BILL ANALYSIS
AB 1428
Page 1
Date of Hearing: May 3, 2005
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Gloria Negrete McLeod, Chair
AB 1428 (Levine) - As Introduced: February 22, 2005
(As Proposed to be Amended)
SUBJECT : Genetically modified and cloned pets.
SUMMARY : Establishes the Cloned and Genetically Modified Pet
and Consumer Protection Act (Act) that prohibits the retail sale
or transfer of cloned or genetically modified pets, as defined,
within California. Specifically, this bill :
1)Establishes the Act to include all the provisions therein.
2)Defines "Clone" as the practice of creating or attempting to
create an animal by: (a) Transferring the nucleus or
chromosomes/chromatin from a cell into an egg cell from which
the nucleus or chromosomes have been removed for the purpose
of creating a cloned embryo; (b) Implanting a cloned embryo to
initiate a pregnancy that could result in the birth of an
animal; or, (c) Any cloning technology seeking to create an
animal genetically identical to another animal, whether living
or dead.
3)Defines "Genetically Modified" or "Transgenic" as genetically
altered by introducing DNA from another species or through
engineered endogenous constructs, as defined. This definition
excludes hybridization between closely related species, as in
traditional hybridization.
4)Defines "Pet" as any amphibian, bird, fish, mammal, or reptile
that is kept for companionship rather than utility.
5)Provides that no person may engage in the retail sale or
transfer of cloned or genetically modified pets within
California.
6)Permits any person to file a complaint with the Department of
Health Services (DHS) alleging a violation of this Act,
pursuant to conditions specified within the Act.
7)Provides that the Director of DHS may levy administrative
penalties against any person who violates this Act in the
AB 1428
Page 2
amount of $500,000 per violation. Any administrative
penalties received shall be deposited in the General Fund.
8)Provides that if any provision of the Act, or its application,
is held invalid, that invalidity shall not affect other
provisions or application that can be given effect without the
invalid provision or application.
9)Establishes that no part of the Act shall be construed as
interfering with properly conducted scientific experiments or
investigations performed under the authority of the faculty of
an accredited medical college or university of this state.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to a February 2004 Opinion
Research Corporation national survey, 84% of those surveyed
stated that companies should not be allowed to genetically
engineer and sell pet animals. In an ABC/BeliefNet Poll (August
2001), six out of ten Americans said all animal cloning should
be illegal. This bill does not prohibit animal cloning in
California. This bill does not prohibit the cloning of pets
such as cats or dogs in California. This bill does not prohibit
the cloning of non-pet animals such as horses or cows for retail
sale in California. This bill does not prohibit the cloning and
retail sale of animals that may sometimes be pets, such as mice,
that are being cloned specifically for research or other
utilities.
According to a co-sponsor of this bill, the American
Anti-Vivisection Society (AAVS), "This bill is intended to
prohibit the sale of cloned and genetically modified pets to
private consumers, or pet owners of California" and is not
intended to interfere with the important research and practice
of accredited medical colleges or universities of this state.
The cloning of pets for public sale is very new. In fact, the
first cloned cat was born in 2001 and the first cloned cat sold
to the public, Little Nicky, was born in 2004. There are no
long term or short term studies of these cloned pets. It is
unknown how these new cloned animals will age, how they will
reproduce, or if there are any unintended consequences of
cloning these domesticated animals. Furthermore, no studies
AB 1428
Page 3
have been done on the transgenic pets that are already for sale,
but not actually in existence yet.
AAVS asserts: "genetically modified pets, including glowing fish
and hypothetical 'hypoallergenic cats' are being marketed to
consumers. Genetic modification relies on the births of
numerous animals, of whom only a tiny percentage might carry the
desired trait. And, because they don't yet exist,
'allergon-free' cats have not been evaluated as being safe for
people." Furthermore, "The pet cloning industry is currently
operating without federal regulatory oversight, in violation of
the law. Pet cloning companies are essentially conducting
animal experiments, but have no accountability to regulatory
agencies charged with enforcing animal welfare laws. Therefore,
there are no inspections and no authenticated public record of
how many animals are used in experiments or their fate."
Without regulation we have seen the invention of a transgenic
glowing rabbit solely for display as a piece of art (France,
2003) and the mass manufacture of transgenic glowing fish
(Florida, 2003) solely for the viewing pleasure of consumers who
want to spice up their home aquariums.
