BILL ANALYSIS
SENATE HEALTH AND HUMAN SERVICES
COMMITTEE ANALYSIS
Senator Deborah V. Ortiz, Chair
BILL NO: AB 2943
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AUTHOR: Pavley
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AMENDED: May 20, 2004
HEARING DATE: June 23, 2004
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FISCAL: Appropriations
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CONSULTANT:
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Machi/Margolis/sl
SUBJECT
Mercury poisoning prevention: Childhood vaccines
SUMMARY
Prohibits, starting January 1, 2006, a person who is
pregnant or who is under three years of age from being
vaccinated with a mercury-containing vaccine or injected
with a mercury-added vaccine that contains more than 0.5
micrograms of mercury per 0.5 milliliter dose.
ABSTRACT
Existing law:
1.Lists mercury and mercury compounds, including ethyl
mercury, on California's Proposition 65 list, which
includes toxins known to the state to cause reproductive
harm.
2.Designates a category of hazardous wastes called
"Universal Waste" under hazardous waste regulations.
Universal wastes are hazardous wastes that are more
common and pose a lower acute risk to people and the
environment (such as many consumer products containing
mercury) than other hazardous wastes.
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3.Requires industrial wastes containing mercury be managed
as hazardous wastes. When discharged to land or water,
mercury-containing wastes are also regulated under waste
discharge requirements issued by a regional water quality
control board.
4.Bans the manufacture and sale of dry cell batteries
containing more than incidental amounts of mercury and
the sale of toys coated with paints containing more than
0.1% soluble mercury, mercury fever thermometers, with
certain exceptions, and novelty items containing mercury.
5.Requires art and craft materials containing toxic
substances, including mercury, be labeled in a specified
manner, bans the use of these materials in elementary
schools, and allows their use in middle and high schools
only when labeled properly.
6.Prohibits the purchase of mercury-containing materials in
K-12 schools with specified exceptions.
7.Requires the State Department of Health Services (DHS) to
maintain a program of maternal and child health.
8.Requires DHS to provide vaccinations through the Medi-Cal
and Healthy Families programs.
9.Requires children to be vaccinated against many diseases
in order to be admitted to child care centers and public
schools.
This bill:
Prohibits, starting January 1, 2006, a person who is
pregnant or who is under three years of age from being
vaccinated with a mercury-containing vaccine or injected
with a mercury-added vaccine that contains more than 0.5
micrograms of mercury per 0.5 milliliter dose.
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
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Purpose of the bill
AB 2943 specifically bans the administration of mercury
containing vaccines, that contain more than trace amounts
of mercury (per the U.S. Food and Drug Administration's
definition), in pregnant women and children under 3 years
of age as of January 1, 2006. According to the author,
this bill is intended to respond to growing concern that
thimerosal, a preservative containing approximately 50%
ethyl mercury, could be contributing to increasing rates of
neurodevelopment disorders, including autism, in children.
Though the medical and scientific communities are still
discussing the significance of the research, the author
believes that it would be good and prudent public policy to
remove thimerosal from all vaccines given to young children
and pregnant women. AB 2943 is meant to be a precautionary
measure that would reduce infants' and children's overall
exposure to mercury during critical developmental years.
The author points out that the bill is timely because the
federal Centers for Disease Control and Prevention (CDC)
recommends that in 2005, all children ages 6 months to 2
years receive the flu vaccine, even though many of the
pediatric doses will contain thimerosal.
DHS, which purchases publicly-financed vaccines with the
help of the federal Vaccines for Children Program, has
ordered thimerosal-free flu vaccines for children 3 years
and under for next year's flu shots. Therefore, all
children covered by Medi-Cal, Healthy Families, and other
publicly financed health care programs, will receive
thimerosal-free flu shots in California. However, many
children who are covered by private insurance, or who have
no medical coverage, will receive a thimerosal-containing
flu vaccine.
The author states that AB 2943 will extend DHS'
thimerosal-free policy into the private sector and ensures
that all children will receive a thimerosal-free flu
vaccine. The bill also extends this safeguard to children
who would be given any other type of thimerosal containing
vaccine, and to pregnant women who are carrying fetuses
that are highly sensitive to mercury's effects.
Mercury
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Mercury is used in household and commercial products, as
well as industrial processes, because it is liquid at room
temperature, combines easily with other metals, and expands
and contracts evenly with temperature changes. Mercury is
an element that does not break down. It is a persistent
and toxic pollutant that bioaccumulates in the environment
and in the food chain and in the human body. There is no
dispute within the scientific and medical communities
concerning the serious ecological and health effects
related to mercury.
Mercury is a widely recognized toxin that can damage the
central nervous system, kidneys and liver, at very low
levels of exposure. Nervous system disorders include
impaired vision, speech, hearing, and coordination.
