponsors of 15 VCCEP chemicals submitted Tier 1 Peer
Consultation Documents to EPA.  EPA expects that sponsors of 3 more
chemicals will submit Tier 1 Peer Consultation Documents by the end of
July 2009.  Therefore, for the period from October 2002 through July
2009, EPA expects that sponsors will have submitted a total of 18Tier 1
Peer Consultation Documents to EPA under the VCCEP. 

- By July 2008, the sponsors presented the results of their chemical
assessments at 11 public Peer Consultation meetings that addressed 15
VCCEP chemicals.  (Two meetings addressed two chemicals each and another
meeting addressed three chemicals, the remaining eight meetings
addressed one chemical each).  EPA expects that sponsors will present
Tier 1 chemical assessments at 3 ore Peer Consultation meetings that
will cover 3 chemicals.  Therefore, for the period from October 2002
through July 2009, EPA expects that sponsors will have presented Tier 1
chemical assessments for 18 VCCEP chemicals at 14 public Peer
Consultation meetings.

- The sponsors responded to EPA’s request for upper tier data as
follows:

 -On August 25, 2005, EPA requested sponsors of three chemicals that had
completed the Tier 1 process to conduct some Tier 2 tests.  The basis
for the request was contained in EPA’s Data Needs Decision documents
for decabrominateddiphenyl ether (DBDE), octabrominated- diphenyl ether
(OBDE), and pentabrominateddiphenyl ether (PBDE).  EPA requested that
fate and transport tests be conducted for DBDE and that 2-generation
reproductive toxicity tests be conducted for OBDE and PBDE, and
requested sponsors to volunteer within four months.  The company sponsor
of OBDE and PBDE declined to sponsor its chemicals in the upper tiers of
VCCEP.  On December 20, 2005, the trade association representing the
company sponsors of DBDE committed to sponsor DBDE in Tier 2.  By May
2008, adequate Tier 2 studies had not been submitted and EPA terminated
DBDE’s participation in VCCEP. VCCEP did not obtain the requested Tier
2 data on the three brominated diphenyl ethers.

-  On March 9, 2007, EPA requested the sponsors of m-xylene and o-xylene
to conduct Tier 2 tests including a neurotoxicity screening battery and
the developmental neurotoxicity test. As of June 2008, EPA has not
received a commitment for the Tier 2 tests from the companies of either
chemical.

-  On July 2, 2007, EPA requested the sponsors of benzene to provide
additional Tier 1 exposure and environmental fate information and to
conduct Tier 3 tests including a neurotoxicity screening battery and the
developmental neurotoxicity test. In a letter dated February 21, 2008,
the American Chemistry Council, acting on behalf of the sponsors,
provided additional exposure and environmental fate information, but
declined to sponsor the Tier 3 neurotoxicity tests.

-  On May 1, 2008, EPA requested the sponsors of toluene to provide Tier
2 information on occupational and general population exposure.  As of
June 30, 2008, EPA has not received a commitment to provide Tier 2
information on toluene, but there are still 2 months remaining in the
4-month commitment period.  

The following Table 2 lists the dates when the sponsors submitted their
Tier 1 chemical assessments, made their presentations at the Peer
Consultation meetings, and, where applicable, committed to or declined
to conduct Tier 2 or Tier 3 testing requested by EPA during the period
from October 2002 through July 2009.  For dates listed in 2009 and late
2008, EPA has estimated the date when it expects an activity to occur.

Table 2.(Sponsor Activities from October 2002 through July 2009.

Chemical Name/ CAS No.	Submission Date of Tier 1 Peer 

Consultation 

Document	Date of Peer Consultation Meeting	Date of Tier 2 or 3
Commitment	Submission

Date of

Adequate

Tier 2 or 3 Data

Vinylidene chloride

75-35-4	12/30/02	01/29-30/03	NA	

Decabrominated diphenylether

1163-19-5	12/20/02	04/02(03/03	12/20/05	

Not provided.

Octabrominated diphenylether

32536-52-0	04/21/03	06/04-05/03	No commitment	

Pentabrominated diphenylether

32534-81-9	04/21/03	06/03-04/03	No commitment	

Acetone

67-64-1	09/10/03	11/18-19/03	

NA

	Methyl ethyl ketone

78-93-3	12/04/03	02/19/04	NA

	n-Dodecane

112-40-3	06/17/04	09/14/04	NA

	Undecane

1120-21-4	06/17/04	09/14/04	NA

	Decane

124-18-5	06/17/04	09/14/04	NA

	m-Xylene

108-38-3	

10/07/05	

12/13-14/05	

	o-Xylene

95-47-6	10/07/05	12/13-14/05	

	Toluene

108-88-3	9/29/06	11/7-8/06	

	Benzene

71-43-2	3/30/06	8/8/06	No commitment

	p-Dioxane 

123-91-1	3/13/07	5/1-2/07	Maybe NA.

	Ethylbenzene

100-41-4	12/12/06	2/22-23/07	Maybe NA.

	Dichlorobenzene

106-46-7	Oct 2008*

	Dec 2008*

	Maybe NA.

	Ethylene Dichloride

107-06-2	After Aug 2009	After Aug 2009

	Maybe NA.

	Alpha-Pinene

80-56-8	Oct 2008*

	Dec 2008*

	Maybe NA.

	Tetrachloro-ethylene

127-18-4	After Aug 2009	After Aug 2009	Maybe NA.

	Trichloroethy-lene

79-01-6	Jan 2009*	Mar 2009*	Maybe NA.

	

*Estimated date.

NA =Not applicable because Tier 2 testing was not requested by EPA.

Maybe NA = Maybe not applicable because the need for Tier 2 data has not
yet been determined. 

NS = Not scheduled.

5	THE INFORMATION COLLECTION - AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

5(a)	Agency Activities

In order to sustain three tiers of VCCEP, EPA performs the following
applicable activities:

reviews letters of commitment for Tiers 1, 2, and 3, or Tiers 1 and 2/3
(separate

	 letter for each tier or combined tiers) for completeness;

provides information on the commitments and progress of program on the 

	VCCEP website and updates as needed;

maintains a cooperative agreement with the organization that manages the
Peer 

Consultation process to: arrange public meetings of the Peer
Consultation, solicit recommendations from EPA and stakeholder for
experts to serve as Peer Consultation members, identify and invite
scientific experts to serve as Peer Consultation members, distribute
Peer Consultation Documents and other guidance to Peer Consultation
members, act as facilitator at the public meeting, summarize results of
the Peer Consultation, and send the report to EPA and the sponsor;

reviews the sponsor-prepared Peer Consultation Documents and the report
of 

the Peer Consultation meeting; drafts Data Needs Decisions; and
coordinates review and approval of the Data Needs Decisions with EPA
offices before approval by OPPT Director;

announces the Data Needs Decisions after reviewing submissions for Tiers
1 and 

	2 on the VCCEP website and in letters to relevant sponsors;

provides explanation of Data Needs Decisions if they differ
substantially from the 

	report of the Peer Consultation meeting;   

makes the Peer Consultation Documents, the Peer Consultation meeting
reports, 

and the Data Needs Decisions available to the public in the TSCA NCIC
and on the VCCEP website; and

h)	monitors progress and efficiency of VCCEP by requesting and
evaluating information from participants and other stakeholders.

In addition to the activities cited above, the Agency may also
participate in other activities related to this program, e.g., relevant
workshops, other voluntary efforts to identify data needs and develop
test data, efforts to establish test guidelines or standards that may be
used in the VCCEP, and international efforts related to chemical testing
and associated testing issues.

In carrying out the activities related to the VCCEP pilot, EPA will use
existing EPA guidance and policies, and follow acceptable scientific
standards to conduct its reviews and make decisions.  Guidance related
to the assessments conducted under the VCCEP has been provided to the
sponsors and is available publicly on the VCCEP website, along with
Agency Guidance on risk characterizations and assessing risks to
children.