Basic cloning process . A simplified description of the cloning
process follows:
1)An egg is harvested from an unrelated donor animal and the
nucleus removed (enucleated egg).
2)An adult somatic cell is harvested from the donor. The cell
can be skin, blood, bone or muscle. The cell will have a
complete copy of the donor's DNA in its nucleus.
3)The DNA is removed from the cell with a device used to extract
the nucleus.
4)The donor cell is fused to the enucleated egg and either
treated with chemicals or jolted by electricity to trick the
egg into thinking it's been fertilized.
5)Once the egg has become a viable embryo it is inserted into a
surrogate animal to develop into a clone.
Species cloned . The following is a brief history of species
that have been cloned:
1)Frogs (1962) Unsuccessful
2)Carp (1963) Successfully cloned
3)Sheep (1996) "Dolly"
AB 1428
Page 4
4)Rhesus monkey: (2000) "Tetra"
5)Pig: (2000)
6)Cattle: (2001)
7)Cat: "CC" (2001), Little Nicky, Tabouli and Baba Ganoush
(2004)
8)Mice: (2002)
9)Rabbit: Glowing bunny (2003). Human-rabbit hybrid in China
(2003)
10)Mule: (2003)
11)Horse: (2003)
12)Rat: (2003)
13)Fruit flies: (2004)
California transgenic fish prohibition . SB 245 (Sher), Chapter
871, Statutes of 2003, provides that it is unlawful to spawn,
incubate or cultivate any species of finfish belonging to the
family Salmonidae, transgenic fish species, or any exotic
species of finfish, in the waters of the Pacific Ocean that are
regulated by the California.
GloFish regulation . These transgenic fish are the result of
inserting a fluorescent sea coral gene into the eggs of zebra
fish and then breeding the "glowing" fish for pets. The sale of
these fish are currently prohibited in California.
According to Yorktown Technologies, L.P., the manufacturers of
GloFish, there are three levels of regulation their product, the
GloFish, must pass through before they will be allowed for sale
in California.
The first level of oversight is provided by the U.S. Food and
Drug Administration (FDA) to ensure human health and
environmental safety in relation of the product. However, in
this case, the FDA decided not to formally regulate Glofish.
The second level of independent oversight lies with the state of
Florida where the manufacturer is based.
The third level of review lies with the California Fish and Game
Commission (Commission), which in February 2003, adopted
regulations prohibiting the sale, importation, transportation
and possession of any genetically modified fish without a
special permit. Yorktown Technologies states: "While the
Commission initially denied our request [for a special permit]
in December 2003 due to ethical considerations, they
AB 1428
Page 5
subsequently voted to allow our request in April 2004. However,
we were later informed that, in addition to the commission
approval, we would be required to submit an Environmental Impact
Report in compliance with CEQA."
Cloned and transgenic pets: an unregulated product . According
to the Center for Food Safety, which supports this bill, "Cloned
pets and genetically modified pets, such as allergen-free cats
and the GloFish, have escaped federal regulation. The GloFish
for example, did not go through the full regulatory review
process at the U.S. Food and Drug Administration yet is
currently being sold to consumers (although the GloFish is not
being sold in California, this fish could be sold here soon).
The U.S. Department of Agriculture (USDA) is also currently not
regulating companies selling cloned and genetically modified
pets. As a result, there is a huge gap in the federal
regulatory process for cloned and genetically modified animals.
This means that there is no monitoring to ensure the welfare of
the animals used to create cloned or genetically modified pet
animals. There is also no mandatory federal oversight to ensure
that these novel pets do not pose threats to human health and
the environment."
Unlike other laboratories that experiment on cats and dogs, the
laboratories researching and producing cloned and genetically
modified pets for public sale are not regulated or accredited by
agencies or institutions requiring basic standards of animal
care and use. Because pet cloning is an unregulated industry,
no one outside of the labs knows the success rates and other
details of the cat and dog experiments.
Genetic Savings and Clone (GSC), which opposes this bill and is
the only business currently cloning pets in California, states
that its internal standards already exceed any likely to be
required by regulation. In fact, GSC Chief Executive Officer
Lou Hawthorne stated in a magazine article, "Our internal
welfare protocols have higher standards than those required by
the Animal Welfare Act. I find it impossible to imagine that
government oversight would constrain our activities."
