TRAINING AND PROCEDURES FOR USE OF SELECT AGENTS CDC Final Rule (42 CFR 73) & APHIS Final Rules (7 CFR 331 & 9 C

1. TRAINING AND PROCEDURES FOR USE OF SELECT AGENTSCDC Final Rule (42 CFR 73) &APHIS Final Rules (7 CFR 331 & 9 CFR 121) DREXEL UNIVERSITY and DREXEL UNIVERSITY COLLEGE OF MEDICINE

2. Questions Any questions pertaining to the enclosed information should be directed to one of the following: • Drexel University Department of Safety and Health at 215 895-5891; • Drexel University Office of Research at 215 762-8103; • The CDC Office of Health and Safety in Atlanta at 404 639-3235, or Fax 404 639-2294.

3. Additional Information Detailed information on additional exemptions, registration, policies, enforcement and material safety data sheets (MSDS) can be found in the manual entitled “Drexel University’s Select Agents Policies for Researchers and their Staff”

4. Introduction - 42 CFR Part 73 The U.S. Departments of Health and Human Services (HHS) under the control of the Center for Disease Control (CDC) and the Animal and Plant Health Inspection Service (APHIS)/United States Department of Agriculture (USDA) have established new safeguards for the possession, use, and transfer of select biological agents and toxins (select agents) that could pose a threat to public, animal and plant health and safety. This new rule will continue to strengthen programs aimed at protecting the American people from acts of terrorism and these safeguards will help protect the food supply without sacrificing valuable research being done on these agents. The rule updates the previous select agent rule by requiring facilities to register with HHS’ Centers for Disease Control and Prevention (CDC) if they possess a select agent or agents that pose a potential threat to human health. All provisions of the current final rules supersede those contained in the interim final rules and became effective on April 18, 2005.

5. Introduction - continued On June 12, 2002, President Bush signed the “Public Health Security and Bioterrorism Preparedness Response Act of 2002” (Public Law 107-188). The law is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. Section 202(a) of the Law requires that all persons possessing biological agents or toxins deemed a threat to public health to notify the Secretary, Department of Health and Human Services (HHS). Section 213(b) of Law requires all persons possessing biological agents or toxins deemed a threat to animal or plant health and to animal or plant products notify the Secretary, United States Department of Agriculture (USDA).

6. Definitions • CDC – Center for Disease Control • APHIS – Animal and Plant Health Inspection Service • USDA – United States Department of Agriculture • CFR – Code of Federal Regulations • HHS – Department of Health and Human Services • ORC – Drexel University College of Medicine Office of Research Compliance • DSH – Drexel University Department of Safety and Health

7. Select Agent PoliciesSelect Agent Use Purchase of select agents require authorization from the Office of Research Compliance (ORC) and completing “Declaration of Possession of Select Agents Form”. To obtain permission to purchase a select agent whether in exempt quantities or not submit to the ORC a summary of your experimental procedure, where experiments are going to be conducted, quantity of the agent to be purchased and assure that you will be following policies and procedures for purchase, storage, disposal and transfer of the agent to another laboratory. All transfers of select agents which are exempt must be reported to and approved by the DSH before they are transferred

8. Select Agent Use continued Transfer of select agents which are non-exempt require approval by both The Center for Disease Control (CDC) and the Drexel University College of Medicine’s responsible official. Shipping and receiving of all select agents is only allowed through DHS. To obtain “Declaration of Possession of Select Agents” form please go to http://research.drexel.edu/research/compliance/biosafety/guidelines.asp. In addition, you must obtain approval from the Institutional Biosafety Committee (IBC) before receiving and/or using select agents at the University. For application to obtain approval from the UBSC visit http://research.drexel.edu/research/compliance/biosafety/guidelines.asp.

9. Procedures for labs working with Federally Exempt Quantities Toxin quantities, per principal investigator, not exceeding those shown in the following tables are exempt from federal select agent registration and regulations. However, labs using or possessing exempt quantities of select agent toxins must follow the procedures outlined in the following slides. A complete listing of all regulated agents / toxins and there MSDS can be found in your training materials

10. HHS Regulated Toxins and Exempt QuantitiesMaterial Safety Data Sheets for each agent are included in your manual Abrin 100 mg Conotoxin 100 mg Diacetoxyscirpenol (DAS) 1000 mg Ricin 100 mg Saxitoxin 100 mg Shiga-like ribosome inactivating proteins 100 mg Tetrodotoxin 100 mg

11. HHS/USDA Overlap Toxinsand Exempt QuantitiesMaterial Safety Data Sheets for each agent are included in your manual Botulinum neurotoxins 0.5 mg Staphylococcal enterotoxins 5.0 mg Clostridium perfringens epsilon toxin 100 mg Shigatoxin 100 mg T-2 toxin 1000 mg

12. Additional Criteria for Agents or Toxins to Meet Exclusion Any HHS or overlap select agent or toxin that is in its naturally occurring environment provided the select agent or toxin has not been intentionally introduced, cultivated, collected, or otherwise extracted from its natural source. Non-viable HHS or overlap select agents or nonfunctional HHS or overlap toxins.

13. Application for Exclusion for Attenuated Agent or Toxin It is possible under the rule to apply for exclusion for any attenuated agent or toxin using an appropriate form obtainable from CDC. Exclusions for specific strains may be granted if the attenuated strain is determined not to pose a significant public health or safety threat. Exclusions for specific strains should be requested in writing and sent to the Select Agent Program.

