BIO 4418 Food law Chapter 10 - spkx.gsau.edu.cn

4/6/2017

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Chapter 10Biotechnology and Genetically Modified Agricultural Crops and Food

Introduction

• Much debate around the costs versus benefits of producing genetically modified (GM) crops and food.

Introduction

Alliance for Bio-Integrity v. Shalala

• Plaintiff argued for- for mandatory GM labeling- that GM foods should undergo the same

testing requirements as food additives as they are "materially changed" and have potentially unidentified health risk

- that FDA did not follow the Administrative Procedures Act in formulating and disseminating its policy on GM foods

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Introduction

Alliance for Bio-Integrity v. Shalala

• Federal district court - rejected all arguments- found that the FDA's determination that

GMO's are Generally Recognized as Safe was neither arbitrary nor capricious

- gave respect to the FDA's process on all issues- gave future plaintiffs little legal recourse to

challenge the FDA's policy on GM foods

Introduction

Debate is focused on 3 issues

1. Are GM crops and food safe for human health?2. Are they safe for the environment?3. How do we regulate products of modern

biotechnology?

To date, consumption of GM crops or GM foods has not been correlated or linked to any health problems for animal or humans

Introduction

• Numerous groups have filed cases alleging ”fraud-on-the-FDA” since the introduction of GM foods in 1996

• FDA bottom line statementGM food does not depend on the methods by which the food was developed, but rather regulation rests on the characteristics of the crop/food and its intended use or the use of its components

Benefits Costs

Enhanced quality and taste Human health impact (introduction of allergens and antibiotic resistance)

Increased productivity (reduced maturation time) and yield

Effects on non-targeted organisms

Improved health and resistance to disease and pests (use less pesticide and herbicides)

Food monopolies by a few companies

Increased and improved nutrients Biopiracy (foreign explotation of natural resources)

Drought resistance crops Animal stress from over-production

Improved feed conversion (meat producing animals)

No world-wide labeling standards (mix GM with non-GM products)

Improved food security Potential skewed interest of rich countries

Benefits and costs of using genetically modified or genetically engineered foods

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Biotechnology, Genetically Modified and Genetic Engineering

• Biotechnology- application of scientific knowledge to living

organisms or their constituents for practical purposes

- utilization of biologically-derived molecules, structures, cells or organisms to carry out a specific function


• Genetically modified• Genetic engineering

- refer to an organism (animal, plant, bacteria) that has been exposed to a technique that changes its genetic makeup or DNA

- generally thought of as modern food science tools

- reality is that people have been manipulating food since ancient times

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• Genetically modified• Genetic engineering

- Wine was produced as early as the Bronze Age (6000 BCE)

- Bread was first leavened over 4000 years ago using yeast

- Animals have been bread to produce the strongest or most productive


• Gene splicing• Recombinant DNA

- Combine genetic elements of two or more living cells to produce desirable traits

- Example: dairy cows have been genetically modified to produce more milk without costing the farmer more

- Critics say that these changes are against nature and do not provide any advantages to the consumer

Regulation of GM Foods in the USGeneral policy of the US Government regarding new technology• Manufacturer must demonstrate to the

appropriate agencies that exposure to the new technology shows no significant risk to humans, animal-producing foods and the environment

• Regulators focus on whether or not the modified crops or foods are compatible with nature

• Three agencies oversee the regulation of GM foods

FDA USDA EPA

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Regulation of GM Foods in the US

USDA• Responsible for safety and wholesomeness of

meat, poultry and egg products

• Regulates potential agricultural plant pests and noxious weeds

• Ensures safety and efficacy of meat-producing animals


USDA• Two USDA agencies are responsible for GM crops

and foods1. Animal and Plant Health Inspection Service

(APHIS)oversees the Federal Plant Pest Act, which regulates interstate movement, importation and field testing of GM organisms/products that are not yet proven safe

2. Food Safety Inspection Service (FSIS)


EPA• Follow the guidelines of the US Federal

Insecticide, Fungicide, and Rodenticide Act- Regulate the sale, use and testing of

plants and microorganisms that produce pesticide substances

- Example: Bacillus thuringiensis and BT corn, Bt cotton, Bt potatoes

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EPA• Follow the guidelines of the US Federal