During the seven years from October 2002 through July 2009, EPA and the
organization that manages the Peer Consultation process completed or
plan to complete the following activities:

- The organization that manages the Peer Consultation process held 11
Peer Consultation meetings that evaluated chemical assessments submitted
for 15 VCCEP chemicals.  EPA expects the organization that manages the
Peer Consultation process to hold 6 more Peer Consultation meetings by
the end of July 2009, which will cover 3 additional pilot VCCEP
chemicals and 3 ChAMP chemicals.  Therefore, for the period from October
2002 through July 2009, EPA expects that the organization that manages
the Peer Consultation process will have held 18 Peer Consultation
meetings covering 21 VCCEP chemicals (18 pilot VCCEP and 3 ChAMP
chemicals).

- The organization that manages the Peer Consultation process prepared
summary reports of 11 Peer Consultation meetings covering 15 VCCEP
chemicals.  EPA expects the organization that manages the Peer
Consultation process will prepare 6 more reports of Peer Consultation
meetings covering 6 chemicals by the end of July 2009, for a total of 17
summary reports covering 21 VCCEP chemicals (18 pilot VCCEP and 3 ChAMP
chemicals) for the period from October 2002 through July 2009.

- EPA issued Data Needs Decisions for 6 chemicals on September 20, 2005,
2 chemicals on March 9, 2007, 3 chemicals on April 16, 2007, 1 chemical
on July 9, 2007, and 1 chemical on May 1, 2008,for a total 11 Data Needs
Decisions covering 13 chemicals 

- EPA asked for additional data from Tier 2 for 7 of the 13 chemicals.

- EPA decided that additional data were not needed for 6 of the 13
chemicals to characterize their risk to children. 

EPA expects to release Data Needs Decisions for 2 more chemicals before
the end of July 2009.  Therefore, for the period from October 2002
through July 2009, EPA expects to have released Data Needs Decisions for
15 chemicals.

- EPA met with sponsors and/or their representatives to discuss and
clarify the additional Tier 1 or upper tier data which EPA had
requested. 

 

- EPA cancelled the participation in VCCEP of decabromo-diphenyl ether
because adequate Tier 2 data had not been provided to the Agency.

The following Table 3 lists the dates of the Peer Consultation meetings,
the release dates of the summary reports of the Peer Consultation
meetings, the announcement date of EPA’s Data Needs Decisions for the
15 chemicals addressed during the period from October 2002 through July
2009, the Tier 2 testing requested by EPA, and EPA’s response to the
upper tier submissions.  For dates listed in late 2008 to 2009, the last
year of the second ICR, EPA has estimated the dates when activities will
occur.

Table 3. VCCEP Activities of the Agency and the organization managing
the Peer Consultation process from October 2002 through July 2009.

Chemical Name/ 

CAS No.	

Date of Peer Consul-tation Meeting	

Release Date of Peer Consul-tation Meeting Report	

Announce-ment Date of EPA’s Data Needs Decisions	

Tier 2 or 3 Testing Requested by EPA	

EPA’s Response to Upper Tier Submis-sions

Vinylidene chloride

75-35-4	01/29-30/03	06/03/03	09/20/05	None

	Decabrominated diphenylether

1163-19-5	04/02-03/03	09/30/03	09/20/05	Tier 2: Fate and transport
Cancelled participation     in VCCEP.

Octabrominated diphenylether

32536-52-0	06/04-05/03	01/22/04	09/20/05	Tier 2: 2-gen repro tox with
body burden satellite 

	Pentabrominated diphenylether

32534-81-9	06/03-04/03	01/22/04	09/20/05	Tier 2: 2-gen repro tox with
body burden satellite

	Acetone

67-64-1	11/18-19/03	03/05/04	09/20/05	None

	Methyl ethyl ketone

78-93-3	02/19/04	04/29/04	09/20/05	None

	n-Dodecane

112-40-3	09/14/04	01/07/05	04/16/07	None

	Undecane

1120-21-4	09/14/04	01/07/05	04/16/07	None

	Decane

124-18-5	09/14/04	01/07/05	04/16/07	None

	m-Xylene

108-38-3	12/13-14/05	02/23/06	03/09/07	Tier 3: neurotox screening
battery & Dev neuro

	o-Xylene

95-47-6	12/13-14/05	02/23/06	03/09/07	Tier 3: neurotox screening battery
& Dev neuro

	Toluene

108-88-3	11/7-8/06	01/16/07	05/01/08	Tier 2: occup & general population
exp

	Benzene

71-43-2	6/15-16/06	08/08/06	07/09/07	Tier 3: neurotox screening battery
& Dev neuro	

p-Dioxane 

123-91-1

	5/1-2/07	7/27/07	July 08*

Ethylben-zene

100-41-4	2/22-23/07	5/31/07	July 08*

Dichloro-benzene

106-46-7	Dec 2008*	Feb 2009*	After Aug 2009

Ethylene Dichloride

107-06-2	After Aug 2009	After Aug 2009	After Aug 2009

Alpha-Pinene

80-56-8	Dec 2008*	Feb 2009*	After Aug 2009

Tetrachlo-roethylene

127-18-4	After Aug 2009	After Aug 2009	After Aug 2009

Trichloro-ethylene

79-01-6	Jan 2009*	Mar 2009*	After Aug 2009

*Estimated date.

5(b)	Collection Methodology and Management

Data collected under the VCCEP are received by the TSCA Nonconfidential
Information Center (NCIC), and a copy is placed in the official docket
(OPPTS-00274).   The NCIC transfers the data to the program manager in
the Office of Pollution Prevention and Toxics, Chemical Control Division
(CCD), Chemical Testing and Information Branch (CITB), where the data
are reviewed for completeness and then, depending on the data received,
routed as follows:

- Letters of Commitment are routed to the person in CITB assigned to
track the progress of the VCCEP and update the VCCEP website.

-Peer Consultation Documents are routed to the organization that manages
the Peer Consultation (one copy), to the person in CITB maintaining the
VCCEP files (one copy and the electronic copy), and to the OPPT
workgroup that drafts the Data Needs Decision (one copy).

- Peer Consultation meeting reports prepared by the organization that
manages  the Peer Consultation are routed to the person in CITB
maintaining the VCCEP files (one copy) and to the OPPT workgroup that
drafts the Data Needs Decision (one copy).

- EPA’s Data Needs Decision document is routed to the person in CITB
maintaining the VCCEP files (one copy), and to the OPPT workgroup that
drafted the November 9, 2005 Data Needs Decision (one copy).

The Peer Consultation Document prepared by the sponsor for Tier 1
contains hazard, exposure, risk, and data needs assessments.  The
sponsor presents its assessments to the Peer Consultation that will then
discuss the assessments with emphasis on the data needs assessment. 
TERA, the third party scientific organization that has arranged and
facilitated the meeting, summarizes the results of the Peer Consultation
meeting and sends a report to EPA and the sponsor.  EPA reviews the
third party’s report and the Peer Consultation Document and decides
whether any information from the next tier is needed to assess the risks
to children of the chemical in question.  EPA announces any data needs
on the VCCEP website and in a letter to the sponsor.  If EPA’s
decision differs substantially from the meeting report of the
organization that manages the Peer Consultation, EPA provides an
explanation for its decision.  There is a 4-month period for the sponsor
or others to volunteer to provide the data requested in Tier 2 or Tier
2/3.  The steps in Tier 1 are repeated for Tier 2; the steps in Tier 1
are repeated in Tier 2/3 and in Tier 3 up to but not including a Data
Needs Decision.  At the end of Tier 2/3 or Tier 3 or if EPA decides that
sufficient data have been provided at the end of Tier 1 or Tier 2 to
evaluate risk to children, EPA and the sponsor may use the data in risk
management activities, if necessary.  To date, EPA has collected data in
other testing programs that have been used to support such activities as
the development of water quality criteria, hazardous waste listings,
chemical advisories, and reduction of workplace exposures.

For the chemicals identified for evaluation as part of the VCCEP pilot,
the specific data requested at Tier 1, the data that might be requested
at Tiers 2, 3, or 2/3 (which will not be known with certainty until EPA
issues its Data Needs Decisions), the guideline requirements for
conducting any needed tests, the time frame for completing the
testing/data collection, and the time frame for submitting a Peer
Consultation Document to the Agency were established in the notice
announcing the VCCEP (65 FR 81700, December 26, 2000).

