Biotechnology in Animal Agriculture: Status and Current Issues
Biotechnology in Animal Agriculture:
Status and Current Issues
Updated September 23, 2008
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science, and Industry Division
Analyst in Agricultural Policy
Resources, Science, and Industry Division
Biotechnology in Animal Agriculture:
Status and Current Issues
Animal agriculture is being transformed by rapid advances in biotechnology —
a term that encompasses a variety of technologies, including genetic engineering
(GE), genetic modification, transgenics, recombinant DNA techniques, and cloning,
among others. Producers are interested in the application of biotechnology to
improve productivity, consistency, and quality; to introduce new food, fiber, and
medical products; and to protect the environment. Potential human health
applications of transgenic animals include producing biopharmaceuticals and
generating organs, tissues, and cells for xenotransplantation. Criticisms of such
applications involve issues ranging from food safety and social resistance to potential
negative impacts on animal welfare and on ecosystems. Questions also have arisen
about the adequacy of the current regulatory structure to assess and manage any risks
created by these technologies.
On September 18, 2008, the U.S. Food and Drug Administration (FDA) released
draft guidance on how it intends to regulate GE animals and products. FDA intends
to do so under its existing statutory authority and regulations. Generally, GE-derived
foods, for example, will be regulated like non-GE foods; if their composition does
not differ from their conventional counterparts, they will not have to be labeled.
Nonetheless, developers of GE animals (which will have to be accompanied by
labeling) and of GE-derived products will have to gain FDA pre-market approval.
Although animal biotechnology involves many techniques other than cloning,
this latter technology has attracted the most attention in 2007 and 2008. A final risk
assessment and industry guidance on the safety of meat and milk from cloned cattle,
pigs, and goats and their offspring were released January 15, 2008, by FDA. The
documents generally echoed the FDA’s December 28, 2006, draft risk assessment,
which found that such products are as safe to eat as those of conventionally bred
animals. The FDA also concluded that cloning poses the same risks to animal health
as those found in animals created through other assisted reproductive technologies
— although the frequency of such problems is higher in cloning. (Scientists stress
that cloning is an assisted reproduction technique that does not involve any transfer
or alteration of genes through GE.) The agency said it was no longer asking industry
to refrain voluntarily from marketing the products of cloned animals and their
offspring, although the U.S. Department of Agriculture (USDA) has since asked that
it be continued for products from clones (but not from the offspring of clones).
The Senate-passed version of the 2007-2008 farm bill would have delayed the
FDA final risk assessment and continued the marketing moratorium until completion
of newly mandated studies on the safety and on the market impacts of introducing
such products. This language was not retained in the enacted version of the bill (P.L.
110-234). H.R. 4855 is a pending House bill with this study language. Other
pending bills on animal cloning include S. 414 and H.R. 992, to require all food from
cloned animals or their offspring to be labeled; and S. 536/H.R. 1396, to prohibit
food from cloned animals from being labeled as organic. Bills on further regulation
of GE animals and plants generally include H.R. 6635, H.R. 6636, and H.R. 6637.
In troduction ..................................................1
In Vitro Fertilization.......................................5
Regulation and Oversight........................................5
Food and Drug Administration (FDA)..........................6
FDA Draft Guidance on GE Animals..........................7
U.S. Department of Agriculture (USDA).......................7
Cloning Policy Developments....................................8
FDA Risk Assessment......................................9
Other Policy Concerns.........................................14
Consumer and Social Acceptance............................16
List of Tables
Table 1. Agricultural Applications of Animal Transgenics.................4
Biotechnology in Animal Agriculture:
Status and Current Issues
The U.S. Food and Drug Administration (FDA) released two documents in 2008
that renewed public and congressional interest in animal biotechnology in general
and animal cloning in particular. On September 18, the agency released draft
guidance representing its current thinking on the regulation of genetically engineered
(GE) animals for food or drugs. FDA intends to do so under its existing statutory
authority and regulations.1 Earlier, on January 15, FDA had unveiled its final risk
assessment and industry guidance on the safety of milk and meat from cloned
animals and their offspring. The FDA found that, generally, meat and milk products
from cattle, pigs, and goats are as safe as products from their non-cloned
Still, some in the United States remain concerned about the safety and other
impacts of GE animals and of animal cloning, and they continue to advocate a
cautious approach to commercialization of such products. Outside of the United
States, animal biotechnology, including both GE and cloning, is the focus of ongoing
regulatory, policy and scientific discussions within the European Union (EU) as well
as within the international organization for animal health, known by its French
acronym, the OIE. (Cloning by itself is not considered to be genetic engineering; see
discussion later in this report).
Biotechnology is a broadly defined term of relatively recent origin describing
the range of modern knowledge, applications, and techniques underlying advances
in many fields, notably health care and agriculture. Animal biotechnology has been
defined as “that set of techniques by which living creatures are modified for the3
benefit of humans and other animals.” By its very nature, agricultural development
1 CVM, FDA, Guidance for Industry: Regulation of Genetically Engineered Animals
Containing Heritable rDNA Constructs. A notice regarding the guidance appeared in the
September 19, 2008 Federal Register. The guidance could be accessed through the FDA
website at: [http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2008-D-0394-gdl.pdf].
2 FDA documents were posted on the Internet at [http://www.fda.gov/cvm/cloning.htm] on
January 15, 2008.
3 National Research Council (NRC), Animal Biotechnology: Science-Based Concerns,
(Washington, DC, National Academy Press, 2002). (Hereafter cited as NRC, Animal
Biotechnology.) Unless noted, this CRS report is based on material in that document and
the following additional sources: Institute of Medicine (IOM) and NRC, Safety of
Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects
(Washington, DC, National Academy Press, 2004). (Hereafter cited as IOM-NRC, Safety
is the history of humans modifying plants and animals to maximize desirable traits.
For example, domestication and selective breeding of animals date back many
thousands of years. Artificial insemination of livestock, notably dairy cattle, is a
more recent technology, first finding wide commercial acceptance in the 1950s.
Discovery of the genetic code in the 1950s gave birth to modern techniques of
biotechnology. One of the first commercial products of this new biotechnology in
animal agriculture was bovine somatotropin (bST), a naturally occurring metabolic
modifier that is now being manufactured in larger quantities through the use of
recombinant DNA technology. Manufactured bST came onto the market in 1994 and
is now administered to as many as half of all U.S. dairy cattle to increase per-cow
milk output. Although bST is being used commercially in approximately 20
countries, it is banned in the European Union (EU).
Other developments include pigs that have been engineered for increased sow
milk output to produce faster-growing piglets. Cloned cattle also have been
developed to resist mastitis, and transgenic salmon with enhanced growth
characteristics are under regulatory consideration for possible commercialization.
Output traits such as drugs recovered from animal milk (“pharming”), milk that lacks
allergenic proteins, and animal organs for human transplant (xenotransplantation)
that resist rejection are other contemporary objectives of animal biotechnology
research. In March 2006, researchers at the University of Missouri announced the
creation of transgenic pigs whose tissue contains omega-3 fatty acids.4 The
consumption of omega-3 fatty acids, found primarily in fish, has been linked to
lowered incidence of heart disease in humans. Similar research is also under way to
produce omega-3 fatty acids in cow’s milk and in chicken eggs.
