Category Archives: Risk Management

TSCA reform 2.0, aka, Safe Chemicals Act of 2011: Tastes great, less filling

By | Bio | Published: April 14, 2011

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

The Safe Chemicals Act of 2011 was introduced in the U.S. Senate today by Senator Frank Lautenberg and is co-sponsored by Senators Amy Klobuchar, Charles Schumer, and Barbara Boxer.

In the TSCA reform debate, some things haven’t changed from last year:  TSCA is just as badly in need of an overhaul, and consumers and the chemical industry’s customers have no more confidence in the safety of chemicals in use today than they did a year ago.  States, other countries and the marketplace all continue to act to advance modern chemical safety policies and practices.  We in the advocacy community are still waiting for the chemical industry to offer some of its own proposals for reform – though some individual companies and product associations have been more forthcoming.

In contrast, the 2011 version of the Safe Chemicals Act has changed in some important ways – and for the better.  It includes a number of improvements over last year’s version that would both boost health protections and ease implementation and workability. 

[Updated 5-9-11:  Here's a side-by-side comparing the 2011 version to the 2010 version of the Act.]  Read More »

Also posted in Confidential business information (CBI), Data requirements, EPA, Exposure, Hazard, Policy, Risk Assessment, States, TSCA | Comments closed

Side-by-sides of TSCA, Senate bill and House discussion draft

By | Bio | Published: June 5, 2010

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

I have updated and made some minor corrections to the summary chart I posted earlier comparing current TSCA to the proposed TSCA reform legislation (Senate bill and House discussion draft) at the 10,000 foot level. It's displayed below.

In addition, I have prepared a much more detailed side-by-side of the Senate bill and House discussion draft, which I'm posting here as a PDF.

Currently under TSCA Under the Senate and House proposals
DATA:  Few data call-ins are issued, even fewer chemicals are required to be tested and no minimum data set is required even for new chemicals. Up-front data call-ins for all chemicals would be required.  A minimum data set (MDS) on all new and existing chemicals sufficient to determine safety would be required to be developed and made public. 
BURDEN OF PROOF:  EPA is required to prove harm before it can regulate a chemical. Industry would bear the legal burden of proving their chemicals are safe.
SAFETY ASSESSMENT:  No mandate exists to assess the safety of existing chemicals.  New chemicals undergo a severely time-limited and highly data-constrained review. All chemicals, new and existing, would be subject to safety determinations (in the case of certain new chemicals, at some point after entry into commerce).
SCOPE OF ASSESSMENT:  Where the rare chemical assessment is undertaken, there is no requirement to assess exposure to all sources of exposure to a chemical, or to assess risk to vulnerable populations. The safety standard would require the assessment of a chemical to account for aggregate and cumulative exposures to all uses and sources, and to ensure protection of vulnerable populations that may be especially susceptible to chemical effects (e.g., children, the developing fetus) or subject to disproportionately high exposure (e.g., low-income communities living near contaminated site or chemical production facilities).  “Hot spots” would be specifically identified and addressed.
REGULATORY ACTION:  Even chemicals of highest concern, such as asbestos, have not been able to be regulated under TSCA’s “unreasonable risk” cost-benefit standard.  Instead, assessments often drag on indefinitely without conclusion or decision. Chemicals would be assessed against a health-based standard, and deadlines for decisions would be specified.  Chemicals of highest concern would be subject to expedited safety determinations and/or actions to reduce use or exposure to them.
INFORMATION ACCESS:  Companies are free to claim, often without providing any justification, most information they submit to EPA to be confidential business information (CBI), denying access to the public and even to state and local government.  EPA is not required to review such claims, and the claims never expire. All CBI claims would have to be justified up front.  EPA would be required to review them, and only approved claims would stand.  Approved claims would expire after a period of time.  Other levels of government would have access to CBI.
RULEMAKING REQUIREMENTS: To require testing or take other actions, EPA must promulgate regulations that take many years and resources to develop. In addition to the MDS requirement, EPA would have authority to issue an order rather than a regulation to require reporting of existing data or additional testing.