Participants in the VCCEP will submit some information electronically to
allow EPA to respond to public requests for information more
efficiently.  EPA requests one electronic copy and 2 hard copies of the
Peer Consultation Document for each chemical at each tier(s) committed
to. The organization that manages the Peer Consultation must also be
sent one electronic copy of the Peer Consultation Document. If a Peer
Consultation Document were developed for each of the 20 pilot VCCEP
chemicals and 12 ChAMP chemicals for each of the three tiers there could
be as many as 96 electronic submissions ((3 x 20) + (3 x 12)).  EPA
already knows, however, that 6 pilot VCCEP chemicals will have only Tier
1 information submitted, reducing the maximum number of electronic
submissions of Peer Consultations Documents to 84 (96 – (6 x 2)).

5(c)	Small Entity Flexibility

Under the VCCEP, no company, including small businesses, is required to
participate.  Any small businesses that do participate will likely do so
as part of a consortium.  Participation in a testing consortium relieves
the small business of sole responsibility for collecting or submitting
test information, while still allowing the small business to participate
in the program.

5(d)	Collection Schedule

This information collection activity does not involve more than one
submission per activity.  Needed testing is conducted only once, and
each related submission is a one-time on-occasion submission.  The time
to complete each tier of testing/data collection is based on the test in
that tier that requires the longest time to complete.  An additional
four months can be requested to complete the Exposure Assessment, Risk
Assessment, and Data Needs Assessment for each tier.  Following, in
Table 4, are the times that EPA believes are reasonable to complete each
test, if needed, in the VCCEP.  It is assumed that tests in the same
tier or combined tier (i.e., Tier 2/3) will be conducted simultaneously.

Table 4.--Time Allowed to Conduct Toxicology Test and Prepare Final
Report

Test	

Months 

Acute oral toxicity (up/down) OR Acute inhalation toxicity 	

18

In vitro gene mutation: Bacterial reverse mutation assay	

18

In vitro chromosomal aberrations	

18

90 Day subchronic in rodents	

18

Reproduction and fertility effects	

29

Prenatal developmental toxicity (two species)	

12

In vivo mammalian bone marrow chromosomal aberrations, OR in vivo
mammalian erythrocyte micronucleus	

16

Immunotoxicity	

121

Metabolism and pharmacokinetics	

12

Carcinogenicity OR chronic toxicity/carcinogenicity	

60

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.

6	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

Overview

This section presents the assumptions and methods that were used to
estimate the burden and costs for this ICR covering August 2009 through
July 2012, along with a summary of the cost and burden calculations. 
If, in the context of implementing the VCCEP, the Agency determines that
the total annual burden covered by this ICR needs to be revised, it will
submit an Information Correction Worksheet (ICW) to amend the total
annual burden for this ICR in the OMB inventory.

Assumptions

The estimated burden and costs to the Federal Government and to the
respondents are based on the assumptions listed below.  These
assumptions are based on historical experience with the TSCA testing and
information gathering programs, conservative projections for the VCCEP
and its pilot over the period August 2009 through July 2012, and the
progress made in information collection from October 2002 through July
2009 (described in Units 4(d) and 5(a)).  EPA would like to stress that
these assumptions are used only to estimate burden and costs that are
presented in this ICR and should not be considered to be a presumption
of testing needs.  The need for testing will be science driven and
testing will be required only to the extent that it is reasonably
necessary to characterize potential health risks to children.

It is important to note that the first ICR assumed that the entire VCCEP
pilot would be completed in the three-year ICR period.  As stated in
section 4(d) and 5(a), 3 of the 20 pilot chemicals were not completed in
the six years of the first and second ICRs.  Although EPA believes that
the remaining 3 pilot chemicals will be completed during the third ICR,
along with several new chemicals from ChAMP, the estimates of cost and
burden in this ICR should be seen as extremely conservative.  See also
Assumption 4.

EPA assumes that data will be collected on 20 chemicals during the
course of the VCCEP pilot.  Although 23 chemicals had been selected for
the VCCEP pilot, thus far only 20 chemicals have been sponsored. 
Thirty-five companies acting through ten consortia are the sponsors. 

Of the 20 pilot VCCEP chemicals listed in Tables 2 and 3, the Tier 1
information collection was addressed or is expected to be addressed for
18 chemicals by the end of the second ICR. Data Needs Decisions will
have been issued for 15 chemicals before the expiration date of the
second ICR.  To date, i.e., June 2008, Data Needs Decisions for 13
chemicals have been issued and 6 of the 13 chemicals have been
determined to have sufficient data to characterize their risk to
children based on the Tier 1 information collection.  Additional
information has been requested for 7 of the 13 chemicals, but, to date
has not been provided or no commitment has been received. 

Although EPA also assumes that the Tier 1 Peer Consultation Document
will be completed for the other 3 of the 18 chemicals (listed in Tables
2 and 3 and below) and 3 ChAMP chemicals by the end of the second ICR,
EPA assumes that Data Needs Decisions for these 6 chemicals will not be
issued during the effective period of the second ICR.

 

alpha-Pinene (CAS No. 80-56-8)

p-Dichlorobenzene (CAS No. 106-46-7)

Trichloroethylene (CAS No. 79-01-6)

EPA assumes that sponsors of the remaining two pilot VCCEP chemicals,
listed below, will begin and complete the entire three-tier process or
be judged to have sufficient data short of the three tiers during the
effective period of the third ICR, i.e. from August 2009 through July
2012:

		Ethylene dichloride (CAS 107-06-2)

	Tetrachloroethylene (CAS No. 127-18-4)

EPA understands that the initiation of VCCEP testing of ethylene
dichloride and tetrachloroethylene has been delayed pending the release
of ongoing evaluations by ATSDR and NAS, respectively.

5)	EPA assumes that 5 to 10 chemicals will be referred from the ChAMP
per year for consideration to be evaluated in VCCEP between July 2008
until the end of the third ICR(July 2012), but that only 3 chemicals per
year will be accepted for evaluation in VCCEP. It should be noted, that
“3 chemicals per year” is only an estimate due to the lack of
experience with ChAMP at this point in time.

6)	EPA assumes that the work to be addressed during the period of the
third ICR will include: 

The preparation and submission of 11 Tier 1 Peer Consultation Documents
(and likely subsequent revisions) for Ethylene Dichloride,
Tetrachloroethylene, and 9 ChAMP chemicals by the sponsors.

The preparation and submission of 11 Tier 1 Peer Consultation meeting
reports covering 11 chemicals (Ethylene Dichloride, Tetrachloroethylene,
and 9 ChAMP chemicals) by the organization that manages the Peer
Consultation. 

The preparation of 17 Tier 2 Data Needs Decisions for alpha-Pinene,
p-Dichlorobenzene, Trichloroethylene, Ethylene Dichloride,
Tetrachloroethylene, and 12 ChAMP chemicals by EPA, as the last step in
Tier 1.

The conduct of Tier 2 tests and information collection for 17 chemicals.
  The “17 chemicals” come from the 26 chemicals that will at some
point reach Tier 2 during the period of the 3rd ICR; those 26 chemicals
are alpha-Pinene, p-Dichlorobenzene, Trichloroethylene, Ethylene
Dichloride, Tetrachloroethylene, 12 ChAMP chemicals), 7 VCCEP chemicals
with previously identified, but not provided Tier 2 data needs, and 2
pilot VCCEP chemicals with yet to be announced (as of June 2008) Tier 2
tier data needs.  Of the 26 chemicals, 7 are known to have Tier 2 data
needs and it is assumed that of the remaining 19 (26 – 7), 50% or 10
will have Tier 2 data needs, making a total of 17 chemicals (7 + 10).

The preparation and submission of 17 Tier 2 Peer Consultation Documents
(and likely subsequent revisions) by the sponsors.  

The preparation and submission of 17 Tier 2 Peer Consultation meeting
reports covering 17 chemicals by the organization that manages the Peer
Consultation. 

The preparation of 17 Tier 3 Data Needs Decisions by EPA, as the last
step in Tier 2.

The conduct of Tier 3 tests and information collection for 9 chemicals. 
 The “9 chemicals” come from the 17 chemicals that were in Tier 2
during the period of the 3rd ICR.  Of the 17 chemicals, it is assumed
that 50% or 9 will have Tier 3 data needs, making a total of 9 chemicals
which may be in Tier 3 during the period of the 3rd ICR.

