EPA's Champ emphasizes efficiency

Champ enters the race

16 April 2008 17:29  [Source: ICB]

The US EPA's new chemical assessment and management program, Champ, reflects an American approach to regulation

Clay Boswell/New York

THE US Environmental Protection Administration (EPA) debuted "Champ," its new Chemical Assessment and Management Program, last month. According to the EPA official directing it, the initiative is not meant to compete with the EU's Registration, Evaluation, and Authorisation of Chemicals (Reach), but there is no question that the chemical industry would prefer that the US initiative were emulated globally in preference to the EU's more onerous program.

Whether that occurs will likely depend on whether Champ can achieve a similar outcome for less money, in less time. That will in turn depend on the support of the chemical industry, which is being asked to voluntarily comply with the program's ­objectives, and perhaps, as well, on the ­support of Congress, which would provide additional resources.

Reach may still become the de facto global standard, however, because any firm that wants to participate in the large European market will have to conform. Around the world, chemical businesses will have to decide whether the opportunity cost is justifiable.

BIRTH OF A REGULATION

The outlines of Champ were announced at the conclusion of an August 2007 ­meeting of US President George W. Bush, Canadian Prime Minister Stephen Harper and Mexican President Felipe Calderon in Montebello, Quebec, for the Security and Prosperity Partnership (SPP) of North America's Leaders' Summit. In the resulting agreement, the three countries committed themselves to cooperative action on several fronts, one of which was to coordinate efforts to assess and take action on industrial chemicals.

The US committed to complete risk characterizations and to take action, "as needed," on more than 9,000 chemicals produced in volumes over 25,000 lbs (11 tonnes)/year by 2012. The three partners agreed to share scientific information, technical understanding, best practices and research on new approaches to chemical testing and assessment. They also set goals to be met by the year 2020, including the creation and updating of chemical inventories in each country, as well as the coordination of chemical management in North America as outlined in other international agreements.

Champ is the US contribution to the "Montebello Agreement," but its origins extend further back in time, according to Jim Willis, director of the chemical control division in the EPA's office of pollution prevention and toxics. Indeed, Champ is not an entirely new program, but an extension of the EPA's High Production Volume (HPV) Challenge, a voluntary program begun in 1998 in collaboration with the environmentalist group Environmental Defense, the American Petroleum Institute, and the American Chemistry Council (ACC).

Under the HPV Challenge Program, companies are "challenged" to make health and environmental effects data publicly available on chemicals produced in, or imported into the US in quantities of at least 1m lbs/year. As of June 2007, more than 2,200 HPV chemicals have been sponsored. Of these, about 1,400 were sponsored directly through the HPV Challenge Program, and over 860 chemicals were sponsored indirectly through international efforts. About 300 remain unsponsored "orphans," however.

"We built [Champ] first on the HPV data, because we have data now in hand on a couple of thousand chemicals or categories of chemicals," says Willis. "We also have the new Inventory Update Recording [IUR] data, where we have not just production volumes, but also a lot of exposure related information."

Drawing on hazard, exposure and risk-screening characterizations, in addition to other information such as biomonitoring, the EPA is developing "risk-based prioritizations" for the HPV chemicals, initial evaluations that will be used to prioritize future action based on risk concerns or gaps in the available data.

The roughly 6,500 chemicals produced in volumes between 25,000 and 1m lbs/year are known as medium production volume (MPV) chemicals. The assessment of these MPV chemicals is a new initiative begun as part of Champ.

"We will be taking the same sorts of ­prioritization-based decisions, but clearly the cases are not always going to be as data-rich, and so they'll probably be targeting steps to collect additional data," Willis notes.

"We can use HPV data to a certain degree, because they are members of the same categories, for example. We will have IUR data for those MPV chemicals. Plus, we have a number of assessment-related tools that we have developed in the New Chemicals Program."

These tools, based on quantitative ­structure-activity relationships (QSAR), address a range of properties, ­including environmental fate, aquatic toxicity, ­persistence and bioaccumulation, as well as health effects such as carcinogenicity.

An HPV-like program is also being considered for inorganic chemicals.

"The original HPV Challenge was for just organic chemicals, and it looks like there may be several hundred inorganic HPV chemicals on the inventory," Willis explains. "We'll be exploring this over the next several months. There are a number of technical and substantive issues that are different from the organics."

To facilitate Champ, the EPA is "resetting" the Toxic Substances Control Act (TSCA) inventory to better reflect the market. Chemicals that are no longer in production will be removed if a firm wants to bring one back to market, it will have to be evaluated by the New Chemicals Program, which provides a new opportunity for testing and risk assessment. Willis expects about 20,000 chemicals to come off the inventory.

The screening achieved by Champ will have real consequences. "We see some regulation coming out of this," says Willis.

FINDING RESOURCES

The TSCA states that the EPA should not fund chemical testing, and regulatory action may be necessary for chemicals that do not find a sponsor, or "orphans." There will, nonetheless, be costs associated with the program. Some resources may be freed up by new electronic reporting capabilities, extending to premanufacturing notification, which will eliminate considerable manual processing.

"Without reprogramming resources internally, 2012 is not a very attainable ­target," Willis acknowledges.

The chemical industry also plans to press Congress to expedite additional funding.

"For US chemicals to survive Reach, the EPA will need our support," Joe Acker, president of the Synthetic Organic Chemical Manufacturers Association (SOCMA), has said. Both the American Chemistry Council (ACC) and SOCMA have questioned the need for a program as elaborate as Reach.

"Reach is an extremely complex process to achieve a simple outcome," says Bill Allmond, director, government relations at SOCMA. "As proposed, Champ is a much more practical and efficient process to achieve a similar outcome. However, a number of our members are having to participate in Reach, so, for them, it may not be a question of which model is preferred."

Reach will require the registration and characterization of every chemical sold or manufactured in the EU in volumes of 1 tonne or more, even isolated synthetic intermediates.

EPA Administrator Stephen Johnson has similarly stated that, while the EPA supports the goals for Reach, "we believe that effective protection can be obtained through a more targeted and strategic approach to chemical assessment and management." Champ, by building on existing efforts, not only at the EPA, but also by Canada, "will enable us to act more quickly, efficiently and cost-effectively on a greater number of chemicals," he asserted at the program's debut.

However, the EPA has not developed Champ to compete with Reach, says Willis. He notes that the head of the new European Chemicals Agency (ECHA) will be visiting Washington, D.C., shortly to discuss coordination between the two programs.

"It's fine enough to have a friendly rivalry, to see who can make the most progress in a number of areas, but we've done our best to avoid actual or even the appearance of trying to compete or outdo one another," he says. "That just doesn't serve anyone."

Willis suggests that the differences in the two approaches should be viewed in light of the historical and legal context of their adoption.

"There's no reason why we can't both have a great approach," he says. "Let's see how this plays out in the next couple of years. I'm sure both the US and Europe are flexible and can adapt to changing conditions."

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