Tuesday, August 31, 2010
Monday, August 23, 2010
There is a widely-shared criticism of how new chemicals are regulated under TSCA. TSCA Section 5 requires a Pre-Manufacturing Notice (PMN) for both new chemicals and proposed new uses of chemicals already on the market. The PMN need not be accompanied by comprehensive health data on the compound, merely that information already in the possession of the applicant. This leaves industry without a strong incentive to compile a robust data set, and the resulting information gaps impair EPA’s ability to make informed judgments about the safety of a given chemical.
Both the House and Senate TSCA bills would substantially toughen PMN and review, requiring applicants to provide a "minimum data set" about the chemical and potential health and environmental impacts. Manufacturers and processers would for the first time have the responsibility of identifying or generating research needed to complete this data set or risk losing access to the marketplace.
Proponents of the bill argue that stringent data collection and review of new chemical products have been features of federal pesticide regulation for decades, and that this has not unduly burdened the crop protection industry or the agriculture sector. This analogy was made by Rep. Frank Pallone (D-NJ) at the July 29 subcommittee hearing on H.R. 5820.
The pre-market screening of pesticides under the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) and related statutes is undoubtedly stringent. Registrants must be prepared to provide studies on carcinogenic, neurological, developmental and reproductive effects, as well as information on fate and transport, persistence, and metabolic byproducts. Another essential element of the petition is an assessment of exposure to humans and other non-target organisms.
In light of these requirements, the agency itself acknowledges that “depending on the class of pesticide and the priority assigned to it, the review process can take several years.” Despite this, U.S. regulation of pesticides is generally viewed as a success, a point often made by those drawing comparisons to TSCA modernization.
But is this comparison apt? Pesticides present a relatively contained range of exposure scenarios, including exposed agricultural workers, contaminated groundwater, and pesticide residues on crops.
In contrast, the chemicals that would be governed by a revised TSCA present multiple routes of exposure, and the interaction of these various exposures must be modeled and aggregated to make meaningful decisions about chemical use. Further, a reworked TSCA is virtually certain to require modeling of exposures by vulnerable populations such as children and the elderly, something that is not required for pesticides.
The net result could be a registration process with a complexity that resembles REACH rather than FIFRA, one that will delay market access for some chemicals by years, and discourage others from being commercialized at all. Such an outcome might be tolerable for some mundane products and uses. But for components of lifesaving technologies such as medical devices and time-to-market critical products like smartphones, is our society prepared to accept such a delay?
Friday, August 13, 2010
Agency Continues Pattern of Deploying Existing Authority
On August 11, 2010, EPA proposed changes to its TSCA Inventory Update Reporting (IUR) rule that would increase the frequency and standards for reporting by IUR- covered facilities. First promulgated in 1986, the IUR rule is designed to provide the agency with the volume of chemicals produced, imported or processed, along with basic information on how those chemicals are used. The goal is to inform agency prioritization and safety determinations for chemical substances, and (consistent with confidentiality restrictions) to release relevant data to the public.
This proposal fits squarely within a pattern of more deliberative assertion by the agency of its TSCA authority in recent years. The agency has expedited the collection and review of data for chemicals under voluntary programs such as the Voluntary Children’s Chemical Evaluation Program (VCCEP), the Chemical Assessment and Management Program (ChAMP), and the High Production Volume (HPV) Challenge Program. More recently, a series of “action plans” utilizing TSCA Section 6 and Section 5(b)(4) authority have directed scrutiny onto chemicals suspected of properties such as persistence, bioaccumulation and endocrine disruption.
Some have speculated that the Fall elections and other legislative priorities will hinder if not prevent TCSA modernization for several years. Nevertheless, what is clear is that EPA will continue to push for more comprehensive, precise and transparent chemicals management with a renewed insistence on industry responsibility for these data. Furthermore, administrative agencies and legislatures around the globe mirror these objectives. Some may view this as yet another regulator burden; however, we believe that this creates a unique opportunity for the most proactive industries and companies to gain a competitive advantage. Efforts to address EPA’s administrative demands can be structured to give companies a head start compiling an understanding of their chemical use, potential health effects, exposures, and product life cycle that a revised TSCA and its overseas counterparts will ultimately require. In the process, they will distinguish their firms as responsible and forward-looking in the eyes of regulators, customers, and consumer advocates.