The preparation and submission of 9 Tier 3 Peer Consultation Documents
(and likely subsequent revisions) by the sponsors.  

The preparation and submission of 9 Tier 3 Peer Consultation meeting
reports covering 9 chemicals by the organization that manages the Peer
Consultation. 

7)	The assumptions provided in this ICR renewal are a conservative
estimate of the cost and burden associated with the VCCEP and its pilot.
 In the event that fewer than 32 chemicals (20 pilot chemicals and 12
ChAMP chemicals) complete the program, or some of the chemicals do not
participate to the degree assumed, then the total cost and burden will
be less than estimated here.  Additionally, if, as is assumed, the
process for any of the 32 chemicals lasts beyond the expiration date of
the third ICR, then the total burden and cost will be extended over a
longer time frame, thus reducing the annual burden and cost of the
program.

8)	One or several chemicals may be sponsored by one company or a 
consortium representing several companies.  For purposes of this ICR,
however, EPA assumes that the VCCEP program will have one respondent per
chemical.  That one respondent will represent a company or consortium of
companies that manufacture the chemical.  Thus, the total number of 
respondents for the pilot VCCEP will be no more than 20 and no more than
12 for the ChAMP chemicals to be evaluated in VCCEP, for a total of 32
respondents.

9)	The three tiers of tests listed in Table 1 of this ICR allow sponsors
to choose among a number of test guidelines.  EPA has assumed that, as a
default, sponsors will conduct tests defined at 40 CFR 799 (i.e., the
799 series).  In cases where sponsors have a choice between more than
one 799 series test, EPA assumes that sponsors will choose the lower
cost test.  In cases where EPA did not have cost and burden estimates
for a 799 series test, EPA assumes that sponsors will choose the
least-cost test from among the alternative test guidelines for which
cost and burden data are available.  Details on the default testing
assumptions can be found in Table 5.

10)	For the 90-day subchronic toxicity test in Tier 2, three 	routes of
exposure are possible (inhalation, oral, dermal). Although many VCCEP
chemicals have multiple potential routes of exposure relevant to total
dose, EPA expects that sponsors will	conduct the test using the one
route most relevant to 	expected exposure.  Considering that the VCCEP
chemicals are expected to be present in indoor air, drinking water, or
breast milk, EPA assumes that 67% of the subchronic tests will be
conducted by inhalation (guideline 799.9346), and 33% will be conducted
by the oral route of administration (870.3100).  (EPA made no such
assumption about route for the acute toxicity test in Tier 1 because the
testing is assumed to have already been completed.)

11)	Each respondent must submit one letter of commitment, and one Peer
Consultation Document for each chemical they have committed to for each
Tier or combined Tiers.  The Peer Consultation Document (PCD) contains a
hazard assessment, an exposure assessment, and a risk assessment.  The
PCDs for Tiers 1 and 2 also contain data needs assessments. An initial
review by the Peer Consultation may recommend that the document be
revised before being evaluated by EPA.  At this point, the sponsor will
revise and resubmit his Peer Consultation Document.

12) 	In conducting any test that will be submitted to EPA under TSCA,
the respondent 	must comply with Good Laboratory Practice Standards
(GLPS).  Because the 	GLPS represent basic standard practices used by
laboratories, any burden and 	costs related to GLPS are fully captured
in the laboratory cost and burden 	estimates provided in Table 5.

13)	EPA assumes that all of the chemicals have Tier 1 test data 
available through the EPA High Production Volume (HPV) Challenge
program, the OECD SIDS program, or the ChAMP.

14)	EPA assumes some of the Tier 2 and Tier 3 tests identified in Table
1 of this ICR have been conducted for some of the VCCEP 	pilot chemicals
and the chemicals to be added to VCCEP.  EPA used a baseline testing
rate to estimate the number of chemicals needing specific tests (see
Laboratory Costs and Burdens in Section 6(a)).  EPA does not calculate
test costs for chemicals assumed to have already been tested.

15)	Judging from the VCCEP experience discussed in Unit 5(a), EPA
estimates that 50% of the chemicals in the pilot will move on to the
Tier 2 or 2/3 chemical assessment, and 50% which have had a Tier 2
assessment will require Tier 3.  Again, EPA stresses that these
assumptions are used only to estimate burden and costs that are
presented in this ICR and should not be considered to be a presumption
of testing needs.  The need for testing will be determined through the
VCCEP process.

16)	For estimating the burden and costs for conducting the testing, EPA
used 	available information regarding the price that a laboratory would
charge for 	conducting the test.  Some respondents, however, may use
their own facilities to 	conduct the testing.

17)	The programs established for the VCCEP and HPV Challenge chemicals
are voluntary initiatives under which manufacturers (including
importers) of chemicals targeted for information gathering and possible
testing will voluntarily submit data on hazard endpoints; the VCCEP also
includes exposure, risk, and data needs information.

18)	For purposes of this ICR, EPA estimates that participants conducting
tests for the VCCEP would incur roughly the same costs and burdens that
they would incur if the chemicals were subject to a TSCA section 4 rule,
but would not submit study plans or progress reports and would not
submit full study reports to EPA unless specifically requested to do so.
 Instead, study results would be submitted in the robust summary format.
 In addition, to determine which endpoints need to be tested, VCCEP
participants would most likely undertake a search for any existing
studies for each chemical, and include them in the robust summaries. 
The costs and burden associated with these data searches are included as
reporting costs and are described below under Reporting Costs and
Burdens.

Due to the 2008 program changes, the cost of the organization that
manages the Peer Consultation process is expected to be paid by the
sponsors for half of the Peer Consultations. 

Based on previous requests for comment, EPA estimates that any future
poll of VCCEP participants and stakeholders for their opinions on
VCCEP-related matters will result in 6 to 12 responses (average of 9)
when there are 20 chemicals in the program.  A response may vary from 1
to 10 pages (average of 4).

6(a)	Respondent Cost and Burden

For purposes of calculating the PRA paperwork-related burden and costs
for this ICR, the Agency estimated costs for both non-paperwork burdens
(e.g., laboratory testing costs) and paperwork burdens (e.g.,
administrative costs and burden) participants will incur in the program.
 For costs such as the laboratory testing costs, only a portion of the
total cost may be attributed to the paperwork-related requirements
(i.e., reporting burden) that EPA imposes on the participants.  EPA is
presenting all costs, not just paperwork or reporting burden, in the
ICR.

The unit burden for each activity is based upon previous TSCA section 4
ICRs and EPA’s best estimates of the burdens that will be incurred
under the VCCEP over the next three-year period.  Loaded hourly labor
rates, including fringe costs and overhead are $60.29 for management
time, $51.95 for technical time, and $25.82 for clerical time.  These
labor rates adhere to the latest Bureau of Labor Statistics (BLS) data
and are summarized as follows:

INDUSTRY LABOR CATEGORY	

LOADED HOURLY RATE ($2008)

  Managerial

  Technical

  Secretarial	

$60.29

$51.95

$25.82

Based upon the assumptions and labor rates discussed above, various
factors can be derived that are employed to estimate total costs and
burdens for the respondents.  These factors are presented in the
sub-sections that follow.

Number of Respondents

The Agency assumes that each chemical will have one respondent: a
company or consortium of companies that manufacture (including import)
the chemical.  Thus, there will be 20 total respondents for the VCCEP
and 12 for ChAMP.  EPA recognizes, however, that more than one entity
may participate in the VCCEP, and that the participation of these
“non-respondents” may not be reflected in the burden and cost
estimates for the respondent.  For example, whenever more than one
entity form a consortium to provide the requested data, only one entity
may experience the full burden of data gathering and submission as
estimated here, but the other entities still experience some burden and
costs related to their participation in the consortium, described below.
 At this time, a total of 45 entities (35 pilot chemical companies and
10 pilot chemical consortia) are participating in the VCCEP. 

Types of Costs and Burdens

The following discussion presents estimates of the costs and burdens of
each of the main categories of collection activities that will be
undertaken in response to the VCCEP: laboratory cost and burdens (hazard
assessments), administrative costs and burdens, exposure assessments,
risk assessments, data needs assessments, preparing the peer
consultation document, presenting the assessments at public meetings,
and responding to VCCEP surveys.  EPA’s estimated costs and burdens
for each of these respondent activities are discussed below.

