FOOD BIOTECHNOLOGY: A LEGAL PERSPECTIVE University of Richmond School of Law 14 March 2003

L. Val Giddings, Ph.D. Vice President for Food & Agriculture Biotechnology Industry Organization Washington, DC

Regulating “Genetically Modified” Foods in the United States Fact vs. Fiction

Oft Peddled Fiction: Foods derived from crops improved through biotech were surreptitiously imposed on an unwilling public Foods derived from crops improved through biotech were surreptitiously imposed on an unwilling public Consumers want labels but labeling stymied to keep public in the dark Consumers want labels but labeling stymied to keep public in the dark Inadequate safety reviews; uncooperative companies Inadequate safety reviews; uncooperative companies Novel food safety risks (allergenicity, toxicity, etc…) Novel food safety risks (allergenicity, toxicity, etc…) Inadequate knowledge of long term consumption impacts Inadequate knowledge of long term consumption impacts Environmental threats inadequately considered Environmental threats inadequately considered

More fiction… Benefits only companies, not consumers or farmers Benefits only companies, not consumers or farmers Encourages monoculture & unsustainable agriculture Encourages monoculture & unsustainable agriculture Encourages corporate control of food production; economic concentration Encourages corporate control of food production; economic concentration

“There is no sadder sight than to see a beautiful hypothesis rent limb from limb by packs of bloodthirsty facts.” --Thomas Henry Huxley

“…surreptitiously imposed on an unwilling public…” How much coverage in newspapers, radio, tv…? How much coverage in newspapers, radio, tv…? Regulations promulgated under APA notice & comment rulemaking Regulations promulgated under APA notice & comment rulemaking Public hearings at every significant juncture (USDA, FDA, EPA) Public hearings at every significant juncture (USDA, FDA, EPA) Routine permits etc. promulgated under notice and comment rulemaking of APA Routine permits etc. promulgated under notice and comment rulemaking of APA Public databases on USDA website; more at FDA & EPA Public databases on USDA website; more at FDA & EPA

“Consumers want labels…” Benjamin Disraeli: “There are lies, damn lies, and statistics.” Benjamin Disraeli: “There are lies, damn lies, and statistics.” Push polls bought & paid for by global protest industry suggest consumers want labels Push polls bought & paid for by global protest industry suggest consumers want labels When existing FDA labeling policy explained consumers embrace by wide margins, 80%+ ( When existing FDA labeling policy explained consumers embrace by wide margins, 80%+ ( Labels required to be accurate, informative, not misleading. Must include safety related info, e.g., change in composition, allergenicity, etc. Labels required to be accurate, informative, not misleading. Must include safety related info, e.g., change in composition, allergenicity, etc. Non biotech choice a preference not based on safety data; afforded via market forces, organic Non biotech choice a preference not based on safety data; afforded via market forces, organic Fact: most consumers are not concerned, don’t want labels, wouldn’t read them if they were there. Fact: most consumers are not concerned, don’t want labels, wouldn’t read them if they were there.

We are going to force them to label this food. If we have it labeled, then we can organize people not to buy it. -- Andrew Kimbrell “Center for Food Safety”

…labeling has nearly the same effect as a ban. -- Craig Winters -- Craig Winters Campaign to Label Genetically Campaign to Label Genetically Engineered Foods Engineered Foods

“Inadequate safety reviews…” Every reasonable question one could imagine is asked of crops & foods improved through biotechnology, and some unreasonable ones (e.g., some DNA sequences) Every reasonable question one could imagine is asked of crops & foods improved through biotechnology, and some unreasonable ones (e.g., some DNA sequences) Far more rigorous scrutiny than conventional or organic (e.g., allergenicity, kiwi fruit) Far more rigorous scrutiny than conventional or organic (e.g., allergenicity, kiwi fruit) Nice to know vs. need to know Nice to know vs. need to know

Assuring Safety U.S. Regulatory Framework Coordinated Framework 1986 White House Coordinated Framework 1986 White House U.S. Department of Agriculture U.S. Department of Agriculture Environmental Protection Agency Environmental Protection Agency Food and Drug Administration Food and Drug Administration

