1. University Registration Procedures
All entities must register with the Federal Government in order to have access to select agents or (non-exempt) toxins. An entity is any government agency (Federal, State, or local), academic institution, corporation, company, partnership, society, association, firm, sole proprietorship, or other legal entity. The University of Iowa has completed all necessary procedures and is operating under a Certificate of Registration. The RO is responsible for renewing this registration every three years.
2. Individual Person Registration Procedures
Each Individual must complete the following procedure to register with the Federal government.
- All University of Iowa employees must contact Haley Sinn, Biological Safety Officer, EHS, 335-9553.
- Federal law requires a user’s registration be based at each facility in which select agents will be stored or used.
- A Select Agent Internal Registration form will be emailed from EHS’s Biosafety Office to each PI requesting access. The internal form must be completed and returned to Haley Sinn. This form contains the information necessary to process the CDC Select Agent application. All communication with the CDC will take place through the RO or ARO.
- All individuals requesting access to Select Agents or Select Agent Toxins above the exempted amount must complete a security risk assessment by the Federal Bureau of Investigation (FBI) and receive a registration approval number prior to gaining access to select agents. The PI and any staff listed in Section A on the Select Agent Internal Registration form will be contacted for fingerprinting and completion of the FBI FD-961 form.
Additionally, individuals will be subject to a pre-access suitability assessment by the UI's Suitability Assessment Review Committee (SARC). The SARC will review address and work history, perform a credential and criminal background check, contact references and require interviews of individuals requesting access to the lab.
- As defined in the USA Patriot Act, “restricted persons” are not allowed access to these materials. A Restricted Person is an individual who:
- Is under indictment for a crime punishable by imprisonment for a term exceeding 1 year.
- Has been convicted in any court of a crime punishable by imprisonment for a term exceeding 1 year.
- Is a fugitive from justice.
- Is an unlawful user of any controlled substance as defined in the Controlled Substances Act.
- Is an alien (not a citizen or a national of the United States) illegally or unlawfully in the United States.
- Has been adjudicated as a mental defective or has been committed to any mental institution.
- Is an alien (other than an alien lawfully admitted for permanent residence) who is a national of a country as to which the Secretary of State has made a determination that such country has repeatedly provided support for acts of international terrorism; this includes Iran, Iraq, Libya, Cuba, North Korea, Syria, and Sudan.
- Has been discharged from the Armed Services of the United States under dishonorable conditions.
- The registration process should be initiated as soon as possible as there are often significant time delays in receiving registration approval from the federal government.
- The RO or Laboratory Director will notify appropriate individuals when access to select agents has been authorized by the federal government and the SARC. Individuals will then be enrolled in the ongoing suitability assessment program as long as access to the agents is maintained.
3. Authorization for Access – University Procedures
An individual must complete the required security risk assessment and all training prior to receiving full access to a select agent or toxin. An internal access form will be initiated by the RO, requiring several signatures before access will be granted. Necessary requirements include:
- Passing the FBI security risk assessment.
- A research protocol describing all experiments, procedures, and practices to be carried out in the lab must be submitted to the appropriate oversight committee. All organisms and research protocols must be approved by this committee prior to initiating research with Select Agents or Toxins.
- Individuals must undergo facility-specific safety, security, and recordkeeping training. This training will be provided through the appropriate laboratory.