Beth Bosley Testimony at Congressional Hearing on TSCA Chemical Control

Today I continue with the testimony of the final witness present at the November 17, 2009 Congressional hearings on "Prioritizing Chemicals for Safety Determination." Earlier I gave an overall summary. Beth Bosley is Managing Director of the Boron Specialties company, but spoke on behalf of the Society of Chemical Manufacturers and Affiliates (SOCMA). SOCMA is a trade association that represents the batch and custom chemical industry, which are typically small to medium-sized businesses and thus may not have the more extensive resources of the larger chemical firms.

Bosley noted that SOCMA agrees with the idea that TSCA needs to be modernized, but said that this should be done in a way that "doesn't devastate a strategic American industry that is already facing recession and foreign competition." She offered two essential principles for "a sustainable chemical management law that won't eliminate jobs, economic growth, or products."

1) Priorities must be based on risk: Bosley noted that this means "basing priorities and regulatory criteria on the scientific evaluation of toxicological response and exposure factors." She gave an example of a chemical that may be highly toxic but used only in strictly controlled industrial environments or in small quantities, and as such would actually have a fairly small risk to public health.

2) Proven regulatory mechanisms should be the basis for modernization: Bosley insisted that the modernized TSCA must rely on leveraging regulatory mechanisms that work in the US. She said that applying an approach like the European REACH approach in the US "would devastate small and medium sized companies...and do so unnecessarily since a more practical alternative is available. She suggested that "the Canadian approach to chemicals management has systematically prioritized that nation's inventory and is, therefore, much farther ahead of the EU with respect to evaluating chemicals in commerce."

Bosley also said that SOCMA supports the idea of an "inventory reset," which was part of EPA's Chemical Assessment and Management Program (ChAMP), a program that was recently discontinued. She noted that of the "over 80,000 chemicals now listed on the inventory, data suggest that only about 1/3 of these are presently in commerce." Thus, "resetting" the inventory to include only those now in production would significantly reduce the number of chemicals that need to be prioritized and categorized. Bosley suggested that "ChAMP should not have been abandoned, because it will just have to be reinstituted under another name."

Bosley said that we should "embrace TSCA mechanisms that have worked well, like the New Chemicals Program," which through its PreManufacture Notice (PMN) process reviews over 1,000 new chemicals every year. She also encouraged everyone to recognize "the massive amount of data that was generated by EPA's High Production Volume Program and leverage that data in making initial determinations of risk." She felt that "with reasonable amendments," TSCA could provide an easier mechanism to collect data from manufacturers and users related to a) volumes manufactured, processed or used, b) health effects, and c) exposure characteristics.

Finally, she noted that the "safety" standard used by EPA to make determinations should involve:

1) Not overlooking the basic principle of risk (i.e., the evaluation of both hazard and exposure, not just hazard),

2) Not let EPA get burdened with having to determine that each chemical is safe for its intended use (i.e., chemicals need to be prioritized so that only those really of concern should need to be evaluated in depth, and for only those uses that are of concern), and

3) EPA must be adequately funded no matter what approach Congres takes in modernizing TSCA. Bosley noted that "the biggest shortcoming of the TSCA program today is lack of resources, not lack of authority."

Well, that summarizes all of the witnesses who testified at the November 17, 2009 House subcommittee hearing. This is the follow up to a House hearing held back on February 26, 2009, which I discussed earlier.

In addition to the in-person witnesses there was some written testimony provided to the subcommittee. There were also statements published by several other interested stakeholders such at the American Chemistry Council, the Environmental Defense Fund, the Environmental Working Group, and others. I'll be reviewing these in the coming days. I'll also be providing some critical analysis contrasting the different viewpoints and looking at what a final bill might look like.

Daryl Ditz Testimony at Congressional Hearing on TSCA Chemical Control

This is a continuation of my series taking a closer look at the November 17, 2009 Congressional hearings on "Prioritizing Chemicals for Safety Determination." Earlier I gave an overall summary. Today I look at the testimony of Daryl Ditz, a Senior Policy Advisor for the Center for International Environmental Law.

Ditz started by saying that "despite its aspirational title, the Toxic Substances Control Act (TSCA) has failed to assess, let alone guarantee, the safety of the great majority of chemicals in use today." He further suggested that "TSCA stymies action by EPA and other agencies, perpetuates a reliance on dangerous substances, leaves businesses in the dark, and undermines U.S. competitiveness." Needless to say, Mr. Ditz believes the time is right to modernize TSCA.

He offered three recommendations for fixing TSCA.

1) To expedite action, Ditz said that "Congress should authorize EPA to promptly identify and phase out non-essential uses of a set of high-priority chemicals." He believes that "a slow, cumbersome safety determination process for these high-priority chemicals is neither necessary nor appropriate." He identifies these as the "worst-of-the-worst," defined primarily as those chemicals that exhibit PBT properties, i.e., Persistent, Bioaccumulative, and Toxic. Many PBT chemicals have already been identified and are characterized by remaining largely unchanged in the environment or people's bodies for long periods of time, biomagnify up the food chain (e.g., concentrations get higher as you move from plant to animal to higher order animal), and show high toxicity. Ditz believes that the old "unreasonable risk" standard in TSCA has actually prevented EPA from taking action on chemicals it knows need to be regulated.

2) Congress should "authorize EPA to prioritize the order in which all chemicals, new as well as existing, are assessed against a health-based standard." Ditz said that industry should be required to prove the safety of their chemicals (rather than the current system in which EPA must demonstrate lack of safety). He mentioned that the 2008 Kid Safe Chemical Act (which was never passed) would have prioritized chemicals for further review, but that prioritization shouldn't be used to exclude them from review, just determine the order they are reviewed. He noted that the previous administration's ChAMP initiative was "misguided" in that in trying to sort through nearly 7000 chemicals it "wrongly labeled 'low risk'" many chemicals on the basis of inadequate and unreliable data. Ditz felt the process advocated by the American Chemistry Council in its recently released "principles for TSCA modernization" would "repeat this mistake by subjecting only a fraction of existing chemicals," often based on limited data, to a safety determination and "letting the majority of chemicals sidestep credible evaluation."

