Attachment 28: AHS Privacy Impact Assessments

Attachment 28: HHS PIA Summary and Approval for NIH/NCI Agricultural Health Study - Westat
and NIH/NIEHS/NCI Agricultural Health Study

06.3 HHS PIA Summary for Posting (Form) / NIH NCI Agricultural Health
Study --Westat (AHSW)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA 2011? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: 7/29/2011
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: No
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN
number is required for Q.4): 09-25-0200
5. OMB Information Collection Approval Number: 0925-0406
6. Other Identifying Number(s): AHSW
7. System Name (Align with system Item name): NIH NCI Agricultural Health Study - Westat
(AHSW)
9. System Point of Contact (POC). The System POC is the person to whom questions about
the system and the responses to this PIA may be addressed: Michael Alavanja / Stanley
Legum
10. Provide an overview of the system: The Agricultural Health Study is a collaborative effort
involving the National Cancer Institute (NCI), the National Institute of Environmental Health
Sciences (NIEHS), and the U.S. Environmental Protection Agency (EPA). The study has four
major components:
1. The main prospective cohort study - cancer and non-cancer outcomes
a. linkage with cancer registries, vital statistics, United States Renal Data
System (USRDS)
b. ongoing data collection (i.e., telephone interview, food frequency
questionnaire and cheek cell collection
2. Cross-sectional studies - including questionnaire data, functional measures,
biomarkers, and GIS
3. Nested case-control studies
4. Exposure assessment and validation studies
The cohort includes 89,658 private pesticide applicators, spouses of private applicators, and
commercial pesticide applicators recruited within Iowa and North Carolina. Phase I, initial
cohort recruitment, began in 1993 and concluded in 1997. Phase II follow-up began in 1999 and
concluded in 2003. The Phase III follow-up began in 2005 and concluded in February 2010.
Phase I observation involved administration of a questionnaire to obtain information on pesticide
use, other agricultural exposures, work practices that modify exposures, and other activities that

may affect either exposure or disease risks (e.g. diet, exercise, alcohol consumption, medical
conditions, family history of cancer, other occupations, and smoking history). Phase II had three
data collection components: a computer-assisted telephone interview (CATI), buccal cell
collection, and a mailed dietary questionnaire. Phase II interviews are designed to record
updated information on pesticide use since enrollment, current farming and work practices, and
changes in health status. In addition, the Dietary Health Questionnaire in Phase II makes a
detailed evaluation of subjects' cooking practices and dietary intake. The buccal cell collection
of Phase II was implemented to assess the impact of genetic risk factors on epidemiologic
outcomes. Phase III included two data collection components: a CATI interview and a buccal
cell collection for selected members of the cohort. In addition to Phase II and Phase III data
collection activities that include the whole cohort, a series of sub-studies involving a small
number of study participants will directly measure applicator and family member exposures to
selected pesticides and/or focus in greater detail on subgroups with specific diseases or
exposures.
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII
within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This
question seeks to identify any, and all, personal information associated with the system.
This includes any PII, whether or not it is subject to the Privacy Act, whether the
individuals are employees, the public, research subjects, or business partners, and whether
provided voluntarily or collected by mandate. Later questions will try to understand the
character of the data and its applicability to the requirements under the Privacy Act or
other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass
through PII within any database(s), record(s), file(s) or website(s) hosted by this system?):
Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21
must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s):
Information Management Services (IMS - separately contracted by NCI - performs data analyses
for NCI) National Death Index (NDI) - Annual match with NDI Plus files. Internal Revenue
Service - to obtain updated address information. This system is also covered under the Privacy
Act System of Records Notice 09-25-0200.
30. Please describe in detail: (1) the information the agency will collect, maintain, or
disseminate; (2) why and for what purpose the agency will use the information; (3) in this
description, explicitly indicate whether the information contains PII; and (4) whether
submission of personal information is voluntary or mandatory: AHS analytic data files do
not contain direct identifiers such as name, address, or SSNs. PII is shared with NDI and the IRS
when we are performing matches to NDI and IRS files. Contact information (name, address,
phone number) are stored in anticipation of use in future substudies, cohort maintenance
purposes (e.g., possible mailings of study update newsletters), and matching with state and
national vital statistics and health registries.
The AHS has four major components:

