EPA’s World Wide Web site: http://www.epa.gov/triage

Over 500 copies of the data base have been distributed on diskette, and it is accessed by approximately 30 users per month on the Internet. The revised version of the Triage information product will include all CAP submissions, in addition to other recent 8(e) submissions. It is expected to be available to the public by early 1997.

Evolution of the TSCA Interagency Testing Committee
John D. Walker, Office of Pollution Prevention and Toxics

Introduction

The Interagency Testing Committee (ITC) was created by the U.S. Congress under Section 4(e) of TSCA as an independent advisory committee to the EPA Administrator. Its purpose was to recommend chemicals to which EPA should give priority consideration when requiring chemical testing under TSCA Section 4(a).

There are 16 U.S. Government organizations represented on the ITC, including the EPA, Consumer Product Safety Commission, Interior Department, Food and Drug Administration, National Cancer Institute, National Institute of Environmental Health Sciences, National Institute for Occupational Safety and Health, and the Occupational Safety and Health Administration.

The ITC is responsible for establishing the TSCA Section 4(e) Priority Testing List, revising the List at least every six months, identifying and coordinating the Federal Government's data needs for chemicals on the List, and recommending these chemicals to the EPA Administrator for further action. The ITC meets monthly as a full Committee to satisfy its responsibilities under TSCA. Subcommittees of the ITC form partnerships with the producers, processors and users of rec ommended chemicals to discuss Federal data needs. The Committee also reviews and summarizes unpublished data for recommended chemicals and transmits semiannual Federal Register reports to the EPA Administrator.

Since its creation, the ITC has:

• convened 270 meetings;
• issued testing decisions on 40,000 chemicals;
• recommended 3,500 chemicals for testing;
• established dialogue groups with 30 trade associations;
• reviewed 30,000 unpublished studies;
• prepared 1,500 chemical dossiers; and
• transmitted 39 semiannual reports to the EPA Administrator.

The history of the ITC was recently published in a peer-reviewed book (Walker, 1993, 451-509).

1970-1976

The ITC was created after several years of intense debate in Congress over proposed toxic substances control legislation. In 1970, the President's Council on Environmental Quality expressed concern about chemicals that were not regulated under the Federal Insecticide Fungicide and Rodenticide Act and the Federal Food Drug and Cosmetic Act and the need for a committee to coordinate interagency concerns on chemical testing.

In 1971, the Nixon Administration proposed toxic substances legislation. It was passed by the U.S. House of Representatives and the U.S. Senate, but compromise could not be reached. Two years later, in 1973, the Chemical Manufacturers Association (CMA) lobbied Congress for a study to address the need for toxic substances legislation. In 1975, two bills that addressed chemical testing were proposed. One proposed that all existing chemicals be tested within five years of TSCA enactment; the other proposed creation of an independent advisory committee to the EPA Administrator to recommend a prioritized list of chemicals for testing. On October 11, 1976, TSCA was enacted with an effective date of January 1, 1977, and the ITC was created.

1977-1980

When the ITC was established, the TSCA Inventory from which chemicals could be selected for recommendation to the EPA Administrator had not yet been created. To implement ITC’s statutory agenda, member organizations provided lists of chemicals for which there were concerns about the adequacy of test data. The ITC organized a Chemical Scoring Workshop to prioritize these chemicals for consideration. From the ITC's first meeting in February 1977 to its 117th meeting in October 1980, all the chemicals that were deferred or recommended in ITC Reports 1 through 7 were from the first Chemical Scoring Workshop.

1981-1988

Chemicals chosen for consideration from 1981 to

1988 were selected from Chemical Scoring Workshops; chemicals were deferred for testing or recommended in ITC Reports 8 through 24.

1989-1996

Chemicals selected for consideration from 1989 to 1996 were nominated by ITC members because their organizations had clearly defined data needs for these chemicals. In addition, the ITC organized subcommittees to review, prioritize, and coordinate these data needs; developed a computerized system for identifying potentially hazardous chemicals in chemical groups; and established partnerships with the CMA and other trade associations to discuss the needed data and develop databases of unpublished studies.

References

Walker, J.D. The TSCA Interagency Testing Committee, 1977 to 1992: Creation, Structure, Functions and Contributions. In Environmental Toxicology and Risk Assessment: Second Volume (ASTM STP 1216). eds. Joseph W. Gorsuch, F. James Dwyer, Christopher G. Ingersoll, and Thomas, W. La Point, 451-509. Philadelphia: American Society for Testing and Materials, 1993.

The New Chemicals Program: A Legacy of Progress
Paul Bickart, Economics, Exposure and Technology Division

In July of 1979, the first premanufacture notices (PMNs) began arriving at EPA. These notices are required under TSCA for new chemicals that manufacturers want to produce for the first time. We expected, at most, a few hundred notices a year. A study prepared for the Agency projected that, if testing and paperwork costs were kept low, the American economy might be able to turn out 400 new chemicals a year. That was considered optimistic. Thus, after receiving 30,000 notices, we are at a fine vantage point for looking back on the past twenty years.

The initial, few PMNs gave only a few hints of changes brewing in the chemical industry. Even so, in the first year there were suggestions of a trend toward manufacturing chemicals that were better from an environmental point of view.

Examples included the synthesis of a pesticide with negligible toxicity toward mammals and birds, a resin to increase the tread life of tires, and a new lubricant derived from a renewable source.

As the flow of notices increased, we started to see other trends emerge. When crude oil prices were high, we saw a surge of energy-efficient coating materials. When the fear of an oil crisis abated, use of some energy-efficient coatings fell off in favor of less costly solutions. At the same time, use of other coatings continued to grow. Why? The other coatings met strict new air quality standards to lower the emission of volatile organic compounds.

Nearly half of all notices were filed for polymers, a class of chemical distinuished by their high molecular weight and repetitive chemical structure. After years of experience, we recognized that about half of all polymers presented no real risk to health or the environment, either because of their composition or their properties. We devised chemical criteria to classify these relatively safe polymers, first for expedited internal review, and in 1984, for exemption from some of the rigors of PMN reporting. In 1995, the polymer exemption was expanded to eliminate PMN reporting altogether for certain polymers. (Notwithstanding these steps, we still get many notices for polymers.)

The PMN process reflected the growth of the microelectronic revolution. Some new chemicals have been created for the semiconductor itself, while others are for photolithographic manufacture of the microchips, like photoresists, contrast enhancers, and sensitizing dyes. Still others are for peripheral devices, such as liquid crystals for display devices, dyes for inkjet printers, colorants for sublimation-transfer printers, and charge-control agents for toners for laser printers, to name a few.

In the last couple of years, we have seen an emerging trend towards inherently safer chemicals, design of safer and less waste-producing chemical processing, and greater recycling of wastes and byproducts. We are working to stimulate and encourage these trends through pollution prevention programs, such as the Green Chemistry Challenge and the Environmental Technologies Initiative.

Some trends that we anticipated have not yet happened. We thought the biotechnology industry would have produced more PMNs by now. We looked forward to seeing chemicals for high-temperature superconductors, but we have seen only one so far. We had hoped to see more materials from renewable resources, but as long as oil stays cheap that will probably remain in the future.

What can we hope to see in future PMNs? As a chemist and a long-time science fiction buff, I am looking forward to self-assembling molecular arrays, and eventually, a whole new chemical industry based on nanotechnology - but I am not holding my breath.

The New Chemicals Program: A Legacy of Prevention and Risk Reduction
David Di Fiore, Chemical Control Division

As we recognize the 20th anniversary of TSCA, the New Chemicals Program is nearing a major milestone of its own--the review of 30,000 newchemical notifications. Since the implementation of TSCA, the New Chemicals Program has acted as gatekeeper for new chemicals seeking to enter the commercial marketplace in the U.S. Only those chemicals that can be manufactured, processed, used and disposed of in a safe manner are allowed unrestricted market entry. Substances that present unacceptable risks to human health or the environment may be restricted entirely from commerce.

While the vast majority of chemicals proposed for manufacture do not pose a concern for human health or environmental effects, a significant minority do--about 10% of all submissions or roughly 200 chemicals per year. In these cases, OPPT raises a cautionary flag by taking some form of regulatory action. For example, the program might require testing prior to any manufacture, to refine the toxicity and risk profile of a chemical. Testing might be followed up with certain control measures, for example, a restriction of releases to water. Or, manufacture might be allowed without prior testing only under specified conditions, such as restricting discharges to a stream or landfill or providing workers with protective equipment.

Requiring chemical manufacturers and processors to implement protective measures limits exposures to potentially toxic substances and thereby lessens the risk of harm to people and their environment. The potential beneficiaries of these actions are many. They may include, for example, the worker who weighs or mixes substances at a chemical plant, the environment and aquatic life surrounding a facility, and the individuals living in a plant's vicinity who might drink water from nearby rivers or wells or eat fish from local streams.

Many times the harm that is avoided involves chronic effects, like cancer or lung disease, which may result from repeat exposures to a toxic substance over a period of time. In some situations, however, the potential effect is immediate and life-threatening. For example, EPA staff have alerted chemical manufacturers to the potential for its new substance to cause instant death from contact with the eye. Following this notification and program instructions, companies have tested these chemicals to determine whether they have a lethal effect, and if so, at what concentrations. If the test results show lethality, a company may decide not to manufacture the chemical. If they plan to manufacture anyway, they must use appropriate warnings and protective equipment when producing and distributing the substance.

