Tag Archives: Confidential Business Information (CBI)

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

By Richard Denison | 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 »

Posted in Health Policy, TSCA | Also tagged chemical identity, data requirements, Persistent Bioaccumulative and Toxic (PBT), prioritization, Safe Chemicals Act, Safer Chemicals Healthy Families | Comments closed

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

By Allison Tracy | Published: April 5, 2011

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

The November 31^st 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 »

Posted in Health Policy, REACH | Also tagged Carcinogenic Mutagenic or Toxic for Reproduction (CMR), data requirements, IUR/CDR, Japan, Office of Management and Budget (OMB), Persistent Bioaccumulative and Toxic (PBT), South Korea, Turkey | Comments closed

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

By Richard Denison | 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:

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
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.

Posted in Health Policy, TSCA | Also tagged chemical identity, DuPont, oil dispersant | Comments closed

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

By Richard Denison | 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 »

Posted in Health Policy, TSCA | Also tagged American Chemistry Council (ACC), children's safety, IUR/CDR, Office of Information and Regulatory Affairs (OIRA), Office of Management and Budget (OMB), Office of Pollution Prevention and Toxics (OPPT) | Comments closed

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

By Richard Denison | 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 »

Posted in Health Policy, TSCA | Also tagged chemical identity, risk assessment | Comments closed

Regulating nanomaterials to life, not death

By Richard Denison | Bio | Published: January 28, 2011

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

As we enter a new year and legislative season, we face a changed political climate where the thought of new regulation is anything but de rigueur. I will argue in this post that a little regulation would have done – and still could do – the world of nanotechnology a world of good.

Come again?

Back when the debate over nanomaterial safety really got started, which I would place ‘round about 2004 (or was that just my first involvement in it?), there seemed to be broad agreement on first-order needs to ensure that nanotechnology would survive and thrive. The aim was to “get it right the first time,” by identifying and addressing potential risks up front and in the open. That meant we needed to adequately fund and direct risk research. We also needed to make sure adequate regulatory authority existed to address potential risks, ideally before they arose.

Most fundamentally, there was virtual consensus on the need for prompt action to ensure regulatory agencies had at hand the basic information they needed to understand the lay of the nano-land: what nanomaterials are already being produced and are in the pipeline; in what applications and products are they being used; and where along the nanomaterial lifecycle are the most likely points for potential releases and exposures.

With respect to this most fundamental of needs, I’m sorry to say that, in 2011, we are essentially no closer to achieving it than we were in 2004. Read More »

Posted in Health Policy, Nanotechnology, TSCA | Also tagged data requirements, National Nanotechnology Initiative (NNI), Office of Management and Budget (OMB), Significant New Use Rule (SNUR), test rule | Comments closed

Public health advocates to the chemical industry: Stop hobbling EPA

By Richard Denison | Bio | Published: October 12, 2010

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

Today, EDF joined with 32 other environmental justice, health and environmental organizations to file comments [PDF] with EPA that strongly support its effort to improve its ability to obtain – and share with the public – robust information about the production, processing and use of chemicals in the U.S.

While the details of EPA's proposed rule and many of our comments are heavily wonky, the motivation and goals are far from it: To make sure that EPA, the marketplace and the public have the information they need to guard against harm from dangerous chemicals. That requires knowing a whole lot more than we do today about what chemicals are in commerce, in what quantities, how they're used – essential to understanding how we may be exposed.

Robust information is the lifeblood of a sound chemicals management system. Government needs access to comprehensive, reliable information to inform policy, programmatic and regulatory decisions it must make to carry out its mission. The market needs access to such information to inform the myriad decisions made every day by producers, sellers and users of chemicals and products and materials made using chemicals. And researchers, the public and groups that work in the public interest need access if they are to have confidence in, and be able meaningfully to contribute to, decisions and actions taken by government and the private sector.

In an earlier post, we made the point that the chemical industry's reactions to these modest proposals will be a litmus test for how serious it is in acting on its rhetoric about the need for EPA and the public to have more and better information on chemicals. With the comment period closing today for EPA's proposed rule, look here in the coming weeks for our assessment on industry's comments.

What follows is a summary of our comments, indicating both what we support and what more is needed. Read More »

Posted in Health Policy, TSCA | Also tagged data requirements, exposure and hazard, IUR/CDR | Comments closed

Affirming a thing of beauty: Comments filed today support new EPA CBI policy

By Richard Denison | Bio | Published: August 25, 2010

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

Today EDF joined with Earthjustice and 24 other health, labor and environmental organizations in filing comments with EPA that support its recently announced policy change restoring the public's right to know the identities of all chemicals for which health and safety data have been submitted to the agency.

I have already done a post on the details of EPA's new policy, which I termed "a thing of beauty." The comments we filed today – in response to EPA's request when it issued its new policy back in May – make clear that the policy reflects both the clear meaning of the Toxic Substances Control Act (TSCA) and the clear intent of its drafters. Read More »

Posted in Health Policy, TSCA | Also tagged chemical identity, prioritization | Comments closed

More than weather heating up in DC: Rush-Waxman House bill puts TSCA reform back on front burner

By Richard Denison | Bio | Published: July 22, 2010

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

We've just moved another step closer to protecting Americans and our environment from dangerous chemicals.

The Toxic Chemicals Safety Act of 2010 (H.R. 5820) has been formally introduced by Congressmen Bobby Rush (D-IL) and Henry Waxman (D-CA). The legislation would implement a top-to-bottom overhaul of the outmoded and ineffectual 1976 Toxic Substances Control Act (TSCA). Read More »

Posted in Health Policy, TSCA | Also tagged data requirements, exposure and hazard, Safe Chemicals Act, Safer Chemicals Healthy Families | Comments closed

Dispersants are a teachable moment for TSCA reform

By Richard Denison | Bio | Published: June 10, 2010

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

The Safer Chemicals, Healthy Families campaign just held a press call to draw direct links between the huge unknowns associated with the unprecedented use of chemical dispersants in the Gulf and the failures of TSCA. The campaign called upon Congress to ensure that legislation to reform TSCA fully addresses dispersant safety so that, the next time a disaster of this sort unfolds, the country won't be caught with its proverbial pants down.

While the reform bills would go a long way to improve the situation, the campaign also provided a detailed description of enhancements to the current reform bills needed to address:

the lack of public access to sufficient information about dispersants, their ingredients and their concentrations;
the lack of adequate safety testing for long- as well as short-term effects on both marine environments and people, including affected workers, volunteers and nearby residents;
the lack of a requirement that dispersants be shown to be safe as a condition for allowed use; and
the lack of adequate EPA authority to disallow unsafe dispersants and to halt or alter dispersant use based on on-the-ground developments.

As the legislation advances, we will be pressing Congress to include additional provisions to address these deficiencies. There could be no better illustration of the limits to our current policies than that provided by government's forced reliance on under-tested chemical dispersants the use of which is raising more questions than answers.

Posted in Health Policy, TSCA | Also tagged BP Oil Disaster, oil dispersant, Safer Chemicals Healthy Families | Comments closed

Chemicals & Nanomaterials

Tag Archives: Confidential Business Information (CBI)

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

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

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

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

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

Regulating nanomaterials to life, not death

Public health advocates to the chemical industry: Stop hobbling EPA

Affirming a thing of beauty: Comments filed today support new EPA CBI policy

More than weather heating up in DC: Rush-Waxman House bill puts TSCA reform back on front burner

Dispersants are a teachable moment for TSCA reform

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