BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Deborah V. Ortiz, Chair
BILL NO: SB 600
S
AUTHOR: Ortiz and Perata
B
AMENDED: March 29, 2005
HEARING DATE: March 30, 2005
6
FISCAL: Environmental Quality/Appropriations
0
0
CONSULTANT:
Vazquez/ak
SUBJECT
Healthy Californians Biomonitoring Program
SUMMARY
This bill establishes the Healthy Californians
Biomonitoring Program, to be administered jointly by the
Division of Environmental and Occupational Disease Control
at the Department of Health Services (DHS) and the Office
of Environmental Health Hazard Assessment within the
California Environmental Protection Agency (CalEPA). The
Program is established to monitor the presence and
concentration of designated chemicals in Californians. The
bill requires DHS and CalEPA to establish an advisory panel
to assist the department and the agency and establishes the
Healthy Californians Biomonitoring Fund for deposit of
funds for the purposes of the Program.
ABSTRACT
Existing law:
1.Provides for various cancer screening and detection
programs that are administered by DHS, including the
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Breast and Cervical Cancer Treatment Program.
2.Establishes various programs for the protection of the
public from exposure to toxins, including, but not
limited to, the Childhood Lead Poisoning Prevention Act,
administered by DHS, which imposes a fee upon
manufacturers or persons who are responsible for lead
contamination and applies the proceeds of the fee to
reduction or elimination of the harm caused by the lead
contamination.
3.Establishes a process for DHS and stakeholders to develop
a statewide health tracking system, with a report that
was due to DHS, the Office of Environmental Health Hazard
Assessment, and appropriate legislative committees by
July 1, 2003 on findings and plans for the establishment
of such a system.
4.Requires DHS, CalEPA, and the University of California to
jointly develop and sign a memorandum of understanding to
assess the feasibility of integrating existing
environmental hazard, exposure, and health outcome data,
and describing how the data correspond to specified
recommendations of the working group, on or before July
1, 2004. Current law also requires the California
Environmental Health Tracking Program to obtain specified
information and authorizes the California Environmental
Health Tracking Program to collect any relevant
information from state agencies, boards, departments, and
offices.
This bill:
1.Makes various legislative findings and declarations,
including the following:
Chronic disease has reached epidemic proportions in
the United States. An estimated 125 million
Americans, or 43 percent of the population, have at
least one chronic condition. Approximately 60 million
people, or 21 percent of the population, suffer from
multiple chronic conditions.
Chronic diseases cost the state billions of dollars
a year; the estimated lifetime costs of medical and
other treatment, plus lost productivity for all
affected individuals born in 1988 with one or more of
the 18 most common birth defects, exceeds $1 trillion.
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An estimated 85,000 synthetic chemicals are
registered for use today in the United States.
Another 2,000 chemicals are added each year. Some
toxicological screening data exists for only 7 percent
of these chemicals.
Biomonitoring data supports public health by
establishing trends in chemical exposures, validating
exposure modeling and survey methods, supporting
epidemiological studies, identifying
disproportionately affected communities or
particularly vulnerable communities, identifying new
chemicals of concern, linking environmental exposures
and pollution-related disease, assessing the
effectiveness of current regulations, and helping to
set priorities for action.
Biomonitoring studies have scientifically
demonstrated that human exposure to a multitude of
persistent chemicals is both chronic and widespread.
A report by the Centers for Disease Control and
Prevention (CDC) documented the presence of 116
environmental chemicals in the blood and urine of
Americans of all ages and races.
The priority public policy recommendation from the
2002 International Summit on Breast Cancer and the
Environment, held in Santa Cruz, California, was to
establish a national biomonitoring program in the
United States using breastmilk and other biospecimens
to assess community health.
1.Creates the Healthy Californians Biomonitoring Program
utilizing the following definitions:
a. ''Department'' means the State Department of Health
Services (DHS).
b. ''Agency'' means the California Environmental
Protection Agency (CalEPA).
c. ''Director'' means the Director of the Department
of Health Services.
d. ''Secretary'' means the Secretary for Environmental
Protection.
e. ''Division'' means the Division of Environmental
and Occupational Disease Control within the
department.
f. ''Office'' means the Office of Environmental Health
Hazard Assessment within the agency.
