Is it in us? Does it matter?
Biomonitoring in a
public health context
EPHT Brown Bag Seminar
Series
July 8, 2010
Joanne Bartkus, Director, Public Health
Laboratory Division
Jean Johnson, Program Director,
Environmental Public Health Tracking &
Biomonitoring Program
Michonne Bertrand, Coordinator,
Environmental Public Health Tracking &
Biomonitoring Program
What is biomonitoring?
Biomonitoring is directly measuring the amount
of a chemical (or the products a chemical breaks
down into) in people’s bodies.
Why do biomonitoring?
Depends on who you ask…..
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Physician
Police officer
Employer
Academic researcher
Environmental advocacy group
Community member
Public health professionals
Uses of biomonitoring

In clinics: Doctors test the lead levels
in children.

In law enforcement: Breathalyzer tests
estimate blood alcohol content by
testing a breath sample.
Uses of biomonitoring, cont.

In occupational settings: Workers
whose jobs expose them to chemicals
are tested to ensure safety.

In research: Biomonitoring data are
used in health studies to explore the
links between exposure to chemicals
and health outcomes.
Uses of biomonitoring, cont.

In advocacy organizations: Biomonitoring is
sometimes used to raise awareness about
the chemicals in people’s bodies.
Uses of biomonitoring, cont.

In communities: Biomonitoring may be used
to address community concerns about
exposures – e.g., from manufacturing plants,
landfills, spills.
Biomonitoring in
public health practice

Federal biomonitoring: National
Biomonitoring Program: National Report on
Human Exposure to Environmental
Chemicals

State and local biomonitoring: California, New
York State, Washington, New York City,
Minnesota, and others
Uses of biomonitoring in public
health practice

Track trends over time
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Identify exposure disparities
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Evaluate interventions to reduce exposure
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Set priorities for public health interventions,
research, and policy
Biomonitoring has shown levels of Perflurorochemicals (PFCs)
declining in the general population since 2000.
3M stopped production in 2002.
Temporal trends for five polyfluoroalkyl concentrations (ng/mL) from the CDC
NHANES and American Red Cross study populations for the population
geometric means (95% confidence intervals.)
Source: Olsen et al, 2008, Env. Sci. Technol, 42, 4989-4995.
Uses of biomonitoring in public
health practice

Track trends over time

Identify exposure disparities
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Evaluate interventions to reduce exposure
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Set priorities for public health interventions,
research, and policy
Identifying disparities
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Higher mercury levels are measured in
populations that consume a high fish diet.

NYC HANES measured elevated mercury
levels in people born in the Dominican
Republic; this was largely attributed to the
use of skin-lightening creams.
Uses of biomonitoring in public
health practice
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Track trends over time
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Identify exposure disparities

Evaluate interventions to reduce exposure

Set priorities for public health interventions,
research, and policy
Blood lead levels in
the
U.S. population, 1976-2002
18
Blood lead levels (g/dL)
16
14
12
10
8
6
lead
paint
ban
1976
lead soldered
cans, phase-out
begins 1978
leaded
gas
removal
complete
1991
unleaded
gasoline
introduced
1975
4
lead soldered
cans, phase-out
ends 1992
2
0
1976
1980
1984
1988
Year
1992
1996
2000
2004
Serum cotinine
(50th percentile in ng/mL)
Decline in Exposure of U.S. Population
to Environmental Tobacco Smoke
0.20
0.20
0.10
0.05
0.00
1988 - 1991
1999 - 2000
Uses of biomonitoring in public
health practice
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Track trends over time

Identify exposure disparities

Evaluate interventions to reduce exposure

Set priorities for public health interventions,
research, and policy
Setting priorities

