Controversies and Laws Governing GMOs

Controversies

• Safety• Access and Intellectual Property• Ethics• Labeling• Society• Food and Fuel• Genetic Pollution

Safety

– Potential human health impacts, including allergens, transfer of antibiotic resistance markers, unknown effects

– Potential environmental impacts, including: unintended transfer of transgenes through cross-pollination, unknown effects on other organisms (e.g., soil microbes), and loss of flora and fauna biodiversity

Access and Intellectual Property

– Domination of world food production by a few companies

– Increasing dependence on industrialized nations by developing countries

– Biopiracy, or foreign exploitation of natural resources

Ethics

– Violation of natural organisms' intrinsic values– Tampering with nature by mixing genes

among species– Objections to consuming animal genes in

plants and vice versa– Stress for animal

Labelling

– Not mandatory in some countries (e.g., United States)

– Mixing GM crops with non-GM products confounds labeling attempts

Society

– New advances may be skewed to interests of rich countries

Food and Fuel

• Supporters of GMOs believe such crops help increase yield, which could help curtail skyrocketing food prices. In addition, GMOs could potentially be influential in the gas crisis. Alternatives such as increased use of biofuels (made from GMOs) seem to be a positive advantage because they could lessen the nation’s dependence on oil as well as reduce greenhouse gas emissions. Although the use of biofuel has been expanding, many believe the full effects on the environment and elsewhere must be further researched.

• The international “food vs. fuel” debate has been another topic of great controversy in and of itself. Critics of biofuel worry that investment into the sector has driven up the price of food. Creating biofuels requires massive amounts of raw material, and although the land used by GM crops is a huge percentage of land farmed, the question remains whether ultimately using it for food or fuel is the best use of it, time and money.

Genetic Pollution• One of the major problems with GMOs is that they have

no boundaries. Once planted, they run the risk of contaminating any conventional crops planted nearby. A survey reports that in the Midwest, where there are millions of acres of GM corn and soybean crops, up to 80% of organic farmers reported direct costs or damages resulting from genetic trespass. This trespassing can occur in a variety of common, natural ways, which makes keeping the GMOs on their own fields impossible. For example, winds (particularly high winds, but even breezes can be problematic) and water runoff are full of seeds and spores, and can easily bring GMOs to fields where they are not purposely grown.

• Often, these seeds and spores will then implant themselves into soil and produce plants that are genetically altered—with the farmer having no idea his crops have been genetically polluted. Other sources of GMO contamination include commingling during harvest and cross-pollination, which is particularly rampant with corn. Farmers often hire combines to harvest their food, instead of using their own, and if these have not been cleaned well enough, residual GM grains from previous harvests can contaminate the crop. Something as small as a particle on a tarp is enough to cause contamination. There has been some talk of creating GMOs whose offspring would be sterile, thus eliminating many of these plants; as of yet there has been no great move to implement the modification on a large scale.

Laws Governing GMOs

• USA FDA• EU (European Union)

US FDA

• In the U.S., 3 agencies are responsible with th release of GM food plants. The Food and Drug Administration (FDA), the United States Department of Agriculture (USDA), and the Environmental Protection Agency (EPA).

• GM foods labeling is optional.

US FDA (cont’n)

• The FDA only makes sure that the food consumers consumed is safe, and wholesome– does not consider the fact that the sources of GM

foods are genetically engineered.– Flavr Svar, did not require labelling as it was

found safe and contains the same amount vitamins, proteins, and mineral as original tomato.

– same case with Bt potatoes that are in grocery stores.

US FDA (cont’n)

• Safety testing on GM foods is also voluntary by the FDA as long as the new product is not "significantly different" from its traditional counterpart– not surprising that if most of the products sold

in the market now is categorized as “substantially equivalent” and safe by their manufacturers.

European Union (EU)• The European Union (EU) has possibly the most stringent

GMO regulations in the world. All GMOs, along with irradiated food, are considered "new food" and subject to extensive, case-by-case, science based food evaluation by the European Food Safety Authority (EFSA). The EFSA reports to the European Commission who then draft a proposal for granting or refusing the authorisation. This proposal is submitted to the Section on GM Food and Feed of the Standing Committee on the Food Chain and Animal Health and if accepted it will be adopted by the EC or passed on to the Council of Agricultural Ministers. Once in the Council it has three months to reach a qualified majority for or against the proposal, if no majority is reached the proposal is passed back to the EC who will then adopt the proposal

• As of August 2012, the European Union had authorised 48 GMOs. Most of these were for animal feed imports or for feed and food processing. There is also a safeguard clause that Member States can invoke to temporarily restrict or prohibit the use and/or sale of a GMO within their territory if they have a justifiable reasons to consider that the approved GMO constitutes a risk to human health or the environment

• In 2010 Austria, Bulgaria, Cyprus, Hungary, Ireland, Latvia, Lithuania, Malta, Slovenia, and the Netherlands wrote a joint paper requesting that individual countries have the right to decide whether to cultivate GM crops.

