TSCA Chemical Control and CBI - Confidentiality is Good (to a point)

Yesterday's Federal Register publication by the USEPA of a "new general practice" for restricting the withholding of chemical identities when submitting health and safety studies under TSCA Section 8(e) has received some mixed reviews. Most people agree that a certain amount of confidentiality is necessary to protect trade secrets and provide incentives for companies to develop new chemicals. And most agree that previous practices resulted in overuse of the CBI provisions.

In general it can be said that the environmental and health advocacy groups are supportive of EPA's move toward greater transparency. No surprises there, as the advocacy groups routinely advocate for greater communication of potential hazards to the public. But industry groups like the national Petrochemical & Refiners Association (NPRA) have also come out in support of EPA's action. NPRA released a statement yesterday saying that “We applaud the Obama Administration for taking this step that, frankly, previous administrations would have been wise to consider.” Charles Dreva, NPRA President, further said that “We support EPA’s action because it is the right thing do with regard to addressing health and safety concerns.” Needless to say, other industry trade associations are perhaps less enthusiastic, though they do agree that the use of CBI can probably be controlled better.

This CBI issue will continue to be a topic of contention as EPA continues to aggressively use its current TSCA authority and Congress moves towards introducing a bill to reform TSCA. In the end there will still be CBI - there has to be - but it will be much more tightly controlled under the new regime. Companies will have to provide justification, but more importantly, EPA and/or Congress will need to stipulate strict limits on what justifications will be considered acceptable and unacceptable in the future to cut down on the back-and-forth between industry and EPA that ate up resources.

EPA Expands Transparency on Confidential Business Information Claims for Hazardous TSCA Chemicals

As noted previously, one of the issues being discussed in relation to reforming the Toxic Substances Control Act (TSCA) is that of Confidential Business Information (CBI). Recently the NGO Environmental Working Group issued a report called "Off the Books: Industry's Secret Chemicals," in which they claimed that industry's use of CBI was out of control, and that they could pretty much hide the identity and other information from the public. Industry has countered that CBI is necessary to protect new products from being stolen by competitors, a problem made possible because TSCA allows anyone to make the chemical once it is put on the Inventory.

EPA has now taken one more step to reining in the confidentiality claims to only that information that is really necessary. Today the EPA published in the Federal Register a new general practice of barring industry from withholding chemical identities when submitting health and safety studies under TSCA Section 8(e), at least in those cases where the name of the chemical is already listed on the TSCA Inventory. Section 8(e) requires all manufacturers to let EPA know if they become aware of a study that suggests "substantial risks" of the chemical.

As I've been saying, EPA is taking a proactive and assertive attitude toward their current TSCA authority, something that hasn't always been true in the past. It is possible that industry will rebel and start filing lawsuits claiming EPA is overstepping their authority, though that might give more impetus to explicitly stipulating that authority in the "new TSCA." On the flip side, industry may be able to argue that Congress does not need to significantly change TSCA if EPA's more aggressive actions demonstrate that it already has the authority it needs but simply failed to use it to its full extent.

In the end I think it is inevitable that TSCA will be reformed. Given the recent Massachusetts Senatorial results and the potential impact it may have on the health care bill, it's quite possible that a window may open up for introduction of a revamped Kid Safe Chemical Act.

I will keep updating as new information becomes available, and add some analysis of what Kid Safe might look like.

TSCA Bill in March?

It's become somewhat of a parlor game to figure out when (assuming ever) Senator Lautenberg will reintroduce the newest version of his expected TSCA Reform bill. The assumption is that it will still be called the Kid Safe Chemical Act but that the last year of active information collection and meetings with various stakeholders will morph it into something rather different from the original. Still, we won't really know until it is reintroduced.

And when might that be?

The latest insight suggests that they are actively working on a new draft of the legislation, and that it will be introduced "in the near future." Not much help there since Lautenberg has been saying it was imminent since last February. The hold up seems to be timing and resources issues as Congress has been rather busy on health care reform. So don't expect the TSCA bill to show up until that is passed and there is a signing ceremony at the White House (assuming tomorrow's special election in Massachusetts doesn't shoot the health care bill down completely).

