House Hearing on TSCA Chemical Control March 4th

The House of Representatives Energy and Commerce Committee’s Subcommittee on Commerce, Trade, and Consumer Protection has announced it will hold a hearing on “TSCA And Persistent, Bioaccumulative, And Toxic Chemicals: Examining Domestic And International Actions.”

The hearing is scheduled for next Thursday March 4.

As of this writing, no witnesses had been identified. I will update as soon as I know.

It is highly likely that a TSCA reform bill will be introduced very shortly. I believe that whatever window of opportunity that occurs in March when Senator Lautenberg is healthy enough to do so, he will introduce the bill in the Senate, with the House following suit with a mirror bill.

Are "Chemicals of Concern" Lists Really Blacklists for Chemicals?

As the TSCA reform process moves in fits and starts, with serious questions being raised recently because of the poor health of its major sponsor, Senator Lautenberg, and the continuing anti-science politics of the ranking minority member, one question floats to the surface. Does creation of a "concern list" mean that those chemicals will become blacklisted on the marketplace?

In short, probably yes.

Many countries have what can be called "negative lists," that is, lists of chemicals that the country believes are in need of either greater scrutiny to discern risk, or where risk has already been found to be unacceptable and the chemicals are slated to be banned or severely restricted. Besides the country by country lists, there are also international negative lists of chemicals to be banned or restricted, e.g., the persistent organic pollutants and CFCs in the Stockholm Convention and Montreal Protocols. There are also "positive lists" in which chemicals are added after they have been evaluated and found to be safe. It's possible we may be headed in the positive list direction with the new TSCA, but for now let's focus on the negative lists.

EPA has indicated in its recently released "action plans" that it will use one of the authorities it already has under the existing TSCA law to create what is called a Section 5(b)(4) Concern List. In Europe, the REACH regulation, which requires registration of all chemicals, both existing and new, also has a separate track called Authorization (the "A" in REACH). Under Authorization the new European Chemicals Agency periodically publishes a list of "candidate chemicals" that are "substances of very high concern" that will then be evaluated for possible banning and restriction.

The result of these "negative lists" is the same as for other negative lists, including ones such as the Wal-Mart list of chemicals they do not want to see in their products. Formulators and end product makers get pressure from consumers to remove these "bad chemicals" from their products, so they start to push back on their suppliers, who push back on the manufacturers of the basic chemicals, who start looking for alternatives that provide the same functionality without the risk.

So is this a good thing? Well, yes and no. Often a chemical gets targeted not so much for its actual risk but for its perceived risk or for its hazard, which because of the lack of exposure may actually not cause a risk at all. On the other hand, without any kind of pressure to replace inherently hazardous materials with inherently less hazardous ones, there isn't any incentive for companies to find alternatives. Why would a company spend a lot of money doing R&D to find a chemical to replace one that they already make, has extensive market penetration, and brings them significant profit? They won't, at least unless the manufacturer believes that some future event or change in attitudes or policy will cause his original chemical to become less favorable to the market. For market forces to work there has to be the potential for significant upside return on investment. Consumers have indicated they are willing to pay a little more to purchase more sustainable products, though it is often difficult to know if new products, e.g., cleaning products, are "green washers" versus "greenwashing." But without there being a way to identify "problem chemicals," the consumer has no way to make informed choices in the market place. Thus their only recourse is to assume that all chemicals in all products have been adequately tested and found to be safe. Consumers have come to realize that that is not the case and thus are less willing to simply take it for granted. Hence, the reason why negative lists may be one mechanism to encourage greater review of chemical safety.

State of Maine Adopts Regulations to Protect Public from Chemicals

As noted previously, the individual states are acting in the absence of a new federal level reform to the Toxic Substances Control Act (TSCA). This past week the Maine Board of Environmental Protection unanimously adopted the final regulations implementing a chemical policy law enacted in 2008 by the Maine Legislature.

Specifically, the new rules are designed to protect the public, especially children, from toxic chemicals in consumer products and toys. The 2008 law required the Department of Environmental Protection to create and regularly update a database of chemicals that they've determined to be unsafe. In compliance with that requirement, in July of 2009 the DEP released a list identifying 1,300 chemicals.