'Lifestyle pets' . Allerca, Inc., a new genetic technologies
company, is already taking $500 deposits for "hypoallergenic"
cats that have a particular gene 'knocked-out' that produces Fel
d 1, a certain protein known to cause allergies in people.
However, the company has never successfully genetically altered
AB 1428
Page 6
a cat in this manner. Looking to create a broad market in
'lifestyle pets', Allerca also plans to sell 'genetically
protected' cats (that resist certain feline diseases) in the
future.
In its letter of support, the People for the Ethical Treatment
of Animals (PETA), states regarding genetic engineering of
designer pets: "These 'frankenpets' have genes from other
animals spliced into their DNA to make them more attractive to
consumers. But while it may be possible to create
hypoallergenic cats or dogs who glow in the dark, these animals
will suffer the same painful defects as cloned animals. No
animals should have to suffer for such petty reasons."
However, the California Veterinary Medical Association (CVMA),
which opposes this bill, cites a newspaper article about the
benefits of genetic modified research, such as the development
of hypo-allergenic cats. "UCLA and Virginia Commonwealth
University have joined together to develop a new treatment that
involves linking a feline protein that causes cat allergies to a
human protein that stops immune system cells from releasing
histamine, the chemical that sets off allergy symptoms. The
article states that the results of the UCLA research 'may lead
to better therapy for millions of people who are allergic to
cats - including 14 percent of children from age 6 to 9?and for
the estimated 50 million Americans who suffer from some type of
allergy." Furthermore, CVMA states, "If genes can be
manipulated to prevent certain animal breeds from being born
with predisposition to diabetes, or in the UCLA case study,
prevent breeds from producing allergens, these developments
could have widespread implications for animal health and human
health."
Cloning endangered species . GSC states: "The canine and feline
cloning research being done at GSC may improve the technologies
available for the cloning of endangered species. We are
developing non-profit partnerships to provide technical know-how
on canine reproduction (especially in vitro fertilization, IVF,
and cloning) to organizations that work to repopulate endangered
canids, including varieties of wolves, foxes, and wild dogs.
GSC has begun to subsidize the gene banking of endangered
relatives of the cat and dog. We gene bank one male and one
female member of these species at no charge, and we gene bank
additional members at a reduced rate."
AB 1428
Page 7
Additionally, according to the Cat Fanciers' Association, Inc.,
which opposes this bill, "the technology funded through the
sales of cloned pet animals can be applied to endangered species
threatened by extinction. Cloning may provide alternatives to
capture and transport of wild animals to zoos."
Cloning the best pets for public service . GSC states:
"genetically exceptional, highly trained dogs perform valuable
services for humans, such as assisting people with disabilities,
rescuing disaster victims, and detecting arson and explosives.
Only certain individual dogs within specific breeds have the
right mix of sensitivity, intelligence, temperament, and other
qualities to successfully perform these jobs. Furthermore, less
than half the dogs entering assistance or other working dog
training programs end up being placed with clients; the others
are rejected for health and/or behavioral reasons."
Further, according the GSC, "once a suitable dog is placed, it
may be able to provide assistance for eight or nine years. Or
it may become ill, lame, or die long before that, in some cases
due to genetic disorders including progressive retinal atrophy,
hip dysplasia, thyroid problems, etc. When an assistance dog
becomes unable to perform due to early illness or death, a
client faces the burden of coping with that loss as well as
coping with training and acclimating to a new dog. By providing
clients with clones of the healthiest, best-performing
assistance and other working dogs, we will reduce the frequency
and duration of the transitional periods."
Gauging the success of cloning . Experimentation in this field
has already shown that cloned and genetically modified animals
are subject to abnormally high rates of miscarriage, early
death, deformity, disease, and other serious medical conditions.
For example, many cloned animals are stillborn or are missing
limbs and organs. The CEO of GSC, Lou Hawthorne, acknowledges
that up to 45% of the cats born alive will die within the first
month of life.
In support of this bill, People for the Ethical Treatment of
Animals states: "For every animal considered 'successfully'
cloned, many others are born with deformed limbs and organs.
These unfortunate animals are killed, and those with less
apparent abnormalities linger and soon die. It is estimated
that 98 animals die for every animal successfully cloned - but
even a successful clone, such as little Nicky, is likely to have
AB 1428
Page 8
an abbreviated life plagued by illness. The most famous cloned
animal, Dolly the sheep, suffered progressive lung disease and
premature arthritis and was euthanized while still young."