3) Congress should ensure that "up-to-date, comprehensive information is available on all chemicals, to protect the health and safety of Americans and foster confidence in the market." Ditz noted repeatedly that the quantity and quality of data available in which to do these prioritizations was severely limited for most chemicals. He said that "U.S. policy should require chemical manufacturers to develop, submit and periodically update data on the potential hazards, exposures, and uses of chemicals they manufacture or import." He insisted that minimum data requirements are needed because major data gaps limit the ability to make informed assessments.

Finally, Mr. Ditz seconded the need for CDC and other organizations to conduct biomonitoring as "an important check on human exposures in the real world." He also believes that the ongoing efforts in Europe (REACH) and Canada (Chemical Categorization Program) can be used to help inform the evaluation of chemicals in the United States.

Tomorrow I will take a look at the testimony of William J. Greggs, a consultant for the Consumer Specialty Products Association, the Grocery Manufacturers Association, and the Soap and Detergent Association (and formerly with Procter & Gamble).

Eric Sampson Testimony at Congressional Hearing on Chemical Control

Yesterday I gave a summary of the testimony of EPA Assistant Administrator Steve Owens from the November 17, 2009 Congressional hearings on "Prioritizing Chemicals for Safety Determination." Earlier I gave an overall summary. Today I continue with the series as I take a closer look at the testimony of Eric Sampson, who is Director of the Division of Laboratory Sciences in the National Center for Environmental Health with the Centers for Disease Control and Prevention, which we all know as the CDC.

Sampson emphasized the value of biomonitoring in prioritization efforts. He described the current CDC biomonitoring programs and how they may be expanded. For those who don't know, biomonitoring refers to the taking of samples from humans, usually blood and urine samples, and analyzing them for a variety of chemicals. Sampson notes that biomonitoring, unlike measures of environmental samples like air, soil, water and food, tells the actual amount of chemical from all sources that gets into people. He did say that biomonitoring is pretty far ahead of the science of interpreting what they see, but is still valuable for a variety of human health purposes such as "identifying relative levels of exposure in the population, particularly in children and other vulnerable groups," as well as "setting priorities for research into the health effects of chemicals."

He gave an overview of several ongoing biomonitoring efforts, including the National Health and Nutrition Examination Survey (NHANES), which is a snapshot study repeated several times since the 1970s and then every two years since 1999. The Fourth National Exposure Report is due out by the end of this year. CDC also does targeted biomonitoring surveys in partnership with states, other federal agencies, academic institutions, and international organizations. One important collaboration is the National Children's Study, which is "designed to follow 100,000 children from conception to ae 21.

They key point of Dr. Sampson's testimony is that biomonitoring data by the CDC and other organizations can be an important tool in prioritizing chemicals for further review. Several studies have already shown that hundreds of chemicals are routinely found in the blood (including cord blood), breast milk, and urine, and that these findings can help identify those chemicals of greatest concern for review. He also notes that past biomonitoring has helped regulators "monitor the effectiveness of interventions designed to reduce exposures," as was demonstrated by tracking lead concentrations in blood as lead-based gasoline additives were phased out.

It should be noted that the Kid Safe Chemical Act of 2008, some version of which is expected to be reintroduced in this session of Congress, included a greater emphasis on biomonitoring. Whether it is in the new version remains to be seen as California's attempt to institute a biomonitoring program have been stymied by the economic downturn.

Tomorrow I'll take a closer look at the testimony of Daryl Ditz, Senior Policy Adviser at the Center for International Law, who urged Congress to focus first on "the worst of the worst" chemicals.

Steve Owens testimony at Congressional Hearings on TSCA Chemical Control

Yesterday I gave an overall summary of the November 17, 2009 Congressional hearings regarding TSCA chemical control modernization in the House. The Subcommittee on Commerce, Trade, and Consumer Protection, chaired by Illinois Representative Bobby Rush, listened to a series of witnesses on the subject of "Prioritizing Chemicals for Safety Determination." See yesterday for a brief review of each testimony.

Today I take a closer look at the testimony of Steve Owens, who is the new Assistant Administrator for EPA’s Office of Prevention, Pesticides, and Toxic Substances. OPPTS would have the major role for EPA in any new version of the Toxic Substances Control Act (TSCA). Owens made a point of reminding the Representatives that TSCA, which was enacted in 1976, is the only major environmental statute that has not been reauthorized. In addition, the TSCA Inventory was created by simply grandfathering all the existing chemicals at the time - about 63,000 of them - onto a list with the intent of reviewing them for safety considerations at some later date. After 33 years, only about 200 have been required by EPA to have any safety testing done, and "only five of these existing chemicals have been regulated under TSCA's ban authority."

Owens also noted that "today, advances in toxicology and analytical chemistry are revealing new pathways of exposure." In particular he mentioned "subtle and troubling effects of many chemicals on hormone systems, human reproduction, intellectual development and cognition, particularly in young children." He added that it was "clear that in order for EPA to properly do its job of protecting human health and the environment, TSCA must be updated and strengthened. EPA needs the tools to do the job the public expects."

He reiterated the principles introduced by Administrator Lisa Jackson in late September, which I've summarized previously.

Owens then talked about "a number of steps that EPA will be taking over the coming months to put in place a multi-pronged approach to strengthen EPA's efforts to manage industrial chemicals." He noted that the ChAMP program was reviewed and determined to be "too focused on categorizing thousands of chemicals, which would take years." He said the reviews also showed that "most of the evaluation was based on limited and incomplete test and exposure data." In short, ChAMP was a lot of effort and not much value.

Instead they are starting up an "enhanced chemical management program," which will "require that companies submit information to fill the remaining gaps in basic health and safety data on HPV chemicals." EPA also plans to "make the reporting to chemical use information more transparent, more current, more useful, and more useable by the public." In short, Owens said that Administrator Jackson directed his office "in the interim to utilize our current authority under TSCA to the fullest extent possible, including Section 6 authority to label, restrict, or ban a chemical, to ensure that we do everything we can to protect the American people from dangerous chemicals."