• Currently (2010) the only GMO food crop with approval for cultivation in Europe is MON810, a Bt expressing maize conferring resistance to the European corn borer, that gained approval in 1998. On 2 March 2010 a second GMO, a potato called Amflora, was approved for cultivation for industrial applications in the EU by the European Commission and was grown in Germany, Sweden and the Czech Republic that year. Gene flow will occur between related crops and the EC issued new guidelines in 2010 regarding the co-existence of GM and non-GM crops. 

France adopts EU Laws

• France adopted the EU laws on growing GMOs in 2007 and were fined €10 million by the European Court of Justice for the six year delay in implementing the laws. In February 2008 the French government used the safeguard clause to ban the cultivation of MON810 after Senator Jean-François Le Grand, chairman of a committee set up to evaluate biotechnology, said there were "serious doubts" about the safety of the product

Germany adopts EU Laws• In April 2009 German Federal Minister Ilse

Aigner announced an immediate halt to cultivation and marketing of MON810 maize under the safeguard clause. The ban was based on "expert opinion" that suggested there was reasonable grounds to believe that MON810 maize presents a danger to the environment. Three French scientists reviewing the scientific evidence used to justify the ban concluding that it did not use a case-by-case approach, confused potential hazards with proven risks and ignored the meta-knowledge on Bt expressing maize, instead focusing on selected individual studies.

Adoption

• Spain is the largest producer of GM crops in Europe with 76,000 hectares (190,000 acres) of GM maize planted in 2009 (20% of Spain's maize production).Smaller amounts were produced in the Czech Republic, Slovakia, Portugal, Romania and Poland. France and Germany are the major opponents of genetically modified food in Europe, although Germany has approved Amflora a potato modified with higher levels of starch for industrial purposes

• In addition to France and Germany, other European countries that placed bans on the cultivation and sale of GMOs include Austria, Hungary, Greece, and Luxembourg. Poland has also tried to institute a ban, with backlash from the European Commission. Bulgaria effectively banned cultivation of genetically modified organisms on March 18, 2010.

GMO (CU)

• The primary piece of legislation that applies to the use of genetically modified organisms in the workplace is the Genetically Modified Organisms (Contained Use) Regulations 2000 (GMO(CU))   as amended by Genetically Modified Organisms (Contained Use) (Amendment) Regulations in 2002, 2005 and 2010.

• The GMO (CU) Regulations provide for human health and safety and environmental protection from genetically modified micro-organisms in contained use, and additionally the human health and safety from genetically modified plants and animals (GMOs). The key requirement of the GMO (CU) Regulations is to assess the risks of all activities and to make sure that any necessary controls are put in place. The GMO (CU) Regulations provide a framework for making these judgments, and place clear legal obligations on people who work with GMOs.

The Genetically Modified Organisms (Contained Use) Regulations 2000:

– require risk assessment of activities involving genetically modified micro-organisms and activities involving organisms other than micro-organisms. All activities must be assessed for risk to humans and those involving GMMs assessed for risk to the environment;

– introduce a classification system based on the risk of the activity independent of the purpose of the activity. The classification is based on the four levels of containment for microbial laboratories;

– require notification of all premises to HSE before they are used for genetic modification activities for the first time;

– require notification of individual activities of Class 2 (low risk) to Class 4 (high risk) to be notified to the Competent Authority (which HSE administers). Consents are issued for all Class 3 (medium risk) and Class 4 (high risk) activities. Class 1 (no or negligible risk) activities are non notifiable, although they are open to scrutiny by HSE's specialist inspectors who enforce the Regulations. Activities involving GM animals and plants which are more hazardous to humans than the parental non modified organism also require notification;

– require fees payable for the notification of premises for first time use, class 2, 3 and 4 activities notifications, and notified activities involving GM animals and plants.

– require the maintenance of a public register of GM premises and certain activities.

• There are also other pieces of health and safety legislation that are relevant to work with GMOs. These include the general requirements of the Health and Safety at Work Act 1974, the Management of Health and Safety at Work Regulations 1999, and the Carriage of Dangerous Goods legislation. There are also some biological agents aspects of the Control of Substances Hazardous to Health Regulations 2002 which may be applicable in some circumstances.

• The Department for Environment Food and Rural Affairs (DEFRA) is responsible for deliberate releases of genetically modified organisms (GMOs).

Sources

• Controversies (GMOs)– http://www.ornl.gov/sci/techresources/Human_Genome/elsi/

gmfood.shtml– http://www.wholefoodsmagazine.com

/columns/consumer-bulletin/gmo-controversy-what-you-need-know

• Laws Governing GMOs– http://en.wikipedia.org

/wiki/Regulation_of_genetically_modified_organisms_in_the_European_Union

– http://www.hse.gov.uk/biosafety/gmo/law.htm– http://classes.soe.ucsc.edu/cmpe080e/Spring05/projects/gmo/

laws.htm