Minnesota Department of Health
Environmental Health Tracking and Biomonitoring
Advisory Panel Meeting
December 7, 2010
1:00 p.m. – 4:00 p.m.
Snelling Office Park
Red River Room
1645 Energy Park Drive
St. Paul, Minnesota
ENVIRONMENTAL HEALTH TRACKING AND
BIOMONITORING ADVISORY PANEL
MEETING AGENDA
DECEMBER 7, 2010
Time
Agenda item
Presenter(s)
1:00
Welcome and
introductions
Beth Baker, Chair
Item type/Anticipated outcome
TRACKING
1:05
MN DATA
Demonstration and
Update
Chuck Stroebel
David Stewart
Michelle DeMist
Discussion item.
Panel members will have an opportunity to view an
on-line demonstration of MN DATA (the new state
tracking data portal). Staff will provide highlights of
usability testing and lessons learned, and discuss
plans for 2011, including integration of new data and
GIS.
Panel members are invited to provide input on future
enhancements and uses of the data.
1:50
Academic Partners
Research: U.
Illinois-Chicago
Leslie Stayner
Karl Rockne
Judith Graber
Information item.
Researchers from the University of Illinois will
present information about “A Linkage Study of
Health Outcome Data in Children and Agrichemical
Water Contamination Data in the Midwest”, a 3-year
CDC-EPHT funded study using state EPHT data.
Panel members are invited to ask questions or
provide input on ways that MN EPHT will
collaborate with investigators on the study.
2:30 Break
BIOMONITORING
2:45
Biomonitoring
Pilots: Lessons
Learned from the
Lab
Paul Swedenborg
Carin Huset
Discussion Item
MDH Public Health Laboratory staff will review
lessons learned from the biomonitoring pilot program
concerning laboratory analytical procedures, quality
assurance, safety, resources and other topics.
i
Time
Agenda item
Presenter(s)
Item type/Anticipated outcome
Panel members are invited to ask questions and
provide input to strengthen recommendations to the
Legislature for meeting the needs of the public health
laboratory for ongoing biomonitoring .
3:05
New Protocols for
Research Use of
Newborn Screening
Specimens
Kristin Oehlke
Information sharing.
Newborn Screening program staff will present a new
protocol developed for responding to requests for use
of residual newborn blood spots for research
purposes.
Panel members are invited to provide input on how a
similar protocol should be applied for use of stored
biomonitoring specimens.
3:35
Biomonitoring
Updates
 East Metro PFC
Follow-up Study
 Lake Superior
Mercury Project
 Riverside
Prenatal Project
OTHER
3:40 Legislative Report
Outline and
Success Stories
---
Information sharing.
No formal presentations will be made on these topics.
Panel members are invited to ask questions or
provide input on any of the written biomonitoring
project updates included in the meeting materials.
Jean Johnson
Discussion item.
Staff will review an outline of the Legislative Report
and present a summary of key successes of the
program for Legislators.
Panel members are invited to ask questions and
provide input to strengthen the report.
3:55
New business
Beth Baker
4:00
Adjourn
Beth Baker
The chair will invite panel members to suggest topics
for future discussion.
Next meeting:
Tuesday, March 8, 2011, 1-4 p.m. Red River Room, Snelling Office Park
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TABLE OF CONTENTS
Agenda ................................................................................................................................... i
Table of contents ................................................................................................................. ii
MATERIALS RELATED TO SPECIFIC AGENDA ITEMS
TRACKING
MN DATA Demonstration and Update
Section Overview: .....................................................................................1
MN DATA Web-based information system: Demonstration and
Update ..........................................................................................................3
Academic Partners Research: U. Illinois-Chicago
Section Overview: .......................................................................................7
Overview of Academic Partners Research ...............................................9
BIOMONITORING
Section Overview: Biomonitoring Pilots: Lessons Learned from the
Lab..............................................................................................................11
Lessons Learned from Biomonitoring Pilot Program Analytic Lab
Perspective ................................................................................................13
Section Overview: New Protocols for Research Use of Newborn
Screening Specimens ...............................................................................17
New Protocols for Scientific Use of Residual Dried Blood Spots an
Newborn Screening Program Data ..........................................................19
Questions and answers about storage and use of dried blood spots
for Minnesota families ..............................................................................21
Biomonitoring Updates
Section Overview ......................................................................................25
East Metro PFC Follow-up Study ..................................................27


Riverside Prenatal Project ............................................................29

Lake Superior Mercury Project .....................................................30
Other information
Section overview: Legislative Report January 2011 ..............................31
Outline of Report to the Legislature ........................................................32
Report to the Legislature (draft continued) ............................................35
iii
EHTB advisory panel meeting summary (for September 14, 2010)............................... 37
APPENDICES
Dates of 2011 Meetings.................................................................................47
EHTB Advisory Panel Roster .......................................................................48
Updated Biographical Sketches ..................................................................50
Glossary.........................................................................................................53
Statute ............................................................................................................59
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SECTION OVERVIEW: MN DATA DEMONSTRATION AND
UPDATE
A key activity of the MDH Tracking program described in Minnesota’s state law for
Environmental Public Health Tracking (Minn. Stat. Section 144.998) is the dissemination
of aggregate data about environmental hazards, exposures and chronic diseases to the
general public and to researchers in an accessible format for their use. MDH is further
tasked with the organization, analysis and interpretation of the available data.
Analysis and display of Tracking data includes the characterization of statewide and
localized trends and geographic patterns of population based measures of chronic
diseases, hazards and exposures. Where possible, the Tracking program will analyze
patterns that relate to socioeconomic status, race and ethnicity.
MN EPHT is currently working with our partners in the Information Systems and
Technology Management division at MDH to develop a web-based information system,
called MN DATA (Data Access for Tracking and Assessment).
Panel members will have an opportunity to view an on-line demonstration of MN DATA
(the new state tracking data portal). Staff will provide highlights of usability testing and
lessons learned, and discuss plans for 2011, including integration of new data and GIS.
ACTION NEEDED: At this time no formal action is needed by the advisory panel.
Panel members are invited to ask questions or provide input on future enhancements
of the MN DATA portal. In particular, members are asked to consider the questions:

Are the key audiences for public access to Tracking data identified?

Are there additional modifications needed that would make the MN DATA site
more user friendly, or more informative for those key audiences?

When role-based access is implemented, what would be some important functions
or needs that could be addressed (that are not already addressed by the public
portal)?
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2
MN DATA Web-based information system:
Demonstration and Update
Background
In September 2010 MN EPHT conducted a “soft launch” of a new web-based
information system (portal) for disseminating health and environment data on MDH’s
web site. This system is named MN DATA or Minnesota Data Access for Tracking &
Assessment: https://apps.health.state.mn.us/mndata/
MN DATA provides public access to summary data (including basic charts and tables,
and custom queries). These data may be used to:
 Inform state and local actions and policies
 Determine opportunities for research
 Target programs to improve health
Ultimately, MN DATA supports MDH’s mission -- to protect, maintain, and improve the
health of all Minnesotans.
Content Areas (“Topics”)
MN DATA includes summary data on the following topics:
 Drinking water quality (arsenic, nitrate, disinfection byproduct concentrations for
Community Water Systems)
 Carbon monoxide poisonings (hospitalizations, emergency department visits,
deaths)
 Asthma (hospitalizations)
 Heart attacks (hospitalizations)
 Chronic obstructive pulmonary disease (hospitalizations)
Data for an additional 5 topics will be added to MN DATA by mid-2011, including:
blood lead, air quality, birth defects, reproductive outcomes, and cancer.
Target Audiences
The primary target audience for MN DATA is local health departments (i.e., city and
county health professionals). Local health professionals in Minnesota routinely gather
and report data, for example, to inform assessment, policy, and planning activities.
Other potential audiences for MN DATA include: state and local government agencies,
non-profit organizations, policy makers, researchers, health care professionals and the
public.
3
Communications & Outreach Activities
MN EPHT has developed a communications and outreach plan which includes
demonstrations of MN DATA with key program partners (e.g., data stewards, steering
committees, Advisory Panel). Information gathered from these demonstrations is being
used to inform planning and priorities for enhancing the portal in 2011.
In addition, MN EPHT hired a contractor to conduct usability testing of MN DATA with
external audiences. Twelve participants representing different user groups (e.g., local
health departments, Minnesota Pollution Control Agency, state legislative research,
general public) were interviewed and asked to conduct a list of specific tasks using MN
DATA. A summary report provides highlights of comments and feedback from
participants about the ease/difficulty of completing the tasks. This testing provides
important feedback regarding steps to enhance and improve MN DATA, including data,
web design, and messaging.
Future Plans
Assessing Needs
An important part of activities over the next year is assessing users’ needs to enhance and
expand MN DATA. MN EPHT will be collecting and evaluating information about
needs through multiple channels, including demonstrations, surveys, presentations, and
additional usability testing (planned for the implementation of GIS by mid-2011). These
elements will help to ensure that the messaging and data are meaningful and useful to
inform public health.
Developing New Content & Features
Additional content areas and features will be added to MN DATA over the next year
(2011). Year 2 activities include: providing access to more spatially refined data (countylevel), adding GIS (mapping capability), and implementing 5 new content areas (blood
lead, birth defects, reproductive outcomes, cancer, and air quality).
MN EPHT also is working actively on the development of Minnesota-specific data and
measures, including: radon, pesticides, environmental tobacco smoke, and climate
change. These content areas may be made available on MN DATA in 2011-2012
depending on Advisory Panel recommendations and resources (staff time) and program
priorities.
In addition, MN EPHT is initiating planning to develop a secure portal for MN DATA (a
requirement under cooperative agreement with CDC). The initial plan for the portal is to
include roll-based access (identity management) for authorized users to obtain secure
access to custom data sets on a case by case basis.
MN EPHT currently is collecting information from CDC and other tracking states to
develop a list of requirements for this project. Implementation of the secure portal will
be limited to content areas where MN EPHT has authorization from data partners and the
authority per MN Statutes and terms of use specified in data use agreements.
4
Hard Launch (May 2011)
A “hard launch” of MN DATA is planned for May 2011. This launch will include a
media press release, as well as public announcements via electronic newsletters and other
methods (GovDelivery).
Comments & Questions
MN EPHT welcomes comments and questions about MN DATA. For comments or
questions, please contact the MN EPHT Program Manager, Chuck Stroebel, at
[email protected] or 651/201-5662.
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SECTION OVERVIEW: ACADEMIC PARTNERS
RESEARCH: U ILLINOIS-CHICAGO
The National EPHT Tracking Network has recently announced that they have awarded
several new grants for academic partners to conduct research that will utilize data from
the Tracking network. Minnesota’s EPHT program will collaborate on two of the
national EPHT research projects. In this section, an overview of the new academic
partner grants is provided as background.
One of the research projects that MN EPHT will be collaborating on is being conducted
by investigators at the University of Illinois-Chicago (UIC), School of Public Health.
The title of the study is “A Linkage Study of Health Outcome Data in Children and
Agrichemical Water Contamination Data in the Midwest.” The goal of the proposed
project is to develop and implement methodology for linking health outcomes and
exposure data available through the Environmental Public Health Tracking (EPHT)
program. UIC investigators plan to study the effects of exposure to drinking water
contaminates, including atrazine and nitrate, on reproductive, developmental , and cancer
outcomes using data form the EPHT Network as well as from state health and
environmental departments.
MN EPHT is pleased to host UIC Principal Investigator, Leslie Stayner, PhD, and his
colleagues, Karl Rockne, PhD, and Judith Graber, MS, for a visit with staff from MN
EPHT, the Minnesota Cancer Surveillance System, and the MN Drinking Water
Information System on December 7-8, 2010.
Dr. Stayner and colleagues will present an overview of their research to the Advisory
Panel and welcome discussion of the project.
ACTION NEEDED:
There is no action needed on this item. Panel members are invited to ask questions of
the investigators and to provide input on ways that MN EPHT will collaborate on the
study.
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Overview of Academic Partners Research
In 2010, the national EPHT network awarded grants to four academic partner institutions.
Projects were awarded to address one of the 4 research goals as follows:

Development of environmental epidemiologic and statistical methods for
use on the Tracking Network

Development of environmental exposure assessment methods for use on the
Tracking network.

Linkage study of PM2.5 and cardiovascular effects data from the Tracking
Network

Linkage study of exposure date from State drinking water information
systems and health outcome data from the Tracking Network.
The new projects awarded in 2010 include:
University of California Berkeley, PI Michael Jerrett, PhD.
Project Title: A Multi-level Geographic Model for Environmental Public Health
Tracking.
