Monday, February 8, 2010

What Will Be in the Kid Safe Chemical Act - Random Thoughts on TSCA Chemical Reform

I'm running a bit behind today so will give you some quick thoughts on some of the things to look out for in the new Kid Safe Chemical Act (which I presume it will still be called) to reform the old Toxic Substances Control Act law.

1) Expect to see some sort of requirement for companies to provide at least a base set of health and safety data when they apply for approval of new chemicals. Currently the PreManufacture Notification (PMN) for new chemicals only requires a company submit whatever data is "readily available," which usually means next to nothing. Figure on that changing.

2) Expect to see some way to prioritize existing chemicals for closer evaluation. Most chemicals were grandfathered onto the TSCA Inventory when the law was enacted, so about 60,000 chemicals have had virtually no review at all. (At least the other 20,000-30,000 got the cursory PMN review as new chemicals). With other countries revisiting their Inventories of existing chemicals, the pressure is on the US to do the same (though not necessarily in the same way).

3) With that in mind, expect the TSCA Inventory to be "reset." Under the ChAMP program that was shelved in mid 2009 as ineffective, there was a conceptual plan to eventually cut the Inventory of chemicals down from about 85,000 or more listed to a much smaller number to be evaluated. For years industry has been saying that the Inventory doesn't reflect the actual number of chemicals still on the market, which they have estimated to be as low as 7,000 to as many as 25,000. By resetting the Inventory to only those currently on the market EPA would accomplish two things: (1) make the list more manageable for health and safety assessment (why assess it if no one is making it), and (2) put companies in a position of having to provide adequate health and safety information for any old chemicals that they then wish to start manufacturing again.

4) Expect to see biomonitoring playing a significant role. There are two ways this could happen. One is to require biomonitoring for some chemicals if there is a concern that they may build up in the body. That seems less likely given that if there is a bioaccumulation concern it is more probable that the chemical will be severely restricted. However, it might be used in the same way that "Authorization" (the "A" in REACH) is being used in Europe, that is, as a mechanism for phasing out chemicals and replacing them with something safer. The more immediate use of biomonitoring will be to identify chemicals that will get higher priority for closer evaluation. Both stringent government programs (e.g., the CDC and NIEHS analyses) and more anecdotal private studies (e.g., the EWG study and mother who testified at the hearing) consistently show that there are dozens, even hundreds, of chemicals in our bodies. While in almost all cases the levels are far below any level that has been shown to be a problem, the fact that there is a "body burden" at all is offensive to many of the public and thus must be considered an important metric.

5) Expect some flexibility. While there likely will be a standard set of data requirements for new chemicals and old, there are many ways to fulfill these requirements other than straight animal testing. Given the lobbying power of the animal welfare groups, I would expect the new law to allow use of computer modeling, read-across from similar chemicals, and grouping techniques. This is essentially what the EPA currently does, but the onus is likely to be shifted to industry now. Also, the new law will likely allow flexibility to use the more advanced technologies as discussed in the "Toxicity Testing for the 21st Century" report and as being evaluated now in the ToxCast program. So, definitely new testing and heavier data requirements, but a more flexible approach that takes advantage of all types of sound science.

More to come!


Samantha said...

Hi Dake,

I've been reading your blog and wondering if you know about Safer Chemicals, Healthy Families? We are a coalition of groups from around the country working to reform TSCA. I would love it if you would check out our site, and get involved with us!

Let me know! Thanks for your blog, it's great!

Dake said...

Hi Samantha

Yes, I have heard of Safer Chemicals, Health Families. I appreciate that there are people out there who are working hard to improve how we manage chemicals.

Keep up the good work and let me know if there are any issues that you think are important for me to discuss.

Kristie said...

Hi, Dake. My colleagues and I have been following TSCA because we are concerned about whether any revision will rely on animal toxicology, or become an instrument for reform of the field.

Your column has been helpful and I'm glad to see you have such faith in our lobbying power! All the same we would really appreciate a post dedicated to exploring some of the considerations around animal-based toxicology and alternatives to it.

We think ensuring flexibility by avoiding a checklist of data requirements, requiring alternatives be used when available, and investing in new methods are good principles to ensure a win for all stakeholders.

I'd be happy to talk further on this if you like.

Kristie Sullivan, MPH