Document ID: EPA-HQ-OPPT-2007-0716-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-11-14T05:00Z

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:  TSCA Section 4 Test Rules, Consent Orders, Test Rule
Exemptions, and

		Voluntary Data Submission

		EPA ICR No.:  1139.08	OMB Control No.:   2070-0033

1(b)	Short Characterization

	This data collection program is designed to provide the Environmental
Protection Agency (EPA) with necessary test data on health effects,
ecological effects and environmental fate to predict the probable
impacts on human health or the environment of chemicals that may present
an unreasonable risk.  Section 4 of the Toxic Substances Control Act
(TSCA)(see Attachment 1) provides the authority for collecting these
test data, and is intended to ensure that chemicals that may pose
serious risks to human health or the environment undergo testing by
manufacturers or processors, and that the results of such testing are
made available to EPA.  EPA uses the information collected to assess
risks associated with the manufacture, processing, distribution, use or
disposal of a chemical, and to support any necessary regulatory action
with respect to that chemical.

	The Chemical Testing Program in EPA’s Office of Pollution Prevention
and Toxics (OPPT) also works with members of the U.S. chemical industry
and other interested parties to develop needed data via TSCA Section 4
Enforceable Consent Agreements (ECAs) and consent orders and Voluntary
Testing Agreements (VTAs).  ECAs and VTAs are usually less resource
intensive than formal TSCA rulemaking and allows EPA to consider
agreed-upon pollution prevention and other types of product stewardship
initiatives by the chemical industry as a possible substitute for or
adjunct to certain types of needed testing.

	The Chemical Testing Program requires the development of test data that
provide critical information on health effects, ecological effects and
environmental fate that enables EPA and others to properly assess and
manage health and environmental risks that may be posed by existing and
new chemicals covered by TSCA.  The “universe” of existing chemicals
on the TSCA Chemical Substances Inventory that may present the greatest
potential health and/or environmental concerns have been and continue to
be identified and refined through various existing chemical screening
activities within OPPT.  EPA also makes the testing data publicly
available to help the public understand the risks posed by exposure to
chemicals and to facilitate the public’s involvement in environmental
decision-making.  (For more information about the Chemical Testing
Program, go to: http://www.epa.gov/opptintr/chemtest/index.htm.)

	In addition to developing actions under TSCA section 4 that meet
specific needs identified by OPPT, EPA may also develop such actions to
meet the information needs of other offices within EPA and other
agencies.  For example, test data in the past have been developed for
EPA’s Office of Solid Waste and Emergency Response (OSWER), Office of
Air and Radiation (OAR), and Office of Water (OW).  At the present time,
EPA anticipates that data gathered by activities conducted during this
ICR renewal period will be used, in addition to those above, by other
agencies, including the Occupational Safety and Health Administration
(OSHA) and the Organization for Economic Cooperation and Development
(OECD).

	EPA may obtain the needed test data (1) by issuing a test rule through
notice and comment rulemaking, (2) through negotiation with industry and
issuing an ECA, or (3) through commitments from industry as VTAs.

	The testing specified in a rule or consent order issued under TSCA
section 4, or any testing identified in the voluntary High Production
Volume (HPV) Challenge Program, only needs to be conducted once for each
specified chemical.  As such, only one of the entities that manufacture,
import or process the specified chemical, or a consortia formed by these
entities, will conduct the specified testing and report the results of
that testing to EPA.  An entity subject to a test rule may also apply
for an exemption from the testing requirement if that testing will be or
has been performed by another party.

	Responses to the collection of information specified in a rule issued
under TSCA section 4 are mandatory (see 40 CFR part 790)(see Attachment
2), while response to a consent order issued under TSCA section 4 is
only mandatory for participants in the ECA.  Participating in a VTA is
voluntary.  The export notification provisions of TSCA section 12 apply
to any exporter of a chemical subject to a rule or consent order issued
under TSCA section 4, regardless of their participation in the ECA or
any related testing consortia.

	Respondents may claim all or part of a document confidential.  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.

	EPA maintains an official record for all activities conducted under
TSCA section 4 (rulemakings, ECAs, and VTAs).  The official record
consists of the documents referenced in a specific activity (rulemaking,
ECA, VTA), any public comments received during an applicable comment
period, any test data developed (including letters of intent to conduct
testing, exemption letters, study plans, progress reports and the final
study report), and other information related to the activity, including
information claimed as CBI.  The official record includes the documents
that are physically located in the docket, as well as the documents that
are referenced in those documents.  The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period, is available for
inspection in the Office of Pollution Prevention and Toxics (OPPT)
Docket, EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301
Constitution Ave., NW, Washington, D.C.  The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.

2	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

	TSCA section 2(b)(1) 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, TSCA section 4(a) mandates that EPA require manufacturers and
processors of chemical substances and mixtures to conduct testing if it
finds that:

“(1)(A)(i) the manufacture, distribution in commerce, processing, use,
or disposal of a chemical substance or mixture, or that any combination
of such activities, may present an unreasonable risk of injury to health
or the environment,

(ii) there are insufficient data and experience upon which the effects
of such manufacture, distribution in commerce, processing, use, or
disposal of such substance or mixture or of any combination of such
activities on health or the environment can reasonably be determined or
predicted, and

(iii) testing of such substance or mixture with respect to such effects
is necessary to develop such data; or 

(B)(i) a chemical substance or mixture is or will be produced in
substantial quantities, and (I) it enters or may reasonably be
anticipated to enter the environment in substantial quantities or (II)
there is or may be significant or substantial human exposure to such
substance or mixture,

(ii) there are insufficient data and experience upon which the effects
of the manufacture, distribution in commerce, processing, use, or
disposal of such substance or mixture or any combination of such
activities on health or the environment can reasonably be determined or
predicted, and

(iii) testing of such substance or mixture with respect to such effects
is necessary to develop such data [.]”

	If EPA makes these findings for a chemical substance or mixture, the
Agency must require that testing be conducted on that chemical substance
or mixture.  The purpose of the testing would be to develop data about
the substance or mixture’s health and environmental effects where
there is an insufficiency of data and experience in order to support a
determination that the manufacture, distribution in commerce,
processing, use or disposal of the substance or mixture, or any
combination of such activities, does or does not present an unreasonable
risk of injury to health or the environment.

	Once the Agency has made a finding under TSCA section 4(a)(1), EPA may
require any type of health or environmental effects testing necessary to
address unanswered questions about the effects of the chemical
substance.  EPA need not limit the scope of testing required to the
factual basis for the TSCA section 4(a)(1)(A)(i) or (B)(i) findings, as
long as EPA finds that there are insufficient data and experience upon
which the effects of the manufacture, distribution in commerce,
processing, use, or disposal of such substance or mixture or of any
combination of such activities on health or the environment can
reasonably be determined or predicted, and that testing is necessary to
develop the data.  This approach is explained in more detail in EPA’s
statement of policy for making findings under TSCA section 4(a)(1)(B)
(frequently described as the “B” policy) in the Federal Register of
May 14, 1993 (58 FR 28736, 28738-39; FRL-4059-9).

	The statute also specifies that EPA should give priority consideration
to chemicals that the Interagency Testing Committee (ITC) places on the
TSCA §4(e) “Priority Testing List.”  The ITC is an independent
advisory committee to the EPA Administrator that includes 16 U.S.
Government organizations.  The ITC was created under TSCA §4(e) to: 1)
review chemicals regulated by TSCA, 2) determine which chemicals need
ecological effects, environmental fate or health effects test data and
3) add those chemicals with test data needs to the Priority Testing List
and recommend them for testing or information reporting in May and
November Reports to the EPA Administrator.  (For more information about
the ITC, see: http://www.epa.gov/opptintr/itc/.)

