[Federal Register Volume 65, Number 248 (Tuesday, December 26, 2000)]
[Notices]
[Pages 81686-81698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32498]



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

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ENVIRONMENTAL PROTECTION AGENCY

[OPPTS-42213; AR-201; FRL-6754-6]


Data Collection and Development on High Production Volume (HPV) 
Chemicals

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  Although HPV chemicals are produced or imported in large 
quantities in the United States, there is little or no publicly 
available information regarding the potential hazards associated with 
most HPV chemicals. In order to obtain such information, EPA has 
established a data collection and development program for existing HPV 
chemicals. Through the HPV Initiative, which includes the voluntary HPV 
Challenge Program, certain international efforts, and potential 
rulemaking under the Toxic Substances Control Act (TSCA), basic 
screening level hazard data necessary to provide critical information 
about the environmental fate and potential hazards associated with HPV 
chemicals will be collected or, where necessary, developed. A primary 
component of this HPV Initiative is the voluntary HPV Challenge 
Program, which was created in cooperation with industry, environmental 
groups, and other interested parties, and is designed to assemble basic 
screening level test data on the potential hazards of HPV chemicals 
while avoiding unnecessary or duplicative testing. Data needs which 
remain unmet in the voluntary HPV Challenge Program, may be addressed 
through the international efforts or rulemaking. Data collected and/or 
developed under the HPV Initiative will provide critical basic 
information about the environmental fate and potential hazards 
associated with these chemicals which, when combined with information 
about exposure and uses, will allow the Agency and others to evaluate 
and prioritize potential health and environmental effects and take 
appropriate follow up action. EPA has taken steps, as described in this 
document, to consider animal welfare and to provide instructions on 
ways to reduce or in some cases eliminate animal testing, while at the 
same time ensuring that the public health is protected.

FOR FURTHER INFORMATION CONTACT:  For general information contact: 
Barbara Cunningham, Acting Director, Environmental Assistance Division 
(7408), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (202) 554-1404; e-mail address: [email protected].
    For technical information contact: Barbara Leczynski, Existing 
Chemicals Branch, Chemical Control Division (7405), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 
260-3945; fax number: (202) 260-1096; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Document Apply to Me?

    This document applies to the public in general and, in particular, 
those companies that manufacture (defined by statute to include import) 
industrial chemicals for which the aggregate U.S. production/
importation volumes meet or exceed 1 million pounds per year. Those 
chemicals that meet these criteria are referred to as HPV chemicals. 
The HPV chemicals that are included in the voluntary HPV Challenge 
Program are listed in ChemRTK HPV Challenge Program Chemical List  
(Ref. 1). If you have any questions regarding the applicability of this 
action to a particular entity, consult the technical person listed 
under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Support Documents?

    1. Electronically. You may obtain copies of this document, and 
certain other related documents that might be available electronically, 
from the EPA Internet Home Page at http://www.epa.gov/. To access this 
document, on the Home Page select ``Laws and Regulations,'' 
``Regulations and Proposed Rules,'' then look up the entry for this 
document under the ``Federal Register--Environmental Documents.'' You 
can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines 
referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.
    You may also access additional information about the Chemical 
Right-to-Know Program at http://www.epa.gov/chemrtk/ or about the TSCA 
testing program at http://www.epa.gov/opptintr/chemtest/sct4main.htm.
    For your convenience, EPA has also provided some non-EPA internet 
addresses. In doing so, the Agency has verified the accuracy of these 
addresses at the time of signature. However, since EPA is not 
responsible for these non-EPA sites, the Agency does not exercise any 
control over these addresses. A paper copy of any document referenced 
in this way has been included in the public version of the official 
record for this document as described in Unit I.B.2.
    2. In person. The official record for this document, which includes 
the public version, has been established under docket control number 
OPPTS-42213 and administrative record number AR-201. This official 
record consists of the documents referenced in this document, as well 
as any comments received, and other information related to this 
document, including information claimed as Confidential Business 
Information (CBI). This official record includes the documents that are 
physically located in the docket, as well as all documents that are 
referenced in those documents. The public version of the official 
record does not include any information claimed as CBI. The public 
version of the official record, which includes printed, paper versions 
of any electronic comments that may be submitted, is available for 
inspection in the TSCA Nonconfidential Information Center, Northeast 
Mall, Rm. NE B-607, Waterside Mall, 401 M St., SW., Washington, DC. The 
Center is open to the public from noon to 4 p.m., Monday through 
Friday, excluding legal holidays. The telephone number of the Center is 
(202) 260-7099.

C. Can I Submit Comments Under the Voluntary HPV Challenge Program?

    Yes. Although this document does not establish a specific comment 
period, you may submit comments at various times throughout the 
voluntary HPV Challenge Program. This document describes the various 
opportunities that are available for you to submit comments under the 
voluntary HPV Challenge Program. In addition, specific information 
about the voluntary HPV Challenge Program and the opportunities for you 
to submit comments is provided on the Agency's web site identified in 
Unit I.B.1.
    In general, you may submit comments under the voluntary HPV 
Challenge Program via the following methods: The mail, in person, or 
electronically. To ensure proper receipt by EPA, please identify the 
docket control number OPPTS-42213 and the administrative record number 
AR-201 in the subject line on the first page of your response. In 
addition, Challenge Program sponsors should reference the unique seven-
digit registration number they were assigned

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when the Agency verified the information presented in their original 
commitment letters. Sponsors who need to confirm their registration 
numbers should call (202) 260-6199.
    1. By mail. Submit your comments to: Carol Browner, Administrator, 
Environmental Protection Agency, P.O. Box 1473, Merrifield, VA 22116, 
Attention: Chemical Right-to-Know Program.
    2. In person or by courier. Deliver your comments to: OPPT Document 
Control Office (DCO) in East Tower Rm. G-099, Waterside Mall, 401 M 
St., SW., Washington, DC. The DCO is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
DCO is (202) 260-7093.
    3. Electronically. Submit your comments electronically by e-mail to 
[email protected], [email protected], and [email protected] (please be 
sure to send your e-mail to all three addresses). (Note: To submit 
comments on a test plan, please go to http://www.epa.gov/chemrtk/viewsrch.htm.) Do not submit any information electronically that you 
consider to be CBI. Electronic comments must be submitted as an ASCII 
file avoiding the use of special characters and any form of encryption. 
Comments will also be accepted on standard computer disks in 
WordPerfect 6.1/8 or ASCII file format, mailed or delivered to the 
address identified in Unit I.C. All comments in electronic form must be 
identified by docket control number OPPTS-42213 and administrative 
record number AR-201. Electronic comments may also be filed online at 
many Federal Depository Libraries.

D. How Should I Handle CBI Comments that I Want to Submit to the 
Agency?

    Considering that one of the goals of the HPV Initiative is to 
provide information needed to meet the public's right-to-know about the 
hazards that may be posed by exposure to HPV chemicals, EPA encourages 
companies and other interested parties not to make CBI claims in 
submitted comments. If you do choose to submit CBI in your comments, 
adhere to the following procedures. Do not submit any information 
electronically that you consider to be CBI. You may claim information 
that you submit to EPA in response to this document as CBI by marking 
any part or all of that information as CBI. Information so marked will 
not be disclosed except in accordance with procedures set forth in 40 
CFR part 2. In addition to one complete version of the comment that 
includes any information claimed as CBI, a copy of the comment that 
does not contain the information claimed as CBI must be submitted for 
inclusion in the public version of the official record. Information not 
marked confidential will be included in the public version of the 
official record without prior notice. If you have any questions about 
CBI or the procedures for claiming CBI, consult the technical person 
listed under FOR FURTHER INFORMATION CONTACT.

II. Background

A. Why is EPA Pursuing Hazard Information on HPV Chemicals?

    EPA found that, of those non-polymeric organic substances produced 
or imported in amounts equal to or greater than 1 million pounds per 
year based on 1990 reporting for EPA's Inventory Update Rule (IUR) (40 
CFR part 710), only 7% have a full set of publicly available 
internationally recognized basic health and environmental fate/effects 
screening test data (Ref. 2). Of the over 2,800 HPV chemicals based on 
1990 data, 43% have no publicly available basic hazard data. For the 
remaining chemicals, limited amounts of the data are available. This 
lack of available hazard data compromises EPA's and others' ability to 
determine whether these HPV chemicals pose potential risks to human 
health or the environment, as well as the public's right-to-know about 
the hazards of chemicals that are found in their environment, their 
homes, their workplaces, and the products that they buy. It is EPA's 
intent to close this knowledge gap. EPA believes that for most of the 
HPV chemicals, insufficient data are readily available to reasonably 
determine or predict the effects on health or the environment from the 
manufacture (including importation), distribution in commerce, 
processing, use, or disposal of the chemicals, or any combination of 
these activities. EPA has concluded that a program to collect and, 
where needed, develop basic screening level toxicity data is necessary 
and appropriate to provide information in order to assess the potential 
hazards/risks that may be posed by exposure to HPV chemicals.
    On April 21, 1998, a national initiative, known as the ``Chemical 
Right-To-Know'' Program, was announced in order to empower citizens 
with knowledge about the most widespread chemicals in commerce--
chemicals that people may be exposed to in the places where they live, 
work, study, and play. EPA's Chemical Right-To-Know (ChemRTK) 
initiative is being designed in such a way as to make certain basic 
information about HPV chemicals available to the public.
    EPA plans to make available to the public the summarized data 
obtained on HPV chemicals. In addition, any subsequent information that 
EPA receives will be shared with the public, other Federal agencies, 
and any other interested parties. As appropriate, this information will 
be used to ensure a scientifically sound basis for risk assessment/
management actions. This initiative will serve to further the Agency's 
goal of identifying and controlling human and environmental risks as 
well as providing greater protection and knowledge to the public. In 
addition, EPA and other parties agreed to work with other nations and 
international groups to ensure commensurate increases in the pace of 
complementary voluntary international data collection and development 
efforts on HPV chemicals.
    This ChemRTK initiative is consistent with the U.S. policy as 
presented in section 2(b)(1) of TSCA, 15 U.S.C. 2601(b)(1), which 
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 and 
those who process such chemical substances and mixtures.''

