More on the "reasonable certainty of no harm" standard under the new Safe Chemicals Act of 2010

A couple of days ago I asked the question "What does "reasonable certainty of no harm" mean anyway?" and offered some ideas. I want to follow up on that and talk about a definition of "adverse effect" as stipulated in the Senate bill.

‘‘(14) ADVERSE EFFECT.—The term ‘adverse effect’ means a biochemical change, anatomic change, functional impairment, or pathological lesion, or its known precursor, that—
‘‘(A) affects or alters the performance of an anatomic structure of a vital system of an organism or progeny of an organism;
‘‘(B) causes irreversible change in the homeostasis of an organism;
‘‘(C) increases the susceptibility of an organism or progeny of an organism to other chemical or biological stressors or reduces the ability of an organism or progeny of an organism to respond to additional health or environmental challenges; or
‘‘(D) affects, alters, or harms the environment such that the health of humans or other organisms is directly or indirectly threatened.

Again, that is a lot.

Okay, the first bullet "(A)" sounds pretty normal. Does the chemical kill or otherwise cause observable harm to test organisms? That has been the standard for a long time.

The second bullet "(B)" deals with homeostasis, or roughly, the ability of the body to regulate itself through physiological and biochemical means. This has also been used to some extent in the past, but the use here suggests that EPA will have flexibility to include more subtle effects like biomarkers, endocrine disruption, and even some of the new "Toxicology for the 21st Century" enzyme and gene markers currently being developed.

Bullet "(C)" is a little more difficult to pin down. Presumably a chemical that would decrease the body's ability to react to the heat stress of a very hot summer day could fall under this definition. That isn't the intent, of course, but EPA will need to be a lot clearer in defining what this means before it starts to require "minimum data sets" and identify priority chemicals.

The final bullet point "(D)" is interesting because it gets into not what the chemical does to organisms (humans, plants or animals), but what it might do to the ecosystems in which we and they live. This almost sounds like something from the Endangered Species Act, where protection of habitat can be part of the rationale for listing. It's hard to determine exactly what this might mean with respect to the ability to measure environmental impacts without some form of monitoring.

So it looks like EPA will have some work to do before the Safe Chemicals Act will go into force.

More tomorrow.

So what happens to the TSCA Inventory under the new Safe Chemicals Act?

As most readers probably know, the current Toxic Substances Control Act (TSCA) has what is called an Inventory of existing chemicals. The list was created soon after TSCA was enacted to "grandfather" the chemicals already in commerce at that time (the late 1970s) onto a list. The idea was that it was simply impossible to assess them all at once for health and safety and that they could be assessed systematically over time. Meanwhile, new chemicals added to the list would undergo a new Premanufacture notice (PMN) procedure to assess their safety. In reality very few of the original 63,000 grandfathered chemicals have received substantive health and safety evaluations. And as the new Safe Chemicals Act anticipates that there will be a "minimum data set" needed for both existing and new chemicals, the fact that the old Inventory was largely made up of chemicals no longer in commerce anyway became evident.

The Lautenberg Safe Chemicals Act of 2010 takes a step towards eliminating the old Inventory and creating a new one. Section 9 of the new act (which amends Section 8 of TSCA, I know, it gets hard to follow), states that "Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2010, each manufacturer or processor of a chemical substance distributed in commerce shall submit to the Administrator the declaration described in paragraph (2) or (3), accompanied by the certification described in subsection (i)." The declaration noted in paragraph (2) includes information on the chemical identity and characteristics, locations of manufacturing and processing facilities, a list of health and safety studies available, and any other relevant information regarding the physicochemical and toxicological properties and annual production volumes. In essence, the section requires companies to provide information similar to a PMN for new chemicals. The companies would also be required to declare to EPA when they have ceased production.

All of this effectively sets up a new dynamic Inventory where chemicals can be removed as well as added. In the old Inventory once a chemical was on the list it stayed there and anyone could decide to start making it again in the future without any further review. This new system would require there to be the minimum data set produced for any new chemical, which would be defined as any chemical not currently on the list. Companies would be required to update their information every three years, so if no one reports a chemical as being produced after than time presumably it would be removed from the Inventory.

And since EPA would establish a rolling list of 300 chemicals for priority review, presumably from only those chemicals that make the new Inventory list, eventually all chemicals would get reviewed for health and safety. If the new Inventory list of only those chemicals that are currently in commerce is substantially less than the approximately 85,000 chemicals on the current Inventory (some industry figures suggest less than 10,000 are currently in commerce in the US), then the job becomes much more manageable.