	Although the Agency may not have yet made the TSCA section 4(a) finding
for a particular chemical substance, EPA may still cooperate with
industry or others to identify data gaps and develop testing plans to
fill some or all of these gaps.  These voluntary efforts help provide
additional information about the many chemicals on the TSCA Inventory,
and can be used to assess the potential risks associated with the
manufacture, processing, distribution, use or disposal of the chemical,
as well as allowing the Agency to establish a regulatory agenda that
focuses on those chemicals of greater concern.

	The information collected through the Chemical Testing Program, whether
submitted pursuant to a rule or consent order or voluntarily, provides
critical information on health effects, ecological effects and
environmental fate that enables EPA and others to properly assess and
manage health and environmental risks that may be posed by existing and
new chemicals covered by TSCA.  This information is also made publicly
available to help the public understand the risks posed by exposure to
chemicals and to facilitate the public’s involvement in environmental
decision-making.

2(b)	Use/Users of the Data

	Data collected under the Chemical Testing Program are used, in
conjunction with exposure information, by EPA scientists to determine
whether the subject chemicals are likely to present an unreasonable risk
to human health or the environment.  Furthermore, such information,
considered in conjunction with toxicological and health effects data,
ecological effects data, and environmental fate data, will be used by
scientists, professional industrial hygienists, other occupational
health professionals and workers for hazard communication and
right-to-know purposes, including Material Safety Data Sheets (MSDSs),
and product labels.  Additionally, data developed for chemicals used or
produced in particular work sites will be useful in developing and/or
maintaining 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
respondents as part of the Chemical Testing Program allow EPA to ensure
that the necessary testing data will be developed, that the results meet
basic scientific standards of acceptability and adequacy, that
unforeseen complications or issues can be addressed, and that the
testing is progressing on schedule.

	If the test data submitted indicate that potentially unreasonable risks
may exist, the data will be used by EPA and the manufacturer to
determine the appropriate action necessary to avoid or mitigate the
risks.  To date, EPA has used collected data 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.  EPA has also used the resulting
assessments to identify chemicals that may not warrant additional
regulation or concern, or should otherwise be treated as a low priority
for further consideration.

	In addition, since EPA is required under section 4(d) of TSCA to
publish a Federal Register notice announcing the receipt of test data
developed under a TSCA section 4 rule, the data collected may be used by
other agencies, and interested parties.

	Since 1979, approximately 230 of the 15,000 chemicals on the TSCA
Inventory that are, or have been, produced in quantities greater than
10,000 pounds per year have been the subject of testing actions within
the OPPT Existing Chemicals Testing Program.  Virtually all of the 230
chemicals are “HPV chemicals.”  The testing actions taken to date
include a mix of formal TSCA Section 4 Test Rules and Section 4
Enforceable Consent Agreements, and Negotiated Testing Agreements.  In
addition, almost 250 formal TSCA Section 4 “Decisions Not To Test”
(DNTs) have been issued by EPA to date.  Screening efforts to identify
priorities and determine testing needs for other chemicals are currently
underway in OPPT.

3	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION

	CRITERIA

	3(a)	Non-Duplication

	3(a)(1)  Test Rules and Consent Orders

	Prior to proposing a test rule or issuing a consent order, EPA searches
the scientific literature, holds public information gathering meetings
if deemed appropriate, and has discussions with industry representatives
in order to determine what types of data have already been obtained
about the chemical under consideration.  The Agency proposes a test rule
or issues a consent order only after it has determined that necessary
tests have not yet been conducted.

	3(a)(2)  Exemptions

	Exemption applicants are not required to supply information that the
Agency can obtain by other existing processes.  The equivalence
information required provides verification that a chemical is the same. 
Often this information is CBI and only the manufacturer or processor of
the chemical has this information.

	3(a)(3) HPV Voluntary Challenge Programs

	EPA has searched the publicly-available scientific data bases for
screening-level hazard and fate test data for those chemicals included
in the HPV Voluntary Challenge Program and held meetings with public
interest groups and industry.

	Industry sponsors of chemicals in the Program also search
publicly-available data bases as well as unpublished sources for the
screening-level hazard and fate test data that are the subject of the
Program.  Consequently, any new test data that are developed and/or
submitted as a result of the Program are unlikely to be duplicative.

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

	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

	The Agency has issued two procedural rules on the test rule development
and exemption process (October 1984 and May 1985) and one procedural
rule on the consent order process (June 1986) that describe the
information collection requirements for test rules and consent orders. 
Of particular note, the Agency held a series of public meetings at the
request of the American Chemistry Council (formerly the Chemical
Manufacturers Association (CMA)) and Environmental Defense (ED)
(formerly the Environmental Defense Fund) during the spring and summer
of 1985 to develop the consent order process.  In addition to the
procedural rules, each individual test rule solicits comment on the
information collection requirements.

	Previous commenters on EPA’s information gathering requirements under
test rules, consent orders, and the exemption process have included
numerous representatives of the chemical industry, environmental groups
and the public at large.  A number of issues were discussed including
the schedule for the test rule and consent order process, what
constitutes confidential information, how EPA should provide guidance
for submission of equivalence data, how the Agency will provide
standards for development of test data, enforceability of consent
orders, and how to make consent orders equivalent to test rules.

	In addition to the public notice and comment period required by the OMB
regulations that implement the Paperwork Reduction Act (see Section 3(b)
of this Supporting Statement), the OMB regulations, 5 CFR 1320.8(d)(1),
also require agencies to consult with potential ICR respondents and data
users about specific aspects of an ICR before the agency submits the ICR
to OMB for review and approval.  In accordance with this regulation and
based on OPPTS Regulatory Coordination Staff guidance, EPA will solicit
comments from no more than nine potential ICR respondents and data users
with respect to the renewal of this ICR.

3(d)	Effects of Less Frequent Collection

	Test rules and consent orders require the test sponsor to submit a
letter notifying EPA who will be conducting the testing, study plans
before beginning testing, and a final report of the study results.  Each
exemption applicant is required to submit an exemption application. 
Less frequent information collection would jeopardize EPA’s ability to
ensure that testing is being conducted in accordance with the rules and
consent orders, and to grant exemptions from test rules.

3(e)	General Guidelines

	The data retention requirements for test rules and consent orders
exceed one of the Paperwork Reduction Act guidelines contained in 5 CFR
1320.6.  Documentation records, raw data, and specimens pertaining to a
test rule or consent order study are required to be retained for ten
years from the effective date of the applicable test rule or publication
date of the consent order.  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.

3(f)	Confidentiality

	Information submitted to EPA in response to test rules and consent
orders and in exemption applications is, in most cases,
non-confidential.  EPA, for purposes of the HPV Challenge Program, has
also discouraged the submission of CBI material. If respondents wish to
claim information submitted in response to a test rule or consent order
confidential, they may do so.  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.

	3(g)	Sensitive Questions

	The information requested does not include information of a sensitive
nature other than CBI, which is discussed above.

	3(h)	Electronic Reporting 

	A description of data collection/management activities specifically
regarding the High Production Volume (HPV) Chemical Challenge Program,
including electronic reporting of data, is presented in Section 5(b).

4	THE RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)	Respondents/NAICS Codes

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

                    

Type of Entity	NAICS	Examples of Potentially Affected Entities

Chemical Manufacturers and Importers	325,

32411	Persons who manufacture (defined by statute to include import) one
or more of the subject chemical substances.

Processors	325,

32411	Persons who process one or more of the subject chemical
substances.

4(b)	Information Requested

4(b)(i)	Data Items

	EPA may require any type of health effects, ecological effects and
environmental fate testing necessary to address unanswered questions
about the effects of a chemical substance.  EPA need not limit the scope
of testing required to the factual basis for the TSCA section
4(a)(1)(A)(i) or (B)(i) findings, as long as EPA also finds that there
are insufficient data and experience upon which the effects of the
manufacture, distribution in commerce, processing, use, or disposal of
such substance or mixture or of any combination of such activities on
health or the environment can reasonably be determined or predicted, and
that testing is necessary to develop such data.  This approach is
explained in more detail in EPA’s statement of policy for making
findings under TSCA section 4(a)(1)(B) (frequently described as the
“B” policy) in the Federal Register of May 14, 1993 (58 FR 28736,
28738-39; FRL-4059-9).

