Genetically Modified Organisms

ROBIN C. KOON, EXECUTIVE VICE-PRESIDENT

BEST FORMULATIONS

An Industry Update:

GMO

An emerging issue with consumers, and as such now one for our industry. Primarily due to a growing focus by the media and consumers. There is a clear divergent opinion between consumers and the food/agra-business on GMO safety and labeling.

• Biotechnology and bioengineering are the fields of science that study and create GMOs.

• GMOs are subject to intellectual property law like all other man-made inventions.

New field of study

Increase request on GMO status • The requests for GMO status of nutritional ingredients and products has increased significantly this last year.

• 60-70% of processed foods contain GMO ingredients. With 90% of the average American’s food budget going towards processed foods, it is probable that the majority of Americans are consuming GMOs.

• Perception: The term “natural” is seen as inherently positive; whereas “unnatural” is not. And anything that involves human manipulation is considered highly unnatural— and so is something like GMOs (even though they already lines the shelves at grocery stores).

"ipsa scientia potestas est" ('knowledge itself is power') - Frances Bacon (Meditationes Sacrae 1597)

Perceptions can get out of control

Audrey Jr.

• What is your attitude toward genetically modified foods?

• Are you confident they are safe?

• Is it acceptable to alter "Mother Nature"?

• Do you trust the science or do you worry there may there be long term "Frankenstein" consequences?

• Do you even care?

POP QUIZ

The genetically modified foods controversy is a huge growing international debate over the use of food and other goods derived from genetically modified crops instead of from conventionally grown crops.

The main areas of controversy related to GMO food risks are:

1) whether GM materials are safe to ingest (there is a small potential for adverse events to exist, due mainly to horizontal gene transfer, allergenicity, and toxicity).

2) concerns about a lack of independent impartial unbiased scientific testing and review of GMO materials.

3) whether such foods should be labeled as GMO (as it is in 60 countries).

4) the effect of GM crops on health, the environment, and on farmers.

The controversy

What are some of the criticisms against GM foods?

Environmental activists, religious organizations, public interest groups, professional associations and other scientists have all raised concerns about GM foods, and criticized agribusiness for pursuing profit without adequate concern for potential hazards, and the government for failing to exercise adequate regulatory oversight. It seems that everyone has a strong opinion about GM foods.

The specific criticisms/concerns/issues raised are:

● The knowledge about the genes and the understanding of how they work is too incomplete at this time, and make it impossible to predict and understand all consequences of genetic engineering.

● The knowledge about the health safety of GE foods is incomplete.

● The knowledge about the environmental safety of GE organisms is incomplete. Superweeds?

● It has been scientifically established that unexpected effects can occur from genetic engineering that can or are hazardous to health and the surroundings.

● Biodiversity - how will this new biotechnology alter evolution or the future?

● Science has established that there is no need for GE organisms for feeding the world or solving nutritional deficiency problems.

● Government oversight is dangerously lax.

● Ten corporations control nearly 70% of the world's seed market, yet small-scale farmers produce the majority of the world’s food.

GMOs have been on the market for two decades (the first in the United States was the Flavr Savr tomato in 1994).

But the controversy over their use is certainly growing, since more and more US consumers are asking for non-GMO products or at least products that are labeled as such. As a response to consumers, some companies are changing their products.

Some examples:

• General Mills recently announced Cheerios® will now have a non-GMO version. • The New York Times (March 8, 2013) announced that Whole Foods Market, became the first retailer in the United States to require labeling of all genetically modified foods sold in its stores by 2018.

TIME-FRAME

The best definition I’ve seen:

A genetically modified organism (GMO) is one whose genetic material has been altered in such a way that does not occur naturally, using genetic engineering techniques.

Other names for the process include Genetic Engineering (GE) or Genetic Modification (GM).

Organisms that have been genetically modified include: micro-organisms (such as bacteria and yeast), insects, plants, fish, and mammals.

Applications for genetic engineering include: crops, disease control (biotherapeutics and gene therapy),

hormone and protein synthesis, and animal research.

The Definition

The definition of GMO varies by country. The USA does not have a federal official definition of GMO at this time, instead the US FDA uses the term “genetic modification” for certain methods that are used to introduce new characteristics to an organism.