EPA is currently "evaluating an initial set of chemicals based on available hazard, exposure and use information." Factors used to prioritize this initial set include:

1) use in consumer products (because people may have regular exposure to them even though they usually are not of particular hazard)

2) presence in human blood (e.g., chemicals found in recent biomonitoring studies by the CDC and advocacy groups)

3) persistent, bioaccumulative and toxic characteristics (i.e., PBT chemicals, which my remain in humans or the environment for a long time without breaking down, plus are toxic)

4) toxicity (for obvious reasons)

5) production volume (the voluntary HPV Challenge programs and the EU's new mandatory REACH program also focused on chemicals made in the highest volumes)

Once prioritized, EPA plans to complete and make public a series of "action plans" that will "outline the risks that use of these chemicals may present and what steps we may take to address those concerns."

EPA would then engage with stakeholders (both manufacturers, users, and the public) to prioritize additional chemicals for evaluation. Owens noted that EPA plans to make new action plans available to the public every four months.

According to EPA's web site, they are currently evaluating an initial set of chemicals for action plan development, including:

* Benzidine dyes and pigments
* Bisphenol A (BPA)
* Penta, octa, and decabromodiphenyl ethers (PBDEs) in products
* Perfluorinated chemicals
* Phthalates
* Short-chain chlorinated paraffins

Four of these will have action plans released in December.

And so it begins. TSCA reform is in the works and all stakeholders agree that the way the US manages chemicals needs to be modernized. I'll continue to provide updates and commentary as the process moves forward.

Tomorrow I'll talk more about what Eric Sampson at the CDC had to say about the value of biomonitoring in prioritization efforts.

Summary of Congressional Hearings on TSCA Chemical Control

As I noted yesterday, the House held a hearing on November 17th, 2009 to discuss prioritization of chemicals for control in the United States. This is part of the process for introducing a reform (or "modernization") of TSCA, the prevailing chemical control law for the last 33 years.

Here's a quick summary of the main points from each speaker's testimony. I will do more in-depth reviews of each in the following days.

Steve Owens, Assistant Administrator in EPA’s Office of Prevention, Pesticides, and Toxic Substances, indicated that EPA does not have sufficient authority to reevaluate existing chemicals that were grandfathered into the Inventory at the time of its creation. He explained that EPA will prioritize chemicals based on their presence in human blood, whether they are PBTs, their toxicity, and their volume of production. Mr. Owens also mentioned EPA’s plan to issue “action plans” for a set of chemicals every four months, starting in December.

I'll talk more about Steve Owens' testimony tomorrow.

Eric Sampson, Director of the Division of Laboratory Sciences in the National Center for Environmental Health with the Centers for Disease Control and Prevention, emphasized the value of biomonitoring in prioritization efforts.

Daryl Ditz, a Senior Policy Advisor for the Center for International Environmental Law, proposed three ways to fix TSCA, beginning with giving EPA the authority to effectively regulate “the worst of the worst” chemicals.

William J. Greggs, a consultant for the Consumer Specialty Products Association, the Grocery Manufacturers Association, and the Soap and Detergent Association (and formerly with Procter & Gamble), stated that prioritization of chemicals should be based on hazard and exposure.

Beth Bosley, a consultant for the Society of Chemical Manufacturers and Affiliates, suggested to the Congresspersons that TSCA should be amended in a way that does not eliminate jobs or useful chemicals.

More analysis will follow in the coming days. Past articles related to TSCA can be found here.

EPA outlines "Essential Principles" for TSCA Chemical Control Reform

Previously I have reported on EPA's shutting down of the voluntary ChAMP program of chemical control priortization. We've been waiting for word of what might replace it as reform of TSCA - the current chemical control law in the US - is under discussion in a very busy Congress. Well, the first signs of a framework are beginning to emerge in a presentation given by EPA Administrator yesterday.

Jackson outlines a series of "principles" that she hopes will be incorporated into new legislation. These principles underline the core belief of the Administration, which is that "it is important to work together to quickly modernize and strengthen the tools available in TSCA to increase confidence that chemicals used in commerce, which are vital to our Nation’s economy, are safe and do not endanger the public health and welfare of consumers, workers, and especially sensitive sub-populations such as children, or the environment."

According to Jackson and the EPA web site:

The following Essential Principles for Reform of Chemicals Management Legislation (Principles) are provided to help inform efforts underway in this Congress to reauthorize and significantly strengthen the effectiveness of TSCA. These Principles present Administration goals for updated legislation that will give EPA the mechanisms and authorities to expeditiously target chemicals of concern and promptly assess and regulate new and existing chemicals.

Principle No. 1: Chemicals Should Be Reviewed Against Safety Standards That Are Based on Sound Science and Reflect Risk-based Criteria Protective of Human Health and the Environment.

EPA should have clear authority to establish safety standards that are based on scientific risk assessments. Sound science should be the basis for the assessment of chemical risks, while recognizing the need to assess and manage risk in the face of uncertainty.

Principle No. 2: Manufacturers Should Provide EPA With the Necessary Information to Conclude That New and Existing Chemicals Are Safe and Do Not Endanger Public Health or the Environment.

Manufacturers should be required to provide sufficient hazard, exposure, and use data for a chemical to support a determination by the Agency that the chemical meets the safety standard. Exposure and hazard assessments from manufacturers should be required to include a thorough review of the chemical’s risks to sensitive subpopulations.

Where manufacturers do not submit sufficient information, EPA should have the necessary authority and tools, such as data call in, to quickly and efficiently require testing or obtain other information from manufacturers that is relevant to determining the safety of chemicals. EPA should also be provided the necessary authority to efficiently follow up on chemicals which have been previously assessed (e.g., requiring additional data or testing, or taking action to reduce risk) if there is a change which may affect safety, such as increased production volume, new uses or new information on potential hazards or exposures. EPA’s authority to require submission of use and exposure information should extend to downstream processors and users of chemicals.

Principle No. 3: Risk Management Decisions Should Take into Account Sensitive Subpopulations, Cost, Availability of Substitutes and Other Relevant Considerations.

EPA should have clear authority to take risk management actions when chemicals do not meet the safety standard, with flexibility to take into account a range of considerations, including children’s health, economic costs, social benefits, and equity concerns.

Principle No. 4: Manufacturers and EPA Should Assess and Act on Priority Chemicals, Both Existing and New, in a Timely Manner.

EPA should have authority to set priorities for conducting safety reviews on existing chemicals based on relevant risk and exposure considerations. Clear, enforceable and practicable deadlines applicable to the Agency and industry should be set for completion of chemical reviews, in particular those that might impact sensitive sub-populations.