	In addition to submitting the specified test data to EPA, respondents
may also need to submit a letter of intent, study plans and progress
reports, or an exemption application.  Respondents must also maintain
certain records related to the testing.

	The specific requirements and procedures governing testing consent
orders, test rules, and exemption from test rules are found in 40 CFR
part 790.  The requirements regarding Good Laboratory Practice standards
(GLPs) are found in 40 CFR part 792, the various test guidelines that
are incorporated into the individual test rules are in 40 CFR parts 795
through 799, and the chemical specific testing requirements are in 40
CFR part 799.

	The following is an overview of the specific requirements for each type
of activity:

Test Rules And Consent Orders - EPA promulgates a rule or consent order
describing what type of testing must be performed on the chemical and
specifying specific test guidelines that have been published by the EPA
or alternative methods proposed by industry and approved by EPA as
methods.  In combination with the GLPs requirements, these guidelines or
methods provide the TSCA-mandated standards (TSCA section 4(d)) for
development of adequate and reliable data.  Records concerning data
developed according to these standards must be retained for a minimum of
ten years, as described in GLP standards.

Exemptions - Information collection authorized by section 4(c) of TSCA
is designed to reduce the burden of duplicative testing under test
rules.  Test rules generally require testing of only a single
representative chemical substance and all chemicals subject to the test
rule are assumed equivalent to it.  Exemption applicants are required to
submit only that information necessary to establish the identity of the
applicant and the test requirements from which the exemption is being
requested.  In those few cases in which more than one representative
substance is to be tested under a test rule, exemption applicants will
also be required to submit data showing to which of these representative
substances their chemical is equivalent.  The type of data needed may
vary with the chemical being tested, and will be described in detail in
each individual test rule.

HPV Voluntary Challenge Program - The HPV Challenge Program is a
voluntary initiative under which manufacturers of HPV chemicals
voluntarily develop and submit certain OECD screening level studies for
the chemicals they manufacture.  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.

	4(b)(ii)  Respondent Activities

	Respondents may undertake one or more of the following activities:

	(a)  Review rulemaking and/or participate in ECA or VTA discussions.

	(b)  Conduct searches for relevant existing data.  If data are found:

		- Determine whether the data are relevant;

		- Prepare and review summary of existing data; and

		- Submit summary of existing data to EPA.

	(c)  Submit “Letter of Intent” to EPA or an application for an
exemption.

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

	(e)  Prepare and submit periodic progress reports.

	(f)   Record and prepare test data for submission (includes QA/QC
reviews).

	(g)  Prepare and review final report.

	(h)  Review submission for CBI.

	(i)   Submit final report with test data to EPA.

	(j)   Maintain test data and final report in records.

	These activities may vary based on the type of activity:

Test Rules and Consent Orders - Test rules and consent orders require
test sponsors to submit a letter identifying who is sponsoring the
required testing and study plans before testing begins, semi-annual
progress reports during the conduct of the testing, and a final report
of the test results.

Exemptions - Test Rules.  Exemption applicants are not required to
supply information that the Agency can obtain by other existing
processes.  Equivalence data are often confidential business information
(CBI) and only the manufacturer or processor of the chemical has this
information.  In general, the rule reduces the burden associated with
preparing exemption applications to a minimum by restricting the
information required to that absolutely necessary to determine if the
applicant is eligible for an exemption.  In most cases, the manufacturer
is required to give only its identity, address, a technical contact and
a list of the tests for which an exemption is being requested.  When
equivalence data are needed because more than one representative
substance is being tested, the Agency will limit the data required by
giving minimum chemical specific requirements in the individual test
rules.  This approach was devised in response to comments by industry
that applying the broad equivalence data requirements to all exemptions
candidates would, in some cases, result in submission of unnecessary
data.

	Consent Orders.  Exemption applications are not necessary for chemicals
being tested under consent orders because the consent order process
inherently eliminates duplicative testing.

	HPV Voluntary Challenge Program.  Exemption applications are not
necessary for chemicals being tested under the HPV Voluntary Challenge
Programs.  However, companies may submit relevant information pertaining
to the production volume for chemicals that EPA believes are produced or
imported in substantial amounts.  Based on this information, EPA may
de-list a chemical.  That is to say, companies may submit information
that indicates that specific chemicals are not produced in substantial
quantities and, therefore, testing of these chemicals is not necessary
for purposes of this Program.  Based on a review of the information
submitted, EPA may remove a chemical from the list of HPV chemicals
according to guidance on the HPV website at www.epa.gov/chemrtk.

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

	5(a)	Agency Activities

	Data collected under TSCA section 4 test rules and consent orders are
received by the Office of Pollution Prevention and Toxics (OPPT),
Chemical Control Division (CCD), Chemical Information and Testing Branch
(CITB), where they are reviewed for completeness and then routed to
biologists, chemists, toxicologists, and wildlife scientists within OPPT
to determine whether the subject chemicals are likely to present an
unreasonable risk to human health or the environment.  Similarly, data
received under the HPV Voluntary Challenge Program will be reviewed as
described above for purposes of developing preliminary hazard
characterizations for those chemicals.  If the HPV data indicate that
potential hazards may exist, then these data – coupled with exposure
and use information received under the Inventory Rule Update Amendments
(IURA) and other information sources – will be reviewed by EPA staff. 
Once reviewed, these data may support possible risk management action. 
To date, EPA has collected data 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.

	In order to sustain this Program, the EPA must undertake the following
applicable activities:



	a)    review letters of intent and study plans for completeness;

b)    review progress reports;

c)    review final reports for completeness, accuracy, adherence to test
rule guidelines and GLPs;

d)    process and review exemption applications; and

	e)    facilitate development of ECAs and VTAs.

	In addition to the activities cited above the Agency maintains a
facility inspection and test data audit program to ensure testing is
done in compliance with GLPs, and may also participate in other
activities related to this program, e.g., other voluntary efforts to
identify data gaps and develop test data, efforts to establish test
guidelines or standards that may be used in the Chemical Testing
Program, and international efforts related to chemical testing and
associated testing issues.

5(b)	Collection Methodology and Management

	For each chemical identified for testing within EPA’s TSCA Chemical
Testing Program, the specific data requested, the testing necessary to
generate those data, along with the test protocols, the time frame for
completing the testing, and the date by which the requested data are to
be submitted to the Agency, are established in the TSCA Section 4 Test
Rule, TSCA Section 4 ECA or VTA.  Information about the data
collection/management activities specifically regarding the HPV Chemical
Challenge Program is presented at the end of this discussion

	It is also important to note that the TSCA Chemical Testing Program is
an integral component of OPPT’s TSCA existing and new chemicals
programs. These programs are responsible for assessing and managing
health and environmental risks that may be posed by existing and new
chemicals covered by TSCA.  The “universe” of existing chemicals on
the TSCA Chemical Substances Inventory that may present the greatest
potential health and/or environmental concerns have been and continue to
be identified and refined through various existing chemical screening
activities within OPPT.

