Seafood Safety: Background and Issues
Seafood Safety: Background and Issues
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science, and Industry Division
Harold F. Upton
Analyst in Natural Resources Policy
Resources, Science, and Industry Division
Summary
Although seafood consumption can contribute to a healthy diet, some fish and
shellfish can cause foodborne illnesses or contain environmental contaminants. Are
current food safety programs sufficiently protecting consumers, and if not, what changes
should be considered? A complexity is that most U.S. seafood consumption is fromth
imports. In the 110 Congress, the farm bill (P.L. 110-234) established new U.S.
Department of Agriculture (USDA) catfish inspection requirements. Elsewhere, a
Senate committee-approved bill (S. 2688) is intended to strengthen oversight of seafood
imports. Other pending bills include H.R. 3077 and S. 2914, also to improve seafood
import safety; and H.R. 5219, to increase funding for seafood inspections.
Seafood Safety Risks1
Studies and dietary recommendations have suggested that increased consumption of
seafood can contribute to a more healthful diet.2 Nonetheless, seafood consumption is not
without risk. Although hazards caused by microbes and naturally occurring toxins in
seafood have been well characterized, the public health burden has been difficult to
quantify or to assess over time due to data limitations. Foodborne illness data are prone
to under-reporting, and in many cases the cause of the illness (called the food vehicle)
may not be determined. The U.S. Centers for Disease Control and Prevention (CDC)
1 Sarah A. Lister, Specialist in Public Health and Epidemiology, CRS Domestic Social Policy
Division, contributed to this section of the report.
2 National Academy of Sciences (NAS), Institute of Medicine, Food and Nutrition Board,
Seafood Choices: Balancing Benefits and Risks, 2007. The U.S. Dietary Guidelines for
Americans, 2005, for example, cites limited evidence suggesting an association between
consumption of fatty acids in fish and reduced risks of mortality from cardiovascular disease for
the general population. Accessed at [http://www.health.gov/dietaryguidelines/default.htm].
published data for approximately 3,550 reported outbreaks of foodborne illness that
occurred during calendar years 2004 through 2006. A causative food vehicle was reported
for about 1,900 of the outbreaks. Of these, seafood (finfish or shellfish) was reported as
a vehicle in 310 (16% of the 1,900) outbreaks. In comparison, red meats were reported
in 325 (17%) outbreaks, and poultry in about 290 (15%).3 To put these data in context,
annual U.S. per capita consumption of seafood was about 16 pounds in 2005, compared
with 110 pounds for red meats and 74 pounds for poultry.4 However, an average outbreak
related to seafood consumption generally affects a smaller number of people (i.e., fewer
individual cases per outbreak).
Naturally occurring toxins were involved in more than half of all seafood-associated
outbreaks with known or suspected causes in 2004-2006. Such toxins are primarily
ciguatera, from certain tropical reef-dwelling finfish, and scombroid poisoning, which
develops in some species after harvest due to inadequate refrigeration. Other common
problems are norovirus, the bacterium Vibrio parahaemolyticus in raw shellfish, and
various other pathogens, such as Clostridium botulinum, in processed seafood products.
The Institute of Medicine (IOM) has cited other risks of consuming seafood: that of
high levels of chemical and heavy metal pollutants from the environment such as mercury,
lead, polychlorinated biphenyls (PCBs), and pesticides. Some of these problems, such as
high mercury levels, are more evident in carnivorous fish at the top of the food chain,
such as shark, swordfish, and bluefin tuna.5 But the IOM also has noted that it has been
difficult to quantify the risks of some of these hazards due to incomplete data, the
complexity of dietary and nondietary contaminant exposures, and the fact that certain
health effects such as cancer develop over a much longer period than microbial illnesses.6
Worldwide, one-third of all seafood now comes from aquaculture, as producers seek
to meet rising seafood demand at a time when wild stock production has leveled off at 90
to 95 million metric tons annually. Aquacultured (farm-raised) seafood also may contain
high levels of potentially harmful chemicals. This was illustrated on June 28, 2007, when
the Food and Drug Administration (FDA, in the U.S. Department of Health and Human
Services) issued an import alert on the “Detention Without Physical Examination” of all
aquacultured products of certain fish species from China. FDA said it issued the notice
after targeted sampling in the prior year “repeatedly found that farm-raised seafood
3 CRS analysis of CDC Summary Statistics for Foodborne Outbreaks, accessed January 2008 at
[http://www.cdc.gov/foodborneoutbreaks/outbreak_data.htm]. An outbreak is an incident
involving at least two persons (cases).
