This first wave or first generation of transgenic crops has primarily benefitted farmers, and they are some of the biggest proponents of the technologies. To understand a bit more about their perspective, click here. The benefits of the second and third generation, or next waves of biotech crops, should be more visible to consumers,(n19) but also potentially more contentious and controversial. They include things such as "improved" fruits and vegetables, and "edible vaccines" grown in crops such as bananas and potatoes.(n20) These will be discussed at greater length in next month's essay. It is important to note here that although transgenic crops may provide benefits, there are also potential environmental and human health risks associated with their cultivation. The ultimate custodian of the public safety when it comes to monitoring and regulating their approval and use is the federal government. The discussion will turn briefly to a look at the risks associated with GM food products and the government controls that allow them to eventually become part of the nation's food supply.

"Between Two Worlds" © 1985, 2005 Dorothy A. Birsic

Regulation and Risk

    The material covered up to now is undoubtedly a lot of information to digest (no pun intended). Perhaps you're thinking to yourself that you want to go out to the kitchen and get something to eat or drink before continuing. Please do. While you're on your way, take a look at some of the labels on the food items in your pantry or refrigerator. Unless you've purchased something from a company that voluntarily notes whether or not their products contain GMOs, you have no way of knowing if anything you're eating has come from a transgenic crop. Compare this to a law which took effect throughout the European Union (EU) in April of this year. The EU law states that "Any food or feed containing, consisting of or produced from genetically modified organisms (GMOs) will need to be labelled in a way that indicates it contains GMOs. For GMOs that are currently approved in the EU, . . . levels of up to 0.9% will be permitted without the need for labelling. GMOs that have received neither EU approval nor a favorable risk evaluation will be forbidden. The labelling requirements do not apply to food products for which the manufacturing process commenced before April 18, 2004."(n21)

    Voluntary labelling in the U.S. versus mandatory labelling in the E.U.? Why the difference? Differences across the Atlantic may be due to many factors, but partly to matters of philosophy (when it comes to assessing risk) and practice (when it comes to labelling). The philosophical framework behind much of the decision-making in the U.S. on GM products is a doctrine called "substantial equivalence." The principle was originally developed by international organizations such as the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO) and the OECD. "The underlying concept is the requirement that any safety assessment should show that a genetically modified variety [of plant, in this case] is as safe as its traditional counterparts [substantially equivalent] through a consideration of a wide range of both intended and unintended effects. This involves consideration of a wide range of information including agronomic properties, phenotypic changes, and . . . data on critical nutrients and toxicants."(n22)

    The more prevalent doctrine in Europe is known as the "precautionary principle." Although there are several definitions of the term, it is essence is a belief [that] there is an obligation to be certain that our actions (or . . . chemicals, food ingredients or technologies) do not cause harm or potential harm to people."(n23) The differences between the two play out in the assessment of risk and uncertainty over the effects of a new substance or technology. "The utilitarian/science model as used in the U.S. would have it that if the probability of harm is judged to be low and it the genetically modified foodstuffs are of some social benefit, then the introduction or use of those substances is 'safe.' A strict application of the precautionary approach says that if there remains any uncertainty or the extremely remote possibility of a disaster, prudence and ethics demand the substance/technology in question not be permitted."(n24) Application of the principle in the EU, especially as it applies to food labelling, may reflect the notion that people should be allowed to " exercise their autonomy to be able to choose not to consume or be exposed to possibly risky substances."(n25)

    As a contrast to this, in "North America, regulators and companies agree that mandatory labels should be reserved for those products carrying a documented health risk or substantial change in nutritional composition. If the GM products are 'substantially equivalent' to conventional counterparts, companies argue, the GM label would be 'misleading,'"(n26) since they have already been determined to be 'safe.'

    So who makes the decisions in the United States when it comes to these products? In the U.S., three agencies share responsibility for regulating the products of modern agricultural biotechnology.

• The Animal and Plant Health Inspection Service (APHIS) of the USDA regulates the field testing and commercial sale of agricultural bioengineered plants.(n27)

• The Environmental Protection Agency (EPA) is responsible for regulating pesticides, including what they call the "plant incorporated protectants", or insecticidal properties, of transgenic plants.(n28)

• The Food and Drug Administration (FDA) regulates the safety of foods and the safety and efficacy of pharmaceuticals and animal feeds, as well as elements of labelling.(n29)

The three agencies together maintain the U.S. Regulatory Agencies Unified Biotechnology Website. Click here to visit the site and learn more about the regulatory process for GMOs in the United States. Also, to view a searchable database of legislation concerning all aspects of GMOs which have been introduced in the state and federal legislatures, click here.