Insecticide, Fungicide, and Rodenticide Act- controls allowable residues levels of

herbicides in areas planted with GM-derived herbicide resistant crops

Regulation of GM Foods in the USEPA• Toxic Substance Control Act

- enables EPA to regulate commercialization of GM organisms that possess pesticidalactivities

- requires EPA to review and issue a permit for field testing of a protectant > 10 hectares of land

- before commercialization, EPA reviews the application and asks for public opinion and scientific expert feed-back


FDA• ensures the food safety and wholesomeness for

all foods excluding those regulated by the USDA

• agencies that regulate GM foods- Center for Food Safety and Applied

Nutrition- Center for Veterinary Medicine- Center for Drug Evaluation and Research


FDA• follows the guidelines of the Food, Drug

and Cosmetic Act of 1938• has authority to remove by seizure and

forced recall any food that does not meet the safety standards

• relies on companies to notify them before marketing new items

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FDA• Once notification of new product is

received: - FDA provides consultation to help

developers of new food products to meet safety requirements

- goal is to evaluate safety before product becomes commercial


FDA• addresses labeling requirements of food

- oponents of GM foods cite that these foods are misleading or misbranded according to the FDCA

- FDA does not regulate GM foods as new products or new food additives

- FDA does not considered these products mislabeled or misbranded


FDA• addresses labeling requirements of food

- if the GM food has significantly altered nutritional properties from its conventional counterpart, then it needs to be reflected in the label

- FDA encourages voluntary labeling of foods indicating if they are GM foods

Regulation of GM Foods in the USFDA• regulation of GM foods is based on ”substantial

equivalence”• 1992 policy – Statement of Policy: Foods Derived

from New Plant Varieties- provides guidance to the industry regarding

FDA’s position on biotechnology and GM foods- basic premise is that there are no special

labeling requirements for GM foods as they are not seen to be different if they are substantially equivalent to their conventional counterparts

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Regulation of GM Foods in the USFDA• GM food undergo a safety assessment that compares GM foods

to conventional counterparts with respect to molecular, compositional, toxicological, and nutritional data1. Evaluation of the purpose or technical effect of the

modification2. Evalutation of the source, identity, function, and stability of

the introduce genetic material3. Analytical studies to determine effects on composition of

the food4. Evaluation of GM substance in food5. Animal feeding studies or other toxicological tests are done

when the analytical methods cannt resolve safety concerns

Regulation of GM Foods in the USFDA• Example where substantial equivalence was not found –

StarLink corn- GM corn produces an insecticidal protein from B.

Thuringiensis- Protein digestion and heat stability tests showd that a

unique Bt protein was produced and was seen as a potential human allergen

- Not approved by FDA but was approved for use in animal feed by EPA

- StarLink corn found in taco shells- CDC provided evidence of the corn as potential allergen

linking it to 51 illnesses though inconclusively- Removed from the market in 2000


GM food regulation summary: fictional example• Very Cherry Company developed GM cherries

that include new gene ”gene R”• Gene enhances the red color but does not

affect the products safety as determined by field tests and molecular/chemical evaluations

• Product was tested on land and shown not to pose an environmental hazard

• Data was presented to FDA, USDA, and EPA and an exemption was requested

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GM food regulation summary: fictional example• Since the product does not produce any

pesticides, the EPA would not regulate it• FDA ensures the safety and wholesomeness

of the product for human consumption• Very Cherry Co. notified the FDA of the new

product and proceeded with a two-step process- discussion of the relevant safety issues- submission of a report on safety

assessment


GM food regulation summary: fictional example• FDA evaluated the data and sent a letter

regarding the product status• FDA does not approve the products but

states ”all relevant scientific questions have been addressed”

