Changes to the requirements for making confidential business information (CBI) claims under the Frank R. Lautenberg Chemical Safety for the 21st Century Act:
The recent revisions to TSCA affect how CBI claims are to be made. Some key changes in the law include the following:
TSCA § 14(c) includes a new certification requirement. A submitter of information claimed as CBI must certify agreement with several statements required by the law. The certification language is already incorporated into electronic reporting tools, for TSCA submissions requiring or permitting electronic reporting, but those who make TSCA submissions on paper must include the following statement in the submission:
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.
Existing substantiation requirements for certain types of CBI claims continue to be in effect. EPA may be developing further guidance and additional requirements in the future.
A structurally descriptive generic name is now required where specific chemical identity is claimed as CBI. EPA will be relying on existing generic name guidance for the creation and approval of generic names until updated guidance is developed. /sites/production/files/2015-08/documents/genericnames.pdf.
EPA will be reviewing and approving or denying CBI claims for specific chemical identity and a proportion of CBI claims for other types of information, in accordance with TSCA § 14. Submitters of CBI claims may be contacted by EPA to provide comment on their CBI claims, to the extent that substantiation has not already been provided.
There are additional changes to Section 14 and other parts of TSCA that affect or may affect how TSCA CBI claims are made and maintained. Additional information will be made available as it is developed.