This report describes several scientifically emerging animal biotechnologies that
are raising a variety of questions concerning risks to humans, animals, and the
environment, as well as ethical concerns. The report examines applications of the
technologies and discusses major issues that may arise. Consumers, agricultural
producers, the biotechnology industry, and federal regulatory bodies are debating the
relative costs and benefits of these technologies. As technologies move toward
commercialization, Congress is being asked to examine these issues and possibly to
of Genetically Engineered Food.); Council for Agricultural Science and Technology
(CAST), Biotechnology in Animal Agriculture: An Overview (Issue Paper 23) (Washington,
DC, February 2003). (Hereafter cited as CAST, Animal Agriculture.); Pew Initiative on
Food and Biotechnology, Issues in the Regulation of Genetically Engineered Plants and
Animals, (Washington, DC, Pew Initiative April 2004. See [http://pewagbiotech.
org/research/regulation/].) (Hereafter cited as Pew, Issues in Regulation.); Pew Initiative
on Food and Biotechnology, Post-Market Oversight of Biotech Foods (Washington, DC,
Pew Initiative April 2003) (and other Pew materials); information accessed through the
websites of the Biotechnology Industry Organization at [http://www.bio.org/]; the Center
for Food Safety, at [http://www.centerforfoodsafety.org/]; the Union of Concerned
Scientists, at [http://www.ucsusa.org/]; and the Consumer Federation of America, at
[ h t t p : / / www.consumer f e d.or g/ ] .
4 New York Times, March 27, 2006.
refine the current federal regulatory structure governing the technologies and their
Given the breadth of the term “animal biotechnology,” one might reasonably
define it to include thousands of years of humans selectively breeding animals:
observing desirable animal traits and attempting to breed those traits into successive
lines of animals. One of the first modern forms of assisted reproductive technology
(ART) was artificial insemination (AI). AI has been long established as a
technological advance in traditional selective breeding and an important adjunct to
the development of modern industrial animal production, especially in dairy and
poultry. AI was adopted by producers and accepted by the public with virtually no
controversy. For example, more than 70% of all U.S.-bred Holstein cows, by far the
most widely used milk producers, are artificially inseminated.5 Estrus
synchronization, which improves the efficiency of AI by more accurately controlling
when a female was in heat, is also an important animal biotechnology.
With the development in the 1970s and patenting in the 1980s of recombinant
DNA techniques, and the subsequent analysis of genes, their resulting proteins, and
the role played by the proteins in animal biochemical processes (functional
genomics), modern biotechnology is increasingly equipped with a set of sophisticated
tools holding the promise of transforming the selective breeding of animals. The
range of new techniques and technologies could transform animal biotechnology in
ways that plant biotechnology was transformed in the 1980s and 1990s.
Modern animal biotechnology is developing against the background of public
experience with plant biotechnology, and controversy over the technologies may be
a continuing feature of animal biotechnology development, not least because of the
closer connection between humans and some animals and the belief that techniques
developed for animals are only a step away from application to humans. Some of the
better known animal biotechnologies follow. A number of them are types of assisted
reproductive technology (ART).
Embryo Transfer. After AI and estrus synchronization, embryo transfer (ET)
is the third most commonly used biotechnology. In ET, a donor cow of superior
breeding is chemically induced to superovulate. The eggs are then fertilized within
the donor, the embryo develops and is then removed and implanted in a recipient
cow. Between removal and implantation, embryos may be frozen for safekeeping.
Because of the relatively high costs, ET is used mostly within registered cowherds.
Transgenics. A prominent area of contemporary animal biotechnology
research is the development of transgenic animals through genetic engineering (GE)6
technology. Transgenic animals are produced by introducing an isolated DNA
5 FDA, “A Primer on Cloning and Its Use in Livestock Operations,” at
[ h t t p : / / www.f d a . go v/ c vm/ Cl oni ngRA_Pr i me r .ht m] .
6 Genetic engineering (GE) here refers to the use of molecular biology to alter cells by
fragment into an embryo so that the resulting animal will express a desired trait.
Transgenic animals may be generated by the introduction of foreign DNA obtained
through animals of the same species, animals of different species, microbes, humans,
cells, and in vitro nucleic acid synthesis. The only currently routine use of transgenic
animals, primarily mice, is in the area of human disease research. Potential
agricultural applications for such genetic engineering, however, include improved
feed use and faster growth; more resistance to disease; meat that is leaner or that has
more of some other desirable quality; and possibly even animal waste that is more
environmentally benign. Table 1 provides examples of various objectives of animal
biotechnology involving genetic modification.
Table 1. Agricultural Applications of
Purpose Animal model Transgenic source
Faster growth/leaner meatCattle, swine, rabbits,Growth hormones/factors:
sheepHuman, Bovine, Porcine,
Altered milk compositionCattleExtra copies of casein
(higher protein)genes; disruption of
lactoglobulin gene: Cow
“Biosteel” production in milkaGoatSpider
Reduced phosphorus in swineSwinePhytase gene; Bacteria
Increased wool productionSheepCysteine synthesis gene:
Growth factor: Sheep
Disease resistanceSwine, sheep, rabbitMonoclonal antibodies:
Viral envelope genes:
Developing animal organs foractivating factor: Human
human transplantationCD59: Human
Source: GeneWatch UK, April 2002.
a. “Biosteel” is the trade name for spider web material intended to be produced in the milk of a
transgenic goat. Said to be twenty times stronger than steel, “Biosteel” has an envisioned
breaking strength of about 300,000 pounds per square inch and could produce microscopically
fine, super strong fibers for industrial use.
inserting or removing genes. GE is a form of genetic modification, which refers more
broadly to the practices of altering an organism’s genetic composition by both GE and non-
In Vitro Fertilization. With in vitro fertilization (IVF), a technician removes
unfertilized eggs (oocytes) from the donor cow’s ovaries, usually recovering 6-8
useable oocytes. The oocytes mature in an incubator and are fertilized with sperm.
The resulting zygotes incubate and develop in the laboratory before being placed into
the recipient cow. While IVF can produce many fertilized embryos, the added
expense of ET makes the procedure prohibitive in most cases.
Sexing Embryos. The dairy industry prefers heifers and the beef industry
prefers bulls. Embryo sexing methods in cattle have been developed using a bovine
Y-chromosome probe. Technicians remove a few cells from the embryo and assess
the DNA in these cells for the presence of a Y-chromosome. Presence of a Y-
chromosome determines the embryo is male. Research is also developing in sperm
Cloning. Cloning, discussed at greater length later in this report, is a
biotechnology developing rapidly and with significant public controversy. Most
people think of cloning as the creation of an organism that is genetically identical to
another one. However, scientists use the term more broadly, to refer to production
not only of such organisms but also of genetically identical cells, and to replication
of DNA and other molecules. It also refers to a form of reproduction found naturally
in many single-celled organisms, as well as plants and animals. Those differences
in meaning and usage have caused some confusion in public debate about cloning,
where the main area of controversy relates to artificial cloning involving higher7
organisms, including humans.
Gene Knockout. This is a technique where researchers inactivate, or “knock
out,” a gene by replacing it or disrupting it with an artificial piece of DNA in order
to determine what that particular gene does — e.g., cause or protect against some
disease, alter metabolism, and so forth. A knockout mouse is a laboratory mouse8
subjected to this technology.