• No reason to prevent marketing of their product

Biotechnology versus Organic Agriculture

• Organic Food Protection Act of 1990- created under the Farm Bill - establishes national standards that govern

marketing of organic agricultural products- ensures that consumers receive products

that meet consistent standards- regulates interstate commerce of organic

food


• Organic Food Protection Act of 1990- authorized a new USDA program – National

Organic Program established organic standards and

definitions placed Agricultural Marketing Service

within the USDA as agency to oversee NOP prohibits use of any GM ingredient in the

product label as organic- Organic standards are expressed in Title 7,

part 205 of the Code of Federal Regulations

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Legal issues – NOP and biotechnology• If a producer adheres to all aspect of the

NOP regulations, including no GM seeds, but a certifying agent finds GM material in the crop, then the crop may still be ”certified” as organic

• Organic certification is ”processed-based” and not ”product-based”

• This is opposite to FDA’s view on GM food which is ”product-based”


Legal issues – NOP and biotechnology• Organic certifying agents are USDA trained

and ensure that the organic operations follow the OFPA and NOP regulations

• If all regulations are followed, then detectable residue does not constitute a violation of the regulations

• When unintended GM substances are found, certifying agents work with the organic producers to find the source of the GM substance

Common Examples of GM Products

Flavr Savr Tomato• Developed by Calgene, Inc California• First GM crop to be commercialized in the US• Concept: traditional commercial tomatoes

- picked green to prevent damage during transportation

- ripened by ethylene gas, a growth hormone


Flavr Savr Tomato• Concept: flavr savr tomato

- supress the enzymes responsible for ripening polygalacturonase degrades pectin in the

cell wall- without PG the fruit remains firm and

artificial ripening is avoided- Result: vine-ripen flavor without the

softening

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Flavr Savr Tomato• May 21, 1994, Flavr Savr tomato was

introduced - demand was high- product was not profitable as

production/distribution costs were too high


Bt corn• What is Bt pesticide?

- refers to an insecticidal protein- produced by a common soil bacterium

Bacillus thuringiensis- B. thuringiensis discoverd in 1901 by a

Japanese biologist

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- B. thuringiensis produces a insecticidal crystal or toxic Bt protein

- Bt protein paralyzes the digestive tract of insects and pests

- Bt is harmless to humans and non-pest species



- first marketed in the US in 1958- registered with EPA in 1961- popularity increased in 1980

1. more insects were becoming resistant to synthetic pesticides

2. scientists and environmentalists were becoming aware that the synthetic instecticides were harming the environment



- affects specific insects- does not persist in the environment

• Researchers moved the gene encoding Bt into plants

• 1995, corn was the first Bt genetically engineered plant

• Today Bt cotton Bt potato also are used

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Bt corn• Based on federal food law

- Bt altered food crops require premarket approval from FDA

- Bt altered crops are not considered GRAS- Food products altered via rDNA are

considered food additives only if they are different in structure, function, or nutrient levels


Bt corn• Based on federal food law

- Bt altered food crops contain insecticidal proteins and are considered to contain a food additive

- Bt crystal protein may cause allergies as was suggested in the StarLink corn


L-Tryptophan• First genetically modified food supplement to

be produced world-wide• One of seven essential amino acids for adults• A required amino acid• Traditionally, supplements are produced

through fermentation using large vats of bacteria, extracted from the bacteria and purified

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L-Tryptophan• Late 1980s, Japanese company Showa Denko

KK manufactered tryptophan from GM bacteria

• Production efficiency was increased• Bacteria contained segments of DNA that

altered their metabolism and increased production of tryptophan


L-Tryptophan• Tryptophan from GM bacteria was introduced

in the US in the 1988• FDA did not require testing because Showa

Denko had sold non-GM tryptophan in the US• FDA did not require that the tryptophan be

labled as a GM product


L-Tryptophan• 1989, health department was notified of

several patients seeking medical treatment for similar symptoms linked to GM tryptophan

• In a few weeks, a nation-wide outbreak of a disease termed eosinophilia-myalgia syndrome

• 37 people died and 1500 permanently disabled from the product


L-Tryptophan• Poisoning was due to dimerized tryptophan• Comprised less than 0.1% of the total weight• Higly toxic• Showa Denko paid over 1 billion dollars to

EMS victims

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Biotechnology – related court cases

