Status and Future Directions of the
High Production Volume
Challenge Program
Office of Pollution
Prevention and Toxics
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Status and Future Directions of the
High Production Volume
Challenge Program
Office of Pollution
Prevention and Toxics
&EPA
United Stutos
Environ mental Protection
Agency
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Table of Contents
The HPV Challenge Program 1
History of the Program 2
How the Program Works 3
Overall HPV Challenge Program Achievements 5
EPA's Work with Sponsors to Address Overdue Test Plans 10
Orphan Chemicals 10
Future Directions and Developing Issues 10
HPV Challenge Program Conclusions 12
Appendix 1: History of the Program 14
Appendix 2: How the Program Works 18
Appendix 3: Overall HPV Challenge Program Achievements 38
Appendix 4: Overdue Test Plans 52
Appendix 5: Orphan Chemicals 58
Appendix 6: Future Directions and Developing Issues 96
Key Terms and Acronyms 100
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The HPV Challenge Program
The U.S. EPA's High Production Volume
(HPV) Challenge Program is ensuring
that basic health and environmental effects
data on approximately 2,800 HPV chemicals is
made available to the public. Since the Program's
inception in 1998, industry chemical manufacturers
and importers have participated in the Challenge by
sponsoring over 2,200 chemicals. More than 400
companies and 100 consortia have sponsored 1,371
chemicals directly in the Program and an additional
851 chemicals have been sponsored indirectly in an
international counterpart to the HPV Challenge
Program, the International Council of Chemical
Associations (ICCA) HPV Initiative. Three hundred
fifty-three test plans have been submitted as of July
2004 for 1,266 of the 1,371 chemicals sponsored
directly in the HPV Challenge Program (or 92%).
EPA expects that the end of 2004 will be a critical
time as sponsors work to fulfill their commitments
by submitting test plans and data summaries for the
remaining 8% of the sponsored chemicals, and also
to submit completed data packages where additional
testing was needed.
Overall, the HPV Challenge Program has continued
to strive to meet its outlined goals. Extensive
voluntary participation has been achieved as
companies, individually or as part of consortia, have
agreed to sponsor chemicals. Additionally, the public
has been an important participant in the Program
by providing feedback to sponsors on their test plans
and data summaries. A key EPA goal in managing
the HPV Challenge Program has been to provide
clear guidance for assisting participating sponsors.
Guidance has been made available on a wide variety
of subjects, including category formation, developing
robust data summaries, and assessing the adequacy
of existing data. Because of the HPV Challenge
Program, significant amounts of data have been made
public for the first time (59% of the data submitted
was not publicly available at the start of the Program).
The Agency is also stepping up its efforts to provide
the public with available data. EPA is developing
the HPV Information System (HPVIS), which
will provide the public with an efficient way to
comprehensively search and retrieve data included in
the sponsor-submitted data summaries. EPA is also
working collaboratively with the European Union
to develop a Global HPV Portal. The Agency is
designing the Portal to provide a central location for
domestic and international users to access consolidated
international HPV chemical data repositories. In
addition to the database development efforts, the
Agency is working on implementing a strategy to
address orphan (unsponsored) HPV chemicals in an
effort to secure data related to those chemicals. The
orphan strategy is outlined in Appendix 5 of this
report.
Since the Programs inception in 1998, industry chemical
manufacturers and importers have participated in the ^
Challenge by sponsoring over 2,200 chemicals.
cals.
In summary, the HPV Challenge Program has made
outstanding progress toward meeting its goals and
commitments, and on preparing for future work on
HPV chemicals.
After briefly summarizing the background of the HPV
Challenge Program, the following topics are described
in this report:
How the Program Works,
Overall HPV Challenge Program Achievements,
EPA's Work With Sponsors To Address Overdue
Test Plans,
Orphan Chemicals, and
Future Directions and Developing Issues.
History of the Program
The HPV Challenge Program, officially launched in
late 1998, was created to ensure that a baseline set of
data on approximately 2,800 high production volume
chemicals would be made available to the public. The
American Chemistry Council (ACC)1, Environmental
Defense (ED)2, and the American Petroleum Institute
(API) participated in the launch of the Program.
HPV chemicals are manufactured or imported in
amounts equal to or greater than one million pounds
per year and were identified for this program through
data reported under the Toxic Substances Control Act
(TSCA) Inventory Update Rule (IUR) during 1990.
HPV chemicals that are not sponsored in the Program
maybe subject to regulations ("test rules") under
Section 4 TSCA because these chemicals require
needed testing.
A basic premise of the Program is that the public has
a right to know about the hazards associated with
chemicals in their environment. Everyone - including
industry, environmental protection groups, animal
welfare organizations, government groups, and the
general public, among others can use the HPV
chemical data provided through the HPV Challenge
Program to make informed decisions related to the
human and environmental hazards of chemicals that
they encounter in their daily lives.
The HPV Challenge Program was established in
response to several studies that showed that there
were relatively few U.S. HPV chemicals for which
an internationally agreed upon set of data for hazard
screening was available to the public. This data
set addresses areas, also known as "endpoints," that
illustrate a chemical's properties and effects.
One of the studies providing motivation for the
Challenge was EPA's Chemical Hazard Data
Availability Study3 (1998). This study (see the
figure on the following page) showed that 43% of
1ACC = formerly known as the Chemical Manufacturers Association.
2ED = formerly known as Environmental Defense Fund.
3Chemical Hazard Data Availability Study: What Do We Really Know About the Safety of High Production Volume Chemicals? (1998). Washington, DC: U.S. Environmental
Protection Agency. (Website: http://www.epa.gov/oppt/chemrtk/hazchem.pdf).
EPA's High Production Volume Challenge Program
Status and Future Directions
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Lack of Publicly
Available Screening Data
12345
Number of Endpoints with
Publicly Available Data
high production volume chemicals had no publicly
available data on basic toxicity and only 7% had a full
set of basic data for six endpoints4. Subsequently, the
Agency challenged U.S. manufacturers and importers
of HPV chemicals to voluntarily sponsor chemicals in
the Program. Sponsorship entails making screening-
level health and environmental data available to
the public. Public availability of these data is a
fundamental principle of the Program. The data set
sought by the HPV Challenge Program is known
as the Screening Information Data Set (SIDS) that
was developed by the Organization for Economic
Cooperation and Development (OECD). The SIDS
provides an internationally agreed upon set of test data
for screening high production volume chemicals for
human and environmental hazards, and helps to make
an informed, preliminary judgment about the hazards
of HPV chemicals.
For a more detailed History of the Program, see
Appendix 1.
How the Program Works
Commitments to sponsor chemicals in the HPV
Challenge Program have come from companies
and consortia both inside and outside the United
States. The chemical industry has demonstrated
this commitment to product stewardship by making
publicly available screening-level hazard data that
will allow EPA, industry, and other stakeholders to
effectively gauge potential hazards of HPV chemicals.
As part of their commitment to the HPV Challenge
Program, sponsors submit data summaries of existing
information along with a test plan that proposes a
strategy to fill data gaps. These documents are then
posted to the HPV Challenge Program website. The
following timeline graphic shows how the majority
of sponsors' materials were submitted to the Agency
between 2001-2003.
Sponsors submit test plans for either individual
chemicals or for a category of chemicals. A chemical
category comprises a group of substances, usually
similar in chemical structure, with a regular pattern
of properties and effects. Data for chemicals in
the category can be used to estimate the chemical
properties and effects of other category members.
A 120-day comment period begins when test plans
and data summaries submitted directly to the HPV
Challenge Program are posted to the Program website.
It is at this time when all stakeholders industry,
environmental protection groups, animal welfare
groups, private citizens, etc. - can comment on the
data summary and test plan submissions, and EPA
comments on all of the submissions.
Sponsors can also indirectly submit data through
the International Council of Chemical Associations
(ICCA) HPV Initiative, which is a complementary
program aimed at HPV chemicals from around the
world.
For more information regarding Hoiv the Program
Works, see Appendix 2.
HPV Challenge Program Timeline
October 1998
The HPV Challenge Program is officially
launched. EPA sends a letter to
manufacturers, soliciting companies to
sponsor chemicals in the program.
2001-2903
The majority of materials are submitted
to the Agency, covering 1,016 chemicals
that were sponsored directly in the HPV
Challenge Program.
December 31, 2005
All data for sponsored
chemicals should be
submitted.
1998
1999
J2000
2001
2002
2003
2004
2005
April 2000
The first test plans and data summaries
are posted on EPA's HPV Challlenge
Program Website.
December 31, 2004
All test plans for sponsored
chemicals should be submitted.
4The six endpoints: acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, mutagenicity, ecotoxicity, and environmental fate.
EPA's High Production Volume Challenge Program
Status and Future Directions
4
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Overall HPV Challenge Program
Achievements
The HPV Challenge Program has resulted in many
achievements. The accomplishments include:
chemical manufacturers work individually or through
consortia to sponsor chemicals, test plans and
data summaries for the chemicals that have been
submitted, the public has commented on materials
posted to the website, and EPA has provided
detailed guidance documents to assist stakeholders in
participating in the Program.
Extensive Voluntary Participation
Participation in the HPV Challenge Program has created
attention by exceeding all expectations. A total of 2,222
chemicals have been sponsored, with 1,371 chemicals
sponsored directly in the Program by 401 companies and
103 consortia and an additional 851 chemicals sponsored
indirectly in the ICCA HPV Initiative.
For chemicals sponsored directly in the HPV Challenge
Program, 353 test plans have been submitted for 1,266 of
the 1,371 sponsored chemicals (or 92%).
Chemicals Sponsored Directly in the HPV Challenge Program
n submitted outstanding
500
495
03
O
"E
0)
_c
O
275
44 46 37
n ni
2000 2001
2002 2003
Year
2004
Of these 353 test plans, 114 are for categories of
chemicals and the remaining 239 are for individual
chemicals. EPA expects that the end of 2004 will
be a critical time as sponsors work to fulfill their
commitments by submitting test plans and data
summaries for the remaining 8% of the sponsored
chemicals, and also work to submit completed data
packages where additional testing was needed.
Public Comments
The HPV Challenge Program provides a unique
opportunity for all stakeholders, including the
public, to comment on test plan and data summary
submissions. Comments are important because
sponsors consider this feedback when revising their
test plans and data summaries. All comments are
posted to the website for public availability.
Environmental Defense has submitted comments
on 89% of all posted test plans. Two animal welfare
groups People for the Ethical Treatment of Animals
(PETA) and Physicians Committee for Responsible
Medicine (PCRM) submitted comments on 62%
of all test plans, and private individuals and other
groups submitted comments on fewer than 3% of all
test plans. Comments from Environmental Defense
often refer to whether they are in agreement with
the sponsor's category hypothesis, use of supporting
chemicals, estimations or Structure-Activity
Relationships (SARs, which are techniques to show
how data for one chemical can be used to cover data
needs for a similar chemical), proposed testing, and
adequacy of submitted data. Comments from PETA
and PCRM generally indicate whether they agree
with the proposed test plan or not, and specifically
with regard to whether animals will be used for testing
purposes. These animal welfare organizations often
state reasons for why testing should not be performed.
Guidance Documents
A key EPA goal in managing the HPV Challenge
Program has been to provide clear guidance to assist
stakeholders in participating in the Program. EPA's
"Guidance Documents" webpage can be found on the
EPA website at http://www.epa.gov/chemrtk/guidocs.
htm. Guidance is provided for subjects such as
category formation, developing robust data summaries,
and assessing adequacy of existing data, to name a few.
A number of EPA's guidance documents have achieved
international acceptance through their incorporation in
OECD guidance documents.
The guidance document on development of chemical
categories provides guidance on approaches and
issues encountered in category formation and
application under the HPV Challenge Program. The
document offers advice on how companies could
group chemicals with similar characteristics into
EPA's High Production Volume Challenge Program
Status and Future Directions
6
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categories, and then evaluate existing data and conduct
testing to characterize the category all without
having to perform every test on every individual
chemical. EPA's "Guidance on Developing Robust
Summaries" document presents guidance on what
technical information, on an endpoint-by-endpoint
basis, is necessary to adequately describe a particular
study. The term "robust summary" is used to describe
this technical content. Robust study summaries are
intended to provide sufficient information to allow a
technically qualified person to make an independent
assessment of a given study report without having
to go back to the full study report, and to also allow
evaluation of the proposed test plan. A robust study
summary therefore concisely reflects the objectives,
methods, results, and conclusions of the full study
report.
Test Plan and Data Submissions Are Now Available
EPA analyzed submitted test plans to determine how
the health and environmental effects endpoints were
addressed. Sponsors proposed to meet data needs
through the use of existing scientifically adequate
data, estimation techniques such as Structure-Activity
Relationships (SARs), or proposed new testing.
An examination of submitted data revealed that a
significant amount of unpublished data have now
been made public by the sponsors. This indicates that
many sponsors made significant efforts in evaluating
the hazards of their chemicals prior to the launch
of the HPV Challenge Program, but often did not
make the data available to the public. In fact, 59% of
the existing data reported under the HPV Challenge
Program, which represents over 6,800 studies, was not
publicly available before the launch of the Program.
This represents a major success of the HPV Challenge
Program.
Sources of Existing Data
Published Studies
(4,800) (41 %)
Unpublished Studies
(6,801) (59%)
The submission of existing, unpublished data to
EPA under the HPV Challenge Program has also
significantly minimized the amount of new testing
that sponsors have proposed. Sponsors have made
maximum use of Program guidance concerning the use
of SAR and category proposals, which also reduced the
need for new testing. New testing has been proposed
for fewer than 10% of the chemicals' endpoints.
The Category Approach
One of the most significant results of the HPV
Challenge Program has been the use of the category
approach to address the SIDS endpoints. In fact,
81% of all chemicals addressed in test plans have
been included in a category. Categories require a
Endpoint Data Sources
Fate
o
ill
Phys.chem.
Human Health
Ecotoxicity
Existing Data
SAR and Other Techniques
Proposed Testing
0 10 20 30 40 50 60 70
Percent
EPA's High Production Volume Challenge Program
8
Sfafus and Future Directions
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supporting hypothesis of how the category chemicals
relate to each other, as well as a description of how
data for one chemical can be used to predict the
toxicological responses of similar chemicals in the
category. EPA and other stakeholders then comment
on the reasonableness of the hypothesis, the adequacy
of supporting data, and any proposed testing. Once
the sponsor submits its final category analysis, EPA
will either agree that the category "held," or will notify
the sponsor that the sponsor may need to consider
additional testing or restructure the category.
The ICCA HPV Initiative
Test plans and data summary submissions for chemicals
sponsored indirectly through the ICCA HPV Initiative
are not provided to EPA to post on the HPV Challenge
Program website. Therefore, EPA determines progress
in the ICCA HPV Initiative by tracking how many
chemicals sponsored in the Initiative go to an OECD
SIDS Initial Assessment Meeting (SIAM), which is
a meeting where OECD member countries agree on
initial hazard assessment for HPV SIDS chemicals.
Chemicals Sponsored Indirectly through the ICCA HPV Initiative
Start Year or Test Plan
Receipt Year
1999
2000
2001
2002
2003
2004
Total
Total Expected
Chemical Submissions
38
149
487
133
127
40
974
SIAM Chemicals Sponsored
by ICCA
14
54
98
19
17
27
229
Of the 974 chemicals sponsored in the ICCA HPV
Initiative, 229 chemicals had been through the
OECD SIDS process by July 2004. This number
accounts for 24% of the total ICCA commitments.
It is important to point out that 123 chemicals are
dually sponsored both directly in the HPV Challenge
Program as well as indirectly in the ICCA HPV
Initiative. Earlier in this report, it was noted that 851
chemicals are sponsored in the ICCA HPV Initiative;
however, when the 123 dually sponsored chemicals are
considered, total ICCA HPV Initiative sponsorship
increases to 974 chemicals.
For more information regarding Overall HPV
Challenge Program Achievements, see Appendix 3.
EPA's Work With Sponsors To Address
Overdue Test Plans
Although EPA has received a large number of test
plans, a few commitments to supply information in
2003 or earlier have not been met. In order to evaluate
which sponsors were responsible for overdue test
plans, the Agency reviewed commitment information
submitted by companies and consortia, and then sent a
letter to sponsors of chemicals with overdue test plans in
April 2004. EPA received responses from many of these
sponsors updating the status of their commitments. As
of July 2004, test plan and data summary submissions
were overdue from 24 sponsors for 47 chemicals.
The Agency expects that sponsors will uphold their
commitments and submit test plans and data summaries
for these chemicals by the end of 2004.
For more information regarding Overdue Test Plans, see
Appendix 4.
Orphan Chemicals
While the success of the HPV Challenge Program
has been significant, 330 chemicals that were eligible
for sponsorship in the Program continue to remain
unsponsored. These chemicals are also known as
"orphans." The Agency is taking steps to ensure that
screening-level data are made available to the public
for the 330 orphan chemicals through a last chance at
voluntary sponsorship, as well as through future TSCA
information gathering and test rules.
For more information regarding Orphan Chemicals,
including a detailed outline of EPA's Draft Orphans
Strategy, see Appendix 5.
Future Directions and Developing Issues
Public access to hazard data is integral to the HPV
Challenge Program. Test plan and data summary
submissions, sponsor commitment information,
EPA's High Production Volume Challenge Program
Status and Future Directions
10
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chemical lists, guidance documents, and other
materials can be found at the HPV Challenge Program
Website (http://www.epa.gov/chemrtk). EPA has
recently provided enhanced search capability on its
existing "Robust Summaries and Test Plans" webpage
(http://www.epa.gov/chemrtk/hpvrstp.htm) that
allows the public to more efficiently search for test
plan and data summary submissions. Production
of the HPV Information System (HPVIS), a much
more comprehensive, data-searchable application,
is the ultimate goal. This system will allow users to
thoroughly search across all test plan and data summary-
related materials - including the data presented within
and among data summaries. The first release of HPVIS
is scheduled for late 2004 / early 2005.
As the HPV Challenge Program enters its final year
and as EPA prepares to provide the industry-submitted
data to the public in a searchable database format, the
Agency has made great strides to press forward with
developing and planning for the delivery of a Global
HPV Portal. The Portal is a system that will provide
a central location for domestic and international users
to access consolidated international HPV chemical
data repositories. EPA is working collaboratively
with the European Commission (EC), in consultation
with the Organization for Economic Cooperation
and Development (OECD), and with the additional
participation of Canada and Japan to develop this
system. The aim of the Global HPV Portal is to
provide seamless information sharing between the
European Union's (E.U.) International Uniform
Chemical Information Database (IUCLID) and
EPAs HPVIS. The two leads - EC and EPA - have
worked diligently on the Portal requirements in an
effort to share information and make data more readily
available to stakeholders from around the world.
Additionally, now that the majority of the test plans
and data summaries that were committed to under the
HPV Challenge Program have been submitted, the
Agency is focusing on using the data for identifying
chemicals of concern. The Agency is working with
the National Pollution Prevention and Toxics Advisory
Committee (NPPTAC) and NPPTAC's HPV
Work Group to develop a screening approach for
identifying and prioritizing chemicals for further work.
Once EPA has implemented a plan for prioritizing
chemicals, the next steps include employing
mechanisms to obtain additional hazard data (beyond
the basic screening-level of the SIDS) or exposure
data through voluntary or regulatory approaches for
priority chemicals as needed. Developing approaches
to obtain data on newly emerging HPV chemicals that
were reported in recent IUR cycles is also viewed as an
important follow-on step for the Challenge.
For more information regarding Future Directions and
Developing Issues, see Appendix 6.
HPV Challenge Program Conclusions
In conclusion, EPA is very pleased with the
overwhelming response from companies and consortia
to the HPV Challenge Program. The extraordinary
response to the Program has resulted in a tremendous
amount of sponsor-submitted test plan / summary
data being made publicly available. More than 400
companies and 100 consortia have sponsored over
2200 chemicals in the Program. In addition to the
851 chemicals sponsored indirectly through the ICCA
HPV Initiative, 353 test plans have been submitted for
1,266 (92%) of the 1,371 chemicals sponsored directly
in the HPV Challenge Program.
The majority of the test information that addresses
the SIDS endpoints was comprised of unpublished,
existing data, which because of the HPV Challenge
Program has now been made publicly available. In
addition, category approaches and SAR techniques
have been applied to extend the available data to
other related chemicals, thereby reducing the need for
new testing. The Agency has developed a strategy to
address those from the original list of approximately
2800 chemicals that have either not been sponsored
or have been sponsored but submission of test plans /
data summaries are currently overdue. This strategy,
plus efforts to develop the HPVIS while working with
other governments in developing the Global HPV
Portal, will help ensure that more data are accessible in
the U.S. and internationally.
The Agency is working with the National Pollution
Prevention and Toxics Advisory Committee
(NPPTAC) and NPPTAC's HPV Work Group to
develop a screening approach for identifying and
prioritizing chemicals for further work. In addition
to chemicals identified from the 1990 IUR, EPA is
in the process of considering options for addressing
HPV chemicals that were reported in the most recent
IUR reporting. EPAs Office of Pollution Prevention
and Toxics will continue to inform the public about
the HPV Challenge Program and the potential uses
of the collected data. Continued cooperation by
sponsors and other participating stakeholders in the
Program will ultimately result in public accessibility
to a large amount of useful HPV chemical data that
were largely not available to the public at the Program's
start in 1998. EPA recognizes the contributions by
industry and other stakeholders in the HPV Challenge
Program's accomplishments.
11
EPA's High Production Volume Challenge Program
Status and Future Directions
12
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Appendix 1: History of the Program
The HPV Challenge Program was established
in 1998 in response to several studies that
revealed how little health and environmental
effects data were publicly available for HPV chemicals.
Environmental Defense's Toxic Ignorance5 study in
1997 showed that, for a sample of 100 HPV chemicals,
there were relatively few U.S. HPV chemicals with
health hazard screening data. In 1998, EPA's Chemical
Hazard Data Availability Study6 addressed all HPV
chemicals and resulted in similar findings; specifically,
43% of high production volume chemicals had no
publicly available data on basic toxicity and only 7%
had a full set of basic data (see the figure below).
These results were subsequently supported by the
American Chemistry Council's Public Availability of
SIDS-Related Testing Data for U. S. High Production
Volume Chemicals' study in 1998. This lack of data
Lack of Publicly Available
Hazard and Fate Data
ro
.o
CD
.c
O
Q_
I
"S
^
Af)
on
m
42.5
13'8 10.3 9.3 g.O 8.1 7.1
0123456
Number of Endpoints with
Publicly Available Data
inhibits the public's ability to evaluate whether the
chemicals that may be found in their environment,
homes, workplaces, and the products that they buy are
of concern. Prior to the HPV Challenge Program,
such data were generally not available to the public.
EPA responded to this lack of data by inviting U.S.
manufacturers and importers of HPV chemicals to
voluntarily sponsor chemicals in the HPV Challenge
Program. Sponsorship entails the identification and
initial assessment of the adequacy of existing data, the
conduct of new testing only if the sponsor determines
that adequate data do not exist, and making the
new and existing data available to the public. Public
availability of data is the fundamental principle of this
program. Any new testing on the HPV chemicals in
the HPV Challenge Program is to be completed by the
end of 2004 with all data to be made available to the
public by the end of 2005.
