Wholesome, Holistic and Holy: Controversies over Biotechnology and Food
by Thomas M. Zinnen
We are now ten years into the public debate over modern
biotechnology applied to food production, a debate that pivots as
much on fears, perceptions and values as on safety (1). In the mid
1980's, the development of bovine somatotropin (BST, also called
bovine growth hormone, or BGH) as a method to increase milk
production made news. So did plans to test in a California field
whether a bacterium modified by cut-and-splice gene technology
could reduce frost damage when sprayed on crops. The legacy of
this decade includes cartoons of emaciated drug-junkie cows, and
images of Moon-suited scientists walking on Earth among rows of
There is another part of the legacy. We are now five years into
the era of commercial foods produced using such recombinant DNA
technology. Less than a dozen such products have jumped the
hurdles faced by any new food going from lab bench to the kitchen
table: feasibility, safety and quality assurance, profitability, test
These foods have also passed through a series of regulations that
some describe as a maze, others as an unnecessary gauntlet (2), and
still others as inadequate relative to public health and input (3).
Products of a new tool of genetic manipulation, they have been
more controversial than the several thousand new food products
placed in US supermarkets every year.
Three federal agencies share in the regulation of new foods developed using rDNA techniques: the FDA under the Food, Drug and Cosmetic Act; the USDA, principally under the Plant Pest Act; and the EPA under the Federal Insecticide, Fungicide and Rodenticide Act and the Toxic Substances Control Act. The agencies split the responsibilities according to policies originally described in a "Coordinated Framework" in 1986.
In the coming few years, the number of foods produced using
gene-splicing techniques will likely double or treble to 20 or 30.
Most public attention has focused on two pioneering products: BST
and the "FlavrSavr" tomato. Consumer concern, at least as
measured by news coverage, about foods introduced later has
This article will review the stories and the controversies of the
first 10 years, compare the issues raised by the first five foods
produced using recombinant DNA brought to market, assess the
current situation, and seek ways to accommodate a range of values
One way to express the spectrum of attitudes towards food is the
phrase "Wholesome, Holistic and Holy." The "Wholesome" point of
view asks, "Is this food safe and nutritious?" These are questions
that experiments and experimentalists can address and sometimes
answer. The "Holistic" viewpoint asks not only about safety and
nutrition, but also questions such as "Who made this food? How?
Where? At what social cost? At what environmental cost?" These
are not always answerable by experiment. The "Holy" viewpoint
asks, "Is this food made in accordance with my religious dietary
laws, or in a manner consistent with my profound spiritual beliefs?"
Questions of faith such as these cannot be answered by
Food: Symbol in the Sustenance Raised a Catholic, I was
astonished at my first Seder to see the origin of the use of
unleavened bread and wine so familiar to me from the Christian
Eucharist. The Last Supper was really the Last Seder, and even
two thousand years ago it was no ordinary meal but an
extraordinary remembrance of the formative event in the birth of
a nation and its covenant with its God.
Few traditions demonstrate the role of food in spiritual as well as
physical life as does the Passover Seder observed by Jews each
spring. Based in history, held at home, centered around the family,
its ritual foods symbolize the struggle from bondage to freedom.
The power of food as symbol is not limited to religion. John
Tallmadge, in a review of two books examining the role of new
technology in agriculture, notes that "biologically and culturally, we
become what we eat, so we should choose our food with care" (4).
Religious or moral restrictions, such as keeping kashrus or choosing
vegetarianism, often impose a restraint on the sweep of human
action, reserving some actions to God or to Nature, and thereby
distinguishing the human from the deity or the natural. These
restrictions also serve to set one group apart from another. Such
self-imposed restraints can be embraced by some people as a
liberating source of humility, humanity and humaneness. But when
applied by compulsion rather than persuasion, other people chafe
at the same restraints.
Food: Fuel and Building Blocks for Life What we eat literally
does become what we are, in the biochemical building-block sense.
Food is also the physiological fuel that drives our lives. And almost
all food eaten by humans comes from other living things: plants,
animals, microbes. These living things are the common ground
linking food and biotechnology.