More information can be found here.

Inspector General Report Puts On More Pressure for TSCA Chemical Reform

This past week the Office of the Inspector General, which is part of the USEPA, released a report called "EPA Needs a Coordinated Plan to Oversee Its Toxic Substances Control Act Responsibilities." The report concludes that "EPA does not have integrated procedures and measures in place to ensure that new chemicals entering commerce do not pose an unreasonable risk to human health and the environment." They found limitations in three key processes - assessment, oversight, and transparency.

The OIG report recommended that EPA better coordinate risk assessment and oversight activities by establishing a management plan, establish criteria for selecting chemicals for low-level exposure and cumulative risk assessment, and development a management plan for TSCA enforcement. This last point is critical as the current enforcement activity is woefully funded and barely staffed. You can read the full report here and a critique by EDF scientist Richard Denison here.

Those who have been following the TSCA reform process will know that this isn't the first analysis of the weaknesses of TSCA. The GAO has had a series of reports over the years, and the common theme is that the data requirements of the 1976 law simply do not give EPA sufficient information to adequately protect human health and the environment. As I have been reporting, EPA has been working hard this past year to use it's current TSCA authority to the fullest, but even aggressive use of that existing authority cannot change the fact that EPA is, as Senator Lautenberg noted during his opening remarks at the recent Senate hearing, trying to do its job "with one hand tied behind its back."

The new TSCA will undoubtably have a base set of data that is required for new chemicals, and some mechanism for reviewing the Inventory of existing chemicals. If written correctly, it should allow enough flexibility for data to include not only the usual animal testing but also, and perhaps even in particular, non-animal data such as QSARs, read-across from similar chemicals, in vitro studies, and the new crop of testing being developed as part of the recommendations from the "Toxicity Testing in the 21st Century" report.

USEPA Revising Enforceable Consent Agreement Procedures to Generate TSCA Chemical Test Data

On Friday, February 19, 2010, EPA published in the Federal Register a proposed rule to revise the procedures for developing Enforceable Consent Agreements (ECAs) to generate test data under TSCA. This seems to be yet another way that EPA is using the current TSCA authority to its fullest ability, as Administrator Lisa Jackson indicated she would do when she first took over the Agency.

According to the Federal Register notice, the main features of the ECA process that EPA is proposing to change include "when and how to initiate negotiations and inserting a firm deadline at which negotiations will terminate." There is also a proposal to amend several sections of 40 CFR part 790 to put all the ECA provisions in one section and the Interagency Testing Committee (ITC) information in a separate section.

ECAs are agreements between EPA and the manufacturers of chemicals to conduct specific testing on a particular chemical substance. They help provide data to EPA that then can be used to make assessments. But the key is that the ECA procedure gets data to the Agency without the Agency having to first make risk or exposure findings (which is hard to do without the data they can't request before they do it) or to promulgate a Section 4 test rule (which takes forever to do).

But the average time to negotiate an ECA has been two years, with negotiations for several chemicals taking much more than two years. And that is just to negotiate the ECA, after which the company would have several years to complete the testing, then another period of time for EPA to evaluate the data, then more negotiations to determine the remediation path forward if a concern is identfied. On top of this, many ECAs that begin negotiations never get finished. So the idea of this proposed change is to make the ECA negotiation process more efficient, more flexible, and more transparent.

As noted, the proposed rule was published in the Federal Register on Friday and the comment period is now open. Comments must be received on or before March 22, 2010. After that EPA will evaluate the comments, make any necessary adjustments in response, and then issue a final rule with a date in which it will go into effect.

So it seems there continue to be two roads that both lead to changes in how chemicals are regulated. On the current road EPA is trying to move from a crawl to a walk and maybe to a run. But it's clear that the old dirt road of the past will be replaced with a new paved road of the future. The question remains, however, whether the new road will be a superhighway at rush hour or one at off-peak hours with respect to efficiency and efficacy.