"Genetic modification" means the alteration of the genotype of a plant using any technique, new or traditional. "Modification" is used in a broad context to mean the alteration in the composition of food that results from adding, deleting, or changing hereditary traits, irrespective of the method. Modifications may be minor, such as a single mutation that affects one gene, or major alterations of genetic material that affect many genes. Most, if not all, cultivated food crops have been genetically modified.”* *Statement of Policy: Foods Derived From New Plant Varieties, Friday, May 29, 1992) – is their policy statement to clarify its interpretation of the Federal Food, Drug, and Cosmetic Act, with respect to human foods and animal feeds.

US Government - FDA’S Definition

Does this mean that eating a hamburger from a cow that ate GM feed mean you ingested a GMO burger? Clearly more clarification is needed here, since the answer depends on who you ask.

MEANING ?

Scientific POV

Scientific arguments are not settled by counting the number of people supporting or opposing an opinion. It starts with a careful search for scientifically valid evidence, and then carry this forward with open-minded and careful logical reasoning and false conclusions are eliminated from the discussion. Good scientific reasoning also takes notice of the whole body of evidence on a topic, and updates the verdict as new evidence becomes available. “How many scientists believe that GMOs are good?”

When asked this question, most scientists would say something like—not all GMOs are bad, and some GMOs are a really good idea.

There are scientists on both sides of this issue.

There are scientists in support of using GMOs. Especially some consensus in the regulatory/industry scientific community that GMO crops pose no greater risk than conventional food. This is primarily due to no documented reports of any ill effects in the human population from consuming GMO food.

Several USA scientific organizations do support the use of GM crops:

The American Association for the Advancement of Science The American Medical Association The National Academy of Science The World Health Organization (WHO) The Food and Agriculture Organization of the United Nations. The U.S. Food and Drug Administration

pro Scientific POV

Opponents of genetically modified food (e.g. the advocacy groups American Public Health Association, Organic Consumers Association, the Union of Concerned Scientists, and Greenpeace), say risks have not been adequately identified and managed, and they have questioned the objectivity of regulatory authorities.

Some groups say there are unanswered questions regarding the potential long-term impact on human health from food derived from GMOs, and have propose mandatory labeling or a moratorium on such products.

These concerns include: safety of ingesting on human health, contamination of the non-genetically modified food supply, effects of GMOs on the environment and nature, the rigor of the regulatory process, and consolidation of control of the food supply in companies that make and sell GMOs.

con Scientific POV

Scientific safety debate Substantial equivalence

Governments worldwide assess and manage the risks associated with the release of genetically modified organisms and the marketing of genetically modified food on a case by case basis. There are differences among countries in the risk assessment of GM food, and therefore in the regulation of GMOs.

Regulators generally examine: the genetic modification, its protein products, and any intended changes that those proteins make to the food. They also check to see whether the food derived from a GMO is "substantially equivalent" to its non-GMO-derived counterpart, which provides a way to detect any negative non-intended consequences of the genetic engineering. In addition to reviewing any studies that may have been done.

There are many who believe this method of substantial equivalence is not valid process and is flawed; since it does not actually measure risks, but instead identifies differences between existing products and new ones.

GMO Methodology

Definitions 1

Cisgene is a natural gene, coding for an (agricultural) trait, from the crop plant itself or from a sexually

compatible donor plant that can be used in conventional breeding. The gene belongs to the conventional

breeder’s gene pool and is the already existing result of natural evolution.

Cisgenesis (from “the same”) is the process of introducing a gene from a crossable organism (same

species or sexually crossable species) into a living organism, so that the organism will exhibit a new

property and transmit that property to its offspring.

Cisgenic plant contains no foreign genes (cisgenes only).

Transgene is a gene from a non-crossable species (or it is a synthetic gene). It represents a new gene

pool for plant breeding. The introduction has the potential to change the phenotype of an organism.

Transgenesis is the process of introducing an exogenous gene or genes (transgene) into a living

organism, so that the organism will exhibit a new property and transmit that property to its offspring.

Transgenic plant is a GM-plant that contains transgenes.

