Privacy Act System Notice 09-20-0170

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SYSTEM NAME:   National Select Agent Registry (NSAR)/Select Agent Transfer and Entity Registration Information System (SATERIS), HHS/CDC/COTPER.

Security Classification:  Unclassified.

System Location: Division of Select Agents and Toxins (DSAT), Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER), Bldg. 20, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Atlanta, GA 30333 and Federal Records Center, 4712 Southpark Blvd., Ellenwood, GA 30294.

Categories of Individuals Covered By the System: The Responsible Official, alternate Responsible Official, owners of non-governmental entities, and individuals requesting access to select agents under the provisions of Part 73, of Title 42 of the Code of Federal Regulations (42 CFR part 73), Part 121 of Title 9 of the Code of Federal Regulations (9 CFR Part 121), and Part 331 of Title 7 of the Code of Federal Regulations (7 CFR part 331).

Categories of Records in the System: The DSAT maintains records which include the names of the Responsible Official, alternate Responsible Official, owners of non-governmental entities, and individuals who have access, or who have applied to have access to select agents (defined as a virus, bacteria, fungus or toxin that could pose a severe threat to public health and safety, to animal or plant health; or animal or plant products), and the list of select agents to which they have access. The Responsible Official, alternate Responsible Official, owners of non-governmental entities, and individuals requesting access to select agents are required to provide their name, address, date of birth, and job title and the name of the institution that would be housing the select agent(s).

Authority For Maintenance of the System: Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 and The Agricultural Bioterrorism Protection Act of 2002 (Pub. L. 107-188).

Purpose(s): Records maintained in the National Select Agent Registry (NSAR)--a joint DSAT and U.S. Department of Agriculture/Animal and Plant Health Inspection Service (APHIS) information management system--are accessed by DSAT through the Select Agent Transfer and Entity Registration Information System (SATERIS) which is an user interface for data entry, data query, and routine reporting activities. The purpose of this system of records is to limit access to those select agents listed in 42 CFR Part 73, 9 CFR Part 121, and 7 CFR Part 331 to those individuals who have a legitimate need to handle or use such select agents, and who are not identified as a restricted person by the U.S. Attorney General. The NSAR is also used to track the possession, use, and transfer of select agents and is a single Web-based system shared by DSAT and APHIS.

DSAT conducts regulatory oversight of individuals and entities that possess, use, or transfer select agents. This includes the review of registration applications, conducting inspections of registered facilities or facilities requesting registration, processing requests to import select agents, processing all reports and requests received from individuals or entities regarding a select agent, and maintaining this information pertaining to individuals and entities that possess, use, and/or transfer select agents.

Routine Uses of Records Maintained In the System, Including Categories of Users and the Purposes of Such Uses:
1. Records may be disclosed to contractors to handle program work overflow duties, performing many of the same functions (listed in the Purpose section above) as DSAT employees. Contractors are required to maintain Privacy Act safeguards with respect to such records.
   
2. Records may be disclosed to health departments and other public health or cooperating medical authorities to deal more effectively with outbreaks and conditions of public health significance.

3. Personal information from this system may be disclosed as a routine use to assist the recipient Federal agency in making a determination concerning an individual's trustworthiness to access select agents; to any Federal or State agency where the purpose in making the disclosure is to prevent access to select agents for use in domestic or international terrorism or for any criminal purpose; or to any Federal or State agency to protect the public health and safety with regard to the possession, use, or transfer of select agents.

4. Disclosure may be made to a congressional office from the record of an individual in response to a verified inquiry from the congressional office made at the written request of that individual.
  
5. In the event of litigation where the defendant is: (a) The Department, any component of the Department, or any employee of the Department in his or her official capacity; (b) the United States where the Department determines that the claim, if successful, is likely to directly affect the operations of the Department or any of its components; or (c) any Department employee in his or her individual capacity where the Justice Department has agreed to represent such employee, disclosure may be made to the Department of Justice to enable that Department to present an effective defense, provided that such disclosure is compatible with the purpose for which the records were collected.

Policies and Practices For Storing, Retrieving, Accessing, Retaining, and Disposing of Records In the System Storage: File folders, computer tapes and disks, CD-ROMs.

Retrievability: By name or DOJ identifier number.

Safeguards: The following special safeguards are provided to protect the records from inadvertent disclosure:

1. Authorized Users: A database security package is implemented on CDC computers to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Individuals who have routine access to these records are limited to Select Agent Program staff (DSAT FTEs and contractors) who have responsibility for conducting regulatory oversight of individuals and entities that possess, use, or transfer select agents.

