Risks on Record: An Overview of TSCA's Substantial Risk Reporting System with Bulletins in Selected Chemicals

Chemical manufacture and use in this country is steadily on the rise as industry increasingly turns to synthetic compounds to make the products on which modern commerce and consumers depend. More than 77,000 chemicals have at some point been manufactured in or imported to the United States since 1979, as listed in the inventory created by the Toxic Substances Control Act (TSCA). Chemical production and imports, including fuels (but excluding all inorganic compounds, such as ammonia, sulfuric acid, and lye), now total nearly 6 trillion pounds annually. A number of chemicals have been found, sometimes only after years of use, to cause serious health and environmental problems. Such substances include lead, asbestos, certain pesticides, and a large category of chemicals now suspected of causing damage to the reproductive and immune systems of many animal species, including humans. Often, the substances have been dispersed widely in the environment and used commercially in consumer and industrial products, and there is no process in place to systematically track or control these uses, even for many chemicals that are known to be toxic. With more varieties of chemicals "in commerce" than ever before, there is a growing need for reliable, publicly available scientific information on the toxicity and use of commercial chemicals to determine the extent to which their use may cause damage to human health or the environment.

INFORM has examined a little-known source of chemical health and safety information-a database of reports known as "Notices of Substantial Risk"-with the goal of increasing public awareness of the availability of this potentially significant database. In this report, inform presents the results of its analysis of selected Substantial Risk notices and the insights they offer; identifies a number of findings that may be important to potentially affected groups (other manufacturers, governmental agencies, and workers); and explores ways to make this database a more effective resource. inform's goal in disseminating this report and the accompanying Bulletins is to catalyze efforts to address the reported risks.

Section 8(e) of the Toxic Substances Control Act requires chemical manufacturers, processors, and distributors to submit information to the United States Environmental Protection Agency (EPA) concerning "substantial risks" posed by substances used in commerce within 15 days of learning of such risks. The information in Substantial Risk notices consists primarily of results of toxicity tests conducted with laboratory animals to predict effects in humans. But some notices also include findings of tests for ecosystem toxicity (effects on fish, wildlife, and other organisms), incidents of chemical release, human epidemiology studies, or anecdotal reports of worker illness that may be related to chemical exposures. Some of the findings in the notices are preliminary, while others are more conclusive. Results from studies designed for a given animal model and a particular exposure pathway may raise concerns about effects in other organisms exposed by similar or alternate exposure pathways.

The information reported in Substantial Risk notices, generally unavailable from other public sources, is critical for:

• Informing chemical manufacturers and users (companies, workers, consumers) about newly identified risks they may face.
  
• Improving the ability of the above groups as well as government officials and policy-makers to take actions to reduce reported risks (by such measures as substituting chemicals, reducing quantities of chemical used, and preventing exposures, releases, and waste generated at the source).
  
• Designing new research projects to address important gaps that remain in our understanding of the risks posed by the use of commercial chemicals.

Since the Substantial Risk reporting program began in 1977, EPA has received 13,000 Notices of Substantial Risk. But these findings have not been widely publicized or readily available to the public, due to a number of factors discussed starting on page 6. As a result, manufacturers and users of a particular chemical may be unaware of the substantial risk information generated for that chemical by other manufacturers and users.

INFORM used a screening process to identify, from the 13,000 notices, a group of particularly noteworthy submissions that contain unpublished information concerning previously undefined, but potentially serious, risks to human health and the environment. The result of this work is a set of nine inform Bulletins (listed in Table 1) summarizing findings from 12 of the Substantial Risk notices submitted to EPA. Designed for environmental health practitioners such as industrial hygienists, toxicologists, corporate product stewardship staff, and those who may be directly affected by the reported risks, such as workers, inform's Bulletins supplement, but are not intended to replace, other important health and safety references such as Material Safety Data Sheets (MSDS).

Summary of Findings

inform's research identified valuable information on chemical risks that is summarized in the following Bulletins. However, four obstacles undermined our ability to screen the 8(e) notices for more serious findings and to evaluate their significance for specific groups that may be affected by the reported risks.

1. There is no standard reporting format. Some notices did not provide enough information about the nature of the risk, or the research method used, to assess the significance of the results.

2. Confidentiality is frequently claimed on the identity of chemicals of concern. This made many notices, as presented in the public record, unusable.

3. For most of the chemicals of concern examined by INFORM, information on the specific uses of and exposures to these chemicals-which is needed to fully assess potential risks-is not included in the notices themselves nor in a wide range of sources that inform consulted. As a result, the actual or even potential significance of the toxicity information that is available for these chemicals is not clear.

4. EPA's systems for accessing the notices limited our ability to screen them for specific selection criteria.

Because of the gaps in information reported through the Substantial Risk program, inform asks Bulletin recipients to contact us with more information about: the use of these chemicals; the extent to which humans and other species may be exposed to them; and any prior, ongoing, or planned initiatives undertaken to address the reported risks. inform hopes to use any feedback it receives to expand the Bulletins, to broaden their distribution, and to report further on the impact of this important information.

INFORM's findings about the Substantial Risk reporting program suggest ways the process might be improved to make the reported information more useful and accessible to those who may be most affected by the risks, or are in a position to take action to reduce them.

1. Develop a standardized reporting format to ensure that all notices provide complete information about the nature of the risk, the methodology, and the research.

2. Substantially restrict the amount of information withheld as confidential regarding the identity of chemicals of concern in the notices, particularly chemicals that are currently distributed in commerce (as noted by their presence on the TSCA chemical inventory) or eventually enter commerce. For situations in which such a confidentiality claim is justified, ensure that the public version of the notice includes a meaningful generic name that clearly identifies the portion of the substance that may be responsible for the adverse effect.

3. Develop a public database to track use and exposure-related information such as: manufacturers that are producing/using the chemicals, quantities in commerce, potentially exposed populations, and the range of exposures and releases generated by specific use applications.

4. Revise and complete the electronic indexing systems to allow more focused and reliable searching on significant parameters such as chemical names, type of effect, type of finding, species involved, and production volume and commercial status of the chemical(s) of concern.