Definitions of Biotechnology. The word "biotechnology" is a
lexicographic amoeba. It's also politically charged. So it is prudent
to be aware of a range of meanings and connotations.
Biotechnology derives from three ancient Greek words: bios, life;
teuchos, tool; logos, meaning 'study of' or 'word' or 'essence.'
Thus extracted etymologically, it becomes 'the study of tools from
Historically, Robert Bud of the Science Museum in London has
traced the use of "biotechnology" at least as far back as 1917.
During the World War, it referred to the use of industrial
fermentations to produce industrial feedstocks, such as acetone
used to make cordite, an explosive. Now "biotechnology" can
encompass ancient uses such as microbial fermentations to flavor
and preserve foods, including leavening bread, brewing beer, and
making cheese and yogurt.
Biotechnology tools also include selection and breeding,
chromosome analysis (such as used to diagnose Down Syndrome),
tissue culture for growing tissues or cells in glass jars (used in
plant propagation and in producing drugs such as penicillin and
monoclonal antibodies), and DNA analysis (for example, DNA
fingerprinting, or massive DNA sequencing efforts such as the
Human Genome Project). But for many people, biotechnology
means recombinant DNA and genetic engineering.
Gene Transfer:The Crucial, Controversial Tool
During the 1970's scientists and reporters used "biotechnology" as shorthand for "recombinant DNA techniques." With these cut-and-splice tools developed in the early 1970's, researchers can cut a copy of a segment of DNA containing a gene, and paste it into another segment of DNA.
The power of this tool is that the DNA segment can come from
any organism, and can be transferred to any organism. The gene
on the transferred DNA can be active in the recipient organism,
and the gene can be inherited by the offspring of the recipient. This
means researchers can transfer a copy of a gene from a bacterium
to a bull--or from a bull to a bacterium.
Scientists and writers commonly refer to this cutting-and-splicing
as genetic engineering. A term coined by a Danish microbiologist in
1941, its meaning has mutated from its original reference to the
precise selection of yeast strains.
"Genetic engineering" generates a gut-level reaction among some
consumers. Ironically, the two words are related. Ask most US
consumers for the name of the first book of the Bible, and they can
answer "Genesis." It's about origins, beginnings, and inheritance.
Knock off the "-is" and you get "genes." Rub the right lamp and
you get a "genie." If the genie is real smart, it's a genius. If it's
good with its hands and its head, it's ingenious and shows
ingenuity. In French (and almost every other language of western
Europe save English), ingenious people are called "ingenieurs." In
English, the word is engineer--one who designs and builds. The
string of ideas from Godly creation to human manipulation helps
explain the concern of consumers reacting to the words and the
concepts of genetic engineering.
Critics of biotechnology have used other symbols from mythology
and literature to express their concern or opposition.
"Frankenfood" is a coinage notable for its impact and its chief
invoker--Jeremy Rifkin (5). Mary Shelley's book has spawned a
genre of movies that focuses on the monster more than the man, on
the creation more than the creator. Yet in the book, the monster is
just a supporting role; the leading man is the scientist-surgeon. In
both the book and the movies, the monster provides the gore; the
man provides the horror. Frankenstein counterposes humility and
Likewise, "Frankenfood" is ambiguous, and therefore more
effective. Is the concern about the creation or the creator? About
the food or the foodmaker?
First Use: A Human Protein from Bacteria In 1982 Eli Lilly &
Co. successfully introduced the first commercial product of genetic
engineering: human insulin made by bacteria given a copy of the
human gene for insulin. This technical and commercial success in
high-profit pharmaceuticals suggested that the same technology
could be used to produce proteins valuable in food production. The
success did not suggest, however, that it would take eight years to
Cases of Foods: The First Five Products The first two products
of recombinant DNA technology in the US food supply actually
resulted from a gene transfer from 'bull to bacterium.' But the first
was not the infamous hormone BST. In 1990 Pfizer, Inc. introduced
"CHY-MAX" brand chymosin, a protein purified from bacteria
given a copy of the chymosin gene from cattle. Traditionally
extracted from "chyme" or stomach slime of suckling calves,
chymosin is not a hormone but is an enzyme that digests milk
proteins. Chymosin is the active ingredient in rennet used by
cheesemakers to coagulate milk into curds and whey. CHY-MAX
extracted from bacteria grown in a vat is identical in chemical
composition to the chymosin extracted from cattle.
