In the workshop’s final session, various speakers synthesized, commented on, and expanded on the presentations and discussions that had taken place on the previous day and a half.
Kimberly Thigpen Tart, Program Analyst in the Office of Policy, Planning, and Evaluation at the National Institute of Environmental Health Sciences, commented on topics raised during the presentations looking at the challenge of chemicals in today’s society (see Chapter 2). She noted that Lynn Goldman’s remarks on the Toxic Substances Control Act (TSCA) of 19761 and the difficulty of determining how many chemicals are in use in the United States (and in what forms) helped set the stage for later presentations. From a public health perspective, William E. Halperin described the difficulty in approaching industrial chemical assessments when at least five different paradigms could be used: industrial hygiene, prevention, surveillance, embeddedness, and dose response. Thigpen Tart highlighted that a better public health approach, as articulated by Halperin, may try to focus assessment and management efforts on reducing chemical exposures to everyone in order to reach a greater number of people affected by significant exposures, not just those with the highest level of exposures. Efforts are under way, including the National Conversation on Public Health and Chemical Exposures, to join diverse public and private stakeholders in working to ensure that chemicals are used and managed in ways that protect the health and safety of individuals. Thigpen Tart noted that some workshop participants expressed concerns that the public’s voice in chemical risk evaluation is being lost, and that the resource base for addressing community concerns has been “tattered” at
1 Toxic Substances Control Act of 1976, Public Law 94-469, 94th Congress.
every level. She highlighted remarks from Goldman that social media and related technologies show promise for empowering people to connect and network outside traditional structures, but that public health officials and researchers should be involved in research translation to ensure that accurate and appropriate information is disseminated at the community level, and that people and communities know how best to apply this information to their decision-making processes.
Bernard Goldstein, Emeritus Dean and Emeritus Professor of Environmental and Occupational Health at the University of Pittsburgh Graduate School of Public Health, discussed some of the common themes emerging from the discussions on current programs for safeguarding the public from the potential health risks of industrial chemicals. After the presentation on the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) legislation, by Canice Nolan, the talks by the other presenters could be summarized in two words, he said: Fix TSCA. “All three—Wendy Cleland-Hamnett from the U.S. Environmental Protection Agency (EPA), Richard Denison from Environmental Defense Fund, and Michael Walls from the American Chemistry Council—agreed on the need to move something forward in legislation,” he said. “I found them pretty close in terms of the details.”
Beyond that, Goldstein addressed what he described as “hidden assumptions” in the field. One lies in the area of toxicology testing. There are about 20,000 new chemicals that have come to market since TSCA was passed. If you assume that existing toxicology is good enough to pick up, say, 99 percent of the chemicals that are causing reproductive and developmental effects, that still leaves 1 percent, or 200 chemicals that are potential reproductive and developmental toxins that the EPA has allowed into commerce. “I do not think we are 99 percent effective,” he said. “I think we have a long way to go. I picked reproductive development. You can pick neurotoxins. You can pick chronic disease issues. You can pick lots of the other systems for which our test are inadequate to predict the effects of chemicals.”
The assumption seems to be that the problem can be fixed by doing more toxicology, Goldstein said. “I think a lot of the presentations in the fourth panel assumed that as long as we did the toxicology testing that we know how to do, we would be fine. No. We will not be fine.” A key issue, he said, will be “how do you develop the Toxic Substances Control Act in a way that makes sure that we have the best testing rather than just saying you have to test everything.”
A second issue is how best to promote innovation by industry to decrease pollution emissions. Do thresholds exist to promote innovation in approaches to meet the threshold, or the opposite? Will the size of the threshold make a difference? Will the kind of testing that is required make a difference? Will putting chemicals in different levels help or hurt innovation? Goldstein mentioned an experience in which an emission threshold put in under the Clean Air Act led a company to replace a solvent with another solvent that had one-tenth the volatility so it would not exceed the reporting levels, but one-hundredth the odor threshold so that now the community smelled the emissions. Was this new solvent more toxic? “I am not sure whether it was or not, but it is an example of how we sometimes drive toward agents that may be more toxic.” Thus, a key question is, Are we able to design TSCA in a way that allows for innovation and does not drive us toward chemicals that may be more of a problem?
Finally, Goldstein said, transparency is a difficult issue to deal with. There is certain information that businesses need to keep confidential in order to maintain their intellectual property and competitive advantage, he said, but industry has shown over and over again that it uses the excuse of confidential business information to hide things that it does not need to hide—and sometimes things that it should not hide. How does one craft a policy that protects innovation by allowing companies to keep some things secret while maintaining the distinction between things that need to be kept secret and those that do not?
Hal Zenick, Director of the National Health and Environmental Effects Research Laboratory at the EPA, also provided some observations concerning the presentations, particularly those from the session on improved approaches to chemical prioritization (see Chapter 5). One thing that struck him forcibly, he said, is that the discussions were far from having a one-size-fits-all approach. The prioritizations were aimed at different groups—some at populations, others at communities, for example—and were also accountable to different sets of stakeholders. “I think when we begin to look at a system for prioritization, it probably is not going to be widely applicable across these different venues and populations,” he said. Although all the prioritization approaches more or less use a matrix that characterizes hazard on one axis and exposure on the other axis, Zenick noted that the level of precaution tends to differ across the approaches with some groups moving ahead boldly and others conservatively.
Zenick felt that biomonitoring was mentioned repeatedly and he explained that “the opportunity for acquiring biomonitoring data is becoming greatly enhanced.” The example of the state laboratory capabilities brought up in the discussion time of that session could be a resource for investigating biomonitoring and environmental monitoring data. Zenick stated that those resources could be used to provide exposure information in geographic units more valuable than what can be extracted at the national level.
Lynn Goldman offered a few common themes that appeared from all of the case studies presented in Session 5. First, she said, it is clear that there are many drivers for reducing the risk of chemicals; some of them have to do with reducing costs, some with reducing risk, and some with such intangibles as the reputation of products and companies. Second, everyone seemed to believe that a life-cycle approach was very important. “If you are just working at the end of pipe, you can miss things that are important.”
Third, information is both a driver and an enabler. That seemed to be a very important point, Goldman said, as well as the fact that our lack of information about so many chemicals leads people to rely on lists that are created on the basis of very limited existing information and assessments that have been done. She noted that we look under the same lamppost where the light has shone for years, and at the same substances that have been tested again and again, and measured again and again, while there are so many other substances about which we know so little that we cannot factor them into assessments.
A fourth common point was the importance of educating or working with the organic and analytic chemists themselves whose work lies at the core of the decisions that will ultimately be made. “The decisions that they make about how methods should be done can have enormous implications,” Goldman said. If an analytic method required by the government uses a large amount of methylene chloride, then that is going to drive the use of methylene chloride in laboratories across not only the United States, but also other countries.
Frank Loy, chair of the Roundtable, then commented on the workshop as a whole. He highlighted the interesting, thoughtful work done on the prioritization of chemicals for risk assessment in the state of California and in Canada. “I thought this work was quite impressive and useful,” he said. He noted the differing views that were expressed related to the European Union’s REACH program. In his opinion, the REACH program has gone over well with relative ease, and while Europe is not
the United States, there are lessons to learn from this program when updating TSCA. One missing element from the workshop was someone representing labor and workers who may be exposed to toxic chemicals. “We need to recognize that some people are more exposed to these chemicals than others. If there are categories of people like that, we need to have them participate in these sessions,” he said. Loy stated that all the workshop presentations and discussions were thoughtful, and he hopes the views and opinions expressed will help inform next steps.
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