Offi ce of Pollution

Prevention and Toxics

Status and Future Directions of the

 High Production Volume

 Challenge Program
Status and Future Directions of the

 High Production Volume

 Challenge Program

Office of Pollution

Prevention and Toxics
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
EPA’s High Production Volume Challenge Program

1

Status and Future Directions

2

The HPV Challenge Program Since the Program’s inception in 1998, industry chemical 

manufacturers and importers have participated in the 

Challenge by sponsoring over 2,200 chemicals.

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 

fi fty-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 fulfi ll 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, signifi cant amounts of data have been made 

public for the fi rst 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 effi cient 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.

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 briefl y 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, offi cially 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 identifi ed 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 

may be 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 

fi gure on the following page) showed that 43% of 

1

ACC = formerly known as the Chemical Manufacturers Association.

2

ED = formerly known as Environmental Defense Fund.

3

Chemical 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

3

Status and Future Directions

4

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 screeninglevel 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 How the Program 

Works, see Appendix 2.

October 1998

The HPV Challenge Program is officially

launched. EPA sends a letter to

manufacturers, soliciting companies to

sponsor chemicals in the program.

April 2000

The first test plans and data summaries

are posted on EPA’s HPV Challlenge

Program Website.

2001-2003

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.

December 31, 2004

All test plans for sponsored

chemicals should be submitted.

1998 1999 2000 2001 2002 2003 2004 2005

HPV Challenge Program Timeline

Lack of Publicly

Available Screening Data

10.3 9.3 9.0 8.1 7.1

13.8

42.5

0

10

20

30

40

50

0 1 2 3 4 5 6

Number of Endpoints with

Publicly Available Data

% of HPV Chemicals

Lack of Publicly

Available Screening Data

4

The six endpoints: acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, mutagenicity, ecotoxicity, and environmental fate.
EPA’s High Production Volume Challenge Program

5

Status and Future Directions

6

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%). 

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 

Chemicals Sponsored Directly in the HPV Challenge Program

204

7

495

9

246

8

275

44 46 37

0

100

200

300

400

500

# of Chemicals

2000 2001 2002 2003 2004

Year

submitted outstanding
EPA’s High Production Volume Challenge Program

7

Status and Future Directions

8

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

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 

Published Studies

(4,800) (41%)

6,801

4,800

Unpublished Studies

(6,801) (59%)

Endpoint

Fate

Phys.chem.

Human Health

Ecotoxicity

0 10 20 30 40 50 60 70

Percent

Existing Data

SAR and Other Techniques

Proposed Testing

Endpoint Data Sources
EPA’s High Production Volume Challenge Program

9

Status and Future Directions

10

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.

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, 

Chemicals Sponsored Indirectly through the ICCA HPV Initiative

Start Year or Test Plan 

Receipt Year

Total Expected 

Chemical Submissions

SIAM Chemicals Sponsored 

by ICCA

1999 38 14

2000 149 54

2001 487 98

2002 133 19

2003 127 17

2004 40 27

Total 974 229
EPA’s High Production Volume Challenge Program

11

Status and Future Directions

12

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 summaryrelated 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 

EPA’s 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. EPA’s 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. 
Status and Future Directions

14

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 Chemicals7 study in 1998. This lack of 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 

Lack of Publicly Available

Hazard and Fate Data

10.3 9.3 9.0 8.1 7.1

13.8

42.5

0

10

20

30

40

50

0 1 2 3 4 5 6

Number of Endpoints with

Publicly Available Data

% of HPV Chemicals

Lack of Publicly Available 

Hazard and Fate Data

5

Toxic 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).

6

Chemical 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). 

7

Public Availability of SIDS-Related Testing Data for U.S. High Production Volume Chemicals (1998). Arlington, VA: Chemical Manufacturers Association. 
EPA’s High Production Volume Challenge Program

15

Status and Future Directions

16

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 screeninglevel 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.
Status and Future Directions

18

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 

Appendix 2: How the Program Works

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. 
EPA’s High Production Volume Challenge Program

19

Status and Future Directions

20

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.}

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

15

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 Trade

Association(s)

Number of

Chemicals

Sponsored

Companies

3M ACC 4

A.E. Staley Manufacturing Company 14

Abitibi Consolidated (Formerly Donohue, Inc.) 1

Aceto Corp SOCMA 3

Agri-Energy, LLC 1

Air Liquide America ACC 1

Air Products and Chemicals, Inc. ACC 9

Akzo Nobel ACC 1

Akzo Nobel - Eka Chemicals Incorporated ACC 36

Akzo Nobel - Polymer Chemicals Business Group ACC 1

Akzo Nobel - Polymer Chemicals Metal Alkyls ACC 21

Akzo Nobel - Resins ACC 36

Akzo Nobel Chemicals Inc. ACC 91

Akzo Nobel Functional Chemicals LLC ACC 3

Akzo Nobel Functional Chemicals LLC - Phosphorus Chemicals ACC 9

Al-Corn Clean Fuel Cooperative 1

Albemarle Corporation ACC, API, SOCMA 32

Albina Fuel Co. dba Albina Asphalt 36

Alchem, Ltd. 1

ALCO Chemical 34

Alliance Forest Products 1

Alliant Techsystems Inc. 1

Amerada Hess Corporation 392

Ameribrom Inc. SOCMA 6

Angus Chemical Company 2

Aqua-Clor 3

Arch Chemicals, Inc. ACC 3

Archer Daniels Midland Company (ADM) 14

Arizona Chemical Company 129
EPA’s High Production Volume Challenge Program

21

Status and Future Directions

22 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

16

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Asahi Glass Co., Ltd. 1

Ashland Inc. ACC, API 2

Asphalt Materials, Inc. 36

Atlantic Richfield Company (ARCO) 392

Atofina Chemicals, Inc. ACC 38

Atofina Oil and Chemical Company ACC 392

Atofina Petrochemical Inc. ACC 3

Ausimont S.p.A. 1

Ausimont USA, Inc. 2

Baerlocher USA 19

Baker Petrolite Corporation API, SOCMA 35

BASF Corporation ACC, SOCMA 149

BASF Performance Copolymers, LLC ACC, SOCMA 1

Baule USA 1

Bayer AG Corporation ACC, SOCMA 3

Bayer Corporation ACC 70

Bedoukian Research, Inc. SOCMA 45

Big West Oil LLC/Flying J Inc. 392

Bimasco, Inc. 5

BioLab, Inc. 4

Blacklidge 5

Blackman Uhler Chemical Company (Division of Synalloy Corp.) SOCMA 1

Blue Ridge Paper Products 1

Boise Cascade Corporation 82

Borden Chemical, Inc. SOCMA 1

Borden Chemicals and Plastics (BCP) Limited Operating Partnership SOCMA 2

Borregaard Italy SOCMA 4

Bowater Incorporated 1

BP ACC, API 480

Broin Enterprises, Inc. 1

Buckeye 1

Buffalo Color Corporation 14

Bush Boake Allen Inc. 32

The C.P. Hall Company ACC 49

Cabot Corporation 1

Calcasieu Refining Company 392

Capital Resin Corporation SOCMA 2

Cardolite Corporation SOCMA 1

Cargill, Inc. North American Corn Milling Division 1

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

17

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Cargill, Incorporated 13

Caribbean Methanol Company Limited 1

CBC (America) Corp. SOCMA 1

Celanese Ltd. ACC 22

Cenex Harvest States Cooperatives 392

Champion International Corporation 45

Chevron Oronite Company LLC ACC, SOCMA 75

Chevron Phillips Chemical Company, LP ACC, SOCMA 91

Chevron Products Company ACC, SOCMA 394

Chief Ethanol Fuels, Inc. 1

Chippewa Valley Ethanol Company (CVEC) 1

Ciba Specialty Chemicals Corporation ACC, API 49

Ciba Specialty Chemicals Corporation - Water Treatments ACC, API 3

Ciba Specialty Chemicals Corporation, Plastic Additives Segment ACC, API 14

Citgo Asphalt Refining Corporation (CARCO) 392

Citgo Petroleum Corporation 392

Citrus and Allied Essences, Ltd. 45

Clariant Corporation SOCMA 37

Clearon Corporation 3

Cleveland Asphalt Products, Inc. 36

The Clorox Company 65

Cobitco, Inc. 36

Cognis Corporation ACC, SOCMA 134

Colas, Inc. 36

Color Intermediates, Inc. 25

Colorcon, Inc. 5

Condea Servo LLC 19

ConocoPhillips Company API 392

Copperhead Chemical Company Inc. SOCMA 1

Corn Plus 1

Corsicana Technologies, Inc. SOCMA 29

Countrymark Cooperative, Inc. 392

Crompton & Knowles Colors Incorporated ACC 1

Crompton Corporation ACC 447

Cross Oil Refining & Marketing, Inc. 392

Crown Central Petroleum Corporation 392

CVC Specialty Chemicals, Inc. 2

Cytec Industries Inc. ACC 67

Daikin America, Inc. ACC 1
EPA’s High Production Volume Challenge Program

23

Status and Future Directions

24 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

18

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Dakota Gasification Company ACC 395

