06.05.2019 EPA Proposes Rule for Confidential Business Information Claims under TSCA
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The 2016 amendments to the Toxic Substances Control Act (“TSCA”) made numerous changes to TSCA, including increasing public transparency of chemical information. To accomplish this, the amendments required EPA to establish a plan for reviewing all confidential business information (“CBI”) claims for a specific chemical identity asserted by a manufacturer. EPA was required to do this no later than one year after it completed the TSCA inventory of active and inactive substances (“Inventory”). EPA released the updated Inventory on February 19, 2019, and published a proposed rule on April 23, 2019. Once the rule is effective, EPA is required to complete its review of all CBI claims no later than five years after the Inventory was released, or by February 19, 2024.
In 2016, TSCA was amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The 2016 amendments require EPA to keep a comprehensive list of active and inactive chemical substances processed or manufactured (including those imported) in the United States for nonexempt commercial purposes during the “Lookback Period.” The Lookback Period for reporting purposes was June 21, 2006, through June 21, 2016. Under the TSCA regulations, a manufacturer/importer of a chemical substance subject to “commercial activity designation” during the Lookback Period was required to submit a Notice of Activity (“NOA”) Form A between August 11, 2017, and October 5, 2018 (“NOA Deadline”). EPA reviewed the forms submitted, and, on February 19, 2019, released the active and inactive substances Inventory.
The TSCA Inventory has a confidential portion and a public, non-confidential portion. The TSCA regulations were amended in 2017 (“Amended TSCA Regulations”). The Amended TSCA Regulations allow persons submitting an NOA to request to maintain an existing claim of confidentiality for chemicals already listed on the confidential portion of the Inventory at the time the notice was submitted. If the request to maintain confidentiality is not made at the time the NOA Form A is submitted, the chemical was moved from the confidential Inventory list to the public Inventory list.
The Amended TSCA Regulations also require a person requesting a new CBI claim or seeking to maintain an existing CBI claim to substantiate the claim in accordance with existing or future EPA regulations. The deadline to substantiate is different for new claims versus maintenance of existing CBI claims. New claims had to be substantiated and certified by the NOA Deadline. Those requesting to maintain CBI were not required to substantiate the claim by the NOA Deadline. Rather, those requesting to maintain were allowed to either wait for EPA to issue new regulations or voluntarily offer substantiation by the NOA Deadline.
II. What does the Proposed CBI Rule require?
The Proposed CBI Rule provides: 1) mandatory “substantiation requirements” for claims to maintain chemical substances on the confidential portion of the TSCA active-list Inventory; 2) provisions clarifying the duration of protection for approved CBI claims; and 3) publication of annual review goals and results.
The Proposed CBI Rule does not apply to persons who already voluntarily provided substantiations during the initial submittal of the NOA Form A or during the 5-year period ending on the substantiation deadline. CBI claims by those exempt companies are reviewed under the procedures already set forth in TSCA and the TSCA regulations. If your company submitted an NOA Form A, requested to maintain a claim of confidentiality but did not voluntarily provide substantiation of that claim at that time, the Proposed CBI Rule, once finalized, will apply. Finally, the Proposed CBI Rule does not apply to CBI claims for specific chemical identity in an NOA Form B used to report the reintroduction of “inactive” chemical substances into the United States.
A. Substantiation Requirements
For companies that submitted substantiation to EPA in the past, but not with the NOA Form A, the Proposed CBI Rule requires they provide EPA with the following information within 90 days of the effective date of the final rule: (1) the submission date; (2) the submission type; (3) the case number, transaction ID, or equivalent identifier that uniquely identifies the previous submission; and (4) the substantiation upon which the company is relying. EPA will review the submission to determine if the substantiation previously provided is sufficient.
For companies that never provided substantiation, but have claimed CBI in the NOA Form A, the Proposed CBI Rule requires they file their substantiations no later than 90 days after the effective date of the final rule. The Proposed CBI Rule specifically requires an authorized official for the company to provide substantiation in the form of certified answers to the following questions:
- Do you believe that the information is exempt form substantiation pursuant to TSCA section 14(c)(2)? If yes, under what exemption?
- Will disclosure of the information likely result in substantial harm to your business’ competitive position? If so, how?