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g. ''Biomonitoring'' means the process by which the
presence and concentration of toxic chemicals and
their metabolites are identified within a biospecimen
as a means to assess the chemical body burden.
h. ''Biospecimen'' means a sample of human blood,
hair, urine, breastmilk, body fat and other body
tissue, or any other biophysical substance that is
reasonably available as a medium to measure the
presence and concentration of toxic chemicals.
i. ''Panel'' means the Healthy Californians
Biomonitoring Program Advisory Panel established
pursuant to the Article.
j. "Community" means geographically or
nongeographically based populations that may
participate in the biomonitoring program. A
"nongeographical community" includes, but is not
limited to, populations that may share a common
chemical exposure through similar occupations,
populations experiencing a common health outcome that
may be linked to chemical exposures, or populations
that may experience similar chemical exposures because
of comparable consumption, lifestyle, or product
preferences.
aa. "Designated chemicals" means those
chemicals that are known to, or strongly suspected of,
adversely impacting human health or development, based
upon scientific, peer-reviewed, animal, human, or in
vitro studies.
1.Requires the division in collaboration with the agency to
establish the Program, with the division as the lead
agency unless otherwise specified, to utilize
biospecimens, as appropriate, to identify toxic chemicals
that are present in the bodies of Californians.
2.Requires that appropriate biospecimens be used to monitor
and assess the presence and concentration of designated
chemicals.
3.Specifies that biomonitoring shall take place on a
strictly voluntary and confidential basis and that
results reported shall not disclose individual
confidential information of participants.
4.Requires all participants to be evaluated for the
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presence of designated chemicals as a component of the
biomonitoring process.
5.Requires services to be delivered to participants, such
as health care referrals and follow-up counseling, and
that these activities may be provided through a public or
private entity by contract.
6.Specifies that, after review and analysis of the data, to
the extent program resources permit, any office or
department may collaborate to determine the presence of a
designated chemical in the environment and possible
routes of exposure. Specifies that subsequent activities
may include, but are not limited to:
a. The sharing of existing data and studies,
including, but not limited to, archived biospecimins.
b. Assessments of soil, water, air, food, homes,
consumer products, or other aspects of a particular
community.
c. Community education programs to help avoid exposure
or reduce harmful exposures.
9.Requires the department to adopt guidelines and model
protocols that address the science and practice of
biomonitoring to accomplish specified goals, including
ensuring confidentiality and informed consent, that the
program is culturally sensitive, and guidelines for
individual consultation and community education for
biomonitoring using breastmilk.
10.Permits the department to consider and adapt as
appropriate, the analytical methods utilized by the
federal Centers for Disease Control and Prevention for
the studies known collectively as the National Report on
Human Exposure to Environmental Chemicals.
11.Specifies the programs and entities that the department,
office, and panel are required to collaborate with and
which entities the department may enter into contractual
agreements with.
12.Requires the director, the secretary, the President Pro
Tempore of the Senate, and the Speaker of the Assembly to
each appoint four members of the 16-member Advisory Panel
by July 1, 2007.
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13.Requires that eight members have expertise in public
health, environment, epidemiology, and biology, and the
other eight members have expertise in the special
vulnerability of children, women of childbearing age,
seniors, health affected groups, breastfeeding promotion,
and other communities of concern.
14.The secretary shall appoint the chair of the Scientific
Committee, and the director shall appoint the chair of
the Community Representative Committee from the panel's
membership, who shall also serve as co chairs of the
panel.
15.Requires formation of subcommittees of the panel
reflecting the composition of the community to be formed
to advise the panel regarding community-based
biomonitoring activities.
16.Requires the panel to make recommendations to the
division and the office regarding the design and
implementation of the program, review program priorities,
draft protocols, study reports, and outreach materials,
and make recommendations to the secretary and director on
other specific program components.
17. Creates the Healthy Californians Biomonitoring Fund
within the State Treasury and, upon appropriation by the
Legislature, continuously appropriates the fund for the
biomonitoring program.
18. Limits administrative costs associated with
implementing the program to not more than 15 percent of
the total funds deposited into the fund for that fiscal
year.
19. Requires, by January 1, 2009, the department to
submit an interim report to the Legislature summarizing
the activities of the program, including program
descriptions, methodology, program outcomes, and
assessment of the activities of the various biomonitoring
functions conducted by the Program.
