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Frequently
Asked Questions
Five Questions
About Advanced Hybrid Salmon
Q.
With advanced hybrid salmon growing much larger than other salmon,
could they gain a mating advantage or outcompete native salmon
for food or space?
A. No. Advanced
hybrid salmon grow faster than other salmon but they do
not grow any larger by the time they reach maturity.
Male salmon
do not gain a mating advantage because of size. In fact, “precocious
parr,” only 6 inches in length, father about one-fifth of
each new generation before they go to sea. Studies of escaped
farmed salmon, which are almost always larger than wild fish,
have found them to mate successfully only 16 percent as
often as native salmon.
Farmed salmon
are trained to eat fish feed - small, dry pellets that look exactly
like the “dog chow” we feed our family pets. If they
escape, they look for something similar. Most don’t find
it. More than 85 percent of the farm escapees caught off British
Columbia and Alaska had no food in their bellies. In a
1999 study, the Washington State Department of Ecology found farm
escapees to be eating tree bark in local rivers, because
it apparently looked like fish feed. Advanced hybrid salmon may
forage even more poorly because they spend more energy to pursue
prey, deplete their energy reserves more quickly and expose themselves
to predators more often in the search for food.
Q.
Researchers at Purdue University found that only 60 advanced hybrid
salmon could drive a wild population to extinction. If advanced
hybrid salmon do breed successfully with native fish, will their
novel gene escape into the wild gene pool and destroy native salmon
populations?
A. Muir and
Howard, the Purdue scientists who proposed the “Trojan
Gene Hypothesis,” did not study advanced hybrid salmon.
They designed a mathematical model based on the behavior of Japanese
medaka, a small, freshwater fish that matures in 56 days and breeds
daily until it dies. Salmon take three, five and even ten years
to mature and most breed only once in their lifetimes. Sterile
salmon do not breed at all.
The U.S. Food
and Drug Administration will not approve the use of advanced hybrid
salmon unless they can be demonstrated to be sterile. Aqua
Bounty has stipulated that it will market only sterile, all
female advanced hybrid salmon. There can be no gene flow to
wild salmon because sterile fish can not reproduce.
Q.Can
we be sure that advanced hybrid salmon will really be sterile?
A. Yes. Scientists
can test for triploidy by scanning blood or embryonic fluids in
a flow cytometer. The sterility of every batch of advanced hybrid
salmon eggs can be verified before they ever leave the hatchery.
Q.
Aren't advanced hybrid salmon voracious predators that will consume
all the available food in an ecosystem and will prey on native
juveniles?
A. No. Advanced
hybrid salmon actually consume less food per pound of weight
gained because they process their food 10 to 30 percent more efficiently.
Advanced hybrid
salmon may be highly prone to starvation in the natural environment
as they learn to identify and hunt for wild food. They maintain
a higher metabolic level for a longer period of time in food deprivation
studies, and deplete their energy reserves more quickly than do
standard salmon.
Any food competition
would occur in the marine environment because sterile advanced
hybrid salmon can not produce the juveniles that occupy freshwater
habitat. In the marine life stages, advanced hybrid salmon would
compete with older native salmon of about the same size. Because
food availability is not limiting in the marine environment, advanced
hybrid salmon would gain no advantage from their higher feeding
motivation.
Sterile female
salmon do not engage in spawning behaviors and almost never return
to freshwater habitat after they begin to feed at sea. Native
juveniles are confined to freshwater habitat. Any predation risk
would, therefore, be lower than now occurs in conventional salmon
aquaculture.
Q.
Do advanced
hybrid salmon produce antifreeze proteins and excessive
amounts of growth hormone?
A. No. Advanced
hybrid salmon produce no antifreeze proteins. Only the molecular
“switch” from the antifreeze gene is used.
Advanced hybrid
salmon produce the same amount and kind of circulating growth
hormone as wild-type salmon, but they produce it through the entire
year.
Five Questions About Federal Regulation of Advanced Hybrid
Fish
Q.
Are there federal laws that specifically govern the regulation
of genetically engineered fish and marine organisms grown for
human consumption?
A. Yes. Federal
regulation of advanced hybrid fish is governed by the Food, Drug
and Cosmetics Act. As far back as 1986, the U.S. Food and Drug
Administration asserted jurisdiction over advanced hybrid animals
and fish on the grounds that the transgene and any expressed proteins,
affect the “structure and function” of the receiving
animal analogous to the modalities of alternative veterinary drug
formulations. FDA jurisdiction has been upheld by the federal
courts.