DanChem Technologies, Inc. ACC, SOCMA 1

Day-Glo Color Corp. 1

Degussa AG ACC, SOCMA 3

Deltech Corporation SOCMA 3

Denco, LLC 1

Derivados Electroquimicos Levante SA (DELSA) 3

Dixie Chemical Company, Inc. ACC, SOCMA 6

Dover Chemical Corporation ACC 5

Dow AgroSciences ACC, API, SOCMA 1

The Dow Chemical Company ACC, API, SOCMA 124

DRAGOCO, Inc. 45

DSM Chemicals North America, Inc. ACC, SOCMA 2

DSM Fine Chemicals, Inc. ACC, SOCMA 1

DynaChem, Inc. 2

Dynegy Midstream Services LP 392

Dyno Nobel Inc. 1

DyStar LP 1

E. A. Mariani Asphalt Company 36

E.I. du Pont de Nemours and Company ACC 167

Eastern Paper, Inc. 1

Eastman Chemical Company ACC, SOCMA 204

Eastman Kodak Company ACC 13

Ecofuel 1

Ecolab Inc 5

Edginton Oil Company 392

Eighty-Eight Oil Company 392

Eliokem, LLC ACC 34

Elkhorn Operating Company 392

Emulsion Products of Alaska, Inc. 5

Enron Methanol Company 1

Enterprise Products Company 392

Equilon Enterprises, LLC and Motiva Enterprises, LLC 392

Equistar Chemicals, LP 77

Equitable Oil Purchasing Company 392

Equiva Services LLC 392

Ergon - West Virginia, Inc. 392

Ergon Asphalt & Emulsions, Inc. 36

Ergon Ref Inc 392

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

19

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

ESCO Company Limited Partnership SOCMA 5

Ethanol2002 1

EXOL 1

Exxon Company, USA ACC, API 392

ExxonMobil Chemical Company ACC, API 263

Farmland Industries Inc. 392

Ferro Corporation ACC, SOCMA 86

Fertilizers & Chemicals, Ltd. 3

Fina Oil and Chemical Company, Inc. 455

Finch, Pruyn & Company, Incorporated 1

FINETEX, Inc. 3

Firmenich, Incorporated 17

First Chemical Corporation 5

Flexsys America L.P. SOCMA 34

Flint Hills Resources LP 392

FMC Corporation ACC, API, SOCMA 10

Formosa Hydrocarbons Company, Inc. 392

Formosa Plastics Corporation, USA 74

Fragrance Resources 45

Gaylord Chemical Corporation 2

GE Plastics API 1

General Electric (GE) API 15

GEO Specialty Chemicals 1

Georgia Gulf Corporation ACC 4

Georgia-Pacific Corporation 2

Georgia-Pacific Resins, Inc. 38

Giant Industries, Inc. 392

Givaudan Fragrances Corporation 60

Global Octanes Corporation 392

Golden Bear Oil Specialties 392

The Goodyear Tire & Rubber Company 475

Great Lakes Chemical Corporation ACC 13

Greif Bros. Corporation 1

Groupe SNPE 59

Gulf States Asphalt Co., LLP 5

Gulf States Paper Corporation 1

Haarmann & Reimer (H&R) 13

Hampshire Chemical Corp. 5

Harcros Chemicals Inc. 6
EPA’s High Production Volume Challenge Program

25

Status and Future Directions

26 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

20

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Hatco Corporation SOCMA 47

Heartland Corn Products 1

Heartland Grain Fuels, LP 1

Hercules Incorporated 130

High Plains Corporation 1

Hills Materials Company 5

Holly Corporation 392

Honeywell International Inc. ACC, SOCMA 395

Hovensa LLC 392

Hunt Refining Company API 392

Huntsman Advanced Materials Americas Inc. SOCMA 3

Huntsman Corporation SOCMA 83

Huntway Refining Company 392

ICI ACC 1

ICI Americas, Inc. ACC 156

Ihara Chemical Industry Co., Ltd. 1

INDSPEC Chemical Corporation 1

INEOS N.V. 1

Infineum USA L.P. ACC, API 73

Inland Paperboard and Packaging, Inc. 37

Inland Refining, Inc. 392

Inolex Chemical Company 72

International Flavors & Fragrances, Inc. (IFF-US) 48

International Paper 37

International Specialty Products (ISP) ACC, SOCMA 4

ISOCHEM INC (formerly Vandemark Inc.) SOCMA 2

J. Manheimer Inc. 46

Kao Corporation ACC 1

Kao Specialties Americas LLC (formerly High Point Chemical

Corporation) ACC 58

Kemin Industries, Inc. 19

Kern Oil & Ref Co 392

King Industries, Inc. 4

Koch Industries, Inc. 470

Koei Chemical Co., Ltd. 9

Korea Hyeop Hwa Chemical Industry Company, Ltd. 1

KoSa 13

Kuraray Co., Ltd. SOCMA 46

La Gloria Oil and Gas Company 392

Lindau Chemicals, Inc. 6

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

21

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Lion Oil Company 392

Loctite Corporation 1

Longview Fibre Company 1

Lonza Inc. SOCMA 38

Louis Marsch, Inc. 5

Louisiana-Pacific Corporation 1

The Lubrizol Corporation ACC, API, SOCMA 103

Lyondell Chemical Company 22

Lyondell Methanol Co. 1

Lyondell-Citgo Refining Company Ltd. 392

Mallinckrodt Inc. 32

Marathon Ashland Petroleum LLC API 409

Mason Chemical Company 5

McAsphalt Industries Limited 36

McIntyre Group, Ltd. 3

MeadWestvaco ACC 112

Merichem Chemicals & Refinery Services LLC ACC, API 392

Merisol USA LLC ACC, API 405

Metachem Products, LLC 4

Methanex Methanol Company ACC 1

The Methanol Sector Group, a Sector Group of CEFIC 1

MFG Chemical, Inc. SOCMA 3

Midwest Grain Products 1

Millennium Chemicals Inc. ACC 60

Milliken Chemical ACC 6

Minnesota Corn Processors, Inc. (MCP) 1

Mitsubishi Gas Chemical Company, Inc. ACC 2

MLPC International 1

Mobil Oil Corporation 392

Monsanto Company ACC 2

Morflex, Inc. SOCMA 1

Motiva Enterprises, LLC 392

Murphy Oil USA, Inc. API 392

Nalco Chemical Company ACC 10

Nan Ya Plastics Corporation, America 3

National Cooperative Refinery Association 392

National Starch (ICI Americas) ACC 2

Navajo Refining Company 392

Nepera, Inc. ACC 7
EPA’s High Production Volume Challenge Program

27

Status and Future Directions

28 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

22

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Neville Chemical Company 392

New Energy Corp. 1

New England Emulsions Corp. 36

NIPA Inc. 1

Nippon Petrochemicals Co., Ltd. 1

Nissan Chemical America Corporation 3

Nissan Chemical Industries, Ltd. 1

Nisso America, Inc. 3

NOVA Chemicals Inc. ACC 78

Noveon, Inc. SOCMA 132

Occidental Chemical Corporation (OxyChem) ACC, API 4

OMG Americas, Inc. ACC 32

OmniSpecialty Corporation 2

Omnova Solutions Inc. SOCMA 1

Ondeo Nalco Energy Services (ONES) 29

P. H. Glatfelter Company 1

Packaging Corporation of America (PCA) 37

Parlallel Products 1

PDV Midwest Refining, L.L.C. 409

Pelron Corporation SOCMA 19

Pennzoil-Quaker State Company 392

Phillips Petroleum Company 386

Pilot Chemical Company SOCMA 5

Placid Refining Company LLC 392

Plasmine Technology, Inc. 36

PMC Specialties Group, Inc. SOCMA 9

Polarome International Incorporated 45

Port Townsend Paper Corporation 1

Potlatch Corporation 1

PPG Industries, Inc. ACC, SOCMA 9

Praxair Inc ACC, API 1

Premcor Refining & Marketing INC 392

Prime Materials & Supply Corp. 5

Pro-Corn, LLC 1

The Procter & Gamble Company ACC 89

Proviron Fine Chemicals NV SOCMA 1

PURAC America, Inc. 1

Quaker Chemical Corporation 47

Quest International 45

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

23

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

R. T. Vanderbilt Company, Inc. ACC 37

Raisio Chemicals 36

Rayonier 37

Reichhold Inc. 2

Reilly Industries, Inc. ACC 10

Resolution Performance Products LLC 32

Reynolds Metals Company 392

Rhein Chemie Corporation 59

Rhodia Inc. ACC, SOCMA 216

Rhodia Organique Fine Limited ACC, SOCMA 1

Riverwood International Corporation 37

Rohm and Haas Company ACC 73

Rubicon Inc. 1

Rutgers Organics Corporation SOCMA 2

Rutherford Chemicals LLC dba Nepera ACC 9

Sabic Americas Inc. ACC 1

Safety-Kleen Oil Recovery 392

Sand Creek Chemical Limited Partnership 1

Sartomer Company, Inc. ACC 2

Sasol North America Inc. ACC 499

Saturn Methanol Company, LLC 1

Schenectady International (SII) ACC 18

Seaco, Inc. 5

Sensient Colors Inc. 5

Sensient Flavors Inc 45

Shell Chemical Company ACC, API 74

Shell Chemicals Limited ACC, API 1

Shell Oil Company ACC, API 392

Shepherd Chemical Company ACC 32

Shikoku Chemicals Corporation 3

ShinWon Corporation 1

Sid Richardson Gasoline Co 392

Silver Eagle Refining, Inc. 392

Sinclair Oil Corporation 392

Smurfit Stone Container Corp. 37

SNF Holding Company ACC 3

Solutia ACC 55

Solvay Advanced Polymers, Inc. (SAPI) ACC, SOCMA 1

South Hampton Refining Co. 392
EPA’s High Production Volume Challenge Program

29

Status and Future Directions

30 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

24

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Southern Chemical Corporation 1

SpecialtyChem Products Corporation 4

Specified Fuels & Chemicals, LLC 392

St. Laurent Paperboard Inc. 1

St. Marks Powder, Inc. 1

Star Enterprise 392

Stepan Company ACC 95

Sterling Chemicals, Inc. 18

Stockhausen GmbH & Co. KG 2

Stora Enso North America (Formerly Consolidated Papers, Inc.) 1

Suit-Kote Corporation 5

Sumitomo Chemical America, Inc. ACC, SOCMA 1

Sun Chemical Corporation SOCMA 26

Sunoco, Inc. (R&M) ACC 526

Sybron Chemicals Inc. 1

Symrise 45

Syngenta Crop Protection AG SOCMA 1

Takasago International Corporation (USA) 1

Tecnal Corporation 45

Tejas Energy, LLC 392

Teknor Apex Company 22

Terra Industries 1

Tesoro Petroleum Companies, Inc. 392

Texaco Inc. API 392

Texas Petrochemicals Corporation (TPC) 74

Thompson-McCully Oil Co. 36

Ticona LLC 2

Tomah3 ACC 46

Toray Fine Chemicals Co., Ltd. 1

Tosco Corporation 392

Trinidad and Tobago Methanol Company Limited (TTMC) 1

Troy Chemical Company ACC 3

Troy Corporation ACC 19

True Oil Company 392

U.S. Oil & Refining Co. 392

Ultramar Diamond Shamrock Corporation 392

Unilever Home & Personal Care - USA 48

Unique Paving Materials Corporation 36

Unitex Chemical Corporation SOCMA 1

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

25

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Unocal Corporation API 392

Valero Energy Corporation 392

Vance Brothers, Inc 36

VanDeMark Chemical Company Inc. 1

Velsicol Chemical Corporation 53

Vestal Asphalt, Inc. 36

Vulcan Chemicals ACC 45

Vulcan Construction Materials, LP ACC 5

W.R. Grace & Co. ACC 13

Wacker Biochem Corporation ACC, SOCMA 2

Wacker Silicones Corporation ACC, SOCMA 1

Westlake Chemical Corporation 75

Weyerhaeuser Company 37

Whitaker Roads Corporation 36

Willamette Industries, Inc. 1

Williams Energy Services 393

Williams Ethanol Services, Inc. (and its affiliate Nebraska Energy LLC) 1

Williams Olefins, LLC (formerly Union Texas Petrochemicals

Corporation) 74

Williams Refining, LLC 392

Wynnewood Refining Company 392

Zeneca Ag Products, Inc. 3

Consortia

Akzo Nobel - Polymer Chemicals Business Group / PPG Industries, Inc. ACC, SOCMA 1

Akzo Nobel - Polymer Chemicals Metal Alkyls / E.I. Du Pont de Nemours

and Company ACC 1

Albemarle Corporation / Ciba Specialty Chemicals Corporation -

Additives ACC, API, SOCMA 1

Alkyl Diphenyl Oxide Sulphonates (ADPOS) 5

Aluminum Alkyls Consortium 20

Ameribrom Inc. / Great Lakes Chemical Corporation ACC, SOCMA 1

American Chemistry Council (ACC)

Acetic Acid and Salts Panel ACC 13

Acetylene HPV Consortium ACC 1

Aliphatic Esters Panel ACC 47

Benzoates Panel ACC 1

Brominated Biocides Panel Dimethylhydantoin (DMH) Task

Force ACC 1

Brominated Flame Retardant Industry Panel (BFRIP) ACC 3

Brominated Phthalates Panel ACC 1

Diisocyanates (DIC) Panel ACC 1
EPA’s High Production Volume Challenge Program

31

Status and Future Directions

32 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

26

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Ethylbenzene Panel HPV Test Group ACC 3

Fatty Nitrogen Derived (FND) Amides Panel ACC 29

Fatty Nitrogen Derived (FND) Amines Panel ACC 29

Fatty Nitrogen Derived (FND) Cationics Panel ACC 13

Fatty Nitrogen Derived (FND) Nitriles Panel ACC 17

Health, Environmental, and Research Task Group (HERTG) ACC 59

Higher Olefins Panel ACC 24

Hydroquinone Precursors & Derivatives Panel ACC 4

Monocyclic Aromatic Amines and Nitro Aromatics (MAANA)

Panel ACC 5

Olefins Panel HPV Work Group ACC 74

Oxo Process Panel ACC 1

Phosgene Panel ACC 1

Phthalate Esters (PE) Panel HPV Testing Group ACC 21

Pyridine and Pyridine Derivatives HPV Work Group ACC 9

Rubber and Plastics Additives (RAPA) Panel ACC 34

Specialty Acrylates and Methacrylates (SAM) HPV Work Group ACC 2

American Forest & Paper Association (AF&PA) 1

American Methanol Institute Testing Group (AMITG) 1

American Petroleum Institute (API) Petroleum HPV Testing Group API 392

APAG 1

Aromatic Sulfonic Acids Association (ASAA) 2

Asphalt Emulsion Manufacturers Association (AEMA) 36

ATOFINA Chemicals, Inc. / Celanese Ltd. ACC 1

ATOFINA Chemicals, Inc. / Chevron Phillips Chemicals, LP ACC, SOCMA 1

Benzotriazoles Coalition 3

BPD/BPA Coalition 2

Cabot Corporation / Degussa AG / Wacker Silicones Corporation ACC, SOCMA 1

Chlorobenzene Producers Association 4

Ciba Specialty Chemicals Corporation - Additives / Cytec Industries Inc. ACC, API 1

