Journal of Food Protection 86 (2023) 100090

Contents lists available at ScienceDirect

Journal of Food Protection

journal homepage: www.elsevier.com/locate/jfp

Review

An Analysis of Seafood Recalls in the United States, 2002 Through 2022

Erika Rene Blickem 1, Jon W. Bell 2, Alexandra C.M. Oliveira 3, D. Mona Baumgartel 4,
John DeBeer 5,⇑
1
J. R. Simplot, Boise, Idaho, United States
2
NOAA Fisheries, National Seafood Laboratory, Pascagoula, Mississippi, United States
3
Chicken of the Sea International, 2150 E. Grand Ave, El Segundo, California, United States
4
1630 Burgundy Rd, Encinitas, California, United States
5
Chicken of the Sea International, United States

A R T I C L E I N F O A B S T R A C T

Keywords: This review analyzes the seafood recalls registered by the United States Food and Drug Administration
Allergens (USFDA) from October 2002 through March 2022. There were more than 2,400 recalls for seafood products
HACCP over this 20‐year period. Biological contamination was the listed root cause for about 40% of these recalls.
Listeria Almost half were designated as Class I recalls, due to the high risk of the recalled seafood to cause disease
Salmonella
or death. Independent of the recall classification, 74% of the recalls were due to violations of the Current
Seafood recalls
Good Manufacturing Practices (cGMPs) regulations. The most common cause for these seafood recalls was
due to undeclared allergens (34%). More than half of the undeclared allergen recalls were for undeclared milk
and eggs. Recalls for Listeria monocytogenes accounted for 30% of all recalls and were all Class I. Finfish com-
prised 70% of the recall incidents, and salmon was the single most recalled species (22%). Improper cold smok-
ing treatment that resulted in Listeria monocytogenes contamination was the most common reason reported for
the salmon recalls.
The goal of this review was to evaluate the main causes of food safety failures within the seafood manufac-
turing and distribution sectors. Human errors and failures to control food safety risks during the processing of
food are the main driving factors for most reported recalls in the U.S. Properly applying the Hazard Analysis
Critical Control Points (HACCP) approach and procedures are needed to identify the potential food safety risks.
The key to reducing the risks of human error and loss of process control is the development and implementa-
tion of an effective food safety culture program at the manufacturing facility, which must require strong senior
management support at corporate and enterprise levels.

Contents

Overview of the Seafood Sector. . . . . . . . . . . . . . . . . . . . . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Seafood Preparation and Preservation . . . . . . . . . . . . . . . . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Seafood Hazards from Harvest through Consumption . . . . . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Seafood Regulations in the USA . . . . . . . . . . . . . . . . . . . . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Seafood Recalls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
FDA Food Recall Database . . . . . . . . . . . . . . . . . . . . . . . . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Implementing a Food Safety Culture Program to Reduce Food Safety Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Demonstrated Management and Leadership Commitment. . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Employee Acceptance and Commitment to Food Safety . . . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Effective Employee Training Programs. . . . . . . . . . . . . . . . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Traceability and Recalls Preparedness . . . . . . . . . . . . . . . . . . ..... ..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

⇑ Corresponding author.
E-mail address: jdebeer2005@gmail.com (J. DeBeer).

https://doi.org/10.1016/j.jfp.2023.100090
Received 14 November 2022; Accepted 31 March 2023
Available online 5 April 2023
0362-028X/© 2023 The Author(s). Published by Elsevier Inc. on behalf of International Association for Food Protection.
This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Blickem, E.R. et al. Journal of Food Protection 86 (2023) 100090

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Declaration of Competing Interest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