University of Califorinia Berkeley, PI John Balmes, MD.
Project Title: PM2.5 –Cardiovascular Disease Associations: Use of Modeled Heirarchical
Bayesian vs Ambient Monitoring Exposure data; Use of Census–based Geographic and
Lifestyle Variables; Exploration of Biomarkers of Exposure and Effect
University of Pittsburgh, PI Evelyn Talbot, DrPH.
Project Title: Ecological and Case Control Study of Ambient Air levels and Childhood
Blood Lead Levels
University of Pittsburgh, PI Evelyn Talbot, DrPH.
Project Title: Linkage Study of Air Quality PM2.5 and Cardiovascular Effects Data from
the Tracking Network
UMDNJ, PI Dan Wartenberg, PhD.
Project Title: Linkage Study of Air Quality PM2.5 and Cardiovascular Effects Data from
the Tracking Network*
University of Utah, PI Jim VanDerslice, PhD.
Project Title: Advancing the Science of Linkage Studies between Drinking Water
Contaminants and Adverse Birth Outcomes
University of Illinois-Chicago, PI Leslie Stayner, PhD. Project Title: A linkage Study of
Health Outcome Data in Children and Agrichemical Water Contamination Data in the
Midwest. *
* MN EPHT provided letters of support as collaborators on two of the projects. Access
to Minnesota data will be provided for use in the research. One of these projects is
described below and will be presented by the investigators to the Panel for discussion.
9
Adverse Childhood Health Outcomes and the Agrichemical Water Contamination
in the Midwest; A Linkage Study.
University of Illinois-Chicago Environmental Public Health Tracking StudyUIC
Investigators: L. Stayner (PI), L. Conroy, K. Rockne, M. Turyk, R. Anderson, R.
Jones, J. Graber.
Statistical consultant: L. Waller (Emory U)
A series of studies will be performed by linking data with information on adverse health
outcomes in children with data containing information on exposure to agrichemical water
contaminants in the Midwest.
Concentrations of atrazine and nitrate in ground and surface water in the Midwestern
states are among the highest in the U.S. Limited evidence from toxicology and
epidemiological studies suggest atrazine and nitrate exposures may be associated with an
increased risk of adverse reproductive/birth outcomes and of childhood cancers including
leukemia.
The study has three phases, which will be completed sequentially during the three years
of the study. Each phase uses increasingly sophisticated data and statistical methods, and
will enhance our ability to address spatial and temporal variation in drinking water
contaminant exposure, and the potential confounding by other personal and
environmental risk factors. The phases are:
1. Phase 1 of the study will link county-level data on adverse reproductive and birth
outcomes derived from birth certificates with annual county-level values of
drinking water atrazine and nitrate concentrations. This Phase, as well as Phase 2,
will be addressed using data that have already been assembled for the National
Environmental Public Health Tracking Network (EPHTN) as well as data that are
routinely collected by the states and by federal agencies.
2. Phase 2 of the study will include the additional outcomes of birth defects and
childhood cancers. This phase will also assess exposure to other water
contaminants including arsenic, disinfection byproducts and other pesticides.
3. Phase 3 of the study will use spatially-referenced health outcome data to consider
seasonal variability in drinking water contaminant concentrations, time-windows
of exposure during pregnancy, and spatial correlations of health and water data.
This approach better reflects the complexity of public and well water systems, and
controls for personal risk factors. In addition, in Phase 3 we will explore the
feasibility of using biomarker data to evaluate our atrazine exposure estimates.
The study is designed to advance the methodology of water contaminant and health-datalinkage studies for the CDC Environmental Public Health Tracking (EPHT) Program and
state health departments. Water contaminant linkage studies are relatively new, and this
study will involve close collaboration with our states and CDC to develop and share the
methodology and experiences of this study.
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SECTION OVERVIEW: BIOMONITORING PILOTS:
LESSONS LEARNED FROM THE LAB
The statute that created the EHTB program directs MDH and the advisory panel to assess
the pilot program and to make recommendations for future biomonitoring stemming from
that assessment. Staff continue to gather and compile information about what worked
well and what could be improved related to the biomonitoring pilot projects. From this
information, recommendations for future biomonitoring efforts are being developed and
included as part of the program’s legislative report due in January 2011.
At the December meeting, staff from the MDH Public Health Laboratory will present
some overall “lessons learned” and laboratory perspectives related to the four
biomonitoring pilot projects.
In addition, staff will briefly describe efforts underway by the Association of Public
Health Laboratories to promote a National Biomonitoring Plan.
Included in this section of the meeting materials:
 Lessons learned From Biomonitoring Pilot Program – Analytic Lab Perspective
ACTION NEEDED: At this time, no formal action is needed by the advisory panel.
Panel members are invited to provide input on the summary of lessons learned from the
biomonitoring pilot program. In particular, panel members are asked to respond to the
following questions:
 What recommendations should the program report make with regard to ensuring that
Minnesota maintains a high level of state public health laboratory capacity and
expertise for future biomonitoring?
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Lessons Learned from Biomonitoring Pilot Program Analytic Lab Perspective
Since 2007, staff from the MDH Public Health Laboratory have conducted laboratory
method development, analyses and reported results for all 4 biomonitoring pilot projects
including measurement of speciated arsenic and environmental phenols in urine, 7 PFC
compounds in serum, and mercury in newborn screening blood spots. The following is a
summary of lessons learned from the perspective of the laboratory that will help to
inform recommendations for ongoing biomonitoring.
1. Resources
The combination of complex biomonitoring matrices and unique analytes present a
challenge for the analytical chemist to develop and support method development. There
is very little information and limited peer resources available to support method
development for biomonitoring studies. CDC is an excellent resource for biomonitoring
methods and method trouble-shooting, however there are some limitations. CDC has
published methods which are available from peer-reviewed journals as well as Standard
Operating Procedures (SOPs) that are available online. Unfortunately, these published
methods are not always up-to-date, nor do they include complete information on quality
control criteria.
Available information regarding method validation is another limitation for method
development. The CDC SOPs provide information on method validation, but due to the
scale of the intended use of the method, their validation protocol may be unrealistic for
much smaller scaled studies, like a pilot project. For example, a CDC validated method
may be used to analyze thousands of samples, whereas the scope of the pilot
biomonitoring studies in Minnesota was 50-200 samples. Additionally, the types of
quality control samples that are used to monitor method performance in drinking water or
soil (MDH’s historical strength) may not be appropriate for blood or urine.
2. Proficiency Testing (PT)
Proficiency testing is done to ensure an analytical method is meeting specified
performance criteria. In proficiency testing, proficiency test (PT) samples are obtained
from a vendor, or third-party supplier, and analyzed as unknown samples. The results are
then submitted to the third-party supplier for evaluation, resulting in a “pass” or “fail” of
the sample. Since PTs are a performance based activity, a method is deemed adequate as
long as the results of the analysis are “pass,” regardless of the method used for analysis.
This means that PT programs may be used for both standardized methods and nonstandardized methods (which includes many laboratory-developed biomonitoring
methods), as long as the analyte and sample matrix match between the method and the PT
program. Unfortunately, PTs are generally not readily available for clinical matrices or
the analytes studied in clinical matrices, including those analytes of interest for
biomonitoring. An agency can work with a PT vendor to establish a PT study but that
agency usually absorbs the complete cost of the PT study and must also find partners
willing to participate in the study.
13
3. Safety
The Public Health Laboratory has historical experience working with environmental
matrices. Clinical matrices present new health and safety issues with respect to sample
handling, storage, and disposal. Specific training and potentially new engineering
controls (such as, BioSafety Level cabinets (BSL)) may be necessary within the
laboratory to support worker safety.
4. Equipment Maintenance
In general, analytical instruments processing biomonitoring samples require more
preventative maintenance than those processing primarily environmental matrix samples.
Urine and blood present new matrix interference and analytical instrument issues that
must be monitored daily, potentially causing instrument down-time and higher costs as
parts need to be replaced more often.
5. Management/Analyst Interest
There is resounding interest by management and the analysts with respect to conducting
biomonitoring studies. Biomonitoring is the most direct connection to people and public
health and having laboratory staff involvement in data interpretation and project planning
is important as well as exciting for all involved. This early involvement is also very
important from the analyst’s standpoint as it allows for a chance to learn about program
expectations which might affect the analysis directly.
6. Sample Storage/Data Privacy
From the analysts perspective biomonitoring samples present new expectations with
respect to storage and handling rules and data privacy. Making sure that these protocols
are followed is critical.
7. Sample Receipt/Transport – New, additional training is required for environmental
staff on how to handle clinical specimens. A protocol for the use of stored specimens is
being developed.
8. Scheduling
There can be back-ups for staff time and instrument usage because projects take longer
than anticipated. In this respect, biomonitoring can be resource intensive. For example,
the Public Health Laboratory has significant experience with perfluorochemical analyses
in environmental matrices and it followed that the respective biomonitoring analyses
went relatively smooth. On the other hand working with phenols has been challenging
and a significant reason has been our lack of experience with these compounds.
9. Training
Peer training is very important. It was invaluable to be included in aspects of project
planning in order to anticipate and avoid problems with sampling and sample handling.
It was also useful to learn about some of the challenges associated with the
communication of the results. As opportunities may arise in the future to partake in
“Laboratory Based” biomonitoring projects, its important to understand what can and can
not be done from an epidemiology standpoint; almost like an “Epidemiology 101”.
14
10. Clinical Laboratory Improvement Act (CLIA)
CLIA is the accrediting authority for clinical sample results that are reported for patient
management. Many regulatory rules apply to clinical laboratory analyses and laboratory
audits are conducted generally every two years. The PHL Environmental Section has
historical experience with Environmental Protection Agency regulatory activities but
limited experience with the requirements for clinical analyses. This has been a
significant learning curve for making sure that we are compliant with the CLIA
regulatory requirements, which include specific training, documentation, and reporting.
Fortunately, most of our biomonitoring samples to date have not been used for patient
management. However, we have still needed to be vigilant about following many of the
regulatory requirements and documenting a comment on our reports that laboratory
results are “For Research Purposes Only”.
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SECTION OVERVIEW: NEW PROTOCOLS FOR
RESEARCH USE OF NEWBORN SCREENING
SPECIMENS
The Minnesota Department of Health Public Health Laboratory has developed a review
process for scientific proposals that seek to use residual dried blood spots and/or
Newborn Screening Program data for research and development purposes. This section
describes this new protocol.
Residual dried blood spots are a limited and scientifically valuable resource. They
provide a unique sample for researchers to study and develop approaches for
understanding and addressing many health conditions that affect Minnesotans. Therefore,
MDH needs to make sure that any scientist using residual dried blood spots has a proven
track record of successful research.
These new protocols are of interest to EHTB because EHTB supports a biomonitoring
pilot project (research funded mostly by EPA) that uses the newborn screening
specimens, and because EHTB now stores blood and urine samples from the PFC and
Prenatal biomonitoring pilot projects, with informed consent of participants, for future
research uses. A similar process of review and approval for future research use of stored
biomonitoring specimens at MDH is needed. The process should be designed to ensure
that research use of biomonitoring specimens is appropriate with scientific, legal and
ethical considerations reviewed.
ACTION NEEDED: Panel members are invited to ask questions and to provide input on
the following questions:
 Are there any special considerations with respect to the research use of stored
biomonitoring specimens for developing a similar protocol?
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New Protocols for Scientific Use of Residual Dried
Blood Spots and Newborn Screening Program Data
Overview The Newborn Screening Program is committed to furthering the Minnesota Department
of Health’s mission (Protecting, maintaining, and improving the health of all
Minnesotans) while also ensuring adherence to strict ethical, legal, and privacy standards.
The Minnesota Department of Health has developed a review process for scientific
proposals that seek to use residual dried blood spots and/or NBS Program data for
research and development purposes. Only researchers at accredited institutions can
submit proposals for the use of residual blood spots or data. A researcher must be
employed by an accredited institution for two reasons.


Studies using residual dried blood spots or data need to be approved by the
Institutional Review Board (IRB) of both the Minnesota Department of Health
and the institution that is proposing the study. An IRB makes sure that the
proposed study meets established standards for protecting the rights and safety of
the individuals in research. Studies that use specimens that can be linked to a
particular person require informed consent; studies that use ‘anonymized’
specimens do not require informed consent, per federal regulations.
Residual dried blood spots are a limited and scientifically valuable resource.
Residual dried blood spots provide a unique sample for researchers to study and
develop approaches for understanding and addressing many health conditions that
affect Minnesotans. Therefore, MDH needs to make sure that any scientist using
residual dried blood spots has a proven track record of successful research.
