EPA to Decommission Important Chemical Identification Tool Due to Lack of Funding

The USEPA has announced that it will soon decommission an important chemical identification tool "due to lack of funding support." The Analog Identification Methodology (AIM) tool was "designed to help identify publicly available, experimental toxicity data on closely related chemical structures."  Once decommissioned, AIM will no longer be available on EPA's website.  Funding to EPA has been severely cut by Congress 9with threats of even more cuts) for a variety of programs designed to protect health and safety of humans and the environment. 

AIM has been a valuable tool for industry to identify chemicals that are similar to the ones for which they are filing PreManufacture Notices (PMN).  PMNs are filed prior to putting a new chemical on the market.  Without the AIM tool industry will have less certainty as to whether they have provided the proper information to ensure an efficient approval process.  Under TSCA, EPA has 90 days to inform industry if their PMN raises concerns for the new chemical; without concerns being raised the submitter is allowed to put the chemical into production after the 90 days.  Without use of AIM as a screening tool there is a potential for more concerns to be raised in order to give more time to review the PMN.

EPA is asking all those in industry, NGOs, and consultants who use the AIM tool to email coordinator Kelly Mayo-Bean (mayo.kelly@epa.gov) with a note indicating their use of the the tool and its importance in their work.  Ms. Mayo-Bean will compile comments and provide to management in hopes of having the funding and tool reinstated in the future.

Is the agency charged with ensuring chemical safety running out of money?

Chemicals are on everyone's mind these days, it seems. In the US there is talk of "reforming TSCA," the chemical control law that has been in force for over 30 years. In Canada they are prioritizing chemicals for further review. And in Europe, the chemicals agency created to manage the REACH process is struggling to keep its roughly $30 million a year budget.

The European Chemicals Agency (ECHA), which is based in Helsinki, Finland, is tasked with managing the Registration, Evaluation, and Authorisation of Chemicals (REACH) program. The problem is that its funding is dependent on registration fees that haven't started coming in yet. So to help fund it the European Union member states agreed to provide up front money, but due to the worldwide recession states are trying to cut back everywhere they can. And that might include ECHA.

Last year companies who manufacture or important chemicals in quantities of one tonne or more were required to "pre-register" their intent to keep the chemicals on the market. Pre-registration, which ended December 1, 2008, was free to companies, which meant no funds to ECHA. Registration fees vary by tonnage produced but can range up to around $70,000 per chemical and per legal entity. Given that many companies have several legal entities in Europe (e.g., different affiliates manufacturing the chemical in France, Germany and Italy, each one considered a legal entity), the fees going to ECHA can be large per chemical. While ECHA expected about 300,000 pre-registrations, the actual number was on the order of 2.7 million. So ECHA should be well-funded to handle the registrations once they come in.

But what about the period until then. The first registration deadline (for high quantity or more hazardous chemicals) isn't until November 30, 2010, and most of the pre-registered chemicals are slated for later deadlines. So until then ECHA is running on borrowed money, which according to ECHA's Executive Director, Geert Dancet, is barely sufficient to hire and train the needed staff (and get them to move to Finland).

All is not lost, as the European parliament’s environment committee voted recently to maintain ECHA’s annual budget, but this must still be approved by two other committees and the full Parliament. Dancet is relatively confident that he will get full funding for another year, just long enough for the large numbers of registration fees expected to arrive in mid 2010 as companies finish compiling the vast amounts of data needed to support the safety of their chemicals.

USEPA Offers "Strategic Plan" for Evaluating the Toxicity of Chemicals

This week the USEPA released a "Strategic Plan for Evaluating the Toxicity of Chemicals," which departs from "the traditional risk assessment approach that relies heavily on data generated through the intentional dosing of experimental animals." As most people know, animal welfare issues have led to a desire to find non-animal testing methods. At the same time there is pressure to provide data that adequately characterizes the hazards and risks of industrial and consumer chemicals.

According to EPA, while the traditional approach

"has provided EPA with sound science to support regulatory decision making over the past several decades, EPA must address ever-increasing demands, including consideration of complex issues such as cumulative exposures, life-stage vulnerabilities, and genetic susceptibilities, not to mention the increasing number of chemicals and cost of toxicity testing. A new approach is proposed to address these demands, an approach based on the application of advances in molecular biology and computational sciences to transform toxicity testing and risk assessment practices."

Based on a 2007 report by the National Research Council (NRC) of the National Academies, "Toxicity Testing in the 21st Century: a Vision and a Strategy," an Agency workgroup coordinated to produce the new Strategic Plan that "focuses on identifying and evaluating "toxicity pathways," i.e., cellular response pathways responsible for adverse health effects when sufficiently perturbed by environmental agents under realistic exposure conditions."

While EPA expects that the new paradigm will "create more efficient and cost-effective means to screen and prioritize for further assessment the tens of thousands of chemicals that are already found in the environment," there is some question as to whether that expectation is realistic. For example, I see four major challenges.

1) Developing and validating the methodologies: Development of new methods generally takes many iterations to determine the conditions that provide the most information with reliability and repeatability. Thus, it will likely be quite a few years before the methods being developed can be used for decision-making. Can we wait that long?