Regulation and Oversight
The basic federal guidance for regulating the products of agricultural
biotechnology is the Coordinated Framework for Regulation of Biotechnology (51
Fed. Reg. 23302), published in 1986 by the White House Office of Science and
Technology Policy (OSTP). A key principle has been that GE products should
continue to be regulated according to their characteristics and unique features, not
their methods of production, that is, whether or not they were created through
biotechnology. The framework provides a regulatory approach intended to ensure
the safety of biotechnology research and products, using existing statutory authority
and previous policy experience.
7 See archived CRS Report RL31358, Human Cloning, by Judith A. Johnson and Erin D.
8 National Institutes of Health, National Human Genome Research Institute, “Knockout
Mice,” accessed January 17, 2008, at [http://www.genome.gov/12514551].
Some newer applications of biotechnology did not exist when the current
regulatory framework was enunciated. The NRC animal biotechnology report
concluded that this regulatory regime “might not be adequate to address unique
problems and characteristics associated with animal biotechnologies” and that federal
agency responsibilities are not clear.9
Food and Drug Administration (FDA). Within the Department of Health
and Human Services (HHS), the FDA regulates food, animal feed ingredients, and
human and animal drugs, primarily under the Federal Food, Drug, and Cosmetic Act
(FFDCA; 21 U.S.C. §301 et seq.). The FDA has stated that most — although
probably not all — gene-based modifications of animals for production or therapeutic
claims fall within the purview of the agency’s Center for Veterinary Medicine
(CVM), which regulates them under the FFDCA as new animal drugs. A new animal
drug (NAD) must be approved by the agency after it is demonstrated to be safe to
man and animals, as well as being effective. Regulation of transgenic animals as
NADs, however, suggests to some observers (e.g., the Center for Food Safety, Union
of Concerned Scientists) the inherent weakness of existing regulatory structures to
respond adequately to the complexities that arise with animal biotechnology
Primarily under the FFDCA, FDA’s Center for Food Safety and Applied
Nutrition (CFSAN) is responsible for assuring that domestic and imported foods are
safe and properly labeled. Generally, FDA does not review new foods themselves
for safety before they enter commerce but does have enforcement authority to act if
it finds foods that are adulterated under the act. All food additives, whether or not
introduced through biotechnology, must receive FDA safety approval before they can
be sold; the exception to pre-market approval are those on a list the FDA has11, 12
determined to be “generally recognized as safe” (GRAS).
Sections of the FFDCA and of the Public Health Service Act (42 U.S.C. §262
et seq.) provide the authorities for FDA’s Center for Drug Evaluation and Research
and Center for Biologics Evaluation and Research to regulate the safety and
effectiveness of human drugs and other medical products, including those produced
by GM animals. Under these laws, the FDA requires pre-market review and
9 NRC, Animal Biotechnology, p. 14.
10 See Center for Food Safety website, at [http://www.centerforfoodsafety.org/geneticall7.
cfm]; and the Union of Concerned Scientists website, at [http://www.ucsusa.org/food_and_
environment/genetic_engineering/]. Also see discussion of FDA’s draft guidance for
industy, later in this section.
11 The FDA, as of early 2008, has not granted approval for any human foods from transgenic
(or cloned) animals, although a “very limited number have been approved for rendering into
animal feed components.” The only FDA-approved product of biotechnology in wide
commercial use is bST, and an application is pending for a GE salmon. (Questions and
Answers about Transgenic Fish, at [http://www.fda.gov/cvm/transgen.htm]).
12 Also see CRS Report RL34247, Federal Regulation of Substances Generally Recognized
As Safe (GRAS) and the Use of Carbon Monoxide in Packaging for Meat and Fish, by
Vanessa K. Burrows and Cynthia Brougher.
licensing of such products, and requires that their production conditions ensure purity
FDA Draft Guidance on GE Animals. On September 18, 2008, FDA’s
CVM released a document containing draft industry guidance on how it plans to
regulate GE animals.14 The document asserts that FDA’s authority to regulate GE
animals comes under the new animal drug provisions of the FFDCA. A drug is
defined by the act, in part, as “intended to affect the structure or any function in the
body of man or other animals.” Also, part of the FFDCA definition of “new animal
drug” is one intended for use in animals that is not generally recognized as safe and
effective for use under the conditions prescribed or recommended, and that has not
been used to a material extent or for a material time.
“The rDNA construct in a GE animal that is intended to affect the structure or
function of the body of the GE animal, regardless of the intended use of products that
may be produced by the GE animal, meets the FFDCA drug definition,” the draft
guidance states (on page 4). A new animal drug is considered “unsafe”unless FDA
has approved an application for that particular use, or it is for investigational use and
subject to an exemption from the drug approval requirement (among a few other
specified exemptions). Therefore, most developers will have to submit to the
“Investigational New Animal Drug” (INAD) process at FDA prior to shipping any
GE animals or to marketing any food or feed derived from GE animals. In other
words, it is illegal to introduce food from a GE animal into the food supply that has
not been approved by FDA. The draft guidance lays out the pre-market approval
process including the information to be required of developers.
Under the draft guidance, FDA will examine both the direct toxicity (including
allergenicity) potential of food from a GE animal as well as any indirect toxicity.
Generally, food and feed will be considered safe if the composition of edible
materials from the GE animal can be shown to be as safe as from a non-GE animal.
The labeling requirements for GE-derived foods would be the same as for other
foods: FDA has oversight over the labeling of seafood, dairy products, and whole
shell eggs, and USDA over the labeling of most meat, poultry, and egg products (see
below). More specifically, food from GE animals would not have to be so labeled,
except when it takes on a different character from its non-GE counterpart. However,
labeling would have to accompany GE animals themselves.
U.S. Department of Agriculture (USDA). Several USDA agencies,
operating under a number of statutory authorities, also have at least potential roles
13 NRC, Animal Biotechnology, p. 163.
14 Guidance for Industry: Regulation of Genetically Engineered Animals Containing
Heritable rDNA Constructs. FDA noted that much of the new guidance will be relevant also
to non-heritable rDNA constructs (such as modifications intended for gene therapy); a
separate guidance for non-heritable constructs might come later.
The agency states: “FDA’s guidance documents, including this guidance, do not
establish legally enforceable responsibilities. Instead, guidances describe the Agency’s
current thinking on a topic and should be viewed only as recommendations, unless specific
regulatory or statutory requirements are cited. The use of the word ‘should’ in Agency
guidances means that something is suggested or recommended, but not required.”
in the regulation of transgenic and cloned animals and their products. As several
critical reviews have indicated, USDA has not had a clearly spelled out policy in this
area, including whether it intends to exercise these authorities to regulate GE
animals.15 USDA’s Animal and Plant Health Inspection Service (APHIS) has
expressed its intention to publish an advance notice of proposed rulemaking (ANPR)
on GE animals, possibly in 2008.16 In concert with the FDA’s notice on its draft
guidance, APHIS published, in the September 19, 2008, Federal Register, a request
for information from the public and scientists on how GE animals might affect U.S.
animal health. Comments were being accepted until November 18, 2008, as they
were for the FDA draft guidance.
APHIS has broad authority, under the Animal Health Protection Act (AHPA;
7 U.S.C. §8301 et seq.) to regulate animals and their movement to control the spread
of diseases and pests to farm-raised animals. APHIS also administers the Viruses,
Serums, Toxins, Antitoxins, and Analogous Products Act (21 U.S.C. §151-159),
aimed at assuring the safety and effectiveness of animal vaccines and other biological
products, including those of GM origin, and the Animal Welfare Act (7 U.S.C. §2131
et seq.), portions of which govern the humane treatment of several kinds of warm-
blooded animals used in research (but generally not agricultural animals). Elsewhere
at USDA, the Food Safety and Inspection Service (FSIS) is responsible for ensuring
the safety and proper labeling of most food animals and meat and related products
derived from them under the Federal Meat Inspection Act (21 U.S.C. §601 et seq.)
and Poultry Products Inspection Act (21 U.S.C. §451 et seq.).