Thursday, August 5, 2010
An understanding of the various routes of exposure for chemicals in products, as well as their interaction with similar chemicals, are an important element of REACH and will likewise be central to a reformed TSCA. In combination with data on health effects, this information will allow authorities to make required safety determinations. Reliable modeling of exposure scenarios will also equip companies to persuasively defend their products against unfounded accusations in the media, the internet and the courts.
An influential 1994 National Academy of Sciences report called Science and Judgment in Risk Assessment was one of the first voices citing aggregate and cumulative chemical exposures as critical to understanding real-world risk. Aggregate and cumulative exposures 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 Lautenberg bill directs EPA to “consider” the work of the Academy in this area. H.R. 5820 goes further, directing EPA to incorporate aggregate exposures in its determination of “reasonable certainty of no harm” (RCNH) for a particular chemical. At the July 29 hearing, there was some disagreement among witnesses and subcommittee members whether EPA or the chemical manufacturer or processor bore the ultimate responsibility for examining and making judgments on these complex issues.
Several lawmakers, including Rep. Diana DeGette (D-CO) noted that a recent modification to the bill agreed to by its drafters would make the company 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. Consequently, if EPA is thwarted in its efforts by the complexity of the analysis, by resource constraints or other factors, 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.
Tuesday, August 3, 2010
Another observation from the July 29th hearing was the extent to which debate over chemicals managment is circumscribed by the concept of hazard as opposed to risk. The witness testimony, as well as the question/answer exchanges, stressed the need to find “safer chemicals” to replace “toxic, persistent, and/or bioaccumulative chemicals” currently on the market.
However, as any first year toxicology student can attest, “the dose makes the poison.” A chemical demonstrating toxic properties in the laboratory can nonetheless 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). This is one of a number of areas where a more informed embrace of scientific principles could benefit the final legislative product.
Monday, August 2, 2010
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). One recurring theme at the 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. In recent years, similar arguments have been made about the innovation and job-creation potential of carbon regulation and other environmental initiatives.
Let's not reflexively reject the notion that public policies can promote economic growth and competitiveness. Consider the Interstate Highway System. Is the nation’s economy healthier and its standard of living higher by virtue of the massive federal program to construct our network or highways, bridges, and roads? Economists across the political spectrum say “yes,” citing increased safety, workforce mobility, just-in-time delivery of industrial inputs, and the resulting growth of cities in the Sun Belt.
Turing our focus on chemicals policy, one can envision a regulatory framework that might help bring newer, safer products into the marketplace. It would require, on one hand, a fairly burdensome regimen of testing and reporting for existing chemicals (particularly those with indicia of hazard), and greater transparency into chemical formulations and other information now deemed proprietary. This would have to be coupled by more lenient treatment of new chemical formulations, including a comparatively expeditious path to market for those that are likely free of health and environmental concerns.
But is this type of framework embodied in H.R. 5820? Some proponents argue that it is. Dr. Richard Denison of the Environmental Defense Fund said at the hearing that the bill would allow “safer” chemicals to enter the market with less burdensome safety determinations. Stated that way, the argument appears internally inconsistent, because it is safety determinations that are chiefly relied upon to distinguish between good and bad chemical actors. Denison’s written testimony more explicitly defines what he means by “safer”: H.R. 5820 would allow new chemicals to enter the market without safety determinations if they are intrinsically low hazard, are safer for particular uses than chemicals already on the market, or serve critical uses.
What types of chemicals could be considered “intrinsically low hazard”? This category would include substances whose biological action is acknowledged to be benign and compounds with extremely low toxicity. However, most of the promising chemicals that have not yet been commercialized would fall outside of these relatively narrow classes. For these, structure-activity relationship (SAR) analysis would be needed to establish “intrinsically low hazard.” 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.