U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection

FDA and Aquaculture
 
 
 
 
 
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FN93-06              FDA AND AQUACULTURE             04/07/93
 
 
 
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               3                                 3
               3      A Speech Presented by      3
               3                                 3
               3      George P. Hoskin, PhD      3
               3                                 3
               3       Associate Director        3
               3                                 3
               3        Office of Seafood        3
               3                                 3
               3               on                3
               3                                 3
               3          March 4, 1993          3
               3                                 3
               3         before the Joint        3
               3                                 3
               3         Subcommittee on         3
               3                                 3
               3           Aquaculture           3
               3                                 3
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FDA is a regulatory agency.  In part FDA is responsible for ensuring
the safety, wholesomeness, and economic integrity of food. Food
includes seafood.  Seafood, in turn, refers to any food from an
aquatic source, whether fresh water or marine, whether wild caught
or produced by aquaculture. The only exclusion, for convenience, is
aquatic birds and mammals.
 
The principle law enforced by FDA is the Food Drug and Cosmetic Act.
 
The Act requires that FDA approve drugs, food and feed additives,
and color additives before they may be used for man or animals.
Sources of radiation used to treat foods are food/feed additives as
defined in the Act.
 
The Act prohibits interstate commerce in adulterated and misbranded
food.  Adulterated foods are foods which are unsafe (including those
containing unapproved drugs or food or color additives), filthy,
decomposed, or containing added substances to make them appear
better than they are.  Misbranded foods are those which are
deceptively packaged or labeled -  short weight, labeled as from a
species which they are not, etc.
 
A fundamental concept is that the responsibility to produce safe,
wholesome, properly labeled food lies with the food supply
industries. FDA is not the quality assurance arm of these
industries; FDA does not conduct continuous in-plant inspections,
for example.
 
As part of its work to assure that foods are legal, FDA does conduct
inspections, and collects and analyzes samples of domestically
produced and imported foods.
 
The Act gives the agency the authority to conduct these inspections,
but does not tell us specifically to inspect at such and such an
interval. This flexibility of the law has lead to confusion
regarding the phrase "mandatory seafood inspection".
 
While FDA is not mandated to conduct inspections, it is authorized
to conduct them and does so. FDA inspected every domestic operation
at least once during the last year. FDA inspections generally
include collection of food and other samples for laboratory
analyses.
 
FDA also conducts a limited number of foreign inspections as well as
domestic inspections. Thus far in FY 93, FDA has conducted 15
foreign inspections of seafood processors. We intend to conduct
approximately 40 foreign inspections of seafood canners covering 5-6
countries. Other inspection trips to foreign processing and
aquaculture operations are planned as well.
 
Currently, however, import product testing, and application of
automatic detention to products from sources frequently in violation
of regulations, are the primary approach to control imported
products. In FY '92 FDA conducted 6,125 wharf exams and collected
9,667 import samples for analysis. Most of these samples were
analyzed for multiple defects so that the number of laboratory
analyses performed greatly exceeded the number of samples collected.
 
There are additional strategies being pursued for imports, such as
establishing inspection Memoranda of Understanding with countries
which, by virtue of their own inspection systems, consistently ship
acceptable products. The establishment of such MOUs will aid FDA in
directing its efforts to the products of greatest concern.
 
A major endeavor of FDA is the conduct of research directed towards
elucidating hazards, determining risk, and managing risk. The Office
of Seafood has laboratories in Washington DC, Rhode Island, and
Alabama dedicated to seafood research. The Field component of FDA
has a major Seafood Products Research Center on the West coast which
works closely with us. Other research work in FDA may be relevant to
seafood as well as other foods, such as our microbiological research
program.
 
It is important to note that as part of risk management, FDA relies
upon education and information dissemination to consumers and to
industry such as the FDA Seafood Hotline (1-800-FDA-1410; in DC,
205-4314), and the work being led by Gary Stefan of CVM, under the
auspices of the JSA, to produce the recently available booklet,
Federal Regulation of Druqs Biologicals and Chemicals Used in
Aquaculture Produdtion. Recently FDA published a series of brochures
directed to persons with certain health conditions which would
increase their risk should they consume raw molluscan shellfish.
 
This, then, is the framework under which FDA operates. The agency's
role with respect to aquaculture does not differ significantly from
its role in food regulation in general. However, let us take a bit
more detailed look at the potential problems of concern to FDA
associated with seafoods, and especially those which may be unique
to seafood from aquaculture.
 
