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.
The following changes were made:
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 26th, 2014.
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).