20. Requires, by January 1, 2010, the department to
submit a report to the Legislature regarding additional
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activities and recommendations for improving the program.
Every two years thereafter, in consultation with the
panel, requires the department to forward a report to the
Legislature on the program, policy, and relevant
interagency activities.
21. Requires the division and office to disseminate
biomonitoring findings to the general public via
governmental and other Web sites in a manner that is
understandable to the average person and in a summary
format to protect the confidentiality of program
participants.
22. Requires that reports be made available to the public
within 30 calendar days after the division releases its
interim and final report to the Legislature.
FISCAL IMPACT
No funding amount is specified in the bill.
BACKGROUND AND DISCUSSION
SB 600 establishes a 16-member advisory panel to assist
both the Department of Health Services (DHS), principally
through the Division of Environmental and Occupational
Disease Control (DEODC) and CalEPA, principally through the
Office of Environmental Health Hazard Assessment, on the
design and development of a Healthy Californians
Biomonitoring Program. The bill calls for the design and
implementation of a program that will study biospecimens to
identify designated chemicals that are present in the
bodies of Californians. After review and analysis of
biomonitoring data, the department or office may enter into
activities, such as information sharing, assessment of
environmental elements, such as soil, water, and air, or
community education programs to help avoid exposure or
reduce harmful exposure. This bill calls for an initial
reporting of activities by January 1, 2009, with subsequent
reports required at set dates thereafter.
Need for the bill
According to the author, chronic and acute illnesses and
diseases have reached epidemic proportions in the United
States. Cancer, asthma, Alzheimer's disease, autism, birth
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defects, developmental disabilities, endometriosis,
infertility, multiple sclerosis, and Parkinson's disease
are becoming increasingly common, and mounting evidence
links incidence and severity of these diseases to
environmental contaminants. While chronic illnesses affect
people regardless of race, ethnicity, and income,
disparities along geographic and socioeconomic lines can
result in disproportionate environmental exposures to
certain individuals and communities.
It is known that certain toxic chemicals cause adverse
human health effects and biomonitoring gives us the tool to
conduct assessments and determine the best course of
action, both for individuals and communities.
Biomonitoring facilitates scientific improvements in
detection and increases the knowledge base about toxic
chemicals in human bodies so that intervention and efforts
at mitigation are enhanced due to the specific scientific
measurements of toxicants. Of course, more research is
needed to better understand the relationship between
environmental toxins and the increasing incidence of
disease. Improved and expanded epidemiological data will
increase understanding of this relationship, resulting in
saving substantial state dollars each year in health care
costs spent treating disease because of prevention.
The data produced through biomonitoring can support efforts
to improve public health by indicating trends in chemical
exposures; validating exposure modeling and survey methods;
supporting epidemiological studies; identifying
disproportionately affected communities or particularly
vulnerable communities; identifying new chemicals of
concern; linking environmental exposures and
pollution-related disease; assessing the effectiveness of
current regulations; and helping to set priorities for
action. Furthermore, the systematic collection and
analysis of biospecimens from individuals may also have
significant public health implications since individual
body-burden data may be used to extrapolate the levels of
exposure to environmental toxicants by a community as a
whole.
With the increasing rates of chronic and acute diseases and
the evidence linking these diseases to environmental
factors, biomonitoring offers the opportunity to study the
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relationship between body burden levels and health more
thoroughly. Given the rates of disease in the last fifty
years, scientists have ruled out genetics as the principal
factor and are increasingly prioritizing environmental
causation of disease.
Results of biomonitoring
Biomonitoring, short for "biological monitoring," is the
process by which industrial compounds, pollutants, and
other chemicals in a person's body, also known as their
"body burden," are measured using samples of breastmilk,
blood, urine, or fatty tissue. The data produced through
biomonitoring can improve public health by indicating
trends in chemical exposures and can help scientists,
medical professionals, and community members understand the
effects of environmental contaminants on human health.
Biomonitoring also helps us learn more about the
effectiveness of current chemical regulation, inform us in
our quest to identify new chemicals of concern, and assist
in revealing trends in exposure and health. With a growing
body of evidence linking the thousands of synthetic
chemicals in our environment to a host of chronic illnesses
and diseases, biomonitoring is an extremely valuable tool
in protecting the environmental health and wellbeing of
California communities.