Proposal Submission and Review Process Investigators wishing to obtain residual dried blood spots, begin the process by accessing
the Scientific Review web page on the MDH website (not yet operational).
The proposal submission process then proceeds as follows:
1. The investigator submits an abstract of the project idea via an online form
provided by MDH.
2. MDH internally reviews the abstract to make sure all necessary information is
complete and to determine whether the proposed study corresponds with the
MDH scope and mission.
1. If the abstract is accepted, the investigator will be invited to submit a full
proposal. A unique link to the full proposal form will be sent to the investigator
via e-mail.
2. The full proposal will be reviewed for scientific merit by two internal (MDH) and
two external (non-MDH) reviewers.
3. MDH administration will assess reviewer comments and recommendations and
will make the final decision regarding approval.
19
4. MDH notifies the investigator of the decision.
5. If the proposal is accepted, the investigator must provide MDH with the following
before samples are released:
o Institutional IRB approval
o MDH IRB approval
o An abstract summarizing the proposed work written for the general public
(this will be posted on the MDH website)
Community Involvement MDH maintains public openness and transparency with their Scientific Review Process,
while also protecting the intellectual property (ideas) of the investigator. The process
outlined above follows established review practices used by major public research bodies,
such as the National Institutes of Health and the National Science Foundation. The
human subjects protection review practices used by MDH are consistent with the
Common Rule (Title 45 CFR (Code of Federal Regulations) Part 46) and regulated by the
Office of Human Research Protection.
The community is involved in and informed of the Minnesota Scientific Review Process
in a number of ways:



IRB panels (both at MDH and outside institutions) include members of the local
community-at-large. IRB approval is necessary for release of the residual dried
blood spots.
An abstract of each study will be made available online as a public record.
An online yearly report is generated detailing the number of proposals submitted,
number of proposals approved, titles and brief descriptions of every investigation,
number of samples used in each study, and the citation for any publication from
the study.
I
20
QA:
&
Q: A: questions and answers about
storage and use of dried blood spots
for Minnesota families
Why are Minnesota babies tested by Newborn Screening?
Newborn screening is mandated by law in Minnesota for the early identification of disorders that can
affect a baby’s health and life. Newborn screening is done by a small heel stick between 24 and 48 hours
of birth. Parents may refuse screening by opting out in writing. The opt-out form is available on the
Newborn Screening web site at: http://www.health.state.mn.us/newbornscreening. Without screening,
your baby could die or have permanent and severe health problems, such as physical disability and
developmental delays. Each year, the Newborn Screening Program finds about 150 babies whose lives
are improved or saved by newborn screening. Additionally, over 150 babies a year are found to have a
hearing loss through Newborn Hearing Screening.
Q:
What happens to the drops of blood that are collected from babies for newborn screening?
A: The drops of blood are collected on special filter paper, dried, and sent to the Minnesota Department of
Health (MDH) laboratory where they are tested for over 50 disorders that can cause serious health
problems like illness, physical disability, mental retardation, or even death if left untreated. After the
tests are done, there is a very small amount of dried blood left on the cards. MDH securely stores these
leftover samples and the newborn screening results.
Q:
I heard that the Mayo Clinic does some of the testing. Is that true?
A:
Yes, the Mayo Clinic is under contract with MDH to perform some of the newborn screening tests. Biochemical Genetics Laboratory staff at the Mayo Clinic are experts in testing for disorders of
amino acids, organic acids, and fatty acids. Rather than duplicating the work and equipment available at
the Mayo Clinic, MDH sends part of each specimen to the Mayo Clinic for testing.
Q:
Is all the blood used in the testing?
A:
Newborn screening requires a very small amount of blood and most of this blood is used up in the
testing. The amount remaining depends on how much blood is collected on the cards at the hospital and
whether the results of the tests require further testing for confirmation of the result. The amount of dried
blood left on the filter paper is smaller than a dime.
Q:
What is a dried blood spot?
A:
A dried blood spot is the tiny amount of dried blood that is placed on the special filter paper used to do
newborn screening. This is the only type of specimen MDH has; MDH does not have tubes of blood.
Newborn Screening Program, 601 Robert St. N., St Paul, MN 5515521
Phone: (800) 664-7772 or (651) 201-5466, Web: www.health.state.mn.us/newbornscreening
page
2
Q: A:
Why do MDH and the Mayo Clinic store the leftover specimens?
MDH and the Mayo Clinic store leftover bloodspots for several reasons. To make sure MDH has the best
newborn screening program operations, samples of the leftover blood are used for quality control
testing. Quality control is a process to monitor the quality of testing and accuracy of results. Using leftover samples for quality control purposes is a common practice in all clinical and hospital labs. The
babies’ names and date of birth are not revealed when the dried blood spots are used for quality testing.
Quality testing ensures that test results are reliable and consistent. Like all clinical labs, MDH and the
Mayo Clinic want to make sure that the testing done one month gives the same results as the testing
done the next month.
Q:
Does MDH or the Mayo Clinic use the specimens for any other reasons?
A: When testing begins for a new disease or when an improved testing method starts in the lab, professional
staff need to make sure the new test is running properly. This practice needs to be done on the same type
of specimens that the testing will be done on, so all practice testing must be done on dried blood spots
from newborns. The babies’ names and dates of birth are not revealed when the dried blood spots are
used for quality testing.
In cases where a child later develops health problems, a parent or healthcare provider might request
repeat or other health-related testing on the leftover specimen.
Q:
Is the stored blood ever used for research?
A:
Public health studies and research may be done only if the researchers follow these guidelines:
•
•
•
•
The project must be done to help develop a new newborn screening test or to better understand
diseases for the benefit of the general public.
The baby’s name and any identifying details about the baby are removed before the sample is
provided.
The project must be approved by the Institutional Review Board (IRB) where the researcher
works to make sure it meets high ethical standards and to ensure that the privacy and safety of
the babies is fully protected.
The project must be approved by the Institutional Review Board (IRB) at MDH to make sure it
meets high ethical standards and to ensure that the privacy and safety of the babies is fully
protected.
Newborn Screening Program, 601 Robert St. N., St Paul, MN 5515522
Phone: (800) 664-7772 or (651) 201-5466, Web: www.health.state.mn.us/newbornscreening
page
3
Q:
A:
How are the dried blood spots stored?
The cards containing the very small bit of leftover blood are securely stored. MDH takes the utmost
care to ensure that all stored blood samples are secure. Specimens received by MDH between July 1,
1997 and September 7, 2005 are securely stored in an offsite protected record center. MDH employees
do not have direct access to these specimens. Requests for specimens housed at the offsite record center
go through both a trained Records Coordinator and the outside record management and document
storage facility. Specimens received by MDH beginning September 8, 2005 are stored onsite in a locked
storage room. Only MDH employees who have received thorough data privacy training are allowed access to this area.
Q:
A:
Is my child’s blood stored by MDH and the Mayo Clinic?
Specimens collected since July 1, 1997 are still stored by MDH. Since the Mayo Clinic does some of the
testing for all Minnesota babies, samples are stored there as well. The blood specimens sent to the Mayo
Clinic are destroyed two years after they arrive. Like MDH, the Mayo Clinic also securely stores
specimens in a secure storage area.
Q:
Can a parent choose to screen, but choose not to store his or her child’s sample with MDH/Mayo?
A:
Yes, parents who do not want their child’s sample being stored by MDH or the Mayo Clinic can
complete the “Directive to Destroy” form available at: http://www.health.state.mn.us/newbornscreening.
This form can be completed and sent to MDH at the child’s birth or at any time in the future.
Q:
A:
How will parents know when MDH destroys the leftover blood after they request that it be
done?
MDH maintains the highest commitment to respecting parents’ rights and privacy in newborn
screening. A letter confirming that the destruction has taken place will be sent to the address provided on
the “Directive to Destroy” form.
Newborn Screening Program, 601 Robert St. N., St Paul, MN 5515523
Phone: (800) 664-7772 or (651) 201-5466, Web: www.health.state.mn.us/newbornscreening
page
4
Q: A: I am concerned that the blood from screening or the results will be used to deny my child
insurance. Is this true?
No, MDH does not release blood or test results from newborn screening to insurance companies.
Further, it is against federal law to use test results to discriminate against people with genetic conditions.
Q:
What is DNA?
A:
DNA is the hereditary material in humans; it can be found in all parts of the body including blood, hair,
skin, and saliva. It contains the genetic instructions used in the development and functioning of all
organisms. Changes or mutations in DNA can cause diseases. DNA cannot be used to accurately predict
personal traits like intelligence, athletic ability, or violent tendencies. Without another sample for
comparison, DNA cannot be used to identify an individual person. For example, a person would have to
provide another blood sample to MDH to compare to the dried blood spot before any identification could
be made.
Q:
I heard that MDH collects specimens to create a DNA bank or warehouse. Is that true?
A: No, it is not true. The only specimen stored is the tiny bits of leftover blood on the cards. We do not store
extracted DNA. No “DNA profile” or unique DNA sequence is ever created.
Q:
Is one spot collected just for a DNA warehouse?
A:
No, all 5 dried blood spots are collected in order to ensure newborn screening can be completed. A spot
is NOT collected for the sole purpose of storage.
Q:
How can I get answers to any other questions I have about storage and use of dried blood spots?
A:
There are several ways you can get more information about storage and use of dried blood spots in
Minnesota. The Newborn Screening website at www.health.state.mn.us/newbornscreening has
additional information about newborn screening in general, as well as storage and use. You can also
contact the Newborn Screening Program at [email protected] or call
(651) 201-5466 or (800) 664-7772 and ask to speak to one of the genetic counselors on staff. We
encourage you to contact us with any questions or concerns you might have.
Newborn Screening Program, 601 Robert St. N., St Paul, MN 5515524
Phone: (800) 664-7772 or (651) 201-5466, Web: www.health.state.mn.us/newbornscreening
SECTION OVERVIEW: BIOMONITORING UPDATES
Given the limited time available for advisory panel meetings, updates on some items will
be provided to the panel as information items only. This information is intended to keep
panel members apprised of progress being made in program areas that are not a featured
part of the current meeting’s agenda and/or to alert panel members to items that will need
to be discussed in greater depth at a future meeting.
Included in this section of the meeting packet are status updates on the following:



East Metro PFC Biomonitoring Follow-up Project
Riverside Prenatal Biomonitoring Project
Lake Superior Mercury Biomonitoring Study
ACTION NEEDED: At this time no formal action is needed by the advisory panel. Panel
members are invited to ask questions or provide input on any of these topics during the
designated time on the meeting agenda.
25
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26
BIOMONITORING UPDATE:
EAST METRO PFC BIOMONITORING FOLLOW-UP
PROJECT
November 2010
Project overview
The East Metro PFC Biomonitoring Follow-up Project will measure the change over a
two-year period in blood levels of perfluorochemicals (PFCs) in residents of the East
Metro area. Participants in the 2008 PFC Biomonitoring Pilot Project will be contacted
and asked to provide a second blood sample. We will compare current PFC blood levels
to those from 2008 and to the U.S. population as a whole. This will help to evaluate how
well the changes made in the community’s water systems are working to decrease PFC
exposure. We will also ask participants to fill out a questionnaire on possible sources of
exposure to PFCs.
IRB approval
The follow-up project received initial approval from the MDH and HealthEast IRBs over
the summer. Study protocols and documents were amended based on MDH IRB
stipulations and suggestions, and on revised thinking about the project. Amended
protocols and documents were resubmitted in October and approved by both IRBs in
mid-November.
Outreach to communities
Project staff have been working to inform local public health departments about the
follow-up project. Meetings have been conducted with officials from Washington
County, and phone contact has been made with the cities of Lake Elmo, Cottage Grove,
and Oakdale, and Dakota County. Future meetings are being planned. Outreach to
legislators has also been initiated. We will not undertake larger-scale media and
community outreach until we have project results.
Participant recruitment
The 186 individuals from the 2008 project who agreed to future contact were mailed an
initial letter inviting their participation in the follow-up project on November 17. This
letter also contained the consent forms and questionnaire, which participants are asked to
send back.
Timeline
Once participants return their materials, they will receive a phone call from study staff
thanking them, clarifying questionnaire responses, and providing instructions for making
their blood draw appointment at the HealthEast Oakdale clinic. They will also receive a
second mailing with this information. Those who have not responded to the initial
mailing by Dec. 2 will be called with a reminder. Study staff will collect blood samples
27
from HealthEast Oakdale on a weekly basis and deliver them to the MDH Public Health
Laboratory. We hope to complete blood collection by early February.
