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

Getting it up front: EPA clarifies substantiation requirements for CBI claims under the new TSCA

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

The Environmental Protection Agency (EPA) is publishing a notice in tomorrow’s Federal Register affirming that the Lautenberg Act requires upfront substantiation of all confidential business information (CBI) claims submitted under the Toxic Substances Control Act (TSCA), except for certain claims that the law exempts from substantiation requirements.

While EPA initially took a narrower approach on an interim basis in the flurry of activity following last June’s passage of the Lautenberg Act, today’s notice supersedes that earlier approach and clarifies the upfront substantiation requirement.

In today’s notice, EPA notes the strong support for its clarification in the statute itself as well as in the legislative history in both Houses of Congress leading up to its final passage.

This clarification hopefully won’t be controversial:  A broad swath of stakeholders have voiced support for the upfront substantiation requirement and have noted that it is a key reform made by the new law.

In November the American Alliance for Innovation (AAI) sent a letter to EPA Administrator McCarthy signed by more than 60 trade associations – including the American Chemistry Council, the Society of Chemical Manufacturers and Affiliates, the American Cleaning Institute, the American Petroleum Institute and the Consumer Specialty Products Association – noting that under the Lautenberg Act “[c]laims for CBI protection must be accompanied by an upfront substantiation.”

And back in 2013, the American Chemistry Council provided responses to questions for the record posed by then-Congressman Henry Waxman that stated that “[i]mprovements to the CBI provisions in a modernized TSCA should include … [r]equiring upfront substantiation of the CBI claim.”  The same response letter noted that:  “The American Chemistry Council and its members support up-front substantiation of CBI claims.”

Importantly, EPA’s notice makes clear that the substantiation requirement applies to all non-exempt CBI claims made since passage of the law last June, although EPA is providing an exceedingly generous length of time for companies to comply.

Given the law’s 90-day deadline for EPA review of CBI claims, there are strong policy reasons for requiring upfront substantiation of CBI claims:

  • First, EPA’s own experience based on recent chemical reporting it has required demonstrates that requiring upfront substantiation reduces the number of CBI claims asserted. That means fewer claims EPA has to review and a greater likelihood that claims are only asserted for information that warrants protection.
  • Second, when those reviews are conducted, EPA will already have the information it needs to review the claim instead of having to request it from the company, wasting precious days or weeks of the 90-day review period.
Posted in EPA, Health Policy, TSCA Reform| Also tagged | Comments are closed

Separating fact from fancy in the TSCA Inventory reset mandated by the Lautenberg Act

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

A key reform under the Lautenberg Act is the requirement that the Environmental Protection Agency (EPA) generate an accurate, up-to-date list of all chemicals in active commerce.  This is to be accomplished by promulgating a rule to do a full “reset” of the TSCA Inventory that distinguishes between active and inactive chemicals.  It is necessary because the 85,000 chemicals on that Inventory represent a cumulative listing of all chemicals that have been in commerce at some point since its establishment in 1979, but no doubt includes many that are not now in commerce.

I have blogged previously about why it is important that EPA and the public know how many and which chemicals are in use today in the U.S.  Among other reasons, it is essential that we understand the magnitude of the task that awaits EPA under the new TSCA, with respect to prioritization, risk evaluation, risk management, and substantiation and review of confidential business information (CBI) claims.  That has implications for the pace of the program and the resources EPA will need to do its job, which extends ultimately to reviewing the safety of all chemicals in commerce.

EDF provided EPA with our comments on what should be included in EPA’s upcoming rule establishing the Inventory reset.  Unfortunately, comments on that rule received from some in industry indicate that they are seeking to limit the Inventory reset in ways that are not allowed under the new law and are short-sighted or even counterproductive to the purpose of the reset.  I provide a critique here of three of those proposed limitations.   Read More »

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

Compromise that strengthens, not weakens, TSCA is the key to getting a new law

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

My recent blog post about the public’s right to know the names of chemicals in health and safety studies brought a response from the Vice President for Government and Public Relations at the Society of Chemical Manufacturers and Affiliates (SOCMA), a trade association of specialty chemical firms.

The response devotes considerable space to arguing for something we don’t oppose:  why it’s important for a company to be able to protect information relating to the process by which a chemical is made.  We have no quarrel with that:  EDF has never sought to change the provision of TSCA that precludes EPA from disclosing such information, even in the context of a health and safety study.  That provision is preserved in both the Senate and House bills, and that has been and remains acceptable to us.

Let me be crystal clear:  EDF has not sought to alter TSCA’s requirement that EPA withhold the identity of a chemical even in a health and safety study if revealing that identity would reveal process information.

What we do strongly oppose, however, is the effort to expand TSCA’s exclusion so as to allow a company always to hide from the public the identity of the chemical in a health and safety study – even where knowing that chemical’s name would not reveal the process used to make it.  That is exactly what the provision in the House TSCA reform bill that SOCMA is pressing for would do.

This would be a major weakening of current TSCA that would severely limit the public’s right to know about health and environmental impacts of chemicals in use today.

SOCMA’s response argues this would be okay for two reasons:  First, EPA will know the chemical’s identity, so no one else needs to know.  And second, the public should be content with a “generic” name.  Let me briefly address each of these arguments.   Read More »

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

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 »

Posted in EPA, Health Policy| Also tagged , , , | Comments are closed

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 , , , , | Comments are closed
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