Review - OMB Approves BIS Chemical Weapons Convention ICR

Yesterday the OMB’s Office of Information and Regulatory Affairs announced that it had approved an information collection request (ICR) revision/extension from the DOC’s Bureau of Industry and Security on “Chemical Weapons Convention Provisions of the Export Administration Regulations”. The 60-day ICR notice was published on August 28^th, 2024 and the 30-day notice was published on November 29^th, 2024.

The table below shows the burden estimate for the previously approved version and the new version of this ICR.

For a more detailed look at the changes in the burden estimate, including a description of the individual information collections included in the estimate, see my article a CFSN Detailed Analysis - https://patrickcoyle.substack.com/p/omb-approves-bis-chemical-weapons - subscription required. 

BIS Publishes Final Rule Adding Chemicals to CWC Schedule 1 List

Today the DOC’s Bureau of Industry and Security (BIS) published a final rule in the Federal Register (86 FR 936-944) on “Additions to Schedule 1(A) of the Annex on Chemicals to the Chemical Weapons Convention”. This rule amends the Chemical Weapons Convention Regulations (CWCR) and the Export Administration Regulations (EAR) to reflect recent additions to Schedule 1(A) of the Annex on Chemicals to the Chemical Weapons Convention (CWC).

The rule adds one new chemical and three families of chemicals to the Schedule 1 list of toxic chemicals regulated under the CWC. The new chemical is Methyl(bis(diethylamino)methylene)phosphonamidofluoridate (CAS No. 2387496-14-0). The three new families of chemicals are described here, here, and here.

Commentary

This will almost certainly not have any major effect on chemical manufacturing in the United States. Any manufacturing or use of these chemicals will be very limited. I am mentioning this rulemaking here because there are minor implications for the Chemical Facility Anti-Terrorism Standards (CFATS) program. All of the other CWC Schedule 1 chemicals are listed in the Appendix A, 6 CFR Part 27, list of DHS chemicals of interest as theft/diversion chemical weapons security issues and require Top Screen reporting inventories of very low quantities of these chemicals. Today’s addition of these chemicals to Schedule 1 should, in turn, drive their addition to Appendix A. There is no formal mechanism for doing so.

Fortuitously, CISA is starting the undertaking of a rulemaking that would make separate modifications to Appendix A. It is early enough in that rulemaking process where it would be appropriate to suggest that there should be included in that rulemaking a methodology for making updates to Appendix A to reflect additions of chemicals to Schedule 1 of the CWC.

Specifically, I would like to suggest that that rulemaking be expanded to include:

• Adding the one new chemical and three families of chemicals listed in today’s BIS final rule to the DHS list of COI, and

• Adding provisions to Appendix A requiring the initiation of an interim final rule, followed (after publication and comment) in 180-days by a final rule adding any future additions to Schedule 1 of the CWC are finalized by the BIS.

A copy of this blog post will be submitted as a comment to the CISA Appendix A advanced notice of proposed rulemaking.

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).

Annual Look at CWC Effects on Industry

Today the DOC’s Industry and Security Bureau (BIS) published their annual notice in the Federal Register (78 FR 75910-75911) requesting information about the effects of the enforcement of the Chemical Weapons Convention (CWC) on ‘legitimate’ commercial activity.

When Congress approved the adoption of the CWC they required that the President provide an annual report on the effects of the implementation of rules on the use and production of ‘Schedule 1’ chemicals. Schedule 1 chemicals are those toxic chemicals (and their immediate precursors) that have been or can be used as chemical weapons (interestingly chlorine gas is not included). Since some of these chemicals have legitimate uses outside of the chemical weapons realms Congress was concerned about the effects of the CWC provisions on those legitimate uses.

Every year the BIS publishes this notice in the Federal Register soliciting comments from industry so that they can prepare the President’s report to Congress. Comments may be emailed to BIS (willard.fisher@bis.doc.gov) and should be submitted by January 13^th, 2014. 

Annual CWC Reporting

The Bureau of Industry and Security (BIS) of the Department of Commerce published in the Federal Register (77 FR 75145-75147) their annual notice concerning the impact on industry of the implementation of the Chemical Weapons Convention (CWC). This annual report was required by the Senate when they ratified the Chemical Weapons Convention in 1997.

This report should allow the President to certify that the “legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms in the United States are not being significantly harmed by the limitations of the Convention on access to, and production of, those chemicals and toxins listed in Schedule 1 of the Annex on Chemicals” {S Res 75; 1997; §2(9)}. The list of Schedule 1 chemicals can be found here.

 

Interestingly the same section requires the certification to be made on January 1^st of every year. This notice provides for public comment through January 18^th, 2013. Somehow it is not surprising that the Administration will be late with this routine report because of a late publication of this notice. Public comments may be submitted via email (willard.fisher@bis.doc.gov) and should not include classified or business confidential information; all comments will be part of the public record.

