Effective August 15, 2019, the EPA will no longer notify companies that they have not met the requirements to substantiate claims that information about their chemicals provided to that Agency is entitled to confidentiality, and they have 30 days to submit complete substantiations. The notification practice was initiated in the final days of the Obama administration to help companies transition into the confidential business information (CBI) substantiation requirements included in the 2016 amendments to the Toxic Substances Control Act (TSCA). In a new notice, the EPA now says that industry has now had over 2 years to adjust to the requirements and that removal of the notification practice will make the EPA’s implementation of TSCA section 14 (Confidential Information) more efficient. That section gives the Agency 90 days to review CBI claims for chemical identification.

Up-front substantiations

In the amended TSCA, Congress wrote new requirements relating to the assertion, substantiation, and review of CBI claims, except for CBI claims for information that TSCA exempts from substantiation requirements (e.g., information about manufacturing processes and percentages of constituents in a chemical). The amendments indicate that any CBI claim must be substantiated. While Congress did not specify when companies needed to provide the EPA with substantiations, it added that such substantiations must be made “in accordance with such rules as the Administrator has promulgated or may promulgate.” In its 2017 notice, the EPA reviewed the legislative history of the amendments and found that the EPA had been criticized for not requiring up-front substantiations of CBI claims. The Agency also found no evidence either in the legislative history or in the amendments themselves that Congress was opposed to provision of substantiations “at the time” the CBI claim is made,

“Having determined that TSCA section 14(c)(3) requires substantiation of all non-exempt TSCA CBI claims, EPA believes the provision is best interpreted as requiring substantiation concurrent with the submission,” the Agency explained. “This is the natural reading of the requirement that ‘a person asserting a claim … shall substantiate the claim.’”

30 days to correct a claim

Also, in the 2017 notice, the EPA launched its notification policy. Under the policy, any nonexempt CBI claim submitted without a substantiation will be considered deficient, and the Agency will send a notice of deficiency letter to the affected business. The letter informs the affected business that it must submit its substantiation within 30 calendar days to remedy its deficient CBI claim. The letter also informs the affected business that if a timely substantiation has not been received by the EPA within 30 days of receipt of the letter, any CBI claims not substantiated will be considered withdrawn, and the information may be made public with no further notice to the affected business.

Outreach conducted

The EPA now states that since the publication of the 2017 notice, it has taken a number of steps to educate interested parties about the up-front substantiation requirement. These actions included webinars, meetings with members of the public, and telephone conversations with TSCA submitters, trade groups, and others about the requirements of TSCA section 14. The Agency has also updated its webpages about CBI to provide detailed guidance to facilitate compliance with the new requirements of TSCA. The communications and outreach have been effective, says the EPA.

“Since the March 21, 2017, effective date of the interpretation, EPA has sent out 984 notices of deficiency, the vast majority which relate to submissions received before March 21, 2017,” the Agency explains. “Only 97 notices have been generated, to date, that related to filings directed to EPA after March 21, 2017.”

The EPA says that phasing out the notification policy will provide the Agency with more time to meet its 90-day requirement to review CBI claims for chemical identity. In place of the 2017 notification policy, the Agency says it will provide written notice to affected business submitters that those CBI claims are invalid and that the underlying information is treated as not subject to a confidentiality claim and is therefore subject to disclosure without further notice.

“EPA will continue to assist submitters with compliance with TSCA section 14(c)(3) and has revised its [web]pages at https://www.epa.gov/tsca-cbi to include additional information on this policy,” says the Agency.