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Genetically engineered foods and regulatory recommendations
Submitted for SPEA Undergraduate Honors Thesis Rebecca Mandell
Policy Analysis Junior
Beth Cate
Associate Professor, Adjunct Associate General Counsel School of Public and Environmental Affairs
Faculty Mentor
ABSTRACT
This paper examines the prevalence of genetically engineered foods in the United
States and the risks to human and environmental health associated with their production
and consumption. It will review the regulatory roles of federal departments with particular
attention to legal and policy controversies surrounding food labeling. A survey study
conducted in Bloomington, Indiana will look at the risks of genetically engineered foods as
perceived by the consumer, consumer knowledge regarding the prevalence of genetically
engineered products, and related purchasing preferences and awareness of food labeling.
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Table of Contents
INTRODUCTION 3
GENETIC MODIFICATION VERSUS GENETIC ENGINEERING 6 PREVALENCE OF GENETICALLY ENGINEERED CROPS 8
DISCUSSION 10
BENEFITS OF GENETICALLY ENGINEERED FOODS 11 HUMAN HEALTH AND SAFETY 16 REGULATORY RESPONSE: FOOD AND DRUG ADMINISTRATION 20 ENVIRONMENTAL HEALTH AND SUSTAINABILITY 23 REGULATORY RESPONSE: ENVIRONMENTAL PROTECTION AGENCY 30 REGULATORY RESPONSE: UNITED STATES DEPARTMENT OF AGRICULTURE 34 ETHICS AND TRANSPARENCY 39 REGULATORY RESPONSE: FOOD AND DRUG ADMINISTRATION 42 GLOBAL COMPETITIVENESS 49 REGULATORY RESPONSE: INTERNATIONAL REGULATIONS & DOMESTIC LABELING 51 REGULATORY CONCERNS 56 REGULATORY RESPONSE: OFFICE OF GOVERNMENT ETHICS 61
THE ROLE OF THE CONSUMER 62
LESSONS LEARNED FROM MILK 63 CONSUMER PREFERENCES 66 SURVEY 69 METHODS 69 FINDINGS 72
REGULATORY ALTERNATIVES 80
RECOMMENDTIONS 83
STAGE ONE: TRANSPARENCY AND LABELING 84 STAGE TWO: MITIGATE ENVIRONMENTAL CONSEQUENCES 88 STAGE THREE: RESPONSIVE DISCOURSE 91
BIBLIOGRAPHY 93
APPENDIX 105
NON-REGULATED GE PLANTS 105 SURVEY 107 SURVEY PARTICIPATION FLIER 110
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INTRODUCTION
Over the past two centuries agricultural production has rapidly increased in order
to meet the needs of a world population that has grown from less than one billion to over
six billion. According to Giovanni Federico’s Feeding the World: An Economic History of
Agriculture, 1800-2000, this growth is so extensive that, while “each person in the world
has, in theory, 2,800 calories available, with a minimum of some 2,200 in sub-Saharan
Africa,”1 inadequate distribution of said calories and income results in undernourished
populations. Up until the 1950’s, agricultural production grew in proportion to the
population and labor force, by that time doubling world output from 1870. However, for
the years between 1950 and 2000, the World Trade Organization estimates 2.3 percent
annual growth in agricultural output2 – a rate that more than tripled production – while
the world population grew at an annual rate of 1.1 percent3. Due to restrictions on arable
land across the world, much of this growth has relied on capital improvements that allowed
for more produce to come from the same land area. These improvements include both
technological developments associated with the mechanization of the agricultural industry
and new types and methods of fertilization and pesticide management, among other
innovations.4
1 Federico, G. (2010). Feeding the World: An Economic History of Agriculture, 1800-2000. p. 1. Princeton, NJ, USA: Princeton University Press. 2 Federico, G., Feeding the World 3 United States Census Bureau. (2012, April 30). International Data Base, Data:12.0625 Code:12.0321. Retrieved June 2012, from International Programs: http://www.census.gov/population/international/data/idb/worldgrgraph.php 4 Federico, G., Feeding the World
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What separates the agricultural industry from so many others is that as long as the
population remains stable, there is a distinct limit on demand that is unrelated to
purchasing power. A given number of consumers can only eat so much, regardless of how
much they can financially afford to consume and, as mentioned earlier, the world is
producing more than enough food to meet the nutritional demands of the current
population. In fact, overconsumption is proving to be a public health issue of comparable
significance to malnutrition in previous centuries. A report in The New England Journal of
Medicine predicts that the current obesity epidemic will foster the first generation to have a
shorter lifespan than their parents, by up to five years.5 With overproduction threatening
price reductions beyond sustainable rates, the agricultural industry turned toward
development via increased efficiency and product elevation – developing products with
more desirable characteristics. As scientific developments revealed more about the genetic
composition dictating those desirable traits, genetic modification was introduced to a
whole new realm of possibility in the form of genetic engineering.6
Genetic engineering was introduced to the agricultural industry in the 1980s, and
spread at an overwhelming rate. The most common applications offer alternative
fertilization and pesticide management methods, which allow for the maintenance of high
production levels while decreasing production costs. Such results are possible because
these methods allow for more mechanized work, reducing the need for human labor. This
is particularly advantageous for industrial-sized operations where small per acre cuts can
make a huge impact. Examples of such methods include shortened growing cycles that 5 Olshansky, J. S., Passaro, D. J., Hershow, R. C., Layden, J., Carnes, B. A., Brody, J., et al. (2005). A Potential Decline in Life Expectancy in the United States in the 21st Century. The New England Journal of Medicine , 352 (11), 1138-1145. 6 See section titled Genetic Modification Versus Genetic Engineering for clarification regarding these terms.
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allow for multiple harvests per season, increased resistance to adverse growing conditions
and pests (both flora and fauna), and Monsanto’s Round Up Ready regimen of pesticide
management, detailed below. This technology also includes modifications beyond those
related to crop production that aim to produce a product with enhanced characteristics
rather than simply produce more or more efficiently. Examples include produce with a
longer shelf life, products containing more nutrients, or crops that contain a greater
amount of starch or other components commonly used in food processing. This is only a
small selection of the current applications of the technology; the possible combinations and
potential applications are virtually limitless.
However, these accomplishments have not come without controversy, and the legal
and ethical dilemmas surrounding them include questions regarding the ownership of life
itself. Much of the public concern regarding the production and consumption of genetically
engineered crops revolves around threats to human and environmental health as well as a
consumer’s right to know how his or her food is made or grown. Before discussing the
controversial aspects of genetic engineering, this paper will review the basics of the
technology and introduce some of the most common and interesting examples of its use. It
will then discuss consumer concerns associated with the production and consumption of
genetically engineered foods including issues related to transparency and ethics, and global
competitiveness, as well as how current regulations address these concerns and associated
enforcement issues. A survey of consumers in Bloomington, Indiana will be used to
consider consumer perceptions of, and attitudes towards, genetically engineering foods.
This report will conclude with recommendations for how domestic regulations can better
address public concerns.
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GENETIC MODIFICATION VERSUS GENETIC ENGINEERING
Since the beginnings of agriculture humans have bred plants to either encourage or
eliminate specific characteristics by selectively choosing which plants and seeds to use in
the following season. This earliest and most simple form of genetic modification began long
before the discovery of genes and is comparable to conventional breeding methods used
today, although the scientific understanding of genetics has elevated breeders’ capabilities
to target specific characteristics. Methods such as selective seed saving and hybridization
allowed farmers to breed crops with increased yields, resistance to harmful insects and
disease, and shortened growing cycles, among other traits.7
The conventional breeding techniques mentioned above are considered non-
recombinant DNA techniques. Genetic engineering, as defined by the United States
Department of Agriculture, differs from these techniques in that it is recombinant, meaning
that genetic material within the species has been rearranged or removed, or that genetic
material from a different species has been introduced.8 The direct transfer of genes from
one species to another is referred to as transgenic.9 Watson and Crick’s 1953 discovery of
the structure of DNA allowed for traits to be explained by genetic codes, eventually
allowing specific traits to be transplanted from one organism to another through gene
7 International Service for the Acquisition of Agri-Biotech Applications. (2006, November). Conventional Plant Breeding. Retrieved June 2012, from International Service for the Acquisition of Agri-Biotech Applications: http://isaaa.org/resources/publications/pocketk/13/default.asp 8 Fernandez-Cornejo, J., & Caswell, M. (2012, May). The First Decade of Genetically Engineered Crops in the United States. Retrieved June 2012, from The United States Department of Agriculture Economic Research Service: http://www.ers.usda.gov/publications/eib-economic-information-bulletin/eib11.aspx 9 Schneider, K. R., & Schneider, R. G. (2009, November). Genetically Modified Food. Retrieved June 2012, from Electronic Data Information Source: http://edis.ifas.ufl.edu/fs084
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splicing. Boyer and Bohen created the first successful recombinant organism, a strain of E.
coli, in 1973.10
Genetic modification (GM, or GMO for genetically modified organism) is an umbrella
term that includes conventional and modern breeding technologies such as genetic
engineering (GE or GEO for genetically engineered organism). Confusion surrounding
these terms often arises because they are frequently used interchangeably, which is
inaccurate. Biotechnology, or biotech, is another general term that is often used to describe
recombinant-DNA procedures. In actuality, biotechnology simply refers to the use of living
organisms by humans.11 Food related uses of biotechnology include the use of yeast in
bread and alcoholic products as well as bacteria cultures used to make cheese – neither of
which genetically alters the organism in any way. The terms modern biotechnology and
bioengineering are often used to denote recombinant forms of biotechnology. Various
terms may be used throughout this paper depending upon the context or literature being
referenced, though they should be assumed to carry the meaning of genetic engineering.
Genetically engineered crops are classified into one of three generations based on
the intention of the modification. First generation crops include modifications that impact
input traits of the plant including, but not limited to, herbicide tolerance, insect resistance,
and endurance under stressful environmental conditions. Second generation crops can
include first generation modifications but are distinct in that they also include added-value
output traits, such as enhanced nutrition. The third generation consists of crops that have
10 Genome News Network. (2004). Genetics and Genomics Timeline. Retrieved June 2012, from Genome News Network: http://www.genomenewsnetwork.org/resources/timeline/1973_Boyer.php 11 Biotechnology Institute. (2010). What is Biotechnology? Retrieved June 2012, from Biotechnology Institute: http://www.biotechinstitute.org/what-is-biotechnology
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been modified for uses “beyond traditional food and fiber12” such as in pharmaceuticals
and bio-fuels.13
PREVALENCE OF GENETICALLY ENGINEERED CROPS
Since the introduction of the first genetically engineered products in the 1980’s
(Humulin, human insulin produced by bacteria, in 1982 and the FlavrSavr tomato, altered
to have a longer shelf life, in 198714) genetically engineered crops have inundated the
market and have proven to be “the fastest-adopted crop technology in the history of
modern agriculture”15. Their prevalence in hectares in 2010 was eighty-seven times that of
1996.16 Since 1987, over 11,600 genetically engineered seeds have been submitted to the
United States Department of Agriculture for field-testing, ninety-two percent of which have
been approved. These include over 5,000 varieties of corn and over 6,600 seeds
engineered to tolerate herbicides or be more resistant to insects. In 2006, 25% of corn
acreage, 38% of soybeans, and 45% of cotton grown in the United States was genetically
engineered.17 The International Service for the Acquisition of Agri-biotech Applications
(ISAAA) reported that in 2012 those numbers had increased to 88% of corn, 93% of
soybeans, and 94% of cotton.18 Other common genetically engineered crops include wheat,
12 Fernandez-Cornejo, The First Decade of Genetically Engineered Crops in the United States 13 Schneider, Genetically Modified Food 14 American RadioWorks. (2012). History of GMOs. Retrieved June 2012, from American Public Media: http://americanradioworks.publicradio.org/features/gmos_india/history.html 15 Schneider, Genetically Modified Food 16 International Service for the Acquisition of Agri-Biotech Applications. (2011, February 22). Press Release: Biotech Crops Surge Over 1 Billion Hectares. Retrieved June 2012, from International Service for the Acquisition of Agri-Biotech Applications: http://www.isaaa.org/resources/publications/briefs/42/pressrelease/default.asp 17 Schneider, Genetically Modified Food 18 United States Department of Agriculture Economic Research Service. (2012, July 12). Adoption of Genetically Engineered Crops in the U.S. Retrieved August 2012, from United
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squash, beets, and canola. The Institute of Food and Agricultural Sciences at the University
of Florida estimates that this translates into store shelves containing sixty to seventy
percent genetically engineered foods or food products containing genetically engineered
ingredients.19 For processed foods alone this number is estimated to be over seventy
percent.20 Given these numbers it is almost impossible to go a day without ingesting a
product that has been genetically engineered or contains genetically engineered material.
Internationally, more than 2.47 billion acres of genetically engineered crops have
been planted across twenty-nine countries throughout the past fifteen years. As the
country producing the most genetically engineered crops, the United States is responsible
for 165 million of those acres. Brazil, in second place, is more than 100 million acres
behind the United States with just under 63 million acres.21 Completing the top ten list,
from highest to lowest land area planted, are Argentina, India, Canada, China, Paraguay,
Pakistan, South Africa, and Uruguay, each planting over 2.5 million acres of genetically
engineered crops.22 According to the ISAAA 2010 annual report, “developing countries
grew forty-eight percent of the global biotech crops in 2010 and will exceed industrialized
nations in their plantings of biotech crops by 2015.”23
States Department of Agriculture Economic Research Service: http://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx 19 Schneider, Genetically Modified Food 20 Center for Food Safety. (2012). Genetically Engineered Crops. Retrieved August 2012, from Center for Food Safety: http://www.centerforfoodsafety.org/campaign/genetically-engineered-food/crops/ 21 ISAA, Press Release: Biotech Crops Surge Over 1 Billion Hectares 22 ISAA, Press Release: Biotech Crops Surge Over 1 Billion Hectares 23 ISAA, Press Release: Biotech Crops Surge Over 1 Billion Hectares
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DISCUSSION
Developments in genetic engineering technology have provided the agricultural
industry with an indispensible tool for manipulating everything about a crop – from the
way it grows to the specific characteristics of the product produced. Much of the
industrialized agriculture industry and the regulatory authorities involved in the
production and sale of genetically engineered crops have embraced the technology despite
persistent public concern regarding its use. When applied properly, this technology has the
ability to increase productivity and nutritional content, among other desired traits, while
lowering production costs by providing alternative pesticide and fertilizer management
systems associated with lower labor requirements. The downside is that these same
techniques may also have a negative effect on nutritional content and the natural
surroundings where the crop is cultivated via the production of toxins and other
potentially dangerous pathogens threatening human health and the environment. The
controversy also includes ethical issues primarily regarding the consumer’s right to know
how their food was grown or made and the transparency of regulatory review processes
that deem genetically engineered food to be safe for production and consumption. Even if
consumers are comfortable with the use of genetic engineering in food production, issues
remain under the current state of regulation regarding global competitiveness and
regulatory enforcement. This section will introduce the current and possible benefits of
genetic engineering, explore consumer concerns regarding the current state of genetically
engineered foods, and discuss the success or failure of current regulations to address these
concerns.
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BENEFITS OF GENETICALLY ENGINEERED FOODS
The benefits associated with genetic engineering vary greatly and are dependent
upon the particular trait introduced. For this reason it is impossible to speak generally
about the benefits of genetic engineering other than to acknowledge the vast possibilities
enabled by the technology and the expectation of profit increases by farmers cultivating
genetically engineered crops. It is this expectation, based on the practices that aim to
increase yields and decrease inputs, which have fostered such high rates of adoption.24 In
order to discuss the benefits associated with the cultivation and consumption of genetically
engineered crops, this section will review the benefits, found on both the production and
consumption side of the equation, associated with some of the most common traits
engineered into foods such as herbicide- and insect-resistance, and product elevation
qualities.
Increased productivity credited to the use of genetic engineering does not generally
come in the form of direct increases in crop yields, rather indirectly through the use of
herbicide-tolerant and insect-resistant traits.25 Herbicide-tolerant crops allow for the
application of herbicides in order to clear out weeds competing for resources across a crop
field, the introduced trait protecting the crop from the otherwise harmful herbicide. This
trait is primarily marketed in Monsanto’s Roundup Ready seeds, which are genetically
engineered to resist glyphosate, the active ingredient in Monsanto’s herbicide, Roundup.
