Status and Future Directions of the High Production Volume Challenge Program Office of Pollution Prevention and Toxics ------- Status and Future Directions of the High Production Volume Challenge Program Office of Pollution Prevention and Toxics &EPA United Stutos Environ mental Protection Agency ------- 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 ------- The HPV Challenge Program The U.S. EPA's High Production Volume (HPV) Challenge Program is ensuring that basic health and environmental effects data on approximately 2,800 HPV chemicals is made available to the public. Since the Program's inception in 1998, industry chemical manufacturers and importers have participated in the Challenge by sponsoring over 2,200 chemicals. More than 400 companies and 100 consortia have sponsored 1,371 chemicals directly in the Program and an additional 851 chemicals have been sponsored indirectly in an international counterpart to the HPV Challenge Program, the International Council of Chemical Associations (ICCA) HPV Initiative. Three hundred fifty-three test plans have been submitted as of July 2004 for 1,266 of the 1,371 chemicals sponsored directly in the HPV Challenge Program (or 92%). EPA expects that the end of 2004 will be a critical time as sponsors work to fulfill their commitments by submitting test plans and data summaries for the remaining 8% of the sponsored chemicals, and also to submit completed data packages where additional testing was needed. Overall, the HPV Challenge Program has continued to strive to meet its outlined goals. Extensive voluntary participation has been achieved as companies, individually or as part of consortia, have agreed to sponsor chemicals. Additionally, the public has been an important participant in the Program by providing feedback to sponsors on their test plans and data summaries. A key EPA goal in managing the HPV Challenge Program has been to provide clear guidance for assisting participating sponsors. Guidance has been made available on a wide variety of subjects, including category formation, developing robust data summaries, and assessing the adequacy of existing data. Because of the HPV Challenge Program, significant amounts of data have been made public for the first time (59% of the data submitted was not publicly available at the start of the Program). The Agency is also stepping up its efforts to provide the public with available data. EPA is developing the HPV Information System (HPVIS), which will provide the public with an efficient way to comprehensively search and retrieve data included in the sponsor-submitted data summaries. EPA is also working collaboratively with the European Union to develop a Global HPV Portal. The Agency is designing the Portal to provide a central location for domestic and international users to access consolidated international HPV chemical data repositories. In addition to the database development efforts, the Agency is working on implementing a strategy to address orphan (unsponsored) HPV chemicals in an effort to secure data related to those chemicals. The orphan strategy is outlined in Appendix 5 of this report. Since the Programs inception in 1998, industry chemical manufacturers and importers have participated in the ^ Challenge by sponsoring over 2,200 chemicals. cals. In summary, the HPV Challenge Program has made outstanding progress toward meeting its goals and commitments, and on preparing for future work on HPV chemicals. After briefly summarizing the background of the HPV Challenge Program, the following topics are described in this report: How the Program Works, Overall HPV Challenge Program Achievements, EPA's Work With Sponsors To Address Overdue Test Plans, Orphan Chemicals, and Future Directions and Developing Issues. History of the Program The HPV Challenge Program, officially launched in late 1998, was created to ensure that a baseline set of data on approximately 2,800 high production volume chemicals would be made available to the public. The American Chemistry Council (ACC)1, Environmental Defense (ED)2, and the American Petroleum Institute (API) participated in the launch of the Program. HPV chemicals are manufactured or imported in amounts equal to or greater than one million pounds per year and were identified for this program through data reported under the Toxic Substances Control Act (TSCA) Inventory Update Rule (IUR) during 1990. HPV chemicals that are not sponsored in the Program maybe subject to regulations ("test rules") under Section 4 TSCA because these chemicals require needed testing. A basic premise of the Program is that the public has a right to know about the hazards associated with chemicals in their environment. Everyone - including industry, environmental protection groups, animal welfare organizations, government groups, and the general public, among others can use the HPV chemical data provided through the HPV Challenge Program to make informed decisions related to the human and environmental hazards of chemicals that they encounter in their daily lives. The HPV Challenge Program was established in response to several studies that showed that there were relatively few U.S. HPV chemicals for which an internationally agreed upon set of data for hazard screening was available to the public. This data set addresses areas, also known as "endpoints," that illustrate a chemical's properties and effects. One of the studies providing motivation for the Challenge was EPA's Chemical Hazard Data Availability Study3 (1998). This study (see the figure on the following page) showed that 43% of 1ACC = formerly known as the Chemical Manufacturers Association. 2ED = formerly known as Environmental Defense Fund. 3Chemical Hazard Data Availability Study: What Do We Really Know About the Safety of High Production Volume Chemicals? (1998). Washington, DC: U.S. Environmental Protection Agency. (Website: http://www.epa.gov/oppt/chemrtk/hazchem.pdf). EPA's High Production Volume Challenge Program Status and Future Directions ------- Lack of Publicly Available Screening Data 12345 Number of Endpoints with Publicly Available Data high production volume chemicals had no publicly available data on basic toxicity and only 7% had a full set of basic data for six endpoints4. Subsequently, the Agency challenged U.S. manufacturers and importers of HPV chemicals to voluntarily sponsor chemicals in the Program. Sponsorship entails making screening- level health and environmental data available to the public. Public availability of these data is a fundamental principle of the Program. The data set sought by the HPV Challenge Program is known as the Screening Information Data Set (SIDS) that was developed by the Organization for Economic Cooperation and Development (OECD). The SIDS provides an internationally agreed upon set of test data for screening high production volume chemicals for human and environmental hazards, and helps to make an informed, preliminary judgment about the hazards of HPV chemicals. For a more detailed History of the Program, see Appendix 1. How the Program Works Commitments to sponsor chemicals in the HPV Challenge Program have come from companies and consortia both inside and outside the United States. The chemical industry has demonstrated this commitment to product stewardship by making publicly available screening-level hazard data that will allow EPA, industry, and other stakeholders to effectively gauge potential hazards of HPV chemicals. As part of their commitment to the HPV Challenge Program, sponsors submit data summaries of existing information along with a test plan that proposes a strategy to fill data gaps. These documents are then posted to the HPV Challenge Program website. The following timeline graphic shows how the majority of sponsors' materials were submitted to the Agency between 2001-2003. Sponsors submit test plans for either individual chemicals or for a category of chemicals. A chemical category comprises a group of substances, usually similar in chemical structure, with a regular pattern of properties and effects. Data for chemicals in the category can be used to estimate the chemical properties and effects of other category members. A 120-day comment period begins when test plans and data summaries submitted directly to the HPV Challenge Program are posted to the Program website. It is at this time when all stakeholders industry, environmental protection groups, animal welfare groups, private citizens, etc. - can comment on the data summary and test plan submissions, and EPA comments on all of the submissions. Sponsors can also indirectly submit data through the International Council of Chemical Associations (ICCA) HPV Initiative, which is a complementary program aimed at HPV chemicals from around the world. For more information regarding Hoiv the Program Works, see Appendix 2. HPV Challenge Program Timeline October 1998 The HPV Challenge Program is officially launched. EPA sends a letter to manufacturers, soliciting companies to sponsor chemicals in the program. 2001-2903 The majority of materials are submitted to the Agency, covering 1,016 chemicals that were sponsored directly in the HPV Challenge Program. December 31, 2005 All data for sponsored chemicals should be submitted. 1998 1999 J2000 2001 2002 2003 2004 2005 April 2000 The first test plans and data summaries are posted on EPA's HPV Challlenge Program Website. December 31, 2004 All test plans for sponsored chemicals should be submitted. 4The six endpoints: acute toxicity, repeat dose toxicity, developmental and reproductive toxicity, mutagenicity, ecotoxicity, and environmental fate. EPA's High Production Volume Challenge Program Status and Future Directions 4 ------- Overall HPV Challenge Program Achievements The HPV Challenge Program has resulted in many achievements. The accomplishments include: chemical manufacturers work individually or through consortia to sponsor chemicals, test plans and data summaries for the chemicals that have been submitted, the public has commented on materials posted to the website, and EPA has provided detailed guidance documents to assist stakeholders in participating in the Program. Extensive Voluntary Participation Participation in the HPV Challenge Program has created attention by exceeding all expectations. A total of 2,222 chemicals have been sponsored, with 1,371 chemicals sponsored directly in the Program by 401 companies and 103 consortia and an additional 851 chemicals sponsored indirectly in the ICCA HPV Initiative. For chemicals sponsored directly in the HPV Challenge Program, 353 test plans have been submitted for 1,266 of the 1,371 sponsored chemicals (or 92%). Chemicals Sponsored Directly in the HPV Challenge Program n submitted outstanding 500 495 03 O "E 0) _c O 275 44 46 37 n ni 2000 2001 2002 2003 Year 2004 Of these 353 test plans, 114 are for categories of chemicals and the remaining 239 are for individual chemicals. EPA expects that the end of 2004 will be a critical time as sponsors work to fulfill their commitments by submitting test plans and data summaries for the remaining 8% of the sponsored chemicals, and also work to submit completed data packages where additional testing was needed. Public Comments The HPV Challenge Program provides a unique opportunity for all stakeholders, including the public, to comment on test plan and data summary submissions. Comments are important because sponsors consider this feedback when revising their test plans and data summaries. All comments are posted to the website for public availability. Environmental Defense has submitted comments on 89% of all posted test plans. Two animal welfare groups People for the Ethical Treatment of Animals (PETA) and Physicians Committee for Responsible Medicine (PCRM) submitted comments on 62% of all test plans, and private individuals and other groups submitted comments on fewer than 3% of all test plans. Comments from Environmental Defense often refer to whether they are in agreement with the sponsor's category hypothesis, use of supporting chemicals, estimations or Structure-Activity Relationships (SARs, which are techniques to show how data for one chemical can be used to cover data needs for a similar chemical), proposed testing, and adequacy of submitted data. Comments from PETA and PCRM generally indicate whether they agree with the proposed test plan or not, and specifically with regard to whether animals will be used for testing purposes. These animal welfare organizations often state reasons for why testing should not be performed. Guidance Documents A key EPA goal in managing the HPV Challenge Program has been to provide clear guidance to assist stakeholders in participating in the Program. EPA's "Guidance Documents" webpage can be found on the EPA website at http://www.epa.gov/chemrtk/guidocs. htm. Guidance is provided for subjects such as category formation, developing robust data summaries, and assessing adequacy of existing data, to name a few. A number of EPA's guidance documents have achieved international acceptance through their incorporation in OECD guidance documents. The guidance document on development of chemical categories provides guidance on approaches and issues encountered in category formation and application under the HPV Challenge Program. The document offers advice on how companies could group chemicals with similar characteristics into EPA's High Production Volume Challenge Program Status and Future Directions 6 ------- categories, and then evaluate existing data and conduct testing to characterize the category all without having to perform every test on every individual chemical. EPA's "Guidance on Developing Robust Summaries" document presents guidance on what technical information, on an endpoint-by-endpoint basis, is necessary to adequately describe a particular study. The term "robust summary" is used to describe this technical content. Robust study summaries are intended to provide sufficient information to allow a technically qualified person to make an independent assessment of a given study report without having to go back to the full study report, and to also allow evaluation of the proposed test plan. A robust study summary therefore concisely reflects the objectives, methods, results, and conclusions of the full study report. Test Plan and Data Submissions Are Now Available EPA analyzed submitted test plans to determine how the health and environmental effects endpoints were addressed. Sponsors proposed to meet data needs through the use of existing scientifically adequate data, estimation techniques such as Structure-Activity Relationships (SARs), or proposed new testing. An examination of submitted data revealed that a significant amount of unpublished data have now been made public by the sponsors. This indicates that many sponsors made significant efforts in evaluating the hazards of their chemicals prior to the launch of the HPV Challenge Program, but often did not make the data available to the public. In fact, 59% of the existing data reported under the HPV Challenge Program, which represents over 6,800 studies, was not publicly available before the launch of the Program. This represents a major success of the HPV Challenge Program. Sources of Existing Data Published Studies (4,800) (41 %) Unpublished Studies (6,801) (59%) The submission of existing, unpublished data to EPA under the HPV Challenge Program has also significantly minimized the amount of new testing that sponsors have proposed. Sponsors have made maximum use of Program guidance concerning the use of SAR and category proposals, which also reduced the need for new testing. New testing has been proposed for fewer than 10% of the chemicals' endpoints. The Category Approach One of the most significant results of the HPV Challenge Program has been the use of the category approach to address the SIDS endpoints. In fact, 81% of all chemicals addressed in test plans have been included in a category. Categories require a Endpoint Data Sources Fate o ill Phys.chem. Human Health Ecotoxicity Existing Data SAR and Other Techniques Proposed Testing 0 10 20 30 40 50 60 70 Percent EPA's High Production Volume Challenge Program 8 Sfafus and Future Directions ------- supporting hypothesis of how the category chemicals relate to each other, as well as a description of how data for one chemical can be used to predict the toxicological responses of similar chemicals in the category. EPA and other stakeholders then comment on the reasonableness of the hypothesis, the adequacy of supporting data, and any proposed testing. Once the sponsor submits its final category analysis, EPA will either agree that the category "held," or will notify the sponsor that the sponsor may need to consider additional testing or restructure the category. The ICCA HPV Initiative Test plans and data summary submissions for chemicals sponsored indirectly through the ICCA HPV Initiative are not provided to EPA to post on the HPV Challenge Program website. Therefore, EPA determines progress in the ICCA HPV Initiative by tracking how many chemicals sponsored in the Initiative go to an OECD SIDS Initial Assessment Meeting (SIAM), which is a meeting where OECD member countries agree on initial hazard assessment for HPV SIDS chemicals. Chemicals Sponsored Indirectly through the ICCA HPV Initiative Start Year or Test Plan Receipt Year 1999 2000 2001 2002 2003 2004 Total Total Expected Chemical Submissions 38 149 487 133 127 40 974 SIAM Chemicals Sponsored by ICCA 14 54 98 19 17 27 229 Of the 974 chemicals sponsored in the ICCA HPV Initiative, 229 chemicals had been through the OECD SIDS process by July 2004. This number accounts for 24% of the total ICCA commitments. It is important to point out that 123 chemicals are dually sponsored both directly in the HPV Challenge Program as well as indirectly in the ICCA HPV Initiative. Earlier in this report, it was noted that 851 chemicals are sponsored in the ICCA HPV Initiative; however, when the 123 dually sponsored chemicals are considered, total ICCA HPV Initiative sponsorship increases to 974 chemicals. For more information regarding Overall HPV Challenge Program Achievements, see Appendix 3. EPA's Work With Sponsors To Address Overdue Test Plans Although EPA has received a large number of test plans, a few commitments to supply information in 2003 or earlier have not been met. In order to evaluate which sponsors were responsible for overdue test plans, the Agency reviewed commitment information submitted by companies and consortia, and then sent a letter to sponsors of chemicals with overdue test plans in April 2004. EPA received responses from many of these sponsors updating the status of their commitments. As of July 2004, test plan and data summary submissions were overdue from 24 sponsors for 47 chemicals. The Agency expects that sponsors will uphold their commitments and submit test plans and data summaries for these chemicals by the end of 2004. For more information regarding Overdue Test Plans, see Appendix 4. Orphan Chemicals While the success of the HPV Challenge Program has been significant, 330 chemicals that were eligible for sponsorship in the Program continue to remain unsponsored. These chemicals are also known as "orphans." The Agency is taking steps to ensure that screening-level data are made available to the public for the 330 orphan chemicals through a last chance at voluntary sponsorship, as well as through future TSCA information gathering and test rules. For more information regarding Orphan Chemicals, including a detailed outline of EPA's Draft Orphans Strategy, see Appendix 5. Future Directions and Developing Issues Public access to hazard data is integral to the HPV Challenge Program. Test plan and data summary submissions, sponsor commitment information, EPA's High Production Volume Challenge Program Status and Future Directions 10 ------- chemical lists, guidance documents, and other materials can be found at the HPV Challenge Program Website (http://www.epa.gov/chemrtk). EPA has recently provided enhanced search capability on its existing "Robust Summaries and Test Plans" webpage (http://www.epa.gov/chemrtk/hpvrstp.htm) that allows the public to more efficiently search for test plan and data summary submissions. Production of the HPV Information System (HPVIS), a much more comprehensive, data-searchable application, is the ultimate goal. This system will allow users to thoroughly search across all test plan and data summary- related materials - including the data presented within and among data summaries. The first release of HPVIS is scheduled for late 2004 / early 2005. As the HPV Challenge Program enters its final year and as EPA prepares to provide the industry-submitted data to the public in a searchable database format, the Agency has made great strides to press forward with developing and planning for the delivery of a Global HPV Portal. The Portal is a system that will provide a central location for domestic and international users to access consolidated international HPV chemical data repositories. EPA is working collaboratively with the European Commission (EC), in consultation with the Organization for Economic Cooperation and Development (OECD), and with the additional participation of Canada and Japan to develop this system. The aim of the Global HPV Portal is to provide seamless information sharing between the European Union's (E.U.) International Uniform Chemical Information Database (IUCLID) and EPAs HPVIS. The two leads - EC and EPA - have worked diligently on the Portal requirements in an effort to share information and make data more readily available to stakeholders from around the world. Additionally, now that the majority of the test plans and data summaries that were committed to under the HPV Challenge Program have been submitted, the Agency is focusing on using the data for identifying chemicals of concern. The Agency is working with the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) and NPPTAC's HPV Work Group to develop a screening approach for identifying and prioritizing chemicals for further work. Once EPA has implemented a plan for prioritizing chemicals, the next steps include employing mechanisms to obtain additional hazard data (beyond the basic screening-level of the SIDS) or exposure data through voluntary or regulatory approaches for priority chemicals as needed. Developing approaches to obtain data on newly emerging HPV chemicals that were reported in recent IUR cycles is also viewed as an important follow-on step for the Challenge. For more information regarding Future Directions and Developing Issues, see Appendix 6. HPV Challenge Program Conclusions In conclusion, EPA is very pleased with the overwhelming response from companies and consortia to the HPV Challenge Program. The extraordinary response to the Program has resulted in a tremendous amount of sponsor-submitted test plan / summary data being made publicly available. More than 400 companies and 100 consortia have sponsored over 2200 chemicals in the Program. In addition to the 851 chemicals sponsored indirectly through the ICCA HPV Initiative, 353 test plans have been submitted for 1,266 (92%) of the 1,371 chemicals sponsored directly in the HPV Challenge Program. The majority of the test information that addresses the SIDS endpoints was comprised of unpublished, existing data, which because of the HPV Challenge Program has now been made publicly available. In addition, category approaches and SAR techniques have been applied to extend the available data to other related chemicals, thereby reducing the need for new testing. The Agency has developed a strategy to address those from the original list of approximately 2800 chemicals that have either not been sponsored or have been sponsored but submission of test plans / data summaries are currently overdue. This strategy, plus efforts to develop the HPVIS while working with other governments in developing the Global HPV Portal, will help ensure that more data are accessible in the U.S. and internationally. The Agency is working with the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) and NPPTAC's HPV Work Group to develop a screening approach for identifying and prioritizing chemicals for further work. In addition to chemicals identified from the 1990 IUR, EPA is in the process of considering options for addressing HPV chemicals that were reported in the most recent IUR reporting. EPAs Office of Pollution Prevention and Toxics will continue to inform the public about the HPV Challenge Program and the potential uses of the collected data. Continued cooperation by sponsors and other participating stakeholders in the Program will ultimately result in public accessibility to a large amount of useful HPV chemical data that were largely not available to the public at the Program's start in 1998. EPA recognizes the contributions by industry and other stakeholders in the HPV Challenge Program's accomplishments. 