IHS Chemical Week


Blog: Chemical Regulations in the U.S. Turn toward Reach


from law firm AllenOvery

When the the European Union's Reach regulation was adopted in 2006, it was regarded as one of the largest and most complex pieces of chemical control legislation to have been introduced anywhere in the world. It reversed the burden of proof so that industry was, for the first time, required to prove that the chemicals they were placing on the market were safe.  It was strongly criticised by Europe's main trading partners, particularly the U.S., which argued that it created a potential barrier to trade. However, there is now increasing evidence that momentum is growing in the US (at both a state and federal level) behind chemical policies nearly as ambitious.

Recent developments suggesting that the tide has now turned towards a more precautionary Reach-style approach include:
* The proposed reform of Toxic Substances Control Act (TSCA), the existing federal regulatory regime for chemicals.
* A twin package of legislation enacted in California requiring the identification, prioritization and evaluation of alternatives for chemicals of concern in consumer products and the establishment of a Toxics Information Clearinghouse.
* The creation of a list of industrial chemicals that present the greatest health and environmental risk by the Environmental Protection Agency (EPA) and the development of new chemical action plans to address those risks.

Depending upon the outcome of these various initiatives, the landscape of chemical control regulation in the U.S. could radically alter over the next decade.

TSCA Reform: still just a pipedream?
Critics and experts have been arguing for years that Congress should revise TSCA, which is the existing federal regulatory regime for chemicals. 
TSCA was first enacted in 1976 and has remained largely unchanged since then. Chemicals that were already in commerce at the time TSCA was passed were considered "existing" chemicals and placed on a TSA inventory.  Anyone can manufacture or use those chemicals without notifying the EPA, although use and exposure reporting has been required in the last few years for high-volume chemicals. For "new" chemicals that were not in commerce at the time TSCA was passed, the EPA has pre-manufacturing review authority, but there is no requirement in TSCA for hazard data to be provided up front; chemicals companies only need to supply such data where the EPA asks for it as part of a 90-day review, which many believe is an inefficient and inadequate process. 
In the past several months, however, increasingly strong support for reform has emerged from a variety of camps.  Federal legislators, the EPA, state governments, industry associations, NGOs and environmental groups alike have all encouraged TSCA amendment and indicated their intentions to participate in shaping chemicals policy.

EPA Administrator Lisa Jackson may have catalyzed much of this recent action when she announced the EPA's "Essential Principles for Reform of Chemicals
Management Legislation" in September 2009.

The American Chemistry Council (ACC; Washington, DC) as well as NGOs and environmental groups like the Environmental Working Group and the Pew Charitable Trusts also co-sponsored a stakeholder conference on TSCA legislation in October 2009, where three industry groups shared their "Building Blocks for U.S. Chemicals Management Policy". The ACC had also previously (August 2009) issued its "10 Principles for Modernizing TSCA." 

These discussions culminated (in December 2009) in a joint hearing of the U.S. Senate Committee on Environment and Public Works and its Subcommittee on Superfund, Toxics and Environmental Health, chaired by Senator Frank Lautenberg. Lautenberg reiterated the need for updated chemicals policy in the U.S. and said that he will soon introduce legislation to amend TSCA. That same day, 13 states released a statement of joint principles for TSCA reform.

Sources now suggest that the House Energy and Commerce Committee's Subcommittee on Commerce, Trade and Consumer Protection is actively working to prepare a new draft of legislation to reform TSCA.  The bill could be brought forth as quickly as within the next three months, subject to an agreement being reached on who will be the primary sponsor of the bill. However, such a bill was eagerly anticipated throughout 2009 with no result, so for now, TSCA reform remains a plan rather than a reality.

Key Areas for Reform
Although the various position statements and proposals mentioned above come from diverse sources, most of them share common ground. Prevalent concerns, many of which echo the basic tenets of Reach, include: shifting the "burden of proof" from government to industry (currently under TSCA, the EPA must demonstrate that a chemical "presents or will present an unreasonable risk" before it can take regulatory action); minimum data requirements for new and existing chemicals (to eliminate the "new chemical bias"); establishment of criteria upon which chemicals are to be prioritized and acted upon;  protection of sensitive subpopulations such as children and pregnant women and increasing public access to data on chemicals; and extending the EPA's authority to involve downstream processors and users.
These proposals for reform have given rise to a number of key areas for concern for stakeholders including:
* Details of what safety standards should look like; criteria that EPA can or should use to evaluate chemicals.
* Appropriate protection of confidential business information.
* How to balance costs, benefits and alternatives.
* Interaction with other regulatory regimes, such as the role of state governments and delegation of EPA authority, pre-emption of state and local laws and overlap with FDA authority.