In any case, look for TSCA to show up only after health care (and maybe climate change and finance reform?). Additional hearings are still likely, perhaps one in each house of Congress, though it seems they wouldn't be decisive in shaping the bill as they will likely be shortly before its introduction. Again, assuming the health care bill is finished by early February, we're looking at sometime in February or even March for hearings.

European Chemicals Agency (ECHA) Adds 14 More "Substances of Very High Concern"

As REACH moves towards its first major registration deadline at the end of this year, the European Chemicals Agency (ECHA), located in Helsinki, Finland, has now added an additional 14 "substances of very high concern" (SVHC) to its candidate list. The candidate list is the first step in the Authorization portion of the REACH regulation of chemicals. Authorization is a bit of a misnomer. While it may sound good ("hey, I'm authorized to keep making my chemical"), in reality it signifies that ECHA has deemed the chemical to be hazardous enough to severely limit its current use and put it on track for a complete ban.

This is the second installment of the candidate list; the first featured 15 chemicals. These 29 chemicals will now get further evaluation and if they are determined to be sufficiently risky to put onto the Annex IV Authorization list, companies that manufacture or import them will have to apply for authorization to continue to do so. Even if they get authorization, it is likely that the volumes and uses will be significantly restricted. And on top of that, authorization requires the company to present a plan for finding a substitute. Companies may have only a few years to continue using the substance before it will be banned from the market.

Issuance of these candidate SVHC chemicals is a reminder that there are parallel tracks going on in REACH. While most companies are focused on the Registration phase (the "R" in REACH), member states and ECHA are already working on Evaluation dossiers and the candidate lists for Authorization. And for those chemicals that have been registered early, not only are they getting the automated "completeness" check, they are getting the human review for compliance. In short, ECHA is very very busy right now in cold, blustery Helsinki.

And you thought TSCA Reform in the US was the only chemical control issue on people's minds.

EPA Administrator Jackson Expands Her Priorities from Five to Seven

Way back when Lisa Jackson offered a list of five priorities in her "First Day" memo, she promised to provide updates as time went by. Now, in a new memo to all EPA staff issued yesterday, she says that EPA has "made enormous strides on all five, and our achievements reflect your hard work and dedication." She then goes on to note that EPA has "strengthened our focus and expanded the list of priorities." She lists "seven key themes to focus the work of our agency" for 2010.

Taking Action on Climate Change: Continuing the effort to enact clean energy and climate legislation, as well as use their current authority to develop "common-sense solutions for reducing GHG emissions from large stationary sources like power plants."

Improving Air Quality: Building on the proposed stronger ambient air quality standards for ozone to "develop a comprehensive strategy for a cleaner and more efficient power sector, with strong but achievable emission reduction goals for SO2, NOx, mercury and other air toxics," as well as other critical activities.

Assuring the Safety of Chemicals: Continuing to push for "significant and long overdue progress in assuring the safety of chemicals in our products, our environment and our bodies," which includes more aggressively using their current TSCA authority.

Cleaning Up Our Communities: "Using all the tools at our disposal, including enforcement and compliance efforts, we will continue to focus on making safer, healthier communities." This includes additional strategies for Superfund, brownfields, and other challenges.

Protecting America’s Waters: Continuing "comprehensive watershed protection programs for the Chesapeake Bay and Great Lakes," and initiating other "measures to address post-construction runoff, water quality impairment from surface mining, and stronger drinking water protection."

Expanding the Conversation on Environmentalism and Working for Environmental Justice: Expanding "a new era of outreach and protection for communities historically underrepresented in EPA decision-making," including "building strong working relationships with tribes, communities of color, economically distressed cities and towns, young people and others."

Building Strong State and Tribal Partnerships: EPA "must do its part to support state and tribal capacity and, through strengthened oversight, ensure that programs are consistently delivered nationwide."

Jackson notes that there will also be focus on strengthening internal operations, performance measures and agency processes. The priorities she lists will be the focus of 2010, but will also set the stage for continuing efforts beyond this year.

The full memo can be read here.

TSCA is a ch-ch-changing....Some Take Away Points from the Recent EPA Chemical Action Plans

I mentioned before that the UESPA issued four "action plans" on December 30, 2009 (which seems oh so long ago already). I followed it up with a note about how industry and EPA were "butting heads" a bit about the action plans. Today I'll offer a few "take away" points from this event.