4 U.S. Department of Agriculture (USDA), Economic Research Service (ERS), Food Availability
(Per Capita) Data System, accessed at [http://www.ers.usda.gov/Data/FoodConsumption/]. See
also General Accounting Office (now Government Accountability Office, or GAO) report, Food
Safety: Federal Oversight of Seafood Does Not Sufficiently Protect Consumers (GAO-01-204),
January 2001.
5 In March 2004, FDA and the Environmental Protection Agency, for example, issued a joint
consumer advisory about mercury in fish and shellfish, directed at women who might become or
are pregnant, nursing mothers, and young children. Backgrounder for the 2004 FDA/EPA
Consumer Advisory: What You Need to Know About Mercury in Fish and Shellfish, accessed
January 29, 2008, at [http://www.fda.gov/oc/opacom/hottopics/mercury/backgrounder.html].
6 Seafood Choices: Balancing Benefits and Risks, 2007; and Seafood Safety, 1991, both National
Academy of Sciences, Institute of Medicine, Food and Nutrition Board.
imported from China were contaminated with antimicrobial agents that are not approved
for this use in the United States.”7
Increased imports, including from many other Asian countries in addition to China,
have complicated efforts to protect consumers from unsafe fish and shellfish. In 1995,
imports already constituted more than half of U.S. per-capita seafood consumption; by
2007 they reached 84%.8 By 2005, more than 150 countries were exporting seafood to
the United States, FDA observed.
Current Inspection Programs
FDA Safety Inspection. FDA has primary responsibility for the safety of all
domestic and imported foods, including seafood, under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended (21 U.S.C. Sec. 301 et seq.). Excepted are most
meat and poultry products, which the U.S. Department of Agriculture’s Food Safety and
Inspection Service (FSIS) inspects under other statutory authorities. The FFDCA requires
that all such foods be safe, wholesome, and accurately labeled. FDA-regulated foods may
be deemed adulterated or misbranded for a variety of statutorily prescribed reasons. FDA
also sets maximum safe levels of unavoidable toxic substances in foods, including fish,
and requires that all domestic and foreign food manufacturing facilities adhere to Good
Manufacturing Practices (GMPs; 21 C.F.R. Part 110), which address safe handling and
plant sanitation. Generally exempt are establishments such as farms, including fish farms,
that merely raise and/or harvest a raw commodity.
Seafood is one of the few FDA-regulated food groups further regulated under a
system of risk prevention controls known as HACCP, for Hazard Analysis and Critical
Control Points. Under HACCP, domestic processors are to prepare site- and product-
specific plans that analyze potential safety hazards, determine where they are likely to
occur during processing, identify control points and how they will be monitored, and
hazards controlled. Importers of foreign seafood must take steps to verify that the
products obtained from foreign processors are in compliance with the HACCP rules.9
As the 2001 GAO report (see footnote 4) noted, if a processor determines and FDA
inspectors agree that a particular product is of low risk, no plan is needed; therefore not
all firms necessarily will have a plan. Moreover, fishing vessels are exempt, unless they
do more than minimal processing. Following publication of its HACCP rule, FDA sought
to inspect all regulated seafood establishments to ensure that HACCP was being
7 FDA Import Alert #16-13, accessed January 23, 2008, at [http://www.fda.gov/ora//fiars/
ora_import_ia16131.html]. The fish species are catfish, basa (related to catfish), shrimp, dace
(related to carp), and eel. The banned agents are nitrofuran, malachite green, and gentian violet,
which have been found to be carcinogenic to laboratory animals; and fluoroquinolones, an
antibiotic whose use may lead to antibiotic resistance. Under the import alert, FDA detains all
covered products until the importer demonstrates, through independent testing, that a
representative sample of the product is free of these contaminants.
8 U.S. Department of Commerce, National Oceanic and Atmospheric Administration, Seafood
Consumption Declines Slightly in 2007, at [http://www.noaanews.noaa.gov/stories2008/
9 Seafood HACCP regulations (at 7 U.S.C. Part 123) were published in final form in the
December 18, 1995 Federal Register and became effective on December 18, 1997.
implemented, and to continue to visit each one annually. FDA has indicated that it is
inspecting higher-risk seafood firms annually and lower-risk firms every two to three
years.