CDC communications study
MDH continues to assist CDC with its qualitative study of attitudes and understanding
about biomonitoring, which includes interviewing biomonitoring study participants from
an affected community (their MN case study). As part of our outreach for the follow-up
study, once a select number of participants have agreed to be in our study, we will ask
permission to provide their contact information to the CDC. By agreeing, the participant
is not consenting to participate in the CDC project, only to be contacted by the CDC for
more information. We hope to provide the CDC with information for a total of 16 people
in four different gender and age subgroups.
For more information, please contact Jessica Nelson, PhD, Biomonitoring Program
Coordinator, at [email protected].
28
BIOMONITORING UPDATE:
RIVERSIDE PRENATAL PROJECT
November 2010
The status of this project has not changed since the September Advisory Panel meeting.
Participants (n=66) have been recruited from the larger Riverside Birth Study, conducted
by Dr. Logan Spector at the University of Minnesota. Sample collection is complete, and
the MDH PHL is currently analyzing urine samples for 7 environmental phenols. The
laboratory analysis has been delayed by some QA/QC issues, but environmental phenol
results should be available by the end of the year. A summary of demographics and
cotinine results have already been presented to the Advisory Panel.
Once the laboratory results are available, the study will proceed. Statistical analyses will
be conducted, and results will be communicated to participants and the larger community.
Development of informational fact sheets on environmental phenols and cotinine has
begun.
For more information, please contact Jessica Nelson, PhD, Biomonitoring Program
Coordinator, at [email protected].
29
BIOMONITORING UPDATE:
LAKE SUPERIOR MERCURY IN NEWBORNS PROJECT
November 2010
Sample Collection:
 Sample collection of MN blood spots is complete.
 MI continues to work to provide specimens.
Blood Spot Mercury Analysis:
Initial mercury analysis of MN blood spots is complete. Repeat analysis of 111
specimens, due to quality control issues, will be completed by February 2011.
Status details
EPA approved a project extension through June 30, 2011.
Collaboration between EH and the PHL (sample collection and mercury analysis) and
between EH and MCH/LPH (participant recruitment) continues to go well.
30
SECTION OVERVIEW: LEGISLATIVE REPORT
JANUARY 2011
The Environmental Health Tracking and Biomonitoring statute requires the EHTB
program to submit a report to the legislature every two years and the next report is due on
January 15, 2011. This report is to describe the status of biomonitoring and environmental
health tracking activities. The report is currently under development and will be reviewed
by the EHTB steering committee as well as the MDH communications office and
executive office before being finalized.
Included in this section is an outline of the legislative report. This is provided to give
advisory panel members a sense of what will be included in the required legislative
report.
This legislative report will include a progress report from the tracking and biomonitoring
program, summary reports of the results of the two completed biomonitoring pilot
projects already published, and the biomonitoring program framework with
recommendations for the development of an ongoing biomonitoring program.
Also included in this section is a part of the report called Tracking in Action: Success
Stories of the MN Environmental Public Health Tracking program. This section
summarizes a few of the more significant outcomes of the program for achieving the goal
of informing actions and policies that protect public health.
As defined in statute, the advisory panel has a role in advising both the department of
health and the legislature. MDH wishes to ensure that the advisory panel’s voice is
adequately heard in relation to the legislative report. To this end, panel members are
asked to provide input on what information and recommendations should be incorporated
into the January legislative report. A portion of the December advisory panel meeting
will be dedicated to this topic.
In addition, panel members are welcome to submit their own responses to the legislative
report and/or their own program recommendations directly to the legislative committee
members receiving the legislative report if they choose. Program staff will gladly provide
contact information for the legislators who receive the legislative report.
ACTION NEEDED: Panel members are invited to ask questions and to provide
suggestions for strengthening the legislative report.
No formal vote is anticipated on this agenda item.
31
Outline of Report To The Legislature (draft)
January 2011
EXECUTIVE SUMMARY
MN ENVIRONMENTAL PUBLIC HEALTH TRACKING
o Brief background
o what is tracking, why tracking is important, the promise/goals of tracking
o types/categories of data included
o mission and strategic plan of the MN tracking program
o Progress and news
o MN joined the national EPHT network in 2009; state funding for tracking
was instrumental in making MN eligible for an implementation grant
o Four program goals: overview
o Goal 1: Quality content, data collection/analysis:
 Describe the national content areas
 Development of process and criteria for new Minnesota content
 Progress with development of new MN indicators – radon,
secondhand smoke, pesticide hazards
 Progress in establishing partnerships with data stewards and data
use agreements
o Goal 2: data access and dissemination for users:
 state reports published in 5 content areas
 data submission to CDC national EPHT portal
 development/launch of MN DATA and user testing and demos
ongoing feedback sought to improve
 how data are kept private
 importance of data visualization, interpretation and messaging
o Goal 3: Communications and outreach
 Audiences identified and communications plans developed
 website development, govdelivery list
 presentations, trainings, brownbag seminars
 brochures, displays
o Goal 4: Collaborations
 Research collaborations with academic partners
 Collaborations with MDH-EH Private Wells data survey
 Collaborations on MDH-EH Climate Change initiatives
 Participant with Investing in our Children initiative
 Building relationships with local pubic health and community
groups
32
o Driving Public Health Action: success stories, ways data have been used
 First statewide surveillance of COPD part of ALA COPD
Coalition strategic plan for COPD prevention and control
 First published CO Poisoning report used to support CO poison
prevention activities in MDH and Public Safety, and in media
reports
 Asthma tracking information used by EH scientists in health
impact assessment of light rail central corridor project;
o Future directions
o Increase functionality and content on portal
 Geospatial displays
 Integrate biomonitoring data
 Demographic and behavioral risk factors
 Role-based access for special data requests
o Evaluating data and measures, identify data gaps
o Outreach to expanded audiences, training and information to build data
user capacity and skills
o Publication of special reports, presentations
BIOMONITORING PILOT PROGRAM
o Brief intro/background
o what is biomonitoring
o pilot program objectives
o overview of four pilots required by statute
o summary table with basic background info on community, study
population, specimen, recruitment goal and enrollment, timeframe, etc
o pilot program guidelines
o MN role in national initiatives
o BIOMONITORING PILOTS
 South Minneapolis Children’s Arsenic Study
 Summary of project goals
 Study community
 Community outreach
 Challenges/lessons learned
 Recommendations for follow-up
 East Metro PFCs Biomonitoring Project
 Summary of project goals
 Study community
 Community outreach
 Challenges/lessons learned
 Recommendations for follow-up

Lake Superior Mercury Biomonitoring Project
33

 Summary of project goals
 Study community
 Community outreach
Riverside Prenatal Biomonitoring Project
 Summary of project goals
 Study community
 Community outreach
o Pilot program Lessons Learned - Summary
o Successes
o Challenges
o FRAMEWORK AND RECOMMENDATIONS FOR A BASE BIOMONITORING
PROGRAM
o Steps for Strategic Planning
o Vision and purpose of the MN Biomonitoring Program
o Comprehensive model and 3 public health approaches
 Statewide exposure tracking
 Targeted population exposure tracking
 Exposed community investigations
o Recommended approach and rationale
o Next steps
ADVISORY PANEL
 Membership
 Roles and Meetings
 Significant Contributions
PROGRAM GOVERNANCE
 Steering Committee
 Organization and Staffing
POSSIBLE ADDENDA TO LEGISLATIVE REPORT
Community Report: East Metro PFC Biomonitoring Project
Community Report: South Minneapolis Children’s Arsenic Study
APHL National Biomonitoring Plan
34
Report to the Legislature (draft-continued)
Tracking in Action: Success Stories from Environmental
Public Health Tracking
Tracking the Impact of a Statewide Carbon Monoxide Alarm Law
Each year, unintentional carbon monoxide (CO) poisonings result in several deaths and
hospitalizations in Minnesota. The cold Minnesota winter season is prime time for CO
poisonings. In 2007-2009 Minnesota took an important step towards prevention by
implementing a state law requiring CO alarms in all single family homes and multidwelling units. However, without a tracking system for CO poisonings, the Minnesota
Department of Health had no means to evaluate the impact of the law on the occurrence
of CO poisonings.
Minnesota EPHT collaborated with National Tracking Network to develop data and
measures for CO poisonings. These data were summarized in a tracking report and press
release that resulted in local media coverage about CO poisoning prevention. In addition,
MN EPHT, in partnership with the state Behavior Risk Factor Surveillance System
(BRFSS), initiated collection of data on the number of Minnesota homes that have CO
alarms.
The timing of the implementation of the CO alarm law and the establishment of data and
measures for CO has created the perfect environment in which tracking can be used to
evaluate trends and the impact of policy changes. MN EPHT will use CO tracking and
Behavioral Risk Factor data to assess the effectiveness of the state CO alarm law.
Tracking data also will be used by Minnesota indoor air and healthy homes programs to
target and evaluate outreach activities to improve public health.
Using Tracking to Inform Communities about the Built Environment and Health
The Central Corridor Light Rail Transit (CCLRT) line currently is under development
between Minneapolis and St. Paul, Minnesota. This project presented a unique
opportunity for the Minnesota Department of Health (MDH) Environmental Health
Division to work with local communities to identify and evaluate health and the
environment issues early in the CCLRT planning process.
Populations living near the CCLRT line (e.g., along University Avenue) expressed
concerns about health disparities and several environmental health issues, including:
asthma, air pollution and traffic, childhood blood lead poisoning, and contaminated lands
(i.e., brownfields). While existing health and environment data had been collected in this
urban area, the data were not systematically reported or easy for the public to access.
Minnesota EPHT collaborated developed data and measures for asthma (hospitalizations)
to support this project. Data were aggregated by zip code and placed in a map that was
distributed, along with other environmental health information, to local communities
living near the CCLRT line. These data, ultimately, were used by MDH to inform the
community, local government, and developers about the relationship between health and
the environment (e.g., air pollution and traffic), and measures to prevent and reduce
exposures to environmental health hazards.
35
Methods and data developed through this project may be used by MDH, in collaboration
with MN EPHT and the National Tracking Network, to assess how changes in the built
environment (i.e., resulting from the CCLRT line), influence health and environment at
the local level.
Making State-Specific Data & Measures Accessible: Chronic Obstructive
Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is the fourth-leading cause of death in
the US, and is an important cause of hospitalization and mortality in our aging
population. In 2006, there were 9.5 million US adults with chronic bronchitis (4.3%) and
4.1 million adults with emphysema (1.8%).*
Many states routinely collect COPD data (as a part of hospital discharge data sets);
however, these data are not readily accessible to health professionals or the public. Given
the magnitude of public health and economic impacts of COPD in the US, this is an
important data gap in information that could be used to inform public health actions and
policy.
In September 2010 Minnesota Environmental Public Health Tracking (MN EPHT)
published state-specific data and measures for COPD hospitalizations (rates and counts)
on the state tracking data portal. MN EPHT developed these data using methods that are
consistent with the National Environmental Public Health Tracking Network, so that they
may be easily adapted by other states and at the national level. In addition, in 2009
Minnesota was one of a small number of states in the country to measure COPD
prevalence statewide using the Minnesota Behavior Risk Factor Surveillance System.
Together these data provide useful information to evaluate trends and spatial patterns
over time, and to inform the public about important risk factors and public health actions.
MN EPHT currently is working with the Minnesota American Lung Association to use
COPD data to educate health professionals and others about the impact of COPD in
Minnesota. This activity resulted in additional media coverage of COPD in the state, and
initiated discussions with key partners regarding mechanisms for raising awareness about
this poorly recognized and underestimated public health issue. In addition, MN EPHT
has shared the COPD data and measures with other states and CDC as a potential future
developmental area for the National EPHT Network.
Footnote:
*American Lung Association’s Epidemiology and Statistics Unit. Trends in COPD:
Morbidity and Mortality. Dallas, TX, American Lung Association, December 2007.
36
Summary of the Minnesota Department of Health (MDH)
Environmental Health Tracking & Biomonitoring
Advisory Panel Meeting
September 14, 2010, 1-4 p.m.
Advisory panel members – Present:
Bruce Alexander, Fred Anderson, Alan Bender, Jill Heins Nesvold, Cathi Lyman-Onkka,
Pat McGovern, Geary Olsen, Cathy Villas-Horns (for Dan Stoddard), Lisa Yost
Advisory panel members – Regrets:
Beth Baker, Greg Pratt, Debra McGovern, Dan Stoddard, Samuel Yamin
Welcome and introductions
Bruce Alexander, serving as chair for Beth Baker, convened the meeting. Following
introductions, Jean Johnson, EHTB Program Director, announced several staff changes.