First, this is new for EPA. They have decided that they must more forcefully apply what they believe is their current authority under the Toxic Substances Control Act (TSCA). In Administrator Jackson's words, EPA will implement TSCA "to the fullest extent possible."

Second, EPA is showing that it intends to employ every weapon in its arsenal. The action plans include use of Section 4, Section 6, Section 5, SNURS, TRI, DfE/Green Chemistry, voluntary stewardship and international programs, etc. EPA is leaving no stone unturned.

Third, they are pushing the envelope as far as they can go. One example is the use of a Section 5(b)(4) Concern List rulemaking, which they hope to start as early as this fall. This is an unprecedented action even though the provision has been on the books since TSCA was enacted in 1976. It allows EPA to establish a "chemicals of concern" list for chemicals the Agency feels are in need of more draconian restrictions.

Fourth, this is only the beginning. Depending on industry reaction, EPA intends to push out new action plans every four months. Never has EPA acted so aggressively in the past.

Okay, enough with the "EPA makes aggressive use of existing TSCA authority" stuff. Despite these seemingly forceful actions the reality is less chilling. Most of the actions are planned for a later date. For example, while a concern list action for phthalates is planned for fall of this year, the Section 6 rulemaking isn't planned until 2012. And even here the action plan is phrased as "Consider initiating TSCA Section 6 rulemaking..." So they may "consider" it and never follow through. And even if they do, a rulemaking can take months or years to complete. Other plans have even longer target dates. So in reality most of the action right now is on planning action rather than taking action.

Another thing to take away is that the chemicals in these first actions plans are "low-hanging fruit." Most manufacturers of PBDEs have recently agreed to voluntarily phase out their production and use in the US (and some of the PBDEs are banned already in Europe and some states). Similarly, Dupont agreed a while back to phase out PFOA and related chemicals. Phthalates are already being targeted at the municipal and state levels. And short-chain chlorinated paraffins are also already being looked at closely. So to some extent EPA is just reinforcing what is already happening with respect to reducing use and exposure to these four chemicals. Obviously, future action plans would be expected to get higher in the fruit tree.

So there you have it...a few take away points from the recent EPA action plans. I'll keep up on the TSCA chemical reform process and report it here as it happens.

Book Review – Am I Making Myself Clear? A Scientist’s Guide to Talking to the Public by Cornelia Dean

A much needed book for scientific and non-scientific communities alike. Written by science writer (and former New York Times editor) Cornelia Dean, the book makes the case that scientists need to make “their work more accessible to the media, and thus to the public.” This doesn’t come naturally to most scientists, and so the book gives some practical tips on how scientists can accomplish this goal.

Dean starts with “an invitation to researchers” to put aside their natural reticence and distrust of the media and help themselves and journalists get the key messages of their science across to the public. Because there are plenty of people out there who don’t hesitate to misinform the public about the science in order to protect their own interests (e.g., the climate change debate). In ensuing chapters she provides some insights into how scientists can better “know your audience,” help educate and work with journalists, and how to get the message across on radio and TV, online, and in the courtroom. She also offers tips on writing books, writing Op-Eds and letters to news outlets, and writing about science and technology in other venues.

Two of the most valuable chapters actually have to do with how journalists cover science issues. In “Covering Science,” Dean notes some of the differences in style and communication between journalism and scientific writing. These differences set up an inherent conflict. Scientific researchers view journalists as being superficial, insufficiently concerned with accuracy, focused on controversy, and even “ignorant.” In turn, journalists view researchers as boring, “caveating things to death,” prone to incomprehensible jargon, and incapable of drawing a definitive conclusion. In “The Problem of Objectivity,” Dean discusses the limitations of journalistic “balance” in which one opposing voice is given equal weight to the thousands of proponent voices because both sides are represented. This journalistic trait is exploited by, for example, climate change deniers, who know that TV interviews with one scientist and one naysayer (even if he is a non-scientist) looks to the public like “two sides” of a debate, even when the science is overwhelmingly in favor of one view. Given that it is often difficult for a journalist to know the state-of-the-art of the science, this opens the door for imbalance in an effort to provide balance.