	Test data submitted to the Agency under the TSCA Chemical Testing
Program are reviewed by scientists to determine whether or not the data
developed are adequate for the purposes for which they were gathered and
to determine whether or not further regulatory action is necessary.  In
addition to being housed in an appropriate EPA TSCA docket, references
to the data are entered into the TSCA Test Submission Database (TSCATS).
 TSCATS is a publicly available, online index to unpublished,
non-confidential studies covering chemical testing results and other
submitted studies on the possible effects of chemicals on health and
ecological systems.  Submitted studies are indexed in TSCATS under three
broad categories: health effects, ecological effects and environmental
fate. TSCATS contains information that is pertinent to risk assessment
and hazard evaluation processes. The information can be used in
conjunction with published material and is a valuable source along with
or in the absence of published data. The data are used by federal and
state agencies, researchers, toxicologists, risk assessors, the
regulated industry, attorneys, trade and professional associations as
well as the public at large. TSCATS was developed by EPA in 1985 to make
the results of ongoing and completed chemical testing available to the
public and includes chemical exposure studies, epidemiology,
environmental fate, monitoring, episodic incidents, such as spills and
case reports. There are four primary types of documents referenced in
the TSCATS database: TSCA section 4 chemical testing results, TSCA
section 8(d) health and safety studies, TSCA section 8(e) substantial
risk of injury to health or the environment notices, and voluntary
documents submitted to EPA known as  For Your Information (FYI)
submissions.  TSCATS is available through a number of electronic
sources; the studies referenced in TSCATS can be viewed in EPA’s
public TSCA docket located at EPA’s Headquarters in Washington, D.C.,
or, alternatively, via microfiche copies that are available through the
National Technical Information Service (NTIS).

	HPV Challenge Program

	Public access to hazard data is integral to the HPV Challenge Program. 
Test plan and data summary submissions, sponsor commitment information,
chemical lists, guidance documents, and other materials can be found at
the HPV Challenge Program web site (http://www.epa.gov/hpv).  EPA
continues to enter sponsor-submitted HPV Challenge Program data into the
HPV Information System (HPVIS), which is a comprehensive, online,
data-searchable application for HPV chemical information
(http://www.epa.gov/hpvis/index.html).  This system allows users to
thoroughly search across all test-plan and data summary materials –
including the data presented within and among data summaries.  Once
HPVIS is fully populated with HPV Challenge Program data, then the
system can be used for producing endpoint statistics and prioritizing
chemicals for review.  

	The HPV Challenge Program has nearly completed its sponsor-submitted
data collection effort.  The Agency has received data submissions for
1,357 (98%) of the 1,385 chemicals that were sponsored directly in the
Program as of May 2007, and expects to receive data for the remaining 28
(2%) chemicals.  EPA also continues to receive revised submissions from
sponsors, in an effort to eliminate data gaps. 

Other current HPV Challenge Program efforts focus on reviewing submitted
HPV chemical data for quality and completeness, and preparing summary
reports for the public that will outline any hazards associated with HPV
chemicals.  Based upon review findings, EPA will determine whether
Agency actions are required to protect human health and the environment
from risks posed by HPV chemicals.  

5(c)	Small Entity Flexibility

	The test rule process minimizes the burden on small businesses by
giving them the option of fulfilling their responsibilities under a test
rule by either joining a testing consortium or by applying for a test
rule exemption.  Participation in a testing consortium relieves the
small business of direct responsibility for collecting or submitting
test information as well as applying for an exemption.

	Under consent orders, small businesses are not required to participate,
but if they do, they would participate as part of a consortium.

	Small businesses are also apportioned a smaller proportion of the cost
of testing than their larger counterparts.  The decision as to how the
cost of testing is to be divided among these firms has, to date, been
decided by the manufacturers subject to the rule or consent order. 
Generally, small businesses are assigned a proportion of the costs that
is proportionate to their size and market share.  However, if any party
believes a particular reimbursement arrangement is unfair, TSCA directs
the Administrator of EPA to assist in resolving the conflict and the
Agency will certainly consider the special needs of small businesses if
such action becomes necessary.  To date, no party has requested that the
Agency assist in reimbursement decisions.

5(d)	Collection Schedule

	This information collection activity does not involve more than one
submission per activity.  Required testing is conducted only once, and
each related submission is a one-time on-occasion submission.  The
testing period is based on the individual rule, consent order, or VTA,
the standard time required to conduct the required test according to the
testing guidelines, according to the timing established in the approved
test plan, or timing otherwise established by the Agency.

	The time period for screening level testing, like that conducted under
the HPV Initiative, is usually less than a year.  The typical time
period for other types of testing is around three years, although it can
be longer and varies according to the chemical and the test required.

6	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	Overview

	The methodology used in estimating the annual burden and costs to
industry resulting from TSCA section 4 test rules, consent orders and
agreements, and voluntary submissions over the next three years is based
on EPA’s most recent cost and burden estimates.  These have been
combined with current information concerning the number and type of TSCA
section 4 test rules under development, estimates of the potential
number of consent orders and agreements, and the current and anticipated
level of industry participation in the voluntary HPV Challenge Program,
all of which may result in industry submitting existing data or
conducting new testing to provide EPA with information necessary to
evaluate chemicals under its TSCA section 4 mandate.

	Individual actions covered by this ICR may impact industry over most or
all of the three year ICR period.  In these cases, the impacts of the
action have been converted to an annual basis by assuming, for example,
that one-third of the chemicals covered by the action would be addressed
in each of the three years.

	Additional data collection efforts beyond those identified in this ICR
may be conducted during the three year ICR period, but the extent of
such activities cannot be projected at this time. For example, although
the Agency anticipates the need to issue test rules for HPV chemical
data needs that remain unaddressed by the voluntary HPV Challenge
Program, this ICR assumes that most of the HPV chemicals will be
captured by the voluntary program.  If, in the context of a rulemaking,
the Agency determines that the total annual burden covered by this ICR
needs to be increased, it will submit an Information Correction
Worksheet (ICW) to increase the total annual burden in the OMB
inventory.

	The following sections explain the assumptions and methods that were
used to estimate the burden and costs for this ICR, along with a summary
of the cost and burden calculations.

  SEQ CHAPTER \h \r 1 6(a)	Respondent Cost and Burden

Consent Orders and Enforceable Consent Agreements

	Based on historical experience with the TSCA testing program and
expected consent order activity over the three year ICR period, EPA
assumes that one consent order or enforceable consent agreement (ECA)
will be issued per year for a total of three consent orders/agreements
issued during the ICR period.  Past consent orders and agreements have
covered an average of one to five chemicals.  For this ICR, EPA assumes
five chemicals will be covered by each order/agreement.  

	The testing required under future consent orders or agreements cannot
be predicted and will be determined on a case by case basis. For
purposes of the ICR, EPA assumes as in past ICRs that each chemical will
be evaluated by performing the tests specified in a “Standard”
testing battery (see Table 1).  The test battery includes 10 studies per
chemical (7 short term, 3 long term).  Each test sponsor must submit one
letter of intent and one set of study plans for each chemical; five
semi-annual progress reports for each long-term study; and one final
report for each study.  EPA estimates that 10% of the studies completed
will be accompanied by a robust summary.  These assumptions are used to
estimate the costs and are recorded in Table 3.

	 EPA generates and maintains a listing of the laboratory cost and
burden data for numerous TSCA and OECD test protocols.  Test cost
estimates were adjusted to end-of-year 2006 dollars using the Bureau of
Labor Statistics’ Employment Cost Index (ECI) and are shown in Table
1. The mean cost of the “Standard” battery is $1,287,890.  

EPA has also included costs for analytical chemistry method development
and validation where it was judged that such method development would be
necessary to conform to good laboratory practices.  Method development
and validation is typically performed to determine the effectiveness of
an analytical method to determine the levels of the chemical in the
dosing matrix in toxicity studies.  Short term and long-term studies are
assigned a cost of $3,500 and $8,500 respectively, based on typical
costs cited by industry experts (Piccirillo, 2004).   Total validation
costs for the testing battery are $50,000, resulting in a total
laboratory cost of $1,337,890.

