1. Biosafety/Biosecurity: An Update February 27, 2004

2. Where is the emphasis? Biosafety   Biosecurity

3. Biosafety Policy –Handbook 1200.8 “Safety of Personnel Engaged in Research” –VA Directive 7701 & Handbook 7701.1 “Occupational Safety & Health” –OSHA’s regulations Plans –Minor updates to 1200.8 –Revise biosafety form (10-0398) –Define training needs

4. Role for Research Biosafety Ensure safety of personnel Identify hazards: chemical, physical, and biological Incorporate into VAMC wide occupational safety program, fire safety, PPE and precautions Safety & health inspections: local, VA CO, or others Policies, plans and procedures

5. Hazard Categories Chemical: corrosive, toxins, carcinogens, mutagens, flammables, explosive Physical: ionizing and non-ionizing radiation, noise, temperature extremes, electrical mechanical Biological: pathogens, organism, recombinant DNA, toxins produced by organisms and human or animal tissue, body secretions, & blood

6. Biosecurity An increasing concern Effects all research laboratories Special emphasis on BSL-3s & labs with select agents or toxins Required revising Directive 2002.075 (Control of Hazardous Agents) Draft is unofficial & in concurrence

7. The Concurrence Process Draft  Concurring Offices  Final Document

8. Control of Hazardous Agents (Why The Re-draft) Approach: –Facility’s comprehensive program Address concerns of IG Meet new standards –HHS (CDC) –USDA (APHIS) Clarify current requirements

9. Control of Hazardous Agents Program A unified approach Integrates: –VAMC safety & security program and –Research safety & security program Medical Center Director (MCD) is responsible institutional official Requires coordination and cooperation of many offices

10. Definition:Select Agents (SA) & Toxins SA: Group of agents designated by HHS/CDC as requiring registration with CDC lab registration program –Viruses, bacteria, rickettsiae, fungal, toxins, recombinant DNA Biological agents and toxins (USD/APHIS): agents with potential to be severe threat to animal & plant health -- Labs must also register Overlap agents: found in CDC & APHIS lists Directive refers to CDC & APHIS agents collectively as SA & toxins

11. Definition: Hazardous Agents Hazardous agents include: –Select agents & toxins –Exempt quantities of toxins –Other hazardous chemicals –Radioactive material –Sensitive material List in Directive 2002-075 and draft directive

12. Control of Hazardous Agents Program (cont) Based on regulatory, scientific & ethical principals Relevant policies and regulations –VHA Research & non-research –HHS/CDC –USDA/APHIS –Dept. of Commerce –Dept. of Transportation –EPA –OSHA

13. Roles and Responsibilities MCD is the Responsible Official ACOS/AO – Research point of contact –Liaison with VAMC committees, personnel, police etc – Personnel, lab access, resources –Annual assessments and drills –Role with R&D committee/SRS –Ensure compliance

14. Roles and Responsibilities: R&D/SRS committee Advises the MCD on the R&D program R&D responsibilities: –M-3, Part 1, Chapter 2 & 3 –Safety of Personnel in Research (1200.8) –Hazardous Agents directive R&D committee may form a Subcommittee on Research Safety (SRS) SRS = Institutional Biosafety Committee (IBC)

15. SRS/IBC: A Special Issue Research on recombinant DNA & gene transfer –Regulated under NIH Guidelines –Incorporated into VHA policy IBC –Specific membership –Specific responsibilities –Specific requirements www4.od.nih.gov/oba

16. Roles and Responsibilities: R&D/SRS committee In addition to other responsibilities Ensure biosafety review completed & determines need for changes to protocol Oversee requests for lab registration Reviews requests for: –Lab access & access to BSL-3/SA labs –Purchase transfer or destruction of SA & toxins –Policies & procedures –Results of vulnerability assessments, drills, incidents Document all reviews and findings

17. Roles and Responsibilities: Biosafety Officer Varies from institution to institution Expertise: science, safety, security, & applicable policies Responsible for or delegates: –Training (delivery & record keeping) –Inventory control –Vulnerability assessments/drills –Ensure compliance POC and resident expert

18. Roles and Responsibilities: Lab Directors & Investigators Ethical conduct of research Compliance with regulations –Handook1200.8, Directive 2002-075 –Select agents (SA) & toxins –BSL-3 Safety & security within the lab All lab staff –Trained –Work within their scope of work Inventory control

19. Responsible Official & Alternate Responsible Official Term specific to select agents & toxins regulations (CDC: 42 CFR 73; APHIS: 7 CFR 331, 9 CFR 121) RO = MCD Alternate RO can be the Biosafety Officer, ACOS, AO, other qualified person

20. Responsible Official (RO) Alternate Responsible Official Approved security risk assessment Ensure facility compliance Alternate RO –Delegated authority from RO –Day to day operations –Knowledgeable (regulations, policy, science) –Coordinate with non-research offices: Human Resources, Police, Safety, etc.