Chemical Weapons Convention ICR Renewal

The Commerce Department’s Bureau of Industry and Security published an information collection request (ICR) renewal notice in the Federal Register (77 FR 59891-59892) on Monday (available on the Internet today) for the submission of declarations, reports and inspections required by the Chemical Weapons Convention Implementation Act of 1998 and Commerce Chemical Weapons Convention Regulations (CWCR).

The current ICR (0694-0091) expires 02/28/2013 and there are no changes in this renewal request. The numbers provided in this request are:

• Estimated Number of Respondents: 816.

• Estimated Time per Response: 10 minutes--12 hours per response.

• Estimated Total Annual Burden Hours: 16,047.

• Estimated Total Annual Cost to Public: $41,740.

Public comments may be submitted via email to Jennifer Jessup (JJessup@doc.gov). Comments need to be submitted  by November 30, 2012.

NOTE: Most of the facilities required to submit Schedule 1 and 2 reports under this program will also be covered under the CFATS program.

BIS Considering Amending Concentration Limits for CWC Reporting

Today the Bureau of Industry and Security (BIS) of the Department of Commerce published two notices in the Federal Register (76 FR 41366-41370 and 41372-41373) relating to possible changes to the Chemical Weapons Convention Regulations (15 CFR Parts 713 and 716). BIS is requesting public comment on possible impacts that changes to the mixture concentration thresholds for CWC reporting requirements.

The first notice deals with Schedule 2A (toxic precursor) chemicals under the CWC and the second notice deals with Schedule 3 (other organic chemicals of CWC concern) chemicals. The first of these notices will be of most interest to the chemical security community because DHS has used the list of Schedule 2 chemicals as one of the documents upon which it based the list of DHS Chemicals of Interest (COI), Appendix A to 6 CFR part 27.

Changes to Chemical Mixture Rules

Currently the CWCR exempts Schedule 2A chemicals in mixtures where they constitute less than 30% by volume or weight of the mixture from being counted in the determination of whether or not the facility meets the verification threshold reporting requirements for the CWCR. In many ways this determination was the model upon which DHS based their development of the CFATS Top Screen requirements.

The proposal that BIS is considering is a lowering of the concentration that would trigger the reporting requirements and making it a two tiered concentration rule. The first tier would exempt any Schedule 2A chemical “produced, processed, or consumed at one or more plants on a plant site” if its concentration in a mixture was less than 1%. The second tier would cover mixtures more than 1% but less than or equal to 10% as long as “the annual amount of the Schedule 2A chemical produced, processed, or consumed is less than the relevant verification threshold” (76 FR 41366). Not specifically mentioned in the notice is the fact that the proposal would add all mixtures containing between 10 and 30% of Schedule 2A chemicals to the list of covered mixtures.

This change would almost certainly expand the number of facilities in the US that would be covered by the international inspection requirements of the CWC. Additionally, if these changes are adopted in the CWCR, DHS might find it necessary to revisit some of the concentration requirements for these chemicals that are listed in Appendix A.

Similar types of changes would be made by second notice for Schedule 3 chemicals. Combined the changes in the two notices would make the US declaration requirements consistent with the international agreements adopted by the Organization for the Prohibition of Chemical Weapons (OPCW).

Congressional Action Required

It is interesting that this notice is not an advanced notice of proposed rulemaking. That is because making these changes to the CWCR would require legislative changes to be made to the Chemical Weapons Convention Implementation Act (CWCIA; (22 U.S.C. 6701 et seq.). The CWCIA sets a lower concentration limit of 10%. BIS would need the impact information that it is requesting in these two notices to be able to successfully get Congress to amend that act.

Annual CWC Report

The Department of Commerce published their annual request for information about the effects of the Chemical Weapons Convention Regulations (15 CFR parts 710-722) on commercial activities involving Schedule 1 chemicals. The DOC’s Bureau of Industry and Security (BIS) needs this input to provide their annual report to Congress on the affects of the CWC implementation on the legitimate commercial activities and interests of chemical, biotechnology, and pharmaceutical firms in the United States. ‘Schedule 1’ chemicals are those chemicals listed in Supplement 1 to 15 CFR 712. They are generally considered to be chemicals that can be used as chemical weapons or their direct precursors. The CWCR restrict commercial production of ‘Schedule 1’ chemicals to research, medical, or pharmaceutical purposes. The Federal Register ‘notice of inquiry’ (74 FR 58004) lists summarizes the specific restrictions placed on facilities that produce or use Schedule 1 chemicals. The BIS is requesting that comments be submitted by December 10th, 2009. They may be submitted by email (wfisher@bis.doc.gov), or delivered/mailed to: Willard Fisher U.S. Department of Commerce Bureau of Industry and Security Regulatory Policy Division 14th Street & Pennsylvania Avenue, NW., Room 2705 Washington, DC 20230