HPV Challenge Program Design
Sponsors can participate in the HPV Challenge
Program either directly through the Program or
indirectly through the International Council of
Chemical Associations (ICCA) HPV Initiative and/
or the Organization for Economic Cooperation and
Development's (OECD) HPV Screening Information
Data Set (SIDS) Program. The ICCA HPV Initiative
6Toxic Ignorance: The Continuing Absence of Basic Health Testing for Top-Selling Chemicals in the United States (1997). New York, NY: Environmental Defense Fund.
(Website: http://www.environmentaldefense.org/documents/243_toxicignorance.pdf).
6Chemical Hazard Data Availability Study: What Do We Really Know About the Safety of High Production Volume Chemicals? (1998). Washington, DC: U.S. Environmental
Protection Agency. (Website: http://www.epa.gov/oppt/chemrtk/hazchem.pdf).
7Public Availability of SIDS-Related Testing Data for U.S. High Production Volume Chemicals (1998). Arlington, VA: Chemical Manufacturers Association.
14
<-.
Sfafus and Future Directions
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and OECD HPV SIDS Program are aimed at HPV
chemicals from around the world. The information
sought by the HPV Challenge Program is based on
the OECD HPV SIDS Program, which includes
an internationally agreed upon set of endpoints for
screening high production volume chemicals for
human and environmental hazards. The SIDS is
regarded as the minimum data set needed to make an
informed, preliminary judgment about the hazards of a
given HPV chemical.
For chemicals sponsored directly through the HPV
Challenge Program, each sponsor submits a test plan
to identify SIDS data needs along with a strategy to
fill data gaps. Each sponsor also submits a detailed
summary of existing data (robust summaries) for an
individual chemical or a group of chemicals with
similar structures and/or functionalities (category).
The sponsor's test plan is posted for public comment
to EPA's "Robust Summaries and Test Plans" webpage
at http://www.epa.gov/chemrtk/hpvrstp.htm. The test
plan is subject to a 120-day public comment period
to allow EPA and other stakeholders to review and
comment on the test plan and robust summaries and
to submit additional data that may be used to reduce
the need for new testing. Sponsors subsequently
develop new data, if necessary, and submit appropriate
robust summaries. As described below, voluntary
participation in the HPV Challenge Program provides
the flexibility to propose chemical categories and more
flexible schedules for conducting necessary testing.
Chemicals sponsored indirectly through the ICCA
HPV Initiative are tied in directly with the OECD
HPV SIDS Program (http://www.icca-chem.org).
The basic ICCA HPV Initiative process consists of
first obtaining company or consortium sponsorship
for the ICCA-listed HPV chemicals. Then, the
ICCA HPV Initiative solicits national sponsorship
from an OECD member country. Once the member
country sponsorship is achieved, the company or
consortium works with the sponsor country to develop
the necessary materials. Completed materials will be
submitted to OECD by countries so that a screening-
level hazard assessment can be completed.
Chemicals not otherwise sponsored will be considered
for inclusion in a test rule under TSCA Section 4.
The purpose of the test rule is to serve as a regulatory
backstop to the voluntary HPV Challenge Program
and the ICCA HPV Initiative; and thereby ensure
that basic data are available for all HPV chemicals.
The first HPV test rule was proposed on December
26, 2000 (65 FR 81658). On that same date, another
Federal Register notice (65 FR 81686) was also issued,
and described the HPV Challenge Program (http://
www. epa.gov/chemrtk/ts42213 .pdf).
1990 HPV Challenge Program Chemical List
The 1990 HPV Challenge Program Chemical List
consists of all HPV chemicals reported in the 1990
Inventory Update Rule. Inorganic chemicals and
polymers, except in special circumstances, were not
subject to the IUR reporting requirements. The 1990
HPV Challenge Program Chemical List contained
2,782 chemicals. A second list, the 1994 List of
HPV Additions, contained approximately 500 HPV
chemicals that were newly reported as HPV in the
1994 IUR. The 1994 List of HPV Additions is not
a part of the HPV Challenge Program at this time,
but was provided for use by companies who desired
to propose categories of chemicals and wished to
include chemicals from the 1994 list in their category
definitions. Additionally, in some cases, companies
or consortia have sponsored chemicals that are not on
either the 1990 HPV Challenge Program Chemical
List or the 1994 List of HPV Additions. For the
purposes of this report, these chemicals are included in
the number of sponsored chemicals, and no distinction
is made between these chemicals and those chemicals
on the 1990 HPV Challenge Program Chemical List
once they are sponsored.
15
EPA's High Production Volume Challenge Program
Status and Future Directions
16
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Appendix 2: How the Program Works
U.S. manufacturers and importers of HPV
chemicals were invited to voluntarily
sponsor chemicals in the HPV Challenge
Program. To become a sponsor of one or more HPV
chemicals a company or consortium sends a letter to
EPA announcing its commitment to participate in
the HPV Challenge Program and its willingness to
adhere to the Program's procedures. The commitment
letter includes chemical names and Chemical Abstract
Services (CAS) registry numbers to be sponsored,
the year of the Program in which the sponsor will
submit test plans and supporting robust summaries,
and the name and contact data for the technical
person within the company to contact for additional
information. Sponsorship can be undertaken by
individual companies or through a consortium of
companies. Many companies collaborate with other
companies or trade associations that manufactured
the same or similar chemicals by forming consortia.
Consortia help avoid duplication of effort and reduce
individual companies' expenditures needed for data
collection or testing. As a first step toward fulfilling a
commitment, the sponsor submits robust summaries
of existing data and a test plan showing how it plans to
fill data gaps. Chemicals can be submitted individually
or as categories of chemicals. Categories of chemicals
are proposed when test plan and robust summaries
are submitted, and are not identified in the initial
sponsorship commitment letter.
EPA has received numerous commitments to sponsor
chemicals since the beginning of the Program in late
1998. The Agency extended the initial timeframe
for commitments to be received from March 1999 to
December 26, 2000. This date was chosen because it
was the date on which a proposed TSCA Section 4
test rule containing 37 unsponsored chemicals from
the 1990 HPV Challenge Program Chemical List was
published. Commitments received after December 26,
2000, were deemed "viable commitments." In addition
to adhering to the standard components of the HPV
Challenge Program, companies agreeing to sponsor
chemicals via viable commitments also provide full
copies of new and existing studies. Companies and
consortia that committed to sponsor chemicals prior to
issuance of the proposed test rule were not expected to
submit full studies; instead, they were to submit robust
summaries of the studies. When defining the number
of sponsored chemicals within the HPV Challenge
Program, the Agency does not consider viable
commitments a separate sponsorship classification.
18
Sfafus and Future Directions
-------
Companies and Consortia Sponsoring Chemicals
Participation in the HPV Challenge Program has
been remarkable and has exceeded all expectations.
As of July 2004, a total of 401 companies and 103
consortia were sponsoring chemicals directly through
the HPV Challenge Program. These numbers include
companies and consortia that sponsor chemicals
through the HPV Challenge Program and those
that sponsor chemicals in both the HPV Challenge
Program and through the ICCA HPV Initiative. The
following table contains a list of the participating
companies and consortia, along with their trade
association affiliation, if applicable, and the number of
chemicals that they are sponsoring.
Participating Companies and Consortia in the HPV Challenge Program
{Company and consortium names are presented according to how they were submitted to the Agency. Participating
companies in the ICCA HPV Initiative or OECD HPV SIDS Program are not included if they are not also participating
directly in the HPV Challenge Program. Trade association affiliation is noted for members of the following three trade
associations: American Chemistry Council (ACC), American Petroleum Institute (API), and Synthetic Organic Chemical
Manufacturers Association (SOCMA). Lists of ACC and SOCMA member companies were found on their web sites. A
member company list for API is not available on its website; however, a list of links to API member companies is available at
http://api-ec.api.org/links/index.cfm, and was used in this analysis to identify known API member companies it is not a
complete list.}
Sponsoring Organization Name
Comoanies
Trade
Association(s)
Number of
Chemicals
Sponsored
3M
A.E. Staley Manufacturing Company
Abitibi Consolidated (Formerly Donohue, Inc.)
Aceto Corp
Agri-Energy, LLC
Air Liquide America
Air Products and Chemicals, Inc.
Akzo Nobel
Akzo Nobel - Eka Chemicals Incorporated
Akzo Nobel - Polymer Chemicals Business Group
Akzo Nobel - Polymer Chemicals Metal Alkyls
Akzo Nobel - Resins
Akzo Nobel Chemicals Inc.
Akzo Nobel Functional Chemicals LLC
Akzo Nobel Functional Chemicals LLC - Phosphorus Chemicals
Al-Corn Clean Fuel Cooperative
Albemarle Corporation
Albina Fuel Co. dba Albina Asphalt
Alchem, Ltd.
ALCO Chemical
Alliance Forest Products
Alliant Techsystems Inc.
Amerada Hess Corporation
Ameribrom Inc.
Angus Chemical Company
Aqua-Clor
Arch Chemicals, Inc.
Archer Daniels Midland Company (ADM)
Arizona Chemical Company
^^^^^^^^^H
ACC
SOCMA
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC, API, SOCMA
SOCMA
ACC
^^^^^^^^^m
4
14
1
3
1
1
9
1
36
1
21
36
91
3
9
1
32
36
1
34
1
1
392
6
2
3
3
14
129
19
EPA's High Production Volume Challenge Program
Status and Future Directions
20
-------
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
Asahi Glass Co., Ltd.
Ashland Inc.
Asphalt Materials, Inc.
Atlantic Richfield Company (ARCO)
Atofina Chemicals, Inc.
Atofina Oil and Chemical Company
Atofina Petrochemical Inc.
Ausimont S.p.A.
Ausimont USA, Inc.
Baerlocher USA
Baker Petrolite Corporation
BASF Corporation
BASF Performance Copolymers, LLC
Baule USA
Bayer AG Corporation
Bayer Corporation
Bedoukian Research, Inc.
Big West Oil LLC/Flying J Inc.
Bimasco, Inc.
BioLab, Inc.
Blacklidge
Blackman Uhler Chemical Company (Division of Synalloy Corp.)
Blue Ridge Paper Products
Boise Cascade Corporation
Borden Chemical, Inc.
Borden Chemicals and Plastics (BCP) Limited Operating Partnership
Borregaard Italy
Bowater Incorporated
BP
Broin Enterprises, Inc.
Buckeye
Buffalo Color Corporation
Bush Boake Allen Inc.
The C.P. Hall Company
Cabot Corporation
Calcasieu Refining Company
Capital Resin Corporation
Cardolite Corporation
Cargill, Inc. North American Corn Milling Division
ACC, API
ACC
ACC
ACC
API, SOCMA
ACC, SOCMA
ACC, SOCMA
ACC, SOCMA
ACC
SOCMA
SOCMA
SOCMA
SOCMA
SOCMA
ACC, API
ACC
SOCMA
SOCMA
1
2
36
392
38
392
3
1
2
19
35
149
1
1
3
70
45
392
5
4
5
1
1
82
1
2
4
1
480
1
1
14
32
49
1
392
2
1
1
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
Cargill, Incorporated
Caribbean Methanol Company Limited
CBC (America) Corp.
Celanese Ltd.
Cenex Harvest States Cooperatives
Champion International Corporation
Chevron Oronite Company LLC
Chevron Phillips Chemical Company, LP
Chevron Products Company
Chief Ethanol Fuels, Inc.
Chippewa Valley Ethanol Company (CVEC)
Ciba Specialty Chemicals Corporation
Ciba Specialty Chemicals Corporation - Water Treatments
Ciba Specialty Chemicals Corporation, Plastic Additives Segment
Citgo Asphalt Refining Corporation (CARCO)
Citgo Petroleum Corporation
Citrus and Allied Essences, Ltd.
Clariant Corporation
Clearon Corporation
Cleveland Asphalt Products, Inc.
The Clorox Company
Cobitco, Inc.
Cognis Corporation
Colas, Inc.
Color Intermediates, Inc.
Colorcon, Inc.
Condea Servo LLC
ConocoPhillips Company
Copperhead Chemical Company Inc.
Corn Plus
Corsicana Technologies, Inc.
Countrymark Cooperative, Inc.
Crompton & Knowles Colors Incorporated
Crompton Corporation
Cross Oil Refining & Marketing, Inc.
Crown Central Petroleum Corporation
CVC Specialty Chemicals, Inc.
Cytec Industries Inc.
Daikin America, Inc.
SOCMA
ACC
ACC, SOCMA
ACC, SOCMA
ACC, SOCMA
ACC, API
ACC, API
ACC, API
SOCMA
ACC, SOCMA
API
SOCMA
SOCMA
ACC
ACC
ACC
ACC
13
1
1
22
392
45
75
91
394
1
1
49
3
14
392
392
45
37
3
36
65
36
134
36
25
5
19
392
1
1
29
392
1
447
392
392
2
67
1
21
EPA's High Production Volume Challenge Program
Status and Future Directions
22
-------
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
Dakota Gasification Company
DanChem Technologies, Inc.
Day-Glo Color Corp.
Degussa AG
Deltech Corporation
Denco, LLC
Derivados Electroquimicos Levante SA (DELSA)
Dixie Chemical Company, Inc.
Dover Chemical Corporation
Dow AgroSciences
The Dow Chemical Company
DRAGOCO, Inc.
DSM Chemicals North America, Inc.
DSM Fine Chemicals, Inc.
DynaChem, Inc.
Dynegy Midstream Services LP
Dyno Nobel Inc.
DyStar LP
E. A. Mariani Asphalt Company
E.I. du Pont de Nemours and Company
Eastern Paper, Inc.
Eastman Chemical Company
Eastman Kodak Company
Ecofuel
Ecolab Inc
Edginton Oil Company
Eighty-Eight Oil Company
Eliokem, LLC
Elkhorn Operating Company
Emulsion Products of Alaska, Inc.
Enron Methanol Company
Enterprise Products Company
Equilon Enterprises, LLC and Motiva Enterprises, LLC
Equistar Chemicals, LP
Equitable Oil Purchasing Company
Equiva Services LLC
Ergon - West Virginia, Inc.
Ergon Asphalt & Emulsions, Inc.
Ergon Ref Inc
ACC
ACC, SOCMA
ACC, SOCMA
SOCMA
ACC, SOCMA
ACC
ACC, API, SOCMA
ACC, API, SOCMA
ACC, SOCMA
ACC, SOCMA
ACC
ACC, SOCMA
ACC
ACC
395
1
1
3
3
1
3
6
5
1
124
45
2
1
2
392
1
1
36
167
1
204
13
1
5
392
392
34
392
5
1
392
392
77
392
392
392
36
392
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
ESCO Company Limited Partnership
Ethanol2002
EXOL
Exxon Company, USA
ExxonMobil Chemical Company
Farmland Industries Inc.
Ferro Corporation
Fertilizers & Chemicals, Ltd.
Fina Oil and Chemical Company, Inc.
Finch, Pruyn & Company, Incorporated
FINETEX, Inc.
Firmenich, Incorporated
First Chemical Corporation
Flexsys America L.P.
Flint Hills Resources LP
FMC Corporation
Formosa Hydrocarbons Company, Inc.
Formosa Plastics Corporation, USA
Fragrance Resources
Gaylord Chemical Corporation
GE Plastics
General Electric (GE)
GEO Specialty Chemicals
Georgia Gulf Corporation
Georgia-Pacific Corporation
Georgia-Pacific Resins, Inc.
Giant Industries, Inc.
Givaudan Fragrances Corporation
Global Octanes Corporation
Golden Bear Oil Specialties
The Goodyear Tire & Rubber Company
Great Lakes Chemical Corporation
Greif Bros. Corporation
Groupe SNPE
Gulf States Asphalt Co., LLP
Gulf States Paper Corporation
Haarmann & Reimer (H&R)
Hampshire Chemical Corp.
Harcros Chemicals Inc.
SOCMA
ACC, API
ACC, API
ACC, SOCMA
SOCMA
ACC, API, SOCMA
API
API
ACC
ACC
5
1
1
392
263
392
86
3
455
1
3
17
5
34
392
10
392
74
45
2
1
15
1
4
2
38
392
60
392
392
475
13
1
59
5
1
13
5
6
23
EPA's High Production Volume Challenge Program
Status and Future Directions
24
-------
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
Hatco Corporation
Heartland Corn Products
Heartland Grain Fuels, LP
Hercules Incorporated
High Plains Corporation
Hills Materials Company
Holly Corporation
Honeywell International Inc.
Hovensa LLC
Hunt Refining Company
Huntsman Advanced Materials Americas Inc.
Huntsman Corporation
Huntway Refining Company
ICI
ICI Americas, Inc.
lhara Chemical Industry Co., Ltd.
INDSPEC Chemical Corporation
INEOS N.V.
Infineum USA L.P.
Inland Paperboard and Packaging, Inc.
Inland Refining, Inc.
Inolex Chemical Company
International Flavors & Fragrances, Inc. (IFF-US)
International Paper
International Specialty Products (ISP)
ISOCHEM INC (formerly Vandemark Inc.)
J. Manheimer Inc.
Kao Corporation
Kao Specialties Americas LLC (formerly High Point Chemical
Corporation)
Kemin Industries, Inc.
Kern Oil & Ref Co
King Industries, Inc.
Koch Industries, Inc.
Koei Chemical Co., Ltd.
Korea Hyeop Hwa Chemical Industry Company, Ltd.
KoSa
Kuraray Co., Ltd.
La Gloria Oil and Gas Company
Lindau Chemicals, Inc.
SOCMA
ACC, SOCMA
API
SOCMA
SOCMA
ACC
ACC
ACC, API
ACC, SOCMA
SOCMA
ACC
ACC
SOCMA
47
1
1
130
1
5
392
395
392
392
3
83
392
1
156
1
1
1
73
37
392
72
48
37
4
2
46
1
58
19
392
4
470
9
1
13
46
392
6
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
Lion Oil Company
Loctite Corporation
Longview Fibre Company
Lonza Inc.
Louis Marsch, Inc.
Louisiana-Pacific Corporation
The Lubrizol Corporation
Lyondell Chemical Company
Lyondell Methanol Co.
Lyondell-Citgo Refining Company Ltd.
Mallinckrodt Inc.
Marathon Ashland Petroleum LLC
Mason Chemical Company
McAsphalt Industries Limited
Mclntyre Group, Ltd.
MeadWestvaco
Merichem Chemicals & Refinery Services LLC
Merisol USA LLC
Metachem Products, LLC
Methanex Methanol Company
The Methanol Sector Group, a Sector Group of CEFIC
MFG Chemical, Inc.
Midwest Grain Products
Millennium Chemicals Inc.
Milliken Chemical
Minnesota Corn Processors, Inc. (MCP)
Mitsubishi Gas Chemical Company, Inc.
MLPC International
Mobil Oil Corporation
Monsanto Company
Morflex, Inc.
Motiva Enterprises, LLC
Murphy Oil USA, Inc.
Nalco Chemical Company
Nan Ya Plastics Corporation, America
National Cooperative Refinery Association
National Starch (ICI Americas)
Navajo Refining Company
Nepera, Inc.
SOCMA
ACC, API, SOCMA
API
ACC
ACC, API
ACC, API
ACC
SOCMA
ACC
ACC
ACC
ACC
SOCMA
API
ACC
ACC
ACC
392
1
1
38
5
1
103
22
1
392
32
409
5
36
3
112
392
405
4
1
1
3
1
60
6
1
2
1
392
2
1
392
392
10
3
392
2
392
7
25
EPA's High Production Volume Challenge Program
Status and Future Directions
26
-------
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
Neville Chemical Company
New Energy Corp.
New England Emulsions Corp.
NIPA Inc.
Nippon Petrochemicals Co., Ltd.
Nissan Chemical America Corporation
Nissan Chemical Industries, Ltd.
Nisso America, Inc.
NOVA Chemicals Inc.
Noveon, Inc.
Occidental Chemical Corporation (OxyChem)
OMG Americas, Inc.
OmniSpecialty Corporation
Omnova Solutions Inc.
Ondeo Nalco Energy Services (ONES)
P. H. Glatfelter Company
Packaging Corporation of America (PCA)
Parlallel Products
PDV Midwest Refining, L.L.C.
Pelron Corporation
Pennzoil-Quaker State Company
Phillips Petroleum Company
Pilot Chemical Company
Placid Refining Company LLC
Plasmine Technology, Inc.
PMC Specialties Group, Inc.
Polarome International Incorporated
Port Townsend Paper Corporation
Potlatch Corporation
PPG Industries, Inc.
Praxair Inc
Premcor Refining & Marketing INC
Prime Materials & Supply Corp.
Pro-Corn, LLC
The Procter & Gamble Company
Proviron Fine Chemicals NV
PURAC America, Inc.
Quaker Chemical Corporation
Quest International
ACC
SOCMA
ACC, API
ACC
SOCMA
SOCMA
SOCMA
SOCMA
ACC, SOCMA
ACC, API
ACC
SOCMA
392
1
36
1
1
3
1
3
78
132
4
32
2
1
29
1
37
1
409
19
392
386
5
392
36
9
45
1
1
9
1
392
5
1
89
1
1
47
45
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
R. T. Vanderbilt Company, Inc.
Raisio Chemicals
Rayonier
Reichhold Inc.
Reilly Industries, Inc.
Resolution Performance Products LLC
Reynolds Metals Company
Rhein Chemie Corporation
Rhodia Inc.
Rhodia Organique Fine Limited
Riverwood International Corporation
Rohm and Haas Company
Rubicon Inc.
Rutgers Organics Corporation
Rutherford Chemicals LLC dba Nepera
Sabic Americas Inc.
Safety-Kleen Oil Recovery
Sand Creek Chemical Limited Partnership
Sartomer Company, Inc.
Sasol North America Inc.
Saturn Methanol Company, LLC
Schenectady International (Sll)
Seaco, Inc.
Sensient Colors Inc.
Sensient Flavors Inc
Shell Chemical Company
Shell Chemicals Limited
Shell Oil Company
Shepherd Chemical Company
Shikoku Chemicals Corporation
ShinWon Corporation
Sid Richardson Gasoline Co
Silver Eagle Refining, Inc.
Sinclair Oil Corporation
Smurfit Stone Container Corp.
SNF Holding Company
Solutia
Solvay Advanced Polymers, Inc. (SAPI)
South Hampton Refining Co.
ACC
ACC
ACC, SOCMA
ACC, SOCMA
ACC
SOCMA
ACC
ACC
ACC
ACC
ACC
ACC, API
ACC, API
ACC, API
ACC
ACC
ACC
ACC, SOCMA
37
36
37
2
10
32
392
59
216
1
37
73
1
2
9
1
392
1
2
499
1
18
5
5
45
74
1
392
32
3
1
392
392
392
37
3
55
1
392
27
EPA's High Production Volume Challenge Program
Status and Future Directions
28
-------
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
Southern Chemical Corporation
SpecialtyChem Products Corporation
Specified Fuels & Chemicals, LLC
St. Laurent Paperboard Inc.
