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Biological Compliance

Biological Compliance. Dr. Sue A. Tolin Plant Pathology, Physiology & Weed Science Plant Molecular Biology Building Old Glade Road stolin@vt.edu 231-5800 September 12, 2007. What is Biological Compliance.

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Biological Compliance

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  1. Biological Compliance Dr. Sue A. Tolin Plant Pathology, Physiology & Weed Science Plant Molecular Biology Building Old Glade Road stolin@vt.edu 231-5800 September 12, 2007

  2. What is Biological Compliance • Identifying applicable rules and regulations for handling biological organisms, and complying with these rules and regulations • Obtaining necessary approvals and permits, and following specified conditions and practices for specific organisms and activities

  3. Biocompliance = Risk Management • Identify the Hazard • Assess the Risk Level (Hazard x Exposure) • Apply Risk Management • Federal Rules and Regulations • Quarantines and Permits • Federal Guidelines • Performance and Design Standards for Containment or Confinement • Scientifically-accepted Practices • None High Low

  4. Types of Biological Risks Hazard X Exposure • Human health • Agricultural (production loss, economic loss, quarantines, trade barriers) • Animal diseases • Plant diseases and pests • Environmental, e. g. invasive species • Impact on non-target species, especially on endangered species

  5. What Organisms are Subject to Rules and/or Regulations? • Pathogenic Microorganisms • Viruses and Sub-viral agents, Prions • Bacteria, Rickettsia, Mycoplasma • Fungi, Nematodes • Pests and parasites • Broadly defined • Invasive Species • Plants/weeds • Arthropods/Insects • Microorganisms/Pathogens

  6. Other Organisms with Rules for Compliance • Plants and Animals • Biological Control Agents • [of insects, weeds, pests, invasive species] • Insects • Microorganisms • Potential bioterrorism organisms (select agents) • Recombinant DNA-containing organisms • Transgenics made by biotechnology • Discussed later

  7. Risk Assessment and Management of Human Agents • Centers for Disease Control (CDC) • Periodically publishes a Biosafety Manual • Categorizes organisms as to risk • Describes safety equipment and facility design for reducing exposure and risk www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm • Applies to Human Health Risks • Minimize exposure of clinical and laboratory workers • Minimize accidental release

  8. Human Health Risks (non-select agents) • Centers for Disease Control (CDC) • categorizes organisms, describes lab practices for reducing exposure www.cdc.gov/od/ohs/biosfty/biosfty.htm • RG1: not associated with human disease • RG2: diseases not serious or treatable • RG3: serious disease but likely treatable • RG4: serious or lethal disease and treatment is questionable • Reduces risk by reducing exposure of laboratory workers – biosafety

  9. Risk Management Components in Research or Clinical Laboratories Biosafety Biocontainment

  10. Oversight of Biological Compliance at Virginia Tech Environmental Health and Safety Services • Office of Research Compliance • David Moore, Director • Office of Sponsored Programs • Compliance must be demonstrated to get $ Mission – includes: • Assure safe work practices through effective education and consultation • Help achieve compliance with all health and safety local, state and federal regulations and University policies www.ehss.vt.edu

  11. VT Environmental, Health and Safety Services (EHSS) • Programs (of 34 total) • Biological Safety • Bloodborne Pathogens • Chemical Safety • Hazard Communication • Hazard Monitoring • Radiation Safety

  12. Virginia Tech EHSS • Biological Safety Program • Biosafety for Lab Workers • PDF file – 129 pageswww.ehss.vt.edu • Institutional Review Board (IRB) – human subjects • Institutional Animal Care and Use • Biosecurity and Bioterrorism – information • Select Agent and Toxin Program • (PDF file – 61 pages) • Recombinant DNA Research

  13. Compliance for Animal Use • All research, instruction, and testing using vertebrate, nonhuman animals must comply with the Animal Welfare Act of 1966 as implemented by the USDA APHIS set forth in the Guide for the Care and Use of Laboratory Animals. Virginia Tech's Institutional Animal Care and Use Committee • reviews proposed uses of animals in research, testing, and education; • evaluates programs and animal activity areas; and • inspects facilities used to house animals.