This review is an analysis of seafood recalls based on the USFDA pia (1.1), Alaska pollack (0.9), cod (0.6), crab (0.5), catfish (0.5),
database of all food recalls from October 2002 through March 2022. Pangasius (0.4), and scallops (0.2) (National Fisheries Institute, 2019).
The USFDA is the federal agency with the authority to order a manda-
tory recall for a food item, as described by the Food Safety Moderniza-
Seafood Preparation and Preservation
tion Act of 2011 (FSMA) (U.S. Food and Drug Administration, 2017).
This analysis is limited to the recall of food products that are subject to
Seafood can be consumed raw as sushi or sashimi, cooked or
Seafood HACCP (Federal Register, 1995), including catfish species, up
grilled, canned, smoked, acidified, or used as an ingredient in soups,
to 2016. For example, if anchovies are used in salad dressings or bat-
salads, or sandwiches. Food preservation methods include smoking,
ter, the item is regulated by Seafood HACCP Regulation, and the
drying, freezing, holding at refrigeration temperatures below 4°C,
anchovies are included in this review. However, if the item is a batter
applying high pressure, reducing the water activity, retorting, acidify-
or seasoning used for seafood, but is not seafood itself, it is not
ing, using low water phase salt, or a combination of these methods
included in this analysis. A similar analysis for recalls of tuna products
(Amit et al, 2017). Seafood preservation techniques can be quite var-
in the U.S. was published in 2022 (Blickem et al., 2022).
ied and are mostly covered by the Seafood HACCP regulation. A list
The goal of evaluating food recalls is to understand food safety fail-
of preservation methods is presented by Amit et al., 2017.
ures with the view to providing safer preserved foods. In general, food
Acid foods are defined as foods with a natural pH of <4.6 and in
is preserved by controlling bacterial decomposition or other forms of
general are not regulated. Foods that are between a pH of 4.0 and
degradation by using applications of cold or freezing, heat, retorting
4.6 must be tested with a pH meter or potentiometer to verify the
or canning, pressure, acid, fermentation, or drying (Amit et al,
pH while foods below a pH of 4.0 can be tested with colorimetric
2017). Conducting these preservation techniques properly without
pH test strips, 21CFR§114 (Federal Register, 1979d).
subsequent contamination should produce food that is safe to con-
Acidified foods are subject to the federal regulations 21CFR§114
sume. If control of these processes is compromised, pathogenic bacte-
(Federal Register, 1979d) and 21CFR§108.25 (Federal Register,
ria may grow or toxins may form, and the food may become rendered
1979a). Acidified foods have a pH reduced to less than 4.6 and a water
unsafe. Other forms of food safety failures may occur from cross‐
activity (Aw) of >0.85. Additionally, acidified foods may need to be
contact of unintended ingredients or components such as allergens
subject to additional preservation methods such as pasteurization or
or vegetative bacteria.
refrigeration, among others. From 21CFR§114 (Federal Register,
Following Good Manufacturing Practices (GMPs) for general clean-
1979d), “Acidified foods shall be thermally processed to an extent that
liness and sanitation control is required in a food processing plant, and
is sufficient to destroy the vegetative cells of microorganisms of public
records must be kept of the procedures for preservation and sanitation.
health significance and those of nonhealth significance but capable of
For example, the presence of undeclared allergens resulting from
reproducing in the food under the conditions in which the food is
cross‐contact may cause illness to sensitive individuals. Such food
stored, distributed, retailed, and held by the user. Permitted preserva-
safety control failures present risks to public health, are prohibited
tives may be used to inhibit reproduction of microorganisms of non-
by law, and may result in the recall of these unsafe products.
health significance (in lieu of thermal processing).” The scheduled
process for an acidified food must be established by a competent pro-
cess authority, 21CFR§114 (Federal Register, 1979d).
Overview of the Seafood Sector Dried seafood is generally characterized as having a water activity
(Aw) of less than 0.85. Salting and other methods can also be used to
The seafood sector in the U. S. economy comprises a broad range of lower the Aw (Oregon State, 2002). Examples include salt cod (ba-
species and products supported by a complex supply chain. Over 90% calao), dried shrimp, stock fish, salmon jerky, and octopus’ chips
of the seafood consumed in the U.S. is imported from more than 150 (Oregon State, 2002).
other countries (Johnson‐Weider, 2017; Shamshak et al., 2019). The Fermented foods are the result of undergoing a microbial process
majority of this seafood is imported from China, Thailand, Canada, which permanently transforms the seafood product. A good example
Indonesia, Vietnam, and Ecuador (National Oceanic and of a fermented food is canned anchovies which are fermented in salt
Atmospheric Administration, 2023). Examples of this seafood include for several months prior to canning without vacuum sealing or retort-
many finfish species (both bony and cartilaginous), and shellfish such ing (Alfonzo et al., 2018). Consumption of fermented seafood products
as oysters, clams, shrimp, lobster, crayfish, squid, abalone, and octo- dates back centuries and has continued popularity in Southeast Asian
pus. Additional examples of seafood include other animals that live countries (Narzary et al., 2021).
either in fresh or saltwater, such as alligators, frogs, sea cucumbers, Low-acid canned foods (LACFs) are defined as foods with a pH of
and aquatic turtles, as long as they are legal to harvest and sell into >4.6 and a water activity of >0.85 and are regulated by
interstate commerce. The product safety of all seafood, except for Sil- 21CFR§113 (Federal Register, 1979c) and 21CFR§108 (Federal
uriformes (catfish family), is regulated by the USFDA (Sea Grant, Register, 1979a). LACF must have a scheduled heating process, estab-
Delaware, 2020; U.S. Department of Agriculture, 2020). The product lished by a competent process authority, 21CFR§113 (Federal Register,
safety of Siluriformes has been regulated by the United States Depart- 1979c), that is sufficient to kill Clostridium botulinum spores. The pro-
ment of Agriculture (USDA) since 2016 (Federal Register, 2015a). duct in the center of the container must be heated to an F0 of at least
Seafood is an important part of the American diet, and seafood con- 3.0 (121°C for 3 min or equivalent) to destroy the C. botulinum spores.
sumption in 2019 was estimated at 19 lb per capita (National Fisheries LACFs are very tightly regulated with formal rules for process times,
Institute, 2019). The top ten seafood species with the annual consump- container closure regulations, record keeping, and for periodic inspec-
tion in pounds are shrimp (5.0), salmon (2.8), canned tuna (2.6), tila- tions of the seals of containers and temperatures of the retorts. Each