Principle No. 5: Green Chemistry Should Be Encouraged and Provisions Assuring Transparency and Public Access to Information Should Be Strengthened.

The design of safer and more sustainable chemicals, processes, and products should be encouraged and supported through research, education, recognition, and other means. The goal of these efforts should be to increase the design, manufacture, and use of lower risk, more energy efficient and sustainable chemical products and processes.

TSCA reform should include stricter requirements for a manufacturer’s claim of Confidential Business Information (CBI). Manufacturers should be required to substantiate their claims of confidentiality. Data relevant to health and safety should not be claimed or otherwise treated as CBI. EPA should be able to negotiate with other governments (local, state, and foreign) on appropriate sharing of CBI with the necessary protections, when necessary to protect public health and safety.

Principle No. 6: EPA Should Be Given a Sustained Source of Funding for Implementation.

Implementation of the law should be adequately and consistently funded, in order to meet the goal of assuring the safety of chemicals, and to maintain public confidence that EPA is meeting that goal. To that end, manufacturers of chemicals should support the costs of Agency implementation, including the review of information provided by manufacturers.

I will be looking more closely into these principles and reporting further in the days ahead.

NGO Reaction to the Decision to Suspend ChAMP Chemical Program

As previously noted, the Obama EPA suddenly suspended its ChAMP program last week. ChAMP was the Agency's mechanism for evaluating the data received during the voluntary HPV Challenge, in which industry agreed to provide available health and safety data on about 2200 high production volume chemicals (i.e., those produced or imported in excess of 1 million pounds per year in the US).

Yesterday I gave some of the reaction from industry. Most felt that ChAMP was a good program and didn't understand its sudden suspension. Some feel it was so the Obama administration could institute more "command-and-control" regulation over chemicals, rather than the more voluntary (and EPA-onused) ChAMP.

The non-governmental organization (NGO) reaction, on the other hand, has been generally in favor of the move. The Environmental Defense Fund (EDF), whose 1997 report "Toxic Ignorance" was the catalyst that led to the HPV Challenge in the first place, has been very critical of the ChAMP program. According to EDF's Richard Dennison,"[i]t probably goes without saying that EDF welcomes EPA's decision to suspend the development and posting of risk-based prioritizations under its Chemical Assessment and Management Program (ChAMP)." Dennison has been writing a series of blog posts in recent months in which he notes some of the failings of ChAMP, arguing "that ChAMP's "rush to risk" has taken EPA badly off-track." He claims, however, that "we have also identified many useful things that EPA's existing chemicals program can and should be doing with the data it obtained through the HPV Challenge (whether called ChAMP or not)," and that EDF looked "forward to working with EPA to craft a new approach, grounded in a return to developing scientifically defensible hazard, not risk, characterizations and transparently identifying and addressing data gaps and data quality problems."

Another environmental advocacy group that has been following ChAMP, and in particular has been very supportive of the proposed Kid Safe Chemical Act, is the Environmental Working Group (EWG). EWG recently launched an interactive online site "featuring news and commentary, as well as a forum for a thought-provoking exchange of ideas on reforming the nation’s federal toxic chemicals policies." According to EWG, the site "will feature analysis and opinion by scientists, lawmakers, industry officials, community activists, policy specialists, journalists and others interested in environmental health issues." A major focus of the site "will be the emerging debate over reform of the 1976 Toxic Substances Control Act (TSCA)."

Another group interested in the ChAMP and TSCA reform is the Natural Resources Defense Council (NRDC). Commenting on the EDF blog, Gina Solomon of NRDC notes that "[t]his is a very important step toward meaningful chemical reform. It was clear that EPA needed to sweep the house clean before bringing in the new furniture, and the elimination of ChAMP does exactly that. Now we can get on with the job of really reforming U.S. chemical policy." She also congratulated EDF for its series of blog stories, saying "I really think this blog brought down ChAMP!"

Many in the NGO community feel that the administration's decision to suspend ChAMP is a clear signal that "ChAMP is grossly, indefensibly ineffective." EDF's Dennison says the decision is "implicit acknowledgement" that the ChAMP prioritization process needed an overhaul. According to the ChAMP web site, as of March 2009, EPA had "developed and posted risk-based prioritizations for 220 HPV chemicals and has posted hazard-based prioritizations for 83 chemicals." The goal of the program was to develop "screening-level hazard, exposure, and risk characterizations for an estimated 6,750 chemicals produced or imported in quantities of 25,000 pounds or greater a year" by 2012.

Clearly the administration felt that the program could not accomplish those goals and that a better way was needed. According to EPA, they expect to offer a new direction some time this summer.

Industry Reaction to Obama Decision to Suspend ChAMP Chemical Program

As noted a few days ago, the Obama EPA has decided to suspend its voluntary Chemical Assessment & Management Program (ChAMP). The news came as a bit of a shock to most policy watchers, both on the industry and NGO side (and apparently also within the Agency).

Industry reaction has been mixed, some attacking the decision as "less about science and more about the new administration's desire for a command-and-control approach to chemicals management policy." For example, the National Petrochemical & Refiners Association (NPRA) attacked the move in a statement issued June 18th by accusing the EPA of remaining “silent about its full intentions, contradicting President Obama's commitment to transparency and support for scientific integrity.” NPRA's President, Charles Drevna further noted that “[i]t is extremely disheartening that the administration would abandon its priority-setting chemicals management process before it is even given the opportunity to work.” Drevna further "urge[d] the administration to reconsider its abandonment of both the scientifically sound ChAMP initiative and the United States’ commitments to Canada and Mexico under the Security & Prosperity Partnership of North America."

Similarly, the Society of Chemical Manufacturers and Affiliates (SOCMA) issued a statement in which indicated that the suspension of ChAMP “is creating confusion over how or whether to continue activities already begun by industry in this effort.” In the SOCMA statement, Bill Allmond, vice president of government relations, urged "EPA to not delay the forward progress it has been making under ChAMP. We applaud the agency for wishing to strengthen its chemicals management program, but we’re concerned that, in order to do so, they’re stopping it altogether. We hope that EPA’s evaluation of ChAMP will be brief and maintain the program’s original intent.”