Senator Lautenberg Diagnosed with Stomach Cancer

From the Associated Press

TRENTON, N.J. -- The office of New Jersey Sen. Frank Lautenberg says the 86-year-old Democrat has stomach cancer.

Spokesman Caley Gray says doctors for the nation's second-oldest U.S. senator found B-cell lymphoma of the stomach. His office says the tumor is "curable" and will require treatment over the next few months.

Dr. James Holland of New York City's Mount Sinai Medical Center says Lautenberg will receive six to eight chemotherapy treatments. The doctor says he expects a "full and complete recovery."

Lautenberg was taken to the hospital Monday after his office said he fell. The office said Tuesday the senator was treated for a bleeding ulcer.

More details are here.

Senator Lautenberg is expected to introduce the new version of his Kid Safe Chemical Act shortly. Watch his opening remarks at the recent Senate hearings on TSCA reform here on YouTube.

Do Chemicals in the Body Pose a Risk?

Biomonitoring studies routinely demonstrate that the human body has become a receptable for a variety of chemicals. Whether these are large scientifically robust analyses such as those conducted by the Center for Disease Control or less robust studies in which a handful of mothers or environmental ministers are checked for a laundry list of chemicals, the fact is that there are many chemicals that are virtually always found in our bodies. But does it really mean anything?

Ah, that's the $64,000 question (or perhaps with inflation, the $64 billion question).

An article published in the February 15, 2010 edition of the New York Times discusses this issue as it relates to the ongoing debate about reform of the Toxic Substances Control Act.

The one thing that is clear is that "presence of a chemical in the body does not necessarily mean it will have an effect." This is repeated by the chemical industry whenever an environmental or health advocacy group publishes a report based on the analysis of a handful of people. And it is absolutely true. Both Henry Falk (of the CDC) and Linda Birnbaum (of the National Institute of Environmental Health Sciences) concur that our ability to measure tiny amounts of chemicals in our bodies has far outpaced our ability to understand what the presence of these chemicals means relative to effects...or the lack of effects.

But others argue that the very presence of so many chemicals in the body is enough to take action.

Aye, and there is the rub. What action is appropriate?

Clearly we are in a situation in which we must make decisions even with uncertainties in our knowledge. So it seems that the focus of TSCA reform should be on collecting the information necessary to reduce that uncertainty and provide greater confidence in decision-making. The results of biomonitoring studies can inform the prioritization process under the new TSCA (or Kid Safe Act) by identifying chemicals that can be given a closer look. But biomonitoring can't be the only prioritization mechanism since we can't adequately measure all chemicals in the Inventory (roughly 85,000 of them). And new chemicals are put on the market every day. So there will be testing of new chemicals, and at the very least, of existing chemicals that have been identified as priorities for further work by their presence in the body, their widespread use, their high production volumes, or their persistent, bioaccumulative and toxic (PBT) properties.

Do we need the new law to require biomonitoring of every new chemical? No. Do we need some sort of biomonitoring, such as the CDC program? Yes. Do we need a way to identify new chemicals to look for in biomonitoring studies? Yes. Will we have to make decisions based on uncertainty? Yes.

The bottom line is that biomonitoring will play a role in prioritizing chemicals for closer review, but we can't get lost focusing on biomonitoring as an end in itself. The key is to reduce risk, not merely document exposure.

Book Review - Our Choice: A Plan to Solve the Climate Crisis, by Al Gore

Climate change and sustainable energy seems to be one of the most polarizing issues on the planet right now, and Al Gore seems to be a focal point around which much of that polarization is based. Those who love him may read this book just because of that; those who hate him may be predisposed not to read it. That would be a mistake. Everyone, and I mean everyone, should read this book.

The book, of course, is “Our Choice: A Plan to Solve the Climate Crisis.” Published in November of 2009, the book takes an honest look at the unsustainability of our current energy usage, and the ways we can become more sustainable. After identifying the issue, Gore takes us through a series of chapters, each of which deals with our sources of energy. The chapters include a look at our current reliance on oil, natural gas and coal; solar power; wind energy; geothermal energy; biofuels; the possibility of carbon capture and sequestration; and finally “the nuclear option.” For each energy source he gives a very readable and visually appealing overview of the current state of the technology, the advantages of each, the drawbacks of each, and the political and technological obstacles to taking fullest advantage of each. He also provides some ideas for future enhancements.