11 EPA's High Production Volume Challenge Program Status and Future Directions 12 ------- Appendix 1: History of the Program The HPV Challenge Program was established in 1998 in response to several studies that revealed how little health and environmental effects data were publicly available for HPV chemicals. Environmental Defense's Toxic Ignorance5 study in 1997 showed that, for a sample of 100 HPV chemicals, there were relatively few U.S. HPV chemicals with health hazard screening data. In 1998, EPA's Chemical Hazard Data Availability Study6 addressed all HPV chemicals and resulted in similar findings; specifically, 43% of high production volume chemicals had no publicly available data on basic toxicity and only 7% had a full set of basic data (see the figure below). These results were subsequently supported by the American Chemistry Council's Public Availability of SIDS-Related Testing Data for U. S. High Production Volume Chemicals' study in 1998. This lack of data Lack of Publicly Available Hazard and Fate Data ro .o CD .c O Q_ I "S ^ Af) on m 42.5 13'8 10.3 9.3 g.O 8.1 7.1 0123456 Number of Endpoints with Publicly Available Data inhibits the public's ability to evaluate whether the chemicals that may be found in their environment, homes, workplaces, and the products that they buy are of concern. Prior to the HPV Challenge Program, such data were generally not available to the public. EPA responded to this lack of data by inviting U.S. manufacturers and importers of HPV chemicals to voluntarily sponsor chemicals in the HPV Challenge Program. Sponsorship entails the identification and initial assessment of the adequacy of existing data, the conduct of new testing only if the sponsor determines that adequate data do not exist, and making the new and existing data available to the public. Public availability of data is the fundamental principle of this program. Any new testing on the HPV chemicals in the HPV Challenge Program is to be completed by the end of 2004 with all data to be made available to the public by the end of 2005. HPV Challenge Program Design Sponsors can participate in the HPV Challenge Program either directly through the Program or indirectly through the International Council of Chemical Associations (ICCA) HPV Initiative and/ or the Organization for Economic Cooperation and Development's (OECD) HPV Screening Information Data Set (SIDS) Program. The ICCA HPV Initiative 6Toxic Ignorance: The Continuing Absence of Basic Health Testing for Top-Selling Chemicals in the United States (1997). New York, NY: Environmental Defense Fund. (Website: http://www.environmentaldefense.org/documents/243_toxicignorance.pdf). 6Chemical Hazard Data Availability Study: What Do We Really Know About the Safety of High Production Volume Chemicals? (1998). Washington, DC: U.S. Environmental Protection Agency. (Website: http://www.epa.gov/oppt/chemrtk/hazchem.pdf). 7Public Availability of SIDS-Related Testing Data for U.S. High Production Volume Chemicals (1998). Arlington, VA: Chemical Manufacturers Association. 14 <-. Sfafus and Future Directions ------- and OECD HPV SIDS Program are aimed at HPV chemicals from around the world. The information sought by the HPV Challenge Program is based on the OECD HPV SIDS Program, which includes an internationally agreed upon set of endpoints for screening high production volume chemicals for human and environmental hazards. The SIDS is regarded as the minimum data set needed to make an informed, preliminary judgment about the hazards of a given HPV chemical. For chemicals sponsored directly through the HPV Challenge Program, each sponsor submits a test plan to identify SIDS data needs along with a strategy to fill data gaps. Each sponsor also submits a detailed summary of existing data (robust summaries) for an individual chemical or a group of chemicals with similar structures and/or functionalities (category). The sponsor's test plan is posted for public comment to EPA's "Robust Summaries and Test Plans" webpage at http://www.epa.gov/chemrtk/hpvrstp.htm. The test plan is subject to a 120-day public comment period to allow EPA and other stakeholders to review and comment on the test plan and robust summaries and to submit additional data that may be used to reduce the need for new testing. Sponsors subsequently develop new data, if necessary, and submit appropriate robust summaries. As described below, voluntary participation in the HPV Challenge Program provides the flexibility to propose chemical categories and more flexible schedules for conducting necessary testing. Chemicals sponsored indirectly through the ICCA HPV Initiative are tied in directly with the OECD HPV SIDS Program (http://www.icca-chem.org). The basic ICCA HPV Initiative process consists of first obtaining company or consortium sponsorship for the ICCA-listed HPV chemicals. Then, the ICCA HPV Initiative solicits national sponsorship from an OECD member country. Once the member country sponsorship is achieved, the company or consortium works with the sponsor country to develop the necessary materials. Completed materials will be submitted to OECD by countries so that a screening- level hazard assessment can be completed. Chemicals not otherwise sponsored will be considered for inclusion in a test rule under TSCA Section 4. The purpose of the test rule is to serve as a regulatory backstop to the voluntary HPV Challenge Program and the ICCA HPV Initiative; and thereby ensure that basic data are available for all HPV chemicals. The first HPV test rule was proposed on December 26, 2000 (65 FR 81658). On that same date, another Federal Register notice (65 FR 81686) was also issued, and described the HPV Challenge Program (http:// www. epa.gov/chemrtk/ts42213 .pdf). 1990 HPV Challenge Program Chemical List The 1990 HPV Challenge Program Chemical List consists of all HPV chemicals reported in the 1990 Inventory Update Rule. Inorganic chemicals and polymers, except in special circumstances, were not subject to the IUR reporting requirements. The 1990 HPV Challenge Program Chemical List contained 2,782 chemicals. A second list, the 1994 List of HPV Additions, contained approximately 500 HPV chemicals that were newly reported as HPV in the 1994 IUR. The 1994 List of HPV Additions is not a part of the HPV Challenge Program at this time, but was provided for use by companies who desired to propose categories of chemicals and wished to include chemicals from the 1994 list in their category definitions. Additionally, in some cases, companies or consortia have sponsored chemicals that are not on either the 1990 HPV Challenge Program Chemical List or the 1994 List of HPV Additions. For the purposes of this report, these chemicals are included in the number of sponsored chemicals, and no distinction is made between these chemicals and those chemicals on the 1990 HPV Challenge Program Chemical List once they are sponsored. 15 EPA's High Production Volume Challenge Program Status and Future Directions 16 ------- Appendix 2: How the Program Works U.S. manufacturers and importers of HPV chemicals were invited to voluntarily sponsor chemicals in the HPV Challenge Program. To become a sponsor of one or more HPV chemicals a company or consortium sends a letter to EPA announcing its commitment to participate in the HPV Challenge Program and its willingness to adhere to the Program's procedures. The commitment letter includes chemical names and Chemical Abstract Services (CAS) registry numbers to be sponsored, the year of the Program in which the sponsor will submit test plans and supporting robust summaries, and the name and contact data for the technical person within the company to contact for additional information. Sponsorship can be undertaken by individual companies or through a consortium of companies. Many companies collaborate with other companies or trade associations that manufactured the same or similar chemicals by forming consortia. Consortia help avoid duplication of effort and reduce individual companies' expenditures needed for data collection or testing. As a first step toward fulfilling a commitment, the sponsor submits robust summaries of existing data and a test plan showing how it plans to fill data gaps. Chemicals can be submitted individually or as categories of chemicals. Categories of chemicals are proposed when test plan and robust summaries are submitted, and are not identified in the initial sponsorship commitment letter. EPA has received numerous commitments to sponsor chemicals since the beginning of the Program in late 1998. The Agency extended the initial timeframe for commitments to be received from March 1999 to December 26, 2000. This date was chosen because it was the date on which a proposed TSCA Section 4 test rule containing 37 unsponsored chemicals from the 1990 HPV Challenge Program Chemical List was published. Commitments received after December 26, 2000, were deemed "viable commitments." In addition to adhering to the standard components of the HPV Challenge Program, companies agreeing to sponsor chemicals via viable commitments also provide full copies of new and existing studies. Companies and consortia that committed to sponsor chemicals prior to issuance of the proposed test rule were not expected to submit full studies; instead, they were to submit robust summaries of the studies. When defining the number of sponsored chemicals within the HPV Challenge Program, the Agency does not consider viable commitments a separate sponsorship classification. 18 Sfafus and Future Directions ------- Companies and Consortia Sponsoring Chemicals Participation in the HPV Challenge Program has been remarkable and has exceeded all expectations. As of July 2004, a total of 401 companies and 103 consortia were sponsoring chemicals directly through the HPV Challenge Program. These numbers include companies and consortia that sponsor chemicals through the HPV Challenge Program and those that sponsor chemicals in both the HPV Challenge Program and through the ICCA HPV Initiative. The following table contains a list of the participating companies and consortia, along with their trade association affiliation, if applicable, and the number of chemicals that they are sponsoring. Participating Companies and Consortia in the HPV Challenge Program {Company and consortium names are presented according to how they were submitted to the Agency. Participating companies in the ICCA HPV Initiative or OECD HPV SIDS Program are not included if they are not also participating directly in the HPV Challenge Program. Trade association affiliation is noted for members of the following three trade associations: American Chemistry Council (ACC), American Petroleum Institute (API), and Synthetic Organic Chemical Manufacturers Association (SOCMA). Lists of ACC and SOCMA member companies were found on their web sites. A member company list for API is not available on its website; however, a list of links to API member companies is available at http://api-ec.api.org/links/index.cfm, and was used in this analysis to identify known API member companies it is not a complete list.} Sponsoring Organization Name Comoanies Trade Association(s) Number of Chemicals Sponsored 3M A.E. Staley Manufacturing Company Abitibi Consolidated (Formerly Donohue, Inc.) Aceto Corp Agri-Energy, LLC Air Liquide America Air Products and Chemicals, Inc. Akzo Nobel Akzo Nobel - Eka Chemicals Incorporated Akzo Nobel - Polymer Chemicals Business Group Akzo Nobel - Polymer Chemicals Metal Alkyls Akzo Nobel - Resins Akzo Nobel Chemicals Inc. Akzo Nobel Functional Chemicals LLC Akzo Nobel Functional Chemicals LLC - Phosphorus Chemicals Al-Corn Clean Fuel Cooperative Albemarle Corporation Albina Fuel Co. dba Albina Asphalt Alchem, Ltd. ALCO Chemical Alliance Forest Products Alliant Techsystems Inc. Amerada Hess Corporation Ameribrom Inc. Angus Chemical Company Aqua-Clor Arch Chemicals, Inc. Archer Daniels Midland Company (ADM) Arizona Chemical Company ^^^^^^^^^H ACC SOCMA ACC ACC ACC ACC ACC ACC ACC ACC ACC ACC ACC, API, SOCMA SOCMA ACC ^^^^^^^^^m 4 14 1 3 1 1 9 1 36 1 21 36 91 3 9 1 32 36 1 34 1 1 392 6 2 3 3 14 129 19 EPA's High Production Volume Challenge Program Status and Future Directions 20 ------- Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored Asahi Glass Co., Ltd. Ashland Inc. Asphalt Materials, Inc. Atlantic Richfield Company (ARCO) Atofina Chemicals, Inc. Atofina Oil and Chemical Company Atofina Petrochemical Inc. Ausimont S.p.A. Ausimont USA, Inc. Baerlocher USA Baker Petrolite Corporation BASF Corporation BASF Performance Copolymers, LLC Baule USA Bayer AG Corporation Bayer Corporation Bedoukian Research, Inc. Big West Oil LLC/Flying J Inc. Bimasco, Inc. BioLab, Inc. Blacklidge Blackman Uhler Chemical Company (Division of Synalloy Corp.) Blue Ridge Paper Products Boise Cascade Corporation Borden Chemical, Inc. Borden Chemicals and Plastics (BCP) Limited Operating Partnership Borregaard Italy Bowater Incorporated BP Broin Enterprises, Inc. Buckeye Buffalo Color Corporation Bush Boake Allen Inc. The C.P. Hall Company Cabot Corporation Calcasieu Refining Company Capital Resin Corporation Cardolite Corporation Cargill, Inc. North American Corn Milling Division ACC, API ACC ACC ACC API, SOCMA ACC, SOCMA ACC, SOCMA ACC, SOCMA ACC SOCMA SOCMA SOCMA SOCMA SOCMA ACC, API ACC SOCMA SOCMA 1 2 36 392 38 392 3 1 2 19 35 149 1 1 3 70 45 392 5 4 5 1 1 82 1 2 4 1 480 1 1 14 32 49 1 392 2 1 1 Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored Cargill, Incorporated Caribbean Methanol Company Limited CBC (America) Corp. Celanese Ltd. Cenex Harvest States Cooperatives Champion International Corporation Chevron Oronite Company LLC Chevron Phillips Chemical Company, LP Chevron Products Company Chief Ethanol Fuels, Inc. Chippewa Valley Ethanol Company (CVEC) Ciba Specialty Chemicals Corporation Ciba Specialty Chemicals Corporation - Water Treatments Ciba Specialty Chemicals Corporation, Plastic Additives Segment Citgo Asphalt Refining Corporation (CARCO) Citgo Petroleum Corporation Citrus and Allied Essences, Ltd. Clariant Corporation Clearon Corporation Cleveland Asphalt Products, Inc. The Clorox Company Cobitco, Inc. Cognis Corporation Colas, Inc. Color Intermediates, Inc. Colorcon, Inc. Condea Servo LLC ConocoPhillips Company Copperhead Chemical Company Inc. Corn Plus Corsicana Technologies, Inc. Countrymark Cooperative, Inc. Crompton & Knowles Colors Incorporated Crompton Corporation Cross Oil Refining & Marketing, Inc. Crown Central Petroleum Corporation CVC Specialty Chemicals, Inc. Cytec Industries Inc. Daikin America, Inc. SOCMA ACC ACC, SOCMA ACC, SOCMA ACC, SOCMA ACC, API ACC, API ACC, API SOCMA ACC, SOCMA API SOCMA SOCMA ACC ACC ACC ACC 13 1 1 22 392 45 75 91 394 1 1 49 3 14 392 392 45 37 3 36 65 36 134 36 25 5 19 392 1 1 29 392 1 447 392 392 2 67 1 21 EPA's High Production Volume Challenge Program Status and Future Directions 22 ------- Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored Dakota Gasification Company DanChem Technologies, Inc. Day-Glo Color Corp. Degussa AG Deltech Corporation Denco, LLC Derivados Electroquimicos Levante SA (DELSA) Dixie Chemical Company, Inc. Dover Chemical Corporation Dow AgroSciences The Dow Chemical Company DRAGOCO, Inc. DSM Chemicals North America, Inc. DSM Fine Chemicals, Inc. DynaChem, Inc. Dynegy Midstream Services LP Dyno Nobel Inc. DyStar LP E. A. Mariani Asphalt Company E.I. du Pont de Nemours and Company Eastern Paper, Inc. Eastman Chemical Company Eastman Kodak Company Ecofuel Ecolab Inc Edginton Oil Company Eighty-Eight Oil Company Eliokem, LLC Elkhorn Operating Company Emulsion Products of Alaska, Inc. Enron Methanol Company Enterprise Products Company Equilon Enterprises, LLC and Motiva Enterprises, LLC Equistar Chemicals, LP Equitable Oil Purchasing Company Equiva Services LLC Ergon - West Virginia, Inc. Ergon Asphalt & Emulsions, Inc. Ergon Ref Inc ACC ACC, SOCMA ACC, SOCMA SOCMA ACC, SOCMA ACC ACC, API, SOCMA ACC, API, SOCMA ACC, SOCMA ACC, SOCMA ACC ACC, SOCMA ACC ACC 395 1 1 3 3 1 3 6 5 1 124 45 2 1 2 392 1 1 36 167 1 204 13 1 5 392 392 34 392 5 1 392 392 77 392 392 392 36 392 Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored ESCO Company Limited Partnership Ethanol2002 EXOL Exxon Company, USA ExxonMobil Chemical Company Farmland Industries Inc. Ferro Corporation Fertilizers & Chemicals, Ltd. Fina Oil and Chemical Company, Inc. Finch, Pruyn & Company, Incorporated FINETEX, Inc. Firmenich, Incorporated First Chemical Corporation Flexsys America L.P. Flint Hills Resources LP FMC Corporation Formosa Hydrocarbons Company, Inc. Formosa Plastics Corporation, USA Fragrance Resources Gaylord Chemical Corporation GE Plastics General Electric (GE) GEO Specialty Chemicals Georgia Gulf Corporation Georgia-Pacific Corporation Georgia-Pacific Resins, Inc. Giant Industries, Inc. Givaudan Fragrances Corporation Global Octanes Corporation Golden Bear Oil Specialties The Goodyear Tire & Rubber Company Great Lakes Chemical Corporation Greif Bros. Corporation Groupe SNPE Gulf States Asphalt Co., LLP Gulf States Paper Corporation Haarmann & Reimer (H&R) Hampshire Chemical Corp. Harcros Chemicals Inc. SOCMA ACC, API ACC, API ACC, SOCMA SOCMA ACC, API, SOCMA API API ACC ACC 5 1 1 392 263 392 86 3 455 1 3 17 5 34 392 10 392 74 45 2 1 15 1 4 2 38 392 60 392 392 475 13 1 59 5 1 13 5 6 23 EPA's High Production Volume Challenge Program Status and Future Directions 24 ------- Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored Hatco Corporation Heartland Corn Products Heartland Grain Fuels, LP Hercules Incorporated High Plains Corporation Hills Materials Company Holly Corporation Honeywell International Inc. Hovensa LLC Hunt Refining Company Huntsman Advanced Materials Americas Inc. Huntsman Corporation Huntway Refining Company ICI ICI Americas, Inc. lhara Chemical Industry Co., Ltd. INDSPEC Chemical Corporation INEOS N.V. Infineum USA L.P. Inland Paperboard and Packaging, Inc. Inland Refining, Inc. Inolex Chemical Company International Flavors & Fragrances, Inc. (IFF-US) International Paper International Specialty Products (ISP) ISOCHEM INC (formerly Vandemark Inc.) J. Manheimer Inc. Kao Corporation Kao Specialties Americas LLC (formerly High Point Chemical Corporation) Kemin Industries, Inc. Kern Oil & Ref Co King Industries, Inc. Koch Industries, Inc. Koei Chemical Co., Ltd. Korea Hyeop Hwa Chemical Industry Company, Ltd. KoSa Kuraray Co., Ltd. La Gloria Oil and Gas Company Lindau Chemicals, Inc. SOCMA ACC, SOCMA API SOCMA SOCMA ACC ACC ACC, API ACC, SOCMA SOCMA ACC ACC SOCMA 47 1 1 130 1 5 392 395 392 392 3 83 392 1 156 1 1 1 73 37 392 