Meanwhile, the American Chemistry Council (ACC) also issued a statement, though perhaps with a less strident tone. ACC says “[W]e are confident that any changes to ChAMP do not signal a reversal of the U.S. government’s commitment, but rather to further strengthen the program.” ACC seems to believe that the initial reports are overreactive and that EPA will find a way to get chemical reviews moving again. ACC was the original industry lead in developing the voluntary High Production Volume (HPV) Challenge program, from which ChAMP evolved as a means to evaluate the collected data.

Consistent with ACC's view is the fact that EPA has requested an additional $3 million for the program in its fiscal year 2010 budget proposal. The budget request includes monies to hire additional employee resources in order to accelerate the development of the ChAMP prioritization documents. Now, according to an EPA spokesman, the EPA is looking at options “to determine how best to ramp up efforts to assess, prioritize and take risk management action on chemicals of concern. EPA plans to announce the specifics of this effort this summer and will seek public input into the discussion.”

So it seems that EPA already has some idea in mind about how it prefers to proceed. Expect more updates and potential options for moving forward as information continues to become available.

Obama Administration Shuts Down ChAMP Chemical Program?

EPA sources report that the Obama administration and EPA leadership are shutting down EPA's Chemical Assessment and Management Program (ChAMP). ChAMP was initiated as a mechanism to implement the Montebello Agreement, also called the Security & Prosperity Partnership between the three countries (Canada, Mexico and the US), signed in August 2007 by former President Bush.

Apparently EPA staff were told of this decision in an internal meeting within the last two weeks. It remains unclear what might replace it. However, it should be known that highly placed EPA executives believe the report misrepresents what is actually happening, which is merely to "renovate" the program rather than shut it down completely.

If the decision is to shut ChAMP down completely, it would come as a bit of a surprise to EPA watchers. Just a few months ago EPA Administrator Lisa Jackson had indicated that she wanted to accelerate the full assessments of high priority chemicals. For the time being it actually looks like the risk-based prioritization activities have ceased pending further review. Jackson also suggested that she had been leaning toward a ChAMP like program rather than the original Kid Safe Chemical Act concept previously introduced to Congress by Senator Lautenberg and Congressman Waxman. TSCA reform has been a hot topic of discussion in Congress and Lautenberg repeated only a few days ago that he plans to reintroduce the bill later this year, though the bill is expected to be substantially altered from the original to incorporate new ideas...and some thought, ChAMP-like provisions.

According to the Montebello Agreement, the United States agreed to complete risk characterizations by 2012 on more than 9,000 chemicals produced above 25,000 pounds per year. The regional agreement also provided for the sharing of scientific information and technical understanding, best practices and research on new approaches to chemical testing and assessment. The agreement established additional goals to be met by 2020, which include creating and updating chemical inventories in all three countries, as well as coordinating the management of chemicals in North America as outlined in other international agreements. ChAMP was on its way toward meeting those goals, and in fact was anticipated to be expanded to take on additional enhancements that would look at inorganic chemicals and reset the TSCA Inventory.

Obstensibly a voluntary program which put much of the onus for evaluation on EPA, ChAMP is the second large voluntary program that has been shut down by the current administration - the first being the Performance Track program. There is no question that the ChAMP program takes substantial EPA resources, and this announcement may simply be a sign that the administration is intending to revamp the program in a way that allows its stated goals to be pursued within a revised Kid Safe Act when it is reintroduced later this year.

I will continue to update as I get more information.

More Chemical Testing from EPA - The 3rd HPV List

Coming soon to a Federal Register near you, the USEPA is expected to publish its third list of high production volume (HPV) chemicals. Technically the "list" is a proposed test rule authorized under Section 4 of the Toxic Substances Control Act (TSCA). Affected industry and other stakeholders will have time to provide comment on the approximately 29 HPV chemicals on the list, after which the EPA will publish a final rule. For the previous two test rules industry was given approximately 24 months to complete the specific health and safety testing identified in the rule.

This test rule is part of the ongoing process stemming from the voluntary HPV Chemical Challenge Program, which was initiated in 1998. Under the program, companies were asked to compile available environmental health and safety data on a list of 2,800 chemicals that were manufactured in or imported into the U.S. in quantities of greater than one million pounds. But several hundred of these were not sponsored by industry and thus were considered "orphan" chemicals. Since then EPA has been slowly reviewing the available data and issuing - now mandatory - requirements for companies to test these chemicals.

The process has been quite lengthy. The first rules was proposed in 2000 and only finalized in 2006. Another proposed rule was published last year and has yet to be finalized. The fact that the process takes so long and handles only small numbers of the thousands of chemicals on the Inventory has been part of the impetus leading some activists to argue for reform of TSCA. In short, the feeling is that there has to be a better way to ensure that chemicals are proven safe being placed, or continuing to be placed, on the market.

Which gets the crux of the problem. While the voluntary HPV program and these testing rules focus on only the highest production volume chemicals - an important prioritization tool but limited in scope - there are approximately 63,000 chemicals that were grandfathered onto the TSCA Inventory without substantive review. Add to that the 30,000 new chemicals added since then in which very limited data were actually provided, thus requiring EPA to assess them largely based on modeling and comparison with chemicals of similar structure.

The ChAMP process is starting to look at medium production volume chemicals, that is, those greater than 25,000 pounds. There is also a desire at EPA to extend ChAMP to looking on inorganic chemicals and to "reset" the TSCA Inventory, though these "enhancements" are currently under review by the new administration. All of this leads into what both advocacy groups and industry agree is a need to revamp the TSCA law. Industry favors something more like ChAMP, while many advocacy groups prefer something more like the Kid Safe Chemical Act that has been introduced in Congress twice before (though was never acted upon even in committee).

Some of the many issues driving TSCA reform include the problem that increased testing (which is needed to prove safety) means increased used of animal models, which animal welfare advocates such as PETA find objectionable. Whether the onus should be put on EPA to review and prioritize chemicals for testing, e.g., via the test rules above, or on industry to do a full suite of base set testing to prove safety is also a subject of heavy debate. As is how much any new law should subsidize "green chemistry" and substitution mechanisms that would either encourage the development of inherently safer chemicals and/or force more hazardous chemicals off the market even though safer substitutes may not be available. Furthermore, should the new law mandate or encourage the development and use of new assessment methods such as in vivo being defined by the National Center for Computational Toxicology’s ToxCast Program. While these tests will eventually lead to less animal testing, they carry a greater degree of uncertainty as to what any observed results might actually mean, as I have noted in a previous post.