In the course of reviewing premanufacture notices on tens of thousands of new chemicals, we have seen patterns of toxicity within certain chemical classes. Through publication of a list of these chemical classes, communications with new chemical manufacturers, and regulatory actions, the Program has put the chemical industry on notice about its concerns for these substances. In response, chemical manufacturers and their customers have had to change the way they produce, handle and dispose of certain substances. In some cases this has meant halting manufacture entirely, instead concentrating their efforts on new chemicals that do not present a concern to human heath or the environment.

By intervening to prevent harm before it occurs, the New Chemicals Program is changing behavior patterns in industry, causing companies to: rethink which chemicals they make and how they're manufactured, distributed and used; take steps to prevent exposures to and releases of potentially harmful substances; and, develop safer substitutes for existing chemistries. As a result, the program contributes significantly to improved human health and to safer work places, households and communities.

The OPPT Structure Activity Team
Becky Jones, Health and Environmental Review Division

The OPPT Structure Activity Team (SAT) is a team of expert scientists, including chemists, biologists, toxicologists, and information specialists. The function of the SAT is to evaluate the potential health and environmental hazards and environmental fate of chemicals through the use of chemical structure - biological activity relationships. (Chemical structure - biological relationships, or SAR, refers to the link between a chemical’s structure and its effects on people and environmental organisms.) A hazard assessment developed by the SAT relies on available test data (although frequently little or nothing is known about the chemical) and expert judgment to provide a preliminary assessment of chemical hazards and environmental fate.

The health hazard assessment includes a description of the potential for a chemical to be absorbed through the skin, lungs, and intestinal tract. It also identifies how the chemical may be changed in the body and the potential for the chemical to cause acute toxicity, neurotoxicity (effects on the brain and other nerves), effects on internal organs such as the liver or kidneys, birth defects, infertility, effects on DNA, and cancer, if exposure to the chemical occurs.

The environmental fate profile predicts how quickly the chemical will degrade if released into the environment. Additionally, the potential transport of the chemical through the environment is predicted. The environmental hazard profile judges how toxic the chemical will be to plants and environmental organisms living in water (such as fish) or on land (such as birds).

Important factors in developing hazard assessments are information on the subject chemical, information for structurally similar chemicals, known toxicity of chemical classes or parts of a chemical, and the knowledge and judgment of SAT members.

The SAT was originally formed in 1979 to evaluate new chemicals (that is, chemicals not currently made or used in the U.S.) submitted to OPPT under Section 5 of TSCA. Since that time, the SAT has evaluated over 30,000 chemicals. Today, the SAT reviews over 2,500 new chemicals each year. The SAT is also called upon to screen chemicals which are already being made or used in the U.S. Over 3,500 existing chemicals have been evaluated for OPPT and other EPA offices, including regional offices and other gove rnment agencies. During the past year, the SAT evaluated approximately 60 chemicals in support of EPA’s Office of Solid Waste for two of their hazardous waste listings. The SAT also evaluated over 50 chemicals for the Office of Air and Radiation as an early step in identifying replacements for chlorinated solvents and chlorofluorocarbons (CFCs) that are being phased out because of their effects on the ozone layer. Presently, the SAT is in the process of evaluating approximately 1,500 inactive ingredie nt chemicals added to pesticide products.

The SAT interacted with the U.S. chemical industry to share the SAR principles routinely used in evaluating chemicals. Ideally, this type of cooperation will result in the design and use of less toxic chemicals.

The SAT recently participated in a joint study with the European Union (EU) to determine how well the SAR methods employed by the SAT work. The SAT evaluated the chemicals in the usual way and then compared the assessments to the results of studies that were submitted to the EU. This exercise found that the SAT was highly successful both in predicting the environmental fate and environmental hazard and identifying potential human health effects of the chemicals. Since that time, the methods employed b y the SAT have been studied by the Canadian, Japanese, and Australian governments, as well as the members of the European Union, for possible use in programs to screen chemicals that are of concern in their respective countries.

Joseph Seifter, M.D., one of the original members of OPPT’s celebrated Structure Activity Team, was a remarkable individual and scientist who was central to the early technical development and establishment of the SAT. Dr. Seifter’s work with the SAT capped an eminent career spanning more than 50 years which produced major contributions in basic medical research and outstanding service as a teacher, experimentalist (over 200 scientific publications), administrator, and scientific advisor. Dr.Seifter’s profound understanding of the chemical basis of pharmacology and toxicology was seminal in establishing and guiding the SAT through its early years. His death in 1982 brought a remarkable career to a close. Though we miss him still, the analytic approach, insights, and technical excellence which he exemplified and freely extended to others as both a colleague and mentor continue to resonate in the SAT and in the careers of the many individuals whose lives he touched and enriched. -- Charles M. Auer, Director, Chemical Control Division/OPPT and former Chairman of the SAT.

For more information about the SAT and the risk assessment process for chemicals see the Winter 1995/1996 issue of Chemicals in the Environment.

OPPT’s Chemical Testing Program
Dave Williams, Chemical Control Division

Under the Toxic Substances Control Act (TSCA) of 1976, EPA is given broad authority to gather health/safety and exposure information on, and require testing of, chemical substances and mixtures. TSCA states that "it is the policy of the United States that adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data be the responsibility of those who manufacture [and import] and those who process such chemicals and mixtures." This article provides a brief history of the TSCA Chemical Testing Program in EPA's Office of Pollution Prevention and Toxics (OPPT).

Before requiring companies to test chemicals, EPA reviews numerous publicly available data sources as well as the data we collect through our reporting rules. Based on this information, we must decide that:

1. Existing data show that the chemical "may present an unreasonable risk of injury to health or the environment" and that there is probably exposure; and/or
2. The chemical is produced or imported in substantial quantities, and either enters the environment in substantial quantities or results in significant human exposure ; and
3. Existing data cannot reasonably predict human health or environmental effects; and
4. Testing is necessary to develop adequate data to conduct a risk assessment.

In the early years of TSCA, EPA used a complicated two-phase rulemaking process to require chemical testing under Section 4 of TSCA. In the first phase, following issuance of a proposed rule for public comment, EPA issued a final rule identifying the chemicals and the type(s) of testing required. This final rule required industry to submit test protocols and study plans for EPA review. EPA accepted the protocols (including public comments on them) through a second rulemaking. This approach gave the chemical industry a maximum amount of flexibility in developing testing protocols, but it proved very cumbersome. In fact, EPA was sued by the Natural Resources Defense Council (NRDC) in 1980 because the Agency was not meeting its statutory deadlines for Test Rules on chemical designatedfor testing by the TSCA Interagency Testing Committee (ITC). ( See Walker article this issue.) The Agency launched an effort to obtain testing via "Negotiated Testing Agreements" (NTAs) with the chemical industry. This effort was successful in many ways and resulted in important dialogue between EPA and the chemical industry. However, the NTA process lacked public input and enforceability under TSCA, which resulted in another NRDC lawsuit in 1983. The court found the NTA process illegal.

In collaboration with NRDC and the Chemical Manufacturers Association (CMA), EPA developed

a formal "Enforceable Consent Agreement/Order" (ECA) process in the mid-1980's that encourages public participation. EPA also streamlined the process by developing formal Test Guidelines, which allows EPA to simply cite the appropriate testing methodology in Test Rules. In the mid-1980's, therefore, EPA felt that it was well on its way to affecting a strong Chemical Testing Program.

The Program had continuing legal challenges, however. During the mid-1980's, CMA and EPA agreed that EPA’s risk finding (#1 above) is based on both the toxicity of the substance and exposure to it. However, CMA and EPA differed over three specific questions -- whether EPA: (a) must find that an unreasonable risk is more-probable-than-not, (b) must specifically rebut any industry evidence suggesting no human exposure by direct evidence of exposure, and has the authority to issue a test rule where any individual’s exposure is an isolated, non-recurrent event. In response to a lawsuit filed by CMA, the court upheld EPA’s views that a Test Rule is appropriate where EPA has substantial reason for suspecting that some amount of exposure takes place and the chemical is sufficiently toxic at that exposure level to present an “unreasonable risk of injury to health.”

In the late 1980's, CMA again sued EPA, charging that the Agency had not sufficiently developed and publicized its criteria for making the substantial exposure finding (#2 above). This lawsuit delayed the Program for over three years while the Agency developed and officially announced its criteria in 1993. Although EPA still was able to obtain some testing through ECAs, the Agency also looked to voluntary industry initiatives to bolster the Testing Program. EPA encouraged members of the chemical industry to initiate voluntary testing activities to develop data needed to protect human health and the environment. EPA now has 3 primary tools to obtain testing: Test Rules, ECAs, and Voluntary Testing Agreements.

EPA continued to receive much criticism from the U.S. Congress and others about the slow pace of its testing program in the early 1990's. Along with the issuance of the exposure criteria in 1993, OPPT issued a Chemical Testing Program Vision Statement with the following goals:

• Increase the overall productivity of the Chemical Testing Program;
• Establish a clear agenda for chemical testing;
• Ensure that testing is directed toward meeting data needs, not just filling data gaps;
• Redefine success to recognize the contributions of each of the 3 primary tools to fill data needs;
• Emphasize pollution prevention initiatives to reduce exposure or risk as a possible substitute for, or adjunct to, testing;
• Promptly review and evaluate test results; and
• Improve internal and public access to test data and EPA reviews.