Toxic Substances Control Act (TSCA)
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Registration, Evaluation, Authorization and
Restriction of Chemical Substances (REACH)
Biomonitoring at the Minnesota
Department of Health
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Blood lead surveillance
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Investigator-initiated research
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Minnesota Arsenic Study, 1998-2000
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CDC Laboratory Biomonitoring Planning Grant, 2002-03
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CDC Bioterrorism funds build lab capacity, 2003-present
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EPA/MN funded mercury in newborn blood spots, 2007-ongoing
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State Legislation funds MDH to conduct pilot program, and plan ongoing
program, 2007- present
Legislation: Environmental
Health Tracking and
Biomonitoring (EHTB)
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2007 Legislature: Minnesota Statutes 144.995-144.998
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MDH will initiate a pilot biomonitoring program and conduct 4 pilot projects in
communities identified as “likely to be exposed” to:
 Arsenic
 Perflurorochemicals (PFCs)
 Mercury
 TBD (selected environmental phenols and cotinine)
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Projects describe the distribution of exposure in the community population.
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Develop recommendations and implement an ongoing state biomonitoring
program.
Comparison of four pilot
projects
Study
population
Study
community
Biospecimen/
Analyte
Likely source of
exposure
Population
sample
Recruitment
goal
Minneapolis
Children’s
Arsenic Study
Children, 310 years old
Urban;
geographic
community
Urine/
total and
speciated arsenic
Ingestion of
residential soil
contamination,
diet, and other
exposure routes
Random
selection
100
East Metro PFC
Biomonitoring
Study
Adults, 20
years and
older
Suburban;
communities
based on
drinking water
source
Blood serum/
7 PFCs including
PFOA, PFOS,
and PFBA
Ingestion of
contaminated
drinking water;
diet, and other
exposure routes
Random
selection
200
(100 from each
of 2
communities)
Riverside
Prenatal
Biomonitoring
Study
Pregnant
women
Rural;
geographic
community
Urine/
Environmental
phenols including
BPA, and
cotinine
Diet and consumer
product use
(phenols);
secondhand smoke
(cotinine)
Total
population
meeting
inclusion
criteria;
stratified by
ethnicity
90
(30 from each
of 3 ethnic
communities)
Lake Superior
Mercury
Biomonitoring
Study
Newborns
Urban;
clinic-based
community
Newborn dried
blood spot/
total mercury
Maternal dietary
exposure (fish
consumption)
Total
population
meeting
inclusion
criteria
1,150 in
Minnesota; 600
in Wisconsin
and Michigan
Stages of a Biomonitoring Study
Study Hypothesis
Study Design
Population Selection
Statistical Consideration
Ethics
Biomarker Selection and Validation
Study Conduct
Toxicokinetics
Communication
Enrollment and Consent
Sample Collection and Processing
Communication
and Implementation Data
Analysis
of Results
Laboratory Analysis
Statistical Analysis
Sample Banking
Interpretation
Communication of Results
Individual
Risk
Clinical
Setting
Population
and Media
Policy Makers
and Agencies
Human Biomonitoring for Environmental Chemicals; National Research
Council of the National Academies 2006
Minneapolis Children’s
Arsenic Study
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Residents of households in South Minneapolis
where EPA testing has found arsenic in soil at
concentrations > 20 ppm
Children ages 3 to 10 years (randomly selected).
Recruitment methods included mailed letter and survey, and door to
door visits.
With parental consent, each child provided 2 first morning void urine
specimens.
MDH laboratory analyzed for total urinary arsenic
If total arsenic was greater than 15 ug/g creatinine, a speciated arsenic test was
run. Speciation separates organic arsenic (from food mostly) and inorganic
arsenic (from soil, water)

Status: Complete. 65 Children participated. Community
meetings were held in April 2009. Report available.
What are perfluorochemicals?
Manufactured since the 1950s, perfluorochemicals (PFCs) are a
family of chemicals used for decades to make products that
resist heat, oil, stains, grease and water.
East Pilot Metro PFC
Biomonitoring Project
The biomonitoring project measured these 7 PFCs in the
blood of people living in the community:
PFOA
Perfluorooctanoic acid*
C8
PFOS
Perfluorooctane sulfonate*
C8
PFBA
Perfluorobutyric acid*
C4
PFHxS Perfluorohexane sulfonate
C6
PFHxA Perfluorohexanoic acid
C6
PFPeA Perfluoropentanoic acid
C5
PFBS
C4
Perfluorobutane sulfonate
*Legislation required 3 specific PFCs be measured.
East Metro
Perfluorochemicals (PFC)
Individuals must be living in one of the two pilot project communities:
• 98 people from households served by the Oakdale municipal
water supply.
• 98 people from households with private wells that contain
PFCs in Lake Elmo and Cottage Grove.
Participants were adults, age 20 or older, residing at the home prior
to Jan. 1, 2005.
Recruitment by mailed letter and survey to households followed by
random selection of eligible adults.
Blood serum was collected at nearby clinic.
Status: Complete. 196 adults participated. Final report is available.
Community meetings were held July 2009.
Public health challenge:
Data interpretation or “does it matter?”
“Most Americans carry a burden of environmental chemicals in
their bodies” (Mind Disrupted)
What are the health implications to the individual? to their
children? To the community?
3 comparison methods used for interpreting results:
 published medical/clinical reference values
 published risk assessment-based values
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Eg. EPA reference dose, occupational BEIs
other populations, or “reference range”
30
25
5
15- 1 4
11 0
15 - 14
20 19
25 - 24
30 29
35 - 34
40 39
45 - 44
50 - 49
55 54
60 - 59
65 64
70 - 69
75 74
80 - 79
85 - 84
90 89
9 94
10 5 - 99
10 0- 10 4
5
11 - 10 9
11 0- 11 4
12 5- 11 9
0
12 - 12 4
13 5- 12 9
0
13 - 13 4
14 5- 13 9
0
14 - 14 4
15 5- 14 9
15 0- 15 4
5
16 - 15 9
16 0- 16 4
5
17 - 16 9
17 0- 17 4
5
18 - 17 9
18 0- 18 4
19 5- 18 9
0
19 - 19 4
5- 1
99
N u m ber of C hildren
Distribution of Total Urinary
Arsenic in the 65 children
Comparison to published reference values
35
Speciation
Level
50 µg/g creatinine
ATSDR/CDC level of
action
58.9
Total Arsenic µg/g creatinine
200 µg/g creatinine;
health effects at
chronic exposure
20
15
10
155.9
191.3
0
Total Urinary Arsenic µg/g (Creatinine-corrected)
Scatterplot of Urinary Arsenic
Levels vs. Soil Arsenic Levels
200