Mercury is especially hazardous to pregnant women and
children, causing such problems as birth defects and
learning disabilities.
A National Academy of Sciences study published in 2000
estimated that annually 60,000 infants in the United States
face increased risk of brain damage because of pregnant
mothers' elevated exposures to mercury. In California,
there is a special concern regarding the accumulation of
methyl-mercury in the tissues of fish that can be consumed
and result in damaging health effects.
While it is known that mercury, on its own, as a heavy
metal, is a toxin, combined with other chemicals or metals
into different mercuric compounds, mercury may be more or
less toxic to the human body depending on how the compounds
are metabolized. Additionally, the impact of a compound on
infants and children may differ from the effects on adults.
Established studies and guidelines are based on data taken
on methyl mercury as it has been the more prevalent form of
organo-mercury used in products and found as a contaminant
in the environment. The impacts to the human body of ethyl
mercury, which is an ingredient of the vaccine
preservative, thimerosal, are still not fully known.
Thimerosal in Vaccines
Preservatives are used by drug companies to prevent the
growth of bacteria and fungi in vaccines, preventing
potentially life-threatening contamination by harmful
microbes. Thimerosal is a preservative that has been used
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in the United States since the 1930's. It contains 50
percent ethyl mercury. In recent years, drug manufacturers
have developed new products with alternatives or without
preservatives that can be used as substitutes for many of
the vaccinations available today.
In 2001, the Institute of Medicine's (IOM) Immunization
Safety Review Committee convened a meeting to review
selected issues related to immunization safety. The IOM
believed that the effort to remove thimerosal from vaccines
was "a prudent measure in support of the public health goal
to reduce mercury exposure of infants and children as much
as possible." The Committee also urged that "full
consideration be given to removing thimerosal from any
biological product to which infants, children and pregnant
women are exposed."
According to the U.S. Food and Drug Administration (FDA),
"As a precautionary measure, the Public Health Service
(including the FDA, the National Institutes of Health
(NIH), the CDC, Health Resources and Services
Administration (HRSA) and the American Academy of
Pediatrics) issued two Joint Statements, urging vaccine
manufacturers to reduce or eliminate thimerosal in vaccines
as soon as possible (CDC 1999) and (CDC 2000)."
Since 1999, thimerosal has been removed from most of the
vaccines routinely recommended for infants and children.
It is still used in injectable influenza vaccine, though
thimerosal-free flu vaccine is expected to be available
this year. [See attached table obtained from the FDA
Website (www.fda.gov/cber/vaccine/thimerosal.htm) for
information pertaining to thimerosal content in Routine
Pediatric Vaccines.]
In recent years, several studies have been conducted to
look at a possible link between thimerosal and
neurdevelopmental disorders, such as autism, including the
following:
In its report of 2001, IOM concluded that the evidence is
inadequate to either accept or reject a causal
relationship between thimerosal exposure from childhood
vaccines and neurodevelopmental disorders.
A 2003 report published by the Journal of American
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Physicians and Surgeons, conducted by Drs. Mark Geier and
David Geier, asserts strong epidemiological evidence for
a link between mercury exposure from
thimerosal-containing childhood vaccines and
neurodevelopment disorders.
IOM released a report in May, 2004, reputing this and
other studies, stating that the hypotheses regarding how
the measles-mumps-rubella (MMR) vaccine and thimerosal
could trigger autism lack supporting evidence and are
only theoretical, and that the MMR vaccine and the
mercury based vaccine preservative thimerosal are not
associated with autism.
A study done by the University of Columbia, released June
8, 2004, states that the mercury preservative used in
some vaccines can cause behavioral abnormalities in
newborn mice characteristic of autism, but only in mice
with specific genetic susceptibility.
Vaccines
This year, the CDC recommends that all children ages six
months to three years receive the flu vaccine this year
even though most of the doses will contain thimerosal. The
CDC's decision appears to be at odds with recent federal
warnings about exposure to mercury and with the
government's successful effort to see mercury removed from
other childhood vaccines. The mercury-free flu vaccine
will be more expensive, roughly $4 per shot, because it is
more difficult to make in large quantities than the
alternative. Concern has been raised that if CDC were to
warn parents, demand for thimerosal-free shots would rise,
possibly squeezing supplies. Some experts argue that there
is a greater risk in infants and toddlers failing to be
vaccinated against the flu because of a shortage than in
their being vaccinated with shots containing mercury.
DHS will be purchasing thimerosal-free flu vaccinations
this coming year to be administered to children ages three
and under through the department's publicly-funded
programs. In a Los Angeles Times article, on April 2,
2004, a representative from the pharmaceutical company
Aventis Pasteur Inc. is quoted as saying that the company
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believes "we will be able to produce a sufficient amount"
of mercury-free vaccine, "providing we're notified early
enough."
