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Department of Health and Human Services (DHHS).
Notification of Proposed Altered System of Records.
The Department of Health and Human Services proposes to alter System of Records, 09-19-0001, “Records of Persons Exposed or Potentially Exposed to Toxic or Hazardous Substances, HHS/ATSDR.” HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) Memoranda (M) 07-16, Safeguarding Against and Responding to the Breach of Personally Identifiable Information:
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.
These records will be maintained by the Agency for Toxic Substances and Disease Registry (ATSDR), Coordinating Center for Environmental Health and Injury Prevention (CCEHIP), Division of Health Studies.
Comments must be received on or before February 24, 2011. The proposed altered System of Records will be effective 40 days from the date submitted to the OMB, unless ATSDR/CCEHIP receives comments that would result in a contrary determination.
You may submit comments, identified by the Privacy Act System of Record Number 09-19-0001:
- Federal eRulemaking Portal: http://regulations.gov. Follow the instructions for submitting comments.
- E-mail: Include PA SOR number 09-19-0001 in the subject line of the message.
- Phone: 770/488-8660 (not a toll-free number).
- Fax: 770/488-8659.
- Mail: HHS/CDC Senior Official for Privacy (SOP), Office of the Chief Information Security Officer (OCISO), 4770 Buford Highway—M/S: F-35, Chamblee, GA 30341.
- Hand Delivery/Courier: HHS/CDC Senior Official for Privacy (SOP), Office of the Chief Information Security Officer (OCISO), 4770 Buford Highway—M/S: F-35, Chamblee, GA 30341.
- Comments received will be available for inspection and copying at this same address from 9 a.m. to 3 p.m., Monday through Friday, Federal holidays excepted.
ATSDR/CCEHIP proposes to alter System of Records, No. 09-19-0001, “Records of Persons Exposed or Potentially Exposed to Toxic or Hazardous Substances, HHS/ATSDR.” Records in this system are used to carry out the legislated environmental public health mandates of the Agency for Toxic Substances and Disease Registry (ATSDR). Specifically this information is used to: (1) Identify the public health threat caused by exposure to toxic and hazardous substances utilizing health outcome studies, epidemiologic studies, exposure investigations, and other health effects studies; and (2) establish and maintain national registries of persons exposed to toxic substances and persons with serious diseases and illnesses associated or potentially associated with exposure to toxic substances. Registries will have the additional purposes of tracking exposed individuals, keeping them informed of health effects of exposure, preventive measures and possible breakthroughs in treatment, along with serving as a centralized location for research data on these exposed individuals.
This System of Record Notice is being altered to add the Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB) memorandum dated May 22, 2007.
The following notice is written in the present tense, rather than the future tense, in order to avoid the unnecessary expenditure of public funds to republish the notice after the System has become effective.Start Signature
Dated: December 11, 2009.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
This document was received at the Office of the Federal Register on December 27, 2010.
SYSTEM NUMBER: 09-19-0001
Records of Persons Exposed or Potentially Exposed to Toxic or Hazardous Substances, HHS/ATSDR.
Division of Health Studies, Agency for Toxic Substances and Disease Registry (ATSDR), Coordinating Center for Environmental Health and Injury Prevention (CCEHIP), 4770 Buford Highway, Building 106, Atlanta, GA 30341,
Division of Health Assessment and Consultation, ATSDR, CCEHIP, 4770 Buford Highway, Building 106, Atlanta, GA 30341,
Division of Regional Operations, ATSDR, CCEHIP, 4770 Buford Highway, Building 106, Atlanta, GA 30341,
Division of Toxicology and Environmental Medicine, ATSDR, CCEHIP, 4770 Buford Highway, Building 106, Atlanta, GA 30341-3724; and
Federal Records Center, 4712 Southpark Blvd., Ellenwood, GA 30294. Data are also located at contractor sites. 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:
Individuals exposed or potentially exposed to toxic or hazardous substances may include the following: (1) Selected persons living or having lived near a hazardous waste site, including facilities owned or operated by the United States; (2) persons exposed or potentially exposed to environmental hazards resulting from exposure to contaminated water, soil, air, or biota; (3) participants in health outcome studies (including exposure studies, symptom and disease prevalence studies, cluster investigations), and epidemiologic studies to determine the public health threat of exposure to hazardous or toxic substances; (4) registry participants with exposures associated with specific chemicals; (5) participants from sites of emergency activities, and other sites that are the subject of a citizen's petition; (6) persons working or having worked in response actions at hazardous waste sites or other occupational settings where exposure to hazardous substances occurred. The first five categories of persons above may include children as well as adults.