St. Marks Powder, Inc.
Star Enterprise
Stepan Company
Sterling Chemicals, Inc.
Stockhausen GmbH & Co. KG
Stora Enso North America (Formerly Consolidated Papers, Inc.)
Suit-Kote Corporation
Sumitomo Chemical America, Inc.
Sun Chemical Corporation
Sunoco, Inc. (R&M)
Sybron Chemicals Inc.
Symrise
Syngenta Crop Protection AG
Takasago International Corporation (USA)
Tecnal Corporation
Tejas Energy, LLC
Teknor Apex Company
Terra Industries
Tesoro Petroleum Companies, Inc.
Texaco Inc.
Texas Petrochemicals Corporation (TPC)
Thompson-McCully Oil Co.
Ticona LLC
TomahS
Toray Fine Chemicals Co., Ltd.
Tosco Corporation
Trinidad and Tobago Methanol Company Limited (TTMC)
Troy Chemical Company
Troy Corporation
True Oil Company
U.S. Oil & Refining Co.
Ultramar Diamond Shamrock Corporation
Unilever Home & Personal Care - USA
Unique Paving Materials Corporation
Unitex Chemical Corporation
ACC
ACC, SOCMA
SOCMA
ACC
SOCMA
API
ACC
ACC
ACC
SOCMA
1
4
392
1
1
392
95
18
2
1
5
1
26
526
1
45
1
1
45
392
22
1
392
392
74
36
2
46
1
392
1
3
19
392
392
392
48
36
1
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
Unocal Corporation
Valero Energy Corporation
Vance Brothers, Inc
VanDeMark Chemical Company Inc.
Velsicol Chemical Corporation
Vestal Asphalt, Inc.
Vulcan Chemicals
Vulcan Construction Materials, LP
W.R. Grace & Co.
Wacker Biochem Corporation
Wacker Silicones Corporation
Westlake Chemical Corporation
Weyerhaeuser Company
Whitaker Roads Corporation
Willamette Industries, Inc.
Williams Energy Services
Williams Ethanol Services, Inc. (and its affiliate Nebraska Energy LLC)
Williams Olefins, LLC (formerly Union Texas Petrochemicals
Corporation)
Williams Refining, LLC
Wynnewood Refining Company
Zeneca Ag Products, Inc.
API
ACC
ACC
ACC
ACC, SOCMA
ACC, SOCMA
392
392
36
1
53
36
45
5
13
2
1
75
37
36
1
393
1
74
392
392
3
Consortia
Akzo Nobel - Polymer Chemicals Business Group / PPG Industries, Inc.
Akzo Nobel - Polymer Chemicals Metal Alkyls / E.I. Du Pont de Nemours
and Company
Albemarle Corporation / Ciba Specialty Chemicals Corporation -
Additives
Alky I Diphenyl Oxide Sulphonates (ADPOS)
Aluminum Alkyls Consortium
Ameribrom Inc. / Great Lakes Chemical Corporation
American Chemistry Council (ACC)
Acetic Acid and Salts Panel
Acetylene HPV Consortium
Aliphatic Esters Panel
Benzoates Panel
Brominated Biocides Panel Dimethylhydantoin (DMH) Task
Force
Brominated Flame Retardant Industry Panel (BFRIP)
Brominated Phthalates Panel
Diisocyanates (DIC) Panel
ACC, SOCMA
ACC
ACC, API, SOCMA
ACC, SOCMA
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
1
1
1
5
20
1
13
1
47
1
1
3
1
1
29
EPA's High Production Volume Challenge Program
Status and Future Directions
30
-------
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
Ethylbenzene Panel HPV Test Group
Fatty Nitrogen Derived (FND) Amides Panel
Fatty Nitrogen Derived (FND) Amines Panel
Fatty Nitrogen Derived (FND) Cationics Panel
Fatty Nitrogen Derived (FND) Nitriles Panel
Health, Environmental, and Research Task Group (HERTG)
Higher Olefins Panel
Hydroquinone Precursors & Derivatives Panel
Monocyclic Aromatic Amines and Nitro Aroma tics (MAANA)
Panel
Olefins Panel HPV Work Group
Oxo Process Panel
Phosgene Panel
Phthalate Esters (PE) Panel HPV Testing Group
Pyridine and Pyridine Derivatives HPV Work Group
Rubber and Plastics Additives (RAPA) Panel
Specialty Acrylates and Methacrylates (SAM) HPV Work Group
American Forest & Paper Association (AF&PA)
American Methanol Institute Testing Group (AMITG)
American Petroleum Institute (API) Petroleum HPV Testing Group
APAG
Aromatic Sulfonic Acids Association (ASAA)
Asphalt Emulsion Manufacturers Association (AEMA)
ATOFINA Chemicals, Inc. / Celanese Ltd.
ATOFINA Chemicals, Inc. / Chevron Phillips Chemicals, LP
Benzotriazoles Coalition
BPD/BPA Coalition
Cabot Corporation / Degussa AG / Wacker Silicones Corporation
Chlorobenzene Producers Association
Ciba Specialty Chemicals Corporation - Additives / Cytec Industries Inc.
Color Pigments Manufacturers Association, Inc. (CPMA)
Committee on HPV Challenge for Cyclohexanol
Consumer Specialty Products Association (CSPA) ADBAC Steering
Committee/Joint Venture
DADMAC HPV Committee
The DCB Coalition
Diethyl Ether Producers Association, Inc. (DEPA)
Dimethyl Sulfoxide (DMSO) Producers Association
Dioxolane Manufacturers Consortium
DMMP Consortium
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
API
ACC
ACC, SOCMA
ACC, SOCMA
ACC, API
3
29
29
13
17
59
24
4
5
74
1
1
21
9
34
2
1
1
392
1
2
36
1
1
3
2
1
4
1
25
1
5
1
1
1
1
1
1
Number of
Sponsoring Organization Name Trade Chemicals
Association(s) Sponsored
The Dow Chemical Company / Solutia
E.I. du Pont de Nemours and Company / ExxonMobil Chemical Company
/ The Dow Chemical Company
E.I. du Pont de Nemours and Company / Solutia
Eastman Chemical Company / Solutia
Eastman Chemical Company / The Dow Chemical Company
ETAD North America Disperse Blue 79:1 Consortium
ETAD North America Stilbene Fluorescent Brighteners
Ethanol HPV Challenge Consortium
European Fluorocarbon Technical Committee
ExxonMobil Chemical Company / Resolution Performance Products LLC
Ferro Corporation / Ticona LLC
The Flavor and Fragrance High Production Volume Consortia (FFHPVC)
Alicyclic Primary Alcohol Aldehyde Car boxy lie Acid
Consortium
Aromatic Consortium
Cyclohexyl Derivatives Consortium
Linear Aliphatic C7-C9 Alcohol Aldehyde Car boxy lie Acid
Consortium
Terpene Consortium
Great Lakes Chemical Corporation / Albemarle Corporation
Hexamethoxymethylmelamine (HMMM) Coalition
Huntsman-Nissan-TGIC Consortium
IMF Committee on HPV Challenge for Cyclic Acid Anhydrides
IMF Committee on Nylon 6 and Its Precursors
INDSPEC Chemical Corporation / Sumitomo Chemical America, Inc.
International Association of Color Manufacturers
Isocyanurate Industry Ad Hoc Committee (IIAHC)
LAB Sulfonic Acids Coalition
Lesser Ketones Manufacturing Association
The MBOCA Consortium
McConnaughay Technologies, Inc.
Metal Car boxy lates Coalition
NMA/NBMA Association
Phenolic Benzotriazoles Association
Phosphite Producers HPV Consortium
Pine Chemicals Association (PCA) HPV Task Force
Propylene Carbonate / T-Butyl Alcohol HPV Committee
Quat HPV Challenge Task Force
The Soap and Detergent Association (SDA)
ACC, API, SOCMA
ACC, API, SOCMA
ACC
ACC, SOCMA
ACC, API, SOCMA
ACC, API
ACC, SOCMA
ACC, API, SOCMA
ACC, SOCMA
1
1
6
3
1
1
8
1
1
1
1
1
13
1
3
45
2
1
1
6
1
1
5
3
3
1
1
36
19
2
4
4
36
2
2
31
EPA's High Production Volume Challenge Program
Status and Future Directions
32
-------
Sponsoring Organization Name
Linear Alkylbenzene Sulfonate Alkyl Benzene Sulfonate
(LAS/ABS) Consortium
Triclocarban (TCC) Consortium
Society of the Plastics Industry Inc. (SPI)
Epoxy Resin Systems Task Group
Synthetic Organic Chemical Manufacturers Association (SOCMA)
Biphenyl Work Group (BWG)
Dibasic Esters (DBE) Group
Isatoic Anhydride Coalition
Sulfosuccinates Group
Urea Resins Group
Thioesters Association
Toluenesulfonamide Testing Group
Trioxane Manufacturers Consortium
U.S. Nitroglycerin Producers Consortium (USNPC)
Trade
Association(s)
Number of
Chemicals
Sponsored
SOCMA
SOCMA
SOCMA
SOCMA
SOCMA
Companies and consortia sponsoring chemicals
exclusively through the ICCA HPV Initiative are
not included in these numbers. The record of ICCA
commitments is supplied to the Agency by the
American Chemistry Council.
Sponsored Chemicals
Throughout the course of the Program, the chemical
lists have been annotated to reflect changes in the
status of chemicals; for instance, whether the chemical
has been determined to fall outside of the scope of
the Program or if the chemical is sponsored through
the ICCA HPV Initiative. Chemical lists are posted
on EPA's website at http://www.epa.gov/chemrtk/
volchalLhtm.
Chemicals considered outside the scope of the
Program include those: that were not HPV according
to 1990 IUR information; for which it was determined
that testing would not further our understanding of
the chemicals' properties; chemicals sponsored under
the OECD HPV SIDS Program; that are polymers
or inorganics; or that are no longer considered
high production volume. However, sponsorship of
chemicals that fall outside the scope of the Program
was permitted. In fact, 50 such chemicals have
been sponsored. Many of these 50 chemicals were
sponsored as a member of a category and many were
already sponsored in the OECD HPV SIDS Program.
Sponsorship of categories was encouraged under
the HPV Challenge Program. Benefits of category
sponsorships include:
Economic savings, because less testing may be
needed for category chemicals,
Fewer animals are needed to test a category of
chemicals as opposed to doing each test on each
individual chemical, and
Screening-level data on a larger number of
chemicals may be provided to the public (by
including chemicals beyond the scope of the
Program).
Status of Chemical Sponsorship
At the HPV Challenge Program's start, 368 chemicals
that would otherwise have been included in the
Program fell outside the scope of the Program for the
reasons described in the previous section. Removing
chemicals from the scope of the Program left 2,414
chemicals available for sponsorship from the 1990
HPV Challenge Program Chemical List. Over
the course of the Program, due to factors such as
sponsorship of some of the 368 chemicals over time,
the number of chemicals that fell outside the scope of
the Program decreased to 352 chemicals.
The overall number of sponsored chemicals as of July
2004 as compared to the October 1998 launch of the
Program is remarkable. As of July 2004, EPA received
commitments for 1,859 of the 2,782 chemicals on the
1990 HPV Challenge Program Chemical List. An
additional 363 chemicals that were not on the List
have also been sponsored, bringing the total number of
sponsored chemicals to 2,222.
By July 2004, of the 2,782 chemicals on the 1990 HPV
Challenge Program Chemical List, there were 571
chemicals left unsponsored. The Agency has further
analyzed the high production volume status of the 571
chemicals, and, based upon the results, the number of
chemicals still available for sponsorship decreased to
330. The Unsponsored Chemicals analysis presented
later in this report provides a complete description
of this analysis. In addition to the 1,859 sponsored
Detailed Status of 1990 HPV Challenge Program Chemical List
Chemicals on 1990 HPV Challenge
Chemicals Removed from Scope of Program*:
Testing Would Not Further Our Understanding
Sponsored under OECD HPV SIDS Program (and
Not ICCA HPV Initiative)
Polymer or Inorganic
"No Longer HPV"
Total Removed*
Sponsored (includes chemicals sponsored under the
ICCA HPV Initiative)
Unsponsored
Total
# of Chemicals
39
190
62
61
352
1,859
571
2782
* Note that chemicals removed from the scope of the Program may fall into more than
one classification. Additionally, chemicals sponsored that are not considered within the
scope of the Program are included in the 1,859 count, often as members of a category;
they are not removed.
33
EPA's High Production Volume Challenge Program
Status and Future Directions
34
-------
chemicals and 571 orphan chemicals, 352 chemicals
that would otherwise have been included in the
Program are not considered within the scope of
the HPV Challenge Program. The following table
provides a detailed description of these chemicals that
are considered outside the scope of the Program for
the reasons described in the previous section.
The figure below illustrates the progress of chemical
sponsorship in the Program.
Sponsorship Status of the 2,782
Chemicals on the 1990 HPV Challenge
Program Chemical List (as of July 2004)
Not Within Scope
of Program (352)
Sponsored (Includes
ICCA) (1,859)
Unsponsored
(571)
In addition to the 1,859 chemicals sponsored from
the 1990 HPV Challenge Program Chemical List, an
additional:
99 have been sponsored from the 1994 List of
HPV Additions, and
264 have been sponsored that are not on either the
1990 HPV Challenge Program Chemical List or
the 1994 List of HPV Additions.
The Agency considers all of these 2,222 chemicals
to be sponsored under the HPV Challenge Program.
The figure below illustrates this distribution.
2,222 Chemicals Sponsored Within the
HPV Challenge Program
1994 List of HPV
Additions (99)
1990 HPV
Challenge Program
Chemical List
(1,859)
Other (264)
Of these 2,222 chemicals for which commitments
have been made, some are sponsored through the HPV
Challenge Program and some are sponsored through
the ICCA HPV Initiative. Note that 123 chemicals
are sponsored both in the HPV Challenge Program
and through the ICCA HPV Initiative (see the figure
below).
Sponsorship Distribution Between HPV
Challenge Program, ICCA HPV Initiative,
and Both Programs
123
HPV Challenge
Program (1,248)
ICCA HPV
Initiative (851)
Both (123)
The sponsor of a chemical may or may not be the same
in both programs. Additionally, a sponsor may have
chosen to work through only one program, but has
not officially informed EPA that the dual sponsorship
status has changed. Until EPA is notified in writing
by the sponsor stating that sponsorship has changed
from one program to another, records will continue to
show the chemical as sponsored under both programs.
35
EPA's High Production Volume Challenge Program
36
Sfafus and Future Directions
-------
IP
Appendix 3: Overall HPV Challenge
Program Achievements
I'll
/
A the onset of the HPV Challenge Program,
LPA provided guidance documents to assist
takeholders in participating in the Program.
As of July 2004, sponsors had submitted 353 test
plans, covering 1,266 chemicals. Environmental
protection and animal welfare groups have submitted
the majority of public comments on these test plans.
As part of their commitment to the HPV Challenge
Program, sponsors submit a test plan and robust
summaries in a start year that they chose at the
initial time of sponsorship. Sponsors submit test
plans for either individual chemicals or for a category
of chemicals. A chemical category is a group of
related chemicals that lend themselves to evaluation
and testing as a group. The chemicals can be
grouped based on similarities in chemical structure
or functionality. If testing is strategically planned,
fewer than the full number of tests for each individual
chemical will be necessary thereby reducing testing
costs, as well as often reducing the number of animals
needed. Each chemical or category of chemicals will
have a test plan that describes how the sponsor intends
to fill data gaps. Test plans are submitted along with
robust summaries of existing data. Testing will only be
conducted when there are inadequate existing data or
when other approaches (e.g. SAR) are not adequate to
meet the need. EPA reviews the categories and makes
suggestions as to how to improve them.
Guidance Documents
HPV Challenge Program guidance documents can be
found on EPA's "Guidance Documents" webpage at
http://www.epa.gov/chemrtk/guidocs.htm. Guidance
is provided for subjects such as category formulation,
developing robust summaries, and assessing data
adequacy, to name a few. A number of EPA's guidance
documents have achieved international acceptance
through their incorporation in OECD guidance
documents.
The following documents help stakeholders participate
in the Program:
1. Revision of Two Toxicity Test Guidelines
2. Submissions of Exposure Information
3. Supplemental Acute Toxicity Protocol
4. Guidance on Developing Robust Summaries
5. Letters to Manufacturers/Importers Regarding
Animal Welfare
6. The Use of Structure-Activity Relationships
(SAR) in the HPV Challenge Program
7. Guidance on Searching for Chemical Information
and Data
8. Guidance on Confidentiality Claims Related to
Company-Chemical Associations under the HPV
Challenge Program
38
Sfafus and Future Directions
-------
9. HPV Chemical Human Health Testing: Animal
Welfare Issues and Approaches
10. Guidance for Assessing Adequacy of Existing
Data
11. Guidance for Development of Chemical
Categories in the HPV Challenge Program
12. Manual for Investigation of HPV Chemicals
13. Guidance for Testing Closed System
Intermediates for the HPV Challenge Program
14. Procedures for Removing Chemicals that are No
Longer HPV and are not Likely to Become HPV
Again from the HPV List
15. Guidance for "What to Test" for the HPV
Challenge Program
16. OECD SIDS Manual (this OECD guidance
document links from the EPA website to the
OECD website)
The guidance document on development of chemical
categories provides guidance on approaches and
issues encountered in category formation and
application made to the HPV Challenge Program.
The document offers advice on how companies could
group chemicals with similar characteristics into
categories, and then evaluate existing data and conduct
testing to characterize the category all without
having to perform every test on every individual
chemical. EPA's "Guidance on Developing Robust
Summaries" document presents guidance on what
technical information, on an endpoint-by-endpoint
basis, is necessary to adequately describe a particular
study. The term "robust summary" is used to describe
this technical content. Robust study summaries are
intended to provide sufficient information to allow a
technically qualified person to make an independent
assessment of a given study report without having
to go back to the full study report, and to also allow
evaluation of the proposed test plan. A robust study
summary therefore concisely reflects the objectives,
methods, results, and conclusions of the full study
report.
Submitted Test Plans
There were 353 total test plans submitted to the HPV
Challenge Program as of July 2004. Of these 353 test
plans, 114 were for categories of chemicals, and the
remaining 239 were for individual chemicals. There
were 1,266 submitted test plan chemicals, along with
621 submitted supporting chemicals that were used to
augment the chemical analyses. The 114 category test
plans average 9 chemicals per category.
Test Plan Comments
After test plans and robust summaries are submitted
and then posted to the website, a 120-day comment
period begins. It is at this time that all stakeholders
industry, environmental protection groups, animal
welfare groups, private citizens, etc. - have the
opportunity to make comments on the test plan
and robust summary submissions. Comments are
important because sponsors consider this feedback
when revising their test plans and robust summaries.
EPA comments on all test plans. All of the comments
are posted to the website for public availability. As
of July 2004, there were 350 test plans posted to the
website. Of these 350 test plans:
11 test plans had not yet reached the end of the
120-day comment period.
EPA commented on 290 test plans.
Environmental Defense commented on 302 test
plans.
Animal welfare organizations - People for the
Ethical Treatment of Animals (PETA) and
Physicians Committee for Responsible Medicine
(PCRM) commented on 210 test plans.
Private individuals and other groups commented
on 10 test plans.
Environmental Defense submitted comments on
the majority (89%) of all posted test plans that had
reached the end of the 120-day comment period.
PETA and PCRM submitted comments on 62% of
all test plans that had reached the end of the 120-day
comment period. Note that these two animal welfare
organizations are grouped together because they often
jointly submit comments, as well as submit comments
on behalf of other animal welfare organizations.
Comments from Environmental Defense often refer
to whether they are in agreement with the sponsor's
category hypothesis, use of supporting chemicals,
estimations or Structure-Activity Relationships,
proposed testing, and adequacy of submitted data.
Comments from PETA and PCRM generally indicate
whether they agree with the proposed test plan,
and specifically in regard to whether animals will
be used for testing purposes. These animal welfare
organizations often state reasons for why testing
should not be performed.
Test Plan and Data Submissions
There are 1,371 chemicals that are sponsored in either
the HPV Challenge Program alone (1,248) or together
in both the HPV Challenge Program and the ICCA
HPV Initiative (123). In order to evaluate the progress
of the HPV Challenge Program, EPA analyzed
the number of chemical sponsorships expected and
received under the Program. For this section of the
report, the Agency did not consider commitments
made exclusively through the ICCA HPV Initiative
(851) because the Agency does not expect to receive
test plan and robust summary submissions for these
submissions. Commitment goals are met for the
ICCA HPV Initiative through the Organization for
Economic Cooperation and Development's (OECD)
HPV Screening Information Data Set (SIDS)
Program.
Start Years
Sponsors establish chemical commitments by stating
the "start year" in which they will begin participation
in the HPV Challenge Program by submitting a test
plan showing how it plans to fill data gaps and robust
summaries of existing data. Complete submissions
of test plans and robust summaries, revisions,
and results from new studies - are expected for all
sponsored chemicals by the end of 2005. At the
beginning of the Program, EPA envisioned that the
receipt of test plans would spread out through the
39
EPA's High Production Volume Challenge Program
Status and Future Directions
40
-------
years 1999 and 2003, with an anticipated breakdown
of 5% of those test plans in 1999, 20% in 2000, and
25% through each of the years 2001-2003. The figure
below illustrates the anticipated and actual test plan
submissions.
Anticipated Test Plan Submission Year
Versus Actual Test Plan Submission Year
40
35
30
25
4->
8 20
36
25
15
10
5
0
1999 2000
2001 2002
Year
2003 2004
Anticipated
Submissions
Actual
Submissions
As shown above, 92% of all chemical commitments
were actually met by July 2004. The remaining 8% of
the commitments are expected to be met by the end of
2004.
Sponsors have notified EPA of changes in their start
years. These changes in start year appear to result
primarily from sponsors who experience problems in
analysis, while many others experience coordination
problems with fellow consortium members. While
some sponsors submit their materials in an earlier year
(thereby moving up their start year), most changes in
start year commitment occur when sponsors request
a later start year. Hence, some of the chemical
commitments expected prior to 2004 will be fulfilled
in that year.
Number of HPV Sponsored Chemicals
Included In Test Plans (as of July 2004)
w »
"1
Ei
Number of Ch
Covered by Te
400-
300-
200-
n
504 495
319
275
254 246
211 204
83
44 46 ,7
000 7 9 8 Al
1999 2000 2001 2002 2003 2004
Year
Expected
Submitted
Outstanding
The figure above displays when test plans have been
submitted for sponsored chemicals, and the number of
chemicals with outstanding test plans:
Expected: 1,371 chemicals
Submitted: 1,266 chemicals
Outstanding: 105 chemicals
For recordkeeping purposes, if a sponsor submitted
a test plan in a year that is later than their original
start year, then their start year was changed to the
year in which they actually submitted their materials.
