So how is TSCA related to the BP Deepwater Horizon oil leak?

Apparently the NGO coalition called Safer Chemicals, Healthy Families is planning to continue its very high profile, very high activity advocacy for TSCA reform. Last week they held a webinar on TSCA reform and yesterday they did a conference call with the press to "announce a proposal and to help reporters make the connection between Corexit, the worrisome chemical dispersant being used to clean up the Gulf oil spill, and our nation’s failing system for regulating such chemicals, the Toxic Substances Control act of 1976 (TSCA)."

SCHF claims that "[w]hat’s going on in the Gulf is not an isolated incident — it’s a very dramatic, very public example of our nation’s broken system for managing chemicals." They go on to say

In their attempt to reassure Americans that Corexit was no more dangerous than common household products, chemical manufacturer Nalco unwittingly highlighted the fact that, because our laws are so weak, it’s entirely possible that our household products are quite dangerous! The reality is, our laws don’t require companies to show household products are safe before they arrive under our kitchen sinks, any more than they have to prove chemical dispersants are safe before they get dumped into our oceans. Hardly reassuring.

The group released a comparison chart showing the provisions of TSCA as it currently stands and how the Senate and House bills could "fix the problem." They go further and recommend what they believe are necessary additions to the current Safe Chemical Act proposals that would have required dispersants to demonstrate safety BEFORE being used in emergency situations like the Deepwater Horizon disaster (indicated in red in the chart).

Needs of Downstream Users Critical to Safe Chemicals Act Developments

"The impact of chemicals on business is felt well beyond the factories where chemicals are manufactured or processed into other substances and mixtures," said Bob Sussman at last week's Business and NGO Forum on Safer Chemicals Policy Reform. Sussman, who is a senior policy counsel to EPA Administrator Lisa Jackson, went further and noted that "companies at the end of the value chain" have a unique position because they serve "a critical interface where the public comes into contact with chemical-containing products." As such, these downstream users (DUs) must play an active role in helping to define the developing Safe Chemicals Act (or Toxic Substances Safety Act in the House).

The forum was designed to do just that. Sponsors included the NGO Safer Chemicals, Healthy Families coalition, the Business-NGO Working Group, and the American Sustainable Business Council. Points of discussion included a widespread agreement on the need for transparency, harmonization with other chemicals programs, and an emphasis on encouraging development of safer alternatives. Unlike some of the chemical trade associations, members of the Business-NGO Working Group strongly support a minimum data set on chemicals to be generated within five years. In short, they want to see data on all chemicals, not just a select few, so that there is enough information on potential alternatives to make sure they aren't just as bad as the ones that are being replaced. That can't be done unless there are data on everything.

According to Safer Chemicals, Healthy Families, there is an expectation that votes on the House's Toxic Substances Safety Act could begin some time this month. Some even suggest that a floor vote could happen before the summer is up. Still, it seems rather unlikely that any bill will be passed by both the House and Senate this year given the paucity of actual legislation days left and the critical (and often contentious) mid-term elections on every legislators mind.

Petrochemical Manufacturers and Refiners Comment on TSCA Chemical Reform Bills

Specialty chemical manufacturer and downstream user positions on the proposed TSCA reform bills introduced on April 15th were discussed in previous posts. Today the National Petrochemical & Refiners Association weighs in on the topic. NPRA represents virtually all US refiners and petrochemical manufacturers, whose members "supply consumers with a wide variety of products and services that are used daily in homes and businesses."

Like others, NPRA is concerned that the House discussion draft "significantly broadens the scope of TSCA by substantially changing the definition of 'substance' and 'mixture' to include practically any manufactured or processed good." And that makes the proposed law totally unworkable in a practical sense. NPRA is also concerned that most actions could actually be taken by EPA without the current provisions of "public notice and comment," which they say results in a lack of transparency. The draft also eliminates most opportunities for judicial review, thus potentially allowing arbitrary and unchallengeable decisions by EPA.

NPRA also feels that while there has been much emphasis on green chemistry and innovation, the "draft legislation imposes barriers to innovation that will inhibit all chemistry, including green chemistry policy and goals." They offer as an example the minimum data set requirement, which they feel will "raise the barrier of entry into the marketplace for new products as there will be a large cost imposed on companies to conduct the required testing and gather the required information for a single product." They claim that there is "an inversely proportional relationship between barriers of entry and the number of products introduced into any given market." They note that the minimum data set requirement in Europe has allowed the introduction of only 4000 new chemicals while the US introduced 18,000 in the same period.