2) Translating expressions of exposure at the gene, protein, molecular, and cellular levels to the target organ and organism level: Whereas a standard animal study provides easily interpretable and accepted measures of toxicity (e.g., death, loss of body weight, reduced reproduction), the new methods provide much more nuanced results whose toxicological significance may be very difficult to establish. These subtle responses may simply be adaptive rather than result in diminished capacity.

3) Communicating why this is better than the current QSAR-based screening methods: The new methods will serve only as screening tools for prioritizing chemicals for further review. Ultimately the final risk management decision-making may still be based on the established standard testing methods. EPA will need to explain why these new screening level methods are better than the current US approach to screening chemicals. This may be especially difficult given that a Canadian prioritization program reviewed the 23,000 chemicals on its existing chemicals inventory based largely on existing study data and QSAR analysis.

4) Funding: The 2007 NRC report “Toxicity Testing in the 21st Century” suggested that transitioning into this new computational, informational, and molecular-based strategy would require $100M in funding every year for a period of 10-20 years. Given the current economic situation and competing issues such as climate change, TSCA reform, green chemistry, endocrine disruption, and others, it is hard to imagine that adequate funding can be made available for this endeavor.

Got Imagination? Get $100,000 in Research Awards

Are you imaginative? Okay, I should be a little more exact than that. Are you imaginative and do research in the fields of wastewater, water reuse, biosolids, stormwater, watersheds, and similar areas?

Yes? Well, welcome to WERF.

The Water Environment Research Foundation (that's the WERF part), through its Paul L. Busch Award, is offering $100,000 to encourage researchers in the above fields to "use their imagination, take risks, explore new directions, and ultimately realize the possibilities inherent in their valuable work." The annual Award is one of the largest in the water quality industry, and has provided nearly a million dollars in its nine years "to support researchers imbued with the visionary spirit of its namesake, a leader in the water quality community who challenged engineers and scientists to devise new technologies and solutions for addressing ongoing water quality issues."

According to WERF, which is based in Alexandria, Virginia, "recent recipients are already addressing many of the growing concerns of today’s communities, such as maintaining healthy waters in which we fish, swim, and play; improving energy efficiency to reduce greenhouse gasses and improve the air we breathe; and assuring that we are prepared to address new challenges as they arise."

One recent recipient, David Sedlak of the University of California, Berkeley extols the benefits of the $100,000 award: "By the very nature of it being an award and not a more traditional grant," he explains, "it has given us a lot more flexibility to explore the possibilities and to pursue new lines of research that arise in our ongoing work." It should be noted that the Award can go to a team of researchers, or to an individual.

Interested individuals or teams must submit their application to WERF by June 1, 2009. More information on the Paul L. Busch Award, as well as the application process, is online at www.werf.org/PaulLBusch.

Science Policy Takes Center Stage at the White House - Embryonic Stem Cells and More

Today, American President Barack Obama signed an Executive Order that lifted the ban on federal funding for embryonic stem cell research. The ban was put in place by past-president George W. Bush shortly after taking office in 2001. In lifting the ban, Obama said "we will vigorously support scientists who pursue this research. And we will aim for America to lead the world in the discoveries it one day may yield."

But perhaps even more importantly, Obama took this occasion to issue a Presidential Memorandum directing the head of the White House Office of Science and Technology Policy "to develop a strategy for restoring scientific integrity to government decision making."

In sharp contrast to what many feel was a former president adverse to science, President Obama insisted that supporting science was a critical function of government. The memorandum, he said, would

"ensure that in this new Administration, we base our public policies on the soundest science; that we appoint scientific advisors based on their credentials and experience, not their politics or ideology; and that we are open and honest with the American people about the science behind our decisions. That is how we will harness the power of science to achieve our goals – to preserve our environment and protect our national security; to create the jobs of the future, and live longer, healthier lives."

He made clear that his decision was not made based on his belief in science alone: "As a person of faith, I believe we are called to care for each other and work to ease human suffering." Further, he said that "a false choice has often been presented between science and faith, and that corrupting, shielding, or shying away from the facts science lays bare benefits nobody."

The emphasis on science is very welcome to most scientists who feel that their ability to pursue meaning research has been unduly restricted in recent years.

Mixed Responses - Scientists in US Happy, Scientists in Canada Not So Much

Most scientists didn't miss the obvious reference to reinvigorating and respecting science in President Obama's inauguration speech. The Kansas City Star newspaper had a nice article yesterday about this:

Researchers welcome Obama’s emphasis on science by Malcolm Garcia

In contrast, researchers in Canada have had a slightly different response to science budgets.

Researchers fear 'stagnation' under Tories by Carolyn Abraham

What do you think?

Past Director of Health Institutes Lauds Stimulus Funding for Science

A week or so ago I posted some of the new funding for science added to the stimulus package passed by Congress. Well, now the immediate past director of the U.S. National Institutes of Health, Elias A. Zerhouni, says that "the timing and amount of this stimulus could not have been more opportune." He notes that not only have science budgets fallen steadily since 2003, philanthropic foundations and private gifts that helped lessen the shortfall have been severely cut back as well due to the current economic downturn.