Furthermore, in its letter of support, Friends of the Earth
claims: "Pet cloning poses unnecessary health risks to the
cloned animals. Cloning also raises questions about the welfare
of maternal surrogate animals that would be kept in confinement
in unknown numbers in order to allow for cloned embryos to
mature." AAVS explains, "To produce genetically modified
kittens, female cats are bought from animal dealers to be used
as 'surrogate mothers.' They often undergo multiple abdominal
surgeries to implant embryos and extract fetuses. This use of
animals is significantly invasive and experimental; there is no
legitimate comparison to traditional animal breeding."
GSC refutes these claims. "The transfer of clone embryos to a
surrogate mother is no more invasive than a common spay.
Routine and effective steps are taken to prevent discomfort to
the surrogate mother. During their pregnancies and deliveries,
our surrogate mothers spend most of their time in the care of
private breeders who are under contract to GSC and who adhere to
our strict animal care protocols. The clones are born either at
a breeder facility or a veterinary clinic, and are weaned either
at a breeder facility or a private residence with the same high
standards of care our surrogate mothers receive. The comfort of
all animals in our care is important to us."
Consumer protection concerns . The sponsors of this bill claim
that pet cloning companies are misleading the public and
continue to profit from DNA banking services, even though a
handful of cats have been cloned and no dog has ever been cloned
successfully anywhere in the world. One company that promotes
so-called genetically modified hypo-allergenic cats has never
actually produced such a cat, but began taking deposits from
interested customers.
Additionally, cloned pets will not be exact copies of pets their
owners have lost, as a pet's personality is determined by
environment as well as genes."
However, the Animal Council asserts in its letter of opposition,
"those few consumers interested in obtaining a cloned animal are
aware of the process issues and that any animal from any source
is subject to varied risks and an inherently limited life
AB 1428
Page 9
expectancy. Truly motivated consumers would seek outside
sources if they cannot obtain services in California."
Current fees of gene banking, the first step to cloning your
pet, range dramatically depending on the service requested.
PerPETuat, a California pet gene banking business, charges $700
for processing and genotyping your pet's DNA and an additional
$90 per year for storing the DNA. GSC offers several services
ranging from $295-$1,395 for gene banking with an additional
$100-$150 annual storage fee. Currently, the fee to have your
pet cloned at GSC it $32,000 - although your gene banking fees
are deducted from the price of the cloning.
Chilling effect on scientific activity . The Animal Council,
which opposes this bill, believes "AB 1428 would have a chilling
effect on scientific activity in California that otherwise
benefits California residents in many respects. These include
local access to gene banking of the DNA of valuable animals; a
wide range of potential applications from research involving
genetics and cloning of animals, including commercially valuable
or endangered species; enhanced understanding of the
heritability of traits in breeding programs of animals, pets or
otherwise; and for a very few consumers the opportunity to
obtain animals genetically like another - for whatever reason."
According to the Center for Genetics and Society, which supports
this bill, "the new genetic technologies are arguably the most
profound consequential technologies ever developed. Used
wisely, they hold great promise for treating disease and
alleviating suffering. If abused, however, they could have
consequences of nightmarish proportions. They could open the
door to a world in which all forms of life - plants, animals,
and human beings - have been turned into artifacts to be
manipulated, programmed, and commodified, at whim of any one
individual. If ever there was a set of technologies that called
for the utmost precaution regarding their development and use,
it is these."
Cloning and pet overpopulation . The National Pet Alliance,
which opposes this bill, asserts, "that feral cats and their
unweaned offspring are being euthanized in large numbers at
shelters due to their unadoptability, has no relation to a need
to prohibit cloning a replacement beloved deceased pet.
Further, the scientific value of such research cannot be
underestimated, when one considers that cloning, and the
AB 1428
Page 10
associated scientific research involved, could very well lead to
a method to save a beloved, soon to be deceased, human
relative."
According to the sponsors, cloned pets that are sold are not
required to be spayed and neutered. Considering that pet
cloning companies forecast sales of thousands of animals, and
people who pay tens of thousands of dollars for animals likely
will want to breed the animals, pet cloning will exacerbate the
already severe cat and dog overpopulation.
