BILL ANALYSIS
SENATE HEALTH
COMMITTEE ANALYSIS
Senator Sheila J. Kuehl, Chair
BILL NO: SB 63
S
AUTHOR: Migden
B
AMENDED: As Introduced
HEARING DATE: April 18, 2007
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FISCAL: Appropriations
3
CONSULTANT:
Patterson
SUBJECT
Food labeling
SUMMARY
This bill requires a manufacturer or producer of food to
label any food products that contain products from a cloned
animal or its progeny.
CHANGES TO EXISTING LAW
Existing federal law:
Federal law requires the U.S. Food and Drug Administration
(FDA) to enforce federal food safety laws, including
labeling requirements, for processed foods, and requires
the U.S. Department of Agriculture (USDA) to enforce
federal food safety laws for meat and poultry. Federal law
says that, for any food in interstate commerce, states may
not directly or indirectly establish food labeling
standards that are not identical to federal labeling
standards.
Existing state law:
Existing state law generally conforms to federal food
labeling laws and regulations. State law requires the
California Department of Health Services (DHS) to license
any person or entity that manufactures, processes or holds
processed foods, and also provides DHS the authority to
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inspect processed foods and enforce labeling laws.
Existing state law also requires DHS to inspect meat
products and packing plants which are not inspected by
federal inspection authorities, and gives DHS the authority
to enforce applicable labeling requirements. DHS does not
routinely inspect meat products or packing plants, as the
USDA maintains a pervasive inspection and enforcement
program in California.
Existing state law requires the California Department of
Food and Agriculture (CDFA) to license and inspect dairy
farms and processors that produce milk products or products
resembling milk products. State law also establishes
standards for dairy products, including standards for
bacterial levels and fat composition.
This bill:
This bill would require a manufacturer or producer of food
for human consumption that contains any product from a
cloned animal or its progeny to label the food to indicate
that it contains such cloned animal products. The bill
requires the food labels to be displayed in a conspicuous
and easily legible boldface print or type that is in clear
contrast to the other matter on the package, and that meets
the type size specifications set forth in federal
regulations.
The bill would define a cloned animal as one that arises
from somatic cell nuclear transfer (SCNT). The bill also
would define the progeny of a cloned animal as an animal
derived from the sexual reproduction of a cloned animal
with another cloned animal, or with an animal that is not
cloned.
FISCAL IMPACT
Unknown.
BACKGROUND AND DISCUSSION
Purpose of Bill
According to the author, food from cloned animals gives
rise to a number of concerns relating to food safety,
animal welfare, biodiversity threats, and ethical and moral
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challenges. The author states that, because of these
concerns, consumers should have the right to know what they
eat. Given the uncertainties about the safety of, and lack
of studies about food from cloned animals, as well as other
personal and societal concerns, many consumers should be
able to choose not to use products made from cloned
animals, even if the products are approved by the FDA. The
author argues that, at a minimum, consumers need
transparency so they can make informed decisions about the
products they buy, and that this bill is intended to enable
California consumers to make knowledgeable choices about
food consumption based on the disclosure of information
concerning the makeup of that food.
Cloned animals
Most animal cloning uses SCNT, a process whereby scientists
take an egg from a female animal and remove the
gene-containing nucleus. They insert new genetic material
from another animal into the egg which subsequently becomes
a dividing embryo. The embryo is then implanted into a
surrogate animal which carries it to full term and delivers
it like its own offspring, although the offspring is
genetically identical to the donor animal.
FDA draft risk assessment
The FDA asserts that clones are generated as breeding
animals, and are not likely to be used for food production.
It is their progeny that are generally used for food.
In December 2006, the FDA issued a draft risk assessment of
the potential food consumption risks associated with cloned
animals, as well as an evaluation of animal health risks
associated with cloned animals. The FDA noted a higher
frequency of adverse health outcomes in clones and their
surrogates, and increased risks of adverse health outcomes
in very young clones. However, the FDA observed no adverse
health outcomes in clones or their surrogates that did not
appear in other animals conceived through advanced
reproductive technologies, such as in-vitro fertilization.