1. Main prospective cohort study - cancer and non-cancer outcomes
a. linkage with cancer registries, vital statistics, United States Renal Data
System (USRDS)
b. data collection (i.e., telephone interview, food frequeny
questionnaire and cheek cell collection (no longer on-going)
2. Cross-sectional studies - including quesitonnaire data, functional measures,
biomarkers, and GIS
3. Nested case-control studies
4. Exposure assessment and validation studies
Three were also a series of sub-studies involving a small number of study participants that
directly measured applicator and family member exposures to selected pesticides and/or focus in
greater detail on subgroups with specific diseases or exposures. Additional substudies may be
conducted in the future.
Participation is voluntary.
PII collected and maintained include name, date of birth, social security number, mailing
address, phone number, and pesticide application certificate types.
31. Please describe in detail any processes in place to: (1) notify and obtain consent from
the individuals whose PII is in the system when major changes occur to the system (e.g.,
disclosure and/or data uses have changed since the notice at the time of the original
collection); (2) notify and obtain consent from individuals regarding what PII is being
collected from them; and (3) how the information will be used or shared.
(Note: Please describe in what format individuals will be given notice of consent [e.g.,
written notice, electronic notice, etc.]) There have been no major changes in the system and
none are contemplated. Our IRB would review any major changes prior to implementation and
provide us with guidance on any needed notification and consent requirements.
32. Does the system host a website? (Note: If the system hosts a website, the Website
Hosting Practices section is required to be completed regardless of the presence of PII): No
37. Does the website have any information or pages directed at children under the age of
thirteen?: No
50. Are there policies or guidelines in place with regard to the retention and destruction of
PII? (Refer to the C&A package and/or the Records Retention and Destruction section in
SORN): Yes
54. Briefly describe in detail how the IIF will be secured on the system using
administrative, technical, and physical controls.: Extensive safeguards are in place to ensure
the confidentiality of each subject is protected. Each subject is assigned a six-digit number;
these IDs are used for any references to subjects on an individual basis. Names and other
identifying information are kept in a separate database from the analytic files. These data are
joined only for performing linkages to the mortality and cancer incidences databases and for

direct contacts with cohort members to inform them of study progress or to request their
participation in substudies. Several layers of passwords exist to ensure unauthorized access to
electronically stored data is not permitted. Hard copies of questionnaires that contain any
personal information have been shredded. Informed consent forms, which contain subjects'
names and study IDs are stored in a secure facility separate from other study data. All personnel
involved with the project have signed confidentiality agreements.
Files with PII are stored in a directory accessible only to the project's lead systems manager and
one programmer. Data stored in the SQL Server contact database are protected with application
level security and an additional password. Data stored in other file formats are encrypted when
not in use and the encryption key is known only by the same two staff members. The files are
never left in unencrypted form over night so that automatic backups contain only encrypted
versions.
The system is protected by firewalls, intrusion detection systems, and passwords. There are
comprehensive system security and contingency plans in place. An Incident Response capability
is maintained.
PIA Approval
PIA Reviewer Approval: Promote
PIA Reviewer Name: Suzy Milliard
Sr. Official for Privacy Approval: Promote
Sr. Official for Privacy Name: Karen Plá
Sign-off Date: 9/30/2011
Approved for Web Publishing: Yes
Date Published: May 23, 2012
_____________________________________________________________________________

