![](media/image1.png){width="0.875in"
height="0.8333333333333334in"}**DEPARTMENT OF HEALTH & HUMAN SERVICES**

Public Health Service

Food and Drug Administration

Rockville MD 20857

**Remarks of**

**Donald W. Kraemer**

**Deputy Director**

**Office of Food Safety**

**Center for Food Safety and Applied Nutrition**

**U.S. Food and Drug Administration**

**To the**

**Marine Fisheries Advisory Committee**

**July 3, 2008**

Thank you for the opportunity to participate in today's meeting on
seafood safety. I am pleased to provide remarks for the U.S. Food and
Drug Administration (FDA or the Agency).

**FDA's SEAFOOD SAFETY PROGRAM**

[\
]{.underline}FDA has statutory authority and responsibility for the
safety of all food, except for most meats, poultry and processed egg
products, which are regulated by the U.S. Department

of Agriculture.

With respect to seafood, FDA operates a mandatory safety program for all
fish and fishery products under the provisions of the Federal Food, Drug
and Cosmetic (FD&C) Act, the Public Health Service Act, and related
regulations. The FDA program includes research, inspection, compliance,
enforcement, outreach, and the development of regulations and guidance.
As a cornerstone of that program, FDA publishes the *Fish and Fisheries
Products Hazards and Controls Guidance*, an extensive compilation of the
most up-to-date science and policy on the hazards that affect fish and
fishery products and effective controls to prevent their occurrence. FDA
is finalizing the fourth edition of this guidance document, which has
become the foundation of fish and fishery product regulatory programs
around the world.

FDA's program for fish and fishery products is comprehensive in its
nature and is fully integrated into the food safety structures of FDA's
Center for Food Safety and Applied Nutrition (CFSAN) and FDA's field
organization, the Office of Regulatory Affairs (ORA). Because of the
cold-blooded nature of fish and the nature of the aquatic environment in
which they live, fish and fishery products pose unique food safety
challenges which are quite different than those posed by land animals.
FDA has developed extensive expertise in these areas over decades of
regulating this commodity.

CFSAN experts are responsible for evaluating the hazard to public health
presented by chemical and microbiological contaminants in fish and
fishery products. FDA operates the Gulf Coast Seafood Laboratory in
Alabama, which specializes in seafood microbiological, chemical and
toxins research. In addition, seafood research is conducted at CFSAN's
research laborator**y** in College Park, Maryland. FDA, in collaboration
with the National Oceanic and Atmospheric Administration (NOAA) at the
Department of Commerce, also represents the United States at the Codex
Alimentarius Commission's Committee on Fish and Fishery Products, the
international food safety standard setting body for this commodity.

[Inspections]{.underline}

FDA's field staff is responsible for ensuring regulatory compliance for
fish and fishery products produced in the United States and for those
products imported from abroad. The field staff conducts inspections of
fish and fishery product processing establishments, conducts follow-up
investigations to track food-borne illnesses, and performs other
activities designed to ensure the safety of these products. In FY 2007,
FDA staff and state contractors conducted approximately 3,600
inspections of foreign and domestic seafood manufacturers, processors,
importers, and storage facilities.

Processors of fish and fishery products are subject to FDA's Procedures
for the Safe and Sanitary Processing and Importing of Fish and Fishery
Products, commonly known as the Seafood Hazard Analysis Critical Control
Point (HACCP) Regulation, in 21 C.F.R. Part 123. In short, this
regulation requires both domestic and foreign processors of fish and
fishery products to understand the food safety hazards associated with
their process and product and, through a system of preventive controls,
to keep those hazards from occurring.

The HACCP inspection approach is used by FDA during domestic and foreign
inspections of seafood processors to focus its attention on the parts of
seafood production and processing that are most likely to affect the
safety of the product. In contrast to historical methods of evaluating
processing practices on the day of the inspection, the HACCP approach
allows FDA to evaluate processors' overall implementation of their HACCP
systems over a period of time by having access to the firms' HACCP
Plans, including monitoring, corrective action, and verification
records. In this model, it is the seafood industry's responsibility to
develop and implement HACCP controls and the regulatory agency's to
ensure that the industry complies.

