General Qs and As Relating to CBI under TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act
Q1. The Frank R. Lautenberg Chemical Safety for the 21st Century Act revised TSCA § 14 concerning confidential business information (CBI) claims for information submitted to EPA. What are the major changes for CBI claim submitters?
A1. Summarized, there are new requirements relating to the submission of CBI, its management, and periodic reviews of CBI claims, including expiration of CBI claims.
The law requires that the submitter provide a statement concerning the need for the CBI claim and a certification that the statement of need is true and correct; EPA has collapsed the two requirements into a single certification statement. There is also a requirement that when a chemical identity is claimed as CBI, a non-CBI structurally descriptive generic name be provided. Certain information listed in the statute is exempt from substantiation requirements. Otherwise, the Agency has the authority to require substantiations to support CBI claims.
EPA must, with limited exceptions, review all CBI claims for chemical identity, as well as a representative sample of at least 25% of other claims. These reviews must occur within 90 days of receipt. Other CBI claims can also be reviewed by the Agency based on specific events. For example, EPA may conduct a CBI review pursuant to a FOIA request, when a substance is designated as a high priority or active substance under the statute, or when the Agency believes that disclosure would be important in implementation of TSCA section 6. Most CBI claims expire after 10 years unless the business submitter reasserts and substantiates or re-substantiates the CBI claim. When EPA approves a CBI claim for chemical identity, the Agency must develop a unique identifier for the chemical.
TSCA CBI may also be shared under certain circumstances with non-federal authorities including states, subdivisions of states, tribes, emergency responders, and health care professionals.
Q2. Will substantiation of CBI claims be required with submission of information to EPA under TSCA?
A2. Currently, EPA is using existing authorities to obtain CBI substantiations. This includes substantiation of CBI claims in submissions for which Agency rules currently require it, such as certain CBI claims under the Chemical Data Reporting (CDR) rule, and requests for comment (substantiation) on CBI claims under EPA general confidentiality regulations at 40 CFR § 2.204(e). These regulations allow EPA to request additional information, including substantiation, when making a CBI determination. EPA will use the substantiation provided to inform the confidentiality determinations for chemical identity and other CBI claims. The Agency may revise CBI substantiation requirements for specific types of information submissions by subsequent rulemaking.
Q3. TSCA now requires that when a CBI claim is made for specific chemical identity, the claim shall include a structurally descriptive generic name, developed consistent with EPA guidance. Will the EPA’s reporting processes be modified to enable submitters to comply with this requirement?
A3. There are existing generic name reporting requirements for some reports, and EPA anticipates no change for information submitters for these sections in the near term. For filing types where generic names were not previously required, submitters should use the existing guidance to develop these names. See /sites/production/files/2015-08/documents/genericnames.pdf. EPA will develop further guidance regarding generic names as required by the new law.
Q4. TSCA § 14(c)(1)(B) requires that the assertion of a CBI claim be accompanied by a specific supporting statement. What is the impact of this requirement on filings submitted after June 22, 2016?
A4. As of June 22, 2016, the effective date of the new law, all persons asserting CBI claims are required to include the supporting statement described in TSCA § 14(c)(1)(B) and the certification required in § 14(c)(5). EPA has revised TSCA electronic reporting systems to require persons making CBI claims to make the required statement and certification as a single certification that is part of the submission. Paper submitters must include this certification in their filings. The following required statement incorporates these requirements:
I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate.
I further certify that, pursuant to 15 U.S.C. § 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that
(i) My company has taken reasonable measures to protect the confidentiality of the information;
(ii) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
(iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
(iv) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.
Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.
Q5. The new law provides for potential limitations on duration of CBI claims. What plans does the Agency have regarding implementing this provision?
A5. Information submitters should be aware that the new TSCA § 14(e) limits the duration of many confidentiality claims to ten (10) years, unless those claims are timely reasserted and substantiated. EPA will develop policies, rules, and guidance to implement this provision.
Q6. Will the Agency initiate a review of CBI claims made in TSCA information submissions?
A6. EPA will review and make determinations within 90 days on new CBI claims for chemical identity in submissions to the Agency filed after June 22, 2016, as required by TSCA § 14(g)(1)(C)(i). A representative subset of CBI claims for other kinds of information filed after June 22, 2016 will be reviewed in accordance with TSCA § 14(g)(1)(C)(ii). The Agency’s procedures for CBI determinations are reflected in Agency confidentiality regulations at 40 CFR part 2 and in regulations for certain specific TSCA reporting obligations. The regulations at 40 CFR part 2 allow EPA to request additional information, including substantiation, when making a CBI determination. EPA will use the substantiation provided as part of the information considered when making a CBI determination.
Q7. TSCA § 14(c)(2) provides certain information are not subject to substantiation requirements, including “[s]pecific information describing the processes used in the manufacturing or processing of a chemical substance, mixture, or article,” and “[s]pecific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture or article” Do these provisions conflict with the existing substantiation requirements under the Chemical Data Reporting (CDR) Rule?
A7. No. The information for which substantiation at the time of submission is required under CDR (e.g., chemical identity in health and safety studies as described in 40 CFR § 711.30 or general use and process information collected under 40 CFR § 711.15(b)(4) of CDR), is not the type of specific information referenced in TSCA § 14(c)(2).
Q8: EPA must review a representative sample of at least 25% of other, non-chemical identity CBI claims under § 14(g). How will the Agency be selecting its representative sample?
A8: EPA is reviewing CBI claims in 25% of those TSCA submissions that include such claims. Submissions in which the only CBI claim is for chemical identity will not be reviewed as part of the 25% because chemical identity CBI claims are already to be reviewed under TSCA §14(g)(1)(C)(i). Also not included in the reviews will be CBI claims for the data elements identified in § 14(c)(2). The intended approach is that every fourth submission received, containing CBI claims, is to be reviewed. EPA may modify its selection and review procedures in the future, as it gains experience with the new law. TSCA CBI will be reviewed consistent with the provisions of TSCA, its implementing regulations and in accordance with the Agency procedures set forth in 40 CFR part 2. Pursuant to 40 CFR § 2.204(e), submitters of filings selected for this 25% review who have not previously been required to substantiate their CBI claims will be notified and provided an opportunity to comment (substantiate) on the claims. If the CBI claims are not waived and comments were received in a timely manner, EPA will proceed in making its final determination.