Color Pigments Manufacturers Association, Inc. (CPMA) 25

Committee on HPV Challenge for Cyclohexanol 1

Consumer Specialty Products Association (CSPA) ADBAC Steering

Committee/Joint Venture 5

DADMAC HPV Committee 1

The DCB Coalition 1

Diethyl Ether Producers Association, Inc. (DEPA) 1

Dimethyl Sulfoxide (DMSO) Producers Association 1

Dioxolane Manufacturers Consortium 1

DMMP Consortium 1

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

27

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

The Dow Chemical Company / Solutia ACC, API, SOCMA 1

E.I. du Pont de Nemours and Company / ExxonMobil Chemical Company

/ The Dow Chemical Company ACC, API, SOCMA 1

E.I. du Pont de Nemours and Company / Solutia ACC 6

Eastman Chemical Company / Solutia ACC, SOCMA 3

Eastman Chemical Company / The Dow Chemical Company ACC, API, SOCMA 1

ETAD North America Disperse Blue 79:1 Consortium 1

ETAD North America Stilbene Fluorescent Brighteners 8

Ethanol HPV Challenge Consortium 1

European Fluorocarbon Technical Committee 1

ExxonMobil Chemical Company / Resolution Performance Products LLC ACC, API 1

Ferro Corporation / Ticona LLC ACC, SOCMA 1

The Flavor and Fragrance High Production Volume Consortia (FFHPVC)

Alicyclic Primary Alcohol/Aldehyde/Carboxylic Acid

Consortium 1

Aromatic Consortium 13

Cyclohexyl Derivatives Consortium 1

Linear Aliphatic C7-C9 Alcohol/Aldehyde/Carboxylic Acid

Consortium 3

Terpene Consortium 45

Great Lakes Chemical Corporation / Albemarle Corporation ACC, API, SOCMA 2

Hexamethoxymethylmelamine (HMMM) Coalition 1

Huntsman-Nissan-TGIC Consortium 1

IHF Committee on HPV Challenge for Cyclic Acid Anhydrides 6

IHF Committee on Nylon 6 and Its Precursors 1

INDSPEC Chemical Corporation / Sumitomo Chemical America, Inc. ACC, SOCMA 1

International Association of Color Manufacturers 5

Isocyanurate Industry Ad Hoc Committee (IIAHC) 3

LAB Sulfonic Acids Coalition 3

Lesser Ketones Manufacturing Association 1

The MBOCA Consortium 1

McConnaughay Technologies, Inc. 36

Metal Carboxylates Coalition 19

NMA/NBMA Association 2

Phenolic Benzotriazoles Association 4

Phosphite Producers HPV Consortium 4

Pine Chemicals Association (PCA) HPV Task Force 36

Propylene Carbonate / T-Butyl Alcohol HPV Committee 2

Quat HPV Challenge Task Force 2

The Soap and Detergent Association (SDA)
EPA’s High Production Volume Challenge Program

33

Status and Future Directions

34

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/

volchall.htm. 

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

* 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.

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

29

later in this report provides a complete description of this analysis. In addition to the 1,859

sponsored 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.

------------------------------------------------------------------------------------

Detailed Status of 1990 HPV Challenge Program Chemical List

The table below illustrates the status of chemicals on the 1990 HPV Challenge Program

Chemical List as of July 2004. In addition to the numbers of chemicals that were sponsored

and unsponsored at that time, the table includes the number of chemicals removed from the

scope of the Program because:

• The chemical is not considered a candidate for testing under the HPV Challenge

Program, based on preliminary EPA review indicating that testing using the SIDS data

set would not further our understanding of the chemical's properties,

• The chemical is being handled under the Organization for Economic Cooperation and

Development (OECD) HPV Screening Information Data Set (SIDS) Program – and not

the ICCA HPV Initiative,

• The chemical is a polymer or inorganic substance, or

• The chemical meets the criterion described in Program guidance for being “No Longer

HPV.”

Chemicals on 1990 HPV Challenge

Program Chemical List # of Chemicals

Chemicals Removed from Scope of Program*:

 Testing Would Not Further Our Understanding 39

 Sponsored under OECD HPV SIDS Program (and

 Not ICCA HPV Initiative) 190

 Polymer or Inorganic 62

 “No Longer HPV” 61

Total Removed* 352

Sponsored (includes chemicals sponsored under the

 ICCA HPV Initiative) 1,859

Unsponsored 571

Total 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.

------------------------------------------------------------------------------------

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

28

Sponsoring Organization Name Trade

Association(s)

Number of

Chemicals

Sponsored

Linear Alkylbenzene Sulfonate/Alkyl Benzene Sulfonate

(LAS/ABS) Consortium 6

Triclocarban (TCC) Consortium 1

Society of the Plastics Industry Inc. (SPI)

Epoxy Resin Systems Task Group 2

Synthetic Organic Chemical Manufacturers Association (SOCMA)

Biphenyl Work Group (BWG) SOCMA 1

Dibasic Esters (DBE) Group SOCMA 3

Isatoic Anhydride Coalition SOCMA 1

Sulfosuccinates Group SOCMA 3

Urea Resins Group SOCMA 1

Thioesters Association 4

Toluenesulfonamide Testing Group 1

Trioxane Manufacturers Consortium 1

U.S. Nitroglycerin Producers Consortium (USNPC) 1

 ------------------------------------------------------------------------------------

 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/volchall.htm.

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
EPA’s High Production Volume Challenge Program

35

Status and Future Directions

36

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) 

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

 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

Not Within Scope

of Program (352)

1,859

352

Sponsored (Includes

ICCA) (1,859)

571

Unsponsored

(571)

1994 List of HPV

Additions (99)

1990 HPV

Challenge Program

Chemical List

(1,859)

Other (264)

1,859

264

99

HPV Challenge

Program (1,248)

Both (123)

851

1,248

123

ICCA HPV

Initiative (851)

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. 
Status and Future Directions

38

Appendix 3: Overall HPV Challenge 

Program Achievements

At the onset of the HPV Challenge Program, 

EPA provided guidance documents to assist 

stakeholders 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
EPA’s High Production Volume Challenge Program

39

Status and Future Directions

40

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 
EPA’s High Production Volume Challenge Program

41

Status and Future Directions

42

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

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)

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)

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.

Anticipated Test Plan Submission Year Versus

Actual Test Plan Submission Year

2000

Year

Percent

0

5

10

15

20

25

30

35

40

5

1999 2001 2002 2003 2004

0

20

15

25

36

25

18

25

20

0

3

Anticipated

Submissions

Actual

Submissions

Number of HPV Sponsored Chemicals

Included In Test Plans (as of July 2004)

2000

Year

Number of Chemicals

Covered by Test Plans

1999 2001 2002 2003 2004

0

Expected Submitted

0

100

200

300

400

500

600

0 0

211 204

7

504 495

9 8

254 246

319

275

44

83

46 37

Outstanding

Published Studies

(4,800) (41%)

Unpublished Studies

(6,801) (59%)

4,800

6,801
EPA’s High Production Volume Challenge Program

43

Status and Future Directions

44

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 

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.

Numbers of Published and Unpublished Sources of Existing Data, by Endpoint

(as of June 2004)

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 

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

36

Numbers of Published and Unpublished Sources of Existing

Data, by Endpoint (as of June 2004)

Discipline Area Specific Endpoint Published Unpublished Total

Acute-Oral 357 864 1221

Acute-Inhalation 138 346 484

Acute-Dermal 101 472 573

Repeat Dose 556 682 1238

Gene Tox-In-Vitro 901 889 1790

Gene Tox-In-Vivo 303 275 578

Repro/Dev 459 431 890

Health Effects

Subtotal 2815 3959 6774

Acute-Fish 223 639 862

Acute-Daphnid 154 490 644

Acute-Algae 94 312 406

Environmental Effects

Subtotal 471 1441 1912

Environmental Fate Biodegradation 308 590 898

Subtotal 308 590 898

Water Solubility 319 224 543

Vapor Pressure 278 221 499

Partition Coefficient 183 189 372

Boiling Point 426 177 603

Physicochemical

Properties

Subtotal 1206 811 2017

Totals (41%) 4800 (59%) 6801 (100%) 11601

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

Endpoint Data Sources (as of June 2004)

Endpoint

Fate

Phys.chem.

Human Health

Ecotoxicity

0 10 20 30 40 50 60 70

Percent

Existing Data

Estimate/SAR/

Read Across

Proposed Testing
EPA’s High Production Volume Challenge Program

45

Status and Future Directions

46

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.
EPA’s High Production Volume Challenge Program

47

Status and Future Directions

48

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. 

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. 

Changes in Sponsorship in the HPV Challenge Program, ICCA HPV Initiative, Changes in Sponsorship in the HPV Challenge Pr and Both Programs (as of July 2004) ogram,

ICCA HPV Initiative, and Both Programs (as of July 2004)

Nov. 2000

Date

Number of Chemicals

Jan.

2000

Jan.

2002

Jan.

2003

Jan.

2004

Jul.

2004

0

500

1000

1500

2000

HPV only ICCA Only Both
EPA’s High Production Volume Challenge Program

49

Status and Future Directions

50

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; 

Details of Sponsorship in the HPV Challenge Program, ICCA HPV Initiative, 

and Both Programs (as of July 2004)

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.

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

41

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.

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)

Date Chemicals

% of

Total Chemicals

% of

Total Chemicals

% of

Total

Total

Chemicals

01/25/2000 2123 100.0 0 0.0 0 0.0 2123

06/16/2000 1815 86.9 70 3.4 204 9.8 2089

11/06/2000 1715 79.6 144 6.7 296 13.7 2155

05/21/2001 1713 79.6 155 7.2 285 13.2 2153

01/15/2002 1643 78.9 178 8.5 262 12.6 2083

07/12/2002 1417 64.1 491 22.2 302 13.7 2210

01/31/2003 1357 63.1 624 29.0 169 7.9 2150

07/18/2003 1321 61.0 664 30.7 179 8.3 2164

01/16/2004 1325 59.2 736 32.9 177 7.9 2238

07/30/2004 1248 56.2 851 38.3 123 5.5 2222

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 

Chemicals Sponsored Indirectly through the ICCA HPV Initiative (as of July 2004)

* This table does not reflect the year in which the chemical went through a SIAM.

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. 

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

42

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.

Chemicals Sponsored Indirectly through the ICCA HPV

Initiative (as of July 2004)

Start Year or Test Plan

Receipt Year

Total Expected Chemical

Submissions

SIAM Chemicals

Sponsored by ICCA*

1999 38 14

2000 149 54

2001 487 98

2002 133 19

2003 127 17

2004 40 27

Total 974 229

* This table does not reflect the year in which the chemical went through a SIAM.

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.

8

 SIAM: 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.

8

SIAM: 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.
Status and Future Directions

52

Appendix 4: Overdue Test Plans

I

n 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. 
EPA’s High Production Volume Challenge Program

53

Status and Future Directions

54

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. 

 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. 

 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). 

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, VA 22116

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, 

 Charles M. Auer, Director

 Office of Pollution Prevention and Toxics

Attachment
EPA’s High Production Volume Challenge Program

55

Status and Future Directions

56

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/links/index.cfm, was not a complete list.}

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

45

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/links/index.cfm, was not a complete list.}

CAS # Sponsor Name Trade Association

110-03-2 Air Products and Chemicals, Inc. ACC

142-30-3

1163-19-5 American Chemistry Council (ACC) Brominated Flame Retardant Industry Panel

(BFRIP)

ACC

298-07-7 American Chemistry Council (ACC) Health, Environmental, and Research Task

Group (HERTG)

ACC

64771-72-8 American Petroleum Institute (API) Petroleum HPV Testing Group API

68333-23-3

112-18-5 APAG

26040-51-7 BTBP Consortium

100-50-5 The Dow Chemical Company ACC, API, SOCMA

109-87-5

630-20-6

68390-96-5

68411-72-3

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

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

46

CAS # Sponsor Name Trade Association

7336-20-1

13863-31-5

16470-24-9

29637-52-3

67786-25-8

100-40-3 ExxonMobil Chemical Company ACC, API

108083-43-8

98510-89-5 The Flavor and Fragrance High Production Volume Consortia (FFHPVC) Terpene

Consortium

96-49-1 Huntsman Corporation

929-06-6

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 King Industries, Inc.

25619-56-1

57855-77-3

63512-64-1

101-14-4 The MBOCA Consortium

13560-89-9 Occidental Chemical Corporation (OxyChem) ACC

1809-19-4 Rhodia Inc. ACC, SOCMA

143-29-3 Rohm and Haas Company ACC

 27090-63-7 Solutia ACC

68052-49-3

111960-92-0

1333-07-9 Toluenesulfonamide Testing Group

10605-21-7 Troy Chemical Company

34375-28-5

55406-53-6

553-26-4 Zeneca Ag Products, Inc.

