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On 10 April 2019 the U.S. Environmental Protection Agency (EPA) released a pre-publication of a proposed rulemaking outlining the process for reviewing Confidential Business Information (CBI) claims for the identities of chemicals listed as “active” on the confidential portion of the Toxic Substances Control Act (TSCA) inventory. Businesses may expect a 60-day commentary to follow, and when finalized, substantiations will be expected to be filed no later than 90 days after the publication of the final rule in the Federal Register.
Verisk 3E Review
By statute, the EPA is required to promulgate this rule one year after publishing the TSCA inventory containing the first-ever “active” designations. The active-inactive inventory was published on 19 February 2019. For an overview of the new inventory 3E Monitor users can refer to the news article titled “U.S. EPA Makes History with First-ever TSCA Active-Inactive Inventory”.
Persons that asserted a CBI claim for a specific chemical identity but did not voluntarily substantiate when they submitted their notice of activity (NOA) form A will have 90 days after the effective date of the final rule to substantiate in accordance to the criteria outlined in section 14 of TSCA.
How to substantiate?
Substantiation will require a self-assessment to support the validity of a CBI claim based on a series of questions identified in 40 CFR 2.204(e)(4). The EPA understands that responses to these questions should aid businesses in providing the factual basis for the assertion of a data element considered CBI. These guiding questions are as follows:
- “The portions of the information which are alleged to be entitled to confidential treatment;
- “The period of time for which confidential treatment is desired by the business (e.g., until a certain date, until the occurrence of a specified event, or permanently);
- “The purpose for which the information was furnished to EPA and the approximate date of submission, if known;
- “Whether a business confidentiality claim accompanied the information when it was received by EPA;
- “Measures taken by the business to guard against undesired disclosure of the information to others;
- “The extent to which the information has been disclosed to others, and the precautions taken in connection therewith;
- “Pertinent confidentiality determinations, if any, by EPA or other Federal agencies, and a copy of any such determination, or reference to it, if available;
- “Whether the business asserts that disclosure of the information would be likely to result in substantial harmful effects on the business' competitive position, and if so, what those harmful effects would be, why they should be viewed as substantial, and an explanation of the causal relationship between disclosure and such harmful effects; and
- “Whether the business asserts that the information is voluntarily submitted information as defined in §2.201(i), and if so, whether and why disclosure of the information would tend to lessen the availability to EPA of similar information in the future.”
Further, substantiation should be accompanied by a signed certification statement. For your convenience, the EPA has drafted sample substantiation templates here.
Persons who substantiated their claims concurrent with their submission of the NOA form A will be exempted from the substantiation requirements. Likewise, the agency is proposing that businesses that asserted substantiation for a claim made during the five-year implementation period be also exempted from the requirements of this rule.
The EPA has five years to implement the CBI review plan, which is expected to be concluded by 19 February 2024 with the possibility for an extension of two years. While the agency does not expect to use the extended period, an extension request could result from competing TSCA obligations or litigation that may result involving the substantiation of a CBI claim.
The agency will evaluate all the facts provided in the substantiation as well as any other available information that aids the decision-making process of granting confidential treatment, including previous determinations on CBI claims. Hence, the EPA will be applying substantive criteria for confidentiality determinations (see 40 CFR 2.208 and 2.306(g)).
Same chemical identity, multiple assertions
If the agency where to be faced with more than one claim asserting confidentiality for the same chemical identity, these will be reviewed together.
Businesses may expect the CBI claim to be either approved or denied. Approved CBI claims will be protected from disclosure for up to ten years starting from the date on which the claim was asserted. The agency has clarified that CBI claims that were asserted during the retrospective reporting exercise required by the active-inactive rule will start their period of protection from disclosure on the date the NOA form A was filled. Substances that were exempted from the retrospective reporting exercise because they were notified under the chemical data reporting (CDR) rule for the 2016 reporting cycle or had a notice of commencement (NOC) available on or after 2016 can be expected to be protected starting from the date of submission of the first filling in which the specific chemical identity was claimed as CBI.
Transparency while implementing the plan
As part of the plan, the EPA is also proposing to publish its annual goals for reviews completed at the beginning of each year and to track the number of CBI reviews completed each year. Businesses may expect transparency on the agency’s goals as early as February 2020, and a progress report of CBI reviews completed in February 2021.
A copy of the pre-publication of the proposed rule is available here.
Verisk 3E Analysis
The proposal directly impacts chemical identities of chemicals present on the confidential portion of the TSCA inventory. Thus, businesses that reported a chemical under the process outlined in the active-inactive rule and asserted a CBI claim for a specific chemical identity without voluntarily substantiating their claim will need to provide substantiations. Substantiation reports will need to be submitted through the Central Data Exchange (CDX) portal no later than 90 days after the publication of the final rule.
Businesses may expect the EPA to finalize the rule by 19 February 2020. The EPA has to implement the CBI review plan five years after the publication of the first active-inactive TSCA inventory. Further, agency review of CBI claims is expected to conclude by 19 February 2024 with the possibility of a two-year extension.
Last, a commentary period is schedule to start 60 days after the rule is published in the Federal Register. Comments may be submitted via the Federal eRulemaking portal by accessing docket EPA-HQ-OPPT-2018-0320, or mailed to the Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Businesses are recommended to exclude from comments any confidential business information.