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June 17, 1999

Mr. Chairman and distinguished members of the Subcommittee, my name is Dr. William Sanders and I have been Director of the Office of Pollution Prevention and Toxics at the U.S. Environmental Protection Agency since 1995. As such, I am the primary senior career official directing EPA's implementation of the Toxic Substances Control Act, the Pollution Prevention Act, and sections of the Emergency Planning and Community Right-to-Know Act. I am the Agency official directly responsible for implementing the High Production Volume, or HPV, Chemical Challenge, the subject of today's hearing. Prior to my current position, I served as Director of the Environmental Sciences Division in EPA Region 5 in Chicago for 16 years, and overall, have worked in the Agency for more than 26 years.

I want to thank you for the chance to speak about EPA's HPV Challenge Program and share with you the need for this program as well as the exciting opportunity and benefits it presents for the Agency, industry and the American public. This program, which many believe is a model effort, is the unprecedented result of cooperation between government, industry and the environmental community. It is an example of the positive steps forward in environmental protection that are possible when government looks to achieve results cooperatively with industry and the environmental community.

Our efforts in this program are guided by the principle that the public has a right-to-know about chemical hazards. The HPV Challenge Program advances the purposes of the Toxic Substances Control Act (TSCA), which states at Section 2(b)(1), 15 U.S.C. 2601(b)(1): "It is the policy of the United States that adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that development of such data should be the responsibility of those who manufacture and those who process such chemical substances and mixtures."

Based on reporting under EPA's Inventory Update Rule (IUR) in 1990, EPA identified roughly 2800 high production volume (HPV) chemicals. HPV chemicals are chemicals produced or imported at or above 1 million pounds per year. I would like to include this list in my testimony. When EPA looked at basic screening level hazard data on high production volume chemicals we found that only 7% of those chemicals had publicly available data on all of the internationally recognized toxicity screening endpoints. Forty-three percent of the 2800 chemicals produced in the greatest quantity in this country had absolutely no publicly available test data for these endpoints. For the remaining chemicals, limited amounts of the data were available. Separately, the Chemical Manufacturers Association and the Environmental Defense Fund reached similar conclusions. I would also like to include in my testimony, a copy of EPA's Data Availability Study for the record, which presents the results of EPA's analysis of data availability on HPV chemicals.

This lack of available hazard data reduces EPA's ability to determine whether these HPV chemicals pose potential risks to human health or the environment, as well as the public's right-to-know about the hazards of chemicals that are found in their environment, their homes, their workplaces and the products that they buy. These chemicals are present in products - cleaning supplies, paints, lubricants -- that are used daily across the country. Some of these chemicals have been manufactured for decades. EPA believes, quite simply, that more data are needed on HPV chemicals. It is EPA's intent to close this knowledge gap. In most cases, EPA cannot reasonably assess the effects on health or the environment from the manufacture, distribution, processing, use or disposal of these chemicals because of insufficient data. EPA has concluded that a program to collect, and where necessary generate, basic screening level data is necessary and appropriate to provide adequate information in order to evaluate the potential hazards and risks that may be posed by exposure to HPV chemicals.

The availability of hazard information on individual chemicals is fundamental to EPA's ability, based on sound science, to accomplish its mission of environmental protection -- risk assessment, risk management, safeguarding children's health, expanding the public's right-to-know, and promoting the pollution prevention ethic. Activities to ensure the availability of basic hazard information on HPV chemicals are an integral part of meeting these objectives. The information obtained under the HPV Challenge Program and the HPV Test Rule is essentially identical in scope and applicability to that which has been internationally agreed upon by the OECD as providing the minimum needed to screen HPV chemicals and identify priorities for additional testing or assessment. EPA will use the information obtained under the HPV Challenge Program and the HPV Test Rule to support development of preliminary risk assessments for these HPV chemicals. Furthermore, the data obtained via these activities will be used to set priorities for further testing that will produce hazard information needed by EPA, other Federal agencies, the public, industry and others to support adequate risk assessments on industrial/commercial chemicals. For example, EPA has used data obtained via TSCA Test Rules to support such activities as the development of water quality criteria, Toxic Release Inventory listings, chemical advisories, and workplace exposure standards.