CATEGORIES OF RECORDS IN THE SYSTEM:
Name, address, (including length of time at current address), telephone number, date of birth, Social Security number, sex, current and past occupations, dates, pathways and routes of toxic or hazardous substance exposure or potential exposure, environmental sampling data, smoking history, results of medical and laboratory tests, records on biological specimens (e.g. blood, urine, etc.), and related documents such as Start Printed Page 4433questionnaire responses. The specific type of records collected and maintained is determined by the needs of the individual registry or study.
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
“Comprehensive Environmental Response, Compensation, and Liability Act of 1980” as amended by “Superfund Amendments and Reauthorization Act of 1986” (42 U.S.C. 9601, 9604); and the “Resource Conservation and Recovery Act of 1976” as amended in 1984 (42 U.S.C. 6901).
Records in this system are used to carry out the legislated environmental public health mandates of the Agency for Toxic Substances and Disease Registry (ATSDR). Specifically this information is used to: (1) Identify the public health threat caused by exposure to toxic and hazardous substances utilizing health outcome studies, epidemiologic studies, exposure investigations, and other health effects studies; and (2) establish and maintain national registries of persons exposed to toxic substances and persons with serious diseases and illnesses associated or potentially associated with exposure to toxic substances. Registries will have the additional purposes of tracking exposed individuals, keeping them informed of health effects of exposure, preventive measures and possible breakthroughs in treatment, along with serving as a centralized location for research data on these exposed individuals.
Records may be disclosed to the National Center for Environmental Health, CCEHIP, and Centers for Disease Control and Prevention (CDC), for laboratory analysis of samples and for collaborative efforts (i.e., providing staff, performing statistical analysis, etc.) in coordinating investigations.
Records (i.e., name, Social Security number, date of birth) may be disclosed to the National Center for Health Statistics, CDC to obtain a determination of vital status. Death certificates with the cause of death will then be obtained from Federal, State, or local agencies to enable ATSDR to: (1) Determine whether excess mortality is occurring among individuals exposed to toxic or hazardous substances; and (2) notify similarly exposed persons.
ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSES OF SUCH USES:
Records may be disclosed to Department of Health and Human Services contractors to locate individuals exposed or potentially exposed to toxic or hazardous substances (e.g., in the establishment of the National Exposure Registry), conduct interviews, perform medical examinations, collect and analyze biological specimens, evaluate and interpret data, and perform follow up health investigations so that the research purposes for which the records are collected may be accomplished. The contractor must comply with the requirements of the Privacy Act with respect to such records.
Records may be disclosed to Federal agencies such as the Environmental Protection Agency (EPA), State and local health departments, and other public health or cooperating medical authorities in connection with program activities and related collaborative efforts to deal more effectively with exposures to hazardous or toxic substances, and to satisfy mandatory reporting requirements when applicable.
Records (i.e., name, Social Security number) may be disclosed to other Federal agencies and to missing person location agencies to obtain information to aid in locating individuals involved in these studies.
Records may be disclosed for a research purpose, when the Department:
(A) Has determined that the use or disclosure does not violate legal or policy limitations under which the record was provided, collected, or obtained; (B) has determined that the research purpose (1) cannot be reasonably accomplished unless the record is provided in individually identified form, and (2) warrants the risk to the privacy of the individual that additional exposure of the record might bring; (C) has required the recipient to (1) establish reasonable administrative, technical, and physical safeguards to prevent unauthorized use or disclosure of the record, (2) remove or destroy the information that identifies the individual at the earliest time at which removal or destruction can be accomplished consistent with the purpose of the research project, unless the recipient has presented adequate justification of a research or health nature for retaining such information, and (3) make no further use or disclosure of the record except (a) in emergency circumstances affecting the health or safety of any individual, (b) for use in another research project, under these same conditions, and with written authorization of the Department, (c) for disclosure to a properly identified person for the purpose of an audit related to the research project, if information that would enable research subjects to be identified is removed or destroyed at the earliest opportunity consistent with the purpose of the audit, or (d) when required by law; and (D) has secured a written statement attesting to the recipient's understanding of, and willingness to abide by these provisions.
Disclosures may be made to a congressional office from the records of an individual, in response to a verified inquiry from the congressional office made at the written request of that individual.
In the event of litigation initiated by EPA in collaboration with ATSDR, ATSDR may disclose such records as it deems desirable or necessary to the Department of Justice to enable the Department to effectively represent ATSDR. The types of litigative proceedings that ATSDR may request include the recovery of expenses incurred in cleanup operations at Superfund or Resource Conservation and Recovery Act sites, including program and staff costs.
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 claims, if successful, are 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 Department of Justice has agreed to represent such employee, for example, in defending a claim against the Public Health Service based upon an individual's mental or physical condition and alleged to have arisen because of activities of the Public Health Service in connection with such individual, 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.
