Momentum Building for TSCA Modernization

The House Subcommittee on Commerce, Trade and Consumer Protection held a hearing on July 29, 2010 on H.R. 5820, recently-introduced legislation to revamp the Toxic Substances Control Act (TSCA). With prospects for carbon control legislation diminishing, the July 29, 2010 hearing likely signals TSCA modernization as the top environmental priority on Capitol Hill next year.

Pre-Manufacturing Notice and Review

Addressing one of the most common criticisms of the existing TSCA law, the House and Senate bills would substantially toughen the process for the submission and review of data on new chemicals. TSCA Section 5 does not currently require a submitter to conduct testing before submitting a Pre-Manufacturing Notice (PMN), but merely to provide any information on health or environmental effects that are in its possession. In practice, the dearth of data accompanying submissions impairs the agency's ability to make informed judgments about the safety of a given compound.

Both TSCA modernization bills would, for the first time, require new chemicals submissions to be accompanied by a "minimum data set." This data set would consist of the chemical’s identity, physical characteristics, toxicological properties, hazard, exposure and use, along with other information that EPA establishes by rule. Indications are that the agency will require data on both traditional endpoints such as carcinogicity and mutagenicity, and also emerging concerns such as bioaccumulation, environmental persistence and endocrine disruption.

The current presumption that a chemical is appropriate for the marketplace in the absence of an "unreasonable risk" or "insufficient data" finding will be inverted. Instead, a six-month to one-year review of the application will be triggered unless EPA affirmatively finds that the chemical is "reasonably anticipated" to meet safety standards.

Manufacturers and processers will have the responsibility of identifying or generating research needed to complete the data set for a new chemical or new chemical use, effectively shifting the "burden of proof" to them. They would also be responsible for updating data submissions to reflect new information.

Fostering Innovation?

One recurring theme at the subcommittee hearing was the contention that fuller information about chemicals and their potential health effects would encourage the development and commercialization of safer alternatives. It was suggested that this in turn would advance the innovation and competitiveness of U.S. chemical producers. It is conceivable that TSCA could be structured to favor new chemical formulations over compounds already on the market. This would be the case, for example, if a relatively burdensome regimen of testing and reporting for existing chemicals were coupled by more lenient treatment of new entries into the marketplace.

Such a dual-track approach is not clearly embraced in H.R. 5820. Proponents of the bill contend it would expedite pre-market review of new chemicals with "intrinsically low hazard." This contention has elements of circular reasoning, given that data submission and review is the principal mechanism by which "low hazard" can be established. The suggestion may be that substances that fall within classes of compounds generally viewed as less worrisome would be candidates for such classification. However, to avoid subjective judgments, a more formal decisionmaking framework such as structure-activity relationship (SAR) analysis would need to be employed. This type of analysis comes with its own complexities, and may not represent a significant decrease in burden as compared with traditional safety determinations. As such, it is not clear that chemicals in this category would benefit from an expedited route to market to the extent that the bill would promote innovation.

Regulating Risk or Hazard?

Also noteworthy was the extent to which debate over chemicals management remains circumscribed by the concept of hazard as opposed to risk. The comments of the witnesses and lawmakers tended to group chemicals into the categories of "safe" or "toxic" with little regard for the use and exposure scenarios involved. A chemical demonstrating toxic properties in the laboratory can be used with minimum risk provided that exposures are controlled. For example, most of us readily accept the presence of cadmium and other metals in auto batteries because the sealed battery housing, coupled with deposit and recycling programs, minimize the potential for human and environmental exposure. It would be unfortunate if legislators miss a chance to significantly improve how we manufacture, distribute, use, and dispose of chemicals by continuing to focus on toxicity (in the abstract) as opposed to risk (in real-world context).

