EDF Health

ECHA keeps the ball rolling on Authorisation under REACH

Alissa Sasso is a Chemicals Policy Fellow.

In our last update on the European Union’s Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), we noted a major milestone under the “A” of REACH, as the first application for an authorisation was passed to and is awaiting decision by the European Commission. The authorisation process is continuing to move along: as of May 19th, ECHA has received 13 applications for 35 uses of six different substances on the Authorisation list. Interest in ECHA’s authorisation work is also increasing, eliciting a greater variety of stakeholder input than in the first round.  Read More »

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Chemical Safety Reform: Will the Center Hold?

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

Copyright © 2014, Environmental Law Institute®, Washington, D.C. www.eli.org
Reprinted by permission from The Environmental Forum®, May/June 2014

Compromise is tough. It can be thankless and unsatisfying, and, by definition, you don’t get everything you want. But it’s the only way reform of the Toxic Substances Control Act will happen. Nearly everyone, from environmentalists to industry honchos, agrees TSCA is badly broken. But start talking about how to fix the problems and you’ll find there are legitimate core principles held by different stakeholders that are difficult to reconcile. Here are just three examples:

New chemicals. The common-sense notion that new chemicals should be shown safe before entering the market, versus the desire not to hinder innovation or U.S. companies’ ability to compete globally by getting chemicals to market quickly;

Preemption. The appeal of a single federal oversight system that does not impede interstate commerce, versus the view that states have the right to act to protect their residents; and

Confidential business information. The right of citizens, consumers, and the market to information on potential risks of chemicals they may use or be exposed to, versus assurance that legitimate trade secrets submitted to regulators will not generally be disclosed.

As an active participant in the past decade’s debate, I’ve seen firsthand how such conflicting principles complicate — politically and substantively — prospects for achieving reform. I’ve also learned that progress comes only when both sides accept they have to give something to get something. Conversely, progress stalls when stakeholders get greedy. The past year has seen both tendencies.

The late Senator Frank Lautenberg (D-NJ) assessed the landscape last year and saw the need for compromise. He took the political risk of working on legislation with Senator David Vitter (R-LA), who had been about to introduce his own legislation. The result was the first-ever bipartisan legislation to reform TSCA, the Chemical Safety Improvement Act.

Sadly, Senator Lautenberg died shortly after CSIA was introduced. But the legislation remains very much alive, and although it was (and is) far from perfect, there has been major progress thanks to the continuing work of Senator Vitter and Senator Tom Udall (D-NM) to address major concerns raised about the bill and strengthen its health protections.

Additional progress is endangered, however, as some players have fallen back to their core principles and hardened their positions. And after holding a promising series of constructive, balanced hearings on TSCA, the House majority floated reform legislation — albeit a discussion draft rather than a bill — that tilts heavily in industry’s favor.

These challenges have led some stakeholders to consider forgoing the present opportunity and either opt to retreat to the status quo or try to forestall action and wait for more political advantage in the future. In my view, this notion of an easier path any time in the foreseeable future is illusory. The conflicting needs of stakeholders are so fundamental, and the political climate so polarized, that counting on them to change appreciably is wishful at best.

The only recourse is to do the hard work of negotiating to forge a legitimate and fair compromise that delivers an efficient and effective chemicals management system. Let me use my earlier three examples to illustrate what common ground looks like:

New chemicals. EPA should make an affirmative determination of safety before market entry, but using a standard that allows prompt review based on the limited information available for a new chemical. Where that information is insufficient, EPA should be able to require more — or impose conditions sufficient to address potential risks even in its absence;

Preemption. States should be able to act to address a chemical’s risks wherever EPA has not, or when they can make the case for going further. Preemption should apply prospectively, and when, but only when, the agency has all the information it needs to make a definitive safety decision and takes final action on a chemical. Requirements that do not directly restrict a chemical’s manufacture or use — such as for reporting, warnings, monitoring or assessment, which do not unduly impede interstate commerce — should remain available to states; and

Confidential business information. Legitimate trade secrets should be protected, but not information on health and environmental effects or general information on a chemical’s use. Identities of chemicals should generally be available once they enter commerce. Up-front substantiation and EPA approval of claims should be required. Claims should generally be time-limited but renewable upon resubstantiation. State and local governments, medical personnel, first responders, and health and environmental officials should have access to confidential business information.

The opportunity before us is apparent: Our best chance to fix an outdated law that serves nobody’s interests. The alternative — sticking with a piecemeal system that undermines consumer confidence and puts our health at risk — is no alternative at all. All it takes to seize this opportunity is to agree that compromise doesn’t have to be a dirty word.

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Flame retardants impair normal brain development: Even more evidence, still no action

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

Today a new study was published linking fetal exposure to certain flame retardants called polybrominated diphenyl ethers (PBDEs) with cognitive and behavioral effects that develop later in childhood.  While the specific findings in this study are new, the link between these types of neurodevelopmental effects and exposure to PBDEs is not. 

Numerous scientific studies and governmental bodies across the globe have flagged the health effects of PBDEs.  At the same time, current proposals by the Environmental Protection Agency (EPA) to better understand the hazards and sources of certain PBDEs remain in limbo.  Read on to learn more about today’s new study on PBDEs and the stalling of EPA initiatives to help protect us from exposure to them.  Read More »

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A gift for mothers (and daughters, and all of us): New tools for breast cancer monitoring and prevention

Rachel Shaffer is a research assistant.

Our mothers are no doubt on our minds right now, after Mother’s Day weekend. And I am no exception, especially since, as I blogged about last year, this month is the anniversary of my own mother’s breast cancer diagnosis.

This year though, in addition to celebrating my mother’s recovery, I can find hope in a new report from researchers at the Silent Spring Institute that provides guidance to improve our ability to screen for and study potential breast carcinogens — thereby enhancing efforts to prevent this widespread disease. Good news, certainly… and a timely gift for all of the women in our lives.

This new report describes biomonitoring methods for 102 breast carcinogens with high exposure potential and identifies existing cohort studies into which these methods could be integrated immediately. These chemicals are among the 216 previously identified by the authors as chemicals linked to mammary gland tumors in rodents. By testing for exposure markers of these priority breast carcinogens in the population, researchers should be able to better identify and study high-risk groups, and regulators will be better able both to limit dangerous exposures and to demonstrate the public health benefits of these exposure reductions.

The full report is available online, but I want to highlight a few key themes that are particularly relevant to current scientific and political debates.  Read More »

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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.

   

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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.

 

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