Traditional or conventional breeding is using all classical and modern insights and techniques,

including those related to biotechnology, however, without genetic modification. It includes a number of

techniques that are not regarded as genetic modification or that are exempted from the GMO-legislation.

The human race has been selectively breeding crops genetically in order to develop new plant varieties (altering plants' genomes) for the most part of the past millennia. conventional or natural breeding

The traditional genetic modification techniques typically used is hybridization (crossbreeding, backcrossing) between varieties of the same plant species, and screening the offspring for the desired characteristics. A simple example of this is used in growing flowers, developing a new color or strain for roses.

GMO Methodology

2

Researchers and scientists have developed a number of techniques and technologies to expand the range of genetic modifications possible. These techniques introduce genetic variation by using either:

• mutagenesis (exposure to chemicals or radiation) to alter the genome.

• gene-splicing, introducing (or modifying) DNA segments (including DNA segments derived from other organisms) – also referred to as recombinant DNA (rDNA) technology. This process allows DNA from one species to be injected into another species in a laboratory, creating combinations of plant, animal, bacteria, and viral genes that do not occur in naturally in nature. This results in creating

transgenic/cisgenic organisms with traits that are not present in the unmodified organisms. There are several different genetic modifications used, some are singular and others multiple. Recombinant DNA is widely used in biotechnology, medicine and research. Examples include: Recombinant: chymosin (an enzyme required to manufacture cheese), human insulin, human growth hormone (HGH, somatotropin), blood clotting factor VIII, hepatitis B vaccine.

The most commonly used characteristic changes for crops are: herbicide tolerance, insect resistance, drought tolerance. With 85 percent of GE crops designed to resist herbicides.

GMO Methodology

3

The FDA regulates the safety of foods and food products from plant sources, including food from genetically engineered plants, under the Federal Food, Drug, and Cosmetic Act.

The FDA regulates GM foods as part of a coordinated process between two other federal agencies (called “Coordinated Framework for Regulation of Biotechnology”) – that includes:

• the Environmental Protection Agency (EPA) • the United States Department of Agriculture (USDA)

The FDA policy (unchanged since 1992) places responsibility on the producer or manufacturer to evaluate the safety of the food and assure that the safety requirement of section 402(a)(1) of the act is met.

So it is the company, not any independent scientific review, that is providing the research that is relied on to assert safety. There are currently no regulatory plans requiring GM food to be tested to see whether it is safe for humans to eat.

Federal oversight

ROAD MAP

The U.S. Food and Drug Administration currently requires labeling of GE foods only if: 1) if the new food has a significantly different nutritional property, 2) if the new food includes an allergen that consumers would not expect to be present (e.g., a allergenic brazil nut protein in a soybean product), 3) or if the new food contains a toxicant beyond acceptable safety limits. So far, no commercially grown genetically engineered food crops sold have any known properties that would require foods made from them to be labeled as such.

Currently, there is no other federal standard for GMO labeling, so labeling a product as GMO is considered as voluntary. Many companies are using third-party certification programs (e.g. non-GMO Project) to certify their products are non-GMO.

The GMO producers state that requiring special labeling for genetically modified foods would be onerous and costly, and would raise food prices.

More than 60 countries already require such labeling.

Labeling

1

For now, consumers in the USA, via state legislatures, have begun to mobilize and address the labeling issue. Already in 2014, there are more than 60 active bills in 23 states requiring labeling. Additionally, there are numerous petitions submitted (and being submitted) to the FDA as well.

For example: Proposition 37 in California would have required manufacturer labeling of these food products. But voters in California (and Washington) rejected ballot proposals in the past two years that would have required GMO labeling. In California, big money was spent to have the voters reject the proposition: big agrochemical and food giants gave a combined $46 million for advertising (to convince voters to reject the proposal). The anti-GMO side spent only $9 million.

Three states (Connecticut, Maine, and Vermont) did pass GMO-labeling mandates year.

More states are sure to follow.

Labeling

The issue should be decided in Washington on a federal standard on how GMO foods are to be labeled.

2

In this regulatory battle over labeling of genetically modified foods, the Grocery Manufacturers Association (GMA) is leading an industry group, the Coalition for Safe Affordable Food (http://coalitionforsafeaffordablefood.org) to advocate for a new federal law using a voluntary (not mandatory) labeling standard. If these initiatives pass, it would basically prohibit or ban any GMO labeling requirement nationally.