B. What do we Currently Know about the Basic Health and Environmental 
Hazards of HPV Chemicals?

    The information relevant to understanding the basic health and 
environmental hazards of HPV chemicals is derived from a battery of 
tests agreed upon by the international community as appropriate for 
screening international HPV chemical substances for toxicity. Six basic 
testing endpoints have been adopted by the Organization for Economic 
Cooperation and Development (OECD) as the minimum required to screen 
international HPV chemical substances for toxicity (Ref. 3). The 
agreed-upon testing endpoints, known as the OECD's ``Screening 
Information Data Set'' (SIDS) include: Acute toxicity; repeat dose 
toxicity; developmental and reproductive toxicity; mutagenicity (gene 
mutation and chromosomal aberration/damage assays); ecotoxicity 
(studies in fish, invertebrates, and algae); and environmental fate 
(including physical/chemical properties [melting point, boiling point, 
vapor pressure, n-octanol/water partition coefficient, and water 
solubility], photolysis, hydrolysis, transport/distribution, and

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biodegradation). As conceived by the OECD, the ``SIDS battery'' of 
tests can be used by governments to conduct an initial assessment of 
the hazards and risks posed by HPV chemical substances and prioritize 
HPV chemicals to identify those in need of additional, more in-depth 
testing and assessment.
    A need for basic screening level data on HPV chemicals has been 
identified and supported by various data availability studies conducted 
by EPA and others. Toxic Ignorance, which was prepared by Environmental 
Defense (formerly the Environmental Defense Fund), raised a variety of 
concerns about the untested chemicals that are produced and/or imported 
into the United States (Ref. 4). Environmental Defense found that 
baseline data on health effects were not publicly available for a 
selected set of 100 HPV chemicals.
    In April 1998, EPA completed a study entitled Chemical Hazard Data 
Availability Study: What Do We Really Know About the Safety of High 
Production Volume Chemicals? (Ref. 2) that evaluated the ``public 
availability'' of health hazard data and environmental hazard/fate data 
on HPV chemicals. EPA's study found major gaps in the basic information 
on HPV chemicals that is readily available to EPA and to the public, 
and reinforced the need for governmental leadership on this issue. The 
study analyzed the availability of test data for 2,863 HPV chemicals 
(defined as those organic substances produced in or imported into the 
United States in amounts equal to or greater than 1 million pounds per 
year based on 1990 reporting for EPA's IUR). EPA searched for publicly 
available data on these chemicals and learned that most of them may 
never have been tested for any or most of the SIDS endpoints. The 
search strategy used a total of 11 publicly accessible databases in its 
analysis. Details of the search strategy can be found in the report 
(Ref. 2). The major conclusions of EPA's study are described in Unit 
II.A.
    In June 1998, the American Chemistry Council (ACC, formerly the 
Chemical Manufacturers Association (CMA)) issued a report (Ref. 5) 
regarding public data availability for HPV chemicals based on a study 
conducted with 11 main data sources, including data sources other than 
those searched by EPA for its study. The ACC report, entitled Public 
Availability of SIDS-Related Testing Data for U.S. High Production 
Volume Chemicals (Ref. 5), reached conclusions similar to EPA, that is, 
that only limited toxicity and environmental fate testing data appear 
to exist in the public domain for many HPV substances. Details of the 
search strategy used can be found in the ACC report (Ref. 5).
    EPA recognizes that additional data may exist beyond those 
identified through either the EPA, ACC, or Environmental Defense 
studies. To the extent that additional relevant data are known to 
exist, EPA is particularly interested in receiving this information as 
part of the HPV Initiative, including, where possible, a full citation 
for publications and ``robust'' (i.e., detailed) summaries of pertinent 
published and unpublished studies. Guidance on the preparation of 
robust summaries is available on EPA's ChemRTK web site (Ref. 6). In 
developing the testing requirements for chemicals contained in the HPV 
Initiative, EPA is utilizing information and sources in EPA's study, 
the Chemical Hazard Data Availability Study (Ref. 2), and ACC's report, 
i.e, Public Availability of SIDS-Related Testing Data for U.S. High 
Production Volume Chemicals (Ref. 5), to determine whether screening 
level data for characterizing the hazards of these HPV chemicals are 
publicly available. Under the voluntary HPV Challenge Program, EPA is 
utilizing the 120 day comment period for test plans to allow for 
further identification of existing data. If no data are available for a 
SIDS testing endpoint, there cannot be sufficient data to characterize 
the potential hazards/risks associated with the chemical. As the Agency 
found in its study, insufficient data are available to characterize 
many of the HPV chemicals with respect to the internationally accepted 
SIDS testing endpoints, including acute toxicity, repeat dose toxicity, 
developmental and reproductive toxicity, mutagenicity (gene mutation 
and chromosomal aberration assays), ecotoxicity (tests in fish, 
Daphnia, and algae), and for environmental fate (including five tests 
for physical chemical properties [melting point, boiling point, vapor 
pressure, n-octanol/water partition coefficient, and water solubility], 
and biodegradation). As a result, EPA and others cannot reasonably 
determine or predict the human health and environmental effects 
resulting from manufacture, processing, and use of these chemical 
substances.
    EPA solicits comment concerning the availability of SIDS data on 
the chemicals included in the HPV Initiative and encourages industry 
and other interested parties to identify and provide any additional 
existing data which are relevant to the hazard characterization to 
avoid any unnecessary or duplicative testing. Furthermore, anyone may 
provide any relevant information to the Agency that indicates that 
certain endpoints need not be tested. If EPA judges the available data 
to be adequate, the data gap identified in the HPV Initiative will be 
considered to be filled. To the extent that additional data relevant to 
the HPV chemicals are known to exist, EPA is interested in receiving 
this information under the voluntary HPV Challenge Program, including a 
full citation for publications and full copies of unpublished studies. 
Although the Agency encourages anyone with such information to submit 
it to EPA during the early stages of this initiative in order to avoid 
any unnecessary testing, such submissions may be made at any time. 
Commenters are also encouraged to prepare a robust summary (Ref. 6) for 
each study to facilitate EPA's review of the full-study report or 
publication. It is important to note that EPA does not intend to 
include any chemicals which are Generally Recognized as Safe (GRAS) for 
a particular use by the Food and Drug Administration (FDA) in its 
initial TSCA section 4 HPV SIDS rulemaking for certain HPV chemicals. 
However, such chemicals may be included in a future TSCA section 4 HPV 
SIDS rulemaking where SIDS data needs remain unmet.

C. Why is EPA Focusing on HPV Chemicals?

    It is generally accepted that chemicals having a high level of 
production have an increased potential for exposure in comparison to 
low production volume chemicals. The HPV focus of the HPV Initiative is 
derived from the experience gained over the past 15 years by EPA and 
the OECD. The OECD is an intergovernmental organization consisting of 
29 developed countries, including the United States, with advanced 
worldwide market economies. The OECD is helping coordinate a 
cooperative, international effort to secure basic toxicity information 
on HPV chemicals in use worldwide.
    The OECD, after considering a variety of priority-setting 
approaches, concluded in 1990 that consideration of HPV status provided 
a useful and effective organizing focus for a voluntary testing and 
assessment effort to screen and thereby identify priorities among 
international HPV chemicals.

III. HPV Chemical Data Collection and Development Initiative

A. What is the HPV Initiative?

    Through the HPV Initiative, which includes the voluntary HPV 
Challenge Program, certain international efforts, and potential 
rulemaking under TSCA,

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basic screening level hazard data necessary to provide critical 
information about the environmental fate and potential hazards 
associated with HPV chemicals will be collected or, where necessary, 
developed. These data, when combined with information about exposure 
and uses, will allow the Agency and others to evaluate and prioritize 
potential health and environmental effects and take appropriate follow 
up. Created in cooperation with industry, environmental groups, and 
other interested parties, a primary component of this initiative is the 
voluntary HPV Challenge Program. To fill any data gaps not addressed as 
part of the voluntary HPV Challenge Program, EPA is continuing to 
participate in the international efforts coordinated by the OECD to 
secure basic hazard information on HPV chemicals in use worldwide, 
including some of those on the HPV chemicals list. The voluntary HPV 
Challenge Program and the international efforts will be supplemented by 
rulemaking under TSCA, which the Agency intends to use to collect or 
develop data on those HPV chemical substances for which data needs 
remain unmet in the voluntary HPV Challenge Program, or as part of the 
international efforts.
    Although an important component of the HPV Initiative is the 
potential for TSCA rulemaking to address any data needs identified that 
are not met by either the voluntary HPV Challenge Program or 
international efforts, the focus of this document is the voluntary HPV 
Challenge Program. The specific requirements for any associated TSCA 
section 4 HPV SIDS rulemaking will be addressed in that rulemaking.
    The voluntary HPV Challenge Program and any associated rulemaking, 
will generally be carried out in a manner consistent with the OECD HPV 
SIDS Program to ensure that the data and information generated can be 
contributed to the international efforts and, conversely, that 
international SIDS testing and assessments can be used to fulfill the 
data gaps identified as part of the voluntary HPV Challenge Program or 
in related TSCA section 4 HPV SIDS rulemaking thus avoiding unnecessary 
or duplicative testing and its associated costs. The elements of this 
strategy and the overall approach that EPA is using to address data 
collection needs for HPV chemicals are discussed in this document, 
along with the components of the voluntary HPV Challenge Program.

