EPA Will Begin Reviewing TSCA CBI Claims
On May 27, 2010, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing that it will begin a general practice of reviewing confidentiality claims for chemical identities in health and safety studies submitted under the Toxic Substances Control Act (TSCA). 75 Fed. Reg. 29754, available online. EPA states that TSCA Section 14(b) “does not extend confidential treatment to health and safety studies, or data from health and safety studies, which, if made public, would not disclose 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.” According to EPA, where a chemical identity does not explicitly contain process information or reveal portions of a mixture, EPA expects to find that the information would “clearly” not be entitled to confidential treatment. EPA states that this interpretation builds on similar efforts regarding confidentiality of chemical identities listed on the public version of the TSCA Inventory and submitted in notifications pursuant to TSCA Section 8(e). According to the notice, EPA expects to begin reviews of confidentiality claims — both newly submitted and existing claims — in accordance with this guidance on August 25, 2010. EPA states that, though it is not required to solicit comment for this action, comments received before then “will inform these reviews.”
Some in industry are concerned with the potential implications of the proposal and its implementation. Some believe that it raises anew significant concerns regarding potential conflicts with the statutory provisions governing protection of confidential business information. The extent and validity of these concerns will likely become clearer as EPA moves forward with this proposal, particularly in light of the currently ongoing debates regarding the various draft bills that would amend TSCA to address this issue, among many others.
EPA states that it intends to respond to certain confidentiality claims regarding chemical identities in health and safety studies and in data from health and safety studies with a determination letter under 40 C.F.R. Sections 2.306(d), 2.204(d)(2), and 2.205(f) “that such information is clearly not entitled to confidential treatment.” At this time, EPA expects to issue determination letters when the chemical identity claimed as confidential:
- Was submitted as part of a health and safety study, or of data from a health and safety study, submitted under TSCA that is subject to TSCA Section 14(b)(1).
- Does not explicitly contain process information.
- Does not reveal data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.
The TSCA Inventory lists chemical substances subject to TSCA and in commerce in the U.S. The fact that a chemical substance is on the TSCA Inventory may be claimed as confidential, and EPA notes that release of a chemical identity under TSCA Section 14(b) may correspondingly affect the validity of a TSCA Inventory confidentiality claim. According to the notice, EPA expects to examine TSCA Inventory confidentiality claims for chemical identity as it makes determinations under TSCA Section 14(b). EPA will issue determinations on confidential Inventory status when appropriate.
EPA states that TSCA Section 14(b)(1) provides that health and safety studies, and data from health and safety studies, are not entitled to confidential treatment unless such information, if made public, would disclose 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. According to EPA, the Federal Register notice “discusses the disclosure of process information element only, and does not deal with the portion of a mixture information element, which pertains to the concentrations of the components of a mixture.”
In a January 21, 2010, Federal Register notice, EPA announced that “[w]here a health and safety study submitted under section 8(e) of TSCA involves a chemical identity that is already listed on the public portion of the TSCA Chemical Substances Inventory, EPA expects to find that the chemical identity clearly is not entitled to confidential treatment.” EPA stated:
Where the identity of a chemical substance is already contained on the public portion of the TSCA Chemical Substances Inventory, which is publicly available from the National Technical Information Service and other sources, EPA believes that the identity itself, even assuming it might otherwise be CBI, as well as any information that might be derived from it about processes or portions, has already been disclosed.
The January 21, 2010, Federal Register notice did not address chemical substances not on the public TSCA Inventory, however. According to the May 27, 2010, notice, with respect to such chemical substances, “EPA is aware that some companies believe their competitors are sufficiently knowledgeable that if EPA were to disclose the chemical identity, the competitors would be capable of ascertaining on their own how the chemical substance might be manufactured or processed, and therefore this would in effect disclose process information.” EPA questions the assertion that disclosing a chemical identity will inspire a competitor to ascertain a process for manufacturing the chemical substance, and that such disclosure is thus the equivalent of disclosing the process itself. According to EPA, disclosing the end product of a process (i.e., a chemical identity) is not the same thing as disclosing the process to make that end product. The process information would come from the competitor’s expertise, research, or publicly available sources, not from EPA. EPA states: “Carried to its logical conclusion, the argument that the manufacturing process for chemical substances can be figured out by someone knowledgeable in the area and for that reason disclosure of chemical identities is considered equivalent to disclosing process information, would yield the perverse result that chemical identities would rarely, if ever be subject to TSCA section 14(b) disclosure.” The notice includes the following examples:
It is EPA’s view that as a general matter disclosure of a chemical identity does not disclose process information except where the identity explicitly contains process information. For example, a name such as “formaldehyde” (Chemical Abstracts Service (CAS) No. 50-00-0) reveals nothing about the process to make the chemical substance, even if any chemist could figure out independently that formaldehyde can be generated by oxidizing methanol.
In contrast, the names of some chemical substances — especially polymers and chemical substances of unknown or variable composition, complex reaction products and biological materials (known as UVCB substances) — do explicitly contain process information. An illustrative UVCB example is CAS No. 64742-28-5, specific chemical substance’s name “Distillates (petroleum), chemically neutralized light paraffinic.” A polymer example is CAS No. 68474-52-2, safflower oil, polymer with adipic acid, glycerol and phthalic anhydride. The monomers adipic acid, glycerol and phthalic anhydride are reactants, information pertaining to manufacture of the polymer. EPA expects that such names would not be subject to TSCA section 14(b) disclosure in those instances where the chemical substances’ name were claimed as confidential in a study.
EPA intends to begin reviewing confidentiality claims for identities of chemical substances in health and safety studies, and data from health and safety studies on August 18, 2010. EPA requests comments prior to that date regarding classes of chemical substances and attributes of chemical identities that do or do not disclose process information. Where process information in the chemical identity is unnecessary to characterize the chemical substance or mixture, EPA states that it may release a version of the chemical identity with the process information removed.