Other Authorities. Reports and studies have cited a number of other
authorities and federal agencies that are or could be relevant. The National
Environmental Policy Act (NEPA; 42 U.S.C. §4321 et seq.) requires federal agencies
to consider the environmental impacts of their actions.17 The Environmental
Protection Agency derives its authority from, among other laws, the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA; 21 U.S.C. §301 et seq.);
pesticides derived from living organisms, including those of biotechnology, are
within its purview. The Interior Department’s Fish and Wildlife Service and the
Commerce Department’s National Marine Fisheries Service have also been cited.
Cloning Policy Developments
In 1997, scientists at the Roslyn Institute in Scotland used nuclei from the
mammary cells of an adult sheep to clone “Dolly.” Such nuclear transfer (NT)
techniques were first developed in amphibians in the 1950s. They were first used in
15 See, for example, Pew, Issues in Regulation. Beginning on p. 139, the report contains an
extensive discussion on how these and several other USDA authorities might be utilized for
oversight of animal biotechnology.
16 APHIS in 2007 established an Animals Branch within its Biotechnology Regulatory
Services “to develop a regulatory framework for the possible regulation of genetically
engineered animals.” Source: APHIS website, “Regulation of Genetically Engineered
Animals,” at [http://www.aphis.usda.gov/biotechnology/news_transgenic_animals.shtml].
17 The FDA draft guidance discusses how NEPA requirements will apply to the GE animal
sheep in 1986, with the production of clones using nuclei taken from sheep embryos.
The significance of Dolly was that she was cloned from differentiated cell types
obtained from an adult (called “somatic cell nuclear transfer” or SCNT), rather than
undifferentiated cells from an embryo (“embryonic NT”).
Cloning in animal agriculture is generally not applied in isolation from other
biotechnologies such as genetic engineering. Scientists note that cloning does not
require fertilization and is not, by itself, a form of genetic engineering, i.e., altering,
removing, or inserting genes into an animal’s existing DNA. However, cloning can
involve transgenic as well as non-transgenic cells.
SCNT is not yet a notably efficient technique ready for widespread commercial
adoption. For example, only about 6% of the embryos transferred to recipient cows
resulted in healthy, long-term surviving clones, according to a 2005 report.18 The
European Food Safety Authority (EFSA) recently reported that overall success rates
vary by species, ranging from 0.5% to 5%.19
Success rates are said to be improving, however. As more efficient cloning
technologies, which can overcome the range of cloning abnormalities that have
resulted from SCNT, are introduced, they could provide new opportunities in human
medicine, agriculture, and animal welfare. This is the focus of much of the current
international animal biotechnology research.
The EFSA draft scientific opinion estimated the number of live clones
worldwide in 2007 to be less than 4,000 cattle and 1,500 pigs, of which about 750
cattle and 10 pig clones were in the United States.20 EFSA reported that life span
data were limited, with only a few reports on cattle of six to seven years of age and
no data available in 2007 on the full natural life span of livestock clones generally.21
FDA Risk Assessment. The FDA in July 2001 began asking companies to
refrain voluntarily from marketing the products of cloned animals and their offspring
until it could fully assess the scientific information on their safety. It subsequently
issued two draft risk assessments on the matter, culminating in the release of a final
risk assessment — and industry guidance that effectively lifted its voluntary
moratorium — on January 15, 2008.
18 D. N. Wells, “Animal Cloning: Problems and Prospects,” Review of Science and
Technology, 24(1): 251-264, 2005.
19 European Food Safety Authority. Draft Scientific Opinion on Food Safety, Animal Health
and Welfare and Environmental Impact of Animals Derived from Cloning by Somatic Cell
Nucleus Transfer (SCNT) and their Offspring and Products Obtained from the Animals,
Enorsed for public consultation December 19, 2007 and released January 11, 2008.
Hereinafter cited as EFSA draft scientific opinion. Accessed on the Internet at
[ ht t p: / / www.ef sa.eur opa.eu/ EFSA/ e f s a_l ocal e-1178620753812_1178676922939.ht m] .
20 According to FDA and USDA, approximately 600 cloned animals exist in the United
States, most of them breeding animals and most beef cattle.
What Is Cloning?
Cloning, or somatic cell nuclear transfer, is a process by which animals are
reproduced asexually ..... In cloning, a differentiated somatic cell (a non-germ line
cell from an existing animal) is introduced to an oöcyte (a cell that is the
immediate precursor of a mature egg) that has had its nucleus (and thus its
genome) removed, and then, following some manipulations, is induced to start
replicating. If all goes well, the dividing cell is implanted into a female animal
(dam), continues to develop normally, and is delivered just as any newborn.
— Animal Cloning: A Risk Assessment, p. 20
What’s the Difference Between a Cloned and a GE Animal?
Clones covered by FDA’s January 2008 risk assessment and guidance are “just
clones” — that is, they are copies of individual conventionally-bred animals,
and do not contain any rDNA constructs. What can be confusing is that an
animal clone can be genetically engineered (i.e., have an rDNA construct
introduced into it), and a GE animal can be reproduced by cloning. The
September 2008 guidance covers GE animals, regardless of whether they were
reproduced by cloning, but does not cover animal clones that do not contain an
— Q and A to Accompany FDA’s September 18, 2008 Draft Guidance
Some stakeholders, including several Members of Congress, wanted a
continuation of the moratorium until more studies are completed on safety and other
aspects of animal cloning. Their views were reflected in nonbinding language to
accompany the omnibus spending measure for FY2008, which passed in late 2007,
and binding language in the Senate version of the pending farm bill (H.R. 2419); see
“Congressional Action,” at the end of this report, for details.
In an October 2003 draft risk assessment, the FDA had concluded that “the
current weight of evidence suggests that there are no biological reasons ... to indicate
that consumption of edible products from clones of cattle, pigs, sheep or goats poses
a greater risk than consumption of those products from their non-clone
counterparts.”22 However, shortly after the assessment’s publication, many members
of the FDA’s Veterinary Medicine Advisory Committee stated that there were not
enough data to fully understand any potential risks from this relatively new
On December 28, 2006, the FDA’s CVM released another long-awaited risk
assessment — also in draft form, along with a proposed risk management plan and
22 See [http://www.fda.gov/cvm/Documents/CLRAES.pdf].
23 “Panel Calls for More Data on Animal Cloning Risks,” Food Chemical News, November
draft guidance for industry — on the safety of animal clones and their offspring.24
The lengthy risk assessment examined two important questions: the safety of food
from cloned animals and their progeny, and the effects of the process on the health
of these animals. FDA officials stressed that the risk assessment did not address any
other issues, such as the social and ethical aspects of cloning or consumer acceptance
of cloned animal products. The risk assessment also focused only on cloning from
non-transgenic cells. This risk assessment is now final.25
The final risk assessment concluded — as had the December 26, 2006 draft —
that the meat and milk of clones of adult cattle, pigs, and goats, and the meat and
milk from the offspring of these clones, were as safe for human consumption as the
food from conventionally bred animals. The FDA added that not enough data were
available to reach the same conclusions about sheep clones (or other species) and
recommended that they not yet be used for human food. The risk assessment arrived
at these conclusions after analyzing physiological, anatomical, health, and behavioral
data on the animals and evaluating available information on the chemical
composition of their milk and meat. FDA said its final assessment was peer-
reviewed by an independent panel of experts, who agreed with the findings. The
final assessment also took into account many thousands of public comments and
additional data that became available since the draft was prepared, the agency said.
