GxP Perspectives

The difference in approach to regulation between the European Union (EU) and the United States has been the topic of conversation with a lot of people developing drugs and medical devices. This could change as the U.S. FDA and the European Medicines Agency have increased their collaborative efforts. The EU is trying a new approach to the regulation of chemicals, paralleling the jurisdiction of the Environmental Protection Agency.

In this Guest Commentary Sid Olufs, a professor at Pacific Lutheran University, discusses REACH, which is a new program in the EU for the regulation of chemicals. You can read book reviews by Sid on the page at the top of the blog on topics of regulation, food safety, and public health policy.

GUEST COMMENTARY: REACH—A New Approach to Regulation of Chemicals.

By Sid Olufs

The European Union (EU) has embarked on a far reaching regulatory undertaking—to investigate the chemicals we release into the environment, and move toward enactment of a precautionary approach. This means that some chemicals could be used only for specific applications, after being tested for effects on the environment and human health. REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) was passed in 2007, and is now in the early stages of implementation.

The European Chemicals Agency (ECA) is empowered to enact REACHs many provisions, including choosing a list of “substances of very high concern” (SVHC) that will be the first targets of scrutiny. This has been a focus of intense political conflict, as chemical companies want a very small list of SVHCs, while groups that favor regulation want a large list. The current list of the ECA contains 34 chemicals, several of them alternative versions of a single substance. The NGOs that favor stronger regulation are advocating a list that contains 356 chemicals at present, and is likely to grow.
One surprising feature of REACH is how little attention it receives in US media outlets. This is unfortunate, because it is a big deal for US chemical companies, manufacturers, exporters, farmers, and food companies.

In the United States, efforts to substantially reform TOSCA (the Toxic Substances Control Act of 1976, our main law dealing with chemicals) broke down in 2010. TOSCA does not use a precautionary approach. After minor review, usually conducted by the companies that produce them, new chemicals and new uses for old chemicals are applied in the environment. However, even under existing law REACH will have significant effects in the United States, in several ways.

• The EU is a large market for companies that manufacture or use chemicals in their products. The EU has half again as many people as does the US.

• The US imports many chemicals and items containing chemicals from the EU. The possible effects on the availability and labeling of these substances could be large.

• Existing US law (TOSCA, for example) contains triggers for more aggressive regulation that may be set off by REACH. For example, currently the EPA may require investigation of a chemical that it reasonably expects to cause harm, but usually it may not conduct the research that would produce those reasonable expectations. Yet the giant pile of data produced under REACH will doubtless contain grounds for such expectations. Environmental groups will probably resort to courts to require the EPA and other agencies to launch more aggressive regulation, particularly if the party controlling the White House is against enhanced regulation.

• Agencies that regulate chemicals and substances for which chemicals are used in their production will be faced with that giant pile of data from REACH. As a recent report on the FDA noted, for example, the agency is not prepared to deal with its present responsibilities for managing information. This will get much worse without substantial change, and money.

Since REACH will produce a very large amount of scientific data that may have policy consequences, we can expect a struggle over the interpretation of the science. One focus of conflict will be over the use of QSARS (Quantitative Structure/ Activity Relationships), which allows rapid testing of many substances.

We can also expect a well-financed effort to produce material that will cast doubt on efforts to regulate, perhaps as intense as in the case of climate change.

For those interested in reading more about REACH and its possible effects on the US, please check this web page—it has links to websites of the ECA, industry associations and NGOs interested in policy. It also links some of the best research comparing REACH and US approaches to regulation.

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This entry was posted on Sunday, November 14th, 2010 at 5:22 PM and is filed under Commentaries by Guest Writers. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.