This document summarizes the key controversies surrounding genetically modified organisms (GMOs), including potential human health and environmental impacts, as well as issues regarding intellectual property, ethics, labeling, and society. It also outlines laws governing GMOs in the United States, European Union countries like France and Germany, and the United Kingdom. The US FDA regulates GMOs differently than the EU, which has more stringent safety testing and labeling requirements. Debate continues around the risks and benefits of GMO cultivation and consumption.

1. Controversies and Laws
Governing GMOs

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

3. 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

4. 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

5. 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

6. Labelling
– Not mandatory in some countries (e.g., United
States)
– Mixing GM crops with non-GM products
confounds labeling attempts

7. Society
– New advances may be skewed to interests of
rich countries

8. 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.

9. • 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.

10. 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.

11. • 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.

12. Laws Governing GMOs
• USA FDA
• EU (European Union)

13. 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.

14. 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.

15. 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.

16. 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

17. • 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

18. • 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.

19. • 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.

20. 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

21. 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.

22. 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

23. • 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.

24. 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.

25. • 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.

26. 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;

27. – 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;

28. – 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;

29. – 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.

30. • 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.

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

32. Sources
• Controversies (GMOs)
– http://www.ornl.gov/sci/techresources/Human_Genome/elsi/gmfo
od.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/la
ws.htm