Finally, OPPT has developed a "Master Testing List" (or MTL) to establish the agenda and priorities for the Testing Program and to serve as a cornerstone by presenting the universe of existing chemicals that have the greatest need for testing. The MTL identifies the testing needs of the federal government and international programs of U.S. interest (e.g., Organization for Economic Cooperation and Development (OECD) "Screening

Information Data Set" (SIDS) Program. See CIE, Spring/Summer 1996, pp. 14-15.) Based on broad public input, the MTL both focuses on priority chemical testing needs and publicizes those priorities, to encourage voluntary industry testing. Listing on the MTL occurs via formal requests from other EPA Program Offices, from other Federal agencies, from within OPPT’s Existing Chemicals Program (see CIE, Spring/Summer 1996, pp. 11-12), or by way of designations by the TSCA Interagency Testing Committee.

It is important to note that OPPT has been using the MTL since 1990 to set the agenda for the Chemical Testing Program. Since 1979, about 550 chemicals have been tested (almost all of these are U.S. High Production Volume or HPV chemicals), and more than 50% of these actions occurred in the last several years. In addition, EPA has issued approximately 250 TSCA 4 Section "Decisions-Not-To-Test" since 1979; many of these DNTs have also involved HPV chemicals. The MTL currently contains over 500 specific chemicals and more than 15 categories - virtually all of these are currently in testing or a testing action is under development. A revised MTL, which also contains a list of those chemicals removed from the MTL (because, e.g., testing has been

completed), was issued on December 13, 1996 (see 61 Federal Register 65936).

Today's TSCA Chemical Testing Program can be characterized by the following attributes:

• EPA has a clear testing agenda; the MTL presents a consolidated public list of the priority industrial chemical testing needs of EPA and other Federal agencies;
• More chemical testing is being conducted --more than 300 tests are underway, and OPPT is developing testing actions on over 200 chemicals;
• EPA will continue to develop testing actions by using a mix of Test Rules, Enforceable Consent Agreements, and Voluntary Testing Agreements.
• Many U.S. chemical companies appear willing to conduct testing and to establish voluntary product stewardship programs for their chemicals;
• International efforts such as the voluntary OECD/SIDS testing program continue to be integral to OPPT's Testing Program, and we will continue to encourage U.S. industry participation;
  
• Enforceable Test Agreements and Voluntary Testing Agreements offer an increased role for pollution prevention and risk reduction measures as an offset to some testing;
• Efforts are underway to further improve public access to OPPT test data.

Evolution of Risk Management of Existing Chemicals Under TSCA
Ed Brooks, Chemical Control Division

Birth of Section 6

From 1971 to 1976, while several toxic substances control bills were being debated in Congress, three concerns animated the drive for an authority to control existing chemicals (i.e., commercial chemicals already in production):

• The cancer mortality rate had been accelerating since before World War II;
• Industrial chemicals were believed to be a major cause of the increase; and
• Authorities to control many problems posed by industrial chemicals were either non-existent or inadequate.
• Prevailing opinion regarding the first two concerns was captured in Dan Rather’s introduction to a CBS documentary, aired at the time, entitled The American Way of Cancer:
  

  “The news tonight is that the United States is number one in cancer. The National Cancer Institute estimated that if you’re living in America your chances of getting cancer are higher than anywhere else in the world. Evidence indicates a link between rising cancer rates and industrialization, and we have led the world in both.”

The third concern was articulated in a 1971 Council on Environmental Quality (CEQ) Report entitled Toxic Substances, which noted that:

• The Federal Water Pollution Control Act had no authority to regulate specific toxic chemicals in effluents;
• There was no Federal authority to regulate disposal of toxic substances; and
• There was no Federal authority to regulate toxic substances in consumer products that were not food, drugs or pesticides.

Moreover, even where adequate authorities did exist to control toxic substances, the reach of those authorities was restricted to particular environmental media (such as air, water, or land) or to particular settings or applications (such as workplaces, food, drugs, or pesticides). A Federal authority was needed that could effectively address risks posed by toxic chemicals found in more than one medium or setting or that could move from one type to another.

Based on these concerns, the CEQ recommended passage of a Federal authority that would fill the regulatory gap by, among other things, empowering EPA “to restrict or prohibit the use or distribution of a chemical substance if such restriction were necessary to protect health and the environment”. Congress responded by enacting Section 6 as part of TSCA. That section provided not only the authority to ban or restrict production or use of toxic chemicals, but also to regulate disposal of such chemicals and to require labeling and notification of risk. Following enactment, questions arose as to whether TSCA was actually intended to fill regulatory gaps, or whether it was intended to fill a broader “umbrella” role, wherein it would become the primary Federal statute for dealing with toxic substances. In either case, it was anticipated that, at a minimum, any existing chemical problems not effectively addressed under other statutes would be handled primarily by rules promulgated under Section 6 to ban or limit use of chemicals that pose an unreasonable risk -- where unreasonable risk was broadly and somewhat imprecisely defined as a risk outweighing the benefits of use.

To this end, EPA’s Office of Toxic Substances (subsequently renamed Office of Pollution Prevention and Toxics, or OPPT) devoted the next several years searching for industrial chemicals that (1) satisfied the unreasonable risk standard, and (2) were insufficiently controlled by other authorities.

The Early Years

That goal proved elusive -- in part because of the apparent hurdles to be overcome in meeting the unreasonable risk standard, and in part because Congress subsequently enacted other statutes that essentially closed the void Section 6 was designed to fill.

With respect to the unreasonable risk issue, after taking action under Section 6 to curb aerosols containing chlorofluorocarbons (CFCs), the Agency came to view Section 6 rulemaking as an inherently large and complex undertaking that offered little prospect of resulting in success.

With respect to new legislation, following publication of the CEQ report Congress passed the:

• Resource Conservation and Recovery Act, authorizing Federal control of disposal of toxic substances;
• Clean Water Act, authorizing, for the first time, regulation of specific toxic chemicals in effluents;
• Consumer Product Safety Act, authorizing, among other things, banning consumer products posing unreasonable risks of injury; and the
• Safe Drinking Water Act, authorizing the Federal government to establish maximum allowable concentrations of specific substances in public water supplies.

Collectively, these and other subsequently enacted statutes greatly limited the regulatory gap that TSCA Section 6 was designed to address. As a consequence of these discrepancies between the anticipated and actual regulatory situation, Section 6 has been used only sparsely. The statute itself mandated regulation of polychlorinated biphenyls. Beyond that, regulations have been promulgated to ban or restrict use of asbestos, chlorinated fluorocarbons, dioxin, hexavalent chromium, and lead.

As EPA matured during this period, successive administrations became increasingly aware of both the difficulty and the inefficiency -- in an area fraught with uncertainties -- of attempting to coerce private sector behavior by regulatory edict. The emphasis gradually shifted from adversarial confrontation to negotiated and voluntary agreements, and to cooperative efforts to find solutions to toxic chemical problems. TSCA Section 6 is now viewed as an option to be used only when private sector cooperation is lacking, and where there are no other suitable regulatory authorities.

Current Operations

While regulation remains an option when circumstances so dictate, management of existing chemical problems today more frequently employs suasive approaches involving dissemination of information, participation by all factions, and multi-party negotiations to arrive at consensual and effective solutions. Typical specific strategies are highlighted below.

Assisting other public sector officials - OPPT provides technical and analytical expertise to Regional, State, and local entities to support their counterparts’ efforts to reduce toxic chemical risks. In a typical example, OPPT’s assessment of a serious and continuing toxic chemical exposure in Hammond, Indiana enabled Region 5 and the State authorities to initiate actions that virtually eliminated that risk.

Preventing pollution - In recent years, the Office has undertaken several projects that have prevented pollution by: (1) identifying safer substitutes for toxic chemicals used in commerce and encouraging their use; (2) compelling removal of toxic chemicals from commercial use, often within the context of potential regulation; and (3) providing technical assistance to industries in developing ways to eliminate or reduce emissions of injurious chemicals into the surrounding environment.

Empowering communities - Under the authority of the Emergency Planning and Community Right to Know Act, OPPT collects annual data on the location and amounts of toxic chemicals released to the environment by industrial facilities. The Office has now begun disseminating analyses of these industrial emissions, to communities identified as having excessive loadings, as a means of enabling citizenry to resolve problems at the local level.

Utilizing assessments - In order meet its regulatory responsibilities, a substantial fraction of OPPT’s resources are devoted to identifying and assessing risks posed by specific toxic chemicals. These assessments, which may require two or more years to complete, almost always entail intensive involvement with the relevant industries to obtain and interpret the necessary information. While these assessments generally conclude that the identified risks do not warrant regulation, they also typically find that the risks are nevertheless not insubstantial. In these circumstances, the Office has now started using the completed assessments to exhort manufacturers, processors and commercial users of the chemicals to voluntarily find ways to reduce the attendant risks. As a further inducement to action, the assessments are often publicized.