620-22-4

626-17-5
Status and Future Directions

58

Appendix 5: Orphan Chemicals

While the success of the HPV Challenge 

Program has been significant, some 

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)

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

47

Appendix 5

Orphan Chemicals

While the success of the HPV Challenge Program has been significant, some 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)

CAS # TSCA Chemical Name

56-40-6 Glycine

62-23-7 Benzoic acid, 4-nitro62-56-6 Thiourea

74-95-3 Methane, dibromo74-97-5 Methane, bromochloro75-07-0 Acetaldehyde

75-34-3 Ethane, 1,1-dichloro75-36-5 Acetyl chloride

75-46-7 Methane, trifluoro75-87-6 Acetaldehyde, trichloro77-76-9 Propane, 2,2-dimethoxy78-11-5 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester)

78-42-2 Phosphoric acid, tris(2-ethylhexyl) ester

81-07-2 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide

81-16-3 1-Naphthalenesulfonic acid, 2-amino81-84-5 1H,3H-Naphtho[1,8-cd]pyran-1,3-dione

83-41-0 Benzene, 1,2-dimethyl-3-nitro-
EPA’s High Production Volume Challenge Program

59

Status and Future Directions

60 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

48

CAS # TSCA Chemical Name

84-65-1 9,10-Anthracenedione

84-69-5 1,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester

85-40-5 1H-Isoindole-1,3(2H)-dione, 3a,4,7,7a-tetrahydro89-32-7 1H,3H-Benzo[1,2-c:4,5-c']difuran-1,3,5,7-tetrone

90-43-7 [1,1'-Biphenyl]-2-ol

91-53-2 Quinoline, 6-ethoxy-1,2-dihydro-2,2,4-trimethyl91-68-9 Phenol, 3-(diethylamino)-

94-75-7 Acetic acid, (2,4-dichlorophenoxy)-

94-96-2 1,3-Hexanediol, 2-ethyl95-94-3 Benzene, 1,2,4,5-tetrachloro96-22-0 3-Pentanone

96-23-1 2-Propanol, 1,3-dichloro97-00-7 Benzene, 1-chloro-2,4-dinitro98-09-9 Benzenesulfonyl chloride

98-16-8 Benzenamine, 3-(trifluoromethyl)-

98-56-6 Benzene, 1-chloro-4-(trifluoromethyl)-

99-51-4 Benzene, 1,2-dimethyl-4-nitro100-64-1 Cyclohexanone, oxime

101-34-8 9-Octadecenoic acid, 12-(acetyloxy)-, 1,2,3-propanetriyl ester, (9Z,9'Z,9''Z,12R,12'R,12''R)-

104-15-4 Benzenesulfonic acid, 4-methyl104-66-5 Benzene, 1,1'-[1,2-ethanediylbis(oxy)]bis104-93-8 Benzene, 1-methoxy-4-methyl107-39-1 1-Pentene, 2,4,4-trimethyl107-40-4 2-Pentene, 2,4,4-trimethyl107-45-9 2-Pentanamine, 2,4,4-trimethyl108-19-0 Imidodicarbonic diamide

108-20-3 Propane, 2,2'-oxybis109-86-4 Ethanol, 2-methoxy110-18-9 1,2-Ethanediamine, N,N,N',N'-tetramethyl110-33-8 Hexanedioic acid, dihexyl ester

110-44-1 2,4-Hexadienoic acid, (2E,4E)-

111-44-4 Ethane, 1,1'-oxybis[2-chloro111-85-3 Octane, 1-chloro111-91-1 Ethane, 1,1'-[methylenebis(oxy)]bis[2-chloro112-52-7 Dodecane, 1-chloro118-82-1 Phenol, 4,4'-methylenebis[2,6-bis(1,1-dimethylethyl)-

118-90-1 Benzoic acid, 2-methyl119-33-5 Phenol, 4-methyl-2-nitro119-61-9 Methanone, diphenyl121-45-9 Phosphorous acid, trimethyl ester

121-69-7 Benzenamine, N,N-dimethylStatus and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

49

CAS # TSCA Chemical Name

121-82-4 1,3,5-Triazine, hexahydro-1,3,5-trinitro124-18-5 Decane

124-63-0 Methanesulfonyl chloride

127-68-4 Benzenesulfonic acid, 3-nitro-, sodium salt

131-57-7 Methanone, (2-hydroxy-4-methoxyphenyl)phenyl137-20-2 Ethanesulfonic acid, 2-[methyl[(9Z)-1-oxo-9-octadecenyl]amino]-, sodium salt

138-25-0 1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester

139-40-2 1,3,5-Triazine-2,4-diamine, 6-chloro-N,N'-bis(1-methylethyl)-

140-08-9 Ethanol, 2-chloro-, phosphite (3:1)

140-93-2 Carbonodithioic acid, O-(1-methylethyl) ester, sodium salt

142-73-4 Glycine, N-(carboxymethyl)-

143-28-2 9-Octadecen-1-ol, (9Z)-

144-62-7 Ethanedioic acid

149-44-0 Methanesulfinic acid, hydroxy-, monosodium salt

150-50-5 Phosphorotrithious acid, tributyl ester

307-35-7 1-Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro330-54-1 Urea, N'-(3,4-dichlorophenyl)-N,N-dimethyl409-02-9 Heptenone, methyl460-00-4 Benzene, 1-bromo-4-fluoro506-51-4 1-Tetracosanol

506-52-5 1-Hexacosanol

513-74-6 Carbamodithioic acid, monoammonium salt

515-40-2 Benzene, (2-chloro-1,1-dimethylethyl)-

529-33-9 1-Naphthalenol, 1,2,3,4-tetrahydro529-34-0 1(2H)-Naphthalenone, 3,4-dihydro542-75-6 1-Propene, 1,3-dichloro542-92-7 1,3-Cyclopentadiene

557-61-9 1-Octacosanol

563-72-4 Ethanedioic acid, calcium salt (1:1)

579-66-8 Benzenamine, 2,6-diethyl590-19-2 1,2-Butadiene

592-45-0 1,4-Hexadiene

594-42-3 Methanesulfenyl chloride, trichloro597-31-9 Propanal, 3-hydroxy-2,2-dimethyl598-72-1 Propanoic acid, 2-bromo617-94-7 Benzenemethanol, .alpha.,.alpha.-dimethyl624-83-9 Methane, isocyanato624-92-0 Disulfide, dimethyl

625-55-8 Formic acid, 1-methylethyl ester

628-13-7 Pyridine, hydrochloride

628-96-6 1,2-Ethanediol, dinitrate
EPA’s High Production Volume Challenge Program

61

Status and Future Directions

62 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

50

CAS # TSCA Chemical Name

629-59-4 Tetradecane

629-76-5 1-Pentadecanol

645-62-5 2-Hexenal, 2-ethyl693-07-2 Ethane, 1-chloro-2-(ethylthio)-

693-95-8 Thiazole, 4-methyl756-80-9 Phosphorodithioic acid, O,O-dimethyl ester

870-72-4 Methanesulfonic acid, hydroxy-, monosodium salt

928-72-3 Glycine, N-(carboxymethyl)-, disodium salt

939-97-9 Benzaldehyde, 4-(1,1-dimethylethyl)-

1000-82-4 Urea, (hydroxymethyl)-

1002-69-3 Decane, 1-chloro1111-78-0 Carbamic acid, monoammonium salt

1115-20-4 Propanoic acid, 3-hydroxy-2,2-dimethyl-, 3-hydroxy-2,2-dimethylpropyl ester

1323-65-5 Phenol, dinonyl1324-76-1 Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-

ylidene]methyl]phenyl]amino]-

1401-55-4 Tannins

1445-45-0 Ethane, 1,1,1-trimethoxy1459-93-4 1,3-Benzenedicarboxylic acid, dimethyl ester

1498-51-7 Phosphorodichloridic acid, ethyl ester

1558-33-4 Silane, dichloro(chloromethyl)methyl1562-00-1 Ethanesulfonic acid, 2-hydroxy-, monosodium salt

1646-75-9 Propanal, 2-methyl-2-(methylthio)-, oxime

1691-99-2 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)-

1738-25-6 Propanenitrile, 3-(dimethylamino)-

1912-24-9 1,3,5-Triazine-2,4-diamine, 6-chloro-N-ethyl-N'-(1-methylethyl)-

1918-02-1 2-Pyridinecarboxylic acid, 4-amino-3,5,6-trichloro1929-82-4 Pyridine, 2-chloro-6-(trichloromethyl)-

2152-64-9 Benzenamine, N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]-,

monohydrochloride

2210-79-9 Oxirane, [(2-methylphenoxy)methyl]-

2372-45-4 1-Butanol, sodium salt

2409-55-4 Phenol, 2-(1,1-dimethylethyl)-4-methyl2425-54-9 Tetradecane, 1-chloro2494-89-5 Ethanol, 2-[(4-aminophenyl)sulfonyl]-, hydrogen sulfate (ester)

2524-03-0 Phosphorochloridothioic acid, O,O-dimethyl ester

2524-04-1 Phosphorochloridothioic acid, O,O-diethyl ester

2611-00-9 3-Cyclohexene-1-carboxylic acid, 3-cyclohexen-1-ylmethyl ester

2691-41-0 1,3,5,7-Tetrazocine, octahydro-1,3,5,7-tetranitro2702-72-9 Acetic acid, (2,4-dichlorophenoxy)-, sodium salt

2814-20-2 4(1H)-Pyrimidinone, 6-methyl-2-(1-methylethyl)-

2905-62-6 Benzoyl chloride, 3,5-dichloroStatus and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

51

CAS # TSCA Chemical Name

2915-53-9 2-Butenedioic acid (2Z)-, dioctyl ester

2941-64-2 Carbonochloridothioic acid, S-ethyl ester

3039-83-6 Ethenesulfonic acid, sodium salt

3088-31-1 Ethanol, 2-[2-(dodecyloxy)ethoxy]-, hydrogen sulfate, sodium salt

3132-99-8 Benzaldehyde, 3-bromo3338-24-7 Phosphorodithioic acid, O,O-diethyl ester, sodium salt

3386-33-2 Octadecane, 1-chloro3586-14-9 Benzene, 1-methyl-3-phenoxy3710-84-7 Ethanamine, N-ethyl-N-hydroxy3724-65-0 2-Butenoic acid

3779-63-3 1,3,5-Triazine-2,4,6(1H,3H,5H)-trione, 1,3,5-tris(6-isocyanatohexyl)-

3965-55-7 1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt

4035-89-6 Imidodicarbonic diamide, N,N',2-tris(6-isocyanatohexyl)-

4080-31-3 3,5,7-Triaza-1-azoniatricyclo[3.3.1.13,7]decane, 1-(3-chloro-2-propenyl)-, chloride

4170-30-3 2-Butenal

4300-97-4 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.)

4316-73-8 Glycine, N-methyl-, monosodium salt

4719-04-4 1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol

4860-03-1 Hexadecane, 1-chloro5026-74-4 Oxiranemethanamine, N-[4-(oxiranylmethoxy)phenyl]-N-(oxiranylmethyl)-

5216-25-1 Benzene, 1-chloro-4-(trichloromethyl)-

5460-09-3 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, monosodium salt

5915-41-3 1,3,5-Triazine-2,4-diamine, 6-chloro-N-(1,1-dimethylethyl)-N'-ethyl6381-77-7 D-erythro-Hex-2-enonic acid, .gamma.-lactone, monosodium salt

6473-13-8 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]azo]-4-hydroxy-, trisodium salt

6863-58-7 Butane, 2,2'-oxybis6865-35-6 Octadecanoic acid, barium salt

7320-37-8 Oxirane, tetradecyl7446-81-3 2-Propenoic acid, sodium salt

7795-95-1 1-Octanesulfonyl chloride

8001-58-9 Creosote

8005-02-5 C.I. Solvent Black 7

8007-45-2 Tar, coal

10265-69-7 Glycine, N-phenyl-, monosodium salt

12645-31-7 Phosphoric acid, 2-ethylhexyl ester

13749-94-5 Ethanimidothioic acid, N-hydroxy-, methyl ester

13826-35-2 Benzenemethanol, 3-phenoxy14143-60-3 2-Pyridinecarbonitrile, 4-amino-3,5,6-trichloro14666-94-5 9-Octadecenoic acid (9Z)-, cobalt salt

16883-83-3 1,2-Benzenedicarboxylic acid, 2,2-dimethyl-1-(1-methylethyl)-3-(2-methyl-1-oxopropoxy)propyl phenylmethyl ester
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64 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

52

CAS # TSCA Chemical Name

17103-31-0 Urea, sulfate (2:1)