As with the other trade associations, NPRA talks about the issues they see with prioritization, imminent hazard provisions, lack of preemption of state regulations, fees, what they see as unnecessary the emphasis on giving PBT chemicals special attention.

I'll look closer at key issues that pop up in most of the comments in future posts.

EU Takes Steps to Reduce Animal Experimentation

Two new steps have been taken in Europe to reduce the number of animals used in scientific testing.

In the first, the Council of the European Commission adopted what is called its "first-reading position" on a draft directive for the protection of animals used for scientific purposes. Under the provisions of the directive, member states would be required to pass legislation that ensures (among other things):

- experiments with animals are replaced, wherever possible, by an alternative method that is scientifically satisfactory,

- the number of animals used in projects is reduced to a minimum without compromising the quality of the results, and

- the degree of pain and suffering caused to animals is limited to the minimum.

In a second move, the European Chemicals Agency (ECHA) issued a "practical guide" on how to avoid unnecessary testing on animals in support of REACH registrations. ECHA anticipates that there will be between 25,000 and 75,000 registrations before the November 30, 2010 deadline. The vast majority of these will not require additional animal testing, and in fact, any animal testing specified in Annexes IX and X of REACH are required to be proposed for ECHA review only at this time. In addition, many companies are working together in consortia to create data packages that all companies can share, thus reducing all kinds of testing. The practical guide gives specific steps that companies can take to fill data gaps with non-animal data, for example QSARs, read-across, in vitro studies, the use of categories, and weight-of-evidence when literature data are available.

Lessons learned under the REACH program will likely be transferred to the new US chemical control law currently under development.

Downstream User Groups Comment on Upcoming House TSCA Chemical Reform Bill

As the House readies its formal introduction of their version of the TSCA reform bill, called the Toxic Substances Safety Act, various stakeholders are offering their views on what it should include. Or more accurately perhaps, what it shouldn't include. Friday I talked about what SOCMA thinks in representing their mostly smaller specialty chemical manufacturers. Today are downstream user organizations such as the Consumer Specialty Products Association (CSPA), the Grocery Manufacturers Association (GMA), and the Soap and Detergent Association (SDA, soon to become the American Cleaning Institute).

Like other industry trade associations, these downstream user (DU) groups see the need for TSCA modernization. But they are also concerned about the burden this may put on DUs. One of their primary concerns with the discussion draft seems to be the language that would expand TSCA to cover all chemical substances, mixtures, and articles (things made from substances and mixtures). As written, they say, "every single change to a mixture and article would constitute a 'new use' and require notification and approval by EPA." Given that consumer product manufacturers routinely "substitute new ingredients, use alternate material suppliers, switch among color shades and scents, and tweak formulations to rebalance existing ingredients in different proportions," such language could become a nightmare for downstream users. Which is one of the reasons that I think the mixture and article provisions will likely be dropped from the final bill and dealt with separately.

The DUs have many other concerns as well, and some of which overlap the major and specialty manufacturers' complaints like, e.g., questions about the minimum data set, priority setting, safety standards, CBI, etc. I'll look at each of these in more depth in future posts.

SOCMA Comments on House Toxic Chemicals Safety Act Discussion Draft

As I noted yesterday, not everyone is happy with the way things are panning out on the House "discussion draft" version of the Toxic Substances Safety Act, aka, TSCA reform. House members have been having stakeholders meetings since it's unveiling in April, and a formal bill is expected to be introduced this summer. One stakeholder group, the Society of Chemical Manufacturers and Affiliates (SOCMA) is worried that “the potential universe of chemical substances, and the burdens of the new law, would skyrocket.” Specifically, they note:

1) The "sheer scope and the lack of definition" of the bill will be unworkable. Because EPA would receive "300 minimum data sets" within 18 months after it finalizes the priority list, and they would be required to act on them within 6 months, SOCMA fears that there would not be time for peer review and thus the safety determinations would be rushed and not in sufficient depth for decision-making.

