Latest cry for transparency in the Washington Post: “Use of potentially harmful chemicals kept secret under [TSCA] law” http://bit.ly/4zTzjC
Yes, there are companies who claim too much information to be secret under TSCA, including the very identity of a chemical.
But then there are valid reasons that some chemicals are claimed confidential. When a company has invested a lot of money to develop a new chemical molecule, it'd be nice not to have to give it away in a government document available to the public - especially potential competitors. Chemicals for which PMNs and 8(e) notices have been filed are mostly at the R&D stage when But that doesn't have to mean there is no public information. In general, generic names must be provided that reveal as much as possible, especially about structures that have toxicity concerns. Companies have naturally pushed the envelope of what they can get away with.
How do they get away with that? EPA requires up front written substantiation under TSCA with regard to the submission of new chemical notifications under TSCA PMNs and notices of substantial risk (8(e). But the agency has been less than rigorous about always vetting the substantiation of those claims. And even if they do push back initially, over time the validity of the claims may disappear. Companies that have placed the chemical on the market where competitors can analyze it, or even when the company advertises the chemical composition, there is no requirement to withdraw the claim they made years ago. But sometimes the claims of trade secret remain valid - especially for site limited intermediates and hard to analyze compositions.
Frankly, going back and resubstantiating claims is a huge pain - for companies and for EPA. But maybe necessary, at least for certain categories of chemicals. If a chemical never makes it to sustained commercialization (a large portion of new PMN chemicals) there's not much point. But after a certain significant volume (10,000 kg?) is marketed, maybe so.
But what about those statements made in the article?
- "95 percent of the notices for new chemicals sent to the government requested some secrecy" Hmmmm... "some secrecy" like how much they were going to make? the specific uses? what plant sites were going to make it? Business plans that are still in the works, since PMNs have to be submitted several months in advance of the first commercial molecule being made?
- "...more than half of the 65 "substantial risk" reports filed with the Environmental Protection Agency involved secret chemicals." That's because most of these notices are triggered by toxicity studies being conducted on R&D chemicals. Some of them are never PMN'd or commercialized because of the rotten tox results seen in these screening efforts. The whole point of TSCA, after all.
- "Of the 84,000 chemicals in commercial use in the United States ... nearly 20 percent are secret" First, EPA does not know if there are 84,000 chemicals in commercial use. Only 6,200 were reported under the last Inventory reporting (albeit polymers and inorganics and chemicals made under 25,000 lbs weren't reported). A general rule of thumb is that only 10% of R&D efforts generate any first year sales. And many of those fail to last in the marketplace.
- "Of the secret chemicals, 151 are made in quantities of more than 1 million tons a year and 10 are used specifically in children's products, according to the EPA." Not sure where this came from. EWG claims 151 over 300,000 lbs, 10 in children's products. Not quite the same as a million tons. EPA hasn't said how many, if any, of the Inventory Update reports claimed chemical identity secret. Surely they would have touted that if it had occurred. I don't know where these numbers come from.
- ZetaFlow and Firemaster 550 allegations. I don't know enough to comment. I do believe that companies should provide doctors information needed to treat their patients (which may or may not include a specific chemical identity that an MD hasn't a clue what it means). My experience is that the toxicologists in a company will talk to doctors. What they don't do is contribute to fishing expeditions. If necessary, confidentiality agreements can be prepared with academic and NGO researchers.
- If you need help figuring out what legitimate confidentiality claims to make for TSCA contact EHS Strategies, Inc.
Bottom Line: I think there is opportunity under today's law to appropriately use trade secret protection and to share sufficient information to do risk assessment and management. If reform is needed, it may include resubstantiation of some, but not all, claims and enforcement of the rules.
News 1/21/10: EPA says it won't allow confidentiality for chemical identity substantial risk notices under TSCA 8(e) if the chemical identity appears on the TSCA Inventory. In general this seems OK, particularly since companies can hide their identity and use information that may be in the notice. But once in a blue moon there might be legitimate claims. EPA seems to allow for that by giving the company a chance to prove the claims are valid.