Laboratory Costs and Burdens (Hazard Assessments)

Each chemical that is sponsored in the VCCEP pilot is expected to be
evaluated by performing the tests specified for each tier, unless there
are adequate existing data for one or more of the endpoints addressed by
tests in that Tier.  Table 1 of this ICR provides the list of possible
tests.  As can be seen in Table 1, sponsors have some choice in the
tests that are conducted.  As noted above, EPA assumes that sponsors
will choose the least-costly test among the alternatives listed in Table
1.  In preparing the estimates for this ICR, EPA used the costs of the
testing alternative based on 799 series as a default, and has not
attempted to develop costs for all of the alternatives.  Assumptions
about routes of administration are discussed under Assumption 7 above. 
Table 5 summarizes EPA’s assumptions regarding which test protocol
will be chosen for each testing requirement in Table 1, as well as the
cost and burden estimate for those protocols.  Costs and burden for the
protocols are best estimates taken from a database EPA generates and
maintains.  As mentioned previously, laboratory testing costs are not
paperwork costs under the PRA, but are presented for completeness.

EPA expects that at least some of these chemicals will already have been
subjected to a number of these tests.  EPA used information gathered in
preparing the draft Children’s Health Proposed Test Rule to determine
the number of chemicals that could require each specific test.  Table 5
presents EPA’s estimate of the percentage of chemicals that have
undergone each test from the draft Children’s Health Proposed Test
Rule analysis (i.e., the baseline testing rate in Table 5).  EPA assumes
that these percentages can be applied in this analysis.  Using this
information, the number of chemicals requiring a specific test is
calculated by multiplying the baseline testing rate by the number of
chemicals participating in that Tier and then subtracting the result
from the total number of chemicals for each tier.  As noted above, EPA
has assumed that all chemicals have Tier 1 testing data.

For each protocol, the total testing cost is calculated by multiplying
the cost per test by the number of chemicals for that protocol.  Total
laboratory costs of the ICR are estimated to be $23.1 million and
210,253 hours of labor over the three-year ICR period.  EPA estimates
that a total of 59 studies (equal to the total number of chemical tests
conducted under all tiers) will be conducted over the three-year ICR
period.  The average laboratory cost is $392,181 per study ($23.1
million / 59 studies).

Once a study is complete, sponsors are required to develop a robust
summary of the results.  A robust summary must also be developed for
each available, adequate study that addresses endpoints in any of the
three tiers, but EPA assumes that robust summaries have already been
developed for Tier 1 tests.  Therefore, the number of robust summaries
to be developed will equal the number of tests in Tier 2 multiplied by
17 chemicals (6 tests * 17 chemicals = 102) plus the number of tests in
Tier 3 multiplied by 9 chemicals (3 tests * 9 chemicals = 27), for a
total of 129 robust summaries.  EPA assumes that the robust summaries
will require 15 hours of technical time and 5 hours of clerical time. 
Based on this assumption, EPA estimates that robust summaries will
impose a burden of 2,580 hours and $117,177 over the same period.

Administrative Costs and Burdens

Part of the administrative costs and burdens associated with this ICR
include preparing letters of commitment and performing data searches and
reviews.  EPA has summarized its estimates for these categories in Table
6, and discusses each below.

For letters of commitment, EPA assumed that each sponsor would submit
one letter for each tier.  Thus, a total of 26 letters would be received
over the three-year ICR period (17 in Tier 2, plus 9 in Tier 3; Tier 1
is completed).  Consistent with other TSCA ICRs, EPA assumed that
submitting these letters would impose a burden of four hours of
technical labor for each submission.  This implies a total burden of 104
hours and $5,403 over the three-year ICR period.  These costs and burden
hours are considered reporting burdens by EPA.

Table 5.  The VCCEP Test Battery

Protocol Name	Protocol Number	Cost Estimate Per Test	Lab Burden Per Test
(Hours)	Baseline Testing Rate	Number of Chemicals Needing Test a,b,c,d
Total Testing Cost	Total Testing Burden (Hours)

Tier 1: 11 Chemicals participating	 	 	 	 	 	 	 

1	Acute inhalation toxicity	OECD 403	 $          18,740 	184	100%	0	 $  
               -   	               -   

2	In vitro gene mutation: Bacterial reverse mutation assay	799.9510	 $  
         9,404 	61	100%	0	 $                  -   	               -   

3	Repeated dose oral toxicity	OECD 407	 $          51,708 	328	100%	0	 $
                 -   	               -   

4	In vivo mammalian erythrocyte micronucleus	799.9539	 $          19,291
	132	100%	0	 $                  -   	               -   

 	TOTAL FOR TIER 1

 $          99,143 	705

0	 $                 -   	               -   

Tier 2: 17 Chemicals participating

 

 	 

1	90-day subchronic toxicity in rodents	870.3100	 $        133,726 	757
81.8%	1[c]	 $         133,726 	             757 

799.9346	 $        388,807 	2,458	81.8%	2[d]	 $         777,614 	       
  4,916 

2	Preproduction and fertility effects	799.9380	 $     1,052,082 	9,449
29.5%	12	 $     12,624,984 	       113,388 

3	Prenatal developmental toxicity (two species)	799.9370	 $       
112,565 	1,079	38.6%	10	 $       1,125,650 	        10,790 

4	In vivo mammalian erythrocyte micronucleus	799.9539	 $          19,291
	132	81.8%	3	 $           57,873 	             396 

5	Immunotox	870.7800	 $          80,703 	415	31.8%	12	 $         968,436
	          4,980 

6	Metabolism and pharmacokinetics	870.7485	 $          40,227 	330	90.9%
2	 $           80,454 	             660 

 	TOTAL FOR TIER 2

 $     1,827,401 	14,620

42	 $    15,768,737 	      135,887 

Tier 3: 9 Chemicals participating

 

 	 

1	Carcinogenicity	799.9420	 $     1,603,145 	17,953	68.2%	3	 $      
4,809,435 	        53,859 

2	Neurotoxicity screening battery	799.9620	 $        127,268 	883	45.5%
5	 $         636,340 	          4,415 

3	Developmental neurotoxicity	870.6300	 $        213,798 	1,788	4.5%	9	
$       1,924,182 	        16,092 

 	TOTAL FOR TIER 3	 	 $     1,944,211 	20,624

17	 $      7,369,957 	        74,366 

GRAND TOTALS	 	 	 	 	59	 $     23,138,694 	       210,253 

a  These numbers also represent the number of studies that would be
conducted

b  To calculate the number of tests for any tier, EPA multiplied the
baseline testing rate by the number of chemicals in that tier, and then
subtracted the result from the number of chemicals in that tier.

c  To calculate the number of tests performed in Tier 2 by the oral
route, EPA multiplied the number of chemicals needing testing (3) by 33
percent, per assumption 10.

d  To calculate the number of tests performed in Tier 2 by inhalation,
EPA multiplied the number of chemicals needing testing (3) by 67
percent, per assumption 10.



Table 6. Administrative Costs and Burden

Category	

Letters of Commitment 	

Data Searches	

TOTAL

Tier 2

Number	17	51	68

Burden 	68	1,641	1,709

Cost	$ 3,533	$ 84,038	$ 87,571

Tier 3

Number	9	27	36

Burden 	36	869	905

Cost	$ 1,870	$ 44,491	$ 46,361

TOTALS

Number	26	78	104

Burden 	104	2,509	2,613

Cost	$ 5,403	$ 128,529	$ 133,931

To estimate the cost and burden of performing data searches, EPA assumes
that two firms per chemical would search their internal records and one
sponsor per chemical would perform an external search of the literature
(i.e., a total of three searches per chemical per Tier).  The assumption
of two firms per chemical is based on the fact that 35 companies are
currently involved in sponsoring 20 chemicals; with the possibility that
more could join, rounding up to two seems prudent.  Based on this, EPA
estimates that 51 searches will occur for Tier 2 and 27 searches will
occur under Tier 3.  This results in a total of 78 data searches over
the three-year ICR period.  Following previous testing ICRs, EPA assumes
that firm’s searches require 17.75 burden hours per search.  This
includes 3 hours of managerial time for corporate review, 9 hours of
technical time for a file search, one hour of clerical time for a
summary sheet, 1.75 hours of clerical time for reproduction, and 3 hours
of managerial time for a CBI review.  The sponsor-level searches require
61 hours: 60 hours of technical time for an external records search and
one hour of clerical time for a summary sheet.  Based on these
assumptions, EPA estimates that data searches will impose a burden of
2,509 hours and $128,529 over the three-year ICR period.  This is a
non-reporting burden.