  14. Agriculture Regulatory Authorities • USDA Marketing & Regulatory Programs • Animal and Plant Health Inspection Service (APHIS) www.aphis.usda.gov/ • Veterinary Services (VS) • Animal Care Rules • Establishes Quarantines • Issues Permits • Approves Vaccines under the USDA Virus, Serum, Toxin Act

  15. Animal Risk Compliance • Veterinary Services requires permits for the importation of certain animals and animal products. • Permits are also required for importation and interstate movement of bacteria, viruses, and prion agents that are disease agents of animals and poultry • Permits require conditions to minimize risk • Containment, confinement • Practices

  16. USDA Regulates Plants and Plant Pest Risks • USDA Marketing and Regulatory Programs • Animal and Plant Health Inspection Service (APHIS) www.aphis.usda.gov/ • Plant Quarantines and Permits – 7CFR340 • Biotechnology Regulatory Services • The Plant Protection Act of 2000 requires a permit for the movement (introduction into the United States or interstate movement) of plant pests and pathogens. • PPQ permits describes all organisms needing permits • Plant Pests • Arthropods; Pathogens (fungi, bacteria, virus, etc.) • Weeds; Exotic Plant Germplasm • Biological Control Organisms

  17. Plant Pest Risk Compliance: A Permitting Process • Establish the need for a permit • Complete request to APHIS PPQ for permit • Form 526 from APHIS website, • www.aphis.usda.gov/ppq/permits • Obtain review at Federal and State level • Complete Request is reviewed at Federal and State level • Permit is issued by APHIS to the individual, with approval conditions and term

  18. You need an APHIS Permit if you: • Import, release, or make interstate shipments of live invertebrates (e.g., insects, mites, nematodes, slugs, snails), microorganisms (protozoa, bacteria, fungi), viruses, viroids, phytoplasmas), parasitic plants, or federally listed noxious weeds. Organisms intended for use as biological control agents are included. Shipments of dead organisms do not require a permit. • A permit from APHIS is not needed for organisms isolated within state

  19. Information Needed on Form 526 • Taxonomic identity – complete name • Life stages to be shipped (insects), to indicate possible presence of parasites. For plants, the plant parts – seeds, fruits, stem cuttings, etc. • Number of specimens or units – 1 to millions • Host material (if parasite or obligate pathogen) • Intended use: Research in quarantine lab or outside of quarantine; direct release into field or greenhouse • Method of final disposition • For single organisms or groups of organisms

  20. USDA-APHIS - ePermits • A web-based system so customers may apply for permits online, check status, and view. http://www.aphis.usda.gov/permits • How? Register – eAuthentification system to identify and validate USDA customers • Allows regulatory officials to issue, track, and rapidly verify validity of import permits • Reduces data-entry, processing, delivery time • Reduces expense

  21. Compliance for Plant Pests – the Process • APHIS-PPQ reviews: • Qualifications of personnel • Containment – both facilities and practices • May require on-site inspection by APHIS • Can the facility contain the requested organisms? • Can it be remodeled? • Demonstration of security of the organisms • Disposal – efficacy and documentation

  22. Actions taken on a 526 • Federal and State review and approval • Permits are issued for a finite time period • Conditions are essentially case-by-case • PI must agree to conditions, and accept responsibility • Qualifications – personnel • Containment – facilities and practices • Security, if required • Proper disposal • No local oversight at Virginia Tech by EHSS, currently

  23. Biological Control Organisms • APHIS Guidelines and Regulations http://www.aphis.usda.gov/ppq/permits/biological/index.html • Entomopathogens • Bacteria, fungi, viruses and nematodes used for control of insects and mites. • Predators and Parasitoids of insects and mites • Weed Biocontrol • Specialists prepare a report on environmental safety and host specificity, before release

  24. Biological Pesticides • EPA FIFRA Regulations – • Exemption for field tests <10 acres • Applies to large-scale experimental and commercial microorganisms – Bacillus thuringiensis • Approves all microbes used commercially for pest mitigation (insects and pathogens) http://www.epa.gov/pesticides/biopesticides/

  25. Summary • Working with biological organisms may pose some risk, particularly known pathogens, parasites, or pests. • Risk to their hosts can be assessed and managed. • Knowledge of the pathogenicity, mode of dissemination, and survival allow design of safe handling procedures and facilities to minimize undesired infection or escape. • Biological compliance means knowing and following the applicable rules and regulations, getting permits. • Institutional oversight and assistance is provided for human and animal risks by the Virginia Tech Environmental Health and Safety .

  26. New Issues – following 9/11/01 • USA Patriot Act of 2002: “Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism” • Established Policies and Procedures for Biosecurity and Clearance • BioterrorismUse of biologic agents or toxins (e.g., pathogenic organisms that affect humans, animals, or plants) for terrorist purposes.