- What precautions has your business taken previously in disclosing the identity to other persons (internally and externally)? Identify the measures or internal controls taken, including non-disclosure agreements prior to access, limited access on need-to-know business, physical safeguards of information, etc.
- Does the identity already appear in any public documents, including safety data sheets, advertising, professional or trade publications, or other media available to the public?
- If the confidentiality claim is for less than 10 years, how many years are requested?
- Has EPA, other federal agency, or a court made any confidentiality determination regarding information associated with the chemical substance?
- Is the chemical substance publicly known to have been offered for commercial distribution in the United States at any time?
The official submitting the CBI claim must also certify the following to be true and correct: (1) the company has taken reasonable measures to protect the confidentiality of the information; (2) the information is not required to be disclosed or made public under other Federal laws; (3) the disclosure is likely to cause substantial harm to the competitive position of the company; and (4) there is a reasonable basis to believe the information is not readily discoverable through reverse engineering.
The certified answers to the substantiation questions must be submitted electronically in the same manner the NOA Form A was previously submitted. Late submittals will be deemed deficient and will lead to the identity of the chemical substance being treated as non-confidential without further public notice.
To determine if a substantiation claim is sufficient, EPA will consider the facts provided, any pertinent previously issued confidentiality determinations, and other reasonably available information that EPA finds appropriate. Under the Proposed CBI Rule, EPA will consider whether: (1) the claim has not expired or been waived or withdrawn; (2) the business has taken reasonable measures to protect the confidentiality of the information and intends to continue to take such measures; (3) the information is not reasonably obtainable without the business’ consent by other persons by use of legitimate means (not including in a judicial or quasi-judicial proceeding); (4) no statute specifically requires disclosure of the information; and (5) the business has satisfactorily shown that disclosure of the information is likely to cause substantial harm to the business’ competitive position.
B. EPA CBI Review Process
Under the Proposed CBI Rule, if EPA decides to deny a CBI claim, it will notify the submitter in writing by certified mail or personal delivery, specify its reasons, and state its intent to disclose the specific chemical identity (“Denial Notice”). EPA will not disclose the chemical identity until 30 days after the date on which the submitter receives the Denial Notice. Submitters can challenge the Denial Notice by commencing an action in federal district court to prevent disclosure. If EPA approves a CBI claim, it will notify the submitter in writing, and the chemical will be identified by a unique identifier in subsequent publications of the TSCA Inventory. Chemicals with approved CBI claims will be protected from disclosure for a period of 10 years from the date on which the person asserts the claim, as required by TSCA. EPA states in the preamble to the Proposed CBI Rule that it interprets the date that starts the 10-year clock to be the date on which the first person asserts a CBI claim for a specific chemical – which in most circumstances (but not all) will be the date the person files the NOA Form A. EPA will notify the person claiming CBI of the date on which the 10-year clock began. In any event, the non-disclosure period can be shorter than 10 years where the claimant withdraws the confidentiality claim or EPA otherwise becomes aware that the information does not qualify for protection from disclosure. For the latter case, EPA will notify the claimant of its intent to disclose the information prior to doing so.
C. EPA Annual Reviews
Finally, under the Proposed CBI Rule and as required by the 2016 TSCA amendments, EPA will publish annual goals for reviews completed at the beginning of each calendar year, starting with the goals for 2020. It will track the number of CBI reviews completed in the preceding year, to be published on the EPA website beginning in February of 2021.
EPA will accept public comment until June 24, 2019. Portions of the proposed rule that seem likely to elicit comment are how EPA calculates the 10-Year Period for non-disclosure and the process for appealing a denial. EPA estimates that 126 companies will be affected by the Proposed CBI Rule (i.e. not exempt). Of those, EPA estimates that 23 companies will be allowed to reference previous substantiations made during the 2016 Chemical Data Reporting. Companies that have submitted TSCA NOA Form A’s and requested maintenance of an existing CBI claim on the identity of an active chemical should review their NOA Form A’s and other applicable information to see if they have grounds to claim previous substantiations. Companies that believe they have already substantiated their claims in conformance with the rule will have 90 days after the effective date of the final rule to notify EPA of the previous substantiation. Those who have not previously provided substantiation will need to do so within that same 90-day period. The takeaway: companies affected by the Proposed CBI Rule should consider filing comments and should monitor it closely to ensure compliance after the final rule is issued.