Setting the stage for new right-to-know regulations

Area Development Site and Facility Planning, Dec 1998

COMPANIES THAT HAVE become accustomed to community right-to-know requirements are going to encounter a new breed of "right-to-know" regulations, beginning in 1999. According to Vice President Al Gore, the new program, administered by the U.S. Environmental Protection Agency (EPA), is designed to "...close the gap in the public's right to know about the potentially harmful chemicals released into our air, our land, and our water."

The Chemical Right-to-Know Initiative (ChemRTK) is an outgrowth of an EPA study indicating that little basic toxicity information was publicly available about most of the high production volume (HPV) commercial chemicals manufactured in or imported to the United States. The new ChemRTK program is a response to that information gap, providing for methods to test chemicals and make related data available to scientists, policymakers, industry - and the public.

Three major components comprise the new initiative:

1. Chemical manufacturers and importers have been asked to participate in a voluntary "challenge" program to provide the basic toxicity data on the HPV chemicals they produce or use. The invitation carries teeth: Any chemicals listed by EPA that are not tested under the voluntary program will be tested under the HPV Test Rule, and EPA has indicated its intention to use its regulatory power to require additional testing if companies do not voluntarily provide the necessary information in a timely manner.

2. In a separate but related effort, EPA is pursuing additional reporting of information on chemicals that are persistent, bioaccumulative, and toxic (PBT).

3. HPV chemicals of particular concern to children's health will be subjected to more detailed and extensive testing in a separate Children's Health Test Rule.

There will be a great many tests required. According to EPA, of the 2,800 most widely used chemicals, complete data on health effects are available for only 7 percent.

The HPV Challenge

Under the voluntary challenge, participating companies will make a commitment to identify the chemicals they will sponsor and test. The companies will then assess the adequacy of existing data, design and submit test plans, provide test results as they are generated, and prepare comprehensive summaries characterizing the information on each chemical. The challenge will require the same tests and testing protocols employed by the Organization of Economic Cooperation and Development's (OECD) Screening Information Data Set (SIDS) program, a cooperative international effort designed to secure basic toxicity information on HPV chemicals worldwide.

"The best possible outcome of the HPV Challenge Program," according to EPA, "would be for all HPVs to have voluntary test sponsors, obviating the need for rule-making for any HPV chemicals." Just in case the "best possible outcome" doesn't occur, however, the agency intends to promulgate HPV Chemicals Test Rules under Section 4 of the Toxic Substances Control Act (TSCA) for any HPV chemicals that are not sponsored. EPA plans to finalize the HPV test rule by the end of 1999. Chemicals for which a sponsor makes a definitive commitment by Feb. 1, 1999 will not be included in the proposed HPV Chemicals Test Rule, and those by Dec, 1999 will not be included in the final HPV Chemicals Test Rule.

Information generated through the ChemRTK Program and HPV Challenge will be posted on EPA's Chemical Right-to-Know web site (www.epa.gov/opptintr/chemrtk), which will also contain technical guidance for chemical manufacturers participating in testing programs. According to EPA, the posted information will fill a gap in the Community Right-to-Know's Toxic Release Inventory (TRI): specific hazard data that allow the risk equation to be completed (hazard X exposure = risk), ensuring that at least a base level of hazard data is available on the local level.

Persistent Bioaccumulators

Persistent bioaccumulators (PBTs) are toxic chemicals that persist and bioaccumulate in the environment, remaining for significant periods of time (and in organisms exposed to them) at ever-increasing concentrations. EPA's TRI PBT project includes several activities geared to improved reporting of PBTs and dissemination of that information to the public.

With the exception of facilities subject to the alternate threshold exemption, EPA imposes across-the-board reporting thresholds for all listed chemicals. As the TRI program evolves and the emphasis on public access to environmental information deepens, however, EPA believes that reporting requirements of the EPCRA Section 313 may require modification to ensure that relevant, topical information and data are collected and made available to the public. Consequently, EPA wants to increase the usefulness of TRI to the public by adding PBT chemicals to the Section 313 list and by lowering the reporting thresholds for those chemicals. By the end of this year, EPA plans to publish a proposed rule that includes three major components:

1. Proposed persistence and bioaccumulation criteria for EPCRA Section 313