B. Which Industrial Chemicals are Covered in this HPV Initiative?

    1. How were chemicals identified for inclusion in the HPV 
Initiative? The industrial chemicals covered by the HPV Initiative are 
those non-polymeric organic chemicals that are produced in, or imported 
into, the United States in amounts equal to, or greater than, 1 million 
pounds per year according to the 1990 IUR. This list of HPV chemicals 
can be viewed at EPA's ChemRTK web site (Ref. 1).
    2. How will chemicals that are solely produced as closed system 
intermediates be included in the HPV Initiative? Chemicals which meet 
the requirements for ``closed system intermediates'' as described in an 
available guidance document (Ref. 7 and Unit IV.B.1.) on this topic, 
will be eligible for a reduced SIDS testing battery. For further 
information you should check EPA's ChemRTK web site (Ref. 7) to obtain 
a copy of this document. EPA's guidance is based on section 3.6 of the 
Screening Information Data Set (SIDS) Manual which concerns 
``intermediates contained in closed systems.'' The requirements for 
classification as a closed system intermediate must be met by all U.S. 
manufacturers (including importers) for a chemical to be eligible for a 
reduced level of testing. Under the voluntary HPV Challenge Program, 
EPA asked that participants in that program observe certain principles 
laid out in an October 14, 1999, letter (Ref. 8). One principle is that 
participants shall not develop sub-chronic or reproductive toxicity 
data for the HPV chemicals that are solely closed system intermediates 
as defined by the OECD/SIDS guidelines, and that testing of closed 
system intermediates shall be deferred until 2003.
    3. Are HPV Chemicals that are no longer produced or imported 
included in this HPV Initiative? EPA previously issued guidance for 
verifying that a chemical is ``no longer HPV'' (based on national 
aggregate production/importation volume) and is not likely to become 
HPV in the future. This guidance document can be found on the Agency's 
ChemRTK web site (Ref. 9).
    For EPA to conclude that a ``no longer HPV'' claim is valid, a 
chemical cannot be produced by any company or group of companies at a 
total aggregate production volume of 1 million pounds per year or 
greater, and the chemical must be shown as not likely to become an HPV 
chemical in the future, based on business plans, past production 
patterns, and credible trends in the market. These conditions are 
intended to satisfy the terms of the voluntary HPV Challenge Program 
Framework Document, as quoted on the EPA Chemical Right-to-Know web 
site: ``Substances that sponsors verify are no longer ``HPV'' and are 
not likely to become HPV again will not require testing and will be 
removed from the list.''
     In accordance with the policy announced in the guidance document 
(Ref. 9), EPA has set the minimum criteria for identifying chemicals as 
no longer HPV as a total annual aggregate production volume below 1 
million pounds for the last two IUR reporting cycles (i.e., 1994 and 
1998).
    Written documentation demonstrating that the current aggregate U.S. 
production/importation volume of a chemical was substantially less than 
1 million pounds per year and was likely to remain so was required as 
described in the guidance document (Ref. 9). This justification had to 
have been provided for all U.S. producers and importers of the 
chemical. Once it has been established via specific requests received 
before the end of the voluntary HPV Challenge Program sign up period 
that a chemical is ``no longer HPV'' and is not likely to become an HPV 
chemical again, EPA would remove the chemical from the HPV Initiative.
    4. How will EPA handle HPV chemicals that do not warrant any 
further SIDS testing? As of November 9, 2000, EPA has determined that 
for 44 HPV chemicals, SIDS level testing is not warranted. These 
chemicals are identified on the Agency's web site at http://www.epa.gov/chemrtk/hpv_1990.htm. EPA's preliminary review of these 
chemicals indicates that testing using the SIDS base set would not 
further our understanding of the chemicals' properties. These chemicals 
are identified on the voluntary HPV Challenge Program Chemical List 
(Ref. 1) with an indicator value of ``1.'' EPA has invited, and 
continues to invite, industry and other interested parties to identify 
additional chemicals that might be appropriate for this designation. 
This identification process would take the form of a review of the 
available information which shows that, for a given chemical, 
conducting the SIDS battery of tests would not be of value in 
furthering an understanding of the chemical's properties including 
physical/chemical, environmental fate, environmental toxicity, and 
mammalian toxicity endpoints. Alternatively, for well-tested chemicals, 
companies are encouraged to provide the information in a ``no test'' 
test plan along with robust summaries of the existing data which 
indicate that no testing is required. In addition, as part of EPA's

[[Page 81690]]

efforts under the OECD HPV SIDS Program, the Agency will be working 
with other OECD member countries to identify chemicals for which 
adequate data may have been produced in the context of foreign 
regulatory or testing regimes.

C. What Information is Being Collected on HPV Chemicals?

    The OECD member countries reached consensus in 1990 on a set of 
basic screening-level tests deemed needed for all international HPV 
chemicals. This OECD understanding was captured in a formal 1991 OECD 
decision (Ref. 10) with which the United States concurred. This 
decision resulted in the OECD HPV SIDS Program, which is part of the 
OECD overall program on existing chemicals. The OECD HPV SIDS review 
process includes information on the identity of each chemical, its 
uses, sources and extent of exposure; physical and chemical properties; 
environmental fate; and certain limited toxicity data for humans and 
the environment. The SIDS data set is not intended to describe a 
chemical thoroughly, but rather is intended to provide enough 
information to support an initial (or screening level) assessment and 
to assign a priority for further work, if necessary. To date, the OECD 
has initiated or completed work on over 350 HPV chemicals. The OECD HPV 
SIDS Program seeks the development of test data, if such data are not 
already available, related to six health and environmental effects 
endpoints for international HPV chemicals (see Unit II.B.). The SIDS 
test guidelines are regarded as the minimum data set required to make 
an informed preliminary judgment about the hazards of a given HPV 
chemical.
     EPA is implementing the HPV Initiative as part of its domestic 
industrial chemical screening efforts, in a manner that is consistent 
with OECD efforts. The information to be gathered under EPA's HPV 
Initiative comes from the same battery of tests agreed upon by the OECD 
member countries as being appropriate for screening international HPV 
chemicals for toxicity and environmental fate (Ref. 3). As conceived by 
the OECD, the SIDS data set can be used by governments and others 
worldwide to conduct an initial assessment of the hazards and risks 
posed by HPV chemical substances and to prioritize chemicals to 
identify those which are in need of additional, more in-depth testing 
and assessment, as well as those of lesser concern.
    In addition to addressing the six basic screening endpoints, basic 
exposure information including general and occupational use patterns, 
and sources and levels of exposure, can be submitted under the HPV 
Initiative. The basic exposure information could be similar to that 
gathered as part of the OECD HPV SIDS Program. EPA encourages companies 
to provide exposure information to help place the hazard information 
into an appropriate context. Additional guidance may be made available 
at EPA's ChemRTK web site or through other means. In the interim, the 
voluntary HPV Challenge Program sponsors are encouraged to consult 
Annex 5 of the SIDS Manual (Ref. 3) which presents the exposure 
information recommendations developed by the Use and Exposure 
Information Project (UEIP) in the United States.
    The OECD HPV SIDS Program includes the step of preparing an initial 
assessment of the SIDS data. Although this step is not formally 
included as an element in the voluntary HPV Challenge Program 
commitment, EPA encourages sponsors to prepare an initial assessment 
using the OECD's procedure for preparing a SIDS Initial Assessment 
Report (SIAR) that can be subsequently reviewed through the OECD HPV 
SIDS Program. The International Council of Chemical Associations' 
(ICCA) (Ref. 11) HPV Initiative, which complements the OECD's HPV SIDS 
Program, has committed to completing the full SIDS battery and 
preparing a SIAR.

D. What Role do Existing Data Play Under the HPV Initiative?

    The HPV Initiative is designed to make maximum use of 
scientifically adequate existing test data and to avoid unnecessary, 
duplicative testing, thereby avoiding the excessive use of animal 
testing. Opportunities to comment on identified data gaps or submit any 
available adequate data are being provided during the voluntary HPV 
Challenge Program, in response to this document, and in response to any 
future proposed TSCA section 4 HPV SIDS rulemaking. EPA will also post 
the test plans submitted under the voluntary Program to allow for a 120 
day review period before testing begins. It is also EPA's intention for 
the comment period in the associated TSCA section 4 HPV SIDS rulemaking 
to run for 120 days to allow for an equivalent review to occur before 
the rulemaking requirements are finalized. If at any time the Agency 
receives adequate existing data that fulfill a specific data gap, EPA 
will ensure that unnecessary testing is not conducted.
    During the continued development of the HPV Initiative, EPA was 
encouraged to consider the relationship between existing data submitted 
under the HPV Initiative and reporting requirements under TSCA section 
8(e). In response to these concerns, and as part of the Agency's 
efforts to encourage the fullest use of existing test data, EPA intends 
to consider existing data submissions under the voluntary HPV Challenge 
Program in the manner described in an October 14, 1999, letter to 
program participants (herein after ``the October 14, 1999, letter'') 
(Ref. 8). EPA's voluntary HPV Challenge Program guidance document on 
literature searches deals with part of this issue (Ref. 18). EPA 
believes that it is in the economic best interest of companies to 
identify and make publicly available all relevant existing data in 
order to reduce possible testing costs. To the extent that data exist 
which address any SIDS endpoints, the voluntary HPV Challenge Program 
is designed to ensure that sponsors identify and use such data to fill 
the related data gap(s) identified. In addition, EPA plans to post an 
announcement on its ChemRTK web site for incoming test plans. Many of 
these test plans will also be submitted electronically by sponsors to 
the ``US HPV Chemical Tracking System'' (Ref. 19).
    Studies that have been conducted as specified in appropriate OECD 
test guidelines (as noted in the SIDS Manual (Ref. 3) or comparable EPA 
test guidelines (such as the OPPTS Harmonized Guidelines (http://www.epa.gov/opptsfrs/home/guidelin.htm)), and appropriate Good 
Laboratory Practice Standards (GLPS) (e.g., see the TSCA GLPS at 40 CFR 
part 792) consistently generate data adequate to fulfill the HPV 
Initiative needs. Data from studies that did not follow these 
procedures, however, may not be adequate.
    As indicated in the October 14, 1999, letter to the voluntary HPV 
Challenge Program participants, in analyzing the adequacy of existing 
data, EPA encouraged participants to conduct a thoughtful and 
qualitative analysis rather than using a rote checklist approach. If 
EPA judges the available data to be adequate, the data gap identified 
in the HPV Initiative will be considered to be filled. In addition, 
participants in the voluntary HPV Challenge Program may conclude that 
certain endpoints need not be tested if, given the totality of what is 
known about a chemical, including human experience, there is sufficient 
existing data that is consistent with the Agency's guidance on 
determining the data adequacy. EPA has developed a guidance document on 
determining data adequacy which is available on EPA's ChemRTK web site 
(Ref. 12). This

[[Page 81691]]

guidance document is useful in assessing whether a study design used in 
generating existing data is sufficient to meet the needs of the HPV 
Initiative. For example, summary information, such as that taken from 
Material Safety Data Sheets (MSDSs), is not considered adequate to meet 
the needs of the HPV Initiative. Where relevant existing studies are 
identified, companies should provide information at the level of a 
``robust summary'' for each study (Ref. 6).