Every three years, FDA issues compliance programs that outline the
Agency's field staff's inspection responsibilities. The Domestic Fish
and Fisheries Products Compliance Program (CP 7303.842) and the Import
Seafood Compliance Program (CP 7303.844) provide a priority list for
inspection coverage based mostly on risk. Examples of high priority
products include ready-to-eat products, such as hot or cold smoked fish,
scombrotoxin-forming fish, such as tuna or mahi-mahi, aquacultured
seafood products, and fish packed in reduced oxygen packages.

Annually, FDA determines a "work plan" for each FDA district office that
outlines the Agency's field staff's domestic inspection
responsibilities. This work plan focuses on areas that are a priority
for the Agency, and allocates available resources.

Even though inspectional coverage is based primarily on product risk,
FDA district offices may adjust that coverage to a particular
establishment, such as one that may have been associated with a consumer
complaint or illness or one with a poor compliance history. For example,
the work plan may dictate that a processor be inspected annually, but if
during an inspection the processor is found out of compliance
re-inspection will occur more rapidly.

The regulatory sanctions that FDA has available to apply to domestic
processors of fish and fishery products that are non-compliant are
warning letters, seizure of products, injunction against further
noncompliant practices, or prosecution of an individual or
establishment.

**REGULATION OF FOOD IMPORTS**

FDA's primary authority over imported food and other products under our
jurisdiction derives from section 801 of the FD&C Act, which provides a
broad statutory framework to ensure that the products are safe,
wholesome, and accurately labeled.

When an FDA-regulated product is offered for import into U.S. commerce,
Customs and Border Protection (CBP) procedures ensure that FDA is
notified. If the product appears to be adulterated or misbranded, based
on examination or other information such as prior history of the
product, manufacturer or country, FDA will give notice advising the
owner or consignee of the appearance of a violation and the right to
provide evidence (such as a laboratory analysis by an independent
laboratory) to rebut the appearance of the violation. In some
circumstances, importers may request permission to recondition the
product to bring it into compliance with applicable requirements and
regulations. If the product is ultimately refused admission, it must be
destroyed within 90 days unless re-exported by the owner or consignee.

To better manage the increasing volume of imported products that we
regulate, FDA currently screens electronically-submitted information on
all incoming shipments, and then uses a risk-based approach to target
our inspectional resources at products having the greatest potential for
causing harm to public health. It is important to note that while FDA is
not able to physically inspect a large percentage of import entries, all
import entries are electronically screened for a variety of risk
factors, using the Operational and Administrative System for Import
Support (OASIS). OASIS is an automated system for processing and helping
FDA make admissibility determinations for regulated products offered for
import.

In 2002, Congress gave FDA significant new authorities to enhance
protection of the food supply in the Public Health Security and
Bioterrorism Preparedness and Response Act (the Bioterrorism Act). One
of the most important provisions is the requirement that FDA be provided
prior notice of food (including animal feed) that is imported or offered
for import into the U.S. This advance information enables FDA, working
closely with CBP, to more effectively target food that may be
intentionally contaminated with a biological or chemical agent or which
may pose a significant health risk to the American public. Suspect
shipments then can be intercepted before they arrive in the U.S. and
held for further examination. Prior notice can be submitted either
through CBP's Automated Broker Interface/Automated Commercial System
(ABI/ACS) or FDA's Prior Notice System Interface (PNSI). Currently, FDA
receives approximately 33,400 prior notice submissions per business day.

FDA has numerous other tools and authorities that enable the Agency to
take appropriate action regarding imported products. The Agency conducts
some inspections of food manufacturers overseas. FDA also performs
routine surveillance examinations of imported goods to check for
compliance with U.S. requirements. Because of the large volume of
FDA-regulated foods being exported from a large number of countries, it
is not feasible to routinely inspect every shipment of foreign-produced
foods at the point of import. We do, however, work with foreign
governments and food producers to help ensure that imported food is
produced, processed, and packed in accordance with U.S. requirements.

Another key tool for screening imported goods is the Import Alert.
Import Alerts inform FDA field personnel that the Agency has sufficient
evidence or other information about a particular product, producer,
shipper or importer to believe the product does not meet U.S.
requirements or is otherwise unsafe. On the basis of that evidence, FDA
field personnel may detain the article that is being offered for entry
into the U.S. without physically examining the product. When an Import
Alert is issued and FDA detains a shipment, the owner or consignee has
an opportunity to introduce evidence to demonstrate that the product is
not violative.