Perhaps the most valuable chapter to scientists is “The Scientist as Source.” Here Dean provides some practical hints as to how scientists can best interact with journalists. Again she encourages scientists to put aside their hesitations to speak to the press and to embrace the opportunity to get out a message that accurately reflects both the research itself and the ramifications of that research to the public.

“Am I Making Myself Clear?” is quite readable, as one might expect from a science journalist. I recommend reading this book along with Chris Mooney and Sheril Kirshenbaum’s “Unscientific America” and Randy Olson’s “Don’t Be Such a Scientist.” All three books are useful to the scientist to help him or her relate better to the public, and to the public at large to better understand how science works.

Other science-related book reviews here.

EPA and Industry Butt Heads on Recently Released Chemical Action Plans

On December 30, 2009 the USEPA released four "chemical action plans" that summarized the Agency's plan to regulate four chemicals: Phthalates, Short-chain chlorinated paraffins, Polybrominated diphenyl ethers (PBDEs), and Perfluorinated chemicals (including PFOA). That same day the largest chemical trade group issued a news release expressing "strong concerns about EPA's approach." EPA says that the scientific basis for selection of the four chemicals is sound and in accordance with the procedure outlined on its website.

That doesn't mean industry is satisfied. According to the news release, the organization "and its member companies are disappointed that the initial set of chemicals seem to have been selected based on little more than their current “high-profile” nature." They are also concerned about what they believe is a lack of transparency in the way the "action plans" were developed. EPA disagrees and says it has no plans to refine the process.

This little give-and-take between EPA and the major trade association representing industry is to be expected as EPA lays out its plans and industry reacts with challenges. While it's unlikely that EPA will change anything in the short-term, the action plans do provide quite a bit of wiggle room for future flexibility. For example, a couple of the plans indicate that EPA "will consider initiating Section 6 rulemaking" in 2012 or 2013, which gives another 2 or 3 years to work out voluntary phase outs of the chemicals (and in fact EPA recently announced such a phase out by the manufacturer of decaBDE). Even if EPA does initiate a Section 6 rulemaking, the process could take anywhere from months to years to complete, during which time lots of other things could happen.

So while a little tiff between EPA and industry might make headlines, what it really signals is that EPA is going to push the envelope on using the authority that it believes TSCA already gives them. Authority that EPA really hasn't been particularly forceful in using in the past. The reasons for doing it now are uncertain and perhaps quite complex. It may simply be that the new Administration wants to accomplish the worthwhile goals of "protecting human health and the environment." Or it may be that they know they might get sued for "overreaching" that perceived authority, which might light a fire under Congress to finally introduce a bill to modernize TSCA.

Either way, the next few months should be very interesting. Stay tuned!

New York State Considers "Chemical Avoidance List"

As Congress anticipates introduction of a modernized TSCA chemical control law, perhaps an updated version of the Kid Safe Chemical Act previously introduced by Senator Lautenberg, several US states have been moving forward on their own. The latest effort at the state level is the consideration by New York state of a "chemical avoidance list," which would be chemicals that the state would avoid in their purchasing and procurement of products by state and municipal agencies.

Recently, an advisory council known as the Interagency Committee on Sustainability and Green Procurement proposed creation of such a “Chemical Avoidance List.” At this point the chemicals listed have not been released, but the current draft apparently identifies about 95 "priority toxic chemical substances" that would be phased out when cost-effective safer alternatives are identified. In short, the state would create a "black list" of chemicals that would no longer be considered acceptable, despite them being approved by the USEPA for production and marketing in the US.

So what is on this list? Well, we don't know yet, but there are some likely suspects are provided by the Sierra Club, one of the members of the advisory panel. They say the list includes chemicals that fit into the following categories:

1) Persistent, bioaccumulative, and toxic chemicals (PBTs)

2) Carcinogens

3) PBDEs (brominated flame retardants)

4) Bisphenol A (a common plasticizer)

5) Perfluorinated compounds (e.g., PFOS and PFOA, which are used in fabrics and the manufacture of non-stick surfaces)

New York state has yet to act on these recommendations, but it seems likely that they will since Governor Paterson had issued an Executive Order charging the Advisory Council with focusing on actions that would "reduce or eliminate health and environmental risks," etc.

