Thursday, April 15, 2010
Well, it's finally here. And it's a doozy. [That's a technical term, trust me] Senator Lautenberg on April 15th introduced the 169-page Safe Chemicals Act of 2010 (SCA) to replace the 1976 Toxic Substances Control Act (TSCA). Meanwhile Congressmen Rush and Waxman introduced a slightly less bulky "discussion document" version in the House. A first look suggests the House bill is pretty close, especially on the main provisions, so any section numbers mentioned below are based on the Senate version.
First thing to notice is that the SCA will require a baseline data set on all chemicals. Some of the major provisions include:
1) The SCA will require EPA to establish a "minimum data set" for all chemicals and mixtures [this mixture thing will need a closer look]. EPA will have the authority to require testing as necessary using rules and orders.
2) Like TSCA, the SCA would require a PMN-type notification, but the data requirements would be more demanding and notifiers would have to demonstrate that their chemical meets the new safety standard.
3) Chemicals would be prioritized based on risk (not just hazard), and EPA would be required to establish a "priority list" within 18 months of enactment of "not less than 300 chemicals" for which safety determinations will first be made. Chemicals can come off the list as they are deemed safe, and new chemicals will be added for priority review so that the list will always have at least 300 substances.
4) EPA would apply a standard of "a reasonable certainty of no harm" in their determinations of safety, for which they will have a 6 month period to complete.
5) EPA would have authority to take immediate action as necessary to deal with chemicals that are deemed to be of "imminent and substantial" hazard. Actions could include banning, stop sale orders, etc.
6) Section 9 requires that within one year all manufacturers and processers must provide a declaration of current production so that an accurate Inventory of chemicals in commerce can be maintained. With this declaration they will be required to submit existing health and safety studies, information on chemical identity, production volume, uses and exposures, etc., and the declaration must be updated every three years.
7) Section 14 allows EPA to require "substantiation" of all claims of confidential business information, and the EPA is required to set standards on what is eligible for CBI.
8) A new section 29 expedites action on chemicals of highest concern.
9) A new section 30 requires the establishment of a Children's Environmental Health Research Program within 90 days after enactment of the law.
10) Section 31 stipulates that great effort should be put into the reduction of animal testing to support data needs, including the use of QSARs, read-across, in vitro methods, etc.
11) Section 32 provides incentives for development of safer chemical alternatives and greener chemistry.
12) Section 35 creates a new section in which EPA is required to identify, assess and develop action plans to address the disproportionate exposures of certain populations and localities (i.e., environmental justice concerns).
13) The cooperation of the US with international efforts to reduce chemical risk is highlighted. Specifically mentioned (as I have noted here previously) are the Stockholm Convention, LRTAP POPs protocol, and Rotterdam Convention, all of which deal with persistent organic pollutants (POPs) and persistent, bioaccumulative and toxic (PBT) chemicals. The US has signed on to all of these in the past but never ratified them, which puts us in the awkward position of not being able to vote on what other countries want to do with chemicals used in the US.
There are many other sections and provisions, of course, that deal with the nuts and bolts and logistics of implementation. In the following days I will take a look at the reactions of NGOs, the EPA, and industry. I'll also dig into the details and see where the main areas of contention will likely be as the bills are discussed over the following months.
Representatives Rush and Waxman have indicated they expect to have a series of meetings with stakeholders over the next month and a half in an effor to fine-tune the bill. While Lautenberg still hopes that the bill will pass in this Congress, there is a general sense by many that it won't be possible given the incredibly busy Congressional docket and the likely contentiousness of this year's mid-term elections. So we'll have to see what happens. While I believe all stakeholders are interested in getting something passed, it could be that the next several months are focused on getting a bill that both protects human health and the environment and is workable.
Download the Senate bill here
Download the House bill here
Download a section-by-section summary of the House bill here
The Safe Chemicals Bill of 2010 was introduced minutes ago by Senator Frank Lautenberg.