Monsanto first introduced the technology to the market via soybeans in 1996; today the
24 Fernandez-Cornejo, The First Decade of Genetically Engineered Crops in the United States 25 Fernandez-Cornejo, The First Decade of Genetically Engineered Crops in the United States
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trait may be found in ninety percent of soybean crops26 as well as in alfalfa, corn, cotton,
canola, and sugar beets.27 Conventional pesticide management systems often require
precise applications of a variety of different herbicides, each targeting a different group of
pests and performing best under specific weather conditions and carefully timed
applications.28 In addition, these herbicides require labor-intensive application procedures
in order to avoid contact with the intended crop. In contrast, the Roundup Ready routine
allows for less frequent, imprecise, large-scale herbicide applications, lending itself to
mechanized application generally associated with lightened labor requirements and
therefore reduced production costs. Additional benefits stem from reduced- or no-till
practices found to be used more by growers of herbicide-resistant crops. Among American
soybean producers it was found that Roundup Ready growers used reduced- or no-till
practices nineteen percent more often than those growing conventional soybeans,29 with
twice as many Roundup Ready growers using no-till practices than conventional growers -
forty percent and twenty percent respectively.30 No-till practices are significantly healthier
for the environment because it reduces the impact of natural erosion caused by wind and
26 Pollack, A. (2012, August 1). Monsanto Wins Big Award in a Biotech Patent Case. Retrieved August 2012, from NYTimes: http://www.nytimes.com/2012/08/02/business/monsanto-wins-big-award-in-a-biotech-patent-case.html?_r=1& 27 Monsanto. (2012). Roundup Ready System. Retrieved August 2012, from Monsanto: http://www.monsanto.com/weedmanagement/pages/roundup-ready-system.aspx 28 Public Forum Roundup Ready Sugar Beet Draft Environmental Impact Statement. (2011, November 15). Biotechnology. Retrieved August 2012, from USDA Animal and Plant Health Inspection Service: http://www.aphis.usda.gov/biotechnology/downloads/sugarbeet/RRSB_Pub_Mtg_111511 (Environmental Protection Agency, 2011) 29 Purdue Extension Weed Science. (2009). Benchmark Study Glyphosate Resistance Mangement. Retrieved August 2012, from Purdue Extension Weed Science: http://btny.purdue.edu/weedscience/2009/GlyTillage09.pdf 30 Fernandez-Cornejo, The First Decade of Genetically Engineered Crops in the United States
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water. Decreased erosion increases water retention that, in turn, reduces water and
chemical runoff helping to maintain the integrity of the soil.31
Insect-resistant crops reduce yield losses in a similar manner. In these plants,
known to have a Plant Incorporated Protectant, or PIP, genes are introduced that allow the
plant to produce a pesticide, typically in the form of a protein, which is toxic to the targeted
pest. Insects are killed when they ingest the plant, protecting the plant from further
damage and eliminating the need for topical pesticides.32 Baccillus Thuringiensis (Bt), the
most common PIP33, is a naturally occurring bacterium that produces proteins toxic to
many insects.34 Transfer of the gene into a range of crops including corn, cotton, and
potatoes,35 causes the crops to produce the same protein, forming a self-defense
mechanism.36 Transgenic applications of the gene became available on the market in
199537 and proved to provide an effective and cost-efficient pesticide management
alternative.38 The elimination of topical pesticide use offers significant savings for
producers of crops that would otherwise require frequent pesticide applications, also
reducing the farmers’ pesticide management responsibilities and associated labor
31 Fernandez-Cornejo, The First Decade of Genetically Engineered Crops in the United States 32 Environmental Protection Agency. (2011, November 30). Current & Previously Registered Section 3 PIP Registrations. Retrieved August 2012, from US EPA: http://www.epa.gov/oppbppd1/biopesticides/pips/pip_list.htm 33 Felsot, A. S. (2012). More Details on Specific Issues. Retrieved August 2012, from Agricultureal Biotechnology Communicators: http://www.agribiotech.info/details/Felsot%20Final%2006%20layout.pdf 34 University of California San Diego. (n.d.). What is Bt? Retrieved August 2012, from University of California San Diego: http://www.bt.ucsd.edu/what_is_bt.html 35 University of California San Diego. (n.d.). History of Bt. Retrieved August 2012, from University of California San Diego: http://www.bt.ucsd.edu/bt_history.html 36 University of California San Diego. (n.d.). Bt GM Corn. Retrieved August 2012, from University of California San Diego: http://www.bt.ucsd.edu/bt_crop.html 37 University of California San Diego, History of Bt. 38 University of California San Diego, Bt GM Corn
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requirements.39 Other genetic alterations similarly reduce input costs by reducing water
and fertilization requirements.40 Consumer support for the aforementioned applications of
genetic engineering is often generated by the idea that reduced production costs will
translate into lower market prices, though little evidence of this price shift has been seen.41
Many supporters of genetically engineered foods are more focused on the use of the
technology on crop outputs, in other words modifications that affect the food product,
rather than crop inputs previously mentioned. In fact, modifications of this nature were
the first to be released on the market via the 1994 FlavrSavr tomato, the first commercially
available genetically engineered food.42 In this case, an enzyme responsible for fruit
softening was removed from the tomato allowing for it to be vine-ripened without
shortening its shelf life.43 The product was pulled from shelves by 199744 though similar
products have continued to permeate the market. Food products have also been
engineered to contain specific nutrients, containing either higher concentrations of
naturally present nutrients or nutrients introduced from other species. One such product,
known as golden rice, has become the star child of the modern biotechnology industry. 39 University of California San Diego, Bt GM Corn 40 Borlaug, N. E. (2000). Ending World Hunger. The Promise of Biotechnology and the Threat of Antiscience Zealotry. Plant Physiology , 124 (2), 487-490. 41 World Health Organization. (2012). 20 questions on genetically modified foods. Retrieved 2012, from World Health Organization: http://www.who.int/foodsafety/publications/biotech/20questions/en/ 42 http://californiaagriculture.ucanr.org/landing Bruening, G., & Lyons, J. (2000, July). California Agriculture Online. Retrieved August 2012, from California Agriculture: http://californiaagriculture.ucanr.org/landingpage.cfm?article=ca.v054n04p6&fulltext=yes 43 GMO Compass. (2006, November 27). Genetically Modified Tomatoes. Retrieved August 2012, from GMO Compass: http://www.gmo-compass.org/eng/grocery_shopping/fruit_vegetables/15.genetically_modified_tomatoes.html 44 Public Broadcasting Service. (n.d.). Gallery of Genetic Modifications. Retrieved August 2012, from Public Broadcasting Service: http://www.pbs.org/wnet/dna/pop_genetic_gallery/index.html
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Industry hopefuls claim that golden rice, genetically engineered to contain beta-carotene, a
primary source of vitamin A, to be a large part of the solution to eliminating fatal nutrition
deficiencies in developing countries where deficiencies annually cause death and blindness
in one million and 350,000 children, respectively.45 With rice as a staple element in the
diets of the afflicted population it was an obvious mechanism through which nutritional
supplements could be provided.46 Critics of golden rice draw attention to distribution
issues responsible for much of the world’s malnutrition; the success of golden rice is
heavily dependent upon whether the distribution methods exist for it to be accessible to
the target population. The FlavrSavr tomato and golden rice are examples of product
elevation where the targeted consumer intends to benefit from the product by direct
consumption, though genetic engineering also targets industrial consumers seeking traits
beneficial to processing, such as increased starch content. Together, these factors make
genetic engineering a promising technology for increasing agricultural production, or
increased nutritional value in current agricultural production, in developing nations
currently facing famine and nutritional deficiencies. Of course, as mentioned previously,
the success of the technology relies on its ability to diffuse into the areas that it would most
benefit. However, the rise of genetic engineering and speculation of possible
accomplishments has not come without controversy. Before investment in genetic
engineering continues, scientists, policy makers, and the general public alike must consider
the long-term health impacts of the technology on human and environmental health, as
well as the economic and regulatory implications under the current regulatory regime.
45 Nash, J. M. (2001, February 12). Grains of Hope. Retrieved August 2012, from Time Magazine: http://www.time.com/time/magazine/article/0,9171,98034,00.html 46 Golden Rice Humanitarian Board. (2012). The Golden Rice Project. Retrieved August 2012, from The Golden Rice Project: http://www.goldenrice.org/
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Furthermore, the legal and ethical dilemmas surrounding these consequences address
issues regarding the ownership of life itself. The following sections will explore these
issues as well as how they are addressed under current regulation.
HUMAN HEALTH AND SAFETY
As humans who consume the products of genetic engineering as food it obvious why
the impacts of consumption would be of primary concern. Though direct connections
between the consumption of genetically engineered foods and negative consequences on
human health are arguable, much concern revolves around a fear of the unknown. Some
concerns are dispelled by an increased understanding of the technology but many
consumers maintain that genetic engineering, and human consumption of its applications,
has simply not been around long enough, and consequently not tested thoroughly enough,
for human safety to be confirmed. Many also argue that not enough independent research
has been conducted and that the influence of big business on regulatory authorities has
been detrimental to the development of necessary regulation. This latter point of criticism
is an issue of ethical practice in policymaking and will be discussed a following section.
Supporters of recombinant technology argue that extensive testing on genetically
engineered foods is simply unnecessary since conventional foods are deemed to be
“generally recognized as safe” (with the exception of food additives) by the FDA.47 If these
foods do not require certification of safety, why should genetically engineered foods,
especially considering that conventional methods of genetic modification have been used in
these “safe” foods for hundreds, if not thousands of years? However, attention is drawn to
the fact that recombinant technology introduces alterations that are beyond unlikely in
47 Genetically Engineered Foods: Hearing before the Subcommittee on Basic Research House Committee on Science, U.S. House, 106th Cong. (1999) (testimony of James H. Maryanski).
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nature; they are entirely impossible. Conventional foods, even naturally present variations,
have been a part of the human diet for centuries and have evolved along with the species
that eat them. The defense responds by referencing the many studies that have indeed
been conducted on the safety of genetically engineered foods. In fact, Dr. David Tribe, a.k.a
the GMO pundit, is an Australian applied geneticist affiliated with the University of
Melbourne48 who has complied references to combat this specific critique citing over 440
scientific, peer-reviewed published safety assessments on genetically engineered foods as
of 2012, 30 percent of which were conducted independently of the commercial industry,49
granted he does not provide commentary on the proportion or nature of negative findings.
Even so, these numbers must be taken with a grain of salt considering the incredible scope
of the technology. For obvious reasons, most research has been dedicated to the most
popular variations (herbicide and pesticide resistance) and variations which have battled
significant public criticism, with little attention given to more rare varieties. Furthermore,
this fails to address concerns regarding long-term effects of consumption of genetically
engineered foods. Regardless of the number of studies conducted, products of recombinant
technology have only been available on the market since the 1980s50 and did not constitute
a significant presence until the 2000s.51 Moreover, without labeling of such products it is
nearly impossible to link effects of consumption to the foods that produced them.
48 The Conversation Media Group. (2012). David Tribe on The Conversation. Retrieved November 2012, from The Conversation: https://theconversation.edu.au/profiles/david-tribe-3908 49 Tribe, D. (2012). 450+ published safety assessments. Retrieved November 2012, from GMO Pundit a.k.a. David Tribe: http://gmopundit.blogspot.com/p/450-published-safety-assessments.html 50 American RadioWorks., History of GMOs. 51 Schneider, Genetically Modified Food
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Beyond those issues which have yet to be studied and fears about the unknown,
scientific evidence has provided concrete reasons for which consumers should be
concerned about consuming genetically engineered foods – and not just for specifically
negative consequences, but also for the reduction in beneficial qualities. The most
prominent concern regarding the consumption of genetically engineered foods revolves the
introduction of allergens for which consumers run the risk of consuming unknowingly.
When allergens are transferred into an organism in which they do not naturally occur they
become “hidden,” particularly when labeling, or the lack thereof, fails to alert consumers.
For example, proteins from a peanut inserted into a soybean may cause that particular
strain of soybean to produce an allergic reaction in a consumer who is otherwise only
allergic to peanuts.52 The FDA has accounted for this risk by requiring producers to
adequately label products if they cannot provide evidence that the product does not
contain potential allergens.53 Genetic engineering may also increase susceptibility to
viruses and produce related threats given evidence suggesting that proteins disabling a
particular virus may increase environmental compatibility with a different virus, causing it
to thrive, a fact that remains true once such proteins have been consumed as food. Such
proteins may also directly impact human health by attacking fundamental biological
processes in their attempts to disable the virus it was created to combat. For example,
52 Smith, J. M. (2012). Disease-resistance Genetically Engineered Crops May Make Humans (and Plants) More Vulnerable to Viruses. Retrieved November 2012, from Institute for Responsible Technology: http://www.responsibletechnology.org/gmo-dangers/health-risks/articles-about-risks-by-jeffrey-smith/Disease-resistant-genetically-engineered-crops-may-make-humans-and-plants-more-vulnerable-to-viruses-June-2006 53 U.S. Food and Drug Administration. (2001, January). Guidance for Industry: Voluntary Lableing Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering; Draft Guidance. Retrieved May 2012, from U.S. Food and Drug Administration: http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodlabelingnutrition/ucm059098.htm
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disruptions in cellular reproduction are associated with the development of cancer.54 With
similar consequences to human biology, genetic engineering also has the potential to
introduce new toxins to foods in which they otherwise would not occur or increase the
concentrations of naturally occurring toxins. Although the EPA determines mammalian
toxicity thresholds for pesticides before market approval is granted, all genetically
engineered foods to date have been determined to be exempt from this requirement.55 Few
studies have addressed the issue of human toxicity, so few in fact that, according to Arpad
Pusxtai, “no peer-reviewed publications of clinical studies on the human health effects of
GM food exist[ed]” as of 2001.56
Other concerning threats involve the risk of gene transfer from genetically
engineered foods to cells and pathogens in the human body. When consumed, such foods
gain exposure to healthy and naturally present bacteria in the body. Not only are these
bacteria safe, but some are necessary to healthy functions, particularly in the
gastrointestinal tract. The risk to human health originates from the potential for genetic
transfer to occur to these bacteria that may result in adverse health effects by either
preventing the bacteria from performing the activities necessary for healthy functions,
causing the bacteria to produce a harmful activity, or by developing harmful bacteria
resistant to antibiotic treatment. Although this risk is low, it is enough cause for scientists
and health authorities to denounce the use of antibiotic resistant genes.57
54 Smith, J. M., Disease-resistance Genetically Engineered Crops 55 Environmental Protection Agency, Introduction to Biotechnology Regulation for Pesticides 56 Pusztai, A. (2009, June 30). Genetically Modified Foods: Are They a Risk to Human/Animal Health? Retrieved September 2012, from ActionBioscience: http://www.globalmagazine.info/uploads/Pusztai-GM-Foods-Risk-Human-Animal-Health-2001.pdf 57 World Health Organization, 20 questions on genetically modified foods
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Regulatory Response: Food And Drug Administration The FDA is responsible for ensuring the safety of all food on the market, including
animal feed, with the only exceptions being meat, poultry, and egg products, which are
regulated by the UDSA’s Food Safety and Inspection Service.58 At this point in time
however, there are no meat, poultry, or egg products derived from biotechnology on the
market so currently the FDA regulates the safety of all genetically engineered foods and
food additives on the market. According to the FDA, any substances “intentionally added to
food,” regardless of the methods used to add them, are considered food additives. This
definition includes any genetic modifications that introduce substances typically added
during traditional food manufacturing. In order to be released on the market, GE foods and
food additives are held to the same standards as conventional foods, meaning that they
must be considered as safe as traditional foods.59 The only exceptions to the requirement
of FDA premarket approval are pesticides in the form of Plant Incorporated Protectants
(PIPs), which are regulated by the EPA, and substances that are deemed “generally
recognized as safe.” Commonly exempt from premarket approval are whole foods, such as
grains and fresh produce, which have been a part of the human diet for a long period of
time. The FDA maintains that because genetic modifications to food thus far have been in
the form of introduced proteins, fats, and carbohydrates that are “functionally very similar
to other proteins, fats, and carbohydrates that are commonly and safely consumed in the
diet and so will be presumptively generally recognized as safe,” those modifications are
also generally recognized as safe and are therefore exempt from premarket approval.
Because the FDA has determined there is no significant difference between genetically
58 Maryanski, Genetically Engineered Foods: Hearing before the Subcommittee 59 Maryanski, Genetically Engineered Foods: Hearing before the Subcommittee
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engineered foods and food additives and their conventional counterparts, the two are
regulated under the same provisions. This being said, the FDA has identified four
categories of safety concerns pertaining to foods derived from recombinant DNA
procedures that should be taken into consideration during development and evaluation:
1. The degree to which the food is consumed
2. “The need to ensure that the changes in the food, such as the level of natural toxins
in the food, if any, stay within normal safe levels;
3. The need to ensure that significant nutrients stay within normal range; and
4. The need to analyze the potential for introduced proteins to cause allergic
reactions”60
These concerns have been used to develop “standard of care” guidelines
available to food developers to ensure that FDA safety standards are met. In addition, the
FDA has established an informal reporting process by which development firms may
submit safety and nutritional assessments for review in order to resolve any potential
safety or regulatory issues before the product’s release on the market. The FDA states, “it is
our expectation and experience that all firms have complied with this request for all plant
varieties that have been commercialized to date.”61 The FDA provides industry guidelines
for the content of nutritional and safety assessments and how they should be submitted62;
the examples below provide insight into the content requested by the FDA.
60 Maryanski, Genetically Engineered Foods: Hearing before the Subcommittee on Basic Research 61 Maryanski, Genetically Engineered Foods: Hearing before the Subcommittee on Basic Research 62 U.S. Food and Drug Administration. (2006, June 1). Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use. Retrieved May 2012, from U.S. Food and Drug Administration:
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“The name of the food and the crop from which it is derived;
• The uses of the food, including both human food and animal feed uses;
• The sources, identities, and functions of introduced genetic material;
• The purpose or intended technical effect of the modification and its expected effect
on the composition or characteristic properties of the food or feed;
• The identity and function of any new products encoded by the introduced genetic
material, including an estimate of its concentration;
• Comparison of the composition or characteristics of the bioengineered food to that
of food derived from the parental variety or other commonly consumed varieties
with special emphasis on important nutrients, anti-nutrients, and toxicants that
occur naturally in the food;
• Information on whether the genetic modification altered the potential for the
bioengineered food to induce an allergic response; and,
• Other information relevant to the safety and nutritional assessment of the
bioengineered food.”63
This information draws attention to the genetic changes made to the product compared to
the food’s conventional counterpart and how these changes alter the expression of
proteins, toxins, and nutrients, among other traits, valuable when assessing how the food
will behave through out the digestive and metabolic processes it will undergo when
consumed.
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Biotechnology/ucm096156.htm 63 Maryanski, Genetically Engineered Foods: Hearing before the Subcommittee
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The overall regulatory regime of the FDA has offers very few consumer protections
to speak of. Because of the fundamental determination of “substantial equivalence,” the
FDA has been able to skirt having to regulate virtually any genetically engineered foods on
the market, with the exception of the occasional labeling requirement, which remains
unaccompanied by any thorough safety assessment. By lumping all recombinant
alterations together, the FDA ignores the variety of traits expressed and the multitude of
potential health implications. It is imperative that before a food that has been
fundamentally altered is consumed, studies confirm that the metabolism of new or altered
traits does not present adverse health effects. This is of utmost importance given the fact
that such products are dispersed throughout the market unlabeled, eliminating any
opportunity consumers would otherwise have to protect themselves from the unknown
and the ability for unintended consequences to be recognized with any connection to
consumption of such foods.
ENVIRONMENTAL HEALTH AND SUSTAINABILITY
In addition to direct impacts on human health, it is imperative that the
environmental impacts of the production of genetically engineered crops are considered.
For some, concern regarding environmental health is founded in ethical motives; others
require more compelling and tangible motives for investing in the health of the
environment. Such examples include the need to protect naturally occurring resources,
resources with high economic value and increasingly important roles in numerous
disciplines ranging from clean energy to pharmaceutical development to new food sources.
In addition, the inevitable impact of the environment on human health merits attention,
after all, we are but a part of our surrounding ecosystem. This section will consider the
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impact of genetically engineered foods on the health of our environment, including a
discussion on the role of sustainable food production. Margret Mellon and Jane Rissler of
the Union of Concern Scientists reported on the environmental impacts of genetically
engineered crops, categorizing the potential impacts of such crops into six categories: (1)
GE crops become weeds, (2) GE crops allow transgenes to move to wild species which then
become weeds, (3) GE crops producing viruses spread the virus which has the potential to
mutate to stronger and different strains, (4) Expressed traits present a toxic threat to other
organisms and species, (5) Impacts may have a “ripple effect” through an ecosystem in an
unpredictable manner, (6) Threats to biodiversity.64 Though these categories are not
exhaustive, they draw attention to the most concerning threats of environmental release of
genetically engineered crops. Many of these categories of impacts are best explained by
reviewing the characteristics of genetically engineered crops that generate the threat. For
example, GE crops becoming weeds (by either proliferation or gene transfer) and threats
biodiversity both stem from the fact that the most popular varieties of genetically
engineered crops have been engineered to resist herbicides (e.g. Round Up Ready traits)
and pests (e.g. Plant Incorporated Protectants), and propagate under more harsh growing
conditions, in addition to the ability for transgenes to spread through natural reproduction.
Such traits allow for genetically engineered crops to persist where they may not be wanted
and to have a better chance at survival than other species under dry or crowded conditions
or in soil with low-nutritional content. This proliferation of genetically engineered crops,
64 Mellon, M., & Rissler, J. (2003, June 12-13). Environmental Effects of Genetically Modified Food Crops -- Recent Experiences. Retrieved September 2012, from Union of Concerned Scientists: http://www.ucsusa.org/food_and_agriculture/our-failing-food-system/genetic-engineering/environmental-effects-of.html
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particularly over non-genetically engineered crops, threatens biodiversity.65 When
biodiversity is lost, those reliant on crop production become more vulnerable to threats to
the species left behind – if a threat presents itself, whether it is a disease, pest, adverse
growing conditions, or an act of bioterrorism the entire crop is at stake.
