House Finally Introduces H.R. 5820, the Toxic Chemicals Safety Act of 2010

Finally. After releasing a "discussion draft" in April to coincide with Frank Lautenberg's Chemical Safety Act introduction in the Senate, Representatives Henry Waxman (D-CA) and Bobby Rush (D-IL) yesterday formally introduced H.R. 5820, the Toxic Chemicals Safety Act of 2010.

According to Waxman and Rush, "the legislation would amend the Toxic Substances Control Act of 1976 to ensure that the public and the environment are protected from risks resulting from chemical exposure."

Key provisions of the Toxics Chemicals Safety Act of 2010 include:

* Establishes a framework to ensure that all chemical substances to which the American people are exposed will be reviewed for safety and restricted where necessary to protect public health and the environment.

* Requires the chemical industry to develop and provide to the Environmental Protection Agency (EPA) essential data, and improves EPA’s authority to compel testing where necessary.

* Ensures that non-confidential information submitted to EPA is shared with the public and that critical confidential information is shared among regulators, with states, and with workers in the chemical industry.

* Establishes an expedited process for EPA to reduce exposure to chemical substances that are known to be persistent, bioaccumulative, and toxic.

* Creates incentives and a review process for safer alternatives to existing chemicals, promoting innovation and investment in green chemistry.

* Creates a workforce education and training program in green chemistry, promoting and ensuring long-term viability of American jobs.

* Encourages the reduction of the use of animals in chemical testing.

* Allows EPA to exempt chemicals already known to be safe from requirements of the Act.

* Promotes research to advance understanding of children’s vulnerability to the harms of chemicals.

* Directs EPA to address community exposures to toxic chemicals in certain “hot spot” locations.

* Requires EPA to engage in international efforts to control dangerous chemicals.

* Ensures that EPA actions are transparent, open to public comment, and subject to judicial review, without unreasonable procedural burdens.

* Gives EPA the resources needed to carry out this Act.

I'll have more after reviewing the 166-page document.  The big question is how much of the input from the various stakeholders meetings since the discussion draft have made it into the final bill.  And now that it has finally been introduced on the virtual eve of the August recesses and upcoming mid-term elections, what will become of it.

European Trade Group Updates Chemical Authorization Priority List

The European Trade Union Confederation (ETUC) last week updated its "Priority List" of chemical substances of very high concern. The trade union organization is pushing to have most of the chemicals in its list to require authorization under REACH.

According to their press release, the "Trade Union List version 2.0 includes 334 substances or group of substances ordered by priority, this represents 29 new entries compared to the first version published in March 2009. Most of these substances are identified as causative agents for recognised occupational diseases in the EU countries." So far the European Chemicals Agency (ECHA) has only identified 38 substances as candidates for authorization. ETUC wants to see this process sped up.

The ETUC is convinced that including the union-listed chemicals in the Authorisation List would cut the incidence of chemical-related occupational diseases and the attendant costs for the community, workers and industry itself. It will also be a strong incentive for companies to innovate and replace them by safer alternatives.

The ETUC list can be downloaded here.

US Agencies Work Together to Develop Chemical Screening Methods

One of the big questions regarding the new TSCA reform discussions is how exactly will companies meet any data obligations imposed by the new law. In the past any "data" request was expected to be filled by animal testing, but the animal welfare advocates and a realization of the limitations of animal testing have led many to look for alternative testing techniques.

The Tox21 collaboration merges the resources (research, funding and testing tools) of several US agencies "to develop ways to more effectively predict how chemicals will affect human health and the environment." The agencies include the EPA, the National Institute of Environmental Health Sciences (NIEHS) National Toxicology Program (NTP), the National Institute of Health (NIH) Chemical Genomics Center (NCGC), and most recently the Food and Drug Administration (FDA).