14. Policies and Procedures for Use of Exempt Toxin Quantities • Notify a biosafety officer at the Department of Safety and Health (DSH) 215-895-5891, if you anticipate obtaining any quantity of the above toxins. • Notify DSH biosafety officer at 215-895-5891 if you already possess one of the above toxins and anticipate obtaining additional amounts so that the total quantity may approach the above threshold limits. • Use of select agent toxins, in any quantity, must receive prior approval from the Institutional Biosafety Committee (IBC). IBC approvals are subject to continuing review and expire after three years. • All select agents must be kept in locked storage when not under the control of a trained worker.

15. Exempt Toxin Quantity Use Continued • Waste and disposal of unwanted biologically-derived toxins must be notified to the biosafety officer at 215-895-5891. • All laboratories using biologically-derived toxins must have written standard operating procedures (SOPs) for their use. SOPs should include: potential exposure hazards during sample preparation and experimental manipulations (e.g. aerosol generation when transferring, mixing, or centrifuging; use of sharps; excretion by animals; etc.), safety procedures that will be employed to minimize risk (e.g. protective clothing, use of biological safety cabinet, sharps disposal procedures, waste disposal procedures, etc.), proper material disposal techniques, and accidental spill/exposure procedures.

16. Exempt Quantity Use Continued • All laboratories possessing exempt quantities of select agents will be audited at least annually to review quantities on hand and SOPs.

17. Exempt Quantity Use Continued Immediate Notification is required when… Contact DSH at 215-895-5891 during regular business hours or after hours call 215-895-2222 and ask for a hazardous materials response for any of the following situations: • Security breaches such as break-in or other unauthorized access • Theft, loss, or release of a select agent • Spills (to determine if hazardous material assistance is needed) • Request by an outside agency auditor for laboratory entrance

18. Regulated and Exempt Quantities Immediate Notification is required when… • Worker exposures such as ingestion, needle stick, or face splash (after first seeking medical attention) • Any changes that need to be made to the University’s federal Certificate of Registration on file with the CDC. This includes a change in location of select agent, change in authorized users, or a significant change in select agent protocol or research objective. Both UBSC and federal registration need to be renewed every three years. • Approval to ship or receive a select agent outside of the University

19. Regulated and Exempt Quantities - Continued Immediate Notification is required when… • Notification of transfer of a select agent to another approved location within the University. “Record of Transfer Destruction of Select Agent” and “Change in Inventory” forms required. • Approval to inactivate or destroy a select agent stock • New employee training (provided by DSH and Investigator pertinent to the select agent (s) to be used in PI’s laboratory) • Authorized access requests

20. Monthly Inventory Checks Every month Verify that physical inventory matches paper inventory. Record date, time and name of the person who checked the inventory.

21. Quarterly Inventory Checks These are conducted by the Department of Safety and Health (DSH). DSH will collect copies of monthly inventory forms from each of the laboratory which is in possession of select agents.

22. Audits Every Six Months the DSH will audit the laboratory for: • A review of lab access logs to verify they are kept up to date • To verify that work is being done as indicated on the University’s Federal Certificate of Registration on file with the CDC • To review safety/security protocols and implementation

23. Annual Training Update • Select agent update training is required annually for all individuals with authorized access. • Investigators must keep all training records for three years.

24. Regulated Select Agent Use • Follow pertinent lab practices in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories or follow procedures outlined on Drexel University College of Medicine’s Select Agents Policies and Procedures manual. The procedure manual is posted on the Office of Research website www.research.drexel.edu under “research”, “compliance” and “Biosafety”. • Follow all procedures as outlined in the University’s Security Plan for Select Agents outlined on Drexel University College of Medicine’s Select Agents Policies and Procedures manual.

25. Regulated Select Agent Usecontinued • Maintain up-to-date standard operating procedures (SOPs) for each select used in the laboratory. Submit a copy of this SOP to the DSH. SOPs should include: availability of MSDS sheets for each of the select agents used; potential exposure hazards during sample preparation and experimental manipulations (e.g. aerosol generation when transferring, mixing, or centrifuging; use of sharps; excretion by animals; etc.), safety procedures that will be employed to minimize risk (e.g. protective clothing, use of biological safety cabinet, sharps disposal procedures, waste disposal procedures, etc.), proper material disposal techniques, and accidental spill/exposure procedures. • Maintain up-to-date inventory and access logs. Contact a DSH Biosafety Officer at 215-895-5891 with record keeping questions.

26. CDC Registration Information The Centers for Disease Control and Prevention is required to regulate the possession of biological agents and toxins that have the potential to pose a severe threat to public health and safety. CDC's Select Agent Program oversees these activities. The Select Agent Program currently requires registration of facilities including government agencies, universities, research institutions, and commercial entities.

27. CDC Registration InformationContinued On this Web site http://www.cdc.gov/od/sap/, you will be able to download application packages, view current regulations regarding select agents and access additional resource information. If you still have questions or concerns after reviewing the material contained in this website, please contact our program via email at lrsat@cdc.gov, phone at 404-718-2000 or fax at 404-718-2096 or contact the Office of Research Compliance at 215-762-3453.

28. Appendicesincluded in your training materials Appendices include the following • Copy of “Drexel University’s Select Agents Policies for Researchers and their Staff” • Record of Transfer to a Registered Lab Within the University or Destruction of a Select Agent • Select Agent Inventory Record of Changes to Long-term Storage • Select Agent Research Lab Record of Training • List of Select Agents • Material Safety Data Sheets (MSDS) for each select agent / toxin