Additional Information on the Interim Final Rule November 3, 2003

Interim Final Rule Amending the Security Risk Assessment Applicability Requirements

We are amending an interim final rule published on December 13, 2002, that established requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins. The requirements were established to implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. The December 2002 interim final rule established a phase-in period for certain requirements to allow entities to comply without causing disruption or termination of research or educational projects. The phase-in for entities that on February 7, 2003, were already conducting activities under a certificate of registration issued under 42 C.F.R. § 72.6, or already were lawfully possessing select agents and toxins, required that entities applying for registration with the select agent program, and individuals requiring access to select agents and toxins, to undergo a security risk assessment by the Attorney General before November 12, 2003. The regulations also provided that an entity that on February 7, 2003, was not already conducting activities under a certificate of registration issued under 42 C.F.R. § 72.6, or was not already lawfully possessing select agents and toxins, would be eligible for registration to possess, use, or transfer select agents and toxins as soon as the entity met all of the applicable requirements of Part 73, including the requirement for the Attorney General to conduct a security risk assessment. We are now amending the applicability requirements to allow for the issuance of provisional registration certificates for all entities, and provisional grants of access for all individuals, from whom, prior to November 12, 2003, the Attorney General has received all of the information required by the Attorney General to conduct a security risk assessment if those entities and individuals otherwise meet all of the requirements of Part 73. This action is necessary to ensure that both ongoing and new research and educational efforts important to the national defense are not disrupted.

FAQ for New Regulation

1. What is the purpose of the IFR?

We are amending the interim final rule published on December 13, 2002, that established requirements regarding possession and use in the United States, receipt from outside the United States, and transfer within the United States, of select agents and toxins (42 C.R.F. Part 43, of the Select Agent regulations). The amendment would change the applicability requirements to allow for the issuance of provisional registration certificates for all entities, and provisional grants of access for all individuals. For entities and individuals to be eligible for this provisional status the Attorney General must have received all of the information required to conduct a security risk assessment and meet all other requirements under the interim final rule by November 12, 2003. In addition the amendment would allow for the issuance of provisional registration certificates for entities not currently in possession of select agents or toxins. For entities and individuals to be eligible for this provisional status the Attorney General must have received all of the information required to conduct a security risk assessment and meet all other requirements under the interim rule by November 12, 2003.

2. Why is an IFR necessary at this time?

Amending Part 73 of the interim final rule was necessary to ensure that both ongoing and new research and educational efforts important to the national defense are not disrupted. In general, the entities regulated under the December 2002 interim final rule are academic institutions and biomedical centers; commercial manufacturing (the pharmaceutical industry) or distribution facilities; federal, state, and local laboratories, including clinical and diagnostic laboratories; and research facilities. The December 2002 interim final rule established a phase-in period for certain requirements to allow entities to comply without causing disruption or termination of research or educational projects. The phase-in for entities that on February 7, 2003, already conducting activities under a certificate of registration issued under 42 C.F.R. § 72.6, or already were lawfully possessing select agents and toxins, required that entities applying for registration with the select agent program, and individuals requiring access to select agents and toxins, to undergo a security risk assessment by the Attorney General before November 12, 2003. The Attorney General has assigned the responsibility to conduct the security risk assessments required by the Act to the Criminal Justice Information Services (CJIS) Division of the Federal Bureau of Investigation (FBI). With the CJIS Division currently able to process approximately 1,200 applications per month, the CJIS Division has projected that even if immediately completed, many of the 4,600 incomplete applications would not be processed by the November 12, 2003, regulatory deadline.

3. What am I required to submit to the Attorney General?

All individuals or nongovernmental entities seeking to register with CDC under the provisions of 42 C.F.R. Part 73 must have a security risk assessment (SRA) conducted by the Attorney General. The Attorney General, U.S. Department of Justice, has designated the Federal Bureau of Investigation (FBI), Criminal Justice Information Services Division (CJIS), to conduct the security risk assessments. As part of the FBI’s security risk assessment, each individual who has been identified as requiring access to select biological agents and toxins, as well as the RO, ARO, and any individual who owns or controls the entity, must complete FBI Form FD-961 and submit two legible fingerprint (FP) cards to CJIS. Individuals and entities should submit their FD-961 forms and fingerprint cards to the CJIS Division in one package. For additional instructions or if you have any questions concerning the FBI/CJIS SRA process, please contact FBI/CJIS at 304-625-7470 or visit their Web site at http://www.fbi.gov/hq/cjisd/cjis.htm.

4. How do I know if the Attorney General has all of my information?

The Criminal Justice Information Services Division of the Federal Bureau of Investigation is notifying those that have not submitted all of the required information. You may also contact them at 304-625-7470.

5. When should I expect to receive my provisional registration or a provisional grant of access?

The Responsible Official of the entity will receive a reminder of who has submitted all of the required information to the FBI, and is therefore eligible for a provisional registration or provisional granting of access to select agents and toxins by December 13, 2003.

6. What are we supposed to do with our select agents until we receive our provisional registration?

Through your point of contact with the Select Agent Program you already know whether the Select Agent Program has identified any deficiencies in your application that would disqualify your entity from being granted a provisional registration. If an entity otherwise meets all of the requirements for registration under the provisions of 42 C.F.R. Part 73, it may continue to possess and use select agents as it has since February 2003.

7. What are we supposed to do until we receive our provisional grant of access to a select agent?

Each Responsible Official should know whether an individual has successfully submitted all of the information and the fingerprint card required by the Attorney General for a security risk assessment. Such individuals who are therefore eligible to receive provisional grants of access should be allowed to continue to have the same access to a select agent that they have had since February 2003.

8. How long is a provisional certificate or a provisional grant of access effective?

A provisional registration certificate will be effective until the HHS Secretary either issues a certificate of registration or suspends or revokes the provisional registration. A provisional grant of access will be effective until the HHS Secretary either grants the individual access or denies access to a select agent or toxin.

Some documents are available for viewing, printing, and downloading (saving) in Adobe Acrobat's portable document file (PDF) format. You will need the Adobe Acrobat Reader 5.0 or above on your computer and configured to work on your browser to access the file.

 If you do not have the latest version of Adobe Acrobat Reader, you may download a free copy from
Adobe

SAP Home | Site Map | Contact Us
Accessibility | Privacy Policy
CDC Home | Search | Health Topics A-Z

This page last reviewed March 16, 2004

United States Department of Health and Human Services
Centers for Disease Control and Prevention
Office of the Director
Select Agent Program