Through the collaboration the agencies hope to develop methods to screen all chemicals for risk quickly, efficiently, and in most cases without the use of animal testing. About 2,000 chemicals "have already been screened against dozens of biological targets," with hopes of getting that number up to five times that much by the end of this year. Eventually all 85,000+ chemicals on the market will have had at least an initial screening, which will help prioritize any chemicals of concern for more closer analysis.

A major component of the Tox21 collaboration is development of rapid and automated methods, which is the focus of a testing program called ToxCast. Many of these methods use sensitive cell culture and even genomic markers to screen for toxicity rather than going directly to standard animal testing. The idea is "high-throughput," i.e., screening a lot of chemicals fast so that those that are clearly not toxic can be put aside, those that are clearly very toxic can be prioritized, and those that are somewhere in the middle can get more targeted testing to address the specific questions raised.

National Research Council releases Climate Stabilization Targets report

As promised last week, the National Research Council of the US National Academy of Sciences has released a new report where they state that "emissions of carbon dioxide from the burning of fossil fuels have ushered in a new epoch where human activities will largely determine the evolution of Earth's climate." In short, human activity is causing climate change, and we need to do something about it.

The full (243 page) report, called "Climate Stabilization Targets; Emissions, Concentrations, and Impacts Over Decades to Millenia" can be downloaded for free on the National Academy Press web site.

The NRC is concerned that "because carbon dioxide in the atmosphere is long lived, it can effectively lock the Earth and future generations into a range of impacts, some of which could become very severe."

According to the report, "important policy decisions can be informed by recent advances in climate science that quantify the relationships between increases in carbon dioxide and global warming, related climate changes, and resulting impacts, such as changes in streamflow, wildfires, crop productivity, extreme hot summers, and sea level rise." The report takes the tack that "one way to inform these choices is to consider the projected climate changes and impacts that would occur if greenhouse gases in the atmosphere were stabilized at a particular concentration level." The report tries to do just that using data from the literature. NRC intends the report to be "a useful resource for scientists, educators and policy makers, among others."

House TSCA bill release delayed until next week

On Wednesday I noted that the US House of Representatives was expected to release the formal version of their TSCA reform bill this week. But the full responsible committee was tied up in Mark Ups of other bills all day yesterday, so the formal release is now planned for next Thursday, July 22nd.

A committee hearing is tentatively scheduled for the following Thursday, July 29th, and will be officially announced when the bill is introduced.

In April the House had released a "discussion draft" to coincide with the introduction of Senator Lautenberg's Safe Chemicals Act of 2010 bill. As previously noted, a series of stakeholder meetings were held following the discussion draft, and all stakeholders will be very interested to see how much of their input was incorporated into the formal bill. A good faith effort to acknowledge stakeholder concerns will help passage of the bill.

Though when that will happen is anyone's guess. It is highly unlikely to happen this session of Congress with control of possibly both houses uncertain, as I noted in a previous commentary. But no matter which party is in control of Congress, there is at least public support from all stakeholders to modernize the 34 year old law - industry to avoid a patchwork of state regulations and advocacy groups to strengthen EPA's ability to require data be submitted.

National Research Council to Release New Report on Climate Stabilization Targets Tomorrow!

On Friday, July 16th, at 2 pm EDT, the National Research Council will release a new report called Climate Stabilization Targets: Emissions, Concentrations, and Impacts over Decades to Millennia, which draws on the most current science available to quantify the relationships between emissions, concentrations, warming, and future impacts. The report examines the implications of a range of different greenhouse gas emission levels being discussed, including likely impacts and the potential for serious or irreversible climate changes.

According to the NRC announcement, the public is invited to join a web seminar and teleconference highlighting the report's findings presented by Dr. Susan Solomon, chair of the report's authoring committee and senior scientist at the National Oceanic and Atmospheric Administration in Boulder, Colorado. Following Dr. Solomon's presentation, there will be a brief question and answer session.

Though separate from their previous series of reports, tomorrow's report is related to the America's Climate Choices program.