Further, according to Californians Against Pet Cloning, a
co-sponsor of this bill, "One company has claimed at times that
the animals used in its experiments are adopted into private
homes after use, in one instance, that total was 245 dogs and
cats. Even if true, this is not a realistic plan if the pet
cloning industry develops, because as the industry grows so does
the number of former experimental animals in need of adoption."
In addition to the many animals used during the pet cloning
process, clones also may be born that are unhealthy or do not
have the desired traits and, therefore, are not "sellable,"
potentially adding to an already staggering problem and further
burdening shelters and municipal animal control agencies.
However, according to GSC, "pet cloning may actually reduce pet
overpopulation. We have developed a program in which we
purchase reproductive tracts from spay clinics in order to
obtain the cat and dog eggs we need for the cloning procedure.
Spay clinics typically discard the tracts, but thanks to our
program, these clinics have a new source of revenue that helps
continue their valuable work. In this way, our cloning
technology helps prevent the uncontrolled breeding of cats and
dogs."
In its letter of opposition, the Animal Issues Alliance included
a copy of a letter published in the Los Angeles Daily News
stating:
Maybe humane groups are taking too narrow a view on
cloning. Would we never again hear 'I just want ONE like
him/her' as an excuse for breeding a litter of ten puppies
- nine of which will end up homeless? Would it stop
hobbyists who regularly breed litters of 'disposable'
animals to produce one show-quality champion? Does it mean
AB 1428
Page 11
that breeders who produce and sell continuous litters to
'preserve the bloodline' would be out of business?
Could cloning be the end of mass production by puppy mills
and exploitation by pet shops of baby pets crammed into
crowded pens and filthy cages? If cloning means that
wanting one pet would result in producing only one pet, the
overpopulation problem would be solved and the suffering
and killing would cease.
"Sale" versus "cloning," and related "facts ." It may be helpful
to reiterate that this bill prohibits the sale of cloned pets
within California, but this bill does not prohibit cloning.
Although this bill may create some inhibitions to cloning (by
eliminating certain profit motives and adversely impacting a
limited number of businesses within the state), cloning will
continue. Consequently, while the debate over the merits and
demerits of cloning may be relevant to this bill, that debate is
not entirely on target.
Likewise, the debate over whether or not, and to what degree,
cloning should be regulated involves issues that are not exactly
on target. This bill does not create a regulatory scheme;
rather, this bill imposes a prohibition on the sale of cloned
pets in California. Moreover, it seems clear that this bill
will not prevent California consumers from possessing cloned
pets. If California consumers are rich enough and motivated
enough to acquire a cloned pet within the state, it is very
likely that those consumers will do the same thing out-of-state.
Much of the controversy associated with this bill is based on
speculation that is debatable and over which reasonable people
could reasonably differ. One clear "fact" is that we cannot be
confident about what cloning means for the future. Because of
the unknowns, this bill raises two fundamental and opposing
questions about the proper role of government and, more
specifically, about when government should intervene. First,
because of the uncertainties and possible harms resulting from
cloned pets, should the sale of these pets be prohibited now?
Second, and conversely, because of the uncertainties and
possible benefits resulting from cloned pets, is it premature to
prohibit the sale of these pets?
REGISTERED SUPPORT / OPPOSITION :
AB 1428
Page 12
Support
American Anti-Vivisection Society (co-sponsor)
Californians Against Pet Cloning (co-sponsor)
International Center for Technology Assessment/Center for Food
Safety (co-sponsor)
United Animal Nations (co-sponsor)
Animal Legislative Action Network
Animal Protection Institute
Association of Veterinarians for Animal Rights
California Lobby for Animal Welfare
California Federation for Animal Legislation
Capitol Resource Institute
Center for Genetics and Society
Contra Costa Humane Society
Doris Day Animal League
Friends of the Earth
Humane Society of the United States
In Defense of Animals
National Anti-Vivisection Society
New England Anti-Vivisection Society
Paw Project
People for the Ethical Treatment of Animals
Numerous Individuals
Opposition
Animal Council
Animal Issues Movement
California Veterinary Medical Association
Cat Fanciers' Association, Inc.
Genetic Savings and Clone
National Pet Alliance
Pet Industry Joint Advisory Council
Numerous Individuals
Analysis Prepared by : Tracy Rhine / B. & P. / (916) 319-3301