    Throughout history, new technologies have brought with them risks and benefits, intended and unintended consequences. The debate on GM plants cannot be fully understood without looking at some of the specific risks associated with modern agricultural biotechnology, risks both to the environment and to human health. These risks include:

• Gene flow (pollen from GM plants finding its way into native plants producing new plants with adverse or unintended effects)

• Emergence of new forms of resistance and secondary pest or weed problems

• Recombination of the viruses or bacteria [from the GM plants] to produce new pathogens

• Direct and indirect effects of new [plant-based] toxins

• Changes in farm practices leading to changes in biodiversity.(n30)

These five risks are classified as risks to the environment. The two primary risks to human health which have been identified to date are: 1) the new substances in transgenic crops might cause allergenic or immune system reactions, and 2) antibiotic resistance that might be transferred to humans from organisms used in developing the GM crops (antibiotic resistance marker genes).(n31) It is important to note here that no adverse effects on human health (from genetically modified foods) have been reported.(n32) However, it has also been suggested that "there could, in theory, be long-term effects on human health that have not yet been detected because GM foods have been available for less than ten years."(n33) [To view these issues in greater detail, you can click here to link to a 2002 report entitled Benefits and Risks of Food Biotechnology. The report also contains extensive information about transgenic plants in California.]

    The issues of risks versus benefits, and how those risks versus benefits should be handled in the interest of mankind, are significant portions of the overall debate on GM food and modern biotechnology in general. As much as been said about proponents of the technologies such as some farmers, industry organizations, scientists, agribusiness companies and others, there are also very vocal opponents to GM foods.

To return to the top of the page, click here.

"Sarajevo Courtyard" © 1984, 2005 Dorothy A. Birsic

The Greens: Organics and Environmentalists

    Few consumers may realize that there is a family of products which by definition and by law must be free of GMOs. These are organic products. Although some major grocery stores have begun devoting small portions of their produce sections to organics, for many the term still conjures up images of the social and political movements of the 1960s and 1970s. Sales of organic products, however, have been increasing at about 20% per year, from about $1 billion in 1993 to about $13 billion in 2003.(n34)

    What exactly is organic farming? The organic farming philosophy centers "on practices designed to improve the richness and stability of the soil by restoring its organic matter and avoiding synthetic fertilizers, pesticides and herbicides."(n35) A goal of this type of agricultural practice is "to optimize the health and productivity of interdependent communities of soil life, plants, animals and people."(n36) [Click here to read more about organic farming and organic products.]

    Congress passed the Organic Foods Production Act (OFPA) back in 1990. Its objective was to ensure consumers that foods labelled "organic" met a defined set of production criteria,(n37) which now has come to specifically exclude GM products. (These are deemed to be incompatible with the practices of organic farming.) The Act established the National Organic Program (NOP) within the USDA, and NOP regulations require that all food labelled as organic originate from farms or handling operations certified by a state or private entity that has been accredited by the USDA. [For further information on the NOP and organic standards, click here.]

    The pictures below depict two of the types of labels which can be found on organic products. The one on the left is the official seal of the USDA. This seal may only appear on foods which consist of at least 95% organically produced ingredients. The words "organic" or "100% organic" may also appear on the labels of such items. Processed foods containing at least 70% organic ingredients may use the phrase "made with organic ingredients," but not the seal. All other products may not use word "organic" on the main display portion of the label.

    The label on the right (image courtesy of QAI) is from one of the certification agencies accredited by the USDA. Organizations such as this one, Quality Assurance International (QAI), verify that growers, processors and handlers of organic products meet all applicable standards, statues and regulations.(n38) Both of the seals may appear on products marked "organic" or "100% organic." Anyone intentionally violating the label laws may be fined up to $10,000; operators whose gross agricultural income from organic sales is less than $5,000 is exempt from them. The full text of laws governing growers can be found in the Code of Federal Regulations, 7 CFR Subchapter M, Part 205.

    In general, organic farming is part of the much broader organic movement. The organic movement also "encompasses such tenets as animal welfare, energy efficiency, social justice and the simple agrarian ideals of small farms growing produce for local communities."(n39) As such, the movement finds close kin in many environmental organizations. Some of the largest of these organizations have taken the most prominent and visible stands against transgenic products. To read some of their positions on the debate, click on the links below. Where possible, direct links have been made to the pages stating positions on agricultural biotechnology and/or GM foods.

• Greenpeace USA

• Sierra Club

• Friends of the Earth

• The Campaign (to label GM foods)