Reuters news service reported on Jan 13, 2014: - The Grocery Manufacturers Association, which represents more than 300 food companies, is preparing a petition to the chief U.S. food safety regulator [FDA] and a push in Congress to require changes in oversight and labeling of new genetically modified foods, an association leader said Monday. The double-pronged strategy, which the group expects roll out early this year, is aimed at squelching state-by-state efforts to mandate labeling of foods containing biotech crops, and at the same time setting a standard that among other things would authorize GMO foods to be touted as "natural.“

Labeling

3

Legislative status

• 04/09/2014 – H.R. 4432, - 'Safe and Accurate Food Labeling Act of 2014‘. [Rep. Pompeo, Mike (R)]. The industry-friendly bill is designed to: amend the Federal Food, Drug, and Cosmetic Act with respect to food produced from, containing, or consisting of a bioengineered organism, the labeling of natural foods, and for other purposes. Basically, GMO foods on a national level (preempting states) would not be labeled, and even allowed to be called natural.

• 04/24/2013 – S.809 / H.R. 1699 - 'Genetically Engineered Food Right-to-Know Act‘ 113th Congress (2013-2014) [Senator Barbara Boxer (D)] Amends the Federal Food, Drug, and Cosmetic Act to deem misbranded any food that has been genetically engineered or contains one or more genetically engineered ingredients, unless such information is clearly disclosed. STATUS: still pending - read twice and referred to the Committee on Health, Education, Labor, and Pensions.

• 03/20/2013 – H.R. 933 - The Farmer Assurance Provision Rider was a fiscal bill (commonly referred to as the “Monsanto Protection Act” by its critics) that was passed by the Senate on March 20, 2013 and then signed into law as part of the Consolidated and Further Continuing Appropriations Act, 2013 by President Barack Obama on March 26, 2013. It stated: If a biotech crop had already been approved (or deregulated) by the USDA and a court reversed that approval, the provision directed the Secretary of Agriculture to grant temporary deregulation status at the request of a grower or seed producer, to allow growers to continue the cultivation of the crop while legal challenges to the safety of those crops would still be underway. The provisions of this law remained in effect for six months, until the end of the fiscal year on September 30, 2013. The rider was removed from the subsequent funding bill, and is no longer in effect.

Consumers More than 1.4 million

people have signed

the Center for Food

Safety's petition

urging the FDA to

require GMO

labeling.

Food labeled organic is not allowed to use products of genetic modification in organic agriculture. The Organic Foods Production Act (OFPA) in 1990 (Title XXI, 1990 Farm Bill) created the U. S. National Organic Standards. The National Organic Program (NOP) of the Agricultural Marketing Service, United States Department of Agriculture (USDA), is authorized to enforce OFPA. The regulations state:

prohibit the use of irradiation, sewage sludge, or genetically modified organisms in organic production;

reflect NOSB recommendations concerning items on the national list of allowed synthetic and prohibited natural substances; prohibit antibiotics in organic meat and poultry; require 100% organic feed for organic livestock

Organic

The North American GMO acreage consists of: 93% of soy, 88% of field corn, 94% cotton, 90% Canola seed, and 95% Sugar beets planted in the U.S. (2012 data) are genetically modified. Globally, only a tenth of the world's cropland includes GM plants. With four countries — the U.S., Canada, Brazil and Argentina — growing 90 percent of the planet's GM crops.

Alfalfa (Medicago sativa) Apple (Malus domestica) Argentine Canola (Brassica napus) Bean (Phaseolus vulgaris) Canola - rapeseed (Brassica napus L.) Carnation (Dianthus caryophyllus) Chicory (Cichorium intybus) Corn - Maize (Zea mays L.) Cotton (Gossypium hirsutum L.) Creeping Bentgrass (Agrostis stolonifera) Eggplant (Solanum melongena) Flax (Linum usitatissumum L.) Melon (Cucumis melo) Papaya (Carica papaya) Petunia (Petunia hybrida) Plum (Prunus domestica) Polish canola (Brassica rapa) Poplar (Populus sp.) Potato (Solanum tuberosum L.) Rice (Oryza sativa L.) Rose (Rosa hybrida) Soybean (Glycine max L.) Squash (Cucurbita pepo) Sugar Beet (Beta vulgaris) Sugarcane (Saccharum sp) Sweet pepper (Capsicum annuum) Tobacco (Nicotiana tabacum L.) Tomato (Lycopersicon esculentum) Wheat (Triticum aestivum) Orange (citrus sinesis)

