EDF Health

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

Will private interests trump public ones when it comes to our right to know under TSCA?

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

Why this matters …

… to an exposed worker

Today: You are a worker handling a new product. You look at the label, which lists it as containing the chemical dimethyl doorknob. You want to know what health information is available on the chemical, so you go to EPA’s TSCA chemical information databases and search for dimethyl doorknob. You find several studies EPA has received from a company indicating it found dimethyl doorknob to be a potent carcinogen in animal studies it conducted. This is because, under EPA’s TSCA CBI policy, EPA has declassified those studies, making them public and linking them to dimethyl doorknob. You are now able to alert your coworkers and management, and press for actions to reduce or eliminate your exposure to dimethyl doorknob.
If SOCMA gets its way: You are a worker handling a product containing the same chemical. You do your search and find none of the studies EPA has received. This is because under SOCMA’s TSCA, the company was able to claim the identity of dimethyl doorknob to be CBI when it submitted the studies, and EPA could not challenge the claim; it made the studies public – but did not link them to dimethyl doorknob.

… to an environmental health researcher

Today: You are a university-based researcher studying the water quality in a local town. You identify a chemical – unobtanium trichloride – in water samples you’ve collected that has quadrupled in concentration since a local business significantly expanded its production. You want to know what health information is available on unobtanium trichloride, so you go to EPA’s TSCA chemical information databases and search for unobtanium trichloride. You find several studies EPA has received from a company indicating it found unobtanium trichloride to cause birth defects in animal studies it conducted at levels at or below those you’re seeing in the water the submitted studies. This is because, under EPA’s TSCA CBI policy, EPA has declassified those studies, making them public and linking them to unobtanium trichloride. You are now able to alert state authorities of your findings, which leads it to tighten restrictions on discharges of wastewater from the company’s production site containing unobtanium trichloride. The cost of these additional regulations leads the company to reformulate its product, eliminating altogether the use of unobtanium trichloride.
If SOCMA gets its way: You are the same university-based researcher. You do your search and find nothing. This is because under SOCMA’s TSCA, the company was able to claim the identity of unobtanium trichloride to be CBI when it submitted the studies, and EPA could not challenge the claim; it made the studies public – but did not link them to unobtanium trichloride.

One of the few bright spots of the original Toxic Substances Control Act (TSCA) was Congress’ clear intention that the public have access to health and safety information on chemicals and mixtures.

The very first section of the 1976 law expressly states:  “It is the policy of the United States that adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment.”  The law goes on to expressly exclude “data from health and safety studies” submitted to the Environmental Protection Agency (EPA) from the reach of TSCA’s confidential business information (CBI) provisions, by stating that those provisions do not prohibit disclosure of health and safety information.  Congress provided only two narrow exceptions:  where disclosure of such information would disclose the process by which a chemical is made or processed, or the portion of a mixture that a particular chemical comprises.

Now some in the chemical industry are brazenly pressing to thwart that original intent, by codifying into the law the ability of companies to black out the names of chemicals when health and safety studies they submit on a chemical are released to the public.

The Society of Chemical Manufacturers and Affiliates (SOCMA), a trade association of specialty chemical manufacturers, is publicly taking credit for adding a provision to the House’s TSCA reform legislation that would do just that.  In its annual report, SOCMA touted “successfully inserting provisions strengthening Confidential Business Information protections.”  (SOCMA also took credit for the fact that the House bill maintains TSCA’s current New Chemicals provisions, another of its severe weakness about which I blogged last week.)

Should SOCMA get its way and its pet provision ends up in the final TSCA legislation, then you – whether you are a worker, consumer, business, researcher, or concerned member of the public – would get to learn that a new study shows a chemical in a product you may make, use, study or are otherwise exposed to is, say, a potent human carcinogen.  What you would not be allowed to know, however, is what chemical it is!  How useless is that?

See the sidebar for why this matters.

More background for TSCA geeks

I’ll spend the remainder of this post diving a little deeper into the law and history on this issue that SOCMA seeks to wipe out with just a few words inserted into a bill.   Read More »

Posted in Health policy, TSCA reform / Also tagged | Comments are closed

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 »

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Links to essential reading on Senate and House TSCA reform legislation

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

[UPDATE 2/26/16:  Updated versions of (1) our detailed side-by-side comparison of Senate and House bills — now with bill section references — and (2) our 5-part series have 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 , , , , | Authors: / 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 »

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