In light of these findings, the FDA concluded that food
products derived from cattle, swine, and goat clones or
their progeny pose no more risk than food derived from
sexually reproduced animals. The FDA stated that, because
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no unique food consumption hazards were identified for
clones, food from animal clones and their progeny would be
subject to the same safety standards as food from any other
animal. The FDA stated that there is no science-based
reason to recommend any additional safeguards, and offered
no recommendations for additional food safety measures
related to the human consumption of products from cattle,
swine or goat clones or their progeny.
The FDA did not make a determination on the food
consumption risks of sheep clones, citing insufficient
information. As such, the FDA recommends that products
from sheep clones or their progeny should not be introduced
into the human food supply.
The FDA will release a final risk assessment on cloned
animal food products, including finalized food safety
recommendations and industry guidance, later this year.
Related federal legislation
S. 414 (Mikulski) would amend the federal Food, Drug and
Cosmetic Act (FDCA) and the Federal Meat Inspection Act
(FMIA) to require the labeling of a food product that
contains any part of a cloned animal. Referred to U.S.
Senate Committee on Health, Education, Labor and Pensions
H.R. 992 (DeLauro) would amend the federal FDCA and FMIA to
require the labeling of a food product that contains any
part of a cloned animal. Referred to the U.S. House
Subcommittee on Specialty Crops, Rural Development, and
Foreign Crops
Related state legislation
AB 1100 (Ruskin) would require a food manufacturer or
producer to label food products that contain any product
from a cloned animal or its progeny, and would define a
cloned animal and progeny from a cloned animal. Referred
to the Assembly Health Committee
Prior legislation
AB 1058 (Koretz) would have required retailers to label
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meat products offered for sale with the country or
countries of origin to the extent permitted under federal
law. Vetoed by the Governor
Arguments in support
The Consumers Union and the Center for Food Safety contend
that the FDA's findings that cloned animal food products
are safe are based on insufficient research that does not
adequately determine the long-term effects of cloned animal
consumption on humans. They state that many cloned animals
die in fetal stages or shortly after birth and require
drugs such as antibiotics to survive. They also argue that
surrogate animals that carry cloned cells must be given
large dosages of hormones to carry the clone to full term.
Supporters contend that consumers should have the right to
know whether or not the foods they eat contain cloned
animal products. They state that many consumer studies
show that consumers will not choose to consume foods that
contain cloned animal products, even if cloned animal
products are deemed safe to eat, and that without the
labeling requirement imposed by this bill, consumers who do
not want to consume products that contain cloned animal
products will have to avoid meats, milk, and other products
entirely. Lastly, the Center for Food Safety asserts that
because federal law does not provide labeling requirements
for cloned animal food products, the provisions of this
bill should not be preempted by federal law.
Arguments in opposition
Opponents contend that state-specific meat labeling is
pre-empted by federal law. Additionally, opponents state
that the FDA has determined that there is no difference
between products from cloned animals and products from
conventionally raised animals, and that federal law
prohibits manufacturers from making claims on labels that
would declare or imply otherwise. They argue that federal
courts have ruled in other mandatory labeling cases that
stating the presence of a factor the FDA determines to be
of no health or safety consequence is false and misleading,
and, thereby, illegal. Opponents assert that when the FDA
issues its final determination on the safety of cloned
animal food products, it will issue labeling guidance to
food manufacturers that will allow processors to inform
their customers if they opt not to accept meat or milk
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products from cloned animals. Opponents claim that they
are aware that consumers are generally not accepting of
products of cloned animals, and that consumer preferences
will ultimately determine if meat and milk products from
cloned animals will be sold in the marketplace. They state
that when the FDA makes final recommendations on such
products, food manufacturers and producers will abide by
labeling guidance provided by the agency.