I'll take a look at other aspects in upcoming days, including what is meant by the "minimum data set."

What does "reasonable certainty of no harm" mean anyway? [Safe Chemicals Act]

One of the areas of concern in the new Safe Chemicals Act of 2010 bill is the new "safety standard." The main chemical industry trade group said in its initial response that "the proposed decision-making standard may be 'legally and technically impossible to meet.'"

According to the Senate version of the bill, the standard is a "reasonable certainty of no harm," which is defined as:

‘‘(23) REASONABLE CERTAINTY OF NO HARM.—
The term ‘reasonable certainty of no harm’ means, in establishing whether a chemical substance or mixture meets the safety standard under this subchapter, that aggregate exposure and cumulative exposure of the general population or of any vulnerable population to the chemical substance or mixture presents a negligible risk of any adverse effect on the general population or a vulnerable population.

But if one looks at it closely there is a lot in that one paragraph.

Aggregate exposure: Presumably this would include exposures to a particular chemical or mixture from all sources. But how does one assess that based on the "minimum data set" that is specified in the bill? (more on the minimum data set in future pieces)

Cumulative exposure: So not single exposures but perhaps multiple exposures over time. This would be particularly relevant for chemicals that are persistent or bioaccumulate, and also for chemicals to which people get exposed to over and over.

General or vulnerable populations: So there would have to be specific ways to protect vulnerable populations, which would entail adding additional safety factors to whatever safety margin is assessed. Since children tend to be more sensitive and have less developed immune systems, special safety margins would be necessary to protect them.

Negligible risk: Okay, here is a key question that needs to be addressed. What does "negligible" mean? Some risk is always going to happen. We assume the acceptable risks of driving and flying and even eating new foods. So where is the line drawn for "negligible" when it comes to exposure to chemicals?

All of these pieces of the standard need still to be defined. The bill stipulates that the EPA "shall use the best available science when conducting an assessment," and goes on to say they "shall consider the most recent recommendations of the National Academy of Sciences on ways to better protect people, including pregnant women, infants, children and other vulnerable populations from harm by exposure to toxic substances when assessing such potential risks." This should give EPA the flexibility to accept, and request, studies that are currently still under development, such as those mentioned in the "Toxicity Testing for the 21st Century" report.

The bill also stipulates that an assessment "shall address health or environmental impacts including potential or demonstrated cancer and noncancer endpoints," so the potential is there to also address "new" issues such as endocrine disruption.

All of these will likely be discussed during this period of meetings and negotiations between law makers and industry and advocacy representatives.

Key Areas in Need of Negotiation for new Safe Chemicals Act

Now that the new "Safe Chemicals Act of 2010" has been introduced in the Senate (and a largely mirror version in the House, but with a few important differences), the time for negotiations with stakeholders has begun. All stakeholders expressed the usual "we support the goals" statements, but all also indicated where they feel the bill goes too far, or not far enough.

One of the key chemical trade associations, ACC, issued a statement pointing out three areas of disagreement:

- that the proposed decision-making standard may be "legally and technically impossible to meet"
- that the proposed changes to the new chemicals program "could hamper innovation in new products, processes and technologies"
- that the bill "undermines business certainty by allowing states to adopt their own regulations and create a lack of regulatory uniformity for chemicals and the products that use them"

Another trade association, SOCMA, representing many smaller and medium sized companies, was more worried that the scope of the bill was severely "overreaching." They worry that the requirement for a rolling 300 chemical list of priority substances for closer scrutiny is "overly prescriptive." The "minimum data sets" also were cause for concern.

Meanwhile, environmental and health advocacy groups felt the bill didn't go far enough in some respects, though they applaud the bill for finally "getting serious" about reforming TSCA. EDF thinks that one problem area is the fact that some new chemicals will be allowed to enter the marketplace with "inadequate safety data" if they don't immediately trigger one of the higher concern criteria.

I'll take a look at some of these issues in the following days, including what is really meant by the new risk standard of "a reasonable certainty of no harm" and how the "reset of the TSCA Inventory" has seemingly become a "throw out the old TSCA Inventory and start a new one."

