Business Potential for Agricultural Biotechnology - Asian Productivity ...

Business Potential for Agricultural Biotechnology Products
(Boyer and Shannon, 2003; Carey et al., 1982; Marshall and Tracey, 2003; Sprague and Dudley,
1988). Conventional plant breeding is also being used to combine two or more separately developed
biotechnology-derived traits. Biotechnology-derived combined-trait products were first
introduced in 1997 and were grown on 6.8M ha globally in 2004 (James, 2004). Examples of
crops that are being grown or developed through the combination of biotechnology-derived traits
by conventional breeding include varieties of maize that combine the Roundup Ready, Yield-
Gard ® Corn Borer, and YieldGard Rootworm traits and varieties of cotton that combine the
Roundup Ready trait with either Bollgard ® or Bollgard II ® traits.
Any new regulatory requirements for combined-trait crops should be carefully considered
to determine whether they address risks that are any greater than those in crops developed by
conventional methods. Australia, Canada, and the U.S. do not generally require submission of
additional safety data on combined-trait products developed by conventional breeding if the
single-trait products have completed the regulatory process and the two traits are unrelated. The
U.S. EPA regulates products that contain two insect-control traits, requiring the identification of
any synergistic effects and confirmation that the insect resistance management (IRM) plan for
the combined-trait product is appropriate. Canada and Australia require that developers notify
them of their intent to commercialize combined-trait products. Canada also reserves the right to
request data demonstrating that combined-trait products are substantially equivalent to the
parents, although this has not been done to date for the currently commercial combined-trait
products.
Japanese regulatory authorities recently issued guidelines for combined-trait products,
based on a classification system. Category 1 includes traits that do not alter a metabolic pathway
of host plants, for example, agronomic traits such as insect protection or herbicide resistance.
Category 2 includes traits that alter a metabolic pathway of host plants, resulting in the enhancement
of nutritional content. Category 3 includes traits that introduce new metabolites that have
previously not been present in the host plant. Based on this classification scheme, there is no
need for a separate review for combined-trait products developed by conventional breeding of
Category 1 traits, as long as the individual traits have been previously reviewed. A separate food
safety review is required for combined-trait products comprised of Category 2 or Category 3
traits. Whether the individual traits are related or interact metabolically will be key to determining
if additional safety data are required for combined-trait products that contain Category 2
or 3 traits.
In Korea, a notification system is in place where the applicant files a justification for
exemption from further safety assessment of the combined-trait product, based on three criteria:
no change in the stacked-trait progeny produced from conventional crossing of the single traits
(other than the additional trait), no crossing between different species, and no change anticipated
in the resulting human consumption levels, edible plant portions, or purpose of usage. If the
product is not exempted, a separate safety assessment must take place, with data requirements to
be specified.
In the Philippines, developers submit a notification for evaluation of combined-trait
products for which the individual traits have prior approval and where the combined-trait products
are used directly for food, feed, or processing. A risk assessment is conducted on possible or
expected interactions between genes or gene products, where the potential for genetic interaction
to form new allergen or toxins, affect protein compartmentalization, or change phenotypic characteristics
and the impact on mode of action and protein levels for single- and combined-trait
products are assessed.
The Republic of China has a voluntary notification process for traits combined by conventional
breeding and where the individual traits have received prior approval. In some other Asia–
® YieldGard, Bollgard, and Bollgard II are registered trademarks of Monsanto Technology LLC.
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