GMO Crops List

Milk: About a quarter of the milk in the United States comes from cows injected with recombinant bovine growth hormone (rGBH), also known as rBST (recombinant bovine somatotropin). This is a GE variation on a naturally occurring hormone used to increase milk production.

Honey: coming from bees that work on GMO crops.

Highly processed or refined materials contain very little GMO (or none) material. These include vegetable oils, lecithins, corn starches, sugars.

US FDA GMO listing: http://www.accessdata.fda.gov/scripts/fdcc/?set=Biocon

GMO Items List

Non-GMO testing is not well regulated in USA at this time (no single standard exists). Which tests do you want or are acceptable? EU accepts PCR. Methods being used are:

Identity Preserved (IP) certification • Tracking/monitoring documentation from seed to customer, not a test.

DNA Testing Methods (genetic based methods, to detect foreign DNA) • Polymerase Chain Reaction (PCR) Technology • DNA microarrays

Protein Testing Methods (Immuno-analysis, detecting proteins, produced by introduced genes) • ELISA (Enzyme-Linked Immunosorbent Assay) • Lateral flow strip (strip test)

BART (Bioluminescent Assay in Real Time) - New A combination of two technologies — bioluminescence and isothermal DNA. Lumora’s bioluminescence technology, uses luciferase, the same enzyme that lights up fireflies.

Testing

Testing LIMITS: No Standard in the US for what is termed “GMO-Free”.

Sampling errors (cannot test all seeds)

Testing limits of equipment “Detected” or “Not detected” at the limit of detection of 0.01%”.

There is no such thing as zero. Because a functional zero really means no evidence of GMO detected. Which does not necessarily mean that there is no GMO present.

So what is an acceptable limit? When to label? ▪ The USA has no official limit. ▪ The European Union recently introduced the mandatory labeling of food products with a GMO content > than 1%. ▪ The non-GMO Project says: non-GMO < 0.9% GMO

The discussion of GMOs is a highly emotional one — both ideological and political. Many times the discussion is neither very factual nor evidence-based on either side. There is a lot of uncertainty and concern regarding the safety of taking perceived GMO risks, real or not.

When a gene is introduced into a plant, the general outcome is the formation of a new protein. These proteins are oftentimes new for human consumption. So, expecting possible effects on human health is not entirely out of the question. Additionally, any possible negative environmental effects needs to be considered.

It is the potential for unintended, unanticipated or unforeseen consequences that would seem to dictate that we should be very careful about introducing new organisms into the world. So the real concern here is on safety. Though the debates continue, there is no clear scientific consensus on the safety of ingesting GMOs.

Summary

In this presenter's humble opinion, perhaps we need a more precautionary approach — requiring non-industry sponsored long-term peer reviewed safety studies that are relevant to human health. Genetic engineering is a new technology.

The safety testing being performed now appears to be possibly inadequate. In the long run, genetic engineering may prove to be useful, or not. Even its strongest advocates can guarantee that there aren’t any hidden dangers at this time.

So consumers are understandably cautious, so it would seem prudent that we have a right to know if what we are consuming contains GMO ingredients. If the FDA isn’t going to test GE foods for safety, leaving it up to the industry — the least it could do is require labeling, so people can choose to avoid GMOs if they want. Additionally, a lack of labeling denies health professionals the ability to trace potential toxic or allergic reactions to, and other adverse health effects from ingesting GM food.

Summary

Labeling promotes trust. Not labeling does not allow choice.

Lastly,

Audrey Jr.

Thank You

QUESTIONS

Genetically Modified Organisms

ROBIN C. KOON, EXECUTIVE VICE-PRESIDENT

BEST FORMULATIONS

An Industry Update: