In this document you will find California Biomonitoring Plan. In the year 2003 they did not receive CDC Funding for this Plan. That is displayed in the cover letter to this California Plan. You can view the original document at: http://downey.kaiserpapers.info/pdfs/CDHS_Biomonitoring_Plan.pdf
CALIFORNIA BIOMONITORING PLAN
California Department of Health Services
2003
3 4 5 6 R
September 2003
Dear Biomonitoring Supporters:
Enclosed for your information is the California Biomonitoring Plan. As many of you know, the
California Department of Health Services developed the Plan under a two-year grant from the Cen-
ters for Disease Control and Prevention (CDC). The goal was to promote planning for the
development, implementation and expansion of state-based biomonitoring programs to help pre-
vent disease resulting from exposure to toxic substances.
Several months ago we submitted a grant application to CDC to implement the Plan. Our
Biomonitoring Application to CDC was not chosen for funding this year. We are of course disap-
pointed not to be funded. However, the reviewer’s comments were very positive and speak highly of
our planning efforts over the past two years.
CDC expected to award a total of $5 million per year for five years to approximately five states or
state consortia. Over thirty states and state consortia carried out planning projects and applied for
funds. During the final months of the planning process, CDC announced that internal budget
problems reduced the total amount available. CDC awarded a total of $2.1 million to New York,
New Hampshire and a consortium led by New Mexico.
Although we will not receive funds from CDC this year, we are proud of the effort and of the appli-
cation that was submitted. Thank you for your participation, support and advice during the planning
process. We remain committed to expanding the state lab’s capacity for public health biomonitoring
in California. We have come a long way together in the last two years and we hope you will continue
to work with us to achieve our goal of expanding biomonitoring in California.
Sincerely,
Peter Flessel
On behalf of the Biomonitoring Planning Project Team
The Biomonitoring Planning Project Team
The California Biomonitoring Advisory Committee Project Staff
Peter Flessel, Ph.D.
Linda Aston (ex officio) Ann Katten
Principal Investigator
Pacific Toxicology Laboratory California Rural Legal Assistance
Bill Draper, Ph.D.
Asa Bradman Martin Kharrazi
Co-Principal Investigator
UC Berkeley School of Public Health Genetic Disease Branch, CDHS
Kusum Perera, Ph.D.
Wendel Brunner Amy Kyle
Co-Principal Investigator
Director of Public Health, Contra Costa UC Berkeley School of Public Health
County Lori Copan, R.Ph., MPH
Michael Lerner
Patricia Clary Project Manager
Commonweal
Californians for Alternatives to Toxics Thu Quach, MPH
Myrto Petreas
Rupali Das Health Effects Analyst
Hazardous Materials Laboratory, DTSC,
Occupational Health Branch, CDHS Cal/EPA Christine Arnesen, RN, MPH
Michael DiBartolomeis Eddie Phillips Consultant
Office of Environmental Health Assessment, San Manuel Band of Serrano Mission Elinor Blake, MSW
Cal/EPA Indians Consultant
Bruce Fujikawa Margaret Reeves Jennifer Liang, B.S.
Director, Long Beach Public Health Pesticide Action Network of North America Laboratory Research Assistant
Laboratory Beate Ritz
Debra Gilliss UCLA School of Public Health
Environmental Health Investigations Gina Solomon
Branch, CDHS Natural Resources Defense Council
David Harrington Marilyn Underwood
Occupational Health Branch, CDHS Environmental Health Investigations
John Harris Branch, CDHS
California Birth Defects Monitoring Jed Waldman
Program, CDHS Environmental Health Laboratory Branch,
Kim Hooper CDHS
DTSC, Hazardous Materials Laboratory, Jane Williams
Cal/EPA California Communities Against Toxics
Mark Horton
Health Officer, Orange County
Contact Information The California Biomonitoring Planning Project was a joint project of the
California Department of Health Services and Impact Assessment, Inc.
Peter Flessel, Ph.D., Chief
It was funded by The Department of Health and Human Services Centers
Environmental Health Laboratory Branch
for Disease Control and Prevention Program Announcement 01072.
California Department of Health Services
Mail Stop G365
850 Marina Bay Parkway cover design: Diane Sherman
Richmond, CA 94804
report design: e.g. communications
Tel: 510.620.2805
Fax: 510.620.2825
E-mail:
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
www.dhs.ca.gov/ehlb/BPP
TABLE OF CONTENTS
Executive Summary ............................................................................................................. 1
1. The Need for a California Biomonitoring Program ........................................................ 6
1.1 Introduction .............................................................................................................................. 6
1.2 California’s Population is Vulnerable to Exposure ................................................................... 6
1.3 A Biomonitoring Program Will Provide Unique Information to
Promote the Health of Californians .......................................................................................... 7
2. Strategic Directions to Meet California’s Needs .......................................................... 9
2.1 Strategic Direction 1: Develop Laboratory Methods for Target Analytes .............................. 9
2.2 Strategic Direction 2: Provide Laboratory Support for Epidemiologic Studies ................... 11
2.3 Strategic Direction 3: Provide Laboratory Support for Collection of Normative Data ....... 12
2.4 Strategic Direction 4: Maintain and Increase Collaborative Relationships ........................... 13
2.5 The Needs Assessment .......................................................................................................... 14
3. Chemicals Selected for Study ..................................................................................... 17
3.1 Pesticides ................................................................................................................................ 17
3.2 Persistent Organic Pollutants ................................................................................................. 18
3.3 Non-Persistent Organic Pollutants ......................................................................................... 19
3.4 Heavy Metals .......................................................................................................................... 20
4. Project Selection for the Biomonitoring Plan............................................................... 21
4.1 Decision Method and Criteria ................................................................................................ 21
4.2 Responsible Research ............................................................................................................. 21
5. Staffing, Organization and Timeline ............................................................................ 23
5.1 Staffing Plan ........................................................................................................................... 23
5.2 Organization Structure .......................................................................................................... 24
6. Program Evaluation ..................................................................................................... 25
6.1 Evaluation Objective 1: Meeting Goals and Objectives ........................................................ 25
6.2 Evaluation Objective 2: Assessing New Public Health Needs ............................................... 26
6.3 Evaluation Objective 3: Impact on Environmental Public Health ......................................... 26
Epilogue ............................................................................................................................. 27
References and Works Consulted ..................................................................................... 28
Tables
Table 1. Chemical Groups and Biomatrices in the California Biomonitoring Plan ................................. 3
Table 2. Chemical Groups and Biomatrices in the California Biomonitoring Plan ............................... 10
Table 3. Chronology of Methods Development .................................................................................. 10
Table 4. Substances of Concern Most Cited by California Local Officials and Tribal and
Non-Governmental Organizations ........................................................................................ 15
Figures
Figure 1. California Biomonitoring Plan Collaborative Relationships .................................................. 13
Figure 2. Comparison of Sources of Reproductive and Developmental
Toxicants Released into the Environment ........................................................................... 18
Figure 3. Project Organization and Coordination ............................................................................... 24
EXECUTIVE SUMMARY
Introduction
In 2001, the US Centers for Disease Control (CDC) issued the first-ever nationwide report on Ameri-
cans’ exposures to potentially harmful chemicals. The second, more extensive 2003 report included
116 chemicals. These reports reflect the public’s growing interest in the health effects of environ-
mental chemicals and the new technology to measure those chemicals in the body. The assessment
of exposure by measurement of chemicals in biological samples such as human blood, urine, saliva,
and breast milk is called “biomonitoring.”
California’s Need for a Biomonitoring Program
California’s 34 million residents have good reason to be interested in environmental exposures.
The state has the greatest number of industrial sites in the United States. It is first in the volume of
restricted pesticides applied annually. It ranks second in the number of National Priorities List
Superfund sites and first in the number of hazardous waste sites. Industrial air pollution coupled
with more than 23 million vehicles that travel over 4 billion miles a year threaten the health of our
most sensitive populations, including children, the elderly, and people with respiratory conditions.