Generating consensus - To ensure that issues are examined from the broadest perspective, all potentially affected parties are brought together at the outset of every OPPT regulatory assessment, and their collective involvement is encouraged throughout the investigation. The Office has found that the very process of developing a common understanding of issues goes a long way toward achieving consensus regarding solutions. In these instances, industry will often voluntarily undertake remedial actions that would have taken far more time and effort to achieve by regulation. More importantly, the interactive process generates cohesive and mutually respectful relationships that stand in stark contrast to the divisive bitterness that often accompanies rulemaking.

Establishing accountability - Most contemporary industries and trade associations have voluntarily developed and adopted Codes of Conduct or Product Stewardship programs that stipulate, among other things, how member companies should handle toxic chemical problems prevalent in their respective areas. OPPT is now beginning to determine how well individual companies live up to these standards, and to give public recognition, both to those that excel and to those that fall below par.

Interagency Committee Improves Cooperation
Matt Gillen, Environmental Assistance Division

Section 9 of TSCA describes the relationship between TSCA and other Federal laws. Under this section, if EPA finds that a toxic chemical poses an “unreasonable risk” that could be reduced by an action taken by another agency, then EPA can file a request to the other agency to take action. Section 9 also calls for EPA to consult and coordinate with other agencies. Because toxic chemical risks can affect consumers and workers, EPA coordinates with other agencies that have primary authority for protecting these groups. Employees working directly with chemicals typically have greater opportunity for exposure in comparison to members of the public, so this is an area of special concern. EPA chemical screening activities often lead to questions or concernsabout the possibility or need for reducing occupational exposures.

In order to improve coordination among Federal agencies on worker toxics issues, EPA entered into a memorandum of understanding with two other occupational agencies in 1987. The agencies were the Occupational Safety and Health Administration (OSHA), which is part of the Department of Labor, and the National Institute for Occupational Safety and Health (NIOSH), which is part of the Department of Health and Human Services. The agreement created a standing committee, called the ONE (OSHA, NIOSH, EPA) Committee, to provide a forum for agency managers to discuss worker toxics issues. In 1990, the Mine Safety and Health Administration (MSHA), also from the Department of Labor, was added. (The acronym ONE was retained.)

The ONE Committee has provided a useful vehicle for the agencies to learn more about each other’s authorities, projects, and priorities. Each agency has different, although related, responsibilities and objectives for addressing worker toxics issues. OSHA and MSHA have the lead role for risk reduction and regulation of existing chemicals. NIOSH has the lead role on research and on tracking the rates of work-related disease. EPA has the lead role for regulation of workplace risks in two areas: new chemicals (under TSCA) and field worker exposure to pesticides (under other laws). EPA also has the lead role for testing and collecting information on existing chemicals.

The ONE Committee meets monthly to discuss ongoing activities, to initiate joint efforts where appropriate, to avoid potential duplication of effort, and to plan collaborative projects. Two examples illustrate how the agencies can work together:

• Skin permeation testing - There are many substances without any data as to whether or not they can penetrate the skin. This important information can be taken into account when establishing workplace exposure standards. OSHA does nothave the authority to require testing, but EPA does. The agencies are working together, with EPA using its testing authority to require chemical manufacturers to perform tests for 80 chemicals so that OSHA can use the results to inform employers and adjust their workp lace standards.
• Metalworking Fluids - OSHA, NIOSH, and EPA are working together with industry and labor stakeholders to identify, evaluate, and reduce risks from exposures to these materials. They are used by large numbers of workers during metal machining operations. NIOSH pulled together the available information and performed an initial review of the issues, and OSHA will convene stakeholders to further evaluate the risks and to recommend approaches for risk reduction so that regulations can be developed. EPA is coordinating with both agencies so that data gaps found to pose an obstacle to risk reduction can be filled using TSCA testing tools.

In summary, our national laws divide up the various roles to be played on worker toxics issues to different agencies. The ONE Committee is the forum by which these agencies coordinate and collaborate to help insure that a comprehensive approach can be taken where appropriate.

Section 21 Petitions Highlight Citizens’ Concerns
Michelle Price, Environmental Assistance Division

Section 21 of TSCA provides that any person may petition EPA to initiate proceedings for the issuance of rules under Sections 4, 6, and 8 of TSCA. Such a petition must set forth the facts which the petitioner believes establish the need for the rules requested. EPA is required to grant or deny the petition within 90 days. If EPA grants the petition, the Agency must promptly commence an appropriate proceeding. If EPA denies the petition, the Agency must publish its reasons in the Federal Register.

Since the creation of TSCA, EPA has received approximately 60 TSCA Section 21 petitions from states, trade associations, environmental groups, individual citizens, businesses, public interest groups, and unions. They have covered a wide range of issues, from polychlorinated biphenyls (PCBs) and asbestos to requesting actions on various individual chemicals.

One well-publicized action under Section 21 recently culminated in a report entitled, “Summary of Information Collected from U.S. Parent Companies of Maquiladoras Relating to the New River.” (Maquiladora is the Mexican term for a foreign-owned factory operating in Mexico that uses local labor to manufacture goods for export.) The report followed investigation into three Section 21 petitions from citizens living in the vicinity of New River who expressed concern about the river’s pollution and potential threats to health and the environment.

Publication of this report in February 1996 marked the end of information gathering efforts begun in 1994 in response to the New River petitions. It describes EPA’s information collection efforts and the pollution of New River. It also summarizes information collected from U.S. parent companies of maquiladoras with facilities in Mexicali, Mexico in the vicinity of the New River. This information was provided to EPA in response to both EPA’s April 1994 letter and subpoenas issued under the authority of Section 11 of TSCA. It was collected to determine whether these subsidiaries manufacture, process, or otherwise use, import, export, or dispose of chemicals that could be contributing to industrial contamination of the New River.

In the case of New River, EPA denied the initial petition, and the two subsequent petitions were withdrawn by the petitioners based on actions taken by EPA to address the issues raised in the petitions.

Based on the releases reported by U.S. parent companies of 83 maquiladoras, they do not appear to be major contributors to industrial pollution in the New River. However, the information contained in the responses from the U.S. parent companies was insufficient to permit EPA to independently assess whether the data are representative of the actual releases of industrial pollutants from the maquiladoras. Further, EPA does not currently possess the data necessary to make such a determination and believes that the continued monitoring of the New River is the most effective way to provide accurate information on the pollutants in the river.

Even though the petitions were denied in this instance, EPA’s actions under Section 21 of TSCA have clearly increased the community’s knowledge about sources of pollution of the New River.

For information on other TSCA Section 21 petitions and their disposition, contact the TSCA Non-Confidential Information Center at (202) 260-7099.

Evolution of CBI Policy under TSCA
Scott Sherlock, Information Management Division

I think the essential element of this legislation is that it has attempted to provide the individual - not only who works, but for the rest of society - the right to know what is in store as far as the toxicity of chemicals is concerned.” Senator Pearson, Legislative History of the Toxic Substances Control Act (1976) Chapter 2, S.3149, Senate debate, 218.

“(T)he Committee recognizes that some information which the Administrator may obtain will be of tremendous competitive advantage to the person providing it. Accordingly, section 14 contains specific prohibitions against release of such information so that the competitive position of those supplying information will be protected.” Committee Report, Legislative History of the Toxic Substances Control Act (1976) Chapter 3, H.R. 14032, 457.

These two comments succinctly summarize the competing interests for EPA in implementing TSCA: right-to-know versus the obligation to protect proprietary data. Since 1976, we have struggled to find a balance between these interests.

In its effort to achieve balance, EPA was hampered because it operated in essentially uncharted territory. TSCA was the first statute that allowed the Agency to address the risks of toxic chemicals from cradle to grave. TSCA gives EPA the authority to manage substances from the research and development stage, to manufacturing, use and, finally, disposal. In order to adequately address its obligations under TSCA, EPA required the regulated community to direct an unprecedented amount of sensitive, confidential data to the Agency.

One important initiative, little remembered now, was the effort to secure the confidence of industry that the we could protect this sensitive information. Securing that confidence was an absolute precondition to successful implementation of the statute. Keeping that trust is an ongoing responsibility.

The second critical initiative, which continues today, is addressing EPA’s statutory obligation to advise the public on the risks of chemicals in commerce. This issue of keeping the public apprised and ensuring opportunities for public participation in chemical management proceedings under TSCA has always been a cornerstone of the Federal toxics program. It has become even more important since 1986 when the Emergency Planning and Community Right-to-Know Act was passed. This Act called for creation and dissemination of the Toxics Release Inventory (TRI). With the successful implementation of TRI, the Agency recognized the tremendous power given the public by requiring chemical manufacturers and processors to provide to the public basic information on chemicals released into the environment. As a result, the public became an indispensable party in environmental protection and a powerful force in reducing releases of toxic substances into the environment.

EPA has struggled to fulfill the right-to-know component of TSCA. In 1994, it devised a multifaceted strategy to reduce inappropriate CBI claims and to increase the availability of TSCA data to the public yet maintain our traditional vigilance to protect genuine CBI. Efforts have included:

Educational Programs: Cooperative efforts with industry to advise the regulated community of what may and may not be claimed as confidential.

TSCA Information Products: By increasing availability of TSCA products, OPPT increases the public’s interest in TSCA data.