  SEQ CHAPTER \h \r 1 Exemption applications are not necessary for
chemicals being tested under consent orders because the consent order
process inherently eliminates duplicative testing.

 	Table 1.  TSCA Section 4 “Standard” Testing Battery Costs 

 	Test Protocol Name	Protocol Number	Date of Estimate	Mean Cost
Estimate ($2006)a	Validation Costs ($2006)

 	 	 	 	 	 

1	Algal Acute Toxicity	797.1050	8/3/1990	$26,454	$3,500

2	Daphnid Acute Toxicity	797.1300	4/25/1996	$10,251	$3,500

3	Fish Acute Toxicity	797.1400	4/25/1996	$20,814	$3,500

4	Gene Mutations in Somatic Cells	798.5300	8/16/1994	$22,962	$3,500

5	Subchronic Oral Toxicity	870.3100	9/3/1996	$169,884	$3,500

6	Prenatal Developmental Tox. (2 species)	870.3700	8/27/1996	$130,453
$8,500

7	Reproduction/Fertility Effects	870.3800	8/27/1996	$673,124	$8,500

8	Salmonella Reverse Mutation Assay	870.5265	9/16/1996	$8,448	$3,500

9	In vivo Bone Marrow Cytogenetics	870.5395	2/27/1997	$17,683	$3,500

10	Developmental Neurotoxicity	870.6300	8/27/1996	$207,816	$8,500

 	Subtotal	 	 	$1,287,890	$50,000

 	TOTAL	 	 	$1,337,890

a Where multiple versions of a test have been costed by EPA (e.g.,
covering different species or routes of exposure), the mean cost
estimate is used.  All test costs updated to 2006 dollars.  

Source: U.S. EPA, Office of Pollution Prevention and Toxics, Economic
and Policy Analysis Branch.

Voluntary Programs

	This ICR also incorporates estimates of the burdens and costs
associated with the voluntary component of the HPV chemicals testing
program launched in 1998.  Under the HPV Challenge Program manufacturers
of chemicals targeted for testing agree voluntarily to submit data on
certain hazard, physical/chemical property, and environmental fate
endpoints.  EPA would exclude any chemicals enrolled in the Program from
its planned section 4 test rules and would provide recognition to
Program participants for their voluntary actions. 

	Table 2 shows the full set of endpoints to be submitted under the HPV
Challenge Program.  The testing suite is based on the Tier I tests from
the OECD Screening Information Data Set (SIDS).  The Tier I battery
includes 16 endpoints.  Following the approach used in the previous ICR,
EPA assumes that industry participation in the voluntary HPV Challenge
Program will result in new testing to satisfy an average of one
additional endpoint per sponsored chemical during the first year of this
ICR for those chemicals for which a test plan has been submitted.  The
cost per endpoint is recorded in Table 2 and ranges from $129 for the
transportation/distribution endpoint (which is modeled) to $125,861 for
the repeated-dose test with reproductive and developmental toxicity.



Table 2.  TSCA Section 4 ICR SIDS Tier I (HPV) Testing

Test Protocol Name	Protocol Number	Mean Cost Estimate ($2006)a
Validation Costs

 	 	 	 	 

1	Melting Point	OECD 102	$1,547 	$0

2	Boiling Point	OECD 103	$1,580 	$0

3	Vapor Pressure	OECD 104	$9,434 	$0

4	Water Solubility	OECD 105	$6,594 	$0

5	Partition Coefficient (shake flask)	OECD 107	$6,730 	$0

 	SUBTOTAL	 	$25,885 	$0 

 	 	 	 	 

6	Photo-degradation	OECD 113	$9,785 	$0

7	Inherent Biodegradation	OECD 302	$14,160 	$0

8	Stability in Water	OECD 111	$59,589 	$0

9	Transportation/Distribution	EQC Model	$129 	$0

 	SUBTOTAL	 	$83,664 	$0

 	 	 	 	 

10	Acute Toxicity to Aquatic Plants	OECD 201	$9,845 	$3,500

11	Acute Toxicity to Fish	OECD 203	$10,910 	$3,500

12	Acute Toxicity to Daphnia OR	OECD 202(I)	$5,419 	$3,500

 	Chronic Toxicity to Daphnia	850.1300	$38,961 	$8,500

 	SUBTOTAL (AVERAGE)	 	$42,945	$13,000

 	 	 	 	 

13	Acute Oral Toxicity OR	OECD 401	$3,799 	$3,500

 	Acute Dermal Toxicity OR	OECD 402	$5,127 	$3,500

 	Acute Inhalation Toxicity	OECD 403	$13,290 	$3,500

 	SUBTOTAL 	 	$7,405 	$3,500

 	 	 	 	 

14	Genetic Toxicity (Salmonella)	OECD 471	$7,932 	$3,500

15	Chromosomal Aberration, in vitro OR	OECD 473	$22,378 	$3,500

 	Chromosomal Aberration, in vivo	OECD 474	$17,479 	$3,500

 	SUBTOTAL	 	$27,860 	$7,000

 	 	 	 	 

16	Combined Repeated Dose with Repro./Devel. Toxicity Screen OR	OECD 422
$125,861 	$8,500

 	Repeated Dose Oral Toxicity AND	OECD 407	$60,200 	$8,500

 	Repro./Devel. Toxicity Screening Test	OECD 421	$124,277 	$8,500

 	SUBTOTAL (AVERAGE)	 	$155,169	$12,750

 	TOTAL	 	$342,928 	$36,250

“SIDS TIER I” - GRAND TOTAL	 	$379,178

For each of SIDS Tier 1 toxicity tests shown in Table 2, EPA assigned an
analytical methodology development and validation cost of $3,500 for
short term studies and $8,500 for long-term studies, based on typical
costs cited by industry experts (Piccirillo 2004).  Analytical
methodology validation is not expected to be necessary for physical,
chemical and other non-toxicological testing.  For chemicals undergoing
the complete suite of SIDS tests, analytical chemistry method
development and validation adds $36,250 to the $342,928 in testing
costs, for a total laboratory cost of $379,178. 

	During the previous ICR period, many of the HPV Challenge Program
participants undertook a search for any existing chemical testing
studies and submitted “robust summaries” of such studies to EPA. 
For those endpoints not adequately covered by existing studies, sponsors
also prepared test plans and submitted these to EPA.  Based on the
studies and test plans received by May 2007, EPA estimates that the
current sponsorship program encompasses 1,385 chemicals.  This includes
1,357 chemicals for which sponsors have already submitted test plans and
robust summaries.  Given that data for these 1,357 chemicals are mostly
submitted, or expected to be submitted, prior to the effective date of
this ICR, estimates of the burden and costs associated with testing and
provision of test results for those chemicals are not included.  Test
plans and testing are estimated still pending for 28 sponsored chemicals
(1,385 - 1,357 = 28).  On an annual basis, this implies that
approximately 9 chemicals per year (28 / 3 = 9) will be addressed
through test plans and necessary testing (see Table 3, line b).  EPA
estimates that five endpoints will be addressed through testing for each
chemical and the remainders consist of existing data.  Ten percent of
the existing studies are estimated to be accompanied by robust
summaries.

	This ICR also provides estimates of cost and burden for the test result
submissions for about 200 sponsored HPV Challenge “Class 2
Substances.”  These Class 2 Substances are complicated process stream
and mixture chemicals that pose extra difficulties in testing and
describing, and therefore, test results are not expected prior to this
ICR taking effect.  The substances have been referenced in category test
plan submissions, and EPA therefore considers test plans for these
chemicals as submitted, but the actual data for the endpoints are
lacking until the sponsors of such chemicals submit the associated data
summaries.  On an annual basis, this implies that sponsors will submit
test plans and robust summaries for approximately 67 chemicals per year
(200 / 3 = 67) (Table 3, line b).  EPA estimates that five endpoints
will be addressed through testing for each chemical and the remainders
consist of existing data.  Ten percent of the existing studies are
estimated to be accompanied by robust summaries.