For example, EPA expected test plans covering 211
chemicals in 2000 and received 204 chemical analyses
from those expected, leaving 7 outstanding chemicals
that have not yet been submitted in subsequent years
- the start year for these chemicals will be changed
to reflect the year in which actual submissions occur.
As the chart reflects, the largest number of chemicals
expected and received occurred in 2001, with 504
chemicals expected and 495 chemicals received.
Since there are a total of 105 outstanding chemicals,
it is anticipated that many of the sponsors of these
chemicals will submit materials by the end of 2004.
Sponsors of late chemicals have been notified that
test plans and robust summaries for these chemicals
have passed the start year to which the sponsor had
committed.
Data Submitted to the HPV Challenge Program in
Test Plans
As discussed earlier, the primary impetus for the
HPV Challenge Program was the consistent results of
reports from Environmental Defense, the American
Chemistry Council, and EPA that publicly available
hazard data were lacking on a majority of the 2,782
1990 HPV chemicals. Following EPA's guidance,
sponsors identify existing data on HPV chemicals and
submit these data in the form of robust summaries and
test plans. To determine the source of existing data
included in test plan submissions (that is, published
and publicly available at some level, or unpublished
data), each test plan posted on the HPV website,
for which comments were due through June 2004,
was examined accounting for 344 test plans. This
examination revealed that an extremely large amount
of previously unavailable data has been submitted in
test plans and robust summaries and is now publicly
available. The figure to the right illustrates the number
of studies that were published and unpublished.
Sources of Existing Data Submitted in
Test Plans (as of June 2004)
Published Studies
(4,800) (41%)
Unpublished Studies
(6,801) (59%)
The table on the following page shows the numbers
of published and unpublished studies broken down by
ecological and human health endpoints, and selected
physicochemical and environmental fate endpoints;
some endpoints are routinely determined with
estimation techniques. The numbers of published
and unpublished studies documented in the robust
summaries prepared for each SIDS endpoint are listed.
41
EPA's High Production Volume Challenge Program
42
Sfafus and Future Directions
-------
Numbers of Published and Unpublished Sources of Existing Data, by Endpoint
(as of June 2004)
Discipline Area
Health Effects
Environmental Effects
Environmental Fate
Physicochemical
Properties
Specific Endpoint Published Unpublished
Acute-Oral
Acute-Inhalation
Acute-Dermal
Repeat Dose
Gene Tox-ln-Vitro
Gene Tox-ln-Vivo
Repro/Dev
Subtotal
Acute-Fish
Acute-Daphnid
Acute-Algae
Subtotal
Biodegradation
Subtotal
Water Solubility
Vapor Pressure
Partition Coefficient
Boiling Point
Subtotal
Totals
357
138
101
556
901
303
459
2815
223
154
94
471
308
308
319
278
183
426
1206
(41%) 4800
864
346
472
682
889
275
431
3959
639
490
312
1441
590
590
224
221
189
177
811
(59%) 6801
^^BdrH^I
_
1221
484
573
1238
1790
578
890
6774
862
644
406
1912
898
898
543
499
372
603
2017
(100%) 11 601
As can be seen from the numbers of studies listed in
the above table, a significant amount of unpublished
data has now been made public by the sponsors.
This indicates that the sponsors, either individually
or through the many consortia participating in the
Program, have made a concerted effort to bring forth
such existing data and represents a major success of
the HPV Challenge Program. It also indicates that
many sponsors made significant efforts to evaluate
the hazards of their chemicals prior to the launch of
the HPV Challenge Program, but often did not make
those underlying data available to the public.
The submission of existing, unpublished data has had
a significant effect on the amount of new testing that
sponsors have proposed (as discussed in the following
section). When isolating the statistics for acute
endpoints (for both health effects and environmental
effects) from the table, it is seen that 75% of acute
studies were unpublished. The 75% value greatly
contrasts the 50% value for unpublished studies for
all other endpoints and can possibly be explained by a
previously lower interest in publishing acute studies.
Data Development Strategies Described in Test
Plans
The following analysis is directly related to the above
discussion and shows how sponsors have proposed
to address the SIDS endpoints. EPA analyzed test
plans for which comments were due through June
2004 to determine how the health and environmental
effects endpoints were addressed. Three methods were
available to meet the minimum data needs for each
SIDS endpoint. Data needs were met by:
Using existing scientifically adequate data,
Using an estimation technique such as Structure
Activity Relationship (SAR) or "read-across"
categories, or
Proposing new testing.
For human health effects, five endpoints (acute,
repeat dose, reproductive, developmental, and genetic
toxicity) were considered. For environmental effects,
three acute toxicity endpoints were examined (acute
toxicity to fish, daphnia, and algae). The 344 reviewed
test plans address 112 categories and 232 single
chemicals.
The figure below illustrates that sponsors have made
maximum use of EPA's guidance concerning the
use of SAR and category proposals. Additionally,
and in combination with the significant amount of
unpublished data made available through the robust
summaries, only a minimal amount of new testing
has been proposed. Overall, for physicochemical and
fate endpoints, as well as health and environmental
effects, fewer than 10% of the endpoints are proposed
to be addressed with new testing. The exact mix and
number of new tests may change as sponsors consider
EPA and public comments and the remainder of
test plans is submitted; however, there is no reason
to believe that the overall conclusions will change
significantly. Comments could lead to some additional
tests being performed, but could also result in fewer
tests. Perhaps the most striking conclusion from these
statistics and the illustration below is that most of the
data existed, but were simply unpublished. Consistent
with that conclusion is how relatively little new testing
is being contemplated.
Endpoint Data Sources (as of June 2004)
o
a.
o
ill
Fate
Phys.chem.
Human Health
Ecotoxicity
Existing Data
Estimate/SAR/
Read Across
Proposed Testing
0 10 20 30 40 50 60 70
Percent
43
EPA's High Production Volume Challenge Program
Status and Future Directions
44
-------
Categories
One of the most significant results of the HPV
Challenge Program has been the use of the category
approach to address the SIDS endpoints. The
category approach has led to the need to conduct far
less testing than initially anticipated. As of July 2004,
of the 353 submitted test plans, 114 contain category
proposals covering 1,027 chemicals. These 1,027
chemicals represent 81% of the chemicals addressed by
the test plans. EPA developed guidance on category
formulation, and this guidance can be found on EPA's
"Development of Chemical Categories in the HPV
Challenge Program" webpage at http://www.epa.gov/
chemrtk/categuid. htm.
There are three types of category proposals. The
first type is referred to as a "traditional" category. A
traditional category is a set of chemicals that share a
similar functional group or cover a regular increase in
chain length over the category. The second type of
category is a "complex mixture family." The complex
mixture family category contains chemicals from a
complex mixture of similar chemical structures; e.g.,
long-chain fatty acids or tall oils. They are commonly
structured around a manufacturing process where
different products are created and differ only in
the relative proportions of the structurally similar
mixture components. The third type of category is a
"process stream." A process stream category typically
contains petroleum-related groupings, again based on
a manufacturing process, except that in this type the
mixture is composed of structurally different materials;
e.g., paraffins, aromatics, or alicyclics.
Each of the three types of categories that are submitted
to the HPV Challenge Program rely on a supporting
hypothesis or underlying theory of how the chemicals
are related and how data reported for one chemical can
be used to predict the toxicological responses of similar
chemicals in that category. The supporting category
hypothesis varies by the category type. "Traditional"
categories are usually premised on predictable increases
or decreases in toxicity through the category members
or, in the case of ecotoxicity, a change in the toxicity
manifested as the physicochemical properties change;
e.g., an increasing LogKow where the toxicity is likely
to shift from acute to chronic toxicity. (LogKow is
the octanol-water partition coefficient for a neutral
molecule, and it is generally used as a relative indicator
of the tendency of an organic compound to adsorb to
soil.) For a "complex mixture family," the hypothesis
is based on the assumption that because the complex
mixtures are composed of similar components, the
toxicity will be similar for the individual products in
the category. Finally, for process stream categories,
the hypothesis is usually that increasing or decreasing
amounts of a particular component will determine the
toxicity of the various category members; e.g., removal
of the aromatic fraction as the petroleum stream is
further processed will ultimately result in decreased
toxicity.
While about 30 percent of the categories initially
submitted by sponsors needed additional information
or restructuring to support the category hypothesis
(most have been revised by the sponsors), the
significant result has been that a large number of
chemicals were able to be characterized with a limited
amount of additional testing and within a time period
significantly shorter than if a chemical-by-chemical
approach to developing the needed data was used.
EPA's approach to the assessment of categories under
the HPV Challenge Program has two principle
steps. The first step is a review of the category test
plan and supporting robust summaries. In this step,
EPA comments on the reasonableness of the category
hypothesis and the adequacy of the supporting data
and any proposed testing. EPA's comments are sent
to the sponsors at the end of the 120-day comment
period. Sponsors revise their submissions based upon
comments that they receive from the public and EPA.
The second step involves the sponsor's preparation
and submission of the "Final Category Analysis" per
the category guidance, which follows completion of
any needed testing. The sponsor's analysis is used
to indicate that the underlying category hypothesis
is reasonable and that existing and new test data
can be extrapolated to address the untested category
chemicals' endpoints. EPA's review at this step would
be either to agree with the analysis as presented or to
advise the sponsor that EPA does not believe that the
category "held." If a category does not hold, then EPA
advises the sponsor that additional testing needs to be
considered and/or the category needs restructuring,
possibly with the need to subdivide the category or
treat the category members as individual chemicals.
Accomplishments of the ICCA HPV
Initiative
The International Council of Chemical Associations
(ICCA) as identified earlier in this report has its
own initiative on international HPV chemicals and
plays a role in the overall HPV Challenge Program.
The ICCA HPV Initiative has evolved from interest
regarding the OECD HPV SIDS Program, as well
as other general concerns related to chemical testing
and assessment on a global scale. The ICCA HPV
Initiative calls for providing data on approximately
1,000 international high production volume chemicals
by the end of 2004. The assessment work will be
tied directly to the OECD HPV SIDS Program.
Completed dossiers will be submitted to OECD
so that a screening-level hazard assessment can be
completed. OECD has been working to restructure
its program to accelerate its process and handle the
increased volume of data. More detail on OECD's
process and program can be found at http://www.oecd.
org/topic.
Comparison of the HPV Challenge Program and
ICCA HPV Initiative
There is considerable consistency between the HPV
Challenge Program and the ICCA HPV Initiative,
as well as with the OECD HPV SIDS Program. All
three programs:
Are focused on HPV chemicals (note that HPV
thresholds vary from the domestic to international
programs);
Are based on the OECD SIDS battery of testing;
Include steps of data gathering, test plan
development, and conducting SIDS testing
as needed to provide a complete set of SIDS
endpoints; and
Allow the use of category approaches to group
chemicals and the use of SAR analysis as an
alternative to testing, where scientifically acceptable.
45
EPA's High Production Volume Challenge Program
Status and Future Directions
46
-------
The OECD HPV SIDS Program and ICCA HPV
Initiative also include the step of preparing the SIDS
Initial Assessment Report (SIAR), which provides a
screening-level assessment of chemical hazards. The
submission of exposure data and the preparation of a
SIAR are not elements for participation under the HPV
Challenge Program, although EPA encourages industry
to include these elements in their submissions under the
Challenge. One additional notable difference between
the HPV Challenge Program and the ICCA HPV
Initiative is that of public accessibility of data. The
HPV Challenge Program posts all test plan and robust
summary submissions on the HPV Challenge Program
website and includes a provision for receiving public
comment; the ICCA HPV Initiative and the OECD
HPV SIDS Program provide for comment within
the country of sponsorship, and each country decides
how broadly to share the data during the review stage.
When completed, OECD HPV assessments are made
available internationally through the United Nations
Environment Programme (UNEP).
Companies willing to perform the additional work under
these other programs (providing exposure data and
preparing a SIAR) are welcome to identify their HPV
Challenge Program chemicals as contributions to either
or both of the OECD HPV SIDS Program and the
ICCA HPV Initiative. Additionally, companies deciding
to sponsor chemicals under the HPV Challenge Program
were given the opportunity to identify those chemicals as
U.S. contributions to the OECD HPV SIDS Program
and/or the ICCA HPV Initiative.
Sponsorship Under the ICCA HPV Initiative
Official notification of ICCA commitments is received
through ICCA's contact at the American Chemistry
Council. Some ICCA commitments are currently
unconfirmed, and these "tentative" commitments have
not been included in this analysis. Although chemicals
sponsored through the ICCA HPV Initiative are
considered as commitments to the HPV Challenge
Program, the Agency did not include ICCA chemicals
in its overdue test plan analysis. The Agency
encourages ICCA to address those chemicals that are
overdue within its own program and to more routinely,
and in more detail and precision, update the Agency
and the public about the current status of chemicals
within the ICCA HPV Initiative.
In February of 2000, the HPV Challenge Program
began to recognize commitments made to sponsor
chemicals indirectly through the ICCA HPV
Initiative. Since then, overall sponsorship under the
HPV Challenge Program increased with the addition
of chemicals sponsored through the HPV Challenge
Program and through the ICCA HPV Initiative. In
addition, some sponsors decided to modify how they
complete their commitments for sponsorship, usually
by moving from the HPV Challenge Program to the
ICCA HPV Initiative.
The Agency did not track the specific movements of
sponsors or chemicals from one program to another,
but rather focused its tracking on overall sponsorship
numbers. The figure below illustrates shifts in
sponsorship over time among chemicals sponsored
through the HPV Challenge Program, through the
ICCA HPV Initiative, and those chemicals sponsored
in both programs.
Changes in Sponsorship in the HPV Challenge Program, ICCA HPV Initiative,
and Both Programs (as of July 2004)
V)
05
O
0)
_C
O
^
i_
0)
n
2000
1500
1000
500
Jan. Nov. Jan. Jan. Jan. Jul.
2000 2000 2002 2003 2004 2004
HPV only
Date
ICCA Only
Botn
As previously mentioned in this report, chemicals
can be sponsored either directly through the HPV
Challenge Program or indirectly through the ICCA
HPV Initiative. At the beginning of the Program, all
sponsorships were in the HPV Challenge Program,
with none in the ICCA HPV Initiative. Over time,
sponsorship in the ICCA HPV Initiative has increased
while sponsorship in the HPV Challenge Program
has decreased. It is important to note that the overall
number of sponsored chemicals (when including
ICCA sponsorships) has increased. As of July 2004, a
total of 1,248 chemicals had been sponsored through
the HPV Challenge Program alone, 851 chemicals
had been sponsored through the ICCA HPV Initiative
alone, and 123 through both the HPV Challenge
Program and the ICCA HPV Initiative. The
following table details the number of chemicals in each
program over time.
47
48
EPA's High Production Volume Challenge Program
Status and Future Directions
-------
Details of Sponsorship in the HPV Challenge Program, ICCA HPV Initiative,
and Both Programs (as of July 2004)
HPV Only
ICCA Only
Both (HPV, ICCA)
% of % of
Date Chemicals Total Chemicals Total
Chemicals
% of Total
Total Chemicals
01/25/2000
06/16/2000
11/06/2000
05/21/2001
01/15/2002
07/12/2002
01/31/2003
07/18/2003
01/16/2004
07/30/2004
2123
1815
1715
1713
1643
1417
1357
1321
1325
1248
100.0
86.9
79.6
79.6
78.9
64.1
63.1
61.0
59.2
56.2
0
70
144
155
178
491
624
664
736
851
0.0
3.4
6.7
7.2
8.5
22.2
29.0
30.7
32.9
38.3
0
204
296
285
262
302
169
179
177
123
0.0
9.8
13.7
13.2
12.6
13.7
7.9
8.3
7.9
5.5
2123
2089
2155
2153
2083
2210
2150
2164
2238
2222
The number of chemicals that have moved from the
HPV Challenge Program to ICCA HPV Initiative
raises a concern because the data submitted under
ICCA are not as readily publicly accessible OECD
makes final reports available through UNEP, but access
is limited before this occurs.
Data Submitted Under the ICCA HPV Initiative
As a measure of progress within the ICCA HPV
Initiative, the Agency has chosen to consider SIDS
Initial Assessment Meeting (SIAM8) agendas as
equivalent to submitting a test plan and robust
summaries under the HPV Challenge Program;
in both cases, a full set of SIDS hazard data is
ultimately provided. This was chosen as a measure
because participation in the OECD process is part of
participating in the ICCA HPV Initiative.
Using the SIAM agendas with ICCA chemicals, the
table below illustrates progress of chemicals under the
ICCA HPV Initiative. Note that this table reflects
the start year given by ICCA and whether or not the
chemical has been through a SIAM as of year-end
2003; it does not reflect the year in which the chemical
actually went through a SIAM. That year may or may
not be the same.
Of the 974 chemicals sponsored in the ICCA HPV
Initiative, 229 chemicals had been through the OECD
SIDS process by July 2004. This number accounts for
24% of the total ICCA commitments. It is important
to point out that 123 chemicals are dually sponsored
both directly in the HPV Challenge Program as well
as indirectly in the ICCA HPV Initiative. Earlier in
this report, it was noted that 851 are sponsored in the
ICCA HPV Initiative; however, when the 123 dually
sponsored chemicals are considered, total ICCA HPV
Initiative sponsorship increases to 974 chemicals.
Chemicals Sponsored Indirectly through the ICCA HPV Initiative (as of July 2004)
Start Year or Test Plan Total Expected Chemical SIAM Chemicals
Receipt Year Submissions Sponsored by ICCA*
1999
2000
2001
2002
2003
2004
Total
38
149
487
133
127
40
974
14
54
98
19
17
27
229
' This table does not reflect the year in which the chemical went through a SIAM.
49
SSIAM: SIDS Initial Assessment Meeting: A gathering of OECD member countries that agree on the initial hazard assessment for HPV SIDS chemicals, and that identify those
HPV chemicals that are a priority for further work.
EPA's High Production Volume Challenge Program
Status and Future Directions
50
-------
%
In order to evaluate which sponsors were
responsible for overdue test plans, the Agency
reviewed commitment information submitted by
companies and consortia. Correspondence concerning
commitments is recorded and posted to EPA's
"Summary Report" webpage at http://www.epa.gov/
chemrtk/sumresp.htm, including correspondence from
individual sponsors, consortia, consortium members,
and from companies not participating in the Program.
The Agency has received much correspondence from
companies and consortia committing to sponsor
chemicals, changing an aspect of their commitment, or
in some cases, withdrawing their commitment.
The Agency developed an approach for determining
overdue test plans and their sponsors, taking into
consideration HPV Challenge Program goals and the
fact that there are cases of more than one sponsor for
a given chemical. If a test plan were received, then
the chemical's test plan was not considered overdue,
regardless of whether another company or consortium
had also sponsored it. If no test plan had been
received for a particular chemical, then all consortia
(but not their members) and independent sponsors of
that chemical were considered to have an overdue test
plan for that chemical.
The Agency sent the following letter to sponsors of
chemicals with overdue test plans in April 2004.
52
Sfafus and Future Directions
-------
Letter Sent to Sponsors with Overdue Test Plans in April 2004
April 12, 2004
Technical Contact
Organization Name
Organization Address
City, State, Zip Code
Dear :
I want to personally acknowledge and thank you for your commitment to the High Production Volume
(HPV) Challenge Program. Participation in the HPV Challenge Program has exceeded EPA's expectations
and, although the success of the program has been significant, there are a number of commitments that have
not yet been met and are considered late. Preparations are underway for release of the HPV Challenge Program
Status Report in May, 2004. The HPV Challenge Program Status Report will identify those sponsors whose
commitments are overdue.
The Agency understands that over time, for a variety of reasons, sponsorship plans may change; however, it is
incumbent upon sponsors of unmet commitments to update the Agency so that its records may accurately reflect
the current commitment status. Information should be sent to:
Administrator
US Environmental Protection Agency
P.O. Box 1473
Merrifield,VA22116
Attention: Chemical Right-to-Know Program
or through e-mail at: ncic_oppt@epa.gov and chem.rtk@epa.gov by April 30, 2004. Please note that any
correspondence containing Confidential Business Information (CBI) should not be sent to the above address or
through e-mail.
If you have any questions or concerns, please contact Karen Lannon of my staff at
202-564-8163. Thank you.
Sincerely,
Our records indicate that your organization has sponsored the chemical(s) listed in the attached table for
a start year of 2003 or earlier but robust summary and test plan information has not been received by the Agency.
The commitment start year indicates the year of the Program in which sponsors agreed to begin the evaluation of
each chemical by submitting robust summaries of existing data and a test plan showing how the sponsor plans to
fill any data gaps. Under the HPV Challenge Program, all test plans and robust summary submissions should be
submitted in the year indicated. Any needed new testing on the HPV chemicals in the HPV Challenge Program
is to be completed by the end of 2004 with all data to be made available to the public by 2005. So that the
Agency may meet its HPV Challenge Program's objectives, we are no longer accepting changes to start years and
commitments not yet fulfilled are considered late.
Charles M. Auer, Director
Office of Pollution Prevention and Toxics
Attachment
While we are not accepting changes to start years, the Agency does expect sponsors to uphold their
commitments and submit test plans and robust summaries as soon as possible. If no test plan/robust summary
submission is received before the end of 2004 for these commitments, then the Agency will consider these
chemicals as "orphans"or unsponsored. Chemicals not voluntarily sponsored in the HPV Challenge Program
will become candidates for test rules under Section 4 of the Toxic Substances Control Act (TSCA).
53
EPA's High Production Volume Challenge Program
54
Sfafus and Future Directions
-------
EPA received responses from many of these sponsors
updating the status of their commitments. Some
intend to fulfill their commitments through the
ICCA HPV Initiative; others have withdrawn from
the Program; some have submitted test plans; and
others still intend to fulfill their commitments through
providing a test plan at a later date.
As of July 2004, test plan and robust summary
submissions were overdue for 47 unique chemicals.
Note that this reference to 47 chemicals contrasts the
270 outstanding Program chemicals from earlier in the
report, as this 47 figure does not include: chemicals
that were due in 2004, chemicals for which test plans
have most recently been submitted, withdrawals from
the Program, and chemicals moving to the ICCA
HPV Initiative, among other factors. One of the
47 chemicals has two sponsors; therefore, there are a
total of 48 overdue sponsorship commitments. There
are 24 sponsors (13 companies and 11 consortia)
responsible for these 48 commitments. The Agency
expects that sponsors will uphold their commitments
and submit test plans and robust summaries. If no
test plan or robust summary submission is received for
overdue chemicals, then the Agency will ultimately
consider these chemicals as unsponsored B or orphans.
A complete listing of the 48 overdue chemical
commitments is shown below.
Chemicals and Sponsors with Overdue Test Plans (as of July 2004)
{Trade association affiliation is noted for members of the following three trade associations: American Chemistry Council
(ACC), American Petroleum Institute (API), and Synthetic Organic Chemical Manufacturers Association (SOCMA). The
API member list, found at http://api-ec.api.org/linlcs/index.cfm, was not a complete list.}
110-03-2 Air Products and Chemicals, Inc.
