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New Research Compliance Issues for Biological and Hazardous Materials

New Research Compliance Issues for Biological and Hazardous Materials. Peter A. Reinhardt, Director Dept. of Environment, Health & Safety. Overview of Today. Shipment/mailing of research materials, sample and specimens Department of Commerce Export rules Select Agent requirements

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New Research Compliance Issues for Biological and Hazardous Materials

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  1. New Research Compliance Issues for Biological and Hazardous Materials Peter A. Reinhardt, Director Dept. of Environment, Health & Safety

  2. 2 March 2005 Overview of Today • Shipment/mailing of research materials, sample and specimens • Department of Commerce Export rules • Select Agent requirements • “Dual Use” concerns for biological research • Institutional controls

  3. 2 March 2005 Themes for TodayWhy are these changes taking place? • Prevent risks to the public from research activities and materials • Address “Dual Use” concerns: Research activities and materials used for social good have the potential to be used for social harm. • Internal and external controls to prevent access to dual use materials, technology and information by those who wish us harm.

  4. 2 March 2005 Shipping/Mailing Research Materials “Violations contrary to the U.S. Code of Federal Regulations (CFR) 49, if substantiated, may result in the assessment of a civil penalty of up to $27,500 per violation, and deliberate violations may result in criminal prosecution of up to $500,000 and 5 years in prison.”

  5. 2 March 2005 Laws for the Transport of Hazardous Material... • U.S. Department of transportation (DOT): title 49 of the code of federal regulations (CFR) • For air transport: • International civil aviation organization (ICAO) technical instructions • International air transport association (IATA) dangerous goods regulations

  6. 2 March 2005 Preparing Hazardous Materials for Shipment... If you prepare or package a shipment, you must receive additional function-specific training in: • Approved packaging materials and procedures • Labeling packages • Marking packages • Preparing shipping papers • Emergencies response contact information

  7. 2 March 2005 No Vial In Pocket

  8. Monday, September 13, 2004 Professor at U. of Delaware Pleads Guilty in Case Involving Smuggled Poultry Virus A popular professor of microbiology at the University of Delaware pleaded guilty last week to criminal charges related to the smuggling of a poultry virus from Saudi Arabia. If the federal judge presiding over the case accepts a plea agreement reached with the U.S. attorney for Maine, the professor, John K. Rosenberger, will serve six months of home detention, be on probation for two years, and pay a fine of up to $250,000. Mr. Rosenberger, a former chairman of the department of animal and food sciences at Delaware's College of Agriculture and Resources, is known for his work on avian disease. He pleaded guilty in the U.S. District Court in Bangor, Me., to aiding and abetting the receipt and concealment of a smuggled virus -- in this case, a type of avian influenza that can devastate commercial flocks -- in his university laboratory. George T. Dilworth, an assistant U.S. attorney in Maine, said there are no bioterrorism connections in the case. However, he said, before the September 11 terrorist attacks, people were too cavalier about violating regulations on the importing of viruses from other countries. "We now understand why these rules are as strict as they are," he said.

  9. 2 March 2005 U.S. Export Control Laws Regulate the distribution to foreign nationals and foreign countries of strategically important products, services and information for reasons of foreign policy and national security Credits: Erica Kropp and Anne Bowden, University of Maryland College Park Robert Hardy, Council on Government Relations

  10. 2 March 2005 U.S. Export Control Laws and Agencies

  11. 2 March 2005 Implications of Export Laws • No effect on 90% of university research • Impact on: • Ability of foreign students to participate in research involving a controlled technology (mostly under ITAR) • Ability to provide services (e.g., training) involving controlled equipment to foreign nationals (ITAR, EAR, OFAC) • Ability to send controlled equipment to foreign countries (ITAR, EAR, and OFAC)

  12. 2 March 2005 ITAR Licensing Requirements for Shipping Controlled Equipment Out of the U.S. • A license is required to ship equipment controlled by ITAR to any foreign country • There are few exclusions or exceptions • It can take months to obtain a license from the State Department

  13. 2 March 2005 EAR Licensing Requirements for Shipping Controlled Equipment Out of the U.S. • A license may be required to ship materials, samples or equipment out of the U.S. under the EAR depending on whether the equipment is controlled, where it is being sent and whether an exception applies. • A license may be required to ship software out of the US! • The process to classify equipment under the EAR is very tedious, detailed and time consuming.

  14. 2 March 2005 OFAC Prohibitions for Shipping Controlled Equipment Out of the U.S. • There is a presumption under OFAC laws that any and all shipments of materials, equipment and provision of services to countries subject to US sanctions/boycotts or persons in those countries are ILLEGAL. • Balkans, Burma, Cuba, Iran, Iraq, Libya, Liberia, Sudan, Syria, Zimbabwe

  15. 2 March 2005 Fundamental Research Exclusion Applies to information resulting from basic and applied research in science and engineering conducted at an accredited institution of higher education (EAR) or higher learning (ITAR) located in the U.S. that is not restricted for proprietary reasons or specific national security reasons (EAR) or subject to specific U.S.G. access and dissemination controls (ITAR) See 15 CFR 734.8(a) and 22 CFR 120.11(a)(8).