In the late 1980's Pfizer's analyses showed that the product met
the industry standard of care for a new food additive. Under the
Food, Drug and Cosmetic Act, FDA requires a sponsoring company
to establish the safety, efficacy and quality of the additive. Pfizer
demonstrated that the composition and activity of its protein were
identical to that extracted from calves, and that bacterial DNA
could not be detected in the product. After preparing the data to
gain approval as a food additive, the FDA approval actually came
as acceptance of GRAS status: Generally Regarded as Safe.
Ironically, because it was indistinguishable from chymosin from
stomachs, the bacterial chymosin therefore did not require
certification as a food additive.
Pfizer's product quickly won over half the market for rennet
because cheesemakers found it to be a cost-effective source of high-
quality chymosin in consistent supply. Before CHY-MAX, the sole
source of chymosin was the stomachs of slaughtered suckling
calves--calves usually less than 10 days old. This meant the supply
of chymosin fluctuated with the supply of suckling calves.
Moreover, the traditional source of chymosin also kept cheese
from being kosher. Such cheese was considered a mixture of milk
and of flesh, and violated kashrus. Certain vegetarians also
refused to accept cheese with calf-rennet. Some Jewish rabbis and
vegetarian groups gave an unanticipated benefit to Pfizer by
approving cheese made with rennet from bacteria.
Unlike BST, under development at the same time, CHY-MAX
made few headlines. It was a protein produced through gene
transfer, but it was an enzyme and not a hormone. It was
identical to chymosin produced by calves. It offended the values of
few people. It did not threaten the health of consumers, the wealth
of cheesemakers or family dairy farmers, or the well-being of
cattle. Finally, it did not threaten the image of milk as "nature's
most perfect food." rBST was suspected of all that, and more.
rBST/BGH BST is a protein that functions as a hormone in cattle
but not in humans. BST occurs in trace amounts in cow's milk.
Fifty years ago experiments with BST extracted laboriously from
cattle pituitary glands showed that injections of BST into cows
increased milk production. Recombinant DNA technology provided
an alternative and plentiful source of the protein hormone:
bacteria that had been given a copy of a BST gene to make "rBST"
Just as words in English are written using strings of letters
selected from a 26-letter alphabet, proteins are chains composed of
links or building blocks called amino acids. The "protein alphabet"
contains 20 amino acids. Cattle make four similar but distinct
versions of BST. Each is 190 or 191 amino acids long.
Beginning in the early 1980's, Monsanto developed a recombinant
DNA-derived version called rBST that differed from one of the
four naturally-occurring versions only in the addition of one amino
acid at one end. Introduced in 1994 under the tradename Posilac,
farmers inject the drug into a cow starting at 60 days into her
milking period (feeding rBST to animals is ineffective because the
protein is degraded in the cow's stomach). Injections can increase
milk production up to 20% compared to untreated animals.
rBST: A Decade in Development and Review FDA is
empowered by the federal Food, Drug and Cosmetic Act (FD&C)
to review new animal drugs before approval for commercial sale.
The sponsoring company must demonstrate to FDA's satisfaction
that the drug is safe to humans and to livestock, that it is effective
at the administered dose, and that the drug can be produced with
consistent and adequate quality.
Many rBST opponents have argued that these three criteria are
inadequate. They support the addition of a Fourth Criterion: an
assessment of the economic and social impact. Although Congress
has yet to authorize such a criterion, nevertheless during the late
1980's critiques of rBST raised a spectrum of objections. They
claimed that it was not safe for cows because it caused mastitis or
other ailments; that it was not safe for humans; that the drug was
not effective; alternatively, that the drug was too effective, and
that the increase in milk supply would drive down the income of
family farms; that even if the drug were safe and effective, its
commercial use would preferentially benefit large corporate dairy
farms its commercial use would ruin the dairy industry; and that its
use would ruin small dairy farms because opinion polls predicted a
10% drop in demand for milk.