The aquaculturist is faced with essentially the same requirements as
the producer of wild caught fish, but with a few of the specific
issues more familiar to traditional agriculturists. Thus, while I am
aware of the general complaint that aquaculture is restrained by too
much regulation, and have perused some assembled tomes which attempt
to lay out all the federal, state, and local regulations a start-up
aquaculture operation faces in some particular state, I submit that
those which are administered by FDA are familiar to food producers
in general and should contain no surprises. A good way to approach
this might be to recognize that there are hazards in producing any
food, and conduct a hazard analysis.
 
1. Site selection: just as the fisher of wild fish is faced with
the possibility of contamination of his catch by pesticides
and industrial chemicals from pollution, or, depending on
species or (location, from heavy metals or toxins of natural
causes, the aquaculturist should be aware of the potential for
such contamination by the water source, and perhaps by the
soil of the selected site.
 
FDA enforces the EPA requirements for pesticide contamination.
Whether contamination occurs because of poor site selection or
from the intentional application of pesticides by the
aquaculturist, there remains the potential hazard of pesticide
contamination, and this hazard must be avoided.
 
2. The aquaculturist may elect to use therapeutics. This topic
has been exhaustively explored elsewhere and I won't replow it
here, except to refer to the above booklet. If you still have
questions, contact FDA CVM, either Richard Geyer or Gary
Stefan. The need here, as expressed so often, is two fold;
first to develop animal husbandry practices that minimize the
occurrence of disease, and second, to develop the data which
can be used to secure FDA approval of new drugs and new uses
of drugs. Research by USDA, FWS, and FDA includes studies to
aid in this area, but other sources of data are clearly
needed.
 
3. Methyl mercury and natural toxins, such as ciguatoxin or
domoic acid, pose problems principally for wild caught marine
fisheries. The US aquaculture industry is currently more
focused on fresh water species, but knowledge of the potential
for toxins is essential to avoid problems. Similarly, there is
the problem of natural compounds from soil and algae that may
not pose a safety concern, but may produce off flavors and
ruin the marketability of the product.
 
4. As for any food, filth and decomposition are problems which
may introduced at any point from harvest onward. The
aquaculturist as producer and, in some cases the first level
processor, needs to understand this set of hazards. While few
species which produce histamine during decomposition are
currently in commercial aquaculture production, awareness of
this decomposition produced hazard and control to prevent it
are needed.
 
5. Parasites are a problem for wild caught fisheries.
Understanding the potential for this problem in aquaculture is
also important. The interaction of endemic wild animals,
usually as they try to steal the aquaculturist's products, may
be a source of such problems. Conversely, the introduction of
a species for aquaculture into a new area carries the
potential for the introduction of parasites and the start up
of a host parasite cycle by inadvertent introduction of a
parasite from infected brood stock or fry.
 
6. Contamination of products with pathogenic microorganisms is
a potential hazard. This is particularly true for molluscan
shellfish, and exacerbated as a hazard because molluscan
shellfish are frequently consumed raw, but also may be a
problem for other species, such a shrimp which may become
contaminated by Salmonella.
 
7. Contamination with unapproved food or color additives is a
problem relevant to aquaculture. The use of sulfites on
crustacea to prevent post harvest melanization, for example,
is more likely to be found in use for wild caught fisheries
but could arise in situations demanding long transportation
from shrimp pond to processing plant.
 
The salmonid aquaculturists are familiar with the situation on
the use of the pigmenting agents canthaxanthin and
astaxanthin. As well as the fact that color additives, which
include compounds added to feed which result in coloration of
the flesh of the food animals, require pre approval for their
use- such did Congress write the FD&C Act- there may also
arise the related issue of common or usual name of products
artificially colored.
 
And that brings us to the issues of truthful labeling and
avoidance economic fraud.
 
The common or usual name is to be used for aquaculture
produced foods. Beefalo is not marketed as beef. So, too,
hybrid striped bass are not to be marketed as striped bass.
Tilapia is tilapia that's it. This is essentially the same
issue as that faced by the marketer of any old or new fishery,
such as Orange Roughy or Monk fish.
 
Other aspects of economic fraud, such as adding water directly
or facilitated by the use of sodium tripolyphosphate, for
example;short weight; adding the weight of glaze to the net
weight; andother such practtces are little different for
products from aquaculture than those from wild caught
fisheries-it's "the same old same old" as far as FDA is
concerned. And we care about this and take action when it
occurs.
 
The Office of Seafood is compiling a hazard analysis guide
which will incorporate these hazards with additional detail,
provide some suggested control measures, and relate them to
the species most likely to be affected.
 
This has been a rapid thumbnail sketch of the role of FDA
relative to aquaculture. I hope it has been helpful, I will,
if time permits, attempt to answer questions. I encourage you
at any time to contact the Office of Seafood ((202) 254-3888),
or the Center for Veterinary Medicine when you have questions.
Thank you for your attention.