BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1381
AUTHOR: Evans
INTRODUCED: February 21, 2014
HEARING DATE: March 26, 2014
CONSULTANT: Marchand
SUBJECT : Food labeling: genetically engineered food.
SUMMARY : Enacts "The California Right to Know Genetically
Engineered Food Act" to require the labeling of all genetically
engineered foods sold within California.
Existing state law:
1.Enacts the Sherman Food, Drug and Cosmetic Law, enforced by
the Department of Public Health (DPH), which provides broad
authority for DPH to enforce food safety requirements,
including that food is not adulterated, misbranded, or falsely
advertised. Food labeling requirements generally adopt
federal food labeling laws as the state requirement, including
nutrition labeling and allergen labeling, but DPH is
permitted, by regulation, to adopt additional food labeling
regulations.
Existing federal law:
1.Establishes, through the U.S. Food and Drug Administration
(FDA), various requirements for food labels under the Federal
Food, Drug, and Cosmetic Act, which includes the Nutritional
Labeling and Education Act and the Food Allergen Labeling and
Consumer Protection Act. These include requiring specified
nutrition information, a listing of all ingredients, and
whether a produce contains any of eight major food allergens,
such as milk, eggs, shellfish, tree nuts, etc.
2.Permits, under the United States Department of Agriculture's
(USDA) National Organic Program, products to be labeled as
"100% organic" if they are comprised of 100 percent certified
organic ingredients, or as "organic" if they are comprised of
95 percent certified organic ingredients. Prohibits the use
of genetic engineering, or genetically modified organisms, in
organic products.
This bill:
1.Enacts "The California Right to Know Genetically Engineered
Continued---
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Food Act" (Act), states the intent of the Legislature, with
this Act, to require the labeling of all foods produced with
genetic engineering sold within the state, and deems a food
misbranded if its labeling does not conform to the provisions
of the Act.
2.Defines "genetically engineered," for purposes of the Act, as
produced from an organism or organisms in which the genetic
material has been changed through the application of either of
the following:
a. In vitro nucleic acid techniques, as defined,
which include, but are not limited to, recombinant
deoxyribonucleic acid (rDNA) or ribonucleic acid (RNA)
direct injection of nucleic acid into cells or
organelles, encapsulation, gene deletion, and
doubling; or,
b. Methods of fusing cells beyond the taxonomic
family that overcome natural physiological,
reproductive, or recombinant barriers, and that are
not techniques used in traditional breeding and
selection such as conjugation, transduction, and
hybridization.
3.Exempts from the definition of "genetically engineered" an
animal who has not itself been genetically engineered,
regardless of whether that animal has been fed or injected
with any food or any drug that has been produced through means
of genetic engineering.
4.Defines various terms for purposes of the Act, including
"agriculture," "commercially cultivated," "food," "food
facility," "label," "organism," "packaged food," and
"supplier."
5.Requires any raw agricultural commodity or packaged food that
is entirely or partially produced with genetic engineering to
be labeled in accordance with this Act, and deems it
misbranded if not so labeled.
6.Requires a manufacturer of a raw agricultural commodity
packaged for retail sale to include the words "Genetically
Engineered" clearly and conspicuously on the front or back of
the package of that commodity.
7.Requires a retailer of a raw agricultural commodity that is
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not separately packaged or labeled to place a clear and
conspicuous label on the retail store shelf or bin in which
that commodity is displayed for sale.
8.Requires a supplier of a raw agricultural commodity to label
each container used for packaging, holding, or transporting a
raw agricultural commodity produced with genetic engineering
that is delivered directly to a retailer in California.
9.Requires a manufacturer of packaged food containing some
products of genetic engineering to label the product in clear
and conspicuous language on the front or back of the package
with the words "Produced with Genetic Engineering" or
"Partially Produced with Genetic Engineering."
10.Prohibits the provisions of this bill from being construed to
require a label that lists or identifies an ingredient that
was genetically engineered, or that the words "genetically
engineered" be placed immediate preceding any common name or
primary product descriptor of a food.
11.Permits the Attorney General to bring an action to enjoin a
violation of the Act in any court of competent jurisdiction.
12.Permits an injured resident of California, 60 days after
giving notice of the alleged violation to the Attorney General
and the alleged violator, to bring an action to enjoin a
violation of this article by a manufacturer or retailer in any
court of competent jurisdiction. Permits the court to award to
a prevailing plaintiff reasonable attorney fees and costs
incurred in investigating and prosecuting the action, but
prohibits the court from awarding monetary damages.