During the late 1980's the issue burned in dairying regions but
was not yet significant nationally. Then in the spring of 1990,
Wisconsin passed a one-year ban on the drug, blocking its
experimental use there. In August 1992 the federal General
Accounting Office issued a report criticizing the FDA's review of
rBST, and recommended that approval be delayed until FDA
resolved issues of mastitis (an udder inflammation) in treated
cows. Also in November 1992, Wisconsin voters elected Russell
Feingold, a state senator and a leading opponent of rBST, to the
In March 1993 FDA convened an advisory panel to review issues
raised in the GAO report. The panel concluded that sufficient
safeguards were in place to ensure the safety of the milk supply.
During August, Senator Feingold, who considered the issue more
about milk and Monsanto than about biotechnology per se,
sponsored an amendment to the federal budget bill that delayed
commercial sale of rBST for 90 days following FDA approval. On
November 5, 1993, FDA announced approval of Monsanto's rBST product; commercial sales were delayed until the following February.
During the 90 day moratorium, the Executive Branch of the
federal government compiled a wide-ranging assessment of rBST,
including economic impacts. The report confirmed the FDA's
conclusion that rBST was safe and effective, and discounted the
predictions of severe economic upheaval in the dairy industry.
Opponents of rBST criticized the report's analysis and conclusions.
In early February 1994 national news media intensely covered the
start of sales of rBST. However, the steep drop in consumer
demand for milk predicted by some opinion polls never
materialized, and demand remained steady.
Labeling Another sharp issue over rBST was labeling: should
labeling milk from cows treated with rBST be compulsory,
permitted or prohibited? Based on what criteria? Proponents of
compulsory labeling of milk held that those who used the new
product should have to bear the burden of labeling their milk, and
that consumers have a "right to know" about processes used to
produce food. Proponents of rBST argued that the FD&C act
requires labels only when composition of a food is changed, and
since rBST did not change the composition of milk, there were no
grounds for FDA to mandate a label. The FDA kept its own counsel
until it published labeling guidelines in the Federal Register on
February 14, 1994.
The FDA "found that there was no significant difference between
milk from treated and untreated cows and, therefore, concluded
that under the Federal Food, Drug and Cosmetic Act, the agency
did not have the authority in this situation to require special
labeling...." In this sentence, the FDA answered two key questions:
milk composition was unchanged, and by implication, the milk was
The FDA also permitted voluntary labels for dairies wishing to
accommodate consumer concern by selling milk from untreated
cows. All label claims must be both true and not misleading.
Furthermore, the FDA advised that both "the presence and the
absence of information are relevant to whether labeling is
misleading." To meet these tests, the FDA recommended a two-
part phrase: "Milk from cows not treated with rBST. No
significant difference has been shown between milk derived from
rBST-treated and non-rBST-treated cows."
The FDA also suggested that, in assessing a label statement
(should a producer choose a phrase different from the one
recommended in the guidelines), "available data on consumers'
perceptions of the label statements could also be used to determine
whether a statement is misleading." Apparently, a label-writer is
responsible not only for what the label language implies, but also
for what the consumer infers from the label.
States have the option of establishing their own label standards.
Vermont has enacted a law that compels mandatory labeling of
milk from cows treated with rBST. The label must include the "no
significant difference" disclaimer. In August 1995 US District Judge
J. Garvan Murtha upheld the law in deciding a lawsuit brought by
the International Dairy Foods Association and five other groups
(6). (Editor's note: a federal court overturned this decision.)
The First Whole Food: FlavrSavr Tomato Also in the spring of
1994, Calgene's FlavrSavr tomato entered the final stages of FDA
review. FlavrSavr was the first whole food from plants reviewed
under the policy issued by the FDA in May 1992.
In the debate whether regulation should be based on "the product
or the process," the FDA decided to continue to base its judgments
on the product. The policy assessed new foods from all genetically
modified plants based on the expected characteristics of the food
and the genetic makeup of plant used to produce the food,
including any introduced genes, regardless of the genetic techniques
used to introduce the gene. Thus, the mere use of rDNA techniques
would not trigger any unique regulations. Nor did FDA require
special labeling of foods developed using recombinant DNA
The policy included special provisions to safeguard against the
potential transfer of an allergen from one food plant to another.