Other non-reporting administrative activities include the effort of
respondents to organize a testing program, obtain and review bids from
laboratories that would conduct the testing, and prepare and submit
samples to the laboratory for testing.  EPA’s experience in test rule
development has shown that these administrative costs and burdens
associated with testing programs to be approximately 25 percent of the
laboratory costs.  EPA applied this assumption to the Tier 2 and 3
estimates (Tier 1 testing is assumed to be complete).  Under EPA’s
standard 25 percent assumption, the cost estimate per test is used to
calculate the cost of the paperwork or administrative burden associated
with conducting that test.  EPA typically states that this is the data
generation paperwork costs and calculates the burden by dividing the
loaded hourly rate for the technical person into it.  For example, if
the test cost is $100,000, then the paperwork/administrative costs are
$25,000, and the paperwork burden is 481 hours ($25,000 / $51.95 per
hour)

From Table 5, Tiers 2 and 3 testing involve a total cost of $23.1
million and 210,253 hours.  To calculate total administrative costs
(reporting plus non-reporting administrative) for Tiers 2 and 3, EPA
multiplies each estimate by 25 percent to get $5.8 million and 52,563
hours over the three-year ICR period.  Because these activities are only
undertaken at the discretion of the individual respondent and are not
part of the Agency’s testing program, these estimates are only being
provided for completeness, and are not attributable as reporting burden
and costs for the purposes of this ICR.  Additionally, the Exposure
Assessment and Risk Assessment (see below) also impose some
non-reporting administrative costs and burdens.  In the summary tables
below, EPA combines the non-reporting administrative costs and burdens
estimated here with those that are estimated for the Exposure Assessment
and Risk Assessment.

In addition, to account for initial participation burden for
non-respondents, EPA estimated that the level of effort for the typical
activities associated with initial participation in a consortium might
be reasonably represented by an estimate of 21 hours, representing 4
hours for management ($241.16), 16 hours for technical ($831.20) and 1
hour for clerical ($25.82).  With 45 entities currently participating in
the program, the total burden for this activity would be 945 hours (21
hours * 45 participants), with a cost of $49,418 ($1,098.18 * 45).  This
is also considered a non-paperwork burden.

Exposure Assessments

EPA has estimated the labor hours and costs associated with exposure
assessments by soliciting information from within the Agency and from
several of its contractors that have experience in performing exposure
assessments that are similar in scope and complexity to the exposure
assessment need defined in the Federal Register notice for the VCCEP
pilot.  Based on this information, EPA has estimated that a Tier 1
exposure assessment would require 500 labor hours, a Tier 2 assessment
would require 1,000 labor hours, and a Tier 3 assessment would require
1,200 labor hours.  Furthermore, EPA has assumed that 85 percent of
those hours are for technical labor, 10 percent are for clerical labor,
and 5 percent are for managerial labor.  Thus, over the three-year ICR
period, 37 exposure assessments will take place (11 remaining in Tier 1,
17 in Tier 2, plus 9 in Tier 3).  Table 7 summarizes EPA’s estimates
for exposure assessments for the VCCEP pilot.  Based on EPA’s
information, the exposure assessment for the VCCEP pilot will result in
a three-year burden of 33,300 hours and $1.7 million.

A sponsor typically hires a contractor to conduct an exposure
assessment, but EPA still considers the total cost of the assessment as
paperwork burden and costs.  EPA also assumes that the exposure
assessment will impose some non-reporting administrative costs and
burdens.  As with testing costs, EPA estimates that these costs and
burdens will amount to 25 percent of the estimated cost for performing
the Exposure Assessment, or 8,325 hours and $414,202 over the three-year
ICR period.  In the summary tables below, EPA includes these estimates
in the non-reporting administrative costs category with similar costs
for the hazard assessment (testing) and risk assessment.

Table 7. Burden and Cost Estimates for Exposure Assessments and Risk
Assessments

Requirement/

Tier	

Burden Per Chemical	

Total 

Burden [a]	

Total 

Cost [b]

	

Technical Labor	

Clerical Labor	

Management

Labor	

TOTAL

Exposure Assessment

Tier 1	

425	

50	

25	

500	5,500	 $ 273,647 

Tier 2	

850	

100	

50	

1,000	17,000	 $ 845,818 

Tier 3	

1,020	

120	

60	

1,200	10,800	 $ 537,343 

Total	33,300	$ 1,656,808

Risk Assessment

Tier 1	

255	

30	

15	

300	       3,300 	 $ 164,188 

Tier 2	

425	

50	

25	

500	       8,500 	 $ 422,909 

Tier 3	

510	

60	

30	

600	       5,400 	 $ 268,672 

Total	

17,200	

$855,769

[a] Total burden is calculated by multiplying the total burden per
chemical by 11 chemicals for Tier 1, 17 chemicals for Tier 2, and 9
chemicals for Tier 3.

[b] Total cost is calculated by multiplying the burden per chemical for
each labor category (technical labor, clerical labor, and managerial
labor) by the category’s loaded hourly rate ($51.95 for technical
labor, $25.82 for clerical labor, and $60.29 for managerial labor),
adding, and then multiplying by 11 chemicals for Tier 1, 17 chemicals
for Tier 2, and 9 chemicals for Tier 3.

Risk Assessments

EPA has also estimated the labor hours and costs associated with risk
assessments by soliciting information from within the Agency and from
several of its contractors that have experience in performing risk
assessments that are similar in scope and complexity to the requirement
defined in the Federal Register notice for the VCCEP. Based on this
information, EPA has estimated that a Tier 1 risk assessment would
require 300 labor hours, a Tier 2 assessment would require 500 labor
hours, and a Tier 3 assessment would require 600 labor hours.  As with
the exposure assessment, EPA has assumed that 85 percent of those hours
are for technical labor, 10 percent are for clerical labor, and 5
percent are for managerial labor.  Thus, over the three-year ICR period,
37 risk assessments will take place (11 remaining in Tier 1, 17 in Tier
2, and 9 in Tier 3).  Table 7 also summarizes EPA’s estimates for risk
assessments for the VCCEP pilot.  Based on EPA’s information, the risk
assessment for the VCCEP will result in a three-year burden of 17,200
hours and $855,769.

A sponsor typically hires a contractor to conduct a risk assessment but
EPA still considers the total cost of the assessment as paperwork burden
and costs.  EPA also assumes that the risk assessment will impose some
non-reporting administrative costs and burdens. EPA assumes that these
costs and burdens will represent 25 percent of the estimated cost for
performing the risk assessment, or 4,300 hours and $213,942 over the
three-year ICR period.  In the summary tables below, EPA includes these
estimates in the non-reporting administrative costs category with
similar costs for the hazard assessment (testing) and exposure
assessment.

Data Needs Assessment

The data needs assessment for the VCCEP program involves identifying the
additional hazard and/or exposure information that is needed to
adequately assess the potential risks to children and, where
appropriate, parents.  The data needs assessment is expected to be
submitted with Tiers 1 and 2, but not with Tier 3.  Thus, a total of 28
data needs assessments will be prepared and submitted under the ICR (11
chemicals in Tier 1 plus 17 chemicals in Tier 2).

To estimate the costs associated with this activity, EPA assumed that
the burden would be proportional to the time that sponsors spend on the
hazard, exposure, and risk assessments because the data needs assessment
is derived from these three other assessments.  EPA further expects that
the time for this activity would represent only a small proportion of
the total time for the three other assessments.  EPA bases this
assumption on the fact that the skilled technical professionals who will
conduct the hazard, exposure, and risk assessments should be able to
spot data gaps for each chemical.  Thus, EPA assumes that the data needs
assessment will represent two percent of the total hours spent on the
three other assessments and that all of the hours will be for technical
labor.  From Tables 5 and 6, hazard assessments, exposure assessments,
and risk assessments are estimated to impose 170,187 hours for Tiers 1
and 2.  Based on the two-percent assumption, the data needs assessment
will impose a burden of 3,404 hours over the three-year ICR period. 
Assuming all of this labor is technical labor results in a three-year
cost of $176,824 (3,404 * $51.95).