State Programs: States are a natural constituency for TSCA information and OPPT information products. Fostering and building this constituency of state chemical managers encourages the regulated community to reduce inappropriate CBI claims.

Sculpted Regulations: Since 1994, the Agency has proposed a number of regulations that were carefully crafted to limit burden but which ensure that CBI claims are well thought out and limited to only that information which is sensitive and must be claimed as confidential.

These programs have succeeded in limiting some inappropriate CBI claims. We fully recognize, however, that what has been achieved so far is not enough. While EPA recognizes the absolute need to protect CBI information in a manner consistent with the statute, the Agency needs to continue to address its obligation to make information on toxic chemicals available to the public. To this end, EPA is strongly considering additional voluntary and regulatory initiatives which will reduce unnecessary CBI claims for plant site identities and for ensuring “retirement” of older CBI claims.

TSCA as a Tool for Integrated Environmental Management
Cindy Fournier, Chemical Management Division

A major purpose of TSCA was to fill gaps left by other media-specific environmental statutes. For example, in the absence of TSCA, regulations limiting the air emissions of a toxic chemical could result in increased water emissions of that chemical. Now, however, EPA can consider and manage total human or environmental exposure of a chemical, by using TSCA authority to regulate all aspects of the manufacture, processing, distribution, use and disposal of toxic chemical substances. If the EPA Administrator determines that any of these activities pose an unreasonable risk to health or the environment, Section 6 of TSCA contains a number of risk management tools that EPA may use. These tools include:

• bans or limits on manufacturing, processing, or distribution;
• labeling requirements for products;
• recordkeeping requirements for manufacturers and processors;
• bans or limits on commercial uses;
• specific disposal requirements; and
• hazard communication requirements for manufacturers and processors.

Before a TSCA Section 6 rule can be issued, EPA must consider health effects, environmental effects, magnitude of exposure, the benefits of the substance, the availability of substitutes for the substance, and the effect that such a rule will have on the economy. EPA is also required to choose the least burdensome regulatory tool that will adequately address the risks of a substance.

Because Congress was so concerned about the health and environmental effects of polychlorinated biphenyls (PCBs), a specific ban on the manufacture, processing, distribution, and use of PCBs was incorporated into TSCA Section 6. PCBs were manufactured as a fire-resistant insulating fluid for electrical equipment. They are potential carcinogens that can also cause skin disorders and adversely affect reproduction and development. In the environment, PCBs are toxic to fish and impair reproduction in mammals and birds. The PCB regulations cover the marking of PCB transformers and other electrical equipment that are still in use, clean up of spills, procedures to be followed in the event of a PCB transformer fires, and disposal methods.

Another example of comprehensive regulations that address a single chemical involves asbestos. Asbestos, which is a naturally-occurring fibrous mineral, has been extensively used in thermal insulation, fireproofing, and acoustical applications. Inhalation of asbestos fibers can cause lung and other cancers, as well as asbestosis, or “white lung.” The emission of asbestos fibers has been regulated by the Clean Air Act since 1973. However, these regulations are intended to safeguard air quality in general, rather than protect workers and other building occupants. To address these risks in schools, EPA used the authority of TSCA Section 6 to regulate asbestos-containing materials in school buildings. This 1982 rule required primary and secondary schools to inspect their buildings for the types of asbestos that are most likely to release fibers into the air. In 1986, Congress superseded the old asbestos-in-schools rule with the Asbestos Hazard Emergency Response Act, which required schools to conduct thorough inspections, prepare asbestos management plans, and respond appropriately to asbestos hazards present in their buildings. Also in 1986, EPA issued a regulation to protect the health of state and local government employees who perform asbestos removals and who are not otherwise covered by OSHA or an OSHA-approved state plan.

Although the asbestos-in-schools and worker protection rules covered serious gaps in the regulations under the Clean Air Act and the OSHA standards, they did nothing to prevent future health risks caused by manufacturing, processing, use, and disposal of asbestos-containing materials. In 1989, EPA issued the

Asbestos Ban and Phaseout Rule, which banned, in stages, most of the common uses of asbestos. Nearly all aspects of this regulation were overturned by the Fifth Circuit Court of Appeals in 1991. The Court’s decision shows how important it is for EPA to fully consider all of the factors required by TSCA 6, such as economic effects and the availability of substitutes. According to the Court, EPA had not demonstrated that the Asbestos Ban and Phaseout Rule was the least burdensome regulation that would address the risks. Also, the Court was concerned that EPA had not adequately explored the effects on motor vehicle safety that could result from requiring automobile manufacturers to substitute other materials for asbestos in brake linings.

EPA has also used TSCA Section 6 to reduce environmental risks from chlorofluorocarbons (CFCs), which adversely affect the earth’s ozone layer. In March 1978, EPA banned the manufacture and processing of CFCs for use as aerosol propellants and required annual reports from manufacturers and processors on CFCs for these uses. Before TSCA, there was no effective way to regulate CFC propellant emissions, because CFCs are not air pollutants in the traditional sense. They are not considered poisonous and pose no risk to workers. This rule is a good example of how TSCA Section 6 can be used to control chemical hazards where other environmental laws cannot.

The broad scope of TSCA Section 6 means that actions taken under its authority can have severe consequences on the economy and other factors. This explains why EPA has been so careful in regulating chemicals under this provision. In addition to the three chemicals described above, EPA has used TSCA Section 6 to issue regulations covering two other situations, the disposal of dioxin-contaminated waste and the use of hexavalent chromium in comfort cooling towers. EPA also has published proposed rules to limit acrylamide in grouting materials and lead and zinc in fishing sinkers. While it has been argued that the Court’s ruling on the Asbestos Ban and Phaseout Rule may dissuade EPA from taking future actions under this section of TSCA, it has more likely provided us with valuable lessons in using this powerful tool to protect human health and the environment.

CAS Numbers: Unique Identifiers for Chemicals
Doug Sellers, Information Management Division

Under TSCA, OPPT collects a wide variety of information on chemicals. These various information collections are described elsewhere in this publication. However, with tens of thousands of chemicals on the Inventory, including classes of closely-related chemicals, one critical question that must always be answered is, “How can we be sure we are referring to precisely the same chemical substance?” OPPT does this by relying on the Chemical Abstract Service (CAS) Registry Numbers.

CAS numbers are assigned by the Chemical Abstracts Service to identify unique chemical substances. Even different forms of the same chemical structure will have a unique CAS number. OPPT needs this kind of identification because of the uncertainty of chemical names. There can be different names for a single chemical. Some generic names cover several substances. On the other hand, chemical names can be very specific and complicated, describing the location and attachment of every atom in the structure. What this means is that chemical names are not a useful and convenient method of specifically identifying a given chemical substance.Precise chemical nomenclature is very important in OPPT’s chemical information activities. The original chemical inventory collected under TSCA in 1977 was based on CAS numbers. (See Lau article this issue). CAS numbers provide more precise definition for the regulated community, to assure that OPPT requests and they provide information on the exact chemical needed. Chemical assessments and studies rely on correct chemical identification. OPPT uses CAS numbers to clearly identify chemicals in its public databases and information products.

CAS numbers are easy to locate. They are frequently included on product labels. Additionally, there are both printed and computer-based systems available in your local library that confirm CAS numbers. Including the CAS number in a request for information will ensure that OPPT provides you with the information that you are seeking.

Changes in Information Technology under TSCA

Information Collection
Nancy Vogel, Information Management Division

Advances in information technology are underway in Advances in information technology are underway in the TSCA docket. The Agency workgroup focusing on docket issues is encouraging regulation developers to submit large support documents (such as meeting transcripts) to the docket in electronic (diskette) format, as well as on paper. In addition, we are working with the Office’s Federal Register staff to begin uploading docket indices to the Internet. OPPT is also experimenting with ways to facilitate the electronic submission of public comments (on rules, policies, etc.) to the dockets.

In 1994, OPPTS began accepting comments electronically on the proposed biotechnology rule and the lead SNUR. (SNUR means Significant New Use Rule, which may be issued by EPA when a companyidentifies a new way of using an exis ting chemical.) Beginning in 1995, as a result of these and other pilot projects throug hout the Agency, Federal Register notices for all TSCA rulemaking actions contained instructions for how the public could submit commentsand data electronically. Submissions containing no TSCA confidential business information, in ASCII or WordPerfect format, may now be sent via electronic mail to OPPT.NCIC@EPAMAIL.EPA.GOV. EPA transfers all comments received electronically into hard copy format as they are received. These paper copies are placed in the official record, which also includes all comments submitted directly in writing. These efforts should conserve resources as well as increase the speed and accuracy of handling.

Information Dissemination - Past and Present
Doris Bloch, Information Management Division

At the inception of TSCA and for some years thereafter, EPA’s information dissemination practices could be summed up by two types of outputs: copies of paper documents and products from large, mainframe systems.

EPA received all information either in paper format or, a small percentage, on computer-readable tapes formatted for mainframe use. The same was true for dissemination: the majority of information was sent out as paper, in some cases reports extracted from mainframe systems, or on tapes. For instance, EPA published the TSCA Inventory in two formats; a five-volume book available from the Government Printing Office and computer tapes available for purchase from the National Technical Information Service. Other major distribution channels were individual responses to written Freedom Of Information Act (FOIA) requests and external onlinedatabase providers such as the Chemical Information System. (FOIA responses, especially, involved only small parts of larger data bases or document collections.)