State level actions related to chemical control have been increasing, with significant legislation in many states as well as in several cities. This creates a hodgepodge of different requirements that makes it very difficult for industry to have a consistent regulatory program. This is just one reason why industry is looking for a modernization of the national TSCA chemical control law. It makes no sense for a chemical to be banned in one state when it is perfectly legitimate to produce and market it in most the other states. Consistency is needed and this can only occur at the national level through TSCA reform.

Chemical Industry Rebuts "Secret Chemical" Report as Erroneous

As mentioned yesterday, the Environmental Working Group (EWG), a non-profit advocacy group based in Washington DC, issued a report suggesting that many chemicals on the market today are "secret." The basis for this is that the identity of these chemicals is protected by confidential business information provisions under the existing TSCA chemical control law. On Monday the main chemical industry trade association offered a response in which it claimed that EWG misrepresented the CBI provisions.

According to ACC's news release available on its web site,

"[t]here are no 'secret' chemicals on the market. In those cases where a specific chemical identity has been claimed confidential - in order to protect the significant investment of time, money and human resources that went into the research and development process - the manufacturing and use of that substance must always fully comply with the requirements of the law."

The EWG report and the ACC response demonstrates that while both groups, along with most other stakeholders, are in general agreement on the need for TSCA reform and the basic principles of modernization, there are still some fundamental differences on many of the details. In this case, the advocacy groups feel that the more information available to the public and the more transparency the better. The industry, on the other hand, must deal with the fact that competitors can free ride off of the research expenditures of others and thus have a need to keep some information to themselves.

The key seems to be in developing a system that gives confidence that chemicals are adequately tested for safety prior to being put on the market. If the public can be convinced that the process protects them, then they will be less concerned if there are confidentiality protections for companies. But if the public feels that the process is insufficient to protect them from chemicals because those chemicals have not been demonstrated to be safe, then the public will want to see more information to allow them to make choices on their end.

The saga continues. I expect there to be quite a bit of activity in the next few weeks and months as Congress leads up to introducing a bill in the first quarter of this year.

Environmental Working Group Releases "Secret Chemicals" Report

On a note related to my post of yesterday, the Environmental Working Group (EWG) has released a report called "Off the Books: Industry's Secret Chemicals." In the report they call TSCA "an extraordinarily ineffective law."

EWG is a non-profit organization founded in 1993 by Ken Cook and Richard Wiles, the latter whom is a co-author on the current report. EWG's mission "to use the power of public information to protect public health and the environment." In the fall of 2009 the organization sponsored a widely attended stakeholder "dialogue" that included Lisa Jackson and Steve Owens from EPA, the heads of many industry trade associations, the advocacy community, and other interested stakeholders.

In their report, EWG is quite critical of the current system under TSCA and feels that industry has abused the privilege of claiming confidential business information. The report also faults EPA for allowing so many - 17,000 of the 83,000 on the TSCA Inventory - to be kept "secret" from the public, which according to EWG is "a de-facto witness protection program for chemicals," a large number of which are "used everyday in consumer products."

With advocacy groups seemingly intent on pressing the issue, I reiterate my belief that the "new TSCA" will significantly restrict the amount and type of CBI that companies may claim for new chemicals. The burden will also shift to industry to prove that their CBI claims are legitimate, rather than putting the onus on resource-strapped EPA to make an effort to reject claims. Whether this is a good or bad thing will have to wait until the details are worked out.

"Secret Chemicals" a Target of TSCA Chemical Control Reform?

In this space I have been tracking the ongoing efforts of the current Congress to modernize the 33-year old Toxic Substances Control Act (TSCA), which is the primary law governing the regulation of chemicals in the United States. One of the issues that hasn't received too much press yet is the question of Confidential Business Information (CBI), which advocacy groups like to refer to as "secret chemicals."

The current TSCA gives companies the right to claim certain information on their new chemicals as "confidential." This was designed to protect companies from having to disclose information to their competitors that would effectively eliminate the advantage of developing a new chemical. Without this provision it makes no sense for a company to spend millions on research and development, only to have their competitors just use their information to copy them.

However, EPA and advocacy groups have argued that industry has taken advantage of the provision to keep not only the names of the chemicals secret but even such things as who makes it, which has occasionally led to some emergency response problems and safety research limitations. Steve Owens, EPA Assistant Administrator for the Office of Prevention, Pesticides and Toxic Substances ended the confidentiality protection for over 500 chemicals within a week after taking the job in July of last year. His reason? Because "people...saw that they can claim virtually anything as confidential and get away with it."