17321-47-0 Phosphoramidothioic acid, O,O-dimethyl ester

17976-43-1 2,4,6,8,3,5,7-Benzotetraoxatriplumbacycloundecin-3,5,7-triylidene, 1,9-dihydro-1,9-dioxo19438-61-0 1,3-Isobenzofurandione, 5-methyl19525-59-8 Glycine, N-phenyl-, monopotassium salt

20068-02-4 2-Butenenitrile, 2-methyl-, (2Z)-

20227-53-6 Phosphorous acid, 2-(1,1-dimethylethyl)-4-[1-[3-(1,1-dimethylethyl)-4-hydroxyphenyl]-1-methylethyl]phenyl bis(4-

nonylphenyl) ester

20469-71-0 Hydrazinecarbodithioic acid, compd. with hydrazine (1:1)

21351-39-3 Urea, sulfate (1:1)

22527-63-5 Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester

24448-09-7 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-N-methyl24615-84-7 2-Propenoic acid, 2-carboxyethyl ester

24634-61-5 2,4-Hexadienoic acid, potassium salt, (2E,4E)-

24794-58-9 Formic acid, compd. with 2,2',2''-nitrilotris[ethanol] (1:1)

25154-38-5 Piperazineethanol

25168-05-2 Benzene, chloromethyl25168-06-3 Phenol, (1-methylethyl)-

25321-41-9 Benzenesulfonic acid, dimethyl25383-99-7 Octadecanoic acid, 2-(1-carboxyethoxy)-1-methyl-2-oxoethyl ester, sodium salt

25586-42-9 Phosphorous acid, tris(methylphenyl) ester

25646-71-3 Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3)

26377-29-7 Phosphorodithioic acid, O,O-dimethyl ester, sodium salt

26401-27-4 Phosphorous acid, isooctyl diphenyl ester

26680-54-6 2,5-Furandione, dihydro-3-(octenyl)-

27193-28-8 Phenol, (1,1,3,3-tetramethylbutyl)-

28106-30-1 Benzene, ethenylethyl28188-24-1 Octadecanoic acid, 2-(hydroxymethyl)-2-[[(1-oxooctadecyl)oxy]methyl]-1,3-propanediyl ester

28777-98-2 2,5-Furandione, dihydro-3-(octadecenyl)-

28908-00-1 Benzothiazole, 2-[(chloromethyl)thio]-

30574-97-1 2-Butenenitrile, 2-methyl-, (2E)-

31138-65-5 D-gluco-Heptonic acid, monosodium salt, (2.xi.)-

32072-96-1 2,5-Furandione, 3-(hexadecenyl)dihydro32210-23-4 Cyclohexanol, 4-(1,1-dimethylethyl)-, acetate

33509-43-2 1,2,4-Triazin-5(2H)-one, 4-amino-6-(1,1-dimethylethyl)-3,4-dihydro-3-thioxo34689-46-8 Phenol, methyl-, sodium salt

35203-06-6 Benzenamine, 2-ethyl-6-methyl-N-methylene35203-08-8 Benzenamine, 2,6-diethyl-N-methylene37439-34-2 2(1H)-Pyridinone, 3,5,6-trichloro-, sodium salt

37734-45-5 Carbonochloridothioic acid, S-(phenylmethyl) ester

37764-25-3 Acetamide, 2,2-dichloro-N,N-di-2-propenylStatus and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

53

CAS # TSCA Chemical Name

38185-06-7 Benzenesulfonic acid, 4-chloro-3,5-dinitro-, potassium salt

38321-18-5 Ethanol, 2-(2-butoxyethoxy)-, sodium salt

39515-51-0 Benzaldehyde, 3-phenoxy40630-63-5 1-Octanesulfonyl fluoride

40876-98-0 Butanedioic acid, oxo-, diethyl ester, ion(1-), sodium

51632-16-7 Benzene, 1-(bromomethyl)-3-phenoxy52184-19-7 Phenol, 2,4-bis(1,1-dimethylpropyl)-6-[(2-nitrophenyl)azo]-

52556-42-0 1-Propanesulfonic acid, 2-hydroxy-3-(2-propenyloxy)-, monosodium salt

52663-57-7 Ethanol, 2-butoxy-, sodium salt

56038-89-2 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.)

56803-37-3 Phosphoric acid, (1,1-dimethylethyl)phenyl diphenyl ester

57693-14-8 Chromate(3-), bis[3-(hydroxy-.kappa.O)-4-[[2-(hydroxy-.kappa.O)-1-naphthalenyl]azo-.kappa.N1]-7-nitro-1-

naphthalenesulfonato(3-)]-, trisodium

61788-76-9 Alkanes, chloro

61789-32-0 Fatty acids, coco, 2-sulfoethyl esters, sodium salts

61789-65-9 Resin acids and Rosin acids, aluminum salts

61789-85-3 Sulfonic acids, petroleum

63302-49-8 Phosphorochloridous acid, bis(4-nonylphenyl) ester

64742-24-1 Sludges, petroleum, acid

64743-02-8 Alkenes, C>10 .alpha.-

64743-03-9 Phenols, petroleum

64771-71-7 Paraffins, petroleum, normal C>10

65652-41-7 Phosphoric acid, bis[(1,1-dimethylethyl)phenyl] phenyl ester

65996-78-3 Light oil, coal, coke-oven

65996-79-4 Solvent naphtha, coal

65996-80-7 Ammonia liquor, coal

65996-81-8 Fuel gases, coke-oven

65996-82-9 Tar oils, coal

65996-83-0 Extracts, coal tar oil alk.

65996-86-3 Extract oils, coal, tar base

65996-87-4 Extract residues, coal, tar oil alk.

65996-89-6 Tar, coal, high-temp.

65996-91-0 Distillates, coal tar, upper

65996-92-1 Distillates, coal tar

66071-94-1 Corn, steep liquor

66241-11-0 C.I. Leuco Sulphur Black 1

68081-86-7 Phenol, nonyl derivs.

68082-78-0 Lard, oil, Me esters

68153-60-6 Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates

68187-41-7 Phosphorodithioic acid, O,O-di-C1-14-alkyl esters

68187-57-5 Pitch, coal tar-petroleum
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54

CAS # TSCA Chemical Name

68187-59-7 Coal, anthracite, calcined

68187-76-8 Castor oil, sulfated, sodium salt

68187-84-8 Castor oil, oxidized

68188-18-1 Paraffin oils, chlorosulfonated, saponified

68308-74-7 Amides, tall-oil fatty, N,N-di-Me

68309-16-0 Fatty acids, tall-oil, 2-(2-hydroxyethoxy)ethyl esters

68309-27-3 Fatty acids, tall-oil, sulfonated, sodium salts

68334-01-0 Disulfides, alkylaryl dialkyl diaryl, petroleum refinery spent caustic oxidn. products

68441-66-7 Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid

68442-60-4 Acetaldehyde, reaction products with formaldehyde, by-products from

68442-77-3 2-Butenediamide, (2E)-, N,N'-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs.

68476-80-2 Fats and Glyceridic oils, vegetable, deodorizer distillates

68478-20-6 Residues, petroleum, steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadiene-free

68479-98-1 Benzenediamine, ar,ar-diethyl-ar-methyl68511-40-0 1-Propanamine, 3-(tridecyloxy)-, branched

68512-63-0 Benzene, ethenyl-, distn. residues

68513-62-2 Disulfides, C5-12-alkyl

68514-41-0 Ketones, C12-branched

68515-89-9 Barium, carbonate nonylphenol complexes

68527-02-6 Alkenes, C12-24, chloro

68553-14-0 Hydrocarbons, C8-11

68584-25-8 Benzenesulfonic acid, C10-16-alkyl derivs., compds. with triethanolamine

68602-81-3 Distillates, hydrocarbon resin prodn. higher boiling

68603-84-9 Carboxylic acids, C5-9

68607-28-3 Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, dichlorides

68608-59-3 Ethane, 1,2-dichloro-, manuf. of, by-products from, distn. lights

68609-04-1 Cyclohexane, oxidized, non-acidic by-products, distn. residues

68609-05-2 Cyclohexane, oxidized, non-acidic by-products, distn. lights

68610-90-2 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters

68611-64-3 Urea, reaction products with formaldehyde

68647-60-9 Hydrocarbons, C>4

68649-42-3 Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts

68650-36-2 Aromatic hydrocarbons, C8, o-xylene-lean

68782-97-8 Distillates, petroleum, hydrofined lubricating-oil

68815-50-9 Octadecanoic acid, reaction products with 2-[(2-aminoethyl)amino]ethanol

68909-77-3 Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues

68915-05-9 Fatty acids, tall-oil, low-boiling, reaction products with ammonia-ethanolamine reaction by-products

68915-39-9 Cyclohexane, oxidized, aq. ext., sodium salt

68918-16-1 Tar, coal, dried and oxidized

68919-17-5 Hydrocarbons, C12-20, catalytic alkylation by-products

68920-64-9 Disulfides, di-C1-2-alkyl

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

55

CAS # TSCA Chemical Name

68937-29-1 1,6-Hexanediol, distn. residues

68937-69-9 Carboxylic acids, C6-18 and C5-15-di68937-70-2 Carboxylic acids, C6-18 and C8-15-di68937-72-4 Carboxylic acids, di-, C4-11

68953-70-8 Oxirane, reaction products with ammonia, distn. residues

68953-80-0 Benzene, mixed with toluene, dealkylation product

68955-37-3 Acid chlorides, tallow, hydrogenated

68955-76-0 Aromatic hydrocarbons, C9-16, biphenyl deriv.-rich

68955-96-4 Disulfides, dialkyl and di-Ph, naphtha sweetening

68987-41-7 Benzene, ethylenated

68987-66-6 Ethene, hydrated, by-products from

68988-22-7 1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from

68988-99-8 Phenols, sodium salts, mixed with sulfur compounds, gasoline alk. scrubber residues

68990-61-4 Tar, coal, high-temp., high-solids

68990-65-8 Fats and Glyceridic oils, vegetable, reclaimed

69029-75-0 Oils, reclaimed

70024-67-8 Benzenesulfonic acid, C16-24-alkyl derivs.

70084-98-9 Terpenes and Terpenoids, C10-30, distn. residues

70693-50-4 Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[(2-nitrophenyl)azo]-

70851-08-0 Amides, coco, N-[3-(dimethylamino)propyl], alkylation products with sodium 3-chloro-2-hydroxypropanesulfonate

71077-05-9 Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine product tower residues

72162-28-8 2-Propanone, reaction products with phenol

72854-27-4 Tannins, reaction products with sodium bisulfite, sodium polysulfide and sodium sulfite

73665-18-6 Extract residues, coal, tar oil alk., naphthalene distn. residues

83864-02-2 Nickel, bis[(cyano-C)triphenylborato(1-)-N]bis(hexanedinitrile-N,N')-

84501-86-0 Hexanedioic acid, esters with high-boiling C6-10-alkene hydroformylation products

90640-80-5 Anthracene oil

90640-86-1 Distillates, coal tar, heavy oils

119345-02-7 Benzene, 1,1'-oxybis-, tetrapropylene derivs.

125997-20-8 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.