International dairy foods Assoc v Boggs• Bovine somatropin (BST)

- is a peptide hormone- produced by the cow’s pituitary gland- dairy industry uses to increase milk

production in dairy cows• Recombinant BST first approved for use in diary

cows in 1993• FDA stated ”milk from rBST treated cows was

safe for human consumption and that use of the product did not have a significant impact on the environment”


International dairy foods Assoc v Boggs• Stauber versus Shalala

- Court ruled in favor of Donna Shalal the Secretary of Health and Human Services

- Defendents argued that the FDA decision to approve rBST was arbitrary and did not include the safety and health of the milk

- Plantiffs failed to show that the rBST milk was different to non-rBST milk


International dairy foods Assoc v Boggs, 2010• Sixth Circuit Court

- found that milk produced using rBST was substantially different in composition to that of non-rBST

- disregarded the FDA’s prior decision in the Stauber v. Shalala case

- struck down Ohio regulation prohibiting milk producers from labeling milk as coming from non-rBST cows


International dairy foods Assoc v Boggs, 2010• rBST milk differed in that

- it has increased levels of the hormone IGF-1

- a period of lower nutritional quality of milk occured during each lactation

- it has increased somatic cell counts, which indicates a lower quality of milk that will sour quicker

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International dairy foods Assoc v Boggs, 2010• rBST-free milk came into question

- Failure to detect rBST was due to an imperfect test used in the detection

- Court ruled that the compositional statements on the label that state - rBST free, hormone-free, no artifical hormones, or no hormones were not misleading to the consumer


Alliance for Bio-Integrity v Shalala• September 2000, court dismissed this

challenge to FDA’s regulatory policies concerning GM foods

• Plantiff group, consisting of public interest groups, religious groups, and individuals, made allegations on the legality of the agency’s 1992 policy statement – Foods Derived from New Plant Varieties


Alliance for Bio-Integrity v Shalala• Court deferred to FDA’s interpretation of

the FDCA under which GM foods are presumed to GRAS and do not require food additive petition without specific evidence against that presumption


Monsanto v Geerston Farms (organic farms)• First GM crop case brought before the Supreme

Court• 2010, United States Supreme Court case decided

7-1 in favor of Monsanto• Supreme Court overturned a decision by the

court of appeals for the Ninth Circuit that allowed Monsanto to sell GM alfalfa seeds to farmers, and allowed farmers to plant them, grow crops, harvest them, and sell the crop into the food supply

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Monsanto v Geerston Farms (organic farms)• Case came about as the Animal and Plant

Health Inspection Service (APHIS) deregulated GM alfalfa plants

• The approval was challenged in district court by Geertson Seed Farms and other groups who were concerned that the GM alfalfa would spread too easily

• Plaintiffs claimed the APHIS decision violated the National Environmental Policy Act of 1969


Monsanto v Geerston Farms (organic farms)• Plaintiffs claimed that because of the ruling,

they would have to incur significant costs to test their plants for contamination

• Plaintiffs claimed that the ruling would require them to incur costs to decrease the likelihood that their plants are infected

• The plaintiffs won


Monsanto v Geerston Farms (organic farms)• Monsanto (defendant) appealed, claiming,

among other things, that the plaintiffs lacked constitutional standing to bring the claim

• Monsanto lost• Monsanto appealed again to the Supreme

Court and won, upholding the original approval and allowing the seeds to be sold


Monsanto v Geerston Farms (organic farms)• Court recognized that a plantiff could sue

without proof of actual environmental harm if they can show they suffer economic losses from testing and reduced measures related to the harm

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Conclusion• Primary reason for GM crops or foods is to

grow bigger, better crops and to produce more food in an efficient manner compared to conventional techniques

• Several concerns associated with GM crops or foods- Human health impact- Environmental impact- Harm to non-targeted species by crops

with incorporated genes

Conclusion

• Biotechnology has blurred the lines between GM techniques and traditional breeding methods

• As technology develops, opportunities to ensure food safety will be developed

• Question then becomes how important is food sufficiency

BIO 4418 Food law Chapter 10 - spkx.gsau.edu.cn

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