CBI protection remains in place in the recently revised TSCA but the Frank R. Lautenberg Chemical Safety for the 21st Century Act (LCSA) amendment changes what is protected, what is required to substantiate the need for protection, and the duration of protection. Many of the individual changes do not extensively change the status quo, but the cumulative result is that companies will need to do more to protect less. On January 19, 2017 the USEPA provided notice of some of the changes.
The effect of the CBI changes differs depending on the date of document submission:
Submissions filed on or after March 20, 2017 need to provide substantiation for all non-exempt information claimed as confidential at the time of submission. On that date, electronic submissions through CDX automatically prompted the preparer for the required information when the claim was made.
For submissions made between June 22, 2016 and March 20, 2017 if the required substantiation was not already made the Agency is giving submitters until September 18, 2017 to provide it. For electronic submissions submitted through CDX the information must be supplied through CDX using the amendment process for the relevant submission type. For paper submissions the substantiation must be sent to:
TSCA Confidential Business Information Center (7407M) WJC East
Attn: TSCA CBI Substantiations
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue NW
Washington, DC 20460–0001
Unless a Section 5 notice (e.g., PMN) was submitted in the relevant time period, the most likely case where post June 22, 2016 substantiation might be required is information claimed as CBI in the 2016 Chemical Data Report (CDR), assuming substantiation was not supplied at that time. For the CDR, the list below includes the specific information that EPA believes1 is exempt from substantiation:
1EPA is evaluating which information provided under various sections of TSCA may not be CBI under section 14(b)(3). EPA expects to publish guidance regarding this in the near future.
EPA is evaluating which information provided under various sections of TSCA may not be CBI under section 14(b)(3). EPA expects to publish guidance regarding this in the near future.
If you believe that any other information is eligible you may note this in your substantiation response, citing the exemption and the reason you believe it applies.
The USEPA provides guidance on the requirements and process of CBI substantiation on their website:
The guidance includes downloadable data-gathering templates for generic and specific CBI substantiation information that may be used in preparing submissions for PMNs, CDR amendments and other purposes.
In addition to the increased reporting burden the new requirements present, other components of the amendments have consequences to be considered (e.g., certain information is explicitly not protected, for instance health and safety studies). Also CBI protection is no longer “infinite”; re-substantiation will be required after 10 years. While the Agency is mandated to inform the CBI protection holder prior to expiration, this represents a new task that will require vigilance. How will substances subject to this re-substantiation be “flagged” in your system? Will the information used as the basis for substantiation still be valid?The USEPA must also review all CBI claims regarding chemical identity and at least 25% of all other non-exempt claims. , Because the pre-LCSA process was relatively simple CBI claims have been used extensively, a major criticism of the old regulation. There is guidance on “general exemptions”.
General exemptions from the need to provide substantiation include:
Also specific chemical identity of a substance subject to a notice under TSCA 5 prior to commercialization.
Although claiming other information confidential may be defensible, the added burden of maintenance makes a strong case to strategically consider the value of the claim versus the consequence of disclosure.
knoell USA will continue to follow the new TSCA regulation and can help you determine what your company’s vulnerabilities may be under the new law. We can also provide your company with periodic TSCA updates and assist you in positioning your company to address future regulatory requirements. knoell USA can provide representatives of your company with a free consultation to talk you through the major changes enacted by the new law and how these changes could affect your business.
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