Michonne Bertrand has accepted a mobility assignment in the Statewide Health
Improvement Program (SHIP) and Adrienne Kari has accepted a new position in
Occupational Health surveillance. Work is underway to fill these two vacancies. New
Tracking unit staff include: Eric Hanson, GIS specialist; Naomi Shinoda, environmental
epidemiologist; and Hilarie Martin, CSTE Epidemiology Fellow.
Minnesota-specific Tracking Content Areas
Jeannette Sample, environmental epidemiologist with the Tracking program, reviewed
the Advisory Panel’s statutory role in guiding content for tracking in Minnesota. Content
thus far has stayed consistent with national program content areas. Criteria and a process
are being established for staff and Advisory Panel members to select new Minnesotaspecific content areas for tracking. The process has been piloted using three proposed
content areas for environmental hazards: radon levels in homes, prevalence of
“secondhand” or environmental tobacco smoke exposure among children, and prevalence
of atrazine in groundwater monitoring wells (as an indicator of potential drinking water
exposure in private wells). The radon and environmental tobacco smoke exposure have
both passed the initiation phase and are now under development in the exploration phase.
In this phase datasets are acquired and new measures are piloted to assess feasibility, data
quality, and cost. The atrazine measure is still under discussion in the initiation phase.
Pat McGovern stated that the three examples are useful and asked how the process got
started. Jeannette Sample responded that initially staff were considering all of the criteria
at once. Based on feedback from the March panel meeting a phased approach was
proposed that would begin by answering the most important questions first. Bruce
Alexander asked whether the staff had given consideration to other topics and decided
not to move ahead. Jeannette responded that no other topics had been suggested or
pursued. Bruce suggested that MDH be sure to report any considerations or criteria that
37
are used in decisions to not include a particular content area. The state program should
stay connected to community interests.
Alan Bender asked about other avenues by which topics could come forward. Jeannette
confirmed that anyone may propose new content. He asked whether this same approach
is being applied to biomonitoring or disease measures. Jean Johnson responded that this
same approach could be used. Biomonitoring is currently a separate activity but the
national EPHT program may add national level biomonitoring data to their network.
Lisa Yost suggested that for clarity, the panel should have input earlier than phase 4 and
5. Phase 1 includes some elements of phase 2 and is not just a resources issue, but should
have public health impact in mind when determining available resources. Jean noted
that future outreach with local public health will likely generate more ideas for content to
meet their needs. Pat McGovern suggested that staff put the process and any decision up
on the website and invite comment from the public and professionals. Jill Heins-Nesvold
suggested merging phases 1 and 2 (pre-initiation and initiation). Alan Bender agreed,
noting that the process could lead to developing necessary resources for new data, where
an important content area is identified.
Lisa Yost asked about the time frame for the process. Jeannette responded that it varies,
depending on the availability of staff, data and the complexity of the proposed measure.
Tracking Updates
Jean Johnson gave a brief update on the status of the web-based information system, MN
DATA, expected to be launched and available to the public on September 30th. The
initial roll-out will have 5 content areas but program staff will continue to work on
functionality and additional content over the next several months. Jill Heins-Nesvold
noted that Nov. 17th is World COPD day and MN ALA would like to make an
announcement about available COPD data on the portal. Bruce asked if Advisory Panel
members could be notified of the launch, and Jean will send the link to the new website.
MN EPHT staff participated in CDC Strategic Planning efforts for the next 5 years of
National EPHT network. New content is being planned and 16 states will have a new
RFA to respond to next year. Jill noted that Iowa just joined the network. Pat asked
whether MN would wait to broaden the scope of data content given that we are not part
of this next funding round. Jean thought MN would probably provide the new content to
stay consistent with other states if possible.
Jean reported that Minnesota staff are collaborating with the CDC Public Health
Laboratory in their research of biomonitoring communications in affected communities
by providing referrals and contact information to various audiences of interest to the
CDC. Also, the Association of Public Health Laboratories is developing a National
Biomonitoring plan and MDH staff are working with APHL, CSTE and ASTHO in
developing guidance documents for biomonitoring.
38
Rita Messing, MDH Environmental Health Division supervisor, announced that MDH
recently received notice that they have been awarded a grant from the EPA Great Lakes
Restoration Initiative to conduct biomonitoring with the Fond du Lac Tribe. The project
will measure levels of specific chemicals of concern that are known contaminants in fish.
Joanne Bartkus, Director of the MDH Public Health Laboratory, noted that MDH is seen
as a model for other states in biomonitoring for our collaborative efforts between the
public health laboratory, epidemiology and toxicology in successfully conducting
biomonitoring activities.
Tracking Needs Assessment
Panel members were asked if they had any comments pertaining to MDH plans to
conduct a needs assessment of local public health officials in the next several months.
The assessment will be part of training and outreach on the new web-based information
system and will attempt to capture the environmental public health information needs of
local health officials. A recent document by the National State Conference of Legislators
provides a recent example of an informal assessment. Geary Olsen stated that the NSCL
assessment was lacking important information needed to interpret the results and
suggested that MDH should be more scientific in its approach.
Lessons Learned From Biomonitoring Pilot Program
Jean Johnson gave a brief overview of the topic and questions that the panel is being
asked to address regarding lessons learned from two biomonitoring projects focused on
vulnerable populations, newborns and pregnant women. Both projects are collaborations
with researchers and are not independent MDH-EHTB projects. Both projects have
completed specimen collection and are currently waiting for analytical results from the
laboratory.
Adrienne Kari reviewed the Riverside Prenatal Biomonitoring project that measured
cotinine and environmental phenols in pregnant women. The project was ancillary to a
research study at the University collecting specimens from 425 women enrolled at the
Riverside clinic in Minneapolis. MDH added a spot urine sample. The recruitment goal
was 90 women, 30 from each of 3 ethnic groups. Of 209 women who were eligible and
agreed to be contacted for additional projects, 79 consented to participate and 66
completed the specimen collection. Research investigators changed their recruitment
protocol during the study to focus on recruitment of Somali women which reduced
recruitment during the study period. Recruitment also declined due to the limitation that
only women in their first trimester of pregnancy were eligible.
Pat McGovern asked if MDH knew why women declined to participate. Adrienne
responded that we did not collect that information; MDH had no direct contact with
participants. Jill Heins-Nesvold commented that it was a successful effort despite the
limitations. Alan Bender commented that the state IRB provides more latitude for
recruitment and direct participant contact than the University IRB.
39
Pat McCann presented an overview of the Lake Superior Basin Mercury biomonitoring
project that is measuring mercury levels in newborns from newborn screening blood
spots. Newborn screening blood spots are stored in state Public Health Laboratories in
Minnesota, Wisconsin and Michigan. MDH has so far collected approximately 1,100
specimens from consenting participants in Minnesota for analysis. Mercury analysis is
ongoing in the MDH laboratory. The lab has completed analysis of 160 specimens from
Wisconsin. The project is expected to be complete by June 2011
Pat McCann described the informed consent process. The newborn screening database
was queried to identify women who gave birth in the study zip codes. About 10% of
newborns were excluded if the screening record identified pregnancy complications, or
babies born with certain health problems to avoid causing the parent to be emotionally
upset. Babies were also excluded if an examination of the blood spot revealed
insufficient quality for analysis (25% of eligible newborns excluded). After exclusions,
44% of those invited consented to participate. Babies were categorized by gender, and
urban/non-urban zip code. There is no information to describe the non-respondents.
Jean described lessons learned from these projects with respect to chemical selection,
recruitment, and communications. Both projects were able to capitalize on partnerships
with researchers and saved money. But challenges with not being able to contact
participants directly limited recruitment and communications between MDH and
participants. Selection bias due to non-participation is an issue for both projects.
Pat McGovern asked for clarification on the health issues that resulted in 10% exclusions.
Pat McCann responded that exclusions included babies that were enrolled in NICU, less
than 200g birth weight, or general maternal complications, if they were checked by the
nurse on the screening card.
Pat McCann noted that the project has raised awareness of the sensitivities of using stored
newborn screening spots, identified some of the limitations with the quality of the spots
for analysis, and the utility of information on the newborn screening cards.
Bruce Alexander asked whether MDH can link the newborn screening data with birth
records and whether there are plans to do that. Pat McCann answered that they can be
linked by staff in newborn screening staff but that the mercury results in Environmental
Health cannot be traced back to the child (spots were anonymized prior to analysis).
Bruce recommended that in the future, a plan for linking back to the birth records would
help to resolve some of the challenges that were identified and would answer questions
about population differences based on birth outcomes and other characteristics. Bruce
noted that the decision to exclude problem births could have major implications for future
monitoring. He cautioned that it could miss an important segment of the population for
establishing a reference range, and could disenfranchise a large group of people from the
process. Pat noted that MDH did accept into the study babies recruited by local public
health that MDH had excluded. Pat noted that MDH needs to develop better policy
around use of newborn screening blood spots for the future. Alan Bender commented
that this is just one example of an ongoing problem and the need to educate the legislators
40
and others about the consequence of informed consent and the impact on public health
surveillance.
Geary Olsen asked if MDH has a definition for a “vulnerable” population, and noted that
any community might consider themselves to be vulnerable if they are involuntarily
exposed. Alan Bender noted that typically the term refers to children, pregnant women
and the elderly. Pat McCann noted that pregnant women are more susceptible to
mercury because of the outcome to the fetus, but people who eat fish are more susceptible
to the exposure.
Cathy Lyman-Onkka asked how many babies were excluded due to emotional
sensitivities for the reasons given on the screening record, such as the congenital
abnormalities or sibling deceased. Pat McCann said that they don’t know exactly, the
total was 10% of all babies screened, and acknowledged that any of those exclusions
could introduce bias in the results (reference range).
Alan Bender asked that the Advisory Panel discuss the scientific implications and cost of
the consent process at the next meeting and make a recommendation to MDH for better
informing legislators on the issue of data privacy versus public health surveillance.
Bruce agreed that the panel should defer this discussion to the next meeting and to
discuss data MDH could use to further illustrate the issue, noting that the data will be
more convincing to legislators.
Biomonitoring Framework
Jean Johnson reviewed the process that MDH used to establish a written framework for
planning and implementing an ongoing, or “base” biomonitoring program in accordance
with our state statute. The framework includes the program vision and goals that were
established through strategic planning efforts in 2008 and 2009, and a comprehensive
model for state biomonitoring. The model includes three basic approaches that are then
described, as well as the strengths and challenges of implementation. The three
approaches presented were: 1) statewide population exposure tracking, 2) targeted
population exposure tracking, and 3) exposed community investigations.
Jean asked the Advisory Panel members to discuss the following recommendation
included in the Biomonitoring Framework:
1. Continue strategic planning for a state biomonitoring program using the targeted
population exposure tracking approach. This would include identification of
stakeholders, selection of a target population, selection of specific chemicals of
concern, identification of biomarkers, development of sampling strategies and
protocols, and identifying agency partners and external collaborators.
2. Seek external grant funding or additional resources for exposed community
investigations.
3. Strategic planning for a statewide exposure tracking program is not
recommended.
41
Fred Anderson confirmed that the recommendation for planning a targeted exposure
tracking approach would not be at the exclusion of community exposure investigations.
Jean responded that the state funding may not support both, and so the recommendation
is to seek external funding resources for special investigations. Fred noted that there may
already be a community expectation out there for special investigations. Cathy LymanOnkka clarified that if an exposed community investigation was needed, MDH would
have to go back to the legislature for additional funding or seek external funding.
Geary Olsen asked whether MDH could be criticized for this recommendation because
for a Minnesota community you would potentially need to go outside the state for
funding. Pat McGovern said the targeted exposure tracking approach seems more
strategic and pro-active which is more in consistent with the definition of public health
approach. Lisa Yost noted that public health ought to be scientifically driven. Andrea
Baeder noted that surveillance of a Minnesota population is a public health approach and
not research.
Bruce Alexander agreed that MDH may be criticized but that this recommendation is the
right way to go. Responding only to the exposed community will not give you a
reference population.
Pat McGovern suggested that the rationale for the legislature should address the tradeoffs, given that we can’t do everything Bruce added that MDH should emphasize that
this approach will build an infrastructure through collaborations and expertise over time
that will be a valuable resource for addressing new questions or threats in the future.
Pre-planned surveillance gives you a capacity to respond, but we still need to identify
where in the MDH budget will the additional response resources come from?
Alan Bender noted that when looking at disease clusters, MDH has learned to get out in
front of the issue so that response decisions are based on sound evidence. This proposal
puts MDH “out in front” of questions about exposures, and the goal should be to harness
limited resources with the most significant impact. Fred Anderson added that there is a
balance that is needed between response and surveillance, need to do both.
