News and Alerts
Interim final rules for select agents and toxins
The Department of Health and Human Services and the U.S. Department of Agriculture have released interim final rules for the registration of possession, use and transfer of select agents and toxins. The rules, which implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, are effective as of February 7, 2003. The requirements for registration will include a Department of Justice security risk assessment for individuals who have access to the listed agents and toxins. Individuals who are determined to meet the criteria of a "restricted person" as defined in the Act will not be approved for access. If you need more information on the list of agents and toxins or have other questions about this new legislation, contact Maureen Kotlas, Director of Environmental Health and Safety at (631) 632-6410 or contact Maureen Kotlas. Copies of the rules are available at:
- DHHS: http://www.aphis.usda.gov/vs/ncie/pdf/cdcfederal.pdf
- USDA: http://www.aphis.usda.gov/vs/ncie/pdf/btarule.pdf
Memo of 12/11/02 to Principal Investigators...
Memo of 12/11/02 to Principal Investigators from Maureen Kotlas, Stony Brook University's Responsible Official:
I am writing to you to notify you that the interim final rules for possession and use of Select Agents were approved and released by the Department of Health and Human Services on December 9 but will not be published in the Federal Register until Friday, December 13. The rules are, however, posted on the CDC's website. If you are interested in viewing the document, the link at the end of this message should bring you to the pdf file. A word of caution before printing - the document is 84 pages in length. The public comment period will be open for 60 days following the posting in the Federal Register. For those of you not familiar with these rules, they implement the provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and establish standards and procedures governing the possession, use and transfer of biological agents and toxins that have been determined to pose a potential severe threat to human, animal health, or plant health.
On or after February 7, 2003, Stony Brook will be required to submit an application to the CDC (and the USDA if applicable in the future) to receive a registration for select agent and toxin possession and use. In order to start the planning for compliance with these rules, I will briefly summarize the actions we'll need to take. You'll note that there are requirements for information such as floor plans, identification of minimal education and experience for those with access, need for written security and emergency response plans, provisions for routine cleaning and maintenance, key and lock/card access control and cyber security. The bold type includes some of the information and documents that will now be required.
Select Agents List:
Most of the viruses, bacteria and toxins remain on the list as previously published. As expected the 'virus causing hantavirus pulmonary syndrome' has been removed from the select virus list. Some exemptions continue to apply such as those agents contained in specimens for diagnosis. More information on the list and exemptions can be found in the Interim Rules.
Registration applications will require submission of the following information:
- Names, sources and characterization of select agents and toxins and quantities held at time of registration.
- Locations by building and room number, floor plans for each building and room where agents are stored or used.
- Information on safety, security and emergency response plans and training related to each select agent and toxin.
- Name, position, identification information on the Responsible Official (RO) and Alternate for the entity. The RO must be identified and authorized by the entity. A security risk assessment by the Department of Justice will be required for the RO and Alternate. (I am designated as the RO on our current registration for transfer of select agents, Gary Kaczmarczyk, Assistant Director in EH&S, is the Alternate RO).
- A list of individuals who will need access to the select agents and toxins. Individuals will need to be approved for access by the Department of Health and Human Services. Approvals will be based on security risk assessments that will be conducted by the Department of Justice. The definition of restricted persons is included in the Interim Rules.
Security Plan for Select Agents:
The Plan must include a description of:
- Inventory control procedures (public comments are being sought on inventory of replicating microorganisms)
- Minimal education and experience criteria for individuals with access to agents.
- Physical security measures (e.g., card access, key pads, changing of access for staff changes)
- Cyber security measures
- Provisions for routine cleaning, maintenance, and repairs (if not DHHS approved, staff must be escorted and continually monitored when in locations that store or use select agents)
- Training of personnel in security procedures
- Procedures for reporting suspicious persons, thefts or loss of agents or toxins or alteration of inventory records
- Inspection of all packages entering and exiting area
Emergency Response Plan:
A detailed list of required elements for the emergency response plan may be found on page 72 and 73 of the document. Although the campus plan addresses many of the requirements, additional information will need to be developed such as information on the hazards associated with the use of the select agents and toxins, hazards associated with the response actions that could lead to a spread of the agent, safe distances and places of refuge, decontamination, and special procedures for specific agents.
Timeline for phase-in of registration:
- For entities already registered with the CDC or USDA (this applies to SBU) some of the provisions will apply on or after February 7, 2003.
- Application to certify Department of Justice review of the Entity and Responsible Official due: March 12, 2003
- DOJ review of entity and RO completed: April 12, 2003
- DOJ review of individuals with access to select agents: June 12, 2003
- Development of security plan: June 12, 2003
- Security plan and related training implemented: September 12, 2003
- Full compliance: November 11, 2003
Additional details on inspections, recordkeeping, required notifications to the RO of modifications of work and provisions for civil and criminal penalties may be found in the Interim Rules.
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