The book then goes into discussions of “living systems” such as the role of forests (and deforestation), soil, and population as related to climate change and energy usage. These are often overlooked in the debate but extraordinarily important. He also has a section on “how we use energy” in which “less is more” and the need for a super grid. The penultimate section is a thorough discussion of “the obstacles we need to overcome.” This section focuses on the need to change the way we think, the need to accurately and honestly put a true cost on carbon, and, of course, the political obstacles. While there are obviously many technological challenges still to be faced, it is clear that the real inhibition to innovation is the lack of political will, and in many cases, the downright political obstructionism. Removing these hindrances will allow America to use our full ingenuity to keep jobs in America and be on the forefront of innovation and energy self-sufficiency.

Gore ends the book with two chapters on “The Power of Information” and the fact that how we proceed is “Our Choice.” We need to “go far quickly” if we are to outcompete other countries that are not holding themselves back and if we are to correct our energy trajectory before it is too late.

To reiterate my lede, people seem to either love Al Gore or hate Al Gore, but it would be a serious mistake to pass up this book. It manages to treat a highly technical topic in a way that is accessible to the public. And it does it in a way that is highly enlightening as well as informative. If you hate Al Gore and don’t want to buy the book, then suck it up and go borrow it from the library. Cover it with a paper bag if you have to, but read it. This book is way too important to miss. Our collective energy future depends on us learning and moving forward.

Other global warming and climate change articles can be found here.

Recession Delaying California Biomonitoring Program Implementation

As people following this blog no doubt have noticed, biomonitoring seems to be playing a significant part in the discussions for reform of the Toxic Substances Chemical Act (TSCA). California always seems to lead the pack when it comes to making changes that protect the environment, but the current recession has caused some problems for the watershed biomonitoring program already signed into law in 2006.

Like many states hard hit by the recession, California has recently had to furlough some staff at the California EPA, which along with the California Department of Public Health, administers the biomonitoring program and that has meant a delay in issuing a mandatory report to the state legislature on the status of the program. But the furloughs seem to be more of the tip of the iceberg, the mass of which is related to the overall deficiency in funding for the program.

The realities of the economy are that money is tight, especially with the state and federal agencies that are responsible for administering the various human and environmental health protections. Evidence seems to show that the economy is picking up and that 2010 will be a better year for most industries, including the chemical industry, but government agencies are likely to see continued cost containment for quite some time. The ramifications of this are two-fold. First, the recovering, though still fairly weak, economy may be used as an excuse not to "put additional regulatory burdens on industry." But it also demonstrates why industry, and not governments, should be responsible for demonstrating the safety of chemicals and products put on the market. Currently the system requires EPA to find significant harm, something they can't easily do given TSCA's lack of requirement to provide test data. The new system will almost certainly require test data, or other relevant and defensible data, to be submitted before new chemicals go on the market and to keep existing chemicals on the market.

The testing issue raises some additional questions related to animal welfare and the extrapolation of animal data to human effects. I'll try to address this aspect in future posts. Let me know if there are specific questions or issues that you would like me to discuss.

Biomonitoring and TSCA Chemical Control Reform

"Mind Disrupted" is a report recently released with the results of a biomonitoriting project sponsored by the Learning and Developmental Disabilities Initiative (LDDI). The project involved "twelve leaders and self-advocates from the learning and developmental disabilities community" who "stepped forward to have their bodies tested for the presence of a set of known or suspected neurotoxic or endocrine disrupting chemicals."

Results indicated that "sixty-one distinct chemicals were detected in the participants." All 12 participants tested positive for at least 26 of the tested chemicals, including bisphenol A, mercury, lead, PBDEs (brominated flame retardants), PFCs (perfluorinated compounds), perchlorate, and organochlorine pesticides. The report then goes on to evaluate possible connections between exposure to these chemicals and various learning and developmental disabilities.