So, the end result of TSCA Reform is still too far away to accurately predict. But as I will continue to discuss on these posts, there are several areas of agreement that are beginning to emerge.

TSCA Reform Seems Inevitable - But Which TSCA Reform?

It's a done deal. Okay, not actually a "done deal." But it seems clear that some sort of TSCA reform is on its way. TSCA, of course, is the Toxic Substances Control Act, which has been the authority for chemical control in the US for over 30 years. Not much has changed since it was passed, and not many of the 63,000 chemicals grandfathered onto the TSCA Inventory have had comprehensive data reviews. New chemicals, on the other hand, all have gone through some review by the EPA, but even here there is no requirement to provide health and safety data so most of the analysis is done by computer modeling and comparison to similar chemicals.

As reported here previously, Senator Lautenberg and Representatives Waxman and Solis introduced the Kid Safe Chemical Act back in 2005 and again in 2008. On both occasions it never got out of committee. Senator Lautenberg is adamant that he will reintroduce it this year. But then what?

In a recent hearing both industry and advocacy groups provided their input in to what TSCA reform should look like. Industry, in particular Cal Dooley of the American Chemistry Council, acknowledged that some sort of TSCA reform is necessary. Environmental groups such as the Environmental Defense Fund agreed that a change is needed. But the agreement stops there.

There are two main options on the table, with lots of options in between. One option is to reintroduce the Kid Safe Act, which would be a radical departure from the current TSCA law, and a bit too close to the European REACH program for industry's tastes. Some environmental groups, e.g., the Environmental Working Group, are in favor of the Kid Safe Act approach. Industry favors something that tweaks the current authority incumbent in TSCA but perhaps not assertively used enough in the past by EPA. EPA itself seems to be leaning in favor of TSCA reform that looks much like its current ChAMP program. Industry generally agrees with that idea.

The difference of opinion is largely one of who has the onus. With the current TSCA and ChAMP, the EPA has the onus of determining that a chemical is not safe, something that has been hard to do given the lack of data available for most chemicals. With the Kid Safe Act and other REACH-like options, the burden shifts almost entirely to industry to prove their chemicals are safe enough to remain (if already existing) or be put (if new) on the market. There are advantages and disadvantages of each approach, which I will examine in coming posts.

Chemical Control Reform - Kids Safe Out...ChAMP In?

As discussed here previously, the US is taking a hard look at its 30+ year old chemical control law, the Toxic Substances Control Act (TSCA). Many argue that the law is outdated, both because it doesn't require health and safety data for new chemical notifications and because the bar for regulating existing chemicals seems too high a hurdle. Around 63,000 existing chemicals were grandfathered onto the TSCA Inventory with no health and safety review, and only a handful have seen such reviews since.

Options abound. Should the US pursue a system more like the new chemical control law in Europe, called REACH, which requires that manufacturers and importers of all chemicals - existing and new - provide a dossier summarizing health and safety for all intended uses? Or something more like the Canadian prioritization review and management program in which the government does the hard work of the initial screen for all existing chemicals? Or something like the Kid Safe Chemical Act that has twice been introduced by the US Congress before?

This week at the annual GlobalChem chemical industry conference being held in Baltimore, MD, Jim Jones, EPA's acting toxics and pesticides chief, told attendees at the GlobalChem chemical industry conference in Baltimore, that at the office's first meeting with new EPA Administrator Lisa Jackson, she told staff that “‘ChAMP is fine, but I want to see more, more quickly.’”

ChAMP is the current semi-authorized by TSCA mechanism that EPA has been using to maximize the value of the reams of data received under the voluntary HPV Challenge program between 1998 and 2008. But ChAMP goes further, with proposed enhancements that would "reset" the TSCA Inventory, look at moderate volume chemicals, and inorganic high production volume chemicals that were excluded from the original HPA Challenge.

Jones' comments signal that EPA may be leaning toward TSCA Reform that mirrors more the ChAMP program than the Kid Safe Act. Environmental and health advocacy groups have favored the Kid Safe Act because it puts the onus on producing data on the manufacturers of chemicals, similar to REACH in the EU. Industry favors something more like ChAMP, which initially would require more Agency effort during the screening process, but may provide for a quicker review and prioritization. Once chemicals are prioritized for more in-depth review, industry would provide specific data focused on addressing any real or perceived concerns.

Jackson has hinted on more than one occasion since taking office that she favors the current chemical management system as a basis for reforming the program. The ChAMP program was initiated following former President Bush's commitment to complete the characterizations of Inventory chemicals by 2012 as part of the 2007 Security and Prosperity Partnership agreement with Mexican and Canadian officials.

Officially though, the administration has not yet taken a position on TSCA reform, but Jones suggests that "the administrator is “very interested” in the issue and has discussed the issue “with her small political team several times.” Meanwhile, EPA will continue to use its existing TSCA authorities to regulate substances that are of concern. While Congress is mulling the future of TSCA, EPA has been more assertive in using such TSCA authorized tools as test rules and enforcement actions. It also has been very busy reviewing the data received from the HPV Challenge and issuing hazard and risk prioritizations.

Revisiting the Toxic Substances Control Act of 1976

I have noted previously that there is a big push in this Congress to take a long hard look at the current chemical control regulations in the United States. Well, on Thursday, February 26, 2009 the House Subcommittee on Commerce, Trade, and Consumer Protection held a hearing on "Revisiting the Toxic Substances Control Act of 1976.” The hearing was designed to address the perception of critical gaps in the statute and explore how those gaps might hinder effective chemical safety policy in the United States.