First Summary of New "Safe Chemicals Act of 2010" Introduced by Senator Lautenberg

Well, it's finally here. And it's a doozy. [That's a technical term, trust me] Senator Lautenberg on April 15th introduced the 169-page Safe Chemicals Act of 2010 (SCA) to replace the 1976 Toxic Substances Control Act (TSCA). Meanwhile Congressmen Rush and Waxman introduced a slightly less bulky "discussion document" version in the House. A first look suggests the House bill is pretty close, especially on the main provisions, so any section numbers mentioned below are based on the Senate version.

First thing to notice is that the SCA will require a baseline data set on all chemicals. Some of the major provisions include:

1) The SCA will require EPA to establish a "minimum data set" for all chemicals and mixtures [this mixture thing will need a closer look]. EPA will have the authority to require testing as necessary using rules and orders.

2) Like TSCA, the SCA would require a PMN-type notification, but the data requirements would be more demanding and notifiers would have to demonstrate that their chemical meets the new safety standard.

3) Chemicals would be prioritized based on risk (not just hazard), and EPA would be required to establish a "priority list" within 18 months of enactment of "not less than 300 chemicals" for which safety determinations will first be made. Chemicals can come off the list as they are deemed safe, and new chemicals will be added for priority review so that the list will always have at least 300 substances.

4) EPA would apply a standard of "a reasonable certainty of no harm" in their determinations of safety, for which they will have a 6 month period to complete.

5) EPA would have authority to take immediate action as necessary to deal with chemicals that are deemed to be of "imminent and substantial" hazard. Actions could include banning, stop sale orders, etc.

6) Section 9 requires that within one year all manufacturers and processers must provide a declaration of current production so that an accurate Inventory of chemicals in commerce can be maintained. With this declaration they will be required to submit existing health and safety studies, information on chemical identity, production volume, uses and exposures, etc., and the declaration must be updated every three years.

7) Section 14 allows EPA to require "substantiation" of all claims of confidential business information, and the EPA is required to set standards on what is eligible for CBI.

8) A new section 29 expedites action on chemicals of highest concern.

9) A new section 30 requires the establishment of a Children's Environmental Health Research Program within 90 days after enactment of the law.

10) Section 31 stipulates that great effort should be put into the reduction of animal testing to support data needs, including the use of QSARs, read-across, in vitro methods, etc.

11) Section 32 provides incentives for development of safer chemical alternatives and greener chemistry.

12) Section 35 creates a new section in which EPA is required to identify, assess and develop action plans to address the disproportionate exposures of certain populations and localities (i.e., environmental justice concerns).

13) The cooperation of the US with international efforts to reduce chemical risk is highlighted. Specifically mentioned (as I have noted here previously) are the Stockholm Convention, LRTAP POPs protocol, and Rotterdam Convention, all of which deal with persistent organic pollutants (POPs) and persistent, bioaccumulative and toxic (PBT) chemicals. The US has signed on to all of these in the past but never ratified them, which puts us in the awkward position of not being able to vote on what other countries want to do with chemicals used in the US.

There are many other sections and provisions, of course, that deal with the nuts and bolts and logistics of implementation. In the following days I will take a look at the reactions of NGOs, the EPA, and industry. I'll also dig into the details and see where the main areas of contention will likely be as the bills are discussed over the following months.

Representatives Rush and Waxman have indicated they expect to have a series of meetings with stakeholders over the next month and a half in an effor to fine-tune the bill. While Lautenberg still hopes that the bill will pass in this Congress, there is a general sense by many that it won't be possible given the incredibly busy Congressional docket and the likely contentiousness of this year's mid-term elections. So we'll have to see what happens. While I believe all stakeholders are interested in getting something passed, it could be that the next several months are focused on getting a bill that both protects human health and the environment and is workable.

Download the Senate bill here

Download the House bill here

Download a section-by-section summary of the House bill here

The Safe Chemicals Bill of 2010 is Now Introduced [UPDATED]

The Safe Chemicals Bill of 2010 was introduced minutes ago by Senator Frank Lautenberg.

A copy of the bill, which still does not have a Senate number, can be found here.

From Senator Lautenberg's press release:

“America’s system for regulating industrial chemicals is broken,” said Senator Lautenberg. “Parents are afraid because hundreds of untested chemicals are found in their children’s bodies. EPA does not have the tools to act on dangerous chemicals and the chemical industry has asked for stronger laws so that their customers are assured their products are safe. My 'Safe Chemicals Act' will breathe new life into a long-dead statute by empowering EPA to get tough on toxic chemicals. Chemical safety reform is not a Democratic or Republican issue, it is a common-sense issue and I look forward to building bipartisan support for this measure.”