California has among the country’s largest proportion of newborns and children under age 5, and
one of the fastest growing populations of the elderly. The surge in California cases of asthma, au-
tism, and other developmental diseases has heightened public concern about environmental causes
of disease. Regardless of which set of measures is applied, California is likely to rank at or near the
top in all environmental health risk criteria.
The California Biomonitoring Plan
The California Department of Health Services (CDHS) received funds from CDC to prepare a
Biomonitoring Plan, the primary purpose of which was to expand laboratory capacity for
biomonitoring in the state’s public health laboratories. Completed in June 2003, the Plan calls for
bringing together the state’s academic, community and government resources in a coordinated
effort. Because biomonitoring measures what is in our bodies, it is considered a better assessment of
exposure than indirect methods such as measuring chemicals in air, water or food. Biomonitoring
promises particularly useful results for making policy and taking other actions that protect the
public’s health.
The Plan calls for CDHS to develop laboratory methods that will analyze biological samples for
chemicals of greatest concern to Californians, and use those methods to assess residents’ exposures.
Under the Plan, several projects will be undertaken.
1
CALIFORNIA BIOMONITORING PLAN
• CDHS and University of California scientists will collaborate to characterize pesticide exposures
and their risks to the health of farmworker families in an agricultural community.
• CDHS and University of California scientists will examine whether there is a relationship
between environmental exposures and autism. Exposures to Californians who do not have
autism will also be analyzed to help identify prevailing, or “background,” chemical levels in the
general population.
• Several CDHS research programs will similarly determine background levels of chemicals in
pregnant women.
Each of these projects involves several chemicals. A fuller description begins on page 9 of this summary.
Preparing the Plan: A Collaborative Effort
To create a successful Plan, CDHS staff wanted participation by many individuals and organizations:
local health and environmental health officials, non-governmental and tribal organizations, envi-
ronmental health researchers, and laboratories. An Advisory Committee was established with
representatives from these groups and a Needs Assessment conducted that included surveys of those
constituencies. Scientific and policy literature on biomonitoring was reviewed and incorporated.
The Advisory Committee
The twenty-five members provided guidance at every step in the process, including design of the
Needs Assessment and selection of the research projects.
The Needs Assessment
The Committee’s decisions were informed by a comprehensive Needs Assessment documenting na-
tional and state perspectives on biomonitoring. It identified priority substances, health outcomes,
populations at risk, and current issues. Surveys provided statewide stakeholder input to the selection
criteria for projects to include in the Plan. The Researcher Survey additionally assessed the state’s
environmental health research terrain. The surveys also helped identify potential collaborators and
projects for inclusion in the Plan. An inventory of state laboratory capacity provided a baseline for
laboratory expansion. (The Biomonitoring Needs Assessment is available online at www.dhs.ca.gov/
ehlb/BPP.)
Deciding Which Projects to Include
Potential projects were reviewed for inclusion in the Plan by the Advisory Committee using a formal selec-
tion process developed by staff. Projects were evaluated using criteria grouped under eight headings:
• scientific criteria;
• inclusion of vulnerable populations;
• ability to evaluate the impact of the project on public health needs;
• ability of the collaborator to provide project support;
• laboratory feasibility;
• responsible research criteria;
2 CALIFORNIA BIOMONITORING PLAN
• public health benefits;
• support from the broad public health community.
About a fifth of the selection criteria were written by the Advisory Committee’s Responsible Re-
search subcommittee, which was charged with providing guidance on ethical issues arising from
biomonitoring. Topics included individual notification of results, community participation, informed
consent in the use of newly collected and archived samples, and the interpretation and dissemina-
tion of results so that they are available to the affected community for action and policy change.
Strategic Directions and New Projects for a Biomonitoring Program
Rooted in findings from the Needs Assessment, the California Biomonitoring Plan calls for collabo-
rations with several epidemiologic research programs to investigate associations between exposures
and health, and determine background levels of exposure in California’s population. The Plan
features four strategic directions, described below.
Strategic Direction 1:
Develop Laboratory Methods for Target Chemicals of Importance to Californians
CDHS scientists will develop analytical methods for substances and biomatrices of particular interest
to California stakeholders, as determined by the Needs Assessment (see Table 1). Methods developed
in the course of this first Strategic Direction will provide the basis for Strategic Directions 2 and 3.
Table 1. Chemical Groups and Biomatrices in the Biomonitoring Plan
CHEMICAL GROUP BIOMATRIX
Pesticides
Organochlorines*, e.g. DDT Serum,** breast milk
OP dialkyl phosphate metabolites Urine
Pyrethroids, e.g. permethrin Urine
Persistent Organic Pollutants
PCBs Serum, breast milk
Brominated flame retardants* (PBDEs) Serum, breast milk
Organochlorines*, e.g. DDT Serum, breast milk
Chemicals of Emerging Health Concern and Public Interest
Brominated flame retardants* (PBDEs) Serum, breast milk
Phthalates Urine
Heavy Metals
Lead Blood
Total mercury Blood
Speciated mercury Blood
* Listed more than once as the chemicals cross over groups.
** Serum is the fluid obtained after whole blood is permitted to clot.
3
CALIFORNIA BIOMONITORING PLAN
Strategic Direction 2:
Provide Laboratory Support for Epidemiology Studies
Using the methods developed in Strategic Direction 1, CDHS laboratories will collaborate with two
research programs conducting studies involving exposure assessment. These are the Childhood
Autism Risks from Genetics and the Environment (CHARGE) study at the University of California,
Davis and Los Angeles; and the Center for the Health Assessment of Mothers and Children of
Salinas (CHAMACOS), University of California, Berkeley. The researchers will provide samples of
blood, urine, and breast milk, and conduct epidemiologic analysis of the laboratory results.
CHARGE is studying 2,000 children in three regions of California to examine autism in relation to
several environmental exposures and endogenous susceptibility factors. CHARGE researchers’ in-
terests closely reflect the statewide priorities identified by the Needs Assessment and include several
persistent organic pollutants, lead, mercury, certain pesticides, and phthalates.
CHAMACOS seeks to characterize environmental health risks of lower-income, predominantly His-
panic families in a rural agricultural community by characterizing the magnitude and pathways of
their pesticide exposure. CHAMACOS will give CDHS laboratories biological samples collected
outside of the study population. These samples will be used to develop analytic methods for persis-
tent organic pollutants such as DDT, DDE, PCBs, and PBDEs in breast milk and blood, and to test
for organophosphates, pyrethroids, and phthalates in urine. If methods are successfully developed,
CHAMACOS will provide the laboratories with archived paternal urine and possibly other samples
from study subjects to test for the listed compounds.
Strategic Direction 3:
Provide Laboratory Support for the Collection of Normative Data
Over seventy percent of pregnant women in California elect to provide serum for an alpha-feto
protein testing to screen for select birth defects. They also fill out a questionnaire with information
on residence, race, ethnicity, smoking, and other key items. A portion of the serum sample that is
not used may be archived for further chemical testing.
These maternal serum/alpha-feto protein (MS/AFP) samples offer a unique window into expo-
sures during pregnancy. If persistent organic pollutants can be detected in archived samples, the
results would provide normative exposure data on pregnant women and exposure to the fetus.
Normative data are the prevailing (or “background”) levels of exposure in a “normal” population
against which to compare other populations or individuals and changes over time. Preliminary
laboratory studies showed that metabolites of some persistant organic pesticides can be measured
in archived MS-AFP serum. Future laboratory testing could provide data to explore possible link-
ages to health outcomes using state databases and the women’s questionnaires. This type of anlaysis
will support California environmental health tracking activities, which identify and monitor links
between environmental exposures and chronic health conditions. The MS/AFP project may un-
cover environmental exposures during a critical period of fetal development, and demonstrate the
value of these serum samples for ongoing biomonitoring.