142-30-3
1163-19-5 American Chemistry Council (ACC) Brominated Flame Retardant Industry Panel
(BFRIP)
298-07-7 American Chemistry Council (ACC) Health, Environmental, and Research Task
Group (HERTG)
64771-72-8 American Petroleum Institute (API) Petroleum HPV Testing Group
68333-23-3
ACC
ACC
ACC
API
112-18-5 APAG
26040-51-7 BTBP Consortium
100-50-5 The Dow Chemical Company
109-87-5
630-20-6
68390-96-5
68411-72-3
ACC, API, SOCMA
100-40-3 E.I. du Pont de Nemours and Company
81-11-8 ETAD North America Stilbene Fluorescent Brighteners
3709-43-1
4404-43-7
Sponsor Name
7336-20-1
13863-31-5
16470-24-9
29637-52-3
67786-25-8
100-40-3
108083-43-8
ExxonMobil Chemical Company
ACC, API
98510-89-5 The Flavor and Fragrance High Production Volume Consortia (FFHPVC) Terpene
Consortium
96-49-1
929-06-6
Huntsman Corporation
2451-62-9 Huntsman-Nissan-TGIC Consortium
74-87-3 ICI Americas, Inc.
105-60-2 IHF Committee on Nylon 6 and Its Precursors
25322-17-2
25619-56-1
57855-77-3
63512-64-1
King Industries, Inc.
101-14-4 The MBOCA Consortium
13560-89-9 Occidental Chemical Corporation (OxyChem)
ACC
1809-19-4 Rhodialnc.
ACC, SOCMA
143-29-3 Rohm and Haas Company
ACC
27090-63-7
68052-49-3
111960-92-0
Solutia
ACC
1333-07-9 Toluenesulfonamide Testing Group
10605-21-7 Troy Chemical Company
34375-28-5
55406-53-6
553-26-4
620-22-4
626-17-5
Zeneca Ag Products, Inc.
55
EPA's High Production Volume Challenge Program
56
Sfafus and Future Directions
-------
ppendix 5: Orphan Chemicals
«w-
x
v
^
« <
"W "TT TThile the success of the HPV Challenge
% / % / Program has been significant, some
V chemicals eligible for sponsorship in
the Program remain unsponsored. As of July 30,
2004, there were 571 chemicals that were on the
1990 IUR HPV list that remained unsponsored in
the Program. The Agency recognizes that the 1990
HPV Challenge Program Chemical List is based
on IUR reporting from over a decade ago; hence, a
number of unsponsored chemicals may no longer be
manufactured or imported at high production volumes.
In order to determine for which chemicals this may
be true, the Agency conducted a comprehensive "No
Longer HPV" analysis relying upon existing Program
guidance for determining that a chemical is "No
Longer HPV." The "No Longer HPV" guidance may
be found at http://www.epa.gov/chemrtk/nolohpv8.
htm. Based on results of this analysis, the number of
chemicals available for sponsorship decreased from
approximately 571 to 330.
Strategies for Obtaining Data on Unsponsored
Chemicals
The Agency is considering options to ensure that
screening-level data are made available to the public
for the 330 unsponsored, or "orphan," chemicals.
These orphans are listed below.
330 Orphan Chemicals (as of July 30, 2004)
56-40-6
62-23-7
62-56-6
74-95-3
74-97-5
75-07-0
75-34-3
75-36-5
75-46-7
75-87-6
77-76-9
78-11-5
78-42-2
81-07-2
81-16-3
81-84-5
83-41-0
TSCA Chemical Name
Glycine
Benzole acid, 4-nitro-
Thiourea
Methane, dibromo-
Methane, bromochloro-
Acetaldehyde
Ethane, 1,1-dichloro-
Acetyl chloride
Methane, trifluoro-
Acetaldehyde, trichloro-
Propane, 2,2-dimethoxy-
1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester)
Phosphoric acid, tris(2-ethylhexyl) ester
1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide
1 -Naphthalenesulfonic acid, 2-amino-
1 H,3H-Naphtho[1,8-cd]pyran-1,3-dione
Benzene, 1,2-dimethyl-3-nitro-
Sfafus and Future Directions
58
-------
CAS # TSCA Chemical Name
84-65-1
84-69-5
85-40-5
89-32-7
90-43-7
91-53-2
91-68-9
94-75-7
94-96-2
95-94-3
96-22-0
96-23-1
97-00-7
98-09-9
98-16-8
98-56-6
99-51-4
100-64-1
101-34-8
104-15-4
104-66-5
104-93-8
107-39-1
107-40-4
107-45-9
108-19-0
108-20-3
109-86-4
110-18-9
110-33-8
110-44-1
111-44-4
111-85-3
111-91-1
112-52-7
118-82-1
118-90-1
119-33-5
119-61-9
121-45-9
121-69-7
9,1 0-Anthracenedione
1 ,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester
1 H-lsoindole-1 ,3(2H)-dione, 3a,4,7,7a-tetrahydro-
1 H,3H-Benzo[1 ,2-c:4,5-c']difuran-1 ,3,5,7-tetrone
[1,1'-Biphenyl]-2-ol
Quinoline, 6-ethoxy-1 ,2-dihydro-2,2,4-trimethyl-
Phenol, 3-(diethylamino)-
Acetic acid, (2,4-dichlorophenoxy)-
1 ,3-Hexanediol, 2-ethyl-
Benzene, 1,2,4,5-tetrachloro-
3-Pentanone
2-Propanol, 1,3-dichloro-
Benzene, 1-chloro-2,4-dinitro-
Benzenesulfonyl chloride
Benzenamine, 3-(trifluoromethyl)-
Benzene, 1 -chloro-4-(trifluoromethyl)-
Benzene, 1,2-dimethyl-4-nitro-
Cyclohexanone, oxime
9-Octadecenoic acid, 12-(acetyloxy)-, 1,2,3-propanetriyl ester, (9Z,9'Z,9"Z,12R,12'R,12"R)-
Benzenesulfonic acid, 4-methyl-
Benzene, 1 , 1 '-[1 ,2-ethanediylbis(oxy)]bis-
Benzene, 1-methoxy-4-methyl-
1-Pentene, 2,4,4-trimethyl-
2-Pentene, 2,4,4-trimethyl-
2-Pentanamine, 2,4,4-trimethyl-
Imidodicarbonic diamide
Propane, 2,2'-oxybis-
Ethanol, 2-methoxy-
1 ,2-Ethanediamine, N,N,N',N'-tetramethyl-
Hexanedioic acid, dihexyl ester
2,4-Hexadienoic acid, (2E,4E)-
Ethane, 1,1'-oxybis[2-chloro-
Octane, 1-chloro-
Ethane, 1 , 1 '-[methylenebis(oxy)]bis[2-chloro-
Dodecane, 1-chloro-
Phenol, 4,4'-methylenebis[2,6-bis(1 ,1-dimethylethyl)-
Benzoic acid, 2-methyl-
Phenol, 4-methyl-2-nitro-
Methanone, diphenyl-
Phosphorous acid, trimethyl ester
Benzenamine, N,N-dimethyl-
CAS # TSCA Chemical Name
121-82-4
124-18-5
124-63-0
127-68-4
131-57-7
137-20-2
138-25-0
139-40-2
140-08-9
140-93-2
142-73-4
143-28-2
144-62-7
149-44-0
150-50-5
307-35-7
330-54-1
409-02-9
460-00-4
506-51-4
506-52-5
513-74-6
515-40-2
529-33-9
529-34-0
542-75-6
542-92-7
557-61-9
563-72-4
579-66-8
590-19-2
592-45-0
594-42-3
597-31-9
598-72-1
617-94-7
624-83-9
624-92-0
625-55-8
628-13-7
628-96-6
1 ,3,5-Triazine, hexahydro-1 ,3,5-trinitro-
Decane
Methanesulfonyl chloride
Benzenesulfonic acid, 3-nitro-, sodium salt
Methanone, (2-hydroxy-4-methoxyphenyl)phenyl-
Ethanesulfonic acid, 2-[methyl[(9Z)-1-oxo-9-octadecenyl]amino]-, sodium salt
1 ,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester
1,3,5-Triazine-2,4-diamine, 6-chloro-N,N'-bis(1-methylethyl)-
Ethanol, 2-chloro-, phosphite (3:1)
Carbonodithioic acid, O-(l-methylethyl) ester, sodium salt
Glycine, N-(carboxymethyl)-
9-Octadecen-1-ol, (9Z)-
Ethanedioic acid
Methanesulfinic acid, hydroxy-, monosodium salt
Phosphorotrithious acid, tributyl ester
1-Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-
Urea, N'-(3,4-dichlorophenyl)-N,N-dimethyl-
Heptenone, methyl-
Benzene, 1-bromo-4-fluoro-
1 -Tetracosanol
1-Hexacosanol
Carbamodithioic acid, monoammonium salt
Benzene, (2-chloro-1,1-dimethylethyl)-
1 -Naphthalenol, 1 ,2,3,4-tetrahydro-
1 (2H)-Naphthalenone, 3,4-dihydro-
1-Propene, 1,3-dichloro-
1 ,3-Cyclopentadiene
1 -Octacosanol
Ethanedioic acid, calcium salt (1 :1)
Benzenamine, 2,6-diethyl-
1 ,2-Butadiene
1 ,4-Hexadiene
Methanesulfenyl chloride, trichloro-
Propanal, 3-hydroxy-2,2-dimethyl-
Propanoic acid, 2-bromo-
Benzenemethanol, .alpha.,. alpha. -dimethyl-
Methane, isocyanato-
Disulfide, dimethyl
Formic acid, 1-methylethyl ester
Pyridine, hydrochloride
1 ,2-Ethanediol, dinitrate
59
EPA's High Production Volume Challenge Program
60
Sfafus and Future Directions
-------
CAS # TSCA Chemical Name
629-59-4
629-76-5
645-62-5
693-07-2
693-95-8
756-80-9
870-72-4
928-72-3
939-97-9
1000-82-4
1002-69-3
1111-78-0
1115-20-4
1323-65-5
1324-76-1
1401-55-4
1445-45-0
1459-93-4
1498-51-7
1558-33-4
1562-00-1
1646-75-9
1691-99-2
1738-25-6
1912-24-9
1918-02-1
1929-82-4
2152-64-9
2210-79-9
2372-45-4
2409-55-4
2425-54-9
2494-89-5
2524-03-0
2524-04-1
2611-00-9
2691-41-0
2702-72-9
2814-20-2
2905-62-6
Tetradecane
1-Pentadecanol
2-Hexenal, 2-ethyl-
Ethane, 1-chloro-2-(ethylthio)-
Thiazole, 4-methyl-
Phosphorodithioic acid, O,O-dimethyl ester
Methanesulfonic acid, hydroxy-, monosodium salt
Glycine, N-(carboxymethyl)-, disodium salt
Benzaldehyde, 4-(1,1-dimethylethyl)-
Urea, (hydroxymethyl)-
Decane, 1-chloro-
Carbamic acid, monoammonium salt
Propanoicacid, 3-hydroxy-2,2-dimethyl-, 3-hydroxy-2,2-dimethylpropyl ester
Phenol, dinonyl-
Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-
ylidene]methyl]phenyl]amino]-
Tannins
Ethane, 1,1,1-trimethoxy-
1 ,3-Benzenedicarboxylic acid, dimethyl ester
Phosphorodichloridic acid, ethyl ester
Silane, dichloro(chloromethyl)methyl-
Ethanesulfonic acid, 2-hydroxy-, monosodium salt
Propanal, 2-methyl-2-(methylthio)-, oxime
1 -Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-
Propanenitrile, 3-(dimethylamino)-
1,3,5-Triazine-2,4-diamine, 6-chloro-N-ethyl-N'-(1-methylethyl)-
2-Pyridinecarboxylic acid, 4-amino-3,5,6-trichloro-
Pyridine, 2-chloro-6-(trichloromethyl)-
Benzenamine, N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]-,
monohydrochloride
Oxirane, [(2-methylphenoxy)methyl]-
1-Butanol, sodium salt
Phenol, 2-(1,1-dimethylethyl)-4-methyl-
Tetradecane, 1-chloro-
Ethanol, 2-[(4-aminophenyl)sulfonyl]-, hydrogen sulfate (ester)
Phosphorochloridothioic acid, O,O-dimethyl ester
Phosphorochloridothioic acid, O,O-diethyl ester
3-Cyclohexene-1-carboxylicacid, 3-cyclohexen-1-ylmethyl ester
1 ,3,5,7-Tetrazocine, octahydro-1 ,3,5,7-tetranitro-
Acetic acid, (2,4-dichlorophenoxy)-, sodium salt
4(1H)-Pyrimidinone, 6-methyl-2-(1-methylethyl)-
Benzoyl chloride, 3,5-dichloro-
CAS # TSCA Chemical Name
2915-53-9
2941-64-2
3039-83-6
3088-31-1
3132-99-8
3338-24-7
3386-33-2
3586-14-9
3710-84-7
3724-65-0
3779-63-3
3965-55-7
4035-89-6
4080-31-3
4170-30-3
4300-97-4
4316-73-8
4719-04-4
4860-03-1
5026-74-4
5216-25-1
5460-09-3
5915-41-3
6381-77-7
6473-13-8
6863-58-7
6865-35-6
7320-37-8
7446-81-3
7795-95-1
8001-58-9
8005-02-5
8007-45-2
10265-69-7
12645-31-7
13749-94-5
13826-35-2
14143-60-3
14666-94-5
16883-83-3
2-Butenedioic acid (2Z)-, dioctyl ester
Carbonochloridothioic acid, S-ethyl ester
Ethenesulfonicacid, sodium salt
Ethanol, 2-[2-(dodecyloxy)ethoxy]-, hydrogen sulfate, sodium salt
Benzaldehyde, 3-bromo-
Phosphorodithioic acid, O,O-diethyl ester, sodium salt
Octadecane, 1-chloro-
Benzene, 1-methyl-3-phenoxy-
Ethanamine, N-ethyl-N-hydroxy-
2-Butenoic acid
1 ,3,5-Triazine-2,4,6(1 H,3H,5H)-trione, 1 ,3,5-tris(6-isocyanatohexyl)-
1,3-Benzenedicarboxylicacid, 5-sulfo-, 1,3-dimethyl ester, sodium salt
Imidodicarbonic diamide, N,N',2-tris(6-isocyanatohexyl)-
3,5,7-Triaza-1 -azoniatricyclo[3.3. 1 . 1 3,7]decane, 1 -(3-chloro-2-propenyl)-, chloride
2-Butenal
Propanoyl chloride, 3-chloro-2,2-dimethyl- (This is not the official TSCA Chemical Name, since no official name is
available for this CAS number.)
Glycine, N-methyl-, monosodium salt
1 ,3,5-Triazine-1 ,3,5(2H,4H,6H)-triethanol
Hexadecane, 1-chloro-
Oxiranemethanamine, N-[4-(oxiranylmethoxy)phenyl]-N-(oxiranylmethyl)-
Benzene, 1 -chloro-4-(trichloromethyl)-
2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, monosodium salt
1,3,5-Triazine-2,4-diamine, 6-chloro-N-(1,1-dimethylethyl)-N'-ethyl-
D-erythro-Hex-2-enonic acid, . gamma. -lactone, monosodium salt
2-Naphthalenesulfonic acid, 6-[(2,4-diaminophenyl)azo]-3-[[4-[[4-[[7-[(2,4-diaminophenyl)azo]-1-hydroxy-3-sulfo-2-
naphthalenyl]azo]phenyl]amino]-3-sulfophenyl]azoj-4-hydroxy-, trisodium salt
Butane, 2,2'-oxybis-
Octadecanoic acid, barium salt
Oxirane, tetradecyl-
2-Propenoic acid, sodium salt
1-Octanesulfonyl chloride
Creosote
C.I. Solvent Black 7
Tar, coal
Glycine, N-phenyl-, monosodium salt
Phosphoric acid, 2-ethylhexyl ester
Ethanimidothioic acid, N-hydroxy-, methyl ester
Benzenemethanol, 3-phenoxy-
2-Pyridinecarbonitrile, 4-amino-3,5,6-trichloro-
9-Octadecenoic acid (9Z)-, cobalt salt
1,2-Benzenedicarboxylicacid, 2,2-dimethyl-1-(1-methylethyl)-3-(2-methyl-1-oxopropoxy)propyl phenylmethyl
ester
61
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-------
CAS # TSCA Chemical Name
17103-31-0
17321-47-0
17976-43-1
19438-61-0
19525-59-8
20068-02-4
20227-53-6
20469-71-0
21351-39-3
22527-63-5
24448-09-7
24615-84-7
24634-61-5
24794-58-9
25154-38-5
25168-05-2
25168-06-3
25321-41-9
25383-99-7
25586-42-9
25646-71-3
26377-29-7
26401-27-4
26680-54-6
27193-28-8
28106-30-1
28188-24-1
28777-98-2
28908-00-1
30574-97-1
31138-65-5
32072-96-1
32210-23-4
33509-43-2
34689-46-8
35203-06-6
35203-08-8
37439-34-2
37734-45-5
37764-25-3
Urea, sulfate (2:1)
Phosphoramidothioicacid, O,O-dimethyl ester
2,4,6,8,3,5,7-Benzotetraoxatriplumbacycloundecin-3,5,7-triylidene, 1 ,9-dihydro-1 ,9-dioxo-
1 ,3-lsobenzofurandione, 5-methyl-
Glycine, N-phenyl-, monopotassium salt
2-Butenenitrile, 2-methyl-, (2Z)-
Phosphorous acid, 2-(1,1-dimethylethyl)-4-[1-[3-(1,1-dimethylethyl)-4-hydroxyphenyl]-1-methylethyl]phenyl bis(4-
nonylphenyl) ester
Hydrazinecarbodithioic acid, compd. with hydrazine (1 :1)
Urea, sulfate (1:1)
Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester
1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-N-methyl-
2-Propenoic acid, 2-carboxyethyl ester
2,4-Hexadienoic acid, potassium salt, (2E,4E)-
Formic acid, compd. with 2,2',2"-nitrilotris[ethanol] (1:1)
Piperazineethanol
Benzene, chloromethyl-
Phenol, (1-methylethyl)-
Benzenesulfonicacid, dimethyl-
Octadecanoic acid, 2-(1-carboxyethoxy)-1-methyl-2-oxoethyl ester, sodium salt
Phosphorous acid, tris(methylphenyl) ester
Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)
Phosphorodithioic acid, O,O-dimethyl ester, sodium salt
Phosphorous acid, isooctyl diphenyl ester
2,5-Furandione, dihydro-S-(octenyl)-
Phenol, (1,1,3,3-tetramethylbutyl)-
Benzene, ethenylethyl-
Octadecanoic acid, 2-(hydroxymethyl)-2-[[(1 -oxooctadecyl)oxy]methyl]-1 ,3-propanediyl ester
2,5-Furandione, dihydro-S-(octadecenyl)-
Benzothiazole, 2-[(chloromethyl)thio]-
2-Butenenitrile, 2-methyl-, (2E)-
D-gluco-Heptonicacid, monosodium salt, (2.xi.)-
2,5-Furandione, 3-(hexadecenyl)dihydro-
Cyclohexanol, 4-(1,1-dimethylethyl)-, acetate
1,2,4-Triazin-5(2H)-one, 4-amino-6-(1,1-dimethylethyl)-3,4-dihydro-3-thioxo-
Phenol, methyl-, sodium salt
Benzenamine, 2-ethyl-6-methyl-N-methylene-
Benzenamine, 2,6-diethyl-N-methylene-
2(1H)-Pyridinone, 3,5,6-trichloro-, sodium salt
Carbonochloridothioicacid, S-(phenylmethyl) ester
Acetamide, 2,2-dichloro-N,N-di-2-propenyl-
CAS # TSCA Chemical Name
38185-06-7
38321-18-5
39515-51-0
40630-63-5
40876-98-0
51632-16-7
52184-19-7
52556-42-0
52663-57-7
56038-89-2
56803-37-3
57693-14-8
61788-76-9
61789-32-0
61789-65-9
61789-85-3
63302-49-8
64742-24-1
64743-02-8
64743-03-9
64771-71-7
65652-41-7
65996-78-3
65996-79-4
65996-80-7
65996-81-8
65996-82-9
65996-83-0
65996-86-3
65996-87-4
65996-89-6
65996-91-0
65996-92-1
66071-94-1
66241-11-0
68081-86-7
68082-78-0
68153-60-6
68187-41-7
68187-57-5
Benzenesulfonic acid, 4-chloro-3,5-dinitro-, potassium salt
Ethanol, 2-(2-butoxyethoxy)-, sodium salt
Benzaldehyde, 3-phenoxy-
1-Octanesulfonyl fluoride
Butanedioic acid, oxo-, diethyl ester, ion(1-), sodium
Benzene, 1 -(bromomethyl)-3-phenoxy-
Phenol, 2,4-bis(1,1-dimethylpropyl)-6-[(2-nitrophenyl)azo]-
1-Propanesulfonicacid, 2-hydroxy-3-(2-propenyloxy)-, monosodium salt
Ethanol, 2-butoxy-, sodium salt
Benzenamine, N-(1-ethylpropyl)-4,5-dimethyl- (This is not the official TSCA Chemical Name, since no official name
is available for this CAS number.)
Phosphoric acid, (1,1-dimethylethyl)phenyl diphenyl ester
Chromate(3-), bis[3-(hydroxy-. kappa. O)-4-[[2-(hydroxy-.kappa.O)-1-naphthalenyl]azo-. kappa. N1]-7-nitro-1-
naphthalenesulfonato(S-)]-, trisodium
Alkanes, chloro
Fatty acids, coco, 2-sulfoethyl esters, sodium salts
Resin acids and Rosin acids, aluminum salts
Sulfonic acids, petroleum
Phosphorochloridous acid, bis(4-nonylphenyl) ester
Sludges, petroleum, acid
Alkenes, C>10 .alpha. -
Phenols, petroleum
Paraffins, petroleum, normal C>10
Phosphoric acid, bis[(1,1-dimethylethyl)phenyl] phenyl ester
Light oil, coal, coke-oven
Solvent naphtha, coal
Ammonia liquor, coal
Fuel gases, coke-oven
Tar oils, coal
Extracts, coal tar oil alk.
Extract oils, coal, tar base
Extract residues, coal, tar oil alk.
Tar, coal, high-temp.
Distillates, coal tar, upper
Distillates, coal tar
Corn, steep liquor
C.I. Leuco Sulphur Black 1
Phenol, nonyl derivs.