Records may be provided to the Social Security Administration by ATSDR, for the purpose of locating or tracking individuals, to accomplish the research or program purpose for which the records were collected.
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.Start Printed Page 4434
POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:
File folders, computer tapes and disks (hard and floppy), CD-ROMs.
By name or Social Security number.
The following special safeguards are provided to protect the records from inadvertent disclosure:
Authorized Users: A database security package is implemented on CDC's mainframe computer to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a regular basis. Access to records is granted to only a limited number of physicians, scientists, statisticians, and designated support staff of ATSDR or its contractors, as authorized by the system manager to accomplish the stated purposes for which the data in this system have been collected. A list of authorized users will be maintained by the system manager.
Physical Safeguards: Questionnaires, log books, and other source data are maintained in locked cabinets in locked rooms, and security guard service in buildings provide personnel screening of visitors. Access to the CDC Clifton Road facility where the mainframe computer is located (ATSDR utilizes the CDC mainframe computer) is controlled by a cardkey system. Access to the computer room is controlled by a cardkey and security code (numeric keypad) system. The local fire department is located directly next door to the Clifton Road facility. 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 fireproof safe. Computer workstations, lockable personal computers, and automated records are located in secured areas.
Procedural Safeguards: Protection for computerized records both on the mainframe and the ATSDR Local Area Network (LAN) 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 systems is limited to users obtaining prior supervisory approval. When Privacy Act tapes are scratched, a special “an additional procedure” process is performed in which tapes are completely written over to avoid inadvertent data disclosure. 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. Selected safeguards will be applicable to specific elements of the system, as appropriate. Additional safeguards may also be built into the program by the system analyst as warranted by the sensitivity of the specific data set.
ATSDR 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 ATSDR or contractor sites is restricted to specifically authorized personnel.
Appropriate Privacy Act provisions are included in contracts, and the ATSDR Project Director, contract officers, and project officers oversee compliance with these requirements. Upon completion of the contract, all data will be either returned to ATSDR or destroyed, as specified by the contract.
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 ATSDR 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:
Records are retained and disposed of in accordance with the ATSDR Comprehensive Records Control Schedule (B-371). Current procedures allow the system manager to keep the records for 20 years unless needed for further study. Registry records will be actively maintained as long as funding is provided for by legislation. Retention periods vary depending on the type of record. Source documents for computer tapes or disks are disposed of when no longer needed in the study as determined by the system manager, and as provided in the signed consent form, as appropriate.
Records may be transferred to a Federal Records Center for storage when no longer needed for evaluation or analysis. Disposal methods include the paper recycling process, burning or shredding hard copy records, and erasing computer tapes and disks.
SYSTEM MANAGER(S) AND ADDRESS:
Director, Division of Health Studies, Chamblee Bldg 106, Rm 3007, MS F57, ATSDR, CCEHIP, 4770 Buford Highway, Atlanta, GA 30341.
Director, Division of Health Assessment and Consultation, Chamblee Bldg 106, Rm 5007, MS F59, ATSDR, CCEHIP, 4770 Buford Highway, Atlanta, GA 30341.
Director, Division of Regional Operations, Chamblee Bldg 106, Rm 4112, MS F58, ATSDR, CCEHIP, 4770 Buford Highway, Atlanta, GA 30341.
Director, Division of Toxicology and Environmental Medicine, Chamblee Bldg. 101, Rm. 3118, MS F29, ATSDR, CCEHIP, 4770 Buford Highway, Atlanta, GA 30341-3724.
An individual may learn if a record exists about himself or herself by contacting the appropriate system manager at the above address. Persons who knowingly and willfully request or acquire a record pertaining to an individual under false pretenses are subject to criminal prosecution. Requesters in person must provide photo identification (such as driver's license) or other positive identification that would authenticate the identity of the individual making the request. Individuals who do not appear in person must submit a request which has been notarized to verify their identity. A parent or guardian who requests notification of, or access to, a minor's medical 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.Start Printed Page 4435
In addition, the following information should be provided when requesting notification: (1) Full name and Social Security number; and (2) nature of the study, or probable exposure or disease subregistry which might include the requester.
RECORD ACCESS PROCEDURE:
Same as the 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 PROCEDURE (REDRESS):
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:
Subject individuals, families of deceased individuals, concerned citizens associated with a particular site, State and local health departments, physicians' records, hospital records, Social Security Administration, Environmental Protection Agency and other agencies responsible for environmental public health.
SYSTEM EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
None.End Supplemental Information
[FR Doc. 2010-33004 Filed 1-24-11; 8:45 am]
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