The opportunity to create normative data is also an aspect of the CHARGE project. CDHS will use
4 CALIFORNIA BIOMONITORING PLAN
the 700 CHARGE controls (children who do not have autism), their parents and their siblings to
characterize exposures to select environmental chemicals in the CHARGE geographic areas, which
comprise a considerable portion of the state. The results will further assist environmental health
tracking programs. The chemicals are among those recommended for tracking in America’s Environ-
mental Health Gap, an influential 2000 report by the Pew Environmental Health Commission.
Strategic Direction 4:
Maintain and Increase Collaborative Relationships
The Plan rests on a web of CDHS collaborations with CDC, academic and Cal/EPA researchers,
community-based and other non-governmental organizations, local health and environmental health
officials, and California public health initiatives such as the environmental health tracking pro-
grams at CDHS and UC Berkeley. A new Advisory Committee will be convened for implementation
of the Plan that will include several members of the previous Advisory Committee. The committee
will be a prime vehicle for maintaining the close organizational relationships established during the
planning process. Collaborations will extend to two other Western states’ laboratories that will assist
in validating new analytical methods. The intent throughout is to strengthen ties, enhance the
efforts of all involved to link biomonitoring to the concerns and interests of the state’s constituen-
cies, and build for the future.
Biomonitoring Information: A Tool to Prevent Disease
The biomonitoring projects in the Plan will offer Californians exposure information that is not now
available. They provide the base for a state program that could, over time, encompass a larger
portion of the population, additional emergent chemicals, and more epidemiology studies. The
results of such research promise health officials, physicians, policymakers and anyone interested in
environmental health with information to better understand and address disease resulting from
environmental exposures. Below is a partial list of public health uses of biomonitoring.
• To determine which potentially harmful chemicals are in Californians’ bodies, and at what
concentrations.
• To identify new chemicals of concern.
• For chemicals with a known toxicity level, to determine the prevalence of people with levels
above those toxicity levels.
• To establish reference ranges that can be used by physicians and scientists to determine
whether a person or group has an unusually high exposure.
• To assess the effectiveness of public health efforts to reduce exposure of Americans to specific
chemicals.
• To determine whether exposure levels are higher among children, women of childbearing
age, or other potentially vulnerable groups.
• To track, over time, trends in levels of exposure of the population.
• To set priorities for action to protect the public’s health.
5
CALIFORNIA BIOMONITORING PLAN
THE NEED FOR A CALIFORNIA BIOMONITORING PROGRAM
1.1 Introduction
In 2001, the US Centers for Disease Control (CDC) issued the first-ever nationwide report on Ameri-
cans’ exposures to potentially harmful chemicals. The second, more extensive 2003 report included
116 chemicals. These reports reflect the public’s growing interest in the health effects of environ-
mental chemicals and the new technology to measure those chemicals in the body. The assessment
of exposure by measurement of chemicals in biological samples such as human blood, urine, saliva,
and breast milk is called “biomonitoring.”
To gain local information, the California Department of Health Services (CDHS) received funds
from CDC to prepare a California Biomonitoring 5-Year Plan. Completed in June 2003, the Plan
calls for bringing together the state’s academic, community and government resources in a coordi-
nated biomonitoring effort. Because biomonitoring measures what is in our bodies, it is considered
a better assessment of exposure than indirect methods such as measuring chemicals in air, water or
food. Biomonitoring promises particularly useful results for making policy and taking other actions
that protect the public’s health.
1.2 California’s Population Is Vulnerable to Exposure
Population Size and Diversity
California’s 34 million, ethnically diverse inhabitants comprise over 12% of the US population. No
race holds a majority. Non-Hispanic Whites are 47% of residents; Hispanics and Latinos, 32%; Asians,
11%; Blacks, 7%; Native Americans, Native Hawaiians, and other Pacific Islanders, 1.3% (US Cen-
sus, 2000). California has among the largest proportion of newborns and children under age 5 and
one of the fastest growing populations of the elderly, groups known to be at increased risk from
environmental exposures.
Income disparities are dramatic and growing. Poverty, here as elsewhere, is disproportionately the
condition of non-White families. Approximately 22% of the state’s Blacks, Hispanics and American
Indians and 13% of Asians and Pacific Islanders live in poverty; only 8% of the Whites do (US
Census, 2000). A recent study using a “self-sufficiency” standard that defines poverty relative to an
area’s cost of living found that for all California households, over one-half of Latinos, one-third of
African Americans, one-fourth of Asian and Pacific Islanders, and one-fifth of Whites have incomes
insufficient to make ends meet. By the same standard, more than half of households with a child
under 6 years of age have insufficient incomes to keep pace with the cost of living (Pearce, 2003).
Poor and low-income families are the least likely to have health insurance—nearly one-third of
Californians under the age of 65 with incomes below the federal poverty level lacked health cover-
age in 2001 (Center on Budget Priorities, 2003). Such poor access to care makes identification of
6 CALIFORNIA BIOMONITORING PLAN
exposures through biomonitoring particularly important in protecting the health of low-income
residents.
Environmental Contaminants
With the sixth largest economy in the world, California has the greatest number of industrial sites
and the largest agricultural production in the US California is first in the volume of restricted pesti-
cides applied annually—151 million pounds in 2002. California ranks second in the number of
National Priorities List Superfund sites, with 94, and has the nation’s largest number of hazardous
waste sites (27,000). Industrial air pollution coupled with more than 23 million vehicles that travel
over 4 billion miles a year threaten the health of our most sensitive populations. Regardless of which
set of measures is applied, California is likely to rank at or near the top in all environmental health
risk criteria.
Environmental Inequities and Vulnerable Populations
In spite of having the nation’s most stringent environmental laws, environmental inequities in Cali-
fornia range from modest to major and a well-developed environmental justice community regularly
voices concerns. High pesticide use areas are commonly found adjacent to Latino communities and
industrial and hazardous waste sites are often located in or near low-income communities and com-
munities of color. DDT, PCBs and mercury from consumption of fish they catch in near-shore waters
put Southeast Asian populations are at a much higher risk of exposure than the general population.
Vehicle emissions are an additional risk factor for the millions of Californians who live and work
near highways and other heavily-traveled transit corridors, (e.g., Zhu et al., 2002; Wilhelm & Ritz,
2003).
Californians born outside the United States—one-fourth of the state’s residents—may be at risk
from persistent organic pollutants such as DDT that are banned or in restricted use in the United
States but have been restricted in Latin America and Asia only in the last decade, if at all. For all
Californians, exposure levels to another persistent chemical group, the fire-retardant PBDEs, ap-
pear to be rapidly climbing. PBDEs are viewed as a potentially significant threat to pregnant women
and their fetuses, and are classified by the US National Toxicology Program as “reasonably antici-
pated to be human carcinogens.” Levels of one PBDE congener in samples taken during the 1990s
are 3 to 10 times higher among California women than among European and Japanese women
(Petreas et al., 2003). The surge in California cases of asthma, autism, and other developmental
diseases has further heightened anxiety and public concern about environmental causes of disease.
1.3 A Biomonitoring Program Will Provide Unique Information to
Promote the Health of Californians
The biomonitoring projects in the Plan offer Californians exposure information that is not now avail-
able. The projects provide the base for a state program that could, over time, encompass a larger
portion of the population, additional emergent chemicals and more epidemiology studies. The re-
sults of such research promise physicians, health officials, policymakers and anyone interested in
7
CALIFORNIA BIOMONITORING PLAN
environmental health with information to better understand and address environmentally related
disease. Below is a partial list of public health uses of biomonitoring.
• To determine which potentially harmful chemicals get into Californians and at what concen-
trations.
• To identify new chemicals of concern.
• For chemicals with a known toxicity level, to determine the prevalence of people with levels
above those toxicity levels (e.g., a blood lead level greater than or equal to 10 micrograms per
deciliter).
• To establish reference ranges that can be used by physicians and scientists to determine
whether a person or group has an unusually high exposure.
