BILL ANALYSIS �
AB 88
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Date of Hearing: May 3, 2011
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
AB 88 (Huffman) - As Amended: March 21, 2011
SUBJECT : Food labeling: genetically engineered food.
SUMMARY : Deems food to be misbranded if it is genetically
engineered (GE) salmon or other finfish, the product of GE
salmon or other finfish, and the progeny of GE salmon or other
finfish, as defined, and its labeling does not conspicuously
disclose that it is GE.
EXISTING LAW :
1)Establishes, in federal law, the Food, Drug, and Cosmetic Act
(FDCA), enforced by the federal Food and Drug Administration
(FDA), to regulate the safety of food, drugs, and cosmetics.
2)Establishes the Sherman Food, Drug, and Cosmetic Law,
administered by the Department of Public Health (DPH), to
regulate the contents, packaging, labeling, and advertising of
food, drugs, and cosmetics.
3)Deems any food to be misbranded if its labeling is false or
misleading or if its labeling does not conform to the nutrient
content or health claims set forth in the federal FDCA.
4)Makes it a misdemeanor to misbrand any food and subjects
violators to fines of between $1,000 and $10,000 and/or
imprisonment, depending on the nature of the violation.
5)Declares that all food labeling regulations adopted pursuant
to the FDCA are the food labeling regulations of this state.
6)Authorizes DPH, by regulation, to establish definitions and
standards of identity, quality, and fill of container for any
food, when, in its judgment, such action will promote honesty
and fair dealing in the interest of consumers.
7)Makes it unlawful to spawn, incubate, or cultivate any
transgenic (genetically altered) fish species or any exotic
species of finfish in ocean waters regulated by this state.
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FISCAL EFFECT : This bill has not yet been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . The author states that the FDA is
currently weighing approval of the first GE salmon for human
consumption and determining whether labeling of GE salmon in
the marketplace is warranted. The author asserts that the
FDA's current review does not adequately consider the
potential environmental and health effects associated with GE
salmon, including, but not limited to, risks to native salmon
populations and other freshwater and marine species.
Furthermore, the author states that public opinion polls
indicate that 95% of the public wants labeling of genetically
modified foods and nearly 50% of the public would not eat GE
seafood. According to the author, this bill is intended to
require the labeling of all GE salmon and other finfish
entering and sold within the state to provide accurate and
truthful labeling of these products so consumers may protect
their health and California's environment.
2)BACKGROUND . Genetic engineering refers to the use of
recombinant DNA (rDNA) techniques to introduce new
characteristics or traits into an organism. A GE animal is
one that contains a rDNA construct intended to change the
animal, for example by making fish grow faster. The FDA notes
that genetic engineering has been used for approximately 20
years in the production of plants and microorganisms that make
food and medicine. Many staple crops, such as corn and soy,
have been genetically engineered to be resistant to certain
herbicides.
The FDA is responsible for regulating the safety and
effectiveness of GE animals because the rDNA construct meets
the definition of a "drug" under the FDCA as "an article
intended to alter the structure or function of the body of man
or animal." GE animals under development can be divided into
six broad classes based on the intended purpose of the genetic
modification: a) to enhance production or food quality traits
(e.g., pigs with less environmentally harmful waste or faster
growing fish); b) to improve animal health (e.g., disease
resistance); c) to produce products intended for human
therapeutic use (e.g., pharmaceutical products or tissues for
transplantation; sometimes referred to as "biopharm" animals);
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d) to enrich or enhance the animals' interactions with humans
(e.g., hypo-allergenic pets); e) to develop animal models for
human diseases (e.g., pigs as models for cardiovascular
diseases); and, f) to produce industrial or consumer products
(e.g., fibers for multiple uses).