180
160

140
120
100
80
60
40





  
20




  

  
0
0
100
 
200



300
400
Average Soil Arsenic Concentration - ppm
500
600
PFC Results
Interpretation by comparison to a “reference range”

3 chemicals were found in all 196 participants
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PFOA
PFOS
PFHxS
PFBA was found in 55 people (28%)
PFBS was found in 5 people (3%)
PFHxA and PFPeA were not found in any
participants (all below the LOD)
P F O A S eru m L ev els (n g /m l)
18
17
16
15
14
0
0
0
0
0
0
0
0
0
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<=
<
<
<
<
<
<
<
<
<
<
19
18
17
16
15
14
13
12
11
0
0
0
0
0
0
0
0
0
0
90
80
70
60
50
40
30
20
10
10
<
<
<
<
<
<
<
<
<
60
13
12
11
10
90
80
70
60
50
40
30
20
10
0
Number of Participants
Distribution of PFOA in the East Metro
Project Sample
70
GeoMean = 15.4 ng/mL
Range = 1.6 – 177 ng/mL
50
40
30
20
10
0
PFOA:
How do we compare to others?
Study and
Population
(Sample size)
Time period
Geometric
Mean
ng/mL (ppb)
Range
ng/mL (ppb)
E. Metro PFC Biomonitoring Pilot Project
(N=196)
Oct 2008 –
Jan 2009
15.4
1.6 – 177
US NHANES
2,094 individuals (age 12 to > 60) from a
random sample of the US Population
2003
2004
3.9 (3.6 – 4.3)
0.1 – 77.2
Little Hocking, WV (N = 4,465)
Community (age 0 to >70) exposed to PFOA
contaminated drinking water
2005
2006
197
NA
Arnsberg, Germany
101 Males and 164 females from a
community with known PFC water
contamination
2006
Female 23.4
Male 25.3
Female 5.4 -99.7
Male 6.1 – 77.5
Occupational Group (N=215)
3M production workers
2000
1130
40 - 12700
Relationship Between PFOA Blood
Levels and PFOA Water Levels.
For the 98 private well water drinkers – the relationship between their
PFOA blood levels (2008) and well water levels (2005-08) were
analyzed.
180

160
PFOA Blood Concentration ppb

140
120

100

80

60


40


  
 
 
  




  
  


 
   
20
0
0
0 .2




 
  


 

   

0 .4
0 .6





0 .8




1
1 .2
1 .4
P F O A W a te r C o n c e n tra tio n p p b
1 .6
1 .8
2
Limitations of the pilot
projects
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Relatively small sample size limits the ability to compare
subgroups of participants
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The pilot projects do not include a local (Minnesota) comparison
group collected in the same time period
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The pilot projects are not able to determine what illnesses were
or may be caused by participants’ exposure to chemicals

The pilot projects are not able to identify the specific ways
participants were exposed.
High Individual Serum Concentrations
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High PFOA (177 ng/mL) / High PFOS (448 ng/mL) – same
individual
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Male
3rd age category (60+)
2nd residential category (10 – 19 years)
Non-3M employee
Private well owner
High PFHxS (316 ng/mL)
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female
3rd age category (60+)
4th residential category (30+ years)
Non-3M employee
private well owner
Future challenges
Application of laboratory science to public health
practice….many roles.