• To assess the effectiveness of public health efforts to reduce exposure of Americans to specific
chemicals.
• To determine whether exposure levels are higher among minorities, children, women of
childbearing age, or other potentially vulnerable groups.
• To track, over time, trends in levels of exposure of the population.
• To set priorities for action to protect the public’s health, including priorities for research on
human health effects.
8 CALIFORNIA BIOMONITORING PLAN
STRATEGIC DIRECTIONS TO MEET CALIFORNIA’S NEEDS
To create a successful Plan, CDHS staff wanted participation by many individuals and organizations:
local health and environmental health officials, non-governmental and tribal organizations, envi-
ronmental health researchers, and laboratories. An Advisory Committee was established with
representatives from these groups and a Needs Assessment conducted that included surveys of those
constituencies. Scientific and policy literature on biomonitoring was reviewed and incorporated.
Lastly, a formal decision making structure was used to select projects to include in the Plan. These
elements of the planning process are described beginning with Section 2.5.
Rooted in findings from the Needs Assessment, the California Biomonitoring Plan calls for CDHS
to collaborate with several epidemiology research programs to investigate associations between ex-
posures and health and determine background levels of exposure in California’s population. The
Plan features four strategic directions for CDHS:
1. Develop laboratory methods to analyze human samples for chemicals of importance to
Californians.
2. Provide laboratory support for epidemiologic studies.
3. Provide laboratory support for the collection of normative data.
4. Maintain and increase collaborative relationships to promote biomonitoring efforts.
2.1 Strategic Direction 1:
Develop Laboratory Methods for Target Analytes of Importance
to Californians
As the first step when the Biomonitoring Plan is implemented, CDHS laboratories will develop
methods to analyze human samples for four groups of substances of greatest concern to Califor-
nians: pesticides, persistent organic pollutants (POPs), emerging chemicals, and heavy metals. These
choices address both the present and future needs identified by the Needs Assessment (See Sec. 2.5),
from long-known “bad actors” such as PCBs and DDT to emerging concerns such as PBDEs and
phthalates. The Plan also aims to develop methods for analyzing POPs in breast milk, a biomatrix
that has received special attention from many California researchers and organizations.
Table 2 shows the chemical groups and biomatrices. Some substances belong, and are thus listed, in
more than one group.
9
CALIFORNIA BIOMONITORING PLAN
Table 2. Chemical Groups and Biomatrices in the Biomonitoring Plan
CHEMICAL GROUP BIOMATRIX
Pesticides
Organochlorines*, e.g. DDT Serum,** breast milk
OP dialkyl phosphate metabolites Urine
Pyrethroids, e.g. permethrin Urine
Persistent Organic Pollutants
PCBs Serum, breast milk
Brominated flame retardants* (PBDEs) Serum, breast milk
Organochlorines*, e.g. DDT Serum, breast milk
Chemicals of Emerging Health Concern and Public Interest
Brominated flame retardants* (PBDEs) Serum, breast milk
Phthalates Urine
Heavy Metals
Lead Blood
Total mercury Blood
Speciated mercury Blood
* Listed more than once as the chemicals cross over groups.
** Serum is the fluid obtained after whole blood is permitted to clot.
Methods development for these chemicals will be completed during the first two years of program
implementation (Table 3) and will enable the collaborations with health effects researchers and
epidemiologists to proceed.
Table 3. Chronology of Methods Development
YEAR 1 YEAR 2
• Hire staff, obtain standards, and begin methods • Develop and validate breast milk POPs method.
development.
• Synthesize pyrethroid metabolites and develop
• Develop and validate serum POPs. and validate pyrethroid method in urine.
• Develop and validate organophosphate pesticides • Implement CDC phthalate method in urine.
in urine (general alkyPO4 screen, no specific
• Develop method to speciate mercury in whole
metabolites).
blood.
• Total mercury in whole blood.
Once methods are developed, beta-tested, and validated, samples will be received from the collabo-
rators as described in Directions 2 and 3. A statistically significant sample subset from each research
study will be analyzed to determine which chemicals are detectable. Midcourse changes may be
made, and collaborators will determine whether they want to test remaining population samples.
10 CALIFORNIA BIOMONITORING PLAN
2.2 Strategic Direction 2:
Provide Laboratory Support for Epidemiologic Studies
Using the methods described above, CDHS laboratories will collaborate with two research pro-
grams conducting studies that have exposure assessment elements: the Childhood Autism Risks
from Genetics and the Environment (CHARGE) study, based at the University of California, Davis
and Los Angeles; and the Center for the Health Assessment of Mothers and Children of Salinas
(CHAMACOS), at the University of California, Berkeley. The researchers will provide samples of
blood, urine, and breast milk, conduct epidemiologic data analysis of the laboratory results, and
collaborate with CDHS to secure Institutuional Review Board approval when necessary.
The CHARGE Study
Autism is a severe neurodevelopmental disorder characterized by impairment in social interactions
and language and communication skills, and by restricted repetitive behaviors and activities. Causes
and contributing factors for autism are poorly understood, although genetic and environmental
factors both appear to play a role. The rising incidence of this disease among children in California
has become a great public health burden (Department of Developmental Services, 2003). The
CHARGE study is the first major epidemiologic effort to examine autism in relation to a broad array
of environmental exposures and endogenous susceptibility factors. The project will compare chil-
dren with autism to normally developing controls and mentally retarded children. The study aims
to assess the disorder’s associations with exogenous exposures and susceptibility factors, and the
interplay between these two in the etiology of autism.
CHARGE is a five-year case-controlled study that is enrolling 2,000 children, 700 with autism, 600
with mental retardation, and 700 who are developing normally as controls. Begun in early 2003,
CHARGE is currently recruiting subjects in Northern, Central, and Southern California. Urine and
blood samples will be collected from all study children and their parents and siblings.
Substances of interest to CHARGE match those identified by the Needs Assessment. A number of
xenobiotic exposures interfere with neurodevelopment and hence may play a role in predisposing
an infant to autism. Exposures that CHARGE is interested in biomonitoring include halogenated
organics, particularly PCBs and their contaminants (e.g., PCDDs and PCDFs); two metals, lead and
mercury; and pesticides including organophosphates, carbamates, and organochlorines. CHARGE
researchers are also interested in testing for PBDEs and phthalates.
The CHAMACOS Study
The goal of the CHAMACOS study is to understand and characterize the environmental health
risks of farmworkers’ children in a rural agricultural community in the Salinas Valley. As one of the
Centers for Children’s Environmental Health, CHAMACOS has received funding for this work from
1998 through 2003, and recently received funds to extend the study. The study consists of three
interrelated components involving human subjects: the Exposure Study, the Health Effects Study,
and the Intervention Study. The purpose of the Exposure Study is to better characterize the magni-
tude and pathways of pesticide exposure in young children. Its three specific aims are:
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CALIFORNIA BIOMONITORING PLAN
1. to measure prenatal and postnatal organophosphate pesticide exposure in the children and
characterize population-level correlates of exposure,
2. to characterize pesticide concentrations in environmental media along exposure pathways that
link children to pesticide use, and
3. to describe the exposure-prone behavior of young children.
The collaboration with CHAMACOS entails a validation pilot project in which CHAMACOS will
provide CDHS laboratories with biological samples collected outside of the study population. This
pilot project will include methods development for persistent organic pollutants such as DDT, DDE,
PCBs, and PBDEs in breast milk and blood and testing for certain organophosphates, pyrethroids,
and phthalates in urine. If methods are successfully developed, CHAMACOS will provide the labo-
ratories with archived paternal urine and possibly other samples from study subjects to test for the
pollutants mentioned above.
2.3 Strategic Direction 3:
Provide Laboratory Support for Collection of Normative Data
During the planning process, the Advisory Committee and other stakeholders expressed great in-
terest in including in the Plan a normative study to derive reference ranges of environmental
chemicals. Reference ranges are the prevailing (or “background”) levels of exposure in a “normal”
population against which to compare other populations or individuals and changes over time.