 ------------------------------------------------------------------------------------

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

The following table shows the orphan manufacturers of which EPA is aware and that can be made public without 

compromising confidential business information. 
EPA’s High Production Volume Challenge Program

67

Status and Future Directions

68

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.}

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

56

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.}

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

CHATTEM CHEMICALS * *

56-40-6

NAGASE AMERICA CORPORATION

62-23-7 EI DUPONT DE NEMOURS & CO INC ACC

ACETO CHEMICAL COMPANY INC SOCMA

HOECHST CELANESE

MITSUI & CO (USA) INC ACC, SOCMA

SAKAI TRADING NEW YORK INC * *

SKW CHEMICALS INC *

TOMEN AMERICA INC

62-56-6

WEGO CHEMICAL & MINERAL CORPORATION

AMERIBROM INC * * SOCMA

74-95-3

ETHYL CORPORATION - HEALTH SAFETY AND

AMERIBROM INC * * SOCMA

74-97-5

ETHYL CORPORATION - HEALTH SAFETY AND

EI DUPONT DE NEMOURS & CO INC ACC

75-07-0 HOECHST CELANESE

UNION CARBIDE CORPORATION

DOW CHEMICAL USA * * ACC, API, SOCMA

75-34-3 GEORGIA-PACIFIC CORPORATION

ICI AMERICAS INC

75-36-5 DELTECH CORPORATION SOCMA

ETHYL CORPORATION - HEALTH SAFETY AND

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

57

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

HOECHST CELANESE

75-46-7 EI DUPONT DE NEMOURS & CO INC * * ACC

75-87-6 ENIMONT AMERICA INC

77-76-9 NOR-AM CHEMICAL COMPANY

EI DUPONT DE NEMOURS & CO INC ACC

78-11-5 ENSIGN-BICKFORD COMPANY *

TROJAN CORPORATION

ALBRIGHT & WILSON INC

78-42-2

MOBAY CHEMICAL CORPORATION

MITSUI & CO (USA) INC * ACC, SOCMA

81-07-2

PMC SPECIALTIES GROUP INC SOCMA

BASF CORPORATION ACC, SOCMA

BIDDLE SAWYER CORPORATION SOCMA

DIC AMERICAS INC

ENIMONT AMERICA INC

MOBAY CHEMICAL CORPORATION

81-16-3

SUMITOMO CORPORATION OF AMERICA * *

MOBAY CHEMICAL CORPORATION

81-84-5

RUETGERS-NEASE

AMERICAN CYANAMID CO AGRI PRODS RES

83-41-0

EI DUPONT DE NEMOURS & CO INC ACC

ICI AMERICAS INC *

84-65-1 MITSUI & CO (USA) INC ACC, SOCMA

MOBAY CHEMICAL CORPORATION

HULS AMERICA INC

84-69-5

UNITEX CHEM CORP * *

85-40-5 ICI AMERICAS INC

EI DUPONT DE NEMOURS & CO INC * * ACC

89-32-7

HULS AMERICA INC

90-43-7 DOW CHEMICAL USA * * ACC, API, SOCMA
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CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

91-53-2 MONSANTO COMPANY ACC

BASF CORPORATION * ACC, SOCMA

91-68-9 HILTON-DAVIS CHEMICAL COMPANY

SUMITOMO CORPORATION OF AMERICA *

94-75-7 DOW CHEMICAL USA * * ACC, API, SOCMA

HULS AMERICA INC

94-96-2 QO CHEMICALS INC

UNION CARBIDE CHEMICALS & PLASTICS CO

95-94-3 STANDARD CHLORINE OF DELAWARE INC *

BP CHEMICALS AMERICA INCORPORATED ACC, API

96-22-0

UNION CARBIDE CHEMICALS & PLASTICS CO *

ARSYNCO

96-23-1

DOW CHEMICAL USA * ACC, API, SOCMA

97-00-7 HOECHST CELANESE

ICI AMERICAS INC

98-09-9 MTM HARDWICKE INC

SLOSS INDUSTRIES CORPORATION * SOCMA

ELI LILLY AND COMPANY ACC

98-16-8 HOECHST CELANESE

SANDOZ COLORS & CHEMICALS

98-56-6 OCCIDENTAL CHEMICAL CORPORATION * ACC, API

AMERICAN CYANAMID CO AGRI PRODS RES

99-51-4

EI DUPONT DE NEMOURS & CO INC ACC

100-64-1 DSM CHEMICALS NORTH AMERICA INC * *

101-34-8 CASCHEM INC * *

ACETO CHEMICAL COMPANY INC * SOCMA

BIDDLE SAWYER CORPORATION SOCMA

CI SPECIALITY CHEMICALS INC SOCMA

CAPITAL RESIN CORPORATION * *

104-15-4

CL INDUSTRIES INC

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

59

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

INTERNATIONAL FLAVORS AND FRAGRANCES IN

RUETGERS-NEASE * SOCMA

SLOSS INDUSTRIES CORPORATION * SOCMA

104-66-5 KOCH CHEMICAL COMPANY

FRAGRANCE RESOURCES INC

104-93-8 GIVAUDAN CORPORATION

KOCH CHEMICAL COMPANY

NISSHO IWAI AMERICAN CORPORATION *

107-39-1

TEXAS PETROCHEMICALS CORPORATION *

107-40-4 TEXAS PETROCHEMICALS CORPORATION *

HALTERMANN LTD

107-45-9

ROHM AND HAAS COMPANY * * ACC

ARCADIAN CORPORATION

108-19-0

CF INDUSTRIES INC * *

EXXON CHEMICAL COMPANY * * ACC, API

108-20-3 SHELL OIL COMPANY * * ACC, API

UNION CARBIDE CORPORATION

BASF CORPORATION ACC, SOCMA

CAPE INDUSTRIES

CIBA-GEIGY CORPORATION TEXTILE PRODUCTS * ACC, API

DOW CHEMICAL USA * ACC, API, SOCMA

MONTANA REFINING COMPANY

OCCIDENTAL CHEMICAL CORPORATION ACC, API

OLIN CORPORATION * * ACC

109-86-4

UNION CARBIDE CORPORATION

110-33-8 MONSANTO COMPANY

HOECHST CELANESE

MITSUI & CO (USA) INC * * ACC, SOCMA

MONSANTO COMPANY ACC

110-44-1

TOMEN AMERICA INC * *
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60

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

ET HORN COMPANY * *

111-44-4

OCCIDENTAL CHEMICAL CORPORATION ACC, API

HULS AMERICA INC

111-85-3 LONZA INCORPORATED * *

NEVILLE CHEMICAL COMPANY

HULS AMERICA INC

112-52-7 LONZA INCORPORATED * *

NEVILLE CHEMICAL COMPANY

118-82-1 ETHYL CORPORATION - HEALTH SAFETY AND

CHUGAI BOYEKI CORP *

118-90-1

MOBAY CHEMICAL CORPORATION

119-33-5 PMC SPECIALTIES GROUP INC * SOCMA

ACETO CHEMICAL COMPANY INC * SOCMA

CIBA-GEIGY CORPORATION TEXTILE PRODUCTS * * ACC, API

HAARMANN & REIMER CORPORATION

119-61-9

THE UPJOHN COMPANY

ALBRIGHT & WILSON INC

121-45-9

ICI AMERICAS INC

121-69-7 D&O CHEMICALS INC

121-82-4 HOLSTON ARMY AMMUNITION PLANT *

ENIMONT AMERICA INC

EXXON CHEMICAL COMPANY ACC, API

HUMPHREY CHEMICAL COMPANY

SHELL OIL COMPANY ACC, API

STERLING DRUG INC * *

124-18-5

VISTA CHEMICAL CO

124-63-0 ATOCHEM INC POLYMER DIVISION

ACETO CHEMICAL COMPANY INC SOCMA

127-68-4 BASF CORPORATION * * ACC, SOCMA

CROWN METRO INC

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

61

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

ACETO CHEMICAL COMPANY INC * SOCMA

BASF CORPORATION ACC, SOCMA

HOECHST CELANESE

131-57-7

NEVILLE CHEMICAL COMPANY

GAF CHEMICALS CORPORATION

137-20-2

HOECHST CELANESE

138-25-0 EI DUPONT DE NEMOURS & CO INC * ACC

139-40-2 CIBA-GEIGY CORPORATION TEXTILE PRODUCTS ACC, API

ALBRIGHT & WILSON INC

140-08-9

OLIN CORPORATION ACC

140-93-2 AMERICAN CYANAMID CO AGRI PRODS RES

CASCHEM INC

JARCHEM INDUSTRIES INC * *

M MICHEL AND CO INC

143-28-2

SHEREX CHEMICAL COMPANY INC

ALLOYCHEM INC

BROWNING CHEMICAL CORP *

CI SPECIALITY CHEMICALS INC

CALABRIAN CORPORATION

DOW CHEMICAL USA ACC, API, SOCMA

EI DUPONT DE NEMOURS & CO INC * ACC

MARUBENI AMERICA CORPORATION

MITSUBISHI CHEMICAL INDUSTRIES AM INC

MITSUI & CO (USA) INC ACC, SOCMA

SAKAI TRADING NEW YORK INC

VELCO ENTERPRISES LTD

144-62-7

WEGO CHEMICAL & MINERAL CORPORATION

ACETO CHEMICAL COMPANY INC * SOCMA

149-44-0

AMERIPOL SYNPOL COMPANY

307-35-7 3M * * ACC
EPA’s High Production Volume Challenge Program

73

Status and Future Directions

74 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

62

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

MARUBENI AMERICA CORPORATION

330-54-1

THOR CHEMICALS INC

EXXON CHEMICAL COMPANY * * ACC, API

409-02-9

INTERNATIONAL FLAVORS AND FRAGRANCES IN

DIAZ CHEMICAL CORPORATION * *

460-00-4 HOECHST CELANESE

RHONE POULENC INCORPORATED

506-51-4 VISTA CHEMICAL CO *

506-52-5 VISTA CHEMICAL CO *

513-74-6 MERCK AND COMPANY INC

515-40-2 MTM HARDWICKE INC *

529-33-9 RHONE POULENC INCORPORATED

529-34-0 RHONE POULENC INCORPORATED

DOW CHEMICAL USA * * ACC, API, SOCMA

542-75-6

SHELL OIL COMPANY * ACC, API

NAGASE AMERICA CORPORATION

542-92-7

VELSICOL CHEMICAL CORPORATION * *

557-61-9 VISTA CHEMICAL CO *

563-72-4 EXXON CHEMICAL COMPANY * ACC, API

579-66-8 ETHYL CORPORATION - HEALTH SAFETY AND

EXXON CHEMICAL COMPANY * * ACC, API

590-19-2

VISTA CHEMICAL CO *

592-45-0 EI DUPONT DE NEMOURS & CO INC * ACC

594-42-3 ICI AMERICAS INC

HERCULES INCORPORATED *

617-94-7

TEXACO CHEMICAL COMPANY ACC, API, SOCMA

624-83-9 RHONE POULENC INCORPORATED

624-92-0 ATOCHEM INC POLYMER DIVISION

628-13-7 RHONE POULENC INCORPORATED

628-96-6 ICI EXPLOSIVES USA INC

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

63

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

IRECO INC

SHELL OIL COMPANY * ACC, API

629-59-4

VISTA CHEMICAL CO *

629-76-5 SHELL OIL COMPANY * ACC, API

645-62-5 UNION CARBIDE CORPORATION *

693-95-8 MERCK AND COMPANY INC

756-80-9 ICI AMERICAS INC

AGFA

EI DUPONT DE NEMOURS & CO INC ACC

EASTMAN KODAK COMPANY * * ACC

FUJI HUNT PHOTOGRAPHIC CHEMICAL INC SOCMA

HICKSON & WELCH LIMITED

HIGH POINT CHEMICAL CORPORATION

HOECHST CELANESE

KONICA ROYAL COPIERS *

870-72-4

MOBAY CHEMICAL CORPORATION

928-72-3 MONSANTO COMPANY * * ACC

FRAGRANCE RESOURCES INC

939-97-9 GIVAUDAN CORPORATION

INTERNATIONAL FLAVORS AND FRAGRANCES IN

AURALUX CORPORATION

1000-82-4 BASF CORPORATION * * ACC, SOCMA

DYNO POLYMERS INCORPORATED

1002-69-3 LONZA INCORPORATED * *

ARCADIAN CORPORATION

1111-78-0

CF INDUSTRIES INC * *

BASF CORPORATION * * ACC, SOCMA

1115-20-4

UNION CARBIDE CHEMICALS & PLASTICS CO

MONSANTO COMPANY ACC

1323-65-5

TEXACO CHEMICAL COMPANY ACC, API, SOCMA
EPA’s High Production Volume Challenge Program