E. How are Animal Welfare Issues Being Considered in this Initiative?

    EPA recognizes the concerns that have been expressed about test 
procedures that require the use of animals. EPA is making every effort 
to ensure that as the HPV Initiative is implemented, unnecessary or 
duplicative testing is avoided and the use of animals is minimized. As 
a general matter, EPA does not require that tests on animals be 
conducted if an alternative scientifically validated method is found 
acceptable and practically available for use. Where testing must be 
conducted to develop adequate data, the Agency is committed to reducing 
the number of animals used for testing, to replacing test methods 
requiring animals with alternative test methods when acceptable 
alternative methods are available, and to refining existing test 
methods to optimize animal use when there is no substitute for animal 
testing. EPA believes that these reduction, replacement, and refinement 
objectives are all important elements in the overall consideration of 
alternative testing methods.
    The governmental and non-governmental scientific community is 
working to design, validate, and employ new methods of toxicity testing 
that are more accurate, less costly, and that reduce the need to use 
live animals. Over the years, significant research has been pursued to 
develop and validate non-animal test methods. United States scientists 
in academia, government, and industry have participated in both 
domestic and international efforts to develop alternative, non-animal 
tests. As part of the enterprise, the National Institute for 
Environmental Health Science (NIEHS) established a Federal interagency 
committee, the Interagency Coordinating Committee on Validation of 
Alternative Methods (ICCVAM), to review the status and validation of 
toxicological test methods including those that are performed in vitro. 
EPA scientists have contributed significantly to this body of knowledge 
and are continuing to play a vital role by developing test methods for 
consideration. Many test methods have begun the process of validation 
and several have completed the steps leading to government-wide 
regulatory acceptance. Within the SIDS battery of tests, a number of in 
vitro genotoxicity tests, such as the Ames test for gene mutations in 
bacteria, have received uniform acceptance among regulatory agencies.
    In addition, as part of the voluntary HPV Challenge Program, EPA 
asked participants in that Program to observe certain principles laid 
out in the October 14, 1999, letter. In its letter, EPA also indicated 
that it is the intention of the Agency that the HPV Initiative, 
including the voluntary HPV Challenge Program and any associated TSCA 
section 4 HPV SIDS rulemaking, proceed in a manner consistent with 
these principles and concerns. One of the principles in the October 14, 
1999, letter to participants in the voluntary HPV Challenge Program, is 
that participants shall conduct a thoughtful, qualitative analysis of 
existing data before testing and that all animal testing on individual 
chemicals (as opposed to testing of categories of chemicals) under the 
voluntary HPV Challenge Program or under an associated rule(s) be 
deferred until November 2001 and that testing of chemicals solely 
manufactured as closed system intermediates be deferred until 2003.
    Under the voluntary HPV Challenge Program structure, alternatives 
to help further reduce animal testing are available. For example, under 
the OECD HPV SIDS Program, some instances have been identified where, 
using chemical category approaches, less than a full set of SIDS data 
for every chemical in the category has been judged sufficient for 
screening purposes. In addition, the OECD HPV SIDS Program allows some 
use of structure activity relationships (SAR) analysis for individual 
chemicals. These strategies have the potential to reduce the time 
required to complete the program, the number of tests actually 
conducted, and the number of test animals needed. One of the principles 
in the October 14, 1999, letter is that participants in the voluntary 
HPV Challenge Program shall maximize the use of scientifically 
appropriate categories of related chemicals and SAR. Those who wish to 
use these alternative approaches should seriously consider handling the 
chemical voluntarily, by submitting a viable commitment as described in 
Unit IV.C. A viable commitment involving these alternate approaches can 
still be submitted during the regulatory phase of the HPV Initiative, 
but submission in the earlier phases of this initiative will best avoid 
unnecessary or duplicative testing.

F. How Will Data Collected on HPV Chemicals be Used?

    The availability of hazard information on individual chemicals is 
fundamental to EPA's ability to accomplish its mission of environmental 
protection--risk assessment based on sound science, risk management, 
safeguarding children's health, transparency, expanding the public's 
right-to-know, and promoting the pollution prevention ethic. Activities 
to ensure the availability of basic hazard information on HPV chemicals 
are an integral part of meeting these objectives.
    The approach to collection of information and conducting testing 
for identified needs on HPV chemicals is essentially identical in scope 
and applicability to the OECD HPV SIDS Program that has been 
internationally agreed upon by the 29 OECD member countries as 
providing the minimum data set needed to screen HPV chemicals and 
identify priorities for additional testing or assessment. While the 
SIDS data set does not fully measure a chemical's toxicity, it does 
provide a consistent minimum set of information that can be used to 
assess the relative hazards and risks of chemicals and to judge if 
additional testing or assessment is necessary or if a chemical may be 
considered of lesser concern. EPA and others will use the data obtained 
from this program to support the development of preliminary risk 
assessments for these HPV chemicals. Data in addition to those provided 
through the SIDS battery of tests may be needed to provide sufficient 
understanding to adequately assess the hazards and risks presented by 
some HPV chemicals. The data obtained on HPV chemicals under the HPV 
Initiative will be used to develop initial risk assessments that will 
allow EPA, other Federal agencies, the public, industry, and others to 
set priorities for further data collection/development and to identify 
chemicals of lesser concern. EPA has used data from previous data 
collection/development activities to support a variety of EPA and other 
Federal agency programs and actions including the development of water 
quality criteria, Toxics Release Inventory listings, chemical 
advisories, and reduction of workplace exposures.

G. Are There Other Voluntary Means to Address the Data Needs for HPV 
Chemicals?

    Yes. These approaches include agreements to sponsor a HPV chemical 
under either the OECD HPV SIDS

[[Page 81692]]

Program, including sponsorship by OECD member countries beyond the 
United States, or the international HPV Initiative that is being 
organized by the ICCA. The OECD HPV SIDS Program has already been 
described in Unit II.B. The ICCA consists of representatives of 
chemical industry trade associations from the Argentina, Australia, 
Brazil, Canada, Europe, Japan, Mexico, New Zealand, and United States. 
The ICCA HPV Initiative calls for the testing and screening-level 
assessment of 1,000 ``high priority'' chemicals by the end of the year 
2004. Most of the chemicals on the ICCA working list (Ref. 11) are also 
HPV chemicals. The ICCA testing/assessment work will be tied directly 
to that under the OECD HPV SIDS Program.
    Sponsorship under either the OECD HPV SIDS Program or the ICCA HPV 
Initiative also includes the step of preparing the SIAR that provides a 
screening level assessment of chemical hazards and includes the 
reporting of limited exposure information on each HPV chemical. While 
the submission of exposure information and the preparation of the SIAR 
are not required elements under the voluntary HPV Challenge Program, 
EPA encourages industry sponsors to include these elements in their 
submissions under the voluntary HPV Challenge Program.
    Any HPV chemicals that are handled under the OECD HPV SIDS Program 
or the ICCA HPV Initiative are considered by EPA to be ``sponsored'' 
and are not intended to be addressed in either the voluntary HPV 
Challenge Program or in any associated TSCA section 4 HPV SIDS 
rulemaking unless the international commitments are not met.