Exposures to Pregnant Women
California offers an alpha-feto protein screening test to women during the 15th to 19th week of preg-
nancy to diagnose select birth defects. Approximately 70%-80% of pregnant women elect to take this
test. A portion of the serum sample is not used—up to 2 mL. This portion can be archived through a
system developed by the CDHS Genetic Disease Branch. These maternal serum/alpha-feto protein
(MS/AFP) samples offer a unique window into exposures during pregnancy, and they are numerous
and could be made available for additional chemical testing. In utero exposures to toxic chemicals can
have considerable health impact on the fetus (Nakai, 2002; Liu, 1995; Rogan, 1991).
The MS/AFP samples may be used in descriptive studies to provide population cross-sections for
the measured chemicals. From a pool of previously archived samples, random samples could be
selected for additional chemical testing. Preliminary laboratory studies showed that metabolites of
certain persistant organic pesticides can be detected in MS-AFP samples. Results of large scale MS-
AFP testing could be used to establish reference ranges for pregnant women statewide. Linkage is
possible to health endpoint databases (e.g., birth outcomes) because the women fill out a question-
naire when screened on residence, race and ethnicity, smoking, gestational age, diabetic status, and
other key items.
Exposures to Children and Adults
CDHS will use the CHARGE study’s 700 control children and their parents to establish reference
ranges for certain environmental chemicals. In this normative component of the CHARGE collabora-
12 CALIFORNIA BIOMONITORING PLAN
tion, all biomonitoring results of environmental chemicals derived from the CHARGE study will be
used. Reference ranges will be relevant to the populations from which CHARGE draws subjects. This
collaboration between the CHARGE study and CDHS will contribute to California efforts to identify
and monitor the links between environmental exposures and chronic health conditions, called “envi-
ronmental health tracking.” The chemicals are among those recommended for tracking in America’s
Environmental Health Gap, an influential report by the Pew Environmental Health Commission (2002).
2.4 Strategic Direction 4:
Maintain and Increase Collaborative Relationships
The Plan is built on a web of CDHS collaborations with CDC, academic and Cal/EPA researchers,
community-based and other non-governmental organizations, local health and environmental health
officials, and California public health initiatives such as the environmental health tracking pro-
grams at CDHS and UC Berkeley. A new Advisory Committee will be convened for implementation
of the Plan that will include several members of the previous Advisory Committee. The committee
will be a prime vehicle for maintaining the close organizational relationships established during the
planning process. Collaborations will extend to two other Western states’ laboratories that will assist
in validating new analytical methods. The intent throughout is to strengthen ties, enhance the
efforts of all involved to link biomonitoring to the concerns and interests of the state’s constituen-
cies, and build for the future. The collaborations are portrayed in Figure 1.
Figure 1. California Biomonitoring Plan Collaborative Relationships
Non– Governmental Organizations
Inter– Laboratory Collaborators
Intra– Agency Collaborators Pesticide Action Network
California Association of
CDHS Environmental Health Commonweal
Public Health Laboratory Directors
Investigations Branch Natural Resources Defense Council
Alaska State Health Department
CDHS Occupational Health Branch The Breast Cancer Fund
U.C. Davis School of Veterinary
Others TBD
Medicine
CDHS
California Public
Health Laboratories
Research Collaborators California EPA Collaborators
U.C.B: CHAMACOS Office of Environmental Health
Environmental Health
U.C. Davis: CHARGE Hazard Assessment
Laboratory Branch
GDB/EHIB: Normative Study Hazardous Materials Laboratory
Sanitation and Radiation
Laboratory Branch
CDHS Environmental Health California Conference of
Tracking Program Local Health Officers
U.C. Schools of Public Health Federal Collaborators
U.C. Berkeley Center California Conference of
U.C.L.A. Centers for Disease
for Environmental Public Local Directors of
U.C. Berkeley Control and Prevention
Health Tracking Environmental Health
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CALIFORNIA BIOMONITORING PLAN
2.5. The Needs Assessment
The Needs Assessment was an important tool in selecting the projects described above. The full text
of the Biomonitoring Needs Assessment is available online at http://www.dhs.ca.gov/ehlb/BPP. It
further served to involve and inform the public and environmental health community about the
planning project. The Needs Assessment had four components:
1. A survey of local health and environmental health officials and non-governmental and tribal
organizations for input on health hazards and health effects of concern, as well as populations
at higher risk (referred to as the Community Survey);
2. A survey of environmental health researchers to identify current biomonitoring research issues
and potential collaborators in expanding laboratory capacity (referred to as the Researcher
Survey);
3. A review of 20 major environmental health reports to provide an overall perspective on
biomonitoring in support of environmental health; and
4. An inventory of state laboratory capacity to provide a baseline for laboratory expansion,
document special expertise, and identify sophisticated instrumentation, referred to as the
Laboratory Inventory.
The Needs Assessment not only garnered information but also identified potential collaborators for
projects to consider for the Plan. The Needs Assessment is available on request.
Community Survey
The survey was sent by e-mail to each local Health Officer and local Director of Environmental
Health in California, representing 58 counties and four cities. Responding officials represented
82% of the state’s population. The survey was sent to non-governmental organizations with an inter-
est in environmental health using contact lists provided by state and federal agencies, and additionally
forwarded by several environmental coalitions to their organization members. It reached an esti-
mated 300 statewide and local organizations. Tribal Environmental Managers received the survey
from their counterpart on the Advisory Committee.
Pesticides are the substances of most concern to Community Survey respondents (see Table 4).
Health effects of most concern are cancer and respiratory disorders, followed by developmental
disorders. Responses from all the groups surveyed reflect considerable support for expanding the
biomonitoring capacity of state laboratories.
14 CALIFORNIA BIOMONITORING PLAN
Table 4. Substances of Concern Most Cited by California Local Officials and Tribal and
Non-Governmental Organizations
Local Officials Tribal and Non-Governmental Organizations
(N=27) (N=42)
Pesticides (59%) Pesticides (43%)*
Lead (59%) Mercury (24%)
Environmental tobacco smoke (41%) Persistent organochlorines (21%)
MTBE (33%) Lead (19%)
Particulate matter (26%) Particulate matter (19%)
Mercury (15%) Environmental tobacco smoke (17%)
Persistent organochlorines (15%) Arsenic (14%)
Volatile organic compounds (14%)**
Volatile organic compounds (15%)
* There is a potential underestimate for pesticides, as some respondents may have checked “persistent organochlorines” when
their concern is a pesticide.
** Asbestos, drinking water disinfection by-products, and phthalates/plasticizers were also listed by 14% of the respondents.
Researcher Survey
To identify California investigators who might be interested in collaborating on biomonitoring
projects with CDHS, project staff contacted federal and California funding sources (such as the
National Institute of Environmental Health Sciences and the California Endowment) for names of
researchers in environmental and occupational health. Each individual so identified was then asked
to refer staff to other researchers active in the field. The result was a pool of potential collaborators
at state agencies, Kaiser Permanente’s Northern California Division of Research, and several cam-
puses of the University of California.
The researchers were asked about their own biomonitoring-related research and programs, labora-
tory methods in use or under development, and their ideas for biomonitoring priorities including
substances, health conditions, and study populations. Over one-third of their studies focus on pesti-
cides. Health outcomes their studies address include cancer, reproductive outcomes, respiratory
effects, neurodevelopmental disabilities and neurological disease. Insights they offered on emerg-
ing concerns included PBDEs; possible association of trihalomethanes in drinking water and
reproductive effects; pesticides and lymphoma; mold in indoor air; and pharmaceuticals in drink-
ing water.
Most of the researchers expressed interest in collaborating with CDHS laboratories to expand the
capacity for sample analysis, develop new analytic methods, and carry out other activities related to
biomonitoring. Discussions with these researchers led to ideas for collaborative projects that were
later reviewed for inclusion in the 5-Year Plan.
