Saturday, April 25, 2009
Coming soon to a Federal Register near you, the USEPA is expected to publish its third list of high production volume (HPV) chemicals. Technically the "list" is a proposed test rule authorized under Section 4 of the Toxic Substances Control Act (TSCA). Affected industry and other stakeholders will have time to provide comment on the approximately 29 HPV chemicals on the list, after which the EPA will publish a final rule. For the previous two test rules industry was given approximately 24 months to complete the specific health and safety testing identified in the rule.
This test rule is part of the ongoing process stemming from the voluntary HPV Chemical Challenge Program, which was initiated in 1998. Under the program, companies were asked to compile available environmental health and safety data on a list of 2,800 chemicals that were manufactured in or imported into the U.S. in quantities of greater than one million pounds. But several hundred of these were not sponsored by industry and thus were considered "orphan" chemicals. Since then EPA has been slowly reviewing the available data and issuing - now mandatory - requirements for companies to test these chemicals.
The process has been quite lengthy. The first rules was proposed in 2000 and only finalized in 2006. Another proposed rule was published last year and has yet to be finalized. The fact that the process takes so long and handles only small numbers of the thousands of chemicals on the Inventory has been part of the impetus leading some activists to argue for reform of TSCA. In short, the feeling is that there has to be a better way to ensure that chemicals are proven safe being placed, or continuing to be placed, on the market.
Which gets the crux of the problem. While the voluntary HPV program and these testing rules focus on only the highest production volume chemicals - an important prioritization tool but limited in scope - there are approximately 63,000 chemicals that were grandfathered onto the TSCA Inventory without substantive review. Add to that the 30,000 new chemicals added since then in which very limited data were actually provided, thus requiring EPA to assess them largely based on modeling and comparison with chemicals of similar structure.
The ChAMP process is starting to look at medium production volume chemicals, that is, those greater than 25,000 pounds. There is also a desire at EPA to extend ChAMP to looking on inorganic chemicals and to "reset" the TSCA Inventory, though these "enhancements" are currently under review by the new administration. All of this leads into what both advocacy groups and industry agree is a need to revamp the TSCA law. Industry favors something more like ChAMP, while many advocacy groups prefer something more like the Kid Safe Chemical Act that has been introduced in Congress twice before (though was never acted upon even in committee).
Some of the many issues driving TSCA reform include the problem that increased testing (which is needed to prove safety) means increased used of animal models, which animal welfare advocates such as PETA find objectionable. Whether the onus should be put on EPA to review and prioritize chemicals for testing, e.g., via the test rules above, or on industry to do a full suite of base set testing to prove safety is also a subject of heavy debate. As is how much any new law should subsidize "green chemistry" and substitution mechanisms that would either encourage the development of inherently safer chemicals and/or force more hazardous chemicals off the market even though safer substitutes may not be available. Furthermore, should the new law mandate or encourage the development and use of new assessment methods such as in vivo being defined by the National Center for Computational Toxicology’s ToxCast Program. While these tests will eventually lead to less animal testing, they carry a greater degree of uncertainty as to what any observed results might actually mean, as I have noted in a previous post.
So, the end result of TSCA Reform is still too far away to accurately predict. But as I will continue to discuss on these posts, there are several areas of agreement that are beginning to emerge.
Sunday, April 19, 2009
It's a done deal. Okay, not actually a "done deal." But it seems clear that some sort of TSCA reform is on its way. TSCA, of course, is the Toxic Substances Control Act, which has been the authority for chemical control in the US for over 30 years. Not much has changed since it was passed, and not many of the 63,000 chemicals grandfathered onto the TSCA Inventory have had comprehensive data reviews. New chemicals, on the other hand, all have gone through some review by the EPA, but even here there is no requirement to provide health and safety data so most of the analysis is done by computer modeling and comparison to similar chemicals.
As reported here previously, Senator Lautenberg and Representatives Waxman and Solis introduced the Kid Safe Chemical Act back in 2005 and again in 2008. On both occasions it never got out of committee. Senator Lautenberg is adamant that he will reintroduce it this year. But then what?
In a recent hearing both industry and advocacy groups provided their input in to what TSCA reform should look like. Industry, in particular Cal Dooley of the American Chemistry Council, acknowledged that some sort of TSCA reform is necessary. Environmental groups such as the Environmental Defense Fund agreed that a change is needed. But the agreement stops there.
There are two main options on the table, with lots of options in between. One option is to reintroduce the Kid Safe Act, which would be a radical departure from the current TSCA law, and a bit too close to the European REACH program for industry's tastes. Some environmental groups, e.g., the Environmental Working Group, are in favor of the Kid Safe Act approach. Industry favors something that tweaks the current authority incumbent in TSCA but perhaps not assertively used enough in the past by EPA. EPA itself seems to be leaning in favor of TSCA reform that looks much like its current ChAMP program. Industry generally agrees with that idea.
The difference of opinion is largely one of who has the onus. With the current TSCA and ChAMP, the EPA has the onus of determining that a chemical is not safe, something that has been hard to do given the lack of data available for most chemicals. With the Kid Safe Act and other REACH-like options, the burden shifts almost entirely to industry to prove their chemicals are safe enough to remain (if already existing) or be put (if new) on the market. There are advantages and disadvantages of each approach, which I will examine in coming posts.