EDF Health

Selected tag(s): Risk assessment

Chemical safety evaluation: Packing tox tests into single drops of liquid!

By Jennifer McPartland / Published: March 17, 2011

Jennifer McPartland, Ph.D., is a Health Scientist.

Parts in this series:      Part 1     Part 2     Part 3     Part 4

In my last post I introduced EPA’s collaborative NexGen effort and briefly described the scientific advances underpinning the program.  In this post, I’ll explore some of the potential power of EPA’s efforts, which will require that we get a bit into the nitty gritty (nerd spoiler alert!).

NexGen is focusing on how new scientific knowledge and technological capabilities may interplay with traditional hazard and risk assessment that predominantly relies on more expensive and time-consuming animal studies.

There has been a lot of buzz around what is called high-throughput (HT) testing of chemicals.  Just last week, EPA issued a public statement describing the unveiling of a new robot housed at the National Institutes of Health Chemical Genomics Center (NCGC).  I highly recommend watching the robot in action by clicking on the “Toxicity Testing Robot System” video link available on the NIH National Human Genome Research Institute’s website.  The robot is scheduled to test 10,000 chemicals for potential toxicity!   So, what does that actually mean?  Read More »

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ACC endorses cumulative impact assessment for all TSCA regulations!

By / Published: March 14, 2011

Richard Denison, Ph.D., is a Senior Scientist.

In what seemed a startling move, the American Chemistry Council (ACC) last week gave testimony at a Congressional hearing that included a full-throated endorsement of mandating that EPA be required to assess cumulative impacts when developing regulations addressing chemicals under the Toxic Substances Control Act (TSCA).

The call for cumulative impact assessment was a contentious element in last year’s debate over the safety standard that would apply to chemicals under a reformed TSCA.  Reform advocates supported assessing such impacts where the science allows, while ACC had staunchly opposed the concept.  The need to account for cumulative impacts is also a key recommendation of the National Academy of Sciences, in its recent reports Science and Decisions:  Advancing Risk Assessment (2009) and Phthalates and Cumulative Risk Assessment:  The Tasks Ahead (2008).

Ah, but the devil is indeed in the details:  ACC’s apparent change of heart is no such thing.  Rather, ACC is endorsing a step that would make it even harder for EPA to act to control dangerous chemicals under TSCA, namely that the agency would have to consider the cumulative impact of all prior regulations affecting a given industry before it could propose a  new one.  Read More »

Posted in Health policy, Regulation / Also tagged , , , | Comments are closed

Chemical safety evaluation: EPA is doing the “Robot” 21st century style

By Jennifer McPartland / Published: March 2, 2011

Jennifer McPartland, Ph.D., is a Health Scientist.

Parts in this series:      Part 1     Part 2     Part 3     Part 4

Remember that then-new dance move from the 20th century?  Now don’t get too excited, EPA is not adding a dance category to its new sustainability research program.

No, the ‘Robot’ in my title refers to some of the impressive machines involved in EPA’s efforts to develop and apply new automated approaches to chemical toxicity testing.  These approaches integrate modern insights being gleaned from the biological sciences with advances in computation.  A new term has even been coined for all this:  Computational toxicology.

Though perhaps less of a draw than a dance-off featuring EPA staff, EPA’s exploration of new ways to better assess and address the safety of the tens of thousands of chemicals in use today is pretty exciting.    Read More »

Posted in Emerging testing methods, Health science / Also tagged , | Read 2 Responses

EPA’s TSCA CBI policy change yields first increment in restoring public’s chemical right-to-know

By / Published: February 10, 2011

Richard Denison, Ph.D., is a Senior Scientist.

The number 14 is getting to be kind of a magic number when it comes to EPA policy and practice relating to confidential business information (CBI) under the Toxic Substances Control Act (TSCA).

I reported earlier that it had been longstanding EPA practice to allow the vast majority of CBI claims made for data submitted by industry under TSCA to stand indefinitely without any review.  In fact, EPA reported in 2005 that it reviewed an average of only 14 – yes, that’s 14 – CBI claims per year out of the thousands of such claims asserted.

But today the number 14 took on a more positive, if still a bit faint, tint:  That’s the number of chemicals the identities of which EPA announced it will soon reveal in association with data it has received that “reasonably supports the conclusion that [the chemical] presents a substantial risk of injury to health or the environment.” While we’ll have to wait another month, and possibly more, to see the chemicals and their associated risk data, these chemicals represent the first installment in what I hope will become a steady flow arising from EPA’s new policy to review, challenge and likely deny CBI claims that seek to mask the names of chemicals that are the subjects of health and safety studies required to be submitted to the Agency. Read More »

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EPA seeks to improve TSCA data reporting; a real litmus test looms for the chemical industry

By / Published: August 20, 2010

Richard Denison, Ph.D., is a Senior Scientist.

While I was on vacation last week, EPA’s proposed rule to improve chemical information reporting under its so-called Inventory Update Rule (IUR) was finally published in the Federal Register.  (I say “finally” because the proposal languished for almost 6 months over at OMB, nearly double the 90 days such mandatory reviews are supposed to take.  That unfortunate delay is curious given the relatively modest changes that appear to have been made by OMB – mostly limited to compelling EPA to shift a few elements from proposals to options open to comment, and requiring EPA to expand the range of issues on which it now seeks comment.)

I won’t summarize the EPA proposals here; EPA’s factsheet does a good job of that, and Daniel Rosenberg at NRDC has also nicely recapped the proposal on his blog.  Suffice it to say that the proposed changes would go far to address the many failings of the current IUR, which amply manifested themselves in the last reporting cycle and severely hampered EPA’s ability to assess high production volume (HPV) chemicals under its ill-fated ChAMP Initiative.

So how will the chemical industry react?  Here’s why I’ll be watching intently.  Read More »

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EPA clarifies it wants more information on those dispersants made public

By / Published: June 9, 2010

Richard Denison, Ph.D., is a Senior Scientist.

EPA issued a statement today drawing attention to its posting on its website late last week of the ingredients in NALCO’s Corexit® dispersants, more than one million gallons of which have now been released into the Gulf of Mexico.  The statement appears to have been issued in response to queries from myself and others as to why the posting was not more prominently flagged by EPA.  It indicates that the most recent disclosure “was possible because NALCO waived their claim” that the ingredient identities are proprietary.  It also makes clear EPA doesn’t consider Nalco’s disclosure to be the end of the story, and that EPA will continue to seek to provide the public with more information about the dispersants than their producers have produced to date.

I’ve posted EPA’s statement just beyond this jump. Read More »

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