Also posted in Confidential business information (CBI), Data requirements, EPA, Policy, Risk Assessment, Testing, TSCA | Comments closed

EPA deserves an “A for Effort” for its new Chemical Action Plans

By | Bio | Published: January 4, 2010

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

Just squeaking in under its self-imposed deadline, late on December 30 EPA issued the first batch of chemical action plans it has promised under its enhanced chemical management program.  In doing so, EPA has signaled its intention to do all it can using its existing authority under the Toxic Substances Control Act (TSCA) – even as it also makes clear that authority is “both outdated and in need of reform.”  To my ear, that strikes just the right balance. Read More »

Also posted in EPA, Exposure, Hazard, Industry, Regulation, TSCA | Comments closed

How to turn a "quick start" into a choke point

By | Bio | Published: November 18, 2009

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

Over the last few months, I was heartened to hear a number of industry stakeholders in the debate over TSCA reform embrace the idea of designating in TSCA reform legislation a "jump-start" or "quick-start" list of chemicals of high concern or priority.  The idea was to allow EPA to hit the ground running, by having an agreed-to list of chemicals on which it could immediately initiate action.  Well, it now appears many in industry actually have something far slower and far more cumbersome in mind. Read More »

Also posted in California, ChAMP, EPA, Industry, Regulation, TSCA | Comments closed

Straight from the Horse's Mouth: EPA Antes Up on TSCA Reform

By | Bio | Published: September 29, 2009

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

Today, EPA Administrator Lisa Jackson unveiled the Obama Administration's "Essential Principles for Reform of Chemicals Management Legislation."  The principles' significance lies not so much in the words they contain, but rather in what they symbolize:  A clear confirmation that this Administration understands that the Toxic Substances Control Act (TSCA) needs fundamental reform and that it is ready and willing to engage in making it happen. Read More »

Also posted in EPA, Policy, Regulation, Risk Assessment, TSCA | Comments closed

ChAMP's double standard

By | Bio | Published: June 1, 2009

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

This new post serves as a response to Charlie Auer's most recent comment responding to our critique of ChAMP.  (To see the whole exchange, start here, then go here, here and here.)  So far, this exchange has focused mainly on our disagreement over whether or not EPA is somehow required to do risk assessments under ChAMP.  At some point, I hope Charlie and others will engage on the substance of our critique – the serious concerns we've raised about the quality and validity of the ChAMP assessments.
  Read More »

Also posted in ChAMP, EPA, Policy, Regulation, Risk Assessment, Testing | Comments closed

(How) Can ChAMP get back on track?

By | Bio | Published: May 7, 2009

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

As I noted in our first post on ChAMP, after getting off to a strong start in 2007, EPA's abrupt decision in 2008 to steer ChAMP in the direction of cranking out hasty risk decisions was entirely its own.  Can ChAMP be put back on track?  Read More »

Also posted in ChAMP, EPA, Policy, Risk Assessment, TSCA, Worker Safety | Comments closed

EPA's New Chemicals Program: TSCA dealt EPA a very poor hand

By | Bio | Published: April 16, 2009

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

[The first post in this series can be found here.] 

Some in the chemical industry point to EPA's New Chemicals Program as a robust program, one that could serve as a model for reform of the Toxic Substances Control Act (TSCA).  Most recently, the National Petrochemical & Refiners Association (NPRA) did so in its testimony at a recent House of Representatives subcommittee's TSCA oversight hearing.  So just how robust is EPA's program on new chemicals?  Read More »

Also posted in EPA, Policy, Regulation, Testing, TSCA | Comments closed

Clump Change: Challenging conventional wisdom about nanoparticle aggregation

By | Bio | Published: December 5, 2008

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

In some nanotechnology circles, it is almost a mantra that, once released to the environment, nanoparticles will inevitably aggregate or agglomerate into larger masses and thereby lose their nanoscale-related properties and, by implication at least, any associated risks.

But can we count on nanoparticles released to the environment to self-regulate their own risk so conveniently? Read More »

Also posted in Carbon Nanotubes, Environment, Fullerenes, NNI, Research | Comments closed

Burning Questions: Are Sunscreens Containing Nanomaterials Safe?

By | Bio | Published: July 16, 2008

John BalbusCal Baier-Anderson, Ph.D., is a Health Scientist.

Ah, summer!  It’s a great time to be outdoors, enjoying the warm, sunny weather.  Before you go outside, be sure to grab your sunscreen, that essential product that protects against skin cancer and sun damage.  But which kind of sunscreen is best?  There is a mesmerizing array of sunscreen options, but for our purposes let’s limit the question to one:  Nano or not nano?

Read More »

Also posted in Consumer Products, Health, Worker Safety | Comments closed