  27. Public Health Security and Bioterrorism Preparedness Response Act of 2002 • Purpose: To improve the ability of the US to prevent, prepare for, and respond to bioterrorism and other public health emergencies • Provisions • Lists of high consequence biological agents and toxins • Required notification of possession • Registration for possession, use, and transfer • Specified containment conditions • Section II – Enhancing Controls on Dangerous Biological Agents and Toxins • Subtitle B - the “Agricultural Bioterrorism Protection Act of 2002” [August 12, 2002 Federal Register]

  28. Risk Management Components ID cards, special locks, restricted area badges, a sign-in logbook; security checks, etc. Biosecurity Biosafety Biocontainment

  29. Biosafety - Development and implementation of administrative policies, work practices, facility design, and safety equipment to prevent transmission of biologic agent to workers, other persons or the environment. Biosecurity- Protection of high-consequence microbial agents and toxins, or critical relevant information, against theft or diversion by those who intend to pursue intentional misuse. Also, security checks on persons involved. Biosafety vs. Biosecurity Two separate but related subjects

  30. High Consequence Microbial Agents or Toxins – Select Agents Centers for Disease Control (CDC) plays a central role for human agents and toxins and those overlapping with animal agents and toxins. This linkhttp://www.cdc.gov/od/sap takes you to the page explaining their activities. Note also the link to the Etiologic Import Program, as CDC now requires permits for movement of etiologic agents and their vectors The Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition (2007) contains information on Select Agents and requirements for any work with them. This link takes you to the on-line version http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm

  31. High Consequence Organisms“Select Agents” • National Select Agent Registry http://www.selectagents.gov/agentToxinList.htm Reviewed every two years • HHS non-overlap agents and toxins • Ebola, Lassa, Marlburg, Smallpox viruses, etc. • USDA/HHS overlap agents and toxins • Anthrax, EEV, Nipah virus, etc. • USDA only agents and toxins • Livestock – about 20 agents, mostly virus • Avian influenza, FMDV, BSE, exotic strains

  32. “Select Agent” Plant Pathogens • Candidatus Liberobacter africanus • Candidatus Liberobacteramericanus* asiaticus(removed 2007) • Peronosclerospora philippinensis (P. sacchari)* • Phoma glycinicola (formerly Pyrenochaeta glycines)* • Phytophthora kernoviae* • Ralstonia solanacearum race 3, biovar 2 • Rathayibacter toxicus* • Schlerophthora rayssiae var. zeae • Synchytrium endobioticum • Xanthomonas oryzae pv. oryzicola (all pathovars*) • Xylella fastidiosa(citrus variegated chlorosis strain) • Plum pox virus (removed in 2005) • Phakopsora pachyrhizi Soybean rust (removed in 2005) * ProposedChanges August 28, 2007 Federal Register

  33. Oversight of Biological Compliance for Select Agents at Virginia Tech Environmental Health and Safety Services • Help achieve compliance with all health and safety local, state and federal regulations and University policies • http://www.ehss.vt.edu/Programs/LSD/BiologicalSafety.htm • Select Agent and Toxin Program • (PDF – 61 pages) “A Guide to Compliance for Researchers Possessing, Using, or Transferring Select Agents or Toxins” August 2006

  34. VT Select Agent and Toxin Program • A Guide to Compliance for Researchers Possessing, Using, or Transferring Select Agents or Toxins [August 2006] • Meeting biosecurity in university laboratories and classrooms • High Security Clearance for individuals working with certain organisms • Dual Use Issue • Scientific Research and Teaching • Applicability of Results to Bioterrorism

  35. Security and Incident Response Guidelines (Select Agents) - VT • Recognize lab security is related to but different than lab safety • Control access to areas where biologic agents or toxins are used and stored • Know who is in the lab area • Know what materials are brought into and being removed from the lab area • Have an emergency plan • Have a protocol for reporting incidents

  36. Other Restricted Lists Genetic Elements/Recombinant Nucleic Acids/Recombinant Organisms • Infectious nucleic acids of select agent viruses • Nucleic acid encoding functional toxins that can be expressed in vivo or in vitro, even in vectors • Listed agents and toxins that have been genetically modified • Experiments to transfer drug resistance traits or to synthesize select highly lethal toxins require prior approval from CDC and/or APHIS

  37. Additional Bioterrorism Concerns • Concern over genetic modifications that could be made by biotechnology, or from published research with agents • Dual Use of Information • Gives information to enhance qualities of a an agent for bioterrorism

  38. National Science Advisory Board for Biosecurity - NSABB • Established in 2005 to provide advice to federal departments and agencies on ways to minimize the possibility that knowledge and technologies emanating from vitally important biological research will be misused to threaten public health or national security. • The NSABB is a critical component of a set of federal initiatives to promote biosecurity in life science research. NSABB

  39. NSABB • A system of institutional and federal research review that allows for fulfillment of important research objectives while addressing national security concerns; • Guidelines for the identification and conduct of research that may require special attention and security surveillance; • Professional codes of conduct for scientists and laboratory workers that can be adopted by professional organizations and institutions engaged in life science research; and • Materials and resources to educate the research community about effective biosecurity. • Strategies for fostering international collaboration for the effective oversight of dual use biological research.