Pat McGovern asked whether the need for community response isn’t already addressed
through the Site Assessment and Consultation (SAC) unit’s work. Rita Messing added
that the SAC unit and the CDC/ATSDR response programs do have limited capacity and
discussed a recent example where ATSDR was able to quickly respond in an exposed
community in Minnesota. Rita further noted that in some cases biomonitoring results
may not be helpful to getting a clean up done (eg. South Minneapolis arsenic) and results
are not always predictable. Jean agreed that we should remind legislators that there are
other approaches available for community response that may be more appropriate and
helpful.
Jean noted that the panel has one more meeting in December before the Legislative report
is due in January and asked whether panel members would like more time to consider the
recommendation. Panel members responded unanimously that they support the
recommendation. Pat McGovern suggested that the panel could preview a draft
42
presentation of the recommendations in preparation for talking to legislators. Panel
members will receive a draft of the legislative report to review before the next meeting.
Administrative Details
Applications for the Advisory Panel will be considered next week by the EHTB Steering
Committee to recommend appointment by the Commissioner of Health (8 positions
open). Samuel Yamin, a citizen member appointed by the Senate, will not be returning.
Dan Stoddard also will not be returning and the Commissioner of Agriculture has
appointed Cathy Villas-Horn in his place. A new applicant representing Minnesota’s
business community will be appointed to replace Deb McGovern. Jean thanked all of the
panel members for their service over the three years of the program and for their
continued willingness to serve.
There was no new business. Bruce Alexander adjourned the meeting.
Drafted 9/23/10
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44
Appendices
45
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46
EHTB Advisory Panel
2011 Meeting Dates
Tuesday, March 8, 2011
Tuesday, June 7, 2011
Tuesday, September 13, 2011
Tuesday, December 13, 2011
All meetings will be held from 1 - 4 pm and will take place at
MDH’s Snelling Office Park location at 1645 Energy Park Drive.
47
ENVIRONMENTAL HEALTH TRACKING AND
BIOMONITORING
ADVISORY PANEL ROSTER
Thomas Hawkinson, MS, CIH, CSP
Toro Company
8111 Lyndale Avenue S
Bloomington, MN 55420
952-887-8080
[email protected]
Statewide business organization
representative
Bruce H. Alexander, PhD
University of Minnesota School of Public
Health
Environmental Health Sciences Division
MMC 807 Mayo
420 Delaware Street SE
Minneapolis, Minnesota 55455
612-625-7934
[email protected]
Minnesota House of Representatives
appointee
Jill Heins Nesvold, MS
American Lung Association of Minnesota
490 Concordia Avenue
St. Paul, Minnesota 55103
651-223-9578
[email protected]
Nongovernmental organization
representative
Fred Anderson, MPH
Washington County Department of Public
Health and Environment
14949 62nd St N
Stillwater MN 55082
651-430-6655
[email protected]
At-large representative
Cathi Lyman-Onkka, MA
Preventing Harm Minnesota
372 Macalester Street
St. Paul, MN 55105
Beth Baker, MD, MPH
Specialists in Occupational and
Environmental Medicine
Fort Road Medical Building
360 Sherman Street, Suite 470
St. Paul, MN 55102
952-270-5335
[email protected]
At-large representative
Home office
651-647-9017
[email protected]
Nongovernmental organization
representative
Alan Bender, DVM, PhD
Minnesota Department of Health
Health Promotion and Chronic Disease
Division
85 East 7th Place
PO Box 64882
Saint Paul, MN 55164-0882
651-201-5882
[email protected]
MDH appointee
Pat McGovern, PhD, MPH
University of Minnesota School of Public
Health
Environmental Health Sciences Division
MMC Mayo 807
420 Delaware St SE
Minneapolis MN 55455
612-625-7429
[email protected]
University of Minnesota representative
48
Geary Olsen, DVM, PhD
3M Medical Department
Corporate Occupational Medicine
MS 220-6W-08
St. Paul, Minnesota 55144-1000
651-737-8569
[email protected]
Statewide business organization
representative
Lisa Yost, MPH, DABT
Exponent, Inc.
15375 SE 30th Pl, Ste 250
Bellevue, Washington 98007
Local office
St. Paul, Minnesota
651-225-1592
[email protected]
At-large representative
Gregory Pratt, PhD
Minnesota Pollution Control Agency
Environmental Analysis and Outcomes
Division
520 Lafayette Road
St. Paul, MN 55155-4194
651-757-2655
[email protected]
MPCA appointee
Vacant
Minnesota Senate appointee
Cathy Villas-Horns, MS, PG
Minnesota Department of Agriculture
Pesticide and Fertilizer Management
Division
625 Robert Street North
St. Paul, Minnesota 55155-2538
651-201-6291
[email protected]
MDA appointee
Please submit changes and corrections
to: [email protected]
49
BIOGRAPHICAL SKETCHES OF ADVISORY PANEL
MEMBERS
Bruce H. Alexander is an Associate Professor in the Division of Environmental Health
Sciences at the University of Minnesota School of Public Health. Dr. Alexander is an
environmental and occupational epidemiologist with expertise in cancer, reproductive
health, respiratory disease, injury, exposure assessment, and use of biological markers in
public health applications.
Fred Anderson is an epidemiologist at the Washington County Department of Public
Health and Environment and has over 30 years of public health experience. .He holds a
Master of Public Health (MPH) in environmental and infectious disease epidemiology
from the University of Minnesota and is a registered environmental health specialist.
For over 20 years, he has led county-wide disease surveillance and intervention
programs, including numerous multidisciplinary epidemiologic investigations.
Beth Baker is Medical Director of Employee Health at Regions Hospital and a staff physician at
the HealthPartners. She is President of Medical and Toxicology Consulting Services, Ltd. Dr. Baker
is an Assistant Professor in the Medical School and Adjunct Assistant Professor in the School of
Public Health at the University of Minnesota. She is board certified in internal medicine,
occupational medicine and medical toxicology. Dr. Baker is a member of the Board of Trustees for
the Minnesota Medical Association and is on the Board of Directors of the American College of
Occupational and Environmental Medicine.
Alan Bender is the Section Chief of Chronic Disease and Environmental Epidemiology
at the Minnesota Department of Health. He holds a Doctor of Veterinary Medicine degree
from the University of Minnesota and a PhD in Epidemiology from Ohio State University. His
work has focused on developing statewide surveillance systems, including cancer and
occupational health, and exploring the links between occupational and environmental
exposures and chronic disease and mortality.
Tom Hawkinson is the Corporate Environmental, Health and Safety Manager for the Toro
Company in Bloomington, MN. He completed his MS in Public Health at the University of
Minnesota, with a specialization in industrial hygiene. He is certified in the comprehensive
practice of industrial hygiene and a certified safety professional. He has worked in EHS
management at a number of Twin Cities based companies, conducting industrial hygiene
investigations of workplace contaminants and done environmental investigations of subsurface
contamination both in the United States and Europe. He has taught statistics and mathematics at
both graduate and undergraduate levels as an adjunct, and is on the faculty at the Midwest
Center for Occupational Health and Safety A NIOSH-Sponsored Education and Research
Center School of Public Health, University of Minnesota. 50
Jill Heins Nesvold serves as the Director of the Respiratory Health Division for the
American Lung Association of Minnesota, North Dakota, and South Dakota. Her
responsibilities include program oversight and evaluation related to asthma, chronic obstructive
lung disease (COPD), lung cancer, and influenza. Jill holds a master’s degree in health
management and a short-course master’s of business administration. Jill is extensively
published in a variety of public health areas.
Cathi Lyman-Onkka worked in local public health with the Saint Paul – Ramsey County
Department of Public Health for nearly 34 years, until her retirement in 2006. From 1997
through May 2006 she was supervisor of the Community Involvement Program in the
Environmental Health Section. The Community Involvement Program provided
community and professional education related to environmental health, administered the
county Household Hazardous Waste Collection Program, and administered the county
Waste Management Service Charge and its transition to the County Environmental
Charge. Cathi has a B.A. in Biology with a concentration in Environmental Studies from
Macalester College, Saint Paul, Minnesota, and a M.A. in Public Administration from
Hamline University, Saint Paul, Minnesota. From 2002 to May 2006 Cathi was
associated with Preventing Harm through her work for Ramsey County. She has been
active on the Preventing Harm Board since November 2007.
Pat McGovern is a Professor in the Division of Environmental Health Sciences
at the University of Minnesota’s School of Public Health. Dr. McGovern is a
health services researcher and nurse with expertise in environmental and
occupational health policy and health outcomes research. She serves as the
Principal Investigator for the National Children’s Study (NCS) Center serving
Ramsey County, one of 105 study locations nationwide. The NCS is the largest,
long-term study of children’s health and development in the US and the
assessment of environmental exposures will include data collection from
surveys, biological specimens and environmental samples.
Geary Olsen is a staff scientist in the Medical Department of the 3M Company. He
obtained a Doctor of Veterinary Medicine (DVM) degree from the University of Illinois
and a Master of Public Health (MPH) in veterinary public health and PhD in
epidemiology from the University of Minnesota. For 22 years he has been engaged in a
variety of occupational and environmental epidemiology research studies while employed
at Dow Chemical and, since 1995, at 3M. His primary research activities at 3M have
involved the epidemiology, biomonitoring (occupational and general population), and
pharmacokinetics of perfluorochemicals. Recently, he completed a 3-year appointment
on the Board of Scientific Counselors for the U.S. Centers for Disease Control and
Prevention (CDC) ATSDR/NCEH.
51
Greg Pratt is a research scientist at the Minnesota Pollution Control Agency. He holds a
Ph.D. from the University of Minnesota in Plant Physiology where he worked on the
effects of air pollution on vegetation. Since 1984 he has worked for the MPCA on a wide
variety of issues including acid deposition, stratospheric ozone depletion, climate change,
atmospheric fate and dispersion of air pollution, monitoring and occurrence of air
pollution, statewide modeling of air pollution risks, and personal exposure to air
pollution. He is presently cooperating with the Minnesota Department of Health on a
research project on the Development of Environmental Health Outcome Indicators: Air
Quality Improvements and Community Health Impacts.
Cathy Villas Horns is the Hydrologist Supervisor of the Incident Response Unit (IRU) within
the Pesticide and Fertilizer Management Unit of the Minnesota Department of Agriculture. Cathy
holds a Master of Science in Geology from the University of Delaware and a Bachelor of Science
in Geology from Carleton College and is a licensed Professional Geologist in MN. The IRU
oversees or conducts the investigation and cleanup of point source releases of agricultural
chemicals (fertilizers and pesticides including herbicides, insecticides, fungicides, etc. as well as
wood treatment chemicals) through several different programs. Cathy has worked on complex
sites with Minnesota Department of Health and MPCA staff, and continues to work with
interagency committees on contaminant issues. She previously worked as a senior hydrogeologist
within the IRU, and as a hydrogeologist at the Minnesota Pollution Control Agency and an
environmental consulting firm.
Lisa Yost is a Managing Scientist at Exponent Inc., a national consulting firm, in
their Health Sciences Group and she is based in Saint Paul, Minnesota. Ms.
Yost completed her training at the University of Michigan School of Public Health and is
a board-certified toxicologist with expertise in evaluating human health risks associated
with substances in soil, water, and the food chain. She has conducted or supervised risk
assessments under CERCLA, RCRA, or state-led regulatory contexts involving a wide
range of chemicals and exposure situations. Her particular areas of specialization include
exposure and risk assessment, risk communication, and the toxicology of chemicals such
as PCDDs and PCDFs, PCBs, pentachlorophenol (PCP), trichloroethylene (TCE),
mercury, and arsenic. Ms. Yost is a recognized expert in risk assessment and has
collaborated in original research on exposure issues including background
dietary intake of inorganic arsenic. She is currently assisting in a number of projects
including a complex multi-pathway risk assessment for PDDD/Fs that will integrate
extensive biomonitoring data collected by the University of Michigan. Ms. Yost is also an
Adjunct Instructor at the University of Minnesota, School of Public Health.
Rev. November 18, 2010
Please submit additions and corrections to [email protected]
52
GLOSSARY OF TERMS USED IN ENVIRONMENTAL
HEALTH TRACKING AND BIOMONITORING
Biomarker: According to the National Research Council (NRC), a biomarker is an indicator
of a change or an event in a human biological system. The NRC defines three types of
biomarkers in environmental health, those that indicate exposure, effect, and susceptibility.
Biomarker of exposure: An exogenous substance, its metabolites, or the product
of an interaction between the substance and some target molecule or cell that can
be measured in an organism.