72 48 37 4 2 46 1 58 19 392 4 470 9 1 13 46 392 6 Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored Lion Oil Company Loctite Corporation Longview Fibre Company Lonza Inc. Louis Marsch, Inc. Louisiana-Pacific Corporation The Lubrizol Corporation Lyondell Chemical Company Lyondell Methanol Co. Lyondell-Citgo Refining Company Ltd. Mallinckrodt Inc. Marathon Ashland Petroleum LLC Mason Chemical Company McAsphalt Industries Limited Mclntyre Group, Ltd. MeadWestvaco Merichem Chemicals & Refinery Services LLC Merisol USA LLC Metachem Products, LLC Methanex Methanol Company The Methanol Sector Group, a Sector Group of CEFIC MFG Chemical, Inc. Midwest Grain Products Millennium Chemicals Inc. Milliken Chemical Minnesota Corn Processors, Inc. (MCP) Mitsubishi Gas Chemical Company, Inc. MLPC International Mobil Oil Corporation Monsanto Company Morflex, Inc. Motiva Enterprises, LLC Murphy Oil USA, Inc. Nalco Chemical Company Nan Ya Plastics Corporation, America National Cooperative Refinery Association National Starch (ICI Americas) Navajo Refining Company Nepera, Inc. SOCMA ACC, API, SOCMA API ACC ACC, API ACC, API ACC SOCMA ACC ACC ACC ACC SOCMA API ACC ACC ACC 392 1 1 38 5 1 103 22 1 392 32 409 5 36 3 112 392 405 4 1 1 3 1 60 6 1 2 1 392 2 1 392 392 10 3 392 2 392 7 25 EPA's High Production Volume Challenge Program Status and Future Directions 26 ------- Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored Neville Chemical Company New Energy Corp. New England Emulsions Corp. NIPA Inc. Nippon Petrochemicals Co., Ltd. Nissan Chemical America Corporation Nissan Chemical Industries, Ltd. Nisso America, Inc. NOVA Chemicals Inc. Noveon, Inc. Occidental Chemical Corporation (OxyChem) OMG Americas, Inc. OmniSpecialty Corporation Omnova Solutions Inc. Ondeo Nalco Energy Services (ONES) P. H. Glatfelter Company Packaging Corporation of America (PCA) Parlallel Products PDV Midwest Refining, L.L.C. Pelron Corporation Pennzoil-Quaker State Company Phillips Petroleum Company Pilot Chemical Company Placid Refining Company LLC Plasmine Technology, Inc. PMC Specialties Group, Inc. Polarome International Incorporated Port Townsend Paper Corporation Potlatch Corporation PPG Industries, Inc. Praxair Inc Premcor Refining & Marketing INC Prime Materials & Supply Corp. Pro-Corn, LLC The Procter & Gamble Company Proviron Fine Chemicals NV PURAC America, Inc. Quaker Chemical Corporation Quest International ACC SOCMA ACC, API ACC SOCMA SOCMA SOCMA SOCMA ACC, SOCMA ACC, API ACC SOCMA 392 1 36 1 1 3 1 3 78 132 4 32 2 1 29 1 37 1 409 19 392 386 5 392 36 9 45 1 1 9 1 392 5 1 89 1 1 47 45 Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored R. T. Vanderbilt Company, Inc. Raisio Chemicals Rayonier Reichhold Inc. Reilly Industries, Inc. Resolution Performance Products LLC Reynolds Metals Company Rhein Chemie Corporation Rhodia Inc. Rhodia Organique Fine Limited Riverwood International Corporation Rohm and Haas Company Rubicon Inc. Rutgers Organics Corporation Rutherford Chemicals LLC dba Nepera Sabic Americas Inc. Safety-Kleen Oil Recovery Sand Creek Chemical Limited Partnership Sartomer Company, Inc. Sasol North America Inc. Saturn Methanol Company, LLC Schenectady International (Sll) Seaco, Inc. Sensient Colors Inc. Sensient Flavors Inc Shell Chemical Company Shell Chemicals Limited Shell Oil Company Shepherd Chemical Company Shikoku Chemicals Corporation ShinWon Corporation Sid Richardson Gasoline Co Silver Eagle Refining, Inc. Sinclair Oil Corporation Smurfit Stone Container Corp. SNF Holding Company Solutia Solvay Advanced Polymers, Inc. (SAPI) South Hampton Refining Co. ACC ACC ACC, SOCMA ACC, SOCMA ACC SOCMA ACC ACC ACC ACC ACC ACC, API ACC, API ACC, API ACC ACC ACC ACC, SOCMA 37 36 37 2 10 32 392 59 216 1 37 73 1 2 9 1 392 1 2 499 1 18 5 5 45 74 1 392 32 3 1 392 392 392 37 3 55 1 392 27 EPA's High Production Volume Challenge Program Status and Future Directions 28 ------- Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored Southern Chemical Corporation SpecialtyChem Products Corporation Specified Fuels & Chemicals, LLC St. Laurent Paperboard Inc. St. Marks Powder, Inc. Star Enterprise Stepan Company Sterling Chemicals, Inc. Stockhausen GmbH & Co. KG Stora Enso North America (Formerly Consolidated Papers, Inc.) Suit-Kote Corporation Sumitomo Chemical America, Inc. Sun Chemical Corporation Sunoco, Inc. (R&M) Sybron Chemicals Inc. Symrise Syngenta Crop Protection AG Takasago International Corporation (USA) Tecnal Corporation Tejas Energy, LLC Teknor Apex Company Terra Industries Tesoro Petroleum Companies, Inc. Texaco Inc. Texas Petrochemicals Corporation (TPC) Thompson-McCully Oil Co. Ticona LLC TomahS Toray Fine Chemicals Co., Ltd. Tosco Corporation Trinidad and Tobago Methanol Company Limited (TTMC) Troy Chemical Company Troy Corporation True Oil Company U.S. Oil & Refining Co. Ultramar Diamond Shamrock Corporation Unilever Home & Personal Care - USA Unique Paving Materials Corporation Unitex Chemical Corporation ACC ACC, SOCMA SOCMA ACC SOCMA API ACC ACC ACC SOCMA 1 4 392 1 1 392 95 18 2 1 5 1 26 526 1 45 1 1 45 392 22 1 392 392 74 36 2 46 1 392 1 3 19 392 392 392 48 36 1 Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored Unocal Corporation Valero Energy Corporation Vance Brothers, Inc VanDeMark Chemical Company Inc. Velsicol Chemical Corporation Vestal Asphalt, Inc. Vulcan Chemicals Vulcan Construction Materials, LP W.R. Grace & Co. Wacker Biochem Corporation Wacker Silicones Corporation Westlake Chemical Corporation Weyerhaeuser Company Whitaker Roads Corporation Willamette Industries, Inc. Williams Energy Services Williams Ethanol Services, Inc. (and its affiliate Nebraska Energy LLC) Williams Olefins, LLC (formerly Union Texas Petrochemicals Corporation) Williams Refining, LLC Wynnewood Refining Company Zeneca Ag Products, Inc. API ACC ACC ACC ACC, SOCMA ACC, SOCMA 392 392 36 1 53 36 45 5 13 2 1 75 37 36 1 393 1 74 392 392 3 Consortia Akzo Nobel - Polymer Chemicals Business Group / PPG Industries, Inc. Akzo Nobel - Polymer Chemicals Metal Alkyls / E.I. Du Pont de Nemours and Company Albemarle Corporation / Ciba Specialty Chemicals Corporation - Additives Alky I Diphenyl Oxide Sulphonates (ADPOS) Aluminum Alkyls Consortium Ameribrom Inc. / Great Lakes Chemical Corporation American Chemistry Council (ACC) Acetic Acid and Salts Panel Acetylene HPV Consortium Aliphatic Esters Panel Benzoates Panel Brominated Biocides Panel Dimethylhydantoin (DMH) Task Force Brominated Flame Retardant Industry Panel (BFRIP) Brominated Phthalates Panel Diisocyanates (DIC) Panel ACC, SOCMA ACC ACC, API, SOCMA ACC, SOCMA ACC ACC ACC ACC ACC ACC ACC ACC 1 1 1 5 20 1 13 1 47 1 1 3 1 1 29 EPA's High Production Volume Challenge Program Status and Future Directions 30 ------- Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored Ethylbenzene Panel HPV Test Group Fatty Nitrogen Derived (FND) Amides Panel Fatty Nitrogen Derived (FND) Amines Panel Fatty Nitrogen Derived (FND) Cationics Panel Fatty Nitrogen Derived (FND) Nitriles Panel Health, Environmental, and Research Task Group (HERTG) Higher Olefins Panel Hydroquinone Precursors & Derivatives Panel Monocyclic Aromatic Amines and Nitro Aroma tics (MAANA) Panel Olefins Panel HPV Work Group Oxo Process Panel Phosgene Panel Phthalate Esters (PE) Panel HPV Testing Group Pyridine and Pyridine Derivatives HPV Work Group Rubber and Plastics Additives (RAPA) Panel Specialty Acrylates and Methacrylates (SAM) HPV Work Group American Forest & Paper Association (AF&PA) American Methanol Institute Testing Group (AMITG) American Petroleum Institute (API) Petroleum HPV Testing Group APAG Aromatic Sulfonic Acids Association (ASAA) Asphalt Emulsion Manufacturers Association (AEMA) ATOFINA Chemicals, Inc. / Celanese Ltd. ATOFINA Chemicals, Inc. / Chevron Phillips Chemicals, LP Benzotriazoles Coalition BPD/BPA Coalition Cabot Corporation / Degussa AG / Wacker Silicones Corporation Chlorobenzene Producers Association Ciba Specialty Chemicals Corporation - Additives / Cytec Industries Inc. Color Pigments Manufacturers Association, Inc. (CPMA) Committee on HPV Challenge for Cyclohexanol Consumer Specialty Products Association (CSPA) ADBAC Steering Committee/Joint Venture DADMAC HPV Committee The DCB Coalition Diethyl Ether Producers Association, Inc. (DEPA) Dimethyl Sulfoxide (DMSO) Producers Association Dioxolane Manufacturers Consortium DMMP Consortium ACC ACC ACC ACC ACC ACC ACC ACC ACC ACC ACC ACC ACC ACC ACC ACC API ACC ACC, SOCMA ACC, SOCMA ACC, API 3 29 29 13 17 59 24 4 5 74 1 1 21 9 34 2 1 1 392 1 2 36 1 1 3 2 1 4 1 25 1 5 1 1 1 1 1 1 Number of Sponsoring Organization Name Trade Chemicals Association(s) Sponsored The Dow Chemical Company / Solutia E.I. du Pont de Nemours and Company / ExxonMobil Chemical Company / The Dow Chemical Company E.I. du Pont de Nemours and Company / Solutia Eastman Chemical Company / Solutia Eastman Chemical Company / The Dow Chemical Company ETAD North America Disperse Blue 79:1 Consortium ETAD North America Stilbene Fluorescent Brighteners Ethanol HPV Challenge Consortium European Fluorocarbon Technical Committee ExxonMobil Chemical Company / Resolution Performance Products LLC Ferro Corporation / Ticona LLC The Flavor and Fragrance High Production Volume Consortia (FFHPVC) Alicyclic Primary Alcohol Aldehyde Car boxy lie Acid Consortium Aromatic Consortium Cyclohexyl Derivatives Consortium Linear Aliphatic C7-C9 Alcohol Aldehyde Car boxy lie Acid Consortium Terpene Consortium Great Lakes Chemical Corporation / Albemarle Corporation Hexamethoxymethylmelamine (HMMM) Coalition Huntsman-Nissan-TGIC Consortium IMF Committee on HPV Challenge for Cyclic Acid Anhydrides IMF Committee on Nylon 6 and Its Precursors INDSPEC Chemical Corporation / Sumitomo Chemical America, Inc. International Association of Color Manufacturers Isocyanurate Industry Ad Hoc Committee (IIAHC) LAB Sulfonic Acids Coalition Lesser Ketones Manufacturing Association The MBOCA Consortium McConnaughay Technologies, Inc. Metal Car boxy lates Coalition NMA/NBMA Association Phenolic Benzotriazoles Association Phosphite Producers HPV Consortium Pine Chemicals Association (PCA) HPV Task Force Propylene Carbonate / T-Butyl Alcohol HPV Committee Quat HPV Challenge Task Force The Soap and Detergent Association (SDA) ACC, API, SOCMA ACC, API, SOCMA ACC ACC, SOCMA ACC, API, SOCMA ACC, API ACC, SOCMA ACC, API, SOCMA ACC, SOCMA 1 1 6 3 1 1 8 1 1 1 1 1 13 1 3 45 2 1 1 6 1 1 5 3 3 1 1 36 19 2 4 4 36 2 2 31 EPA's High Production Volume Challenge Program Status and Future Directions 32 ------- Sponsoring Organization Name Linear Alkylbenzene Sulfonate Alkyl Benzene Sulfonate (LAS/ABS) Consortium Triclocarban (TCC) Consortium Society of the Plastics Industry Inc. (SPI) Epoxy Resin Systems Task Group Synthetic Organic Chemical Manufacturers Association (SOCMA) Biphenyl Work Group (BWG) Dibasic Esters (DBE) Group Isatoic Anhydride Coalition Sulfosuccinates Group Urea Resins Group Thioesters Association Toluenesulfonamide Testing Group Trioxane Manufacturers Consortium U.S. Nitroglycerin Producers Consortium (USNPC) Trade Association(s) Number of Chemicals Sponsored SOCMA SOCMA SOCMA SOCMA SOCMA Companies and consortia sponsoring chemicals exclusively through the ICCA HPV Initiative are not included in these numbers. The record of ICCA commitments is supplied to the Agency by the American Chemistry Council. Sponsored Chemicals Throughout the course of the Program, the chemical lists have been annotated to reflect changes in the status of chemicals; for instance, whether the chemical has been determined to fall outside of the scope of the Program or if the chemical is sponsored through the ICCA HPV Initiative. Chemical lists are posted on EPA's website at http://www.epa.gov/chemrtk/ volchalLhtm. Chemicals considered outside the scope of the Program include those: that were not HPV according to 1990 IUR information; for which it was determined that testing would not further our understanding of the chemicals' properties; chemicals sponsored under the OECD HPV SIDS Program; that are polymers or inorganics; or that are no longer considered high production volume. However, sponsorship of chemicals that fall outside the scope of the Program was permitted. In fact, 50 such chemicals have been sponsored. Many of these 50 chemicals were sponsored as a member of a category and many were already sponsored in the OECD HPV SIDS Program. Sponsorship of categories was encouraged under the HPV Challenge Program. Benefits of category sponsorships include: Economic savings, because less testing may be needed for category chemicals, Fewer animals are needed to test a category of chemicals as opposed to doing each test on each individual chemical, and Screening-level data on a larger number of chemicals may be provided to the public (by including chemicals beyond the scope of the Program). Status of Chemical Sponsorship At the HPV Challenge Program's start, 368 chemicals that would otherwise have been included in the Program fell outside the scope of the Program for the reasons described in the previous section. Removing chemicals from the scope of the Program left 2,414 chemicals available for sponsorship from the 1990 HPV Challenge Program Chemical List. Over the course of the Program, due to factors such as sponsorship of some of the 368 chemicals over time, the number of chemicals that fell outside the scope of the Program decreased to 352 chemicals. The overall number of sponsored chemicals as of July 2004 as compared to the October 1998 launch of the Program is remarkable. As of July 2004, EPA received commitments for 1,859 of the 2,782 chemicals on the 1990 HPV Challenge Program Chemical List. An additional 363 chemicals that were not on the List have also been sponsored, bringing the total number of sponsored chemicals to 2,222. By July 2004, of the 2,782 chemicals on the 1990 HPV Challenge Program Chemical List, there were 571 chemicals left unsponsored. The Agency has further analyzed the high production volume status of the 571 chemicals, and, based upon the results, the number of chemicals still available for sponsorship decreased to 330. The Unsponsored Chemicals analysis presented later in this report provides a complete description of this analysis. In addition to the 1,859 sponsored Detailed Status of 1990 HPV Challenge Program Chemical List Chemicals on 1990 HPV Challenge Chemicals Removed from Scope of Program*: Testing Would Not Further Our Understanding Sponsored under OECD HPV SIDS Program (and Not ICCA HPV Initiative) Polymer or Inorganic "No Longer HPV" Total Removed* Sponsored (includes chemicals sponsored under the ICCA HPV Initiative) Unsponsored Total # of Chemicals 39 190 62 61 352 1,859 571 2782 * Note that chemicals removed from the scope of the Program may fall into more than one classification. Additionally, chemicals sponsored that are not considered within the scope of the Program are included in the 1,859 count, often as members of a category; they are not removed. 33 EPA's High Production Volume Challenge Program Status and Future Directions 34 ------- chemicals and 571 orphan chemicals, 352 chemicals that would otherwise have been included in the Program are not considered within the scope of the HPV Challenge Program. The following table provides a detailed description of these chemicals that are considered outside the scope of the Program for the reasons described in the previous section. The figure below illustrates the progress of chemical sponsorship in the Program. Sponsorship Status of the 2,782 Chemicals on the 1990 HPV Challenge Program Chemical List (as of July 2004) Not Within Scope of Program (352) Sponsored (Includes ICCA) (1,859) Unsponsored (571) In addition to the 1,859 chemicals sponsored from the 1990 HPV Challenge Program Chemical List, an additional: 99 have been sponsored from the 1994 List of HPV Additions, and 264 have been sponsored that are not on either the 1990 HPV Challenge Program Chemical List or the 1994 List of HPV Additions. The Agency considers all of these 2,222 chemicals to be sponsored under the HPV Challenge Program. The figure below illustrates this distribution. 2,222 Chemicals Sponsored Within the HPV Challenge Program 1994 List of HPV Additions (99) 1990 HPV Challenge Program Chemical List (1,859) Other (264) Of these 2,222 chemicals for which commitments have been made, some are sponsored through the HPV Challenge Program and some are sponsored through the ICCA HPV Initiative. Note that 123 chemicals are sponsored both in the HPV Challenge Program and through the ICCA HPV Initiative (see the figure below). Sponsorship Distribution Between HPV Challenge Program, ICCA HPV Initiative, and Both Programs 123 HPV Challenge Program (1,248) ICCA HPV Initiative (851) Both (123) The sponsor of a chemical may or may not be the same in both programs. Additionally, a sponsor may have chosen to work through only one program, but has not officially informed EPA that the dual sponsorship status has changed. Until EPA is notified in writing by the sponsor stating that sponsorship has changed from one program to another, records will continue to show the chemical as sponsored under both programs. 35 EPA's High Production Volume Challenge Program 36 Sfafus and Future Directions ------- IP Appendix 3: Overall HPV Challenge Program Achievements I'll / A the onset of the HPV Challenge Program, LPA provided guidance documents to assist takeholders in participating in the Program. As of July 2004, sponsors had submitted 353 test plans, covering 1,266 chemicals. Environmental protection and animal welfare groups have submitted the majority of public comments on these test plans. As part of their commitment to the HPV Challenge Program, sponsors submit a test plan and robust summaries in a start year that they chose at the initial time of sponsorship. Sponsors submit test plans for either individual chemicals or for a category of chemicals. A chemical category is a group of related chemicals that lend themselves to evaluation and testing as a group. The chemicals can be grouped based on similarities in chemical structure or functionality. If testing is strategically planned, fewer than the full number of tests for each individual chemical will be necessary thereby reducing testing costs, as well as often reducing the number of animals needed. Each chemical or category of chemicals will have a test plan that describes how the sponsor intends to fill data gaps. Test plans are submitted along with robust summaries of existing data. Testing will only be conducted when there are inadequate existing data or when other approaches (e.g. SAR) are not adequate to meet the need. EPA reviews the categories and makes suggestions as to how to improve them. Guidance Documents HPV Challenge Program guidance documents can be found on EPA's "Guidance Documents" webpage at http://www.epa.gov/chemrtk/guidocs.htm. Guidance is provided for subjects such as category formulation, developing robust summaries, and assessing data adequacy, to name a few. A number of EPA's guidance documents have achieved international acceptance through their incorporation in OECD guidance documents. The following documents help stakeholders participate in the Program: 1. Revision of Two Toxicity Test Guidelines 2. Submissions of Exposure Information 3. Supplemental Acute Toxicity Protocol 4. Guidance on Developing Robust Summaries 5. Letters to Manufacturers/Importers Regarding Animal Welfare 6. The Use of Structure-Activity Relationships (SAR) in the HPV Challenge Program 7. Guidance on Searching for Chemical Information and Data 8. Guidance on Confidentiality Claims Related to Company-Chemical Associations under the HPV Challenge Program 38 Sfafus and Future Directions ------- 9. HPV Chemical Human Health Testing: Animal Welfare Issues and Approaches 10. Guidance for Assessing Adequacy of Existing Data 11. Guidance for Development of Chemical Categories in the HPV Challenge Program 12. Manual for Investigation of HPV Chemicals 13. Guidance for Testing Closed System Intermediates for the HPV Challenge Program 14. Procedures for Removing Chemicals that are No Longer HPV and are not Likely to Become HPV Again from the HPV List 15. Guidance for "What to Test" for the HPV Challenge Program 16. OECD SIDS Manual (this OECD guidance document links from the EPA website to the OECD website) The guidance document on development of chemical categories provides guidance on approaches and issues encountered in category formation and application made to the HPV Challenge Program. The document offers advice on how companies could group chemicals with similar characteristics into categories, and then evaluate existing data and conduct testing to characterize the category all without having to perform every test on every individual chemical. EPA's "Guidance on Developing Robust Summaries" document presents guidance on what technical information, on an endpoint-by-endpoint basis, is necessary to adequately describe a particular study. The term "robust summary" is used to describe this technical content. Robust study summaries are intended to provide sufficient information to allow a technically qualified person to make an independent assessment of a given study report without having to go back to the full study report, and to also allow evaluation of the proposed test plan. A robust study summary therefore concisely reflects the objectives, methods, results, and conclusions of the full study report. Submitted Test Plans There were 353 total test plans submitted to the HPV Challenge Program as of July 2004. Of these 353 test plans, 114 were for categories of chemicals, and the remaining 239 were for individual chemicals. There were 1,266 submitted test plan chemicals, along with 621 submitted supporting chemicals that were used