The following witnesses, spanning a range of government, advocacy, and industry groups, all testified:

John Stephenson, Director, Natural Resources and the Environment, Government Accountability Office

J. Clarence Davies, Senior Fellow, Resources for the Future (Former EPA Assistant Administrator for Policy in the George H.W. Bush Administration)

Maureen Swanson, Healthy Children Project Coordinator, Learning Disabilities Association of America

Cecil Corbin-Mark, Deputy Director/Director for Policy Initiatives, WE ACT For Environmental Justice (West Harlem Environmental Action)

Michael Wright, Director of Health and Safety, United Steelworkers

Richard Denison, Senior Scientist, Environmental Defense Fund

Kathy Gerwig, Vice President, Workplace Safety and Environmental Stewardship Officer, Kaiser Permanente

Cal Dooley, President and CEO, American Chemistry Council

V.M. DeLisi, President, Fanwood Chemical, Inc., Chairman, International Affairs Committee, Synthetic Organic Chemical Manufacturers Association

Charles T. Drevna, President, National Petrochemical & Refiners Association

A link to the written testimony and video of the Subcommittee can be found on the Committee web site.

Chemical Control, Bobby Rush, and Hearings Start on Thursday

Just a few days ago I reported that it was likely that the House Subcommittee on Commerce, Trade, and Consumer Protection was planning to hold hearings soon on reform of the current chemical control law in the United States. Well, seems that "soon" is now Thursday, as in this Thursday, February 26th in the Rayburn House Office Building.

The Toxic Substances Control Act (TSCA) has been in place virtually unchanged since 1976, and there have been increasing calls to make changes to the law over the last few years. The current Chair of the House Energy and Commerce Committee, of which this Subcommittee is a part, is Henry Waxman, who introduced the House version of the Kid Safe Chemical Act (KSCA) back in 2005 and cosponsored the 2008 version introduced by Representative Hilda Solis.

The subcommittee in charge of running hearings on TSCA reform is chaired by Representative Bobby Rush, of the 1st Congressional District in Illinois. Some may remember Rush from his rather controversial speech at the news conference in which now-impeached Governor Blagojevich announced he had appointed the now-embattled Roland Burris to fill now-President Barack Obama's Senate seat.

It is expected that this will be the first of several hearings that take place in both the House and the Senate prior to the reintroduction of the Kid Safe Chemical Act. While the KSCA seems likely to be introduced, there is also pressure to come up with a more workable reform of TSCA, perhaps one that incorporates the current and proposed enhancements to the EPA ChAMP program.

Our Stolen Informed Future - A New Database of Endocrine Disrupting Chemicals

The organization run by Dr. Theo Colburn, famous for her book "Our Stolen Future" has launched a new web page called "Critical Windows of Development." The Endocrine Disruption Exchange (TEDX) is sponsoring the site, which provides a interactive bar graph that allows the user to track stages of fetal development versus scientific studies that show the endocrine (hormone) disrupting effects of three major chemicals - bisphenol-A (sometimes known as BPA), phthalates and dioxin - in rats and mice. Needless to say, these three chemicals have been the subject of quite a bit of controversy and many advocacy groups are seeking to have them banned or regulated severely.

The first two are commonly used in plastics and so have widespread use in consumer goods, which is part of the concern. Some studies suggest both BPA and phthalates can affect critical stages of fetal and young children's development even at very low exposures. The third chemical, dioxin, is not actually commercialized but rather a common by-product of combustion.

In her statement at the web site launch, TEDX president Theo Colburn notes “The unprecedented global increases in endocrine-related disorders such as autism, other learning and developmental disabilities, reproductive problems, diabetes, obesity, thyroid problems, breast, prostate, and testicular cancer and more, signal the need for a crash program in ‘inner-space’ research...The roles of contaminants in the womb must be addressed before it is too late.”

According to Colburn, the site will expand from the initial three chemicals. TEDX expects to add bioaccumulative polychlorinated biphenyls (PCB), polybrominated diphenyl ether (PBDE) flame retardants and the pesticide DDT by the end of this year.

The site represents a growing trend - online publishing of databases that contain the summary results of many studies over many years. This follows on the heels of the High Production Volume (HPV) Chemical databases that have resulted from the voluntary HPV Challenges in the US, Europe and Japan. The new REACH law in Europe will also put data on the web, as will the new US Chemical Assessment and Management Program (ChAMP).

Incoming EPA Administrator Sets Priorities for Action

Lisa Jackson, the incoming US Environmental Protection Agency Administrator, has identified her and President Obama's priorities for the EPA.

In an attempt to signal a change from the previous Administration Jackson states:

"EPA can meet the nation's environmental challenges only if our employees are fully engaged partners in our shared mission. Science must be the backbone for EPA programs. The public health and environmental laws that Congress has enacted depend on rigorous adherence to the best available science. The President believes that when EPA addresses scientific issues, it should rely on the expert judgment of the Agency's career scientists and independent advisors. When scientific judgments are suppressed, misrepresented or distorted bypolitical agendas, Americans can lose faith in their government to provide strong public health and environmental protection. The laws that Congress has written and directed EPA to implement leaveroom for policy judgments. However, policy decisions should not be disguised as scientific findings. I pledge that I will not compromisethe integrity of EPA's experts in order to advance a preference for aparticular regulatory outcome."

Jackson highlighted five priorities that would receive her personal attention:

1) Reducing greenhouse gas emissions: EPA will stand ready to help Congress craft strong, science-based climate legislation that fulfills the vision of the President.

2) Improving air quality: EPA will plug the gaps in our regulatory system as science and the law demand.

3) Managing chemical risks: It is now time to revise and strengthen EPA's chemicals management and risk assessment programs, and reform TSCA.

4) Cleaning up hazardous-waste sites: EPA will strive to accelerate the pace of cleanup at the hundreds of contaminated sites across the country.

5) Protecting America's water: EPA will intensify work to restore and protect the quality of the nation's streams, rivers, lakes, bays, oceans and aquifers.

Jackson is expected to be confirmed and begin work as Administrator shortly. She states that "EPA's strength has always been our ability to adapt to the constantly changing face of environmental protection as our economy and society evolve and science teaches us more about how humans interact with andaffect the natural world. Now, more than ever, EPA must be innovative and forward looking because the environmental challenges faced by Americans all across our country are unprecedented."

Obama Appointments May Affect Chemical Law Reform

I have written before on attempts to reform the way we manage chemicals in the United States (Inorganic chemicals and Montebello, now called ChAMP), as well as in Europe (REACH). With a new Congress and a new President, and with many pressures from all sides, it is likely that there will be renewed efforts to pass a comprehensive reform of the Toxic Substance Control Act (TSCA) in 2009. But it is not guaranteed.

