“Each and every member of the food industry, from farm to fork, must create a culture where food safety and nutrition is paramount.” ~ Bill Marler, Esq. “Each stage of the food supply chain that delivers food from farm to the dinner table is obligated to improve, or at a minimum not degrade, the food risk profile.” ~ Michael C. Robach Vice President Corporate Food Safety, Quality & Regulatory Cargill, Incorporated “We can’t inspect safety in our food supply. Instead we should work on building an organizational culture focused on driving improvements in food safety.” ~ Frank Yiannas, Vice President, Food Safety, Walmart

1. FOOD SAFETY
DRUG RESIDUE IN SEAFOOD
WILD-CAUGHT vs AQUACULTURE-RAISED
IMPORTED SEAFOOD vs U.S. FISHERIES
Three agencies do most of the work to protect the public from residue and
microbial hazards: the U.S. Department of Agriculture (USDA), including
the Food Safety and Inspection Service (FSIS) and the Agricultural
Marketing Service (AMS); the Food and Drug Administration (FDA); and
the U.S. Environmental Protection Agency (EPA).
Source: Drug Residues and Microbial Contamination in Food: Monitoring and
Enforcement. U.S. Food and Drug Administration (FDA); and the U.S. Environmental
Protection Agency (EPA). National Academies of Sciences, Engineering and Science.
(1999) accessed October 11, 2017 https://www.nap.edu/read/5137/chapter/7
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Aquaculture is the farming of aquatic organisms; such as finfish,
mollusks, crustaceans, amphibians, reptiles, turtles and aquatic plants.
Aquaculture can occur in freshwater, coastal and marine environments,
including: inland ponds, tanks, reservoirs, rivers, lakes, estuaries, bays,
fjords, and open sea. Aquaculture is an important industry in many
regions of the world. It supports global food and nutrition security by
contributing to the reduction of poverty and improving the social
wellbeing for millions of people worldwide. For more than 30 years
increased aquaculture production has contributed to the overall global
fisheries supply and helped sustain wild captured fisheries.
Aquacultured and wild caught fish and shellfish are held to the
same food safety standards to ensure that only safe and
wholesome products are offered to consumers.

2. The FDA holds domestic and import producers to the same
standard. All seafood processors, including processors of
aquacultured products, must comply with FDA laws and
regulations including the Seafood HACCP regulation. They are
subject to FDA inspections and examinations at the port of
entry. Adulterated products are not allowed to be sold in the
U.S., and foreign processors that import a violative product
into the U.S. market are placed on the detention without
physical examination (also called an Import Alert).
Five drugs are approved by the FDA for use in aquaculture. Another 4 are
approved by the U.S. Department of the Interior’s Fish and Wildlife
Service for use in hatcheries that supply sport fishing (FWS 1994).
The process for choosing which drugs to test involves using the same
questions of hazard and exposure as used by FSIS but is much less formal.
FDA monitoring of aquaculture products also is constrained by a lack of
test methods.
[Emphasis Supplied]
Source: Aquacultured Seafood. U.S. Department of Health and Human Services,
U.S. Food & Drug Administration. Accessed October 11, 2017
https://www.fda.gov/Food/PopularTopics/ucm518782.htm
Use of unapproved drugs or misuse of approved drugs in aquacultured
fish poses a potential human health hazard. These substances may be
toxic, allergenic, or carcinogenic, and/or may cause antibiotic resistance
in pathogens that affect humans.

3. To control this hazard, drugs for use in food animals, whether they are for
direct medication or for addition to feed, generally must be approved,
conditionally approved or index listed by FDA (Federal Food, Drug, and
Cosmetic Act Section 512). Under certain conditions authorized by FDA,
unapproved new animal drugs may be used in conformance with the
terms of an Investigational New Animal Drug (INAD) application (21 CFR
511 and FDA’s Center for Veterinary Medicine (CVM) Guide 1240.3025).
Off label use in animals of approved human or animal drugs is permissible
in certain circumstances.
Drugs on the Index of Legally Marketed Unapproved New Animal Drugs
for Minor Species (the Index) may not be used in food animals except in
early nonfood life stages of food producing minor species in certain
circumstances.
Reasons for the use of drugs in aquaculture include the need to (1) treat
and prevent disease, (2) control parasites, (3) affect reproduction and
growth, and (4) provide tranquilization (e.g., for weighing).
Relatively few drugs have been approved for aquaculture. This factor may
lead to the inappropriate use of unapproved drugs, general-purpose
chemicals, or approved drugs in a manner that deviates from the labeled
instructions.
Source: Aquaculture Drugs. U.S. Food & Drug Administration. Accessed
October 11, 2017. https://www.fda.gov/downloads/food/guidanceregulation/ucm252410.pdf
Approved Aquaculture Drugs – FDA – May 24, 2017
https://www.fda.gov/animalveterinary/developmentapprovalprocess/aquaculture/ucm132954.htm

4. U.S. General Accounting Office (2017)
Imported Seafood Safety
Published: September 15, 2017
Publicly Released: October 2, 2017
https://www.gao.gov/products/GAO-17-443
Ninety percent of the seafood eaten in the United States is imported, and
about half of that is raised on fish farms. Farmers may treat fish with
antibiotics and other drugs because these fish can be susceptible to
infections. Misuse of drugs can leave residues in seafood that cause health
problems for consumers.
We looked at how the two agencies charged with ensuring seafood safety
protect against unsafe drug residues, and made five recommendations
to strengthen their efforts. For example, agencies could require foreign
governments to do more testing for these drug residues.
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AQUACULTUE IN HAWAII
About 63 percent of seafood consumed in Hawaii is imported
including from the U.S. mainland according to a 2010 study.
The U.S. imports 86 percent of its seafood and the seafood trade deficit
has grown to $10.4 billion annually. U.S. aquaculture accounts for just 5
percent of Americans’ seafood consumption. The high level of imports
exposes us to the vulnerability of volatile prices in the
international market, as well as to variability in the food safety
practices and health standards of exporting countries.

5. Hawaii is fortunate to be a world center of aquaculture expertise in a wide
variety of species and technologies. Public and private research
organizations have pioneered the development of extensive, semi-
intensive and intensive culture systems and regularly consult around the
world. Local entities have extensive expertise in the spawning and rearing
of mullet, milkfish, freshwater prawns, marine finfish, and marine
shrimp. Several companies specialize in the production and sale of
certified disease-free shrimp broodstock and seedstock, and oyster and
clam seed stock. In addition, Hawaii is home to leading technology
companies in microalgae and seaweed production. The level of
cooperation between researchers, extension personnel and commercial
producers in the local community is exceptional.
Source: State of Hawaii. Department of Agriculture.
http://hdoa.hawaii.gov/ai/aquaculture-and-livestock-support-services-branch/aquaculture-in-hawaii/
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STATE OF HAWAII
DEPARTMENT OF HEALTH
FOOD & DRUG BRANCH
As of July 1, 2015 the Food and Drug Branch has been
consolidated with the Sanitation Branch and is no longer a
separate program within the Department of Health.
Please refer to the Sanitation Branch web-page:
http://health.hawaii.gov/san/