21. Control of Hazardous Agents: Specific Requirements 1. Controlling lab access 2. Physical security 3. Registering labs for select agent or toxin use 4. Inventory control 5. Emergency preparedness 6. Training 7. Policies and procedures/plans

22. Controlling Laboratory Access Approve/authorize all staff (paid & WOC) –Approve for all labs HRM “credentialing” OPM background check (SF 85) –Authorize for SA & toxin labs HRM procedures plus Security Risk Assessment (FBI Form FD 961, approval by CDC or USDA) Visitors/visiting scientists, students, etc. escorted at all times unless approved or authorized

23. Physical Security: A Two Tiered System Laboratories in general –Security is for research area –Individual labs: ordinary locks BSL-3s and labs with SA or toxins –More sophisticated security –Ensures 2 security perimeters –3 rd perimeter: locked refrigerators/cabinets

24. Physical Security All Laboratories Control access 24/7 Keycard or more sophisticated system that records access Doors self-closing Intrusion alarm integrated into VAMC Video surveillance at entrances suggested Unobstructed view of exterior entrances

25. Physical Security BSL-3s & Labs with SA or Toxins Security requirements apply to: –BSL-3 without Select Agents or Toxins –BSL-3 with SA or Toxins –Laboratories using SA or T –Storage areas for SA or T

26. BSL-3s and SA or Toxins Security Requirements Security as required by Select Agents regulations (CDC or APHIS) Cardkey or more sophisticated system –Code/keys specific to the laboratory –Must record entrance & egress Access only to those who work in lab –For SA & toxin labs: Authorized (approved Security Risk Assessment & MCD concurrence) –Special approval: BSL-3 without SA or toxins

27. BSL-3s and SA or Toxins Security Requirements (cont.) Audible alarms monitored by police Telephone in lab Video surveillance Lock all containers when out of site, not in use Meet requirements in Handbook 0730 “Security and Law Enforcement for: –Windows –Doors –Overhead spaces

28. Registering Labs for SA or Toxin Use Can NOT begin using SA or toxins unless: –Lab registered –All staff are authorized & have approved SRA Registration by HHS (CDC) or USDA (APHIS) CDC/APHIS inspection of lab

29. Inventory Control For Hazardous Agents Know: –How much on hand –Where it is –Who has control of it Inventory adjusted when purchased, used, transferred or destroyed. Purchase or store only for active or soon to be active protocols

30. Emergency Preparedness & Response Plan coordinated with facility & outside officials (Fire, police etc.) Specific to facility & agents in labs Incorporate OSHA, VHA & research requirements Vulnerability assessments & drills annually Document all activities

31. Training Requirements Integrate Biosafety & Security Applicable regulation (VA, OSHA, CDC) Must occur prior to assignments Annual refresher Generic training Specific to laboratory & agents Maintain good records

32. Required Policies and Procedures Safety plan Security plan –Physical –Personnel & Access –Cyber –Inventory control Emergency planning & response Training

33. Policies & Procedures Written & updated as required Implementation must occur Documentation

34. REVIEW: Control of Hazardous Agents: Specific Requirements 1. Controlling lab access 2. Physical security 3. Registering labs for select agent or toxin use 4. Inventory control 5. Emergency preparedness 6. Training 7. Policies and procedures/plans

35. Other New Issues BSL-3 Laboratories –Annual Safety & Security visits by ORO –IG remains interested in BSL-3 security –Pans for new or decommissioning BSL-3: call ORD Select Agents or Toxins –Final rule may be out in November –No major changes expected –New SA or Toxin use: report to CO Exempt Quantities of Toxins

36. Remain under tight security Prevent misuse or theft If not in sight or use must be locked up Accurate inventory Acquisition, transfer, destruction similar to SA & toxins Possess only for specific protocol

37. Submitting Biosafety Forms: VA Form 10-0398 Required for SRS review Just-in-time document for protocols submitted to CO Problems found: –Not filled out completely –Missing required signatures –Information in form does not match protocol Avoid HOLDS!

38. Requesting Waivers Waivers only if referenced in VHA policy Rarely given for BSL-3 or SA and toxin lab requirements Request sent to ORD Required information: Directive 2002-075, Appendix B. Call or e-mail if any questions

39. Remember! Directive 2002-075 as published in November 2002 is still the official policy Information on slides may change once the new draft of this Directive is signed by the Under Secretary for Health Please contact ORD for questions & help –Brenda Cuccherini, Ph.D. (202)254-0277 –brenda.cuccherini@hq.med.va.gov