Lard, oil, Me esters
Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates
Phosphorodithioic acid, O,O-di-C1-14-alkyl esters
Pitch, coal tar-petroleum
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CAS # TSCA Chemical Name
68187-59-7
68187-76-8
68187-84-8
68188-18-1
68308-74-7
68309-16-0
68309-27-3
68334-01-0
68441-66-7
68442-60-4
68442-77-3
68476-80-2
68478-20-6
68479-98-1
68511-40-0
68512-63-0
68513-62-2
68514-41-0
68515-89-9
68527-02-6
68553-14-0
68584-25-8
68602-81-3
68603-84-9
68607-28-3
68608-59-3
68609-04-1
68609-05-2
68610-90-2
68611-64-3
68647-60-9
68649-42-3
68650-36-2
68782-97-8
68815-50-9
68909-77-3
68915-05-9
68915-39-9
68918-16-1
68919-17-5
68920-64-9
Coal, anthracite, calcined
Castor oil, sulfated, sodium salt
Castor oil, oxidized
Paraffin oils, chlorosulfonated, saponified
Amides, tall-oil fatty, N,N-di-Me
Fatty acids, tall-oil, 2-(2-hydroxyethoxy)ethyl esters
Fatty acids, tall-oil, sulfonated, sodium salts
Bisulfides, alkylaryl dialkyl diaryl, petroleum refinery spent caustic oxidn. products
Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid
Acetaldehyde, reaction products with formaldehyde, by-products from
2-Butenediamide, (2E)-, N,N'-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs.
Fats and Glyceridic oils, vegetable, deodorizer distillates
Residues, petroleum, steam-cracked petroleum distillates cyclopentadiene cone., C4-cyclopentadiene-free
Benzenediamine, ar,ar-diethyl-ar-methyl-
1-Propanamine, 3-(tridecyloxy)-, branched
Benzene, ethenyl-, distn. residues
Disulfides, C5-12-alkyl
Ketones, C12-branched
Barium, carbonate nonylphenol complexes
Alkenes, C12-24, chloro
Hydrocarbons, C8-11
Benzenesulfonic acid, C10-16-alkyl derivs., compds. with triethanolamine
Distillates, hydrocarbon resin prodn. higher boiling
Carboxylic acids, C5-9
Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, dichlorides
Ethane, 1,2-dichloro-, manuf. of, by-products from, distn. lights
Cyclohexane, oxidized, non-acidic by-products, distn. residues
Cyclohexane, oxidized, non-acidic by-products, distn. lights
2-Butenedioic acid (2E)-, di-C8-18-alkyl esters
Urea, reaction products with formaldehyde
Hydrocarbons, C>4
Phosphorodithioicacid, O,O-di-C1-14-alkyl esters, zinc salts
Aromatic hydrocarbons, C8, o-xylene-lean
Distillates, petroleum, hydrofined lubricating-oil
Octadecanoic acid, reaction products with 2-[(2-aminoethyl)amino]ethanol
Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues
Fatty acids, tall-oil, low-boiling, reaction products with ammonia-ethanolamine reaction by-products
Cyclohexane, oxidized, aq. ext, sodium salt
Tar, coal, dried and oxidized
Hydrocarbons, C12-20, catalytic alkylation by-products
Disulfides, di-C1-2-alkyl
CAS # TSCA Chemical Name
68937-29-1
68937-69-9
68937-70-2
68937-72-4
68953-70-8
68953-80-0
68955-37-3
68955-76-0
68955-96-4
68987-41-7
68987-66-6
68988-22-7
68988-99-8
68990-61-4
68990-65-8
69029-75-0
70024-67-8
70084-98-9
70693-50-4
70851-08-0
71077-05-9
72162-28-8
72854-27-4
73665-18-6
83864-02-2
84501-86-0
90640-80-5
90640-86-1
119345-02-7
125997-20-8
1 ,6-Hexanediol, distn. residues
Carboxylic acids, C6-18 and C5-15-di-
Carboxylic acids, C6-18 and C8-15-di-
Carboxylic acids, di-, C4-1 1
Oxirane, reaction products with ammonia, distn. residues
Benzene, mixed with toluene, dealkylation product
Acid chlorides, tallow, hydrogenated
Aromatic hydrocarbons, C9-16, biphenyl deriv.-rich
Disulfides, dialkyl and di-Ph, naphtha sweetening
Benzene, ethylenated
Ethene, hydrated, by-products from
1 ,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from
Phenols, sodium salts, mixed with sulfur compounds, gasoline alk. scrubber residues
Tar, coal, high-temp., high-solids
Fats and Glyceridic oils, vegetable, reclaimed
Oils, reclaimed
Benzenesulfonic acid, C16-24-alkyl derivs.
Terpenes and Terpenoids, C10-30, distn. residues
Phenol, 2,4-bis(1 -methyl-1 -phenylethyl)-6-[(2-nitrophenyl)azo]-
Amides, coco, N-[3-(dimethylamino)propyl], alkylation products with sodium 3-chloro-2-hydroxypropanesulfonate
Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine product tower residues
2-Propanone, reaction products with phenol
Tannins, reaction products with sodium bisulfite, sodium polysulfide and sodium sulfite
Extract residues, coal, tar oil alk., naphthalene distn. residues
Nickel, bis[(cyano-C)triphenylborato(1-)-N]bis(hexanedinitrile-N,N')-
Hexanedioic acid, esters with high-boiling C6-10-alkene hydroformylation products
Anthracene oil
Distillates, coal tar, heavy oils
Benzene, 1,1'-oxybis-, tetrapropylene derivs.
Phosphoric acid, mixed 3-bromo-2,2-dimethylpropyl and 2-bromoethyl and 2-chloroethyl esters
The following table shows the orphan manufacturers of which EPA is aware and that can be made public without
compromising confidential business information.
65
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66
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-------
Manufacturers of 1990 HPV Orphan Chemicals
Based on 1990, 1998, and 2002 IUR Reporting
{EPA is not permitted to refer to Confidential Business Information (CBI) claims for these chemicals in a public context.
Only 296 of the 330 previously identified orphans have a non-CBI manufacturer in 1990; therefore, this table contains 296
and not 330 CAS numbers. An asterisk in the "1998 Manufacturer" or the "2002 Manufacturer" column indicates that the
company in the "1990 Manufacturer" column produced the chemical during that year. Trade association affiliation is noted
for members of the following three trade associations: American Chemistry Council (ACC), American Petroleum Institute
(API), and Synthetic Organic Chemical Manufacturers Association (SOCMA). Lists of ACC and SOCMA member
companies were found on their web sites. A member company list for API is not available on its website; however, a list of
links to API member companies is available at http://api-ec.api.org/links/index.cfm, and was used in this analysis to identify
known API member companies it is not a complete list.}
198OManufae,u,er J~ . AsSon
56-40-6
62-23-7
62-56-6
74-95-3
74-97-5
75-07-0
75-34-3
75-36-5
CHATTEM CHEMICALS
NAGASE AMERICA CORPORATION
El DUPONT DE NEMOURS & CO INC
ACETO CHEMICAL COMPANY INC
HOECHSTCELANESE
MITSUI SCO (USA) INC
SAKAI TRADING NEW YORK INC
SKW CHEMICALS INC
TOMEN AMERICA INC
WEGO CHEMICAL & MINERAL CORPORATION
AMERIBROMINC
ETHYL CORPORATION - HEALTH SAFETY AND
AMERIBROMINC
ETHYL CORPORATION - HEALTH SAFETY AND
El DUPONT DE NEMOURS & CO INC
HOECHSTCELANESE
UNION CARBIDE CORPORATION
DOW CHEMICAL USA
GEORGIA-PACIFIC CORPORATION
ICI AMERICAS INC
DELTECH CORPORATION
ETHYL CORPORATION - HEALTH SAFETY AND
*
*
*
*
*
*
*
*
*
*
*
ACC
SOCMA
ACC, SOCMA
SOCMA
SOCMA
ACC
ACC, API, SOCMA
SOCMA
CAS# 1990 Manufacturer r!998 rf02 A Trad<;.
Manu. Manu. Association
75-46-7
75-87-6
77-76-9
78-11-5
78-42-2
81-07-2
81-16-3
81-84-5
83-41-0
84-65-1
84-69-5
85-40-5
89-32-7
90-43-7
HOECHSTCELANESE
El DUPONT DE NEMOURS & CO INC
ENIMONT AMERICA INC
NOR-AM CHEMICAL COMPANY
El DUPONT DE NEMOURS & CO INC
ENSIGN-BICKFORD COMPANY
TROJAN CORPORATION
ALBRIGHTS WILSON INC
MOBAY CHEMICAL CORPORATION
MITSUI & CO (USA) INC
PMC SPECIALTIES GROUP INC
BASF CORPORATION
BIDDLE SAWYER CORPORATION
DIG AMERICAS INC
ENIMONT AMERICA INC
MOBAY CHEMICAL CORPORATION
SUMITOMO CORPORATION OF AMERICA
MOBAY CHEMICAL CORPORATION
RUETGERS-NEASE
AMERICAN CYANAMID CO AGRI PRODS RES
El DUPONT DE NEMOURS & CO INC
ICI AMERICAS INC
MITSUI & CO (USA) INC
MOBAY CHEMICAL CORPORATION
HULS AMERICA INC
UNITEXCHEMCORP
ICI AMERICAS INC
El DUPONT DE NEMOURS & CO INC
HULS AMERICA INC
DOW CHEMICAL USA
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC
ACC
ACC, SOCMA
SOCMA
ACC, SOCMA
SOCMA
ACC
ACC, SOCMA
ACC
ACC, API, SOCMA
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CAS# 1990 Manufacturer J998 r2002 A Trad<;.
Manu. Manu. Association
91-53-2
91-68-9
94-75-7
94-96-2
95-94-3
96-22-0
96-23-1
97-00-7
98-09-9
98-16-8
98-56-6
99-51-4
100-64-1
101-34-8
104-15-4
MONSANTO COMPANY
BASF CORPORATION
HILTON-DAVIS CHEMICAL COMPANY
SUMITOMO CORPORATION OF AMERICA
DOW CHEMICAL USA
HULS AMERICA INC
QO CHEMICALS INC
UNION CARBIDE CHEMICALS & PLASTICS CO
STANDARD CHLORINE OF DELAWARE INC
BP CHEMICALS AMERICA INCORPORATED
UNION CARBIDE CHEMICALS & PLASTICS CO
ARSYNCO
DOW CHEMICAL USA
HOECHSTCELANESE
ICI AMERICAS INC
MTM HARDWICKE INC
SLOSS INDUSTRIES CORPORATION
ELI LILLY AND COMPANY
HOECHSTCELANESE
SANDOZ COLORS & CHEMICALS
OCCIDENTAL CHEMICAL CORPORATION
AMERICAN CYANAMID CO AGRI PRODS RES
El DUPONT DE NEMOURS & CO INC
DSM CHEMICALS NORTH AMERICA INC
CASCHEM INC
ACETO CHEMICAL COMPANY INC
BIDDLE SAWYER CORPORATION
Cl SPECIALITY CHEMICALS INC
CAPITAL RESIN CORPORATION
CL INDUSTRIES INC
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC
ACC, SOCMA
ACC, API, SOCMA
ACC, API
ACC, API, SOCMA
SOCMA
ACC
ACC, API
ACC
SOCMA
SOCMA
SOCMA
CAS# 1990 Manufacturer J998 2002 A Trad<;.
Manu. Manu. Association
104-66-5
104-93-8
107-39-1
107-40-4
107-45-9
108-19-0
108-20-3
109-86-4
110-33-8
110-44-1
INTERNATIONAL FLAVORS AND FRAGRANCES IN
RUETGERS-NEASE
SLOSS INDUSTRIES CORPORATION
KOCH CHEMICAL COMPANY
FRAGRANCE RESOURCES INC
GIVAUDAN CORPORATION
KOCH CHEMICAL COMPANY
NISSHO IWAI AMERICAN CORPORATION
TEXAS PETROCHEMICALS CORPORATION
TEXAS PETROCHEMICALS CORPORATION
HALTERMANN LTD
ROHM AND HAAS COMPANY
ARCADIAN CORPORATION
CF INDUSTRIES INC
EXXON CHEMICAL COMPANY
SHELL OIL COMPANY
UNION CARBIDE CORPORATION
BASF CORPORATION
CAPE INDUSTRIES
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
DOW CHEMICAL USA
MONTANA REFINING COMPANY
OCCIDENTAL CHEMICAL CORPORATION
OLIN CORPORATION
UNION CARBIDE CORPORATION
MONSANTO COMPANY
HOECHSTCELANESE
MITSUI SCO (USA) INC
MONSANTO COMPANY
TOMEN AMERICA INC
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
SOCMA
SOCMA
ACC
ACC, API
ACC, API
ACC, SOCMA
ACC, API
ACC, API, SOCMA
ACC, API
ACC
ACC, SOCMA
ACC
69
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70
-------
CAS# 1990 Manufacturer J998 r2002 A Trad<;.
Manu. Manu. Association
111-44-4
111-85-3
112-52-7
118-82-1
118-90-1
119-33-5
119-61-9
121-45-9
121-69-7
121-82-4
124-18-5
124-63-0
127-68-4
ET HORN COMPANY
OCCIDENTAL CHEMICAL CORPORATION
HULS AMERICA INC
LONZA INCORPORATED
NEVILLE CHEMICAL COMPANY
HULS AMERICA INC
LONZA INCORPORATED
NEVILLE CHEMICAL COMPANY
ETHYL CORPORATION - HEALTH SAFETY AND
CHUGAI BOYEKI CORP
MOBAY CHEMICAL CORPORATION
PMC SPECIALTIES GROUP INC
ACETO CHEMICAL COMPANY INC
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
HAARMANN & REIMER CORPORATION
THE UPJOHN COMPANY
ALBRIGHT & WILSON INC
ICI AMERICAS INC
D&O CHEMICALS INC
HOLSTON ARMY AMMUNITION PLANT
ENIMONT AMERICA INC
EXXON CHEMICAL COMPANY
HUMPHREY CHEMICAL COMPANY
SHELL OIL COMPANY
STERLING DRUG INC
VISTA CHEMICAL CO
ATOCHEM INC POLYMER DIVISION
ACETO CHEMICAL COMPANY INC
BASF CORPORATION
CROWN METRO INC
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC, API
SOCMA
SOCMA
ACC, API
ACC, API
ACC, API
SOCMA
ACC, SOCMA
CAS# 1990 Manufacturer J998 2002 A Trad<;.
Manu. Manu. Association
131-57-7
137-20-2
138-25-0
139-40-2
140-08-9
140-93-2
143-28-2
144-62-7
149-44-0
307-35-7
ACETO CHEMICAL COMPANY INC
BASF CORPORATION
HOECHSTCELANESE
NEVILLE CHEMICAL COMPANY
GAF CHEMICALS CORPORATION
HOECHSTCELANESE
El DUPONT DE NEMOURS & CO INC
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
ALBRIGHT & WILSON INC
OLIN CORPORATION
AMERICAN CYANAMID CO AGRI PRODS RES
CASCHEM INC
JARCHEM INDUSTRIES INC
MMICHELANDCOINC
SHEREX CHEMICAL COMPANY INC
ALLOYCHEMINC
BROWNING CHEMICAL CORP
Cl SPECIALITY CHEMICALS INC
CALABRIAN CORPORATION
DOW CHEMICAL USA
El DUPONT DE NEMOURS & CO INC
MARUBENI AMERICA CORPORATION
MITSUBISHI CHEMICAL INDUSTRIES AM INC
MITSUI SCO (USA) INC
SAKAI TRADING NEW YORK INC
VELCO ENTERPRISES LTD
WEGO CHEMICAL & MINERAL CORPORATION
ACETO CHEMICAL COMPANY INC
AMERIPOL SYNPOL COMPANY
3M
*
*
*
*
*
*
*
*
*
SOCMA
ACC, SOCMA
ACC
ACC, API
ACC
ACC, API, SOCMA
ACC
ACC, SOCMA
SOCMA
ACC
71
EPA's High Production Volume Challenge Program
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72
-------
CAS# 1990 Manufacturer J998 r2002 A Trad<;.
Manu. Manu. Association
330-54-1
409-02-9
460-00-4
506-51-4
506-52-5
513-74-6
515-40-2
529-33-9
529-34-0
542-75-6
542-92-7
557-61-9
563-72-4
579-66-8
590-19-2
592-45-0
594-42-3
617-94-7
624-83-9
624-92-0
628-13-7
628-96-6
MARUBENI AMERICA CORPORATION
THOR CHEMICALS INC
EXXON CHEMICAL COMPANY
INTERNATIONAL FLAVORS AND FRAGRANCES IN
DIAZ CHEMICAL CORPORATION
HOECHSTCELANESE
RHONE POULENC INCORPORATED
VISTA CHEMICAL CO
VISTA CHEMICAL CO
MERCK AND COMPANY INC
MTM HARDWICKE INC
RHONE POULENC INCORPORATED
RHONE POULENC INCORPORATED
DOW CHEMICAL USA
SHELL OIL COMPANY
NAGASE AMERICA CORPORATION
VELSICOL CHEMICAL CORPORATION
VISTA CHEMICAL CO
EXXON CHEMICAL COMPANY
ETHYL CORPORATION - HEALTH SAFETY AND
EXXON CHEMICAL COMPANY
VISTA CHEMICAL CO
El DUPONT DE NEMOURS & CO INC
ICI AMERICAS INC
HERCULES INCORPORATED
TEXACO CHEMICAL COMPANY
RHONE POULENC INCORPORATED
ATOCHEM INC POLYMER DIVISION
RHONE POULENC INCORPORATED
ICI EXPLOSIVES USA INC
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC, API
ACC, API, SOCMA
ACC, API
ACC, API
ACC, API
ACC
ACC, API, SOCMA
CAS# 1990 Manufacturer J998 2002 A Trad<;.
Manu. Manu. Association
629-59-4
629-76-5
645-62-5
693-95-8
756-80-9
870-72-4
928-72-3
939-97-9
1000-82-4
1002-69-3
1111-78-0
1115-20-4
1323-65-5
IRECOINC
SHELL OIL COMPANY
VISTA CHEMICAL CO
SHELL OIL COMPANY
UNION CARBIDE CORPORATION
MERCK AND COMPANY INC
ICI AMERICAS INC
AGFA
El DUPONT DE NEMOURS & CO INC
EASTMAN KODAK COMPANY
FUJI HUNT PHOTOGRAPHIC CHEMICAL INC
HICKSON & WELCH LIMITED
HIGH POINT CHEMICAL CORPORATION
HOECHSTCELANESE
KONICA ROYAL COPIERS
MOBAY CHEMICAL CORPORATION
MONSANTO COMPANY
FRAGRANCE RESOURCES INC
GIVAUDAN CORPORATION
INTERNATIONAL FLAVORS AND FRAGRANCES IN
AURALUX CORPORATION
BASF CORPORATION
DYNO POLYMERS INCORPORATED
LONZA INCORPORATED
ARCADIAN CORPORATION
CF INDUSTRIES INC
BASF CORPORATION
UNION CARBIDE CHEMICALS & PLASTICS CO
MONSANTO COMPANY
TEXACO CHEMICAL COMPANY
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC, API
ACC, API
ACC
ACC
SOCMA
ACC
ACC, SOCMA
ACC, SOCMA
ACC
ACC, API, SOCMA
73
EPA's High Production Volume Challenge Program
74
Sfafus and Future Directions
-------
CAS# 1990 Manufacturer J998 r2002 A Trad<;.
Manu. Manu. Association
1324-76-1
1401-55-4
1445-45-0
1459-93-4
1498-51-7
1558-33-4
1562-00-1
1646-75-9
1691-99-2
1738-25-6
1912-24-9
1929-82-4
2152-64-9
2210-79-9
2372-45-4
2409-55-4
HOECHSTCELANESE
PMC SPECIALTIES GROUP INC
ACETO CHEMICAL COMPANY INC
CROMPTON & KNOWLES COLORS INCORPORATED
MALLINCKRODT
THE SIEFLOR CORPORATION
HULS AMERICA INC
HOECHSTCELANESE
MORFLEX CHEMICAL COMPANY INC
UNITEXCHEMCORP
RHONE POULENC INCORPORATED
El DUPONT DE NEMOURS & CO INC
GAP CHEMICALS CORPORATION
HENKEL CORPORATION
RHONE POULENC INCORPORATED
ALLIED-SIGNALING
3M
AIR PRODUCTS AND CHEMICALS INC
TEXACO CHEMICAL COMPANY
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
MARUBENI AMERICA CORPORATION
DOW CHEMICAL USA
PMC SPECIALTIES GROUP INC
CL INDUSTRIES INC
KOCH CHEMICAL COMPANY
RHONE POULENC INCORPORATED
SHEREX CHEMICAL COMPANY INC
FMC COMPANY
PMC SPECIALTIES GROUP INC
RHONE POULENC INCORPORATED
*
*
*
*
*
*
*
*
*
*
*
*
*
*
SOCMA
SOCMA
ACC
ACC
ACC
ACC, API, SOCMA
ACC, API
ACC, API, SOCMA
SOCMA
SOCMA
CAS# 1990 Manufacturer J998 2002 A Trad<;.
Manu. Manu. Association
2425-54-9
2494-89-5
2524-03-0
2524-04-1
2611-00-9
2691-41-0
2702-72-9
2814-20-2
2905-62-6
2915-53-9
2941-64-2
3039-83-6
3088-31-1
3132-99-8
3386-33-2
3586-14-9
3710-84-7
3779-63-3
3965-55-7
4035-89-6
LONZA INCORPORATED
ACETO CHEMICAL COMPANY INC
BIDDLE SAWYER CORPORATION
CROMPTON & KNOWLES COLORS INCORPORATED
HOECHSTCELANESE
MITSUI SCO (USA) INC
ICI AMERICAS INC
ETHYL CORPORATION - HEALTH SAFETY AND
ICI AMERICAS INC
UNION CARBIDE CORPORATION
HOLSTON ARMY AMMUNITION PLANT
DOW CHEMICAL USA
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
OCCIDENTAL CHEMICAL CORPORATION
ARISTECH CHEMICAL CORPORATION
MANUFACTURERS SOAP & CHEMICAL CO INC
NATIONAL STARCH AND CHEMICAL CORPORATION
TEXTILE RUBBER & CHEMICAL COMPANY
ICI AMERICAS INC
AIR PRODUCTS AND CHEMICALS INC
LONZA INCORPORATED
MTM HARDWICKE INC
LONZA INCORPORATED
MERICHEM COMPANY
MTM HARDWICKE INC
ATOCHEM INC POLYMER DIVISION
BASF CORPORATION
RHONE POULENC INCORPORATED
El DUPONT DE NEMOURS & CO INC
RHONE POULENC INCORPORATED
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
SOCMA
SOCMA
ACC, SOCMA
ACC, API, SOCMA
ACC, API
ACC, API
ACC
ACC, API
ACC, SOCMA
ACC
75
EPA's High Production Volume Challenge Program
Status and Future Directions
76
-------
CAS# 1990 Manufacturer J998 r2002 A Trad<;.