COMMENTS AND QUESTIONS
1.Unclear if bill is preempted by federal law. According
to DHS, the USDA has asserted that the provisions of this
bill would be preempted by federal law.
2.Disclosure needed at sale of cloned animals or their
progeny. The bill implies that labeling requirements
will be imposed upon food products derived from a cloned
animal or its progeny, but does not imply that the cloned
animal or progeny itself should be labeled as such. The
bill should ensure that manufacturers or producers are
aware that they are purchasing a cloned animal or its
progeny so that they may be able to properly label foods
derived from them. A recommended amendment would be to
require any person that sells a cloned animal or its
progeny to another person for the purpose of deriving
food products to disclose to the purchaser that the
animal is a cloned animal or its progeny.
Suggested amendment:
Page 2, line 5, after 110806, insert:
(a) Any producer who sells or transfers any cloned animal
or its progeny, for the purposes of producing food for
human consumption, to a manufacturer or producer of food
for human consumption, shall disclose to the manufacturer
or producer that it is a cloned animal or the progeny of
a cloned animal.
3.Bill does not specifically apply to foods sold in the
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state. The author's intent is for the bill to impose
labeling requirements on foods sold in the State of
California. The bill should be amended to reflect the
author's intent.
Suggested amendment:
Page 2, line 5, amend subdivision (a) as follows:
(a) (b) A manufacturer or producer of food for human
consumption that sells any food that contains any product
from a cloned animal or its progeny shall label the food
to indicate that the food includes the product of a
cloned animal or its progeny.
4.State cannot enforce bill's requirements for out-of-state
manufacturers or producers. Since the state cannot
enforce the bill's requirements for out-of-state
manufacturers or producers, cloned animal food products
could be imported into the state without a label and
introduced into the food supply. A recommended amendment
that attempts to address this problem, although perhaps
not entirely, would be to impose the bill's requirements
upon an importer of animal food products from
out-of-state manufacturers or producers.
Suggested amendment:
Page 2, line 18, insert:
(c ) An importer of food products from out-of-state
manufacturers or producers shall label those products,
pursuant to subdivision (b), if the importer has any
reasonable knowledge that the imported food product
contains any product from a cloned animal or its progeny.
5.Labeling requirements too narrow. The bill should be
amended to ensure that any person, other than a
manufacturer or producer, keeps the label on the food
product before it is purchased by consumers. For
example, a supermarket that purchases food products from
a manufacturer that has labeled it as containing cloned
animal products should be required to either keep the
label, or affix a new one if necessary, before it is
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placed for sale to consumers.
Suggested amendment:
Page 2, line 18, insert:
(d) Any person who purchases, or otherwise obtains any
food for human consumption that is labeled as containing
any product from a cloned animal or its progeny, must
retain the label on the food or affix a new label
indicating that the food includes the product of a cloned
animal or its progeny, before that food may be sold to
another person.
6.Definition of producer is unclear. For clarity, the bill
should define the term producer.
Suggested amendment:
Page 2, line 18, insert:
(e) Pursuant to this section, a producer is a livestock
producer that engages in the business of animal
production that includes, but is not limited to, the
birth, raising, feeding, weaning, and identifying of the
live animal, and generally does not engage in the
business of preparing any animal food which is derived
wholly or in part from any livestock carcass or its
products.
POSITIONS
Support: California Alliance for Consumer Protection
California Certified Organic Farmers
California Public Interest Research Group
Center for Environmental Health
Center for Food & Justice
Center for Food Safety
Community Alliance with Family Farmers
Consumer Federation of America
Consumer Federation of California
Consumers Union
Food & Water Watch
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In Defense of Animals
Organic Consumers Association
Straus Family Creamery
Oppose:Agricultural Council of California
Biotechnology Industry Organization
California Cattlemen's Association
California Farm Bureau Federation
California Chamber of Commerce
California Grain and Feed Association
California Grocers Association
California Retailers Association
California Seed Association
California Women for Agriculture
Dairy Institute of California
Western Plant Health Association
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