EDF Health

Selected tag(s): Risk assessment

House leadership asks White House to scrap IUR enhancements: Where are ACC’s principles now?

By / Published: April 5, 2011

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

[Update:  Here are links to the Chairmen’s news release and letter to OMB.]

E&E News is reporting (subscription required) that House Energy & Commerce Committee Chairman Fred Upton has called on the White House to scrap the Environmental Protection Agency’s (EPA) soon-to-be-issued enhancements to the only routine reporting system for chemicals across the entire federal government.

The final EPA rule would expand EPA’s Inventory Update Reporting (IUR), which requires periodic reporting of chemicals subject to the Toxic Substances Control Act (TSCA).  The rule was sent to the Office of Management and Budget (OMB) on January 20 and is awaiting approval.

Chairman Upton’s move, in the form of a letter to OMB Director Jacob Lew cosigned by Environment and Economy Subcommittee Chairman John Shimkus, follows closely on the chemical industry’s loud complaints about the rule late last month at the GlobalChem conference, cosponsored by the American Chemistry Council (ACC) and the Society of Chemical Manufacturers and Affiliates (SOCMA).  What gives?  Read More »

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

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 »

Posted in Emerging testing methods, Health science / Also tagged , , , | Comments are closed

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 »

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

Data and safety requirements for new chemicals: China blows past the US

By / Published: November 16, 2010

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

In yesterday’s post, I pointed to a number of ways in which China is taking a proactive stance on chemical safety.  I cited China because the U.S. chemical industry, when saber-rattling about what it regards as overly onerous proposals for TSCA reform, loves to chide all of us that those proposals will drive chemical production overseas to China and that innovation of new chemicals will still happen, only it will happen in China instead of the U.S.

I mentioned yesterday that China is in the process of enhancing its regulatory requirements, including making them more like the European Union’s REACH Regulation.  Well, a great article detailing China’s new requirements for new chemicals was published yesterday by Geraint Roberts in Chemical Watch’s Monthly Briefing for November (subscription required).

Those requirements – which actually took effect October 15 – include the very same elements the U.S. industry has been warning would send chemical production and innovation running to China if they were to be adopted in the U.S., including:

  • registration as well as notification requirements for all new chemicals, whatever their production volume;
  • a minimum data set, which increases with production volume;
  • a requirement for re-notification whenever production volume increases significantly or the uses of a chemical change or expand; and
  • risk assessments for all new chemicals produced or imported above one metric ton per year.

Next up for the Chinese?  Similar requirements for existing chemicals, according to the article.

So much for the chemical industry’s hand-wringing about us losing out to China. When it comes to raising the bar for chemical safety, it appears the U.S. is increasingly the odd one out.

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