Generally, in evaluating GE animals, the FDA examines the
following factors: the safety of the rDNA construct to the
animal; the safety of the food from the animal; the
environmental impact; and, the extent to which the producers
of GE animals (referred to as "sponsors") have met the claims
made for those GE animals (e.g., their effectiveness). All of
these factors are based on a thorough analysis of the rDNA
construct, its integration into the animal's DNA, and its
stability in the animal over multiple generations. If the GE
animal is intended to be used as a source of food, the FDA
assesses whether it is safe to eat by evaluating the rDNA
construct and the health of the animal. FDA experts in food
safety look carefully at the composition of the edible tissues
of the GE animal to determine whether its byproduct (such as
meat, milk, and eggs) differs in any way that affects safety
or nutrition from the non-GE counterparts that consumers eat
today. FDA experts also evaluate whether the levels of key
substances such as proteins, fats, minerals, and vitamins are
in the same range as they are in the food consumers eat from
conventional animals. If there are any differences, the FDA
must determine that there is a reasonable certainty of no harm
from any of those differences. The FDA's food safety experts
also evaluate data to determine whether the GE animal poses
more of an allergic risk than its non-GE counterparts.
The FDA notes that when it approves an application for a GE
animal, it will generally be for a specific set of conditions
of use. For GE animals, this includes the location and
containment conditions. Containment refers to keeping animals
from leaving a physical space, or from interbreeding with
other populations. Types of containment strategies include
physical containment, such as using netting over tanks;
geographic containment, such as locating an aquaculture
facility in conditions unfavorable for fish to survive if they
were to escape; and, biological containment, such as inducing
sterility to limit the spread of a population.
With regard to the labeling of foods derived from GE animals,
the FDA applies key principles of the FDCA. Specifically, the
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FDCA prohibits labeling that is false and misleading,
particularly with regard to material facts about the product.
The FDCA permits voluntary labeling about production methods,
as long as it is neither false nor misleading but the label
must include a name that accurately describes the basic nature
of the food. Lastly, the FDCA states that the FDA cannot
require additional labeling about production methods unless it
is necessary to ensure that the labeling is not false or
misleading.
3)FDA REVIEW OF GE SALMON . Typically, a new animal drug
application (NADA) can take as much as five to10 years from
when it is first filed with the FDA to reach a final
conclusion. In September 2010, the FDA convened two days of
public hearings to review a NADA application by Aqua Bounty
Technologies, Inc. (ABT) pending since 1995 for the approval
of its sterile female AquAdvantage salmon, a GE Atlantic
salmon containing the rDNA construct from both a traditional
Chinook salmon and an ocean pout, a distant relative of the
salmon. Among other things, the review was designed to assess
the accuracy of ABT's claim that the rDNA construct enables
its GE salmon to grow to market weight in half the time of
naturally spawned salmon (16-18 months as opposed to three
years) and to evaluate safety and effectiveness. The public
comment period for the review closed in November 2010 and the
FDA has no deadline for deciding whether or not to approve the
product.
According to pre-hearing documents by the FDA, GE salmon meet
the FDA's standard of identity for Atlantic salmon and,
therefore, the FDA was able to conduct analyses to determine
whether there were any changes in GE salmon relative to non-GE
Atlantic salmon, and if so, if any of those changes posed a
food consumption hazard. The FDA's evaluation of the data
from studies provided by ABT found no direct or indirect food
consumption hazards. Furthermore, the FDA reported that there
were no food consumption risks because no food consumption
hazards were identified. The FDA's analysis also found no
biologically relevant differences between the GE salmon and
its non-GE counterparts in general composition, such as
vitamins, minerals, and heart healthy omega-3 and omega-6
fatty acids, and allergenicity (i.e. risk of causing allergic
reactions). As a result, the FDA made the following
conclusions, based on its assessment of the data: sterile, all
female GE salmon are not materially different from their
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non-GE counterparts; food from these fish is as safe as food
from conventional salmon; and, there is a reasonable certainty
of no harm from consumption of food from GE salmon.
Currently, the FDA is working on the environmental assessment
component of ABT's application, which the agency maintains is
a critical component of its overall decision to approve or
not. With respect to labeling of ABT's GE salmon, the FDA
reports that no final decision has been made but indicates
that its preliminary position is that the FDCA and court
decisions interpreting the agency's labeling authority make it
unlikely that the agency could require that the product be
labeled to indicate it is GE.
