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B. Responsibilities
- Select Agent Program:
Select Agent Toxins are certain toxins of biological origin which are to subject to stringent regulatory requirements under 42 CFR 73 for their potential to pose a severe threat to public, animal or plant health or to animal or plant products. These toxins, along with specified biological agents (viruses, bacteria, fungi), fall under the oversight of the National Select Agents Registry (NSAR) Program
http://www.selectagents.gov/Select%20Agents%20and%20Toxins.html. The Select Agents Program (SAP) at Rowan University ensures compliance with all applicable federal regulations (7 CFR Part 331, 9 CFR Part 121, and 42 CFR part 73) as well as the NIH Guidelines and the standards set forth in Biosafety in Microbiological and Biomedical Laboratories 5th ed.
Possession of any quantity of select agents, or nucleic acids that encode infectious/replication competent forms of the listed viruses, or functional forms of any of the listed toxins requires registration in the program. To register the use of select agents, users must contact EH&S.
This policy requires training, safe handling, use, and storage procedures. Effective tracking (receiving, shipping, and inventory control) and security of select agents and toxins and compliance with federal regulations (42 CFR Part 73).
A Principal Investigator (PI) and a Responsible Official (RO) ensure compliance with all aspects of biosafety, biosecurity and incident response. Researchers that handle the select agents or enter areas where they are stored must be Security Risk Assessment (SRA) approved, medically cleared, trained and have their competency assessed. - Physical Plant:
EH&S, in conjunction with Physical Plant, Facilities Planning and Construction (FP&C) and the Laboratory Safety Committee shall develop Minimum Laboratory Safety Design Guidelines for new/renovated laboratories. The architect/engineer affiliated with the project must bring potential departures from the guidelines to the attention of the Project Manager who shall ensure that it is brought to the attention of Physical Plant, EH&S and the end user and discussed at a planning meeting before being accepted. FP&C shall provide the Architect/Engineer with a copy of the guidelines in the beginning of the planning stage and shall advise them of the above requirement.