And also:

The “Safe Chemicals Act of 2010” requires safety testing of all industrial chemicals, and puts the burden on industry to prove that chemicals are safe in order stay on the market. Under current policy, the EPA can only call for safety testing after evidence surfaces demonstrating a chemical is dangerous. As a result, EPA has been able to require testing for just 200 of the more than 80,000 chemicals currently registered in the United States and has been able to ban only five dangerous substances. The new legislation will give EPA more power to regulate the use of dangerous chemicals and require manufacturers to submit information proving the safety of every chemical in production and any new chemical seeking to enter the market.

Meanwhile, Representatives Waxman and Rush have released a "discussion draft" rather than a formal bill. Their version is called the Toxic Chemicals Safety Act of 2010.

Senator Lautenberg & Representative Rush to Introduce TSCA Chemical Reform Bill TODAY [Updated]

Today's the day!

Ever since Senator Frank Lautenberg said over a year ago that he would introduce some version of his Kid Safe Chemical Act to reform TSCA "soon," we've been waiting for "soon" to come. And today it did. Sort of.

By the time you read this the bill may already have "dropped." But word has it that this may be considered somewhat of a "discussion draft" more than a bill that will be pushed through this session of Congress. So this bill will be just the beginning of a long process that realistically will have to continue with the reintroduction (yet again) of a bill in the next session of Congress beginning January 2011.

In a way that is a good thing. It allows more time for a workable law to be developed that reconciles the very different visions put forth by industry and by the advocacy groups. With a contentious mid-term election season and several other major pieces of legislation on the docket, getting TSCA reformed this year seems to be nearly impossible.

More later after it is released.

Oh, Senator Lautenberg will introduce the Senate version and Representative Rush the mirror House version. Rush and Representative Waxman are expected to hold weekly meetings with stakeholders during the rest of April and May in an attempt to reach a consensus on key aspects of TSCA reform.

Meanwhile, an alliance of environmental and labor groups called the Blue Green Alliance also released a set of TSCA reform principles yesterday. Carl Pope, Executive Chairman of the Sierra Club, a co-founder of the BlueGreen Alliance, said: "Knowing what is in these chemicals, and knowing that this law has the teeth to enforce clear health and safety standards, is imperative to ensuring the health of our people and our environment." He added: "Ensuring a cleaner, safer environment as part of a sustainable economy will result in good jobs and safe communities."

Look for more analysis on this spot.

TSCA Chemical Control Bill to be Introduced by Senator Lautenberg - What Happens Next?

Senator Frank Lautenberg has been promising to introduce his new version of the Kid Safe Chemical Act "soon" for over a year now. But now multiple sources suggest that he will do so as early as tomorrow. Once he does, what happens next?

Based on his statements, and the statements of others, during Congressional hearings, it seems likely that his bill will lean more to the liking of the advocacy community and less to the liking of industry. The bill could very well require data to be provided on all chemicals in commerce, which the NGOs want, and not just on a case-by-case basis for an EPA-prioritized short list, which the industries prefer. Since this is a mid-term election year, and expected to be a contentious one at that, it would not be surprising to see Senators and House members stake claims in firm positions at either end of the spectrum, thus setting up the potential for stalemate that keeps any bill from passing during this session. That would be unfortunate since all stakeholders agree that modernization to TSCA is necessary. Advocacy groups and EPA want greater availalibility to data on chemicals, and industry wants the greater certainty of one federal standard rather than a patchwork of state by state regulations.

Based on public statements by various stakeholders, the key areas of likely disagreement include:

1) What chemicals will require data? Industry believes that only a subset of prioritized by risk chemicals should be the subject of data call-ins while NGOs believe data should be provided on all chemicals.

2) What data should be provided? Should there be a base set of data required or should specific data be requested based on EPA's evaluation of what is needed to fill gaps.

3) Who has the burden? NGOs (and EPA) feel that industry must carry the onus of providing the data to prove their chemicals are safe, but that EPA must make the actual safety decision. Industry feels that EPA should do initial assessments and ask questions only on those chemicals for which they have concerns, which industry would then address in a risk based approach.

