Where Biosecurity, Biosafety, and Export Controls Regulations Meet Traliance LLC

Transcription

1 Where Biosecurity, Biosafety, and Export Controls Regulations Meet Jennifer Saak, Ph.D. NEBSA Symposium November 3, Traliance LLC Today s Topics Overview of U.S. Export Controls Regulations Export Controlled Biological Items Export Control Reform Exclusions Under the Export Administration Regulations Intersection with Other Bio Regulations Compliance Program Best Practices Summary Key Resources 2016 Traliance LLC 2 1

2 OVERVIEW OF U.S. EXPORT CONTROLS 2016 Traliance LLC 3 Primary U.S. Government Agencies Department of Treasury Department of State Department of Commerce Foundation: U.S. foreign policy, national security, Wassenaar Arrangement, Australia Group, Chemical Weapons Convention, and other multi-lateral arrangements 2016 Traliance LLC 4 2

3 Department of State Directorate of Defense Trade Controls (DDTC) International Traffic and Arms Regulations (ITAR) Critical military or intelligence capability items United States Munitions List (USML) Maximum civil penalty $1,094,010 per violation Criminal penalties up to $1,000,000 and 20 years prison per violation Denial of export privileges Damage to reputation 2016 Traliance LLC 5 Department of Commerce Bureau of Industry and Security (BIS) Export Administration Regulations (EAR) Dual-use items Less significant military or defense items Commerce Control List (CCL) Maximum civil penalty $284,582 per violation or 2x the transaction Criminal penalties up to $1,000,000 and 20 years prison per violation Denial of export privileges Damage to reputation 2016 Traliance LLC 6 3

4 Department of Treasury Office of Foreign Assets and Control (OFAC) Economic sanctioned and embargoed countries Restricted/Denied Parties Recent Cuba and Iran updates 2016 Traliance LLC 7 EXPORT CONTROLLED BIOLOGICAL ITEMS 2016 Traliance LLC 8 4

5 EAR Classification Framework Commerce Control List (CCL) Export Control Classification Number (ECCN) Categories (1-9; Category 5 Part 1/2) E.g. Category 2, Materials Processing Groups (A-E) E.g. Group C, Materials Serial Numbers (3 digits) 2016 Traliance LLC 9 EAR Licensing Framework If subject to the EAR Prohibited License required License exception applies No license required (NLR) 2016 Traliance LLC 10 5

6 Biological Materials ECCN 1C351 Human and animal pathogens and toxins ECCN 1C353 Genetic elements and genetically modified organisms ECCN 1C354 Plant pathogens ECCN 1C991 Vaccines, immunotoxins, medical products, diagnostic and food testing kits See list of items controlled Viruses Pathogens Bacteria Vaccines Fungi 2016 Traliance LLC 11 Biological Equipment 2B352 Equipment capable of use in handling biological materials, as follows (see List of Items Controlled). E.g. Fermenters, centrifugal separators, biological safety cabinets (with specifications) 2016 Traliance LLC 12 6

7 EXPORT CONTROL REFORM 2016 Traliance LLC 13 Export Control Reform (ECR) Effect on Exporters New set of regulations (ITAR vs EAR) New classifications (USML to CCL, 600 series) New or updated license exceptions New definitions (export, fundamental research) 2016 Traliance LLC 14 7

8 Export Control Reform (ECR) Recent Final Ruling on Toxicological Agents USML: Category XIV Toxicological Agents, Including Chemical Agents, Biological Agents, and Associated Equipment New ECCNs created on CCL 1A607, 1B607, 1C607, 1D607, 1E Traliance LLC 15 Final Ruling Published Federal Register Notices 81 FR FR Published: July 28, #fr49517 Effective: December 31, 2016 Affects certain equipment: Dissemination equipment Detection equipment Protection equipment Category XIV 1A607 1B607 1C607 1D607 1E Traliance LLC 16 8

9 Remains Under Cat XIV (Examples) Cat XIV (a) Chemical Agents (1) Nerve agents (2) Amiton (3) Vesicant agents See entries for specific chemicals Cat XIV (b) Biological Agents (1) Genetically modified biological agents (2) Biological agent or biologically derived substances controlled in ECCNs 1C351, 1C353, and 1C354 See entry for specific criteria (e.g. particle size) 1C351 1C353 1C354 Human and animal pathogens and "toxins Genetic elements and geneticallymodified organisms Plant pathogens 2016 Traliance LLC 17 EXCLUSIONS UNDER THE EAR 2016 Traliance LLC 18 9

10 Three Major Ones for Academic Institutions If EAR definition applies, then not subject to the EAR Publicly available Fundamental research Recent Definitions Final Ruling from Dept. of Commerce Educational Materials 2016 Traliance LLC 19 Fundamental Research Exclusion (FRE) NSDD-189 Fundamental research means basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons. Reinforced by Dept. of Commerce s Final Ruling 10

11 INTERSECTION WITH OTHER BIO REGULATIONS 2016 Traliance LLC 21 Other Government Agencies Department of Commerce Census Bureau Nuclear Regulatory Commission Department of Energy Department of Homeland Security Citizenship & Immigration Department of Health & Human Services NIH Federal Select Agent Program And more 2016 Traliance LLC 22 11

12 NIH Office of Science Policy Dual-Use Research of Concern (DURC) Policies Federal funding for life sciences research Research involving any of 15 agents and toxins listed in the policy Potential voluntary redaction of the research publications or communications directly impacts the FRE Select Agent Regulations E.g. Health and Human Subjects (HHS) select agents 2016 Traliance LLC 23 NIH Office of Science Policy HHS Select Agent DURC Agent Monkeypox Virus Yersinia pestis Export Controlled Under ECCN 1C351.a.31 Export Controlled Under ECCN 1C351.c Traliance LLC 24 12

13 COMPLIANCE PROGRAM BEST PRACTICES 2016 Traliance LLC 25 Cross-Departmental Involvement Research Compliance Officer Export Control Officer Biosafety Officer Environmental, Health, and Safety Human Resources Visa Office Security More 2016 Traliance LLC 26 13

14 Personnel Considerations Access of export controlled technology by foreign nationals located in the U.S. ( deemed export ) Faculty, staff, students, visitors Green card holders vs. U.S. citizens Dual-citizenship: most recent citizenship or permanent residency I-129 form (e.g H1-B visas) - required deemed export certification 2016 Traliance LLC 27 SUMMARY 2016 Traliance LLC 28 14

15 Key Take-Aways U.S. export controls continue to be dynamic and affect biological items. Effective December 31, 2106, some Toxicological Agents will move from the USML Category XIV to the CCL under 1X607 ECCNs. Understand the connections between the ITAR, EAR, DURC, and Select Agents Regulations. Drive compliance by leveraging cross-institutional roles and initiatives 2016 Traliance LLC 29 Resources BIS: DDTC: OFAC: Specially Designed Tool: Order of Review Tool: Federal Register Notices: DURC: Traliance LLC 30 15

16 Questions? Jennifer Saak, Ph.D. Founder and Managing Director Traliance LLC 31 16