to augment the chemical analyses. The 114 category test plans average 9 chemicals per category. Test Plan Comments After test plans and robust summaries are submitted and then posted to the website, a 120-day comment period begins. It is at this time that all stakeholders industry, environmental protection groups, animal welfare groups, private citizens, etc. - have the opportunity to make comments on the test plan and robust summary submissions. Comments are important because sponsors consider this feedback when revising their test plans and robust summaries. EPA comments on all test plans. All of the comments are posted to the website for public availability. As of July 2004, there were 350 test plans posted to the website. Of these 350 test plans: 11 test plans had not yet reached the end of the 120-day comment period. EPA commented on 290 test plans. Environmental Defense commented on 302 test plans. Animal welfare organizations - People for the Ethical Treatment of Animals (PETA) and Physicians Committee for Responsible Medicine (PCRM) commented on 210 test plans. Private individuals and other groups commented on 10 test plans. Environmental Defense submitted comments on the majority (89%) of all posted test plans that had reached the end of the 120-day comment period. PETA and PCRM submitted comments on 62% of all test plans that had reached the end of the 120-day comment period. Note that these two animal welfare organizations are grouped together because they often jointly submit comments, as well as submit comments on behalf of other animal welfare organizations. Comments from Environmental Defense often refer to whether they are in agreement with the sponsor's category hypothesis, use of supporting chemicals, estimations or Structure-Activity Relationships, proposed testing, and adequacy of submitted data. Comments from PETA and PCRM generally indicate whether they agree with the proposed test plan, and specifically in regard to whether animals will be used for testing purposes. These animal welfare organizations often state reasons for why testing should not be performed. Test Plan and Data Submissions There are 1,371 chemicals that are sponsored in either the HPV Challenge Program alone (1,248) or together in both the HPV Challenge Program and the ICCA HPV Initiative (123). In order to evaluate the progress of the HPV Challenge Program, EPA analyzed the number of chemical sponsorships expected and received under the Program. For this section of the report, the Agency did not consider commitments made exclusively through the ICCA HPV Initiative (851) because the Agency does not expect to receive test plan and robust summary submissions for these submissions. Commitment goals are met for the ICCA HPV Initiative through the Organization for Economic Cooperation and Development's (OECD) HPV Screening Information Data Set (SIDS) Program. Start Years Sponsors establish chemical commitments by stating the "start year" in which they will begin participation in the HPV Challenge Program by submitting a test plan showing how it plans to fill data gaps and robust summaries of existing data. Complete submissions of test plans and robust summaries, revisions, and results from new studies - are expected for all sponsored chemicals by the end of 2005. At the beginning of the Program, EPA envisioned that the receipt of test plans would spread out through the 39 EPA's High Production Volume Challenge Program Status and Future Directions 40 ------- years 1999 and 2003, with an anticipated breakdown of 5% of those test plans in 1999, 20% in 2000, and 25% through each of the years 2001-2003. The figure below illustrates the anticipated and actual test plan submissions. Anticipated Test Plan Submission Year Versus Actual Test Plan Submission Year 40 35 30 25 4-> 8 20 36 25 15 10 5 0 1999 2000 2001 2002 Year 2003 2004 Anticipated Submissions Actual Submissions As shown above, 92% of all chemical commitments were actually met by July 2004. The remaining 8% of the commitments are expected to be met by the end of 2004. Sponsors have notified EPA of changes in their start years. These changes in start year appear to result primarily from sponsors who experience problems in analysis, while many others experience coordination problems with fellow consortium members. While some sponsors submit their materials in an earlier year (thereby moving up their start year), most changes in start year commitment occur when sponsors request a later start year. Hence, some of the chemical commitments expected prior to 2004 will be fulfilled in that year. Number of HPV Sponsored Chemicals Included In Test Plans (as of July 2004) w » "1 Ei Number of Ch Covered by Te 400- 300- 200- n 504 495 319 275 254 246 211 204 83 44 46 ,7 000 7 9 8 Al 1999 2000 2001 2002 2003 2004 Year Expected Submitted Outstanding The figure above displays when test plans have been submitted for sponsored chemicals, and the number of chemicals with outstanding test plans: Expected: 1,371 chemicals Submitted: 1,266 chemicals Outstanding: 105 chemicals For recordkeeping purposes, if a sponsor submitted a test plan in a year that is later than their original start year, then their start year was changed to the year in which they actually submitted their materials. For example, EPA expected test plans covering 211 chemicals in 2000 and received 204 chemical analyses from those expected, leaving 7 outstanding chemicals that have not yet been submitted in subsequent years - the start year for these chemicals will be changed to reflect the year in which actual submissions occur. As the chart reflects, the largest number of chemicals expected and received occurred in 2001, with 504 chemicals expected and 495 chemicals received. Since there are a total of 105 outstanding chemicals, it is anticipated that many of the sponsors of these chemicals will submit materials by the end of 2004. Sponsors of late chemicals have been notified that test plans and robust summaries for these chemicals have passed the start year to which the sponsor had committed. Data Submitted to the HPV Challenge Program in Test Plans As discussed earlier, the primary impetus for the HPV Challenge Program was the consistent results of reports from Environmental Defense, the American Chemistry Council, and EPA that publicly available hazard data were lacking on a majority of the 2,782 1990 HPV chemicals. Following EPA's guidance, sponsors identify existing data on HPV chemicals and submit these data in the form of robust summaries and test plans. To determine the source of existing data included in test plan submissions (that is, published and publicly available at some level, or unpublished data), each test plan posted on the HPV website, for which comments were due through June 2004, was examined accounting for 344 test plans. This examination revealed that an extremely large amount of previously unavailable data has been submitted in test plans and robust summaries and is now publicly available. The figure to the right illustrates the number of studies that were published and unpublished. Sources of Existing Data Submitted in Test Plans (as of June 2004) Published Studies (4,800) (41%) Unpublished Studies (6,801) (59%) The table on the following page shows the numbers of published and unpublished studies broken down by ecological and human health endpoints, and selected physicochemical and environmental fate endpoints; some endpoints are routinely determined with estimation techniques. The numbers of published and unpublished studies documented in the robust summaries prepared for each SIDS endpoint are listed. 41 EPA's High Production Volume Challenge Program 42 Sfafus and Future Directions ------- Numbers of Published and Unpublished Sources of Existing Data, by Endpoint (as of June 2004) Discipline Area Health Effects Environmental Effects Environmental Fate Physicochemical Properties Specific Endpoint Published Unpublished Acute-Oral Acute-Inhalation Acute-Dermal Repeat Dose Gene Tox-ln-Vitro Gene Tox-ln-Vivo Repro/Dev Subtotal Acute-Fish Acute-Daphnid Acute-Algae Subtotal Biodegradation Subtotal Water Solubility Vapor Pressure Partition Coefficient Boiling Point Subtotal Totals 357 138 101 556 901 303 459 2815 223 154 94 471 308 308 319 278 183 426 1206 (41%) 4800 864 346 472 682 889 275 431 3959 639 490 312 1441 590 590 224 221 189 177 811 (59%) 6801 ^^BdrH^I _ 1221 484 573 1238 1790 578 890 6774 862 644 406 1912 898 898 543 499 372 603 2017 (100%) 11 601 As can be seen from the numbers of studies listed in the above table, a significant amount of unpublished data has now been made public by the sponsors. This indicates that the sponsors, either individually or through the many consortia participating in the Program, have made a concerted effort to bring forth such existing data and represents a major success of the HPV Challenge Program. It also indicates that many sponsors made significant efforts to evaluate the hazards of their chemicals prior to the launch of the HPV Challenge Program, but often did not make those underlying data available to the public. The submission of existing, unpublished data has had a significant effect on the amount of new testing that sponsors have proposed (as discussed in the following section). When isolating the statistics for acute endpoints (for both health effects and environmental effects) from the table, it is seen that 75% of acute studies were unpublished. The 75% value greatly contrasts the 50% value for unpublished studies for all other endpoints and can possibly be explained by a previously lower interest in publishing acute studies. Data Development Strategies Described in Test Plans The following analysis is directly related to the above discussion and shows how sponsors have proposed to address the SIDS endpoints. EPA analyzed test plans for which comments were due through June 2004 to determine how the health and environmental effects endpoints were addressed. Three methods were available to meet the minimum data needs for each SIDS endpoint. Data needs were met by: Using existing scientifically adequate data, Using an estimation technique such as Structure Activity Relationship (SAR) or "read-across" categories, or Proposing new testing. For human health effects, five endpoints (acute, repeat dose, reproductive, developmental, and genetic toxicity) were considered. For environmental effects, three acute toxicity endpoints were examined (acute toxicity to fish, daphnia, and algae). The 344 reviewed test plans address 112 categories and 232 single chemicals. The figure below illustrates that sponsors have made maximum use of EPA's guidance concerning the use of SAR and category proposals. Additionally, and in combination with the significant amount of unpublished data made available through the robust summaries, only a minimal amount of new testing has been proposed. Overall, for physicochemical and fate endpoints, as well as health and environmental effects, fewer than 10% of the endpoints are proposed to be addressed with new testing. The exact mix and number of new tests may change as sponsors consider EPA and public comments and the remainder of test plans is submitted; however, there is no reason to believe that the overall conclusions will change significantly. Comments could lead to some additional tests being performed, but could also result in fewer tests. Perhaps the most striking conclusion from these statistics and the illustration below is that most of the data existed, but were simply unpublished. Consistent with that conclusion is how relatively little new testing is being contemplated. Endpoint Data Sources (as of June 2004) o a. o ill Fate Phys.chem. Human Health Ecotoxicity Existing Data Estimate/SAR/ Read Across Proposed Testing 0 10 20 30 40 50 60 70 Percent 43 EPA's High Production Volume Challenge Program Status and Future Directions 44 ------- Categories One of the most significant results of the HPV Challenge Program has been the use of the category approach to address the SIDS endpoints. The category approach has led to the need to conduct far less testing than initially anticipated. As of July 2004, of the 353 submitted test plans, 114 contain category proposals covering 1,027 chemicals. These 1,027 chemicals represent 81% of the chemicals addressed by the test plans. EPA developed guidance on category formulation, and this guidance can be found on EPA's "Development of Chemical Categories in the HPV Challenge Program" webpage at http://www.epa.gov/ chemrtk/categuid. htm. There are three types of category proposals. The first type is referred to as a "traditional" category. A traditional category is a set of chemicals that share a similar functional group or cover a regular increase in chain length over the category. The second type of category is a "complex mixture family." The complex mixture family category contains chemicals from a complex mixture of similar chemical structures; e.g., long-chain fatty acids or tall oils. They are commonly structured around a manufacturing process where different products are created and differ only in the relative proportions of the structurally similar mixture components. The third type of category is a "process stream." A process stream category typically contains petroleum-related groupings, again based on a manufacturing process, except that in this type the mixture is composed of structurally different materials; e.g., paraffins, aromatics, or alicyclics. Each of the three types of categories that are submitted to the HPV Challenge Program rely on a supporting hypothesis or underlying theory of how the chemicals are related and how data reported for one chemical can be used to predict the toxicological responses of similar chemicals in that category. The supporting category hypothesis varies by the category type. "Traditional" categories are usually premised on predictable increases or decreases in toxicity through the category members or, in the case of ecotoxicity, a change in the toxicity manifested as the physicochemical properties change; e.g., an increasing LogKow where the toxicity is likely to shift from acute to chronic toxicity. (LogKow is the octanol-water partition coefficient for a neutral molecule, and it is generally used as a relative indicator of the tendency of an organic compound to adsorb to soil.) For a "complex mixture family," the hypothesis is based on the assumption that because the complex mixtures are composed of similar components, the toxicity will be similar for the individual products in the category. Finally, for process stream categories, the hypothesis is usually that increasing or decreasing amounts of a particular component will determine the toxicity of the various category members; e.g., removal of the aromatic fraction as the petroleum stream is further processed will ultimately result in decreased toxicity. While about 30 percent of the categories initially submitted by sponsors needed additional information or restructuring to support the category hypothesis (most have been revised by the sponsors), the significant result has been that a large number of chemicals were able to be characterized with a limited amount of additional testing and within a time period significantly shorter than if a chemical-by-chemical approach to developing the needed data was used. EPA's approach to the assessment of categories under the HPV Challenge Program has two principle steps. The first step is a review of the category test plan and supporting robust summaries. In this step, EPA comments on the reasonableness of the category hypothesis and the adequacy of the supporting data and any proposed testing. EPA's comments are sent to the sponsors at the end of the 120-day comment period. Sponsors revise their submissions based upon comments that they receive from the public and EPA. The second step involves the sponsor's preparation and submission of the "Final Category Analysis" per the category guidance, which follows completion of any needed testing. The sponsor's analysis is used to indicate that the underlying category hypothesis is reasonable and that existing and new test data can be extrapolated to address the untested category chemicals' endpoints. EPA's review at this step would be either to agree with the analysis as presented or to advise the sponsor that EPA does not believe that the category "held." If a category does not hold, then EPA advises the sponsor that additional testing needs to be considered and/or the category needs restructuring, possibly with the need to subdivide the category or treat the category members as individual chemicals. Accomplishments of the ICCA HPV Initiative The International Council of Chemical Associations (ICCA) as identified earlier in this report has its own initiative on international HPV chemicals and plays a role in the overall HPV Challenge Program. The ICCA HPV Initiative has evolved from interest regarding the OECD HPV SIDS Program, as well as other general concerns related to chemical testing and assessment on a global scale. The ICCA HPV Initiative calls for providing data on approximately 1,000 international high production volume chemicals by the end of 2004. The assessment work will be tied directly to the OECD HPV SIDS Program. Completed dossiers will be submitted to OECD so that a screening-level hazard assessment can be completed. OECD has been working to restructure its program to accelerate its process and handle the increased volume of data. More detail on OECD's process and program can be found at http://www.oecd. org/topic. Comparison of the HPV Challenge Program and ICCA HPV Initiative There is considerable consistency between the HPV Challenge Program and the ICCA HPV Initiative, as well as with the OECD HPV SIDS Program. All three programs: Are focused on HPV chemicals (note that HPV thresholds vary from the domestic to international programs); Are based on the OECD SIDS battery of testing; Include steps of data gathering, test plan development, and conducting SIDS testing as needed to provide a complete set of SIDS endpoints; and Allow the use of category approaches to group chemicals and the use of SAR analysis as an alternative to testing, where scientifically acceptable. 45 EPA's High Production Volume Challenge Program Status and Future Directions 46 ------- The OECD HPV SIDS Program and ICCA HPV Initiative also include the step of preparing the SIDS Initial Assessment Report (SIAR), which provides a screening-level assessment of chemical hazards. The submission of exposure data and the preparation of a SIAR are not elements for participation under the HPV Challenge Program, although EPA encourages industry to include these elements in their submissions under the Challenge. One additional notable difference between the HPV Challenge Program and the ICCA HPV Initiative is that of public accessibility of data. The HPV Challenge Program posts all test plan and robust summary submissions on the HPV Challenge Program website and includes a provision for receiving public comment; the ICCA HPV Initiative and the OECD HPV SIDS Program provide for comment within the country of sponsorship, and each country decides how broadly to share the data during the review stage. When completed, OECD HPV assessments are made available internationally through the United Nations Environment Programme (UNEP). Companies willing to perform the additional work under these other programs (providing exposure data and preparing a SIAR) are welcome to identify their HPV Challenge Program chemicals as contributions to either or both of the OECD HPV SIDS Program and the ICCA HPV Initiative. Additionally, companies deciding to sponsor chemicals under the HPV Challenge Program were given the opportunity to identify those chemicals as U.S. contributions to the OECD HPV SIDS Program and/or the ICCA HPV Initiative. Sponsorship Under the ICCA HPV Initiative Official notification of ICCA commitments is received through ICCA's contact at the American Chemistry Council. Some ICCA commitments are currently unconfirmed, and these "tentative" commitments have not been included in this analysis. Although chemicals sponsored through the ICCA HPV Initiative are considered as commitments to the HPV Challenge Program, the Agency did not include ICCA chemicals in its overdue test plan analysis. The Agency encourages ICCA to address those chemicals that are overdue within its own program and to more routinely, and in more detail and precision, update the Agency and the public about the current status of chemicals within the ICCA HPV Initiative. In February of 2000, the HPV Challenge Program began to recognize commitments made to sponsor chemicals indirectly through the ICCA HPV Initiative. Since then, overall sponsorship under the HPV Challenge Program increased with the addition of chemicals sponsored through the HPV Challenge Program and through the ICCA HPV Initiative. In addition, some sponsors decided to modify how they complete their commitments for sponsorship, usually by moving from the HPV Challenge Program to the ICCA HPV Initiative. The Agency did not track the specific movements of sponsors or chemicals from one program to another, but rather focused its tracking on overall sponsorship numbers. The figure below illustrates shifts in sponsorship over time among chemicals sponsored through the HPV Challenge Program, through the ICCA HPV Initiative, and those chemicals sponsored in both programs. Changes in Sponsorship in the HPV Challenge Program, ICCA HPV Initiative, and Both Programs (as of July 2004) V) 05 O 0) _C O ^ i_ 0) n 2000 1500 1000 500 Jan. Nov. Jan. Jan. Jan. Jul. 2000 2000 2002 2003 2004 2004 HPV only Date ICCA Only Botn As previously mentioned in this report, chemicals can be sponsored either