Category Archives: Confidential business information (CBI)

No shame: ACC plunges to new low in fighting your right to know

By | Bio | Published: May 21, 2012

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

This post is longer than usual and starts with a rather esoteric topic, but I urge you to read it through, as it vividly shows there is no limit to the lengths to which the American Chemistry Council (ACC) will go to squirm out of a regulatory requirement, even if it means violating rules by which ACC had agreed to abide.

But that’s far from the worst of it.  Going farther than even I could imagine when I blogged earlier about its tactics, ACC is sparing no effort to deny your right to know about the health impacts of chemicals, by mustering every argument it can invent – however far-fetched – to  keep health and safety studies from being shared with the public. 

ACC insists that the U.S. Environmental Protection Agency (EPA) should hassle the European Union (EU) instead of its members for the health and safety data ACC promised to provide – despite the fact that the chemical industry itself has thrown up major roadblocks to such sharing.  And reaching a new low in tortured logic, ACC argues that, should EPA succeed in getting its hands on the health and safety data submitted to the EU, EPA can and should deny the public access to those data – despite the fact that the Toxic Substances Control Act (TSCA) clearly prohibits EPA from withholding such information.  Read More »

Also posted in EPA, Hazard, Health, Industry, REACH, Testing, TSCA | Leave a comment

A ray of sunlight up ahead: ECHA to release more information through REACH dossiers

By | Published: April 26, 2012

Allison Tracy is a Chemicals Policy Fellow.

After many months of increasing the quantity but not the quality of dossiers available to the public for chemicals registered under REACH, the European Chemicals Agency (ECHA) has recently announced two improvements.  (REACH is the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals.)  According to the agency, the public will soon have access to more data from the dossiers that were submitted by companies as part of the first wave of REACH’s Registration process.  

In a press release issued a couple of weeks ago, ECHA announced that it will publish information from registered chemicals’ Safety Data Sheets – including the identity of the registrant and whether the chemical was found to be Persistent, Bioaccumulative and Toxic (PBT).  And last week, ECHA said it will also publish (by June) the aggregate production volume ranges (called “tonnage bands”) for chemicals registered under REACH.  These decisions will improve ECHA’s record on disclosure and transparency by increasing the amount of both hazard and exposure data available to the public on chemicals in use.  Read More »

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

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 EPA, Industry, Innovation, Policy, TSCA | Comments closed

Smoke and Mirrors: ACC lawyers are working hard to rein in your right to know

By | Bio | Published: March 1, 2012

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

I’ve blogged here frequently about EPA’s efforts over the past couple of years to make more chemical information available to the public, especially health and safety information.  A key part of this, believe it or not, is simply making sure that when EPA shares a health study with the public – as required by law – you get to know the identity of the chemical that is the subject of that study.

EPA’s initial steps (see below) were met with a little grumbling on the part of the chemical industry, but not a whole lot.  After all, the industry says it wants the public to have more information about chemicals.  At #7 on the American Chemistry Council’s (ACC) top 10 principles for TSCA reform is:  “Companies and EPA should work together to enhance public access to chemical health and safety information.”

Times, apparently, have changed.  In recent weeks, ACC has launched a broadside attack on the EPA’s efforts to compel its member companies ever to name a chemical when submitting health and safety information to EPA.  My evidence?  A 36-page White Paper delivered by ACC to the office of the regulatory czar at the Office of Management and Budget, at a meeting held there on January 20.  The ACC document is a wonder of tortured logic, obfuscation and selective renditions of the history of TSCA.

Today, a response was mounted.  EDF and Earthjustice staff, as well as representatives of health-affected individuals, environmental justice communities and workers, held their own meeting with OMB officials.  And we delivered our own letter to OMB that thoroughly rebuts ACC’s White Paper.  It also points out that, way back in 1976, the drafters of TSCA actually wanted you to have access to health and safety information on chemicals – and they darn well didn’t expect you to have to guess at the identity of those chemicals.  Read More »

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

EPA moves chemical reporting into the 21st century – though we’ll have to wait until mid-decade to actually get there

By | Bio | Published: August 3, 2011

Richard Denison, Ph.D., is a Senior Scientist.  Allison Tracy is a Chemicals Policy Fellow.