Data obtained under the HPV Challenge Program will also have a bearing on the Agency's "Children's Health Testing Voluntary Program" (CHP). Any chemicals likely to be pursued for children's health concerns will also most likely be HPV chemicals, although the number of chemicals which may be candidates under the Children's Health Program is substantially smaller than the chemicals addressed under the HPV Challenge Program. EPA is seeking input into the list of chemicals being developed that may pose health concerns for children and the battery of tests needed to assess these chemicals will be part of a Scientific Peer Review this summer under CHP. Following the peer review process and an opportunity for industry to voluntarily participate in this program, EPA intends to move forward with a test rule to address chemicals not captured in the voluntary effort. EPA will issue a Federal Register Notice in the next few weeks outlining the dialogue process and announcing the first stakeholders meeting that will be in mid-July.

It is important to emphasize that the two programs will not involve duplicative testing of chemicals. The screening level data which would be obtained under the HPV Challenge Program would not be duplicated for chemicals which are candidates under the Children's Health Program. Similarly, if data are received under the HPV Challenge Program on a chemical which is also a candidate under the Children's Health Program, that data could be used to help identify and prioritize testing which is needed on that chemical.

EPA believes that substantial data on HPV chemicals may already exist in corporate files across America. This is due in part to the fact that many studies with negative results do not end up being published. Therefore, EPA's goal was to determine a way to collect and make that information available to the public, so that citizens as well as corporate and government decision makers could make more informed, scientifically sound decisions and judgments about the hazards and risks resulting from the most heavily produced chemicals in our country.

Consequently, on Oct. 9, 1998, EPA joined with the Chemical Manufacturers Association (CMA), the American Petroleum Institute (API), and the Environmental Defense Fund (EDF) to announce a six-year effort to obtain basic toxicity information on high production volume chemicals. Chemical producers and importers were invited to voluntarily provide basic toxicity information on their high production volume chemicals. We contacted over 900 companies and asked them to provide or develop the needed test data by 2004. The information generated through the voluntary Challenge Program will then be made available to the public through, among other sources, an EPA website.

The industry response to the HPV Challenge has been extremely positive. With the strong support of the Chemical Manufacturers Association, the American Petroleum Institute, and other trade associations, individual companies and companies joining in consortia have been stepping forward to make commitments since October, and we expect additional companies to join in the near future. To date, more than 220 companies including over 55 chemical company consortia have committed to sponsor over 1150 HPV chemicals. This clearly demonstrates the strong commitment of the American chemical industry to the public's right-to-know about chemical hazards.

Chemical companies who participate in the voluntary program are making commitments by identifying the chemicals they will sponsor. Companies are also forming consortia to jointly provide data on chemicals and thereby further reduce the costs of testing. Following the guidance established by EPA, participating companies will assemble existing data and assess their adequacy. Companies will then design and submit test plans which identify all existing data, provide summaries of these test results, and identify data needs for which testing is being proposed. Both test plans and test result summaries will be provided through electronic data submission. In order to provide an adequate period for public review of test plans, we intend to request that companies delay the initiation of any testing for a period of at least 90 days after the plan is made public.

The key first step in the HPV Challenge Program, prior to conducting additional studies, involves obtaining existing information about HPV chemicals. Companies have been asked to provide and assess available data as well as to consider alternative approaches to reduce the amount of needed testing. EPA expects the companies to identify these data before any testing is done. Companies also have the opportunity to develop and submit plans for testing chemical categories, involving tests on selected chemicals whose results apply to the entire category. This approach would eliminate the need to test each chemical for every endpoint of concern. Companies are also encouraged to develop Structure Activity Relationship (SAR) approaches. SAR is the analysis of the relationship between chemical structure and chemical or biological activities. The Agency has developed, and is continuing to develop, guidance for these approaches. We believe that these measures will result in a significant amount of basic data being made available to the public while also reducing the number of HPV chemicals for which new testing may be needed.

