Principles of Plant Genetics and Breeding

274 CHAPTER 15
One factor in boosting public confidence is transparency
of the regulatory process. During the application
process, the applicant is required to submit certain
data to the regulatory agency, though it can be claimed
that parts of the submitted data are confidential business
information (CBI) and should not be viewed by the
public. Different regulatory agencies (in the US government
and other governments) have somewhat different
restraints on what sorts of information can be claimed as
CBI. The question then is how much of the information
should be divulged to the public and how much should
remain proprietary information? Because the regulatory
process is claimed to be science based, and because the
custom of scientific enquiry is to be open and completely
transparent, and further, because the decision
of the regulatory authority is based on the scientific
evidence, any attempt to withhold information involved
in the decision-making process may cast doubt on the
integrity of the process.
Biosafety regulation at the
international level
Because biotech products are accepted to varying
extents in various countries, and because international
trade involves crops that are targets for biotechnology, it
is imperative that trading nations develop a consensus
for biosafety regulation. An international delegation was
convened to draft global regulatory guidelines, called
the Cartagena Protocol on Biosafety. An outgrowth
of the Convention on Biological Diversity (which was
adopted at the 1992 Earth Summit in Rio de Janeiro),
the Biosafety Protocol, which entered into force in
September 2004, is designed to provide guidelines for
signatories of the Protocol and their trading partners
on the transfer, handling, and use of what are described
as living modified organisms (LMOs) that have the
potential to impact the conservation and sustainable use
of biodiversity. The Cartagena Protocol on Biosafety
has been interpreted by some to mean that LMOs
intended for food, feed, or processing must be identified
as LMOs.
Basically, an exporter of a product will be under
obligation to provide the importer with information
about the LMO regarding risk assessment and obtain
consent prior to shipment. Critics of the Biosafety
Protocol say that its implementation will adversely
impact international trade by imposing severe trade
barriers on a wide variety of biotech products (bulk
grain, processed food, drugs, etc.). The cost of goods
will increase as shippers will have to segregate products,
thereby increasing handling costs. Scientific development
progress will also be impacted as scientists are compelled
to pay more attention to special interest groups.
Biosafety regulation stringency is variable from one
nation to another. In Japan, the Ministry of Agriculture,
Forestry, and Fisheries is responsible for assessing environmental
and feed safety, while the Ministry of Health
and Welfare is responsible for food safety assessment.
Basically, a product is subject to scrutiny if it was developed
by rDNA technology. In Canada, the basis of
assessment is the safety of the novel traits that have
been incorporated, regardless of the technology used to
produce the product. Gaining access to the European
Union (EU) market is a complicated task. However,
once approved, the product becomes legal in all the
member countries of the EU. The product manufacturer
or importer must submit a notification to the competent
authority of the member state of the EU where
the product is intended to be marketed. In China, the
State Science and Technology Commission has the
responsibility of developing a regulatory system for GM
organisms. Regulations in developing countries are
generally lacking. The Biosafety Protocol might be
beneficial in this regard to assist the less industrialized
economies in gaining market access to developed
economies. There is no denying that a unified regulatory
system of GM organisms would facilitate international
trade involving these products. Unfortunately, a
consensus that will be fully acceptable to all nations will
be difficult to achieve in the near future.
Labeling of biotechnology products
Some propose that consumers should have the right of
“informed choice” about exposure to the risks of GM
products. This push for labeling is partly because of the
perception of lack of transparency from regulatory agencies,
and the absence of balanced risk/benefit analyses.
Because the first generation products of biotechnology
benefited the food-producing industry directly, as previously
indicated, consumers tend to view GM crops as
geared towards enriching large corporations. Some consumer
advocates would like to see all biotech foods
labeled as such. The argument against labeling advanced
by the biotechnology industry is viewed as an attempt to
conceal information from the public. Opponents do not
see a need for labeling since the FDA has ruled that