4) Prioritization? Even if Congress allocates significant new funds to provide EPA with additional resources, all parties understand that any new data and assessment requirements will run into the problem of inadequate resources over the short term. So some way to prioritize the chemicals most of concern is necessary. Here industry again wants EPA to do an initial review and identify a short list of chemicals for which additional data are necessary, while advocacy groups want industry to provide the data first and then the EPA will have the information it needs to prioritize further assessment. One compromise might be to prioritize the low hanging fruit - those chemicals that are PBTs, listed on other "concern lists", or otherwise well known to be substances of very high concern - all while resetting the TSCA Inventory to only those chemicals currently in commerce and having a phased collection of data for only those chemicals that remain.

5) Standard of Regulation? Most stakeholders agree that the current standard is inadequate. EPA has found it difficult to demonstrate that an existing chemical "may present an unreasonable risk of injury to health or to the environment" when in most cases it doesn't have the data on which to base an assessment. But is the "reasonable certainty of no harm" standard lowering the bar for action too much?

6) Jobs? Impacts on jobs will likely be raised by industry, pointing to the current recession as proof that industry is not capable of a REACH-like system. Meanwhile, what provisions will the bill include to ease the disproportionate burden on small and medium sized companies?

7) Confidential Business Information? EPA has taken recent steps to curb what it sees as abuses to the use of CBI claims by industry, but the fact remains that CBI is very important to protect the competitive advantage of companies developing new products.

The list goes on and we could include incentives for green chemistry and innovation, animal welfare issues, logistics of making data public, and many other issues.

Once the bill is introduced I will give a summary of its major provisions, followed in ensuing days with analysis of the specific areas of contention, industry and advocacy proposals, and possible resolutions.

Look for a pretty active next few weeks!!

Industry Representatives Offer "Perspectives on TSCA Modernization"

As I've been talking about for a few days now, the chemical industry held its annual GlobalChem conference in Baltimore in the last week of March. Presentations are available at the website: GlobalChem. I reported the views of the NGO community (while Richard Denison speaks inside, a rubber duck protests outside) and the former head of the EPA toxics office (Charlie Auer). In addition, leaders for the two major chemical manufacturing trade associations, who had sponsored the conference, offered their views.

ACC President Cal Dooley reiterated his organizations guiding principles, while the new President and CEO of SOCMA, Lawrence Sloan, offered what he called a "pragmatic approach" to TSCA modernization. Inlcuded in that approach is:

1) Risk-based prioritization: All priorities should be based on risk, which considers both hazard and exposure, and not just inherent hazard. No exposure means no risk, even if the chemical is hazardous. This prioritization should be "done transparently with clear cut criteria" and decisions by EPA "should be subject to deadlines."

2) EPA should employ proven regulatory mechanisms: Sloan suggested that the "Canadian approach systematically prioritized the nation's inventory" and that the US should do the same to reset the TSCA Inventory to a workable number [note that EPA indicated it doesn't have time to reset the Inventory]. He also suggested we should learn enough from how REACH is unfolding to know that it isn't the way to go in the US.

3) Learn from ourselves: He noted that the EPA's own New Chemicals Program has provided an effective and efficient system for reviewing chemicals, "some 35,000 new chemicals since 1979," while allowing the US to lead the world in innovation.

4) Development of a new safety standard for industrial chemicals: Sloan warned of setting a safety standard that was too restrictive that could easily "black list" any chemicals listed for further study. He noted that industrial chemicals are distinctly different from pesticides, foods, and drugs, which are designed to either be highly toxic (e.g., to kill specific pests) or intentionally exposed to humans (eaten or used as medicine). In contrast, many chemicals see no direct consumer exposure.

5) Avoiding a "one-size-fits-all" approach: Again emphasizing the uniqueness of the specialty chemical sector, Sloan notes that many are small businesses engaging in batch production and not huge corporations, and thus they are "already suffering economy."

6) Adequate funding and oversight: In agreement with all speakers, Sloan emphasized that EPA needs to be adequately resourced to do the job or else it will cause a slow down in reviews and limit innovation.

EPA Official Says They Have No Time for TSCA Reset

Wendy Cleland-Hamnett, Director of EPA's Office of Pollution Prevention & Toxics, told a chemical trade conference recently that the USEPA is postoning indefinitely an initiative to "reset" the TSCA Inventory. The TSCA reset was an integral part of the industry plan to prioritize chemicals for future data collection, since they argue that the vast majority of the approximately 85,000 chemicals on the Inventory aren't actually in commerce any more.