  16. 2 March 2005 EAR Fundamental Research Exclusion • No license is required to disclose to foreign nationals information which is “published and which is generally accessible or available to the public [through, for example] fundamental research in science and engineering at universities where the resulting information is ordinarily published and shared broadly in the scientific community.”

  17. 2 March 2005 EAR Fundamental Research Exclusion, continued. • Also note EAR 734.3(b)(3)(ii) exemption for “publicly available technology” that “arise(s) during or result(s) from fundamental research.” Shipment of controlled materials, samples or other commodities outside of the U.S. is never excluded.

  18. 2 March 2005 The “Deemed Export” Concept • Defined as the transfer or disclosure (including visually or orally) of controlled “technologies” (EAR) or “technical data” (ITAR) to a foreign entity or individual anywhere including in the U.S. See 15 CFR 734.2 and 22 CFR 120.17. • Technology is specific information necessary for the “development,” “production” or ”use” of a product (EAR 772.1)

  19. 2 March 2005 The “Deemed Export” Concept • Technical data is information required for design, development, production, manufacture, assembly, operation, repair, testing, maintenance or modification of controlled articles (ITAR 120.10). • The concept of “deemed export” was added to export regulations in 1994. The intent apparently was to cover information needed for commercial development, production and use of technologies.

  20. EAR Regulated Research On Campus 2 March 2005 = “Deemed Export”

  21. 2 March 2005 EAR Fundamental Research ExclusionIs destroyed if the University accepts any contract clause that: • Forbids the participation of foreign nationals; • Gives the sponsor a right to approve publications resulting from the research; or • Otherwise operates to restrict participation in research and/or access to and disclosure of research results

  22. 2 March 2005 Red Flags for Export Control Laws • The RFP marked “Export Controlled” • Working with a country subject to a U.S. boycott • Shipping equipment to a foreign country • Collaborating with foreign colleagues in foreign countries • Sponsor demands pre-approval rights over publications or the participation of foreign national students • Training foreign nationals in using equipment

  23. 2 March 2005 If Export Control Red Flags Exit • Determine if the research activity is allowed. • Determine if an export control license is required. • If license is needed, it takes much time and effort of faculty. It can take months to process. • The license may be denied. • These laws apply to all research activities—not just sponsored projects

  24. 2 March 2005 EAR Penalties • Civil violations • Up to $12k per violation for individuals and the University/corporations • Criminal violations (willful) • Up to $1 million for the University • Up to $250K per violation for individuals and/or up to 10 years in prison

  25. 2 March 2005 Trouble on the Horizon In March 2004, the Department of Commerce’s Inspector General issued a report on the status of EAR compliance, and stated that: “Technology related to controlled equipment—regardless of how use is defined—is subject to the deemed export provisions (and the requirement to license foreign nationals having access to that equipment) even if the research being conducted with that equipment is fundamental.”

  26. The Four Confirmed Anthrax Letters

  27. 2 March 2005 2002 Public Health Security and Bioterrorism Preparedness and Response Act • 12 June 2002: Signed into law • August 2002: Notification of possession (not just transfers) of all select agents and toxins • 13 December 2002: New 42 CFR 73 Rules (replacing Part 72) promulgated as Interim Final • 7 February-11 November: 42 CFR 73 implementation

  28. HHS-USDA Overlap Bacillus anthracis Botulinum neurotoxin producing species of Clostridium Francisella tularensis Venezuelan Equine Encephalitis virus Botulinum neurotoxins 2 March 2005 Examples of Regulated Select Agents HHS-only • Ebola viruses • Herpes B virus • Variola major virus (Smallpox virus) and Variola minor virus (Alastrim) • Conotoxins • Ricin • Saxitonxin • Tetrodotoxin

  29. 2 March 2005 Implementation of Biological Registry Requirements at UNC • Campuswide Select Agent survey • Via survey, 465 laboratory Principal Investigators asked to thoroughly review their stock and report if they possess a Select Agent or plan to do so • Door-to-door follow-up to ensure 100% response • EHS follow-up of affirmative responses to determine is the agent was exempt

  30. 2 March 2005

  31. 2 March 2005

  32. 2 March 2005 What Constitutes Bona Fide Research? SEC. 817 of the USA Patriot Act:(Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism) “Whoever knowingly possesses any biological agent, toxin, or delivery system of a type or in a quantity that, under the circumstances, is not reasonably justified by a prophylactic, protective, bona fide research, or other peaceful purpose, shall be fined under this title, imprisoned not more than 10 years, or both.”

  33. 2 March 2005 Welcome 42 CFR 73 Requirements • Background checks—Security Risk Assessments (SRA)—done by U.S. Attorney General rather than UNC • Reasonable exclusions for toxins • Largely performance-based: Entity writes the Safety and Security Plans • Not prescriptive for card access, video surveillance, etc. • Inventory quantities generally only apply to toxins.