13.Prohibits injunctive relief or attorneys' fees and costs from
being granted with respect to failure to label either of the
following:
a. Packaged food in which the materials produced
through genetic engineering account for nine-tenths of
1 percent or less of the total weight; or,
b. Food produced without knowledge or intent, as
specified, to use genetic engineering.
14.Specifies that food is produced "without knowledge or intent
to use genetic engineering" under any of the following
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conditions:
a. The food is lawfully certified to be labeled,
marketed, and offered for sale as "organic" pursuant
to the federal Organic Foods Production Act of 1990;
b. A manufacturer or retailer who obtained a
sworn statement from the supplier that the food was
produced without knowledge or intent to use genetic
engineered and has been segregated from, and not
knowingly or intentionally commingled with, foods that
may have been genetically engineered; or,
c. An independent organization has determined
that the food was produced without knowledge or intent
to use genetic engineering and has been segregated
from, and not knowingly or intentionally commingled
with, foods that may have been genetically engineered.
Requires this determination to be made pursuant to a
sampling and testing procedure consistent with
principles recommended by internationally recognized
testing standards organizations and which does not
rely on testing processed foods in which no DNA is
detectable.
15.Exempts a retailer that is not the producer or manufacturer
of food the retailer sells under its brand from being liable
under the Act except if the retailer knowingly and willfully
fails to provide point-of-purchase labeling for an unpackaged
raw agricultural commodity. Specifies that it is a defense in
an action under this Act that a retailer reasonably relied on
a disclosure, as specified, that the food was not produced
through genetic engineering.
16.Prohibits any action from being brought under this Act
against a farmer who is not a retailer or manufacturer, but
specifies that a farmer who swears a false statement under
this Act remain subject to laws pertaining to perjury.
17.Requires the DPH to adopt and enforce regulations as
necessary to implement this Act.
18.Specifies that the provisions of the Act are severable, and
that if any provision of this Act or its application is held
invalid, that invalidity is prohibited from affecting other
provisions or applications that can be given effect without
the invalid provision or application.
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19.States numerous legislative findings and declarations,
including the following:
a. Polls consistently show that the vast majority
of the members of the public, more than 90 percent,
want to know, for health, economic, environmental,
religious, and ethical reasons, if the food they
purchase was produced with genetic engineering;
b. The United States FDA does not require safety
studies of genetically engineered foods, and that
instead, any consultations are voluntary and
genetically engineered food developers may decide what
information to provide to the FDA;
c. United States government scientists have
stated that the artificial insertion of genetic
material into plants via genetic engineering can
increase the levels of known toxicants or allergens in
foods and create new toxicants or allergens with
consequent health concerns;
d. Voluntary labeling is insufficient to provide
consumers with adequate information on whether the
food they are purchasing was produced with genetic
engineering, and in some cases the labels may be
misleading; and,
e. The vast majority of genetically engineered
crops are designed to withstand herbicides, and they,
therefore, promote indiscriminate herbicide use. As a
result, genetically engineered crops have caused 527
million pounds of additional herbicides to be applied
to the nation's farmlands.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. According to the author, this bill would
allow Californians to make more informed food-buying choices
by requiring genetically engineered foods sold in California
to be labeled as such. California would join more than 64
countries around the world that have genetically engineered
food labeling laws. The FDA does not require the labeling of
genetically engineered foods, giving California a duty to the
people, the environment, and the agricultural economy to enact
this requirement.
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The author states that there is overwhelming public support in
California for labeling genetically engineered foods. Polls
both before and after the November 2012 election for
Proposition 37 showed that 67 percent of Californians
supported California having its own genetically engineered
food labeling law.
People want the right to know how their food is produced for
environmental, health, economic, religious, and ethical
reasons. Further, because there is no mandatory labeling of
genetically engineered foods, health professionals have no way
of tracking if these foods are causing allergic reactions or
adverse health effects. SB 1381 would help provide health
professionals and researchers with this tracking mechanism.
Labeling genetically engineered food is about the right to know
and transparency in the marketplace. With clear labels, we can
make our own informed decisions.