Peer Consultation Document

EPA assumes that the Peer Consultation Document (PCD) will not involve
any significant additional time.  The PCD is a compilation of the hazard
assessment, exposure assessment, risk assessment, and data needs
assessment.  The costs associated with these activities have already
been accounted for above.  EPA expects that respondents will develop
each of these components in a manner that can be readily combined into
the Peer Consultation Document.

Present Assessments at Public Meetings

EPA has assumed that at each Tier, a sponsor will incur 50 burden hours
per chemical to complete this task.  To derive this estimate, EPA has
assumed that at least two persons per chemical will attend the public
meeting for each sponsor and that the meeting will require three days of
time (including preparation, travel, and attendance) from each person (2
persons * 3 days * 8 hours per day = 48 total hours).  EPA rounded the
estimate up to 50 hours.  Based on this assumption, this task will
involve a three-year burden of 1,850 hours (50 hours per chemical * 37
chemicals [11 chemicals remaining in Tier 1, 17 chemicals for Tier 2, 9
chemicals in Tier 3]).  Assuming all labor is technical labor results in
a three-year cost of $96,108.  In response to public comments on a
previous ICR, EPA has included travel costs to attend the public
meetings at $1,000 per person.  Travel costs would add $74,000 to the 
three-year costs ($1,000 per person * 2 persons per meeting * 37
meetings (11 remaining meetings for Tier 1, 17 for Tier 2, and 9
meetings for Tier 3).  Therefore, the cost of presenting assessments at
the public meetings would be $170,108 over three years.  These figures
represent a very conservative cost estimate (i.e., a likely
overestimate), as experience with the VCCEP has shown that some meetings
will cover two or three chemicals.

EPA VCCEP Surveys

As needed, EPA may poll or ask VCCEP participants and stakeholders to
comment on certain aspects of VCCEP.  EPA will most likely use the VCCEP
website and e-mail to request and receive comments.  As noted above, EPA
expects to receive an average of 9 responses averaging 4 pages in
length.  The burden associated with this task is limited to writing out
comments only. No time is assumed for data collection or analysis. Based
on best professional judgment, VCCEP participants are expected to spend
up to one hour composing each page of their comments.  Therefore, the
total three year burden is estimated to be 36 hours (9 responses * 4
pages per response * 1 hour per page).  Assuming all of this labor is
technical labor results in a three-year cost of $1,870 (36 * $51.95).

Total Cost and Burden

Table 8 summarizes the total and annual number of responses, costs, and
reporting burdens associated with the VCCEP pilot.  To derive the annual
estimates, EPA divided the relevant numbers by three years.  EPA
estimates that the VCCEP pilot will result in paperwork burdens of
53,220 hours and $2,637,027 over the three-year ICR period.  The
estimated annual industry reporting burdens for the VCCEP are 17,740
hours and $879,008.

EPA has also estimated other non-reporting burdens related to the
paperwork activities for testing, data searches, attending public
meetings, exposure assessments, risk assessments, the data needs
assessment, and non-reporting administrative tasks that respondents will
incur.  EPA estimates that these non-reporting burdens will total
284,149 hours and $30.0 million over the three-year ICR period, or
94,716 hours and $10.0 million annually.

Therefore, the total annual industry burden and costs associated with
this information collection are estimated to be 112,456 hours and $10.9
million.

Number of Responses

EPA estimates that the total number of responses (reporting burdens
only) for the VCCEP pilot will be 238 over the three-year ICR period, or
79 responses annually.  The average number of responses per respondent
is therefore 7.4 responses (238/32) over the three-year period (2.5
responses annually).  Additionally, the average response will take 224
hours (53,220 hours/238) at a cost of $11,080 ($2,637,027/238).

Table 8. Summary of Respondent Cost and Burden Estimates

ACTIVITY	

THREE-YEAR TOTALS	

ANNUAL TOTALS

	

Number	

Burden

Hours	

Costs	

Number	

Burden

Hours	

Costs

REPORTING BURDENS

Letters of commitment	26	104	$           5,403	9	35	$           1,801

Robust Summaries for Hazard Assessments	129	2,580	$       117,177	43	860
$         39,059

Exposure Assessments	37	33,300	$    1,656,808	12	11,100	$       552,269

Risk Assessments	37	17,200	$       855,769	12	5,733	$       285,256

EPA VCCEP Surveys	9	36	$           1,870	3	12	$              623

REPORTING TOTALS	238	53,220	$    2,637,027	79	17,740	$       879,008

NON-REPORTING BURDENS

Initial Burden	45	945	 $          49,418 	15	315	$         16,473

Hazard Assessments	59	210,253	 $   23,138,694 	20	70,084	$    7,712,898

File Searches	78	2,509	 $        128,529 	26	836	$         42,843

Non-Reporting Administrative [a]	133	65,188	 $     6,412,818 	44	21,729
$    2,137,606

Data Needs Assessment	28	3,404	 $        176,824 	9	1,135	$        
58,941

Public meetings	37	1,850	 $        170,108 	12	617	$         56,703

NON-REPORTING TOTALS	380	284,149	 $   30,076,390 	126	94,716	$ 
10,025,464

TOTAL BURDEN AND COSTS	618	337,369	 $   32,713,417 	205	112,456	$ 
10,904,472

Note: totals may not add due to rounding.

[a] Includes non-reporting administrative costs and burdens for hazard
assessments, exposure assessments, and risk assessments.

6(b)	Agency Cost and Burden

The cost and burden to the Agency to process, review, and analyze the
information collected under the VCCEP are discussed below and detailed
in Table 9.

EPA is assuming that the Agency collection activities will continue to
be performed by GS-14 Step 1 employees and GS-11 Step 1 employees.  The
U.S. Office of Personnel Management reports hourly rates for all GS
levels for 2007 in the Washington, DC area.  EPA added 60 percent to
these hourly rates to account for benefits and overhead burden.  Thus,
the 2007 loaded hourly rate for a GS-14, Step 1 employee is $71.94 and
for a GS-11 Step 1 employee is $42.70.  In addition, the final review
and final decision-making activities will be performed by GS-15 Step 1
employees.  The Office of Personnel Management 2007 hourly labor rate
for the Washington, DC area, plus 60 percent, results in a loaded hourly
rate of $84.61 for the GS-15 Step 1 employee.

AGENCY LABOR CATEGORY	

LOADED HOURLY RATE ($2007)

GS-15, Step 1	

$84.61

GS-14, Step 1	

$71.94

GS-11, Step 1	

$42.70

EPA employees will perform a number of activities under the VCCEP pilot
including: reviewing letters of commitment (GS-14), developing and
maintaining a system to track commitments (GS-14), responding to
sponsor’s questions/problems (GS-14), receiving and forwarding the
PCDs (GS-11), reviewing peer consultation reports (GS-14 and GS-15),
making final data needs decisions (GS-15), communicating program
results/status to public on website (GS-14 and GS-11), and overall
program management (GS-14).  These activities will account for
approximately 20% of the GS-14 employees’ time and 10% of the GS-11
employees’ time over the period of the ICR, or annually 400 and 200
hours respectively.  The final review and decision-making process will
require roughly 500 hours annually from the GS-15 employees.

In addition to the activities performed by EPA personnel, the Agency
expects to spend $250,000 annually on a third-party scientific
organization that will arrange peer consultations by relevant experts
who will review submissions by sponsors.  It is important to note that
while this figure represent funds that the Agency expects to expend on
cooperative agreements with contractors, EPA will not have direct
control over these contractors as it would for a typical contract
effort.  These cooperative agreements, while paid for by EPA, will
provide independent support for the VCCEP.

Table 9 summarizes EPA’s estimate.  Based on EPA’s assumptions, the
Agency activities will result in 3,300 labor hours over the three-year
ICR period and $1.0 million.  Of the total dollar amount, $750,000
represents costs associated with the Peer Consultation process, for
which no labor hours are estimated.

