Submission on the DAR for APPLICATION A549 FOOD DERIVED FROM HIGH-LYSINE CORN LY038: to permit the use in food of high-lysine corn

Centre for Integrated Research
in Biosafety
Tel: +64 3 364 2500, Fax: + 64 3 364 2590

4 June 2006

Proposed change to food code not grounded on best available science

The Centre for Research in Biosafety (INBI) is urging the food standards agency to
reconsider its draft recommendation to approve a new type of GM corn.
INBI has recommended that Food Standards Australia New Zealand (FSANZ) should
not approve Monsanto’s genetically modified high-lysine LY038 corn until further
safety studies have been conducted.

FSANZ is the agency responsible for protecting the safety and integrity of food sold
in Australia and New Zealand.

Monsanto has applied to FSANZ for LY038 to be permitted in the food supply, but
has declared that its intention is to market LY038 as animal feed.

INBI believes LY038 is the first genetically modified crop plant substantially
different in its nutritional profile to be considered for approval as a human food.
INBI recommends that safety studies be conducted using GM corn that has been
cooked and processed as it is in human food.

“The key difference between the use of corn as an animal feed and a human food is
cooking and processing, and FSANZ has made no attempt to assess food hazards
resulting from cooking or processing of LY038,” said INBI Director and University
of Canterbury Associate Professor Jack Heinemann.

He said LY038 corn was substantially different to conventional corn in that it has high
concentrations of compounds that are known to produce food hazards when heated
with the sugars found in corn.

“We’ve carefully examined the risk assessment done by FSANZ and its supporting
materials, and we can’t understand why FSANZ does not ask for the obvious
scientific studies that would establish the safety of this product when it is cooked and
processed, the way people—and not chickens—eat it,” Heinemann said.

While the FSANZ assessment assumes that LY038 would enter the food supply only
in small amounts and inadvertently, the INBI submission identifies a number of
realistic pathways, both deliberate and inadvertent, through which the amounts of
LY038 in the food supply could be much more significant.

In its submission to FSANZ, INBI makes over 90 major recommendations, most of
which identify deficiencies in the supporting scientific studies and in the analysis
conducted by FSANZ. INBI also notes ways in which the FSANZ standards deviate
from those recommended by international food safety bodies such as Codex
Alimentarius and the World Health Organisation.

“FSANZ is obligated to use the best scientific evidence available and conduct a caseby-
case assessment. From our point of view, it hasn’t consistently done either,” said

INBI has called on FSANZ to explain how it weighs competing costs and benefits
when coming to its decisions.

“FSANZ is charged with maintaining public confidence in the quality and safety of
food,” said Billie Moore, an INBI researcher.

“This is impossible without public confidence in FSANZ and its decision-making
processes, which must therefore be transparent and open to public scrutiny and
evaluation. It cannot expect the public to have confidence in unsubstantiated
assertions and unexplained reasoning.”

For the full INBI submission, please go to:

For a non-technical version of the submission, please go to: It can also be downloaded from the link below.
For further information, contact:
Dr. Jack Heinemann (


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