2
Blickem, E.R. et al.
facility processing LACF must be registered with the USFDA, and the
scheduled heating process filed with USFDA (Federal Register, 1979c).
Seafood Hazards from Harvest through Consumption
Seafood being processed and prepared from harvest to consump-
tion can be compromised in several ways. The seafood can be unsafe
to consume from physical (foreign material or filth), chemical, and
biological contamination, or hazards, or by being prepared by incorpo-
rating allergenic ingredients, either voluntarily or not, and not prop-
erly labeling the item.
Foreign Material. The USFDA’s Seafood HACCP Guidance (U.S.
Food and Drug Administration, 2021b) and CPG Sec. 555.425 (U.S.
Food and Drug Administration, 2005d) defines foreign material adul-
teration as a hard or sharp foreign object 7 mm to 25 mm (∼ 1/4 in
– 1 in) in length, especially when the food is ready to eat, or has only
minimal preparation steps, i.e., heating (U.S. Food and Drug
Administration, 2005d). Food containing such foreign objects is con-
sidered adulterated with these criteria by 21 U.S.C. 342 (a)(1). This
adulteration can occur naturally during harvest of the seafood from
metal contamination in the fish holds or baskets or during processing
from metal shavings such as welding slag and other metal fragments.
Filth in harvested seafood would also be classed as foreign material.
Chemical contamination. Seafood can be contaminated with pes-
ticides or aquaculture drugs used to enhance growth or prevent dis-
ease. Some chemicals or animal drugs are completely prohibited,
and others have a maximum safety level for use (U.S. Food and Drug
Administration, 2021c, Table A‐5).
Seafood Decomposition. Product degradation can be caused by
many processes as follows: autolysis, oxidative rancidity, viral contam-
ination, bacterial growth, or bacterial enterotoxin‐formation. Spoilage
bacteria can cause the decomposition of seafood and result in off‐
odors, off‐flavors, off‐colors, product spoilage, and formation of bio-
genic amines. All of these forms of decomposition result in human
health concerns.
The growth of pathogenic bacteria can also contaminate seafoods
and may produce food safety hazards. Pathogens of concern in seafood
include Listeria monocytogenes, Salmonella serotypes, Shigella spp., and
E. coli. Bacteria such as Morganella morganii, Hafnia alvei, Klebsiella
spp., (which are histamine‐forming bacteria), Bacillus cereus, Staphylo-
coccus aureus, and others can produce toxins that are heat stable (U.S.
Food and Drug Administration, 2021c). The 2021 Seafood HACCP
Guidance, Appendix 7 (U.S. Food and Drug Administration, 2021c),
lists the following bacterial and viral pathogens of greatest concern
in seafood processing: Bacillus cereus, Campylobacter jejuni, Clostridium
botulinum, Clostridium perfringens, Escherichia coli, Hepatitis A virus,
Listeria monocytogenes, norovirus (also known as Norwalk‐like virus),
Salmonella spp., Shigella spp., S. aureus, Vibrio cholerae O1 and O139,
and non‐O1 and non‐O139, Vibrio parahaemolyticus, Vibrio vulnificus,
and Yersinia enterocolitica. Bacteria such as C. botulinum, S. aureus,
and B. cereus can produce toxins which can be deadly. Seafood decom-
position and its many forms are presented in multiple publications and
reviews (Cliver, 1994; Gecan et al.,1994; Mol & Coşansu, 2022; Self
et al., 2021; U.S. Food and Drug Administration, 2012; Wang et al.,
2022).
In relation to seafood decomposition, the USFDA publishes an
index of Compliance Policy Guides (CPGs) (U.S. Food and Drug
Administration, 2018b) that cover seafood decomposition and adulter-
ation. These include the following: CPG 540.250, Paralytic Shellfish
Poison (U.S. Food and Drug Administration, 2005a); CPG 540.275,
Crabmeat, Filth, E. coli (U.S. Food and Drug Administration, 2016);
CPG 540.370, Fish and Fishery Products, Decomposition (U.S. Food
and Drug Administration, 2009); CPG 540.525, Decomposition and
Histamine, Tuna, and other fish (U.S. Food and Drug Administration,
2021b); CPG 540.590, Adulteration by parasites (U.S. Food and
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Journal of Food Protection 86 (2023) 100090
Drug Administration, 2005b); and CPG 540.650, Salt‐Cured, Air‐
Dried, Uneviscerated Fish (U.S. Food and Drug Administration,
2005c).
Microbiological Contamination. Seafood products can also serve
as a vehicle for transferring virus contamination. The food handlers
can provide a warm‐blooded host for the reproduction of these viruses
and the transfer to, or contamination of, the seafood. These viruses
include Hepatitis A (Fiore, 2004; Food Safety News, 2021; Lemon
et al., 2018) and norovirus (Norwalk) (Bernard et al., 2014; Boxman
et al., 2009; de Graaf et al., 2016; Shaw, 2016; Virginia Department
of Health, 2018). A vaccine exists for Hepatitis A, but there is no vac-
cine for norovirus to date (Centers for Disease Control and Prevention,
2022).
Some pathogens may not cause food decomposition but cause the
food to be adulterated and present a food safety hazard, e.g., the pres-
ence of bacteria or viruses will not always result in physical decompo-
sition of the food. In most cases, bacterial pathogens and/or viruses are
completely undetectable by organoleptic evaluation. The presence of
such organisms can only be detected by microbial analysis or resulting
illness outbreaks, substantiating their classification as food adulterants
under Section 402 of the Federal Food, Drug, and Cosmetic Act, 1938.
Control and destruction of these pathogens must be accounted for by
HACCP food safety risk evaluations and appropriate controls during
processing before shipping the products into interstate commerce.
Tetrodotoxin is a potent natural neurotoxin produced by marine
bacteria that has historically been associated with pufferfish in Japan.
Tetrodotoxin has also been reported in the Mediterranean Sea as well
as the Pacific Ocean (Lago et al., 2015).
Vibrio cholerae, Vibrio parahaemolyticus, and Vibrio vulnificus are
bacteria that are found in salt water. Infections caused by these bacte-
ria, and vibriosis can occur from consuming raw or undercooked sea-
food or exposing a flesh wound to sea water containing high levels of
these Vibrio spp. (Center for Disease Control and Prevention, 2019;
Daniels et al., 2000; Freitas et al., 2020; Hernández‐Cabanyero &
Amaro, 2020; Letchumanan et al., 2014; Love et al., 2019; Pérez‐
Reytor et al., 2018; Strom & Paranjpye, 2000; Twedt et al., 1970; U.
S. Food and Drug Administration, 2005e; Wright et al., 2015; Yeung
& Boor, 2004). Various algal species can produce toxins which accu-
mulate in various shellfish and other seafood species and can cause
a variety of adverse human health conditions including severe gas-
trointestinal distress and even death (Onofrio et al., 2021; Twiner
et al., 2008). Some of these toxins are phytotoxins (saxitoxins and their
congeners) which cause paralytic shellfish poisoning (PSP) in humans
(Trainer et al., 2014). Amnesic shellfish poisoning is caused by domoic
acid produced by diatoms of the genus Pseudo‐nitzchia (Washington
State Department of Health, 2018).
Seafood Allergens. The USFDA broadly defines a food allergy as
the adverse human health effect arising from a specific immune
response that occurs reproducibly on exposure to a given food. A
food allergen is the food or its component(s), often a protein or
peptide that elicits specific immunologic reactions. Adverse reac-
tions to food due to food hypersensitivity can be broadly grouped
into reactions that are mediated by either immune mechanisms
(food allergic reactions) or nonimmune mechanisms (primarily food
intolerances). The Food Allergen Labeling and Consumer Protection
Act of 2004 (U.S. Congress, 2004) lists milk, eggs, fish, crustacean
shellfish, tree nuts, peanuts, wheat, and soybeans as major food
allergens. In 2021, sesame was added to the list, so there are
now nine major allergens (U.S. Congress, 2021). A food is mis-
branded if it contains a major food allergen and fails to declare that