IV. Voluntary HPV Challenge Program

A. What is the Voluntary HPV Challenge Program?

    As a part of the Chemical Right-to-Know initiative that was 
announced in April, 1998, EPA, in partnership with industry and 
environmental groups, announced a voluntary chemical data collection 
effort called the HPV Challenge Program. This program challenges 
industry to make publicly available a complete set of baseline health 
and environmental effects data (i.e., the SIDS data set) on HPV 
chemicals. Under the voluntary HPV Challenge Program, data are to be 
collected for each chemical on EPA's list of 1990 U.S. HPV chemicals. 
For the voluntary HPV Challenge Program, production volumes were 
derived from reporting under the 1990 IUR (Ref. 2). Testing will be 
necessary only when data do not exist or when existing data are not 
adequate.
    The voluntary HPV Challenge Program will generally be carried out 
in a manner consistent with the OECD HPV SIDS Program to ensure that 
the data and information generated can be contributed to the 
international effort and, conversely, that international SIDS testing 
and assessments can be used to fulfill the data gaps identified as part 
of the HPV Initiative. (See also Refs. 1 and 3). Robust summaries of 
all of the data collected through the voluntary HPV Challenge Program 
will be made available by EPA to the public via the Internet in a 
timely manner, fulfilling the Agency's commitment to the public's 
right-to-know about chemical hazard information. The collected data 
will also be used to support efforts by EPA and others to evaluate and 
prioritize potential HPV chemical risks.
    On October 9, 1998, the voluntary HPV Challenge Program was 
announced as a major new effort to close a gap in the public's right-
to-know about possible risks related to HPV chemicals, prompting 
companies to make more informed and sensible decisions about chemical 
use. In this announcement, EPA was joined by the American Petroleum 
Institute (API), ACC, and Environmental Defense. The following three 
elements comprise the voluntary HPV Challenge Program:
    1. Fixed timetable and fixed list of chemicals. Information 
gathering for the chemicals in the voluntary HPV Challenge Program will 
begin in 2000, with voluntary participants indicating commitments to 
provide the needed data for specific HPV chemicals. After relevant 
existing data have been identified, and EPA has judged their adequacy, 
participants will analyze the status of existing data fulfilling the 
SIDS data set and prepare a test plan which identifies needed testing 
based on this analysis. The test plans that are submitted by the 
voluntary participants will be posted for 120 days before any testing 
is initiated, providing an opportunity for interested parties to review 
and provide comments on the test plans, including technical comments 
regarding alterations to the proposed test plans. EPA will also review 
the test plans during the 120 day period, and will judge the adequacy 
of any existing data submitted with the test plan. In addition, as 
indicated in the October 14, 1999, letter, because validated non-animal 
tests for some SIDS endpoints may be available soon, participants in 
the voluntary HPV Challenge Program shall make the following revisions 
to the sequence of testing:
    i. Testing of closed system intermediates (as described in Unit 
III.B.2.), which present less risk of exposure, shall be deferred until 
2003; and
    ii. Individual chemicals (i.e., those HPV chemicals not proposed 
for testing in a category) that require further testing on animals 
shall be deferred until November 2001.
    The Agency also stated in the October 14, 1999, letter that these 
revisions should not be construed to suggest that delay or deferral is 
appropriate with respect to testing of scientifically appropriate 
categories of related chemicals.
    If adequate existing data are submitted to EPA during the 120 day 
test plan review period under the voluntary HPV Challenge Program, or 
at any other time before testing has begun, such that EPA can determine 
that certain endpoints need not be tested, EPA will consider the 
specific data gap to be filled. As indicated previously, the Agency 
strongly encourages participants and any other interested parties to 
maximize the use of existing and scientifically adequate data by 
submitting such data in the early stages of the voluntary HPV Challenge 
Program so that the Program does not lead to the unnecessary use of 
animals in tests, and in order to minimize testing costs.
    2. Continuous public access to program status and results. The 
public will be able to follow the status and progress of the chemicals 
in the voluntary HPV Challenge Program over time. This will be done by 
making information publicly available on the Internet. EPA and other 
parties have committed to help the public stay informed about progress 
in the voluntary HPV Challenge Program, with an emphasis on the status 
of data collection and testing efforts. EPA will have responsibility 
for making the data available in ways which are useful to diverse 
stakeholders.
    3. International sharing of testing responsibility. A significant 
increase in the pace of information gathering and testing by chemical 
manufacturers in other countries is needed. To encourage this, EPA and 
other parties agreed to work with other nations and international 
groups to assure commensurate increases in the rate of these efforts on 
HPV chemicals.

B. What are the Goals and Principles for the Voluntary HPV Challenge 
Program?

    1. HPV Challenge Program goals. The original goals established for 
the voluntary HPV Challenge Program are as follows:

[[Page 81693]]

    i. Ensure full public availability of screening level data on HPV 
chemicals.
    ii. Determine the adequacy of existing published and unpublished 
data to maximize its use for HPV chemicals in order to avoid repeat 
testing.
    iii. Conduct needed testing to ensure the availability of screening 
level data on HPV chemicals.
    EPA intends to make available to the public all the summarized data 
obtained on HPV chemicals. In addition, any subsequent information that 
EPA receives on HPV chemicals would be shared with the public, other 
Federal agencies, and any other interested parties.
    The voluntary HPV Challenge Program is designed to make maximum use 
of scientifically adequate existing test data and to avoid unnecessary, 
duplicative testing, thereby avoiding the excessive use of animal 
testing. EPA encourages industry in general and other interested 
parties to identify and provide any additional adequate existing data 
about these HPV chemicals that are relevant to the hazard 
characterization. If at any time, the Agency receives adequate existing 
data that fulfill a specific data gap, EPA will ensure that unnecessary 
testing is not conducted.
    The Agency will provide additional opportunities in the voluntary 
HPV Challenge Program to minimize the participant's burden where there 
is a need to develop new test data. These opportunities will include:
     Providing guidance for the use of SAR.
     Encouraging the maximum use of category approaches to 
handle groups of HPV chemicals with similar structures or 
functionalities.
     Identifying those HPV chemicals that do not need further 
screening level testing because additional testing will not enhance 
understanding of the potential health or environmental hazards/risks.
     Allowing reduced data sets for closed system 
intermediates.
     Allowing parties to identify and substantiate that certain 
chemicals are ``no longer HPV.''
    Guidance documents have been developed for:
     The Use of Structure Activity Relationships (SAR) in the 
High Production Volume Chemicals Challenge Program (Ref. 13).
     Development of Chemical Categories in the HPV Challenge 
Program (Ref. 14).
     Determining the Adequacy of Existing Data (Ref. 12).
     Guidance for Testing Closed System Intermediates for the 
HPV Challenge Program (Ref. 7).
     Procedures for Removing Chemicals that are No Longer HPV 
and are not Likely to Become HPV Again from the HPV List (Ref. 9).
    2. HPV Challenge Program principles. EPA supplemented these goals 
in the October 14, 1999, letter to the companies participating in the 
voluntary HPV Challenge Program (Ref. 11), by asking the participants 
to observe several principles as they proceed with the program. These 
principles, which were developed after consultation with the 
organizations involved in developing the framework for the program, are 
intended to address concerns raised by certain animal advocacy 
organizations who wish to ensure that the HPV Initiative not lead to 
the excessive use of animals in tests and that attention is paid to 
existing information and alternative testing methods that do not 
require animals as test subjects. A copy of the October 14, 1999, 
letter is available on the ChemRTK web site (Ref. 8) and the public 
version of the official record for this document. As indicated in the 
letter, animal experiments should not be performed if another validated 
method--not involving the use of animals--is reasonably and practically 
available for use.
    The October 14, 1999, letter to participants in the voluntary HPV 
Challenge Program, indicates that participants shall maximize the use 
of existing and scientifically adequate data to minimize further 
testing. EPA also stated that participants, in analyzing the adequacy 
of existing data, shall conduct a thoughtful and qualitative analysis 
rather than use a rote checklist approach. The letter also indicated 
that participants may conclude that there are sufficient data, given 
the totality of what is known about a chemical, including human 
experience, that certain endpoints need not be tested, and that 
participants shall maximize the use of SAR analysis and scientifically 
appropriate category approaches where feasible to address the data 
needs under the voluntary HPV Challenge Program. The letter further 
suggests that participants reviewing the adequacy of existing data for 
GRAS chemicals should specifically consider whether the information 
available makes it unnecessary to proceed with further testing 
involving animals.
    As discussed in Unit IV.H., the letter states that participants in 
the voluntary HPV Challenge Program shall not conduct any terrestrial 
toxicity testing, and should generally not develop any new dermal 
toxicity data. In the letter and as discussed in Unit IV.F.5., EPA also 
encourages participants to use in vitro genetic toxicity testing to 
generate any needed genetic toxicity screening data, unless known 
chemical properties preclude its use.
    In addition, as indicated in Unit IV.A., the letter states that 
individual chemicals (i.e., those HPV chemicals not proposed for 
testing in a category) that require further testing on animals shall be 
deferred until November 2001. The October 14, 1999, letter also 
indicates that testing of chemicals which are determined to meet the 
requirements of closed system intermediates shall be deferred until 
2003, and that participants shall not develop sub-chronic or 
reproductive toxicity data for the HPV chemicals that are solely closed 
system intermediates, as defined by OECD/SIDS Guidelines.
    As indicated in Unit IV.A., and discussed in more detail in Unit 
IV.C.2., the letter indicates that participating companies shall allow 
120 days between the posting of test plans and the implementation of 
any testing plans.

C. What Does Participation in the Voluntary HPV Challenge Program 
Specifically Involve?

    The voluntary HPV Challenge Program contained two phases during 
which sponsors made commitments. The first phase ended on March 15, 
1999, and the second commitment phase ended on December 1, 1999. EPA is 
not currently planning to include in a TSCA section 4 HPV SIDS 
rulemaking any chemicals which were sponsored during these first two 
phases. EPA, however, intends to issue proposed TSCA section 4 HPV SIDS 
rulemaking to address unmet data needs for a portion of those chemicals 
which were not sponsored during these phases. Although the commitment 
phase of the voluntary HPV Challenge Program has ended, EPA can accept 
viable commitments to sponsor additional chemicals, even though the 
chemical may have been included in a proposed rule. Such commitments 
must be consistent with the ``viable commitment'' guidance available on 
the EPA's ChemRTK web site (Ref. 15). EPA does not intend to include a 
chemical covered by a viable commitment in a final TSCA section 4 HPV 
SIDS rulemaking, if, during the regulatory phase of the Program, the 
sponsor, in addition to agreeing to meeting all of the commitments that 
would have been necessary under the voluntary phase of the Program, 
provides the following additional information:
     Evidence that work is underway and proceeding in a timely 
manner.

