System Name: Records of Subjects in Agent Orange, Vietnam Experience, and Selected Cancers Studies, HHS/CDC/NCEH.
Security Classification: None.
National Center for Environmental Health, Chamblee Bldg. 101, Rm. G336, Centers for Disease Control and Prevention, 4770 Buford Highway NE, Atlanta, GA 30341-3724 and Federal Records Center, 1557 St. Joseph Avenue, East Point, GA 30344.
Data are located at contractor sites as data are collected. A list of contractor sites where individually identified data are currently located is available upon request to the system manager.
Categories of Individuals Covered by the System: Selected male U.S. Army veterans at grade E-5 or below who enlisted or were drafted for one tour of duty in Vietnam or other countries during 1966 - 1972; males with birthdates 1929-1953 who have cases of selected cancers (specifically, lymphomas, soft tissue sarcomas, nasal and nasopharyngeal, and primary liver) diagnosed between December 1, 1984 to November 30, 1988; also included are control group participants.
Categories of Records in the System: Information identifying the participants (such as name, address, social security number, military service number, telephone number, date of birth), interview questionnaire responses, medical, laboratory, and psychological test result data, and records on biological specimens (e.g. blood, tumor, urine, etc.).
Authority for Maintenance of the System: Pub. L. 96-151, "Veterans Health Programs Extension and Improvement Act of 1979" (38 U.S.C. 219 note); Pub. L. 97-72, "Veterans' Health Care, Training, and Small Business Loan Act of 1981" (38 U.S.C. 219 note); Public Health Service Act, sections 304, 306, and 308(d), which discuss authority to grant assurances of confidentiality for health research and related activities (42 U.S.C. 242 b, k, and m(d)).
Purpose(s): Records in this system are used to support studies to assess the health of Vietnam veterans relative to the health of other men of similar age. Specifically this information should enable the Centers for Disease Control (CDC) to:
1. Evaluate the relationship of documented exposure to herbicides used in Vietnam (primarily Agent Orange) to possible adverse health consequences. Such possible effects to be evaluated include dermatologic, neurological, psychological, immunological, carcinogenic, reproductive, gastrointestinal, and others.
2. Assess the health effects of service in Vietnam (including factors other than herbicide exposure) as opposed to the experiences of veterans who served in other countries.
3. Evaluate the risk of selected cancers among Vietnam veterans in contrast to men of similar age who did not serve in Vietnam.
Portions of records (i.e., name, social security number or military service number, date of birth) may be disclosed to the National Center for Health Statistics for obtaining a determination of vital status. Death certificates stating the cause of death will then be obtained from the appropriate Federal, State, or local agency to enable CDC to evaluate whether excess mortality is occurring among Vietnam veterans. Portions may also be disclosed to the Social Security Administration who will provide additional sources of information for locating veterans involved in the study.
Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of such Uses: Records have been disclosed to Department of Health and Human Services contractors to locate veterans, cancer cases and controls, conduct interviews, perform medical examinations, analyze pathology specimens, and similar medical services, so that the research purposes for which the records were collected could be accomplished. The contractor was required to comply with the Privacy Act and to follow Section 308(d) of the Public Health Service Act with respect to such records.
Portions of records (i.e., name, Social Security number or military service number) have been disclosed to other Federal agencies such as the Veterans Administration, Internal Revenue Service, and Social Security Administration only to obtain information to aid in locating veterans involved in the study. These disclosures would have been made to update locating information provided by the Army and Joint Services Environmental Support Group.
Records may be disclosed to appropriate Federal agencies and Department contractors that have a need to know the information for the purpose of assisting the Department's efforts to respond to a suspected or confirmed breach of the security or confidentiality of information disclosed is relevant and necessary for that assistance.
Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System—
Storage: File folders, microfilm, computer cards, tapes/disks and printouts.
Retrievability: By name, social security number or military service number (when supplied voluntarily or contained in existing records used in studies under this system), or other identifying number.
Records in this system are collected under an Assurance of Confidentiality authorized by section 308(d) of the Public Health Service Act. To comply with this Assurance, the following special safeguards are necessary:
1. Authorized users: Access is granted to only a limited number of physicians, scientists, statisticians, and designated support staff of CDC or its contractors, as authorized by the Project Director to accomplish the stated purposes for which the data in this system has been collected.