major food allergen on its product label. The label must state the
major food allergen’s common or usual name and also include the
name of the food source from which the major food allergen is
derived (U.S. Food and Drug Administration, 2022a). Undeclared
allergens have been a leading cause of food recalls in recent years
(Food Industry Association, 2020).
Blickem, E.R. et al.
Seafood Regulations in the USA
All seafood that is produced, manufactured, cooked, canned, trans-
ported and/or imported into the United States is regulated by the Fish
and Fishery HACCP regulation, 21CFR§123, promulgated in 1995 and
implemented in 1997 (Federal Register, 1995). Any seafood that is
produced in and/or imported into the U.S. without a HACCP plan is
considered adulterated, 21CFR§123.6(g) (Federal Food, Drug, and
Cosmetic Act, 1938; Federal Register, 1995). The large number of sea-
food species and products and the diversity of seafood safety hazards
amplify the potential opportunities for food safety failures. Not surpris-
ingly, the USFDA selected the seafood industry as the first application
of the HACCP regulations for enforcing these food safety principles
(Penn State Extension, 2020).
The U.S. National Shellfish Sanitation Program (NSSP) (2020), has
a Model Ordinance that provides readily adoptable standards and
administrative practices necessary for the sanitary control of mollus-
can shellfish such as oysters, clams, mussels, and scallops. The NSSP
addresses molluscan shellfish that are raw (live, fresh, or fresh frozen)
and subjected to postharvest processing (PHP).
The Food Safety Modernization Act (FSMA) is an overarching law
that covers all food regulated by the USFDA. Seafood is excluded from
portions of the FSMA regulation only when preexisting regulations are
already in place. For example, Seafood HACCP preempts FSMA’s
Preventive Controls Rule, while seafood products are subject to
FSMA’s Sanitary Transport Rule and Intentional Adulteration Rule,
among other rules (U.S. Food and Drug Administration, 2017).
The processing parameters for seafood products are subject to the
current Good Manufacturing Practices (cGMPs) regulations
21CFR§110 (Federal Register, 1979b) and 21CFR§117 (Federal Regis-
ter, 2015b) and may also be subject to LACF regulations in 21CFR§108
(Federal Register, 1979a) and 21CFR§113 (Federal Register, 1979c) or
the Acidified Foods regulation 21CFR§114 (Federal Register, 1979d).
The labels for ingredients and allergens on seafood products must com-
ply with Food Labeling regulations, 21CFR§101.4 (Federal Register,
1977), cGMPs, 21CFR§117, (Federal Register, 2015b), and the Food
Allergen Labeling Act (U.S. Congress. 2004). Water used for processing
foods must comply with drinking water regulations from the Environ-
mental Protection Agency (EPA) section 40CFR§141 (Federal Register,
1975). Sanitary transport of foods (including seafood) is subject to the
Public Law Sanitary Food Transportation Act of 2005 (U.S. Congress,
2005) and 21CFR§1 Subpart O (Federal Register, 2010, 2016). The
sanitary control of molluscan shellfish is covered by NSSP (National
Shellfish Sanitation Program, 2020; U.S. Food and Drug
Administration, 2021d). Most of the recalls of seafood have occurred
due to violations of one or more of these Acts and regulations.
Seafood Recalls
U.S. food recall regulations classify recalls as Class I, II, or III based
on 21CFR§7.40 and 21CFR§7.3 (U.S. Food and Drug Administration,
2021a). Each recall has a classification assigned to it by the USFDA
based on these criteria:
(i) Class I: reasonable probability that the use of, or exposure to, a
violative food product will cause serious adverse health conse-
quences or death.
(ii) Class II: use of, or exposure to, a violative food product may
cause temporary or medically reversible adverse health conse-
quences or where the probability of serious adverse health con-
sequences is remote.
(iii) Class III: use of, or exposure to, a violative food product is not
likely to cause adverse health consequences.
4
Journal of Food Protection 86 (2023) 100090
In the U.S., food recalls can be mandatory or voluntary. The USFDA
received the authority for requiring mandatory recalls with the pas-
sage of the Food Safety and Modernization Act (FSMA) of 2011(U.S.
Food and Drug Administration, 2017). However, the USFDA prefers
that the companies themselves issue voluntary recalls. There has only
been one mandatory recall enforced by the USFDA since the Agency
received this authority in 2011 (Kaur & Ellison, 2018). Another two
were ordered but quickly became voluntary recalls (U.S. Food and
Drug Administration, 2018a).
In 2007, the USFDA Amendments Act created the Reportable Food
Registry (RFR). This registry is an electronic portal that allows manu-
facturers, processors, packers, and warehouses to report any food that
has been released for public distribution and may pose a serious health
risk (U.S. Food and Drug Administration, 2010). The RFR became the
official method of notification to the USFDA by the food industry con-
cerning Class I recalls in 2009. By law, any potential Class I recall must
be submitted to the RFR. When a food‐handling company is unsure of
the recall classification and the requirement to submit a report to the
RFR, their local USFDA Recall Coordinator will provide this
information.
FDA Food Recall Database
Since October 2002, the USFDA has maintained a recall database
for all recalled items (food, animal food, drugs, equipment, etc.) under
their regulatory responsibility. This recall information is available
through a Freedom of Information Act (FOI) request. Each data item
has an event number and a recall number (incident). The event num-
ber enumerates the overall or master recall, while the recall number
enumerates the individual product or products. This system means that
a recall event number can represent multiple individual product recall
numbers associated with it.
An FOI request for all food recalls from October 2002 through
March 2022 generated over 14,000 recall numbers for separate inci-
dents or product codes. Of these 14,000+ recall numbers, 2,462 were
for seafood products that were part of 911 recall events. Each recall
number or item includes many details, such as class of recall, product
description, reason for the recall, name of establishment, etc. These
seafood recall data were then identified by seafood species, prepara-
tion type, preservation type, overall cause, and specific reason for
the recall. Each recall number was assigned with both the cause and
probable regulation that was violated. The data were sorted, grouped,
and analyzed using Microsoft Excel.
The 2,462 seafood recalls that occurred over the 20‐year period
were reviewed and aggregated in many ways: focusing on the major
seafood types and major preservation methods and the stated and root
causes. Further analysis evaluated the reasons or causes for the recalls
for the most cited seafood groups such as salmon, tuna, and shrimp, as
well as identifying the species groups associated with most of the root
causes for the recalls.
First, the seafood types were identified by phylum or class for each
recall where possible. However, some of the seafoods recalled were
listed only as seafood, shellfish, sashimi, surimi, etc., so that a phylum
identification could not be made. Crustacea and finfish were not sub-
divided further, but the phylum Mollusca was further identified by
class including Bivalvia (has two shells), Cephalopoda (has tentacles),
or Gastropoda (single coiled shell). Table 1 shows the number of
recalls by recall classification and seafood phylum or type of seafood.
Items unidentified by phylum or class are simply denoted by their
recall description.
Table 2 identifies recalls by type of product preservation and shows
the class of recall associated with each type of preservation. The type
of preservation was not always known, and a best estimate decision
was made for the preservation from the name and/or style of product.
Blickem, E.R. et al. Journal of Food Protection 86 (2023) 100090