Where gaps in existing data are identified, the voluntary program uses the same tests, testing protocols, and basic information summary formats employed by the Organization for Economic Cooperation and Development's (OECD's) Screening Information Data Set, or SIDS, program, which is a cooperative, international effort to secure basic hazard information on HPV chemicals worldwide and has been in place since 1990. SIDS represents an internationally agreed upon set of test data needed to screen HPV chemicals and identify potential hazards. These include studies for physical chemical properties (e.g., water solubility), environmental fate (e.g., biodegradation), environmental toxicity to fish and other aquatic species, and mammalian toxicity (acute toxicity, genetic toxicity, repeat dose toxicity, and reproductive and developmental toxicity). The United States is a member of OECD and is a recognized leader in its SIDS program. The information we are collecting in the HPV Challenge is consistent with data being collected internationally on high production volume chemicals. It is important to note that other countries are aggressively pursuing testing efforts that will complement and enhance U.S. efforts. Further, the international business community has risen to the challenge to make existing screening level hazard data publicly available, and conduct new testing when data needs exist. The International Council of Chemical Associations (ICCA), which represents chemical trade associations in industrialized countries, recently announced its own HPV Initiative, integrating its efforts with the OECD SIDS program and with the American chemical industry to ensure that the U.S. and other developed countries "share the burden" of testing and assessing international HPV chemicals -- a development which has important trade and competitiveness benefits for the U.S.

The ICCA HPV Initiative calls for the testing and assessment of 1000 "high priority" chemicals by the year 2004, which coincides with the schedule for completion of the assessment of chemicals under the U.S. HPV Challenge Program. At the current rate at which HPV chemicals were being assessed under the OECD SIDS program, it would take the OECD 30 to 40 years to complete assessment of all HPV chemicals. Under the HPV Challenge Program, in combination with related international efforts, we are accomplishing the truly extraordinary feat of obtaining a greater amount of basic information on the toxicity of chemicals in a shorter period of time than anyone previously thought possible.

In addition to the HPV Challenge, we intend to use a regulatory backstop. As the concepts for applying a voluntary approach to obtaining basic screening data were developed, it became evident to government, industry and NGO stakeholders that accomplishing the goal of obtaining SIDS data on all 2800 HPV chemicals would require some regulatory impetus. Section 4 of the Toxic Substances Control Act (TSCA) gives EPA the clear authority to require testing if, among other criteria, "the Administrator finds that-- . . . a chemical substance or mixture is or will be produced in substantial quantities" and "there are insufficient data upon which the effects . . . on health or the environment can be reasonably determined or predicted . .."

EPA has frequently used the authority in Section 4 of TSCA to require testing or to encourage companies to enter into agreements to test. EPA has announced its intentions to issue test rules on OECD SIDS HPV chemicals in its Regulatory Agenda for the past three years. Test rule development will occur concurrently with the voluntary program. Chemicals which are sponsored under the HPV Challenge Program would not be addressed in a test rule. Chemicals which are handled under the OECD SIDS Program are considered to be "sponsored" by parties in OECD countries and need not be addressed under the voluntary or regulatory components of the U.S. HPV Challenge Program. EPA has indicated that similar treatment will be accorded to chemicals which are sponsored under the ICCA Initiative.

The Agency will publish a proposed HPV Test Rule under TSCA Section 4 later this summer. The final HPV Test Rule is expected to be issued in late 1999. EPA intends to issue additional test rules as needed to cover unsponsored chemicals or to make sure the HPV Challenge Program commitments are met.

To ensure that the interests of small businesses are accommodated by the HPV Challenge, we have been working closely with the Synthetic Organic Chemical Manufacturers Association (SOCMA) and other specialty chemical trade associations to encourage their support and assistance in getting their members to participate in the program and to understand and respond to their unique concerns. In response to a number of the specific concerns raised about the impact of this program on small businesses and specialty chemicals manufacturers, we posted explanatory guidance documents and Frequently Asked Questions (FAQs) on EPA's Chemical Right-to-Know website (www.epa.gov/chemrtk). We are fully committed to working cooperatively with the chemical companies and their trade representatives to address their concerns and to ensure that small companies can better participate.

The Agency appreciates the concerns that this Program has engendered on the part of small businesses. However, we believe that the design of the impact of the Program on small businesses will be limited. For a number of reasons, most small manufacturers are not the focus of the voluntary program. Moreover, we do not expect a substantial impact on small businesses with a test rule. EPA expects that many of the HPV chemicals will be voluntarily sponsored under the HPV Challenge Program, the ICCA Initiative, or the OECD SIDS program. A test rule will only cover chemicals which are not voluntarily sponsored under these efforts. Although all manufacturers, importers, and processors of chemical substances included in a test rule are subject to the rule requirements, regardless of size, TSCA regulations allow testing to be performed by only some of the regulated companies, and provide the opportunity to seek reimbursement of testing costs from others. Typically, larger manufacturers have not sought reimbursement from smaller manufacturers, importers, or processors, dividing the burden instead among those companies that produce or import the bulk of the chemical. Thus, small businesses are, and have been, generally insulated from substantial impacts even under test rules.