[[Page 81694]]

     Data required to complete the SIDS battery are developed 
within the time frame set by EPA in the proposed rule.
     Robust summaries and full copies of all study reports from 
new studies and existing data are submitted to EPA in a timely manner.
    Viable commitments can include categories and SAR consistent with 
the available guidance (Refs. 13 and 14). If a viable commitment is 
made and fulfilled, and the information is deemed adequate, EPA would 
not include that chemical in a multi-chemical HPV TSCA rulemaking for 
SIDS testing.
    The following are expected to be provided by those wishing to 
participate as viable commitment sponsors in the voluntary HPV 
Challenge Program:
    1. A simple commitment letter. The letter lists those HPV 
chemicals, including those included in categories, for which SIDS data 
will be supplied by the company(s). The letter identifies chemicals by 
CAS numbers and chemical names, proposes a ``start year'' for 
evaluation of each chemical, and identifies a technical contact 
(including name and phone number) with whom EPA can consult. Full 
commitments under the voluntary HPV Challenge Program must specify the 
names and CAS numbers of the chemicals to be sponsored, the year test 
plans will be submitted, and the name and other contact data for the 
technical person within the company who should be reached for more 
information. Commitment letters under the voluntary HPV Challenge 
Program were due to the Agency by December 1, 1999. EPA has posted the 
voluntary HPV Challenge Program commitment letters on its ChemRTK web 
site (http://www.epa.gov/chemrtk/smrestbl.htm). EPA anticipates that 
many companies will also submit their commitments electronically to a 
third-party Internet database, the ``US HPV Chemical Tracking System'' 
(Ref. 19), the initial development of which was supported by the ACC. 
For more information on making commitments to the voluntary HPV 
Challenge Program, consult the EPA web site (Ref. 15).
    2. Test plans. Test plans submitted electronically at a pace that 
is specified in the commitment letter. The test plans and accompanying 
robust summaries will be submitted in the year indicated, will identify 
existing adequate test data on the SIDS endpoints, and will propose the 
tests deemed necessary to complete the SIDS testing requirements. For 
those chemicals for which the sponsor determines that existing test 
data are inadequate, needed tests included in the test plan will be 
conducted in accordance with OECD guidelines. The Agency anticipates 
that test plans will be submitted electronically to the ``US HPV 
Chemical Tracking System'' (Ref. 19). To ensure adequate public notice 
about the proposed test plan, a principle in the October 14, 1999, 
letter is that sponsors shall allow 120 days between the posting of a 
test plan and the implementation of any testing plans. EPA will post 
specific reference as to the public availability of the submitted test 
plan and robust summary information on the ChemRTK web site.
    3. A ``Robust Summary.'' A ``robust summary'' prepared in a 
standardized electronic format for each existing and new study. These 
summaries will be submitted to EPA and will be posted on the Agency's 
ChemRTK web site to ensure public access to detailed synopses of the 
studies for the SIDS endpoints. Guidance on the content/format of a 
``robust'' summary can be found on the ChemRTK web site (Ref. 6).

D. How Will the Test Data Collected Under the Voluntary HPV Challenge 
Program be Managed?

    Most information associated with the voluntary HPV Challenge 
Program will be submitted electronically in order to better allow both 
efficient analysis of the data by EPA and real-time public access to 
the collected data. Many submissions will be made electronically via 
the Internet. EPA intends to post the information on the Internet 
immediately following a simple quality control check to ensure the 
information is complete and in a form that can be uploaded on the web, 
and will note that it has not been critically reviewed for adequacy by 
EPA. The web posting will be updated following the Agency's review of 
the information. EPA will provide the public with more complete and 
detailed information via its web site (http://www.epa.gov/chemrtk/elecsubm.htm) about EPA's approach to data management as the voluntary 
HPV Challenge Program progresses.

E. How Many HPV Chemicals Have Been Sponsored Thus Far Under the 
Voluntary HPV Challenge Program?

    As of November 9, 2000, EPA has received full or provisional 
commitments from 469 companies, individually or as part of 187 
consortia (see Unit III.G.) to sponsor 2,155 chemicals under the 
voluntary HPV Challenge Program. A provisional commitment is one that 
is lacking one or more of the specific elements (e.g., name and phone 
number of a technical contact) required for a commitment to be 
considered a ``full'' commitment to sponsor a chemical under the 
voluntary HPV Challenge Program. EPA anticipates that most, if not all, 
of the provisional commitments received thus far will be upgraded to 
full commitments upon the Agency's receipt of the needed additional 
information. Continually updated information regarding the chemicals 
being sponsored under the voluntary HPV Challenge Program and the names 
of company sponsors and consortia can be found on EPA's ChemRTK web 
site (http://www.epa.gov/chemrtk/sumresp.htm), and on the ``US HPV 
Chemical Tracking System'' (Ref. 19).

F. What Specific Testing Endpoints are Called for in the Voluntary HPV 
Challenge Program?

    Definitive test guidance can be found in the third edition of the 
Screening Information Data Set Manual of the OECD Programme on the Co-
operative Investigation of High Production Volume Chemicals, published 
in July 1997 (Ref. 3). The SIDS basic screening-level endpoints are 
listed in section 2.2 of the SIDS Manual (Ref. 3). Because terrestrial 
toxicity testing will normally be considered to belong to the OECD 
post-SIDS tier, terrestrial toxicity testing (including avian toxicity) 
is not included in the voluntary HPV Challenge Program. The actual OECD 
test guideline for each of the SIDS tests can be found at http://www.oecd.org/ehs/guide/index.htm. The EPA-recommended screening level 
tests (with their OECD test guideline numbers) under the voluntary HPV 
Challenge Program are as follows:
    1. Physical/chemical property tests:
     Melting Point (OECD 102).
     Boiling Point (OECD 103).
     Vapor Pressure (OECD 104).
     n-Octanol/Water Partition Coefficient Method (OECD 107 or 
OECD 117).
     Water Solubility (OECD 105 and OECD 112, if applicable).
    2. Environmental fate tests:
     Photodegradation (determined via estimation, see guidance 
document on data adequacy at EPA's ChemRTK web site (Ref. 12).
     Hydrolysis-Stability in Water (OECD 111).
     Transport/Distribution (determined via modeling, see 
guidance document on data adequacy at EPA's ChemRTK web site (Ref. 12).
     Biodegradation (OECD 301 or OECD 302).
    3. Ecotoxicity tests:
     Acute Toxicity to Fish (OECD 203).
     Acute Toxicity to Daphnia (OECD 202).
     Toxicity to Plants (Algae) (OECD 201).

[[Page 81695]]

     Chronic Toxicity to Daphnia, when appropriate (OECD 211).
    4. Mammalian toxicity--acute:
     Acute Oral Toxicity Test (rat)(OECD 425).
     Acute Inhalation Toxicity Test (OECD 403).
    For the ``Mammalian Toxicity--Acute'' endpoint, certain ``Special 
Conditions'' in the form of a chemical substance's physical/chemical 
properties or physical state should be considered in determining the 
appropriate test method that would be used from among those included 
for this endpoint. The OECD HPV SIDS Program recognizes that for most 
chemical substances, the oral route of administration will suffice for 
this endpoint. Under the voluntary HPV Challenge Program, for test 
substances that are gases at room temperature (25 deg.C), the acute 
mammalian toxicity study should be conducted using inhalation as the 
exposure method. In the case of a potentially explosive test substance, 
care should be taken to avoid the generation of explosive 
concentrations. For all other chemicals (i.e., those that are either 
liquids or solids at room temperature), acute toxicity testing should 
be conducted via oral administration. Dermal toxicity testing is not 
included in the voluntary HPV Challenge Program.
    5. Mammalian toxicity--genotoxicity:
    i. Gene mutations.
     Bacterial Reverse Mutation Test: (OECD 471) [or use the In 
Vitro Mammalian Cell Mutation Test (OECD 476)].
    ii. Chromosomal damage.
     In Vitro Mammalian Chromosomal Aberration Test (OECD 473) 
[or use either the In Vivo Mammalian Bone Marrow Chromosomal Aberration 
Test (rodents: mouse (preferred species), rat, or Chinese hamster) 
(OECD 475), or the In Vivo Mammalian Erythrocyte Micronucleus Test 
(sampled in bone marrow) (rodents: mouse (preferred species), rat, or 
Chinese hamster) (OECD 474)].
    Persons who conduct testing for chromosomal damage are encouraged 
to use in vitro genetic toxicity testing (Mammalian Chromosomal 
Aberration Test) to generate needed genetic toxicity screening data, 
unless known chemical properties preclude its use. These could include, 
for example, physical properties or chemical class characteristics. 
With regard to such cases, test sponsors are asked to submit to EPA the 
rationale for conducting one of these alternative tests (OECD 474 or 
OECD 475) as part of the test plan. A primary focus of the voluntary 
HPV Challenge Program is to implement this program in a manner 
consistent with the OECD HPV SIDS Program and as part of a larger 
international activity with global involvement. This approach provides 
the same degree of flexibility as that which currently exists under the 
OECD HPV SIDS Program (Ref. 2).
    6. Mammalian toxicity--repeated dose/reproductive/developmental:
     Combined Repeated Dose Toxicity Study with the 
Reproduction/Developmental Toxicity Screening Test (OECD 422) [or use 
these two tests: Reproduction/Developmental Toxicity Screening Test 
(OECD 421) and Repeated Dose 28-Day Oral Toxicity Screen (OECD 407)].
    For ``Mammalian Toxicity--Repeated Dose/Reproductive/
Developmental,'' EPA recommends the use of the Combined Repeated Dose 
Toxicity Study with the Reproduction/Developmental Toxicity Screening 
Test (OECD 422). EPA recognizes, however, that there may be reasons to 
test a particular chemical using both the Reproduction/Developmental 
Toxicity Screening Test (OECD 421) test guideline and the Repeated Dose 
28-Day Oral Toxicity Screen (OECD 407) test guideline instead of the 
OECD 422 test guideline. With regard to such cases, test sponsors are 
asked to submit to EPA the rationale for conducting these alternative 
tests as part of the test plan.
    Certain of the chemicals for which Mammalian Toxicity--Repeated 
Dose/Reproductive/Developmental data are needed may be used solely as 
``closed system intermediates,'' as described in the EPA guidance 
document developed for the voluntary HPV Challenge Program (Ref. 7). As 
described in this guidance document, such chemicals may be eligible for 
a reduced testing battery which substitutes a developmental toxicity 
study for the SIDS requirement to address repeated dose, reproductive, 
and developmental toxicity. At the present time, EPA does not have 
sufficient information to know with any degree of certainty which if 
any of the chemicals that are included in the voluntary HPV Challenge 
Program are solely closed system intermediates as defined by the OECD/
SIDS guidelines. Persons who believe that a chemical fully satisfies 
the terms outlined in the guidance document are encouraged to submit 
appropriate information which substantiates this belief. If, based on 
submitted information and other information available to EPA, the 
Agency believes that a chemical substance is considered likely to meet 
the requirements for use solely as a closed system intermediate, EPA 
will handle that chemical substance in accordance with the existing 
OECD procedures. A principle in the October 14, 1999, letter to 
participants in the voluntary HPV Challenge Program is that 
participants shall not develop sub-chronic or reproductive toxicity 
data for the HPV chemicals that are solely closed system intermediates 
as defined by the OECD/SIDS guidelines. Actual initiation of testing 
for chemicals that are solely closed system intermediates would be 
deferred until 2003, if adequate existing data are not otherwise 
available.