There is a substantial and growing body of evidence
indicating that exposures to certain toxic chemicals and
hormone-mimicking compounds contribute to the development
of cancers, learning disabilities, Parkinson's disease,
endometriosis, birth defects, infertility, and other
diseases. Biomonitoring research has detected synthetic
and toxic chemicals including flame retardants, such as
PBDEs, dioxins, polychlorinated biphenyls (PCBs), DDT, and
other pesticides in breastmilk, blood, and urine.
In a recent report by the CDC scientists measured and
analyzed 116 chemicals in the blood and urine of almost
8,000 individuals throughout the United States. The study
found that Mexican American children had three times the
levels of the chemical DDT and its breakdown or metabolite
DDE as other participants, despite the fact that DDT has
been banned in the United States for over 30 years. Other
children also have high levels of DDT and DDE in their
bodies, despite being born after the chemical was banned,
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because of the length of time this chemical remains in the
environment. DDT is linked, among other health outcomes,
to preterm birth, a leading cause of infant death in the
United States.
The National Toxicology Program recently listed 228
chemicals as known or reasonably anticipated human
carcinogens in its Tenth Report on Carcinogens. The
National Toxicology Program also has compiled a list of 46
chemicals that induce mammary tumors in laboratory animals
and are associated specifically with an increased risk of
breast cancer. Further studies and tracking of
environmental exposures and their relationships to chronic
illnesses are needed to test how similarly these chemicals
impact human health.
A recent study led by Mount Sinai School of Medicine in New
York, in collaboration with the Environmental Working Group
and Commonweal, revealed over 167 synthetic chemicals in
the blood of nine volunteers. A large number of these
chemicals have been linked to cancer and to disorders of
the reproductive and neurological systems, and to the
functioning of the immune system. Further studies and
tracking of environmental exposures and their relationships
to chronic illnesses are needed to test how these and other
dangerous chemicals impact human health.
Despite the broad public health implications such research
could have worldwide, the United States has not conducted
any systematic, large-scale biomonitoring studies. Sweden
and Norway's experience with the biomonitoring of
breastmilk was that breastfeeding rates remained very high,
even in locations where environmental contamination was
known to be high. The rates of breastfeeding in these
countries exceeded those of the United States, with nursing
mothers breastfeeding at rates as high as 80 to 90 percent.
Germany and Sweden do have long-standing national
biomonitoring programs using breastmilk, however, and these
programs have revealed that many communities are exposed to
numerous synthetic chemicals. When these chemicals were
subsequently reduced or eliminated in the environment,
studies showed that their levels in the environment and in
the body burdens of individuals decreased. Similarly,
studies in the United States have demonstrated that after
legislation on lead products was enacted, lead poisoning
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decreased in children. With such promising results, it is
incumbent on governmental agencies and communities to
demand a prioritization of biomonitoring research.
Partnering agencies for implementation
DHS and CalEPA are drawn into collaboration in the
implementation of this program. The bill additionally
allows the department and the agency to collaborate with
other related governmental bodies and contract with public
or private entities to conduct necessary activities. The
two agencies are also jointly assigned monitoring and
reporting duties in the measure.
This model follows on the recently-released strategies of
the Expert Working Group on Environmental Health
Surveillance, created under Senate Bill 702 (Escutia,
2001). Data sharing, integration, and communication across
offices that share valuable tools for environmental health
tracking was highly recommended by the Working Group, along
with a recommendation for the state to begin a
biomonitoring effort such as the one being forwarded in SB
600.
Arguments in support
Proponents of the measure, in particular the bill's
sponsors, The Breast Cancer Fund and Commonweal, state that
mounting evidence links incidence and severity of many
chronic diseases, including cancer, asthma, Alzheimer's
disease, birth defects, and developmental disabilities, to
environmental toxins. Viewed in economic terms, e.g.
treatment, care, and lost productivity, the cost of chronic
diseases is staggering. Yet, despite these sobering
statistics, fewer than 10 percent of the 85,000 synthetic
chemicals registered for use today in the United States
have been tested for their effects on human health.
Biomonitoring of the sort proposed by SB 600 is an
essential component needed to collect better data on the
presence of dangerous synthetic chemicals in humans and
taking steps to reduce exposure when possible. Commonweal
states that "knowing and understanding our chemical body
burden is a fundamental right-to-know issue."
