Be Prepared To Defend Your Product

May 27, 2003

The testing pressures on the chemical industry today are perhaps more significant than ever before. The U.S. Environmental Protection Agency's (EPA) much-publicized voluntary chemical testing initiatives encourage or, more bluntly, subtly compel chemical testing. The business implications of chemical testing for both chemical producers and their downstream users are great.

Chemical manufacturers are engaged actively in several significant chemical-testing initiatives. The High Production Volume (HPV) Chemical Testing initiative seeks to obtain basic screening-level toxicological and related information for 2,800 HPV chemicals. All test data are made publicly available. HPV chemicals that are not sponsored voluntarily by their producers could be subject to Toxic Substances Control Act (TSCA) Section 4 mandatory testing requirements.

Children's health chemical testing is another agency testing priority. EPA rolled out its Voluntary Children's Chemical Evaluation Program (VCCEP) pilot program in late 2000. The pilot program identifies 23 chemicals found in human tissue and the environment for which data must be collected, analyzed and integrated into a "data needs" assessment and risk assessment. All but three chemicals have been sponsored voluntarily by their producers. Again, all test data are made publicly available.

Finally, on Dec. 30, 2002, EPA released its Endocrine Disruptor Screening Program (EDSP) proposal. The proposal sets forth the agency's approach for selecting the first group of chemicals to be screened in the EDSP. Although chemicals selected for screening are not expressly considered endocrine disruptors, the simple fact that they were selected could bring some people to the opposite conclusion.

Industry implications

These testing programs could result in numerous ," and far-reaching ," consequences. Chemicals believed to pose adverse health or environmental effects could be compromised commercially as the pressure to deselect them intensifies.

Environmental activists and other nongovernmental organizations (NGOs) have shifted gears recently and now target key end uses of chemicals believed to be "bad." Nowhere is this trend more evident than in the much-publicized phthalate attack and the very public campaigns against certain plastic uses, most notably in toys and certain medical device applications.

Testing requirements could inspire reporting under TSCA Section 8(e). EPA takes these reporting obligations very seriously.

The potential for toxic tort liability also is troubling. Once a chemical is believed to cause or contribute to an adverse effect, the ripple effect for chemical producers and for consumer products containing the tested chemical are significant. NGO product deselection campaigns are waged in various venues ," through the media, in regulatory settings through the submission of petitions that seek cancellation of certain chemical uses, in the board room through shareholder campaigns and in legislative contexts through proposed legislation.

Be prepared

What should you, as manufacturers of chemicals or of products containing high-visibility test chemicals, be doing now to blunt the possibility of market injury?

1. Learn about and participate in voluntary and other chemical testing initiatives. As chemical producers, you must be aware of and participate in critical chemical testing initiatives. Those manufacturers that miss opportunities ," or are caught flat footed ," could be forced to pay the price.

2. Know your chemicals. You must have a solid understanding of your chemical products, on both a toxicological basis and an exposure basis. The former is infinitely easier to attain than the latter. Producers and downstream users of chemicals must have both, however, to defend continuing uses of chemicals, particularly in consumer applications.

3. Prepare a communications strategy. You must be able to communicate the value of your products and the benefits they offer to your downstream users and to society in general. Prepare position statements, benefits summaries, frequently-asked question-and-answer documents and other "scripts," and make them readily available for distribution when needed.

4. Blunt the potential for product liability. Chemical manufacturers and marketers of the products in which targeted chemicals are included could be named as defendants in lawsuits invited by the new notoriety given to chemical testing initiatives. Lawsuits alleging personal injury ," or claims for medical monitoring of potential latent injuries caused by exposure to targeted chemicals ," are very likely to result from enhanced chemical testing. Review product labeling and other product materials carefully with this information in mind.

Bergeson is a founding shareholder of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm concentrating on industrial and agricultural chemical, medical device and diagnostic product approval and regulation; product defense; and associated business issues. Contact her at [email protected]. The views expressed herein are solely those of the author.

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