  40. Compliance for Research Involving Recombinant DNA • Recombinant DNA • Cut DNA with restriction enzymes • Splice foreign DNA into a vector • Stable integration of foreign DNA into host – cloning • First done in early 1970’s • Genetic Engineering • Biotechnology

  41. Does R-DNA Research Pose a Risk? • …new kinds of hybrid plasmids or viruses, with biological activity of unpredictable nature, may eventually be created… (Singer and Soll, 1973) • Scientists called for a moratorium on certain types of experiments, mainly toxins and oncogenic or other animal viruses known to be of high risk • Established a system of experiment review, containment protocols for biosafety, and compliance mechanisms – 1976 [in lieu of regulations] • Research proceeded – now for 30 years • No hazards unique to R-DNA have been recognized

  42. To make a very long story short … • NIH: “Guidelines for Research with Recombinant DNA-Containing Organisms” http://www4.od.nih.gov/oba/Rdna.htm • All R-DNA research funded by NIH and all R-DNA research at an institution receiving any NIH funding for R-DNA research must comply with the Guidelines • All other Federal research agencies require grantees to comply with NIH Guidelines • Not mandatory for industry, but GLP requires compliance • Oversight for assuring compliance delegated to Institutional Biosafety Committees (IBC).

  43. The NIHGuidelines • Section I – Scope: Federally funded recombinant DNA research • Section II – Safety Considerations • Assesses risks of experiments with disease agents • Recommends containment of research to reduce risks to workers and environment • Describes Containment – for compliance • Biological • Physical • Appendix G: Laboratory Experiments • Appendix P: Plants and associated organisms • Appendix Q: Animals and associated organisms • Section III – Types of Experiments Covered • Categorizes experiments according to risk • Assigns responsibility for review and approval according to perceived risk • Section IV – Roles and Responsibilities

  44. Guidance for R-DNA Compliance Section II – Safety Considerations • Risk levels are assigned to different types of genes and organisms • Physicaland Biologicalcontainment conditions are recommended for conducting experiments • Appendices give details of procedures and practices for: • Labs (G) http://www4.od.nih.gov/oba/rac/guidelines_02/appendix_g.htm • Plants in greenhouses (P) http://www4.od.nih.gov/oba/rac/guidelines_02/appendix_p.htm • Animals (Q) http://www4.od.nih.gov/oba/rac/guidelines_02/appendix_q.htm

  45. An IBC at a university: Assigned responsibility for oversight of low risk experiments and compliance with Guidelines • Examines experimental protocols that are submitted with grant applications • Evaluates the potential risks of the work • Evaluates the expertise of the Principal Investigator and staff to conduct the work • Evaluates the physical facilities and practices, and the biological containment plan for compliance with the NIH Guidelines recommendations

  46. At Virginia Tech Biotechnology Oversight Committee - BOC • IBC – Institutional Biosafety Committee http://www.biotech.vt.edu/boc/ Chair: Dr. Eric Wong, Animal Sciences In the process of being moved to EHSS Biological Safety Office, and getting more responsibilities related to bioterrorism and dual use research

  47. Responsibilities of the Principal Investigator to be in Compliance for rDNA Research • Make an initial determination of the required levels of physical and biological containment in accordance with the NIH R-DNA Guidelines • Select appropriate microbiological practices and laboratory techniques to be used • Submit the initial research protocol and any subsequent changes to the IBC for review and approval • Remain in communication with the IBC throughout the conduct of the project. NIH Guidelines

  48. Responsibilities of the Principal Investigatorto be in Compliance with rDNA Research Prior to Initiating Research: • Make available to all laboratory staff the protocols that describe the potential biohazards and the precautions to be taken • Instruct and train laboratory staff in: (i) the practices and techniques required to ensure safety, and (ii) the procedures for dealing with accidents • Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested NIH Guidelines

  49. The PI shall, during the work: • Supervise safety performance of laboratory staff to ensure required safety practices and techniques are used • Investigate and report any significant problems pertaining to operation and implementation of containment practices and procedures in writing to the Institutional Biosafety Committee or other applicable authorities • Correct work errors and conditions that may result in the release of recombinant DNA materials • Ensure the integrity of physical containment (e.g., biological safety cabinets) and biological containment (e.g., purity and genotypic and phenotypic characteristics) NIH Guidelines

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