Biomarker of effect: A measurable change (biological, physiological, etc.)
within the body that may indicate an actual or potential health impairment or
disease.
Biomarker of susceptibility: An indicator that an organism is especially
sensitive to exposure to a specific external substance.
Biomonitoring: As defined by Minnesota Statute 144.995, biomonitoring is the process by
which chemicals and their metabolites are identified and measured within a biospecimen.
Biomonitoring data are collected by analyzing blood, urine, milk or other tissue samples in the
laboratory. These samples can provide physical evidence of current or past exposure to a
particular chemical.
Biospecimen: As defined by Minnesota Statute 144.995, biospecimen means a sample of
human fluid, serum, or tissue that is reasonably available as a medium to measure the presence
and concentration of chemicals or their metabolites in a human body.
Community: As defined by Minnesota Statute 144.995, community means geographically or
nongeographically based populations that may participate in the biomonitoring program. A
nongeographical community includes, but is not limited to, populations that may share a common
chemical exposure through similar occupations; populations experiencing a common health
outcome that may be linked to chemical exposures; populations that may experience similar
chemical exposures because of comparable consumption, lifestyle, product use; and
subpopulations that share ethnicity, age, or gender.
Designated chemicals: As defined by Minnesota Statute 144.995, designated chemicals are
those chemicals that are known to, or strongly suspected of, adversely impacting human health
or development, based upon scientific, peer-reviewed animal, human, or in vitro studies, and
baseline human exposure data. They consist of chemical families or metabolites that are
included in the federal Centers for Disease Control and Prevention studies that are known
collectively as the National Reports on Human Exposure to Environmental Chemicals Program
and any substances specified by the commissioner after receiving recommendations from the
53
advisory panel in accordance with the criteria specified in statute for the selection of specific
chemicals to study.
Environmental data: Concentrations of chemicals or other substances in the land, water, or air.
Also, information about events or facilities that release chemicals or other substances into the
land, water, or air.
Environmental epidemiology: According to the National Research Council, environmental
epidemiology is the study of the effect on human health of physical, biologic, and chemical
factors in the external environment. By examining specific populations or communities
exposed to different ambient environments, environmental epidemiology seeks to clarify the
relation between physical, biologic, and chemical factors and human health.
Environmental hazard: As defined by Minnesota Statute 144.995, an environmental hazard
is a chemical or other substance for which scientific, peer-reviewed studies of humans, animals,
or cells have demonstrated that the chemical is known or reasonably anticipated to adversely
impact human health. People can be exposed to physical, chemical, or biological agents from
various environmental sources through air, water, soil, and food. For EPHT, environmental
hazards include biological toxins, but do not include infectious agents (e.g. E. coli in drinking
water is not included).
Environmental health indicators: Environmental health indicators or environmental public
health indicators are descriptive summary measures that identify and communicate information
about a population’s health status with respect to environmental factors. Within the
environmental public health indicators framework, indicators are categorized as hazard
indicators, exposure indicators, health effect indicators, and intervention indicators. See
www.cste.org/OH/SEHIC.asp and www.cdc.gov/nceh/indicators/introduction.htm for more
information.
Environmental justice: The fair treatment and meaningful involvement of all people
regardless of race, national origin, color or income when developing, implementing and
enforcing environmental laws, regulations and policies. Fair treatment means that no group of
people, including a racial, ethnic, or socioeconomic group, should bear more than its share of
negative environmental impacts.
Environmental health tracking: As defined in Minnesota Statute 144.995, environmental
health tracking is the collection, integration, integration, analysis, and dissemination of data on
human exposures to chemicals in the environment and on diseases potentially caused or
aggravated by those chemicals. Environmental health tracking is synonymous with
environmental public health tracking.
Environmental public health surveillance: Environmental public health surveillance is
public health surveillance of health effects integrated with surveillance of environmental
exposures and hazards.
Environmental Public Health Tracking Network: The National Environmental Public
Health Tracking Network is a Web-based, secure network of standardized health and
environmental data. The Tracking Network draws data and information from state and local
54
tracking networks as well as national-level and other data systems. It will provide the means to
identify, access, and organize hazard, exposure, and health data from these various sources and
to examine and analyze those data on the basis of their spatial and temporal characteristics. The
network is being developed by the Centers for Disease Control and Prevention (CDC) in
collaboration with a wide range of stakeholders. See www.cdc.gov/nceh/tracking/network.htm
for more information.
Environmental Public Health Tracking Program: The Congressionally-mandated
national initiative that will establish a network that will enable the ongoing collection,
integration, analysis, and interpretation of data about the following factors: (1) environmental
hazards, (2) exposure to environmental hazards, and (3) health effects potentially related to
exposure to environmental hazards. Visit www.cdc.gov/nceh/tracking/ for more information.
Epidemiology: The study of the distribution and determinants of health-related states or
events in specified populations, and the application of this study to the control of health
problems.
Exposure: Contact with a contaminant (by breathing, ingestion, or touching) in such a way
that the contaminant may get in or on the body and harmful effects may occur.
Exposure indicator: According to the Council of State and Territorial Epidemiologists
(CSTE), an exposure indicator is a biological marker in tissue or fluid that identifies the
presence of a substance or combination of substances that may potentially harm the individual.
Geographic Information Systems (GIS): Software technology that enables the integration
of multiple sources of data and displaying data in time and space.
Hazard: A factor that may adversely affect health.
Hazard indicator: A condition or activity that identifies the potential for exposure to a
contaminant or hazardous condition.
Health effects: Chronic or acute health conditions that affect the well-being of an
individual or community.
Health effect indicator: The disease or health problem itself, such as asthma attacks or birth
defects, that affect the well-being of an individual or community. Health effects are measured
in terms of illness and death and may be chronic or acute health conditions.
Incidence: The number of new events (e.g., new cases of a disease in a defined population)
within a specified period of time.
Institutional Review Board: An Institutional Review Board (IRB) is a specially constituted
review body established or designated by an entity to protect the welfare of human subjects
recruited to participate in biomedical or behavioral research. IRBs check to see that research
projects are well designed, legal, ethical, do not involve unnecessary risks, and include
safeguards for participants.
55
Intervention: Taking actions in public health so as to reduce adverse health effects,
regulatory, and prevention strategies.
Intervention indicator: Programs or official policies that minimize or prevent an
environmental hazard, exposure or health effect.
National Health and Nutrition Examination Survey (NHANES): A continuous survey,
conducted by CDC, of the health and nutritional status of adults and children in the United
States. The survey is unique in that it combines interviews and physical examinations. Since
1970, children in the survey were biomonitored for lead poisoning, and since 1999, an
increasing number of environmental contaminants has been included in the survey. Visit
www.cdc.gov/exposurereport/report.htm for more information.
National Human Exposure Assessment Survey (NHEXAS): An EPA survey designed
to evaluate comprehensive human exposure to multiple chemicals on a community and
regional scale. The study was carried out in EPA Region V, of which Minnesota is a part.
Individual households from four Minnesota Counties were included in the survey. Visit
www.epa.gov/heasd/edrb/nhexas.htm for more information.
Persistent chemicals: Chemical substances that persist in the environment, bioaccumulate
through the food web, and pose a risk of causing adverse effects to human health and the
environment.
Population-based approach: A population-based approach uses a defined population or
community as the organizing principle for targeting the broad distribution of diseases and
health determinants. A population-based approach attempts to measure or shape a community’s
overall health status profile, seeking to affect the determinants of disease within an entire
community rather than simply those of single individuals.
Prevalence: The number of events (e.g., instances of a given health effect or other
condition) in a given population at a designated time.
Public health surveillance: The ongoing, systematic collection, analysis, and
interpretation of outcome-specific data used to plan, implement, and evaluate public
health practice.
Standard: Something that serves as a basis for comparison. A technical specification or
written report drawn up by experts based on the consolidated results of scientific study,
technology, and experience; aimed at optimum benefits; and approved by a recognized
and representative body.
Revised October 10, 2007
Please submit additions and changes to: [email protected]
56
ACRONYMS USED IN ENVIRONMENTAL HEALTH
TRACKING AND BIOMONITORING
ACGIH American Conference of Governmental Industrial Hygienists
ATSDR
Agency for Toxic Substances and Disease Registry, DHHS
CDC
Centers for Disease Control and Prevention, DHHS
CERCLA
Comprehensive Environmental Response; Compensation and Liability Act
(Superfund)
CSTE
Council of State and Territorial Epidemiologists
DHHS
US Department of Health and Human Services, including the US Public
Health Service, which includes the CDC, ATSDR, NIH and other agencies
EPA
US Environmental Protection Agency
EHTB
Environmental Health Tracking and Biomonitoring (the name of
Minnesota Statutes 144.995-144.998 and the program established therein)
EPHI
Environmental Public Health Indicators
ICD
International Classification of Diseases
IRB Institutional
MARS Minnesota
Review Board
Arsenic Study, conducted by MDH in 1998-1999
MDA
Minnesota Department of Agriculture
MDH
Minnesota Department of Health
MEHTS
Minnesota Environmental Health Tracking System
MNPHIN
Minnesota Public Health Information Network, MDH
MPCA
Minnesota Pollution Control Agency
NCEH
National Center for Environmental Health, CDC
NCHS
National Center for Health Statistics
57
NGO Non-governm
ental organization
NHANES
National Health and Nutrition Examination Survey, National Center for
Health Statistics (NCHS) in the CDC
NHEXAS
National Human Exposure Assessment Survey, EPA
NIOSH
National Institute for Occupational Safety and Health, CDC
NIEHS
National Institute of Environmental Health Sciences, NIH
NIH National
Institutes of Health, DHHS
NLM
National Library of Medicine, NIH
NPL
National Priorities List (Superfund)
NTP
National Toxicology Program, NIEHS, NIH
PFBA Perfluorobutanoic
PFC
acid
Perfluorochemicals, including PFBA, PFOA and PFOS
PFOA Perfluorooctanoic
PFOS Perfluorooctane
acid
sulfonate
PHL
Public Health Laboratory, MDH
PHIN
Public Health Information Network, CDC
POP
Persistent organic pollutant
SEHIC
State Environmental Health Indicators Collaborative
Revised October 10, 2007
Please submit additions and changes to [email protected]
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EHTB STATUTE: MINN. STATUTES 144.995-144.998
Minnesota: Environmental Health Tracking and Biomonitoring
$1,000,000 each year is for environmental health tracking and biomonitoring. Of this amount, $900,000
each year is for transfer to the Minnesota Department of Health. The base appropriation for this program
for fiscal year 2010 and later is $500,000.
collectively as the National Reports on Human
Exposure to Environmental Chemicals Program
and any substances specified by the
commissioner after receiving recommendations
under section 144.998, subdivision 3, clause (6).
(i) "Environmental hazard" means a chemical
or other substance for which scientific, peerreviewed studies of humans, animals, or cells
have demonstrated that the chemical is known or
reasonably anticipated to adversely impact
human health.
(j) "Environmental health tracking" means
collection, integration, analysis, and
dissemination of data on human exposures to
chemicals in the environment and on diseases
potentially caused or aggravated by those
chemicals.
144.995 DEFINITIONS;
ENVIRONMENTAL HEALTH TRACKING
AND BIOMONITORING.
(a) For purposes of sections 144.995 to
144.998, the terms in this section have the
meanings given.
(b) "Advisory panel" means the
Environmental Health Tracking and
Biomonitoring Advisory Panel established under
section 144.998.
(c) "Biomonitoring" means the process by
which chemicals and their metabolites are
identified and measured within a biospecimen.
(d) "Biospecimen" means a sample of human
fluid, serum, or tissue that is reasonably
available as a medium to measure the presence
and concentration of chemicals or their
metabolites in a human body.
(e) "Commissioner" means the commissioner
of the Department of Health.
(f) "Community" means geographically or
nongeographically based populations that may
participate in the biomonitoring program. A
"nongeographical community" includes, but is
not limited to, populations that may share a
common chemical exposure through similar
occupations, populations experiencing a
common health outcome that may be linked to
chemical exposures, populations that may
experience similar chemical exposures because
of comparable consumption, lifestyle, product
use, and subpopulations that share ethnicity, age,
or gender.
(g) "Department" means the Department of
Health.
(h) "Designated chemicals" means those
chemicals that are known to, or strongly
suspected of, adversely impacting human health
or development, based upon scientific, peerreviewed animal, human, or in vitro studies, and
baseline human exposure data, and consists of
chemical families or metabolites that are
included in the federal Centers for Disease
Control and Prevention studies that are known
144.996 ENVIRONMENTAL HEALTH
TRACKING; BIOMONITORING.