directly through the HPV Challenge Program or indirectly through the ICCA HPV Initiative. At the beginning of the Program, all sponsorships were in the HPV Challenge Program, with none in the ICCA HPV Initiative. Over time, sponsorship in the ICCA HPV Initiative has increased while sponsorship in the HPV Challenge Program has decreased. It is important to note that the overall number of sponsored chemicals (when including ICCA sponsorships) has increased. As of July 2004, a total of 1,248 chemicals had been sponsored through the HPV Challenge Program alone, 851 chemicals had been sponsored through the ICCA HPV Initiative alone, and 123 through both the HPV Challenge Program and the ICCA HPV Initiative. The following table details the number of chemicals in each program over time. 47 48 EPA's High Production Volume Challenge Program Status and Future Directions ------- Details of Sponsorship in the HPV Challenge Program, ICCA HPV Initiative, and Both Programs (as of July 2004) HPV Only ICCA Only Both (HPV, ICCA) % of % of Date Chemicals Total Chemicals Total Chemicals % of Total Total Chemicals 01/25/2000 06/16/2000 11/06/2000 05/21/2001 01/15/2002 07/12/2002 01/31/2003 07/18/2003 01/16/2004 07/30/2004 2123 1815 1715 1713 1643 1417 1357 1321 1325 1248 100.0 86.9 79.6 79.6 78.9 64.1 63.1 61.0 59.2 56.2 0 70 144 155 178 491 624 664 736 851 0.0 3.4 6.7 7.2 8.5 22.2 29.0 30.7 32.9 38.3 0 204 296 285 262 302 169 179 177 123 0.0 9.8 13.7 13.2 12.6 13.7 7.9 8.3 7.9 5.5 2123 2089 2155 2153 2083 2210 2150 2164 2238 2222 The number of chemicals that have moved from the HPV Challenge Program to ICCA HPV Initiative raises a concern because the data submitted under ICCA are not as readily publicly accessible OECD makes final reports available through UNEP, but access is limited before this occurs. Data Submitted Under the ICCA HPV Initiative As a measure of progress within the ICCA HPV Initiative, the Agency has chosen to consider SIDS Initial Assessment Meeting (SIAM8) agendas as equivalent to submitting a test plan and robust summaries under the HPV Challenge Program; in both cases, a full set of SIDS hazard data is ultimately provided. This was chosen as a measure because participation in the OECD process is part of participating in the ICCA HPV Initiative. Using the SIAM agendas with ICCA chemicals, the table below illustrates progress of chemicals under the ICCA HPV Initiative. Note that this table reflects the start year given by ICCA and whether or not the chemical has been through a SIAM as of year-end 2003; it does not reflect the year in which the chemical actually went through a SIAM. That year may or may not be the same. Of the 974 chemicals sponsored in the ICCA HPV Initiative, 229 chemicals had been through the OECD SIDS process by July 2004. This number accounts for 24% of the total ICCA commitments. It is important to point out that 123 chemicals are dually sponsored both directly in the HPV Challenge Program as well as indirectly in the ICCA HPV Initiative. Earlier in this report, it was noted that 851 are sponsored in the ICCA HPV Initiative; however, when the 123 dually sponsored chemicals are considered, total ICCA HPV Initiative sponsorship increases to 974 chemicals. Chemicals Sponsored Indirectly through the ICCA HPV Initiative (as of July 2004) Start Year or Test Plan Total Expected Chemical SIAM Chemicals Receipt Year Submissions Sponsored by ICCA* 1999 2000 2001 2002 2003 2004 Total 38 149 487 133 127 40 974 14 54 98 19 17 27 229 ' This table does not reflect the year in which the chemical went through a SIAM. 49 SSIAM: SIDS Initial Assessment Meeting: A gathering of OECD member countries that agree on the initial hazard assessment for HPV SIDS chemicals, and that identify those HPV chemicals that are a priority for further work. EPA's High Production Volume Challenge Program Status and Future Directions 50 ------- % In order to evaluate which sponsors were responsible for overdue test plans, the Agency reviewed commitment information submitted by companies and consortia. Correspondence concerning commitments is recorded and posted to EPA's "Summary Report" webpage at http://www.epa.gov/ chemrtk/sumresp.htm, including correspondence from individual sponsors, consortia, consortium members, and from companies not participating in the Program. The Agency has received much correspondence from companies and consortia committing to sponsor chemicals, changing an aspect of their commitment, or in some cases, withdrawing their commitment. The Agency developed an approach for determining overdue test plans and their sponsors, taking into consideration HPV Challenge Program goals and the fact that there are cases of more than one sponsor for a given chemical. If a test plan were received, then the chemical's test plan was not considered overdue, regardless of whether another company or consortium had also sponsored it. If no test plan had been received for a particular chemical, then all consortia (but not their members) and independent sponsors of that chemical were considered to have an overdue test plan for that chemical. The Agency sent the following letter to sponsors of chemicals with overdue test plans in April 2004. 52 Sfafus and Future Directions ------- Letter Sent to Sponsors with Overdue Test Plans in April 2004 April 12, 2004 Technical Contact Organization Name Organization Address City, State, Zip Code Dear : I want to personally acknowledge and thank you for your commitment to the High Production Volume (HPV) Challenge Program. Participation in the HPV Challenge Program has exceeded EPA's expectations and, although the success of the program has been significant, there are a number of commitments that have not yet been met and are considered late. Preparations are underway for release of the HPV Challenge Program Status Report in May, 2004. The HPV Challenge Program Status Report will identify those sponsors whose commitments are overdue. The Agency understands that over time, for a variety of reasons, sponsorship plans may change; however, it is incumbent upon sponsors of unmet commitments to update the Agency so that its records may accurately reflect the current commitment status. Information should be sent to: Administrator US Environmental Protection Agency P.O. Box 1473 Merrifield,VA22116 Attention: Chemical Right-to-Know Program or through e-mail at: ncic_oppt@epa.gov and chem.rtk@epa.gov by April 30, 2004. Please note that any correspondence containing Confidential Business Information (CBI) should not be sent to the above address or through e-mail. If you have any questions or concerns, please contact Karen Lannon of my staff at 202-564-8163. Thank you. Sincerely, Our records indicate that your organization has sponsored the chemical(s) listed in the attached table for a start year of 2003 or earlier but robust summary and test plan information has not been received by the Agency. The commitment start year indicates the year of the Program in which sponsors agreed to begin the evaluation of each chemical by submitting robust summaries of existing data and a test plan showing how the sponsor plans to fill any data gaps. Under the HPV Challenge Program, all test plans and robust summary submissions should be submitted in the year indicated. Any needed new testing on the HPV chemicals in the HPV Challenge Program is to be completed by the end of 2004 with all data to be made available to the public by 2005. So that the Agency may meet its HPV Challenge Program's objectives, we are no longer accepting changes to start years and commitments not yet fulfilled are considered late. Charles M. Auer, Director Office of Pollution Prevention and Toxics Attachment While we are not accepting changes to start years, the Agency does expect sponsors to uphold their commitments and submit test plans and robust summaries as soon as possible. If no test plan/robust summary submission is received before the end of 2004 for these commitments, then the Agency will consider these chemicals as "orphans"or unsponsored. Chemicals not voluntarily sponsored in the HPV Challenge Program will become candidates for test rules under Section 4 of the Toxic Substances Control Act (TSCA). 53 EPA's High Production Volume Challenge Program 54 Sfafus and Future Directions ------- EPA received responses from many of these sponsors updating the status of their commitments. Some intend to fulfill their commitments through the ICCA HPV Initiative; others have withdrawn from the Program; some have submitted test plans; and others still intend to fulfill their commitments through providing a test plan at a later date. As of July 2004, test plan and robust summary submissions were overdue for 47 unique chemicals. Note that this reference to 47 chemicals contrasts the 270 outstanding Program chemicals from earlier in the report, as this 47 figure does not include: chemicals that were due in 2004, chemicals for which test plans have most recently been submitted, withdrawals from the Program, and chemicals moving to the ICCA HPV Initiative, among other factors. One of the 47 chemicals has two sponsors; therefore, there are a total of 48 overdue sponsorship commitments. There are 24 sponsors (13 companies and 11 consortia) responsible for these 48 commitments. The Agency expects that sponsors will uphold their commitments and submit test plans and robust summaries. If no test plan or robust summary submission is received for overdue chemicals, then the Agency will ultimately consider these chemicals as unsponsored B or orphans. A complete listing of the 48 overdue chemical commitments is shown below. Chemicals and Sponsors with Overdue Test Plans (as of July 2004) {Trade association affiliation is noted for members of the following three trade associations: American Chemistry Council (ACC), American Petroleum Institute (API), and Synthetic Organic Chemical Manufacturers Association (SOCMA). The API member list, found at http://api-ec.api.org/linlcs/index.cfm, was not a complete list.} 110-03-2 Air Products and Chemicals, Inc. 142-30-3 1163-19-5 American Chemistry Council (ACC) Brominated Flame Retardant Industry Panel (BFRIP) 298-07-7 American Chemistry Council (ACC) Health, Environmental, and Research Task Group (HERTG) 64771-72-8 American Petroleum Institute (API) Petroleum HPV Testing Group 68333-23-3 ACC ACC ACC API 112-18-5 APAG 26040-51-7 BTBP Consortium 100-50-5 The Dow Chemical Company 109-87-5 630-20-6 68390-96-5 68411-72-3 ACC, API, SOCMA 100-40-3 E.I. du Pont de Nemours and Company 81-11-8 ETAD North America Stilbene Fluorescent Brighteners 3709-43-1 4404-43-7 Sponsor Name 7336-20-1 13863-31-5 16470-24-9 29637-52-3 67786-25-8 100-40-3 108083-43-8 ExxonMobil Chemical Company ACC, API 98510-89-5 The Flavor and Fragrance High Production Volume Consortia (FFHPVC) Terpene Consortium 96-49-1 929-06-6 Huntsman Corporation 2451-62-9 Huntsman-Nissan-TGIC Consortium 74-87-3 ICI Americas, Inc. 105-60-2 IHF Committee on Nylon 6 and Its Precursors 25322-17-2 25619-56-1 57855-77-3 63512-64-1 King Industries, Inc. 101-14-4 The MBOCA Consortium 13560-89-9 Occidental Chemical Corporation (OxyChem) ACC 1809-19-4 Rhodialnc. ACC, SOCMA 143-29-3 Rohm and Haas Company ACC 27090-63-7 68052-49-3 111960-92-0 Solutia ACC 1333-07-9 Toluenesulfonamide Testing Group 10605-21-7 Troy Chemical Company 34375-28-5 55406-53-6 553-26-4 620-22-4 626-17-5 Zeneca Ag Products, Inc. 55 EPA's High Production Volume Challenge Program 56 Sfafus and Future Directions ------- ppendix 5: Orphan Chemicals «w- x v ^ « < "W "TT TThile the success of the HPV Challenge % / % / Program has been significant, some V chemicals eligible for sponsorship in the Program remain unsponsored. As of July 30, 2004, there were 571 chemicals that were on the 1990 IUR HPV list that remained unsponsored in the Program. The Agency recognizes that the 1990 HPV Challenge Program Chemical List is based on IUR reporting from over a decade ago; hence, a number of unsponsored chemicals may no longer be manufactured or imported at high production volumes. In order to determine for which chemicals this may be true, the Agency conducted a comprehensive "No Longer HPV" analysis relying upon existing Program guidance for determining that a chemical is "No Longer HPV." The "No Longer HPV" guidance may be found at http://www.epa.gov/chemrtk/nolohpv8. htm. Based on results of this analysis, the number of chemicals available for sponsorship decreased from approximately 571 to 330. Strategies for Obtaining Data on Unsponsored Chemicals The Agency is considering options to ensure that screening-level data are made available to the public for the 330 unsponsored, or "orphan," chemicals. These orphans are listed below. 330 Orphan Chemicals (as of July 30, 2004) 56-40-6 62-23-7 62-56-6 74-95-3 74-97-5 75-07-0 75-34-3 75-36-5 75-46-7 75-87-6 77-76-9 78-11-5 78-42-2 81-07-2 81-16-3 81-84-5 83-41-0 TSCA Chemical Name Glycine Benzole acid, 4-nitro- Thiourea Methane, dibromo- Methane, bromochloro- Acetaldehyde Ethane, 1,1-dichloro- Acetyl chloride Methane, trifluoro- Acetaldehyde, trichloro- Propane, 2,2-dimethoxy- 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester) Phosphoric acid, tris(2-ethylhexyl) ester 1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide 1 -Naphthalenesulfonic acid, 2-amino- 1 H,3H-Naphtho[1,8-cd]pyran-1,3-dione Benzene, 1,2-dimethyl-3-nitro- Sfafus and Future Directions 58 ------- CAS # TSCA Chemical Name 84-65-1 84-69-5 85-40-5 89-32-7 90-43-7 91-53-2 91-68-9 94-75-7 94-96-2 95-94-3 96-22-0 96-23-1 97-00-7 98-09-9 98-16-8 98-56-6 99-51-4 100-64-1 101-34-8 104-15-4 104-66-5 104-93-8 107-39-1 107-40-4 107-45-9 108-19-0 108-20-3 109-86-4 110-18-9 110-33-8 110-44-1 111-44-4 111-85-3 111-91-1 112-52-7 118-82-1 118-90-1 119-33-5 119-61-9 121-45-9 121-69-7 9,1 0-Anthracenedione 1 ,2-Benzenedicarboxylic acid, bis(2-methylpropyl) ester 1 H-lsoindole-1 ,3(2H)-dione, 3a,4,7,7a-tetrahydro- 1 H,3H-Benzo[1 ,2-c:4,5-c']difuran-1 ,3,5,7-tetrone [1,1'-Biphenyl]-2-ol Quinoline, 6-ethoxy-1 ,2-dihydro-2,2,4-trimethyl- Phenol, 3-(diethylamino)- Acetic acid, (2,4-dichlorophenoxy)- 1 ,3-Hexanediol, 2-ethyl- Benzene, 1,2,4,5-tetrachloro- 3-Pentanone 2-Propanol, 1,3-dichloro- Benzene, 1-chloro-2,4-dinitro- Benzenesulfonyl chloride Benzenamine, 3-(trifluoromethyl)- Benzene, 1 -chloro-4-(trifluoromethyl)- Benzene, 1,2-dimethyl-4-nitro- Cyclohexanone, oxime 9-Octadecenoic acid, 12-(acetyloxy)-, 1,2,3-propanetriyl ester, (9Z,9'Z,9"Z,12R,12'R,12"R)- Benzenesulfonic acid, 4-methyl- Benzene, 1 , 1 '-[1 ,2-ethanediylbis(oxy)]bis- Benzene, 1-methoxy-4-methyl- 1-Pentene, 2,4,4-trimethyl- 2-Pentene, 2,4,4-trimethyl- 2-Pentanamine, 2,4,4-trimethyl- Imidodicarbonic diamide Propane, 2,2'-oxybis- Ethanol, 2-methoxy- 1 ,2-Ethanediamine, N,N,N',N'-tetramethyl- Hexanedioic acid, dihexyl ester 2,4-Hexadienoic acid, (2E,4E)- Ethane, 1,1'-oxybis[2-chloro- Octane, 1-chloro- Ethane, 1 , 1 '-[methylenebis(oxy)]bis[2-chloro- Dodecane, 1-chloro- Phenol, 4,4'-methylenebis[2,6-bis(1 ,1-dimethylethyl)- Benzoic acid, 2-methyl- Phenol, 4-methyl-2-nitro- Methanone, diphenyl- Phosphorous acid, trimethyl ester Benzenamine, N,N-dimethyl- CAS # TSCA Chemical Name 121-82-4 124-18-5 124-63-0 127-68-4 131-57-7 137-20-2 138-25-0 139-40-2 140-08-9 140-93-2 142-73-4 143-28-2 144-62-7 149-44-0 150-50-5 307-35-7 330-54-1 409-02-9 460-00-4 506-51-4 506-52-5 513-74-6 515-40-2 529-33-9 529-34-0 542-75-6 542-92-7 557-61-9 563-72-4 579-66-8 590-19-2 592-45-0 594-42-3 597-31-9 598-72-1 617-94-7 624-83-9 624-92-0 625-55-8 628-13-7 628-96-6 1 ,3,5-Triazine, hexahydro-1 ,3,5-trinitro- Decane Methanesulfonyl chloride Benzenesulfonic acid, 3-nitro-, sodium salt Methanone, (2-hydroxy-4-methoxyphenyl)phenyl- Ethanesulfonic acid, 2-[methyl[(9Z)-1-oxo-9-octadecenyl]amino]-, sodium salt 1 ,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester 1,3,5-Triazine-2,4-diamine, 6-chloro-N,N'-bis(1-methylethyl)- Ethanol, 2-chloro-, phosphite (3:1) Carbonodithioic acid, O-(l-methylethyl) ester, sodium salt Glycine, N-(carboxymethyl)- 9-Octadecen-1-ol, (9Z)- Ethanedioic acid Methanesulfinic acid, hydroxy-, monosodium salt Phosphorotrithious acid, tributyl ester 1-Octanesulfonyl fluoride, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro- Urea, N'-(3,4-dichlorophenyl)-N,N-dimethyl- Heptenone, methyl- Benzene, 1-bromo-4-fluoro- 1 -Tetracosanol 1-Hexacosanol Carbamodithioic acid, monoammonium salt Benzene, (2-chloro-1,1-dimethylethyl)- 1 -Naphthalenol, 1 ,2,3,4-tetrahydro- 1 (2H)-Naphthalenone, 3,4-dihydro- 1-Propene, 1,3-dichloro- 1 ,3-Cyclopentadiene 1 -Octacosanol Ethanedioic acid, calcium salt (1 :1) Benzenamine, 2,6-diethyl- 1 ,2-Butadiene 1 ,4-Hexadiene Methanesulfenyl chloride, trichloro- Propanal, 3-hydroxy-2,2-dimethyl- Propanoic acid, 2-bromo- Benzenemethanol, .alpha.,. alpha. -dimethyl- Methane, isocyanato- Disulfide, dimethyl Formic acid, 1-methylethyl ester Pyridine, hydrochloride 1 ,2-Ethanediol, dinitrate 59 EPA's High Production Volume Challenge Program 60 Sfafus and Future Directions ------- CAS # TSCA Chemical Name 629-59-4 629-76-5 645-62-5 693-07-2 693-95-8 756-80-9 870-72-4 928-72-3 939-97-9 1000-82-4 1002-69-3 1111-78-0 1115-20-4 1323-65-5 1324-76-1 1401-55-4 1445-45-0 1459-93-4 1498-51-7 1558-33-4 1562-00-1 1646-75-9 1691-99-2 1738-25-6 1912-24-9 1918-02-1 1929-82-4 2152-64-9 2210-79-9 2372-45-4 2409-55-4 2425-54-9 2494-89-5 2524-03-0 2524-04-1 2611-00-9 2691-41-0 2702-72-9 2814-20-2 2905-62-6 Tetradecane 1-Pentadecanol 2-Hexenal, 2-ethyl- Ethane, 1-chloro-2-(ethylthio)- Thiazole, 4-methyl- Phosphorodithioic acid, O,O-dimethyl ester Methanesulfonic acid, hydroxy-, monosodium salt Glycine, N-(carboxymethyl)-, disodium salt Benzaldehyde, 4-(1,1-dimethylethyl)- Urea, (hydroxymethyl)- Decane, 1-chloro- Carbamic acid, monoammonium salt Propanoicacid, 3-hydroxy-2,2-dimethyl-, 3-hydroxy-2,2-dimethylpropyl ester Phenol, dinonyl- Benzenesulfonic acid, [[4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1- ylidene]methyl]phenyl]amino]- Tannins Ethane, 1,1,1-trimethoxy- 1 ,3-Benzenedicarboxylic acid, dimethyl ester Phosphorodichloridic acid, ethyl ester Silane, dichloro(chloromethyl)methyl- Ethanesulfonic acid, 2-hydroxy-, monosodium salt Propanal, 2-methyl-2-(methylthio)-, oxime 1 -Octanesulfonamide, N-ethyl-1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)- Propanenitrile, 3-(dimethylamino)- 1,3,5-Triazine-2,4-diamine, 6-chloro-N-ethyl-N'-(1-methylethyl)- 2-Pyridinecarboxylic acid, 4-amino-3,5,6-trichloro- Pyridine, 2-chloro-6-(trichloromethyl)- Benzenamine, N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]-, monohydrochloride Oxirane, [(2-methylphenoxy)methyl]- 1-Butanol, sodium salt Phenol, 2-(1,1-dimethylethyl)-4-methyl- Tetradecane, 1-chloro- Ethanol, 2-[(4-aminophenyl)sulfonyl]-, hydrogen sulfate (ester) Phosphorochloridothioic acid, O,O-dimethyl ester Phosphorochloridothioic acid, O,O-diethyl ester 3-Cyclohexene-1-carboxylicacid, 3-cyclohexen-1-ylmethyl ester 1 ,3,5,7-Tetrazocine, octahydro-1 ,3,5,7-tetranitro- Acetic acid, (2,4-dichlorophenoxy)-, sodium salt 4(1H)-Pyrimidinone, 6-methyl-2-(1-methylethyl)- Benzoyl chloride, 3,5-dichloro- CAS # TSCA Chemical Name 2915-53-9 2941-64-2 3039-83-6 3088-31-1 3132-99-8 3338-24-7 3386-33-2 3586-14-9 3710-84-7 3724-65-0 3779-63-3 3965-55-7 4035-89-6 4080-31-3 4170-30-3 4300-97-4 4316-73-8 4719-04-4 4860-03-1 5026-74-4 5216-25-1 5460-09-3 5915-41-3 6381-77-7 6473-13-8 6863-58-7 6865-35-6 7320-37-8 7446-81-3 7795-95-1 8001-58-9 8005-02-5 8007-45-2 10265-69-7 12645-31-7 13749-94-5 13826-35-2 14143-60-3 14666-94-5 16883-83-3 2-Butenedioic acid (2Z)-, dioctyl ester Carbonochloridothioic acid, S-ethyl ester Ethenesulfonicacid, sodium salt Ethanol, 2-[2-(dodecyloxy)ethoxy]-, hydrogen sulfate, sodium salt Benzaldehyde, 3-bromo- Phosphorodithioic acid, O,O-diethyl ester, sodium salt Octadecane, 1-chloro- Benzene, 1-methyl-3-phenoxy- Ethanamine, N-ethyl-N-hydroxy- 2-Butenoic acid 1 ,3,5-Triazine-2,4,6(1 H,3H,5H)-trione, 1 ,3,5-tris(6-isocyanatohexyl)- 1,3-Benzenedicarboxylicacid, 5-sulfo-, 1,3-dimethyl ester, sodium salt Imidodicarbonic diamide, N,N',2-tris(6-isocyanatohexyl)- 3,5,7-Triaza-1 -azoniatricyclo[3.3. 1 . 