2.Proposition 37. In the 2012 General Election, an initiative
measure, Proposition 37, was defeated by a margin of 51.4
percent to 48.6 percent. Proposition 37 was substantially
similar to this bill, but with several significant
differences. For example, alcoholic beverages were
specifically exempted from the labeling requirements in
Proposition 37, but are not exempted in this bill. Also,
Proposition 37 permitted consumers to sue for violations under
the Consumer Legal Remedies Act, which permits the awarding of
punitive damages, among other remedies. This bill includes
provisions allowing consumers to sue for injunctive relief,
but limits the court to awarding only reasonable attorney fees
and costs, and specifically prohibits the awarding of monetary
damages.
3.Background on federal oversight of genetically modified foods.
According to a paper published by the University of
California, Davis, entitled Plant Genetic Engineering and
Regulation in the United States (UCD paper), as genetic
engineering research was progressing, the United States
decided in the early 1980s to formally regulate genetically
engineered organisms to assess their safety for human and
animal health and the environment. Although many countries
later promulgated entirely new laws to regulate rDNA products,
the United States chose to adapt existing legislation to
accommodate new products derived from rDNA technology. An
early study conducted by the National Research Council (NRC)
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for the National Academies of Science concluded that
transgenic methods of plant breeding pose no new categories of
risk (NRC 1989). This conclusion of "no new risks with
biotechnology" was reiterated in subsequent studies in by the
NRC in 2000, 2002, and 2004. Genetically engineered plants
were first developed in 1983. The first approved field trials
of genetically engineered plants were in 1986, and the first
approval leading to a commercial release of a genetically
engineered food crop was in 1994, with the now defunct
FlavrSavr tomato.
Oversight by USDA, FDA, and EPA
According to the UCD paper, the USDA regulates plants prior to
commercial release. The main concern of the USDA is the
possibility that the new plant will harm agriculture and the
environment, with harm possibly coming from the plant being
modified to increase its ecological fitness and then escaping
into the environment, where it would outcompete and displace
native plants or become a weed in cultivated lands. USDA
oversight comes from the Plant Protection Act of 2000, and
under this Act, USDA considers each genetically engineered
plant a "regulated article" until it is deemed otherwise. In
order to grant "non-regulated" status for genetically
engineered crops, the USDA requires a molecular, biochemical,
and cellular characterization of the genetically engineered
plant, along with data on the life cycle, reproductive
characteristics, and any expected or unexpected changes from
non-engineered plants of the same species.
The FDA is primarily concerned with threats to human health and
to the health of other animals (via feed). The FDA's Center
for Food Safety and Nutrition evaluate a new genetically
engineered food focusing on the presence of additional or
increased allergens and toxins and on any changes to overall
nutrition and composition. However, the UCD paper notes that
one criticism of the regulatory process is that the FDA's
system is "voluntary," so developers of a new biotech-derived
food crop could legally place it on the market without FDA's
knowledge or approval. However, according to the UCD paper, in
practice all genetically modified food has gone to the FDA for
a consultation, and upon completion of the consultation, the
FDA issues a memo summarizing the characteristics of the food
and their implications for safety. The FDA does not formally
"approve" the product as being safe.
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The Environmental Protection Agency (EPA) is mainly concerned
with the environmental and human health impacts of pesticides.
The EPA regulates genetically engineered plants that have
altered pesticide characteristics, no matter whether they
require a shift in the kind or amount of pesticide used.
According to the UCD paper, as an example, Roundup Ready
soybeans were genetically modified to survive exposure to
Roundup herbicide, so EPA demanded an assessment. Technically,
EPA does not assess the soybean plant, but rather the new use
of the Roundup herbicide. On the other hand, genetically
engineered Bt corn can be cultivated without being sprayed
with Bt insecticide because the plant itself produces Bt,
which deters pests from eating the plant. Since the
genetically engineered corn plant itself produces Bt, EPA
refers to this as "plant incorporated protectant" and claims
regulatory oversight.
4.World Health Organization statement on GMO food safety. In
answer to the question as to whether genetically modified
foods safe, the World Health Organization posted the following
answer on its website:
Different GM [genetically modified] organisms include
different genes inserted in different ways. This means that
individual GM foods and their safety should be assessed on
a case-by-case basis and that it is not possible to make
general statements on the safety of all GM foods. GM foods
currently available on the international market have passed
risk assessments and are not likely to present risks for
human health. In addition, no effects on human health have
been shown as a result of the consumption of such foods by
the general population in the countries where they have
been approved. Continuous use of risk assessments based on
the Codex principles and, where appropriate, including post
market monitoring, should form the basis for evaluating the
safety of GM foods.