Formal House TSCA Bill Expected This Week

As previously discussed, Representatives Waxman and Rush have been having meetings with stakeholders on the TSCA reform "discussion draft" introduced in April. It appears they are ready to introduce the formal bill on July 15th. A hearing on the bill the following week is likely. What happens to it after that is less certain.

Expect to see several changes from the discussion draft to incorporate the input from industry, advocacy groups, EPA and others. All stakeholders are looking for a good faith effort on the part of the House committee staff to insert their feedback. Key stakeholders, including EPA Administrator Lisa Jackson, are likely to testify at the hearing.

But then what? In all likelihood, not much. There are only a handful of legislative days left before the mid-term elections and no one seems to be in the mood to do much legislating until then. Most are eager to get back to their districts and commune with voters in an effort to hold onto their seats. With anti-incumbent fever running pretty hot in the electorate, many legislators are hoping for some home-grown remedies.

Given the strong likelihood that nothing will pass this session, the House and Senate bills would have to be reintroduced in the next session of Congress, beginning in January 2011. And all parties are aware that major gains by the Republican party could have significant impacts on the final look of the bills, in particular if the current minority party gains the majority in either the House or the Senate (or both).

Based on the current status of things I would be very much surprised if the current bills, which lean more toward the advocacy group positions, don't migrate significantly toward more industry-friendly final bills in 2011. Which likely means that there will not be an across-the-board data call-in for all chemicals a la REACH. More likely there will be a focused data call-in on chemicals identified as priorities based on specific characteristics like persistence, bioaccumulation and toxicity (PBT) and/or likely carcinogenicity, mutagenicity or reproductive toxicity (CMR), or widespread consumer use and exposure.

More commentary after the bill is introduced.

Six Chemicals in Draft Proposal to be Added to REACH Authorization Annex

The European Commission has drafted a proposal to amend Annex XIV of the REACH regulation. Annex XIV lists the substances which are subject to the authorization requirements. For those who have followed The Dake Page, all of the substances listed in the various candidate lists (and upcoming ones) are in line for the authorization phase should manufacturers or importers choose to support continued limited uses pending development of replacements.

The six chemicals proposed in the draft include musk xylene, MDA, HBCDD, DEHP, BBP and DBP into Annex XIV.

After the "sunset date," these substances would only be eligible to remain on the market for specific uses, and only for those specific operators who have applied for and been granted an authorization in accordance with REACH.

More in the coming days. Lots of US TSCA related activity.

California Dept Toxic Substances Control Announces Green Chemistry Initiative Symposium

The California Department of Toxic Substances Control announces that it will hold a symposium to "explore the alternative analysis process of chemicals in consumer products through case studies from experts actively engaged in various segments of the marketplace."

The event, called "Alternative Analysis Symposium II - Case Studies from the Field," will be held in Sacramento and be webcast live on July 28, 2010.

Presenters include:

George Thompson, Ph.D., Chemical Compliance Systems

Thomas Carter, The Wercs

Margaret Whittaker, Ph.D., Toxservices

Teresa McGrath, NSF International

Pam Palitz, Environment California

Helen Holder, Hewlett-Packard Company

Michael Schmeida, Tremco Inc.

Dennis McGavis, Shaw Industries

More information and an agenda will be available at the event web site.

Business-NGO Working Group Calls for TSCA Chemical Reform

The Business-NGO Working Group (BizNGO) issued a call last week for Congress to deal with the sticky problem of confidential business information (CBI) under the Toxic Substances Control Act (TSCA). The BizNGO is especially concerned about how CBI impacts communication down the supply chain. Downstream users say they need to know about what chemical ingredients are in what products, something that is currently hard to do.

In a press release press release issued by Clean Production Action, one of the key players in the BizNGO coalition, Mark Rossi states:

“Downstream businesses, consumers, investors and governments need chemicals and products that have low to no toxicity and degrade into innocuous substances in the environment. But the current lack of data on the hazardous properties of chemicals and their presence in products -- along with other weaknesses in the existing regulatory structure -- makes it extremely difficult to meet this need. While a handful of businesses and health care organizations require full or partial disclosure of chemicals in products from their suppliers, and a few suppliers publicly provide such information, government action is needed to instill transparency on chemical ingredients in products.”