The agency said it would not require any special measures (including labeling)
relating to the use of food products or animal feed derived from cloned cattle, goats,
and pigs because they are “no different from food derived from conventionally bred
animals. Should a producer express a desire for voluntary labeling (e.g., ‘this product
is clone-free’), it will be considered on a case-by-case basis to ensure compliance
with statutory requirements that labeling be truthful and not misleading.”26 The
industry guidance states that products from the offspring of cloned animals of any
species are suitable for food or feed consumption.
Upon release of the 2006 proposed assessment, FDA officials said they were
continuing to ask livestock breeders and producers to keep food products from cloned
animals and their offspring out of commerce. This moratorium was announced in
July 2001 and remained in effect until the final guidance was released in January
2008. Although the FDA moratorium is no longer in effect, USDA has since been
encouraging technology providers to maintain the voluntary moratorium, but for
products from cloned animals only. Food products from cloned animals’ offspring
would not be similarly constrained. During a continuation of this moratorium,
24 Availability of the draft documents was formally published in the January 3, 2007,
Federal Register (72 FR 135-137; FDA docket no. 2003N-0573); comments were accepted
until May 3, 2007.
25 FDA documents were posted on the Internet at [http://www.fda.gov/cvm/cloning.htm] on
January 15, 2008. They are the Risk Assessment, Risk Management Plan, and Guidance for
26 “FDA Issues Documents on the Safety of Food from Animal Clones,” FDA press release,
January 15, 2008.
USDA said it would “work closely with stakeholders to ensure a smooth and
seamless transition into the marketplace for these products.”27
Officials emphasized that, at least initially, almost all cloning-related foods will
come not from the clones themselves but rather from their sexually reproduced
offspring. Cloned animals — like other “elite” breeding animals such as a prized
bull — are too valuable to use for food production, except possibly when they reach
the end of their productive lives. The FDA observed that it can cost $20,000 or more
to produce one such animal.
One ongoing question has been whether, in fact, milk and meat from the
offspring of clones are entering the food supply. Several press accounts have quoted
farmers and others who say they have sold such offspring to be slaughtered for food,
and that the total number nationwide may be in the hundreds or even thousands. On
the other hand, those numbers would amount to a small fraction of the total number
of U.S. livestock slaughtered (e.g., 34 million cattle and 109 million hogs in 2007).28
FDA’s January 2008 risk assessment did conclude that some animals involved
in cloning (notably cattle and sheep surrogate dams) and some clones are at greater
health risk than conventional animals. While the types of animal health problems
observed in cloned animals are no different than those found with other assisted
reproductive technologies, these problems appear more frequently in cloning than in
the other technologies. Such problems include late gestational complications in the
surrogate mothers, and increased risk of mortality and morbidity in calf and lamb
clones that are apparently caused mainly by large offspring syndrome (LOS). Swine
and goat clones and their mothers do not appear to experience any additional cloning-
related problems, FDA reported.
FDA found that livestock clones as a group tend to have more health problems
and death rates at or right after birth. However, the risk assessment added that most
animals surviving the neonatal period appear to grow and develop normally, and that
no increased risk of adverse health effects have been reported in clones approaching
reproductive maturity. The agency said that the technology was too new to draw any
conclusions on the relative longevity of livestock clones.
European Views. Cloning currently is not in commercial use in Europe, nor
is there any specific authorization procedure in the European Union for products
from cloned animals.29 The European Food Safety Authority (EFSA) on July 24,
and environmental impacts of animals derived from cloning. The EFSA opinion was
limited to cattle and pigs, but its findings generally do not appear to be substantially
27 Statement by Bruce Knight, Under Secretary for Marketing and Regulatory Programs on
FDA Risk Assessment on Animal Clones, January 15, 2008.
28 See for example “Animal Clones’ Offspring Are in Food Supply,” The Wall Street Journal
online, September 2, 2008.
29 “EFSA launches its draft opinion on animal cloning for public consultation,” EFSA press
release, January 11, 2008. Also, “Animal Cloning FAQs,” accessed June 17, 2008 at
[ h t t p : / / www.ef sa.eur opa.eu/ EFSA/ e f s a_l o cal e-1178620753812_Ani ma l Cl oni ngFAQs.ht m] .
different from those in the FDA assessment. According to EFSA, “Based on current
knowledge, and considering the fact that the primary DNA sequence is unchanged
in clones, there is no indication that differences exist in terms of food safety between
food products from healthy cattle and pig clones and their progeny, compared with
those from healthy conventionally-bred animals.” As with FDA, the EFSA
conclusion is based on an examination of compositional and nutritional data, the
probability for the presence of novel constituents, the health status of the animal, and
available data on toxicity, allergenicity, and microbiology.
EFSA agreed that SCNT can be a successful reproductive technique, although
death and disease rates of clones are significantly higher than those of conventionally
reproduced animals. EFSA noted that surrogate dams have higher rates of failed
pregnancies and other problems. “A significant proportion of clones, mainly within
the juvenile period for bovines and perinatal period for pigs, has been found to be
adversely affected, often severely and with fatal outcome. Most clones that survive
the perinatal period are normal and healthy,” however. Adverse health effects were
not observed in the offspring of clones, although studies have not been conducted for
their entire lifespans.30
EFSA also found no indication of new or additional environmental risks
compared with conventionally bred animals.
The EFSA report findings are being used by the European Commission (EC),
the European Parliament, and member states as they discuss their policies regarding
animal cloning. There is disagreement over the issue among officials in the various
European bodies. This was illustrated when the European Parliament in early
September 2008 approved a resolution asking the EC to propose a comprehensive
ban on cloning animals for food, out of animal health and welfare and ethical
Other Views. Critics, including a number of consumer advocacy and animal
rights groups, oppose the use of cloned animals and their offspring for food. In
October 2006, a coalition formally petitioned the FDA to impose a moratorium on
producing foods from cloned animals, and to establish rules for mandatory pre-
market review and approval of cloned foods by regulating clones as new drugs under
the food and drug act. These consumer and animal welfare groups contend that FDA
has ignored or minimized a number of food safety and animal welfare problems.
These include the treatment of surrogate mothers with high doses of hormones and
their clone offspring, who often have severely compromised immune systems, with
large doses of antibiotics, which could enter the human food supply; imbalances in
30 “Scientific Opinion of the Scientific Committee on a request from the European
Commission on Food Safety, Animal Health and Welfare and Environmental Impact of
Animals derived from Cloning by Somatic Cell Nucleus Transfer (SCNT) and their
Offspring and Products Obtained from those Animals,” The EFSA Journal (2008) 767,
31 “European Parliament urges ban on cloning for food,” Food Chemical News, September
clones’ hormone, protein, or fat levels that could compromise meat and milk safety
and quality; the possibility of increased foodborne illnesses; and a wide variety of
health problems and abnormalities in the animals themselves. Consumer advocates
assert that there are no consumer benefits from cloning.
