Selected tag(s): Confidential Business Information (CBI)

EPA simply must do better on transparency and chemical data access

Richard Denison, Ph.D., is a Lead Senior Scientist.  Lindsay McCormick is a Research Analyst.

[This is Part Two of a two-part series.  Here is a link to Part One.]

Under this Administration, EPA has taken some significant steps toward reversing decades of passivity and secretive practices that evolved under the Toxic Substances Control Act (TSCA) when it came to transparency in decision-making and providing access to chemical information it obtains or develops.

Several initiatives undertaken through what EPA originally termed its enhanced chemicals management program have developed and laid out clearer policies and procedures in areas such as:  chemical prioritization (leading to its Work Plan Chemicals Program); enforcing limits on and reviewing confidential business information (CBI) claims asserted by industry (leading to its declassification of hundreds of previously hidden chemical identities and health and safety studies that companies had illegitimately claimed confidential or no longer merited protection from disclosure, but that EPA had not bothered to review or challenge before now); and EPA’s regulatory efforts to reduce risks from exposures to toxic chemicals (leading to its Action Plans on high-concern chemicals and proposed follow-up activities for work plan chemicals where assessments – the first completed in decades – have identified significant risks).

EPA has also developed new databases and tools to provide greater access to chemical information in its possession and regulatory decisions and supporting documents it develops; these include the Chemical Data Access Tool and ChemView.

All of these efforts are still very much works in progress but hold significant potential to improve transparency, information access and risk reduction.

But sometimes the Agency does something that makes clear just how far it still has to go in these respects.  Unfortunately, a case in point is its recent effort toward assessing risks of a cluster of flame retardant chemicals, the brominated phthalates, some of which are in wide use and are showing up in everything from house dust to dolphins.   Read More »

Posted in EPA, Health Policy| Also tagged , , , | Leave a comment

Links to essential reading on Senate and House TSCA reform legislation

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

[UPDATE 2/8/16:  Updated version of our detailed side-by-side comparison of Senate and House bills has been posted below.]

On December 17, 2015, the full Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697, the Lautenberg Act), which would amend the nearly 40-year-old Toxic Substances Control Act (TSCA).

The House of Representatives already passed its TSCA reform bill in June, the TSCA Modernization Act of 2015, H.R. 2576.

Next up in the New Year will be efforts to reconcile these two bills.  In anticipation of this, I am posting here updated analyses of the two bills that examine how and to what extent they would address key flaws in TSCA.  These analyses include:

  • brief and detailed side-by-sides of TSCA and the two bills,
  • a comparison of how the bills deal with the contentious issue of preemption of state authority,
  • a comparison of how well the bills meet the Administration’s principles for TSCA reform, and
  • an earlier blog post on the importance of understanding which chemicals are in use today.

All of these materials (including this post) are available at blogs.edf.org/health.

ANALYSES:

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

TSCA reform legislation: Confidential business information

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

Part 1              Part 2              Part 3              Part 4              Part 5

[UPDATE 4-29-15:  On April 28, 2015, the Senate Environment and Public Works Committee passed a revised version of the Lautenberg Act out of the committee on a bipartisan 15-5 vote.  The new bill made a few revisions to a provision discussed in this post; see update below.]

[UPDATE 5-17-15:  On May 14, 2015, the House Subcommittee on Environment and the Economy passed a revised version of the TSCA Modernization Act of 2015 out of the subcommittee on a bipartisan 21-0 vote.  The new draft made a significant revision to one of the provisions discussed in this post; see update dated 5-17-15 below. UPDATE 5-28-15:  The legislation was formally introduced as H.R. 2576 on May 26, 2015.  The new version made no significant changes to the CBI provisions discussed below.]

This is the fourth in a series of blog posts looking at less talked-about, but critically important, elements of bipartisan legislative proposals to reform the Toxic Substances Control Act (TSCA).  This post deals with how EPA would address industry claims for protection of confidential business information (CBI) pertaining to chemicals, and disclosure of CBI to various parties.  The discussion is divided into three parts, addressing:  (1) CBI claims for chemical identity, (2) access to health and safety information and (3) duration of CBI claims.

Read More »

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

Will 2015 be the year of full product ingredient disclosure?

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

Michelle Harvey, Jennifer McPartland and Boma Brown-West contributed to this post.

[UPDATE 10/28/14:  This post has been updated to reflect information we learned since posting it, regarding additional companies' disclosure initiatives.]

We are nowhere near New Year’s Day, but based on recent corporate resolutions, 2015 is shaping up to be the year for ingredient transparency in products!  And that’s good news for those of us who want to know what we may be exposing ourselves and our families to when we use everyday products in our homes and on our bodies.

Unlike food and drugs, which must bear content labels, there has all too often been no way for consumers to know what’s in the products they use.  In particular, the composition of the myriad fragrances used in household cleaners, detergents and soaps, air fresheners, and other common household products have pretty much been a black box.  But change is on the way.   Read More »

Posted in Health Policy, Markets and Retail| Tagged | Comments are closed

Nothing is forever – and chemical industry trade secret claims shouldn’t be an exception

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

A coalition of health, labor, environmental and environmental justice groups (including EDF), represented by Earthjustice, filed a petition today with the Environmental Protection Agency (EPA) that requests EPA establish a limit on how long information on chemicals submitted and claimed confidential by the chemical industry under the Toxic Substances Control Act (TSCA) can be protected from disclosure.

The petition asks EPA to close a loophole in its current regulations that by default grants indefinite protection for nearly all chemical information claimed confidential.  Because EPA’s only option under its current regulations is to challenge these claims on a case-by-case basis, industry bears no responsibility to ensure that its claims remain valid over time.  The lack of any expiration date for such claims has contributed to a large backlog of excessive and often unwarranted claims – the protection of which imposes large costs on EPA and the American taxpayer and denies public and market access to information that could lead to better-informed decisions about chemicals.

The petition filed today offers a simple solution, one called for in virtually every internal and external review of EPA trade secret policy conducted over the last several decades (see list at the end of this post):  EPA should alter its regulations to create a “sunset” for confidential business information (CBI) claims, which would expire after a set period of time (5 years is proposed) unless the claimant shows that continued protection is warranted.  This approach would allow true trade secrets to continue to be protected while providing public access to information that no longer warrants trade secret protection.  Read More »

Posted in Health Policy, TSCA Reform| Also tagged , | Read 1 Response

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.

Posted in Health Policy, TSCA Reform| Also tagged | Read 2 Responses
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