TSCA: Pre-Manufacture Notification and Review

TSCA reform promises to significantly alter the chemical marketplace. Contemplated changes will have a profound impact on all industries that manufacture, distribute, modify or utilize chemicals, articles or mixtures. Recognizing the magnitude of this potential impact, Science News & Views intends to provide substantive monitoring and analysis as the legislative process proceeds. Today, we will examine the current and proposed system of pre-manufacture notification and review of chemicals, a controversial aspect of the existing statute.

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Section 5 of existing TSCA prohibits the manufacture, processing, or import of a “new chemical substance” or “significant new use” of an existing substance unless a pre-manufacture notification (PMN) is submitted to EPA at least 90 days in advance.

Section 5 does not currently require a submitter to conduct testing before submitting a PMN, but merely to provide any information on health or environmental effects that are in its possession. During the 90-day review period, EPA is to utilize this and other information to determine whether the chemical “may present an unreasonable risk of injury to health or the environment,” and if so, to request more data, prohibit or limit manufacture, or halt the review process. In practice, the dearth of data accompanying submissions impairs the agency’s ability to make informed judgments about the safety of a given compound. Reform advocates cite this as a key weakness of the existing statute.

The proposed bills would toughen the Section 5 PMN and review process. Both the House and Senate would subject new chemicals and uses under Section 5 (as well as existing chemicals under Section 6) to the requirement of 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 carcinogenesis 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. Both bills would give EPA the power to compel testing by administrative order and to specify appropriate methodologies. The House bill would allow the agency to to assess fines for non-compliance.

The PMN and minimum data set provisions will likely be the subject of debate and modification, particularly the timetables for implementation. Recent changes to chemical regulation in Europe help illustrate this point. The REACH law imposed similarly aggressive benchmarks for generation and submission of test data. This approach has proved to be impractical, time-consuming and expensive to implement.

Are we on a similar path with a new TSCA?

Clearly early engagement with legislators to help craft a smart and effective chemical regulation, one that protects human health and the environment in a cost-effective, rational manner, is critical.

TSCA Reform--Moving Forward

In a move which may signal growing momentum for chemical regulation reform, leaders of the House Energy & Commerce Committee introduced TSCA modernization legislation (H.R. 5820) and scheduled a subcommittee hearing for July 29, 2010. We will continue to provide monitoring and analysis of this bill and its Senate counterpart as they move through the legislative process.

Regulating Wood Dust - Is There A Better Way?

California OSHA is in the process of updating permissible exposure limits (PELs) for a number of airborne substances found in the state’s workplaces. Currently under review is wood dust, a byproduct of wood milling, sanding and routing in businesses ranging from small custom cabinetry shops to the largest sawmills and flooring producers. The history of wood dust regulation provides an interesting window into the interaction between researchers, federal and state safety agencies, courts and non-governmental standard setting bodies.

Wood dust first came to the attention of health researchers in connection with nasal adenocarcinoma. In the 1960's, English scientists observed a much higher than expected incidence of tumors in High Wycombe, an area northwest of London that was then a center of the furniture and cabinet industry. Adenocarcinoma cases were several hundred times more common among this group than among comparable industrial workers. When U.S. researchers attempted to replicate these findings, however, they found much lower relative risks associated with occupational wood exposure. In fact, pooled analysis of 220,000 woodworkers studied in North Carolina and Virginia identified only three cases, about what would be expected among the general public.

In light of this ambiguous evidence, U.S. OSHA proposed a fairly reasonable 5 mg /m3 standard for total dust as a time-weighted average (TWA) in 1989. This level, which was supported by key woodworking industry organizations, essentially required older plants to adopt the dust-control technologies such as cyclones and baghouses already being implemented by newer facilities. Unfortunately, OSHA compiled the wood dust standard with proposed PELs for hundreds of unrelated airborne substances. In 1992, a federal court found that not all of these standards were supported by good science and invalidated all of them.

Technically, that left wood dust regulated as a “nuisance dust” at 15 mg/m3. However, state occupational agencies (including Cal OSHA) adopted the 5 mg standard for total dust, and federal OSHA retained the power to cite dusty workplaces under its General Duty Clause. Recent workplace monitoring shows that the vast majority of work stations in woodworking facilities meet the 5 mg level. For example, Glindmeyer (2008) found inhalable dust samples ranging from 0.82 to 2.51 mg/m3 across a group of ten plants, which included furniture, kitchen cabinet, and flooring facilities as well as a sawmill. Geometric standard deviations ranged from 2.1-2.8 mg/m3.

About 15 years ago, researchers began focusing on non-cancer effects of wood dust. The concern was that long-term occupational exposure could compromise pulmonary function. This placed renewed focus on the smallest “respirable” dust particles most likely to reach the lungs. Generally, these measure 2.5 microns or less, the same size as the PM 2.5 particulate matter that have been the subject of ambient air regulation over the last decade.