While some complain that funding for science isn't "stimulus," Zerhouni says that he has "testified in Congress that for every $1 billion shortfall in the NIH base budget, an estimated 6000 to 9000 scientific jobs are lost, with an equal number of jobs lost in indirect support activities." Add to that all the other jobs lost as industry lays off scientific staff.

So while the economic stimulus funds will help in the short term, Zerhouni cautions that this is only a partial answer. To be successful in staving "off the loss of talented scientists" it must be "coupled with a longer-term increase in the base budgets of the research agencies." This will be hard to do in tough economic times, but "it may well be attainable given the clear and welcome commitment to science just shown by the new U.S. administration and Congress."

Finally, Zerhouni notes that "A nation's most strategic resource is the strength of its scientific workforce. It is imperative that the entire scientific community coalesce around a quantifiable and shared rationale for rebalancing the base domestic federal research budget beyond the one-time stimulus package." I think most scientists would agree that funding has been severely limiting the ability to make new discoveries and understand the critical issues that face our future. This is a priority that must be kept in mind even as we deal collectively with economic uncertainties.

[Mr. Zerhouni made these comments as an editorial in the current issue of Science magazine (February 20, 2009), which is accessible by subscription (www.sciencemag.org). Photo credit, National Institutes of Health.]

Stimulating Science - Science Funding in the $787 Billion Economic Stimulus Bill

Science actually came out with a significant increase in new funding as part of the $787 billion economic stimulus bill passed by Congress this week and expected to be signed by President Obama early next week. Key provisions related to science include:

National Institutes of Health (NIH): NIH will get an additional $10 billion spread over two years, ironically, in large part due to lobbying by Republican Senator Arlen Specter of Pennsylvania, who as one of only three Republican Senators to vote for the bill had a bit of influence. Specter is a cancer survivor.

Department of Energy Office of Science: The Energy Department will get $1.6 billion for its office of science, which funds research in areas such as biofuels, nuclear physics, fusion energy, high-energy physics, and also climate change, which is expected to become a priority issue for the new administration as well as Secretary Chu.

National Science Foundation (NSF): NSF is the largest government funder of basic research in science and engineering, and will get an additonal $3 billion to provide in grants. ResearchAmerica, an advocacy group, has said the money could create up to 70,000 jobs, many in laboratories at college campuses.

NASA: The space agency received just over $2 billion, with $400 million to be used for its Earth science climate research missions, as well as to increase its supercomputing abilities.

High-speed and inner-city rail: The final version of the bill included $8 billion for improvements in railway capacity and existing infrastructure, key facets of a sustainable future. Another $6.9 billion is alloacated to improve and maintain public transit. On top of that, Amtrak received $1.3 billion for its operations, though there is a stipulation that no more than 60 percent can go to the Northeast Corridor (essentially Washington DC to Boston).

Funding Science - From Whence the Money Comes?

Science is expensive. And basic science in particular has no immediate connection to making a profit. So where do scientists get the money needed to pay for laboratory equipment, research vessels, online surveys, attendance at scientific meetings, page costs, and even the occasional ramen noodle brick cooked over a bunsen burner in those late night sessions staring at a gas chromatograph? Does the source of the funds matter? All very interesting questions for scientists and funding agencies alike.

There are a variety of possible sources of science funding, depending on whether the money is for basic research (e.g., pure science) or applied research (e.g., finding a cure for pancreatic cancer).

• Government: Government used to be the biggest source of funding for science. But whereas 40 years ago the federal government financed more than 60% of all Research & Development in the United States, that trend has been reversed where now about 65% of R&D is being funded by private interests. The main source of government funds is the National Science Foundation, which provides almost a quarter of the funding to academics for basic research. When it comes to applied medical research, the National Institutes for Health takes over that role.


• Industry: Industry provides much of the funding for applied scientific research, where the research is targeted at find practical (and profitable) uses of the basic scientific knowledge that has been gained.


• Military/NASA: Quite a bit of applied scientific funding has come out of military applications and space exploration. Technically this is government, but its specialized nature warrants its own category.


• Foundations: Private foundations are a good source of funds for both basic and applied science. Two examples are the Camille and Henry Dreyfus Foundation ("advance the science of chemistry, chemical engineering and related sciences as a means of improving human relations and circumstances") and the Bill & Melinda Gates Foundation ("combat disease, hunger and poverty in developing countries").


• Professional Organizations: Some scientific organizations provide funding to its members. These include the Sigma Xi Scientific Research Society's Grants-in-Aid of Research (GIAR) program, the Society for Environmental Chemistry and Toxicology, and others.


• Advocacy Groups: To some extent, environmental and health advocacy groups may provide funds for analysis of scientific research, though largely they obtain their own funding from the sources above.


• Self-Funding: The age of the "gentleman scientist" and the "science benefactors" are sadly long gone, but those scientists who have become financially independent are free to study science without hindrance.

Whether the source of funding influences the science is the subject for a future post.