Selected tags: data requirements

Building scientific bridges to support EPA’s new chemical testing programs

Jennifer McPartland, Ph.D., is a Health Scientist.

Readers of this blog are acutely aware of the dearth of data available for tens of thousands of chemicals in U.S. commerce today.  This state of ignorance reflects legal and resource constraints as well as the “challenge” of continuously integrating advancements in our scientific understanding of human health and disease into the way we assess chemical toxicity.

Fortunately, federal efforts to develop new chemical testing approaches, such as the high-throughput screening programs ToxCast and Tox21, offer a great opportunity to narrow the data gap while also helping to shine light on how environmental chemicals can impact our health.  But realizing the full potential of these new approaches will take a village.

Today in Environmental Health Perspectives we have published a commentary  that calls for greater and more diverse engagement of the basic research community in developing and using the new federal chemical testing data. We also provide recommendations that we believe would help facilitate and improve such engagement.  Read on to learn more.   Read More »

Posted in Emerging Testing Methods, Health Policy, Health Science| Also tagged | Leave a comment

Better late than never: EPA finally takes first step to collect safety data on fracking chemicals

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

Nearly two-and-a-half years after the U.S. Environmental Protection Agency  partially granted a petition filed under the Toxic Substances Control Act (TSCA) by EDF, Earthjustice, and 114 other groups calling for a rulemaking to require companies that make or process chemicals used in oil and gas production, the agency finally responded today.

This morning EPA issued what’s known as an Advanced Notice of Proposed Rulemaking (ANPRM) seeking public input on “the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information.” A 90-day comment period will start once the notice is published in the Federal Register next week.

What Today’s Announcement Means

The process that begins with today’s announcement is directed to manufacturers and processors of fracking chemicals and would call on them to report to EPA health- and safety-related data they have on those chemicals. Notably, it would apply not only to the presently undisclosed chemicals used in these operations, but also to hundreds of substances whose use in fracking is already widely reported, but for which little or no health or environmental safety data are available.

This effort is distinct from others aimed at drilling companies and well operators, which seek to reveal what materials are going down a well, but don’t indicate what their potential effects might be.

While much of the health and environmental effects data EPA would receive could become public and hence would complement and add valuable information to disclosure efforts, the main aim is to ensure EPA has information sufficient to understand the potential risks of the subject chemicals at an aggregate, national level.

It’s also worth noting that not all of the data reported to EPA would necessarily become available to the public; under the Toxic Substances Control Act, companies can claim certain information constitutes confidential business information, in which case EPA cannot disclose it to the public. That is, the agency would know but we would not.

A Long Road Ahead

This is only the first baby step toward initiating the rulemaking process EPA said it would undertake. EPA intends to use input it receives during the comment period to decide both how and what information should be reported.

The original petition asked the agency to require companies that make or process chemicals used in oil and gas production to: a) report basic production, processing and available health and safety information on those chemicals, and b) conduct testing to fill data gaps in the available information. In November, 2011, EPA granted the first part but denied the second, and limited the scope to just chemicals used in hydraulic fracturing. EPA said it would issue the ANPRM, and begin a stakeholder process – both of which would be used to solicit input as to the scope of the reporting rules.

It’s unfortunate that this process has taken so long, as it addresses a critical need to ensure the safety of chemicals used in fracking. It will be essential that the public engage in the development of EPA’s reporting system to ensure it delivers the needed information to EPA and maximizes public access to that information.

   

Posted in Health Policy, Regulation| Tagged | Comments closed

New Draft of House Chemical Safety Bill Falls Short; EDF Calls on All Sides to Redouble Effort

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

Release in response to today's House Environment and Economy Subcommittee hearing on a revised discussion draft of the Chemicals in Commerce Act (CICA)

Today’s hearing makes clear that the discussion draft has made progress but still falls far short of legislation that will fix the fundamental flaws of the current law, according to Dr. Richard Denison, Lead Senior Scientist at Environmental Defense Fund. He urged all sides to keep the bipartisan process moving forward in both houses of Congress.

“While bipartisan discussions have yielded a number of substantial improvements to address serious concerns with the original draft, the most problematic provisions remain virtually untouched,” Denison said. “The goal now should be to keep the conversations going.”

Examples of progress include giving the Environmental Protection Agency (EPA) authority to require testing where data are insufficient for prioritization purposes; incorporation of deadlines for agency action to assess and address risks of high-priority chemicals; and less prescriptive and onerous information quality and evaluation requirements.