Table 1
Seafood recalls by phylum or class and classification of the recall

Seafood Types Class I Class II Class III Grand Total %

Finfish 848 767 114 1729 70%

Crustacea 167 239 28 434 18%
Mollusca – Bivalvia 14 100 40 154 6%
Mollusca - Cephalopoda 15 27 2 44 2%
Mollusca - Gastropoda 1 2 0 3
Shellfish 5 3 0 8
Seafood 40 13 1 54 2%
Surimi 9 13 0 22 1%
Sushi 3 9 0 12
Seaweed 0 1 1 2
Grand Total 1102 1174 186 2462

Table 2
Classification of seafood recalls associated with the type of preservation

Preservation Class I Class II Class III Grand Total %

Refrigeration 815 648 122 1585 64%

Frozen 204 292 14 510 21%
Retorted 9 118 23 150 6%
Dried 49 39 15 103 4%
Acidified 29 45 1 75 3%
Salted 32 4 0 36 1%
Baked 0 2 0 2
Tablets 0 1 0 1
Grand Total 1138 1149 175 2462

The data set was sorted by reason for each recall and classification
with as much granularity as possible from the information available.
The recall reasons and classifications are presented in Table 3.
The major cause of the recall, e.g., biological contamination, is
shown in Table 4. For example, L. monocytogenes, Salmonella spp.,
and other bacterial or viral contaminants were grouped as biological
contamination. Additionally, the cause of undeclared ingredients
includes undeclared allergens, mislabeled, and “not gluten free.” The
information in Table 4 was then grouped into phylum/class groupings
and is presented in Table 5. The top 20 types of seafood items recalled
are shown in Table 6. Recalls of finfish comprised 13 of the top 20
recall incidents.
Figure 1 displays the number of recalls per year. There was a dra-
matic spike in seafood recalls in 2017. In that year, three recall events
resulted in 269 recall incidents out of a total of 417, almost two‐thirds
of the total recall numbers. These recalls were all for undeclared milk,
a potential allergen, in the seafood products. It appears from the
record, that a common seafood breading base had undeclared milk
as an undeclared ingredient. From the record, the recalled items were
breaded fish sticks, scallops, breaded seafood portions, and more, thus
a common mislabeled ingredient caused numerous individual recalls.
The CFR regulations that were violated are displayed in Table 7.
The cGMP violations produced by far the largest percentage of the
recalls, almost three-quarters of the total (74%). Recalls for undeclared
allergens are displayed in Table 8. The most common reason for sea-
food recalls was undeclared allergens, comprising fully one‐third of
all seafood recalls (see Table 3). Undeclared milk and/or eggs
accounted for more than half of this group of recalls. As previously
mentioned, in 2017 alone, there were 297 recalls for undeclared milk,
so the occurrence of undeclared milk allergen in a seafood product was
skewed by these three recall events. This result is a good example of
how a few events can impact the overall recall picture.
Recalls for the most common biological contaminants L. monocyto-
genes and Salmonella spp. were subdivided by preservation process.
This information is displayed in Tables 9 and 10. In Table 9, for L.
monocytogenes, only the top 30 species groups are displayed. The most
common species recalled for L. monocytogenes contamination were
refrigerated salmon and tuna. For Salmonella spp., Table 10, frozen
shrimp and tuna were the most common seafood types. The only
retorted tuna item recalled for Salmonella spp. was part of a retorted
tuna product kit where another food in the kit was contaminated with
Salmonella spp.
The recalls for potential C. botulinum are displayed in Table 11.
These are grouped by primary reason and preservation mechanism
and further organized by phylum and/or class. Finfish items were
responsible for the largest numbers of recalls for C. botulinum recalled,
by far. Some of the seafood items were retorted tuna, while others
were refrigerated fresh fish or uneviscerated fish larger than 5 inches
(U.S. Food and Drug Administration, 2005c).
Salmon, tuna, and shrimp preparations comprised the three most
common types of seafood recalls (Table 6). The reasons for these
recalls are listed in Table 12. Accounting for 24%, salmon species
had the highest number of seafood recalls. The types of salmon prepa-
rations recalled are listed in Table 13. L. monocytogenes accounted for
almost 70% of salmon recalls, and the smoking process was the most
common type of preparation. Over a quarter of the smoked salmon
recalls reported the type of smoking: 80% of these were cold smoked,
and L. monocytogenes accounted for 85% of these smoked salmon
recalls (Data not shown). Since cold smoking does not provide a kill‐
step for L. monocytogenes, the control of these pathogens during the
manufacturing of cold‐smoked salmon relies on strict adherence to
sanitation, cGMPs, and workers’ training and training programs.
Tuna species had the second most recalls at 12% (Table 6). Biolog-
ical contamination accounted for over half of the tuna recalls, which
were primarily due to L. monocytogenes. The third most common spe-
cies grouping was shrimp with 10% of the recalls, and of these, 35%
were due to biological contamination. One distinction of the shrimp
group was that over half of these recalls were for undeclared allergens,
which was higher than any other species group.
Seafood products are perishable and easily contaminated, thus fre-
quently recalled for many reasons. Many of these recalls were caused
by human errors and/or the failure to properly execute HACCP time‐
and‐temperature control procedures. Properly applying the seafood
HACCP approach and process, as well as complying with other appro-

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Blickem, E.R. et al. Journal of Food Protection 86 (2023) 100090

Table 3
Reasons for the seafood recalls and recall classification

Stated reason for the recall Class I Class II Class III Grand Total %

Undeclared allergen 328 450 73 851 35%

Listeria monocytogenes 652 87 739 30%
Potential C. botulinum 92 135 227 9%
Salmonella 48 40 88 4%
Histamine 71 1 72 3%
Filth 52 18 70 3%
Time/Temperature abuse 1 39 1 41 2%
Incomplete seal 31 31 1%
Foreign material 26 26 1%
Mislabeled 3 11 7 21
Rodent activity 19 19
Mislabeled as Octopus 18 18
Did not meet HACCP requirements 18 18
Escherichia coli 14 3 17
Metal fragments 13 1 14
Norovirus 8 6 14
Improper acidification 13 13
Decomposition 6 6 12
Plastic 12 12
Inadequate HACCP plan 11 11
Pesticide residue 11 11
No scheduled process 10 10
cGMPs 9 9
Polluted waters 5 3 8
Nitrofurans 2 6 8
Pathogens 7 7
Underprocessed 4 3 7
Glass 3 3 6
Hepatitis A 6 6
Unsanitary conditions 6 6
Low water phase salt 4 2 6
Chloramphenicol 6 6
Not gluten free 1 5 6
Refrigeration Issues 5 5
Enrofloxacin 4 4
Mislabeled as cooked 4 4
Possible Contamination 4 4
Malachite green 4 4
Inadequate thermal treatment 3 3
Mold 1 2 3
Seams contain lead 2 2
No HACCP plan 2 2
Bloated pouches 2 2
Perfluorooctanoic acid 2 2
Azaspiracid toxin 2 2
Vibrio parahaemolyticus 1 1
Fluoroquinolone 1 1
High water activity 1 1
Swollen cans 1 1
Sanitation issues 1 1
Tetrodotoxin 1 1
Violated consent decree 1 1
Illness compliant 1 1
Petroleum 1 1
Gram-positive bacteria 1 1
Inadequate brine reports 1 1
Unknown 1 1
Sulfadiazine. 1 1
Diesel odor 1 1
No HACCP records 1 1
Grand Total 1138 1149 175 2462

priate regulations, can identify the food safety risks that must be con-
trolled to produce a safe seafood product. These actions and focus are
necessary regardless of the type of seafood, preservation method, or
style of preparation. The majority of the recalls evaluated in this study
have resulted from failure to control a specific process step such as
heating, cooling, packaging, labeling, shipment, or storage. Very few
of the recalls resulted from nonprocessing hazards, such as the natural
seafood toxins in filter‐feeding mollusks that resulted from failures in
harvest strategy. Regarding process control failures, Dr. Pflug, 2010
stated “efforts in C. botulinum control should be concentrated on
reducing human errors in the delivery of the specified heat process
to containers of food.” Retorting produces millions of safe, heat-stable
food products on a daily basis but only if the procedures and controls
are followed correctly. Other processes are safe as well if the proce-
dures and controls are followed correctly. Reducing human error is
critical to preventing almost all of these reported seafood recalls enu-
merated and discussed here.
Violations of the cGMPs and HACCP regulations accounted for 95%
of the recalls. Undeclared allergens accounted for almost 35% of the
total. Undeclared allergens are generally a concomitant of labeling