	Based upon the assumptions and testing batteries discussed above,
various factors can be derived that are employed to estimate total costs
and burdens for the respondents.  These factors are summarized below in
Table 3.

Table 3. Assumptions Used in Estimating Annual Costs and Burdens

(Numbers have been rounded: calculations may not appear exact.)

TSCA Section 4 ICR Assumptions	Consent Orders & Agreements	HPV Challenge
w/ Test Plans	HPV Challenge No Test Plans	Total

a	No. of orders/agreements issued	1	1	1	3

b	Chemicals per order/agreement	5	67	9	--

c	Total no. of chemicals (a × b)	5	67	9	81

d	No. of chemicals per sponsor	5	1.34	1.34	--

e	No. of sponsors per rule or order (b ÷ d)	1	50	7	--

f	Total no. of sponsors (a × e)	1	50	7	58

g	Letters of intent/study plans per sponsor	1	0	1	--

h	Total letters of intent/study plans (f × g)	1	50	7	8

i	No. of short-term studies per chemical	7	5	5	--

j	Total no. of short-term studies (c × i)	35	333	47	415

k	No. of long-term studies per chemical	3	0	0	--

l	Total no. of long-term studies (c × k)	15	0	0	15

m	Total no. of studies per chemical (i + k)	10	1	5	-

n	Total no. of studies (j + l)	50	333	47	430

o	No. of semi-annual progress reports per	 	 	 	 

 	Short-term study	0	0	0	--

 	Long-term study	5	0	0	--

p	Total no. of semi-annual progress reports	 	 	 	 

 	Short-term studies (o x j)	0	0	0	0

 	Long-term study (o x l)	75	0	0	75

q	No. of final reports per study	1	1	1	--

r	Total no. of final reports (n × q)	50	333	47	430

s	No. of robust summaries1	5	73	10	89

t	Total no. of reports (h + p + r + s)	131	407	64	602

u	Total reports per sponsor (t ÷ f)	131	8	9	--

v	Total reports per rule/order (t ÷ a)	131	407	64	--

w	Total reports per chemical (t ÷ c)	26	6	7	--

x	No of exemptions per sponsor	0	0	0	--

y	No. of exemptions per rule/order 	0	0	0	--

z	Total no. of exemptions 	0	0	0	0

aa	Total no. of responses (t + z)	131	407	64	602

bb	No. of responses per rule/order (e + y)	1	50	7	--

cc	Total no. of respondents (f + z)	1	50	7	58

1 For consent orders, only 10% of studies are expected to be accompanied
by robust summaries.  For the HPV challenge chemicals, EPA estimates the
10% of the endpoints where data exist will be accompanied by robust
summaries.

	The number of sponsors was determined based on a review of HPV chemical
sponsorship patterns (Table 3, line f). Currently, there are 105
consortia participating in the Program and these consortia account for
approximately one-third of the HPV Challenge chemicals for which data
are currently or expected to be submitted, or 457 chemicals (1,385 x
0.33). The remaining 928 chemicals are sponsored individually. The total
number of sponsors participating is thus 1,033 (928 + 105), and the
ratio of chemicals to sponsors is approximately 1.34:1.  Applying the
same ratio of one sponsor per 1.34 chemicals to the 200 chemicals for
which test plans have been submitted, EPA estimates there are a total of
approximately 150 sponsors covering these chemicals over the three year
ICR period, or 50 sponsors per year.  For the 28 chemicals with test
plans outstanding, EPA estimates there will be 21 sponsors (28 ÷ 1.34)
over the three year ICR period, or 7 sponsors per year.

Total Number of Respondents

	The Agency’s estimates assume that on an annual basis there will be
one respondent to an enforceable consent order or agreement, 50 sponsors
of HPV Challenge chemicals covered by test plans already submitted to
the Agency, and seven sponsors of HPV Challenge chemicals for which test
plans have yet to be submitted to the Agency (Table 3, line f), for a
total of 58 respondents annually.  These respondents are all expected to
provide reporting and there are no third party disclosures associated
with these activities.    SEQ CHAPTER \h \r 1 Exemption applications are
not necessary for chemicals being tested under the HPV Voluntary
Challenge Programs so there are no exemption applicants counted among
the respondents (Table 3, line y).  

Total Number of Reports

	Over the course of the testing period, a total of 602 reports will be
submitted (Table 3, line t).  Therefore, on average, each test sponsor,
or a common representative of the test sponsors, will submit 10.4
reports per year (i.e., 602 total reports ÷ 58 sponsors = 10.4).  This
may include, but is not limited to: letter of intent and set of study
plans, semi-annual progress reports for long-term studies, and the final
reports for each study. 

Types of Costs and Burdens

	The following discussion presents estimates of the costs and burdens of
each of the main categories of collection activities covered in this
ICR.  Table 4 presents estimates of the laboratory and administrative
costs, and administrative burdens, and is discussed in detail below.

	Laboratory Costs

The costs incurred by sponsors performing laboratory testing are
presented in Table 4.  

For the approximately 9 chemicals (28 over 3 years) for which EPA has
not received test plans, EPA assumes sponsors will submit test plans
during the three year ICR period and conduct all necessary testing.  For
purposes of estimating testing needs for these chemicals, EPA analyzed
the number of tests proposed for chemicals with test plans submitted and
found that approximately 70 percent of chemicals had no testing proposed
and more than 90 percent proposed fewer than five.  EPA assumed that
each test plan still to be submitted will cover five endpoints at the
average test cost of $23,699 for a total of $118,493 (Table 4, line e). 
(This is probably a conservative estimate since the median number of
tests proposed is 1.25).  The cost of submitting the test plan is
estimated at two hours of technical time using a loaded labor rate of
$54.72, or a total cost of $109.44.

For the 200 Class 2 substances for which EPA has received test plans,
EPA maintains the assumption that tests will be performed to cover 5
test endpoints.  Because these chemicals are mixtures or other
complicated substances, EPA has assumed that costs for analytical method
development and validation costs will be higher than for other
chemicals.  Therefore, those validation costs are estimated to be 50%
higher for those chemicals for a total of $54,375 for the entire testing
battery.  The average laboratory cost per test for these chemicals is
$24,831 (($342,928 + 54,375)/16).  The total laboratory cost for testing
is estimated to be $124,155 ($24,831*5) for these chemicals.   

Total laboratory costs associated with activities covered by this ICR
are estimated to be $16.1 million per year (Table 4, line f).  These
costs include $6.7 million for consent orders and agreements; $8.3
million for testing related to HPV Challenge chemicals covered by test
plans; and $1.1 million for HPV Challenge chemicals not yet covered by
test plans. With a projected total of 430 studies to be conducted (Table
4, line d), the average laboratory cost is $37,378 per study (Table 4,
line i).