Sections of the draft pose major concerns and fail to strike a fair and reasonable balance. Examples include the sweeping preemption of state authority for chemicals never subject to a thorough EPA safety review; overly broad allowances for companies to mask the identity of chemicals even long after market entry; and a failure to ensure that conditions placed on new chemicals apply to all companies making or using them.

“We’re optimistic that solutions are at hand that address the needs of all stakeholders, but it is going to take a redoubling of effort by all sides to get there,” he said.

 

Posted in Health Policy, TSCA Reform| Also tagged , , , | Comments closed

The perverting of prioritization: How a good idea for TSCA reform went bad – and how to save it

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

For years, the concept of prioritization as an element of TSCA reform has enjoyed support from a broad array of stakeholders.  The number of chemicals in active commerce is large, if uncertain:  surely less than the 85,000 listed on the TSCA Inventory, but still in the tens of thousands. That sheer number demands that EPA develop and apply a process to decide where to start and how to sequence the enormous task of reviewing the safety of those chemicals. 

There has also been widespread agreement that EPA should make an initial pass using available information to identify three groups of chemicals:  a) those that present significant hazard or exposure potential or both; b) those for which existing information doesn’t raise such concerns; and c) those that need more information to determine their level of concern.

As conceived, prioritization was to be a low-stakes proposition for the various stakeholders, simply the means to get the new system up and running.  Prioritization decisions would not be final actions; rather, they were expressly designed to minimize dispute, and would be barred from legal challenge.  Chemicals identified as high priority and in need of immediate scrutiny would get a more thorough assessment before any decision as to whether they posed significant risk and required a regulatory response.  Chemicals identified as low-priority would be so designated provisionally based on less than a thorough assessment, and could be revisited if and when new information arose.  And chemicals lacking sufficient information to be prioritized would be subject to further data collection and generation, and then funneled back into the prioritization process.

These concepts are well-established both in the outcomes of industry-NGO negotiations and in heavily negotiated provisions of the more recent incarnations of the Safe Chemicals Act.

But then some folks got greedy.  Read More »

Posted in Health Policy, TSCA Reform| Also tagged , | Comments closed

West Virginia officials trust shaky science in rush to restore water service: One-part-per-million “safe” threshold has questionable basis

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

[SEE NOTE ADDED 1/15/14 BELOW]

In a press conference today outlining plans to restart the water system serving 300,000 people, West Virginia state officials and executives from the West Virginia American Water utility company stressed that levels of the toxic chemical that contaminated the supply after last week’s spill had reached a “safe” level of one part per million (1 ppm), the threshold agreed upon by state and federal officials on Saturday.

Unfortunately, the science behind this standard remains unclear.  Based on what we do know, there are good reasons to believe that officials are overlooking significant health risks.  Read More »

Posted in Environment, Health Policy, Regulation| Also tagged , , , | 36 Responses, comments now closed

Repost: The new Safe Chemicals Act fulfills every detail of ACC’s 10 “Principles for Modernizing TSCA”

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

[NOTE:  I am reposting this piece, given that it was first posted during the dog days of August and I don't want those interested to have missed it in digging out from time away from the office.  If you have an interest in understanding just how much the Safe Chemicals Act has changed to account for earlier industry concerns, please take the time to look at the analysis I've done comparing the bill to ACC's TSCA Principles.]

You wouldn’t know it from listening to the American Chemistry Council (ACC) talk about the Safe Chemicals Act, but the new and improved version of the bill that was passed out of the Senate Environment & Public Works Committee on July 25 closely mirrors every detail of ACC’s 10 “Principles for Modernizing TSCA.”.

Those principles, issued in August of 2009, represent a key reference point given that they are virtually the only somewhat detailed public articulation by ACC of its substantive position on TSCA reform, one to which ACC continues to refer today.  In describing its principles, ACC says they “create a roadmap to a modern chemical regulatory system that will protect public health and the environment, while preserving the ability of American chemical companies to drive innovation, grow jobs, and compete in the global marketplace.”

ACC indicated in its statement on the revised bill that it only conducted a “cursory review” of the bill language, which perhaps explains why it got even some basics wrong.  One example:  ACC claims “[t]he bill would also dramatically increase the time it would take for the Environmental Protection Agency (EPA) to review new chemicals.”  In fact, the revised bill retains the 90-day review period for new chemicals operable under current TSCA.

So how does the bill stack up against ACC’s 10 Principles for TSCA Modernization?  Read More »

Posted in Health Policy, TSCA Reform| Also tagged , , , , | Comments closed
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