For example, a company producing a tomato containing a peanut
gene would have show the tomato does not cause an allergic
reaction in people known to be allergic to peanut.
Calgene, headquartered in Davis, California, developed a tomato
that remained firm even as it turned red and tasty as it ripened.
Researchers inserted two genes linked in tandem. One gene was a
tomato gene modified to keep the tomato firm. The other gene
was a tag, a "selectable marker" that enabled the researchers to
find which plants received the two linked genes. Scientists had
originally found the gene in bacteria in nature, so the use of the
gene in tomato did not introduce a new gene to nature.
In January 1993, Calgene asked the FDA for a two-track review.
Calgene asked that the tomato itself be reviewed under the May
1992 policy; and it asked for a review as a food additive of the
"selectable marker" gene and its protein. Calgene's decision to
submit the selectable marker gene and its protein to stringent
review as a food additive was the most cautious approach to
approval. It was also the most expensive approach, and one
intended to maximize consumer confidence in a pioneering product.
Some observers expressed concern, however, that Calgene's
approach might set a precedent that the government would expect
or oblige other companies to follow.
On May 18, 1994, the FDA reached two conclusions: 1) the
modified plant is a tomato and is as safe as other tomatoes, and 2)
the selectable marker gene and its protein product are safe and
effective. The addition of the selectable marker gene originally
found in bacteria and the presence of the protein from the
selectable marker gene did not constitute either a significant change
in composition or an adulteration. Nor did the genetic
manipulations cause any unintended change in nutrient
composition, and the company had satisfied the industry standard
of care in looking for such a change. Furthermore, as expected the
FDA did not require Calgene to include a label stating that the
tomato was modified by recombinant DNA techniques. Lastly,
since the tomato is a whole food, and since the FDA does not
require ingredient labels on whole foods, the agency did not require
the company to include a label listing the selectable marker gene
and its protein products as a food additive.
Virus-resistant Freedom II Summer Squash Late in 1995 the
USDA cleared for commercial use a squash resistant to two types
of virus (7). Developed by Asgrow seed company of Kalamazoo,
Michigan, the squash is remarkable in containing three genes
instead of just two: a selectable marker, and one gene each from
the two similar but distinct viruses. Because of the use of plant
virus genes, the squash was the first time that the USDA, rather than the FDA, was the lead regulatory agency based on authority
given in the Plant Pest Act.
Farmers try to control the virus diseases and the aphids that
spread them by spraying their crops with insecticides. Breeders
have had difficulty developing aphid-resistant plants as well as
virus-resistant plants using genes from wild and cultivated
relatives of squash.
Recombinant DNA techniques enlarged the breeders' gene pool.
Work started in the laboratory in 1986 to find, copy and move the
genes into greenhouse plants. No longer limited to squash for
sources of resistance, researchers inserted into plant's
chromosomes a copy of gene from each virus to make plants resist
the virus. They also used the same "selectable marker" or "tag
gene" used by Calgene to find plants in which the three linked
genes inserted successfully.
Beginning in 1990 Asgrow tested the squash in field trials every
growing season. Asgrow formally petitioned the USDA in 1992 to
declare the squash a "non-regulated article," providing the
clearance needed to commercialize the squash. The petitioning
process requires the USDA to announce in the Federal Register the
company's request for "non-regulated article" status. Any
interested person can then submit comments for a period after the
announcement is published.
USDA sent Asgrow's petition through three rounds of comment.
USDA in response to each round of comments asked Asgrow for
more analysis . USDA was at first concerned with molecular
aspects. Later USDA expressed concerns about weediness, spread
of the resistance gene by pollen, and possible acceleration of new
strains of the virus. After reviewing Asgrow's additional analyses,
USDA declared in late 1994 the squash and any hybrids developed
from it to be "non-regulated articles."
