Principles of Plant Genetics and Breeding

there is no inherent health risk in the use of biotechnology
to develop new food products. The food industry
opposes mandatory labeling because of the concern that
such labeling could be interpreted as being “warning
labels” implying that biotech foods are less safe or nutritious
than their conventional counterparts.
The FDA requires a food product (including biotechnology
foods) to be labeled if the following apply:
1 It contains a protein known to pose allergenic risk
(e.g., milk, eggs, peanuts, tree nuts). Consequently,
any genetic engineering involving gene transfer from
any of these organisms must be labeled.
2 Its nutrient content as a result of the genetic manipulation
is significantly different from what occurs in a
normal product. For example, if a high level of protein
is engineered into a cereal or root crop, the product
must be labeled.
Opponents argue that labeling all biotechnologically
produced foods would increase the cost of products as
a result of the added cost of product segregation for
the purpose of the so-called identity preservation of
GM and non-GM products. To avoid contamination,
biotech and conventional products must be kept apart
at all phases of production, storage, processing, and distribution
at additional cost. This would impact bulk or
commodity products like grains (corn, wheat, soybean).
However, specialty and high value fruits and vegetables
are already identity preserved for premium prices.
Labeling of all products might be helpful to those
who practice certain lifestyles or religious beliefs that
impose strict dietary observances. A plant with an animal
gene may not be acceptable to a strict vegetarian.
However, studies have shown that both the kosher
(Jewish) and halal (Muslim) communities have mechanisms
in place to determine which products are acceptable
to their adherents. Leaders of both religious groups
have ruled that simple gene additions that lead to one or
a few new components in a species are acceptable for
their religious practices. However, the Muslim community
has not resolved the issue regarding acceptability of
gene transfer from swine into species, should that happen.
Both Jewish and Muslim communities accept the
use of bioengineered chymosin (rennin) in the cheese
production.
Many countries have some form of labeling regulations
or guidelines, which can be mandatory or voluntary.
The primary forum for the discussion of food
labeling at the international level is the Codex
Alimentarius Commission. Mandatory labeling has been
ISSUES IN THE APPLICATION OF BIOTECHNOLOGY IN PLANT BREEDING 275
implemented in the EU and is being implemented in
Japan. In Europe, all products containing GM organisms
must be labeled as such. Even where mixtures of
conventional and GM organisms are concerned, a label
must be provided to indicate that GM organisms may be
present. The USA and Canada require GM food products
that could have health or safety effects (possible
allergens or changes in nutritional content from acceptable
levels) to be labeled.
In North America, labeling is generally thought to be
necessary only when there is some feature of the product
itself that needs to be brought to consumers’ attention
(e.g., health risk or nutritional issue). The process by
which the product is produced (e.g., by genetic
modification) is considered inconsequential. This is
described as product-based (as opposed to processbased)
regulation. An exception to this approach in the
USA and Canada is the requirement that food subjected
to the processes of irradiation be labeled. In the USA,
the FDA and the courts generally consider reference
should be made to a “material fact” about the product
that is pertinent to nutritional value or safety. This
affirms the concept of substantial equivalence in which a
new food product that is substantially equivalent to
existing products is exempt from labeling.
Economic impact of labeling
and regulations
The economic impact of food regulations and labeling
on trade depends on the products involved, the cost
of labeling, and sometimes how consumers use such
information. The cost of labeling will depend on the
stringency imposed. That is, whether “zero tolerance”
or “minimum tolerance” of GM product is the goal.
Implementing the former standard would require
expensive safeguards to be implemented to avoid crosscontamination.
Harvesting, processing, shipping, and
other product handling would require modification.
Government approval can have severe adverse consequences
on trade. For example, sale of US corn in EU
countries was dealt a devastating blow in 1999 because
certain GM corn varieties were not approved for sale in
the EU. This action caused US corn export to the EU
to drop from US$190 million in 1997 to $35 million
in 1998, and then to a low of $6 million in 1999.
Consumer response to labeling has an impact on product
demand. Sometimes, products intended for use as
feed may not require labeling.