A concern about the respirable fraction of dust and its impact on pulmonary health has informed analysis and standard setting in recent years. The American Conference of Governmental Industrial Hygienists (ACGIH) has set a recommended threshold limit value (TLV) of 1 mg/m3 for inhalable dust of most wood species. Cal OSHA is evaluating a mandatory PEL of 1 mg/m3 total dust. The agency’s health effects advisory committee wrote earlier this year that “the history of lung disease findings at higher wood dust exposure levels, with recent lower wood dust dose studies showing no or little adverse effect, and the … carcinogenicity of wood dust vis. a vis. sino-nasal cancer [supports] lowering the PEL to 1 mg/m3.” A committee charged with evaluating the technical and economic feasibility of this standard meets this October 6 in Oakland.

Deliberations over wood dust spotlight a complex interaction between researchers, state and federal regulators, industry, and the courts. This is probably not a decision-making apparatus that any of us would design from scratch. However, it has arguably responded effectively to emerging research and technological innovation. Is there a better, time and cost-effective approach?

We welcome your comments.

Pairing Risk Management and Communication

We welcomed, along with the rest of the country, encouraging news about the installation of the latest containment cap on the Macondo well. This development may represent an important step in controlling the Gulf oil spill. Currently, pressure readings are being gathered to demonstrate the structural integrity of the well and crude reservoir, which would allow the cap to remain sealed. Alternatively, the dome is equipped to vent up to 80,000 barrels per day to surface ships, which would eliminate most if not all of oil discharges into the Gulf.

Efforts to contain the Macondo well fostered a constructive debate on the concepts of hazard and risk, and on the phenomenon of comparative risk. As millions of barrels of crude flowed into the Gulf during the Spring and early Summer, response authorities were faced with an emotionally-charged decision about the use of chemical dispersants to mitigate the ecological impacts. Dispersants are typically mixtures of solvents and other compounds designed to separate oil into smaller globules, which are more likely to be diluted to safer levels by currents and broken down by bacteria. The public and the media directed a great deal of focus on the chemical properties and toxicity of the dispersants, and whether they were making an environmental tragedy worse. An estimated 800,000 gallons of dispersants had been employed by June, both on the surface and around the leaking wellhead and riser pipe.

The principal dispersant used in the Gulf has been several versions of Corexit ®, a product of Nalco Holding Company. These reportedly contain 2-butoxyethanol and a proprietary organic sulfonate, along with low levels of propylene glycol. On May 19, EPA directed BP to deploy less toxic alternatives, or to justify its choice of Corexit over those products. BP cited an inadequate supply of most alternatives, and noted toxicological concerns about a more widely available dispersant. That chemical, marketed by Alabaster Corporation as Sea Brat 4 was itself less toxic than Corexit, but BP noted the risk that it could degrade into nonylphenol, which is environmentally persistent and toxic to some marine life.

Based on this information, on May 26 EPA approved the continued use of Corexit, but directed responders to significantly decrease the overall volume used and to cease use of dispersant on the surface whenever mechanical controls such as booms and skimmers could be relied upon. EPA also began its own testing of eight dispersants on native shrimp and fish species. Initial peer reviewed results announced in July indicated that neither Corexit nor the alternative products studied displayed biologically significant endocrine disruption.

The Agency’s approach to dispersants, the assessment of their hazard, and the risk-benefit analysis of their continued use demonstrate the value of sound, risk-based decision-making. Unfortunately, this thoughtful and deliberative process was overshadowed by an ineffective communications plan which failed to reassure the media and public as to the need for dispersants. In general, the inherent toxicity of these chemicals is far outstripped by crude oil. And yet the Agency, in their most recent press briefing, devoted more time and effort explaining the toxicity testing performed on the dispersants and less on the known toxicity of oil and the ecological devastation which its unfettered spread would visit on the region’s estuaries and beaches.

In our experience, risk management is never as effective as when it is coupled with a sound communications plan. Going forward, one would hope that the Agency improve their ability to articulate the risks and benefits associated with their decision-making so that concern over the response to a problem does not hinder action against the primary threat.

Inaugural Post

Welcome to Science News & Views. This forum will explore how decisions concerning hazard, risk, human health and the environment shape modern life. We'll do this by highlighting news events, recent publications, and current trends in the scientific and policymaking communities. We believe this exercise will illustrate how business and consumers are impacted by good (and bad) policy and suggest how decision-making may be improved.

To kick things off, we'll take a look at a recent interview with Richard Hubner about product safety regulation. In this Q & A, Rich argues that elected officials and their staffs are ill-equipped to micro-manage regulatory decisions concerning risk. Instead, they should establish coherent legal frameworks and funding levels for regulatory agencies, put them to work developing risk-based performance standards, and hold them accountable. Rich also urges legislators to get back in the business of oversight, using hearings and subpoena power to monitor the work of regulators--in an ongoing fashion, not just when high profile events compel their attention and intervention.