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CALIFORNIA BIOMONITORING PLAN
Review of Environmental Health Reports
Project staff reviewed twenty major national and state environmental health reports for issues sig-
nificant to the Biomonitoring Planning Project. The reports addressed biomonitoring issues;
considered specific chemicals, exposures, health impacts, and populations; and raised new or emerg-
ing chemical concerns. These reports served Plan development by:
• providing guidance and knowledge for programmatic thinking;
• highlighting concerns regarding specific chemicals, exposures, health impacts, and
populations for the development of the community surveys;
• contributing to the selection criteria used to choose projects for the 5-Year Plan.
Laboratory Inventory
The Inventory focused on the CDHS laboratories but also included selected private, government
and academic laboratories with known expertise in biomonitoring. It does not necessarily capture
the state’s full biomonitoring capabilities. It nevertheless identified a wide range of biomonitoring
methods and compounds analyzed to help plan for laboratory capacity-building, and fostered re-
flection on opportunities for collaboration. The inventory identified a major CDHS strength as
analytical organic chemistry, particularly methods for persistent compounds and pesticides, and
assisted in the consideration of projects for inclusion in the Plan.
16 CALIFORNIA BIOMONITORING PLAN
CHEMICALS SELECTED FOR STUDY
Among the environmental pollutants of greatest concern and interest to community stakeholders,
public health officials and health researchers were pesticides, other persistant and non-persistant
organic pollutants and heavy metals.
3.1 Pesticides
About a quarter of all pesticides used in the United States are applied in California (Donaldson et
al., 2002). In 2001, more than 151 million pounds of pesticide active ingredients were used during
approximately 1 million applications (California Department of Pesticide Regulation, 2002). A re-
cent study comparing data from California air-monitoring stations with USEPA short-term child
reference exposure levels found that pesticide levels in air exceed the EPA levels on a regular basis,
miles from the application sites (Kegley, 2003). As indicated in Figure 2, pesticide use dwarfs indus-
trial sources as the single largest source of emissions of reproductive and developmental toxicants
in California (Shettler, 1999). Many of the pesticides used in California are known or suspected
endocrine disruptors (Liebman, 1997; Keith, 1997), and data suggest the fetus may be especially
vulnerable (Bell et al., 2001).
Children of farmworkers are likely to be at risk of pesticide exposures not only through food and
household use but also from agricultural drift, playing in or near the agricultural fields, and pesti-
cides brought into the home on farmworkers’ clothing. Exposures to California farmworkers’ children
through house dust have been documented (Bradman et al., 1997). The animal literature examin-
ing developmental effects of specific pesticides is abundant, and includes investigations of time
periods for vulnerability (e.g., Ericksson, 1996). The epidemiologic literature suggests links be-
tween residential and occupational pesticide use and adverse reproductive outcomes (Pastore et al.,
1997; Sever et al., 1997; Savitz et al., 1997, Arbuckle & Sever, 1998; Bell & Hertz-Picciotto, 2003) and
outcomes such as childhood cancer (Zahm & Devesa, 1995; Zahm & Ward, 1998); for other out-
comes, such as childhood asthma and neurodevelopment, the literature is more imited (Eskenazi et
al., 1999).
In 1990, California became the first state to require full-use reporting of registered pesticides. The
reports are compiled by the Department of Pesticide Regulation in the most extensive database of
its kind in the nation. Reported uses include production agriculture and post-harvest fumigation of
crops, structural pest control, and landscape maintenance. The registry is already used to provide
exposure information in environmental epidemiology studies (e.g., Bell, 2001). It is a unique source
of data for identifying exposed population groups to determine actual exposure and examine the
relationship between exposure and health effects. A similar resource are Pesticide Illness Reports,
required of California physicians who suspect that a patient is ill due to pesticide exposure.
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CALIFORNIA BIOMONITORING PLAN
Figure 2. Comparison of Sources of Reproductive and Developmental Toxicants Released into
the Environment
7%
Non-Agricultural
Pesticide Use
18%
75%
Facility Releases
Agricultural Pesticide Use
Pesticide use is the single largest source of reported toxic emissions in California, dwarfing reported
industrial emissions. The chart reports 1995 releases for 78 chemicals that are known reproductive
and developmental toxins. (Schettler, et al, 1999)
For biomonitoring, it is useful to categorize pesticides as either persistent or non-persistent organic
pollutants. The two types behave differently in the body and biological samples to analyze for each
type require their own handling and laboratory methods, as discussed below.
3.2 Persistent Organic Pollutants (POPs)
POPs are compounds that accumulate in fatty tissues and remain there for many years, sometimes
decades. They include a number of known or suspected carcinogens, reproductive toxins,
neurodevelopmental poisons, and environmental estrogens. Chlorohydrocarbon-based insecticides
such as DDT and the fire-retardant PCBs and PBDEs are POPs.
Even though many pesticides that are POPs were banned over 30 years ago in the United States,
they are still the most abundant POPs in wildlife and human samples (Safe, 2000). They continue to
be detected in California soils, sediments, and biota such as fish (Draper & Koszdin, 1991), house
dust (Bradman et al., 1997), and other environmental media. Global atmospheric transport of POPs
has been demonstrated in the Great Lakes (Baker & Hites, 2000), the Arctic, and California with
the movement of pesticides from the Central Valley to High Sierra Lakes (Zabic & Seiber, 1993).
The deposition of these substances is ongoing since they are still used in many countries.
18 CALIFORNIA BIOMONITORING PLAN
Polychlorinated biphenyls
Polychlorinated biphenyls (PCBs), although no longer present in products of United States manu-
facture, are yet a ubiquitous contaminant in human samples and associated with numerous adverse
health effects in humans and animals (ATSDR, 2000). Studies have shown an association between
prenatal exposure and neurodevelopmental effects at rather high exposure levels (Kuratsune et al.,
1972; Hsu et al., 1985; Chen et al., 1994), and some have suggested an association at lower levels
(e.g., Jacobson et al., 1990a, 1990b; Jacobson & Jacobson, 1996.)
Polybrominated diphenyl ethers (PBDEs):
Studies have also documented the appearance and increased incidence of polybrominated diphe-
nyl ethers (PBDEs) in California women of childbearing age, since the 1960s. Levels of one PBDE
congener, BDE-47, in samples taken during the 1990s are 3 to 10 times higher among California
women than the levels reported among European and Japanese women (Petreas et al., 2003). PBDEs
have caused health effects in animals exposed in utero. Evidence indicates that health effects of
exposure to PBDEs are likely similar to those of polychlorinated biphenols and include interfer-
ence with thyroid hormone function and disruption of brain development in mice, permanently
impairing learning and movement. The US National Toxicology Program classifies PBDEs as “rea-
sonably anticipated to be human carcinogens.” The reports of increasing levels of PBDE are
particularly alarming as they suggest that fundamental gaps still exist in the control of persistent,
toxic substances.
The European Union has reduced the use of PBDEs, and early in 2003 the Swedes banned them.
North American industry used 74 million pounds of PBDEs in 1999, accounting for half the world
market. California recently enacted legislation to label and eventually ban products containing
specified PBDEs. Because of their relatively recent appearance in research studies and their ongo-
ing use in the United States, PBDEs are of emerging public interest.
POPs are a risk to children
As noted in the Section 1.2, a quarter of California residents were not born in the United States and
are at risk of carrying in their tissues certain POPs such as DDT (Smith, 1999; Petreas et al., 2002).
Recent California studies show, for example, higher levels of DDT and DDE among Laotian immi-
grant women than among women born in the United States (Petreas et al., 2003; Windham et al.,
2002). Their children and the children of other residents with POPs in their bodies can be exposed
in utero or through breast milk, a fatty matrix (Smith et al., 2001), as well as from environmental
exposures. Biomonitoring of breast milk is useful for revealing POPs exposure information on both
the nursing mother and the newborn (or the developing fetus) (Hooper & McDonald, 2000).