Table 4.  Annual Laboratory Cost and Burden Estimates

TSCA Section 4 ICR Factors	Consent	HPV Challenge w/ Test Plans	HPV
Challenge No Test Plans	TOTALS

	Orders/

Agreements

	a	Total no. of rules/orders	1	1	1	3

b	Total no. of chemicals	5	67	9	81

c	Total no. of sponsors	1	50	7	58

d	Total no. of studies	50	333	47	430

e	Lab. cost per chemical	$1,337,890 	$124,155 	$118,493 	$198,424 

f	Total lab. costs (b × e)	$6,689,450 	$8,277,000 	$1,105,934 
$16,072,384 

g	Admin. reporting costs	$251,666 	$1,208,314 	$184,459 	$1,644,528 

 	Admin. non-reporting costs	$1,672,363 	$2,069,250 	$276,484 
$4,018,096 

 	Total admin. costs a	$1,924,028 	$3,277,564 	$461,032 	$5,662,624 

h	Total lab. & admin. costs (f + g)	$8,613,478 	$11,554,564 	$1,566,967 
$21,735,008 

i	Lab. costs per study (f ÷ d)	$133,789 	$24,831 	$23,699 	$37,378 

j	Admin. costs per study (g ÷ d)	$38,481 	$9,833 	$9,879 	$13,169 

k	Total testing costs per study 

(i + j)	$172,270 	$34,664 	$33,578 	$50,547 

l	Total testing costs per sponsor 

(h ÷ c)	$8,613,478 	$232,247 	$224,972 	$375,583 

m	Admin. reporting burden b	5,205	24,213	3,808	34,227

 	Admin. non-reporting burden c	32,615	40,355	5,392	78,362

 	Total admin. burden	37,820	65,568	9,201	112,588

n	Admin. burden per study (m ÷ d)	756	197	197	262

o	Total admin. burden per sponsor	37,820	1,318	1,321	1,951

	(m ÷ c)

Numbers throughout table have been rounded

a Administrative non-reporting costs and burdens are assumed to equal
25% of laboratory costs and burdens.

b The reporting burdens are derived in Table 5.

c The non-reporting administrative burden is estimated by dividing the
administrative cost by $51.28, which represents the weighted average
wage rate.  The weighted average wage reflects an assumed 20/60/20 mix
of managerial/technical/clerical labor.

Administrative Costs

Administrative costs are assumed to comprise both reporting and
non-reporting activities and are explained in detail below.  The average
administrative cost is calculated based on the average lab cost per
study of $37,378 (Table 4, line i), and is equal to $13,169 (Table 4,
line j).  The average administrative cost is divided by the weighted
average hourly labor rate of $51.28 per hour to result in an average
burden of 262 hours per chemical (Table 4, line n).  The weighted
average hourly labor rate is based on a labor mix that is 20 percent
managerial, 60 percent technical, and 20 percent clerical.  The total
administrative cost is estimated to be $5.7 million annually (Table 4,
line g).  

Reporting Costs and Burdens 

Part of the administrative costs associated with this ICR is derived
from reporting activities undertaken by respondents.  These activities
include: preparing letters of intent and study plans; preparing progress
reports; preparing test results for submission to EPA; recording test
results; conducting laboratory or corporate reviews; performing
associated clerical work for final report preparation; record keeping;
conducting administrative activities to preparing for and oversee the
testing program; and applying for exemptions.  Reporting estimates also
include the data search and reviews conducted for the voluntary HPV
Challenge Program.  The burden estimates and unit supply costs
associated with these activities are reported in Table 5 and are based
on estimates provided in the prior ICR.

	Estimates of the respondents’ annual reporting costs and the burden
associated with each reporting activity are detailed in Table 5. The
unit wage rate information is explained in Attachment 3.  The unit labor
hours are derived from previous information collection requests and are
believed to be reflective of the annual amount of time required for each
activity over the next three year period.  

	For the seven sponsors who have not yet submitted test plans and the
one sponsor for the consent order, EPA assumes that there is a 40-hour
administrative burden assigned for submission of the test plans, and
letter of intent in the case of the consent order. The total annual
respondent cost and burden for reporting activities is $1.6 million and
34,228 hours (for reporting costs see Table 4, line g; for reporting
burdens see Table 4, line m; for total reporting costs and burdens see
Table 5).														

Non-reporting Administrative Costs and Burdens

	EPA’s experience in test rule development has shown the non-reporting
administrative costs associated with testing programs to total
approximately 25 percent of the laboratory costs, and is divided as
follows.   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 has included a burden equal
to 15 percent of the test cost to account for management of the
consortium.   This includes activities such as identifying
manufacturers, meetings, organizing payment for testing, developing
contracts for testing, and employing toxicologists who may be hired to
provide technical expertise for the testing.  An additional 10 percent
of the testing cost will be added to cover the costs of technical
experts that may work for the consortium and covers study review and
site visits to the laboratory.  This amounts to a total of 25 percent
for burden associated with administering the testing consortium and
testing.  In some cases, the actual burden of these activities may be
undertaken by an organization or individual contracted by the respondent
and would be included as a cost.  However, because respondents may
undertake some or all of these activities themselves, the burden is
included in this analysis

Based on these assumptions, non-reporting activities associated with
laboratory testing are estimated to cost $4.0 million annually (Table 4,
line g).  These costs are translated into burden estimates using a
weighted average labor cost of $51.28 per hour, which is based on a
labor mix that is 20 percent managerial, 60 percent technical, and 20
percent clerical.  The estimated non-reporting administrative burden
based on this approach is 78,362 hours annually (Table 4, line m).



Table 5.  Total Annual Respondent Cost and Burden for Reporting
Activities

COLLECTION ACTIVITY	UNIT LABOR	UNIT SUPPLY COSTS	TOTAL ANNUAL

ITEMS	GRAND TOTAL

	TYPEa	HOURS	RATE	COST

	HOURS	COSTS

INTERIM REPORTS	 	 	 	 	 	 	 	 

Letter of Intent and Study Plans	T	40	$54.72 	$2,188.80 	$20.00 	8	320
$17,670 

Prepare Progress Report	T	8	$54.72 	$437.76 	$5.00 	75	600	$33,207

INTERIM REPORTS SUBTOTAL

$2,626.56 

83	920	$50,877 

FINAL REPORTS	 	 	 

 	 

Short-term Studies	 	 	 	 	 	 	 	 

Record and Prepare Test for Submission	T	40	$54.72 	$2,188.80 	$0.00 
415	16,600	$908,352 

Laboratory Review	T	6	$54.72 	$328.32 	$0.00 	415	2,490	$136,253 

Corporate Review	M	6	$65.22 	$391.32 	$0.00 	415	2,490	$162,398 

Type and Print Results	S	20	$27.00 	$540.04 	$0.00 	415	8,300	$224,116 

Record Keeping	S	1	$27.00 	$27.00 	$5.00 	415	415	$13,281 

 Short-term Subtotal

$3,475.48 	 	 	30,295	$1,444,399

Long-term Studies	 	 	 

	Record and Prepare Test for Submission	 T	80 	$54.72 	$4,377.60 
$0.00 	 15	1,200 	$65,664 

Corporate Review	M	9	$65.22 	$586.98 	$0.00 	15	135	$8,805

Type and Print Results	S	40	$27.00 	$1,080.08 	$0.00 	15	600	$16,201

Record Keeping	S	1	$27.00 	$27.00 	$5.00 	15	15	$480

 Long-term Subtotal

$6,071.66 	 	 	1,950	$91,150

Robust Summaries	T	12	$54.72	$656.64	$0.00	89	1,063	$58,178

FINAL REPORTS SUBTOTAL	 	 	 

	519	33,308	$1,593,727

EXEMPTION REQUESTS	T	2	$54.72 	$109.44 	$0.00 	0 	0	$0 

TOTALS

602	34,228	$1,644,528

a Labor Type Codes are as follows: T = Technical; M = Managerial; S =
Secretarial	 	 	 	 	 	 

  SEQ CHAPTER \h \r 1 	6(b)	Agency Cost and Burden

	The cost and burden to the Agency to process, review, and analyze the
information collected under section 4 test rules, consent orders and
agreements, and voluntary testing programs are discussed below and
detailed in Table 6.

	The Agency collection procedures are estimated to be accomplished, on
average, by a GS-13, Step 1 employee.  The annual 2007 loaded cost of a
full-time equivalent (FTE) for this level employee is $127,035.  This
includes a base wage of $79,397 plus 60 percent for overhead and
benefits (i.e., $47,638).  Dividing this value by 2,080 (i.e., the
number of hours in a work year) results in an hourly wage rate of $60.86
(see Attachment 3 for derivation of these figures).