Subdivision 1. Environmental health
tracking. In cooperation with the commissioner
of the Pollution Control Agency, the
commissioner shall establish an environmental
health tracking program to:
(1) coordinate data collection with the
Pollution Control Agency, Department of
Agriculture, University of Minnesota, and any
other relevant state agency and work to promote
the sharing of and access to health and
environmental databases to develop an
environmental health tracking system for
Minnesota, consistent with applicable data
practices laws;
(2) facilitate the dissemination of aggregate
public health tracking data to the public and
researchers in accessible format;
(3) develop a strategic plan that includes a
mission statement, the identification of core
priorities for research and epidemiologic
surveillance, and the identification of internal
and external stakeholders, and a work plan
describing future program development and
addressing issues having to do with compatibility
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with the Centers for Disease Control and
Prevention's National Environmental Public
Health Tracking Program;
(4) develop written data sharing agreements as
needed with the Pollution Control Agency,
Department of Agriculture, and other relevant
state agencies and organizations, and develop
additional procedures as needed to protect
individual privacy;
(5) organize, analyze, and interpret available
data, in order to:
(i) characterize statewide and localized trends
and geographic patterns of population-based
measures of chronic diseases including, but not
limited to, cancer, respiratory diseases,
reproductive problems, birth defects, neurologic
diseases, and developmental disorders;
(ii) characterize statewide and localized trends
and geographic patterns in the occurrence of
environmental hazards and exposures;
(iii) assess the feasibility of integrating disease
rate data with indicators of exposure to the
selected environmental hazards such as
biomonitoring data, and other health and
environmental data;
(iv) incorporate newly collected and existing
health tracking and biomonitoring data into
efforts to identify communities with elevated
rates of chronic disease, higher likelihood of
exposure to environmental hazards, or both;
(v) analyze occurrence of environmental
hazards, exposures, and diseases with relation to
socioeconomic status, race, and ethnicity;
(vi) develop and implement targeted plans to
conduct more intensive health tracking and
biomonitoring among communities; and
(vii) work with the Pollution Control Agency,
the Department of Agriculture, and other
relevant state agency personnel and
organizations to develop, implement, and
evaluate preventive measures to reduce elevated
rates of diseases and exposures identified
through activities performed under sections
144.995 to 144.998; and
(6) submit a biennial report to the chairs and
ranking members of the committees with
jurisdiction over environment and health by
January 15, beginning January 15, 2009, on the
status of environmental health tracking activities
and related research programs, with
recommendations for a comprehensive
environmental public health tracking program.
Subd. 2. Biomonitoring. The commissioner
shall:
(1) conduct biomonitoring of communities on
a voluntary basis by collecting and analyzing
biospecimens, as appropriate, to assess
environmental exposures to designated
chemicals;
(2) conduct biomonitoring of pregnant women
and minors on a voluntary basis, when
scientifically appropriate;
(3) communicate findings to the public, and
plan ensuing stages of biomonitoring and disease
tracking work to further develop and refine the
integrated analysis;
(4) share analytical results with the advisory
panel and work with the panel to interpret
results, communicate findings to the public, and
plan ensuing stages of biomonitoring work; and
(5) submit a biennial report to the chairs and
ranking members of the committees with
jurisdiction over environment and health by
January 15, beginning January 15, 2009, on the
status of the biomonitoring program and any
recommendations for improvement.
Subd. 3. Health data. Data collected under
the biomonitoring program are health data under
section 13.3805.
144.997 BIOMONITORING PILOT
PROGRAM.
Subdivision 1. Pilot program. With advice
from the advisory panel, and after the program
guidelines in subdivision 4 are developed, the
commissioner shall implement a biomonitoring
pilot program. The program shall collect one
biospecimen from each of the voluntary
participants. The biospecimen selected must be
the biospecimen that most accurately represents
body concentration of the chemical of interest.
Each biospecimen from the voluntary
participants must be analyzed for one type or
class of related chemicals. The commissioner
shall determine the chemical or class of
chemicals to which community members were
most likely exposed. The program shall collect
and assess biospecimens in accordance with the
following:
(1) 30 voluntary participants from each of
three communities that the commissioner
identifies as likely to have been exposed to a
designated chemical;
(2) 100 voluntary participants from each of
two communities:
(i) that the commissioner identifies as likely to
have been exposed to arsenic; and
(ii) that the commissioner identifies as likely
to have been exposed to mercury; and
(3) 100 voluntary participants from each of
two communities that the commissioner
identifies as likely to have been exposed to
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perfluorinated chemicals, including
perfluorobutanoic acid.
Subd. 2. Base program. (a) By January 15,
2008, the commissioner shall submit a report on
the results of the biomonitoring pilot program to
the chairs and ranking members of the
committees with jurisdiction over health and
environment.
(b) Following the conclusion of the pilot
program, the commissioner shall:
(1) work with the advisory panel to assess the
usefulness of continuing biomonitoring among
members of communities assessed during the
pilot program and to identify other communities
and other designated chemicals to be assessed
via biomonitoring;
(2) work with the advisory panel to assess the
pilot program, including but not limited to the
validity and accuracy of the analytical
measurements and adequacy of the guidelines
and protocols;
(3) communicate the results of the pilot
program to the public; and
(4) after consideration of the findings and
recommendations in clauses (1) and (2), and
within the appropriations available, develop and
implement a base program.
Subd. 3. Participation. (a) Participation in the
biomonitoring program by providing
biospecimens is voluntary and requires written,
informed consent. Minors may participate in the
program if a written consent is signed by the
minor's parent or legal guardian. The written
consent must include the information required to
be provided under this subdivision to all
voluntary participants.
(b) All participants shall be evaluated for the
presence of the designated chemical of interest as
a component of the biomonitoring process.
Participants shall be provided with information
and fact sheets about the program's activities and
its findings. Individual participants shall, if
requested, receive their complete results. Any
results provided to participants shall be subject
to the Department of Health Institutional Review
Board protocols and guidelines. When either
physiological or chemical data obtained from a
participant indicate a significant known health
risk, program staff experienced in
communicating biomonitoring results shall
consult with the individual and recommend
follow-up steps, as appropriate. Program
administrators shall receive training in
administering the program in an ethical,
culturally sensitive, participatory, and
community-based manner.
Subd. 4. Program guidelines. (a) The
commissioner, in consultation with the advisory
panel, shall develop:
(1) protocols or program guidelines that
address the science and practice of
biomonitoring to be utilized and procedures for
changing those protocols to incorporate new and
more accurate or efficient technologies as they
become available. The commissioner and the
advisory panel shall be guided by protocols and
guidelines developed by the Centers for Disease
Control and Prevention and the National
Biomonitoring Program;
(2) guidelines for ensuring the privacy of
information; informed consent; follow-up
counseling and support; and communicating
findings to participants, communities, and the
general public. The informed consent used for
the program must meet the informed consent
protocols developed by the National Institutes of
Health;
(3) educational and outreach materials that are
culturally appropriate for dissemination to
program participants and communities. Priority
shall be given to the development of materials
specifically designed to ensure that parents are
informed about all of the benefits of
breastfeeding so that the program does not result
in an unjustified fear of toxins in breast milk,
which might inadvertently lead parents to avoid
breastfeeding. The materials shall communicate
relevant scientific findings; data on the
accumulation of pollutants to community health;
and the required responses by local, state, and
other governmental entities in regulating toxicant
exposures;
(4) a training program that is culturally
sensitive specifically for health care providers,
health educators, and other program
administrators;
(5) a designation process for state and private
laboratories that are qualified to analyze
biospecimens and report the findings; and
(6) a method for informing affected
communities and local governments representing
those communities concerning biomonitoring
activities and for receiving comments from
citizens concerning those activities.
(b) The commissioner may enter into
contractual agreements with health clinics,
community-based organizations, or experts in a
particular field to perform any of the activities
described under this section.
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shall establish the Environmental Health
Tracking and Biomonitoring Advisory Panel.
The commissioner shall appoint, from the pa
144.998 ENVIRONMENTAL HEALTH
TRACKING AND BIOMONITORING
ADVISORY PANEL.
Subdivision 1. Creation. The commissioner
nel's membership, a chair. The panel shall meet
as often as it deems necessary but, at a
minimum, on a quarterly basis. Members of the
panel shall serve without compensation but shall
be reimbursed for travel and other necessary
expenses incurred through performance of their
duties. Members appointed by the commissioner
are appointed for a three-year term and may be
reappointed. Legislative appointees serve at the
pleasure of the appointing authority.
Subd. 2. Members. (a) The commissioner
shall appoint eight members, none of whom may
be lobbyists registered under chapter 10A, who
have backgrounds or training in designing,
implementing, and interpreting health tracking
and biomonitoring studies or in related fields of
science, including epidemiology, biostatistics,
environmental health, laboratory sciences,
occupational health, industrial hygiene,
toxicology, and public health, including:
(1) at least two scientists representative of
each of the following:
(i) nongovernmental organizations with a
focus on environmental health, environmental
justice, children's health, or on specific chronic
diseases; and
(ii) statewide business organizations; and
(2) at least one scientist who is a
representative of the University of Minnesota.
(b) Two citizen panel members meeting the
scientific qualifications in paragraph (a) shall be
appointed, one by the speaker of the house and
one by the senate majority leader.
(c) In addition, one representative each shall
be appointed by the commissioners of the
Pollution Control Agency and the Department of
Agriculture, and by the commissioner of health
to represent the department's Health Promotion
and Chronic Disease Division.
Subd. 3. Duties. The advisory panel shall
make recommendations to the commissioner and
the legislature on:
(1) priorities for health tracking;
(2) priorities for biomonitoring that are based
on sound science and practice, and that will
advance the state of public health in Minnesota;
(3) specific chronic diseases to study under the
environmental health tracking system;
(4) specific environmental hazard exposures to
study under the environmental health tracking
system, with the agreement of at least nine of the
advisory panel members;
(5) specific communities and geographic areas
on which to focus environmental health tracking
and biomonitoring efforts;
(6) specific chemicals to study under the
biomonitoring program, with the agreement of at
least nine of the advisory panel members; in
making these recommendations, the panel may
consider the following criteria:
(i) the degree of potential exposure to the
public or specific subgroups, including, but not
limited to, occupational;
(ii) the likelihood of a chemical being a
carcinogen or toxicant based on peer-reviewed
health data, the chemical structure, or the
toxicology of chemically related compounds;
(iii) the limits of laboratory detection for the
chemical, including the ability to detect the
chemical at low enough levels that could be
expected in the general population;
(iv) exposure or potential exposure to the
public or specific subgroups;
(v) the known or suspected health effects
resulting from the same level of exposure based
on peer-reviewed scientific studies;
(vi) the need to assess the efficacy of public
health actions to reduce exposure to a chemical;
(vii) the availability of a biomonitoring
analytical method with adequate accuracy,
precision, sensitivity, specificity, and speed;
(viii) the availability of adequate biospecimen
samples; or
(ix) other criteria that the panel may agree to;
and
(7) other aspects of the design,
implementation, and evaluation of the
environmental health tracking and biomonitoring
system, including, but not limited to:
(i) identifying possible community partners
and sources of additional public or private
funding;
(ii) developing outreach and educational
methods and materials; and
(iii) disseminating environmental health
tracking and biomonitoring findings to the
public.
Subd. 4. Liability. No member of the panel
shall be held civilly or criminally liable for an act
or omission by that person if the act or omission
was in good faith and within the scope of the
member's responsibilities under sections 144.995
to 144.998.
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INFORMATION SHARING.
On or before August 1, 2007, the
commissioner of health, the Pollution Control
Agency, and the University of Minnesota are
requested to jointly develop and sign a
memorandum of understanding declaring their
intent to share new and existing environmental
hazard, exposure, and health outcome data,
within applicable data privacy laws, and to
cooperate and communicate effectively to ensure
sufficient clarity and understanding of the data
by divisions and offices within both departments.
The signed memorandum of understanding shall
be reported to the chairs and ranking members of
the senate and house of representatives
committees having jurisdiction over judiciary,
environment, and health and human services.
Effective date: July 1, 2007
This document contains Minnesota Statutes,
sections 144.995 to 144.998, as these sections
were adopted in Minnesota Session Laws 2007,
chapter 57, article 1, sections 143 to 146. The
appropriation related to these statutes is in
chapter 57, article 1, section 3, subdivision 4.
The paragraph about information sharing is in
chapter 57, article 1, section 169. The following
is a link to chapter 57:
http://ros.leg.mn/bin/getpub.php?type=law&year
=2007&sn=0&num=57
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