Declining biodiversity and the spread of undesired genetically engineered crops is
accelerated by genetic contamination. This phenomenon is most clearly responsible for
Mellon and Rissler’s category in which transgenes contaminate wild species66, though the
implications extend far beyond that and could be argued to play a role almost all of the
defined categories. Genetic contamination, also known as genetic pollution, occurs when
transgenes are transferred into organisms in which they were not intended to be present
via natural reproductive process.67 This process is similar to the concept of genetic drift, a
phenomenon that describes the increase or decrease of gene variations present in a
population based on whether the gene is a dominant trait.68 While genetic drift describes
the natural spread or demise of naturally occurring traits and mutations, genetic
contamination often refers specifically to the spread of genes introduced to the species via
man-made technologies. Since the contamination occurs through natural reproductive
means, the degree to which contamination occurs depends on the prevalence of the
genetically engineered crop, the time given for the reproductive cycle to occur, and the
proximity of genetically engineered crops to conventional crops that it is able to 65 Mellon, M., & Rissler, J., Environmental Effects of Genetically Modified Food Crops 66 Mellon, M., & Rissler, J., Environmental Effects of Genetically Modified Food Crops 67 Pollan, M. (2001, December 9). The Year In Ideas: A to Z.; Genetic Pollution. Retrieved September 2012, from The New York Times: http://www.nytimes.com/2001/12/09/magazine/the-year-in-ideas-a-to-z-genetic-pollution.html 68 Nature Education. (2012). random genetic drift/genetic drift. Retrieved September 2012, from Scitable: http://www.nature.com/scitable/definition/random-genetic-drift-genetic-drift-201
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contaminate. Supporters of genetically engineered crops claim that this is an exaggerated
threat since most crops are not grown close enough to their wild relatives for cross-
pollination to occur.69 However evidence suggests otherwise: seeds containing evidence of
genetic contamination were found in wild populations of Mexican corn. Adding to the
disturbance is the fact that genetically engineered varieties of corn had not been approved
for commercial use yet somehow managed to contaminate the Oxaca region of Mexico, a
region home to rich diversity in wild corn species.70 It could be argued that genetic
contamination is one of most ominous consequences of genetic engineering simply because
of the process by which it occurs – natural reproduction. Once genetically engineered
crops have been introduced to the environment transgenes can spread naturally with little
opportunity to intervene. Unless the expressed trait is visible to the eye, genetically
engineered crops are virtually impossible to identify without specific testing. This trait
may not currently seem to be a significant threat since the long-term implications of this
presence are yet to be understood however, imagine the gravity of the issue if a popular
modification was found to have drastic consequences, for example a causal relationship
with a human illness.
As identified by Mellon and Rissler, genetic engineering also has the potential to
introduce harmful components or byproducts to its ecosystem. The report specifically
mentions the risk of producing viruses with the possibility of mutating and the impact of
69 Pollan, M., The Year In Ideas: A to Z.; Genetic Pollution. 70 Yoon, C. K. (2001, October 2). Genetic Modification Taints Corn in Mexico. Retrieved September 2012, from The New York Times: http://www.nytimes.com/2001/10/02/health/genetic-modification-taints-corn-in-mexico.html; Lotter, D. (2004, August 31). Pan American Adventure: Oaxaca, Mexico. Retrieved May 2012, from Rodale Institute: http://newfarm.rodaleinstitute.org/international/pan-am_don/aug04/oaxaca.shtml
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expressed traits on non-target organisms.71 Some crops are genetically engineered to
contain characteristics of a virus in order to develop a resistance.72 Though viruses are
susceptible to combining with transgenes and other viruses, indeed leading to the creation
of novel viruses, many viruses introduced via genetic engineering are not able to be fully
active due to an incompatible environment, inhibiting the virus from thriving and
spreading.73 Though a risk is certainly present, this threat has yet to produce any
significant impacts. In contrast, the release of toxins into an ecosystem is not only a risk
but has come dangerously close to producing devastating implications. Genetic
modifications are often expressed as organic matter found to be toxic to a variety of
species, even humans in large enough concentrations. The presence of such crops poses a
threat to organisms that rely on them as a source of food – whether it is a caterpillar eating
the leaves, a bee gathering nectar, or a fungus thriving on the decomposing remains once
the plant has perished. Bt crops strain of Bt corn, developed to combat the European corn
borer (moth larvae), was found to be lethal to Monarch butterfly larvae that fed on the
plant. By a stroke of luck the threatening strain had been unpopular and the effect on the
Monarch population was minimal.74
Each of the impacts discussed above have the potential to lead to other unintended
and unpredictable consequences. The complexity and size of natural ecosystems is
remarkable and impacted by even the smallest components of life. The presence of
genetically engineered crops impact every component of the natural environment – insects,
fungi, mammals, bacteria, and the soil - regardless of how visible or measurable the impact 71 Mellon, M., & Rissler, J., Environmental Effects of Genetically Modified Food Crops 72 World Health Organization, 20 questions on genetically modified foods 73 Lemaux, P. G. (2009). Genetically Engineered Plants and Foods: A Scientist's Analysis of the Issues (Part II). Annual Review of Plant Biology , 60, 511-559. 74 Mellon, M., & Rissler, J., Environmental Effects of Genetically Modified Food Crops
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may be. The multitude of interactions is far from completely documented, which makes the
study of such interactions impossible to study and therefore protect from the consequences
of various toxins and the introduction of any new species.
Few examples of serious impacts have been reported with concrete ties to genetic
engineering, though consideration must be given to the short timeframe for which
genetically engineered crops have been in use compared to the timeframe necessary for
many of these problems to develop.75 For example, the consequences of genetic
contamination require many reproductive cycles, or a large genetically engineered crop
(which has only been true to the be the case in recent years) in order for any large-scale
contamination to occur. Similarly, the development of novel viruses may be unlikely but
given enough time and the increasing presence of crops altered to contain such traits, the
development of a superbug is certainly plausible. However, evidence of pollution from
mass agricultural production is strong and founded in the use, or over use, of fertilizers and
pesticides. Mass agricultural production lends itself to the specialized production of
monocultures, the same type of production that benefits from the use of fertilizer and pest
management methods fostered by genetic engineering (recall the discussion of the benefits
associated with Round Up Ready pest management routines). The ease with which mass
applications may be applied increases the likelihood of overuse, particularly problematic
because when applied in excess the plant is unable to efficiently use the nutrients and the
remaining chemicals become runoff pollution affecting surface and ground water. The
2000 National Water Quality Inventory reports non-point source pollution, such as
agricultural runoff, as the top source of pollution for rivers and lakes, second largest source
for wetlands, and “a major contributor” to the pollution of estuaries and groundwater of 75 Mellon, M., & Rissler, J., Environmental Effects of Genetically Modified Food Crops
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the sources studied.76 Nitrate concentrations in particular have exceeded safety
thresholds in more than a quarter of rural wells,77 creating health risks and costly
externalities. The use of chemical supplements has also been linked to decreased soil
quality and air pollutants pertinent to ozone depletion and global warming.78 Such
practices, regardless of whether genetically engineered crops are involved, are
environmentally irresponsible practices only encouraged by the development of genetically
engineered crops. Furthermore, synthetic nitrogen-based fertilizers and other petroleum
based chemicals build an unsustainable reliance on fossil fuels79 in a world where the
frequency of conversations regarding energy independence and peak oil are occurring
more often and with more urgency. This reliance is in addition to that of mechanical
processes also associated with mass agricultural production. Peak oil refers to the height
of global production and the recognition that at our continued usage rates, resource
depletion is approaching at an accelerating speed. Scientific predictions range though most
agree that the point of peak oil has passed, with the Association for the Study of Peak Oil
stating “the peak of oil discovery was passed in the 1960s, and the world started using
more than was found in new fields in 1981.”80 The bottom line is that much of today’s mass
agricultural productions has been proven unsustainable and support for such practices 76 Environmental Protection Agency. (2005, March). Agricultural Nonpoint Source Fact Sheet. Retrieved June 2012, from Environmental Protection Agency: http://water.epa.gov/polwaste/nps/agriculture_facts.cfm 77 Altieri, M. A. (2000, July 30). Modern Agriculture: Ecological impacts and the possibilities for truly sustainable farming. Retrieved June 2012, from Agroecology in action: http://nature.berkeley.edu/~miguel-alt/modern_agriculture.html 78 Altieri, M. A., Modern Agriculture 79 Tomczak, J. (2005, December 11). Implications of Fossil Fuel Dependence for the Food System. Retrieved May 2012, from Energy Bulletin: http://www.energybulletin.net/stories/2006-06-11/implications-fossil-fuel-dependence-food-system 80 Campbell, C. J. (2008). About Peak Oil. Retrieved June 2012, from The Association for the Study of Peak Oil and Gas: http://www.peakoil.net/about-peak-oil
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fueled by genetic engineering is conflicts with creating the sustainable food systems
necessary to support a growing population in a world of diminishing fossil fuels.
Regulatory Response: Environmental Protection Agency
The Environmental Protection Agency (EPA) regulates the pesticides that can be
used in or on foods, however the task of enforcing set tolerances is left to the Food and
Drug Administration81. It is the pesticides in foods, or more generally within a plant that
produces food, which are created using genetic engineering. These pesticides come in the
form of Plant Incorporated Protectants, or PIPs. In these plants, genes are introduced that
allow the plant to produce a pesticide, typically in the form of a protein, which is toxic to
the targeted pest. Pests are killed when they ingest the plant, protecting the plant from
further damage and eliminating the need for topical pesticides. All but ten of the forty-one
PIPs registered with the EPA use a protein derived from the bacteria bacillus thuringiensis,
often designated as Bt, including Bt potatoes and several versions of Bt cotton and corn.82
The EPA, UDSA-APHIS, and the Canadian Food Inspection Agency provide
development guidelines for the PIPs registered with the EPA. The registration process
requires a thorough product characterization report as well as a variety of toxicity and
environmental impact assessments. The product characterization and data requirements
focus on the development of the PIP and human/animal toxicity, using the data to set
maximum exposure levels and ensure that the protein will not act as an allergen.
Information required for product characterization include biological descriptions of the
source of the introduced genetic material, justification for its selection and any changes
made to the genetic sequence before introduction into the parent plant, methods used for
81 Schneider, Genetically Modified Food 82 Environmental Protection Agency, PIP Registrations
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genetic extrapolation and alteration, identification of the expressed trait, and any
associated hazards of the genetic transfer. Related data requirements include information
regarding maximum protein exposure levels for each part of the plant, characterization and
allergen analysis regarding expressed proteins, gene flow analyses (contamination
potential), and animal toxicity reports. Protein concentrations and toxicity evaluations are
used to set food tolerances or determine exemption from that requirement.83 All currently
registered PIPs have been deemed exempt,84 presumably based on the notion that
expressed proteins/toxins are not present in significant concentrations in the plant parts
consumed as food.
The environmental risk assessment portion of PIP review and registration focuses
on the impact of the pesticide on soil composition and non-target organisms, and the
potential for genetic contamination. Plant tissues are observed as they decompose in order
to assess the impact of toxicity concentrations and degradation rates as they become part
of the soil. Specific toxicity tests are conducted on a variety of specie categories including
oral toxicity tests to birds, wild mammals, fish and other marine creatures, non-target
plants, non-target insects, and even more specifically on honey bees and other selected
insects deemed to be beneficial to crop growth and natural ecosystems. If adverse effects
result from testing in any of these categories further testing is required in order to better
understand the impact of the PIP on the life cycle, reproduction, and population of the
particular category of species.85 In order to address genetic contamination, environmental
risk assessments also require the development of Insect Resistance Management Programs 83 Environmental Protection Agency. (2012, May 9). Introduction to Biotechnology Regulation for Pesticides. Retrieved August 2012, from US EPA: http://www.epa.gov/oppbppd1/biopesticides/regtools/biotech-reg-prod.htm#pips 84 Environmental Protection Agency, Introduction to Biotechnology Regulation for Pesticides 85 Environmental Protection Agency, Introduction to Biotechnology Regulation for Pesticides
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(IRMs) that aim to prolong the development of resistance to the PIP by determining
appropriate refuge requirements. IRM adoption is a stipulation of PIP use monitored via
grower surveys .86 Follow up inspections or denial of PIP use may occur in cases of
noncompliance. Additional resistance monitoring programs periodically test for growing
resistance to PIPs and recommend remedial action in cases where resistance has
developed.87
Though the EPA has developed thorough means of PIP assessment, it is extremely
problematic that this exhausts the scope of their GE crop oversight. Though PIPs compose
a significant proportion of the most popular strains of genetically engineered crops, each
variation presents unique environmental threats (as described by the “ripple effect”
associated with the complexity of vast ecosystems) dictating that consideration be given to
the environmental consequences of each and every variation. This point of criticism will be
end here as the role of the USDA has yet to be discussed. However, it may be worth
questioning the division of regulatory authority over genetically engineered crops between
the EPA and USDA in accordance with their perspective roles and mission given that the
USDA’s primary role is to advocate for the agricultural industry rather than the
environment.88
86Refuge requirements dictate that portions of the crop field be planted with PIP-free variations in order to support a nonresistant population to breed out any resistance developing in the target species (Environmental Protection Agency, Introduction to Biotechnology Regulation for Pesticides). 87 Environmental Protection Agency, Introduction to Biotechnology Regulation for Pesticides 88 United States Department of Agriculture. (n.d.). Mission Statement. Retrieved September 2012, from United States Department of Agriculture: http://www.usda.gov/wps/portal/usda/usdahome?navid=MISSION_STATEMENT Environmental Protection Agency. (2012, August 31). Our MIssion and What We Do. Retrieved September 2012, from Environmental Protection Agency: http://www.epa.gov/aboutepa/whatwedo.html
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Criticisms regarding the current work of the EPA primarily revolve around
compliance enforcement and their failure to address the need for pollution abatement
regarding large-scale agricultural production. Insect resistance management requirements
(IRM) were not required to accompany use of Bt corn until 2001 with following compliance
rates reported to be between 79 and 96 percent.89 Studies have shown these rates to be
overestimated and more likely between 72 and 76 percent. Compliance rates were found
to increase with farm size and awareness of IRM compliance programs,90 presumably due
to increases in professionalism and size of management staff, affordable due to larger
revenue margins on larger farms. Given this correction compliance measurement remains
problematic due the source of compliance data: grower surveys. Grower surveys are an
ineffective method of assessment due to the fact that they rely on the word of those being
regulated. Though this method of compliance assessment has significantly lower
enforcement costs than alternatives, i.e. genetic testing to ensure refuge requirements have
been planted, the validity of compliance data is indisputably less reliable.
The EPA’s response to runoff pollution is founded in a series of best management
practices rather than specific regulations limiting output.91 The ability for the EPA to
directly regulate farms is limited by the fact that this source of pollution is considered to be
non-point source, therefore preventing regulatory authorities and the public from being 89 Agricultural Biotechnology Stewardship Technical Committee. (2005). Insect resistance management grower survey for corn borer-resistant Bt field corn: 2004 growing season. Retrieved August 2012, from http://www.pioneer.com/biotech/irm/survey.pdf 90 Goldberger, J., Hurley, T., & Merrill, J. (2005). Bt Corn Farmer Compliance with Insect Resistance Mangement Requirements in Minnesota and Wisconsin. The Journal of Agrobiotechnology Management & Economics , 8 (2/3), 151-160. 91 Environmental Protection Agency. (2003, September 23). National Management Measures for the Control of Nonpoint Pollution from Agriculture. Retrieved August 2012, from Environmental Protection Agency: http://water.epa.gov/polwaste/nps/agriculture/upload/2003_09_24_NPS_agmm_chap2.pdf
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able to hold particular farms, or firms, accountable. Though best management practices
may be effectively communicated through mandatory educational requirements, the
adoption of such programs is not currently a regulatory requirement. Even in the case that
such practices were mandatory, individual farm compliance would be difficult to measure
due the non-point source nature of the pollution.
Regulatory Response: United States Department Of Agriculture
The United States Department of Agriculture’s Animal and Plant Health Inspection
Service (USDA-APHIS) regulates imports, interstate movement, and the environmental
release of genetically engineered organisms via permitting and notification procedures.
This includes all field trials of GEOs; however, trials conducted within a contained
laboratory facility are not regulated. Developers can petition for a GEO to obtain non-
regulated status if they can provide enough evidence that the GEO “poses no more of a
plant pest risk than that of an equivalent non-genetically engineered organism,” in which
case the organism may be introduced and transported without any oversight.92 A complete
list of non-regulated GEOs, as of July 17, 2012, may be found in Appendix A. The most
common alterations are lepidopteran resistance, lepidoptera being a group of insects
including moths and butterflies,93 and glyphosate and phosphinothricin tolerance, both
active ingredients in herbicides/plant growth regulators such as Monsanto’s Round Up.94
Other common alterations exempt from regulation include altered fruit ripening, male
92 USDA Animal and Plant Health Inspection Service. (2012, February). Biotechnology. Retrieved August 2012, from USDA Animal and Plant Health Inspection Service: http://www.aphis.usda.gov/biotechnology/submissions.shtml 93 Merriam-Webster Incorporated. (2012). Lepidoptera. Retrieved August 2012, from Merriam-Webster: http://www.merriam-webster.com/medical/lepidoptera 94 U.S. Environmental Protection Agency. (n.d.). Technical Factsheet on Glyphosate. Retrieved August 2012, from US Environmental Protection Agency: http://www.epa.gov/ogwdw/pdfs/factsheets/soc/tech/glyphosa.pdf
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sterility, and resistance to other pests and viruses. For those organisms that may pose a
risk to plant health, including risks to key insects and microbes, the permitting and
notification process of GEOs is implemented by Biotechnology Regulatory Services, a unit
of APHIS.95
Permits
Permits authorize the movement and environmental release, in the form of initial
field tests, of genetically engineered organisms including many food or feed crops and all
GEOs with an industrial or pharmaceutical purpose. Some food and feed crops may meet
criteria for the notification process, but all GEOs with industrial or pharmaceutical
purposes require permits.96 Permits require that specific criteria be met in order to
prevent the natural spread of transgenes from the crops and GEOs to related wild species
in the environment. Separate permits are granted for importation, interstate movement, or
environment release of plants and GEOs, although the application process for each is the
same. All permits allow for federal inspection of the premises including the site of the field
trial and any storage facilities after the plant or GEO has been imported or relocated.97 The
permit also requires that detailed follow up information on field trials be reported to APHIS
95 Animal and Plant Health Inspection Service. (2012, April). Biotechnology. Retrieved September 2012, from Animal and Plant Health Inspection Service: http://www.aphis.usda.gov/biotechnology/brs_main.shtml 96 Animal and Plant Health Inspection Service. (2006, February). Biotechnology Regulatory Services Factsheet. Retrieved June 2012, from Animal and Plant Health Inspection Service: http://www.aphis.usda.gov/publications/biotechnology/content/printable_version/BRS_FS_bionotifcation_02-06.pdf 97Code of Federal Regulations. (2011, January 1). Title 7 - Agriculture Section 340.4 Permits for the introduction of a regulated article. Retrieved June 2012, from U.S. Government Printing Office: http://www.gpo.gov/fdsys/search/pagedetails.action?browsePath=Title+7%2FSubtitle+B%2FChapter+III%2FPart+340%2FSection+340.3&granuleId=CFR-2011-title7-vol5-sec340-3&packageId=CFR-2011-title7-vol5&collapse=true&fromBrowse=true&bread=true
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six months after the completion of the trial in order to track the outcomes and potential
risks of increased environmental exposure.98 Permit applications require a detailed
characterization of the plants or GEO including a description of how the organism will be
introduced to the environment and how genetic spread has been prevented in the country
of origin and how it will be prevented in each of its destinations.99 Permit conditions
further dictate how the organism is packed for transport, how such materials are disposed
of, identification throughout transportation and field testing, and the disposal of all organic
and inorganic material in contact with the GEO throughout and after field testing is
complete. Other conditions assure inspector access to the location of and records
pertaining to the GEO at any point throughout transportation and give authority to
administrators to determine remedial methods for preventing genetic contamination. The
final conditions dictate the content of data reported at the conclusion of the field test and
require immediate notification in cases of accidental unauthorized (beyond the parameters
of the field test) environmental release. Permits may be revoked at any time if these
specific conditions are not upheld. Furthermore, additional information may be required
by the Biotechnology Regulatory Service along with more specific conditions for permit
issuance determined on a case-by-case basis.100
98 Animal and Plant Health Inspection Service., Biotechnology Regulatory Services Factsheet 99 Animal and Plant Health Inspection Service. (2012, September 28). Biotechnology. Retrieved October 2012, from Animal and Plant Health Inspection Service: http://www.aphis.usda.gov/biotechnology/permits.shtml 100 Code of Federal Regulations., Title 7 - Agriculture Section 340.4 Permits
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Notifications
The notification process became available in 1993101 as a streamlined alternative to
obtaining a permit. In order to qualify for the notification option the genetically engineered
plant must be considered a “lower risk plant “ and meet specific eligibility requirements
and performance standards for introduction into the environment102 intended to ensure
genetic confinement.103 According to APHIS, lower risk plants “include those altered for
pest resistance, herbicide tolerance, agronomic properties such as male sterility, and
product quality such as delayed fruit ripening,” and does not include plants modified for
pharmaceutical or industrial purposes.104 In addition, eligibility requirements dictate that
the plant not be on the Federal Noxious Weed list or be considered a week in the region
where the release will occur, introduced genetic material is well-characterized with a
known function and must not be derived from specific human or animal pathogens, is not
likely to pose a risk of creating a new virus or being toxic to non-target organisms, and is
unable to be transferred to new plants via reproductive processes.105 Notifications are
issued with performance standards similar to those of permits.