FDA disagrees, citing the potential to breed livestock that meet consumers’
changing tastes for traits like leanness, tenderness, color, size of meat cuts, and so
forth. These would be in addition to potential producer-related benefits such as
disease resistance, climate suitability, fertility, and improved physical qualities, FDA
st at es. 32
Opinion polls have suggested that the general public may not yet be ready for
widespread animal cloning. A 2006 poll commissioned by the Pew Initiative on
Food and Biotechnology, for example, found that Americans generally were not well
informed about animal cloning, but 64% of those questioned are “uncomfortable”
with it. Forty-three percent of Americans believed that foods from clones are unsafe,
the survey found. Cloning opponents cite these types of findings to argue that
products from cloned animals should be labeled so that consumers could avoid them
if they wanted to. Some critics have urged the President to halt all FDA actions on
cloning until a national panel that includes ethicists and religious leaders can consider
the ethical and other social issues that they believe the technology has raised.
The NRC animal biotechnology report had stated that embryonic splitting and
nuclear transfer using embryonic (not adult) cells were performed with some dairy
cows to successfully produce genetically valuable offspring that were milked
commercially and whose milk and meat did enter the food supply. Few concerns
were raised by NRC authors about using these types of cloned animals for food, since
they are generally believed to pose a low level of food safety concern. However,
evaluating cloned-animal food composition “would be prudent to minimize any food
safety concerns. The products of offspring of cloned animals were regarded as
posing no food safety concern because they are the result of natural matings.”33
Other issues, notably consumer acceptance, social values, and animal welfare, could
eventually overshadow any lingering questions about human health.
Other Policy Concerns
The following are among the policy concerns that have arisen along with the
development of new biotechnologies in animal agriculture. Some may be more
applicable to GE-related technologies than to cloning per se, although others, like
social acceptance and animal welfare concerns, may apply to both.
Environmental Issues. Environmental concerns arising from emerging
animal biotechnologies are largely speculative at this time because few products have
been commercialized. For example, although the EFSA draft scientific opinion
32 “A Primer on Cloning and Its Use in Livestock Operations,” at [http://www.fda.gov/cvm/
CloningRA_Prime r.htm] .
33 CAST, Animal Agriculture, p. 8.
foresaw no environmental impact, it also noted that limited data were available on
this aspect of animal cloning.
Industrial developers of agricultural biotechnology might argue that more
efficient production of animal-based feeds could reduce the resources necessary to
produce food and, thereby, reduce the environmental burden of animal production.
Should the development and widespread adoption of the “EnviroPig” (tm), which
produces less phosphorus in its waste, occur, it might be considered by some to be
a positive environmental benefit of agricultural biotechnology.
The 2002 NRC animal biotechnology report noted potential negative
environmental impacts of genetically altered animals. Escape, survival, and gene
flow into wild populations were identified as major concerns. Of most concern to the
NRC committee was the escape into the environment of “super” salmon that have
been genetically modified for rapid growth, and the likelihood that they could then
breed with wild populations in the environment.34 Other genetically altered animals
such as fish, insects, and shellfish could also potentially escape into natural
environments and become feral, disrupt ecosystems, or introduce novel genes in a
The FDA draft guidance on GE animals notes that requirements of the National
Environmental Policy Act (NEPA) will have to be met prior to any approvals.
Environmental risks are likely to differ depending upon the animal and application.
For example, the types of environmental concerns arising from a GE cow bred for
resistance to mastitis “will be very different from the concerns raised by a GE fresh-
water fish that is engineered to grow more rapidly.”35
Food Safety. Unexpected and unintended compositional changes arise with
all forms of plant and animal genetic modification, including GE, concluded the
IOM-NRC report on genetically engineered foods.36 The report added that, so far,
no GE-related adverse human health effects have been documented. However, the
report’s authors cited “sizeable gaps” in the ability to identify compositional changes
caused by all forms of genetic modification — whether GE or conventional — and
their relevance for human health, and they recommended new approaches for
assessing the safety of new foods both before and after they enter the market.
Previous research and experience with commercializing transgenic plants
suggested that negative effects on human health were virtually nonexistent. While
not asserting that genetically modified organisms necessarily generate health
problems, more recently reported research in peer-reviewed scientific journals has
suggested that GMOs may raise food safety concerns:
!Australian researchers have published an article explaining that the
transfer from a bean to a pea gene that expresses an insecticide
34 NRC, Animal Biotechnology, p. 73.
35 FDA, Consumers Q&A, accompanying its September 18, 2008, draft guidance.
36 IOM-NRC, Safety of Genetically Engineered Food, p. 1.
protein has resulted in antibody production in mice fed the
transgenic pea. The antibody reaction is a marker of allergic
react i on.37
!Italian researchers at the University of Urbino had previously shown
that absorption of transgenic soy by mice induced modifications in
the nuclei of their liver cells. Recent research showed that a return
to non-transgenic soy made the observed differences disappear.38
!Norwegian scientists at the University of Tromso demonstrated that
the catalyst 35S CaMV, an element of the genetic structures used to
modify a plant, can provoke gene expression in cultured human
cells. This catalyst was previously believed to operate in this way
only in plants.39
In the NRC animal biotechnology report, experts observed that the scientific
principles for assessing the safety of GE animals are “qualitatively the same” as for
non-GE animals.40 However, because GE can introduce new proteins into foods, the
potential for allergenicity, bioactivity, and/or toxicity responses should be considered,
they said. Others have remarked that animals genetically engineered for nonfood
products like pharmaceuticals or replacement organs might be of concern if such
animals entered or affected the food supply.
Consumer and Social Acceptance. Criteria for selecting desirable traits
to be produced through transgenic animals will likely be based on the demand for
specific commercial characteristics. Even if scientific evidence is convincing that
GE and cloned animal products are safe and beneficial for human consumption or
economically valuable to producers, other concerns may limit marketplace and
Polls in recent years in the United States indicate that public knowledge about
food and biotechnology generally remains limited. In two 2005 surveys,
approximately half of those surveyed expressed opposition to the use of
biotechnology in the food supply.41 More than half of those in a 2005 Pew-sponsored
37 V. E. Prescott, P. M. Campbell, et al., “Transgenic Expression of Bean-Amylase Inhibitor
in Peas Results in Altered Structure and Immunogenicity,” Journal of Agriculture and Food
Chemistry, 53(23); 9023-9030, November 2005.
38 M. Malatesta, C. Tiberi, et al., “Reversibility of Hepatocyte Nuclear Modifications in
Mice Fed on Genetically Modified Soybean,” European Journal of Histochemistry,
39 M. R. Myhre, K. Fenton, et al., “The 35S CaMV Plant Virus Promoter Is Active in Human
Enterocyte-like Cells,” European Food Research and Technology, 222(1-2):185-193,
40 NRC, Animal Biotechnology, p. 65.
41 Gallup poll on biotechnology and food safety, July 2005; Mellman Group/Public Opinion
Strategies Poll Conducted for the Pew Initiative on Food and Biotechnology, October 2005.
poll said they opposed research into genetically modified animals, although
opposition declined with increased knowledge. Many Americans have heard about
animal cloning; two-thirds expressed discomfort with it — more of them out of
religious or ethical concerns than food safety concerns. A majority of respondents
to the Pew survey believe that regulators should take into account ethical and moral
considerations. (See also the 2006 Pew findings on cloning, under “Cloning Policy
Developments,” section on “Other Views.”)