The bottom line is that downstream users want more information from manufacturers of chemicals that they use. They note that in the current law "there is a loophole that permits chemical producers to avoid disclosing ingredients to companies that use them in their products. Therefore, consumer product manufacturers don’t know if their products contain toxic chemicals."

They insist that any new legislation "to update federal chemicals policy must address this issue."

House Chairman Presents "Must Haves" for TSCA Reform

Congressman Bobby Rush chairs the subcommittee that is in charge of developing the TSCA reform legislation in the US House of Representatives. Along with Henry Waxman, chair of the full committee, Rush introduced the House version of the Toxic Substances Safety Act in April. Recently he offered his views on what in his mind "must" be in the final legislation.

* First, revamped legislation must put the responsibility, and liability, for ensuring the safety of chemical substances squarely at the feet of the manufacturers who produce and sell the substances.

* The Federal government must have the ability to effectively monitor, test or otherwise oversee assorted industries through strengthened legislation.

* Legislation should protect populations that are the most vulnerable to ingesting or being exposed to environmental toxins, but are least able to obtain redress from their government.

* The Environmental Protection Agency should have greater oversight authority to allow it to quickly respond to evidence of environmental toxins.

* New chemical compounds should also pass rigorous safety standards before they are introduced to the marketplace.

The House has been holding meetings to hear from a variety of stakeholders on the discussion draft previously circulated. Apparently there has been cooperation across the aisle to come up with a workable bill to which both parties can agree. The hope is that the formal House legislation will be introduced this summer, but with only a handful of actual legislative days left in the term and a busy campaign season coming up, it's unclear if any action will take place in this Congress.

EPA Testing of BP Oil Spill Dispersants - Nearly Equal Toxicity

The ongoing BP oil spill (though I'm not sure "spill" is the right word for an open tap of oil gushing into the ocean uncontrolled) has stimulated a lot of interest in the toxicity of the chemical dispersant being used. Concerns were that the one BP is using, Corexit, is more toxic and less effective than alternative chemicals. Given that BP has already dumped over 1.6 million gallons of Corexit into the ocean, the question is not insignificant.

EPA initially ordered BP to identify a less toxic brand of dispersant, but BP indicated that "they were unable to find a dispersant that is less toxic than Corexit 9500, the product currently in use." It's unclear how hard BP tried to find an alternative given that they had millions of gallons of Corexit stockpiled and none of any alternative. It's also cheaper. They are also busy trying to stop the flow of oil into the Gulf and thus don't really have the resources at the moment to do a research project. Which, of course, begs the question as to why wasn't this research carried out already so that stockpiles of the most effective yet least toxic chemical dispersant could be ready for the catastrophe that many suggest was inevitable?

Given BP's inability to find an alternative, EPA decided to test a variety of dispersants with the intention of telling BP that they had to switch. But after the first round of toxicity testing, the results seem to show that they are all about the same.

EPA is not yet prepared to tell BP to switch to another brand of oil dispersant for use in response to the ongoing spill in the Gulf of Mexico, after releasing a first round of toxicity testing data that showed all available varieties had roughly similar toxicological properties. EPA did determine that "none of the eight dispersants tested, including the product in use in the Gulf, displayed biologically significant endocrine disrupting activity."

The toxicity of the dispersant is a tradeoff, and all of the chemicals appear to be less toxic than the oil itself. However, one drawback is that the testing is being done only on the individual chemicals; it's unclear whether there would be enhanced, or decreased, toxicity once the dispersant is mixed with the oil. Given that different fractions of the crude oil degrade at different rates (and react with the chemical dispersant differently), there are a lot of uncertainties that remain. EPA will continue to do testing and report their findings on the Response web site.

