OMB Approves BIS Australia Group Implementation Final Rule

Yesterday the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a final rule from the DOC’s Bureau of Industry and Security (BIS) on “Implementation of Certain Australia Group Decisions”. This final rule was sent to OIRA on November 22^nd, 2024. This rulemaking was not listed in the Spring 2024 Unified Agenda.

The Australia Group is an ‘informal’ group of 42 countries that “coordinate their national export controls to limit the supply of chemicals and biological agents-as well as related equipment, technologies, and knowledge-to countries and nonstate entities suspected of pursuing chemical or biological weapons (CBW) capabilities.” 

The most current listing of Australia Group ‘approved’ control lists can be found here. The statement for the Group’s most recent (June 2024) meeting can be found here.

This final rule may receive additional attention in this blog, I just cannot tell at this point. At the very least, I will announce its publication in the appropriate ‘Short Takes’ post.

Australia Group CWC Final Rule Published

Today the DOC’s Bureau of Industry and Security (BIS) published a direct final rule in the Federal Register (79 FR 16664-16668) updating various portions of the Export Administration Regulations (EAR) to implement the understandings reached at the Australia Group (AG) plenary meeting held in Paris, France, on June 3-7, 2013 and the recommendations presented at the AG intersessional implementation meeting held in Bonn, Germany, on December 6-7, 2012.

Changes Made

The following changes were made:

15 CFR 710 – Added 7 countries as signatories to CWC including Somalia and Syria.

15 CFR 738 Country Chart – Removed CB2 listing for Mexico

15 CFR 740 Country Chart – Added Mexico as a member of the Australia Group

15 CFR 745 States Party to CWC – Added Somalia and Syria as signatories to CWC

15 CFR 772.1 – Added definition of Australia Group - The countries participating in the Australia Group have agreed to adopt harmonized controls on certain dual-use chemicals (i.e., precursor chemicals), biological agents, related manufacturing facilities and equipment, and related technology in order to ensure that exports of these items do not contribute to the proliferation of chemical or biological weapons.

15 CFR 774 Supplement 1 (the Commerce Control List)

1C350 Chemicals that may be used as precursors for toxic chemical agents – Changed quarterly reporting of samples shipped to annual reporting.

1C351 Human and zoonotic pathogens and “toxins” –.

Added provision allowing Strategic Trade Authorization license exemption; and

Added “alpha, beta 1, beta 2, epsilon and iota toxins” to d.5 Clostridium perfringens listing

1C352 Animal Pathogens – Changed a.8. listing to “Rabies virus and all other members of the Lyssavirus genus;”

1C353 Genetic elements and genetically modified organisms – Changed Technical Note 1 to read “’Genetic elements’ include, inter alia, chromosomes, genomes, plasmids, transposons, and vectors, whether genetically modified or unmodified, or chemically synthesized in whole or in part.”

2B350 Chemical manufacturing facilities and equipment – Changed para b to read:

Agitators designed [added] for use in reaction vessels or reactors described in 2B350.a…

2B352 Equipment capable of use in handling biological materials – Revised para b to read:

b. Fermenters and components as follows:

b.1. Fermenters capable of cultivation of pathogenic micro-organisms or of live cells for the production of pathogenic viruses or toxins, without the propagation of aerosols, having a capacity of 20 liters or greater.

b.2. Components designed for such fermenters, as follows:

b.2.a. Cultivation chambers designed to be sterilized or disinfected in situ;

b.2.b. Cultivation chamber holding devices; or

b.2.c. Process control units capable of simultaneously monitoring and controlling two or more fermentation system parameters (e.g., temperature, pH, nutrients, agitation, dissolved oxygen, air flow, foam control).

Technical Note: Fermenters include bioreactors (including single-use (disposable) bioreactors), chemostats and continuous-flow systems.

Direct Final Rule

The BIS published this as a final rule without going through any of the intermediate rulemaking processes. BIS maintains that:

“The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military and foreign affairs function of the United States (See 5 U.S.C. 553(a)(1)). Immediate implementation of these amendments is non-discretionary and fulfills the United States' international obligation to the Australia Group (AG).”

The effective date of this final rule is today, March 26^th, 2014.

Commentary

Most of the changes made by this direct final rule seem to be rather standard fine tuning of regulations. Until you get down to the changes made to “2B352 Equipment capable of use in handling biological materials”.

The previous language for paragraph b is now b1. The remaining language in this paragraph specifically adds the separate components that could be assembled into the described fermenter. This now places these classes of equipment on the Commerce Control List which complicates the export of this equipment.

One part of this list may be of special concern to members of the chemical manufacturing community; the equipment listed in paragraph b.2.c:

Process control units capable of simultaneously monitoring and controlling two or more fermentation system parameters (e.g., temperature, pH, nutrients, agitation, dissolved oxygen, air flow, foam control).

The ‘process control units’ very generically described here are not unique to the manufacture of biological materials. Generally speaking these industrial control systems are also used by chemical manufacturers and food manufacturers and just about any other industry that includes the automated process control of liquids.

It is interesting to note that there is no such mention of ‘process control units’ in the very lengthy description of equipment for Chemical manufacturing facilities and equipment (2B350).

OMB Approves WMD Rule

Yesterday the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved the Department of Commerce’s new rule on Implementation of the Understandings Reached at the 2013 Australia Group (AG) Plenary Meeting and the December 2012 AG Intersessional Decisions. No details on this rule are currently available as the rulemaking was not listed in the most recent Unified Agenda.

The Australia Group is an informal forum of countries which, through the harmonization of export controls, seeks to ensure that exports do not contribute to the development of chemical or biological weapons. Press releases are available about the mentioned 2013 and 2012 meetings.

The best I can figure is that this reported final rule implements the export control guidelines mentioned here. I would have thought that this would be at least a notice of proposed rulemaking (NPRM) but the OIRA site states that it is a final rule.