06.3 HHS PIA Summary for Posting (Form) / NIH NIEHS NCI Agricultural
Health Study (AHS)
PIA SUMMARY AND APPROVAL COMBINED
PIA Summary
Is this a new PIA 2011? No
If this is an existing PIA, please provide a reason for revision: PIA Validation
1. Date of this Submission: 9/22/2011
2. OPDIV Name: NIH
3. Unique Project Identifier (UPI) Number: N/A
4. Privacy Act System of Records (SOR) Number (If response to Q.21 is Yes, a SORN
number is required for Q.4): 09-25-0200, Clinical, Epidemiologic, and Biometric Studies of
the National Institutes of Health (NIH), HHS/NIH/OD
5. OMB Information Collection Approval Number: 0925-0406
6. Other Identifying Number(s): AHSW
7. System Name (Align with system Item name): NIH NIEHS NCI Agricultural Health Study
(AHS)
9. System Point of Contact (POC). The System POC is the person to whom questions about
the system and the responses to this PIA may be addressed: Novie Beth Ragan
10. Provide an overview of the system: The Agricultural Health Study system of records
collects clinical and epidemiological data on health volunteer persons who are part of the
Agricultural Health Study cohort, for the purpose of scientific analysis and publication of
epidemiological research. AHS is a collaborative effort involving the National Cancer Institue
(NCI), the National Institute of Environmental Health Sciences (NIEHS), and the U.S.
Environmental Protection Agency (EPA).
13. Indicate if the system is new or an existing one being modified: Existing
17. Does/Will the system collect, maintain (store), disseminate and/or pass through PII
within any database(s), record(s), file(s) or website(s) hosted by this system? (Note: This
question seeks to identify any, and all, personal information associated with the system.
This includes any PII, whether or not it is subject to the Privacy Act, whether the
individuals are employees, the public, research subjects, or business partners, and whether
provided voluntarily or collected by mandate. Later questions will try to understand the
character of the data and its applicability to the requirements under the Privacy Act or
other legislation. Does/Will the system collect, maintain (store), disseminate and/or pass
through PII within any database(s), record(s), file(s) or website(s) hosted by this system?):
Yes
21. Is the system subject to the Privacy Act? (If response to Q.19 is Yes, response to Q.21
must be Yes and a SORN number is required for Q.4): Yes
23. If the system shares or discloses IIF please specify with whom and for what purpose(s):
Disclosure of AHS PII:
National Death Index (NDI) - Annual match with NDI Plus files.

Internal Revenue Service - to obtain updated address information - now stored at Westat (for
NCI); will be stored at coordinating center (TBA) for AHS Phase IV (for NCI ).
Information Management Services - IMS - separately contracted by NCI - performs data
analyses for NCI using analytic datasets. Analytic Data (including date of birth, but not including
other personal information) are shared among members of the AHS research team at NCI,
NIEHS, EPA.

Westat – separately contracted by NCI – currently holds the full AHS participant contact
database, including date of birth as well as other personal identifying information for all AHS
participants – and handles all direct interactions with Iowa and North Carolina participants for
NCI studies within the AHS.
Upon award of the AHS Phase IV Coordinating Center Contract, anticipated by September 30,
2011, the successful offeror will take over the AHS participant contact database.
Westat - separately contracted by NIEHS – performs data analyses for NIEHS. Analytic Data
(including date of birth, but not including other personal information) are shared among
members of the AHS research team at NIEHS.

Social and Scientific Systems - SSS – separately contracted by NIEHS – handles all direct
interactions with AHS participants in NIEHS substudies only: namely AHS Lung Health Study,
GAP Study, AHS Autoimmune Study, GENARM Study, SAFE Study and FAME Study.
Names, addresses and phone numbers of AHS NIEHS add-on research subjects are stored in
secure and locked databases, records and / or files hosted at Social and Scientific Systems (SSS).
This system is also covered und the Privacy Act System of Records Notice 09-25-0200.
North Carolina Field Station - Battelle CPRHE, Durham, NC - separately contracted by NCI handles all direct interactions with NC participants.
National Death Index (NDI) - Annual match with NDI Plus files.
Internal Revenue Service - to obtain updated address information which is stored at the field
stations.

Information Management Services - IMS - separately contracted by NCI - performs data
analyses for NCI using analytic datasets. Analytic Data (including date of birth, but not including
other personal information) are shared among members of the AHS research team at NCI,
NIEHS, EPA.
Westat - separately contracted by NIEHS – performs data analyses for NIEHS. Analytic Data
(including date of birth, but not including other personal information) are shared among
members of the AHS research team at NIEHS.
Iowa Field Station - University of Iowa - separately contracted by NCI - handles all direct
interactions with Iowa participants.
North Carolina Field Station - Battelle CPRHE, Durham, NC - separately contracted by NCI handles all direct interactions with NC participants.
National Death Index (NDI) - Annual match with NDI Plus files.
Internal Revenue Service - to obtain updated address information which is stored at the field
stations.
File Typeapplication/pdfFile Modified2012-10-29File Created2012-09-28