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.
CBI claims for chemical identity
Under current TSCA, companies can claim the identities of any of their chemicals to be CBI. As a result, the identities of about 17,000 chemicals (out of the 85,000) on the TSCA Inventory are hidden from public view, having been claimed by their makers to be CBI. EPA can challenge such CBI claims on a case-by-case basis, but it has no mandate to review them and rarely mounts challenges because of the resources required.
Why is knowing the identities of chemicals in use important? When a chemical’s identity is hidden, that means people – consumers, researchers, health professionals, etc. – cannot determine whether that chemical is present in products, the environment or even in our bodies, nor can they link it to other information about potential health effects or exposures.
The Lautenberg Act limits any presumption of protection from disclosure of chemical identities to the period before they enter the market; and any such claim for a chemical after market entry has to be substantiated and reviewed by EPA.
Importantly, EPA is also required to review and require substantiation of past chemical identity claims for all active chemicals now on the confidential portion of the TSCA Inventory. This review must be completed within five years of enactment. EPA must also review any CBI claim for the identity of any inactive chemical at the time it is moved to active status. Chemical identities not already on the confidential portion of the inventory or added to it per prescribed procedures cannot be claimed confidential in any context.
The House discussion draft [UPDATE 5-28-15: H.R. 2576] makes no changes to current TSCA for chemical identity claims that were made before enactment. That means it would continue the status quo under which those claims are not required to be reviewed by EPA, nor subject to a requirement for companies to re-justify whether the chemical identities are still legitimate trade secrets, sometimes long after the chemicals first entered the market. Such claims made after enactment would be required to be justified by the claimant, but, as under current TSCA, no EPA review of such claims would be mandated.
Access to health and safety information
Under current TSCA, companies are free to claim virtually any information they submit to EPA is CBI. EPA cannot disclose information claimed CBI to the public, to state and local agencies, to health providers or even to first responders. Health and safety studies and their underlying data are generally not eligible for CBI protection under TSCA, but, until recently EPA routinely allowed those studies, or the identities of the studied chemicals, to be hidden from public view.
The Lautenberg Act retains current TSCA’s exclusion of health and safety studies and their underlying data from being claimed CBI. For claims going forward relating to other types of information (e.g., the uses of the chemical or the identity of the company making it), they can only be protected from disclosure if they are legitimate trade secrets, and generally must be substantiated at the time they are asserted. EPA is required to review a representative subset, including at least 25 percent, of all such claims.
For the first time, state and local governments as well as health professionals would have access to CBI, per agreements made with EPA that they keep the information confidential.
EPA would have authority, at any time, to review and require resubstantiation of any claim – whether asserted in the past or future – for chemicals EPA designates as high-priority, finds have sufficient information for a safety determination, or are inactive. EPA also could review and require resubstantiation of claims for information the disclosure of which would assist EPA in conducting safety assessments, making safety determinations, or developing risk management rules.
EPA is mandated to review a CBI claim and require resubstantiation if necessary to comply with a FOIA request; if EPA has reason to believe the claim is not valid; or for chemicals found not to meet the safety standard. CBI claims for a chemical that EPA bans or phases out would generally expire.
[UPDATE 4-29-15: A change made in the bill passed by Senate EPW would make all CBI claims relating to chemicals being banned or phased out subject to a rebuttable presumption of disclosure (rather than being automatic); EPA’s intent to disclose would be subject to appropriate notification of the submitter of the CBI and an opportunity to rebut the presumption that the public interest in disclosure outweighs the private interest in protection of the information. EPA’s decision is to be based on the objective of maximizing disclosure of information relevant to protecting health and the environment.]
The House discussion draft [UPDATE 5-28-15: H.R. 2576] requires CBI claims made after enactment to be justified by the claimant, but as in current law, no EPA review of such claims would be mandated. EPA has authority – but not a mandate – to provide State and local governments with access to CBI. EPA must provide health professionals (though not first responders) with access to CBI, per agreement that they keep the information confidential.
[UPDATE 5-17-15: A change made in the draft passed by the House Environment and the Economy Subcommittee would significantly expand current TSCA’s exception from disclosure for information relating to chemical identities in the context of health and safety information.
- Under current TSCA, two exceptions to the general allowance for disclosing health and safety information are provided: (1) data which discloses processes used in the manufacturing or processing of a chemical substance or mixture, or, (2) 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.
- The House draft adds a third exception: (3) 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 (the extent of the revision made to this provision in the first House discussion draft), 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. This would have the effect of reversing EPA’s policy and practice under current TSCA.
UPDATE 5-28-15: H.R. 2576 retains this provision.]
Duration of CBI claims
Under current TSCA, CBI claims are not subject to time limits and remain in place until and unless challenged by EPA. That means information subject to claims made many years or even decades earlier remains hidden from public view, even though the original basis for the claim may have long since changed.
Under the Lautenberg Act, except for claims for information deemed always eligible for protection (e.g., customer lists, detailed process information), CBI claims expire after 10 years unless resubstantiated. Claims made before enactment that EPA reviews (including the past chemical identity claims discussed above) would also be subject to the 10-year, renewable, limit. In both cases, EPA is required to review all requests for renewals of claims pertaining to chemical identity, and a representative subset (including at least 25%) of all other renewal requests.
The House discussion draft [UPDATE 5-28-15: and H.R. 2576] subjects all claims made after enactment to a 10-year time limit, which can be extended by filing a renewal request. EPA review of any such requests is not required. Past CBI claims would not be subject to any time limit and hence would remain in place indefinitely unless challenged by EPA.
Next up: Consideration of costs and other non-risk factors in risk management decisions.