WASHINGTON (Reuters) - Three U.S. consumer groups petitioned
the Food and Drug Administration on Tuesday to subject a new genetically
engineered salmon to a more rigorous review process than is now in
place before the fish can be approved as safe to eat.
The fish at issue, AquaBounty Technologies' AquAdvantage salmon, is
currently classified as a new animal drug for the purposes of FDA
review.
The FDA considers any genetically altered animal a new animal drug
for approval purposes. The petition calls for the salmon to be
classified as a food additive instead, which would require a more
rigorous FDA review.
AquaBounty is seeking U.S. approval to market its engineered Atlantic
salmon, which contains a gene from another fish species, the Chinook
salmon, to help it grow twice as fast as normal.
The consumer groups' petition says the way these salmon are created
substantially alters their composition and nutritional value, and so
they should be treated as a food additive. Under this standard, they
said, the company's data would have to overwhelmingly prove AquAdvantage
salmon are safe to eat.
The consumer groups -- Food & Water Watch, Consumers Union, and
the Center for Food Safety -- said in a statement the "new animal drug"
designation is insufficient to protect public health. The review process
for food additives offers greater protection, they said.
AquaBounty had no comment on the petition.
The FDA did not comment specifically on the petition, but confirmed
that the company's application for FDA approval for AquAdvantage salmon
is under review, and that genetically engineered animals are evaluated
under the new animal drug provisions of U.S. law.
AquaBounty has said in the past that it sees these genetically
modified salmon as a potential solution to environmental concerns
associated with salmon aquaculture, and discounted fears they might
accidentally escape into the wild and affect other fish.
However, Food & Water Watch Executive Director Wenonah Hauter
said the company's own study showed that genetically engineered salmon
may contain increased levels of a hormone linked to breast, colon,
prostate and lung cancer.
The petitioners said a proper review would require genetically
engineered salmon to go through comprehensive toxicological studies to
ensure the fish are safe to consume and properly labeled.
If approved, AquAdvantage would be the first genetically altered animal for human consumption in the United States.
Genetically modified vegetables such as corn have long been on the
U.S. market, and the FDA allows modified animals as pets or to help
produce biologic medicines.
There is no timeline for an FDA decision. As a matter of policy, the FDA does not comment on citizen petitions.