The report concludes that TSCA needs to be updated to:

"reflect 21st Century science - including the importance of critical windows of development, mixtures of chemicals, and low-dose exposures - to ensure current and future generations reach their fullest potential."

They also suggest that federal chemicals management be modernized to do the following:

1) Take immediate action on the worst chemicals
2) Require basic information for all chemicals in teh market and for those intended to be developed and marketed
3) Protect the most vulnerable from exposure
4) Use the best scientific methods
5) Hold industry responsible for demonstrating chemical safety
6) Prioritize environmental justice and protect low income, communities of colar and indigenous communities that are disproportionately impacted by pollution
7) Enhance government coordination between agencies
8) Promote safer alternatives by implementing the principles of green chemistry
9) Ensure the "right to know" by requiring labeling of chemical ingredients in products.

Other TSCA related posts (click here and scroll for articles)

New EU Report Calls for Responsible Development of Nanotechnology

One of the areas under discussion for TSCA reform in the United States is how to deal with nanotechnology. In short, nanomaterials are really really tiny versions of some common chemicals that are already on the TSCA Inventory, and thus theoretically already considered "existing chemicals." But EPA announced last month that they are planning to issue a series of rules to better regulate nanomaterials.

Now the European Union is getting into the act. Actually, they have been working on this issue for some time and had sponsored a forum called the "FramingNano Project" under the auspices of the EU's 7th Framework Programme. The group is about to publish its recommendations in a new report, a draft of which can be read here. The FramingNano project focused on environmental health and safety, ethical and legal issues, institutional and regulatory control, communications, and international harmonization. They called for the establishment of a nanotechnology governance platform that would both provide technical advise and help make decisions on appropriate actions moving forward.

Back in the US, the new TSCA law - or Kid Safe Chemical Act if it retains the previous Lautenberg offerings - will undoubtably mention nanomaterial control specifically. Whether as a separate Title or not, it is clear that nanotechnology is a growing field of new chemistry and as such imbues a rising public concern similar to the way GMOs were introduced created a public backlash. Look for there to be data requirements triggered by the nano-sized nature of the chemical, even if the chemical composition itself has been on the market already.

"Grassroots" and Federal TSCA Chemical Reform

Grassroots has become a bit of a tenuous term these days. It used to mean that local people got together and started pushing for or against some issue of concern to them. And like grass, it grows from the bottom up until there is a field of activity that impacts the issue. That was in the old days. Now it seems that grassroots means a top down manufacturing of public opinion organized by trade associations, unions, or advocacy groups.

That isn't all bad, I suppose. It can help focus the issues in such a way that local people who are busy with their daily lives can become aware of issues that impact them. The internet has given everyone (including me) a chance to blog about what they think, but also a mechanism by which lobbying organizations can affect public opinion in ways that benefit them (the lobbying organizations, not the public). I guess my concern is that it has to be clear for whom (or what) the "grassroots" are actually rooting.

As has become all too obvious in such issues as climate change, there are many organizations that sound scientific but are really front groups for lobbying efforts. They don't actually conduct science, but rather cherry pick that which can be made to appear to support their goals. While not so extreme, I have seen some organizations starting to pop up that suggest superficially that they are "non-profit" organizations interested in the social welfare of TSCA reform. They give the illusion of being grassroots when in fact they are coalitions of industry groups lobbying for changes to TSCA that maximize the benefits and minimize the obligations of industry. Nothing wrong with looking out for industry interests, just as there is nothing wrong with the advocacy organizations looking out for the public interests, but it just seems that to do so surreptitiously is unbecoming.

I'll have more thoughts on the interaction between science and policy in future pieces. And I'll continue to keep everyone up to date on the upcoming TSCA reform bill. I will also begin addressing some of the issues and questions raised in comments to this blog, so please continue to ask for and offer insights into key issues that may not be getting enough attention.

