China Publishes Revised Draft Guidance for Chemicals Notification

While REACH dominates the attention of Europe and TSCA reform is keeping everyone in the US guessing, the Chinese Environment Ministry has updated its draft guidance to reflect changes to the Environmental Management on New Chemical Substances law. Comments on the draft guidance are open until 1 July. In short, it is China REACH.

Entry in force of the law is set for October 2010 and several big changes are included. For example, new chemicals to be notified much be classified according to the UN Globally Harmonized System (GHS). The new law also introduces a new category of highly toxic, persistent and bioaccumulative substances (PBTs), and a new system of volume-based notification. There also is some reduced requirements for low-risk substances.

In anticipation of the new law, the Environment Ministry has published six guidance documents covering the requirements of the new law, though at this point they are only in Chinese. But a stakeholder's workshop will be held in Beijing on June 25, 2010 for those able to make it.

ECHA Adds Eight New Substances of Very High Concern to the REACH Candidate List

The European Chemicals Agency (ECHA) recently added eight additional chemical substances to the candidate list of Substances of Very High Concern (SVHC). Once on the candidate list the substances are eligible for entry onto Annex XIV and the authorization phase of REACH. Authorization means that companies would have to first apply to be "authorized" for continued use, but that use could be very much restricted and only for a limited period of time while substitutes are being developed.

The eight substances and the criteria for listing are:

Anhydrous disodium tetraborate - Reproductive toxicity

Boric acid - Reproductive toxicity

Ammonium dichromate - Carcinogenicity, Mutagenicity, and Reproductive toxicity

Potassium chromate - Carcinogenicity, Mutagenicity

Potassium dichromate - Carcinogenicity, Mutagenicity, and Reproductive toxicity

Sodium chromate - Carcinogenicity, Mutagenicity, and Reproductive toxicity

Tetraboron disodium heptaoxide hydrate - Reproductive toxicity

Trichloroethylene - Carcinogenicity

The addition of these SVHCs brings the total number of substances to date on the candidate list to 38, with the intent to increase the number listed to 135 by 2012.

More information on the candidate list can be found on the ECHA website.

Soap and Detergent Association Renames Itself the American Cleaning Institute

It's official. The American Cleaning Institute(ACI) is the new name of the former Soap and Detergent Association (SDA). While SDA had announced the change several months ago it has now official and the new website (www.CleaningInstitute.org) has gone live.

From ACI's press release:

"Our new name, brand and website enable us to better tell the story of how cleaning products and practices contribute to better living," said ACI Board Chair Jane Hutterly, EVP of Worldwide Corporate & Environmental Affairs, S.C. Johnson & Son, Inc. "Our industry's commitment to a more sustainable world and enhancing health and the quality of life is stronger than ever and will be well represented by the American Cleaning Institute."

Membership includes the manufacturers and formulators of household, industrial, and institutional cleaning products, their ingredients and finished packaging; oleochemical producers; and chemical distributors to the cleaning product industry. ACI and its members are dedicated to improving health and the quality of life through sustainable cleaning products and practices.

Two Symposia Examine Chemical Toxicity Testing in the US and Beyond

Two upcoming symposia will examine the development of new toxicity testing strategies in the midst of stakeholder negotiations with Congress over the recently introduced Safe Chemicals Act legislation. The meetings follow on to the 2007 National Research Council (NRC) report, "Toxicity Testing in the 21st Century: A Vision and a Strategy." The "NRC vision calls for a revolution in the science of testing chemicals for toxicity that will draw on major advances in scientific tools that are now available—or are rapidly evolving."

Three years later, how are we implementing these proposed changes, from a legal and policy perspective? What are the obstacles? What remains to be done? These two symposia will offer some answers. Both will be held in Washington DC but in two locations.

The Future of Chemical Toxicity Testing in the US: Creating a Roadmap to Implement the NRC's Vision and Strategy (Monday, June 21, 2010, 8am - 5pm, National Press Club)

The symposium will feature a keynote presentation by USEPA Assistant Administrator Stephen A. Owens and will convene a range of legal, policy, and scientific experts to discuss—

* The status of implementation of the vision for chemical toxicity testing three years after the NRC report was issued.
* What the federal agencies are doing—and planning to do—to ensure implementation of the NRC vision.
* Stakeholder perspectives on implementation across a range of viewpoints: industry, public health and environmental protection, the academy, and animal welfare.
* Where implementation of the NRC vision fits into a landscape of potentially broad legislative reform for toxic substances, harmonization with Canadian requirements, and scarcity of financial resources.

International Harmonization in Chemical Toxicity Testing: An EU Perspective on the Way Forward (Tuesday, June 22, 2010, 8am - 1:15pm, Johns Hopkins University School for Advanced International Studies)

EU regulations such as REACH and the 7th Amendment to the Cosmetics Directive have highlighted the crucial role of EU-US relations in the field of humane science. This symposium is intended to examine humane science and toxicity testing from the point of view of important EU stakeholders and experts. This half-day program features speakers from the European Commission, as well as policy leaders from major European corporations, member countries and academic institutions.

More information on both symposia, including agendas and speaker information, can be found at the symposia web site.

EU Commission Gets Close to Issuing Final PBT Chemical Annex for REACH

After much internal (and external) disagreement, the European Commission is finally ready to move ahead with its criteria for identifying Persistent, Bioaccumulative and Toxic chemicals (PBT), as well as those that are not toxic but are Very Persistent and Very Bioaccumulative (vPvB). This new version of what is called Annex XIII of REACH is being forwarded to the CARACAL group this week and could be published some time this fall.

CARACAL is an acronym for the Competent Authorities to REACH and Classification and Labelling (CARACAL). If the proposal is adopted a notification would be sent to the WTO for comment within 60 days, and if no hangups occur there it will enter the REACH comitology procedure. Assuming all goes well there then it will get published in the EU Official Journal and enter into force.

But this still isn't a done deal. The proposal, which relies on established PBT criteria and allows weight of evidence to be included, has been quite vigorously debated inside the Commission. Most of the disagreement has been over the use of weight of evidence (WoE). WoE was omitted from the original proposal in 2008 but now it seems it has been allowed in order to provide some flexibility in assessing the PBT or vPvB status of a chemical.

The PBT guidance is available on the ECHA web site.

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.