G. Are Acute Aquatic Toxicity Studies Always Needed Under the Voluntary 
HPV Challenge Program?

    No, acute aquatic toxicity studies are not always needed under the 
voluntary HPV Challenge Program. For ``Ecotoxicity Tests,'' the OECD 
HPV SIDS Program recognizes that, for certain HPV chemicals, acute 
toxicity studies are of limited value in assessing the substances' 
aquatic toxicity. This issue arises when considering chemicals with 
higher n-octanol/water partition coefficients (log Kow or 
log P) values. In such cases, toxicity is less likely to be observed 
over the duration of acute toxicity studies because of the reduced 
uptake and the extended amount of time required for such substances to 
reach toxic concentrations in the test organism. For such situations, 
the OECD HPV SIDS Program recommends use of chronic toxicity testing in 
Daphnia (OECD 211) in place of acute toxicity testing in fish (OECD 
203) and Daphnia (OECD 202). For the purposes of the voluntary HPV 
Challenge Program, EPA recommends that the need for longer term tests 
be judged based on log Kow and other factors. In general, 
EPA believes that for chemicals determined to have a log Kow 
equal to or greater than 4.2 (which corresponds to a fish 
bioconcentration factor (BCF) of approximately 1,000), the following 
tests should be conducted: Chronic Toxicity to Daphnia study (in place 
of the acute toxicity tests in fish and Daphnia) and Toxicity to Plants 
(Algae; OECD 201). For chemicals determined to have a log 
Kow less than 4.2, EPA believes that Acute Toxicity to Fish, 
Acute Toxicity to Daphnia and Toxicity to Plants (Algae) testing should 
be conducted. EPA recognizes that in some circumstances, however, acute 
aquatic toxicity testing may be relevant for certain chemical 
substances having high log Kow values. For example, chemical 
substances that are dispersible in water (e.g., surfactants, 
detergents, aliphatic amines, and cationic dyes) may have high log Kow 
values and yet may still be acutely toxic to aquatic organisms. 
Sponsors under the voluntary HPV

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Challenge Program are encouraged to consider these factors in 
developing test plans. Thus, a sponsor who believes that acute aquatic 
testing is appropriate for an HPV chemical with a high log 
Kow should provide in its submitted test plan the rationale 
for conducting such testing. Public comments on test plans relating to 
this issue will be considered on a chemical by chemical basis.
    The OECD HPV SIDS Program includes testing on terrestrial organisms 
if ``significant exposure is expected in the terrestrial environment.'' 
Under the voluntary HPV Challenge Program, exposure information need 
not be collected/submitted on each HPV chemical as is done under the 
OECD HPV SIDS Program. In addition, OECD is limiting the collection of 
exposure information to that obtained from the sponsor country/
countries; in the past, each OECD member country was expected to 
provide this exposure information. In recognition of the changing role 
of exposure information in the OECD HPV SIDS process, EPA raised the 
issue of changing the OECD's approach to terrestrial toxicity testing 
at the 8th Meeting of the OECD's workgroup on existing chemicals 
(October 25-28, 1999, Paris). EPA proposed that the OECD move 
consideration of the need for terrestrial toxicity testing to a 
subsequent step in its process (known as ``post-SIDS'' testing). This 
proposal was accepted in part by the OECD. Avian toxicity testing was 
moved to the post-SIDS tier but the OECD retained the element of 
considering the need for soil toxicity testing (earthworms and plants) 
based on the potential for terrestrial exposure. For the purposes of 
the voluntary HPV Challenge Program, EPA is not asking sponsors to 
include consideration of soil toxicity testing. This aspect, however, 
will need to be considered for HPV chemicals which enter the OECD HPV 
SIDS Program.

H. Are Dermal Toxicity or Terrestrial Toxicity Testing Required Under 
the Voluntary HPV Challenge Program?

    No. Another principle in the October 14, 1999, letter, is that 
participants in the voluntary HPV Challenge Program shall not conduct 
any terrestrial toxicity testing and generally should not develop any 
new dermal toxicity data. See also Unit IV.F. Dermal toxicity testing 
is not included in the voluntary HPV Challenge Program.

I. Are Acute LD50 Tests Always Needed for Mammalian Acute 
Toxicity Testing Under the Voluntary HPV Challenge Program?

    No, acute LD50 tests are not always needed for mammalian 
acute toxicity testing under the voluntary HPV Challenge Program. In 
fact, as was discussed in the proposal (Ref. 16) which was submitted by 
the United States to the February 1999, meeting of the OECD workgroup 
on existing chemicals, EPA recommends the use of the ``Up and Down 
Procedure'' (OECD 425) in the voluntary HPV Challenge Program for those 
chemicals in need of acute toxicity testing. This particular test 
greatly reduces the number of test animals required and provides a 
point estimate of the lethal dose that is adequate for screening 
assessments on industrial chemicals. The OECD's Joint Meeting, at its 
29th Session in June 1999, agreed with the general approach to use 
alternative methods for acute oral toxicity testing on industrial 
chemicals and ``specifically encourages this for work under the OECD's 
Existing Chemicals [(i.e., SIDS)] Program'' (Ref. 17).
    As this topic is discussed in section 3.4 of the OECD HPV SIDS 
Manual, ``All substances, except gases and vapors, should be tested by 
the oral route. . . .Gases should be tested by the inhalation route 
alone'' (Ref. 3). The SIDS Manual also notes that ``dependent upon the 
physical-chemical properties . . . and the most important route of 
human exposure, the dermal or the inhalation route could also be 
considered.'' EPA raised a question regarding this guidance for 
consideration by the OECD at the October 1999, meeting of the OECD's 
workgroup on existing chemicals. As originally presented, the United 
States proposed to delete the reference to dermal testing in the SIDS 
data set; however, comments indicated that this would not be accepted 
by other countries. The United States modified its proposal, based on 
comments from other countries, to indicate that acute testing need be 
done by one route of exposure only, such that, where appropriate, 
dermal testing could be done as an alternative to oral testing. This 
revision also failed to gain the needed support. The basis for 
rejection of the revised proposal was that oral testing is necessary to 
satisfy hazard classification requirements and that if dermal exposure 
(or inhalation exposure) was an issue, countries should still consider 
the need for testing by an additional route at the SIDS level. Thus, 
the OECD workgroup did not agree to modify the SIDS battery 
requirements for acute toxicity. As indicated in Unit IV.H., dermal 
toxicity testing is not included in the voluntary HPV Challenge 
Program.
    Recognizing that exposure information need not be collected/
submitted under the voluntary HPV Challenge Program, and the contingent 
nature of the need for acute toxicity testing by a second route of 
exposure, EPA recommends that acute toxicity testing conducted under 
the voluntary HPV Challenge Program be limited to a single route of 
exposure. Decisions regarding the need for acute toxicity testing by a 
second route would be need to be considered for HPV chemicals which 
enter the OECD HPV SIDS Program.

J. Are Both In Vitro and In Vivo Genotoxicity Tests Needed Under the 
Voluntary HPV Challenge Program?

    Sponsors are encouraged to use in vitro testing unless there are 
chemical properties (including chemical class considerations) or other 
aspects which may call its use into question. EPA has recommended 
certain in vitro protocols, and, as appropriate and to the extent 
possible, will review test plans submitted by sponsors of HPV chemicals 
to promote use of such protocols. Participants in the voluntary HPV 
Challenge Program are encouraged to use in vitro genetic toxicity 
testing to generate any needed genetic toxicity screening data, unless 
known chemical properties preclude its use.
    In February 1999, at the meeting of the OECD workgroup on existing 
chemicals, EPA made a proposal (Ref. 16) for the use of the male rats 
from the combined repeated dose/reproductive/developmental toxicity 
screen (OECD 422) for the purpose of running the mammalian erythrocyte 
micronucleus test (OECD 474). This would reduce the number of animals 
needed, and, if the protocol can be successfully developed, would also 
increase the amount of information which would be received from this 
single study. Initial consideration of this approach suggested that 
while this strategy might be acceptable with mice, the use of this 
approach with rats (the species typically used in SIDS testing) 
appeared to present technical issues. Because there seemed to be 
technical problems with this modification of the in vitro micronucleus 
protocol, EPA initiated a review of its approach to this SIDS endpoint 
under the voluntary HPV Challenge Program. Following this review, EPA 
has decided to remove its preference for the use of the in vivo 
chromosomal effects test and to accept

[[Page 81697]]

either in vitro or in vivo studies, as is allowed under the OECD 
procedure for this endpoint. Sponsors are encouraged to use in vitro 
testing unless there are chemical properties (including chemical class 
considerations) or other aspects which may call its use into question.