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Blickem, E.R. et al. Journal of Food Protection 86 (2023) 100090

Table 4
Root cause for seafood recalls (grouped) and classification

Root Cause Class I Class II Class III Grand Total %

Biological contamination 707 239 18 964 39%

Undeclared Ingredient 331 465 79 875 36%
Under processed 96 167 4 267 11%
cGMPs 1 114 42 157 6%
Foreign material 0 54 4 58 2%
Chemical contamination 2 14 23 39 2%
HACCP 0 33 0 33 1%
Incomplete seal 0 31 0 31 1%
Mislabeled 1 19 5 25 1%
Refrigeration issues 0 6 0 6
Sanitary transport 0 4 0 4
Unlabeled and unfrozen 0 2 0 2
Unknown 0 1 0 1
Grand Total 1138 1149 175 2462

Table 5
Cause of seafood recalls by phylum or seafood group

Stated Cause Crustacea Finfish Mollusca - Mollusca - Mollusca - Seafood Seaweed Shellfish Surimi Sushi Grand %
Bivalvia Cephalopoda Gastropoda Total

Biological 144 734 32 6 1 30 15 2 964 39%

contamination
Undeclared 203 599 20 18 2 14 2 8 2 7 875 36%
Ingredient
Under processed 19 233 11 3 1 267 11%
cGMPs 25 41 84 1 2 1 3 157 6%
Foreign material 24 26 1 4 3 58 2%
Chemical 11 28 39 2%
contamination
HACCP 1 30 1 1 33 1%
Incomplete seal 28 3 31 1%
Mislabeled 2 2 3 18 25 1%
Refrigeration 1 5 6
issues
Sanitary transport 4 4
Unlabeled and 2 2
unfrozen
Unknown 1 1
434 1729 154 44 3 54 2 8 22 12 2462

Table 6
Top 20 Seafood names recalled by recall classification

Seafood Name Class I Class II Class III Grand Total %

Salmon 361 186 11 558 23%

Tuna 139 145 10 294 12%
Shrimp 85 134 19 238 10%
Crab 56 67 8 131 5%
Fish 67 49 7 123 5%
Oysters 69 28 97 4%
Herring 75 13 3 91 4%
Anchovies 38 51 89 4%
Pollock 5 72 10 87 4%
Cod 9 59 16 84 3%
Seafood 34 16 1 51 2%
Lobster 22 24 1 47 2%
Trout 20 16 1 37 2%
Tilapia 2 28 5 35 1%
Clams 7 23 4 34 1%
Whitefish 26 6 2 34 1%
Squid 9 22 31 1%
Haddock 5 16 6 27 1%
Flounder 4 15 8 27 1%
Mackerel 17 6 23 1%

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Blickem, E.R. et al. Journal of Food Protection 86 (2023) 100090

Figure 1. Count of seafood recalls by year by reason

Table 7
Regulations violated

Regulations Not Observed Class I Class II Class III Grand Total % Comments

21CFR§117 1024 676 112 1812 74% cGMPs

21CFR§123 107 344 60 511 21% HACCP
21CFR§113 3 97 1 101 4% LACF
21CFR§114 2 28 0 30 1% Acidified foods
21CFR§1 Part O 0 4 0 4 Sanitary transportation
21CFR§189 2 0 0 2 Lead in cans
40CFR§141 0 0 2 2 Chemical contamination
Grand Total 1138 1149 175 2462

errors or from an inadvertent ingredient being added during produc-
tion of the food. Recalls for the presence of L. monocytogenes accounted
for 30% of the seafood recalls. L. monocytogenes is a biological hazard
for fresh or refrigerated seafood and indicates there was a lack of san-
itation or sanitary controls resulting from human error. A proper ther-
mal process step will kill the L. monocytogenes in cooked or retorted
products. The potential presence of C. botulinum accounted for 9% of
the seafood recalls. Products improperly held under refrigeration and
nonretorted products accounted for 45% of these C. botulinum recalls.
Implementing a Food Safety Culture Program to Reduce Food
Safety Risks
The primary purpose of this analysis enumerating and grouping
these seafood recalls is to develop control strategies and practices to
reduce the number of these recalls. The common cause for almost all
of these recalls is human error. Mislabeling of allergens, improper san-
itation to control bacterial vegetative cells, insufficient refrigeration
during distribution, improper storage and other failures are examples
of basic human error. Improved tracing technology is important for
diminishing the impacts of these recalls. Reducing human error is of
critical importance to reduce the causes of seafood recalls and the
food safety hazards.
Human error is invariably the underlying factor in the loss of pro-
duct and process controls that result in a seafood recall, and a formid-
able method for preventing this loss of control is through the
development and implementation of a robust Food Safety Culture
(FSC). A strong FSC can both help reduce the risk of failures and
improve the response to a recall and control of products when failures
do occur. Both are needed to ensure safe food products. There are
many resources on how to develop and implement an FSC. Frank Yian-
nis’ book on FSC is an excellent resource (Yiannas, 2009). Food safety
culture, as such, may be a relatively new concept but recognition of the
importance of company culture has long been a tenet of effective busi-
ness practices, especially in terms of employee safety.
In 1988, safety culture was identified as a principal method to
ensure the safety of nuclear power plants (International Nuclear
Safety Advisory Group, 1988). Safety culture was defined as “the per-
sonal dedication and accountability of all individuals engaged in any
activity which has a bearing on the safety of nuclear power plants”
(International Nuclear Safety Advisory Group, 1988). Similarly, Dr.
Yiannis, 2009 defines FSC as “how an organization or group does food
safety.” An organization needs to create an environment of dedication
and accountability at all levels within the organization to ensure a
robust food safety culture. Three intertwined elements are needed:
demonstrated management/leadership commitment, employee adop-
tion and implementation, and effective training and retraining based
on experience and observations of the process.
Demonstrated Management and Leadership Commitment
The most critical component of a mature and successful food safety
culture is demonstrated management and leadership commitment.
Leaders, especially founding leaders, heavily influence the culture of
organizations, whether they do so intentionally or not (Schein,
2016). Constant focus and emphasis by leadership will define what
is valuable to an organization. Schein, 2016 found that “it is the con-
sistency that is important, not the intensity of the attention.” One‐time
outbursts in response to a food safety failure will have less impact than
daily and repeated activities which are focused on food safety. A con-