2) The draft doesn't seem to authorize collection of data from downstream users, which means all the use and exposure data would still come from manufacturers, who don't always know how their chemicals are used by others.

3) The definition of "adverse effect" is so broad that it could include effects that intended, e.g., pharmaceutical uses. They are also concerned about what is meant by "cumulative exposure" as this seems to be unworkable in a practical sense.

4) The minimum data set is a concern, especially since SOCMA represents many small batch manufacturers. I discussed options for making this more workable in yesterday's post.

5) The discussion draft drops certain exemptions that were present in TSCA. For example, an "articles" exclusion is gone, which would mean that articles would be included in the requirements for data. Most outside parties feel this is a major road block to a workable law. The low volume exclusion is also gone, which means even the smallest production volumes would be required to present some base set of data.

SOCMA has several other concerns as well, including the proposed prioritization scheme, reporting, preemption, fees, and information disclosure, the latter of which is one of SOCMA's highest priorities. They are concerned that their membership, who as small companies are the innovators of the chemical industry, would be exposed to "corporate espionage" should the strict confidential business information protections be loosened.

There's more, and we'll see some of it come out as the discussion process moves forward. And of course once the House introduces the formal bill there will continue to be discussions over the details.

Chemical Industry Expresses Concern Over Developing Toxic Chemical Safety Act

As I mentioned two days ago, the US House of Representatives has been meeting with various stakeholders to get input into the development of the House version of the TSCA Reform bill. In April the House had issued a "discussion draft" while the Senate issued an actual bill. Well, there have been a lot of discussions. And not everyone is happy.

Industry is worried that the draft House bill would "significantly expand" the scope of the law. Frankly, that would seem to be a rather obvious conclusion given that the bill is being introduced because of the widespread belief that TSCA was insufficient. But there are some legitimate concerns as well. For example, small and medium size enterprises could be disproportionately burdened if all chemicals are required to provide the same "base set" health and safety data. These companies tend to be more specialty chemical oriented and produce much smaller volumes.

One solution is to institute a tiered approach to data requirements such as that found in the REACH regulation in Europe. Under REACH, chemicals produced in smaller amounts must only provide the data in the first of four "Annexes" listing data requirements. The first Annex is focused mostly on basic physical-chemical property data such as melting and boiling points, octanol-water partitioning (a measure of whether the chemical will stay in the water column or bind with organic materials such as those associated with sediments or biota), and water solubility. The first Annex also includes requirements for determining how quickly the chemical will biodegrade (e.g., in sewage treatment plants), whether it is toxic to aquatic organisms, and basic acute toxicity to animals.

Chemicals produced at higher tonnage bands are required to fulfill the data specified in up to three additional annexes, with the cost and complication of testing increasing with tonnage produced.

This tiered testing scheme means that companies that only produce small amounts would have much less onerous data needs. Those companies producing very large amounts, and presumably much greater sales income, would need to provide more.

Several of the industry trade associations have issued statements in response to the House stakeholder process and I will be examining specific issues raised in forthcoming days.

EPA Issues Notice to Deny Claims of Chemical Confidentiality Under TSCA

In its continuing quest to use its current authority under the Toxic Substances Control Act (TSCA), EPA has issued a notice in the Federal Register last week that outlines how it expects to "generally deny Confidential Business Information claims for the identity of chemicals in health and safety studies filed under TSCA."

This wouldn't apply if the chemical identity explicitly contains process information or discloses mixture information that would still be protected under TSCA, but basically it would require the chemical to be readily identifiable by the public. The health and safety studies themselves have never been considered CBI, but a lot of good that does if you can't figure out on what chemical the study was done.

The Federal Register Notice can be found here as a PDF. Additional information on EPA's efforts on increasing transparency on chemical information is available on the EPA existing chemicals web site. --------------------------------------------------------------------

House expects to formally introduce its Toxic Chemicals Safety Act

Way back on April 15th Senator Lautenberg introduced his long-awaited Safe Chemicals Act of 2010. That same day Representatives Waxman and Rush in the House introduced a "discussion draft" of the companion bill, which they called the Toxic Chemicals Safety Act of 2010. While not much seems to be happening on the Senate side, a great deal has been going on in the House, and it appears that they will be ready to issue a formal bill very soon.

While they haven't been very public, the House has held a series of "stakeholder meetings" on several important, and sometimes contentious, topics. The meetings were by invitation only in order to find workable paths forward.

The first meeting focused on the minimum data set to be required for new chemicals, as well as EPA’s authority to require testing. The second meeting focused on options for handling new chemicals and new uses of existing chemicals. After that the subject was how to prioritize chemicals for "rapid action," in addition to how best to determine whether a chemical is safe for its intended use.

So will these meetings resolve all the issues and result in a standing ovation by all parties when the bill is formally introduced? Probably not. But it should help work out the details enough to have a solid bill for final debate. And it is likely that the key points resolved in the House version will carry over to the Senate version. Well, at least for the most part.

Not that it will matter much for this session of Congress. There are only 30 or so legislative days left on the calendar, and with a contentious mid-term election coming up in which Republicans are likely to pick up seats in both houses, there is little time or incentive for them to push things through. So it seems that this year is the year to work out the bugs so it can be reintroduced in early 2011.

But then, stranger things have happened.

Environmental Groups Urge Congress to Reinstate Congress' Science Office

Believe it or not, Congress once had a science office. The Office of Technology Assessment (OTA), from 1872 to 1995, provided research and reports to Congress on a variety of important science issues. Targeted first during the Reagan years, the OTA was unceremoniously defunded during the Gingrich "Contract with America" era. But a coalition of 90 environmental and health advocacy groups want it back.

The coalition, which includes such diverse members as Friends of the Earth, OMB Watch and Republicans for Environmental Protection, have formally requested that Congress allocate an unspecified amount of funding to reinstate the OTA. Technically, they argue, the OTA wasn't actually abolished, just defunded, and as such would simply need funds appropriated.

Unfortunately, I don't see this happening. While the economy does seem to be (begrudgingly) improving, the current economic conditions of the US remain tentative. And a plausible argument could be made that the functions of the OTA are being met by the General Accountability Office, the Congressional Research Service, the Library of Congress, and the National Academy of Science.

Another option could be a proposal by the Woodrow Wilson International Center for Scholars called "Reinventing Technology Assessment." It emphasized "citizen engagement" and suggested that a "nationwide network of non-partisan policy research organizations, universities and science museums" could be created, which they called the Expert & Citizen Assessment of Science & Technology (ECAST) network.

Either way, Congress clearly needs to rely on actual science when making decisions.

European Chemicals Director - Don't Forget the CLP Deadline for REACH!

The first REACH registration deadline is coming (November 30, 2010), and everyone is working hard to prepare registration dossiers, communicate with SIEFs, and get their documents in on time. But European Chemicals Agency (ECHA) Executive Director Geert Dancet reminded people attending a REACH conference in Helsinki - "Don't Forget the CLP."

CLP is, of course, the new Classification, Labeling and Packaging regulation in Europe. It implements the European version of the Globally Harmonized System of classification and labeling. And the deadline for notification for the CLP is January 3, 2011, just about a month after the first REACH registration deadline.

Companies that are registering in November will most likely be including the CLP notification as part of their registration package. But registrations are due only for those chemicals produced in amounts greater than 1000 tons per year and/or are considered substances of very high concern (SVHCs). Companies who produce or import smaller tonnages won't have to register their chemicals until 2013 or even 2018.

But the CLP notifications are due by January for all chemicals. And while ECHA anticipates anywhere from 25,000 to 75,000 registrations this year, they expect to see about 2 million notifications relating to the CLP. Each one of those CLP notifications requires companies to say whether their chemicals would be classified as dangerous according to dozens of different measures, including physical-chemical properties, whether they are CMRs (carcinogens, mutagens, or reproductive toxins), PBTs (persistent, bioaccumulative and toxic), or toxic to aquatic organisms.

Of the 2 million notifications expected by the beginning of the year, so far ECHA has received only 1,000.

Clearly companies have a lot of work still to do!

EPA Will Start Reviewing Confidentiality Claims for TSCA Chemicals

The USEPA has announced in a Federal Register notice that it initiate "a general practice of reviewing confidentiality claims for chemical identities in health and safety studies, and in data from health and safety studies, submitted under TSCA."