USDA Regulation of Crops Improved via Biotechnology APHIS Form 2000 requires data on: APHIS Form 2000 requires data on: Detailed characterization of product and source of genetic material; sequences of inserts and flanking regions Detailed characterization of product and source of genetic material; sequences of inserts and flanking regions Detailed explication of intent Detailed explication of intent Replicated data on gene expression in the plant Replicated data on gene expression in the plant Proposed conditions of cultivation & handling Proposed conditions of cultivation & handling Potential for pollen flow/gene transfer Potential for pollen flow/gene transfer Potential impacts of gene flow Potential impacts of gene flow Potential non target impacts Potential non target impacts Other potential ecological impacts Other potential ecological impacts

EPA Regulation of Biotechnology: Pesticides EPA typically reviews data on: EPA typically reviews data on: Product characterization and source of genetic material Product characterization and source of genetic material Vector system and recipient plant Vector system and recipient plant Gene expression in the plant Gene expression in the plant Product analysis and residue chemistry Product analysis and residue chemistry Toxicology Toxicology Potential allergenicity Potential allergenicity Potential ecological impacts Potential ecological impacts

FDA Food Safety Assessment Overview Intended Modification Intended Modification New Substance(s) - New Substance(s) - identity; structure/function identity; structure/function source (allergenicity) source (allergenicity) digestibility digestibility dietary exposure dietary exposure nutrition nutrition Unintended Modifications Unintended Modifications Genetic stability Genetic stability Composition -- nutrients & toxicants Composition -- nutrients & toxicants

“Novel food safety risks” – allergenicity, toxicity, etc. US National Research Council found that risks of crops and foods improved through biotechnology were not novel, but familiar US National Research Council found that risks of crops and foods improved through biotechnology were not novel, but familiar Findings upheld by numerous unbiased, authoritative a priori analyses Findings upheld by numerous unbiased, authoritative a priori analyses Findings upheld by vast body of experience: no confirmed reports of negative human or environmental health impact; NONE! Findings upheld by vast body of experience: no confirmed reports of negative human or environmental health impact; NONE!

“Inadequate knowledge of long term consumption impacts…” Substantial equivalence is a conclusion, not a presupposition Substantial equivalence is a conclusion, not a presupposition Digestion fate studies confirm a priori prediction of protein fate Digestion fate studies confirm a priori prediction of protein fate An amino acid is an amino acid; also known as “nutrition” An amino acid is an amino acid; also known as “nutrition” Smoke screen for confusing lay people Smoke screen for confusing lay people

“Environmental threats shortchanged…” Pollen/gene flow – fact of life. Crucial question is what would be the result? Example – BT traits in Mexican corn landraces Pollen/gene flow – fact of life. Crucial question is what would be the result? Example – BT traits in Mexican corn landraces Non target species impacts – Monarch butterfly Non target species impacts – Monarch butterfly Biodiversity impacts – best place for Monarch larva to be is in a biotech corn field! Positive impacts on other beneficials. Biodiversity impacts – best place for Monarch larva to be is in a biotech corn field! Positive impacts on other beneficials.

“…available scientific data and information indicate that cultivation of Bt crops has a positive ecological effect, when compared with the most likely alternatives.” -- EPA Response to Petition concerning Bt crops from Greenpeace et al., April, Bt crops from Greenpeace et al., April, 1999, p , p. 70