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Table 8 sistent leadership focus is needed to ensure that the food safety culture
Seafood recalls for undeclared allergens is valued by the organization and made part of the organization’s cul-
Undeclared Allergen Total % ture. The attitudes, decisions, and actions of leaders directly impact
how employees view the importance of food safety to their jobs and
Undeclared milk 373 44%
the business, and these attitudes will filter down from the top
Undeclared egg 96 11%
Undeclared wheat 71 8% (Yiannas, 2009).
Undeclared soy 66 8% Organization leaders can also help establish employee engagement
Undeclared anchovy 62 7% in food safety by frequently sharing information and focusing on iden-
Undeclared mayonnaise 30 4% tified food safety risks. Leaders should clearly and consistently share
Undeclared sulfites 26 3%
Undeclared color additives 16 2%
the reasons for food safety procedures and practices to enable the
Undeclared egg and wheat. 13 2% understanding and importance of the employee actions. Leaders
Undeclared allergens 12 1% should instill a company‐wide awareness that each employee plays
Undeclared Yellow #5 11 1% an important role in the manufacturing of safe food. Leaders must also
Undeclared peanut 11 1%
actively seek employee feedback and insights on the effectiveness of
Undeclared krill 8
Undeclared shrimp 8 food safety practices. Engaged employees will be empowered to pro-
Undeclared milk and egg 8 vide this feedback on what does and does not work well to control food
Undeclared tree nuts 6 safety. Leaders should seek and consider these opinions to prove to
Undeclared shellfish (crab) 6 employees that their ideas are valued, even if they are not always
Undeclared cod and lobster. 5
implemented.
Undeclared fish 4
Missing specific fish 3 Food safety training must be routinely provided and reinforced by
Undeclared fish (gelatin) 3 leaders to prevent indifference and emphasize the adoption of a food
Undeclared coconut 2 safety focus. Leaders should also be consistent when addressing food
Undeclared wheat and fish 1
safety incidents and base their decisions on the safety of the food
Undeclared crustaceans 1
Undeclared fish & soy 1 and its impact on consumers when food safety incidents occur. In con-
Undeclared sodium bisulfite. 1 trast, an FSC is immediately undermined if the leadership makes deci-
Undeclared shellfish 1 sions without considering food safety.
Undeclared albacore 1 Adoption of successful practices from other industries can provide a
Undeclared Swai fish 1
great benefit. In the health care industry, a culture of safety for
Undeclared sodium metabisulfite 1
Undeclared himego fish 1 employees, patients, and families also contains principles appropriate
Undeclared salmon 1 for food safety culture development (American College of Healthcare
Undeclared seafood 1 Executives, 2017). The concept of ensuring employee and patient
Grand Total 851
safety is no different than ensuring the safety of food.

Table 9
Seafood recalls for Listeria monocytogenes (top 30)

Listeria monocytogenes Refrigeration Frozen Salted Dried Grand Total %

Salmon 329 58 1 388 53%

Tuna 71 3 74 10%
Herring 36 11 47 6%
Shrimp 35 1 36 5%
Crab 25 7 1 33 4%
Seafood 26 26 4%
Trout 19 19 3%
Lobster 4 14 18 2%
Whitefish 16 16 2%
Imitation Crab 10 10 1%
Tilapia 4 1 5 1%
Mussels 3 2 5 1%
Mackerel 4 1 5
Sablefish 3 1 4
Sea Bass 3 3
Flounder 3 3
Fish 3 3
Turbot 3 3
Squid 1 1 2
Snapper 2 2
Capelin 2 2
Chubs 2 2
Sprats 1 1 2
Cod 2 2
Sushi 2 2
Haddock 1 1 2
Tuna & Salmon 2 2
Bronzini 1 1
Amberjack 1 1
Catfish 1 1

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Blickem, E.R. et al. Journal of Food Protection 86 (2023) 100090

Table 10
Seafood recalls for Salmonella spp.

Salmonella Frozen Refrigeration Dried Retorted Acidified Grand Total %

Shrimp 35 3 1 39 44%
Tuna 17 6 1 24 27%
Clams 1 1 3 5 6%
Seafood 4 4 5%
Anchovies 2 1 3 3%
Crab 1 1 2 2%
Salmon 2 2 2%
Threadfin 1 1 1%
Fish 1 1 1%
Carica soborna 1 1 1%
Catfish 1 1 1%
Snapper 1 1 1%
Mystus cavasius 1 1 1%
Featherback 1 1 1%
Pomfret 1 1 1%
Mixed Fish 1 1 1%
Grand Total 58 20 8 1 1 88

Table 11
Seafood recalls for potential Clostridium botulinum by cause by preservation methods

Potential C. botulinum Crustacea Finfish Mollusca - Bivalvia Seafood Grand Total %

Under processed
Refrigeration 10 80 7 1 98 43%
Retorted 1 52 1 54 24%
Frozen 1 25 26 11%
Dried 25 25 11%
Salted 17 17 7%
Acidified 1 1 2 1%
Unlabeled and unfrozen
Refrigeration 2 2 1%
Refrigeration issues
Refrigeration 1 1 2 1%
HACCP
Refrigeration 1 1
Grand Total 14 204 8 1 227

Employee Acceptance and Commitment to Food Safety
Employee awareness and commitment to food safety is also a key to
a successful food safety culture program. Employees are commonly
referred to as the first line of defense in food safety because the
production‐line employees are the people working directly with the
food produced daily during operations, and they are most‐likely to
encounter unsafe food when a food safety incident occurs, and before
the food product leaves the food manufacturing facility.
Empowering employees and connecting them with organizational
goals to help create a positive organizational culture was identified
by Deloitte Insights, 2021, as an important trend that helps thriving
organizations. Food producers must create a connection between their
employees, the safety of the food they produce, and the employees’
responsibility to protect consumers of their food products. Meeting
employees’ needs for empowerment and providing their jobs with pur-
pose is the key to making this connection. Without the support and
commitment of employees, improvements in food safety systems are
unlikely to be successful.
Effective Employee Training Programs
Another important component for developing and implementing an
effective FSC and awareness program is employee training. Well‐
developed training programs rely on clearly defined job functions
and the type of performance expected from the employees in these
jobs. Employee training is an intrinsic requirement of many USFDA
regulations and guidance documents including Seafood HACCP, LACF,
and FSMA (U.S. Food and Drug Administration, 2017; U.S. Food and
Drug Administration, 2020; U.S. Food and Drug Administration,
2021c). Policies and procedures based on the food safety regulations
mentioned above provide the direction for change, but the actual
implementation is dependent on leadership support and employee
adoption. Developing a robust food‐safety‐awareness training program
will help ensure companies comply with these regulations and, most
importantly, prevent food safety incidents.
Food safety training must communicate “real risks with real conse-
quences” (Yiannas, 2009). Companies need to connect company prac-
tices for the level of food safety risks to their real consumers’
experience that consume the manufactured food that has been pro-
duced. Companies cannot assume employees will make these connec-
tions on their own. Employee training must include various food‐
safety‐related subjects: food safety culture, basic and advanced food
handling, cleanup and sanitation, time‐and‐temperature abuse, and
the use of checklists for each of these processes (Gawande, 2010).
Every position in a seafood manufacturing facility should have a job
description and job task analysis including written standard operating
procedures (SOPs) and sanitation SOPs. Food safety training must be
part of each employee’s initial orientation and followed up by frequent
refresher and annual training activities. Well‐thought‐out and well‐
written procedures are not effective when they are not successfully