2. Physical safeguards: Questionnaires and other source data are maintained in locked fire-resistant cabinets in locked rooms. When entered into the computer, individually identified information is kept separate from data used for analysis. Tape data are stored in fire-resistant safes. There is 24-hour guard service in buildings, personnel screening of visitors, fire extinguishers, overhead sprinkler system and card- access control equipment in the computer room, and computer terminals and automated records are located in secured areas. Electronic anti- intrusion devices are in operation at the Federal Records Center.
3. Procedural safeguards: Protection for computerized records includes programmed verification of valid user identification code, account code and password prior to acceptance of a terminal session or job submission and frequently changed passwords. Knowledge of individual tape passwords is required to access tapes, and access to systems is limited to users obtaining prior supervisory approval. Names and other details necessary to identify individuals are not included in data files used for analysis. These files are indexed by code numbers which are linked with complete identifiers only if there is a specific need such as data verification or followup interviews. Keys which link identification numbers to names are stored separately with access limited to CDC project officers and authorized staff.
CDC and contractor employees who maintain records are instructed in specific rules of conduct to protect the security and confidentiality of records in accordance with section 308(d) of the Public Health Service Act. When individually identified records are being used in a room at a contractor site, admittance to the room is restricted to employees pledged to confidentiality under this statute. All data will be either returned to CDC or destroyed, as specified by the contract.
Appropriate Privacy Act provisions and confidentiality provisions under section 308(d) of the Public Health Service Act are included in contracts. The CDC Project Director, contract officers, and project officers oversee compliance with these requirements.
4. Implementation guidelines: The safeguards outlined above are developed in accordance with Chapter 45-13, "Safeguarding Records Contained in Systems of Records," of the HHS General Administration Manual, supplementary Chapter PHS.hf: 45-13; Part 6, "Automated Information System Security," of the HHS Information Resources Management Manual; the National Bureau of Standards Federal Information Processing Standards (FIPS Pub. 41 and FIPS Pub. 31). FRC safeguards are in compliance with GSA Federal Property Management Regulations, Subchapter B--Archives and Records.
Retention and Disposal: CDC retains research records in accordance with the CDC Records Control Schedule Item 37, which allows the system manager to maintain the records for 20 years unless needed for future reference. Because five-year mortality updates are planned until the study population expires, and health information from the questionnaire will be correlated with the mortality data, the computerized records to which questionnaire data will be converted may be kept as long as research needs dictate. Contractors will retain the records only as long as necessary to complete data collection and verify CDC's receipt of the data in usable form.
Records may be transferred to a Federal Records Center for storage when no longer needed for evaluation or analysis and will be retained there subject to statutory confidentiality requirements. Disposal methods include the paper recycling process, shredding hardcopy records, and erasing computer tapes and disks.
System Manager(s) and Address(es):
Director, National Center for Environmental Health, Chamblee Bldg. 101, Rm. 3116, Centers for Disease Control, 4770 Buford Highway NE, Atlanta, GA 30341-3724.
Notification Procedure: An individual may learn if a record exists about himself by contacting the system manager at the address above. Persons who knowingly and willfully request or acquire a record pertaining to an individual under false pretenses are subject to a 5,000 dollars fine for this criminal offense. Requesters in person must provide photo identification (such as driver's license) or other positive identification (i.e., place of birth, etc.) that would authenticate the identity of the individual making the request. Individuals who do not appear in person must submit a notarized request to verify their identity. A guardian who requests notification of, or access to, a mentally incompetent or severely physically impaired person's record must provide a birth certificate (or notarized copy), court order, or other competent evidence of guardianship. An individual who requests notification of, or access to, a medical record shall at the time the request is made, designate in writing a responsible representative (who may be a physician, other health professional, or other responsible individual) who will be willing to review the record and inform the subject individual of its contents at the representative's discretion.
In addition, the following information must be provided when requesting notification: (1) Full name and social security or military service number; (2) nature of the study in which the requester participated.
Record Access Procedures: Same as notification procedures. Requesters should also reasonably specify the record contents being sought. An accounting of disclosures that have been made of the record, if any, may be requested.
Contesting Record Procedures: Contact the official at the address specified under System Manager 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: Subject individuals, Department of Defense (Army and Joint Services Environmental Support Group), Surveillance, Epidemiology, and End Results Centers (cancer registries). Records are derived from U.S. Army system of records: AO708.02ADAPC, "Official Military Personnel File.`
Systems Exempted from Certain Provisions of the Act: None.