Cui bono? – who benefits? Combating Human Diseases – The first biotechnology products were medicines designed to address human diseases. Combating Human Diseases – The first biotechnology products were medicines designed to address human diseases. Promoting Human Health – Researchers are creating ways to boost the nutritional value of foods using biotechnology. Promoting Human Health – Researchers are creating ways to boost the nutritional value of foods using biotechnology. Combating Animal Diseases – Biotechnology helped produce a vaccine that protects animals in the wild against rabies and a vaccine for “shipping fever” of cattle, the biggest killer of beef cattle in feedlots. Combating Animal Diseases – Biotechnology helped produce a vaccine that protects animals in the wild against rabies and a vaccine for “shipping fever” of cattle, the biggest killer of beef cattle in feedlots. Fighting Hunger by Resisting Plant Diseases and Increasing Crop Yields – Biotechnology can help farmers increase crop yields and feed even more people. Fighting Hunger by Resisting Plant Diseases and Increasing Crop Yields – Biotechnology can help farmers increase crop yields and feed even more people. Helping the Environment by Reducing Pesticide Use – Biotechnology can help farmers reduce their reliance on insecticides and herbicides. Helping the Environment by Reducing Pesticide Use – Biotechnology can help farmers reduce their reliance on insecticides and herbicides.

Cui Bono cont. 6 crops currently on market in US produce an additional 4 billion pounds/year food & fibre, increase farm income by $1.5 billion, and reduce pesticide vol by 46 million pounds (Gianessi) 6 crops currently on market in US produce an additional 4 billion pounds/year food & fibre, increase farm income by $1.5 billion, and reduce pesticide vol by 46 million pounds (Gianessi) Full adoption of crops improved through biotech would “boost aggregate incomes for all regions by ~$310 billion by 2015” with greatest impact on poorest farmers’ incomes and health (Australian Bureau for Agricultural Resource Economics, 2003) Full adoption of crops improved through biotech would “boost aggregate incomes for all regions by ~$310 billion by 2015” with greatest impact on poorest farmers’ incomes and health (Australian Bureau for Agricultural Resource Economics, 2003)

“Encourages monoculture/ unsustainable agriculture” Low/no till agriculture Low/no till agriculture Substituting “gene treadmill” for “synthetic chemical treadmill” Substituting “gene treadmill” for “synthetic chemical treadmill”

“A truly extraordinary variety of alternatives to the chemical control of insects is available. All have this in common: They are biological solutions, based on understanding of the living organisms they seek to control. …Some of the most interesting of the recent work is concerned with ways of forging weapons from the insects’ own life processes.” -- Rachel Carson, -- Rachel Carson, Silent Spring, 1962 Silent Spring, 1962

“Encourages monoculture/ unsustainable agriculture” Encourages monoculture – data on soybean variety introductions Encourages monoculture – data on soybean variety introductions

New Soybean Varieties Introduced by Pioneer Hi-Bred – – 1995 Average = ~ – – 2001 Average = ~ = First year biotech varieties introduced 1996 = First year biotech varieties introduced

Biotech enhances corporate control of food production; economic concentration Concentration is artifact of one of the most powerful forces in human history: consumer choice Concentration is artifact of one of the most powerful forces in human history: consumer choice Consumers choose cheaper food. This has driven concentration since long before Watson & Crick Consumers choose cheaper food. This has driven concentration since long before Watson & Crick What does human nutrition look like where there is the lowest corporate control of food production? What does human nutrition look like where there is the lowest corporate control of food production?

Crops and foods improved through biotechnology have been subjected to more scrutiny, in advance, in depth and detail, than any others in human history. Crops and foods improved through biotechnology have been subjected to more scrutiny, in advance, in depth and detail, than any others in human history.

It is not about safety It is not about safety Agricultural biotech has become a lightning rod, stalking horse, surrogate for other issues (concentration, globalization, concerns over US cultural hegemony…) Agricultural biotech has become a lightning rod, stalking horse, surrogate for other issues (concentration, globalization, concerns over US cultural hegemony…) There is a positive alternative: increase public sector funding for ag R&D There is a positive alternative: increase public sector funding for ag R&D

“The campaign of fear now being waged against genetic modification is based largely on fantasy and a complete lack of respect for science and logic.” -- Patrick Moore, Ph.D., -- Patrick Moore, Ph.D., Ecologist; Greenpeace Ecologist; Greenpeace Co-Founder Co-Founder

When it comes to considering the risks of recombinant DNA, we shy at kittens, and cuddle tigers. -- James Watson