The policy will become effective August 25, 2010 and will include both newly submitted claims and existing claims. The policy takes advantage of Section 14(b) of TSCA, in which the data in health and safety studies is not supposed to be held confidential. If EPA decides to make these studies public they would still "not disclose processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture." The problem is that sometimes the chemical identity has contained confidential process information. But where a chemical identity does not explicitly contain process information or reveal portions of a mixture, "EPA expects to find that the information would clearly not be entitled to confidential treatment."

This is yet another step EPA is taking to improve the transparency of chemical information. Earlier EPA determined that some information previously held confidential would no longer be, and they also put the public portion of the TSCA Inventory on the internet for free availability for all (previously you had to purchase access through private vendors).

If Corexit is so bad, why is BP using it as a dispersant in the Deepwater Horizon spill in the Gulf

Okay, I suppose "spill" isn't the right word, given that the well head continues to gush oil. Maybe leak. I've heard some say "volcano." In any case, they first have to stop the oil from flowing. But while crews are working on what I think is now Plan F or G (or perhaps U or V), other crews are dumping hundreds of thousands of gallons of dispersant into the Gulf. Word is that they will reach a million gallons shortly, with much of it being sprayed on the surface and at least 100,000 gallons injected a mile deep underwater at the well head.

But the EPA and NGOs are concerned that the dispersant of choice, Corexit, is both less effective and more toxic to aquatic life than alternatives. So why choose that one instead of something else?

In large part it is because they have lots of it on hand. And they don't have lots of whatever might be used to replace it. Even White House energy advisor, and former EPA Administrator, Carol Browner has acknowledged that "there are not as many being manufactured as people thought in the quantities" needed.

Which raises two questions. First, shouldn't this remind us that there are significant dangers to an oil-based economy, both economically and environmentally (not to mention from a national security standpoint)? And second, shouldn't companies and agencies ensure that they have on hand adequate supplies of emergency response gear and chemicals? As oil exploration goes into deeper and deeper waters the risks of catastrophic failures such as the Deepwater Horizon are likely to become more frequent.

And the dispersants don't actually get rid of the oil, just disperse it. Which means make it into smaller droplets that in theory can either degrade quicker or dilute out in a wider area. Unfortunately, these droplets actually make the oil more bioavailable to aquatic organisms. Not to mention the impact on the fishing, shellfishing, beaching, and tourist industries of the Gulf region, in particular Louisiana.

And did I mention that hurricane season is just beginning?

Green chemistry gains another proponent in California

Green chemistry has been a hot topic in the last few years, with California, the EPA, the EU, and others pushing to encourage safer, more health and environmentally friendly, and sustainable chemicals. Toward this end, last week saw the formal opening of the Green Products Innovation Institute (GPII) in San Francisco, a non-profit organization founded to promote the cradle-to-cradle (C2C) concept.

The idea of C2C was first developed by architect William McDonough and chemist Michael Braungart. The process looks at the entire life cycle of a product, from its initial extraction from virgin ore to its disposal, or actually, to its reuse or recycling. From their web site, www.gpinnovation.org:

The Green Products Innovation Institute (GPII) is a non-profit organization created to bring about a large scale transformation in the way we make the things we make.

Rather than focusing on how industry can become "less bad," the GPII is set up to be a resource for those who aspire to do "more good". We promote an innovation-oriented model for eliminating toxic chemicals and other negative environmental impacts. The GPII prescribes a set of design principles, based on the laws of nature, to help businesses create products that are safe for people and the environment. This rethinking of how we design, manufacture, use and reuse materials will spur a new era of innovation, simultaneously driving economic, ecological and social prosperity.

GPII plans to work with academia, NGOs, government, and industry to establish a product rating system. Products meeting the criteria will receive a C2C certification mark.

While the founders hope to expand internationally, locating the headquarters in California is no accident as the state has been working to implement a green chemistry philosophy. Indeed, Governor Schwarzenegger attended the opening and reiterated GPII's mantra that the "time is now for us to go beyond simply being 'less bad' and to lead the world in the invention and innovation of 'more good,' which he sees as a way to a "prosperous Cradle-to-Cradle economy."

Initially, funding of GPII is from private donations from organizations and individuals, but once established they expect to be funded through training and product registration fees.