A copy of the bill, which still does not have a Senate number, can be found here.
From Senator Lautenberg's press release:
“America’s system for regulating industrial chemicals is broken,” said Senator Lautenberg. “Parents are afraid because hundreds of untested chemicals are found in their children’s bodies. EPA does not have the tools to act on dangerous chemicals and the chemical industry has asked for stronger laws so that their customers are assured their products are safe. My 'Safe Chemicals Act' will breathe new life into a long-dead statute by empowering EPA to get tough on toxic chemicals. Chemical safety reform is not a Democratic or Republican issue, it is a common-sense issue and I look forward to building bipartisan support for this measure.”
The “Safe Chemicals Act of 2010” requires safety testing of all industrial chemicals, and puts the burden on industry to prove that chemicals are safe in order stay on the market. Under current policy, the EPA can only call for safety testing after evidence surfaces demonstrating a chemical is dangerous. As a result, EPA has been able to require testing for just 200 of the more than 80,000 chemicals currently registered in the United States and has been able to ban only five dangerous substances. The new legislation will give EPA more power to regulate the use of dangerous chemicals and require manufacturers to submit information proving the safety of every chemical in production and any new chemical seeking to enter the market.
Meanwhile, Representatives Waxman and Rush have released a "discussion draft" rather than a formal bill. Their version is called the Toxic Chemicals Safety Act of 2010.
Wednesday, April 14, 2010
Today's the day!
Ever since Senator Frank Lautenberg said over a year ago that he would introduce some version of his Kid Safe Chemical Act to reform TSCA "soon," we've been waiting for "soon" to come. And today it did. Sort of.
By the time you read this the bill may already have "dropped." But word has it that this may be considered somewhat of a "discussion draft" more than a bill that will be pushed through this session of Congress. So this bill will be just the beginning of a long process that realistically will have to continue with the reintroduction (yet again) of a bill in the next session of Congress beginning January 2011.
In a way that is a good thing. It allows more time for a workable law to be developed that reconciles the very different visions put forth by industry and by the advocacy groups. With a contentious mid-term election season and several other major pieces of legislation on the docket, getting TSCA reformed this year seems to be nearly impossible.
More later after it is released.
Oh, Senator Lautenberg will introduce the Senate version and Representative Rush the mirror House version. Rush and Representative Waxman are expected to hold weekly meetings with stakeholders during the rest of April and May in an attempt to reach a consensus on key aspects of TSCA reform.
Meanwhile, an alliance of environmental and labor groups called the Blue Green Alliance also released a set of TSCA reform principles yesterday. Carl Pope, Executive Chairman of the Sierra Club, a co-founder of the BlueGreen Alliance, said: "Knowing what is in these chemicals, and knowing that this law has the teeth to enforce clear health and safety standards, is imperative to ensuring the health of our people and our environment." He added: "Ensuring a cleaner, safer environment as part of a sustainable economy will result in good jobs and safe communities."
Look for more analysis on this spot.
Senator Frank Lautenberg has been promising to introduce his new version of the Kid Safe Chemical Act "soon" for over a year now. But now multiple sources suggest that he will do so as early as tomorrow. Once he does, what happens next?
Based on his statements, and the statements of others, during Congressional hearings, it seems likely that his bill will lean more to the liking of the advocacy community and less to the liking of industry. The bill could very well require data to be provided on all chemicals in commerce, which the NGOs want, and not just on a case-by-case basis for an EPA-prioritized short list, which the industries prefer. Since this is a mid-term election year, and expected to be a contentious one at that, it would not be surprising to see Senators and House members stake claims in firm positions at either end of the spectrum, thus setting up the potential for stalemate that keeps any bill from passing during this session. That would be unfortunate since all stakeholders agree that modernization to TSCA is necessary. Advocacy groups and EPA want greater availalibility to data on chemicals, and industry wants the greater certainty of one federal standard rather than a patchwork of state by state regulations.