Only in recent years has EPA used other options for sharing information with a wider public. For example, EPA publishes data for chemicals on the TSCA Inventory, Notices of Substantial Risk submitted by industry under Section 8(e), and other data bases on diskettes and CD-ROM; we distribute the TSCA Test Submissions data base containing various studies, test results and notices on microfiche.

More recently, EPA has begun publishing a wide variety of document files on EPA’s Internet home page. This change is largely due to the proliferation of desktop computing in so many offices and homes and the expectation that large numbers of people can use information in an electronic format.

We also realize that the extent of the data received under TSCA could be unmanageable and overwhelming without an electronic mechanism to organize it and assist those who are interested in finding relevant information quickly and effectively.

TSCA data are no longer exclusively mainframe-based, as that approach was recognized to be too restrictive. While OPPT is moving to an electronic environment, the Office recognizes that the change will not occur immediately, either internally or externally. And some of our public clients and customers will prefer to receive paper copies, even after internal systems are automated. Paper-based dissemination through FOIA, the docket, and the TSCA Hotline and for Federal Register notices will remain as a distribution option inherited from the past and projected to continue far into the foreseeable future.

New Chemicals Program Embodies Pollution Prevention
Roy Seidenstein, Chemical Control Division

The Pollution Prevention Act of 1990 ranks the preferability of general methods of controlling chemical risks as follows: source reduction, recycling, treatment, and disposal. The rationale for this ranking is that it is usually better, environmentally and economically, to avoid creation of a pollutant than to subsequently control exposures and releases which often results in shifting a pollutant among environmental media (i.e., land, air, water).

EPA's New Chemicals Program, mandated under Section 5 of TSCA, plays an important role in preventing pollution. Section 5 authorizes EPA to review new chemicals before they enter the market for the risks they may pose to human health and the environment. This statutory authority, enacted in 1976 and covering chemicals from cradle to grave and across all environmental media, embodies the modern pollution prevention paradigm.

Since the New Chemicals Program started in 1979, EPA has reviewed almost 30,000 new chemicals. In approximately 2,000 cases, EPA took regulatory action to prevent pollution or risks to human health that otherwise might have resulted from the manufacture, process, use and disposal of these chemicals.

Under the New Chemicals Program, anyone who plans to manufacture or import a new chemical substance must provide EPA with a premanufacture notice (PMN) at least 90 days prior to commencing such manufacture or import. To determine whether a substance is "new,” the company must consult EPA's Inventory of Chemical Substances (commonly known as the TSCA Inventory). If the substance is not listed on the TSCA Inventory, it is a "new” chemical.

EPA scientists from various disciplines work together to predict the potential risk to humans and the environment from each new substance. The evaluation uses data submitted on or with the PMN form, other information available to EPA, and exposure and release modeling. Since EPA revised the PMN form in 1991, it has contained a page encouraging companies to provide information telling EPA about any pollution prevention advantages of the n ew chemical.

After reviewing the PMN, EPA may take a variety, or a combination, of actions:

• If EPA determines that a new chemical may pose an unreasonable risk, EPA can enter into a consent order permitting the company to manufacture or import the new substance under restricted conditions intended to control exposure and releases of the substance. The consent order may require a Pollution Prevention Plan for the chemical either before production begins or when a certain production volume is reached.
• Besides regulating risky new chemicals, EPA has begun sending letters to certain PMN submitters recognizing selected new chemicals that may constitute safer substitutes or be developed via pollution prevention processes. Only about half of all chemicals that go through the PMN process ever go into production, which makes such encouragement all the more important. Criteria include actual test data on the PMN substance itself, less toxicity associated with the new chemical or related chemicals, reduced exposures and releases, conservation of energy and water and environmentally beneficial uses. The letter to the manufacturer of such a chemical notes their contribution to preventing pollution. It also asks the company to inform EPA of the commercial success of the product over time, and of any new toxicity and exposure data that become available.
  
• Whether or not EPA decides to regulate a PMN substance, EPA may suggest the use of “green chemistry” to help the company identify alternate synthetic pathways that will help reduce toxicity and pollution in the production of the chemical.

Additionally, as an exemption from the PMN requirement, EPA has promulgated a new Low Exposure/Low Release Exemption Rule that provides an abbreviated 30-day review period for substances that meet specified criteria for negligible exposures and releases.

For more information on pollution prevention in the New Chemicals Program, contact Roy Seidenstein at 202/260-2252.

Emerging Right-to-Know Themes Under TSCA
Steve Newburg-Rinn, Information Management Division

From its inception, TSCA addressed regulatory control as well as information gathering. Some sections of TSCA (for example, Sections 4 and 5, which provide for chemical testing and approval of new chemicals) seek to gather information, albeit through regulatory means. Sections 6 and 7, which allow EPA to limit or prohibit use of a toxic substance based on its hazards, are “command-and-control” in nature.

In contrast, the intent of Section 8 of TSCA was clearly information gathering. (Section 8 addresses a variety of activities, including record-keeping by industry, creation of the Inventory, and submission of health and safety studies to EPA.) Section 12, concerning exports, was information dissemination.

The Agency, and we as individuals, were used to the more direct approach of regulatory control. Staff would study a situation, marshal their facts, and build a record, and ultimately the Agency would impose specific requirements on the industry sector being examined. But regulations were not nearly as clean and neat as we had anticipated. Toxicologists examining compounds would often disagree on the degree of risk they posed. Our procedures became drawn out and lengthy. When EPA was able to finalize regulations, it found itself subject to what seemed to be an endless round of litigation. The result was that the hoped-for changes were delayed, and the risks continued.

During TSCA’s infancy, we began to realize that regulatory approaches, while important, were not necessarily the only way to achieve good public policy and risk reduction. As early as 1979, the Office began experimenting with negotiation among EPA and industry scientists to define the testing needs for particular chemicals. While subject to occasional litigation and adjustment,this basic approach has continued to this day. The public policy objective of the program was to obtain all the testing data that was needed on chemicals in question as expeditiously and cost-effectively as possible, then to assess the results. EPA also makes the results public. Should the findings be adverse, the testing information collected would probably serve to change behavior long before EPA would be able to develop a new command-and-control regulation.

The initial TSCA Inventory and its successors have given EPA staff and the public a better understanding of the chemicals in commerce and where they might be manufactured. The unpublished health and safety studies collected under Section 8(d) of TSCA have proven quite valuable to regulators and researchers alike, as they study particular chemicals. Substantial risk notices received under Section 8(e) have long been used to directly and immediately influence corporate behavior through the Office’s active dissemination of the information they contain. The Office also issued Letters of Concern under its existing chemicals program as another alternative, where a regulatory approach might take too long or otherwise be inappropriate.

As the Office evolved, these information gathering and dissemination activities were still at the periphery of our conceptualization of our role, until the passage and implementation of the Emergency Planning and Community Right-to-Know Act of 1986. The Toxics Release Inventory (TRI), with its requirement for the active public dissemination of information without being filtered through EPA as regulator, fundamentally changed the Agency’s understanding of the various arrows in its quiver.

Premanufacture review and regulation of hazardous chemicals under Sections 5 and 6 of TSCA are no less important than they ever were, and they remain an essential underpinni ng of any effort to voluntarily change behavior. But OPPT also came to realize that information, by itself, could be a powerful tool both to the public and to industry itself for reducing risks from chemicals. When the CEOs of large chemical companies suddenly were confronted with their own data showing that a lot of valuable product was going up into the air rather than being sold, they began to ask why. They also asked their plant managers to do better. The huge success of EPA’s 33/50 program for reducing releases of selected chemicals would not have been possible without data collection to set the initial baseline and as a measure of progress.

TRI provided the Office with a further tool in examining the issues posed by chemicals which might present risks. The Pollution Prevention Act of 1990 added still more information which has proven important as we seek pollution prevention solutions. A significant part of programs such as Design for the Environment or Green Chemistry is the conceptualization that information and then the technology transfer of better solutions will yield important risk-reduction results. By Executive Order, Federal facilities are now required to comply with EPCRA.

As the Office enters its third decade, several right-to-know initiatives are high on its list of importance. Last year, the Office doubled the number of chemicals covered by TRI to include other chemicals of similar or greater toxicity as those already in the TRI program. Secondly, EPA has proposed that TRI be extended to several industrial sectors (such as power generation) that use the TRI chemicals and account for a significant amount of toxics loading to the environment. Once the regulatory process to add these sectors is finished, expansion to other sectors will be examined. The Office has also proposed expanding the information collected to include chemical use and materials accounting data. These data additions will allow more comprehensive understanding of the roles of chemicals in our lives, and they will provide additional opportunities for pollution prevention and risk reduction.

Finally, the Office has the lead for reinventing how information is collected from the many entities we regulate. We have proposed collecting a common, consistent set of facility identification information about each of those 700,000 or so entities. This would, in the long term, allow elimination of duplicative reporting, facilitate consolidation of collection of data from those entities, and make public access to data both easier and more meaningful. Thus, information collection and right-to-know have become important partners to regulatory approaches for OPPT in fulfilling its mission.