The FFDCA empowers FDA to refuse entry to any food import if it “appears,” based
on a physical examination or otherwise, to be adulterated, misbranded, or in violation of
the law. In exercising its oversight, the agency relies on a system of bonding and of prior
notifications by importers and document reviews at points of entry (ports). From lists of
these entries, the agency selects products for physical examination and/or testing to
determine whether they contain adulterants. FDA inspected, or tested for contaminants,
less than 2% of an estimated 860,000 seafood shipments in 2006.10
Foreign seafood processors are subject to the same requirements, including HACCP,
as domestic firms, and the U.S. importers of their products must take “affirmative steps”
to help ensure that these requirements are being met. FDA conducts inspections to check
compliance of these importers and of selected foreign processors (for example, 72 in 10
countries in FY2005), focusing on those that are major exporters to the United States and
on developing countries less likely to have sophisticated safeguards.
FDA is exploring the potential use of third parties to certify foreign processors of
aquacultured shrimp for compliance with FDA’s seafood HACCP regulations. FDA has
developed a pilot program to collect information for evaluating third-party programs.
Phase I of the program will consist of screening requests from third-party certification
bodies (private, nongovernmental, other federal government, and state government) to
participate in the pilot. In Phase II, FDA will conduct onsite audits of programs by
accompanying inspectors during certification inspections. FDA intends to evaluate
potential use of the pilot program for augmenting agency efforts and for adjusting the
“may proceed” rate for imports of aquacultured shrimp or other food products.11
Shellfish Safety. Under provisions of the FFDCA and the Public Health Service
Act, FDA cooperates with 23 coastal shellfish-producing states and some foreign
countries in a National Shellfish Sanitation Program (NSSP) to promote the safe
production of fresh and frozen molluscan shellfish — oysters, clams, and mussels — for
human consumption.12 FDA works through the Interstate Shellfish Sanitation Conference
(ISSC), an organization of state shellfish regulators who in turn adopt state and local laws,
based on an NSSP “model ordinance,” to ensure that shellfish in their jurisdictions are
safe and sanitary. An objective of these laws is to ensure that products can be traced to
harvest waters that are safe. Generally, dealers must be listed with their state regulatory13
agency in order to ship shellfish products commercially.
10 Food and Water Watch, Import Alert: Government Fails Consumers, Falls Short on Seafood
Inspections, May 2007.
11 73 Fed. Reg. 39705-39708 (July 10, 2008).
12 FDA is authorized to accept assistance from state and local authorities and others in the
enforcement of its laws to assure food safety and to prevent the spread of communicable diseases,
at 21 U.S.C. 372 in the FFDCA, and 42 U.S.C. 243 in the Public Health Service Act, respectively.
13 See FDA, National Shellfish Sanitation Program, Guide for the Control of Molluscan Shellfish,
NOAA Voluntary Inspection. Within the Department of Commerce, the
National Oceanic and Atmospheric Administration (NOAA) administers a voluntary
seafood inspection program under authority of the Agricultural Marketing Act of 1946 (7
U.S.C. Sec. 1621 et seq.). The program offers additional levels and types of inspection
that exceed the FDA HACCP-based requirements, which program participants also must
meet. Examples include on-site NOAA inspections during production hours, certification
that plants or vessels meet specified sanitation requirements, quality inspections of
individual product lots, and/or laboratory testing of products, among other services.
These services are provided on a fee-for-service basis and entitle participants to use
various official grading and labeling marks, which are viewed as making their products
more attractive to buyers. In 2006, NOAA reported active Seafood Inspection Program
contracts with 377 firms, although the participant number changes constantly. The
additional number of foreign participants (currently more than 50) has increased recently
due to such firms’ desire to comply with requirements of the FDA import alert on
aquacultured products from China. The number of participating firms is a small fraction
of all seafood facilities, but they produce a significant portion of the total volume: in
2006, the NOAA voluntary program inspected 1.9 billion pounds or 33% of the total
seafood consumed in the United States.14
Selected Legislation in Congress
Until the mid-1990s through the 104th Congress, many seafood safety proposals
sought to put fish inspection on a par with that of meat and poultry. USDA’s FSIS is
required, under the Federal Meat Inspection Act (FMIA; 21 U.S.C. 601 et seq.) and the
Poultry Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.), to inspect all livestock and
poultry both before and after they are slaughtered, and to be present whenever plants are
processing meat and poultry products.15 Jurisdictional differences were among the
reasons previous bills were not enacted. USDA and the House and Senate Agriculture
Committees have long been responsible for meat and poultry inspection, while FDA, the
Senate Committee on Health, Education, Labor, and Pensions (HELP), and the House
Committee on Energy and Commerce have claimed jurisdiction over the safety of seafood
(and other foods). Others such as the Senate Committee on Commerce, Science, and
Transportation, also have had roles.