3.3 Non-Persistent Organic Pollutants
In contrast to POPs, non-persistent organic pollutants have a short half-life in the body (hours, days,
or weeks). They are rapidly cleared from the blood and excreted principally in urine, or through
exhaling. The excreted form of non-persistent organic pollutants is often not the “parent” com-
pound but rather an oxidation or hydrolysis product or a glucuronide, sulfate, or mercapturate
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CALIFORNIA BIOMONITORING PLAN
adduct. Because these compounds are rapidly excreted, the timing of sampling is far more critical
than that of POPs in ascertaining cumulative exposure.
Pesticides
Non-persistent organic pollutants include many commercially important modern pesticides such as
organophosphate, carbamate and pyrethroid insecticides and several herbicides. Other examples
are combustion products such as PAH and nitroPAH, solvents (TCE, PERC), fuel and fuel additives
(benzene, MTBE), intermediates (styrene), plasticizers (phthalates), and many other substances.
Phthalates
Phthalates warrant attention because they are widely used in consumer products and are found in
human samples (Blount et al., 2000). They are often ingredients in plastic toys and food packaging,
and are used in cosmetics and building materials. Due to the ubiquity of potential sources, most of
the population may be exposed on a daily basis.
An association with adverse effects on the male reproductive system has been suggested in animals
exposed in utero and shortly after birth (Ema et al., 1998; Marsman et al., 1995; Mylchreest et al.,
1998, 1999, 2000; Gray et al., 1999; Wine et al., 1997). CDC researchers have found levels of some
phthalates that were both higher in individuals and more widespread in the population than previ-
ously estimated (Blount et al., 2000). Levels of one phthalate, DBP, in some women of childbearing
age were above federal safety levels set to protect against birth defects. Concern about possible
human health effects is heightened by the rise in recent years in a number of adverse reproductive
effects in males in the United States and elsewhere (Kohn et al., 2000). The California Environmen-
tal Protection Agency recently listed diethylhexyl pthalate (DEHP) as a reproductive toxicant under
Proposition 65 (California Environmental Protection Agency, 2003).
3.4 Heavy Metals
Mercury
Metal mining in California’s mountains has caused mercury contamination of the Sacramento-San
Joaquin Delta watershed, an expansive area that includes San Francisco Bay and many rivers and
streams. Mercury bio-accumulates in fish; at many watershed locations, mercury levels exceed the
health-based screening values set by USEPA. Based on survey results, the California Department of
Fish and Game estimates that anglers spent 3.5 million hours fishing on 554 miles of rivers and
streams in the watershed in 2000. In 2001, the state issued an updated advisory to San Francisco Bay
anglers based on a seafood consumption study of people who eat Bay fish. Mercury is of concern for
all Californians, however, since it is a contaminate in several popular commercial fish species. It is a
known cause of neurodevelopmental effects in the fetus, infants, and young children. It has been
posited as a potential factor in autism through its presence in some vaccines.
Lead
One of the longest-known environmental hazards, lead exposure is a continuing risk to children
and workers in California, as documented by the CDHS Childhood Lead Poisoning Prevention and
Occupational Lead Poisoning Prevention Programs.
20 CALIFORNIA BIOMONITORING PLAN
PROJECT SELECTION FOR THE BIOMONITORING PLAN
4.1 Decision Method and Criteria
Project staff developed a formal yet flexible decision-making structure that brought to bear scien-
tific criteria and decision-maker values, took into account the Needs Assessment results, and favored
projects with the greatest promise of success. Over 60 criteria were grouped under eight topics:
1. Scientific criteria
2. Inclusion of vulnerable populations
3. Ability to evaluate the impact of the project on public health needs
4. Ability of the collaborator to provide project support
5. Feasibility
6. Responsible research criteria
7. Public health benefits and
8. Support from the broad public health community (based on the survey results)
Staff evaluated the proposed projects for the first five criteria. Some projects were eliminated early
because they addressed exposures to substances for which there are no known biomarkers. The
remaining projects were evaluated by the Advisory Committee and staff with regard to criteria 6-8
and, at the final committee meeting, for logistical “best fit” with the 5-Year Plan.
Through this process, the planning team selected the projects described in Section 3. Together they
will significantly expand the ability of CDHS laboratories to conduct biomonitoring.
4.2 Responsible Research
Because the responsible research approach is a unique feature of the California Plan, it is discussed
here in detail. About a fifth of the selection criteria above were devised by the Responsible Research
Subcommittee, which the Advisory Committee decided to form at its first meeting. The subcommit-
tee was charged with examining and providing guidance on ethical issues arising from biomonitoring.
These issues include informed consent, individual notification to participants of study results, and
ownership of samples collected for biomonitoring. Composed of members from community-based
organizations, other non-governmental organizations, and government agencies, the Responsible
Research Subcommittee developed project selection criteria in relation to five core topics:
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CALIFORNIA BIOMONITORING PLAN
• recruitment of people for the project,
• use of specimens,
• results communication,
• community participation, and
• study implications.
These topics address the concerns relevant to CDHS’s partnerships with researchers who use hu-
man subjects in their studies. The criteria listed under each topic address specific ethical issues and
responsibilities involved in the use of samples for biomonitoring.
The topics and criteria emerged from discussions of the Responsible Research Subcommittee and a
literature review of sources such as the National Bioethics Advisory Commission (2001). The crite-
ria were incorporated into the decision-making process for selecting final projects for collaboration.
Topics such as individual notification of results, community participation, informed consent in the
use of newly collected as well as archived samples, and informative interpretation and wide dissemi-
nation of results for community use, including instigation of public policy change, were among the
issues discussed in relation to the projects reviewed.
The following specific Responsible Research concerns were discussed with regard to four projects
in particular at the final Advisory Committee meeting. For two of the studies, concerns were raised
about individual notification of results, meaningful parent and community participation, and ap-
propriate interpretation and dissemination of results in order for the community to use them for
action and policy change. Discussion of these concerns with the researchers led to important changes
in the manner in which these issues were handled in the studies. Issues related to recruitment of
study participants and the use of newly collected as well as banked samples were central to three of
the studies. Issues involved in using samples to develop normative data and how to interpret the
meaning of these results were raised for one of the studies. Last, concerns regarding the use of
breast milk as a biomatrix were discussed, along with how to ensure that results from such
biomonitoring are placed in a public health context that does not discourage breast feeding.
The development and application of these responsible research criteria mark an important and
innovative step in outlining specific rights and responsibilities when epidemiologic and exposure
assessment projects utilize human biomonitoring samples. The application of these criteria to col-
laborations originating from a laboratory-based, capacity-building project requires a shift in the
conventional relationships between researchers and laboratory partners. To our knowledge, this is
the first time that a set of criteria created explicitly to address these kinds of concerns has been
incorporated into discussions between researchers and laboratory partners.
22 CALIFORNIA BIOMONITORING PLAN
STAFFING, ORGANIZATION AND TIMELINE
Successful implementation of the California Biomonitoring Plan is based on close communication
and collaboration among the participants and on careful oversight over program direction. Each
participating organization has a distinct approach to problems, unique tools to implement their
programs, and different target populations. Each has an important contribution to make toward
effective implementation. Collaboration is a key mechanism to achieve the Plan’s goals. The central
role of CDHS is to provide laboratory support for biomonitoring, to create and foster the collabora-
tions, and provide the integration, communication, and coordination necessary to achieve the
long-term goals of the Plan.
5.1. Staffing Plan
CDHS proposes to hire a core staff of analytical chemists with the training and experience needed
to develop, validate, and perform the required biomonitoring methods. The key technical chal-
lenges call for Ph.D.-level analysts with expertise in advanced organic and inorganic instrumental
analysis.
Proposed staff members’ qualifications have been matched to the objective, and the relationships
and staffing have been structured for efficient completion of the specified work tasks. Plan imple-
mentation relies on a core of existing state laboratory staff (provided as a cost-share contribution)
and the recruitment of three Research Scientist II positions and one Research Scientist III position.
