Friday, June 4, 2010
As I noted yesterday, not everyone is happy with the way things are panning out on the House "discussion draft" version of the Toxic Substances Safety Act, aka, TSCA reform. House members have been having stakeholders meetings since it's unveiling in April, and a formal bill is expected to be introduced this summer. One stakeholder group, the Society of Chemical Manufacturers and Affiliates (SOCMA) is worried that “the potential universe of chemical substances, and the burdens of the new law, would skyrocket.” Specifically, they note:
1) The "sheer scope and the lack of definition" of the bill will be unworkable. Because EPA would receive "300 minimum data sets" within 18 months after it finalizes the priority list, and they would be required to act on them within 6 months, SOCMA fears that there would not be time for peer review and thus the safety determinations would be rushed and not in sufficient depth for decision-making.
2) The draft doesn't seem to authorize collection of data from downstream users, which means all the use and exposure data would still come from manufacturers, who don't always know how their chemicals are used by others.
3) The definition of "adverse effect" is so broad that it could include effects that intended, e.g., pharmaceutical uses. They are also concerned about what is meant by "cumulative exposure" as this seems to be unworkable in a practical sense.
4) The minimum data set is a concern, especially since SOCMA represents many small batch manufacturers. I discussed options for making this more workable in yesterday's post.
5) The discussion draft drops certain exemptions that were present in TSCA. For example, an "articles" exclusion is gone, which would mean that articles would be included in the requirements for data. Most outside parties feel this is a major road block to a workable law. The low volume exclusion is also gone, which means even the smallest production volumes would be required to present some base set of data.
SOCMA has several other concerns as well, including the proposed prioritization scheme, reporting, preemption, fees, and information disclosure, the latter of which is one of SOCMA's highest priorities. They are concerned that their membership, who as small companies are the innovators of the chemical industry, would be exposed to "corporate espionage" should the strict confidential business information protections be loosened.
There's more, and we'll see some of it come out as the discussion process moves forward. And of course once the House introduces the formal bill there will continue to be discussions over the details.
Thursday, June 3, 2010
As I mentioned two days ago, the US House of Representatives has been meeting with various stakeholders to get input into the development of the House version of the TSCA Reform bill. In April the House had issued a "discussion draft" while the Senate issued an actual bill. Well, there have been a lot of discussions. And not everyone is happy.
Industry is worried that the draft House bill would "significantly expand" the scope of the law. Frankly, that would seem to be a rather obvious conclusion given that the bill is being introduced because of the widespread belief that TSCA was insufficient. But there are some legitimate concerns as well. For example, small and medium size enterprises could be disproportionately burdened if all chemicals are required to provide the same "base set" health and safety data. These companies tend to be more specialty chemical oriented and produce much smaller volumes.
One solution is to institute a tiered approach to data requirements such as that found in the REACH regulation in Europe. Under REACH, chemicals produced in smaller amounts must only provide the data in the first of four "Annexes" listing data requirements. The first Annex is focused mostly on basic physical-chemical property data such as melting and boiling points, octanol-water partitioning (a measure of whether the chemical will stay in the water column or bind with organic materials such as those associated with sediments or biota), and water solubility. The first Annex also includes requirements for determining how quickly the chemical will biodegrade (e.g., in sewage treatment plants), whether it is toxic to aquatic organisms, and basic acute toxicity to animals.
Chemicals produced at higher tonnage bands are required to fulfill the data specified in up to three additional annexes, with the cost and complication of testing increasing with tonnage produced.
This tiered testing scheme means that companies that only produce small amounts would have much less onerous data needs. Those companies producing very large amounts, and presumably much greater sales income, would need to provide more.
Several of the industry trade associations have issued statements in response to the House stakeholder process and I will be examining specific issues raised in forthcoming days.
Wednesday, June 2, 2010
In its continuing quest to use its current authority under the Toxic Substances Control Act (TSCA), EPA has issued a notice in the Federal Register last week that outlines how it expects to "generally deny Confidential Business Information claims for the identity of chemicals in health and safety studies filed under TSCA."
This wouldn't apply if the chemical identity explicitly contains process information or discloses mixture information that would still be protected under TSCA, but basically it would require the chemical to be readily identifiable by the public. The health and safety studies themselves have never been considered CBI, but a lot of good that does if you can't figure out on what chemical the study was done.
The Federal Register Notice can be found here as a PDF. Additional information on EPA's efforts on increasing transparency on chemical information is available on the EPA existing chemicals web site. --------------------------------------------------------------------
Tuesday, June 1, 2010
Way back on April 15th Senator Lautenberg introduced his long-awaited Safe Chemicals Act of 2010. That same day Representatives Waxman and Rush in the House introduced a "discussion draft" of the companion bill, which they called the Toxic Chemicals Safety Act of 2010. While not much seems to be happening on the Senate side, a great deal has been going on in the House, and it appears that they will be ready to issue a formal bill very soon.
While they haven't been very public, the House has held a series of "stakeholder meetings" on several important, and sometimes contentious, topics. The meetings were by invitation only in order to find workable paths forward.
The first meeting focused on the minimum data set to be required for new chemicals, as well as EPA’s authority to require testing. The second meeting focused on options for handling new chemicals and new uses of existing chemicals. After that the subject was how to prioritize chemicals for "rapid action," in addition to how best to determine whether a chemical is safe for its intended use.
So will these meetings resolve all the issues and result in a standing ovation by all parties when the bill is formally introduced? Probably not. But it should help work out the details enough to have a solid bill for final debate. And it is likely that the key points resolved in the House version will carry over to the Senate version. Well, at least for the most part.
Not that it will matter much for this session of Congress. There are only 30 or so legislative days left on the calendar, and with a contentious mid-term election coming up in which Republicans are likely to pick up seats in both houses, there is little time or incentive for them to push things through. So it seems that this year is the year to work out the bugs so it can be reintroduced in early 2011.
But then, stranger things have happened.