Based on public statements by various stakeholders, the key areas of likely disagreement include:
1) What chemicals will require data? Industry believes that only a subset of prioritized by risk chemicals should be the subject of data call-ins while NGOs believe data should be provided on all chemicals.
2) What data should be provided? Should there be a base set of data required or should specific data be requested based on EPA's evaluation of what is needed to fill gaps.
3) Who has the burden? NGOs (and EPA) feel that industry must carry the onus of providing the data to prove their chemicals are safe, but that EPA must make the actual safety decision. Industry feels that EPA should do initial assessments and ask questions only on those chemicals for which they have concerns, which industry would then address in a risk based approach.
4) Prioritization? Even if Congress allocates significant new funds to provide EPA with additional resources, all parties understand that any new data and assessment requirements will run into the problem of inadequate resources over the short term. So some way to prioritize the chemicals most of concern is necessary. Here industry again wants EPA to do an initial review and identify a short list of chemicals for which additional data are necessary, while advocacy groups want industry to provide the data first and then the EPA will have the information it needs to prioritize further assessment. One compromise might be to prioritize the low hanging fruit - those chemicals that are PBTs, listed on other "concern lists", or otherwise well known to be substances of very high concern - all while resetting the TSCA Inventory to only those chemicals currently in commerce and having a phased collection of data for only those chemicals that remain.
5) Standard of Regulation? Most stakeholders agree that the current standard is inadequate. EPA has found it difficult to demonstrate that an existing chemical "may present an unreasonable risk of injury to health or to the environment" when in most cases it doesn't have the data on which to base an assessment. But is the "reasonable certainty of no harm" standard lowering the bar for action too much?
6) Jobs? Impacts on jobs will likely be raised by industry, pointing to the current recession as proof that industry is not capable of a REACH-like system. Meanwhile, what provisions will the bill include to ease the disproportionate burden on small and medium sized companies?
7) Confidential Business Information? EPA has taken recent steps to curb what it sees as abuses to the use of CBI claims by industry, but the fact remains that CBI is very important to protect the competitive advantage of companies developing new products.
The list goes on and we could include incentives for green chemistry and innovation, animal welfare issues, logistics of making data public, and many other issues.
Once the bill is introduced I will give a summary of its major provisions, followed in ensuing days with analysis of the specific areas of contention, industry and advocacy proposals, and possible resolutions.
Look for a pretty active next few weeks!!
Tuesday, April 13, 2010
As I've been talking about for a few days now, the chemical industry held its annual GlobalChem conference in Baltimore in the last week of March. Presentations are available at the website: GlobalChem. I reported the views of the NGO community (while Richard Denison speaks inside, a rubber duck protests outside) and the former head of the EPA toxics office (Charlie Auer). In addition, leaders for the two major chemical manufacturing trade associations, who had sponsored the conference, offered their views.
ACC President Cal Dooley reiterated his organizations guiding principles, while the new President and CEO of SOCMA, Lawrence Sloan, offered what he called a "pragmatic approach" to TSCA modernization. Inlcuded in that approach is:
1) Risk-based prioritization: All priorities should be based on risk, which considers both hazard and exposure, and not just inherent hazard. No exposure means no risk, even if the chemical is hazardous. This prioritization should be "done transparently with clear cut criteria" and decisions by EPA "should be subject to deadlines."
2) EPA should employ proven regulatory mechanisms: Sloan suggested that the "Canadian approach systematically prioritized the nation's inventory" and that the US should do the same to reset the TSCA Inventory to a workable number [note that EPA indicated it doesn't have time to reset the Inventory]. He also suggested we should learn enough from how REACH is unfolding to know that it isn't the way to go in the US.
3) Learn from ourselves: He noted that the EPA's own New Chemicals Program has provided an effective and efficient system for reviewing chemicals, "some 35,000 new chemicals since 1979," while allowing the US to lead the world in innovation.
