Richard Denison, Ph.D., is a Senior Scientist.
Tomorrow's Federal Register will contain a short notice from EPA that partially corrects a decades-old Agency practice that has denied the public access to the identity of chemicals that present substantial risks.
This welcome action begins to pull back the curtain on the chemical secrecy that has been a hallmark of life for the public under the Toxic Substances Control Act (TSCA). As I noted in a previous post, this action is one of a host of changes needed to remedy the major excesses and abuses of confidentiality under TSCA. EPA's action makes clear that some things can be done even as we await TSCA reform.
Here's what EPA's notice outlines as the new policy and practice, to take effect immediately:
If, in submitting a "notice of substantial risk" as required under Section 8(e) of TSCA, a company claims the identity of the chemical in question to be confidential business information (CBI), EPA will:
- review the claim at the time of submission;
- generally deny the claim if the chemical is on the public portion of the TSCA Inventory (i.e., was not claimed CBI in that context); and
- inform the submitter of that decision in a manner that constitutes a final EPA action and hence is not challengeable except via judicial review.
All three of these steps represent significant departures from the status quo:
First, EPA will actually review such claims as they come in, to determine whether they are consistent with the new policy or not. In the past, EPA has rarely reviewed such claims ever, let alone at the time of submission, with the result being that virtually all such claims were by default allowed to persist in perpetuity.
The Federal Register notice forthrightly acknowledges this past practice:
"Previously, EPA's general practice had been to redact chemical identity from TSCA section 8(e) postings where the identity was claimed CBI even when the chemical identity was listed on the public portion of the TSCA Chemical Substances Inventory."
Second, EPA is putting prospective claimants on notice that, when reviewing such claims, "EPA expects to find that the chemical identity clearly is not entitled to confidential treatment." This effectively reverses prior policy and practice, under which such claims were presumed to be legitimate even without actual review of them.
Third, EPA's decisions will be communicated to the claimant via a "determination letter" that represents a final Agency action. In the past, EPA has often had to engage in a prolonged song-and-dance exchange of letters with claimants as a prelude to making a final decision – chewing up precious Agency resources and hence drastically curbing the number of EPA challenges of CBI claims.
What's the basis for the change?
EPA's new policy is based on the common-sense notion that the identity of a chemical that is already known to the public – by virtue of it being listed on the public part of the TSCA Inventory – has already been disclosed, and hence cannot be claimed CBI in a different context.
EPA also notes that, by the way, this new policy is consistent with a core part of its mission: "To promote public understanding of the potential risks posed by chemicals in commerce."
Why this is only a first step towards what's needed
EPA's action is a great first step, but it's only that. Unless EPA goes further, its new policy will still deny the public access to the identity of many other chemicals posing substantial risk – but whose identities have been masked as CBI and hence don't appear on the public portion of the TSCA Inventory.
(Indeed, I suspect that most of the chemicals with identities claimed CBI in Section 8(e) notices are also claimed CBI on the TSCA Inventory. EPA did not but should provide such statistics, so that the magnitude of the change it's making – and of the larger problem – can be better gauged.)
Here's why EPA must go further:
First, public interest must trump private interest.
While TSCA provides wide latitude for companies submitting information to EPA to claim it CBI, one bright spot – in theory – is that TSCA prohibits granting CBI status to data from health and safety studies (see section 14(b)).
Why would Congress, when drafting TSCA, have gone out of its way to carve out an exemption from CBI eligibility for data from health and safety studies – effectively establishing the public's right to know such information – only to render impotent that right by denying the public the right to know to which chemical the data apply? That makes no sense.
EPA's regulations also acknowledge the primacy of public over private interest. Part 2 of Title 40 of the Code of Federal Regulations lays out EPA's regulatory provisions governing "public information," including procedures to be followed under the Freedom of Information Act (FOIA). Look at this interesting provision found in Section 2.202(d):
"If two or more of the sections containing special rules apply to the particular information in question, and the applicable sections prescribe conflicting special rules for the treatment of the information, the rule which provides greater or wider availability to the public of the information shall govern." (emphasis added)
But as is so often the case under TSCA, what TSCA giveth with one hand it taketh away with the other.
TSCA provides an exception to the exception for health and safety data: In disclosing such data, EPA cannot make public data that discloses either:
- "processes used in the manufacturing or processing of a chemical substance or mixture" or
- in the case of a mixture, "the portion of the mixture comprised by any of the chemical substances in the mixture."
Based presumably on this provision of TSCA, EPA regulations provide certain conditions under which a company may assert a confidentiality claim for the identity of a chemical – even when associated with a health and safety study. It should be noted, however, that these regulations only apply to new, not existing, chemicals. Moreover, they 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).
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?
Finally, the astute reader will notice that nothing in TSCA's exception to the rule that health and safety data must be made public speaks to chemical identity. Only the divulgence of information describing how a chemical is made or processed, or revealing how much of a given chemical is in a mixture, is excepted.
I suspect that some talented chemical industry lawyers have racked up many billable hours devising arguments as to why EPA must interpret such a limited provision so broadly as to extend it all the way to including something never mentioned at all in the provision: chemical identity.
I would argue that such an interpretation flies in the face of:
- the express words of TSCA,
- the clear intent of Congress to provide public access to health and safety information,
- the core principles of right-to-know and the primacy of public over private interest,
- sound public policy, and
- last but not least, plain old common sense.
So I welcome EPA's action as a good first step in correcting a particularly egregious example of chemical secrecy under TSCA. It appears that EPA sees it as a first step toward addressing this problem as well: Its Federal Register notice describes the new policy as "part of a broader effort to increase transparency and provide more valuable information to the public." Other recent actions announced by EPA fit this mold. For example, its disclosure of the identities of 530 chemicals on the TSCA Inventory previously exclude as CBI; and its proposal to require disclosure of the identities of inert ingredients in pesticide formulations.
I also look forward to the next installment in EPA's effort.