Manu. Manu. Association
4080-31-3
4300-97-4
4719-04-4
4860-03-1
5026-74-4
5216-25-1
5460-09-3
5915-41-3
6381-77-7
6473-13-8
6863-58-7
6865-35-6
7320-37-8
7446-81-3
7795-95-1
DOW CHEMICAL USA
PPG INDUSTRIES INC
ECOLAB INC
QUAKER CHEMICAL CORPORATION
STEPAN CHEMICAL COMPANY
LONZA INCORPORATED
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
OCCIDENTAL CHEMICAL CORPORATION
ACETO CHEMICAL COMPANY INC
BIDDLE SAWYER CORPORATION
CROMPTON & KNOWLES COLORS INCORPORATED
FABRICOLOR MANUFACTURING CORPORATION
ICI AMERICAS INC
MOBAY CHEMICAL CORPORATION
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
PFIZER INC
PMP FERMENTATION PRODUCTS INC
AAKASH CHEMICALS & DYE-STUFFS
BIDDLE SAWYER CORPORATION
BURLINGTON CHEMICAL COMPANY INC
CROMPTON & KNOWLES COLORS INCORPORATED
FABRICOLOR MANUFACTURING CORPORATION
EXXON CHEMICAL COMPANY
LYONDELL-CITGO REFINING COMPANY LTD
ANZON LEAD
SYNTHETIC RUBBER PRODUCTS INC
ATOCHEM INC POLYMER DIVISION
UNION CARBIDE CORPORATION
DOW CHEMICAL USA
3M
*
*
*
*
*
*
*
*
*
*
*
*
ACC, API, SOCMA
ACC, SOCMA
ACC, API
ACC, API
SOCMA
SOCMA
ACC, API
SOCMA
ACC, API
ACC, API, SOCMA
ACC
CAS# 1990 Manufacturer J998 2002 A Trad<;.
Manu. Manu. Association
8001-58-9
8005-02-5
8007-45-2
12645-31-7
13749-94-5
13826-35-2
14666-94-5
16883-83-3
17103-31-0
17321-47-0
17976-43-1
19438-61-0
20068-02-4
21351-39-3
22527-63-5
ALLIED-SIGNALING
CROWLEYTAR PRODUCTS COMPANY INC
DAICOLOR-POPE INC
MORTON INTERNATIONAL INCORPORATED
ORIENT CHEMICAL CORPORATION
SHARP ELECTRONICS CORPORATION
USROPTONIXINC
BOSTON COKE CORPORATION
ERIE COKE CORPORATION
KOPPER COMPANY INCORPORATED
TONAWANDA COKE CORP
CHEMTECHJNDUSTRIES INC
HIGH POINT CHEMICAL CORPORATION
HILTON-DAVIS CHEMICAL COMPANY
PETROLITE CORPORATION
PIEDMONT CHEMICAL INDUSTRIES INC
REILLY-WHITEMAN INC
El DUPONT DE NEMOURS & CO INC
AMERIBROM INC
MTM HARDWICKE INC
EXXON CHEMICAL COMPANY
MONSANTO COMPANY
UNOCAL SCIENCE & TECHNOLOGY DIVISION
CHEVRON CHEMICAL CO
ANZON LEAD
AMERICAN CYANAMID CO AGRI PRODS RES
ICI AMERICAS INC
El DUPONT DE NEMOURS & CO INC
UNOCAL SCIENCE & TECHNOLOGY DIVISION
HULS AMERICA INC
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC
SOCMA
ACC, API
ACC, API, SOCMA
ACC
77
EPA's High Production Volume Challenge Program
Status and Future Directions
78
-------
CAS# 1990 Manufacturer J998 r2002 A Trad<;.
Manu. Manu. Association
24448-09-7
24615-84-7
24634-61-5
24794-58-9
25154-38-5
25168-05-2
25168-06-3
25321-41-9
25586-42-9
25646-71-3
26377-29-7
26401-27-4
26680-54-6
27193-28-8
28106-30-1
28777-98-2
3M
HOECHSTCELANESE
RHONE POULENC INCORPORATED
HOECHSTCELANESE
MITSUI SCO (USA) INC
MONSANTO COMPANY
TOMEN AMERICA INC
WR GRACE & CO-CONN
UNION CARBIDE CHEMICALS & PLASTICS CO
OCCIDENTAL CHEMICAL CORPORATION
FMC COMPANY
RUETGERS-NEASE
SLOSS INDUSTRIES CORPORATION
El DUPONT DE NEMOURS & CO INC
AGFA
OLIN CORPORATION
ICI AMERICAS INC
DOVER CHEMICAL CORPORATION
GE SPECIALTY CHEMICALS
WITCO CHEMICAL CORPORATION
DIXIE INTERNATIONAL COMPANY
HUMPHREY CHEMICAL COMPANY
MILLIKENCHEM
GAP CHEMICALS CORPORATION
PMC SPECIALTIES GROUP INC
ROHM AND HAAS COMPANY
DELTECH CORPORATION
DOW CHEMICAL USA
BERCEN INC
ETHYL CORPORATION - HEALTH SAFETY AND
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC
ACC, SOCMA
ACC
ACC, API
SOCMA
ACC
ACC
ACC
API
SOCMA
ACC
SOCMA
ACC, API, SOCMA
CAS# 1990 Manufacturer J998 2002 A Trad<;.
Manu. Manu. Association
30574-97-1
31138-65-5
32072-96-1
32210-23-4
34689-46-8
35203-06-6
35203-08-8
37439-34-2
37734-45-5
37764-25-3
38185-06-7
39515-51-0
40630-63-5
40876-98-0
51632-16-7
52184-19-7
52556-42-0
52663-57-7
56038-89-2
HUMPHREY CHEMICAL COMPANY
MILLIKEN CHEM
El DUPONT DE NEMOURS & CO INC
FARMS INDCHEMCO
BERCEN INC
DIXIE INTERNATIONAL COMPANY
ETHYL CORPORATION - HEALTH SAFETY AND
HULS AMERICA INC
INTERNATIONAL FLAVORS AND FRAGRANCES IN
QUEST INTERNATIONAL
MERICHEM COMPANY
MONSANTO COMPANY
MONSANTO COMPANY
DOW CHEMICAL USA
ICI AMERICAS INC
ICI AMERICAS INC
LOMAC INCORPORATED
FMC COMPANY
MTM HARDWICKE INC
NAGASE AMERICA CORPORATION
3M
AMERICAN CYANAMID CO AGRI PRODS RES
BIDDLE SAWYER CORPORATION
HEICO CHEMICALS INC
NEPERA INC
MTM HARDWICKE INC
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
RHONE POULENC INCORPORATED
FMC COMPANY
AMERICAN CYANAMID CO AGRI PRODS RES
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC
ACC, API
ACC
ACC
ACC, API, SOCMA
ACC
SOCMA
ACC, API
79
EPA's High Production Volume Challenge Program
Status and Future Directions
80
-------
CAS# 1990 Manufacturer J998 r2002 A Trad<;.
Manu. Manu. Association
57693-14-8
61788-76-9
61789-32-0
61789-65-9
61789-85-3
64742-24-1
64743-02-8
64743-03-9
64771-71-7
65996-78-3
BASF CORPORATION
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
CROMPTON & KNOWLES COLORS INCORPORATED
DOVER CHEMICAL CORPORATION
FERRO CORPORATION
OCCIDENTAL CHEMICAL CORPORATION
GAF CHEMICALS CORPORATION
LEVER BROTHERS CO
PPG INDUSTRIES INC
GAYLORD CONTAINER CORPORATION
JAMES RIVER CORPORATION
JAMES RIVER GRAPHICS INCORPORATED
STEPAN CHEMICAL COMPANY
AMOCO CANADA MARKETING CORP
DIAMOND SHAMROCK REFINING/MKT
SUN REFINING AND MARKETING COMPANY
CHEVRON CHEMICAL CO
HALTERMANN LTD
MONSANTO COMPANY
SHELL OIL COMPANY
ASHLAND CHEMICAL COMPANY - ENVIRONMENTAL
COASTAL REFINING & MARKETING INC
FARMLAND INDUSTRIES INC
LYONDELL-CITGO REFINING COMPANY LTD
TEXACO CHEMICAL COMPANY
MONSANTO COMPANY
SHELL OIL COMPANY
ACME STEEL COMPANY
ARMCO STEEL COMPANY LP
BETHLEHEM STEEL CORPORATION
*
*
*
*
*
*
*
*
*
*
ACC, SOCMA
ACC, API
ACC
ACC, SOCMA
ACC, API
ACC, SOCMA
SOCMA
ACC, API, SOCMA
ACC
ACC, API
ACC, API
ACC, API
ACC, API, SOCMA
ACC
ACC, API
CAS# 1990 Manufacturer J998 2002 A Trad<;.
Manu. Manu. Association
65996-79-4
65996-80-7
65996-81-8
65996-82-9
65996-83-0
65996-86-3
BOSTON COKE CORPORATION
CITIZENS GAS & COKE UTILITY
EMPIRE COKE COMPANY
GREAT LAKES CHEMICAL CORPORATION - RESEA
GULF STATES STEEL INC
KOPPER COMPANY INCORPORATED
LTV STEEL COMPANY INC
NATIONAL STEEL CORPORATION
SLOSS INDUSTRIES CORPORATION
TONAWANDA COKE CORP
USS DIVISION OF USX
ARISTECH CHEMICAL CORPORATION
KOPPER COMPANY INCORPORATED
EMPIRE COKE COMPANY
KOPPER COMPANY INCORPORATED
ACME STEEL COMPANY
ARMCO STEEL COMPANY LP
EMPIRE COKE COMPANY
ERIE COKE CORPORATION
KOPPER COMPANY INCORPORATED
SLOSS INDUSTRIES CORPORATION
TONAWANDA COKE CORP
USS DIVISION OF USX
ALLIED-SIGNALING
ARISTECH CHEMICAL CORPORATION
KOPPER COMPANY INCORPORATED
REILLY INDUSTRIES INC
ALLIED-SIGNALING
KOPPER COMPANY INCORPORATED
ALLIED-SIGNALING
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
SOCMA
SOCMA
ACC
81
EPA's High Production Volume Challenge Program
Status and Future Directions
82
-------
CAS# 1990 Manufacturer J998 r2002 A Trad<;.
Manu. Manu. Association
65996-87-4
65996-89-6
65996-91-0
65996-92-1
66071-94-1
68081-86-7
68082-78-0
68153-60-6
KOPPER COMPANY INCORPORATED
ALLIED-SIGNALING
KOPPER COMPANY INCORPORATED
ACME STEEL COMPANY
ALLIED-SIGNALING
ARMCO STEEL COMPANY LP
BETHLEHEM STEEL CORPORATION
EMPIRE COKE COMPANY
GREAT LAKES CHEMICAL CORPORATION - RESEA
GULF STATES STEEL INC
KOPPER COMPANY INCORPORATED
LTV STEEL COMPANY INC
NATIONAL STEEL CORPORATION
REILLY INDUSTRIES INC
SLOSS INDUSTRIES CORPORATION
USS DIVISION OF USX
ALLIED-SIGNALING
ARISTECH CHEMICAL CORPORATION
CROWLEYTAR PRODUCTS COMPANY INC
KOPPER COMPANY INCORPORATED
REILLY INDUSTRIES INC
KOPPER COMPANY INCORPORATED
REILLY INDUSTRIES INC
WESTERN TAR PRODUCTS CORPORATION
GRAIN PROCESSING CORPORATION
EXXON CHEMICAL COMPANY
HENKEL CORPORATION
REILLY-WHITEMAN INC
EXXON CHEMICAL COMPANY
JETCO CHEMICALS INC
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC
SOCMA
ACC
ACC
ACC, API
ACC, API
CAS# 1990 Manufacturer J998 2002 A Trad<;.
Manu. Manu. Association
68187-57-5
68187-59-7
68187-76-8
68187-84-8
68188-18-1
68309-27-3
68334-01-0
68441-66-7
68442-60-4
68476-80-2
68478-20-6
68479-98-1
68511-40-0
68512-63-0
68513-62-2
68514-41-0
68515-89-9
68527-02-6
68553-14-0
ASHLAND CHEMICAL COMPANY - ENVIRONMENTAL
KOPPER COMPANY INCORPORATED
FMC COMPANY
UCAR CARBON COMPANY INC
CLIMAX PERFORMANCE MATERIALS CORPORATION
HIGH POINT CHEMICAL CORPORATION
NATIONAL STARCH AND CHEMICAL CORPORATION
REILLY-WHITEMAN INC
CASCHEMINC
BASF CORPORATION
MOBAY CHEMICAL CORPORATION
CLIMAX PERFORMANCE MATERIALS CORPORATION
MERICHEM COMPANY
HATCO CHEMICAL CORPORATION
HERCULES INCORPORATED
CARGILL INCORPORATED
KARLSHAMNS LIPID SPECIALTIES USA
VELSICOL CHEMICAL CORPORATION
ETHYL CORPORATION - HEALTH SAFETY AND
EXXON CHEMICAL COMPANY
SHEREX CHEMICAL COMPANY INC
CHEVRON CHEMICAL CO
EXXON CHEMICAL COMPANY
MARATHON OIL COMPANY
EXXON CHEMICAL COMPANY
SYNTHETIC RUBBER PRODUCTS INC
WITCO CHEMICAL CORPORATION
DOVER CHEMICAL CORPORATION
OCCIDENTAL CHEMICAL CORPORATION
AMOCO CANADA MARKETING CORP
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC, API
ACC, SOCMA
ACC, API
ACC, API
ACC, API, SOCMA
ACC, API
API
ACC, API
ACC
ACC, API
83
EPA's High Production Volume Challenge Program
Status and Future Directions
84
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CAS# 1990 Manufacturer J998 r2002 A Trad<;.
Manu. Manu. Association
68584-25-8
68602-81-3
68603-84-9
68607-28-3
68608-59-3
68609-04-1
68609-05-2
68610-90-2
68611-64-3
68647-60-9
68650-36-2
68782-97-8
68815-50-9
HB FULLER CO
HUISH DETERGENTS INC
PILOT CHEMICAL COMPANY
SARTOMER COMPANY INC
HENKEL CORPORATION
PETROLITE CORPORATION
BF GOODRICH COMPANY SPECIALTY CHEMICALS
VISTA CHEMICAL CO
BASF CORPORATION
BASF CORPORATION
EXXON CHEMICAL COMPANY
AGRICO CHEMICAL COMPANY
AGRICULTURAL MINERALS CORPORATION
ARCADIAN CORPORATION
CF INDUSTRIES INC
FARMLAND INDUSTRIES INC
SOUTHERN RESIN INC
TERRA INTERNATIONAL INC
TRIAD CHEMICAL
UNOCAL SCIENCE & TECHNOLOGY DIVISION
CHEVRON CHEMICAL CO
LYONDELL-CITGO REFINING COMPANY LTD
BP OIL COMPANY
AMOCO CANADA MARKETING CORP
CHEVRON CHEMICAL CO
LYONDELL-CITGO REFINING COMPANY LTD
HENKEL CORPORATION
HIGH POINT CHEMICAL CORPORATION
PIEDMONT CHEMICAL INDUSTRIES INC
SEDGEFIELD SPECIALTIES
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
SOCMA
ACC
ACC, SOCMA
ACC, SOCMA
ACC, API
ACC, API, SOCMA
ACC, API
ACC, API, SOCMA
CAS# 1990 Manufacturer J998 2002 A Trad<;.
Manu. Manu. Association
68909-77-3
68915-05-9
68915-39-9
68918-16-1
68919-17-5
68920-64-9
68937-29-1
68937-69-9
68937-70-2
68937-72-4
68953-70-8
68953-80-0
68955-37-3
68955-76-0
68955-96-4
68987-41-7
68988-22-7
68988-99-8
68990-61-4
68990-65-8
69029-75-0
70024-67-8
TEXACO CHEMICAL COMPANY
SHEREX CHEMICAL COMPANY INC
BASF CORPORATION
FMC COMPANY
SHELL OIL COMPANY
THE GOODYEAR TIRE & RUBBER CO DEPARTMEN
AMOCO CANADA MARKETING CORP
BASF CORPORATION
HENKEL CORPORATION
HENKEL CORPORATION
HENKEL CORPORATION
DOW CHEMICAL USA
TEXACO CHEMICAL COMPANY
BP OIL COMPANY
SUN REFINING AND MARKETING COMPANY
HERCULES INCORPORATED
CHEVRON CHEMICAL CO
BP OIL COMPANY
LYONDELL-CITGO REFINING COMPANY LTD
EXXON CHEMICAL COMPANY
CAPE INDUSTRIES
AMOCO CANADA MARKETING CORP
CROWN CENTRAL PETROLEUM CORPORATION
TEXACO CHEMICAL COMPANY
TOTAL PETROLEUM INC
BETHLEHEM STEEL CORPORATION
CITIZENS GAS & COKE UTILITY
KARLSHAMNS LIPID SPECIALTIES USA
CHEVRON CHEMICAL CO
PILOT CHEMICAL COMPANY
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
ACC, API, SOCMA
ACC, SOCMA
ACC, API
ACC, SOCMA
ACC, API, SOCMA
ACC, API, SOCMA
ACC, API
SOCMA
ACC, API, SOCMA
ACC, API
ACC, API
ACC, API, SOCMA
ACC, API, SOCMA
SOCMA
85
EPA's High Production Volume Challenge Program
Status and Future Directions
86
-------
87
CAS#
70084-98-9
70693-50-4
70851-08-0
71077-05-9
72162-28-8
73665-18-6
83864-02-2
84501-86-0
90640-80-5
90640-86-1
119345-02-7
125997-20-8
1990 Manufacturer
STEPAN CHEMICAL COMPANY
UNION CAMP CORPORATION
CIBA-GEIGY CORPORATION TEXTILE PRODUCTS
RHONE POULENC INCORPORATED
TEXACO CHEMICAL COMPANY
GE PLASTICS
KOPPER COMPANY INCORPORATED
El DUPONT DE NEMOURS & CO INC
WERNER G SMITH INC
KOPPER COMPANY INCORPORATED
KOPPER COMPANY INCORPORATED
DOW CHEMICAL USA
GREAT LAKES CHEMICAL CORPORATION - RESEA
1998 2002 Trade
Manu. Manu. Association
*
*
*
*
*
*
*
*
*
*
*
ACC, API
ACC, API, SOCMA
API
ACC
ACC, API, SOCMA
The table reveals that for the 330 orphan chemicals,
there are: 151 cases where a company member from
the ACC trade association could have sponsored a
chemical; 83 cases where a company member from
the API trade association could have sponsored a
chemical; and 91 cases where a company member from
the SOCMA trade association could have sponsored
a chemical (note that the API company list was not a
complete list of members).
The figure below, which is a flowchart on the following
page entitled "Preliminary Strategy for Addressing
HPV Challenge Program Unsponsored Chemicals,"
outlines EPA's initial thinking for obtaining hazard
screening-level data for the 330 orphan chemicals
and making the data publicly available in the HPV
Information System. (HPVIS is a data-searchable
application for HPV Challenge Program data that
is discussed later in this report.) EPA continues to
recognize the HPV Challenge Program as a dynamic
and fluid program, and any strategy for addressing
orphan chemicals must be flexible to accommodate
changing Program circumstances and EPA and
stakeholder needs.
Preliminary Strategy for Addressing HPV
Challenge Program Unsponsored Chemicals
571 Unsponsponsored
Chemicals based on 1990 HPV
Challenge Programming List
1.
EPA and others may engage
in activities to secure
additional HPV sponsors.
4.
Finalize the First HPV Test
Rule. Identify SIDS end point
studies not addressed in the
First HPV Test Rule.
Approximately 241 meet the HPV
Challenge Program "No Longer
HPV" criterion and will not be a
direct focus of follow-up work
under the HPV Challenge
Program at this time.
8.
ITC-coordinated TSCA
8(d) Unpublished
Health and Safety Data
Rule and TSCA 8(a)
PAIR Rule to gather
exposure data for
future test rule findings.
T
available/submitted to
EPA adequate to meet
SIDSendpoints?
included in First
HPV Test
Rule?
No v
3.
Does the
chemical meet
I'No Longer HPV;
criterion?
330 orphan
chemicals
Are there any
publicity available
studies that are adequate
to fulfill HPV Challenge
Program needs?
rule exposure-based
findings be made with
currently available
information
Yes
10.
Can test rule
exposure-based
findings be made with
PAIR and/or other
currently available
information?
Yes
No
Propose and finalize Third HPV Test
Rule for Chemicals for which findings
can be made. Consider risk-based
findings for chemicals where needed.
12.
Seek other data
development
mechanism for
chemicals with
continuing hazard
and fate data gaps.
7.
Propose and finalize
Second HPV Test Rule
addressing inadequate
studies for specific
endpoints. Also include
in this test ruls studies
that address endpoints
left uncovered in the
First HPV Test Rule for
which there are
inadquate studies.
88
EPA's High Production Volume Challenge Program
Status and Future Directions
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Flowchart Graphic 1 - EPA and others
may engage in activities to secure
additional HPV sponsors.
EPA encourages companies and consortia to consider
sponsorship of unsponsored chemicals at the present
time, before regulatory actions are initiated. EPA
plans to work with trade associations and others,
and conduct outreach and communications activities
targeted at reducing the number of these chemicals.
The sustained efforts of stakeholder organizations
are essential to making meaningful progress toward
reducing the number of unsponsored chemicals.
Flowchart Graphic 2 - Is chemical
included in First HPV Test Rule?
EPA proposed a TSCA Section 4 test rule using
exposure-based findings (i.e., TSCA section 4(a)(l)(B)
see the description under Flowchart Graphic 5) on
December 26, 2000, that would require manufacturers
and processors of 37 unsponsored HPV chemicals
to conduct specific screening-level testing (65 FR
81658). In this proposed rule, EPA made preliminary
determinations that each of the 37 chemical substances
is produced (i.e., at the time of the proposed rule)
in substantial quantities and that there is substantial
human exposure to each of them. The proposed rule
was EPA's first action addressing HPV Challenge
Program unsponsored chemicals.
Flowchart Graphic 3 - Does the chemical
meet "No Longer HPV" criterion?
At the onset of the HPV Challenge Program, the
Agency established clear guidance for identifying
chemicals as "No Longer HPV" for purposes of the
Program. The Program's criterion is that total annual
national aggregate production volume must be below
one million pounds for both of the two most recent
Inventory Update Rule (IUR) reporting periods. The
Agency's guidance, entitled "Procedures for Removing
HPV Chemicals That Are 'No Longer HPV and are
Not Likely to Become HPV Again From the HPV
List" may be found at http://www.epa.gov/chemrtk/
guidocs.htm. To develop the list of orphan chemicals,
the Agency considered only chemicals from the 1990
HPV Challenge Program Chemical List. Chemicals
on the 1994 List of HPV Additions were not
considered, because sponsorship of these chemicals,
while accepted, was not officially a part of the HPV
Challenge Program.
Of the 2,782 chemicals on the 1990 HPV Challenge
Program Chemical List, 571 chemicals remain
unsponsored. The Agency applied the "No Longer
HPV" criterion using the 1998 and 2002 IUR
reporting periods and determined that 241 (42%) met
the "No Longer HPV" criterion (i.e., the national
aggregate production/importation volumes for these
241 chemicals were less than one million pounds
in both the 1998 and 2002 IUR reporting periods).