4) Development of a new safety standard for industrial chemicals: Sloan warned of setting a safety standard that was too restrictive that could easily "black list" any chemicals listed for further study. He noted that industrial chemicals are distinctly different from pesticides, foods, and drugs, which are designed to either be highly toxic (e.g., to kill specific pests) or intentionally exposed to humans (eaten or used as medicine). In contrast, many chemicals see no direct consumer exposure.
5) Avoiding a "one-size-fits-all" approach: Again emphasizing the uniqueness of the specialty chemical sector, Sloan notes that many are small businesses engaging in batch production and not huge corporations, and thus they are "already suffering economy."
6) Adequate funding and oversight: In agreement with all speakers, Sloan emphasized that EPA needs to be adequately resourced to do the job or else it will cause a slow down in reviews and limit innovation.
Monday, April 12, 2010
Wendy Cleland-Hamnett, Director of EPA's Office of Pollution Prevention & Toxics, told a chemical trade conference recently that the USEPA is postoning indefinitely an initiative to "reset" the TSCA Inventory. The TSCA reset was an integral part of the industry plan to prioritize chemicals for future data collection, since they argue that the vast majority of the approximately 85,000 chemicals on the Inventory aren't actually in commerce any more.
It's not surprising that EPA doesn't have the resources to reset the Inventory given that it's funding has not kept pace with its statutory mandates over the years. In addition, EPA is quite busy right now both in its efforts to get TSCA reformed (or modernized) and its renewed emphasis on forcefully using what it sees as its existing authority under the current TSCA law. Cleland-Hamnett outlined several of the ways EPA has enhanced its chemical management program, including:
1) Taking risk management actions on a variety of specific chemicals such as lead, mercury, formaldehyde, PCBs, glymes and nanomaterials.
2) Developing a series of chemical actions plans for an initial list of six chemicals: phthalates; short-chain chlorinated paraffins; perfluorinateed chemicals; penta, octa, and decabrominated ethers (PBDEs); bisphenol A; and benzidine dyes. All of these have well-known toxicological issues and EPA proposes to use the authority of several sections of TSCA to regulate them.
3) Another set of chemicals for future action plans was released on March 17th, including: Nonylphenol/nonylphenol ethoxylate; HBCD; Siloxanes; and Diisocynates. Again, these are rather "long-hanging fruit" in that health effects are well studied.
4) Filling gaps in HPV data. There are many gaps in the data provided by industry in the previous voluntary High Production Volume Challenge program and EPA is seeking data to fill those gaps by using test rules (to collect missing data), continuing to develop hazard characterizations for those chemicals with data, and addressing chemicals that became HPV after the Challenge program was inititated and thus were not covered.
5) Making changes to the Inventory Update Rule (IUR). EPA is expecting to make a proposal sometime this spring to address problems experienced during the 2006 IUR collection and to expand the data requirements to better match the data collected with EPA's data needs.
6) EPA is also making an effort to better understand how to regulate nanoscale materials under TSCA. The previous voluntary Nanoscale Materials Stewardship Program failed to provide the participation or data needed for adequate evaluation of any special risks of nanoscale materials. So EPA is developing TSCA regulations to ensure that these materials receive appropriate regulatory review.
7) EPA is putting more emphasis on their "Design for the Environment" (DfE) program in which it assists companies to design greener chemistries.
8) And finally, EPA has taken several actions to increase transparency in the Agency, including putting the public version of the Inventory on the internet for easy (and free) access, efforts to increase public awareness, etc.
So it seems EPA is quite busy in this administration using its current TSCA authority to the greatest extent possible. Meanwhile, EPA continues to work with Senator Lautenberg as he develops a "new TSCA" bill that he says he intends to introduce shortly. Most insiders feel that he will do so on Earth Day, April 22nd, though of course it could come any time and in part will depend on his cancer therapy schedule.