A major difference between proposed changes to TSCA and Reach is that no bright-line volume trigger for reviewing or evaluating chemicals appears to be on the table for TSCA. Some U.S. stakeholders fear that using production or import volumes as a proxy for impact analysis may capture many low-risk chemicals.
Some industry representatives have urged legislators to reject any proposals that would make TSCA too similar to Reach, describing such a sweeping overhaul as unnecessary and unwise. However, if such changes are to be introduced, companies will be anxious to ensure that any data they have produced to comply with Reach can be carried over and taken into consideration in any scheme implemented under the TSCA revisons.

EPA Not Waiting for Congress
Although it appears increasingly likely that Congress will act in 2010 to amend TSCA, the EPA has thrown down the gauntlet (perhaps to keep the pressure on Congress to legislate) and is seeking under its current authority, to identify industrial chemicals that present the greatest health and environmental risk and to address those risks with new chemical action plans. 

The EPA is developing an initial list of chemicals based on available data, and released its first action plan on December 30, 2009, covering four groups of chemicals. The action plans include initiating rulemakings for limitations or bans under TSCA, taking enforcement actions on notice and reporting issues, and developing alternatives assessments. 

The EPA intends to issue action plans for about four chemicals or groups of chemicals about every four months.  EPA representatives have stated that they intend to initially target chemicals that have high exposures, particularly to vulnerable populations such as children, and that they will continue to issue action plans until they are no longer needed or TSCA is reformed.

California Leading the Charge
The EPA is not the only catalyst to reform: A number of states, counties and cities across the U.S. have already taken matters into their own hands. The most high profile example is the comprehensive chemicals program signed into law by California in September 2008, which may turn out to be a prototype for legislation in other states.

The new program comprises a two-part legislative package: Assembly Bill 1879 which requires the Department of Toxic Substances Control (DTSC) to identify, prioritize and evaluate alternatives for chemicals of concern in consumer products and Senate Bill 509, which requires the DTSC to also create a Toxics Information Clearinghouse for the collection, maintenance and distribution of specific chemical hazard traits and environmental and toxicological end-point data that must be accessible through the Internet. The DTSC must adopt regulations establishing these processes on or before 1 January 2011. 

The Californian programme shares several key traits with the Reach regime as it also focuses upon addressing marketplace data gaps, generating new information about chemicals, and measuring chemicals against each other in terms of relative hazards and risks, as well as emphasizing public access to information about chemical substances. Unlike Reach, the laws appear initially to require action by regulators rather than industry, it seems clear that the DTSC's implementing regulations will impose on industry the groundwork and financial burden of these initiatives.

Both bills explicitly require the DTSC to reference and use, to the maximum extent feasible, available information from other nations, governments, and authoritative bodies that have undertaken similar chemical prioritization processes, which may be a direct reference to Reach.

The main difference between California’s proposals and Reach is that California is concerned primarily with chemicals as they are used in consumer products, as opposed to chemical substances on their own or in industrial products and settings. That said, the scope of the California law, as drafted, is still quite broad, since "consumer product" is defined as "a product or part of the product that is used, brought or leased for use by a person for any purposes" (with the exception of dangerous drugs or devices, packaging, food, pesticide, etc.). The DTSC's identification and prioritization process must take into account the volume of each chemical in commerce, the potential for exposure to the chemical and potential effects on sensitive subpopulations, including infants and children.

Once the chemicals of concern are identified, the DTSC's evaluation of alternatives must include numerous factors including for example, materials and resource consumption, water and air impacts, waste and end-of-life disposal, public health impacts and economic impacts. If the comparison to Reach proves apt, industry should prepare to face a time-consuming and costly process of gathering and generating new information about chemicals as well as coping with the risk that certain chemicals and process materials may become prohibited or unavailable.
California has also recently seen additional legislative proposals—as have other states such as Massachusetts, Connecticut, Vermont and New York—with a Reach-like aim to identify and prioritize toxic substances, and state legislators and agencies have stated that they intend to maintain their leadership role and pursue further chemicals legislation in 2010 and beyond.

Many North American chemicals companies may, when assessing the potential impact of Reach upon their European markets, have given silent thanks that the same requirements did not apply at home. It seems clear that, in fact, domestic regulation of chemicals may now follow a similar path, although developments across different states are far from uniform and TSCA reforms may take several years.

Against this backdrop, those manufacturers who have exported substances to European markets may ultimately end up having an advantage when dealing with new domestic requirements given their knowledge and experience of Reach and the data they may have accrued as part of the Reach registration process.

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