K. Can Some of the Mammalian Toxicity Protocols Included in the 
Voluntary HPV Challenge Program be Combined?

    For the purposes of the voluntary HPV Challenge Program, EPA 
strongly recommends the use of the combined protocol for repeat dose, 
reproductive, and developmental toxicity (OECD 422) for chemicals where 
data are needed for these endpoints (see Unit IV.F.6.). This particular 
test guideline was initially developed by the United States in the late 
1980's and early 1990's for use in the OECD HPV SIDS Program. This 
screening test guideline provides limited information on systemic 
toxicity following repeated exposure over a limited time period. In 
addition, it provides initial information on developmental and 
reproductive toxicity. The United States has been and remains one of 
its strongest supporters within the OECD and strongly recommends its 
use. Historically, EPA has relied on this combined protocol for HPV 
chemicals needing this type of testing under the OECD HPV SIDS effort.
    EPA also recognizes that the OECD HPV SIDS Program allows for other 
approaches that can be used to meet the repeat dose, reproductive and 
developmental toxicity endpoint needs covered by the combined protocol. 
EPA can also envision circumstances where other such approaches might 
make sense. These can include, for example, situations concerning 
existing data wherein only certain of these endpoints require testing 
or in cases where there is a particular need identified by a sponsor 
(e.g., high-exposure potential) such that a different testing approach 
is indicated. In these cases, voluntary HPV Challenge Program sponsors 
are asked to provide the rationale for conducting such testing in their 
submitted test plans. EPA, as appropriate and to the extent possible, 
plans to follow up with sponsors who propose in their test plans to use 
approaches other than OECD 422 to ensure that their decision to do so 
is an informed one.
    In those cases for which adequate data are available for 
reproductive and developmental toxicity but not for repeat dose 
toxicity, EPA recommends that the 28-day repeated dose toxicity test 
(OECD 407) be used by sponsors to meet the repeat dose data need for 
the voluntary HPV Challenge Program.
    In cases for which adequate data are available for the repeat dose 
endpoint, but not for reproductive and/or developmental toxicity, EPA 
recommends that the combined reproductive and developmental toxicity 
guideline (OECD 421) be used in lieu of separate testing for 
reproductive toxicity (OECD 415) and/or developmental toxicity (OECD 
414) unless there is information indicating that separate testing may 
be advisable. This point was raised by the United States at the 
February 1999 meeting of the OECD's Working Party on Existing Chemicals 
and further discussions will be pursued in that forum.

L. How do the Rulemaking Efforts Relate to the Voluntary HPV Challenge 
Program?

    In the October 14, 1999, letter to participants in the voluntary 
HPV Challenge Program, EPA stated that it was the intention of the 
Agency that the TSCA section 4 HPV SIDS rulemaking proceed in a manner 
that is consistent with the principles and concerns outlined in the 
letter for the participants in the voluntary program. As such, EPA 
would incorporate in the TSCA section 4 HPV SIDS rulemaking the 
criteria established under the voluntary HPV Challenge Program to the 
extent possible in the context of a rulemaking, and would also consider 
improvements based on experiences with implementing that program. The 
specific requirements of any associated TSCA section 4 HPV SIDS 
rulemaking will be addressed in future proposed rulemaking.

V. Administrative Requirements

    As indicated previously, this action describes the HPV Initiative, 
focusing on the Agency's strategy and overall approach to addressing 
data collection needs for HPV chemicals, along with the components of 
the voluntary HPV Challenge Program. Although the Agency has indicated 
that the HPV Initiative may also involve rulemaking under TSCA, any 
TSCA rulemaking associated with the HPV Initiative will be addressed in 
that rulemaking, rather than in this document. Since this action is not 
a regulatory action and does not impose any requirements, the 
regulatory assessment requirements that apply when an agency imposes 
requirements do not apply to this action.

A. Was this Action Reviewed by the Office of Management and Budget?

    Yes. The Agency submitted this action to the Office of Management 
and Budget (OMB) for review under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993), because 
OMB determined that this document may result in a ``significant 
regulatory action'' subject to review by OMB. Any comments or changes 
made during that review have been documented in the public version of 
the official record.

B. Does the Agency Have Approval for this Information Collection 
Activity?

    Yes. Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 
et seq., an agency may not conduct or sponsor, and a person is not 
required to respond to, an information collection request unless it 
displays a currently valid OMB control number. In general, the OMB 
control numbers for EPA's regulations, after appearing in the preamble 
of a final rule, are listed in 40 CFR part 9, and included on the 
related collection instrument. The information collection activities 
related to chemical testing under TSCA section 4(a), which includes 
activities related to chemical testing under a consent order, a 
voluntary program, or a TSCA rulemaking, have already been approved 
under OMB control number 2070-0033 (EPA ICR No.1139). This action does 
not contain any new information collection activities requiring 
additional OMB review and approval.
    As described in this document, the voluntary HPV Challenge Program 
involves the submission of a commitment letter, study or testing plans, 
and a final report. In general, the average annual per chemical burden 
estimate approved under OMB Control number 2070-0033 is about 488 hours 
per response, including time for preparing letter of intent and study 
plans, conducting laboratory testing, submitting progress reports (if 
applicable), and preparing final reports on each study. For 
recordkeeping, the average burden is estimated to be 330 hours per 
recordkeeper. As defined by the PRA and 5 CFR 1320.3(b), ``burden'' 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, or disclose or provide 
information to or for a Federal agency. This includes the time needed 
to: Review instructions; develop, acquire, install, and utilize 
technology and systems for the purposes of collecting, validating, and 
verifying information, processing and maintaining information, and 
disclosing and providing information; adjust the existing ways to 
comply with any previously applicable instructions and requirements; 
train personnel to be able to respond to a collection of information; 
search data sources; complete and review the collection of

[[Page 81698]]

information; and transmit or otherwise disclose the information.

VI. Materials in the Public Docket

    As indicated in Unit I.B.2., the official record for this document 
has been established under docket control number OPPTS-42213 and the 
administrative record number AR-201. The following is a listing of 
documents that are specifically referenced in this document and which 
have already been placed in the public version of the official record 
for this action. For your convenience, EPA has also provided some non-
EPA internet addresses to allow you to access the electronic version of 
the referenced document. In doing so, the Agency has verified the 
accuracy of these addresses at the time of signature. However, since 
EPA is not responsible for these non-EPA sites, the Agency does not 
exercise any control over these addresses. A paper copy of any document 
referenced in this way has been included in the public version of the 
official record for this document as described in Unit I.B.2.
    1. EPA, Office of Pollution Prevention and Toxics (OPPT). ChemRTK 
HPV Challenge Program Chemical List. (May 1999) (This list is updated 
periodically and is available electronically at http://www.epa.gov/chemrtk/hpvchmlt.htm).
    2. EPA, OPPT. Chemical Hazard Data Availability Study: What Do We 
Really Know About the Safety of High Production Volume Chemicals? 
(April 1998) (http://www.epa.gov/opptintr/chemtest/hazchem.htm).
    3. OECD Secretariat. SIDS Manual. Third Ed. Screening Information 
Data Set Manual of the OECD Programme on the Co-Operative Investigation 
of High Production Volume Chemicals. Paris, France; July 1997. Copies 
this Manual can be obtained by accessing EPA's web site at http://www.epa.gov/chemrtk/sidsappb.htm, as well as directly from OECD at 
http://www.oecd.org/ehs/sidsman.htm (non-EPA site).
    4. Environmental Defense. Toxic Ignorance. New York, New York, 
(Summer 1997). Copies of ``Toxic Ignorance'' can be obtained by 
accessing ED's web site (non-EPA site) at http://www.edf.org/pubs/reports/toxic ignorance/ or by calling 1-800-684-3322.
    5. ACC. Public Availability of SIDS-Related Testing Data for U.S. 
High Production Volume Chemicals (June 12, 1998). Copies of ACC's 
report can be obtained by writing to ACC at 1300 Wilson Blvd., 
Arlington, VA 22209 or by calling ACC at (703) 741-5226.
    6. EPA, OPPT. Draft Guidance on Developing Robust Summaries 
(October 22, 1999) (http://www.epa.gov/chemrtk/robsumgd.htm).
    7. EPA, OPPT. Guidance for Testing Closed System Intermediates for 
the HPV Challenge Program (Draft, March 17, 1999) (http://www.epa.gov/chemrtk/closed9.htm).
    8. EPA, Office of Prevention, Pesticides and Toxic Substances 
(OPPTS). Letter from Susan H. Wayland, Deputy Assistant Administrator, 
to participants in the voluntary High Production Volume Challenge 
Program (October 14, 1999) (http://www.epa.gov/chemrtk/ceoltr2.htm).
    9. EPA, OPPT. Procedures for Removing Chemicals that are No longer 
HPV and Not Likely to Become HPV Again from the HPV List (Draft, March 
17, 1999) (http://www.epa.gov/chemrtk/nolohpt8.htm).
    10. OECD. Decision-Recommendation of the Council on the Cooperative 
Investigation and Risk Reduction of Existing Chemicals (January 31, 
1991).
    11. ICCA. ICCA HPV Working List (July 1, 2000). Copies of this List 
can be obtained by accessing ICCA's web site (non-EPA site): http://www.icca-chem.org/hpv.
    12. EPA, OPPT. Determining the Adequacy of Existing Data (May 17, 
2000) (http://www.epa.gov/chemrtk/datadfin.htm).
    13. EPA, OPPT. The Use of Structure-Activity Relationships (SAR) in 
the High Production Volume Chemicals Challenge Program (August 26, 
1999) (http://www.epa.gov/chemrtk/sarfinl1.htm).
    14. EPA. OPPT. Development of Chemical Categories in the HPV 
Challenge Program (Draft, August 25, 1999) (http://www.epa.gov/chemrtk/categuid.htm).
    15. EPA, OPPT. ChemRTK HPV Challenge Program Making Commitments 
(June 29, 2000) (http://www.epa.gov/chemrtk/makecom.htm).
    16. EPA. Proposal Made at the Organization for Economic Cooperation 
and Development (OECD) Working Party Meeting on Existing Chemicals 
(February 1999).
    17. OECD. Acute Oral Toxicity Testing: Data Needs and Animal 
Welfare Considerations Agreement Reached by the 29th Joint Meeting of 
the Chemicals Committee and the Working Party on Chemicals (ENV/JM/HCL/
RD(99)6; June 1999).
    18. EPA, OPPT. Draft Guidance on Searching for Chemical Information 
and Data (April 1999, rev. May 1999) (http://www.epa.gov/chemrtk/srchguid.htm).
    19. ACC. U.S. HPV Chemical Tracking System. Non-EPA site: http://www.hpvchallenge.com.

List of Subjects

    Environmental protection, Hazardous chemicals, Reporting and 
recordkeeping.

    Dated: December 14, 2000.
Susan H. Wayland,
Acting Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 00-32498 Filed 12-22-00; 8:45am]
BILLING CODE 6560-50-S