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.
What TSCA says about your right to know
Section 14(b) of TSCA carves out an exception for health and safety information on chemicals from the general allowance in Section 14(a) for companies to claim any information they submit to EPA to be CBI. The only exceptions to that exception (still with me?) are the ones just mentioned: where the disclosure would reveal either (a) how a chemical is made or processed, or (b) in the case of a mixture, the portion of that mixture a chemical comprises.
What EPA’s TSCA regulations say about your right to know
EPA’s regulations implementing TSCA clearly define chemical identity to be an integral part of a health and safety study; see the definition of a health and safety study at 40 CFR §716.3 and §720.3(k).
Based presumably on the provision of TSCA that provides two exceptions to the general proviso that health and safety information be publicly available, EPA regulations (40 CFR §720.90) provide certain conditions under which a company may assert a confidentiality claim for the identity of a new chemical even when associated with a health and safety study. The regulations state that EPA will deny such a claim unless the claimant demonstrates that “the specific chemical identity is not necessary to interpret a health and safety study.” See 40 CFR §720.90(c)(3). This additional exception appears nowhere in TSCA.
Even so, EPA’s own reports indicate that it would be highly unusual for the agency to conclude that the specific chemical identity is not necessary to interpret a health and safety study. A 1992 report commissioned by EPA’s Office of Pollution Prevention and Toxics (OPPT) summarized the low likelihood that chemical identity would not be necessary to interpret a health and safety study as follows:
OPPT attorneys have argued that it is rarely the case that chemical identity information could legitimately be covered by such an exemption. It is unlikely that any reputable health or environmental scientist could be found who would argue that it is ever the case that chemical identity is unnecessary to interpret health and safety data. (emphases in original).
Likewise, the CBI Final Action Plan developed by OPPT in 1994 declares that:
[t]he utility of a health and safety study, particularly for chemicals in commercial distribution, is greatly enhanced by connection to a specific chemical identity. … This connection allows for risk analysis by all segments of the interested public, including the chemical industry. … Such actions cannot take place when a hazard cannot be associated with a specific chemical.
I ask you: How on earth could it not be essential to know the identity of a chemical in order to understand health and safety information about that chemical?
Based on TSCA’s language and its own implementing regulations, EPA policy and practice is to “generally deny confidentiality claims for the identity of chemicals in health and safety studies filed under TSCA except in specified circumstances.” The House bill would have the effect of obliterating this policy and practice.
What the House bill does
Section 14(b)(1) of TSCA, as amended by the House’s TSCA Modernization Act of 2015 would retain TSCA’s two exceptions from disclosure for information relating to chemical identities in the context of health and safety information: “data which discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.”
But the bill would add a third exception: “data that disclose formulas (including molecular structures) of a chemical substance or mixture.” The inclusion of the term “molecular structures” in this addition goes beyond information relating to a chemical formulation, and would expressly preclude EPA from identifying a chemical that is the subject of health and safety information it is making public, if that chemical identity were claimed CBI.