4)FDA POSITION ON LABELING . According to the FDA, the relevant
federal court decisions interpret the FDCA to mean that the
FDA may require special labeling for GE food when the genetic
change results in a "material" difference in the food, such as
a difference in nutritional content or the range of uses
(e.g., usability for frying). However, as interpreted by the
courts to date, the fact that a food comes from a GE source
does not, by itself, trigger required labeling, absent a
material change in the food itself. The FDA maintains that
food labels are geared to informing consumers about the
attributes of the product, not about the production method.
As a result, courts have held that consumer desire to know is
not sufficient to force a manufacturer to put something on the
label. The FDA states that manufacturers are free to provide
information, such as whether the food is GE or non-GE, to
consumers, provided it is truthful and not misleading. This
voluntary disclosure is similar to the system used for other
foods, in which terms such as "natural" are used on a
voluntary basis to meet a growing consumer interest in the
information, regardless of whether or not the foods have
attributes that could trigger a mandatory labeling
requirement.
5)PENDING FEDERAL LEGISLATION . Three bills have been introduced
in the current congressional session to address the issue of
GE fish. H.R. 520 (Don Young - AK), 112th Cong., (2011) and
S. 229 (Mark Begich - AK), 112th Cong., (2011) amend the FDCA
to deem a food to be misbranded if it contains GE fish unless
the food bears a label stating that it contains GE fish. Two
companion bills, H.R. 521 (Don Young - AK), 112th Cong.,
(2011) and S. 230 (Mark Begich - AK), 112th Cong., (2011),
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amend the FDCA to deem GE fish to be unsafe under provisions
related to new animal drugs and adulterated food.
6)PRIOR LEGISLATION .
a) AB 2079 (Emmerson), Chapter 73, Statutes of 2008,
deems food to be misbranded if the labeling does not
conform to federal food allergen labeling requirements.
b) SB 1121 (Migden) of 2008 would have required a
manufacturer or producer of food to label any food
products that contain products from a cloned animal or its
progeny. SB 1121 died on the Senate Appropriations
Committee Suspense File.
c) SB 1576 (Florez) of 2008 would have required the
retailer of any meats and perishable agricultural
commodities to provide information on the country of
origin of the item by means of a label or other specific
means at the final point of sale to consumers. SB 1576
died on the Senate Appropriations Committee Suspense File.
d) SB 63 (Migden) of 2007, which was substantially
similar to SB 1121 of 2008, was vetoed by the Governor
because it was pre-empted by federal law and would have
required tracking and labeling requirements that could be
unworkable, costly and unenforceable.
e) AB 1058 (Koretz) of 2005 would have required retailers
of beef products to label beef produced outside the United
States with the country of origin, as specified. AB 1058
was vetoed by the Governor because the requirements of
this bill would have demanded a network of tracking from
the rancher, to the processor, to the importer, to the
wholesaler, to the retailers that would be unworkable,
costly, and impossible to enforce.
f) SB 245 (Sher), Chapter 871, Statutes of 2003, makes it
illegal to spawn, incubate, or cultivate any transgenic
fish species or any exotic species of finfish in ocean
waters regulated by this state.
g) AB 2962 (Strom-Martin) of 2002 would have defined
transgenic fish and required that retail sales of any
unpackaged transgenic fish, other than by a restaurateur,
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be accompanied by a notice that clearly discloses to the
consumer that the fish is transgenic. AB 2962 was
referred to the Assembly Agriculture Committee but was
never heard.
h) AB 307 (Strom-Martin) of 2002 would have defined
transgenic fish and made it unlawful to import, transport,
possess, or release alive any transgenic fish, or their
roe, into California, except under a permit. AB 307 was
referred to the Assembly Water, Parks, and Wildlife
Committee but was never heard.
i) SB 1525 (Sher) of 2002 would have defined transgenic
fish; added transgenic species to the list of aquatic
nuisance species established in current law; and,
prohibited the importation of transgenic fish, or their
roe, including transgenic salmon, into California. SB
1525 was referred to the Assembly Water, Parks, and
Wildlife Committee but was never heard.
j) SB 1610 (Bowen) of 2002 would have required the
packaging of certain foods to disclose the amount of trans
fatty acids present in the foods. SB 1610 failed passage
in the Assembly Agriculture Committee.