It's not surprising that EPA doesn't have the resources to reset the Inventory given that it's funding has not kept pace with its statutory mandates over the years. In addition, EPA is quite busy right now both in its efforts to get TSCA reformed (or modernized) and its renewed emphasis on forcefully using what it sees as its existing authority under the current TSCA law. Cleland-Hamnett outlined several of the ways EPA has enhanced its chemical management program, including:

1) Taking risk management actions on a variety of specific chemicals such as lead, mercury, formaldehyde, PCBs, glymes and nanomaterials.

2) Developing a series of chemical actions plans for an initial list of six chemicals: phthalates; short-chain chlorinated paraffins; perfluorinateed chemicals; penta, octa, and decabrominated ethers (PBDEs); bisphenol A; and benzidine dyes. All of these have well-known toxicological issues and EPA proposes to use the authority of several sections of TSCA to regulate them.

3) Another set of chemicals for future action plans was released on March 17th, including: Nonylphenol/nonylphenol ethoxylate; HBCD; Siloxanes; and Diisocynates. Again, these are rather "long-hanging fruit" in that health effects are well studied.

4) Filling gaps in HPV data. There are many gaps in the data provided by industry in the previous voluntary High Production Volume Challenge program and EPA is seeking data to fill those gaps by using test rules (to collect missing data), continuing to develop hazard characterizations for those chemicals with data, and addressing chemicals that became HPV after the Challenge program was inititated and thus were not covered.

5) Making changes to the Inventory Update Rule (IUR). EPA is expecting to make a proposal sometime this spring to address problems experienced during the 2006 IUR collection and to expand the data requirements to better match the data collected with EPA's data needs.

6) EPA is also making an effort to better understand how to regulate nanoscale materials under TSCA. The previous voluntary Nanoscale Materials Stewardship Program failed to provide the participation or data needed for adequate evaluation of any special risks of nanoscale materials. So EPA is developing TSCA regulations to ensure that these materials receive appropriate regulatory review.

7) EPA is putting more emphasis on their "Design for the Environment" (DfE) program in which it assists companies to design greener chemistries.

8) And finally, EPA has taken several actions to increase transparency in the Agency, including putting the public version of the Inventory on the internet for easy (and free) access, efforts to increase public awareness, etc.

So it seems EPA is quite busy in this administration using its current TSCA authority to the greatest extent possible. Meanwhile, EPA continues to work with Senator Lautenberg as he develops a "new TSCA" bill that he says he intends to introduce shortly. Most insiders feel that he will do so on Earth Day, April 22nd, though of course it could come any time and in part will depend on his cancer therapy schedule.

Former EPA Chemicals Chief Gives Recommendations for a "Workable and Effective" Chemical Regulatory System

A few days ago I mentioned that advocacy groups highlighted their differences with industry on TSCA reform at a recent chemical industry trade show called GlobalChem. Also presenting at that conference was the former head of the EPA Office responsible for chemicals management, Charlie Auer, now a private consultant. He offered the following "approach elements" on how to move towards a "workable and effective chemical regulatory system in the US."

1) Improved hazard and exposure/use database: a requirement for regular periodic reporting from companies throughout the chemicals value chain to ensure that EPA's understanding of uses/exposures remains current. Auer noted that this should include an Inventory Reset component. He also suggested that there is a need for tiered datasets, i.e., basic data requirements triggered at each level, the ability for EPA to modify basic requirements based on hazard screening results, and a role for SARs, read-across, and other non-animal testing methods.

2) Staged process for risk assessment and risk management: Auer noted that there must be an "open, measured and timely" process in which there must be risk management following risk assessment, a role for periodic reassessment based on new information, consideration of the life-cycle of chemicals, and decisions based on the best available scientific data.

3) Broad risk management authority providing more flexible and effective tools: To include "rule plus order authority" and the ability to require development of enforceable pollution prevention and green chemistry plans.

4) Control actions: To be based on scientifically sound risk assessments, identification of mitigation or prevention measures to ensure safety, and "a determination by EPA that it is reasonable to require such measures."

Auer also suggested that there needed to be better balancing of confidential business information protection and disclosure, legislation that encourages innovation, and greater responsibility by industry throughout the chemicals value chain. He noted that EPA should be directed to regularly update test guidelines to meet current standards and work to achieve by 2020 the NAS "Toxicity Testing in the 21st Century." EPA should also be able to recognize or apply the work done by other governments.