The HPV Challenge program reflects an evolution of EPA's efforts to regulate existing chemicals under the authority of TSCA. This is a means to accomplish, in a expeditious but voluntary manner, TSCA's mandate to obtain test data on chemicals. This effort reflects the commitment of EPA to ensure that the public gets the information it needs to make informed choices about hazards and risks, while also using cooperative voluntary efforts to meet those goals. With the strong support of industry and the environmental community, we will accomplish our goal of making basic testing data on the most common chemicals used in the U.S. available to the public.

I'd like to clarify the misunderstanding of why the Agency plans to test substances that are commonly known to have toxic or other effects, such as rat poison, turpentine, and caffeine. A very small percentage of the 2800 chemicals on the HPV list fall into this category. For example, we may know that a chemical such as phosgene is acutely toxic. But we may not know what its environmental fate is - that is, what happens to a substance when it enters the environment (e.g., whether it may degrade to a more or less toxic constituent), or whether that substance may pose chronic hazards at subacute exposure levels. Let me reiterate that where acute toxicity or other screening data are already publicly available, EPA will not require duplicative testing under the HPV Challenge or a test rule.

We also clearly recognize that while it is vitally important to achieve the public health and environmental protection goals of this program, it is also important to do so in a manner that involves minimizing where practical the use of animals for testing purposes. Contrary to much of the erroneous information that is being reported on this program, EPA is committed to examining alternative test methods that reduce the number of animals for testing, that reduce pain and suffering of test animals, and that replace animals in testing with in vitro (non-animal) test systems. I want to stress that EPA's attention to animal welfare issues predates the creation in 1998 of the HPV Challenge Program. EPA has been committed to reducing animal testing and refining test methods for the past decade. We have demonstrated this commitment through actions both domestically and internationally. A primary example is EPA's support of the use of the combined protocol (OECD 422). This particular test guideline, which provides information on repeat dose, developmental, and reproductive toxicity, was initially developed by the U.S. in the late 1980's and early 1990's for use in the OECD SIDS program. Use of this guideline results in a significant reduction in the number of animals used as compared to the three separate protocols otherwise used for the same purpose. The U.S. has been and remains one of its strongest supporters within the OECD and strongly recommends its use. Historically, EPA has relied on the combined protocol for U.S. chemicals needing this type of testing under the OECD SIDS effort.

The savings in animals which are achieved by use of the combined protocol are significant. If separate repeat dose toxicity, reproductive toxicity, and developmental toxicity studies were to be conducted, a total of 360 animals would be used for each chemical tested. By contrast, the combined protocol calls for the use of 80 animals. EPA's reliance on the use of the combined protocol therefore results in savings of 280 animals for each chemical studied under the OECD SIDS program using this procedure, which is a reduction in animal usage of up to 80 percent.

Since animal welfare concerns in the specific context of the HPV Challenge Program were brought to my attention late last year, we have made very substantial progress in addressing those concerns. We are recommending under the HPV Challenge the use of specific protocols that significantly reduce animal usage and that allow the use of non-animal testing methods in some cases. EPA recommends use of the "Up-and-Down Procedure" (OECD 425), a method which can evaluate acute toxicity using about 8 animals per test, as an alternative to the LD50 test, which requires 20 animals. I am very pleased to announce that just last week, I headed a delegation to the Joint Meeting of the OECD which accepted a proposal which may lead to the deletion of the LD50 protocol from the OECD SIDS program, possibly as early as the end of the year 2000. In the area of genetic toxicity, EPA has decided to drop its preference for the in vivo micronucleus test and to accept either in vivo or in vitro (non-animal) studies, as is allowed under the OECD SIDS program. Companies which elect to use the in vitro protocol would not use any animals, as compared to about 50 animals needed under the in vivo protocol. As I previously stated, EPA recommends use of the combined repeat dose, reproductive, and developmental toxicity protocol, which can evaluate multiple toxicological endpoints in a single screening study, and results in saving as many as 280 animals per chemical tested. EPA will encourage sponsors of HPV chemicals to follow the OECD guidance on humane endpoints, which is currently under development, to reduce pain and distress in test animals. EPA also believes that the first years of the HPV Challenge may provide an opportunity for non-animal studies to be validated by performing them in parallel with traditional testing. Use of all of our recommendations can result in a 68 to 80% reduction in the use of animals over the "standard" guidelines used in the OECD SIDS program.