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Epidemiologists/Environmental Scientists:
 Selecting populations, chemicals and methods
 Sound, ethical study design and conduct
 Understanding health effects at low levels
Health risk communications
 Communicating the findings with public and policy
makers
Health policy officials
 Recommending public health action
 Using resources wisely
Future directions
1. MDH Strategic Planning
lessons learned from 4 pilots and recommendations
2. Integrations with Environmental Public Health
Tracking, hazard and health outcome data.
Hazard……Exposure……Disease Data
3. Collaborations with other states through APHL and
CSTE, developing national guidance for states.
Laboratory Perspectives
on Biomonitoring
Introduction
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Analytical methods are critical to successful
biomonitoring programs
Sensitivity of methods have improved
dramatically, enabling detection of extremely
low levels of contaminants
Analytical capabilities have in many cases
outpaced the ability to understand the link
between exposure and health outcome
Historical Perspective
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Laboratory has assumed a leadership role in
advancing the science of biomonitoring
CDC’s Environmental Health Laboratory operates
the National Biomonitoring Program
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Can measure more than 450 environmental chemicals and
nutritional indicators
Division of Laboratory Science performs analysis of blood,
serum, urine for NHANES
Methods published in peer-reviewed journals so that other
laboratories can use them.
Methods shared with many state PHLs and provides
training
Provides funding to 3 states for biomonitoring studies
The Role of the Laboratory in
Biomonitoring
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Laboratories
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Provide consultation on study design
Develop and implement analytical test
methods
Perform analytical testing
Conduct preliminary data analysis
Provide quality control and assurance
Ensure that regulatory requirements
are met
Biomonitoring and Associated
Activities at the MDH-PHL
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Perfluorochemicals
Mercury
Arsenic
Environmental
phenols
Chemical terrorism
preparedness

Level 1 surge
laboratory
Quality of Biomonitoring Data

Choice of analyte
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Analytical method
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Utility as biomarker
Characterization & validation
Quality Assurance / Quality Control
Appropriate sample type/collection
Standardized protocols
Interpretive criteria
Optimal Characteristics of
Analytical Method
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Sensitive
Specific
Accurate
Precise/Reproducible
Minimal specimen volume
Multianalyte
High throughput
Quality Assurance / Quality Control
Testing Challenges

Method implementation
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Modification differences in instrumentation
Availability of performance characteristics
Need to develop and monitor proficiency
Availability of reference materials
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Isotope labeled internal standards
Concentration not suited to low-level methods
Emerging contaminants
Testing Challenges

Difficult to detect compounds
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Short half-life
Laborious or inadequate test
methodology
Unknown compounds

Confidential business information
 Hydraulic fracturing


Oil dispersants used in gulf spill
Family of compounds or mixtures
(e.g. nonylphenols, crude oil)


More than 340 chemicals in
fracturing fluid
Law does not require full disclosure
Testing Challenges


Lack of norms and standards for testing and
reporting of data
Regulatory


Some funding announcements specify need for
laboratory to be CLIA certified
Funding for personnel, reagents, and
equipment
National Biomonitoring Plan


APHL convened stakeholders in October
2009
Goal to produce recommendations for a
national biomonitoring system that would
enhance local, state and national capacity
to utilize biomonitoring to develop sound
public health policy and programs
National Biomonitoring Plan


Vision: To improve the health of the
Nation through biomonitoring.
Mission: To provide accurate human
exposure data that will inform important
public health decisions.
National Biomonitoring Plan

Guiding Principles

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

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Process will be highly collaborative by including feedback
from key stakeholders
Plan and related activities will include relevant contextual
information to promote appropriate use and interpretation
of human exposure data
Plan builds on existing activities in the field of biomonitoring
and is meant to provide a coordinated national approach to
addressing public health issues related to chemical
exposures
Guidance will reflect scientific norms and standards to
enable benchmarking and comparisons across studies
Laboratory science will be focus
National Biomonitoring Plan

Goals





Develop national biomonitoring network
Foster collaboration among environmental public
health programs
Disseminate biomonitoring information to guide
policy and practice
Advance biomonitoring science and research
Enhance biomonitoring workforce and
infrastructure




Development of
standardize protocols and
reporting criteria
Guidelines for evaluating
methods
Improved biomarkers or
panels of biomarkers
Markers of host
susceptibility
Summary



Laboratory has the capability and capacity to
provide high quality analytical data
For many chemicals, our ability to detect
surpasses our ability to provide meaning
Further studies needed to ascertain risk and
to guide allocation of scarce resources
Questions?
Thank you!
For more information about environmental
public health tracking or biomonitoring, please
visit our website:
www.health.state.mn.us/tracking/
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