Arguments in support
Supporters of the bill point to: "Toxic effects of
postnatal thimerosal are mouse strain dependent," Molecular
Psychiatry, 2004, a study funded by the UC Davis Mind
Institute, conducted by the University of Columbia, which
indicates that thimerosal can increase the risk of
autism-like damage in autoimmune disease susceptible mice.
According to supporters, this is the first study to
demonstrate that a low dose of ethyl mercury, coupled with
a genetic predisposition, can lead to behavioral and
neurological changes in the developing brain, at least in
mice. The Sierra Club asserts that, "A recent analysis by
the U.S. Environmental Protection Agency nearly doubled -
to 630,000 - the number of children born annually in the
U.S. with unsafe levels of mercury in their blood. To
continue injecting pregnant women and children with a
potent neruotoxin, when safer alternatives are available,
would be irresponsible."
Supporters also argue that, "In the 70 years since
thimerosal was first used in vaccines, science has made
great strides in understanding the danger of exposure to
even minute levels of mercury. We have succeeded in
removing mercury in many items such as paints and
thermometers; and warnings are routinely issued about
mercury in fish. Thimerosal, once marketed as the topical
ointment Mercurochrome, was banned specifically due to
recognition that exposures to mercury could be harmful yet
we continue to inject infants and young children with
vaccines that contain mercury because government officials
which regulate the national vaccine program claim mercury
is safe in trace amounts?this makes no sense."
Arguments in opposition
The opposition is concerned that if thimerosal were
disallowed for use in vaccines given to children in
California, there would not be enough supply. The
opponents state, "Although most people realize the dangers
of influenza to the elderly, many do not appreciate that
infants and toddlers 6-23 months of age have similar rates
of hospitalization and complications. Because of this, the
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CDC, American Academy of Pediatricians, and the American
Academy of Family Physicians all agree that these children
should routinely receive influenza vaccine." However, they
argue that current vaccine manufacturing capacity limits
the number of doses that can be produced each season.
Opponents also assert that if thimerosal were not used,
one-third of all influenza vaccine doses would be wasted.
"Influenza vaccine supplies for children were exhausted
last year even though few 6-23 month-olds were vaccinated.
Further limiting influenza vaccine supply, as would occur
under AB 2943, would leave even more children unprotected,
and vulnerable to inconvenience, hospitalization and even
death."
The opposition states that this bill would also affect a
vaccine for Japanese encephalitis, which does not currently
have a thimerosal-free substitute. Japanese encephalitis
occurs in rural areas of Asia and may cause brain damage or
death. This vaccine, however, would only be administered
if a person were to be traveling to Asia.
Prior legislation
AB 455 (Chu, Chapter 679, Statutes of 2003) enacted the
Toxics in Packaging Prevention Act, which, beginning
January 1, 2006, prohibits the sale of any package, or
product in a package, that includes regulated lead,
mercury, cadmium, or hexavalent chromium, if such metals
have been intentionally introduced during manufacturing or
distribution.
Related Legislation
AB 1699 (Laird) would enact the Mercury Recycling
Enhancement Act of 2004 to develop an effective process for
recycling mercury contained in waste fluorescent lamps.
SB 1180 (Figueroa) would enact the California Mercury Lamp
Recycling Act of 2004 and requires manufacturers and
distributors of fluorescent lamps sold in California to pay
a recycling fee for purposes of a recycling incentive grant
program, collection and processing assistance, grants to
local government and a public information program.
Related federal legislation
H.R. 4169 (Weldon), the Mercury Free Vaccines Act of 2004,
would phase out the use of mercury in vaccines over the
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next three years, giving particular attention to completely
eliminating mercury from childhood vaccines on an expedited
schedule.
Related legislation in other states
In May 2004, Iowa became the first state to ban the use of
thimerosal in vaccines. Similar bills are pending in
Missouri and Nebraska.
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COMMENT
Because this vaccine would rarely be required in children
under the age of three, the author may wish to take an
amendment to exempt the Japanese encephalitis vaccine from
this bill until such time that a substitute has been
licensed by the FDA. As this may not be the only vaccine
that does not have a sufficient substitute, the author may
wish to add a provision to the bill to give DHS the
authority to grant conditional waivers until adequate
substitutes are available, but the author may want to also
require the administering physician to disclose the fact
that the vaccine contains mercury when it is given to a
child aged three or younger or pregnant women.
PRIOR ACTIONS
Assembly Floor: 49 - 22 Pass
Assembly Appropriations: 16 - 5 Do Pass as Amended
Assembly E.S. & T.M.: 5 - 2 Do Pass as Amended
POSITIONS
Support: Autism Autoimmunity Project
Autism Education Network
California Nurses Association
National Autism Association
Sierra Club California
14 individuals
Oppose: American Academy of Pediatrics
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