ACA Submits Comments to EPA in Support of Second Alternative for TSCA ‘Unique Identifiers’
July 18, 2017 •
On July 7, ACA submitted comments to the U.S. Environmental Protection Agency (EPA) on the proposed alternative methods for issuing “unique identifiers” to replace confidential chemical identities in submissions under the Toxic Substances Control Act (TSCA).
As amended under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA §14(g)(4) requires that EPA establish unique identifiers (UI’s) for “each specific chemical identity for which the Administrator approves a request for protection from disclosure…” EPA must “apply that identifier consistently to all information relevant to the applicable chemical substance.” EPA must also annually publish a list of UI’s and dates of expiration. The statute also requires that EPA identify a chemical using the UI in any non-confidential information containing reference to a confidential chemical identity. When EPA denies a claim for confidentiality or confidentiality expires, EPA must clearly disclose the chemical identity associated with a UI.
In early May, EPA proposed two alternative methods of issuing UI’s. Under the First Alternative, EPA would apply one UI for all submissions relevant to a chemical substance, including documents with non-confidential information. Under the Second Alternative, EPA would assign one UI for all submissions from one company related to a chemical. EPA sought public comment on these alternatives and any other methods of assigning UI’s.
In developing UI’s, EPA is challenged with allowing public access to health and safety information while simultaneously protecting information that preserves a company’s market advantage. Information at issue includes chemical identities, specific manufacturing processes and manufacturing volumes. Under TSCA §14(b)(2), EPA is required to disclose health and safety information. TSCA §14(b)(3) specifies that general information about manufacturing processes and volumes are not protected and can be disclosed. TSCA §14(g)(4)(C) indicates that any confidential chemical identities in such disclosures must be replaced by UI’s. The purpose of this requirement is to allow the public to aggregate data about chemicals using the UI, while maintaining confidentiality of a chemical identity and other confidential business information (CBI).
ACA expressed concern in its comments that EPA disclosures identified with one UI per chemical under the proposed First Alternative would allow a company’s competitors or the public to obtain information about new uses, specific marketing data, or information about processes, as noted in examples provided by EPA in its Federal Register notice. ACA argued that in some cases, EPA disclosures could also reveal confidential chemical identities. In effect, required disclosures could undermine years of costly product development while subverting EPA’s process of evaluating and granting CBI claims.
By contrast, ACA argued that the proposed Second Alternative protects confidential identity by not associating UI’s with documents that disclose chemical identity and other CBI. The Second Alternative gives companies more control to replace a confidential identity with its assigned UI when submitting non-confidential information to EPA (e.g. health and safety studies). Under the Second Alternative, EPA would meet the requirement in TSCA §14(g)(4)(C), requiring EPA replace a confidential identity with a UI in non-confidential information, without the administrative burden of having to review submissions and replace a confidential identity in non-confidential submissions.
Public access to health and safety information is an important consideration in developing a system of UI’s. (See 82 FR 21388). TSCA §14(b)(2)(A) requires EPA to disclose health and safety studies. ACA is concerned that EPA might adopt the First Alternative as the most effective method of allowing the public to aggregate health and safety information under one UI. To do so would be remiss of EPA’s statutory obligations. EPA is required by statute to protect CBI. (TSCA §14(a)). EPA is not statutorily required to allow aggregation of disclosed information when meeting its statutory requirement to disclose health and safety studies.
ACA maintains that the Second Alternative meets EPA’s statutory obligation to protect CBI while disclosing health and safety information. This alternative also allows the public to aggregate information submitted by one company under a UI. By reviewing submissions from multiple companies with varying UI’s, the public might also infer linkages between submissions.
As such, ACA urged the agency to elect the Second Alternative for issuing UIs under TSCA Section 14.
Contact ACA’s Riaz Zaman for more information.