How OPPT Works with Outside Parties to Implement and Gain Compliance with TSCA
Ken Moss, Chemical Control Division

While OPPT’s relationship with external constituent groups has ebbed and flowed over the 20 years of TSCA, there are many at EPA who have believed that unless there is some healthy friction between the Agency and its numerous public customers, we are not doing our job correctly.

Times change, however, and EPA has increasingly shifted to an approach of actively working to engage our constituent groups. EPA now strives to engage industry (large and small businesses), trade associations, environmental groups, labor unions, environmental justice groups, and others in the general public in cooperative identification and management of risks from exposures to industrial chemicals. This improves our mutual understanding of chemical exposures and risks and the needs and perspectives of all our customers. We have done this, for example, by exploring the relationship between the chemical industry’s Responsible Care and EPA’s TSCA chemical risk management programs and by recognizing our common need for information.

The Agency communicates its belief to industry and the environmental community of the importance of high quality toxicity, use, and exposure data for risk assessment to permit a better evaluation of the health or environmen tal benefits of new products. This helps all interested parties to better understand comparative risk assessment and some of the many choices to be made in the selection of environmentally preferable products. Toxicity data are valuable to the Agency as well as industry and other external groups both for hazard identification and to help design safer substitutes.

Meeting with the various constituent groups has resulted in the identification of cross-cutting issues and shared environmental concerns. We have found that there is considerable power in pursuing the many common environmental objectives in partnership with these groups, rather than unilaterally. The Office has hoped to build and expand upon dialogue, trust, and cooperation, using forums, public meetings, information exchange, and product stewardship partnerships. We have sought to empower the public with knowledge of pollution prevention and sound environmental management, EPA also strives to provide assistance to chemical users and share tools and risk management techniques with others in efforts to address local environmental concerns.

OPPT now actively seeks partners within relevant industry sectors to identify alternatives to the traditional ways we have gone about managing potential risks under TSCA. This has ushered in a new generation of novel approaches, such as consent agreements with chemical companies, wherein the legal requirements have been scaled back in response to real, voluntary steps taken by industry to foster safe handling of their products by downstream users. We have worked to include all levels of the market in formal product stewardship partnerships between the Agency, companies, and trade groups. Products of these efforts have included the development of product stewardship guides for select groups of both new and existing chemicals, coordination of risk reduction efforts with the environmental insurance industry, and working with chemical manufacturers to establish funds for the purchase of personal protective equipment or other technology that would help smaller businesses afford the equipment needed to reduce exposures in their workplace.

As part of our overall efforts to encourage pollution prevention and the development of safer chemicals or cleaner industrial processes, OPPT continues to engage the chemical industry in dialogue to discuss issues or concerns, jointly develop focused testing programs or novel risk management approaches, implement product stewardship programs, and encourage innovation in commercially promising chemicals. The future is cooperative and lies in finding solutions to common problems.

The Use of Environmental Chemical Databases in OPPT
Becky Jones, Health and Environmental Review Division

The introduction of chemical databases into OPPT’s workflow dramatically changed and streamlined the chemical review and information dissemination processes. OPPT developed a variety of computer data bases to manage the information that is submitted under various sections of TSCA. The data bases are used to track the submission of information, facilitate use of the information in reviewing individual chemicals, look for similar effects for related chemicals, and make the information available to the public.

Computer programs have also been developed to estimate physical/chemical properties of chemicals (such as water solubility), to predict exposure to wildlife and people from releases to the environment, to determine what levels will be harmful to plants and animals that live in water, and to predict how likely a chemical is to cause cancer.

In the future, OPPT intends to combine many of these data bases to further increase the efficiency of the chemical review processes and provide easier public access to the non-confidential information.

To find out more about chemical data bases in OPPT, see the following articles in previous issues of Chemicals in the Environment:

Toxic Substances Control Act Test Submissions (TSCATS), Summer 1995, p. 4
8(e) Triage Chemical Studies Data Base Product, Summer 1995, p. 4
The Use Cluster Scoring System: A Used-Based Approach to Setting Priorities, Winter 1995/1996, p. 8
Integrated Risk Information System, Winter 1995/1996, p. 9
Estimating Exposure: the Graphical Exposure Modeling System (GEMS), Winter 1995/1996, p.11

NEED HELP FINDING OUT ABOUT TSCA?
CALL THE TSCA HOTLINE!

The TSCA Assistance Information Service provides up-to-date information and assistance about programs implemented under the Toxic Substances Control Act (TSCA), the Asbestos School Hazard Abatement Act (ASHAA), the Asbestos Hazard Emergency Response Act (AHERA), the Asbestos School Hazard Abatement Reauthorization Act (ASHARA), the Residential Lead-Based Paint Hazard Reduction Act, and the Pollution Prevention Act (PPA).

The TSCA Hotline is staffed by professionals who are trained to answer technical inquiries about TSCA, ASHAA, AHERA, ASHARA, the Lead-Based Paint Hazard Reduction Act and some Pollution Prevention activities, including the 33/50 program.

The TSCA Hotline stocks a variety of documents, including Federal Register notices, reports, informational brochures, and booklets. These are available free of charge.

For more information or to request a document, Call: (202) 554-1404 / TDD (202) 554-0551
Monday-Friday 8:30 a.m. - 5:00 p.m. (EST). Fax: (202) 554-5603 (7 days, 24 hours).

Perspectives (Supplement to Chemicals in the Environment: Public Access Information Issue No. 4)

Some of the many people instrumental in creating and implementing the Toxic Substances Control Act have agreed to share their personal recollections about TSCA. Chemicals in the Environment thanks them for sharing their thoughts with us.

In the Creation of EPA Lay the Seeds of TSCA
Terry Davies, Director, Center for Risk Management, Resources for the Future
(Assistant Administrator, Office of Program Planning and Evaluation, 1989-1991)

One of the things that makes life both interesting and confusing is that each of us mentally writes history from our own unique and sometimes peculiar vantage point. For me, the creation of EPA and the origins of TSCA are intertwined.

In 1967, having spent two years as (the first ever) budget examiner for environmental programs at the Bureau of the Budget (now the Office of Management and Budget), I returned to academic life. Like all good academics, I had to write a book. Naturally enough, I wrote one entitled The Politics of Pollution, which was published early in 1970. According to the conventions of the day, books of this kind had to have a concluding chapter that made recommendations to cure all the ills that had been identified in the previous chapters. In my concluding chapter I wrote:

"Each year hundreds of new chemical compounds and new uses for existing chemicals and metals are being introduced in the United States. And this is done with little regard for their effects on human health or on ecology.... What is needed is a Federal agency with responsibility for determining the health effects of all such substances, setting standards for human exposures to them, registering and approving new chemicals, and monitoring the course of such substances in the environment, thus tracing the sources of human exposure."

In 1969, as a consultant to the President's Advisory Council on Executive Organization, I worked on the new Federal agency which became EPA. When I went to work for the Council on Environmental Quality the following year, one of my first projects was to draft legislation for "registering and approving new chemicals." I was assisted by Charles Lettow, a young lawyer who was also a chemical engineer. The chemicals legislation was drafted at the same time that Congress was considering the reorganization plan to create EPA. For me, the legislation that became TSCA was intended to take the same holistic, integrated, balanced approach to environmental problems as the new agency. Neither the legislation nor the agency exactly turned out that way a sad commentary on both the pollution control system and my ability as a forecaster.

The Passage of TSCA: A Lesson in Compromise
Warren Muir, President, Hampshire Research
(Director, Office of Toxic Substances, 1977-1981)

The fact that TSCA, unlike virtually any other federal environmental law, has had no significant amendments since its original passage in 1976 does not mean that its legislative history was uneventful. On the contrary, differences over the vision of toxic substances control legislation were so great thatit took three full congresses before a compromise version was passed.

Competing versions were passed in each House by large margins in 1972, 1974, and 1976. The Senate wanted all newchemicals registered by EPA after premanufacture review. The House of Representatives wanted EPA review limited to those new chemicals that EPA, by rule, listed as high priority concerns.

The compromise struck was the current system in which EPA is given notice at least 90 days in advance of manufacture and supplied with existing information. (No testing is required.) If EPA does not act within the review period, the new chemical can be manufactured freely. If EPA finds during the review period that the chemical may pose an unreasonable risk, it can seek to prohibit or restrict the chemical’s use pending the development of additional information. If the submitter objects to EPA's finding, EPA must go to court before the end of the review period and obtain a court order to impose its determination.

In the 1970's, it was taking EPA years to register a relatively few new pesticides. Many observers felt at the time of enactment that the compromise would fail because of the burden on EPA to act on hundreds or thousands of poorlycharacterized chemicals in a 90-day period, requiring this aspect of TSCA to be revisited quickly.

Even after Congressional action on this compromise, its fate was uncertain as President Ford seriously considered vetoing the bill, even though the idea of TSCA was originally a Nixon administration proposal that had been supported by President Ford. In the end, with the urging of both the Manufacturing Chemist Association (now the Chemical Manufacturers Association), organized labor, and the environmental community, he signed the bill into law.