5.Labeling laws in other states and countries. Last year,
Connecticut and Maine became the first two states to adopt
laws requiring the labeling of GE foods. However, both
contain trigger mechanisms that delay implementation until
other adjoining states also adopt genetically engineered
labeling laws. Connecticut's law will not take effect until a
combination of Northeastern states adding up to 20 million
residents adopt similar labeling requirements, while Maine's
law will not take effect until five nearby states have adopted
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a labeling requirement.
Proponents note that numerous other countries already require
genetically engineered foods to be labeled. According to an
editorial published in Scientific American in September of
2013 (Labels for GMO Foods Are a Bad Idea), the European Union
began to require genetically engineered labels in 1997, and by
1999, to avoid labels that might drive customers away, most
major European retailers had removed genetically modified
ingredients from products bearing their brand. According to
this editorial, today it is virtually impossible to find
genetically engineered foods in European markets.
6.Triple referral. This bill has also been referred to Senate
Agriculture and Judiciary Committees. Should it pass out of
this committee, it will be referred to Senate Agriculture
Committee.
7.Related legislation. SB 1138 (Padilla) requires the label of
fresh, frozen or processed fish to clearly identify the
species of fish or shellfish by its common name, as specified.
SB 1138 is pending in Senate Health Committee.
8.Prior legislation. AB 88 (Huffman) of 2012 would have required
genetically engineered salmon or other finfish products
prepared from those fish of the progeny of genetically
engineered fish to be conspicuously disclosed on the label. AB
88 failed passage in Assembly Appropriations Committee.
SB 63 (Migden) of 2007 would have required cloned animals and
their progeny to be labeled. SB 63 was vetoed by Governor
Schwarzenegger. In his veto message, the Governor stated, "I
cannot sign this bill as it is pre-empted by federal law.
Federal law prohibits states from enacting labeling
requirements for meat and poultry that are in addition to
those federally established. Further, I am concerned that this
bill would require tracking and labeling requirements that
could be unworkable, costly and unenforceable."
AB 1100 (Ruskin) of 2007 and SB 1121 (Migden) of 2008 were
substantially similar to SB 63. SB 1100 was held in Senate
Appropriations Committee, and AB 1100, after passing the
Assembly and the Senate Health Committee, was amended into
another subject.
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AB 791 (Strom-Martin) of 2002 would have required transgenic
fish to be labeled. AB 791 died on the Assembly Floor pending
concurrence.
SB 245 (Sher), Chapter 871, Statutes of 2003, prohibited the
spawning, incubation, or cultivation of any species of finfish
belonging to the family Salmonidae or transgenic fish species,
or any exotic species of finfish, in the waters of the
Pacific Ocean that are regulated by California.
SB 1513 (Hayden) of 2000 would have created a task force in
state government to assess the need for labeling of
genetically engineered foods. SB 1513 failed in Assembly
Agriculture Committee.
9.Support. This bill is supported by a coalition of
organizations, which include the Environmental Working Group,
Consumers Union, the California State Grange, the California
Nurses Association, the California Farmers' Markets
Association, and Eden Foods, among other organizations.
Supporters state that Californians should have the choice as
to whether to purchase foods that are genetically engineered,
and this bill would permit people to make informed choices by
requiring genetically engineered foods sold in California to
be labeled as such. Supporters state that more than 64 other
countries have enacted laws specifically focused on overseeing
genetically engineered crops and foods, or their labeling, and
that polls continue to indicate that the majority of
Californians want the labeling of genetically engineered
foods. Supporters also state that this bill would help provide
researchers with the means to track ingestion of genetically
engineered foods in order to determine if there are adverse
health effects. Supporters argue that labeling genetically
engineered foods is about transparency and empowering people
so that consumer can make their own informed choices.
Supporters assert that contrary to the opposition's claim that
genetic engineering labeling will cost consumers at the cash
register, label changes and updates are a routine part of
business for the food industry and don't result in additional
costs to shoppers. Supporters point to an economic assessment
of Proposition 37 conducted by a professor at Emory University
School of Law that found that "prices for many food products
will not change as a result of the Right to Know Act."