A major initiative of EPA’s toxics office finally made it across the finish line yesterday when EPA posted a pre-publication copy of the final rule upgrading its chemical reporting system under the Toxic Substances Control Act (TSCA).  The process took over 16 months just to get from the draft of the proposed rule to yesterday’s final rule, with EPA having to endure not one but two nearly six-month regulatory reviews by the Office of Management and Budget.

The wait was largely worth it:  EPA’s new program – renamed the Chemical Data Reporting (CDR) rule – significantly advances chemical production and use reporting relative to its predecessor, the more arcane-sounding Inventory Update Reporting (IUR) rule.  Most, though not all, of the critical elements EPA proposed last year made it through to the final rule.  The catch is we’ll have to wait until 2016 for the program to reach its full potential.  Read More »

Also posted in Data requirements, EPA, Industry, Inventory Update Rule, Regulation, TSCA | Comments closed

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 Data requirements, EPA, Exposure, Hazard, Policy, Risk Assessment, Risk Management, States, TSCA | Comments closed

Ripples of REACH: Chemicals policy changes in Japan, Turkey and South Korea

By | Published: April 5, 2011

Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.

The November 31st deadline for the first batch of registrations under REACH (the European Union’s Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals) may have passed, but life is far from dull on the international scene of chemicals policy.  As discussed in a previous post, chemicals policy enhancements are ramping up across the globe, many of them mirroring the innovations introduced under REACH.

In this post, we’ll discuss significant advances in Japan, Turkey and South Korea that drive home the message that the ripples from REACH are ever-widening.  Read More »

Also posted in Data requirements, Hazard, Industry, Inventory Update Rule, Policy, REACH, Regulation, TSCA | Comments closed

EPA's right-to-know effort declassifies the chemicals in 42 health and safety studies

By | Bio | Published: March 24, 2011

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

EPA has just released today the full versions — showing the identities of the chemicals in question — of 41 "substantial risk" notices of health and safety studies it had previously received from companies that had denied the public's right to know those identities by claiming them to be confidential business information (CBI).  These notices had been submitted pursuant to Section 8(e) of the Toxic Substances Control Act (TSCA).  One additional notice of a health and safety study that EPA had received under Section 8(d) of TSCA was also released today with its chemical identified.

What's most significant about today's posting is that it makes publicly available the identities of chemicals associated with health and safety data that: 

  1. the submitting companies themselves believed the data “reasonably supports the conclusion that [the chemical] presents a substantial risk of injury to health or the environment;” and
  2. should have been publicly available all along, based on the plain language of TSCA that disallows health and safety studies to be claimed CBI in the first place.

Read More »

Also posted in EPA, Hazard, Health, Industry, TSCA | Comments closed

A modest proposal: ACC should support and defend President’s proposed budget increase for EPA chemical safety efforts

By | Bio | Published: February 15, 2011

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

President Obama unveiled his FY2012 budget yesterday, and the news was rather bleak for EPA:  a proposed 13% decrease.  But one bright spot was a proposed $16.1 million boost in funding for EPA’s chemicals management efforts using its current limited authorities under the Toxic Substances Control Act (TSCA).

That additional funding, according to EPA, is to be directed at activities to further “reduce chemical risks, increase the pace of chemical hazard assessments, and provide the public with greater access to chemical information so they can make better informed decisions about their health.  Learning more about these chemicals will help protect Americans from potential threats to their health.”

What is perhaps most refreshing is EPA’s rationale for its proposal to maintain and enhance its renewed focus on chemical safety (see pages 55-56 of this EPA budget summary):

Chemicals are often released into the environment as a result of their manufacture, processing, use, and disposal. Research shows that children are getting steady infusions of industrial chemicals before they even are given solid food. Other vulnerable groups, including low-income, minority, and indigenous populations, may also be disproportionately impacted by and thus particularly at risk from chemical exposure.

So, what would the money go to, and how will the chemical industry respond?  Read More »

Also posted in EPA, Industry, Inventory Update Rule, TSCA | Comments closed

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

By | Bio | 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 »

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