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CALIFORNIA BIOMONITORING PLAN
5.2 Organization Structure
Figure 3. Project Organization and Coordination
Centers for Disease Control,
National Center for Environmental Health,
Advisory Committee Agency and Scientific
Division of Laboratory Science
Collaborators
Biomonitoring Implementation Program
California Biomonitoring
Advisory Committee U.C. Berkeley: CHAMACOS
Commonweal
Pesticide Action Network California DHS,
U.C. Davis: CHARGE
CALEPA, OEHHA
Public Health Laboratories
California Conference of
Environmental Health Laboratory Branch
Local Health Officers
and Sanitation and Radiation Laboratory Branch CDHS: Genetic Disease Branch
Center for Environmental
Public Health Tracking, UCB
Bill Draper, Ph.D., PI
National Resources Defense Council
CDHS: Environmental Health
Peter Flessel, Ph.D., Co-PI
CDHS ATSDR Cooperative
Investigations Branch
Kusum Perera, Ph.D., Co-PI
UCLA, School of Public Health
CALEPA, Hazardous Mat. Laboratory
Independent Evaluator Research Scientist III Health Program Advisor
Program Staffing
In-Kind Contributed Staff
Research Scientist II Research Scientist I
Research Scientist II Research Scientist II
Mike McKinney (25%) POPS
Inorganic Chemist Technical Assistance
Nonpersistent Persistent
Paramit Behniwal (25%) NOPS
Instrument Support
Organic Pollutants Organic Pollutants
Ray Fornes (10%) Inorganics
Sample Tracking
Mary Fowler (5%) QA/QC
Research Assistant
Extraction, Cleanup
Instrument Maint.
24 CALIFORNIA BIOMONITORING PLAN
PROGRAM EVALUATION
The California Biomonitoring Plan has a two-part evaluation component. The first part will help
ensure that the biomonitoring program described in the Plan achieves its stated goals and objec-
tives in a timely and cost-effective manner. The second is designed for periodic review of goals and
objectives to see that they change appropriately over time to reflect evolving technology, scientific
knowledge, and California priorities. The evaluation is intended to inform the decision-making
process—to improve ongoing activities, analytic techniques and methodologies, and apply timely
corrective programmatic course changes.
A process evaluation and an outcome evaluation will be carried out annually by staff to ensure that
project goals and objectives are being achieved, that program tasks (such as Advisory Committee
meetings, laboratory methodology development, analyses, and publications) are carried out as
planned, that appropriate levels of resources have been allocated, and that stakeholder interests
and Advisory Committee concerns are being adequately addressed. An additional outcome evalua-
tion will be done by an independent external evaluator mid-way in the five years that the Plan
encompasses, and again near the end of the fifth year if deemed necessary by the Advisory Commit-
tee. This evaluation is to determine any appropriate course corrections so that the program continues
to pursue the “right” goals and objectives.
Using impact (quantitative) and process (qualitative) evaluation methodology, the evaluation will
include specific measurable objectives tied to the program timeline.
6.1. Evaluation Objective 1: Meeting Goals and Objectives
The degree to which the program achieves project goals will be measured against the specific pro-
gram timeline. Evaluation questions include:
• Is the program meeting each of its stated goals and objectives?
• Has laboratory capacity expanded in a manner that responds to researcher and community
needs while building on existing laboratory strengths?
• Has the stated number of new methodologies for measuring specific new analytes been devel-
oped, and the stated number of samples been measured?
• Has the additional capacity and equipment necessary to meet the Plan objectives been acquired?
• Has an Advisory Committee been established that is appropriate to the needs of the Project
and have the stated number of its meetings been held and documented through minutes and
other materials?
Qualitative measures will include querying Advisory Committee members and collaborators at six-
month intervals to assess progress and the success of the collaboration. If deemed appropriate by
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CALIFORNIA BIOMONITORING PLAN
the Committee, an independent evaluator will be brought in to assist with these evaluations and a
re-ordering of goals and objectives.
6.2. Evaluation Objective 2: Assessing New Public Health Needs
In evaluating the degree to which new public health needs have been identified, and how program-
matic goals have been adjusted to meet changing public health priorities, we have established a
biannual internal review process, led by the Advisory Committee, in considering the larger societal
benefits of the program to date, as well as their assessment of emerging public health needs and
priorities that could be impacted by biomonitoring activities. The expertise possessed by these indi-
viduals will mean that they are in the ideal position to know about these emerging concerns and
provide us with input and advice regarding these issues. Modifying the existing plan to adjust to
these concerns will be a process built into ongoing iterative program planning. Since the laboratory
capacity expansion proposed already has built in some avenues for emerging concerns, the oppor-
tunity for addressing new concerns will be available. We will build into the biannual assessment by
the Advisory Committee questions related to whether or not there are new, emerging public health
needs that are not being addressed by the current Biomonitoring Program. When new needs are
identified, we will assess our ability to accommodate them by asking ourselves questions such as (1)
in what directions can we expand our existing plan and capacity to interface with and support new
directions; (2) can we obtain or advocate for additional resources to support activities directed at
these emerging concerns; (3) how can we work effectively with other organizations involved in the
issues at hand; and (4) what are the most important priorities that fit with important policy initia-
tives and fit with the laboratory vision of expanding capacity? If answers to these questions suggest
that a midcourse adjustment is appropriate, we will assess what is necessary to make the change,
consult with the Advisory Committee, and make changes. Resources will be allocated in the budget
to accommodate these needs, and outside funding will be sought if necessary.
6.3 Evaluation Objective 3: Impact on Environmental Public Health
The most difficult task will be the evaluation of the program’s impact on the public’s environmental
health and human exposure issues. To carry out that task, the Plan establishes four criteria and
specific measures:
1. Was the program successful in developing laboratory capacity to measure the analytes neces-
sary for participation in specific studies attempting to link exposures and disease?
2. Was the program successful in contributing to the development of normative data, thereby
adding knowledge about a specific population likely to be exposed to chemicals of known or
potential health significance?
3. Was the program successful in articulating opportunities to link regulatory and community
intervention efforts with biomonitoring information, thereby increasing the prevention of
disease from exposures?
4. Was the program successful at furthering efforts to affect state health policy?
The criteria will be met if examples can be given in response to each of these questions.
26 CALIFORNIA BIOMONITORING PLAN
EPILOGUE
An enormous amount of energy and work went into the construction of this Plan by the members of
the Advisory Committee and Project staff. Unfortunately, CDC experienced funding constraints
and was unexpectedly unable to fund at the level they originally anticipated. Due to this, the Califor-
nia Plan was not funded in the 2003 funding cycle.
The Advisory Committee and Biomonitoring Project staff convened to discuss opportunities for
furthering biomonitoring efforts in California in the absence of CDC funding. A number of ap-
proaches are being considered.
We will try to integrate biomonitoring into Health Tracking Projects funded in California.
Members of the Biomonitoring Advisory Committee serve on committees for the Health
Tracking Projects and will work to formalize this integration.
We will continue discussions with the research collaborators identified in the Plan in the hopes
of creating other avenues for funding of the projects proposed in the Plan.
We will pursue funding in collaboration with other non-laboratory partners. Health tracking
and environmental health surveillance efforts are ripe for the integration of biomonitoring.
We will seek opportunities to add biomonitoring to such efforts.
We will continue to support legislative initiatives to establish a California Biomonitoring
Program. However, given the state’s current financial condition, it is important to look
broadly, beyond state resources, for additional funds.
The two-year Planning Project brought together a dedicated and determined Advisory Committee.
Its members included health officials, academicians, toxicologists, epidemiologists, laboratorians,
and representatives of non-governmental advocacy organizations. While differing in perspective,
members of the Advisory Committee share a view in common, that biomonitoring is an important
tool for public health whose time has come.
27
CALIFORNIA BIOMONITORING PLAN
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