States, Regions, and Federals - The Conflicting Interests of TSCA Chemical Reform

The perceived lack of teeth in the Toxic Substances Control Act (TSCA) has led many US states to initiate their own state-level actions to regulate what they call toxic chemicals. Recently I noted that 13 states (no, not just the original 13 colonies) had released "a set of principles designed to ensure that the debate over reforming the nation’s outdated chemical policy stays focused on protecting public health and the environment."

Regional influences are also getting into the act. The Great Lakes Binational Toxics Strategy seeks to address chemicals of concern to the Great Lakes and includes the surrounding US states and Canadian provinces.

And of course the federal Environmental Protection Agency has issued its "essential principles" for TSCA reform.

All of this virtually guarantees that a federal level modernization of TSCA will happen soon. While Senator Lautenberg could be introducing his bill any day now, introducing it doesn't mean passage into law, as can be attested by the fact that this would be the 3rd time he has introduced legislation. The key difference this time, however, is that the industry is behind "modernization." On Tuesday, for example, a new "Michigan Coalition for Chemical Safety" was formed in which "business, manufacturing, agriculture and bioscience leaders" look for a national level reform of TSCA. Not surprisingly, Michigan was one of the 13 states mentioned above. The Coalition is actually a Michigan Chapter of the national Coalition for Chemical Safety, an industry association whose mission is to "create a comprehensive overhaul of the TSCA that protects public safety, promotes industry innovation and preserves jobs." [Interestingly, Richard Denison of the Environmental Defense Fund has had a running conversation on his blog about how the CCS is an "astroturf" group more interested in protecting their own interests than public safety.]

In any case, industry would much prefer that any changes be made at the national level to TSCA rather than a hodgepodge of state level actions that make it more difficult to comply. Which is why the major industry trade associations have been working with Senate and House members to lobby for what they see is a rational path forward. Meanwhile, health and environmental advocacy groups have been doing the same. And recently the debate seems to have finally been discovered in the blogosphere.

This last point is dangerous, in my opinion. Like the climate change debate, while the science is pretty overwhelming, the blogosphere tends to thrive on polarization. I'll have more about this in future posts.

Industry Reaction to the Senate Hearing on TSCA Chemical Reform

During the Senate hearing last week on reform of the Toxic Substances Control Act (TSCA), Senator Vitter noted that while they were not present for in-person testimony, some industry groups had provided written testimony for inclusion in the record. Because of all the snow in Washington DC (up to 3 feet and counting, including more today) the federal government has been closed since last Friday afternoon and the testimony has yet to be posted on the EPW web site. So I thought I would highlight some of the reaction from industry as posted on their web sites.

The American Chemistry Council (ACC) has been in the forefront of negotiations on chemical issues, and was the lead industry organization to agree to the voluntary High Production Volume Challenge with EPA in 1998. They represent 140 member chemical companies, including all of the largest manufacturers of chemicals in the US. In their letter they agreed that biomonitoring data "have an important role along with other hazard, use and exposure factors" in prioritization of chemicals. But they also remind the panel of a statement from the 2006 National Academy of Sciences report "[O]ur technical ability to generate new biomonitoring data has essentially exceeded our ability to interpret them." In other words, we now can measure chemicals at very low concentrations in the body, but that doesn't necessarily mean there will be any effects.

The Society of Chemical Manufacturers and Affiliates (SOCMA) also agrees that TSCA needs to be modernized. SOCMA represents over 300 member companies, but unlike ACC most of their members are small and medium-sized businesses that don't have as many resources as the big companies. SOCMA "believes that the degree of public concern about the health risks of chemical exposures is not justified by what we currently know." They too note that evidence of exposure (from biomonitoring studies) is not the same as evidence of effect.

Another trade association, the National Petrochemical & Refiners Association (NPRA) also submitted written testimony according to Senator Vitter but apparently haven't posted it on their web site yet. NPRA represents "nearly 500 members, including virtually all U.S. refiners and petrochemical manufacturers." It's really not surprising that it hasn't been posted yet given all these associations are located in Washington DC, or as it has come to be known this past week, Arctic South.

The saga continues tomorrow.