Consumers may be less willing to accept the practice of genetically modifying
animals than plants, some have argued, observing that people relate differently to
animals, which many recognize as sentient beings. Some observers have expressed
the concern that cloning farm animals might lead more quickly to human and pet
cloning, which those observers oppose. Others believe that modifying animals, for
example, to save human lives through xenotransplantation or the production of some
important drug, might be more acceptable than doing so simply to produce more or
Further, science alone cannot resolve ethical views that appear to vary widely:
Some people, irrespective of the application of technology, consider genetic
engineering of animals fundamentally unethical. Others, however, hold that the
ethical significance of animal biotechnologies must derive from the risk and
benefits to people, the animals, and/or the environment. Yet another view
focuses on the right of humans to know what they are eating or how their food
or pharmaceuticals are being produced and therefore labeling becomes an issue42
to be addressed.
Food industry leaders appear sensitive to consumer unease with animal
biotechnology in general and cloning in particular. Many companies are not yet
ready to process and sell meat and milk from transgenic and cloned animals because,
they believe, consumers may view the products as less safe than more conventionally
produced food products. The food industry also does not want to be portrayed as
overstepping any widely held ethical or moral concerns about the new technologies.43
Such observations led some skeptics of animal biotechnology to propose that
the FDA not only consider the science and safety issues, but also these broader
concerns. In the area of human reproductive health, for example, the FDA and other
federal agencies have invoked particular moral arguments either to reinforce
scientific arguments or to counterbalance scientific evidence. Others believe that the
FDA should base its decisions only on scientific evidence, and perhaps some other
body should be established to consider the ethical and cultural questions. As the
See [http://www.pewagbiotech.org] (accessed March 20, 2006).
42 NRC, Animal Biotechnology, p. 13.
43 These concerns were explored in depth at an October 2006 symposium, “Animal
Biotechnology: Considering Ethical Issues,” sponsored by the Pew Initiative on Food and
Biotechnology and by Michigan State University. Also reported by Food Chemical News,
October 23, 2006.
NRC animal biotechnology report observed, regulatory decisions and enforcement
involving animal biotechnology “are difficult in the absence of an ethical
Labeling. Some believe that segregating and labeling the products of
biotechnology in agriculture, including meat and milk, would enable the consumer
to choose whether or not to buy such products. Either segregating and labeling
biotechnology products or failing to do so could contribute to public suspicion that
these products are flawed or different in some negative way, which may lead to
contradictory policy decisions.45 Opponents of labeling argue that biotechnology
products essentially are the same as more conventional products — and are subjected
to the same rigorous safety standards — and therefore should be treated no differently
in the marketplace. A study by USDA’s Economic Research Service reported that
consumers’ willingness to pay for a food item declines when the food label indicates46
that it was produced with the aid of biotechnology.
In December 2007, two leading U.S. livestock cloning companies announced
they were creating a voluntary system for tracking cloned animals. The program,
which they asserted “is designed to facilitate marketing claims,” is to involve a
national registry providing for the individual identification of each cloned animal,
affidavits that owners will sign committing to proper marketing and disposal of such
animals, and monetary deposits to be returned when such commitments are fulfilled.
Consumer organizations immediately criticized the initiative, noting that it would not
track the offspring of cloned animals and was not mandatory.47
However, fierce debate continues regarding even the voluntary labeling of
products to denote that they are not derived from biotechnology — notably the use
of so-called “rBST-free” labels on dairy products. Although FDA cleared rBST as
safe for commercial use in 1994, and it has been widely adopted by U.S. dairy
farmers, the substance continues to be viewed skeptically by some consumer
advocates. They have convinced a number of dairy processors and retailers to label
their products as free of added BST manufactured through the use of recombinant
DNA technology. FDA guidance permits such labeling so long as it is not
misleading, is presented in the proper context, and is adequately substantiated. For
example, a firm cannot state that its product is “BST- free” because the substance
occurs naturally in milk, or even simply that it is “rBST-free” because that could
imply a compositional difference between naturally occurring and rBST, which there
45 C. T. Foreman, Can U.S. Support for Food Biotechnology Be Salvaged?, paper prepared
for the American Enterprise Institute for Public Policy Research Conference on
Biotechnology, the Media and Public Policy, June 12, 2003.
46 A. Tegene, W. Huffman, et al., The Effects of Information on Consumer Demand for
Biotech Foods: Evidence from Experimental Auctions, USDA, Economic Research Service,
Technical Bulletin 1903, March 2003.
47 Sources: “Top U.S. Cloning Companies Announce New System to Track Cloned,
Livestock,” December 19, 2007, Viagen press release, and “Consumer Groups Displeased
with Voluntary Animal Clone Registry,” FDA Week, December 21, 2007.
is not, FDA has ruled. But certain claims that no rBST was used could be acceptable,
the agency stated.48
FDA has looked to the states to evaluate the acceptability of such labels, and a
number of these states have challenged processors’ use of them. Battles over such
restrictions have been notable in Pennsylvania, Ohio, Utah, and elsewhere.49
Meanwhile, USDA has reminded stakeholders that products from cloned
animals are not eligible to be labeled as organic, under its National Organic Program
(NOP). While cautioning that the organics program is a marketing, not a food safety,
program, USDA also noted: “Cloning as a production method is incompatible with
the Organic Foods Production Act and is prohibited under the NOP regulations.”50
However, the status of products from clone offspring is less clear. The Department
noted that USDA’s Agricultural Marketing Service, where the NOP is located, was
preparing rulemaking to address the organic status of such offspring.51
Animal Welfare. Some aspects of gene transfer, and of cloning, have the
potential to create infectious disease hazards and/or impaired reproduction. Looming
large in the ethical debate are questions about whether genetic modifications, cloning,
and other technologies stress animals unnecessarily, subject them to higher rates of52
disease and injury, and hasten death. The NRC animal agriculture report noted, for
example, that ruminants produced by in vitro culture or nuclear cell transfer methods
tend to have higher birth weights and longer gestation periods than those produced
by artificial insemination, creating potential calving problems. Nuclear transfer
techniques to propagate genetic modifications may increase risks to the reproductive
health and welfare of both the surrogate female animals and their transgenic
offspring. The report cited other evidence of problems such as anatomical,
physiological, or behavioral abnormalities in many transgenic animals.53 Some
scientists have countered that animal welfare problems have been exaggerated and
tend to recede, particularly as the technologies are perfected. Most appear to agree,
however, that animals originating from some forms of genetic modification or from
cloning may require closer observation and care. (See also the section of this report
48 FDA, “Interim Guidance on the Voluntary Labeling of Milk and Milk Products From
Cows That Have Not Been Treated With Recombinant Bovine Somatotropin,” Federal
Register, February 10, 1994.
49 See for example “Dairy processors fight to save ‘rBST-free’ labels, Food Chemical News,
March 3, 2008.
50 USDA, Questions and Answers, FDA’s Final Risk Assessment, Management Plan and
Industry Guidance on Animal Clones and their Progeny, January 2008.
51 Ibid. Such a rule had not yet been made public as of mid-June 2008.
52 See also H. P. S. Kochhar, G. Adlakha-Hutcheon, and B. R. Evans, “Regulatory
Considerations for Biotechnology-Derived Animals in Canada,” Review of Science and
Technology, 24(1):117-125, 2005.