Though the scope of USDA regulation is much wider than the EPA in that it oversees
the field-testing for all varieties of genetically engineered crops, its current regulatory
regime remains inadequate as it primarily focuses on the development process and fails to
maintain oversight once market approval for crop production has been issued. Concern is
given to the risks of genetic contamination through the duration of field-testing and as 101 Animal and Plant Health Inspection Service., Biotechnology Regulatory Services Factsheet 102 Animal Plant Health Inspection Service. (2012, April 10). Biotechnology. Retrieved June 2012, from Animal Plant Health Inspection Service: http://www.aphis.usda.gov/biotechnology/notifications.shtml 103 Animal and Plant Health Inspection Service., Biotechnology Regulatory Services Factsheet 104 Animal and Plant Health Inspection Service., Biotechnology Regulatory Services Factsheet 105 Animal and Plant Health Inspection Service., Biotechnology Regulatory Services Factsheet
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genetically engineered material is transported, though such precautions are not considered
once production of the marketable product begins. Though the risks of release may have
been determined to be minimal, a test setting, even one located outdoors, can never
adequately replicate the variation and complexity found in nature, revealing little about the
potential “ripple effect” of large-scale production. In addition, it is unclear whether
transportation regulations oversee the movement of GE products on the market, which
often contain seeds.
Regarding the maintenance of consumer transparency, the USDA does not make
assessments and results of field tests readily available to the public. This includes
information regarding additional requirements or remedial measures attached to permit
issuance or reports of accidental unauthorized release of genetically engineered material.
Though this information is likely available via the Freedom of Information Act, this does
not facilitate the ability for the public to become well informed and inhibits their ability to
hold firms accountable for irresponsible practices and noncompliance. In addition, the
issue of compliance enforcement must again be raised due to the self-reporting nature of
regulatory oversight. Although investigator access is a stipulation of permits, information
regarding the rate of such occurrences is unknown, pending a FOIA request. In conclusion,
both the EPA and the USDA fail to recognize the breadth of the potential impact of
genetically engineered crops on the environment. Though the risks, as perceived from field
studies, may be determined as low, this information must be considered with more weight
given to the knowledge that many environmental issues related to genetically engineered
crops do not present themselves unless given ample time to develop, and even then, may
not present devastating threats unless the impacts occur on a large-enough scale. Given
the variety of genetic modifications available, the intimate nature of the science, and the
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irreversibility of genetic dispersion, we must carefully consider whether this is a risk we, as
a global community, are willing to take.
ETHICS AND TRANSPARENCY
The controversy surrounding the impact of genetically engineered foods on human
and environmental health provides consumers with significant reason to want to know if
the food they consume has been genetically engineered. The idea of consumer knowledge
influencing purchasing preferences is not limited to genetic engineering; rather it is an
overarching theme relevant to all areas of consumption where distinct alternatives are
provided. Sometimes information comes in the form of mandatory labeling, other times it
is provided voluntarily by producers in order to appeal to a particular consumer profile.
For example, there is a distinct market for consumers who strongly believe in animal
welfare: cosmetics that are not tested on animals, eggs from free-range chickens, and
consumers who avoid clothing made from fur or leather, or for those who care about the
environment: products that are biodegradable or made from recycled material, or nontoxic
cleaning materials. In these cases, producers are voluntarily including information about
their product in response to consumer demand in the same way that food producers may
voluntarily label products as GE-free.
Regulatory agencies are trusted with the task of determining what information is
relevant enough to require mandatory labeling, whether it is in the form of an ingredients
list or toxicity warning. Regulatory standards are based on scientific evidence and rooted
in the ethical values established in the written law in order to protect consumers who do
not have the ability to protect themselves. These regulations, often a compromise between
ideal practices and the ability for the market to act freely, are essentially minimum
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standards that are built upon by industry standards and consumer expectations. In order
to maintain legitimacy and public trust evaluation materials must be available to the public.
Given that regulatory authorities conduct thorough assessments, which address the
consumer points of concern, this transparency can settle public concern.
When consumer standards are higher than those enforced by regulation, the
consumer must rely on information provided voluntarily in order to express their values
through purchasing preferences. Although regulatory standards and consumer protection
authorities were developed to enhance the safety of product development and
consumption, they often act as a screen, protecting industry from being held responsible to
the consumer directly. Consider this idea using the examples above. With the
establishment of Environmental Protection Agency and the passing of the Animal Welfare
Act the United States made a commitment to the protection of the environment and animal
rights. Though these entities have established regulation to protect the environment and
animal welfare, product testing on animals and the use of toxic chemicals remain legal. In
regard to food production this could be likened to consumer attitudes toward confined
animal feeding operations (CAFOs) or the use of “pink slime” as filler in ground beef,106
neither of which are particularly appealing to consumers but entirely legal. For many
consumers this is a nonissue, but for those that do care, they should have the right to avoid
these products if they so choose. This is of particular importance for highly controversial
issues where public values have yet to be established, as is the case with genetic
engineering.
106USA Today. (2012, April 1). Lean beef or pink slime? It's all in a name. (B. Jones, Editor) Retrieved May 2012, from USAToday: http://usatoday30.usatoday.com/news/opinion/editorials/story/2012-04-01/pink-slime-lean-beef/53933770/1
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Over the past two decades the seemingly ever-increasing prevalence of genetically
engineered foods has occurred without being overtly visible to the consumer. Although
regulatory authorities have accepted the technology, public concern regarding its use
persists. As mentioned above, genetically engineered foods present an extensive
controversy regarding its effects on human and environmental health and safety.
Additionally, the manipulation and ownership of genes presents the public with an
ethically sensitive discussion regarding the makings of life and the role of humankind in
manipulating it. This discussion begins with the ability, granted in Diamond v. Chakrabarty
to patent genes. Ananda Chakrabarty was originally denied patent rights to his genetically
engineered bacterium on the basis that living things are not patentable, however, the
Supreme Court established in a 5 to 4 ruling that since the bacterium are not found in
nature it is in fact a “composition of matter,” patentable under Section 101, Title 35 of the
U.S. Code.107 This landmark case extended the ability to patent life in the form of unique
plant varieties to include specific gene sequences, encompassing virtually all products of
genetic engineering. Although the patentability of gene sequences encourages collective
research by protecting patented information when shared, the decision is a disconcerting
step in the wrong direction for those with ethical oppositions to the manipulation of nature
at such an intimate level.
To date, genetically engineered food products are primarily derived from plants
with several varieties of genetically engineered seafood, though the technology has been
applied in research settings to other species, namely livestock, with primarily
107Diamond v. Chakrabarty, 447 U.S. 303, 79-136 (U.S. Supreme Court June 16, 1980)
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pharmaceutical and medical goals.108 These species are removed enough from humans for
the ethics of this practice to not generally be questioned, but this technology applied to
more relatable species, such as pigs, may generate more attention. In other words,
acceptance of genetic engineering in plants and mollusks opens the door for the technology
to be used in other animals, which begs the question, where should we draw the line? How
would this application of genetic engineering compare to other treatment given to animals
for the sake of satisfying a human food need, whether it be creating leaner or more
flavorful meat by deviating from the species’ natural diet, or shortening the birth to
slaughter cycle by administering growth hormones or steroids? In order to give consumers
the opportunity to express their values regarding genetically engineered foods via
purchasing preferences, they must have access to enough information to distinguish
between product alternatives, namely, access to government safety assessments in order to
determine whether satisfying these requirements meets their needs and, in the case that
they do not, labeling allowing them to identify the products they seek to avoid.
Regulatory Response: Food And Drug Administration The idea that genetically engineered foods and food additives are “substantially
equivalent” to their conventional counterparts also guides FDA labeling regulations of such
foods or foods containing genetically engineered ingredients. The authority granted to the
FDA by the Federal Food, Drug, and Cosmetic Act only permits the FDA to require labeling
108 U.S. Food and Drug Administration. (2011, May 23). Genetically Engineered Animals General Q & A. Retrieved August 2012, from U.S. Food and Drug Administration: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm113605.htm
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that identifies “significant changes in a food’s composition,”109 therefore disqualifying
“substantially equivalent” genetically engineered foods from being labeled as such.
However, labeling criteria for foods in general may require that some genetically
engineered foods be labeled in a manner that identifies compositional changes in the food
caused by the modification or avoids problems that may be created by the absence of a
label. Special labeling requirements may be imposed under the following circumstances:
1. “If a bioengineered food is significantly different from its traditional counterpart
such that the common or usual name no longer adequately describes the new food,
the name must be changed to describe the difference [for example, soybeans altered
to have a high oleic acid content have been renamed as high oleic acid soybeans];
2. If an issue exists for the food or a constituent of the food regarding how the food is
used or consequences of its use, a statement must be made on the label to describe
the issue for example, ‘reduced fat margarine not suitable for frying;’
3. If a bioengineered food has a significantly different nutritional property, its label
must reflect the difference;
4. If a new food includes an allergen that consumers would not expect to be present
based on the name of the food, the presence of that allergen must be disclosed on
the label”110
The term significant in these requirements refers to the traits expressed by the alternation
whereas the “substantially equivalent” determination refers to the introduced genetic
material.
109Maryanski., Genetically Engineered Foods: Hearing before the Subcommittee 110 U.S. Food and Drug Administration., Guidance for Industry: Voluntary Lableing
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Any additional labeling, for instance notification that a product does or does not
contain genetically engineered material, is purely voluntary. The FDA developed industry
guidelines for labeling of this nature as a response to the public’s desire to have the
information and manufacturers’ desire to respond. This desire was expressed to the FDA
during public meetings held in 1999, in which it received over 50,000 written comments
primarily expressing concerns regarding long-term effects and the unknown. Because no
scientific evidence was provided with these comments, the comments did not provide the
FDA with a basis for requiring the labeling of genetically engineered foods. The goal of
industry guidelines, however, is to allow manufacturers to provide information voluntarily,
without being misleading. Statements claiming that a product is or is not genetically
engineered are considered within the context of the entire label in order to determine
whether they are misleading. As guidance, the FDA provides example statements to be
used on labels, accompanied with explanations and comments based on regulations and
consumer studies. For example, based on FDA focus group data discussed in industry
guidelines, consumers prefer the term “biotechnology” over “genetic modification” or
“genetic engineering,” to inform consumers when a product is genetically engineered. Data
also revealed that common acronyms such as “GMO free” and “GM free” are not often
understood by consumers, instead suggesting that whole words be used instead. As
previously mentioned, “genetically modified” is not technically an accurate description of
bioengineering methods and therefore the FDA will not allow the phrase to be used
(because it is misleading) unless within a context that clearly refers to recombinant DNA
technology. The data shows that consumers are also interested in the purpose for which
the product was modified. In response to these expressed preferences, the following
sample labeling statements provided as part of industry guidelines.
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"Genetically engineered" or "This product contains cornmeal that was produced
using biotechnology."
"This product contains high oleic acid soybean oil from soybeans developed using
biotechnology to decrease the amount of saturated fat."
"These tomatoes were genetically engineered to improve texture."
"Some of our growers plant tomato seeds that were developed through
biotechnology to increase crop yield."111
Labeling issues regarding absence labeling – i.e., notification that the product was
not produced with genetic engineering -- primarily revolve around the use of the term
“free” and suggestions that products not containing genetically engineered material are
superior to those that do. Since “free,” implying “zero,” can never be assured, even with
advanced testing capabilities, a testable threshold must be defined for the term’s use.
However, since the realm of possible genetic alterations is so large, and amplified by an
array of products, the FDA is unable to measure, and therefore set, minimum thresholds at
this time. The FDA provides alternative labeling statements that avoid the use of the term
“free,” such as “we do not use ingredients that were produced using biotechnology” and
“this oil is made from soybeans that were not genetically engineered.”112 Note that USDA
organic certification requires that products or ingredients “must not be produced using
biotechnology methods”113 meaning that organic labels are an indirect form of GE-free
labeling.
111 U.S. Food and Drug Administration, Guidance for Industry: Voluntary Lableing 112 U.S. Food and Drug Administration, Guidance for Industry: Voluntary Lableing 113 U.S. Food and Drug Administration, Guidance for Industry: Voluntary Lableing
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Because labeling of genetically engineered foods remains voluntary, consumers rely
on the regulatory authority, in this case the FDA, to ensure such foods are safe for human
consumption. In order to maintain legitimacy in the eyes of the consumer the FDA must be
transparent in their process to determine the safety of genetically engineered foods. As
detailed in the previous section, Human Health and Safety (page 16), the FDA holds that
because genetic modifications introduced into foods thus far have come in the form of
familiar fats, proteins, and carbohydrates, genetically engineered foods are considered to
be “generally recognized as safe.” This classification exempts such foods from requiring
FDA premarket approval and therefore FDA safety assessments.114 Such regulation, in
essence, no regulation, provides the consumer with little reason to increase their
confidence in the actions of the FDA and thus the safety of genetically engineered foods.
However, the informal reporting process previously mentioned allows developers of
genetically engineered foods to submit safety and nutritional assessments to the FDA for
review.115 As previously noted, the FDA claims that it is the agency’s “expectation and
experience that all firms have complied with this request for all plant varieties that have
been commercialized to date.”116 It is unknown whether the FDA would require
submission of safety and nutritional assessments by firms in the absence of voluntary
compliance, though if the FDA required such reports they may be considered with more
validity than under the current circumstances. This statement is based on the fact that all
information provided in these reports is submitted voluntary by the developing firm,
making it unlikely that the reported information includes negative assessments of the
product, which may lead to removal of the product from the market. If safety and 114 Maryanski, Genetically Engineered Foods: Hearing before the Subcommittee 115 Maryanski, Genetically Engineered Foods: Hearing before the Subcommittee 116 Maryanski, Genetically Engineered Foods: Hearing before the Subcommittee
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nutritional assessments were required by the FDA, reports could be reviewed with more
confidence in the information provided knowing that all required information has been
submitted, rather than only information consistent with the current assumption of
“substantial equivalence,” and therefore unregulated introduction in the market. The
information has the potential to address consumer concerns only if fair evaluations are
submitted to the FDA and made available for public review. Although individual
consumers may not have the knowledge to be able to evaluate the reports, third party
watchdog organizations may be able to provide consumers with independent evaluations.
Industry guidelines on the context and submission of assessments inform developers that
the text of submissions as well as the FDA’s response letter will be made publicly available
via the FDA’s website.117 Indeed, inventories of final biotechnology consultations, new
protein consultations, and a master file on food additive petitions may be found on the FDA
website.118 Additionally, any correspondence between the development firm and the FDA
including written materials and inquiries/discussion regarding the submission is recorded
in an administrative file. This additional information is available to the public in
accordance with the Freedom of Information Act.
Upon review of the nine types of information exempt from public release in the
Freedom of Information Act, none were found to restrict the release of information
pertaining to the development or assessment of genetically modified foods with the
117 U.S. Food and Drug Administration, Guidance for Industry: Recommendations for the Early Food Safety Evaluation 118 U.S. Food and Drug Administration. (2011, December 23). Submissions on Bioengineered New Plant Varieties. Retrieved May 2012, from U.S. Food and Drug Administration: http://www.fda.gov/Food/Biotechnology/Submissions/default.htm
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exception of that that protects trade secrets.119 This is potentially problematic in regards
to accessing information about the development of genetically engineered foods because
the courts have interpreted patent rights to include novel recombinant DNA technology120
– the methods used to develop genetically engineered foods. It is at the discretion of the
FDA to determine if recombinant DNA methods constitute a “trade secret or privileged or
confidential commercial… information.”121 It is a reasonable expectation that the
information be deemed accessible if it has received protection under patent law. If novel
recombinant methods that had yet to be granted patent rights, the agency may either deny
the release altogether or delay the public release of information until the patent process is
complete. Even in this scenario, the release of other information regarding the
development and assessment of the food product would not be prevented.
Issues related to the current regulatory response relate to the implications of the
“substantial equivalence” stance which, however true under the limited realm of FDA, fails
to address environmental implications and blocks the Agency’s potential to require the
submission of specific information. The FDA determination of “substantial equivalence”
reacts only to the implications of direct consumption of genetically engineered foods on
human safety and ignores the greater public health implications brought on by the
environmental effects of the production of such foods. This is problematic because it
ignores the deep connection between the health of a people and their environment.
Additionally, the labeling policies derived from the “substantial equivalence” stance
prevent consumers from expressing values unrelated to the consumption of the food. Even
119 Freedom of Information Act, 5 U.S.C. Section 552(b)(4) (1966). Retrieved from: http://www.archives.gov/about/laws/foia.html 120 Diamond v. Chakrabarty 121 U.S. Food and Drug Administration, Submissions on Bioengineered New Plant Varieties
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if a consumer is confident in the stance of the FDA regarding human consumption of
genetically engineered foods, they may choose to avoid such products because of their
values surrounding the ethical or environmental implications of its production.