Additionally, supporters state that genetically engineered
food labeling has not increased food prices in Europe, citing
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a statement to that effect by the former European Commissioner
for Health and Consumer Protection of the European Parliament.
CALPIRG states in support that genetic engineering-centric
agriculture has increased the use of toxic chemicals.
According to CALPIRG, most genetically engineered foods in the
US are designed to withstand herbicides and pesticides, and
therefore enable increased use of these toxic chemicals.
CALPIRG states that high pesticide exposure is associated with
cognitive decline, cancer, and negative birth outcomes.
According to CALPIRG, increased pesticide and herbicide use
also lead to chemical-resistant weeds and insects, which
pushes farmers to both increase the dosages still further, and
return to older, more toxic chemicals to which pests are not
yet resistant.
10.Opposition. This bill is opposed by a number of
organizations, including the Agricultural Council of
California, BAYBIO, BIOCOM, California Citrus Mutual, the
California Chamber of Commerce, the California Farm Bureau
Federation, the California Grocers Association, the California
Retailers Association, the Grocery Manufacturers Association,
and the California Healthcare Institute. Opponents state that
this bill will mandate a California-only labeling scheme that
will increase food costs for California families and raise
liability and compliance costs for farmers, grocers and food
manufacturers. According to opponents, it will confuse
consumers with a label that lacks context and scientific basis
and stigmatize food ingredients that are safe and healthy.
Opponents state that economic studies of Proposition 37
concluded that genetic engineering labeling mandates would
cost the average California family up to $400 per year in
higher grocery bills, and that this would disproportionately
impact low and fixed income populations. Opponents argue that
as food costs increase, the allocated dollars for programs
such as the Supplemental Nutrition Assistance Program will not
purchase as much nutritional food as before and will hurt
California's most vulnerable populations. Opponents also
assert that more than 400 scientific studies have shown foods
made with genetically engineered ingredients are safe, and
that the American Medical Association, the World Health
Organization, the National Academy of Sciences, and the US
Food and Drug Administration all agree.
11.Policy comments and drafting concerns.
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a. Unnecessary definitions. This bill includes a number
of definitions of terms that are not used in the
remainder of the bill. Unless there is a specific reason
to include these definitions, they should be removed from
the bill. Definitions included in this bill for which
there is no further use of the term include:
"agriculture," "cultivated commercially," "food
facility," and "medical food."
b. Should the implementation date be delayed? This
bill, should it be enacted into law, would take effect on
January 1, 2015. Given that it proposes a new labeling
requirement, the author may wish to consider delaying the
implementation date to give the food industry time to
prepare for implementation.
c. What does "clear and conspicuous" mean? This bill
requires the labeling of GE foods to be "clear and
conspicuous," but does not define what this means. This
bill does require DPH to adopt regulations necessary to
implement this bill, and it may be the author's intent to
have "clear and conspicuous" defined through the
regulatory process, but without a delayed implementation
date to give DPH time to adopt regulations, this
requirement may not be sufficiently clear to the food
industry when the bill takes effect in January.
d. Technical correction. On page 8, line 23,
"engineered" should be replaced with "engineering."
SUPPORT AND OPPOSITION :
Support: Alliance for Natural Health USA
Biosafety Alliance
CALPIRG
California Farmers' Markets Association
California Nurses Association
California State Grange
California Right to Know Prop 37 Steering Committee
Californians for GE Food Labeling
Center for Environmental Health
Consumers Union
Eden Foods
Environmental Working Group
Food and Water Watch
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Food Democracy Now!
Friends of the Earth
Good Earth Natural Foods
Green America
Harmony Art
Label GMOs
LaRocca Vineyards
Mercola.com
MOMS Advocating Sustainability
Organic Consumers Association
Pesticide Action Network North America
Pesticide Watch
Silo's
Slow Food California
1 individual
Oppose: Agricultural Council of California
BAYBIO
BIOCOM
Biotechnology Industry Organization
California Chamber of Commerce
California Citrus Mutual
California Cotton Ginners Association
California Cotton Growers Association
California Farm Bureau Federation
California Grain and Feed Association
California Grocers Association
California Healthcare Institute
California League of Food Processors
California Manufacturers and Technology Association
California Retailers Association
California Seed Association
California Women for Agriculture
Family Winemakers of California
Grocery Manufacturers Association
International Formula Council
Pacific Egg and Poultry Association
Western Agricultural Processors Association
Western Growers
Western Plant Health Association
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