Category Archives: Innovation

Striking the right balance between right to know and right to intellectual property protection

By | Bio | Published: April 13, 2012

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

There is clearly a need to balance the legitimate claims of companies to protect certain confidential business information (CBI) from public disclosure with the legitimate need for the market, consumers and the public to have access to information they need to make sound decisions about chemicals that are in commerce.  Unfortunately, most of TSCA’s provisions and their implementation by EPA have skewed this balance radically in the direction of denying the public’s right to know and creating an ill-informed chemicals marketplace.

The core problem is two-fold, constituting a vicious circle:  Too many CBI claims are made, and each of the infrequent examinations of such claims done by EPA has found a large fraction to be illegitimate, i.e., not meeting the well-established criteria for what constitutes a legitimate trade secret.  And because of the large number of claims made, EPA has lost the ability to review claims to ensure they are in fact legitimate and remain so over time; this lack of review has led directly to more claims being made, thereby completing the vicious circle.  Read More »

Also posted in Confidential business information (CBI), EPA, Industry, Policy, TSCA | Comments closed

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

By | Bio | 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.

Also posted in Data requirements, Industry, REACH, Regulation, Testing, TSCA | Comments closed

Adding a hammer to TSCA's tool belt: Clear deadlines and, yes, hammers to ensure they’re met, are essential to TSCA reform

By | Bio | Published: November 15, 2010

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

For decades, the American chemical industry has produced and used chemicals virtually without condition, due to the laissez-faire approach embodied in TSCA.  The consequence?  Tens of thousands of chemicals are in everyday use with little health and environmental data, let alone evidence of their safety.  This has led to a crisis in confidence among commercial buyers, users and sellers of chemicals and products made using chemicals – not to mention consumers, state and local government and the general public. 

Meaningful TSCA reform must address these problems, by not only systematically subjecting chemicals on the market to data requirements and safety determinations – but also ensuring all this is done in an efficient and timely manner. 

That’s where hammers come in.  Read More »

Also posted in EPA, Industry, Policy, TSCA | Comments closed

Raising the bar for chemical safety will spur, not stifle, innovation

By | Bio | Published: May 9, 2010

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

An emerging chemical industry talking point in TSCA reform is the claim that imposing new requirements on new chemicals will somehow stifle innovation.  The milder manifestation of this perspective emanates from those who oppose requiring a safety determination for new chemicals unless they raise major red flags in an initial review.

But some in the industry go further, arguing that even requiring safety data for new chemicals would put the big chill on development of new chemicals.

I beg to differ with both arguments.  This post will make the opposite case, and will also argue that true innovation embraces rather than shuns safety, and demands the information needed to demonstrate it. Read More »

Also posted in Data requirements, EPA, Hazard, Health, Industry, Policy, REACH, TSCA | Comments closed