Additionally, the “substantial equivalence” stance blocks Agency attempts to require
informative submissions in the case that development firms did not comply with Agency
requests for nutritional and safety assessments. Using the same reasoning from which the
FDA’s no regulation policy is derived, this stance prevents the FDA from having justification
to require assessments of genetically engineered foods unless such assessments are also
required for conventionally developed foods. In essence, the “substantial equivalence”
stance prevents the FDA from regulating genetically engineered foods in any manner that
differs from the regulation of conventional foods, eliminating all opportunities for
compromise between the current regulatory regime and consumer demands for strict
regulation of genetically engineered foods.
GLOBAL COMPETITIVENESS
Controversy regarding genetically engineered foods is not limited to the United
States; in fact, many countries across the globe have implemented some sort of ban on
either the production, importation, or market sale of genetically engineered foods, most
prominently the European Union. These bans greatly reduce the market potential for
genetically engineered foods produced in the United States. In addition, United States
labeling regulations, or lack thereof, generate concern that even GE-free imports may be
contaminated with genetically engineered product.
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From 1998 to 2004 the European Union banned all imports of genetically modified
organisms from the United States.122 Today the European Union allows fifty unique
varieties of genetically modified crops grown outside of its borders to be imported, most of
which are used for industrial purposes or as animal feed rather than for direct human
consumption.123 Until the 2011 the European Union maintained a zero-tolerance policy on
imports of genetically engineered foods, which dictated that shipments with even trace
amounts of unauthorized GE strains be rejected. This policy was changed to a 0.1 percent
contamination threshold because of contamination concerns due to the high prevalence of
GE strains throughout the North and South Americas.124 Furthermore, the European
Commission for cultivation within the European Union has authorized only two genetically
modified crops: a maize variety developed by Monsanto and a potato variety developed by
BASF. However, due to the general disapproval of genetically modified foods across
Europe, BASF, a German based company, is moving its production of genetically modified
crops to the United States, stating that it no longer makes sense from a business standpoint
to target the European market. This will likely leave Monsanto’s maize as the only
prominently cultivated GE crop in the European Union. Although some European countries
are more supportive of genetic technology (Spain, Sweden, United Kingdom, Netherlands),
others have attempted to regulate its use beyond the strict regulations already in place by
122 Wright, T. (2005, November 27). Swiss Ban Genetically Modified Crops. Retrieved August 2012, from The New York Times: http://www.nytimes.com/2005/11/27/international/europe/27cnd-swiss.html?_r=2 123 Keating, D. (2012, January 26). What future for GM crops in Europe? Retrieved August 2012, from EuropeanVoice.com: http://www.europeanvoice.com/article/imported/what-future-for-gm-crops-in-europe-/73337.aspx 124 Driver, A. (2011, June 27). EU confirms end of 'zero tolerance' GM feed policy. Retrieved August 2012, from Farmers Guaridan: http://www.farmersguardian.com/home/livestock/livestock-news/eu-confirms-end-of-'zero-tolerance'-gm-feed-policy/39926.article
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the European Union.125 Austria, Hungary, Poland, and Greece have fought against
authorizations for the cultivation of additional genetically engineered varieties126 and
additional bans on genetically engineered foods have been implemented both regionally
and nation-wide. Six EU countries placed bans on all forms of GMOs, though the ban was
ruled invalid by the European Court of Justice, which stated that only the EU has the
authority to make such bans.127
Global weariness of genetically engineered foods poses a problem for both GE and
GE-free producers in the United States. For producers of GE foods the problem is clear: the
global market for genetically engineered foods is limited. For producers of GE-free foods
the problem is slightly more complex. Although their product is welcome in international
markets, the threat of importing a product contaminated with traces of genetically
engineered material is a turnoff. This has led some domestic producers of GE-free foods to
support mandatory labeling initiatives for genetically engineered ingredients hoping to
increase international confidence that GE-free exports are truly GE-free.128
Regulatory Response: International Regulations & Domestic Labeling
The Codex Alimentarius Commission (CAC), a combined organization of the World
Health Organization and the Food and Agriculture Organization of the United Nations, is
125 Keating, What future for GM crops in Europe? 126 Keating, What future for GM crops in Europe? 127 Bloom, J. (2011, March 23). Is Europe's ban on Monsanto's GMO crops illegal? Retrieved August 2012, from Red Green and Blue: http://redgreenandblue.org/2011/03/23/is-europes-ban-on-monsantos-gmo-crops-illegal/ 128 AG Professional. (2012, February 7). Handful of wheat farmers support GM food labeling. (C. Scherer, Editor) Retrieved August 2012, from AG Professional: http://www.agprofessional.com/news/Wheat-farmers-support-GM-food-labeling-138809914.html
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recognized as the international authority on food safety standards.129 Because the
organization does not have an enforcement department, the organization’s impact on its
165 member states, which includes the United States, is limited to making voluntary
recommendations. However, these recommendations are recognized by the World Trade
Organization130 and used as reference points via the WTO’s Agreement on the Application
of Sanitary and Phytosanitary Measures.131 The Agreement urges WTO member countries
to follow international standards for food safety and animal and plant health, and allows
counties to develop higher standards when scientifically justified.132 For example, CAC
standards regarding sanitary measures and hormone use in meat and meat products were
used by the WTO in addressing Dispute DS26, filed in 1996, in which the United States filed
a complaint against the European Community for prohibiting the use of hormones in
livestock farming.133
In 2001 the Codex Alimentarius Commission developed the first global principals
for safety assessments of genetically modified organisms, stating “that the safety of food
derived from genetically modified organisms should be tested and approved by
governments prior to entering the market… in particular… for their potential to cause
129 Codex Alimentarius. (2012). About Codex. Retrieved June 2012, from Codex Alimentarius: http://www.codexalimentarius.org/about-codex/en/ 130 The World Trade Organization is a member-run organization that aims to ease the barriers to international trade. The United States is a member organization of the WTO. 131 World Trade Organization. (2012). Sanitary and Phytosanitary Measures. Retrieved May 2012, from World Trade Organization: http://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm 132 World Trade Organization. (1998, May). Understanding the Sanitary and Phytosanitary Measures Agreement. Retrieved May 2012, from World Trade Organization: https://www.wto.org/english/tratop_e/sps_e/spsund_e.htm 133 World Trade Organization. (2009, September 25). dispute settlement - DS26. Retrieved May 2012, from World Trade Organization: http://www.wto.org/english/tratop_e/dispu_e/cases_e/ds26_e.htm
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allergic reactions.”134 Between 2003 and 2008 the CAC released several guidelines
regarding the conduct of safety assessments on foods produced from recombinant-DNA
plants (Guideline for the Conduct of Food Safety Assessment of Foods Derived from
Recombinant-DNA Plants CAC/GL 45-2003), microorganisms (Guideline for the Conduct of
Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms CAC/GL
46-2003), and animals (Guideline for the Conduct of Food Safety Assessment of Foods Derived
from Recombinant-DNA Animals CAC/GL 68-2008). Each guideline provides a framework
for food safety assessment, suggesting that product characterizations, toxicity and safety
assessments be submitted for thorough review. The Guidelines require that the
experiments conducted to acquire data for the toxicity and safety assessments “be designed
and conducted in accordance with sound scientific concepts and principles, as well as,
where appropriate, Good Laboratory Practice… and [data] analyzed using appropriate
statistical techniques” and that primary data be available to regulatory authorities.135
Additionally, these documents acknowledge the inherent fact that unintended effects, both
predictable and unexpected, may occur, stating that safety assessments should also address
this possibility in a manner that reduces the likelihood of adverse effects on human
health.136
134 World Health Organization. (2001, July 6). Codex Alimentarius Commission Discusses Safety of Genetically Modified Foods, Approves Toxin Limits and Guidelines for Organic Livestock Farming. Retrieved May 2012, from World Health Organicatoin Press Releases: http://www.who.int/inf-pr-2001/en/pr2001-33.html 135 Codex Alimentarius. (2003). List of Standards: CAC/GL 46-2003. Retrieved May 2012, from Codex Alimentarius: http://www.codexalimentarius.org/standards/list-of-standards/en/?no_cache=1 136 Codex Alimentarius. (2003). List of Standards: CAC/GL 45-2003. Retrieved May 2012, from Codex Alimentarius: http://www.codexalimentarius.org/standards/list-of-standards/en/?no_cache=1
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In addition to food safety, the Codex Alimentarius Commission also addresses issues
of food labeling, including those derived from modern biotechnology, in order to facilitate
international trade. In July 2011 the CAC decided, against significant delegate opposition,
to draft an amendment to the General Standard for the Labeling of Prepackaged Foods that
provided voluntary labeling guidelines.137 The decision also protects a country’s right to
mandate labeling of foods or food ingredients derived from modern biotechnology. In
order to appease concerns regarding trade barriers generated by the labeling of GE or GE-
free products, the CAC calls for labeling of exports to be accompanied by the labeling of
domestic products.138 This is intended to level the playing field between the two categories
of products and maintain consistent regulation within a country. In other words, it is
unfair for a country to mandate the labeling of exported products in response to a
perceived difference between them yet determine that domestic products need not be
labeled because the products are not considered to be significantly different.
A second source of international regulation, the Cartagena Protocol on Biosafety,
addresses environmental concerns related to the movement of genetically engineered
living organisms between countries. The legally binding Protocol only regulates LMOs, or
living modified organisms, that are capable of transferring or replicating genetic material,
therefore becoming a source of genetic contamination.139 Developed in the year 2000 and
taking effect in September 2003, the Protocol supplements the Convention on Biological
Diversity by providing importing countries with a framework for becoming informed of the 137 Codex Alimentarius . (2011, May 9-13). Meetings & Reports. Retrieved May 2012, from Codex Alimentarius : ftp://ftp.fao.org/codex/meetings/CCFL/CCFL39 138 Suppan, S. (2011, July 13). The GMO labeling fight at the Codex Alimentarius Commission: How big a victory for consumers? Retrieved May 2012, from Institute for Agrcultural and Trade Policy: http://www.iatp.org/blog/201107/the-gmo-labeling-fight-at-the-codex-alimentarius-commission-how-big-a-victory-for-consum 139 World Health Organization, 20 questions on genetically modified foods
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risks of genetic contamination and precautionary measures for mitigation.140 The
Convention on Biological Diversity, signed by 150 nations at the 1992 Rio Earth Summit, is
a tool for implementing sustainable development principles identified at the Summit.141
The Cartagena Protocol has been ratified by 163 nations including seven of the top ten
producers of genetically engineered crops. As of May 2012, the United States, Argentina,
and Canada, the first, third, and fifth largest producers of genetically engineered crops had
not ratified the Cartagena Protocol.142
Although these regulations offer some degree of confidence in the international
oversight of the development and movement of genetically engineered foods, they do not
address trade issues dealing with the possible contamination of GE-free foods. In order to
prevent contamination, careful tracking mechanisms must be in place to ensure that GE-
free foods never come into contact with GE foods, a practice that can only take place if
labeling of GE foods is required. Though international regulators attempt to address
labeling concerns, they require that foods destined for the domestic or international
market be treated in the same manner. This policy ensures that nations maintain a
consistent view on genetically engineered foods (i.e. nations cannot have a policy that
distinguishes between GE and GE-free exports if domestic regulation deems the two to be
substantially equivalent). Additionally, it ensures that GE-free products intended for
140 Convention on Biological Diversity. (2012, May 29). About the Protocol. Retrieved May 2012, from Convention on Biological Diversity: http://bch.cbd.int/protocol/background/ 141 Convention on Biological Diversity. (2012, July). The Convention on Biological Diversity. Retrieved August 2012, from Convention on Biological Diversity: http://www.cbd.int/convention/ 142 Convention on Biological Diversity. (2011, April 12). Parties to the Protocol and signature and ratification of the Supplementary Protocol. Retrieved May 2012, from Convention on Biological Diversity: http://bch.cbd.int/protocol/parties/
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exportation under the assumption that they have been separated from GE varieties in order
to reduce the risk of contamination have indeed been separated prior to exportation.
However, this policy prohibits the United States from mandating that GE foods
intended for export be labeled as such. As previously stated the FDA maintains a policy of
“substantial equivalence,” meaning that GE foods are not significantly different than their
conventional counterparts and therefore cannot be regulated differently. Unless the FDA
changes this core concept the United States cannot mandate labeling of genetically
engineered foods regardless of its intended market. This leaves American producers of GE-
free foods in the international market to face scrutiny as the international market
continues to fear the contamination of GE-free products.
REGULATORY CONCERNS
The state of genetic engineering in the United States is closely related to the
regulatory regime under which it has been regulated. The “substantial equivalence” decree
by the FDA and the resulting voluntary labeling regulations have allowed for an extremely
high prevalence of genetically engineered products to inundate the market without the
consumers knowledge. Relatively recent spikes in public attention focused on the
relationship between those who regulate and those who are regulated (i.e. Citizens United
v. Federal Election Commission, the recent Supreme Court case which questioned the ethics
behind anonymous corporate donations to political campaigns143) in combination with the
agrochemical giant Monsanto’s history of poor public perception have caused many to
question the history behind the FDA’s regulatory regime. Widely popularized in Marie-
143 Citizens United v. Federal Election Commission, 08-205 (Supreme Court of the United States January 21, 2010).
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Monique Robin’s documentary The World According to Monsanto,144 Michael Taylor’s role
in both the development of Monsanto’s policy recommendations and later, in the
development of the FDA’s policy formalizing the notion of “substantial equivalence” caused
the public to turn a critical eye on the regulation of genetically engineered foods, and the
implications of such regulations, in particular.
The concept of a revolving door is commonly used to explain the movement of
experts between academia, private sector development, and public sector regulation.
Though the motive for seeking industry experts in policy development is clear: to obtain
expert analysis and advice, the movement of an employee from the private sector into the
public sector in particular tends to generate criticisms regarding ethical policymaking due
to the fear of biased decision-making based on previous affiliations and the associated
potential for certain policy choices to be tied to personal benefits. The career path of
Michael Taylor, the current FDA Deputy Commissioner for Foods,145 epitomizes the concept
of a revolving door as he has bounced back and forth between holding executive positions
at Monsanto and the FDA146 with periodical hiatuses in academia at the University of
Maryland’s School of Medicine and the George Washington University School of Public
Health and Health Services.147 Taylor’s career in government began in the FDA as a staff
144 The World According to Monsanto. Dir. Marie-Monique Robin. TulsaTruth, 2008. DVD. 145 U.S. Food and Drug Administration. (2011, October 19). Meet Michael R. Taylor, J.D., Deputy Commissioner for Foods. Retrieved November 2012, from U.S. Food and Drug Administration: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/ucm196721.htm 146 Flock, E. (2012, January 30). Monsanto petition tells Obama: 'Cease FDA ties to Monsanto'. Retrieved November 2012, from The Washington Post: http://www.washingtonpost.com/blogs/blogpost/post/monsanto-petition-tells-obama-cease-fda-ties-to-monsanto/2012/01/30/gIQAA9dZcQ_blog.html 147 U.S. Food and Drug Administration., Meet Michael R. Taylor
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attorney148 before taking a job at the private law firm representing Monsanto where Taylor
helped to establish the firm’s food and drug law practice.149 After a short stint with the
FDA as Deputy Commissioner for Policy in 1991-1992150 Taylor returned to Monsanto, this
time playing an important role in the development of regulatory recommendations
regarding genetically engineered products, advising a no-regulation policy.151 The story
gets fishy when, in Taylor’s next move back to the FDA as Administrator of the Food Safety
& Inspection Service in 1994, he became responsible for the FDA’s adoption of the
“substantial equivalence” determination and resulting no-regulation policy,152 essentially
turning into law the recommendations he had developed as a Monsanto employee. This is
by no means the only example of the movement of employees between the biotech industry
and the federal entities responsible for their regulation. Other examples include William
Ruckelshaus, Lidia Watrud, and Linda Fisher, who each held positions at the EPA and
Monsanto; Michael Friedman of the FDA and Searle, a subsidiary of Monsanto; Anne
Veneman of the Department of Agriculture and Calgene, a subsidiary of Monsanto; and
Justice Clarence Thomas of the Supreme Court and Monsanto.153 It is no wonder the public
consciousness fosters great concern regarding the impact of the agricultural industry on
policy development.
Regulatory enforcement and related tracking issues regarding the cultivation,
manufacturing, and sale of genetically engineered crops are plagued by challenges
associated with the lack of labeling. Regulatory oversight ensuring genetically engineered
148 U.S. Food and Drug Administration., Meet Michael R. Taylor 149 Flock, E., Monsanto petition tells Obama: 'Cease FDA ties to Monsanto'. 150 CITATION 151 CITATION 152 Flock, E., Monsanto petition tells Obama: 'Cease FDA ties to Monsanto'. 153 CITATION
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products are only present within approved contexts becomes extremely difficult without
consistent or mandatory labeling, as evidenced by the StarLink corn incident. StarLink
corn, a Bt PIP variation was approved by the EPA for animal feed but not for direct human
consumption due to concerns regarding allergen risks. Enforcement failures were reveled
when genetic traces of StarLink corn were found in processed corn products.154 This case
study provides an example of the need for labeling beyond the desire to satisfy consumer
demands; labeling is necessary to ensure proper usage and enforcement of genetically
engineered products only approved for use in a specific manner.
The final regulatory challenge discussed in this paper takes issue with conflicts that
arise when patent rights are applied to cases of genetic contamination caused by natural
processes. When farmers purchase genetically engineered seeds from companies like
Monsanto they are required to sign technology agreements that prevent them from selling
or replanting harvested seeds, forcing them to buy new seeds each year.155 Farmers found
to be in violation of this agreement must pay large penalty fees; if they refuse to comply,
they can be sure that Monsanto will follow up with legal action. The point of contention
revolves around the fact that Monsanto’s patent protection includes rights to genetically
altered material beyond that which is known to have been purchased; a reasonable
protection when applied to cases of theft and contract infringement, a unreasonable
expectation in cases when contamination occurs from natural causes. Farmers with
patented material present in their fields are held liable to the patent owner regardless of
the cause of contamination. This means that if genetic information contaminates non-
genetically modified crops, unbeknownst to the farmer, the farmer remains liable for 154 University of California - Davis. (n.d.). StarLink Corn: What Happened. Retrieved November 2012, from http://ccr.ucdavis.edu/biot/new/StarLinkCorn.html 155 CITATION Monsanto vs. U.S. Farmers
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contract infringement.156 Paul J. Heald and James Charles Smith of the University of
Georgia Law School stated it best: “.”157 In fact, Monsanto has an annual multi-million
dollar budget designated specifically for private investigations and litigation.158 The
investigative and legal resources of any individual farmer are minuscule in comparison to
those of Monsanto, essentially pitting the word of “David” against the abundant
investigative and legal resources of “Goliath.” In cases like this, what tests have the courts
established in order to determine whether or not the contamination was due to the
farmers’ behavior? The answer: none. This issue has yet to be confronted in cases in the
United States, although the Supreme Court of Canada addressed it in 2004 in Monsanto
Canada Inc. v. Paul Schmeiser. As explained in Seed Wars: Controversies over Access to and
Control of Plant Genetic Resources by Keith Aoki and Kenneth Luvai, the court decided that
Schmeiser “had infringed upon Monsanto’s utility patents by using genetically modified
canola of unknown origin on his farm.”159 This decision was based of the interpretation
that intent is irrelevant and that the simple presence of the patented material on
Schmeiser’s land, regardless of whether he purchased it, miss used it, or simply failed to
react to its unintended presence placed him in violation of Monsanto’s patent. Aoki and
Luvai predict that similar results would be expected in the United States. Given that
Schmeiser had never violated any laws himself, it is unsettling that he is being held liable.
156 CITATION 157Heald, P. J., & Smith, J. C. (2006, March 30). The Problem of Social Cost in a Genetically Modified Age. Retrieved October 2012, from Michigan Law: http://www.law.umich.edu/centersandprograms/lawandeconomics/workshops/Documents/winter2006/heald.pdf 158 CITATION 159 Aoki, K., & Luvai, K. (2007). Seed Wars: Controversies over Access to and Control of Plant Genetic Resources. In P. K. Yu, Intellectual Property and Information Wealth: Issues and Practices in the Digital Age (p. 265). Greenwood Publishing Group.
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Farmers in his position could face licensing fees, lose profits, and have their crops
confiscated.160
Regulatory Response: Office of Government Ethics
Disconcertingly, the issue of the revolving door is the only regulatory issue
discussed above addressed in any significant manner – though certainly not in completion.
The Office of Government Ethics primarily addresses this issue by limiting the percent of
income earned from sources outside of government employment throughout the duration
of primary employment by the government. Similar compensation limitations are placed
on government officers and board members.161 Beyond this, the Office of Government
Ethics only provides guidelines for ethical behavior once an employee has left government
employment162 and no guidelines that specifically address the issue of private sector
employees moving into government positions. Existing guidelines are enacted to prevent
conflicts of interest at the time when an employee first begins to seek employment or with
the onset of preliminary employment related discussion regardless of which side it is
initiated by. The guidelines limit lobbying activities, prohibit influencing court decisions,
and aim to prevent employees from acquiring future financial gain from their government
work. The guidelines also institute a “cooling off period” once employees have switched
160 Aoki, K., & Luvai, K., Seed Wars 161 Code of Federal Regulations. (2012, April). Title 5: Administrative Personnel Part 2636. Retrieved April 2012, from U.S. Government Printing Office: http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr;sid=cbc7425f9cf4949f6e219b8737e5b2b2;rgn=div5;view=text;node=5%3A3.0.10.10.10;idno=5;cc=ecfr 162 Code of Federal Regulations. (n.d.). Title 5 Part 2641. Retrieved April 2012, from U.S. Office of Government Ethics: http://www.oge.gov/DisplayTemplates/StatutesRegulationsDetail.aspx?id=1405
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jobs, limiting contact with their previous office of employment.163 These guidelines
address part of the revolving door in that they limit the ability for government employees
to make deals with potential or future employers though they fail entirely to address the
scenario presented in the case of Michael Taylor. This is not to say that Taylor received
personal benefits for his actions or that implementation of the no-regulation policy was
contrary to his expert opinion however, his continual movement between Monsanto and
the FDA lends itself to justified questioning if his loyalties and motivations.
THE ROLE OF THE CONSUMER
In industries guided by federal regulations, such as food production and labeling,
the public has the opportunity to utilize the political process to bring about desired change.
However, this requires that the issue be of a high enough national priority to grab the
attention of key political figures and policy makers. Even then, unless drastic consequences
to the status quo are anticipated, it will likely require a significant amount of time before
any change occurs. It is for these reasons that consumers may have a more significant
impact by influencing industry directly, using their purchasing power and right to choose
among products as a way of demanding change. This being said, consumer values may only
be displayed through purchasing preferences when enough product information is
provided to give consumers a clear choice among alternatives. In the case of genetically
modified foods this comes in the form of certified organic products or the few non-organic
products labeled as GE-free. Since GE foods make up between sixty and eighty percent of
the domestic food market it takes a consumer with considerable discipline, willing to
163 Code of Federal Regulations., Title 5 Part 2641
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research GE-free options, and able to pay a premium for organics, to be able to maintain a
GE-free diet. But what would happen if this were not the case? What if the choice was clear
and simple? Suppose that a consumer could choose between two products at the same
price point, one genetically modified and one produced using only conventional methods.
What would the consumers choose? And would their choice be enough to influence an
industry?
LESSONS LEARNED FROM MILK
In 1993 the FDA approved the use of rBGH, recombinant bovine growth hormone, a
product first developed by Monsanto164 that when given to cows increased their milk
production by up to ten percent165. The FDA determined that milk produced by cows
treated with the hormone was not substantially different in any way than milk from
untreated cows and therefore determined that no special labeling would be required.166
They did however develop voluntary labeling guidelines in order to ensure that any
“absence labeling” (i.e., labeling indicating an absence of hormones) did not misleadingly
suggest any substantial difference between the two products.167
Shortly after hormone-treated milk appeared on the market, negative claims
regarding the milk spurred widespread public concern. Reports claimed that the hormone
164 Escobar, C. (2009, March 3). Tale of rBGH, Milk, Monsanto and the Organic Backlash. Retrieved June 2012, from Huff Post Green: http://www.huffingtonpost.com/christine-escobar/the-tale-of-rbgh-milk-mon_b_170823.html 165 Irmer, F. (2012). Those Seeking Mandatory Labeling of Genetically Modified Foods Look to Milk. Retrieved June 2012, from The Ration: http://berkeley.news21.com/theration/2011/07/25/those-seeking-mandatory-labeling-of-genetically-modified-foods-look-to-milk/ 166 Martin, A. (2007, November 11). Consumers Won't Know What They're Missing. Retrieved June 2012, from The New York Times: http://www.nytimes.com/2007/11/11/business/11feed.html?_r=4 167 Irmer, Those Seeking Mandatory Labeling of Genetically Modified Foods Look to Milk
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was linked to reproductive problems in cows and increased the IFG-1 (insulin-like growth
factor) found in the milk.168 The Cancer Prevention Coalition connected elevated levels of
IFG-1 to cancer, citing an increased risk for breast, colon, and prostate cancers.169
Domestic concern was exacerbated by bans on use of the hormone in Europe and
Canada,170 with Europe banning imports of meat and milk from hormone treated cows in
1989171.
These concerns created a market for rBGH-free milk had been created and rBGH-
free producers responded with absence labeling. Hormone free milk appealed to
consumers who feared the risks of hormone treated milk but did not want to pay a
premium for certified organic milk. Over the following years Whole Foods Market, Trader
Joe’s, and Starbucks all offered hormone-free milk with Kroger, Publix, and Costco adopting
hormone-free milk as their house brands. Dean Foods, the nation’s largest milk bottler
advised suppliers to transition to hormone free milk and in 2007 Wal-Mart, Safeway and
Starbucks stopped carrying hormone treated milk altogether.172
Producers of hormone treated milk responded with attempts to ban absence
labeling on the grounds that labeling implied hormone-free milk was safer or healthier
than that from hormone treated cows, and was misleading since cows produce hormones
168 Escobar, Tale of rBGH, Milk, Monsanto and the Organic Backlash 169 Cancer Prevention Coalition. (2003). Milk: America's Health Problem. Retrieved August 2010, from Cancer Prevention Coalition: http://www.preventcancer.com/consumers/general/milk.htm 170 Cancer Prevention Coalition, Milk: America's Health Problem 171 Epstein, S. S. (2009, December 23). American Public Health Association: Ban Genetically Engineered Hormonal rBGH Milk, Meat Adulterated With Sex Hormones. Retrieved June 2012, from Huffpost Healthy Living: http://www.huffingtonpost.com/samuel-s-epstein/american-publlic-health-a_b_399147.html 172 Irmer, Those Seeking Mandatory Labeling of Genetically Modified Foods Look to Milk
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naturally.173 Producers achieved some success through these efforts; a 2007 ban on
absence labeling in Pennsylvania went beyond hormones, and also prohibited the labeling
of products as pesticide- or antibiotic-free. A similar ban was adopted in Ohio in 2008.174
Pennsylvania Department of Agriculture Secretary Dennis Wolff maintained that there is
no difference in the milk and since there are no tests to prove milk came from untreated
cows, the milk cannot be labeled as such. This would suggest that organic certifications are
also improper since there is no way, other than careful tracking, to test that the milk comes
from untreated cows, although this thought process was never used to contest organic
certification.175 A 2008 Consumers Union poll reported that 93 percent of consumers
believed that hormone free milk should be allowed to be labeled as such,176 and in 2010 the
Sixth Circuit federal court agreed, overturning the Ohio ban on absence labeling on the
grounds that the ban violated commercial rights to free speech.177 The First Amendment
protects commercial speech, that is speech intended to advertise products, as long as it is
not false or misleading. For this reason the court decision required a review of whether the
absence labeling in this case was misleading and determining that it was not.178 The court
stated, “A compositional difference does exist between milk from untreated cows and
173 Irmer, Those Seeking Mandatory Labeling of Genetically Modified Foods Look to Milk 174 Irmer, Those Seeking Mandatory Labeling of Genetically Modified Foods Look to Milk 175 Martin, Consumers Won't Know What They're Missing 176 Consumers Union. (2008, October). CR Poll: Two-thirds of Americans want FDA to inspect domestic, foreign food supply. Retrieved June 2012, from Consumers Union: http://www.consumersunion.org/pub/core_food_safety/006298.html 177 International Dairy Foods Association; Organic Trade Association v. Robert J. Boggs, 09-3515/3526 (United States Court of Appeals for the Sixth Circuit September 30, 2012). 178 International Dairy Foods v. Boggs
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conventional milk”179 and additionally to recognized the fact that several characteristics of
the treated milk were “indicator[s] of poor milk quality.”180
In the case of milk, public concern regarding the use of hormones drove consumers
to seek out hormone free milk. Information provided to the consumer, via food labels,
influenced their purchasing preferences, which influenced the products producers put on
shelves.181 Not only did this preference sway the industry to decrease the production of
milk from hormone treated cows, but it also put pressure on the industry to develop a level
of transparency extending beyond milk products, spurring interest in other labeling
campaigns. It is noteworthy that the public did not take particular issue with the fact that
the hormone was genetically modified. The supplemental hormone, regardless of how it
was developed, was enough of an unnatural practice to deter potential customers,
particularly since the product did not provide consumers with a price benefit to offset
perceived health risks. This suggests that Todd Rutter of Rutter’s Dairy accurately
captured consumer sentiment in saying, “we just feel that consumers, when given the
choice, for the same price point, will always choose a product that they believe is the most
naturally produced available.”182
CONSUMER PREFERENCES
Consumers want to know what is in their food. This is a statement confirmed by
various polls, all reporting that an overwhelming majority of Americans believe that
genetically engineered food products should be labeled as such (86 percent of Harris
Interactive poll respondents think the federal government should mandate the labeling of
179 Irmer, Those Seeking Mandatory Labeling of Genetically Modified Foods Look to Milk 180 International Dairy Foods v. Boggs 181 Irmer, Those Seeking Mandatory Labeling of Genetically Modified Foods Look to Milk 182 Martin, Consumers Won't Know What They're Missing
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genetically modified foods183 and 95 percent of Consumers Union poll respondents believe
that “food products made from genetically engineered animals should be labeled”184).
Furthermore, the Consumers Union poll reports that more than 60 percent of Americans
“would not buy meat or milk products from genetically engineered animals or milk/milk
products from cloned animals or their offspring,185 a clear indicator of why industrial
producers of genetically engineered products are opposed to mandatory labeling.
Although the USDA National Organics Program has determined that genetically engineered
foods are not eligible for organic certification,186 the Consumers Union poll reports that 78
percent of Americans think that all products claiming to be “naturally raised” should not
include cloned or genetically engineered foods187.
Polls have also studied the risks and benefits related to the production and
consumption of genetically engineered foods as perceived by the consumer. A 2002 poll by
the Pew Research Center reports “55 percent of Americans say that genetically modified
foods are “bad.”” The poll takes note of a small gap between women, 62 percent of which
think genetically modified foods are bad, and men, of which only 47 percent say genetically
modified foods are bad. However, they also report that the issue tends to be nonpartisan,
with 58 percent of Democrats and 51 percent of Republicans agreeing that genetically
modified foods are bad. This being said, Pew also reports that 37 percent of Americans
believe that some genetic modifications to some produce is good because it increases crop 183 Taylor, H. (2000, June 28). Genetically Modified Foods: An Issue Waiting to Explode? Retrieved June 2012, from Harris Interactive: http://www.harrisinteractive.com/vault/Harris-Interactive-Poll-Research-GENETICALLY-MODIFIED-FOODS-AN-ISSUE-WAITING-TO-EXPLODE-2000-06.pdf 184 Consumers Union, CR Poll: Two-thirds of Americans want FDA to inspect… 185 Consumers Union, CR Poll: Two-thirds of Americans want FDA to inspect… 186 National Organic Program. (2012, June 6). National Organic Program. Retrieved August 2012, from Agricultural Marketing Service: http://www.ams.usda.gov/AMSv1.0/nop 187 Consumers Union, CR Poll: Two-thirds of Americans want FDA to inspect…
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yields, and therefore can feed more people, in addition to being good for the
environment.188 Results from a 2000 Harris Interactive poll supported part of the previous
statement revealing that a 66 to 29 percent majority believe that genetic modifications
increase production, however, the same poll also reported a 56 to 33 percent majority that
the cultivation of genetically modified crops will ”upset the balance of nature and damage
the environment.”189 The reaction to human consumption of genetically engineered foods
was split with 45 percent believing that genetic engineering is very or somewhat likely to
“be poisonous or cause diseases in people who eat them,” and 47 percent saying that such a
result is not very or not at all likely to occur.190 Baker and Burnham aimed to gauge the
impact of such preferences on customers while shopping and developed relative
importance factors for three product characteristics: Price, GMO Content, and Brand,
revealing that the factors are ranked from most important to least important in that order
with relative importance factors of 37, 34, and 29 respectively.191 Of the consumers
surveyed in this study, 30 percent wish to avoid GMOs. The study found that
socioeconomic factors are helpful in predicting consumers interested in a specialty
characteristic such as GMO-free or brand and those primarily interested in price however
consumers are best identified based on what they believe rather than descriptive
188 Pew Reseach Center. (2003, June 20). Broad Opposition to Genetically Modified Foods. Retrieved July 2012, from Pew Research Center: http://www.people-press.org/2003/06/20/broad-opposition-to-genetically-modified-foods/ 189 Taylor, Genetically Modified Foods: An Issue Waiting to Explode? 190 Taylor, Genetically Modified Foods: An Issue Waiting to Explode? 191 Baker, G. A., & Burnham, T. A. (2002). The market for genetically modified foods: consumer characteristics and policy implications. International Food and Agribusiness Management Review , 351-360.
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characteristics.192 Many of these observations were supported by or expanded upon in a
survey study conducted in Bloomington, Indiana.
SURVEY
Methods
A survey study in Bloomington, Indiana sought to gauge consumer knowledge
regarding genetically engineered foods, assess the impact of consumer knowledge on
purchasing preferences, and determine preferred methods and terminology for
communicating information about whether the food they buy has been genetically
engineered. The survey study was conducted during May 2012 at the Kroger on South
College Mall Road and the Bloomingfoods Near West Side location on West Sixth Street.
These two particulars stores were chosen because of the opportunity they provide for
comparing and contrasting two different customer profiles. The City of Bloomington as a
whole may be described as a small, liberal college town located in the center of a typically
red state. Home to Indiana University, Bloomington has a population of just over 80,400
according to 2010 census data193 with a current (Summer 2012) student enrollment of
almost 42,700 undergraduate and graduate students.194 This student to resident ratio
produces an overall population with a relatively low income considering the average level
of education.
192 Baker, The market for genetically modified foods 193 City of Bloomington. (n.d.). Bloomington Census Data. Retrieved October 2012, from City of Bloomington: http://bloomington.in.gov/documents/viewDocument.php?document_id=481 194 Indiana University. (2012, Summer). Official Enrollment Report. Retrieved October 2012, from University Institutional Research and Reporting: http://www.iu.edu/~uirr/reports/standard/enrollment/official.shtml
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Kroger, a name familiar to many, is a national chain of grocery retailers that provide
a variety of services under 35 titles including City Market, King Scoopers, Food 4 Less, Fred
Meyer, and Kwik Shop.195 Together, 15 of these entities, each a supermarket, operate 2,425
grocery stores across the nation. Kroger also operates 38 manufacturing facilities.196 The
mission of the Kroger Corporation is “to be a leader in the distribution and merchandising
of food, pharmacy, health and personal are items, seasonal merchandise, and related
products and services.”197 The Kroger store located on College Mall Road in Bloomington,
Indiana granted permission for surveys to be conducted in the entrance/exit lobby of the
store. The store offers customers a very small (compared to the size of the store overall)
organics section for processed foods near the produce section that also includes a small
section of organic produce.
In contrast, Bloomingfoods is a member-owned, cooperatively-run local grocery
store based in Bloomington, Indiana whose mission and purpose is to promote locally
grown, nutritious, and “non-chemically produced” food to Southern Indiana.198
Bloomingfoods provide shoppers with in-store signs clearly labeling not just organic
produce, but also conventional.ly produced foods. When appropriate, local sources are also
identified. Founded in 1975, the coop now has three locations all in Bloomington,
195 The Kroger Company. (2012). Home. Retrieved August 2012, from The Kroger Co.: http://www.thekrogerco.com/ 196 The Kroger Company. (2012). Operations. Retrieved August 2012, from The Kroger Co.: http://www.thekrogerco.com/about-kroger/operations 197 The Kroger Company. (2012). Vendors and Suppliers. Retrieved August 2012, from The Kroger Co.: http://www.thekrogerco.com/vendors-suppliers 198 Bloomingfoods. (2007, August 28). Our Mission. Retrieved August 2012, from Bloomingfoods: http://www.bloomingfoods.coop/index.php?option=com_content&view=article&id=74&Itemid=127
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Indiana.199 This survey study was conducted at the West location neighboring the City of
Bloomington’s Farmers’ Market. This location was recommended by store management
stating that the location draws the most, and most diverse, business. Based on the core
principles of the organization and the marketing material visible at stores and online, one
may expect that survey respondents who shop at Bloomingfoods represent a population
more knowledgeable about food-related topics, therefore informing stronger attitudes and
preferences for organic, locally grown, and GE-free food products.
The survey200, developed under the guidance of the Indiana University Center for
Survey Research, was administered at each location in two-hour sessions at three different
times: on a weekday afternoon, a weekday evening, and a weekend afternoon in order to
collect a more randomized group of respondents. Survey participation was entirely
anonymous and voluntary. The survey was administered in two forms: 1) on location on a
computer, and 2) flier201 giving instructions for online participation available on any
computer and at any time during the following week. Customers were given a pitch as they
exited the stores asking if they would “mind participating in a study on consumer attitudes
on genetically modified foods.” If the laptop was available, they were encouraged to take
the survey at the store. If not, or if they did not have the time to stop, they were given a
flier. Although the survey administrator attempted to make contact with every customer
that exited the store during each two-hour session, voluntary participation proved to be an
initial filter on the data collected. It can be assumed that some customers simply did not
199 Bloomingfoods. (n.d.). History of Bloomingfoods. Retrieved August 2012, from Bloomingfoods: http://www.bloomingfoods.coop/index.php?option=com_content&view=article&id=34&Itemid=89 200 A transcript of the survey questions may be found in Appendix B. 201 A copy of the flier may be found in Appendix C.
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have the time or interest in survey participation regardless of the survey topic. Some
respondents seemed to have more interest in survey participation once they were aware of
the subject matter however the opposite effect seemed to also be true. There seemed to be
a relatively significant nonresponse rate due to a lack of familiarity with the term
“genetically modified.” Potential respondents that mentioned they were unfamiliar with
the topic were encouraged to participate.
Findings
The survey produced ninety-six complete surveys,202 48 from Kroger, 37 from
Bloomingfoods, and 11 other. Fliers that were retrieved at either Kroger or Bloomingfoods
and passed on to a different individual who completed the survey may explain the “others.”
Of these respondents 38.5% were male and 61.5% were female. 40.6 percent of
respondents had a 2011 household income of $35,000 or below, 55.2% made above
$35,000,203 compared to Bloomington annual household income data from 2010 reporting
that 58.5 percent of the population has a household income of less than $35,000.204
Respondents with an annual household income over $35,000 were more likely to consider
organic, local, and GE-free food characteristics to be an important factor when purchasing
groceries205. Seventy-five percent of survey respondents had obtained a Bachelor’s,
graduate, or other professional degree. These demographics (low-medium income and
highly educated) are characteristic of a university town. Finally, 75 percent of respondents
“usually buy most of the groceries” for his or her household, an ideal trait assuming that
202 A complete survey consisted of four or fewer unanswered questions. 203 Data for four respondents was eliminated due to missing responses. 204 U.S. Census Bureau. Household Income in the Past 12 Months (In 2010 Inflation-Adjusted Dollars) 2006-2010 American Community Survey 5-Year Estimates. U.S. Census Bureau. 205 Of the 84 respondents that considered either organic, locally grown, or GE-free foods to be important, 59.5 percent had an annual household income over $35,000.
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survey respondents who are the usual shopper for his or her household will have more
established purchasing preferences.
Survey respondents were overwhelmingly unaware of the current prevalence of
genetically engineered produce on the market. Only 17.7 percent of respondents answered
that 51-75 percent of produce they buy is genetically engineered, recall that genetically
engineered produce makes up about 70 percent of produce sold in the United States.206
Just over 77 percent reported that less than half of the produce they buy is genetically
engineered, with 15.6 percent of respondents reporting that none of the produce they buy
has been genetically engineered. This may be true if consumers purchase only organic or
GE-free produce, or try to do so most of the time. If this is the case, these consumers should
be certain that they purchase no produce, or 0 percent, that has been produced using
genetic engineering. However, by comparing responses to this question with responses to
the following question one may deduce that this is not the case. The following question
asked respondents how certain they were of their previous response. Forty-five out of 96
respondents were uncertain of their response, with 16 being neither certain or uncertain.
Regarding the 35 respondents who were certain about the amount of genetically
engineered produce they consume, 8 chose 0 percent – we can assume that these
respondents intend to avoid consumption of genetically engineered produce. Ten
respondents who were certain estimated that 1-25 percent of the produce they consume is
genetically engineered; these may also be consumers intending to avoid consumption of
genetically engineered produce, at least most of the time. Only 2 of the 27 who were
certain chose the 51-75 percent category. Not counting these two categories of consumers
(those that were certain they consume either 0 or 1-25 percent genetically engineered 206 Center for Food Safety, Genetically Engineered Crops
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produce), 39 respondents, or 40.6 percent, underestimated the amount of genetically
engineered produce on the market. Results were similar when respondents were asked
how much of the processed foods they buy were genetically engineered or contained
genetically engineered material.
Regardless of a consumers degree of knowledge on the subject of genetically
engineered foods, perceived risks and benefits have the potential to affect purchasing
preferences. Of the 96 individuals surveyed, 69.8 percent believe that eating genetically
engineered foods is bad for your health and 76 percent think that the production of such
foods is bad for the environment. In order to gain insight into why consumers perceive
genetically engineered foods to be good or bad survey respondents were asked if they had
heard any of the statements found in the table below. Three of the statements were
generally supportive of genetic engineering, the others generally discouraging use of the
technology.
Have you heard… Yes No207
Genetically engineered foods may be higher in nutrients than non-genetically engineered foods.
21.8 70.8
Growing genetically engineered crops can reduce the need for tillage and reduce erosion.
36.5 61.5
Growing genetically engineered foods can decrease the use of insecticides, herbicides, and fertilizers.
56.3 40.6
Eating genetically engineered foods may result in unexpected allergic reactions.
62.5 35.4
Growing genetically engineered crops may kill off naturally occurring crops and animals.
80.2 18.8
Growing genetically engineered foods can increase the use of insecticides, herbicides, and fertilizers
55.2 42.7
The majority of respondents had not heard of 2 out of the 3 statements encouraging use of
the technology but had heard of all of the statements discouraging use of genetic
207 Responses expressed as percentages.
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engineering. As seen in the table, responses to the statement “Growing genetically
engineered foods can decrease the use of insecticides, herbicides, and fertilizers” were split
with 56.3 percent saying they had heard the statement and 40.6 percent saying they had
not. Regardless of whether consumers agree with or believe the statements they have
heard, the data shows that public information in circulation generally discourages use of
genetic engineering.
In order to judge how consumer interest in GE-free foods compared to other
marketed traits survey respondents were asked to rate the degree of importance of price,
brand, organic, local, and GE-free on a seven-point scale from not at all important to
extremely important. The mean degree of importance for each category was used to create
an overall ranking of the factors, from most influential to least; the results may be found
below. Four points is associated with “Neither Important or Unimportant” on the seven-
point importance scale, meaning that any mean below four represents a factor that
consumers deemed to be “Unimportant.”
Rank Factor Mean 1 Price 5.44 2 Locally grown 5.32 3 GE-free 5.07 4 Organic 5.01 5 Brand 3.62
These results confirm importance rankings found by Baker and Burnham.208 Taking into
consideration the price premiums commonly associated with the sale of GE-free and
organic foods in particular, it is understandable that price be of greatest concern. In order
to factor out affordability and focus on the traits of the food, the data was analyzed again,
208 Baker, The market for genetically modified foods
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this time considering only the respondents who rated price as unimportant and, separately,
those with an annual household income above $35,000. These perspectives resulted in
unique rankings, which may be found in the table below.
WEALTHIEST PRICE = UNIMPORTANT Rank Factor Mean Factor Mean
1 Locally grown 5.41
Locally grown 5.13 2 Price 5.27 Organic 4.38 3 GE-free 5.13 GE-free 4.00 4 Organic 4.96 Brand 3.38 5 Brand 3.69 Price 2.50
The results of those who consider price to be an unimportant influence on purchasing
preferences also support Baker and Burnham’s conclusion that income characteristics may
be able to distinguish between consumers who are primarily concerned with price and
those that have the fiscal option to consider the value of other traits.209 However, those
consumers who rated price as unimportant rated each factor as less important than its
overall counterpart, perhaps suggesting that these respondents may have an overall lower
level of concern regarding their food, rather prioritizing the impact of their economic
contribution to his or her local community. Similarly, the wealthiest group tended to most
prefer locally grown foods, although all of the remaining factors ranked less important than
price.
Data from this question was also analyzed for correlations between consumer
preference for GE-free and organic foods. This question is of interest because the USDA
National Organic Program does not consider genetically engineered foods to be organic.210
209 Baker, The market for genetically modified foods 210 McEvoy, M. (2011, December 16). Organic 101: What Organic Farming (and Processing) Doesn't Allow. Retrieved August 2012, from UDSA Blog:
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If consumers seeking GE-free foods are aware that organic certification also means GE-free
they should, at minimum, consider organic certification to be of equal importance as GE-
free, though certified organic products may be expected to receive higher importance
ratings than GE-free since it certifies the lack of other specific methods of planting,
growing, raising, and processing foods, for insistence animals raised without the use of
antibiotics or hormones.211
Of the 67 survey respondents that marked GE-free as important and the 66 that
marked organic as important, 59 considered both to have some degree of importance.
Importance of Buying GE-Free
Somewhat Important
Very Important
Extremely Important
Somewhat Important 7 6 6
Very Important 2 11 7
Extremely Important 1 0 19
As demonstrated by the cross tabulation below, most respondents considered GE-free and
organic to be equally important (occurred 37 times). Of the 22 respondents that
considered GE-free and organic to be of different levels of importance, 19 considered GE-
free to be more important. Only three respondents considered organic to be a less
important factor than buying GE-free. This suggests the presence of a market specifically
http://blogs.usda.gov/2011/12/16/organic-101-what-organic-farming-and-processing-doesn’t-allow/ 211 McEvoy, Organic 101
Imp
orta
nce
of B
uy
ing
Org
an
ic
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seeking GE-free foods - consumers not willing or unable to pay organic premiums but still
interested in foods produced under more natural circumstances. Because GE-foods have
yet to present consumers with significant price breaks over GE-free foods, the
unadulterated option is available at the same price point as genetically engineered foods.212
In order to determine how information regarding whether a food is genetically
engineered or contains genetically engineered material may best be delivered to the
consumer, respondents were asked, “Which term best describes the process of putting
artificial genes into plants or animals to produce traits that cannot be produced through
breeding methods?” Of the four possible responses: genetic engineering, genetic
modification, bioengineering, or biotechnology, 51 percent of respondents chose the most
accurate term,213 genetic engineering. This suggests that a significant portion of the
population understands proper usage of the term, however, an explanation that “genetic
engineering” would be the term used throughout the remainder of the survey was visible at
the time the respondent answered the question, so it is unclear how many survey
respondents instinctively chose “genetic engineering” and how many were influenced by
the hint below. This being said, 49 percent of survey respondents still chose the incorrect
term. Just under 40 percent of respondents chose “genetically modified” confirming that
there is indeed consumer confusion regarding the meaning and accurate usage of the term
“genetically modified.” This statement remains true among the most educated survey
respondents. Of those with a bachelor’s or graduate/professional degree (72 of the 96 total
survey respondents) 51.4 percent chose “genetic engineering” and 41.7 percent chose
genetic modification. One may expect Bloomingfoods customers – customers who have 212 World Health Organization, 20 questions on genetically modified foods 213 See section titled Genetic Modification versus Genetic Engineering (page 6) for definitions.
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seemingly sought out a grocer with an organic emphasis - may have a heightened sense of
awareness regarding the issue, therefore producing a more accurate understanding of the
terms, however this was not shown to be the case. Among Bloomingfoods customers, the
same number of respondents chose ”genetic engineering” as “genetic modification.” The
confusion regarding the accurate usage of the terms “genetically engineered” and
“genetically modified” poses a challenge for labeling regulators – how can regulators
clearly communicate to the public if the pubic does not have a clear understanding of the
terms? May the more common term be used without being misleading?
Additional data confirms the importance of informative food labels but also suggests
that alternative methods may be successful in communicating information regarding
whether a food has been genetically engineered or contains genetically engineered
material to the consumer. Most survey respondents (57.3 percent) reported that they
primarily use food labels to find information about how the food buy was grown or made,
for instance grown locally, organically, or with out the use of genetic engineering. Of these,
89.1 percent reported that less than half of food labels provide them with enough
information to determine when a food is genetically engineered or contains genetically
engineered material, with about half reporting that only 1-25 percent of food labels provide
them with enough information to make a determination. Although the respondents who
use store signs or the Internet to determine how their food has been grown or made (22.9
and 13.5 percent respectively) were similarly dissatisfied with the failure of these sources
to provide enough information to determine if the food was genetically engineered or
contained genetically engineered material (51.4% said 1-25% provide enough information,
85.7% said less than half provide enough information), these sources may offer a faster
route to providing the information demanded by consumers. It would be much faster for a
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grocer, even a large chain of grocery stores, to alter in-store signage than changing labeling
regulations.
REGULATORY ALTERNATIVES
Since the FlavrSavr tomato hit the market in 1993, public concern regarding the use
of genetically engineered foods has persisted. National campaigns such as Just Label It!, the
Right 2 Know March, the Right To Know GMOs campaign, and more local campaigns such
as the California, Oregon, and Vermont Right To Know campaigns, have begun to pressure
all levels of government to take action, with some recent successes.214 Although federal
authorities have maintained that genetically engineered foods are safe and have no reason
to be labeled differently than their conventional counterparts, several states are
considering legislation that aims to label or even ban foods derived from bioengineering.
Such labeling regulations aim to provide consumers with reliable methods for determining
whether a food has been developed using genetic engineering, and therefore the ability to
express their acceptance or disapproval of the product, regardless of the factors motivating
their opinion.
214 California Right to Know. (n.d.). Join The Right To Know Campaign. Retrieved June 2012, from Right to know: http://www.carighttoknow.org/; Just Label It! (2012). Genetically Engineered Foods/Tell FDA to Label. Retrieved June 2012, from Just Label It!: http://justlabelit.org/; Oregon Right To Know. (n.d.). Oregon Right To Know. Retrieved June 2012, from Oregon Right To Know: http://www.oregonrighttoknow.org/; Right2Know March. (2011). Home. Retrieved June 2012, from Right2Know March: http://www.right2knowmarch.org/; Right to Know GMOs. (2012). Genetically Modified Food Labeling. Retrieved June 2012, from Right To Know GMOs: http://www.righttoknowgmos.org/; Vermont Right To Know GMOs. (2012). Vermont Right To Know GMOs. Retrieved June 2012, from Vermont Right To Know GMOs: http://www.vpirg.org/gmo/
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To date Alaska is the only state to have passed mandatory labeling legislation,
having passed legislation in 2005 requiring labeling on all fish and fish products derived
from genetically engineered fish raised in-state. The law was passed ahead of FDA
approval of genetically engineered fish, which, as of 2008, had still not been approved.215
According to the law any fish or fish products that have “been altered at the molecular level
by means that are not possible under natural conditions or processes” must be labeled as
“genetically modified.”216 This definition takes the labeling requirement beyond
recombinant DNA and RNA procedures also requiring the label for fish and fish products
developed from “cell fusion, gene deletion or doubling, introduction of exogenous genetic
material, alteration of the position of a gene, or similar procedure.”217 Legislators are
considering broadening the scope of the law to include all fish and fish products sold in the
state, whether raised in state or imported.
In 2011 legislation seeking to ban or label genetically engineered foods was under
consideration in fourteen states including Oregon, New York, Maryland, Vermont,218
Washington,219 and California220. The California Right to Know Genetically Engineered
Food Act, seeking to label all genetically engineered foods, is of particular importance as 215 Institute For Local Self-Reliance. (2008, November 21). Labeling of Genetically Engineered Fish - Alaska. Retrieved August 2012, from Institute For Local Self-Reliance: http://www.ilsr.org/rule/genetically-modified-organisms/2033-2/ 216 24th Alaska State Legislature. (2006). SB 25 Bill Text. Retrieved August 2012, from The Alaska State Legislature: http://www.legis.state.ak.us/basis/get_bill_text.asp?hsid=SB0025Z&session=24 217 24th Alaska State Legislature, SB 25 218 Beecher, Cookson. (2012, January 27). Calls for GMO Labeling Keep Cropping Up. Retrieved June 2012, from Food Safety News: http://www.foodsafetynews.com/2012/01/calls-for-gmo-labeling-keep-flaring-up/ 219 Washington State Legislature. (2012, January 19). H-3624.1 House BIll 2637 State of Washington. Retrieved August 2012, from Washington State Legislature: http://apps.leg.wa.gov/documents/billdocs/2011-12/Pdf/Bills/House%20Bills/2637.pdf 220 Right to Know GMOs. (2012). Genetically Modified Food Labeling. Retrieved June 2012, from Right To Know GMOs: http://www.righttoknowgmos.org/
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California leads the nation in agricultural production. According to 2004 data of the UDSA’s
Economic Research Service, California is responsible for 9.1 percent of the nation’s total
agricultural output (Iowa is second at 5.2 percent).221 Since manufacturers will have to
label their products for instate sale, they may also choose to label products exported to
other states. This would enhance consumers’ ability to demonstrate a preference between
genetically engineered and conventional foods, the results of which would influence the
products provided by the industry within the state of California and across the nation.
Support for the Act, which will be Proposition 37 on the November 2012 ballot, is strong
with results from a poll conducted in April 2012 by KCBS, a San Francisco television
station, reporting that 91 percent of Californians want genetically engineered foods to be
labeled.222 The legislation, as suggested by the title, is based on the idea that consumers
have the right to know what is in their food and how it is made, an idea accompanied by
consistent reports that consumers have an overwhelming (90 percent) desire to know
whether their food has been produced using bioengineering. Also cited in the Act are
concerns regarding environmental impacts, the potential for increased toxicants, the lack of
safety assessments conducted by the FDA, and the fact that labeling of genetically
engineered foods will provide a method for tracking the long-term affects of
consumption.223
221 USDA Economic Research Service. (2012, July 5). Agricultural Productivity in the U.S. Retrieved August 2012, from USDA Economic Research Service: http://www.ers.usda.gov/data-products/agricultural-productivity-in-the-us.aspx#28250 222 CBS San Francisco. (2012). Californial May Vote On Genetically Modified Food Warning Labels. Retrieved September 2012, from CBS San Francisco: http://sanfrancisco.cbslocal.com/video/7062946-california-may-vote-on-genetically-modified-food-warning-labels/ 223 California Legislature. (2012). The California Right to Know Genetically Engineered Food Act. Retrieved September 2012, from Official Voter Information Guide:
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If the California Right to Know Genetically Engineered Food Act is passed it will be
an important victory for labeling campaigns and concerned individuals across the nation.
The legislation provides sample language that may be adopted by other states,
municipalities, or even the FDA. State-by-state adoption of mandatory labeling regulations
complicates the manufacturing process for producers involved in interstate commerce and
would likely lead to industry demand for unified labeling regulations, whether they come in
the form of federal legislation or industry guidelines.
RECOMMENDTIONS
In order to continue to investigate the possible benefits of genetic engineering in
food production regulators must move carefully to address consumer concerns regarding
unintended and dangerous consequences of the technology as well as problems associated
with the current prevalence under the current regulatory regime, such as patent protection
violations due to naturally caused genetic contamination. Until such issues can be resolved
and concrete evidence has proven long-term health and environmental consequences
insignificant, consumers should have the right to know whether any product they consume
has been genetically engineered so that they may express their values and protect
themselves from the unknown. Recommendations reflecting this stance are organized into
three stages to be implemented over time and adjusted as additional information becomes
available. The first stage, to be implemented immediately, responds to current
transparency and labeling issues and seeks to provide consumers with the necessary tools
to be well-informed about the food they consume, giving them the freedom to express
http://vig.cdn.sos.ca.gov/2012/general/pdf/text-proposed-laws-v2.pdf#nameddest=prop37
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attitudes about the current state of genetically engineered foods. The second stage focuses
on the long-term environmental consequences of genetically engineered crop production,
aiming to mitigate these consequences before irreversible damage has been done. This
includes steps to protect the production of conventional crops and those who produce
them. The final stage is designed to respond to consumer values expressed as a result of
the first stage of recommendations. Once consumers have had the opportunity to express
values based on fair and readily available information, there may be a clear public
consciousness dictating further action. Alternatively, additional scientific evidence,
produced from long-term studies, may provide guidance for development firms and
regulators.