Looking back now, it is clear that the new chemical review program that was the big compromise after contentious debate has been TSCA's greatest success. More than 20,000 new chemicals have undergone EPA premanufacture review. On nearly 10 percent, EPA has acted to restrict use and/or obtain more data. No EPA orders have been challenged in court. And most importantly, none of the environmental problems of concern today seem to be tied to chemicals that have been reviewed under the law.

No Rose Garden for the Toxic Substances Control Act
[from Glenn Schweitzer, former Director, Environmental Monitoring Systems Laboratory, Office of Research and Development, in: Borrowed Earth, Borrowed Time, Healing America's Chemical Wounds (Plenum, 1991)]

When TSCA finally overcame all the hurdles in the Congress and arrived at the White House for signature, President Ford delayed his response to the very limit of the time allowed until a pocket veto would take effect. Only a few hours remained when he finally signed the legislation into law in the privacy of his office in October 1976.

But why did he delay? Why didn't he celebrate the passage of this complicated legislation with a signing ceremony in the rose garden? Environmental and industrial leaders, congressional and cabinet officials, and labor and foreign trade executives who had repeatedly clashed during the incubation of the legislation could have joined hands in an unusual display of national consensus. President Ford's campaign for reelection desperately needed demonstrations of support from all sides. Perhaps the President's staff correctly judged that the new legislation was politically insignificant in comparison with education, welfare reform, crime, and other social and economic issues confronting the nation. Perhaps the impassioned congressional debates, the intensity of the lobbying efforts, and the media accounts of the cancer crises had exaggerated the threat of toxic chemicals. But isn't legislation that could affect the daily workings of tens of thousands of industrial firms throughout the country of consi derable importance? The White House inner circles wanted the chemical problems which regularly punctuated the Washington Post and the New York Times to go away. Afterstruggling until the last minute to understand the complicated provisions which Congress had crafted, they undoubtedly concluded that the new legislation would help, even though it could hardly be considered monumental in their eyes.

Meanwhile, the Chemical Manufacturers Association and the Chamber of Commerce had advised the White House of their desires to have the legislation signed and thereby end the regulatory uncertainty that had hung over the chemical industry for five years. The Sierra Club, the Natural Resources Defense Council, and other environmental groups assured the presidential aides that their concerns had been addressed. The AFL-CIO argued that safety was even more important than jobs and that the law should be enacted. The Office of Management and Budget, the EPA, and other agencies endorsed the legislation. Even some of the states had become vocal advocates for the law which would shift to the federal government many of the politically charged problems of public health threats that they were encountering every day. Since no one seemed to object, any need for the President to be concerned with the fine print must have appeared very unimportant in comparison with the large issues of the reelection campaign. In a ny event, the President clearly missed a useful opportunity to enhance his image as a responsible advocate of environmental protection by not taking center stage in the rose garden.

Looking Back: Twenty Years Later

Marilyn C. Bracken, Ph.D. Bracken Associates, L.L.C. (Deputy Assistant Administrator for Toxics Integration, Office of Toxic Substances, 1980-1983)

When I reminisce about the early days of TSCA, I am reminded of the youth and enthusiasm of the staff and the challenges of implementing a new law. In my case, some particular challenges were organizing and publishing the Inventory of Chemicals, writing Section 8 rules, working with member countries of the Organization for Economic Cooperation and Development on international activities in chemicals, and using the integration authorities of TSCA to coordinate and disseminate information. We were pushing technology trying to get computers to talk to each other. Twenty years later, we can all log on to the Internet and find information on chemicals, their uses, exposure data, product data, test data, etc. — much of it a byproduct of the information collection and dissemination statutory authority of TSCA.

A real benefit of TSCA was causing a change in the way companies organize and track information on chemicals. Now companies routinely track exposure, seek ways to prevent releases and negative impacts to human health and the environment, and concern themselves with product stewardship. There is a new awareness of quality management of chemicals that TSCA clearly impacted, perhaps not as explicitly as the original implementers thought but nevertheless a pervasive influence.

The TSCA Program Gathers Momentum

Don R. Clay, President, Don Clay Associates, Inc.

(Director, Office of Toxic Substances, 1981-1986)

From 1981 to 1986 — my tenure as head of the Office of Toxic Substances — were exciting and productive years. We established the new chemical review program without bringing the American chemical industry to its knees, the first Premanufacture Notice (PMN) exemption for polymers was developed, and the great debate within the Organization for Economic Cooperation and Development over the use of structure activity versus using a base set of data was raging. Section 4 testing rules were being developed at a rapid rate and the existing chemicals program was struggling to regulate asbestos. Rules were being written for polychlorinated biphenyls (PCBs), and a lot of time was spent deciding whether or not formaldehyde is a 4 (f) chemical. (OTS later determined that formaldehyde is a 4(f) chemical.)

Unlike many of EPA’s offices, the TSCA Office had the luxury of being able to devote some resources to looking ahead, rather than being driven exclusively by deadlines imposed by statute or court order. As a result, we were able to predict that biotechnology would become a growth industry and that, at least initially, we would need some level of review to assure the public that these living products would not harm them. Thus was born a series of biotechnology regulations, a program that continues to this day.

The TSCA Chemical Inventory

Bob Hagerman (Regulatory Associate, Dow Chemical, 1955-1995)

A review of the Toxic Substances Control Act upon its enactment twenty years ago demonstrated that it provided the EPA powerful, perhaps unique, authority to gather from manufacturers, processors, and users of chemicals data needed to evaluate and regulate risks associated with industry products and activities.

The first application of this authority was the development of the TSCA Chemical Inventory reporting rule as required by Section 8(b) of the Act. A small subgroup of the ChemicalManufacturers Association (CMA) Chemical Regulations Action Committee (then MCACRAC) met with its EPA counterparts over an extended period to determine what information would be both useful and practicably obtainable for the purpose of compiling a list of chemicals in U.S. commerce. This was a pioneering effort because neither side had experience with a law such as TSCA and many of those involved at the time had no experience with the regulatory process.

Initially the effort was aimed at developing a simple list of chemicals in US commerce. This was complicated following proposal when, on a bright Sunday morning on May 1977, Administrator Charles Quarles appeared on “Meet The Press.” Chagrined by lack of an answer when asked how he hoped to regulate chemical risks without knowing where they were produced, by whom and in what quantity, Mr. Quarles vowed to rectify the situation.

Very shortly we were involved in a drastically revised proposal. In addition to this pivotal issue, in always lively and frequently spirited discussions we addressed other majorissues including: What information could be treated as confidential business information? How should quantitative production data be reported and revealed to the public? How should polymers be identified? How should process intermediates be treated? What about chemicals used for research and development?

The process illuminated the perspectives of all interested parties and led, I believe, to a regulation which served at least the essential needs of each. In addition, the effort provided a model for cooperation between industry and EPA in regulation development.

TSCA Consent Order Process for Testing

Robert M. Sussman, Latham & Watkins (Deputy Administrator, EPA, 1993-1994)

An important milestone in the history of TSCA was the development of a framework for enforceable consent orders requiring testing on existing chemicals. This framework has not been a panacea for all of the shortcomings of the TSCA testing program but it has provided a useful and often effective technique for initiating testing that supplements the rulemaking process established in the statute itself.

In its early years, the TSCA testing program proceeded in fits and starts. EPA was slow to develop proposed test rules, in part due to uncertainties about its statutory authority, and the first groups of testing recommendations issued by the Interagency Testing Committee (ITC) languished without follow-up action by the Agency. (See related article about the ITC in CIE, no. 4.)

The Natural Resources Defense Council (NRDC) successfully sued EPA in 1980 to compel the Agency to address ITC-designated chemicals within twelve months either by proposing a test rule or by determining that rulemaking was unnecessary. With the support of the chemical industry, EPA began entering into voluntary testing agreements responsive to data needs on several ITC-designated substances. However, NRDC filed suit again, arguing that these agreements could not substitute for test rules because they were not enforceable and had not been developed through notice-and-comment rulemaking.

After NRDC once more prevailed in the courts in 1984, CMA approached EPA and NRDC representatives to explore developing a legally acceptable process that would preserve the benefits of negotiated agreements, including the opportunity for early technical dialogue betweenknowledgeable experts and the ability to minimize delay and controversy in launching needed testing. All perceived the value of a cost-effective alternative to the TSCA rulemaking process, and productive discussions were soon underway which led to agreement on a new system of negotiated consent orders under Section 4. The hallmarks of this system, which were reflected in a procedural rule EPA published in 1986, were a transparent negotiation process accessible to the public, a strict timetable for developing a consent order or proceeding with rulemaking, and enforceability of consent orders on the same basis as test rules. Simultaneously, the consent order system enabled EPA to conserve resources by eliminating the need to develop and support the findings required for test rules as well as the administrative burdens created by the notice-and-comment process.

The consent order process has shown impressive staying power: EPA has used it for about fifty chemicals over a ten year period. At the same time, EPA has continued to use rulemaking where it seeks testing that is complex or controversial.

The Section 4 testing program is not without critics; many observers remain disappointed with the pace and scope of EPA’s testing activities while others argue that EPA on occasion seeks unnecessarily extensive testing. There is little argument, however, that the availability of consent orders has enhanced the effectiveness of Section 4 — demonstrating the wisdom of CMA, NRDC, and EPA in working together to create an alternative to formal rulemaking ten years ago.

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