66 



ter in gathering and acting upon toxicologic information. It is clear that we can, be- 

 cause in fact we already do. Specifically, U.S. industry, government, and advocacy 

 groups have achieved far more in the international context, through the OECD, 

 than has been accomplished under TSCA. Most other industrialized countries also 

 accomplished more than the U.S. Using the principles that underlay TSCA's enact- 

 ment (and that have largely been lost in its implementation), the European Eco- 

 nomic Community and Japan have developed successful and manageable programs 

 to test new and existing chemicals without impairing their ability to compete 

 through innovation, research and development. 



1. Existing Chemicals 



The intent of TSCA was to provide EPA with the power to gather information on 

 both exposures and hazard upon which to determine the necessity to undertake risk 

 reduction actions of a broad nature, including reducing risks in the occupational set- 

 ting as relevant. It was envisaged that TSCA would encourage a national program 

 of rational and prioritized chemical testing and an effective surveillance system of 

 exposures and effects monitoring. These efforts together would provide EPA with 

 the information needed to identify significant risks and develop risk-based regu- 

 latory responses, including the promulgation of rules for further testing. 



Unfortunately, neither the testing nor the regulatory provisions have been utilized 

 to any significant extent. The testing of existing chemicals has languished. Testing 

 of existing chemicals by the private sector under TSCA has been sparse indeed, with 

 very few test rules issued over the first 10 years of TSCA's lifetime. Of even greater 

 concern, EPA has never linked the programs of its OflBce of Research and Develop- 

 ment to its TSCA responsibilities, as could readily be done to support or conduct 

 research directed towards the development and validation of more effective, and 

 cost-effective, test methods to serve the purposes of TSCA. Opportunities to apply 

 the results of scientific advances in toxicology and the basic sciences have been re- 

 peatedly missed, so the testing that is done utilizes relatively static methods that 

 rightfully provoke those concerned with animal welfare over the use of experimental 

 animals in Itirge quantity. 



The surveillance provisions of section 8(e) have been even less effective: the incen- 

 tives for the private sector to report adverse effects of its products are nonexistent. 

 Moreover, EPA seems to have made little effort to explore the cvurent surveillance 

 systems that already exist: for instance, to my knowledge, EPA has not utilized ei- 

 ther the databases of its own National Human Adipose Tissue Survey, or the Cen- 

 ters for Disease Control's National Health and Nutrition Examination Survey — ^both 

 of which, actually report data on the presence of at least some (though not many) 

 chemicals in the tissue samples fi?om members of the general U.S. population. Such 

 data could help focus attention under TSCA on chemicals to which individuals or 

 populations are demonstrably exposed. 



Similarly, only recently have the resources of the National Toxicology Program 

 (NTP) begun to be effectively harnessed to TSCA through the efforts of the Agency 

 for Toxic Substances and Disease Registry (ATSDR) as it carries out its statutory 

 obligation under Superfund to identify toxicologic data gaps for substances fre- 

 quently found at Superfund sites. For example, we know that groundwater is the 

 medium most often contaminated by releases fi"om hazardous waste sites. It is also 

 known that groundwater contamination can result in massive migration of contami- 

 nants into a wide geographic area, including into private wells. Yet, for many of the 

 substances known to migrate into groundwater, little or no information is available 

 about their effect on the reproductive, neurologic, or immune systems. Filling in 

 these data gaps is essential. 



ATSDR and EPA, in coordination with the NTP, have jointly identified 117 key 

 data gaps for the top 38 substances on the Superfund priority substances list. 

 ATSDR referred approximately 60 of these gaps to EPA in 1992 for action under 

 TSCA. Although some administrative steps have been taken, to date not a single 

 data gap has yet been substantively pursued. 



TSCA must be reinvigorated to provide a more effective means of filling data gaps 

 for Superfund priority substances. Doing so will improve both Superfund site clean- 

 ups (which are risk assessment based) and public health interventions (which are 