Modeling Aggregate and Cumulative Effects

Another theme touched on in recent public discourse was the treatment of aggregate and cumulative exposures. These are related concepts concerning the potential impact of a given chemical through multiple routes of exposure, as well as the possibility that multiple chemicals might interact to produce additive or synergistic effects. For example, a person might be exposed to mercury from a smelting plant, but also in the fish he consumers. The same person might be exposed to different substances that share mercury’s neurotoxic effects, for example, in pesticides he uses in the garden.

The Senate bill directs EPA to "consider" the work of the National Academy of Sciences in this area. H.R. 5820 goes further, directing EPA to incorporate aggregate exposures into its determination of "reasonable certainty of no harm" (RCNH) for a particular chemical. There was some disagreement among witnesses and subcommittee members at the hearing about whether EPA or the chemical manufacturer or processor bore the ultimate responsibility for examining and making judgments on these complex issues.

Bill sponsors cited a modification they agreed to that would make chemical vendors responsible only for providing information on exposure related to the chemical’s "intended use." The agency would then amalgamate company submissions on various uses and exposures and incorporate these into its safety determination. However, other sections of the bill make clear that the agency’s failure to make timely determinations can have the effect of keeping a chemical out of the marketplace. If EPA fails in its efforts to model aggregate and cumulative effects, producers, formulators and commercial users may well have to undertake this effort themselves in order to keep the substance in use.

Regardless of what TSCA eventually requires, we believe there are compelling reasons for companies involved in the production and use of chemicals to take a proactive approach to exposure modeling and life-cycle analysis. Exposure data is a necessary complement to data on human and ecological toxicity in the realm of product stewardship and defense. Given the ready access to information from a variety of media sources and the ease with which this information can be distorted or misunderstood, a company’s ability to substantiate its exposure, hazard and disposal findings will prove critical in defending a product, company or industry. The groundswell of toxic torts cases, along with state initiatives to restrict or eliminate chemicals based on inaccurate data, further support the wisdom of building a baseline understanding of exposure. We believe there’s no need to wait for legislation, news coverage or litigation to begin assembling one's product defense arsenal. 　

Robert G. Tardiff, Ph.D., ATS, Chairman of The Sapphire Group™, was recently featured in the SRA Risk Newsletter, a publication of the Society for Risk Analysis. Along with fellow past presidents of the Society, Dr. Tardiff commented on the effects of the Deep Horizon Oil Spill on the field of risk analysis. As Dr. Tardiff noted, "Considerable human life was lost when the drilling rig exploded, oil- and chemical-mediated ecological and other marine damage is spreading over a vast area of the Gulf Coast, and workers engaged in stemming the spill and striving to clean the spreading oil are claiming signs of assorted health impairments. The magnitude of the oil spill and dispersion is unparalleled in U.S. history, and recovery may be achieved only after decades of persistent human efforts and natural processes." Below is an excerpt from that article:

Questions Raised About the Criticality of Risk Analysis and Risk Management in Offshore Oil Drilling

For the field and practice of risk analysis, the occurrence of "rare events of catastrophic consequences" raises vital questions about the reliability of past risk analysis practices in and for the oil industry, possible needs for changes in those current practices, and overall improvements in engineering risk analysis methods and generates a compelling rationale for expanding research to better understand highly complex engineering processes of oil extraction. This brief does not offer a direct assessment of the nature and appropriateness of specific risk analyses that may have guided BP and its business partners in extracting oil from the deep waters of the Gulf of Mexico, since that documentation is not publicly available. Nor can one scrutinize any critique and guidance that the federal regulators (Minerals Management Service or MMS) may have provided to BP managers prior to issuing approvals for drilling at this designated site; if such documents exist, they also are unavailable for public review.

Rather than speculate about the content of the BP risk analysis, one can, however, identify elements of risk analysis that professionals in our Society would expect it to contain to assure the robustness and thoroughness of a risk analysis for this particular drilling operation and, by extension, to surmise the extent to which risk managers heeded the findings in preparation for drilling and actually prepared for the worst possible outcomes.

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