So it seems highly likely that there will be some provision in "the new TSCA" (or Kid Safe) when it is finally reintroduced that will restrict the amount and type of information that can be claimed as confidential. Also, it is highly likely that there will be a switch in how confidentiality is decided. In the past it was EPA that had to decide the claim should be refused, but EPA really didn't have the resources to do that so pretty much anything that was claimed was accepted. In the new TSCA I would expect that the notifier would have to provide some proof that the claim is necessary to protect its business.

Scientists Need to Talk to the Public - It's Time to Speak Up!!

So says Chris Mooney in an opinion piece in the Washington Post this weekend. Mooney is co-author with marine scientist Sheril Kirshenbaum of "Unscientific America: How Scientific Illiteracy Threatens Our Future." Mooney warns us the the deniers of science, for example those that deny climate change and evolution, are highly organized and experienced in getting their message out. Even if it is false. Or perhaps especially because it is false.

Scientists do their science in labs and the field and communicate through journals and scientific conferences with their peers, but traditionally have left the communication to the public of that science to others. If it was communicated to the public at all. It doesn't help that scientists often distrust the media's ability to get it right. According to Mooney, "[r]ather than spurring greater efforts at communication, such mistrust and resignation have further motivated some scientists to avoid talking to reporters and going on television."

He further notes that scientists "no longer have that luxury. After all, global-warming skeptics suffer no such compunctions." And with "traditional science journalists who have long sought to bridge the gap between scientists and the public" being let go by the struggling media outlets, "[i]f scientists don't take a central communications role, nobody else with the same expertise and credibility will do it for them."

Quoting Scripps Institution of Oceanography marine biologist Jeremy Jackson, who teaches a summer course that introduces young scientists to the media, blogging and even filmmaking:

"Traditionally, scientists have been loathe to interact with the media," Jackson said in a recent interview. But in his class, "the students understand that good science is only the beginning to solving environmental problems, and that nothing will be accomplished without more effective communication to the general public."

So Mooney suggests, "[s]cientists need not wait for former vice presidents to make hit movies to teach the public about their fields -- they must act themselves." To teach scientists how to do this, he recommends two recent books: Randy Olson's "Don't Be Such a Scientist: Talking Substance in an Age of Style" and Cornelia Dean's "Am I Making Myself Clear?: A Scientist's Guide to Talking to the Public."

Here is my earlier review of Mooney and Kirshenbaum's Unscientific America. Ironically, I just finished reading Dean's "Am I Making Myself Clear?" and a few months ago read Olson's "Don't be Such a Scientist."

Other scientific book reviews can be found here.

EPA Ready to Propose New Rules for Nanotechnology

Because of the less than thrilling results from the voluntary Nanoscale Materials Stewardship Program initiative begun during the Bush presidency, the USEPA is planning to propose a new rule requiring manufacturers of nanomaterials to submit data on production, exposure and available safety information.

The rule, developed under Section 8 of the Toxic Substances Control Act (TSCA) will be designed to “establish reporting requirements for certain nanoscale materials.” It would require manufacturers to provide information on “production volume, methods of manufacture and processing, exposure and release information, and available health and safety data." EPA would then evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment. Look for this Section 8 rule by June 2010.

But EPA isn't stopping there. They also plan a second rule, this one under the authority of Section 4 of TSCA, which would require manufacturers to study adverse health effects of multi-walled carbon nanotubes and nanoscale clays and alumina, which are widely used nanomaterials. The Section 4 test rule is expected sometime around November 2010.

As with the recent use of "action plans" for selected chemicals, the move signals that EPA is aggressively using what it sees as existing authority to regulate chemicals under TSCA. In the past the Agency was hesitant to push the envelope, most noticeably after a 10-year battle to ban asbestos was lost in court over the burdens of technical proof. However, the new environment is more of cooperation rather than antagonism between EPA and industry, and all parties seem to be in agreement that TSCA needs to be modernized. With that inevitability in mind, EPA is less likely to be challenged on attempts to use the data they have in-house to take action they feel is necessary.