1 3,7]decane, 1 -(3-chloro-2-propenyl)-, chloride 2-Butenal Propanoyl chloride, 3-chloro-2,2-dimethyl- (This is not the official TSCA Chemical Name, since no official name is available for this CAS number.) Glycine, N-methyl-, monosodium salt 1 ,3,5-Triazine-1 ,3,5(2H,4H,6H)-triethanol Hexadecane, 1-chloro- Oxiranemethanamine, N-[4-(oxiranylmethoxy)phenyl]-N-(oxiranylmethyl)- Benzene, 1 -chloro-4-(trichloromethyl)- 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, monosodium salt 1,3,5-Triazine-2,4-diamine, 6-chloro-N-(1,1-dimethylethyl)-N'-ethyl- D-erythro-Hex-2-enonic acid, . gamma. -lactone, monosodium salt 2-Naphthalenesulfonic acid, 6-[(2,4-diaminophenyl)azo]-3-[[4-[[4-[[7-[(2,4-diaminophenyl)azo]-1-hydroxy-3-sulfo-2- naphthalenyl]azo]phenyl]amino]-3-sulfophenyl]azoj-4-hydroxy-, trisodium salt Butane, 2,2'-oxybis- Octadecanoic acid, barium salt Oxirane, tetradecyl- 2-Propenoic acid, sodium salt 1-Octanesulfonyl chloride Creosote C.I. Solvent Black 7 Tar, coal Glycine, N-phenyl-, monosodium salt Phosphoric acid, 2-ethylhexyl ester Ethanimidothioic acid, N-hydroxy-, methyl ester Benzenemethanol, 3-phenoxy- 2-Pyridinecarbonitrile, 4-amino-3,5,6-trichloro- 9-Octadecenoic acid (9Z)-, cobalt salt 1,2-Benzenedicarboxylicacid, 2,2-dimethyl-1-(1-methylethyl)-3-(2-methyl-1-oxopropoxy)propyl phenylmethyl ester 61 EPA's High Production Volume Challenge Program 62 Sfafus and Future Directions ------- CAS # TSCA Chemical Name 17103-31-0 17321-47-0 17976-43-1 19438-61-0 19525-59-8 20068-02-4 20227-53-6 20469-71-0 21351-39-3 22527-63-5 24448-09-7 24615-84-7 24634-61-5 24794-58-9 25154-38-5 25168-05-2 25168-06-3 25321-41-9 25383-99-7 25586-42-9 25646-71-3 26377-29-7 26401-27-4 26680-54-6 27193-28-8 28106-30-1 28188-24-1 28777-98-2 28908-00-1 30574-97-1 31138-65-5 32072-96-1 32210-23-4 33509-43-2 34689-46-8 35203-06-6 35203-08-8 37439-34-2 37734-45-5 37764-25-3 Urea, sulfate (2:1) Phosphoramidothioicacid, O,O-dimethyl ester 2,4,6,8,3,5,7-Benzotetraoxatriplumbacycloundecin-3,5,7-triylidene, 1 ,9-dihydro-1 ,9-dioxo- 1 ,3-lsobenzofurandione, 5-methyl- Glycine, N-phenyl-, monopotassium salt 2-Butenenitrile, 2-methyl-, (2Z)- Phosphorous acid, 2-(1,1-dimethylethyl)-4-[1-[3-(1,1-dimethylethyl)-4-hydroxyphenyl]-1-methylethyl]phenyl bis(4- nonylphenyl) ester Hydrazinecarbodithioic acid, compd. with hydrazine (1 :1) Urea, sulfate (1:1) Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester 1-Octanesulfonamide, 1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8-heptadecafluoro-N-(2-hydroxyethyl)-N-methyl- 2-Propenoic acid, 2-carboxyethyl ester 2,4-Hexadienoic acid, potassium salt, (2E,4E)- Formic acid, compd. with 2,2',2"-nitrilotris[ethanol] (1:1) Piperazineethanol Benzene, chloromethyl- Phenol, (1-methylethyl)- Benzenesulfonicacid, dimethyl- Octadecanoic acid, 2-(1-carboxyethoxy)-1-methyl-2-oxoethyl ester, sodium salt Phosphorous acid, tris(methylphenyl) ester Methanesulfonamide, N-[2-[(4-amino-3-methylphenyl)ethylamino]ethyl]-, sulfate (2:3) Phosphorodithioic acid, O,O-dimethyl ester, sodium salt Phosphorous acid, isooctyl diphenyl ester 2,5-Furandione, dihydro-S-(octenyl)- Phenol, (1,1,3,3-tetramethylbutyl)- Benzene, ethenylethyl- Octadecanoic acid, 2-(hydroxymethyl)-2-[[(1 -oxooctadecyl)oxy]methyl]-1 ,3-propanediyl ester 2,5-Furandione, dihydro-S-(octadecenyl)- Benzothiazole, 2-[(chloromethyl)thio]- 2-Butenenitrile, 2-methyl-, (2E)- D-gluco-Heptonicacid, monosodium salt, (2.xi.)- 2,5-Furandione, 3-(hexadecenyl)dihydro- Cyclohexanol, 4-(1,1-dimethylethyl)-, acetate 1,2,4-Triazin-5(2H)-one, 4-amino-6-(1,1-dimethylethyl)-3,4-dihydro-3-thioxo- Phenol, methyl-, sodium salt Benzenamine, 2-ethyl-6-methyl-N-methylene- Benzenamine, 2,6-diethyl-N-methylene- 2(1H)-Pyridinone, 3,5,6-trichloro-, sodium salt Carbonochloridothioicacid, S-(phenylmethyl) ester Acetamide, 2,2-dichloro-N,N-di-2-propenyl- CAS # TSCA Chemical Name 38185-06-7 38321-18-5 39515-51-0 40630-63-5 40876-98-0 51632-16-7 52184-19-7 52556-42-0 52663-57-7 56038-89-2 56803-37-3 57693-14-8 61788-76-9 61789-32-0 61789-65-9 61789-85-3 63302-49-8 64742-24-1 64743-02-8 64743-03-9 64771-71-7 65652-41-7 65996-78-3 65996-79-4 65996-80-7 65996-81-8 65996-82-9 65996-83-0 65996-86-3 65996-87-4 65996-89-6 65996-91-0 65996-92-1 66071-94-1 66241-11-0 68081-86-7 68082-78-0 68153-60-6 68187-41-7 68187-57-5 Benzenesulfonic acid, 4-chloro-3,5-dinitro-, potassium salt Ethanol, 2-(2-butoxyethoxy)-, sodium salt Benzaldehyde, 3-phenoxy- 1-Octanesulfonyl fluoride Butanedioic acid, oxo-, diethyl ester, ion(1-), sodium Benzene, 1 -(bromomethyl)-3-phenoxy- Phenol, 2,4-bis(1,1-dimethylpropyl)-6-[(2-nitrophenyl)azo]- 1-Propanesulfonicacid, 2-hydroxy-3-(2-propenyloxy)-, monosodium salt Ethanol, 2-butoxy-, sodium salt Benzenamine, N-(1-ethylpropyl)-4,5-dimethyl- (This is not the official TSCA Chemical Name, since no official name is available for this CAS number.) Phosphoric acid, (1,1-dimethylethyl)phenyl diphenyl ester Chromate(3-), bis[3-(hydroxy-. kappa. O)-4-[[2-(hydroxy-.kappa.O)-1-naphthalenyl]azo-. kappa. N1]-7-nitro-1- naphthalenesulfonato(S-)]-, trisodium Alkanes, chloro Fatty acids, coco, 2-sulfoethyl esters, sodium salts Resin acids and Rosin acids, aluminum salts Sulfonic acids, petroleum Phosphorochloridous acid, bis(4-nonylphenyl) ester Sludges, petroleum, acid Alkenes, C>10 .alpha. - Phenols, petroleum Paraffins, petroleum, normal C>10 Phosphoric acid, bis[(1,1-dimethylethyl)phenyl] phenyl ester Light oil, coal, coke-oven Solvent naphtha, coal Ammonia liquor, coal Fuel gases, coke-oven Tar oils, coal Extracts, coal tar oil alk. Extract oils, coal, tar base Extract residues, coal, tar oil alk. Tar, coal, high-temp. Distillates, coal tar, upper Distillates, coal tar Corn, steep liquor C.I. Leuco Sulphur Black 1 Phenol, nonyl derivs. Lard, oil, Me esters Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates Phosphorodithioic acid, O,O-di-C1-14-alkyl esters Pitch, coal tar-petroleum 63 EPA's High Production Volume Challenge Program 64 Sfafus and Future Directions ------- CAS # TSCA Chemical Name 68187-59-7 68187-76-8 68187-84-8 68188-18-1 68308-74-7 68309-16-0 68309-27-3 68334-01-0 68441-66-7 68442-60-4 68442-77-3 68476-80-2 68478-20-6 68479-98-1 68511-40-0 68512-63-0 68513-62-2 68514-41-0 68515-89-9 68527-02-6 68553-14-0 68584-25-8 68602-81-3 68603-84-9 68607-28-3 68608-59-3 68609-04-1 68609-05-2 68610-90-2 68611-64-3 68647-60-9 68649-42-3 68650-36-2 68782-97-8 68815-50-9 68909-77-3 68915-05-9 68915-39-9 68918-16-1 68919-17-5 68920-64-9 Coal, anthracite, calcined Castor oil, sulfated, sodium salt Castor oil, oxidized Paraffin oils, chlorosulfonated, saponified Amides, tall-oil fatty, N,N-di-Me Fatty acids, tall-oil, 2-(2-hydroxyethoxy)ethyl esters Fatty acids, tall-oil, sulfonated, sodium salts Bisulfides, alkylaryl dialkyl diaryl, petroleum refinery spent caustic oxidn. products Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid Acetaldehyde, reaction products with formaldehyde, by-products from 2-Butenediamide, (2E)-, N,N'-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs. Fats and Glyceridic oils, vegetable, deodorizer distillates Residues, petroleum, steam-cracked petroleum distillates cyclopentadiene cone., C4-cyclopentadiene-free Benzenediamine, ar,ar-diethyl-ar-methyl- 1-Propanamine, 3-(tridecyloxy)-, branched Benzene, ethenyl-, distn. residues Disulfides, C5-12-alkyl Ketones, C12-branched Barium, carbonate nonylphenol complexes Alkenes, C12-24, chloro Hydrocarbons, C8-11 Benzenesulfonic acid, C10-16-alkyl derivs., compds. with triethanolamine Distillates, hydrocarbon resin prodn. higher boiling Carboxylic acids, C5-9 Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, dichlorides Ethane, 1,2-dichloro-, manuf. of, by-products from, distn. lights Cyclohexane, oxidized, non-acidic by-products, distn. residues Cyclohexane, oxidized, non-acidic by-products, distn. lights 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters Urea, reaction products with formaldehyde Hydrocarbons, C>4 Phosphorodithioicacid, O,O-di-C1-14-alkyl esters, zinc salts Aromatic hydrocarbons, C8, o-xylene-lean Distillates, petroleum, hydrofined lubricating-oil Octadecanoic acid, reaction products with 2-[(2-aminoethyl)amino]ethanol Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues Fatty acids, tall-oil, low-boiling, reaction products with ammonia-ethanolamine reaction by-products Cyclohexane, oxidized, aq. ext, sodium salt Tar, coal, dried and oxidized Hydrocarbons, C12-20, catalytic alkylation by-products Disulfides, di-C1-2-alkyl CAS # TSCA Chemical Name 68937-29-1 68937-69-9 68937-70-2 68937-72-4 68953-70-8 68953-80-0 68955-37-3 68955-76-0 68955-96-4 68987-41-7 68987-66-6 68988-22-7 68988-99-8 68990-61-4 68990-65-8 69029-75-0 70024-67-8 70084-98-9 70693-50-4 70851-08-0 71077-05-9 72162-28-8 72854-27-4 73665-18-6 83864-02-2 84501-86-0 90640-80-5 90640-86-1 119345-02-7 125997-20-8 1 ,6-Hexanediol, distn. residues Carboxylic acids, C6-18 and C5-15-di- Carboxylic acids, C6-18 and C8-15-di- Carboxylic acids, di-, C4-1 1 Oxirane, reaction products with ammonia, distn. residues Benzene, mixed with toluene, dealkylation product Acid chlorides, tallow, hydrogenated Aromatic hydrocarbons, C9-16, biphenyl deriv.-rich Disulfides, dialkyl and di-Ph, naphtha sweetening Benzene, ethylenated Ethene, hydrated, by-products from 1 ,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from Phenols, sodium salts, mixed with sulfur compounds, gasoline alk. scrubber residues Tar, coal, high-temp., high-solids Fats and Glyceridic oils, vegetable, reclaimed Oils, reclaimed Benzenesulfonic acid, C16-24-alkyl derivs. Terpenes and Terpenoids, C10-30, distn. residues Phenol, 2,4-bis(1 -methyl-1 -phenylethyl)-6-[(2-nitrophenyl)azo]- Amides, coco, N-[3-(dimethylamino)propyl], alkylation products with sodium 3-chloro-2-hydroxypropanesulfonate Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine product tower residues 2-Propanone, reaction products with phenol Tannins, reaction products with sodium bisulfite, sodium polysulfide and sodium sulfite Extract residues, coal, tar oil alk., naphthalene distn. residues Nickel, bis[(cyano-C)triphenylborato(1-)-N]bis(hexanedinitrile-N,N')- Hexanedioic acid, esters with high-boiling C6-10-alkene hydroformylation products Anthracene oil Distillates, coal tar, heavy oils Benzene, 1,1'-oxybis-, tetrapropylene derivs. Phosphoric acid, mixed 3-bromo-2,2-dimethylpropyl and 2-bromoethyl and 2-chloroethyl esters The following table shows the orphan manufacturers of which EPA is aware and that can be made public without compromising confidential business information. 65 EPA's High Production Volume Challenge Program 66 Sfafus and Future Directions ------- Manufacturers of 1990 HPV Orphan Chemicals Based on 1990, 1998, and 2002 IUR Reporting {EPA is not permitted to refer to Confidential Business Information (CBI) claims for these chemicals in a public context. Only 296 of the 330 previously identified orphans have a non-CBI manufacturer in 1990; therefore, this table contains 296 and not 330 CAS numbers. An asterisk in the "1998 Manufacturer" or the "2002 Manufacturer" column indicates that the company in the "1990 Manufacturer" column produced the chemical during that year. Trade association affiliation is noted for members of the following three trade associations: American Chemistry Council (ACC), American Petroleum Institute (API), and Synthetic Organic Chemical Manufacturers Association (SOCMA). Lists of ACC and SOCMA member companies were found on their web sites. A member company list for API is not available on its website; however, a list of links to API member companies is available at http://api-ec.api.org/links/index.cfm, and was used in this analysis to identify known API member companies it is not a complete list.} 198OManufae,u,er J~ . AsSon 56-40-6 62-23-7 62-56-6 74-95-3 74-97-5 75-07-0 75-34-3 75-36-5 CHATTEM CHEMICALS NAGASE AMERICA CORPORATION El DUPONT DE NEMOURS & CO INC ACETO CHEMICAL COMPANY INC HOECHSTCELANESE MITSUI SCO (USA) INC SAKAI TRADING NEW YORK INC SKW CHEMICALS INC TOMEN AMERICA INC WEGO CHEMICAL & MINERAL CORPORATION AMERIBROMINC ETHYL CORPORATION - HEALTH SAFETY AND AMERIBROMINC ETHYL CORPORATION - HEALTH SAFETY AND El DUPONT DE NEMOURS & CO INC HOECHSTCELANESE UNION CARBIDE CORPORATION DOW CHEMICAL USA GEORGIA-PACIFIC CORPORATION ICI AMERICAS INC DELTECH CORPORATION ETHYL CORPORATION - HEALTH SAFETY AND * * * * * * * * * * * ACC SOCMA ACC, SOCMA SOCMA SOCMA ACC ACC, API, SOCMA SOCMA CAS# 1990 Manufacturer r!998 rf02 A Trad<;. Manu. Manu. Association 75-46-7 75-87-6 77-76-9 78-11-5 78-42-2 81-07-2 81-16-3 81-84-5 83-41-0 84-65-1 84-69-5 85-40-5 89-32-7 90-43-7 HOECHSTCELANESE El DUPONT DE NEMOURS & CO INC ENIMONT AMERICA INC NOR-AM CHEMICAL COMPANY El DUPONT DE NEMOURS & CO INC ENSIGN-BICKFORD COMPANY TROJAN CORPORATION ALBRIGHTS WILSON INC MOBAY CHEMICAL CORPORATION MITSUI & CO (USA) INC PMC SPECIALTIES GROUP INC BASF CORPORATION BIDDLE SAWYER CORPORATION DIG AMERICAS INC ENIMONT AMERICA INC MOBAY CHEMICAL CORPORATION SUMITOMO CORPORATION OF AMERICA MOBAY CHEMICAL CORPORATION RUETGERS-NEASE AMERICAN CYANAMID CO AGRI PRODS RES El DUPONT DE NEMOURS & CO INC ICI AMERICAS INC MITSUI & CO (USA) INC MOBAY CHEMICAL CORPORATION HULS AMERICA INC UNITEXCHEMCORP ICI AMERICAS INC El DUPONT DE NEMOURS & CO INC HULS AMERICA INC DOW CHEMICAL USA * * * * * * * * * * * * * ACC ACC ACC, SOCMA SOCMA ACC, SOCMA SOCMA ACC ACC, SOCMA ACC ACC, API, SOCMA 67 EPA's High Production Volume Challenge Program 68 Sfafus and Future Directions ------- CAS# 1990 Manufacturer J998 r2002 A Trad<;. Manu. Manu. Association 91-53-2 91-68-9 94-75-7 94-96-2 95-94-3 96-22-0 96-23-1 97-00-7 98-09-9 98-16-8 98-56-6 99-51-4 100-64-1 101-34-8 104-15-4 MONSANTO COMPANY BASF CORPORATION HILTON-DAVIS CHEMICAL COMPANY SUMITOMO CORPORATION OF AMERICA DOW CHEMICAL USA HULS AMERICA INC QO CHEMICALS INC UNION CARBIDE CHEMICALS & PLASTICS CO STANDARD CHLORINE OF DELAWARE INC BP CHEMICALS AMERICA INCORPORATED UNION CARBIDE CHEMICALS & PLASTICS CO ARSYNCO DOW CHEMICAL USA HOECHSTCELANESE ICI AMERICAS INC MTM HARDWICKE INC SLOSS INDUSTRIES CORPORATION ELI LILLY AND COMPANY HOECHSTCELANESE SANDOZ COLORS & CHEMICALS OCCIDENTAL CHEMICAL CORPORATION AMERICAN CYANAMID CO AGRI PRODS RES El DUPONT DE NEMOURS & CO INC DSM CHEMICALS NORTH AMERICA INC CASCHEM INC ACETO CHEMICAL COMPANY INC BIDDLE SAWYER CORPORATION Cl SPECIALITY CHEMICALS INC CAPITAL RESIN CORPORATION CL INDUSTRIES INC * * * * * * * * * * * * * * * * ACC ACC, SOCMA ACC, API, SOCMA ACC, API ACC, API, SOCMA SOCMA ACC ACC, API ACC SOCMA SOCMA SOCMA CAS# 1990 Manufacturer J998 2002 A Trad<;. Manu. Manu. Association 104-66-5 104-93-8 107-39-1 107-40-4 107-45-9 108-19-0 108-20-3 109-86-4 110-33-8 110-44-1 INTERNATIONAL FLAVORS AND FRAGRANCES IN RUETGERS-NEASE SLOSS INDUSTRIES CORPORATION KOCH CHEMICAL COMPANY FRAGRANCE RESOURCES INC GIVAUDAN CORPORATION KOCH CHEMICAL COMPANY NISSHO IWAI AMERICAN CORPORATION TEXAS PETROCHEMICALS CORPORATION TEXAS PETROCHEMICALS CORPORATION HALTERMANN LTD ROHM AND HAAS COMPANY ARCADIAN CORPORATION CF INDUSTRIES INC EXXON CHEMICAL COMPANY SHELL OIL COMPANY UNION CARBIDE CORPORATION BASF CORPORATION CAPE INDUSTRIES CIBA-GEIGY CORPORATION TEXTILE PRODUCTS DOW CHEMICAL USA MONTANA REFINING COMPANY OCCIDENTAL CHEMICAL CORPORATION OLIN CORPORATION UNION CARBIDE CORPORATION MONSANTO COMPANY HOECHSTCELANESE MITSUI SCO (USA) INC MONSANTO COMPANY TOMEN AMERICA INC * * * * * * * * * * * * * * * * * * * * * SOCMA SOCMA ACC ACC, API ACC, API ACC, SOCMA ACC, API ACC, API, SOCMA ACC, API ACC ACC, SOCMA ACC 69 EPA's High Production Volume Challenge Program Status and Future Directions 70 ------- CAS# 1990 Manufacturer J998 r2002 A Trad<;. Manu. Manu. Association 111-44-4 111-85-3 112-52-7 118-82-1 118-90-1 119-33-5 119-61-9 121-45-9 121-69-7 121-82-4 124-18-5 124-63-0 127-68-4 ET HORN COMPANY OCCIDENTAL CHEMICAL CORPORATION HULS AMERICA INC LONZA INCORPORATED NEVILLE CHEMICAL COMPANY HULS AMERICA INC LONZA INCORPORATED NEVILLE CHEMICAL COMPANY ETHYL CORPORATION - HEALTH SAFETY AND CHUGAI BOYEKI CORP MOBAY CHEMICAL CORPORATION PMC SPECIALTIES GROUP INC ACETO CHEMICAL COMPANY INC CIBA-GEIGY CORPORATION TEXTILE PRODUCTS HAARMANN & REIMER CORPORATION THE UPJOHN COMPANY ALBRIGHT & WILSON INC ICI AMERICAS INC D&O CHEMICALS INC HOLSTON ARMY AMMUNITION PLANT ENIMONT AMERICA INC EXXON CHEMICAL COMPANY HUMPHREY CHEMICAL COMPANY SHELL OIL COMPANY STERLING DRUG INC VISTA CHEMICAL CO ATOCHEM INC POLYMER DIVISION ACETO CHEMICAL COMPANY INC BASF CORPORATION CROWN METRO INC * * * * * * * * * * * * * * * * ACC, API SOCMA SOCMA ACC, API ACC, API ACC, API SOCMA ACC, SOCMA CAS# 1990 Manufacturer J998 2002 A Trad<;. Manu. Manu. Association 131-57-7 137-20-2 138-25-0 139-40-2 140-08-9 140-93-2 143-28-2 144-62-7 149-44-0 307-35-7 ACETO CHEMICAL COMPANY INC BASF CORPORATION HOECHSTCELANESE NEVILLE CHEMICAL COMPANY GAF CHEMICALS CORPORATION HOECHSTCELANESE El DUPONT DE NEMOURS & CO INC CIBA-GEIGY CORPORATION TEXTILE PRODUCTS ALBRIGHT & WILSON INC OLIN CORPORATION AMERICAN CYANAMID CO AGRI PRODS RES CASCHEM INC JARCHEM INDUSTRIES INC MMICHELANDCOINC SHEREX CHEMICAL COMPANY INC ALLOYCHEMINC BROWNING CHEMICAL CORP Cl SPECIALITY CHEMICALS INC CALABRIAN CORPORATION DOW CHEMICAL USA El DUPONT DE NEMOURS & CO INC MARUBENI AMERICA CORPORATION MITSUBISHI CHEMICAL INDUSTRIES AM INC MITSUI SCO (USA) INC SAKAI TRADING NEW YORK INC VELCO ENTERPRISES LTD WEGO CHEMICAL & MINERAL CORPORATION ACETO CHEMICAL COMPANY INC AMERIPOL SYNPOL COMPANY 3M * * * * * * * * * SOCMA ACC, SOCMA ACC ACC, API ACC ACC, API, SOCMA ACC ACC, SOCMA SOCMA ACC 71 EPA's High Production Volume Challenge Program Status and Future Directions 72 ------- CAS# 1990 Manufacturer J998 r2002 A Trad<;. Manu. Manu. Association 330-54-1 409-02-9 460-00-4 506-51-4 506-52-5 513-74-6 515-40-2 529-33-9 529-34-0 542-75-6 542-92-7 557-61-9 563-72-4 579-66-8 590-19-2 592-45-0 594-42-3 617-94-7 624-83-9 624-92-0 628-13-7 628-96-6 MARUBENI AMERICA CORPORATION THOR CHEMICALS INC EXXON CHEMICAL COMPANY INTERNATIONAL FLAVORS AND FRAGRANCES IN DIAZ CHEMICAL CORPORATION HOECHSTCELANESE RHONE POULENC INCORPORATED VISTA CHEMICAL CO VISTA CHEMICAL CO MERCK AND COMPANY INC MTM HARDWICKE INC RHONE POULENC INCORPORATED RHONE POULENC INCORPORATED DOW CHEMICAL USA SHELL OIL COMPANY NAGASE AMERICA CORPORATION VELSICOL CHEMICAL CORPORATION VISTA CHEMICAL CO EXXON CHEMICAL COMPANY ETHYL CORPORATION - HEALTH SAFETY AND EXXON CHEMICAL COMPANY VISTA CHEMICAL CO El DUPONT DE NEMOURS & CO INC ICI AMERICAS INC HERCULES INCORPORATED TEXACO CHEMICAL COMPANY RHONE POULENC INCORPORATED ATOCHEM INC POLYMER DIVISION RHONE POULENC INCORPORATED ICI EXPLOSIVES USA INC * * * * * * * * * * * * * * * * * * * ACC, API ACC, API, SOCMA ACC, API ACC, API ACC, API ACC ACC, API, SOCMA CAS# 1990 Manufacturer J998 2002 A Trad<;. Manu. Manu. Association 629-59-4 629-76-5 645-62-5 693-95-8 756-80-9 870-72-4 928-72-3 939-97-9 1000-82-4 1002-69-3 1111-78-0 1115-20-4 1323-65-5 IRECOINC SHELL OIL COMPANY VISTA CHEMICAL CO SHELL OIL COMPANY UNION CARBIDE CORPORATION MERCK AND COMPANY INC ICI AMERICAS INC AGFA El DUPONT DE NEMOURS & CO INC EASTMAN KODAK COMPANY FUJI HUNT PHOTOGRAPHIC CHEMICAL INC HICKSON & WELCH LIMITED HIGH POINT CHEMICAL CORPORATION HOECHSTCELANESE KONICA ROYAL COPIERS MOBAY CHEMICAL CORPORATION MONSANTO COMPANY FRAGRANCE RESOURCES INC GIVAUDAN CORPORATION INTERNATIONAL FLAVORS AND FRAGRANCES IN AURALUX CORPORATION BASF CORPORATION DYNO POLYMERS INCORPORATED LONZA INCORPORATED ARCADIAN CORPORATION CF INDUSTRIES INC BASF CORPORATION UNION CARBIDE CHEMICALS & PLASTICS CO MONSANTO COMPANY TEXACO CHEMICAL COMPANY * * * * * * * * * * * * * * * * * ACC, API ACC, API ACC ACC SOCMA ACC ACC, SOCMA ACC, SOCMA ACC ACC, API, SOCMA 73 EPA's High Production Volume Challenge Program 74 Sfafus and Future Directions ------- CAS# 1990 Manufacturer J998 r2002 A Trad<;. Manu. Manu. Association 1324-76-1 1401-55-4 1445-45-0 1459-93-4 1498-51-7 1558-33-4 1562-00-1 1646-75-9 1691-99-2 1738-25-6 1912-24-9 1929-82-4 2152-64-9 2210-79-9 2372-45-4 2409-55-4 HOECHSTCELANESE PMC SPECIALTIES GROUP INC ACETO CHEMICAL COMPANY INC CROMPTON & KNOWLES COLORS INCORPORATED MALLINCKRODT THE SIEFLOR CORPORATION HULS AMERICA INC HOECHSTCELANESE MORFLEX CHEMICAL COMPANY INC UNITEXCHEMCORP RHONE POULENC INCORPORATED El DUPONT DE NEMOURS & CO INC GAP CHEMICALS CORPORATION HENKEL CORPORATION RHONE POULENC INCORPORATED ALLIED-SIGNALING 3M AIR PRODUCTS AND CHEMICALS INC TEXACO CHEMICAL COMPANY CIBA-GEIGY CORPORATION TEXTILE PRODUCTS MARUBENI AMERICA CORPORATION DOW CHEMICAL USA PMC SPECIALTIES GROUP INC CL INDUSTRIES INC KOCH CHEMICAL COMPANY RHONE POULENC INCORPORATED SHEREX CHEMICAL COMPANY INC FMC COMPANY PMC SPECIALTIES GROUP INC RHONE POULENC INCORPORATED * * * * * * * * * * * * * * SOCMA SOCMA ACC ACC ACC ACC, API, SOCMA ACC, API ACC, API, SOCMA SOCMA SOCMA CAS# 1990 Manufacturer J998 2002 A Trad<;. Manu. Manu. Association 2425-54-9 2494-89-5 2524-03-0 2524-04-1 2611-00-9 2691-41-0 2702-72-9 2814-20-2 2905-62-6 2915-53-9 2941-64-2 3039-83-6 3088-31-1 3132-99-8 3386-33-2 3586-14-9 3710-84-7 3779-63-3 3965-55-7 4035-89-6 LONZA INCORPORATED ACETO CHEMICAL COMPANY INC BIDDLE SAWYER CORPORATION CROMPTON & KNOWLES COLORS INCORPORATED HOECHSTCELANESE MITSUI SCO (USA) INC ICI AMERICAS INC ETHYL CORPORATION - HEALTH SAFETY AND ICI AMERICAS INC UNION CARBIDE CORPORATION HOLSTON ARMY AMMUNITION PLANT DOW CHEMICAL USA CIBA-GEIGY CORPORATION TEXTILE PRODUCTS OCCIDENTAL CHEMICAL CORPORATION ARISTECH CHEMICAL CORPORATION MANUFACTURERS SOAP & CHEMICAL CO INC NATIONAL STARCH AND CHEMICAL CORPORATION TEXTILE RUBBER & CHEMICAL COMPANY ICI AMERICAS INC AIR PRODUCTS AND CHEMICALS INC LONZA INCORPORATED MTM HARDWICKE INC LONZA INCORPORATED MERICHEM COMPANY MTM HARDWICKE INC ATOCHEM INC POLYMER DIVISION BASF CORPORATION RHONE POULENC INCORPORATED El DUPONT DE NEMOURS & CO INC RHONE POULENC INCORPORATED * * * * * * * * * * * * * * * * * * * * SOCMA SOCMA ACC, SOCMA ACC, API, SOCMA ACC, API ACC, API ACC ACC, API ACC, SOCMA ACC 75 EPA's High Production Volume Challenge Program Status and Future Directions 76 ------- CAS# 1990 Manufacturer J998 r2002 A Trad<;. Manu. Manu. Association 4080-31-3 4300-97-4 4719-04-4 4860-03-1 5026-74-4 5216-25-1 5460-09-3 5915-41-3 6381-77-7 6473-13-8 6863-58-7 6865-35-6 7320-37-8 7446-81-3 7795-95-1 DOW CHEMICAL USA PPG INDUSTRIES INC ECOLAB INC QUAKER CHEMICAL CORPORATION STEPAN CHEMICAL COMPANY LONZA INCORPORATED CIBA-GEIGY CORPORATION TEXTILE PRODUCTS OCCIDENTAL CHEMICAL CORPORATION ACETO CHEMICAL COMPANY INC BIDDLE SAWYER CORPORATION CROMPTON & KNOWLES COLORS INCORPORATED FABRICOLOR MANUFACTURING CORPORATION ICI AMERICAS INC MOBAY CHEMICAL CORPORATION CIBA-GEIGY CORPORATION TEXTILE PRODUCTS PFIZER INC PMP FERMENTATION PRODUCTS INC AAKASH CHEMICALS & DYE-STUFFS BIDDLE SAWYER CORPORATION BURLINGTON CHEMICAL COMPANY INC CROMPTON & KNOWLES COLORS INCORPORATED FABRICOLOR MANUFACTURING CORPORATION EXXON CHEMICAL COMPANY LYONDELL-CITGO REFINING COMPANY LTD ANZON LEAD SYNTHETIC RUBBER PRODUCTS INC ATOCHEM INC POLYMER DIVISION UNION CARBIDE CORPORATION DOW CHEMICAL USA 3M * * * * * * * * * * * * ACC, API, SOCMA ACC, SOCMA ACC, API ACC, API SOCMA SOCMA ACC, API SOCMA ACC, API ACC, API, SOCMA ACC CAS# 1990 Manufacturer J998 2002 A Trad<;. Manu. Manu. Association 8001-58-9 8005-02-5 8007-45-2 12645-31-7 13749-94-5 13826-35-2 14666-94-5 16883-83-3 17103-31-0 17321-47-0 17976-43-1 19438-61-0 20068-02-4 21351-39-3 22527-63-5 ALLIED-SIGNALING CROWLEYTAR PRODUCTS COMPANY INC DAICOLOR-POPE INC MORTON INTERNATIONAL INCORPORATED