75

Status and Future Directions

76 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

64

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

HOECHST CELANESE

1324-76-1

PMC SPECIALTIES GROUP INC SOCMA

ACETO CHEMICAL COMPANY INC * SOCMA

CROMPTON & KNOWLES COLORS INCORPORATED

MALLINCKRODT

1401-55-4

THE SIEFLOR CORPORATION

1445-45-0 HULS AMERICA INC

HOECHST CELANESE *

1459-93-4 MORFLEX CHEMICAL COMPANY INC

UNITEX CHEM CORP *

1498-51-7 RHONE POULENC INCORPORATED *

1558-33-4 EI DUPONT DE NEMOURS & CO INC * ACC

GAF CHEMICALS CORPORATION

1562-00-1 HENKEL CORPORATION

RHONE POULENC INCORPORATED

1646-75-9 ALLIED-SIGNAL INC *

1691-99-2 3M * * ACC

AIR PRODUCTS AND CHEMICALS INC * * ACC

1738-25-6

TEXACO CHEMICAL COMPANY ACC, API, SOCMA

CIBA-GEIGY CORPORATION TEXTILE PRODUCTS ACC, API

1912-24-9

MARUBENI AMERICA CORPORATION

1929-82-4 DOW CHEMICAL USA * * ACC, API, SOCMA

2152-64-9 PMC SPECIALTIES GROUP INC SOCMA

CL INDUSTRIES INC

KOCH CHEMICAL COMPANY

RHONE POULENC INCORPORATED

2210-79-9

SHEREX CHEMICAL COMPANY INC

2372-45-4 FMC COMPANY *

PMC SPECIALTIES GROUP INC * SOCMA

2409-55-4

RHONE POULENC INCORPORATED

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

65

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

2425-54-9 LONZA INCORPORATED * *

ACETO CHEMICAL COMPANY INC * SOCMA

BIDDLE SAWYER CORPORATION SOCMA

CROMPTON & KNOWLES COLORS INCORPORATED

HOECHST CELANESE *

2494-89-5

MITSUI & CO (USA) INC ACC, SOCMA

2524-03-0 ICI AMERICAS INC

ETHYL CORPORATION - HEALTH SAFETY AND

2524-04-1

ICI AMERICAS INC

2611-00-9 UNION CARBIDE CORPORATION

2691-41-0 HOLSTON ARMY AMMUNITION PLANT *

2702-72-9 DOW CHEMICAL USA * ACC, API, SOCMA

2814-20-2 CIBA-GEIGY CORPORATION TEXTILE PRODUCTS * * ACC, API

2905-62-6 OCCIDENTAL CHEMICAL CORPORATION * * ACC, API

ARISTECH CHEMICAL CORPORATION

MANUFACTURERS SOAP & CHEMICAL CO INC

NATIONAL STARCH AND CHEMICAL CORPORATION

2915-53-9

TEXTILE RUBBER & CHEMICAL COMPANY

2941-64-2 ICI AMERICAS INC

3039-83-6 AIR PRODUCTS AND CHEMICALS INC * * ACC

3088-31-1 LONZA INCORPORATED *

3132-99-8 MTM HARDWICKE INC *

3386-33-2 LONZA INCORPORATED * *

MERICHEM COMPANY * ACC, API

3586-14-9

MTM HARDWICKE INC *

3710-84-7 ATOCHEM INC POLYMER DIVISION

BASF CORPORATION ACC, SOCMA

3779-63-3

RHONE POULENC INCORPORATED

3965-55-7 EI DUPONT DE NEMOURS & CO INC * * ACC

4035-89-6 RHONE POULENC INCORPORATED
EPA’s High Production Volume Challenge Program

77

Status and Future Directions

78 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

66

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

4080-31-3 DOW CHEMICAL USA ACC, API, SOCMA

4300-97-4 PPG INDUSTRIES INC ACC, SOCMA

ECOLAB INC

4719-04-4 QUAKER CHEMICAL CORPORATION

STEPAN CHEMICAL COMPANY

4860-03-1 LONZA INCORPORATED * *

5026-74-4 CIBA-GEIGY CORPORATION TEXTILE PRODUCTS * ACC, API

5216-25-1 OCCIDENTAL CHEMICAL CORPORATION * ACC, API

ACETO CHEMICAL COMPANY INC * SOCMA

BIDDLE SAWYER CORPORATION SOCMA

CROMPTON & KNOWLES COLORS INCORPORATED

FABRICOLOR MANUFACTURING CORPORATION

ICI AMERICAS INC

5460-09-3

MOBAY CHEMICAL CORPORATION

5915-41-3 CIBA-GEIGY CORPORATION TEXTILE PRODUCTS ACC, API

PFIZER INC

6381-77-7

PMP FERMENTATION PRODUCTS INC *

AAKASH CHEMICALS & DYE-STUFFS

BIDDLE SAWYER CORPORATION SOCMA

BURLINGTON CHEMICAL COMPANY INC

CROMPTON & KNOWLES COLORS INCORPORATED

6473-13-8

FABRICOLOR MANUFACTURING CORPORATION *

EXXON CHEMICAL COMPANY * * ACC, API

6863-58-7

LYONDELL-CITGO REFINING COMPANY LTD

ANZON LEAD

6865-35-6

SYNTHETIC RUBBER PRODUCTS INC

ATOCHEM INC POLYMER DIVISION

7320-37-8

UNION CARBIDE CORPORATION

7446-81-3 DOW CHEMICAL USA * * ACC, API, SOCMA

7795-95-1 3M * ACC

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

67

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

ALLIED-SIGNAL INC *

8001-58-9

CROWLEY TAR PRODUCTS COMPANY INC * *

DAICOLOR-POPE INC

MORTON INTERNATIONAL INCORPORATED

ORIENT CHEMICAL CORPORATION * *

SHARP ELECTRONICS CORPORATION

8005-02-5

USR OPTONIX INC * *

BOSTON COKE CORPORATION *

ERIE COKE CORPORATION * *

KOPPER COMPANY INCORPORATED

8007-45-2

TONAWANDA COKE CORP * *

CHEMTECH_INDUSTRIES INC

HIGH POINT CHEMICAL CORPORATION *

HILTON-DAVIS CHEMICAL COMPANY

PETROLITE CORPORATION

PIEDMONT CHEMICAL INDUSTRIES INC

12645-31-7

REILLY-WHITEMAN INC

13749-94-5 EI DUPONT DE NEMOURS & CO INC ACC

AMERIBROM INC SOCMA

13826-35-2

MTM HARDWICKE INC *

14666-94-5 EXXON CHEMICAL COMPANY * * ACC, API

16883-83-3 MONSANTO COMPANY

17103-31-0 UNOCAL SCIENCE & TECHNOLOGY DIVISION *

17321-47-0 CHEVRON CHEMICAL CO ACC, API, SOCMA

17976-43-1 ANZON LEAD

AMERICAN CYANAMID CO AGRI PRODS RES

19438-61-0

ICI AMERICAS INC

20068-02-4 EI DUPONT DE NEMOURS & CO INC * ACC

21351-39-3 UNOCAL SCIENCE & TECHNOLOGY DIVISION *

22527-63-5 HULS AMERICA INC
EPA’s High Production Volume Challenge Program

79

Status and Future Directions

80 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

68

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

24448-09-7 3M * ACC

HOECHST CELANESE

24615-84-7

RHONE POULENC INCORPORATED

HOECHST CELANESE

MITSUI & CO (USA) INC * * ACC, SOCMA

MONSANTO COMPANY ACC

24634-61-5

TOMEN AMERICA INC * *

24794-58-9 WR GRACE & CO-CONN * *

25154-38-5 UNION CARBIDE CHEMICALS & PLASTICS CO

25168-05-2 OCCIDENTAL CHEMICAL CORPORATION * ACC, API

25168-06-3 FMC COMPANY *

RUETGERS-NEASE *

25321-41-9

SLOSS INDUSTRIES CORPORATION * SOCMA

25586-42-9 EI DUPONT DE NEMOURS & CO INC ACC

AGFA * *

25646-71-3

OLIN CORPORATION ACC

26377-29-7 ICI AMERICAS INC

DOVER CHEMICAL CORPORATION * ACC

26401-27-4 GE SPECIALTY CHEMICALS * * API

WITCO CHEMICAL CORPORATION

DIXIE INTERNATIONAL COMPANY

26680-54-6 HUMPHREY CHEMICAL COMPANY *

MILLIKEN CHEM * *

GAF CHEMICALS CORPORATION

27193-28-8 PMC SPECIALTIES GROUP INC * SOCMA

ROHM AND HAAS COMPANY ACC

DELTECH CORPORATION * SOCMA

28106-30-1

DOW CHEMICAL USA * ACC, API, SOCMA

28777-98-2 BERCEN INC

ETHYL CORPORATION - HEALTH SAFETY AND

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

69

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

HUMPHREY CHEMICAL COMPANY *

MILLIKEN CHEM * *

30574-97-1 EI DUPONT DE NEMOURS & CO INC * * ACC

31138-65-5 FARM & IND CHEM CO

BERCEN INC

32072-96-1 DIXIE INTERNATIONAL COMPANY * *

ETHYL CORPORATION - HEALTH SAFETY AND

HULS AMERICA INC

32210-23-4 INTERNATIONAL FLAVORS AND FRAGRANCES IN * *

QUEST INTERNATIONAL * *

34689-46-8 MERICHEM COMPANY * * ACC, API

35203-06-6 MONSANTO COMPANY * * ACC

35203-08-8 MONSANTO COMPANY * * ACC

37439-34-2 DOW CHEMICAL USA * ACC, API, SOCMA

37734-45-5 ICI AMERICAS INC

37764-25-3 ICI AMERICAS INC

38185-06-7 LOMAC INCORPORATED *

FMC COMPANY *

39515-51-0 MTM HARDWICKE INC *

NAGASE AMERICA CORPORATION

40630-63-5 3M * ACC

AMERICAN CYANAMID CO AGRI PRODS RES *

BIDDLE SAWYER CORPORATION SOCMA

HEICO CHEMICALS INC

40876-98-0

NEPERA INC

51632-16-7 MTM HARDWICKE INC *

52184-19-7 CIBA-GEIGY CORPORATION TEXTILE PRODUCTS * ACC, API

52556-42-0 RHONE POULENC INCORPORATED

52663-57-7 FMC COMPANY *

56038-89-2 AMERICAN CYANAMID CO AGRI PRODS RES
EPA’s High Production Volume Challenge Program