Table 9. Total Agency Cost and Burden Estimates, Three-Year ICR Period

COLLECTION ACTIVITY	

GS-15, Step 1	

GS-14, Step 1	

GS-11, Step 1	

GRAND TOTAL

	

HOURS	

COST	

HOURS	

COST	

HOURS	

COST	

HOURS	

COST

Receive PCDs	

1,500	

$126,912	

1,200	

$86,323	

    600	

$25,622	

3,300	

$238,858

Review Letters of Commitment

Track commitments

Respond to sponsors

Communicate results on website

Manage program

Poll VCCEP Participants 

Review Peer Consultation reports

Make data needs decision

Arrange Peer  Consultations	

	

	

NA	

NA	

NA	

NA	

NA	

$750,000

GRAND TOTAL	

	

	

1,200	

$86,323	

600	

$25,622	

3,300	

$988,858

6(c)	Bottom Line Annual Burden Hours and Costs & Master Tables

6(c)(i) 	Respondent Tally

Table 10 summarizes the average annual burden and cost per response. 
EPA estimates that this ICR will impose an average annual paperwork
burden of 225 hours on 79 annual responses over the three-year ICR
period, at an average annual cost of about $11,000.

Table 10. Average Annual Burden Hours Per Response

COLLECTION

ACTIVITY	

ANNUAL RESPONDENT BURDEN PER RESPONSE 

	

TOTAL

RESPONSES	

TOTAL

HOURS	

HOURS PER RESPONSE [a]	

TOTAL COST	

COST PER

RESPONSE [b]

REPORTING BURDENS

Letters of Commitment	9	35	3.9	 $         1,801 	 $             200 

Robust Summaries for Hazard Assessments	43	860	20.0	 $       39,059 	 $ 
           908 

Exposure Assessments	12	11,100	925.0	 $     552,269 	 $        46,022 

Risk Assessments	12	5,733	477.8	 $     285,256 	 $        23,771 

EPA VCCEP Surveys	3 	12 	4.0 	 $            623 	 $            208 

REPORTING TOTALS	79	17,740	224.6	 $     879,008 	 $        11,127 

NON-REPORTING BURDENS

Initial Burden	15	315	21.0	 $       16,473 	 $          1,098 

Hazard Assessments	20	70,084	3,504.2	 $  7,712,898 	 $      385,645 

File Searches	26	836	32.2	 $       42,843 	 $          1,648 

Non-Reporting Administrative	44	21,729	493.8	 $  2,137,606 	 $       
48,582 

Data Needs Assessment	9	1,135	126.1	 $       58,941 	 $          6,549 

Public meetings	12	617	51.4	 $       56,703 	 $          4,725 

NON-REPORTING TOTALS	126	94,716	751.7	 $10,025,464 	 $       79,567 

TOTAL BURDEN AND COST	205	112,456	548.6	 $10,904,472 	 $       53,193 

Note: Totals may contain some rounding error from previous tables

[a] = Total hours/Total responses

[b] = Total cost/ Total responses

6(c)(ii) Agency Tally

The burden hours and costs for the government have been calculated above
in Section 6(b).  These estimates are translated to annual estimates by
dividing each by three years.  The VCCEP will require 1,100 agency-hours
annually and $329,619.  Of the total cost, $250,000 is for peer review
consultations for which no hours have been estimated.  These estimates
are summarized below in Table 11.

Table 11. Summary of Agency Burden and Costs Estimates

COLLECTION

ACTIVITY	

TOTAL ANNUAL AGENCY BURDEN AND COSTS

	

BURDEN (Hours)	

COSTS

Receive PCDs	

1,100	

$79,619

Review Letters of Commitment

Track commitments

Respond to sponsors

Communicate results on website

Manage program

Review Peer Consultation reports

Make data needs decision

Arrange Peer Consultations	

NA	

$250,000

     GRAND TOTAL	

1,100	

$329,619

6(d)	Reasons for Change in Burden 

There is an increase of 6,200 hours (from 106,256 to 112,456 hours) in
the total estimated paperwork respondent burden in this information
collection compared with that identified in the information collection
last approved by OMB.  This increase represents the net effect of
changes in estimates and assumptions made since the previous VCCEP ICR
due to the inclusion of the ChAMP chemicals in the program as well as
the recent inclusion of VCCEP participant surveys.  

Estimates for respondent costs have also increased for the following
reasons.  Costs for the test protocols were increased based on the
most-recent EPA estimates.  Also, labor wage rates were updated
(increased) to current year dollars. 

6(e)	Burden Statement

The annual paperwork burden for this collection of information is
estimated to average about 225 hours per response.  According to the
PRA, “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.  For this collection,
“burden” 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.  An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a
currently valid OMB control number.  In addition, the OMB control
numbers for EPA’s regulations, after initial display in the Federal
Register, are listed in 40 CFR part 9, as well as in any applicable
collection instrument.

  SEQ CHAPTER \h \r 1 To comment on the Agency’s need for this
information, the accuracy of the provided burden estimates, and any
suggested methods for minimizing respondent burden, including the use of
automated collection techniques, EPA has established a public docket for
this ICR under Docket ID No. EPA-HQ-OPPT-2008-0816.  The docket is
available for public viewing at the Pollution Prevention and Toxics
Docket in the EPA Docket Center (EPA/DC).  The EPA/DC Public Reading
Room is located in the EPA West Building, Room 3334, 1301 Constitution
Ave., NW., Washington, DC.  The EPA/DC Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.
 The telephone number for the EPA/DC Public Reading Room is (202)
566-1744, and the telephone number for the Pollution Prevention and
Toxics Docket is (202) 566-0280.  An electronic version of the public
docket is available through the Federal Docket Management System (FDMS)
at     HYPERLINK "http://www.regulations.gov"  www.regulations.gov . 
Use FDMS to submit or view public comments, access the index listing of
the contents of the public docket, and to access those documents in the
public docket that are available electronically.  Once in the system,
select “search,” then key in the docket ID number identified above. 
Also, you can send comments to the Office of Information and Regulatory
Affairs, Office of Management and Budget, 725 17th Street, NW,
Washington, DC 20503, Attention: Desk Office for EPA.  Please include
the EPA Docket ID No. EPA-HQ-OPPT-2008-0816 and OMB control number
2070-0165 in any correspondence.

ATTACHMENTS

[NOTE: Unless otherwise noted, an electronic version of the listed
attachment appears in the electronic file for the ICR, following the
main text of the Supporting Statement.]

Attachment 1 ( Voluntary Children’s Chemical Evaluation Program;
Notice. 65 FR 81699, December 26, 2000.  For an electronic copy of this
notice go to http://www.epa.gov/chemrtk/vccep/pubs/ts00274d.pdf.

Attachment 2 ( Toxic Substances Control Act Section 4 (15 USC 2603)

Attachment 3 ( Procedures Governing Testing Consent Agreements and Test
Rules (40 CFR 790)

      In most instances, test sponsors have formed consortia through a
common trade organization (e.g., American Chemistry Council [formerly
the Chemical Manufacturers Association], Synthetic Organic Chemical
Manufacturers Association) to coordinate testing and preparation of
assessments.

      Guidance on Searching for Chemical Information and Data, May 1999
(http://www.epa.gov/opptintr/chemrtk/srchguid.htm).

      Labor rates are unpublished March 2008 data from BLS for private
industry workers.  The estimates include fringe benefits and 17%
overhead.

      For the 90-day subchronic toxicity in rodents study under Tier 2,
however, the number of chemicals requiring testing was divided among
those that would receive oral route testing (33 percent) and those that
would receive inhalation route testing (67 percent).  This adjustment is
explained in more detail in assumption number 10 above and in the notes
to Table 5.

      The costs for this requirement are estimated as: (129
studies)*[(15 hours technical time)*($51.95)+ (5 hours clerical
time)*($25.82)].

      From Table 5, the hazard assessment imposes 0 hours for Tier 1 and
135,887 hours for Tier 2. From Table 7, the exposure assessment imposes
5,500 hours for Tier 1 and 17,000 hours for Tier 2.  Also from Table 7,
the risk assessment imposes 3,300 hours for Tier 1 and 8,500 hours for
Tier 2.  The total of these six estimates is 170,187 hours.

 Note that the average response burden and cost will differ slightly in
tables 8 and 10 due to rounding in tables.

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