ORIENT CHEMICAL CORPORATION SHARP ELECTRONICS CORPORATION USROPTONIXINC BOSTON COKE CORPORATION ERIE COKE CORPORATION KOPPER COMPANY INCORPORATED TONAWANDA COKE CORP CHEMTECHJNDUSTRIES INC HIGH POINT CHEMICAL CORPORATION HILTON-DAVIS CHEMICAL COMPANY PETROLITE CORPORATION PIEDMONT CHEMICAL INDUSTRIES INC REILLY-WHITEMAN INC El DUPONT DE NEMOURS & CO INC AMERIBROM INC MTM HARDWICKE INC EXXON CHEMICAL COMPANY MONSANTO COMPANY UNOCAL SCIENCE & TECHNOLOGY DIVISION CHEVRON CHEMICAL CO ANZON LEAD AMERICAN CYANAMID CO AGRI PRODS RES ICI AMERICAS INC El DUPONT DE NEMOURS & CO INC UNOCAL SCIENCE & TECHNOLOGY DIVISION HULS AMERICA INC * * * * * * * * * * * * * * * * * * * ACC SOCMA ACC, API ACC, API, SOCMA ACC 77 EPA's High Production Volume Challenge Program Status and Future Directions 78 ------- CAS# 1990 Manufacturer J998 r2002 A Trad<;. Manu. Manu. Association 24448-09-7 24615-84-7 24634-61-5 24794-58-9 25154-38-5 25168-05-2 25168-06-3 25321-41-9 25586-42-9 25646-71-3 26377-29-7 26401-27-4 26680-54-6 27193-28-8 28106-30-1 28777-98-2 3M HOECHSTCELANESE RHONE POULENC INCORPORATED HOECHSTCELANESE MITSUI SCO (USA) INC MONSANTO COMPANY TOMEN AMERICA INC WR GRACE & CO-CONN UNION CARBIDE CHEMICALS & PLASTICS CO OCCIDENTAL CHEMICAL CORPORATION FMC COMPANY RUETGERS-NEASE SLOSS INDUSTRIES CORPORATION El DUPONT DE NEMOURS & CO INC AGFA OLIN CORPORATION ICI AMERICAS INC DOVER CHEMICAL CORPORATION GE SPECIALTY CHEMICALS WITCO CHEMICAL CORPORATION DIXIE INTERNATIONAL COMPANY HUMPHREY CHEMICAL COMPANY MILLIKENCHEM GAP CHEMICALS CORPORATION PMC SPECIALTIES GROUP INC ROHM AND HAAS COMPANY DELTECH CORPORATION DOW CHEMICAL USA BERCEN INC ETHYL CORPORATION - HEALTH SAFETY AND * * * * * * * * * * * * * * * * * * * * * * ACC ACC, SOCMA ACC ACC, API SOCMA ACC ACC ACC API SOCMA ACC SOCMA ACC, API, SOCMA CAS# 1990 Manufacturer J998 2002 A Trad<;. Manu. Manu. Association 30574-97-1 31138-65-5 32072-96-1 32210-23-4 34689-46-8 35203-06-6 35203-08-8 37439-34-2 37734-45-5 37764-25-3 38185-06-7 39515-51-0 40630-63-5 40876-98-0 51632-16-7 52184-19-7 52556-42-0 52663-57-7 56038-89-2 HUMPHREY CHEMICAL COMPANY MILLIKEN CHEM El DUPONT DE NEMOURS & CO INC FARMS INDCHEMCO BERCEN INC DIXIE INTERNATIONAL COMPANY ETHYL CORPORATION - HEALTH SAFETY AND HULS AMERICA INC INTERNATIONAL FLAVORS AND FRAGRANCES IN QUEST INTERNATIONAL MERICHEM COMPANY MONSANTO COMPANY MONSANTO COMPANY DOW CHEMICAL USA ICI AMERICAS INC ICI AMERICAS INC LOMAC INCORPORATED FMC COMPANY MTM HARDWICKE INC NAGASE AMERICA CORPORATION 3M AMERICAN CYANAMID CO AGRI PRODS RES BIDDLE SAWYER CORPORATION HEICO CHEMICALS INC NEPERA INC MTM HARDWICKE INC CIBA-GEIGY CORPORATION TEXTILE PRODUCTS RHONE POULENC INCORPORATED FMC COMPANY AMERICAN CYANAMID CO AGRI PRODS RES * * * * * * * * * * * * * * * * * * * * * * * * * * ACC ACC, API ACC ACC ACC, API, SOCMA ACC SOCMA ACC, API 79 EPA's High Production Volume Challenge Program Status and Future Directions 80 ------- CAS# 1990 Manufacturer J998 r2002 A Trad<;. Manu. Manu. Association 57693-14-8 61788-76-9 61789-32-0 61789-65-9 61789-85-3 64742-24-1 64743-02-8 64743-03-9 64771-71-7 65996-78-3 BASF CORPORATION CIBA-GEIGY CORPORATION TEXTILE PRODUCTS CROMPTON & KNOWLES COLORS INCORPORATED DOVER CHEMICAL CORPORATION FERRO CORPORATION OCCIDENTAL CHEMICAL CORPORATION GAF CHEMICALS CORPORATION LEVER BROTHERS CO PPG INDUSTRIES INC GAYLORD CONTAINER CORPORATION JAMES RIVER CORPORATION JAMES RIVER GRAPHICS INCORPORATED STEPAN CHEMICAL COMPANY AMOCO CANADA MARKETING CORP DIAMOND SHAMROCK REFINING/MKT SUN REFINING AND MARKETING COMPANY CHEVRON CHEMICAL CO HALTERMANN LTD MONSANTO COMPANY SHELL OIL COMPANY ASHLAND CHEMICAL COMPANY - ENVIRONMENTAL COASTAL REFINING & MARKETING INC FARMLAND INDUSTRIES INC LYONDELL-CITGO REFINING COMPANY LTD TEXACO CHEMICAL COMPANY MONSANTO COMPANY SHELL OIL COMPANY ACME STEEL COMPANY ARMCO STEEL COMPANY LP BETHLEHEM STEEL CORPORATION * * * * * * * * * * ACC, SOCMA ACC, API ACC ACC, SOCMA ACC, API ACC, SOCMA SOCMA ACC, API, SOCMA ACC ACC, API ACC, API ACC, API ACC, API, SOCMA ACC ACC, API CAS# 1990 Manufacturer J998 2002 A Trad<;. Manu. Manu. Association 65996-79-4 65996-80-7 65996-81-8 65996-82-9 65996-83-0 65996-86-3 BOSTON COKE CORPORATION CITIZENS GAS & COKE UTILITY EMPIRE COKE COMPANY GREAT LAKES CHEMICAL CORPORATION - RESEA GULF STATES STEEL INC KOPPER COMPANY INCORPORATED LTV STEEL COMPANY INC NATIONAL STEEL CORPORATION SLOSS INDUSTRIES CORPORATION TONAWANDA COKE CORP USS DIVISION OF USX ARISTECH CHEMICAL CORPORATION KOPPER COMPANY INCORPORATED EMPIRE COKE COMPANY KOPPER COMPANY INCORPORATED ACME STEEL COMPANY ARMCO STEEL COMPANY LP EMPIRE COKE COMPANY ERIE COKE CORPORATION KOPPER COMPANY INCORPORATED SLOSS INDUSTRIES CORPORATION TONAWANDA COKE CORP USS DIVISION OF USX ALLIED-SIGNALING ARISTECH CHEMICAL CORPORATION KOPPER COMPANY INCORPORATED REILLY INDUSTRIES INC ALLIED-SIGNALING KOPPER COMPANY INCORPORATED ALLIED-SIGNALING * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * SOCMA SOCMA ACC 81 EPA's High Production Volume Challenge Program Status and Future Directions 82 ------- CAS# 1990 Manufacturer J998 r2002 A Trad<;. Manu. Manu. Association 65996-87-4 65996-89-6 65996-91-0 65996-92-1 66071-94-1 68081-86-7 68082-78-0 68153-60-6 KOPPER COMPANY INCORPORATED ALLIED-SIGNALING KOPPER COMPANY INCORPORATED ACME STEEL COMPANY ALLIED-SIGNALING ARMCO STEEL COMPANY LP BETHLEHEM STEEL CORPORATION EMPIRE COKE COMPANY GREAT LAKES CHEMICAL CORPORATION - RESEA GULF STATES STEEL INC KOPPER COMPANY INCORPORATED LTV STEEL COMPANY INC NATIONAL STEEL CORPORATION REILLY INDUSTRIES INC SLOSS INDUSTRIES CORPORATION USS DIVISION OF USX ALLIED-SIGNALING ARISTECH CHEMICAL CORPORATION CROWLEYTAR PRODUCTS COMPANY INC KOPPER COMPANY INCORPORATED REILLY INDUSTRIES INC KOPPER COMPANY INCORPORATED REILLY INDUSTRIES INC WESTERN TAR PRODUCTS CORPORATION GRAIN PROCESSING CORPORATION EXXON CHEMICAL COMPANY HENKEL CORPORATION REILLY-WHITEMAN INC EXXON CHEMICAL COMPANY JETCO CHEMICALS INC * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * ACC SOCMA ACC ACC ACC, API ACC, API CAS# 1990 Manufacturer J998 2002 A Trad<;. Manu. Manu. Association 68187-57-5 68187-59-7 68187-76-8 68187-84-8 68188-18-1 68309-27-3 68334-01-0 68441-66-7 68442-60-4 68476-80-2 68478-20-6 68479-98-1 68511-40-0 68512-63-0 68513-62-2 68514-41-0 68515-89-9 68527-02-6 68553-14-0 ASHLAND CHEMICAL COMPANY - ENVIRONMENTAL KOPPER COMPANY INCORPORATED FMC COMPANY UCAR CARBON COMPANY INC CLIMAX PERFORMANCE MATERIALS CORPORATION HIGH POINT CHEMICAL CORPORATION NATIONAL STARCH AND CHEMICAL CORPORATION REILLY-WHITEMAN INC CASCHEMINC BASF CORPORATION MOBAY CHEMICAL CORPORATION CLIMAX PERFORMANCE MATERIALS CORPORATION MERICHEM COMPANY HATCO CHEMICAL CORPORATION HERCULES INCORPORATED CARGILL INCORPORATED KARLSHAMNS LIPID SPECIALTIES USA VELSICOL CHEMICAL CORPORATION ETHYL CORPORATION - HEALTH SAFETY AND EXXON CHEMICAL COMPANY SHEREX CHEMICAL COMPANY INC CHEVRON CHEMICAL CO EXXON CHEMICAL COMPANY MARATHON OIL COMPANY EXXON CHEMICAL COMPANY SYNTHETIC RUBBER PRODUCTS INC WITCO CHEMICAL CORPORATION DOVER CHEMICAL CORPORATION OCCIDENTAL CHEMICAL CORPORATION AMOCO CANADA MARKETING CORP * * * * * * * * * * * * * * * * * * * * * * * ACC, API ACC, SOCMA ACC, API ACC, API ACC, API, SOCMA ACC, API API ACC, API ACC ACC, API 83 EPA's High Production Volume Challenge Program Status and Future Directions 84 ------- CAS# 1990 Manufacturer J998 r2002 A Trad<;. Manu. Manu. Association 68584-25-8 68602-81-3 68603-84-9 68607-28-3 68608-59-3 68609-04-1 68609-05-2 68610-90-2 68611-64-3 68647-60-9 68650-36-2 68782-97-8 68815-50-9 HB FULLER CO HUISH DETERGENTS INC PILOT CHEMICAL COMPANY SARTOMER COMPANY INC HENKEL CORPORATION PETROLITE CORPORATION BF GOODRICH COMPANY SPECIALTY CHEMICALS VISTA CHEMICAL CO BASF CORPORATION BASF CORPORATION EXXON CHEMICAL COMPANY AGRICO CHEMICAL COMPANY AGRICULTURAL MINERALS CORPORATION ARCADIAN CORPORATION CF INDUSTRIES INC FARMLAND INDUSTRIES INC SOUTHERN RESIN INC TERRA INTERNATIONAL INC TRIAD CHEMICAL UNOCAL SCIENCE & TECHNOLOGY DIVISION CHEVRON CHEMICAL CO LYONDELL-CITGO REFINING COMPANY LTD BP OIL COMPANY AMOCO CANADA MARKETING CORP CHEVRON CHEMICAL CO LYONDELL-CITGO REFINING COMPANY LTD HENKEL CORPORATION HIGH POINT CHEMICAL CORPORATION PIEDMONT CHEMICAL INDUSTRIES INC SEDGEFIELD SPECIALTIES * * * * * * * * * * * * * * * * * * * * * SOCMA ACC ACC, SOCMA ACC, SOCMA ACC, API ACC, API, SOCMA ACC, API ACC, API, SOCMA CAS# 1990 Manufacturer J998 2002 A Trad<;. Manu. Manu. Association 68909-77-3 68915-05-9 68915-39-9 68918-16-1 68919-17-5 68920-64-9 68937-29-1 68937-69-9 68937-70-2 68937-72-4 68953-70-8 68953-80-0 68955-37-3 68955-76-0 68955-96-4 68987-41-7 68988-22-7 68988-99-8 68990-61-4 68990-65-8 69029-75-0 70024-67-8 TEXACO CHEMICAL COMPANY SHEREX CHEMICAL COMPANY INC BASF CORPORATION FMC COMPANY SHELL OIL COMPANY THE GOODYEAR TIRE & RUBBER CO DEPARTMEN AMOCO CANADA MARKETING CORP BASF CORPORATION HENKEL CORPORATION HENKEL CORPORATION HENKEL CORPORATION DOW CHEMICAL USA TEXACO CHEMICAL COMPANY BP OIL COMPANY SUN REFINING AND MARKETING COMPANY HERCULES INCORPORATED CHEVRON CHEMICAL CO BP OIL COMPANY LYONDELL-CITGO REFINING COMPANY LTD EXXON CHEMICAL COMPANY CAPE INDUSTRIES AMOCO CANADA MARKETING CORP CROWN CENTRAL PETROLEUM CORPORATION TEXACO CHEMICAL COMPANY TOTAL PETROLEUM INC BETHLEHEM STEEL CORPORATION CITIZENS GAS & COKE UTILITY KARLSHAMNS LIPID SPECIALTIES USA CHEVRON CHEMICAL CO PILOT CHEMICAL COMPANY * * * * * * * * * * * * * * * * * * * * * * * * * ACC, API, SOCMA ACC, SOCMA ACC, API ACC, SOCMA ACC, API, SOCMA ACC, API, SOCMA ACC, API SOCMA ACC, API, SOCMA ACC, API ACC, API ACC, API, SOCMA ACC, API, SOCMA SOCMA 85 EPA's High Production Volume Challenge Program Status and Future Directions 86 ------- 87 CAS# 70084-98-9 70693-50-4 70851-08-0 71077-05-9 72162-28-8 73665-18-6 83864-02-2 84501-86-0 90640-80-5 90640-86-1 119345-02-7 125997-20-8 1990 Manufacturer STEPAN CHEMICAL COMPANY UNION CAMP CORPORATION CIBA-GEIGY CORPORATION TEXTILE PRODUCTS RHONE POULENC INCORPORATED TEXACO CHEMICAL COMPANY GE PLASTICS KOPPER COMPANY INCORPORATED El DUPONT DE NEMOURS & CO INC WERNER G SMITH INC KOPPER COMPANY INCORPORATED KOPPER COMPANY INCORPORATED DOW CHEMICAL USA GREAT LAKES CHEMICAL CORPORATION - RESEA 1998 2002 Trade Manu. Manu. Association * * * * * * * * * * * ACC, API ACC, API, SOCMA API ACC ACC, API, SOCMA The table reveals that for the 330 orphan chemicals, there are: 151 cases where a company member from the ACC trade association could have sponsored a chemical; 83 cases where a company member from the API trade association could have sponsored a chemical; and 91 cases where a company member from the SOCMA trade association could have sponsored a chemical (note that the API company list was not a complete list of members). The figure below, which is a flowchart on the following page entitled "Preliminary Strategy for Addressing HPV Challenge Program Unsponsored Chemicals," outlines EPA's initial thinking for obtaining hazard screening-level data for the 330 orphan chemicals and making the data publicly available in the HPV Information System. (HPVIS is a data-searchable application for HPV Challenge Program data that is discussed later in this report.) EPA continues to recognize the HPV Challenge Program as a dynamic and fluid program, and any strategy for addressing orphan chemicals must be flexible to accommodate changing Program circumstances and EPA and stakeholder needs. Preliminary Strategy for Addressing HPV Challenge Program Unsponsored Chemicals 571 Unsponsponsored Chemicals based on 1990 HPV Challenge Programming List 1. EPA and others may engage in activities to secure additional HPV sponsors. 4. Finalize the First HPV Test Rule. Identify SIDS end point studies not addressed in the First HPV Test Rule. Approximately 241 meet the HPV Challenge Program "No Longer HPV" criterion and will not be a direct focus of follow-up work under the HPV Challenge Program at this time. 8. ITC-coordinated TSCA 8(d) Unpublished Health and Safety Data Rule and TSCA 8(a) PAIR Rule to gather exposure data for future test rule findings. T available/submitted to EPA adequate to meet SIDSendpoints? included in First HPV Test Rule? No v 3. Does the chemical meet I'No Longer HPV; criterion? 330 orphan chemicals Are there any publicity available studies that are adequate to fulfill HPV Challenge Program needs? rule exposure-based findings be made with currently available information Yes 10. Can test rule exposure-based findings be made with PAIR and/or other currently available information? Yes No Propose and finalize Third HPV Test Rule for Chemicals for which findings can be made. Consider risk-based findings for chemicals where needed. 12. Seek other data development mechanism for chemicals with continuing hazard and fate data gaps. 7. Propose and finalize Second HPV Test Rule addressing inadequate studies for specific endpoints. Also include in this test ruls studies that address endpoints left uncovered in the First HPV Test Rule for which there are inadquate studies. 88 EPA's High Production Volume Challenge Program Status and Future Directions ------- Flowchart Graphic 1 - EPA and others may engage in activities to secure additional HPV sponsors. EPA encourages companies and consortia to consider sponsorship of unsponsored chemicals at the present time, before regulatory actions are initiated. EPA plans to work with trade associations and others, and conduct outreach and communications activities targeted at reducing the number of these chemicals. The sustained efforts of stakeholder organizations are essential to making meaningful progress toward reducing the number of unsponsored chemicals. Flowchart Graphic 2 - Is chemical included in First HPV Test Rule? EPA proposed a TSCA Section 4 test rule using exposure-based findings (i.e., TSCA section 4(a)(l)(B) see the description under Flowchart Graphic 5) on December 26, 2000, that would require manufacturers and processors of 37 unsponsored HPV chemicals to conduct specific screening-level testing (65 FR 81658). In this proposed rule, EPA made preliminary determinations that each of the 37 chemical substances is produced (i.e., at the time of the proposed rule) in substantial quantities and that there is substantial human exposure to each of them. The proposed rule was EPA's first action addressing HPV Challenge Program unsponsored chemicals. Flowchart Graphic 3 - Does the chemical meet "No Longer HPV" criterion? At the onset of the HPV Challenge Program, the Agency established clear guidance for identifying chemicals as "No Longer HPV" for purposes of the Program. The Program's criterion is that total annual national aggregate production volume must be below one million pounds for both of the two most recent Inventory Update Rule (IUR) reporting periods. The Agency's guidance, entitled "Procedures for Removing HPV Chemicals That Are 'No Longer HPV and are Not Likely to Become HPV Again From the HPV List" may be found at http://www.epa.gov/chemrtk/ guidocs.htm. To develop the list of orphan chemicals, the Agency considered only chemicals from the 1990 HPV Challenge Program Chemical List. Chemicals on the 1994 List of HPV Additions were not considered, because sponsorship of these chemicals, while accepted, was not officially a part of the HPV Challenge Program. Of the 2,782 chemicals on the 1990 HPV Challenge Program Chemical List, 571 chemicals remain unsponsored. The Agency applied the "No Longer HPV" criterion using the 1998 and 2002 IUR reporting periods and determined that 241 (42%) met the "No Longer HPV" criterion (i.e., the national aggregate production/importation volumes for these 241 chemicals were less than one million pounds in both the 1998 and 2002 IUR reporting periods). Because the Agency does not consider chemicals currently meeting the "No Longer HPV" criterion to be available for sponsorship under the HPV Challenge Program, the number of unsponsored chemicals is currently 330. Flowchart Graphic 4 - Finalize the First HPV Test Rule. Identify SIDS endpoint studies not addressed in the First HPV Test Rule. The Agency (as discussed in Flowchart Graphic 2) has already taken some action to obtain data on certain unsponsored HPV chemicals. In this proposed rule, EPA made preliminary findings that each of the 37 chemical substances is produced (i.e., at the time of the proposed rule) in substantial quantities and that the manufacture, processing, distribution in commerce, disposal, and uses of each of the chemicals substances result, or may result in, exposure to a substantial number of workers. The final test rule will not include those chemicals whose national aggregate production volume is less than one million pounds per year as reported to the 2002 IUR or which have been sponsored after the test rule was first proposed on December 26, 2000. Therefore, the 37 chemicals included in the proposed first HPV unsponsored test rule will be reduced in the final rule. Publication of the final rule is expected in 2005. In developing the testing requirements for chemicals contained in the proposed rule, EPA utilized searchable and electronically available data and sources in EPA's "Chemical Hazard Data Availability Study" (1998) and ACC's "Public Availability of SIDS- Related Testing Data for U.S. High Production Volume Chemicals" (1998) to determine whether screening-level data were available. If no data were available through these searches for a SIDS testing endpoint for a given chemical, EPA made the finding that there are insufficient data to reasonably determine the human health and environmental effects for that chemical's endpoint. If data were available through these searches for a SIDS testing endpoint, EPA did not make determinations about the sufficiency or adequacy of those data for the first proposed rulemaking. Those determinations, as described below, are planned for the coming year. Robust summaries for SIDS endpoints that are determined to be adequate will be made available through the High Production Volume Information System (HPVIS). Flowchart Graphic 5 - Can test rule exposure-based findings be made with currently available data? In addition to the First HPV Test Rule described above, the Agency is considering whether it can make the findings needed to promulgate test rules to obtain baseline health and environmental effects data on additional orphan chemicals. In order to promulgate a TSCA Section 4 test rule, certain findings are required by statute. EPA must first make findings under TSCA section 4(a)(l)(A) (risk- based finding) and/or section 4(a)(l)(B) (exposure- based finding). The test rule proposed on December 26, 2000, was based on exposure-based findings, and additional orphan chemical HPV test rules could also be based on such findings. However, EPA is not precluding the option of issuing test rules based on risk-based findings alone or in addition to exposure- based findings. 89 EPA's High Production Volume Challenge Program Status and Future Directions 90 ------- The following statutory TSCA section 4(a) findings are required for issuing test rules: Risk-Based Finding; or Exposure-Based Finding the chemical is or will be produced or imported in substantial quantities and (I) it enters or may reasonably be anticipated to enter the environment in substantial quantities, or (II) there is or may be substantial or significant human exposure to the chemical; and "Data Adequacy" Finding existing data are insufficient to enable a reasonable determination of the effects of the substance on health or the environment; and "Testing is Necessary" Finding testing with respect to such effects is necessary to develop such data. On May 14, 1993, EPA published the "B" (or exposure-based) Policy that articulates the criteria that EPA uses to determine whether a chemical is or will be "produced in substantial quantities," whether it "enters or may reasonably be anticipated to enter the environment in substantial quantities," and whether there is or may be "significant or substantial human exposure" (58 FR 28736). The general quantitative guidance thresholds for making these determinations are summarized below. However, EPA may also make findings in situations where the quantitative thresholds are not met, if additional factors exist. Substantial Production/Importation 1 million Ibs/yr; and Substantial Release 1 million Ibs/yr or 10% of production or import volume/yr; or Substantial Human Exposure 1,000 workers or 10,000 consumers or 100,000 general population; or Significant Human Exposure "case-by-case." Flowchart Graphic 6 - Are there any publicly available studies that are adequate to fulfill HPV Challenge Program needs? For those orphan chemicals for which the necessary exposure-based production/importation volume, release, and/or findings can be made, EPA will identify and evaluate the existing hazard and fate studies to determine if the studies are adequate to meet the needs of the HPV Challenge Program. EPA will also conduct an evaluation of the adequacy of the studies for certain endpoints that were not considered in the First HPV Test Rule; specifically, EPA will evaluate the adequacy of studies identified as "available" when the test rule was proposed but for which a data adequacy evaluation was not conducted at that time. If the studies are determined to be adequate, EPA will make the data publicly available on HPVIS. Flowchart Graphic 7 - Propose and finalize Second HPV Test Rule addressing inadequate studies for specific SIDS endpoints. Also include in this test rule studies that address endpoints left uncovered in the First HPV Test Rule for which there are inadequate studies. If the existing hazard and fate studies are determined to be inadequate, a second test rule would be proposed to obtain hazard and fate data if statutory findings can be made. Flowchart Graphic 8 - ITC-coordinated TSCA 8(d) Unpublished Health and Safety Data Rule and TSCA 8(a) PAIR Rule to gather exposure data for future test rule findings. This step in the proposed strategy will be conducted concurrently with Flowchart Graphics 6 and 7. Regarding those orphan chemicals for which the necessary exposure-based findings cannot readily be made, the Agency will request the Interagency Testing Committee (ITC) to consider adding these chemicals to the TSCA section 4(e) Priority Testing List in the ITC's 55th Report to the EPA Administrator, projected for late 2004. Based on this potential ITC action, EPA may append the chemicals to the TSCA section 8 (a) Preliminary Assessment and Information Reporting (PAIR) rule and the TSCA section 8(d) Health and Safety Data Reporting (HaSDR) rule. The PAIR rule would require producers and importers to submit to EPA within the 90-day reporting period (i.e., 90 days from publication of the rule in the Federal Register) one-time reports on production/ importation volumes, end uses, and exposure-related data. The TSCA section 8(d) HaSDR rule would require producers and importers to submit to EPA within the 90-day reporting period (i.e., 90 days from publication of the rule in the Federal Register) copies and lists of certain types of unpublished health and safety studies for the listed chemicals. Submitters could also be requested or may be required to provide robust summaries for studies addressing health and environmental endpoints. Flowchart Graphic 9 - Are studies available/submitted to EPA adequate to meet SIDS endpoints? The Agency would review all publicly available studies and studies submitted under the TSCA section 8(d) rule for their adequacy in meeting all SIDS endpoints. To the extent robust summaries are submitted (refer to Flowchart Graphic 8), the Agency would make the robust summaries publicly available through the HPVIS. For those chemicals for which the submitted studies are determined to be adequate, but for which robust summaries were not submitted, EPA would prepare the robust summaries and make the data publicly available in the HPVIS. Should the submitted or identified studies be found inadequate for certain chemicals, then PAIR data would be evaluated by EPA to determine if a TSCA section 4(a)(l)(B) finding can be made for those chemicals without further research. Flowchart Graphic 10 - Can test rule exposure-based findings be made with PAIR and/or other currently available information? The Agency will review the PAIR data to determine if the TSCA section 4(a)(l)(B)(i) finding for a test rule can be made. (See the description of Flowchart Graphic 5 for details.) 