2. Physical Safeguards: Paper records are maintained in locked cabinets in locked rooms in a restricted access location that is controlled by a cardkey system, and security guard service provides personnel screening of visitors. Electronic data files are password protected and stored in a restricted access location. The computer room is protected by an automatic sprinkler system, numerous automatic sensors (e.g., water, heat, smoke, etc.) are installed, and a proper mix of portable fire extinguishers is located throughout the computer room. The system is backed up on a nightly basis with copies of the files stored off site in a secure location. Computer workstations, lockable personal computers, and automated records are located in secured areas.

3. Procedural Safeguards: Protection for computerized records includes programmed verification of valid user identification code and password prior to logging on to the system; mandatory password changes, limited log-ins, virus protection, and user rights/file attribute restrictions. Password protection imposes user name and password log-in requirements to prevent unauthorized access. Each user name is assigned limited access rights to files and directories at varying levels to control file sharing. There are routine daily backup procedures and secure off-site storage is available for backup files.

Knowledge of individual tape passwords is required to access tapes, and access to the system is limited to users obtaining prior supervisory approval. To avoid inadvertent data disclosure, a special additional procedure isperformed to ensure that all Privacy Act data are removed from computer tapes and/or other magnetic media. When possible, a backup copy of data is stored at an offsite location and a log kept of all changes to each file and all persons reviewing the file. Additional safeguards may also be built into the program by the system analyst as warranted by the sensitivity of the data set.
   
The DSAT and contractor employees who maintain records are instructed in specific procedures to protect the security of records, and are to check with the system manager prior to making disclosure of data. When individually identified data are being used in a room, admittance at either CDC or contractor sites is restricted to specifically authorized personnel.
   
Appropriate Privacy Act provisions are included in contracts and the CDC Project Director, contract officers, and project officers oversee compliance with these requirements. Upon completion of the contract, all data will be either returned to CDC or destroyed, as specified by the contract.
   
The USDA/APHIS maintains similarly stringent safeguards that are discussed within that agency's Select Agent system of records notice.

4. Implementation Guidelines: The safeguards outlined above are in accordance with the HHS Information Security Program Policy and FIPS Pub 200, ``Minimum Security Requirements for Federal Information and Information Systems.'' Data maintained on CDC's Mainframe and the COTPER LAN are in compliance with OMB Circular A-130, Appendix III.

Security is provided for information collection, processing, transmission, storage, and dissemination in general support systems and major applications.

Retention and Disposal: The DSAT records and associated information are retained and dispositioned in accordance with DSAT records retention schedule, N1-442-06-1, pending approval by the National Archives and Records Administration. The DSAT records will be retained for 10 years in compliance with the records retention schedule requirements or until such time as no longer needed for litigation or other records purposes. Records will be transferred to a Federal Records Center for storage when no longer in active use. Final disposition of records stored offsite at the Federal Records Center will be accomplished by a controlled process requesting final dispositionapproval from the record owner prior to any destruction to ensure records are not needed for litigation orother records purposes. Hard copy records and Sensitive But Unclassified (SBU) information designated for local disposition will be placed in a locked container or designated secure storage area while awaiting destruction. All SBU data will be destroyed in a manner that precludes its reconstruction, such as shredding.

Electronic information will be deleted or overwritten using overwriting software that wipes the entire physical disk and not just the virtual disk. Overwriting is required for the destruction of all electronic SBU information.

System manager(s) and Address: Director, Division of Select Agents and Toxins, Coordinating Office
for Terrorism Preparedness and Emergency Response, Bldg. 20, Rm. 4100, MS A46, Centers for Disease Controland Prevention, 1600 Clifton Road, NE., Atlanta, GA 30333.

Notification Procedure: An individual may learn if a record exists about himself or herself by contacting the system manager at the above address. Requesters in person must provide driver's license or other positive identification. Individuals who do not appear in person must submit a notarized request on institutional letterhead to verify theiridentity. The knowing and willful request for or acquisition of a record pertaining to an individual under false pretenses is a criminal offense under the Privacy Act subject to a $5,000 fine and/or imprisonment.

Record Access Procedures: Same as notification procedures. Requestors should also reasonably  specify the record contents being sought. An accounting of disclosures that have been made of the record, if any, may also be requested.

Contesting Record Procedures: Contact the system manager at the address specified above, reasonably identify the record and specify the information being contested, the corrective action sought, and the reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.

Record Source Categories: Applicants registering for possession, use, and transfer of select
agents and the U.S. Attorney General.

 [FR Doc. E7-12682 Filed 6-29-07; 8:45 am]

BILLING CODE 4163-18-P

[Federal Register: July 2, 2007 (Volume 72, Number 126)] [Notices] [Page 35993-35997] (PDF)