BIS Issues Long-Awaited Notice on Controls on Foundational Technologies, Adds New Entities to Entity List
The U.S. Department of Commerce, Bureau of Industry and Security (BIS) published an advance notice of proposed rulemaking (ANPRM) soliciting comments to identify foundational technologies essential to U.S. national security by October 26, 2020 (the Foundational Technologies ANPRM). The ANPRM is only one step in a multiyear process through which the U.S. government transforms the regulations restricting the availability of U.S.-sourced technology in the global marketplace.
This long-awaited ANPRM launches an intra-agency review process required under Section 1758 of the Export Control Reform Act of 2018 (ECRA), which Congress passed in the National Defense Authorization Act for Fiscal Year 2019 (2019 NDAA). ECRA directed BIS to identify and establish controls on the export, reexport, or transfer (in country) of emerging and foundational technologies essential to the national security of the United States. On November 19, 2018, BIS issued an ANPRM on identification of emerging technologies (the Emerging Technologies ANPRM), indicating that a separate notice for foundational technologies was forthcoming.
Today’s Foundational Technologies ANPRM can be found here. Sidley’s prior updates on ECRA and the Emerging Technologies ANPRM can be found here.1 Here we summarize five key takeaways from today’s notice.
Highest European Court Confirms: No Presumption of Confidentiality Over Documents Submitted in Marketing Authorization Dossier
On January 22, 2020, the Court of Justice of the European Union (CJEU) found that there is not a general presumption of confidentiality over documents containing clinical and preclinical data provided to the European Medicines Agency (EMA) to support a marketing authorization application. However, the CJEU indicated that certain information may be protected if the interested party can specifically show that the disclosure will cause it harm. This is the first time the CJEU has ruled on this matter, upholding the EMA’s approach to handling access to documents requests.
Supreme Court Clarifies Broad Interpretation of FOIA Exemption for Confidential Commercial Information
In a very significant FOIA decision for business, Food Mktg. Inst. v. Argus Leader Media, decided on June 24, 2019, the Supreme Court reversed 45 years of understanding that Exemption 4 only protects confidential business information whose disclosure by the government would cause “substantial competitive harm.”
Relying on the plain meaning of words in the statute – rather than what the Court majority characterized as muddled legislative history – the Court found that the D.C. Circuit had engrafted a condition on the Exemption that is not supported by the text. Rather, so long as the commercial or financial information obtained by the government is “private” or “secret” – the plain and ordinary meaning of “confidential” – it may be withheld from disclosure under FOIA.