91 EPA's High Production Volume Challenge Program Status and Future Directions 92 ------- Flowchart Graphic 11 - Propose and finalize Third HPV Test Rule for chemicals for which findings can be made. Consider risk-based findings for chemicals as needed. If the findings can be made, the Agency would propose a third HPV orphan chemical test rule. EPA would consider requesting or requiring robust summaries for studies conducted under this test rule. Flowchart Graphic 12 - Seek other data development mechanism for chemicals with continuing hazard and fate data gaps. The Agency solicits input on other data development mechanisms that will help fill hazard and fate data gaps for chemicals that remain as orphan chemicals, if any. Projected Orphans Data Development Timeline4 Estimated Timeline First HPV Test Rule Second HPV Test Rule Third HPV Test Rule October 2004 December 2004 June 2005 October 2005 January 2006 September 2006 November 2006 August 2007 Final Rule Published Data Availability/Adequacy Analysis Initiated Proposed Test Rule Published Review of Public Comments on Proposed Rule Initiated Final Test Rule Published 8(a)/8(d) Candidates Provided to ITC 55th ITC Report Published 8(a) and 8(d) Final Rules Published Review of 8(a) and 8(d) submissions initiated Proposed Test Rule Published Review of Public Comments on Proposed Rule Initiated Final Test Rule Published It is anticipated that the proposed Second HPV Test Rule will be published in October 2005. At the same time, EPA would review data submitted under the HaSDR and PAIR rules for inclusion in the HPVIS or for making the TSCA section 4(a)(l)(B)(i) finding for a Third HPV Test Rule. In January 2006, EPA would begin its review of the public comments submitted on the Second HPV Test Rule. In September 2006, it is expected that the Second HPV Test Rule would be promulgated and the proposed Third HPV Test Rule would be published, followed by the review of public comments submitted in response to the Third HPV Test Rule in November 2006 and final promulgation in August 2007. *Timeline assumes that all proposed and final rules will be subject to 90-day OMB review. {This is a projected schedule that the Agency will work to meet in preparing and promulgating test rules as needed. Unanticipated problems or issues could result in delays.} Beginning in October 2004, EPA would initiate efforts to conduct data availability/adequacy searches for orphan chemicals identified for inclusion in the Second HPV Test Rule. Additionally, the list of orphan chemicals designated as candidates for the HaSDR rule under 8(d) and the PAIR rule under 8(a) would be provided to the ITC. Subsequently, in 2005, it is anticipated that the First HPV Test Rule containing fewer than the 37 orphan chemicals included on the proposed First HPV Test Rule would be promulgated. In December 2004, it is expected that the ITC would publish its 55th report to the EPA Administrator outlining the Committee's intended priorities and actions. 93 EPA's High Production Volume Challenge Program Status and Future Directions 94 ------- Appendix 6: Future Directions and Developing Issues EPA's "High Production Volume Challenge Program" website is found at http://www. epa.gov/chemrtk/volchall.htm. Test plan and robust summary submissions, sponsor commitment information, chemical lists, guidance documents, and other materials can be found at this site. EPA has recently provided limited search capability on its existing "Robust Summaries and Test Plans" webpage (http://www.epa.gov/chemrtk/hpvrstp.htm) that allows stakeholders to search more efficiently for test plans and robust summaries. The search feature allows users to locate specific test plans by CAS number, chemical name, sponsor (individual company or consortium), or individual/category test plan name. The search then links users to the appropriate submission materials. Various stakeholder volunteers were used to test the newly developed search component of the website, including members of the NPPTAC's (National Pollution Prevention and Toxics Advisory Committee see "Developing Issues" below) HPV Work Group, a group specifically charged with considering HPV issues, as well as the Forum on State and Tribal Toxics Action (FOSTTA) Chemical Information and Management Project (CIMP) members. Comments were received from the testers, and a production release of this function occurred in April 2004. A much more comprehensive, data-searchable application with a website front-end is the ultimate goal of the HPV Information System (HPVIS). This system will allow users to thoroughly search across all test plan and robust summary-related materials including data presented within and among robust summaries. Among other features, the system will ultimately allow the user to locate specific endpoint data, and it will recognize certain sponsor-provided chemical synonym names in addition to the officially recognized chemical name. The immediate need is to develop enough functionality to populate the HPVIS with data and develop limited querying tools to enable the public to access these data. See the following table for the Projected HPVIS 2004 development timeline. The development process has begun defining the screen flow and designing system screens. The initial focus involves populating the database with historical submissions that were provided in support of the HPV Challenge Program. EPA will be working with sponsors and trade associations on the process of entering and validating legacy data as well as newly submitted test plan and robust summary data. The initial public release of the database is scheduled toward late 2004 / early 2005. Availability of screening-level hazard data on HPV chemicals is a global issue. There are many activities addressing this issue worldwide. Coordination and compatibility of various international HPV data systems are essential. EPA is collaboratively working with the European Commission (EC), in consultation with the Organization for Economic Cooperation and Development (OECD), and with the additional Sfafus and Future Directions 96 ------- participation of Canada and Japan on a Global HPV Portal. The Portal provides a central information technology location for accessing international HPV chemical data repositories. It focuses on information sharing across geographic, programmatic, and political boundaries. The planning around the Portal is still in the conceptual stages. An articulated vision for the Portal into a more tangible project is expected in the coming months. See the figure below for an illustration of the Portal information sharing concept. The aim of the Global HPV Portal is to provide seamless information sharing between the European Union's (E.U.) International Uniform Chemical Information Database (IUCLID) and EPA's HPVIS. The two leads the EC and the Agency have worked diligently on the Portal requirements over the past year in an effort to share information and make data more readily available to stakeholders from around the world. Some of the benefits resulting from the Portal concept include: Information can be shared across IUCLID and EPA's HPVIS without requiring industry to submit data to both systems. Government users can seamlessly access a unified picture of non-CBI data contained in both IUCLID and EPA's HPVIS. Industry can easily submit and obtain information from both the E.U. and U.S. programs. Industry can also share information with other industry representatives as desired. Public users can obtain access to HPV data regardless of whether the data exist in the E.U. program or the U.S. program. Public users can access E.U. and U.S. HPV data through a single interface. Other programs, such as new chemicals or biocides, can be added to the Portal as desired. Databases from other collaborating countries can also be added to the Portal. Countries such as Canada and Japan are working with EC and the Agency. By the end of 2004, the HPV Portal effort expects to be fully active and engaged with a core team of leaders in place, a System Management Plan drafted, a System Concept document finalized, and requirements defined. The key milestone to be reached by this time is the finalization, formalization, and acceptance of fundamental functions through the completion of the Functional Requirements Specifications document. Following these achievements, the HPV Portal will continue to implement and update the System Global HPV Portal Information Sharing Management Plan, as well as identify and initiate security activities related to the Portal and its development. Likewise, active development efforts will begin with the preparation of a Design Decision Paper, exploration of "buy-or-build" options, and the creation of operational platform and administrative policies. Finally, development of a formal System Design Document will commence. As the HPV Challenge Program moves toward 2005 and prepares to provide the industry-submitted data to the public in a searchable database format, the Agency has begun to press forward with developing and planning for the delivery of the HPVIS and the Global HPV Portal. This will lead to an international seamless exchange of data. The Office of Pollution Prevention and Toxics (OPPT) plans to continue working directly with sponsors and trade associations on the process of entering and validating legacy data as well as newly submitted test plan and robust summary data. This is a very important step in ensuring that the HPVIS is populated efficiently. Additionally, now that steadily increasing amounts of the data have been submitted, the Agency, working with the National Pollution Prevention and Toxics Advisory Committee (NPPTAC) and its HPV Work Group, is focusing on approaches for using the data to identify and prioritize chemicals for further work. Once the prioritized chemicals have been identified, the next steps include employing mechanisms to obtain needed hazard (beyond the basic screening-level of the SIDS) or exposure data through voluntary or regulatory approaches. OPPT will continue to inform the public about the HPV Challenge Program and the potential uses of the data. Preparation of various guidance documents and fact sheets are expected to provide the important background information for helping the general public understand the technical data. Another priority related to HPV chemicals is how to proceed with obtaining data on the orphans. Additionally, developing and considering options for a program to obtain data on the newly emerging HPV chemicals, which were reported in recent IUR cycles, is viewed as an important next step. A total of 1,118 additional chemicals, that were not HPV on the 1990 IUR, were reported at one million pounds or more under either or both the 1998 or 2002 lURs. OPPT created the NPPTAC to provide assistance to the office as it begins to address these very important next steps. NPPTAC was specifically established under the Federal Advisory Committee Act (FACA) to provide advice, information, and recommendations on the overall policy and implementation of programs managed by OPPT. OPPT's duties and responsibilities under the Toxics Substances Control Act (TSCA) and the Pollution Prevention Act (PPA) will be addressed, and a work group has been formed to address HPV issues. Specifically, the NPPTAC and its HPV Work Group continue to discuss how OPPT should proceed with using the HPV data to identify and prioritize chemicals of concern, the design and implementation of the HPV Information System (HPVIS), how the Agency should address the emerging HPV chemicals not currently included in the HPV Challenge Program, and how to proceed with obtaining additional data for orphan chemicals. Additional NPPTAC information can be found at http://www.epa.gov/oppt/npptac/. 97 98 EPA's High Production Volume Challenge Program Status and Future Directions ------- 1 990 HPV Challenge Program Chemical List 1994 List of HPV Additions ACC API CAS Number Category Category Analysis Consortium EC ED ED Endpoint HPV HPVIS ICCA IUCLID IUR The list of HPV Chemicals from the 1990 IUR reporting period, from which sponsors may make chemical commitments to supply data. Approximately 500 organic chemicals that were newly reported as HPV in the 1 994 IUR, provided for use by companies in developing categories of chemicals. American Chemistry Council. American Petroleum Institute. Chemical Abstracts Service Number: A unique identification number assigned by the Chemical Abstracts Service (CAS) to each distinct chemical substance recorded in the CAS Chemical Registry System. This number may contain up to 9 digits. For example, the CAS number for Valium is 439-14-5. A group of substances similar in chemical structure that show a regular pattern of properties and effects. In the HPV Challenge Program, being able to interpolate between and among, or extrapolate from, category members often results in reduced testing, since not all chemicals need to be tested for every SIDS endpoint. A submitted plan where a sponsor indicates how their underlying category hypothesis is reasonable, and how existing and new data can be interpolated/extrapolated to address the untested category chemicals' endpoints. EPA reviews the analysis and considers whether it is reasonable or if the category should be considered for restructuring. An organization consisting of two or more companies that agree to sponsor at least one chemical in the HPV Challenge Program. European Commission: An organization that serves to operate in the best interest of the European Union, specifically through proposing legislation, implementing policies, enforcing law, and negotiating international agreements. Environmental Defense. European Union: An organization of democratic European countries that have established common institutions to work toward prosperity. The chemical or biological effect that is assessed by a test method. High Production Volume: Chemicals manufactured or imported in quantities equal to or greater than 1 million pounds per year. High Production Volume Information System: A publicly accessible website where users will access comprehensive data related to HPV Challenge Program test plan and robust summary submissions. International Council of Chemical Associations: A chemical industry organization that represents chemical manufacturers and producers from around the world, it adds information transfer within the international industry. International Uniform Chemical Information Database: A system of data collection and evaluation within the EU Risk Assessment Program and accepted by OECD as the data exchange tool within the OECD Existing Chemicals Program. Inventory Update Rule: A rule promulgated in 1986 and revised extensively in 2003 by EPA that updates the TSCA Chemical Substances Inventory database every four years. This rule requires manufacturers and importers of certain chemical substances included on the TSCA Chemical Substances Inventory to report current data on the production volume, plant site, and site-limited status of these substances. Reporting in 2006 and beyond will include additional components. Sfafus and Future Directions ------- LogKow NPPTAC OECD OPPT Orphan PCRM PETA Robust Summary SAR SIAM SIAR SIDS SOCMA Start Year Test Plan Test Rule TSCA UNEP Viable Chemical The octanol-water partition coefficient for a neutral molecule. It is generally used as a relative indicator of the tendency of an organic compound to adsorb to soil. National Pollution Prevention and Toxics Advisory Committee: National advisory body to provide advice, information, and recommendations on the overall policy and operation of programs managed by the Office of Pollution Prevention and Toxics (OPPT). Organization for Economic Cooperation and Development: A group of 30 member countries sharing a commitment to democratic government and the market economy, covering economic and social issues such as macroeconomics, trade, education, development, and science and innovation. Office of Pollution Prevention and Toxics. EPA's office wherein the HPV Challenge Program is administered. An unsponsored chemical from the 1990 HPV Challenge Program Chemical List that may be manufactured or imported in quantities equal to or greater than one million pounds in the last two IUR reporting periods. Physicians Committee for Responsible Medicine. People for the Ethical Treatment of Animals. An abridged reporting of data that includes the study objective, method, results, and conclusions for one endpoint. Structure-Activity Relationship: An analysis in which a substance's environmental fate or effects relate to the substance's molecular structure. For the HPV Challenge Program, SAR is often used in category analyses where endpoint data for one chemical can be used to cover endpoint data for another similar chemical. SIDS Initial Assessment Meeting: A gathering of OECD member states to agree on initial hazard assessment for HPV SIDS chemicals. SIDS Initial Assessment Report: OECD member states' evaluations, conclusions, and recommendations for SIDS chemicals that are reviewed and accepted by the OECD at the SIDS Initial Assessment Meeting. Screening Information Data Set: An internationally agreed upon set of screening data developed by the OECD, the SIDS consists of a chemical's (1) general information, (2) physical-chemical data, (3) environmental fate and pathways data, (4) ecotoxicity data, and (5) toxicological data. Synthetic Organic Chemical Manufacturers Association: The primary trade association serving the specialty-batch and custom chemical industry. The year in which a sponsor commits to submit a chemical's test plan and robust summary. A summary of available and adequate data, with reference to a summary of data gaps and a rationale for testing, if necessary. A TSCA Section 4 regulatory mechanism that requires testing of chemical substances and mixtures for which the necessary findings have been made. Toxic Substances Control Act: An Act created by Congress that gives EPA the ability to assess and regulate industrial chemicals in the United States. United Nations Environment Programme: An organization that provides leadership and encourages partnership in caring for the environment. It informs and enables nations to improve their quality of life in global and regional contexts. A chemical for which a commitment was made after December 26, 2000, and therefore involves the submission of full studies in addition to robust summaries of studies. 101 EPA's High Production Volume Challenge Program ------- Please make all neces: detach or copy, and re to the address in the upper United States Environmental Protection Agency If you do not wish to receive these reports CHECK I- detach, or copy this cover, and return to the addres; PRESORTED STANDARD POSTAGE & FEES PAID EPA PERMIT No. G-35 Office of Pollution Prevention and Toxics (0000 R) Washington, DC 20460 Official Business Penalty for Private Use $300 EPA743-R-04-001 November 2004 www.epa.gov for more information visif rtecycieu/ rtecycm Printed with vegetakjic-kjdo< paper that contains a minin 50% post-consumer fiber conten processed chlorine free ------- |