New Leaf Potato A common soil bacterium named Bacillus
thuringiensis produces a protein toxic to many plant-eating pests
but harmless to beneficial insects such as honeybees as well as to
humans. "Bt" is available as a commercial pesticide registered by
the EPA. When dusted on potato plants, a specific strain of Bt kills
Colorado potato beetle. The dust is effective for only two to three
In the mid 1980's several companies, including Agracetus,
Agrigenetics (now part of Mycogen) and Monsanto, transferred a
copy of the Bt gene into plants. The goal was to produce plants
resisted insects by producing the Bt protein.
The EPA has been the lead regulatory agency reviewing these
plants. On May 5, 1995, the EPA announced the registration of
Monsanto's "NewLeaf" potato, making it the first registration of a
"plant-pesticide." This action cleared NewLeaf potatoes, a type of
Russett Burbank potato, for commercial production in 1995. The
government required no special label or segregation of Bt potatoes.
The USDA had also previously de-regulated Monsanto's variety.
"What No Change in Sense Discern" These first five food
products are remarkable in that, contrary to Frankenfood
expectations, they look just like their counterparts. No monsters,
no killer tomatoes. After wading through the empirical evidence,
the emotional arguments, the issues of values, and the blatant
scare tactics, it's not surprising to hear a consumer with a
transgenic tomato in hand ask, "So what was all the fuss about?"
Scientifically sound regulations Scientific organizations such
as the National Research Council have concluded that the use of
rDNA techniques poses no special risks not also posed by other
genetic manipulations (crop hybridization, for example). If so, then
why have special regulations triggered by the use of rDNA? (8)
"Reassurance Regulations" One reason to support rDNA-
triggered regulations is to reassure the public that each of the
pioneering products of new technology are safe. Ironically, these
regulations serve to protect biotechnology from the public, rather
than to protect the public from biotechnology. They can impede
university researchers and small companies with small budgets,
and give the public an unfounded feeling of improved safety. The
regulations do not reduce real risks but they do increase real costs,
effectively barring smaller companies from entering the market (9).
There is surprisingly little litigation. Yet the threat of litigation by
people seeking more stringent regulation of rDNA technology is
constantly affecting the decisions of federal policymakers and
How to accommodate people with profound concerns unfounded
by the data? rBST was among the most thoroughly tested and
reviewed drugs ever, yet some consumers conclude it is not safe
enough. Permitting specially-labeled alternative sources of foods
produced according to those concerns has proven practical. But in
these cases, one can argue based on economic justice that those
who value the extra information about the product should pay for
"Education is Key to Acceptance" This mantra is overstated
and misses the mark. A person may completely understand
molecular biology and yet reject its application to food based on
one's personal values. It is essential to provide information, point
out misconceptions, and refute alarmist misinformation, not so
much to assure public acceptance as to ensure public empowerment.
On a topic as basic as food, the challenge is to accommodate
personal values, but without capitulating to emotional or alarmist
arguments that would deny other people access to a safe source of
food. For those with a higher sense of values, let them persuade
rather than compel those with differing views.
Fire in the Cave A little saying: when people first brought fire
into the cave, it was the end of cold nights--and the beginning of
emphysema. The criteria we choose to assess the risks and benefits
of new tools will profoundly affect the personal choices and the
public policies surrounding biotechnology and food.
Henry I. Miller, "Perception of biotechnology risks: the emotional
dimension." Bio/Technology. 11:1075-1076.
Susanne L. Huttner et. al, "Revising oversight of genetically
modified plants." Bio/Technology. 10:967-971.
R. J. Goldburg and D. D. Hopkins, "What EDF wants."
Bio/Technology 10: 1385.
John Tallmadge, "Cultivating disaster? Why modern farming
methods may threaten our food supply." New York Times Book
Review. 13 August 1995.
Jeremy Rifkin and Ted Howard, "Consumers reject
'frankenfoods'." Chemistry & Industry. 18 January 1993, page 64.
Bryan Pfeiffer, "Vermont milk labeling law upheld." Rutland
Herald. 10 August 1995.
Hector Quemada, Asgrow, personal communication. See (2)
Susanne L. Huttner, "Government, researchers and activists: the
critical public policy interface." Chapter 16 in IN: Brauer, D.,
editor, Biotechnology. Weinheim, Germany: VCH, 1995:459-494.