EPA has for many years been a proponent of improvements in testing procedures which reduce and refine animal usage. EPA has been a world leader in the development and acceptance of in vitro methods for genetic toxicity testing. EPA worked closely with the OECD in the early 1990s to develop alternatives to the traditional LD50 test, a leadership role which the Agency continues to play, and in the development of combined protocols, all of which are now part of the SIDS program. EPA co-chairs the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) with the National Institute for Environmental Health Sciences. ICCVAM was formed to foster the validation and acceptance of test methods of multi-agency interest, and works with the National Toxicology Program to evaluate new alternative testing methods. EPA has been instrumental in the review of alternative test methods which have been approved to date by ICCVAM. EPA's involvement with the OECD contributes to the development of harmonized test methods which yield test data that are accepted by Member countries and reduce the need for repeat testing under different national regulatory programs.

Scientific validation is an essential step in determining the adequacy of any alternative test method, such as many of those proposed by animal welfare groups. Validation consists of ensuring that a new method is (1) relevant to the identified need, (2) adequate to meet that need, and (3) reproducible. Before EPA or any other regulatory agency can accept new alternative test procedures for regulatory purposes, the methods must be scientifically validated and peer reviewed by various parties such as ICCVAM, the European Centre for the Validation of Alternative Methods (ECVAM), and the OECD. Following the recommendations of such organizations, federal agencies can then decide whether to adopt alternative test methods for their regulatory purposes.

We are continuing to work closely with all interested parties both here and abroad to address regulatory acceptance of alternative test methods, and to ensure that the generation of data through the HPV Challenge Program will not result in unnecessary testing of animals. In fact, EPA has recently made well-received presentations on strategies to reduce animal testing, including at the TestSmart conferences sponsored by the Center for Alternatives to Animal Testing at Johns Hopkins University in January and April of this year, at a recent meeting organized by the Chemical Industry Institute of Toxicology, and at the OECD. I also expect that we will continue to make significant advances in the coming years in the validation and adoption of alternative test methods.

But the scientific community still has a considerable way to go before animal tests can be entirely replaced. There are currently no scientifically validated and peer reviewed means to address the SIDS human health and environmental toxicity needs without the use of laboratory rats, mice, fish, and aquatic invertebrates that are presently used. It is simply a fact that sound science continues to require the use of animals in tests in many circumstances, particularly for assessing general toxicity (both from acute (single) and repeated exposures), and for complex processes such as fetal development and reproduction. In vitro tests raise valid scientific issues because, by definition, they employ an organism or cell line that may not respond in the same way as humans would to a given chemical.

It is important to remember that the goal of such studies is to predict the toxic response of chemicals in humans by using other species as models/surrogates for humans. Humans have complex organ systems, mechanisms for distribution of chemicals in the body, and metabolic processes for sequestering, metabolizing, and eliminating toxicants. Whole animal testing accounts for the complexity found in human terms of metabolism and target organ specificity. Therefore, other mammalian species such as rats and mice are selected to mimic the complexity of the human body response when presented with a test substance.

The necessity for the use of animals in tests can be posed in stark terms. We as a country need to increase our knowledge about the health and environmental effects of the most widely produced chemicals in our country - knowledge that could ultimately save human lives, prevent illness and reduce losses of wildlife. It is currently necessary to use lab-bred animals in some of the testing. Information on the basic toxicity of chemicals is important to protect public health, for today and for generations to come. We firmly believe that the American public has a right-to-know about the hazards from these chemicals.

Let me conclude by saying that the EPA remains very open to dialogue with any interested parties about the implementation of the HPV Challenge. We are continuing to meet with stakeholders, including the animal welfare community, and are continuing to refine our guidance and approach to what are highly complex technical issues. I would be happy to elaborate on any of my remarks and to answer any questions you may have. Thank you.


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