AGENCY LABOR

CATEGORY	LOADED

HOURLY RATE ($2007)

   GS-13, Step 1	$60.86

	The estimated unit Agency burden of processing letters of intent and
study plans (3 hours), progress reports (1 hour), and final reports (5
hours) is derived from the previous ICRs and is believed to be
reflective of the time required for each activity.  This information is
presented in Table 6.  It takes approximately one hour for the Agency to
process and review each exemption application and 16 hours for the
Agency to enter study plans and results into the HPV Information System
(HPVIS).  The total annual Agency costs and burden for processing
letters and reports is $210,874 and 3,465 hours, or approximately 1.7
FTEs per year, where one FTE is equivalent to 2,080 hours per year.
There are no exemptions associated with these actions and therefore no
associated cost or burden.

Table 6.  Annual Agency Cost and Burden Estimates

COLLECTION ACTIVITY	UNIT LABOR	UNIT SUPPLY COSTS	ANNUAL ITEMS	GRAND
TOTAL

	HOURS	RATE	COST

	HOURS	COSTS

Letter of Intent and Study Plans	3	$60.86 	$182.58 	0 	8	24	$1,454 

Progress Reports	1	$60.86 	$60.86 	0 	75	75	$4,565 

Final Reports	5	$60.86 	$304.30 	0 	430	2,150	$130,849 

HPVIS Data Entry	16	$60.86 	$973.76 	0	7	112	$6,816 

Robust Summary	1	$60.86	$60.86	0	89	89	$5,392

          SUBTOTAL	602	2,449	$149,076 

Exemptions	1	$60.86 	$60.86 	0 	0	0	$0 

         GRAND TOTAL 	602	2,449	$149,076 

	  SEQ CHAPTER \h \r 1 6(c)	Annual Burden Hours and Costs

		6(c)(i) Respondent Tally

	Table 7 summarizes the average annual burden per response. EPA
estimates that this ICR will impose 112,598 burden hours on respondents
annually with an average of 243 hours per response.

Table 7. Average Annual Respondent Burden Hours Per Response

COLLECTION ACTIVITY	 RESPONDENT BURDEN PER RESPONSE 

	TOTAL HOURS	TOTAL ITEMS	HOURS PER RESPONSE

Reporting Activities

 	Letters of Intent/Study Plans 	320	8	40

 	Progress reports	600	75	8

 	Final Reports	33,308	519	64

 	Exemption Requests 	0	0	0

 	            Subtotal (all responses)	34,228	602	112

Non-reporting activities	78,362	602	130

Total	112,590	602	243

			

	The total annual burden hours and costs for respondents were derived in
Table 5, above, and are summarized below in Table 8. 

Table 8. Summary of Annual Respondent Burden and Costs Estimates

COLLECTION

ACTIVITY	Total

	Hours	Cost

Reporting activities

 	Letters of Intent and Study Plans	320	$17,670 

 	Progress Reports	600	$33,207 

 	Final Reports	33,308	$1,593,727 

 	Exemption Requests 	0	$0 

 	             Subtotal	34,228	$1,644,605 

Non-reporting activities	78,362	$4,018,096 

TOTAL (all responses)	112,590	$5,662,701 

		6(c)(ii) Agency Tally

	

	The total annual burden hours and costs for the government were derived
in Table 6, above, and are summarized below in Table 9.

Table 9. Summary of Annual Agency Burden and Costs Estimates 

COLLECTION 

ACTIVITY	TOTAL AGENCY BURDEN AND COSTS

	BURDEN (Hours)	COSTS

Letter of Intent and Study Plans	24	$1,454 

Progress Reports	75	$4,565 

Final Reports	2,150	$130,849 

HPVIS Data Entry	112	$6,816 

Exemptions	0	$0 

TOTAL	2,361	$143,684 

	  SEQ CHAPTER \h \r 1 6(d)	Reasons for Changes in Burden

	Compared with the previous ICR, the present ICR represents a decrease
in total respondent burden from 203,014 hours to 112,590 hours, or a
decrease of 90,424 hours.  The present ICR also represents a decrease in
total respondent administrative cost from $8.66 million to $5.7 million,
or a decrease of $2.96 million. 

	In the previous ICR, the EPA’s estimated burden was based on the
assumption that the Agency would issue one test rule, one ECA or consent
order, and included estimates of testing needs to be completed under the
voluntary HPV Challenge for 508 chemicals.  For this ICR, the burden is
based on the Agency’s expectation that it will issue three ECAs and
does not include any estimates for test rules.  In addition, the
Agency’s estimate of the expected level of testing remaining to be
done under the HPV Challenge Program covers only 228 chemicals, or less
than half those included in the previous ICR.  Therefore, total annual
burden has decreased.  However, burden per respondent has increased. 
This is because this ICR has estimated that up to five studies may be
conducted for each of the HPV chemicals, whereas, the previous ICR
estimated one.  This ICR has used a number closer to the upper end of
the range for numbers of studies submitted, rather than the median for
all types of HPV chemicals (those with and without test plans already
submitted).  Additionally, this analysis includes additional
non-reporting administrative burden that was not included in the
previous analysis and has added an estimated for burden hours associated
with completing robust summaries for both the HPV Challenge Program and
voluntarily under consent orders.

	In addition to these changes, the Agency has adjusted all costs to
reflect an update in the labor rates, and more recent laboratory testing
costs. 

	  SEQ CHAPTER \h \r 1 6(e)	Burden Statement

	The annual public burden for this collection of information, which is
approved under OMB Control No. 2070-0033, is estimated to average 243
hours per response (Table 7).  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 it 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 current and valid OMB control number. 
The OMB control numbers for EPA’s regulations in title 40 of the CFR,
after appearing in the Federal Register, are listed in 40 CFR part 9 and
included on the related collection instrument or form, if applicable.

	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-2007-0716.  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-2007-0716 and OMB control number 2070-0033 in any
correspondence.

References

Moore 2004. Jack Moore, Memo to National Pollution Prevention and Toxics
Advisory Committee, part of minutes from May 13, 2004 meeting, available
at www.epa.gov/oppt/npptac/meetings/summarymay2004.pdf.

Piccirillo 2004.  Vincent Piccirillo, personal communication. September
20, 2004.

USEPA 2004. Economic Impact Analysis and Small Entity Impact Analysis 
of the TSCA Section 4(a) Test Rule for 34 Chemicals Targeted for in
Vitro Dermal Absorption Rate Testing.  Economic and Policy Analysis
Branch, Economics, Exposure and Technology Division, Office of Pollution
Prevention and Toxics.  February 3, 2004.

USEPA 2002. “Wage Rates for Economic Analysis of the Toxics Release
Inventory Program.” Memorandum from Cody Rice, Analytical Support
Branch, Environmental Analysis Division, Office of Environmental
Information, U.S. EPA.  April 11, 2002.

USEPA 1989.  “Administrative costs and burden hours for test rule.”
Note from Dan Axelrad to Bob Lee and Libby Parker, Regulatory Impacts
Branch, Office of Pollution Prevention and Toxics, U.S. EPA.  October
26, 1989.

 “Short-term studies” are tests that can be concluded in the year
they begin; “long-term studies” are concluded within three years.

 The laboratory cost is considered part of the sponsor’s overall cost.

 HPV chemicals are those manufactured in, or imported to, the United
States in annual quantities of one million pounds or more. The HPV
Challenge Program covered 2,782 chemicals at its launch in 1998.

 Some long-term tests assumed to be conducted under consent order may
take more than a year to complete. For purposes of the ICR EPA assumes
the full cost and burden of completing the testing is incurred during
each year.

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