  34. 2 March 2005 Safety Plans • Our Safety Plan is Chapter 20 of UNC’s Biological Safety Manual, “Select Agent Management.” • Our Manual references: • CDC/NIH’s Biosafety in Microbiological and Biomedical Laboratories • OSHA Laboratory Standard (29 CFR 1910.1450) • OSHA Hazard Communication Standard (29 CFR 1910.1200) • NIH Guidelines for Research Involving Recombinant DNA Molecules

  35. 2 March 2005 73.11(b) Security Plan Requirements • Physical security • Procedures for securing the area when no SRA-approved individual is present • Procedures for the loss or compromise of keys, passwords, combinations, etc. • Protocols for changing access following staff changes • Provisions for routine cleaning, maintenance, repairs, security training

  36. 2 March 2005 Security Costsfor one building, one <1,000 sq. ft. lab

  37. Stolen cards Lost cards Loaned cards Are visitors issued cards? Is the card system used to record all area access? Piggybacking/tailgating–following someone inside Revolving door–entering upon someone’s exit Blocking doors open “Innocent” piggybacking—entry by multiple cardholders following a single swipe (no record of cardholders who don’t swipe) 2 March 2005 Card System Failures Security training is required!

  38. 2 March 2005 Security Improvements HARDENING Typical Current University Laboratory Typical Current Federal Government Laboratory “When we have a free path, we go forward. If we meet an obstacle, we go around it. If the object cannot be overcome, we retreat. When the enemy is unprepared, we surprise him. If he is alert, we leave him alone.”—Baader-Meinhoff Gang, infamous German urban terrorist organization

  39. 2 March 2005 73.11(b) Security Plan Requirements, cont. • Procedures for reporting suspicious persons or activities, loss, theft or release, or alteration of inventory records • Procedures for reporting and removing unauthorized persons • Cyber security • Inventory control procedures

  40. 2 March 2005 Select Agent Tracking System“to account for all vials…origin and destination”

  41. 2 March 2005 Physical Inventory Issues • 5,000 microcentrifuge tubes for one Principal Investigator • What’s inside? What can you see through the frost? • Annual joint EHS-PI physical inventories are incredibly time consuming • 5,001 microcentrifuge tubes? • 4,999 microcentrifuge tubes? • If a tube is missing, who took it? Inventory records probably won’t help.

  42. Physical Inventory Issues • Misplaced vials • Misrecorded information • It will happen!

  43. 2 March 2005 Other Typical Stepsfor Select Agent Security • EHS witnesses packing, unpacking and final destruction of Select Agents • Chain of custody for Select Agent receipt • Laboratory staff carry picture IDs • Visitors must sign logbook, wear temporary badges and be escorted at all times • EHS annually inspects lab to verify locations, staff and security and safety measures

  44. 2 March 2005 EHS Access Approval Check Off • Security Risk Assessment of individual • Individual’s Occupational Health compliance • EHS Training of individual • Operational lab engineering controls • Operational security system • Principal Investigator compliance • Current Laboratory Safety Plan • Training, occupational health, SRA compliance for all lab staff • Satisfactory inspection result • Institutional Biosafety Committee approval

  45. Uses in Clinical Research • Products approved under the Federal Food, Drug and Cosmetic Act are exempt • Upon request, HHS may exempt investigational products on a case-by-case basis

  46. 2 March 2005 NIH Bioterrorism Research Funding • President Bush proposed a 0.7% increase for NIH in FY 2006. Not since 1964 has NIH received an annual increase of less than 1%. • However, NIH’s National Institute of Allergy and Infectious Diseases, which funds most of its bioterrorism-related research, is once again the agency's biggest gainer at $4.5 billion, a 1.8% increase of $57 million. • Budgets for the Strategic National Stockpile and environmental biosurveillance—also related to bioterrorism—would also increase by 3.6% to $1.6 billion. • DHHS Secretary Mike Leavitt explained, "We have focused money on the most urgent priorities."

  47. 2 March 2005 Controversial Paper: IL4-Mousepox Ronald J. Jackson and colleagues at Australia's Commonwealth Science and Industrial Research Organization and Australian National University Journal of Virology, February 2001 In trying to develop a mouse contraceptive to control pest populations, the researchers inserted a gene for an immune-system molecule called interleukin-4 into the mousepox virus. Instead of rendering mice infertile, the engineered virus was far more deadly than the natural strain, killing even mice that had been vaccinated against mousepox.

  48. 2 March 2005 Controversial Paper: Synthetic Polio Virus Eckard Wimmer and researchers at the State University of New York at Stony Brook Science, August 9, 2002 (online edition, July 11) Used the genetic sequence of poliovirus to order pieces of DNA from a company. By patching the pieces together and putting the complete DNA chain into a soup of cellular molecules, the team created poliovirus particles capable of paralyzing and killing mice.

  49. 2 March 2005 NRC Report on Dual Use Research Report of the National Research Council of the National Academies: “Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma” (October 2003) Gerald Fink, Committee Chair

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