Q.
Wasn't the 1986 federal “Coordinated Framework” a political
stratagem of the Reagan administration to exempt biotechnology
from regulation?
A. No. The
Coordinated Framework (51 Fed. Reg. 23303) asserts the scope of
well-established statutory authorities to include, rather
than exempt, products produced by modern biotechnology within
traditional regulatory jurisdictions. Recognizing that individual
products, and not the processes by which they are developed, are
the ultimate source of risks and benefits and the focus of regulatory
action, the Coordinated Framework clarified the existing authority
of FDA, the Environmental Protection Agency and the Department
of Agriculture to regulate biotech plants and animals under the
established jurisdictions of the Food, Drug and Cosmetics Act
(FDA), the Federal Insecticide, Fungicide and Rodenticide and
the Toxic Substances Control Acts (EPA), and the Plant Pest Protection,
the Plant Quarantine and the Virus, Serum and Toxin Acts (USDA).
The scientific
rationale in support of the product-based focus of the Coordinated
Framework has been endorsed in three separate reviews by the National
Academies of Science, in 1989, 2000 and 2002.
The regulatory
rationale in support of the Coordinated Framework was reviewed,
evaluated and endorsed by the Clinton administration in 1999-2000.
Q.
Does the FDA evaluate the environmental impact of advanced hybrid
fish or does it limit any assessment to the molecular attributes,
pharmaceutical effects or the impacts of any chemicals used in
the engineering process? And does their environmental risk assessment
extend to potential ecological impacts?
A. Environmental
risk assessment at FDA is governed by the National Environmental
Policy Act and the regulations implementing NEPA adopted by the
Council on Environmental Quality (40 CFR Parts 1500 to 1508) and
by FDA (21 CFR Part 25). The NEPA and CEQ obligations imposed
on the agency are identical to those required of all agencies
throughout the federal government, including the identical scope
of environmental risk assessment.
The agency’s
position on the scope of environmental risk assessment required
to process new drug applications is detailed in its 1998 guidance:
“FDA considers harm to the environment to include not only
toxicity to environmental organisms but also environmental effects
other than toxicity, such as lasting effects on ecological community
dynamics.”
Q.
Does the FDA possess the expertise in fisheries biology, ecology
and environmental science to assess the environmental risks of
advanced hybrid fish?
A. The FDA
staff includes specialists trained in biology, environmental science
and risk assessment who have conducted hundreds of environmental
impact assessments. Each assessment is based on the explicit assumption
that the ultimate repository of agency-approved pharmaceuticals
or food additives will be aquatic ecosystems following their production,
use or disposal.
NEPA and CEQ
require federal agencies to cooperate with other affected agencies
in the assessment of the environmental impacts of agency actions.
In the case of advanced hybrid fish, FDA has engaged the cooperation
of the U.S. Fish & Wildlife Service and the National Marine
Fisheries Service in the design and evaluation of the environmental
risk assessment. In the specific case of advanced hybrid salmon,
the two fisheries Services must also be consulted under the Endangered
Species Act.
Q.
Is science-based risk assessment adequate for the evaluation of
the environmental impacts of biotechnology?
A. Science-based
risk assessment identifies potential hazards, quantifies the probabilities
those hazards will occur and accounts for uncertainty with significant
safety thresholds - typically set at 1000 times the likely level
that a risk will occur. This approach is wholly compatible with
precaution.
The science-based
process, according to a former undersecretary of Commerce in the
Clinton administration, David Aaron, has "shown us that biotech
foods developed and used in the U.S. present no safety risk beyond
those of their 'natural' counterparts. Not a single ailment has
been attributed to biotech foods. Not one. Not a sneeze, not a
rash, not a headache." Similarly, environmental scares ranging
from Monarch butterfly impacts to increased pesticide use to advanced
hybrid superweeds have all been disproved by adequate research
or avoided by appropriate agricultural practice or regulatory
standards.
The Precautionary
Principle as adopted in the 1992 Rio Declaration calls only for
“cost effective measures to prevent environmental degradation”
when “threats of serious or irreversible damage” lack
“full scientific certainty.” U.S. risk management practice
meets this test.
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