aa) AJR 38 (Nation) of 2002 would have urged the FDA to
deny ABT's petition to market GE salmon to consumers as
food and impose a moratorium on the domestic marketing,
importation, and exportation of transgenic fish, as
specified. AJR 38 was referred to the Assembly
Agriculture Committee but was never heard.
bb) AB 791 (Strom-Martin) of 2001, which was substantially
similar to AB 2962 of 2002, was referred to the Assembly
Agriculture Committee but was never heard.
cc) SB 1513 (Hayden) of 2000 would have required a task
force to be convened to consider whether GE food products
should be labeled and make recommendations to the
Legislature by January 1, 2002. SB 1513 failed passage in
the Assembly Agriculture Committee.
7)SUPPORT . Supporters, representing public health, food safety,
environmental, professional, and consumer advocacy groups,
assert that this bill is needed because the public has a right
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to know what is in the food they eat. Supporters remain
particularly concerned about the potential toxicity,
allergenic effects, and diseases posed by the
commercialization of GE fish. They also criticize the FDA's
initial decision to render the GE salmon safe for human
consumption, contending that the regulatory and approval
process has been insufficiently transparent, has failed to
provide enough time for public comment, and has accepted
questionable science from ABT. They argue that distinguishing
GE fish from natural fish via a labeling requirement will
provide consumers with the information they need to make
better informed seafood purchasing decisions, based on concern
for the environment, the potential transfer of allergens and
other health risks, religious tenets, or personal preference.
8)OPPOSITION . Opponents, representing agricultural,
biotechnology, manufacturing, and business groups, contend
that this bill presupposes an issue with food safety and
discourages investment in science and technology that could
bring about more efficient production and more nutritious
foods. They contend that the FDA has determined, after
decades of scientific review, that GE foods are equivalent to
foods developed through crossbreeding and other traditional
methods so compulsory state labeling provides no additional
significant or useful information to consumers. Opponents
also point out that the FDA's initial decision to render GE
salmon safe for consumption in the U.S. does not allow
production in the U.S. as these fish will be produced in
inland tanks in Canada and Panama. Lastly, opponents claim
that labeling food derived through biotechnology only serves
to establish "warning labels" that create a false impression
that there are dangers associated with the consumption of such
products or that their nutritional value has been diminished.
REGISTERED SUPPORT / OPPOSITION :
Support
California State Grange (sponsor)
Center for Food Safety (sponsor)
Ocean Conservancy (sponsor)
American Anti-Vivisection Society
Blue Ocean Institute
Bon App�tit Management Company
Breast Cancer Action
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California Advisory Committee on Salmon and Steelhead
California Church Impact
California Coastal Protection Network
California Coastkeeper Alliance
Center for Environmental Health
Clean Water Action California
Coast Action Group
Coastal Environmental Rights Foundation
Commercial Fishermen's Organization of Morro Bay
Consumers Union
Crab Boat Owners Association
Defenders of Wildlife
Farm Sanctuary
Fishermen's Marketing Association of Bodega Bay
Food & Water Watch
Friends of the Earth U.S.
Golden Gate Fishermen's Association
Half Moon Bay Fishermen's Marketing Association
Heal the Bay
Humboldt Fishermen's Marketing Association
In Defense of Animals
Institute for Fisheries Resources
Institute for Responsible Technology
Monterey Bay Aquarium
Monterey Fisherman's Marketing Association
Moss Landing Commercial Fishermen's Association
Natural Resources Defense Council
New Leaf Community Markets
Ocean Beach People's Organic Food Market
Oceana
Organic Farming Research Foundation
Pacific Coast Federation of Fishermen's Associations
Paw PAC
Port San Luis Fishermen's Association
Pro-Troll Fishing Products
Salmon Trollers Marketing Association
San Diego Coastkeeper
Santa Cruz Fishermen's Marketing Association
Sierra Club California
Small Boat Commercial Salmon Fishermen's Association
Southern California Trawler's Association
South Yuba River Citizens League
Several individuals
Opposition
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BIO
BIOCOM
California Aquaculture Association
California Chamber of Commerce
California Farm Bureau Federation
California Grain and Feed Association
California League of Food Processors
California Seed Association
Grocery Manufacturers Association
Western Plant Health Association
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097