Richard Denison, Ph.D., is a Senior Scientist.
A front page article by Lyndsey Layton in yesterday’s Washington Post – spurred by an intriguing new report by the Environmental Working Group – did a great job of exposing the extent to which the identities of chemicals in widespread use are hidden from view, and of exploring some of the many adverse consequences.
Neither the article nor the report, however, had much to say about how this problem of excessive reliance on confidential business information (CBI) claims by industry might be solved, especially in the context of impending reform of the Toxic Substances Control Act (TSCA).
In this post I’ll provide some concrete proposals for addressing this serious problem.
Should any information be eligible for protection?
While some might argue for full disclosure of all chemical information, let me say I think there are legitimate bases for industry to claim certain types of information as confidential business information (CBI). Most people would agree a company should not be required to divulge the identity of its customers, for example, or the precise recipe or formula for its products (that is different, however, from a requirement to identify which chemicals are used in a product – so-called mandatory ingredient disclosure – which I fully support).
Even with respect to chemical identity, I think it can be legitimate – under certain circumstances and with sufficient justification and documentation provided – for a company making a new chemical to hide from its competitors, for a limited period of time, the fact that it is going to introduce that chemical into commerce.
Think of the entrepreneur who has developed a far safer alternative to a chemical of high concern, and wants to gain a jump on its competitors in getting to market. I'm thinking especially of the pre-marketing period, during development and initial manufacture but before a chemical enters commerce or appears in products.
So the solution is not as simple as requiring all information to be fully disclosed in all cases.
The problem with TSCA’s data disclosure provisions (Section 14) is that they have allowed nearly unfettered opportunity for industry to claim information CBI, and tied EPA’s hands both legally and resource-wise in any effort to challenge or rein in such claims where they are not legitimate.
Section 14(c) of TSCA allows companies to designate virtually any submitted information as CBI: “In submitting data under this Act, a manufacturer, processor, or distributor in commerce may designate the data which such person believes is entitled to confidential treatment.”
And – despite TSCA’s rhetoric to the contrary – whenever a conflict between public and private interests arises, EPA’s practice under TSCA has generally been to let private interests trump.
Finally, because TSCA requires that criminal penalties (including jail time) be imposed on anyone who knowingly discloses CBI (see Section 14(d)), the prevailing culture that has evolved at EPA has been one that effectively creates a strong presumption against disclosure.
So, what would an appropriately reformed data disclosure provision of TSCA look like? Here’s my top-ten wish list:
- EPA should develop standards that define legitimate and illegitimate bases for making CBI claims, specify the required documentation, and delineate the specific types of information that are and are not eligible.
- Companies should only be allowed to make claims that meet the standards and should be required to assert, justify and document the basis for each claim at the time the data are submitted.
- EPA should be required promptly to review all CBI claims against the standards; information for which EPA approves the claim would be protected, and information for which it does not would be disclosed after informing the claimant. EPA would collect a fee from the claimant sufficient to cover its costs of processing and reviewing the claim.
- Each CBI claim should specify and justify the time period for which it is requested. For any claim it approves, EPA should specify an applicable time period after which disclosure will occur unless a new request is submitted and approved.
- Workers should have access to all available information, whether or not CBI-protected, concerning chemical identity, properties, hazards and workplace exposures for any chemical with which they work or to which they could be exposed during work.
- Within the federal government, employees at EPA or other agencies charged with assessing the safety of a chemical should have access to all relevant CBI about that chemical.
- Other levels of government – local, state, Tribal, foreign – should be provided access to information approved as CBI, under agreements that provide that the recipient has procedures in place to ensure it can protect such information from improper disclosure.
- Health and safety information about a chemical – including the identity of that chemical – should never be eligible for CBI protection. As a rule, the identity of the submitter of that information should also be ineligible; EPA should have standards that explicitly delineate the basis for any exceptions.
- In addition, certain other types of information should not be eligible for CBI status:
- chemical identity, except for new chemicals on a time-limited basis and where EPA determines that disclosure is not in the public interest;
- any notices or information submitted to EPA or other agencies that indicate adverse reactions to or significant potential risk of a chemical;
- any determination made by EPA as to a chemical’s safety, and the basis for it;
- identification of a chemical's industrial functions and its commercial and consumer uses; and
- the presence of a chemical in products to which fetuses, infants or children may be exposed.
And last but not least:
10. EPA should promptly make any information not approved as CBI readily available free of charge to the public via Internet-accessible databases and websites.
For more information on these proposals, see:
- my January 2009 Environmental Law Reporter paper, “Ten Essential Elements in TSCA Reform,” especially section IX; and
- my report, Not That Innocent, which provides a comprehensive comparison of the information disclosure policies under TSCA, the European Union’s REACH Regulation and the Canadian Environmental Protection Act (CEPA); see especially Section VIIA.