FDA also performs laboratory analysis on a sampling of products offered
for import into the U.S. and performs periodic filer evaluations to
ensure that import data being provided to FDA is accurate. Certain
violations relating to imported food may lead to civil or criminal
charges.

[Seafood Imports]{.underline}

More than 80 percent of all seafood consumed by Americans is imported.
FDA regulates imported seafood products, including those from
aquaculture, by conducting foreign manufacturer inspections, inspecting
importers, and performing examinations and collecting surveillance
samples of imported goods at the time of entry. FDA prioritizes these
import-related activities based on the products' risk. High priority
products, and foreign processors or importers of high priority products,
are assigned higher priority for surveillance activities. Lower priority
products, processors, and importers are sampled or inspected less
frequently with remaining resources. Examples of high priority imported
products are the same as those produced domestically and include
ready-to-eat products such as hot or cold smoked fish,
scombrotoxin-forming fish such as tuna or mahi-mahi, aquacultured
seafood products, and fish packed in reduced oxygen packages.

It is the importer's responsibility to offer for entry into the United
States product that is fully compliant with all applicable U.S. laws. As
previously stated, under the Seafood HACCP Regulation, HACCP controls
are required for both domestic and foreign processors of fish and
fishery products. Additionally, the regulation requires that U.S.
importers take certain steps to verify that their foreign suppliers meet
the requirements of the regulation.

In fiscal year (FY) 2007, FDA processed approximately 868,000 entries of
imported seafood, while our field staff performed more than 14,000
physical examinations of seafood imports and collected over 6,000
samples of domestic and imported seafood for analysis at FDA field
laboratories.

**FOOD PROTECTION PLAN**

Going forward, all of FDA's seafood safety efforts will be informed by
the Food Protection Plan announced in November 2007. The Food Protection
Plan defines a science and a risk-based approach to better ensure the
safety of domestic and imported foods eaten by American consumers.

The Plan, which focuses on both domestic and imported food, complements
the Import Safety Action Plan that describes how the U.S. can improve
the safety of all imported products. The Import Safety Action Plan lays
out a road map with short- and long-term recommendations to enhance
product safety at every step of the import life cycle. Taken together,
the two plans will improve efforts by the public and private sector to
enhance the safety of a wide array of products used by American
consumers.

The Food Protection Plan is premised on preventing harm before it can
occur, intervening at key points in the food production system, and
responding immediately when problems are identified. Within these three
overarching areas of protection, the plan contains a number of action
steps as well as a set of legislative proposals. Taken together, these
efforts will provide a food protection framework that ensures that the
U.S. food supply remains safe.

To strengthen its efforts to [prevent]{.underline} contamination, FDA
plans to strengthen support of food industry efforts to build safety
into products manufactured either domestically or imported. The Agency
will work with industry, state, local, and foreign governments to
identify vulnerabilities and will look to industry to mitigate those
vulnerabilities, using effective methods such as preventive controls.

The plan\'s [intervention]{.underline} element emphasizes focusing
inspections and sampling based on risk at the manufacturer and processor
level, for both domestic and imported products, that will help verify
the preventive controls. This approach is complemented by targeted,
risk-based inspections at the points where foreign food products enter
the United States.

The plan calls for enhancing FDA\'s information systems related to both
domestic and imported foods to better [respond]{.underline} to food
safety threats and communicate during an emergency.

The Food Protection Plan\'s three core elements\--prevention,
intervention, and response\--incorporate four cross-cutting principles
for comprehensive food protection along the entire production chain by:

-   Focusing on risks over a product\'s life cycle from production to
    consumption;

-   Targeting resources to achieve greatest risk reduction;

-   Using interventions that address both food safety (unintentional
    contamination) and food defense (deliberate contamination); and

-   Using science and employing modern technology, including enhanced
    information technology systems.

**CONCLUSION**

Ensuring the safety of the food supply continues to be a top priority
for FDA and we are working hard to ensure the safety of all human food
and animal feed, in collaboration with our Federal, state, local, and
international food safety partners. FDA is working diligently to
efficiently and effectively use the resources and authorities provided
by Congress to protect the public health of the U.S. and to help ensure
that imported products are safe for American consumers. Despite the
challenges which face us, the American food supply continues to be among
the safest in the world. Thank you for the opportunity to provide
remarks to the Committee.