And he, like just about everyone else, noted that EPA must be given adequate resources to do its job. For Auer, that includes adequate funding but also the institution of some sort of chemical registration fee system.

European Chemicals Agency to Publish List of Chemicals Being Registered This Year

According to Geert Dancet, the Executive Director of the European Chemicals Agency (ECHA), the agency will soon publish a list of thousands of high volume and high hazard chemicals it expects to be registered by the November 30 deadline for doing so under the EU's Registration, Evaluation, and Authorization of CHemicals (REACH) regulation.

Dancet encouraged companies that purchase chemicals used in the European market to review the list to be sure the substances they need and ways they use them will be registered. A newly established "Directors' Contact Group" will review the list and is expected to "identify issues of concern and describe feasible, prioritized solutions" by June 1.

ECHA says it has "a general idea of the number of chemicals" it expects to be registered by the deadline, which it anticipates to be around 9,200 chemicals. The big question is the actual number of registrations since a single chemical may be registered by more than one company. ECHA is expecting the number of registrations to range somewhere between 25,000 and 75,000.

All of this has ramifications for TSCA reform in the US as any major problems, or lack thereof, in this first of three REACH registration deadlines will give some indication of the workability of a general data call-in for all chemicals in the US. As noted yesterday, NGOs are strongly in favor of industry providing at least basic data on all chemicals while industry is stongly in favor of EPA first prioritizing to a short list of chemicals for which specific data requests will then be made to industry.

Advocacy Groups Use Chemical Trade Show to Highlight Differences with Industry [UPDATED]

[NOTE: See the Update at the end]

Two of the largest chemical trade associations recently sponsored the chemical industry trade show called GlobalChem. Among the many industry, consultant, and government speakers was Dr. Richard Denison of the Environmental Defense Fund (EDF). Dr. Denison took the opportunity in his talk to highlight where the EDF-sponsored advocacy coalition, Safer Chemicals Healthy Families, differs from industry in the nuts and bolts of TSCA reform.

Denison first noted that 5 years after the deadline for completion of the voluntary HPV Challenge there are still only 60% of chemicals with final submissions. Not a great track record for self-policing in his opinion. He then listed three major differences between what the SCHF Coalition wants and what he characterizes industry to want.

1) SCHF wants data on all chemicals, while industry wants only to provide data on the small subset of chemicals that are of high priority. Industry believes that a REACH-like data call-in for all of the 85,000 chemicals on the current TSCA Inventory is overly burdensome, impossible to manage, and not very productive. Denison believes that data on all chemicals must be obtained so that safe chemicals can be identified for use as substitutes, otherwise you could identify a problem chemical that needs to be banned but have no data on the safety of potential replacements.

2) SCHF wants prompt action on the "most dangerous" chemicals such as those with high hazard, high exposure, PBTs, and those that have already been identified as of higher concern through other programs, while industry wants a long, costly risk assessment process that prolongs study before taking action.

3) SCHF wants to consider multiple sources of exposure, consistent with the recent NAS recommendations, while industry wants to assume that humans and the environment are only exposed to one chemical at a time. Here there is the logistical problem of just how one might go about determining hazard of mixtures but also of determining exposure not only of one chemical from multiple sources but many similar-acting chemicals from multiple sources.

I suppose one could take exception to whether Denison accurately characterized the industry positions, but at the very least it seems he is close enough for argument. There are very real concerns from industry of the burden of a REACH-like program that requires vast resources, both from industry and EPA (REACH created an entirely new 400-person and growing Agency to deal with the data review). There are also very real concerns that without having data for alternative chemicals there is no way of knowing that they are actually "safer" substitutes for obviously hazardous materials. And if there is no exposure, there is no risk, no matter how hazardous a chemical might inherently be. So an accurate assessment is no easy task.

Clearly there is still a lot of work to be done. Hopefully the expected introduction of the Kid Safe Act will give a concrete proposal on which all stakeholders can then base a dialogue. I think that without an actual bill we will simply be dancing around the edges and not getting into the vast differences in the details.

Update: Note that Richard Denison, the subject of this post, has provided additional information in the comment below, including what he calls “the democratization of chemicals management.” Please click on the Comments link below.

The Perils of Plastic (Time magazine article)

Here is an interesting article from Time magazine.

The Perils of Plastic

I'll come back a little later and explore the article further (rushing to and fro lately).