Meanwhile, problems with the cap have resulted in even more oil gushing into the Gulf and the first hurricane of the season - Alex, now a Category 2 - will pass well below the spill site, though surge effects from it will likely push more oil onshore. Hurricanes also will affect the ongoing activities in the Gulf. And this is expected by hurricane forecasters to be a particularly active season.

Let's hope they're wrong.

Book Review – Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health by David Michaels

“Doubt is our product” is how a tobacco company executive once described the industry’s attempt to hide the fact that smoking cigarettes caused lung cancer and related diseases. And that is the theme that David Michaels uses throughout his book. He argues rather persuasively that the tactic of denying the science first perfected by the tobacco companies has been used over and over again by other industries. The goal – to protect profits and avoid litigation liability from exposing people to dangerous chemicals and other practices.

The book is replete with case studies and examples, many from his personal experience as an epidemiologist and a former Assistant Secretary of Energy responsible for protecting the health and safety of workers, neighboring communities, and the environment surrounding the nation’s nuclear weapons facilities. He talks about problems with lead and children, workplace cancers from beryllium, “popcorn lung” destruction from diacetyl, secondhand smoke, asbestos, chromium, vinyl chloride in plastics, diet drugs fen-phen, Vioxx, and nuclear radiation, among others. In each case the responsible industry delayed action and avoided taking responsibility while the regulators were hamstrung by a combination of insufficient authority, political unwillingness, and nearly always deficient resources.

Throughout the case studies Michaels also discusses some of the tactics and strategies used by industry to keep from being regulated. While he only gives a passing mention of climate change, the tactics he describes in this 2008 book are clearly evident in this new opportunity for delay. I’m familiar with most of the cases he mentions, some quite familiar and others less so, but I learned quite a bit more about the behind the scenes high jinks that frankly I found a bit startling. As the title suggests, the primary tactic is “create doubt,” otherwise known as “highlight the uncertainty.” Science can never be fully certain because there is always another question that can be asked. Industry has exploited this by emphasizing any uncertainty so that no regulatory decision can be made. One common method is to employ “reanalysis.” That is, get the raw data from a study that is adverse to your position, then reanalyze it over and over, changing assumptions and conditions, enough to get a different conclusion, which then can be used to cast doubt. If reanalysis doesn’t do it, then conduct a new study, often designed specifically to create conflicting data, so again there is uncertainty. Call whatever industry does “sound science” (a term invented by the lobbying firm Hill and Knowlton for the tobacco industry) and call whatever regulators do “junk science” (a term made famous by long-time industry propagandist Steven Milloy, who of course got his start from the tobacco industry).

There is much more, of course. The book is extremely well documented, with many pages of end notes. Michaels is himself a former regulator and so experienced many of his case studies first hand. For those who are not familiar with the history of industry-created doubt, the book will be a real eye-opener. Unfortunately, I found it all too familiar.

Find other science related book reviews (click and scroll down).

Nano Nano - Europe Yesterday, US Today

Yesterday I noted that the UK issued a report arguing that there was an almost total lack of exposure data for carbon nanotubes (CNT) present in consumer products. Earlier in the year the EU issued a report from the "FramingNano project" that called for the establishment of a nanotechnology governance platform that would both provide technical advise and help make decisions on appropriate actions moving forward. And now last week the US got into the nanotechnology act with a report by the Government Accountability Office (GAO) called "Nanomaterials Are Widely Used in Commerce, But EPA Faces Challenges in Regulating Risks."

The report made the following recommendations for executive action. First, they recommended that the EPA:

• Complete its plan to issue a Significant New Use rule for nanomaterials.

• Modify FIFRA pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.

• Complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.

In addition, the report recommended that EPA should make greater use of the agency’s authorities to gather information under existing environmental statutes. Specifically, according to the GAO, EPA should:

• complete its plan to use data gathering and testing authorities under TSCA to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies; and

• use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.

Finally, the GAO recommended that EPA consider revising the Inventory Update Rule under TSCA so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material.

The full GAO report can be read in PDF format here.