Seafood safety began to garner new attention in 2007, following a number of reports
of contaminated foods, some from foreign sources, entering the food supply. Numerous
congressional hearings and media reports in 2007 brought wider public recognition of the
role foreign producers now play in meeting U.S. demand for fish and shellfish.
Underlining this awareness was the issuance of the Food and Water Watch report in May
2007 FDA Legislation. Wide-ranging FDA legislation (P.L. 110-85) adopted in
2007 includes a provision (§1006) requiring a report to Congress in 2008 that describes
the specifics of the seafood inspection program, the feasibility of developing traceability
systems for catfish and seafood products to both foreign and domestic processing plants,
and an assessment of the risks associated with contaminants and banned substances. HHS
14 January 25, 2008, personal communication, Seafood Inspection Program, NOAA. Also see
NOAA, USDC Seafood Inspection Program, at [http://seafood.nmfs.noaa.gov/].
15 See CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.
also may enter into partnerships with states on inspection, under § 1006. Under §1007,
FDA must consult with NOAA on a report on environmental risks associated with
genetically engineered seafood products, including the impact on wild fish stocks.
110-234), with a section [§11016(b)] that newly designates “catfish,” as defined by the
Secretary of Agriculture, as an “amenable species” — that is, subject to mandatory
inspection under the FMIA. The amendment will apply to companies that process catfish
for food. It also directs USDA to “take into account the conditions under which the
catfish is raised and transported to a processing establishment,” and to consult with FDA.
The inspection provision reportedly was urged by the U.S. catfish industry, which has
faced strong competitive pressure from foreign catfish producers, particularly in Asia,
where, U.S. interests allege, unacceptable types and levels of veterinary drugs are more
frequently used. The conference report states the intent of Congress “that catfish be
subject to continuous inspection and that imported catfish inspection programs be found
to be equivalent under USDA regulations before foreign catfish may be imported into the
United States.” The report also noted that the Secretary already has authority under the
FMIA to mandate inspection for other seafood species if he deems it appropriate.
Also, §11016(a) amends the Agricultural Marketing Act of 1946 (7 U.S.C. 1622) to
require USDA to establish a voluntary grading program for catfish, which producers could
opt into and pay for with user fees (as exists in other USDA quality grading programs
authorized by the 1946 act). The section further authorizes producers of other farm-raised
fish and shellfish species to apply for voluntary grading services.
Other Bills. Several other bills are pending in the 110th Congress. The Senate
Commerce Committee marked up, on April 24, 2008, the Commercial Seafood Consumer
Protection Act (S. 2688). The committee-approved bill would require the HHS and
Commerce Departments to cooperate on examining and testing seafood imports;
coordinating inspections of foreign facilities; providing for expedited entry for those with
good safety records; increasing seafood testing laboratories; and conducting more
oversight of problem exporters and their countries, among other provisions. Other bills
include S. 2914, on actions to be taken when seafood imports are refused U.S. entry; H.R.
and H.R. 5219, to authorize appropriations of $6.75 million in FY2009 for implementing
an FDA seafood inspection regime. Some changes in seafood regulation might come
through broader legislative proposals to improve food safety policies; more than two
dozen such bills have been introduced.16
In November 2007, the Administration weighed in with its own options, in two
separate reports. Action Plan for Import Safety, prepared by the Interagency Working
Group on Import Safety, covers the safety of most imports. Food Protection Plan,
prepared by FDA, focuses on food, both imported and domestic. Both plans are oriented
toward assessing, prioritizing, and preventing risks — that is, a HACCP-like approach.17
16 Such non-farm bill proposals are discussed in other CRS reports; see “Food Safety and
Nutrition” under the “Agriculture” entry on the CRS home page, at [http://www.crs.gov/].
17 These plans are at, respectively, [http://www.importsafety.gov/report/actionplan.pdf], and
[http://www.fda.go v/ oc /initiatives/advance/food/plan.html ].