81

Status and Future Directions

82 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

70

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

BASF CORPORATION * ACC, SOCMA

57693-14-8 CIBA-GEIGY CORPORATION TEXTILE PRODUCTS * ACC, API

CROMPTON & KNOWLES COLORS INCORPORATED

DOVER CHEMICAL CORPORATION * * ACC

61788-76-9 FERRO CORPORATION ACC, SOCMA

OCCIDENTAL CHEMICAL CORPORATION * ACC, API

GAF CHEMICALS CORPORATION

61789-32-0 LEVER BROTHERS CO

PPG INDUSTRIES INC ACC, SOCMA

GAYLORD CONTAINER CORPORATION *

61789-65-9 JAMES RIVER CORPORATION

JAMES RIVER GRAPHICS INCORPORATED

61789-85-3 STEPAN CHEMICAL COMPANY

AMOCO CANADA MARKETING CORP

64742-24-1 DIAMOND SHAMROCK REFINING/MKT

SUN REFINING AND MARKETING COMPANY SOCMA

CHEVRON CHEMICAL CO ACC, API, SOCMA

HALTERMANN LTD

MONSANTO COMPANY ACC

64743-02-8

SHELL OIL COMPANY ACC, API

ASHLAND CHEMICAL COMPANY - ENVIRONMENTAL ACC, API

COASTAL REFINING & MARKETING INC ACC, API

FARMLAND INDUSTRIES INC *

LYONDELL-CITGO REFINING COMPANY LTD

64743-03-9

TEXACO CHEMICAL COMPANY ACC, API, SOCMA

MONSANTO COMPANY ACC

64771-71-7

SHELL OIL COMPANY ACC, API

ACME STEEL COMPANY * *

ARMCO STEEL COMPANY LP

65996-78-3

BETHLEHEM STEEL CORPORATION *

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

71

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

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 * SOCMA

TONAWANDA COKE CORP * *

USS DIVISION OF USX * *

ARISTECH CHEMICAL CORPORATION

65996-79-4

KOPPER COMPANY INCORPORATED * *

EMPIRE COKE COMPANY *

65996-80-7

KOPPER COMPANY INCORPORATED * *

ACME STEEL COMPANY * *

ARMCO STEEL COMPANY LP

EMPIRE COKE COMPANY *

ERIE COKE CORPORATION * *

KOPPER COMPANY INCORPORATED * *

SLOSS INDUSTRIES CORPORATION * SOCMA

TONAWANDA COKE CORP * *

65996-81-8

USS DIVISION OF USX * *

ALLIED-SIGNAL INC *

ARISTECH CHEMICAL CORPORATION

KOPPER COMPANY INCORPORATED * *

65996-82-9

REILLY INDUSTRIES INC * * ACC

ALLIED-SIGNAL INC *

65996-83-0

KOPPER COMPANY INCORPORATED * *

65996-86-3 ALLIED-SIGNAL INC
EPA’s High Production Volume Challenge Program

83

Status and Future Directions

84 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

72

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

KOPPER COMPANY INCORPORATED * *

ALLIED-SIGNAL INC *

65996-87-4

KOPPER COMPANY INCORPORATED * *

ACME STEEL COMPANY * *

ALLIED-SIGNAL INC *

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 * * ACC

SLOSS INDUSTRIES CORPORATION * SOCMA

65996-89-6

USS DIVISION OF USX * *

ALLIED-SIGNAL INC *

ARISTECH CHEMICAL CORPORATION

CROWLEY TAR PRODUCTS COMPANY INC

KOPPER COMPANY INCORPORATED *

65996-91-0

REILLY INDUSTRIES INC * * ACC

KOPPER COMPANY INCORPORATED * *

65996-92-1 REILLY INDUSTRIES INC ACC

WESTERN TAR PRODUCTS CORPORATION *

66071-94-1 GRAIN PROCESSING CORPORATION * *

68081-86-7 EXXON CHEMICAL COMPANY * ACC, API

HENKEL CORPORATION

68082-78-0

REILLY-WHITEMAN INC

EXXON CHEMICAL COMPANY ACC, API

68153-60-6

JETCO CHEMICALS INC

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

73

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

ASHLAND CHEMICAL COMPANY - ENVIRONMENTAL ACC, API

68187-57-5

KOPPER COMPANY INCORPORATED * *

FMC COMPANY *

68187-59-7

UCAR CARBON COMPANY INC * *

CLIMAX PERFORMANCE MATERIALS CORPORATION

HIGH POINT CHEMICAL CORPORATION

NATIONAL STARCH AND CHEMICAL CORPORATION

68187-76-8

REILLY-WHITEMAN INC

68187-84-8 CASCHEM INC * *

BASF CORPORATION * * ACC, SOCMA

68188-18-1

MOBAY CHEMICAL CORPORATION

68309-27-3 CLIMAX PERFORMANCE MATERIALS CORPORATION

68334-01-0 MERICHEM COMPANY * * ACC, API

68441-66-7 HATCO CHEMICAL CORPORATION *

68442-60-4 HERCULES INCORPORATED * *

CARGILL INCORPORATED * *

68476-80-2

KARLSHAMNS LIPID SPECIALTIES USA

68478-20-6 VELSICOL CHEMICAL CORPORATION *

68479-98-1 ETHYL CORPORATION - HEALTH SAFETY AND

EXXON CHEMICAL COMPANY ACC, API

68511-40-0

SHEREX CHEMICAL COMPANY INC

68512-63-0 CHEVRON CHEMICAL CO ACC, API, SOCMA

EXXON CHEMICAL COMPANY * * ACC, API

68513-62-2

MARATHON OIL COMPANY API

68514-41-0 EXXON CHEMICAL COMPANY * ACC, API

SYNTHETIC RUBBER PRODUCTS INC

68515-89-9

WITCO CHEMICAL CORPORATION

DOVER CHEMICAL CORPORATION * ACC

68527-02-6

OCCIDENTAL CHEMICAL CORPORATION * ACC, API

68553-14-0 AMOCO CANADA MARKETING CORP *
EPA’s High Production Volume Challenge Program

85

Status and Future Directions

86 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

74

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

HB FULLER CO

68584-25-8 HUISH DETERGENTS INC * *

PILOT CHEMICAL COMPANY * SOCMA

68602-81-3 SARTOMER COMPANY INC * * ACC

68603-84-9 HENKEL CORPORATION *

68607-28-3 PETROLITE CORPORATION

BF GOODRICH COMPANY SPECIALTY CHEMICALS

68608-59-3

VISTA CHEMICAL CO

68609-04-1 BASF CORPORATION * * ACC, SOCMA

68609-05-2 BASF CORPORATION * * ACC, SOCMA

68610-90-2 EXXON CHEMICAL COMPANY ACC, API

AGRICO CHEMICAL COMPANY

AGRICULTURAL MINERALS CORPORATION

ARCADIAN CORPORATION

CF INDUSTRIES INC * *

FARMLAND INDUSTRIES INC * *

SOUTHERN RESIN INC

TERRA INTERNATIONAL INC * *

TRIAD CHEMICAL *

68611-64-3

UNOCAL SCIENCE & TECHNOLOGY DIVISION *

CHEVRON CHEMICAL CO ACC, API, SOCMA

68647-60-9

LYONDELL-CITGO REFINING COMPANY LTD

68650-36-2 BP OIL COMPANY * ACC, API

AMOCO CANADA MARKETING CORP *

68782-97-8 CHEVRON CHEMICAL CO ACC, API, SOCMA

LYONDELL-CITGO REFINING COMPANY LTD

HENKEL CORPORATION

HIGH POINT CHEMICAL CORPORATION *

PIEDMONT CHEMICAL INDUSTRIES INC

68815-50-9

SEDGEFIELD SPECIALTIES

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

75

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

68909-77-3 TEXACO CHEMICAL COMPANY ACC, API, SOCMA

68915-05-9 SHEREX CHEMICAL COMPANY INC

68915-39-9 BASF CORPORATION * * ACC, SOCMA

68918-16-1 FMC COMPANY *

SHELL OIL COMPANY ACC, API

68919-17-5

THE GOODYEAR TIRE & RUBBER CO DEPARTMEN * *

68920-64-9 AMOCO CANADA MARKETING CORP *

68937-29-1 BASF CORPORATION * * ACC, SOCMA

68937-69-9 HENKEL CORPORATION *

68937-70-2 HENKEL CORPORATION *

68937-72-4 HENKEL CORPORATION *

DOW CHEMICAL USA * ACC, API, SOCMA

68953-70-8

TEXACO CHEMICAL COMPANY ACC, API, SOCMA

BP OIL COMPANY * ACC, API

68953-80-0

SUN REFINING AND MARKETING COMPANY SOCMA

68955-37-3 HERCULES INCORPORATED * *

68955-76-0 CHEVRON CHEMICAL CO ACC, API, SOCMA

BP OIL COMPANY ACC, API

68955-96-4

LYONDELL-CITGO REFINING COMPANY LTD * *

68987-41-7 EXXON CHEMICAL COMPANY * ACC, API

68988-22-7 CAPE INDUSTRIES

AMOCO CANADA MARKETING CORP

CROWN CENTRAL PETROLEUM CORPORATION * *

TEXACO CHEMICAL COMPANY ACC, API, SOCMA

68988-99-8

TOTAL PETROLEUM INC

BETHLEHEM STEEL CORPORATION * *

68990-61-4

CITIZENS GAS & COKE UTILITY * *

68990-65-8 KARLSHAMNS LIPID SPECIALTIES USA

69029-75-0 CHEVRON CHEMICAL CO * ACC, API, SOCMA

70024-67-8 PILOT CHEMICAL COMPANY SOCMA
EPA’s High Production Volume Challenge Program

87

Status and Future Directions

88 Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

76

CAS # 1990 Manufacturer 1998

Manu.

2002

Manu.

Trade

Association

STEPAN CHEMICAL COMPANY

70084-98-9 UNION CAMP CORPORATION

70693-50-4 CIBA-GEIGY CORPORATION TEXTILE PRODUCTS * * ACC, API

70851-08-0 RHONE POULENC INCORPORATED

71077-05-9 TEXACO CHEMICAL COMPANY ACC, API, SOCMA

72162-28-8 GE PLASTICS * * API

73665-18-6 KOPPER COMPANY INCORPORATED *

83864-02-2 EI DUPONT DE NEMOURS & CO INC * ACC

84501-86-0 WERNER G SMITH INC * *

90640-80-5 KOPPER COMPANY INCORPORATED *

90640-86-1 KOPPER COMPANY INCORPORATED * *

119345-02-7 DOW CHEMICAL USA ACC, API, SOCMA

125997-20-8 GREAT LAKES CHEMICAL CORPORATION - RESEA

 ------------------------------------------------------------------------------------

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.

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

Make data publicly

available in HPVIS.

1.

EPA and others may engage

in activities to secure

additional HPV sponsors.

2.

Is chemical

included in First

HPV Test

Rule?

4.

Finalize the First HPV Test

Rule. Identify SIDS endpoint

studies not addressed in the

First HPV Test Rule.

3.

Does the

chemical meet

“No Longer HPV”

criterion?

5.

Can test

rule exposure-based

findings be made with

currently available

information

6.

Are there any

publicity available

studies that are adequate

to fulfill HPV Challenge

Program needs?

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.

9.

Are studies

available/submitted to

EPA adequate to meet

SIDS endpoints?

10.

Can test rule

exposure-based

findings be made with

PAIR and/or other

currently available

information?

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.

12.

Seek other data

development

mechanism for

chemicals with

continuing hazard

and fate data gaps.

11.

Propose and finalize Third HPV Test

Rule for Chemicals for which findings

can be made. Consider risk-based

findings for chemicals where needed.

571 Unsponsponsored

Chemicals based on 1990 HPV

Challenge Programming List

Yes

No

Yes

No

~330 orphan

chemicals

Yes

No

No No

Yes Yes

No

Yes
EPA’s High Production Volume Challenge Program

89

Status and Future Directions

90

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)(1)(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 SIDSRelated 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)(1)(A) (riskbased finding) and/or section 4(a)(1)(B) (exposurebased 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 exposurebased findings. 
EPA’s High Production Volume Challenge Program

91

Status and Future Directions

92

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 

lbs/yr; and

■ Substantial Release – 1 million lbs/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)(1)(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)(1)(B)(i) finding for a test 

rule can be made. (See the description of Flowchart 

Graphic 5 for details.)
EPA’s High Production Volume Challenge Program

93

Status and Future Directions

94

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 Timeline*

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. 

*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.}

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. 

Projected Orphans Data Development Timeline*

Estimated Timeline First HPV Test Rule Second HPV Test Rule Third HPV Test Rule

October 2004 Data Availability/Adequacy

Analysis Initiated

8(a)/8(d) Candidates Provided to

ITC

December 2004 55th ITC Report Published

June 2005 Final Rule Published 8(a) and 8(d) Final Rules

Published

October 2005 Proposed Test Rule

Published

Review of 8(a) and 8(d)

submissions initiated

January 2006 Review of Public Comments

on Proposed Rule Initiated

September 2006 Final Test Rule Published Proposed Test Rule Published

November 2006 Review of Public Comments on

Proposed Rule Initiated

August 2007 Final Test Rule Published

*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, in2005, 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.

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

lfiliithHPVIS fkithTSCA ti4()(1)(B)(i) fidif

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)(1)(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.
Status and Future Directions

96

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 
EPA’s High Production Volume Challenge Program

97

Status and Future Directions

98

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 

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 IURs. 

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/.

Global HPV Portal Information Sharing
Status and Future Directions

100

Key Terms and Acronyms

Status and Future Directions of the HPV Challenge Program – Final Draft – 10/19/04

86

Key Terms and Acronyms

1990 HPV Challenge

Program Chemical List

The list of HPV Chemicals from the 1990 IUR reporting period, from which sponsors

may make chemical commitments to supply data.

1994 List of HPV

Additions

Approximately 500 organic chemicals that were newly reported as HPV in the 1994

IUR, provided for use by companies in developing categories of chemicals.

ACC American Chemistry Council.

API American Petroleum Institute.

CAS Number 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.

Category 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.

Category Analysis 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.

Consortium An organization consisting of two or more companies that agree to sponsor at least

one chemical in the HPV Challenge Program.

EC 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.

ED Environmental Defense.

EU European Union: An organization of democratic European countries that have

established common institutions to work toward prosperity.

Endpoint The chemical or biological effect that is assessed by a test method.

HPV High Production Volume: Chemicals manufactured or imported in quantities equal to

or greater than 1 million pounds per year.

HPVIS 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.

ICCA 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.

IUCLID 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.

IUR 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.
EPA’s High Production Volume Challenge Program

101

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87

LogKow 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.

NPPTAC 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).

OECD 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.

OPPT Office of Pollution Prevention and Toxics. EPA’s office wherein the HPV Challenge

Program is administered.

Orphan 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.

PCRM Physicians Committee for Responsible Medicine.

PETA People for the Ethical Treatment of Animals.

Robust Summary An abridged reporting of data that includes the study objective, method, results, and

conclusions for one endpoint.

SAR 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.

SIAM SIDS Initial Assessment Meeting: A gathering of OECD member states to agree on

initial hazard assessment for HPV SIDS chemicals.

SIAR 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.

SIDS 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.

SOCMA Synthetic Organic Chemical Manufacturers Association: The primary trade

association serving the specialty-batch and custom chemical industry.

Start Year The year in which a sponsor commits to submit a chemical’s test plan and robust

summary.

Test Plan A summary of available and adequate data, with reference to a summary of data

gaps and a rationale for testing, if necessary.

Test Rule A TSCA Section 4 regulatory mechanism that requires testing of chemical

substances and mixtures for which the necessary findings have been made.

TSCA Toxic Substances Control Act: An Act created by Congress that gives EPA the ability

to assess and regulate industrial chemicals in the United States.

UNEP 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.

Viable Chemical 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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