One factor that may affect the likelihood of TSCA reform this year is the move by several House and Senate members to the new Administration. The House version of the Kid Safe Chemical Act bill (KSCA) (H.R.6100) was introduced in 2008 by Hilda Solis and Henry Waxman. Congresswoman Solis has been tapped by President Obama to be his Secretary of Labor. Her successor will be selected by special election in California's 32nd Congressional District. Because the special election takes up to 4 months to complete, and Solis' successor will be a freshman Congressperson, it is unclear whether they would be in a position to reintroduce the bill in the 111th Congress. Similarly, Congressman Waxman has taken over the chairmanship of the House Committee on Energy and Commerce, previously long led for the Democrats by Michigan Congressman John Dingell. In his new position, Waxman seems intent on working with the many other California Democrats in leadership positions, as well as the Obama Administration, to give greater emphasis to energy and climate change related issues. Of course, the bill could be reintroduced by anyone in the House.

In the Senate, New Jersey's Frank Lautenberg (along with Waxman in the House) was the leader behind the original KSCA introduced first in 2005 and reintroduced it as S.3040 in 2008. As of the fall of 2008 the Senate Committee on Environment and Public works, on which Lautenberg serves and California Senator Boxer Chairs, were indicating that they planned to begin hearings on KSCA/TSCA reform this spring. Certainly there will be several issues competing for resources, but with REACH and the Canadian prioritization programs applying pressure, and the EPA focusing on enhancing the current ChAMP program, there will be incentive from all sides to find a workable alternative to the current TSCA program here in the states.

New EPA Program to Assess Inorganic HPV Chemicals

On November 25, 2008 the U.S. Environmental Protection Agency (EPA) released its “Proposed Approach for the Inorganic High Production Volume (IHPV) Challenge Program.” This new IHPV program picks up on the theme of the voluntary HPV Challenge program, but may be an unexpected surprise for inorganic chemical manufacturers and importers who to date have not been required to provide extensive data sets for common chemicals already on the Toxic Substances Control Act (TSCA) Inventory. It is EPA's way to approach chemical management, rather than adopt the REACH approach now ongoing in Europe.

The IHPV program is just one of two enhancements EPA is proposing to the ongoing Chemical Assessment and Management (ChAMP) program. The other is a TSCA Inventory Reset. The EPA proposals are available at http://www.epa.gov/champ/.

EPA’s proposed program is based on the design of the HPV Challenge program, which began in 1998 and was focused on organic high volume chemicals. Inorganic chemicals were specifically exempted from the original US HPV program (though some were included in the ICCA HPV program in Europe). During the HPV Challenge, industry compiled and summarized the available physical, chemical, and health and safety data for around 2200 organic chemicals. EPA considers this program a success, and it served as the basis for the ChAMP program, where EPA is using the compiled HPV data to develop hazard and risk characterizations and priorities for more in-depth analysis. By proposing to include the IHPV program as part of ChAMP, EPA is signaling that it believes the time has come to assess inorganic HPV chemicals in the same way that it looked at organic chemicals.

The Proposed IHPV Approach

There are three phases to the proposed program:

Phase I: IHPV Challenge: Develop, launch and sign-up (now through December 2009)

In this phase, IHPV chemicals will be identified by EPA and affected manufacturers and importers will be asked to “volunteer” to sponsor chemicals. While technically voluntary, EPA has indicated that it plans to initiate Section 4 and 8 rulemaking under TSCA to obtain information on unsponsored chemicals. EPA has issued two Section 4 final rules for unsponsored organic HPV chemicals, as well as Section 8 rules to request information on additional unsponsored chemicals, with more rules in development. So companies will be in a position of coercive voluntarianism.

Phase II: Receive/Review Data: (~2010-2013)

Following closely on the organic HPV program, companies will compile and submit data on the physical/chemical properties, environmental fate, ecotoxicity and toxicity for each chemical. Modifications to the standard OECD screening level data requirements will be necessary in many cases since inorganic chemicals, especially elemental and alloy substances, may not be amendable to standard test methodologies. As with the original HPV program, companies will find that forming consortia for related inorganic chemical substances provides the most advantageous means of collecting, compiling, and evaluating the data.

Phase III: Assessing and Reducing Risks (~2103-2015)

This third phase falls mainly within the responsibility of EPA as they use the compiled data to develop Risk Based Prioritizations (RBPs). Since the OECD screening data set focuses on provision of hazard data, EPA plans to rely on the 2011 IUR exposure data for inorganic chemicals in order to develop its RBPs. Based on the RBPs, EPA would initiate any action they deemed necessary, which could include rulemaking, restrictions, or requests for additional data. Finally, this third phase is also expected to include the development of Hazard Based Prioritizations (HBPs) for Moderate Production Volume (MPV) inorganic chemicals (i.e., those greater than 25,000 lbs but less than 1 million lbs per year).

Who is affected?

EPA defines inorganic chemicals according to the TSCA Inventory Update Rule (IUR) as substances that do not contain carbon, or contain carbon only in the form of carbonato [=CO3], cyano [-CN], cyanato [-OCN], isocyano [-NC], or isocyanato [-NCO] groups, or the chalcogen analogues of such groups. Thus, chemical substances following under the program would include metals, ammonia, minerals, and inorganic salts. Manufacturers or importers of these substances in the US in volumes greater than 1 million pounds would be asked to participate in the program. In addition, downstream users of these chemicals may also want to participate to assure that their supplies of feedstock remain uninterrupted.

What will it accomplish?

Alas, that is the $64,000 question (or perhaps with inflation it is now the $64,000,000 question). EPA clearly considers that the voluntary organic HPV program has been a success, despite the fact that much of it remains uncompleted more than 3 years after it was scheduled to end (which already included a 2 year extension). The non-profit group, Environmental Defense Fund, whose report "Toxic Ignorance" was the impetus for beginning the original HPV program in 1998, has given the program mixed reviews. The goal is to compile health and safety data on all of the highest production chemicals in use, with the ultimate objective of eliminating those that are excessively risky.

Will this do it? Is the EPA and industry credible in convincing the public that they are ensuring safety of all chemicals on the market? What do you think?