The National Environmental Trust states unlike testing done
on drugs and pesticides, where controlled animal exposure
studies are done in order to extrapolate impacts on humans,
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the entire U.S. population is the test subject for most
synthetic chemicals. The California Nurses Association
writes that the resulting data from biomonitoring can be
used to improve the public health by identifying
communities disproportionately affected by chemical
exposure. California Church IMPACT calls this legislation
a common-sense method of permitting people to be
voluntarily tested for possible exposure to chemical
contaminants that may adversely affect their health.
Arguments in opposition
The opposition writes that this bill could lead to the
creation of a complex set of new rules and regulations that
would be extremely onerous to users of vital chemical
compounds, many of which are essential to improved public
health. These new rules and regulations on the production,
use, or distribution of chemicals come at a time when the
state is trying to reinvigorate the state's business
climate and nurture the life sciences industry.
A letter of opposition was filed from a coalition of
organizations questioning the scientific process that the
Department of Health Services and the California
Environmental Protection Agency will utilize in the
implementation of the biomonitoring program described in
this bill. Additionally, opponents are concerned that the
program will give flexibility to state scientists to
utilize whatever programmatic response that they deem
appropriate in response to epidemiological data collected
through biomonitored specimens. Finally, opponents object
to the inclusion of community-based representatives on the
advisory board.
Related legislation
SB 1446 (Escutia, 2004) proposed establish the
Interagency Office of Environmental Health Tracking
within the Division of Environmental and Occupational
Disease Control within DHS for the purpose of
implementing the health tracking program. The bill died
in the Assembly Appropriations Committee last year.
SB 1168 and 689 (Ortiz) were former iterations of this
proposal in the 2003-04 legislative session. SB 189
(Escutia, Chapter 407, Statutes of 2003) enacted the
California Health Tracking Act of 2003, and would require
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DHS, CalEPA, and the University of California to jointly
develop and sign a memorandum of understanding to assess
the feasibility of integrating existing environmental
hazard, exposure, and health outcome data, and describing
how the data correspond to specified recommendations of
the working group, on or before July 1, 2004. The bill
also required the California Environmental Health
Tracking Program to obtain specified information and
authorizes the California Environmental Health Tracking
Program to collect any relevant information from state
agencies, boards, departments, and offices.
SB 702 (Escutia, Chapter 538, Statutes of 2001) provided
that the purpose of the Environmental Health Surveillance
System (EHSS) shall be to establish an ongoing
surveillance of environmental exposures and the diseases
afflicting Californians. The bill required the division
and the office, in cooperation with the Regents of the
University of California, to create a working group of
technical experts with specified duties, including the
development of possible approaches to establishing the
EHSS.
POSITIONS
Support: The Breast Cancer Fund (co-sponsor)
Commonweal (co-sponsor)
California National Organization for Women
California Nurses Association
California Church IMPACT
California Interfaith Partnership for
Children's Health
and the Environment
City of Berkeley WIC
Clif Bar, Inc.
Environment California
Learning Disabilities Association of
California
Ma'at Youth Academy
Marin Golden Gate Learning Disabilities
Association
National Brain Tumor Foundation
National Environmental Trust
Natural Resources Defense Council
Nursing Mothers Counsel, Inc.
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Pesticide Action Network North America
Sierra Club California
Trust for America's Health
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Oppose: Albemarle Corp.
American Chemistry Council
American Electronics Association
American Forest and Paper Association
BIOCOM
Bromine Science and Environmental Forum
California Chamber of Commerce
California Farm Bureau Federation
California Independent Oil Marketers
Association
California Independent Petroleum Association
California Manufacturers and Technology
Association
California Paint Council
California Retailers Association
California Women for Agriculture
Chemical Industry Council of California
Chlorine Chemistry Council
Consumer Specialty Products Association
Crop Life America
Fresno County Farm Bureau
Grocery Manufacturers of America
IPC California Circuits Association
Industrial Environmental Association
Natural Electrical Manufacturers Association
Rubber Manufacturers Association
Silicon Valley Leadership Group
Styrene Information Research Center
Surface Technology Association
The Soap and Detergent Association
Western Plant Health Association
Western States Petroleum Association
Western Wood Preservers Institute
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