Agriculture Reference
In-Depth Information
Food Safety Commission evaluates their
safety in terms of human health (MHLW,
2012). h e safety assessment of GM crops
for feed uses is under the responsibility of
the Ministry of Agriculture, Forestry and
Fisheries (MAFF). h e safety of GM crops
used as livestock feed must be approved by
the Feed Division of the Livestock Industry
Department of the Agricultural Production
Bureau in the MAFF (Tabei, 2003). Most of
the items evaluated for feed safety are
essentially the same as those for food safety
described in the 'Standards for the safety
assessment of genetically modii ed foods
(seed plants)', published by the food safety
commission of the Ministry of Health
(MHLW, 2004).
Further information on GMO author-
ization in Japan can be found at
http://
html.
and therefore cannot be commercialized. An
adulterated food is a food containing any
poisonous or deleterious substance that may
render it injurious to health, or containing
an unsafe food additive or unsafe pesticide
residue (Sec. 402, FFDCA). An unsafe food
additive is one that has not been used
according to an authorizing regulation (Sec.
409, FFDCA). An unsafe pesticide residue is
one that has not been granted a tolerance or
tolerance exemption (Sec. 408, FFDCA). h e
FDA has oversight of food additives and the
Environmental Protection Agency (EPA) has
oversight of pesticides. h e implication for
biotechnology-derived foods is that if they
contain a food additive or pesticide, that
food additive or pesticide must have gone
through the relevant pre-market authori-
zation procedure by the FDA or EPA before
the GM food could be marketed. However, if
the biotechnology-derived foods do not
contain a food additive or a pesticide, they
are not subject to any pre-market approval
requirement. h erefore, the safety evalu-
ation process is determined by the
characteristics of the food or feed, not by its
method of development. Apart from the
presence of food additives or pesticides,
foods (biotechnology-derived or otherwise)
are still subject to post-market oversight.
Further information on GMO author-
ization in the USA can be found at
http://
In Canada, the safety assessment of GM
food is separated from the safety assessment
of GM feed. GM food is under the
responsibility of the Food Directorate of
Health Canada, whereas GM feed is under
the responsibility of the Animal Feed
Division of the Canadian Food Inspection
Agency (CFIA). Nevertheless, both GM food
and GM feed are considered categories of
'novel products' ('novel food' and 'novel
feed', respectively) without a history of safe
consumption by humans and animals. As far
as novel foods are concerned, regulatory
oversight is triggered by the new char-
acteristics of the product rather than the
process used to create the product. Potential
food safety issues are those associated with
toxins, contaminants and anti-nutritional
In the USA, the Food and Drug
Administration (FDA) is the leading
authority for the safety of food and animal
feed. Within the FDA, the Center for
Veterinary Medicine (CVM) is responsible
for reviewing data on GM plants intended
for use in animal feed. h e Federal Food,
Drug, and Cosmetic Act (FFDCA), which
forms the legal basis for the regulation of
foods by the FDA, dei nes a food as a product
used for humans and animals. h erefore,
requirements for food apply also to feed.
No specii c law on GM plants and their
derived products exists in the USA. In 1992,
the FDA published a statement of policy in
the Federal Register for foods derived from
new plant varieties (FDA, 1992). h is
statement treats GM food and feed in the
same way as conventional food and feed in
the sense that a plant developed using
recombinant DNA techniques (i.e. bio-
technology) is not itself a regulatory trigger
for food and feed safety oversight or
pre-market approval. On the contrary, under
US law, a regulatory oversight is triggered
when a food is adulterated or misbranded