STAGE ONE: TRANSPARENCY AND LABELING
Due to the FDA’s current stance on genetically engineered foods and the subsequent
labeling regulations genetically engineered foods have been able to sneak into the market
to an overwhelming degree without public knowledge. Portions of the public and scientific
community alike have yet to be convinced of the safety of genetically engineered foods both
to human health and to the environment. In addition, the public conscience, having been
eluded by regulation favoring industry, has yet to have the opportunity to express personal
values, purchasing preferences, or support for government determinations of what is
“safe.” The federal government has a responsibility to its constituents to facilitate this
expression by introducing policy that supports the consumers right to choose. Policies
promoting labeling of genetically engineered products and transparent regulation should
be pursued.
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Current legislative proposals to mandate labeling of genetically engineered foods,
such as the bills currently proceeding through the legislative bodies in various states, most
prominently California, serve as a solid starting point for the legislation needed to provide
consumers with the information necessary to make informed purchasing decisions. Such
legislation would mandate labeling of genetically engineered foods and food products made
from genetically engineered ingredients, however consideration must be given to several
additional factors. Since the technology to test for the presence of genetically engineered
material is currently unavailable, adequate legislation must include segregation and
labeling requirements for genetically engineered materials from the point of cultivation
through to the packaging and labeling of foods containing genetically engineered
ingredients. This includes setting a tolerance, if any, for the amount of genetically
engineered material known to be present in processed products before it is required to
bear a label signifying the presence of genetically engineered material. Such legislation
may turn to the current methods used in the USDA’s National Organic Program, which
currently does not certify products containing genetically engineered materials. The
National Organics Program is a process-based system, which relies on a variety of methods
in order to ensure certified producers avoid the use of genetically engineered materials and
producers remain segregated from the threats of genetic contamination. As noted in a
2011 policy memorandum from Miles, McEvoy, Deputy Administrator of the National
Organics Program, these methods include “testing seed sources for GMO presence, delayed
or early planting to get different flowering times for organic and GMO crops, cooperative
agreements with neighbors to avoid planting GMO crops adjacent to organic crops, cutting
or mowing alfalfa prior to flowering, posting signs to notify neighboring farmers of the
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location of organic fields, and thorough cleaning of farm equipment that has been used in
non-organic crop production.224
Additional labeling recommendations address the distinction between the various
types of genetic alterations within a product. Because different types of alterations present
themselves differently, with drastically differing consequences and even varying moral and
ethical implications (consider GE plants v. animals), labeling of genetically engineered
products should reflect these distinctions. This would allow consumers to move beyond
choosing GE and GE-free granting them the opportunity to evaluate and prioritize the
specific concerns they care most about. For example, those with greater concerns about
their personal health, perhaps individuals highly sensitive to allergens, could choose to
avoid foods containing only genetic material from other foods while those with strong
environmental convictions could choose to avoid genetically engineered products most
threatening to the environment. In order to reflect this information labels must include the
organism from which the transgene originated as well as the reasoning for its use.
In order to facilitate each of the aforementioned recommendations, the fundamental
stance of the FDA, that which dictates the substantial equivalence of GE and non-GE
products, first must change. The existing regulatory regime of voluntary labeling is
founded in the belief that there is no significant difference between GE and non-GE
products however this simply not the case. It is a simple fact, founded in the methods of
their creation, that genetically engineered organisms are different than their conventional
counterparts, a difference seen in the most fundamental building blocks that bring the 224 McEvoy, M. (2011, December 16). Organic 101: What Organic Farming (and Processing) Doesn't Allow. Retrieved August 2012, from UDSA Blog: http://blogs.usda.gov/2011/12/16/organic-101-what-organic-farming-and-processing-doesn’t-allow/
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organism to being. Furthermore, these differences are exhibited in differing compounds
dictating the functions of the organism and the role of the organism in its ecological
environment – how can this not be considered significant? If this change is to ever occur it
is likely to be persuaded by one of two events: (1) Public/political pressures on the FDA
will persuade regulators to change the determination of ”substantial equivalence” or, (2) A
Supreme Court decision will recognize a substantial difference between GE and non-GE
organisms in regard to misleading labels, requiring industry to respond or face legal
consequences. This second event is based on the previously discussed case, International
Dairy Foods v. Boggs, in which the Sixth Circuit Federal Court of Appeals overturned Ohio’s
ban on absence lableing, supporting the argument that absence labeling does not mislead
consumers into believing that a disctinction exsists based on the finding that compositional
differences in hormone-treated and unthreated milk do in fact exsist.225
The final component of this stage is the implementation of management practices
that increase transparency between biotechnology developers, regulatory authorities, and
the American public. This requires the FDA, EPA and USDA alike to be more transparent in
their evaluations by including the disclosure of individual assessments in a readily
accessible format. Not only will this give the public access to the information, but it will
allow independent watchdog organizations to evaluate the information and transform it
into a medium better understood by the public. If such practices have any effect on
assessment information currently submitted to the aforementioned regulatory authorities
on a voluntary basis, the regulatory bodies but require the submission of such information,
as it is key to a fair evaluation of the product under consideration. By adopting these
practices, the information asymmetry between producers and consumers will begin to 225 International Dairy Foods v. Boggs
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break down, giving consumers the opportunity to make well-informed decisions, building
trust in the government, and a better public image for producers.
STAGE TWO: MITIGATE ENVIRONMENTAL CONSEQUENCES Environmental impacts of the production and consumption of genetically
engineered crops present some of the most menacing consequences and regulatory
challenges, both primarily founded in the ability of genetic material to spread via natural
means. The most serious efforts must be given to inhibiting this trait as it is problematic to
detect contamination and the continual spread of genetic material will be virtually
impossible to rein in once an undefined threshold has been reached. Potential solutions
include levying a tax on producers of genetically engineered crops in order to raise funds
for perimeter testing and confinement and instituting regional quarantines. Additional
attention must be given to the impact of genetic contamination on farmers producing non-
GE crops in order to eliminate a significant threat currently acting as a disincentive for the
production of non-GE crops. This will help to maintain biodiversity, mitigating the impact
of any serious consequences found to be associated with the production or consumption of
genetically engineered crops.
Like any other regulatory program, perimeter testing and remedial action in the
event that genetic contamination has been found requires funding. It is common practice
to tax the source of an externality in order to afford the cost of abatement/remediation. In
the case of genetic engineering this translates to levying a tax on producers of genetically
engineered crops. Producers of the crops rather than the producers of the organisms are
the chosen target due to the fact that the threat of contamination directly relates to the
prevalence of genetically engineered organisms. In other words, the risk of contamination
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is dependent upon the acres planted with genetically engineered crops. This disincentive
to plant genetically engineered crops is likely to indirectly deter development of such
organisms although it is important to clarify that the goal is to curb the use of a product
posing an environmental threat while raising funds to combat the externalities of said
product, not to hinder research and development of alternative products, ideally, with
more benefits and fewer risks. This concept is not unheard of, in fact in 2005 Denmark
acquired European Commission approval to move forward with the enforcement of a tax,
levied per hectare, on producers of genetically engineered crops in order to “compensate
conventional and organic farmers whose crops are contaminated by genetically modified
(GM) crops.”226 The tax will be implemented at an annual rate of 13.4 Euros per hectare
with funds dispersed to farmers of conventional or organic crops whose fields are found to
have a minimum contamination rate of 0.9 percent.227 A key difference between the Danish
tax and the recommendation of this report is that revenue collected from this
recommendation would be used only to fund perimeter testing to ensure the confinement
of genetically engineered crops. With this structure, tax breaks could be offered to those
producers with a record of low to zero rates of contamination providing an incentive for
the adoption of best practices for reducing contamination, such as the previously listed
recommendations from the National Organics Program regarding contamination
prevention. Tax assessments could easily be conducted periodically alongside perimeter
testing, which presumably would be conducted as a program of either the EPA or USDA, to
be calculated and collected alongside current taxes on business income. To account for 226 International Centre for Trade and Sustainable Developement. (2005, December 9). EC Approved Danish Tax on GM Crops for Co-exsistence. Retrieved November 2012, from International Centre for Trade and Sustainable Developement: http://ictsd.org/i/news/biores/62995/ 227 International Centre for Trade and Sustainable Developement., EC Approved Danish Tax
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varying revenues of different crops, the tax could be assessed as a percentage of per acre
revenue.
Regional quarantines of genetically engineered crop production further reduce the
risk of genetic contamination, and if extreme enough, have the potential to eliminate it
altogether. Genetic contamination relies on the proximity of non-GE crops to be cross-
pollinated, thus producing contaminated fruits and, if seeds are saved, contaminated crops
the following season. If distances are established between GE and non-GE crops the
instances of contamination will decrease; the longer the distance, the smaller the likelihood
that contamination will occur. This may seem like a radical approach, though it is not too
far off from quarantine-based mitigation legislation recently proposed, and passed in the
House, aimed at preventing the spread of disease via contaminated food. The Food Safety
Enhancement Act of 2009 contained several key provisions expanding the authority of the
FDA to respond to threats from contaminated food. These provisions include granting the
FDA the authority to recall and restrict movement of contaminated foods instead of relying
on producers to do so voluntarily, set standards for safe production for food farms and
manufacturers, and require the secretary of Health and Human Services to “identify
technology that can be used by food growers, manufacturers and distributors to determine
the origin of food and its movement in the supply chain.”228 Each of these provisions is
translatable to the topic of genetic contamination. The institution of regional quarantines
of genetically engineered organisms, best practices for reducing the chances that genetic
contamination will occur, and the identification of tracking mechanisms for genetically
engineered organisms and products each reduce the ability for genetic contamination to
228 The Washington Post. (2009, July 31). The Details. The Washington Post , p. A Section.
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occur. In addition, the establishment of regional quarantines, following a genetically
engineered organism from cultivation through processing/packaging, will encourage
regional food systems reducing pollution associated with the cross-country transportation.
The final component of this stage involves addressing the burden of proof in cases
where patent protected genetic material is found without the proper documentation
exhibiting legal cultivation. The burden of proof traditionally falls on the prosecutor, i.e.
defendants are considered innocent until proven guilty, a trend contrary to the events in
Monsanto Canada Inc. v. Paul Schmeiser, though one that is particularly important to
maintain considering the possibility of genetic contamination via natural reproductive
processes. Of course other facts must be taken into consideration, such as the portion of
the field found to be contaminated and the proximity of the field to sources of
contamination. Entirely contaminated fields are likely to be cases of misconduct where as
spotty contamination in combination with a nearby source of contamination suggests
contamination due to unintended causes. Regardless of the scenario, the burden of proof
must remain on the shoulders of the defendant. Not only is this the traditional expectation,
but it is also much more difficult to prove contamination due to natural causes compared to
that from contract infringement. This becomes an important issue given the fact that
threats of litigation under no-fault circumstances may push farmers otherwise interested
in the production of conventional crops to pursue legal cultivation of genetically
engineered crops, threatening the proliferation of conventional crop varieties and overall
biodiversity.
STAGE THREE: RESPONSIVE DISCOURSE
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The final stage of recommendations is essentially a response to the effects of Stage
One recommendations, made with additional knowledge gained from continued research
over the intermediate years. Once the public has had an opportunity to respond to the
information available from increased transparency and the increased role of scientific
watchdog organizations, expressed through both the allocation of their dollars and a
political discourse, a clear course of action may arise. If the public remains weary of edible
applications of genetic engineering, regulatory authorities may be pushed to enact more
thorough safety assessments and higher standards for market approval. If public
uneasiness is severe enough, genetically engineered products may be avoided altogether
and such products will be phased out, with producers gravitating towards good for which
there is a higher demand. On the other hand, increased transparency on the side of
producers may increase public trust in their work and eliminate fears related to the
unknown by eliminating the exotic nature of the technology. If producers are proud of
their products and can begin to offensively advertise their products rather than constantly
defending criticisms, the public perception of generically engineered products will shift,
making consumers less likely to shy away from genetically engineered products, even if
they are labeled as such. This opportunity to advertise the benefits of the technology will
increase the benefits of genetically engineered products as perceived by the consumer,
potentially creating a specific desire for such products. This would prove to be particularly
effective if the claimed reduction in production costs so often responsible for the adoption
of genetically engineered technology ever translated into advertisable savings for the
consumer.
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APPENDIX
NON-REGULATED GE PLANTS229
Institution Regulated Article
Transgenic Phenotype
Monsanto and KWS SAAT AG
Sugar Beet Glyphosate tolerant
Bayer Cotton Glufosinate tolerant, lepidopteran resistant Florigene Rose Altered flower color Monsanto and Forage Genetics
Alfalfa Glyphosate tolerant
Pioneer Corn Glyphosate and lmidazolinone tolerant, male sterile, fertility restored, visual marker
U. of Florida Papaya Papaya Ringspot Virus resistant Bayer CropScience Cotton Glyphosate tolerant Pioneer Soybean Glyphosate and acetolactate synthase tolerant, high
oleic acid Bayer CropScience Rice Phosphinothricin tolerant Syngenta Corn Corn Rootworm protected, lepidopteran resistant,
thermostable alpha-amylase ARS Plum Plum Pox Virus resistant Dow Corn Lepidopteran and Corn Rootworm resistant,
phosphinothricin tolerant Syngenta Cotton Lepidopteran resistant Mycogen/Dow Cotton Lepidopteran resistant Aventis Cotton Phosphinothricin tolerant Aventis Rapeseed Phosphinothricin tolerant, pollination control Vector Tobacco Reduced nicotine Mycogen c/o Dow and Pioneer
Corn Lepidopteran resistant, phosphinothricin tolerant
U. of Saskatchewan Flax Tolerant to soil residues or sulfonyl urea herbicide AgrEvo Rice Phosphinothricin tolerant Monsanto Rapeseed Glyphosate tolerant Novartis Seeds and Monsanto
Beet Glyphosate tolerant
AgrEvo Soybean Phosphinothricin tolerant Pioneer Corn Male sterile, phosphinothricin tolerant AgrEvo Beet Phosphinothricin tolerant AgrEvo Corn Phosphinothricin tolerant, lepidopteran resistant,
male sterile
229 Animal and Plant Health Inspection Service. (n.d.). Biotechnology. Retrieved May 2012, from Animal and Plant Health Inspection Service: http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml
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Institution Regulated Article
Transgenic Phenotype
Bejo Cichorium intybus
Male sterile
Du Pont Soybean High oleic acid oil AgrEvo Rapeseed Phosphinothricin tolerant, pollination control AgrEvo Soybean Phosphinothricin tolerant Cornell U Papaya Papaya Ringspot Virus resistant Asgrow Squash CMV, ZYMV, WMV2 resistant Agritope Tomato Fruit ripening altered Du Pont Cotton Sulfonylurea tolerant Plant Genetic Systems
Corn Male sterile
Northrup King Corn European Corn Borer resistant DeKalb Corn Phosphinothricin tolerant and European Corn Borer
resistant Monsanto Corn Lepidopteran, European Corn Borer, ECB, and Corn
Rootworm resistant, glyphosate and drought tolerant, high lysine
Monsanto Tomato Fruit ripening altered, lepidopteran resistant AgrEvo Tomato Phosphinothricin tolerant Ciba Seeds Corn Lepidopteran resistant Monsanto Cotton Lepidopteran resistant, glyphosate tolerant Zeneca & Petoseed Tomato Fruit polygalacturonase level decreased Monsanto Potato Coleopteran, PLRV, PVY, and CPB resistant DNA Plant Tech Tomato Fruit ripening altered Calgene Rapeseed Oil profile altered Monsanto Soybean Glyphosate tolerant, insect resistant, improved fatty
acid profile, stearidonic acid produced Calgene Cotton Bromoxynil tolerant, lepidopteran resistant Upjohn Squash WMV2 and ZYMV resistant Calgene Tomato Fruit ripening altered
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SURVEY 1. Where did you find out about this survey?
Kroger Bloomingfoods Other
2. Who usually buys most of the groceries for your household?
Me My spouse/other member and I split the shopping pretty evenly Someone else, please specify Other arrangement, please specify
3. Which term best describes the process of putting artificial genes into plants or animals to
produce traits that cannot be produced through breeding methods? Genetic modification Genetic engineering Bioengineering Biotechnology
For the remainder of the survey, the process of putting artificial genes into plants or animals to produce traits that cannot be produced through breeding methods will be referred to as genetic engineering, or GE.
4. How important are the following factors when purchasing groceries? (7 point
importance scale for each factor)
Price Brand Buying organic Buying locally grown or made Buying foods that are GE-free
5. Where do you find information about how the food you buy was grown or made (for
example whether it was grown locally, organic, or GE-free)? Do you use… Store signs Food labels Internet Other, please specify
6. About what percent of food labels provide you with enough information to determine
when food is genetically engineered or contains genetically engineered material? 0% 1-25% 26-50%
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51-75% 76-99% 100%
7. How much of the produce (fresh foods, not including meats/fish) that you buy would
you estimate is genetically engineered? 0% 1-25% 26-50% 51-75% 76-99% 100%
8. How certain are you of your estimate?
Very uncertain Uncertain Neither certain or uncertain Certain Very Certain
9. How much of the processed food that you buy would you estimate is genetically
engineered or contains genetically engineered material? 0% 1-25% 26-50% 51-75% 76-99% 100%
10. How certain are you of your estimate?
Very uncertain Uncertain Neither certain or uncertain Certain Very Certain
11. Regarding your health, do you think eating genetically engineered foods are…
Very bad Bad Poor Neither good nor bad Fair Good Very good
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12. Regarding the environment, do you think eating genetically engineered foods are… Very bad Bad Poor Neither good nor bad Fair Good Very good
13. What have you heard about genetically engineered foods? Mark yes or not for the
following statements. Genetically engineered foods may be higher in nutrients than non-genetically
engineered foods. Eating genetically engineered foods may result in unexpected allergic reactions. Growing genetically engineered foods can decrease the use of insecticides,
herbicides, and fertilizers. Growing genetically engineered foods can increase the use of insecticides,
herbicides, and fertilizers. Growing genetically engineered crops may kill off naturally occurring crops and
animals. Growing genetically engineered crops can reduce the need for tillage and reduce
erosion.
14. What is your sex? Male Female
15. In what year were you born?
16. What is the highest degree or level of school you have completed?
Some high school High school diploma/GED Some college 2-year degree Bachelor’s degree Graduate or other professional degree (J.D., M.D., Ph.D., etc.)
17. Just for statistical purposes, what was the total combined income, before taxes, for all
members of your household for 2011 less than $35,000? If yes
o Was the total household income for 2011 less than $20,000? If no
o Was the total household income for 2011 less than $50,000? If yes, was the total household income for 2011 less than $80,000?
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SURVEY PARTICIPATION FLIER
