1 / 40

Biosafety/Biosecurity: An Update

Biosafety/Biosecurity: An Update. February 27, 2004. Where is the emphasis?. Biosafety   Biosecurity. Biosafety. Policy Handbook 1200.8 “Safety of Personnel Engaged in Research” VA Directive 7701 & Handbook 7701.1 “Occupational Safety & Health” OSHA’s regulations Plans

ita
Download Presentation

Biosafety/Biosecurity: An Update

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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 • 3rd 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 SecurityBSL-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. Exempt Quantities of Toxins • 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

  40. Why we are here!

More Related