Because the Agency does not consider chemicals
currently meeting the "No Longer HPV" criterion to
be available for sponsorship under the HPV Challenge
Program, the number of unsponsored chemicals is
currently 330.
Flowchart Graphic 4 - Finalize the First
HPV Test Rule. Identify SIDS endpoint
studies not addressed in the First HPV
Test Rule.
The Agency (as discussed in Flowchart Graphic
2) has already taken some action to obtain data on
certain unsponsored HPV chemicals. In this proposed
rule, EPA made preliminary findings that each of
the 37 chemical substances is produced (i.e., at the
time of the proposed rule) in substantial quantities
and that the manufacture, processing, distribution in
commerce, disposal, and uses of each of the chemicals
substances result, or may result in, exposure to a
substantial number of workers. The final test rule will
not include those chemicals whose national aggregate
production volume is less than one million pounds
per year as reported to the 2002 IUR or which have
been sponsored after the test rule was first proposed
on December 26, 2000. Therefore, the 37 chemicals
included in the proposed first HPV unsponsored test
rule will be reduced in the final rule. Publication of
the final rule is expected in 2005.
In developing the testing requirements for chemicals
contained in the proposed rule, EPA utilized
searchable and electronically available data and sources
in EPA's "Chemical Hazard Data Availability Study"
(1998) and ACC's "Public Availability of SIDS-
Related Testing Data for U.S. High Production
Volume Chemicals" (1998) to determine whether
screening-level data were available. If no data were
available through these searches for a SIDS testing
endpoint for a given chemical, EPA made the finding
that there are insufficient data to reasonably determine
the human health and environmental effects for that
chemical's endpoint. If data were available through
these searches for a SIDS testing endpoint, EPA
did not make determinations about the sufficiency
or adequacy of those data for the first proposed
rulemaking. Those determinations, as described below,
are planned for the coming year. Robust summaries
for SIDS endpoints that are determined to be adequate
will be made available through the High Production
Volume Information System (HPVIS).
Flowchart Graphic 5 - Can test rule
exposure-based findings be made with
currently available data?
In addition to the First HPV Test Rule described
above, the Agency is considering whether it can make
the findings needed to promulgate test rules to obtain
baseline health and environmental effects data on
additional orphan chemicals.
In order to promulgate a TSCA Section 4 test rule,
certain findings are required by statute. EPA must first
make findings under TSCA section 4(a)(l)(A) (risk-
based finding) and/or section 4(a)(l)(B) (exposure-
based finding). The test rule proposed on December
26, 2000, was based on exposure-based findings, and
additional orphan chemical HPV test rules could
also be based on such findings. However, EPA is not
precluding the option of issuing test rules based on
risk-based findings alone or in addition to exposure-
based findings.
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EPA's High Production Volume Challenge Program
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90
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The following statutory TSCA section 4(a) findings
are required for issuing test rules:
Risk-Based Finding; or
Exposure-Based Finding the chemical is or will
be produced or imported in substantial quantities
and (I) it enters or may reasonably be anticipated
to enter the environment in substantial quantities,
or (II) there is or may be substantial or significant
human exposure to the chemical; and
"Data Adequacy" Finding existing data are
insufficient to enable a reasonable determination
of the effects of the substance on health or the
environment; and
"Testing is Necessary" Finding testing with
respect to such effects is necessary to develop such
data.
On May 14, 1993, EPA published the "B" (or
exposure-based) Policy that articulates the criteria
that EPA uses to determine whether a chemical is or
will be "produced in substantial quantities," whether it
"enters or may reasonably be anticipated to enter the
environment in substantial quantities," and whether
there is or may be "significant or substantial human
exposure" (58 FR 28736). The general quantitative
guidance thresholds for making these determinations
are summarized below. However, EPA may also make
findings in situations where the quantitative thresholds
are not met, if additional factors exist.
Substantial Production/Importation 1 million
Ibs/yr; and
Substantial Release 1 million Ibs/yr or 10% of
production or import volume/yr; or Substantial
Human Exposure 1,000 workers or 10,000
consumers or 100,000 general population; or
Significant Human Exposure "case-by-case."
Flowchart Graphic 6 - Are there any
publicly available studies that are
adequate to fulfill HPV Challenge Program
needs?
For those orphan chemicals for which the necessary
exposure-based production/importation volume,
release, and/or findings can be made, EPA will identify
and evaluate the existing hazard and fate studies to
determine if the studies are adequate to meet the needs
of the HPV Challenge Program.
EPA will also conduct an evaluation of the adequacy
of the studies for certain endpoints that were not
considered in the First HPV Test Rule; specifically,
EPA will evaluate the adequacy of studies identified
as "available" when the test rule was proposed but for
which a data adequacy evaluation was not conducted
at that time. If the studies are determined to be
adequate, EPA will make the data publicly available on
HPVIS.
Flowchart Graphic 7 - Propose and
finalize Second HPV Test Rule addressing
inadequate studies for specific SIDS
endpoints. Also include in this test
rule studies that address endpoints left
uncovered in the First HPV Test Rule for
which there are inadequate studies.
If the existing hazard and fate studies are determined
to be inadequate, a second test rule would be proposed
to obtain hazard and fate data if statutory findings can
be made.
Flowchart Graphic 8 - ITC-coordinated
TSCA 8(d) Unpublished Health and Safety
Data Rule and TSCA 8(a) PAIR Rule to
gather exposure data for future test rule
findings.
This step in the proposed strategy will be conducted
concurrently with Flowchart Graphics 6 and 7.
Regarding those orphan chemicals for which the
necessary exposure-based findings cannot readily be
made, the Agency will request the Interagency Testing
Committee (ITC) to consider adding these chemicals
to the TSCA section 4(e) Priority Testing List in
the ITC's 55th Report to the EPA Administrator,
projected for late 2004. Based on this potential ITC
action, EPA may append the chemicals to the TSCA
section 8 (a) Preliminary Assessment and Information
Reporting (PAIR) rule and the TSCA section 8(d)
Health and Safety Data Reporting (HaSDR) rule.
The PAIR rule would require producers and importers
to submit to EPA within the 90-day reporting period
(i.e., 90 days from publication of the rule in the
Federal Register) one-time reports on production/
importation volumes, end uses, and exposure-related
data. The TSCA section 8(d) HaSDR rule would
require producers and importers to submit to EPA
within the 90-day reporting period (i.e., 90 days from
publication of the rule in the Federal Register) copies
and lists of certain types of unpublished health and
safety studies for the listed chemicals. Submitters
could also be requested or may be required to provide
robust summaries for studies addressing health and
environmental endpoints.
Flowchart Graphic 9 - Are studies
available/submitted to EPA adequate to
meet SIDS endpoints?
The Agency would review all publicly available studies
and studies submitted under the TSCA section 8(d)
rule for their adequacy in meeting all SIDS endpoints.
To the extent robust summaries are submitted (refer
to Flowchart Graphic 8), the Agency would make
the robust summaries publicly available through the
HPVIS. For those chemicals for which the submitted
studies are determined to be adequate, but for which
robust summaries were not submitted, EPA would
prepare the robust summaries and make the data
publicly available in the HPVIS.
Should the submitted or identified studies be found
inadequate for certain chemicals, then PAIR data
would be evaluated by EPA to determine if a TSCA
section 4(a)(l)(B) finding can be made for those
chemicals without further research.
Flowchart Graphic 10 - Can test rule
exposure-based findings be made with
PAIR and/or other currently available
information?
The Agency will review the PAIR data to determine
if the TSCA section 4(a)(l)(B)(i) finding for a test
rule can be made. (See the description of Flowchart
Graphic 5 for details.)
91
EPA's High Production Volume Challenge Program
Status and Future Directions
92
-------
Flowchart Graphic 11 - Propose and
finalize Third HPV Test Rule for chemicals
for which findings can be made. Consider
risk-based findings for chemicals as
needed.
If the findings can be made, the Agency would propose
a third HPV orphan chemical test rule. EPA would
consider requesting or requiring robust summaries for
studies conducted under this test rule.
Flowchart Graphic 12 - Seek other data
development mechanism for chemicals
with continuing hazard and fate data
gaps.
The Agency solicits input on other data development
mechanisms that will help fill hazard and fate data
gaps for chemicals that remain as orphan chemicals, if
any.
Projected Orphans Data Development Timeline4
Estimated Timeline First HPV Test Rule Second HPV Test Rule Third HPV Test Rule
October 2004
December 2004
June 2005
October 2005
January 2006
September 2006
November 2006
August 2007
Final Rule Published
Data Availability/Adequacy
Analysis Initiated
Proposed Test Rule
Published
Review of Public Comments
on Proposed Rule Initiated
Final Test Rule Published
8(a)/8(d) Candidates Provided to
ITC
55th ITC Report Published
8(a) and 8(d) Final Rules
Published
Review of 8(a) and 8(d)
submissions initiated
Proposed Test Rule Published
Review of Public Comments on
Proposed Rule Initiated
Final Test Rule Published
It is anticipated that the proposed Second HPV Test
Rule will be published in October 2005. At the same
time, EPA would review data submitted under the
HaSDR and PAIR rules for inclusion in the HPVIS
or for making the TSCA section 4(a)(l)(B)(i) finding
for a Third HPV Test Rule. In January 2006, EPA
would begin its review of the public comments
submitted on the Second HPV Test Rule.
In September 2006, it is expected that the Second
HPV Test Rule would be promulgated and the
proposed Third HPV Test Rule would be published,
followed by the review of public comments submitted
in response to the Third HPV Test Rule in November
2006 and final promulgation in August 2007.
*Timeline assumes that all proposed and final rules will be subject to 90-day OMB review.
{This is a projected schedule that the Agency will work to meet in preparing and promulgating
test rules as needed. Unanticipated problems or issues could result in delays.}
Beginning in October 2004, EPA would initiate
efforts to conduct data availability/adequacy searches
for orphan chemicals identified for inclusion in the
Second HPV Test Rule. Additionally, the list of
orphan chemicals designated as candidates for the
HaSDR rule under 8(d) and the PAIR rule under 8(a)
would be provided to the ITC.
Subsequently, in 2005, it is anticipated that the First
HPV Test Rule containing fewer than the 37 orphan
chemicals included on the proposed First HPV Test
Rule would be promulgated. In December 2004, it is
expected that the ITC would publish its 55th report
to the EPA Administrator outlining the Committee's
intended priorities and actions.
93
EPA's High Production Volume Challenge Program
Status and Future Directions
94
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Appendix 6: Future Directions
and Developing Issues
EPA's "High Production Volume Challenge
Program" website is found at http://www.
epa.gov/chemrtk/volchall.htm. Test plan and
robust summary submissions, sponsor commitment
information, chemical lists, guidance documents,
and other materials can be found at this site. EPA
has recently provided limited search capability on its
existing "Robust Summaries and Test Plans" webpage
(http://www.epa.gov/chemrtk/hpvrstp.htm) that allows
stakeholders to search more efficiently for test plans
and robust summaries. The search feature allows users
to locate specific test plans by CAS number, chemical
name, sponsor (individual company or consortium), or
individual/category test plan name. The search then
links users to the appropriate submission materials.
Various stakeholder volunteers were used to test the
newly developed search component of the website,
including members of the NPPTAC's (National
Pollution Prevention and Toxics Advisory Committee
see "Developing Issues" below) HPV Work Group,
a group specifically charged with considering HPV
issues, as well as the Forum on State and Tribal
Toxics Action (FOSTTA) Chemical Information and
Management Project (CIMP) members. Comments
were received from the testers, and a production release
of this function occurred in April 2004.
A much more comprehensive, data-searchable
application with a website front-end is the ultimate
goal of the HPV Information System (HPVIS). This
system will allow users to thoroughly search across
all test plan and robust summary-related materials
including data presented within and among robust
summaries. Among other features, the system will
ultimately allow the user to locate specific endpoint
data, and it will recognize certain sponsor-provided
chemical synonym names in addition to the officially
recognized chemical name. The immediate need is to
develop enough functionality to populate the HPVIS
with data and develop limited querying tools to enable
the public to access these data. See the following table
for the Projected HPVIS 2004 development timeline.
The development process has begun defining the
screen flow and designing system screens. The initial
focus involves populating the database with historical
submissions that were provided in support of the
HPV Challenge Program. EPA will be working with
sponsors and trade associations on the process of
entering and validating legacy data as well as newly
submitted test plan and robust summary data. The
initial public release of the database is scheduled
toward late 2004 / early 2005.
Availability of screening-level hazard data on HPV
chemicals is a global issue. There are many activities
addressing this issue worldwide. Coordination and
compatibility of various international HPV data
systems are essential. EPA is collaboratively working
with the European Commission (EC), in consultation
with the Organization for Economic Cooperation
and Development (OECD), and with the additional
Sfafus and Future Directions
96
-------
participation of Canada and Japan on a Global HPV
Portal. The Portal provides a central information
technology location for accessing international HPV
chemical data repositories. It focuses on information
sharing across geographic, programmatic, and political
boundaries. The planning around the Portal is still
in the conceptual stages. An articulated vision for
the Portal into a more tangible project is expected
in the coming months. See the figure below for an
illustration of the Portal information sharing concept.
The aim of the Global HPV Portal is to provide
seamless information sharing between the European
Union's (E.U.) International Uniform Chemical
Information Database (IUCLID) and EPA's HPVIS.
The two leads the EC and the Agency have
worked diligently on the Portal requirements over
the past year in an effort to share information and
make data more readily available to stakeholders from
around the world. Some of the benefits resulting from
the Portal concept include:
Information can be shared across IUCLID and
EPA's HPVIS without requiring industry to
submit data to both systems.
Government users can seamlessly access a unified
picture of non-CBI data contained in both
IUCLID and EPA's HPVIS.
Industry can easily submit and obtain information
from both the E.U. and U.S. programs. Industry
can also share information with other industry
representatives as desired.
Public users can obtain access to HPV data
regardless of whether the data exist in the E.U.
program or the U.S. program.
Public users can access E.U. and U.S. HPV data
through a single interface.
Other programs, such as new chemicals or
biocides, can be added to the Portal as desired.
Databases from other collaborating countries can
also be added to the Portal. Countries such as
Canada and Japan are working with EC and the
Agency.
By the end of 2004, the HPV Portal effort expects
to be fully active and engaged with a core team of
leaders in place, a System Management Plan drafted, a
System Concept document finalized, and requirements
defined. The key milestone to be reached by this time
is the finalization, formalization, and acceptance of
fundamental functions through the completion of the
Functional Requirements Specifications document.
Following these achievements, the HPV Portal
will continue to implement and update the System
Global HPV Portal Information Sharing
Management Plan, as well as identify and initiate
security activities related to the Portal and its
development. Likewise, active development efforts
will begin with the preparation of a Design Decision
Paper, exploration of "buy-or-build" options, and the
creation of operational platform and administrative
policies. Finally, development of a formal System
Design Document will commence.
As the HPV Challenge Program moves toward 2005
and prepares to provide the industry-submitted data
to the public in a searchable database format, the
Agency has begun to press forward with developing
and planning for the delivery of the HPVIS and the
Global HPV Portal. This will lead to an international
seamless exchange of data. The Office of Pollution
Prevention and Toxics (OPPT) plans to continue
working directly with sponsors and trade associations
on the process of entering and validating legacy data as
well as newly submitted test plan and robust summary
data. This is a very important step in ensuring that the
HPVIS is populated efficiently.
Additionally, now that steadily increasing amounts of
the data have been submitted, the Agency, working
with the National Pollution Prevention and Toxics
Advisory Committee (NPPTAC) and its HPV Work
Group, is focusing on approaches for using the data
to identify and prioritize chemicals for further work.
Once the prioritized chemicals have been identified,
the next steps include employing mechanisms to
obtain needed hazard (beyond the basic screening-level
of the SIDS) or exposure data through voluntary or
regulatory approaches.
OPPT will continue to inform the public about the
HPV Challenge Program and the potential uses of
the data. Preparation of various guidance documents
and fact sheets are expected to provide the important
background information for helping the general public
understand the technical data.
Another priority related to HPV chemicals is how
to proceed with obtaining data on the orphans.
Additionally, developing and considering options for a
program to obtain data on the newly emerging HPV
chemicals, which were reported in recent IUR cycles,
is viewed as an important next step. A total of 1,118
additional chemicals, that were not HPV on the 1990
IUR, were reported at one million pounds or more
under either or both the 1998 or 2002 lURs.
OPPT created the NPPTAC to provide assistance to
the office as it begins to address these very important
next steps. NPPTAC was specifically established
under the Federal Advisory Committee Act (FACA)
to provide advice, information, and recommendations
on the overall policy and implementation of
programs managed by OPPT. OPPT's duties and
responsibilities under the Toxics Substances Control
Act (TSCA) and the Pollution Prevention Act (PPA)
will be addressed, and a work group has been formed
to address HPV issues. Specifically, the NPPTAC
and its HPV Work Group continue to discuss how
OPPT should proceed with using the HPV data
to identify and prioritize chemicals of concern, the
design and implementation of the HPV Information
System (HPVIS), how the Agency should address
the emerging HPV chemicals not currently included
in the HPV Challenge Program, and how to proceed
with obtaining additional data for orphan chemicals.
Additional NPPTAC information can be found at
http://www.epa.gov/oppt/npptac/.
97
98
EPA's High Production Volume Challenge Program
Status and Future Directions
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1 990 HPV Challenge
Program Chemical List
1994 List of HPV
Additions
ACC
API
CAS Number
Category
Category Analysis
Consortium
EC
ED
ED
Endpoint
HPV
HPVIS
ICCA
IUCLID
IUR
The list of HPV Chemicals from the 1990 IUR reporting period, from which sponsors
may make chemical commitments to supply data.
Approximately 500 organic chemicals that were newly reported as HPV in the 1 994
IUR, provided for use by companies in developing categories of chemicals.
American Chemistry Council.
American Petroleum Institute.
Chemical Abstracts Service Number: A unique identification number assigned by the
Chemical Abstracts Service (CAS) to each distinct chemical substance recorded in
the CAS Chemical Registry System. This number may contain up to 9 digits. For
example, the CAS number for Valium is 439-14-5.
A group of substances similar in chemical structure that show a regular pattern of
properties and effects. In the HPV Challenge Program, being able to interpolate
between and among, or extrapolate from, category members often results in reduced
testing, since not all chemicals need to be tested for every SIDS endpoint.
A submitted plan where a sponsor indicates how their underlying category hypothesis
is reasonable, and how existing and new data can be interpolated/extrapolated to
address the untested category chemicals' endpoints. EPA reviews the analysis and
considers whether it is reasonable or if the category should be considered for
restructuring.
An organization consisting of two or more companies that agree to sponsor at least
one chemical in the HPV Challenge Program.
European Commission: An organization that serves to operate in the best interest of
the European Union, specifically through proposing legislation, implementing policies,
enforcing law, and negotiating international agreements.
Environmental Defense.
European Union: An organization of democratic European countries that have
established common institutions to work toward prosperity.
The chemical or biological effect that is assessed by a test method.
High Production Volume: Chemicals manufactured or imported in quantities equal to
or greater than 1 million pounds per year.
High Production Volume Information System: A publicly accessible website where
users will access comprehensive data related to HPV Challenge Program test plan
and robust summary submissions.
International Council of Chemical Associations: A chemical industry organization that
represents chemical manufacturers and producers from around the world, it adds
information transfer within the international industry.
International Uniform Chemical Information Database: A system of data collection
and evaluation within the EU Risk Assessment Program and accepted by OECD as
the data exchange tool within the OECD Existing Chemicals Program.
Inventory Update Rule: A rule promulgated in 1986 and revised extensively in 2003
by EPA that updates the TSCA Chemical Substances Inventory database every four
years. This rule requires manufacturers and importers of certain chemical
substances included on the TSCA Chemical Substances Inventory to report current
data on the production volume, plant site, and site-limited status of these substances.
Reporting in 2006 and beyond will include additional components.
Sfafus and Future Directions
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LogKow
NPPTAC
OECD
OPPT
Orphan
PCRM
PETA
Robust Summary
SAR
SIAM
SIAR
SIDS
SOCMA
Start Year
Test Plan
Test Rule
TSCA
UNEP
Viable Chemical
The octanol-water partition coefficient for a neutral molecule. It is generally used as
a relative indicator of the tendency of an organic compound to adsorb to soil.
National Pollution Prevention and Toxics Advisory Committee: National advisory
body to provide advice, information, and recommendations on the overall policy and
operation of programs managed by the Office of Pollution Prevention and Toxics
(OPPT).
Organization for Economic Cooperation and Development: A group of 30 member
countries sharing a commitment to democratic government and the market economy,
covering economic and social issues such as macroeconomics, trade, education,
development, and science and innovation.
Office of Pollution Prevention and Toxics. EPA's office wherein the HPV Challenge
Program is administered.
An unsponsored chemical from the 1990 HPV Challenge Program Chemical List that
may be manufactured or imported in quantities equal to or greater than one million
pounds in the last two IUR reporting periods.
Physicians Committee for Responsible Medicine.
People for the Ethical Treatment of Animals.
An abridged reporting of data that includes the study objective, method, results, and
conclusions for one endpoint.
Structure-Activity Relationship: An analysis in which a substance's environmental
fate or effects relate to the substance's molecular structure. For the HPV Challenge
Program, SAR is often used in category analyses where endpoint data for one
chemical can be used to cover endpoint data for another similar chemical.
SIDS Initial Assessment Meeting: A gathering of OECD member states to agree on
initial hazard assessment for HPV SIDS chemicals.
SIDS Initial Assessment Report: OECD member states' evaluations, conclusions,
and recommendations for SIDS chemicals that are reviewed and accepted by the
OECD at the SIDS Initial Assessment Meeting.
Screening Information Data Set: An internationally agreed upon set of screening data
developed by the OECD, the SIDS consists of a chemical's (1) general information,
(2) physical-chemical data, (3) environmental fate and pathways data, (4) ecotoxicity
data, and (5) toxicological data.
Synthetic Organic Chemical Manufacturers Association: The primary trade
association serving the specialty-batch and custom chemical industry.
The year in which a sponsor commits to submit a chemical's test plan and robust
summary.
A summary of available and adequate data, with reference to a summary of data
gaps and a rationale for testing, if necessary.
A TSCA Section 4 regulatory mechanism that requires testing of chemical
substances and mixtures for which the necessary findings have been made.
Toxic Substances Control Act: An Act created by Congress that gives EPA the ability
to assess and regulate industrial chemicals in the United States.
United Nations Environment Programme: An organization that provides leadership
and encourages partnership in caring for the environment. It informs and enables
nations to improve their quality of life in global and regional contexts.
A chemical for which a commitment was made after December 26, 2000, and
therefore involves the submission of full studies in addition to robust summaries of
studies.
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EPA's High Production Volume Challenge Program
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visif
rtecycieu/ rtecycm
Printed with vegetakjic-kjdo<
paper that contains a minin
50% post-consumer fiber conten
processed chlorine free
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