53 NRC, Animal Biotechnology, p. 11.
In Europe, officials continue to consider the ethical dimensions of animal
welfare in formulating their own cloning policies. The EC charged a separate panel,
the European Group on Ethics in Science and New Technologies, with drafting an
opinion. This group released an opinion on January 16, 2008, stating, in part:
Considering the current level of suffering and health problems of surrogate dams
and animal clones, the EGE has doubts as to whether cloning animals for food
supply is ethically justified. Whether this applies also to progeny is open to
further scientific research. At present, the EGE does not see convincing
arguments to justify the production of food from clones and their offspring.
If such products were to be allowed into the market, certain requirements
regarding food safety, animal welfare and traceability should be met, the group
Genetic Diversity. Could the introduction of a few genetically altered or
cloned “superspecies” bring too much genetic uniformity to herds? As genetic
diversity declines, herds could be more susceptible to diseases, leading to large
production losses and/or much heavier use of antibiotics and other animal drugs to
treat them, some have argued. A related concern is that a relative handful of “elite”
producers or breeders might hold the proprietary rights to these species, to the
disadvantage of many farmers and ranchers. Some animal biotechnology researchers
have pointed to the potential importance of preserving unaltered germlines in
domestic animals because they could prove to be an invaluable “gene bank” in the
event that novel infectious diseases or inheritable genetic defects were inadvertently
introduced into modified subpopulations as a consequence of genetic modification.
Trade Issues. If the United States becomes the first country to approve food
products from cloned animals, how might the decision affect U.S. exports? Any
exports of the products of animal biotechnology would presumably encounter a wide
spectrum of foreign regulatory regimes, some more restrictive than the U.S. system.
For example, the current European Union restriction on new biotechnology products
is likely to encompass various restrictions on animal biotechnology as it does on
plant biotechnology. On the other hand, researchers in a number of other countries,
including some EU members, have been producing clones, and one — France — has
published its own risk assessment on clones that, FDA has observed, generally agrees
with the U.S. assessment.55
International guidelines pertaining to exports of animal products derived from
biotechnology are being considered. The Codex Ad Hoc Intergovernmental Task
Force on Foods Derived from Biotechnology held an initial meeting in September
except for the United States, proposed an animal biotechnology project. The task
force agreed to move forward with a recombinant DNA (r-DNA) animal project,
54 “Ethical aspects of animal cloning for food supply,” Opinion No. 23. The group’s website
is at [http://ec.europa.eu/european_group_ethics/index_en.htm].
55 Stephen F. Sundlof, then Director of FDA Center for Veterinary Medicine, transcript of
a December 28, 2006, teleconference on the draft risk assessment.
specifically to develop guidelines for how countries would assess the safety of foods
derived from r-DNA animals.56 At a meeting in November-December 2006 in Chiba,
the task force, among other things, reviewed the developing guidelines, agreeing to
limit their scope to food safety and nutritional issues (while recognizing the
importance of others like animal welfare, environmental, and ethical concerns).57
USDA has said it would consider “discussion with industry on possible
verification of its supply chain management plan to ensure that trading partners are
aware of whether or not they receive cloned or non-cloned products.”58
Members of Congress in the past have proposed various bills aimed at more
closely regulating the products of agricultural biotechnology, requiring such products
to be labeled, and providing a means to recover any damages caused by the
technology. None of these past bills appears to have focused on transgenic animals
or cloned animals specifically, although bills have been offered to prohibit human
cloning. As with human cloning, ethical issues concerning animal clones and other
animal biotechnologies also may continue to be visible public issues. Congress could
be asked to play a larger role in weighing the benefits and costs of these evolving
technologies, and to refine existing government oversight.
The release of the FDA draft risk assessment in December 2006, just before the
start of the 110th Congress, made it a focal point for some Members with an interest
in the numerous consumer and production issues surrounding animal biotechnology
in general and cloning in particular. During the first session, this interest culminated
in nonbinding language, in explanatory notes to accompany the Consolidated
Appropriations Act, 2008 (P.L. 110-161), strongly encouraging FDA to continue the
voluntary moratorium on marketing products from cloned animals until the agency
can evaluate the need for additional studies. The report language takes note of the
“thousands” of public comments received on the risk assessment, many of which
asked FDA to first obtain additional information, and scientific peer review, on
potential health, economic, and trade impacts. More specifically, the explanatory
The [House and Senate Appropriations] Committees strongly encourage FDA to
continue the voluntary moratorium on introducing food products from cloned
animals into commerce until FDA completes a review and analysis of comments
and evaluates the need for additional studies recommended during the public
56 Codex is recognized by the World Trade Organization (WTO) as the body that sets food
safety standards for facilitating international trade of food products. The WTO cites Codex
texts as a benchmark in the Agreement on Sanitary and Phytosanitary Measures (SPS).
57 The collaborative document is entitled Proposed Draft Guideline for the Conduct of Food
Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex is to consider
the guidelines at its Geneva meeting on June 30-July 5, 2008. The document can be
accessed at [http://www.codexalimentarius.net/web/archives.jsp?lang=en].
58 Questions and Answers, FDA’s Final Risk Assessment, Management Plan and Industry
Guidance on Animal Clones and their Progeny.
comment period. The Committees direct the Food and Drug Administration to
enter into an agreement with the Economic Research Service at USDA to study
the domestic agricultural and international trade economic implications of
permitting commercialization of milk and meat from cloned animals and their59
progeny into the food supply.
The FDA obviously did not heed this nonbinding language — although USDA
officials said they are proceeding with the study of domestic agricultural and
international trade economic implementations of commercialization.
The Senate-passed version of the 2007-2008 farm bill (H.R. 2419, in Section
7507) contained statutory language that would have been binding. This Senate
provision would have required the FDA both to postpone publication of its final risk
assessment until the completion of several newly mandated studies, and also to
maintain the voluntary marketing moratorium until then. However, conferees deleted
the Senate language from the final measure (signed into law as P.L. 110-234).
The Senate bill would have directed the HHS Secretary to contract with the
National Academy of Sciences to conduct a study on the safety of food products from
cloned animals and the health effects and costs attributable to milk from cloned
animals, with a report to Congress due within one year of enactment. The study was
to address whether there were a sufficient number of studies to support the FDA draft
assessment, and whether there were other pertinent ones that were not taken into
account. It would have included an evaluation of potential public health effects and
associated health care costs, and an evaluation of any consumer behavior and
negative health and nutrition impacts resulting from a decrease in dairy consumption
if milk from cloned animals and their offspring is commercialized.
Animal cloning-related bills (S. 414 and H.R. 992) were introduced in early
2007, both of which would amend federal food safety laws to require that foods from
cloned animals and their offspring be so labeled. Also introduced in early 2007 was
S. 536/H.R. 1396, which would prohibit the use of the “organic” label on food
products from cloned livestock or their offspring. Another (H.R. 4855), introduced
in late 2007, would require studies like those in the Senate farm bill on the impacts
of food products from cloned animals entering the food supply.
In late July 2008, three related bills were introduced that, their sponsor said, are
to create a comprehensive framework for regulating GMOs. H.R. 6636 would
require the labeling of all foods produced with GE material. H.R. 6635 would
prescribe relatively stringent new regulations for FDA approval and oversight of GE
crops. H.R. 6637 would regulate business dealings between agricultural producers
and the developers of genetically engineered plants and animals, and would seek to
hold biotechnology companies liable for any adverse on-farm impacts from their
All of the above freestanding bills were pending in late 2008.
59 Joint explanatory statement to accompany H.R. 2764, published in the December 17, 2007