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Table 12
Reason for the recall – Salmon, Shrimp, and Tuna

Stated Reason & Root Cause Salmon Shrimp Tuna Grand Total

Biological Contamination 393 85 168 646

Listeria monocytogenes 388 36 74 498
Salmonella spp. 2 39 24 65
Elevated histamine levels 58 58
Escherichia coli 8 8
Decomposition 1 5 6
Hepatitis A virus 5 5
Pathogens 2 1 3
Temperature not recorded 1 1
Vibrio parahaemolyticus 1 1
Mold 1 1
cGMPs 8 4 12
Time/Temp abuse 4 3 7
Unsanitary conditions 2 2
Rodent activity 1 1
Petroleum 1 1
Refrigeration Issues 1 1
Chemical contamination 4 5 7 16
Pesticide residue 3 2 6 11
Nitrofurans 3 3
Seams contain lead 1 1
Perfluorooctanoic acid 1 1
Foreign material 4 18 6 28
Foreign material 11 1 12
Metal fragments 3 4 5 12
Glass 3 3
Wood Pieces 1 1
HACCP 7 1 8
Did not meet HACCP requirements 5 5
Inadequate HACCP plan 2 2
No HACCP plan 1 1
Incomplete Seal 8 18 26
Loose seals 8 8 16
Pouch seals 9 9
Leaking seals 1 1
Mislabeled 1 2 3
Mislabeled 1 2 3
Refrigeration issues 1 1
Unfrozen vacuum packaging 1 1
Undeclared Ingredient 61 121 61 243
Undeclared milk 18 23 11 52
Undeclared soy 22 5 7 34
Undeclared egg 4 19 5 28
Undeclared wheat 12 8 5 25
Undeclared sulfites 21 21
Undeclared mayonnaise 1 2 17 20
Undeclared color additives 10 2 12
Undeclared shrimp 7 1 8
Undeclared egg and wheat 8 8
Undeclared krill 7 7
Undeclared peanut 6 6
Undeclared cod and lobster. 5 5
Undeclared Yellow #5 1 1 2 4
Undeclared coconut 1 1 2
Undeclared allergens 2 2
Undeclared salmon 1 1
Undeclared fish 1 1
Undeclared wheat and fish 1 1
Undeclared tree nuts 1 1
Undeclared albacore 1 1
Undeclared sodium bisulfite 1 1
Undeclared sodium metabisulfite 1 1
Mislabeled 1 1
Undeclared milk and egg 1 1
Under processed 71 3 32 106
No registered process 31 16 47
Smoked, vacuum packaging 16 16
Undercooked 7 7 14
Improper acidification 3 7 10
Low water phase salt 6 6
Under processed 2 2
Microbial activity 2 2
Under processed and no records 1 1 2
No HACCP plan 1 1

(continued on next page)

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Blickem, E.R. et al. Journal of Food Protection 86 (2023) 100090

Table 12 (continued)
Stated Reason & Root Cause Salmon Shrimp Tuna Grand Total

Swollen cans 1 1
Not labeled properly 1 1
Inadequate brine reports 1 1
Water activity too high 1 1
No scheduled process 1 1
No state license 1 1
Unknown 1 1
Unknown 1 1
Grand Total 558 238 294 1090

food producers, as well as further processors using seafood as an ingre-

Table 13
dient in other foods, will need to comply with the rule.
Salmon recalls – by type of preparation
Competency in traceability means that individual companies are
Type of preparation Count required to ensure that they can trace their products quickly, effec-
Smoked 310 tively, and accurately from raw materials and packaging to their cus-
Sushi 116 tomers. The USFDA has issued the New Era of Smarter Food Safety
Fillets 30 Low‐ or No‐Cost Tech‐enabled Traceability Challenge that are “afford-
Canned & pouch 23
able, create shared value, and can be scaled to encourage widespread
Raw loins & sashimi 22
Dinner & lunch box 11 adoption” for primary producers, importers, manufacturers/proces-
Burgers & cakes 11 sors, distributors, and retailers and foodservice (U.S. Food and Drug
Stuffed, various 7 Administration, 2021e).
Grilled 4 Food companies must review the food traceability proposed rule to
Kippered & salted 4
Rolls, various 5
understand the USFDA’s expectations and to compare them with the
Smoked spread & dip 3 capability of their current traceability system. Each company must rou-
Seared 2 tinely and frequently stress test their traceability system using exer-
Salad 2 cises and mock recalls. The results of each traceability exercise or
Sandwich & Lox 2
mock recall must be reviewed with the food manufacturing facility
Jerky 1
Bites 1 leadership and the entire traceability team. Employees must under-
Gutted 1 stand potential issues or time delays to be able to address or mitigate
Medallions 1 problems before an actual food recall event occurs. Establishing trace-
Chowder 1 ability as a priority and communicating mock recall results to key staff
Marinated 1
will help establish traceability as part of FSC and will improve
Grand Total 558
responses to food safety incidents and actual recall events.
Seafood processing takes special care because seafoods are highly
perishable, lose freshness quickly, and can be easily contaminated so
implemented and adopted by everyone. Flow charts and checklists for clean working surfaces and proper handling are required at all times.
process steps are powerful tools to ensure that specific steps are com- Seafoods are highly diverse (no consistent size, shape, skin, etc.) so
pleted and controlled before other steps are started (Gawande, 2010). there is no single handling and processing technique available. All
cleaning, filleting, packaging, heating, and chilling processes require
Traceability and Recalls Preparedness attention to detail. It is no wonder that are many processing failures
leading to recalls. That is why we think a solution should be to develop
Food safety culture is focused on the prevention of hazards as a strong food safety culture centered on involving leaders and workers
required by LACF, HACCP, and FSMA processes. Leadership support, to make a safe seafood product.
employee engagement, and training programs are all necessary to pre-
vent these failures and rapidly identify any food safety failures before
food products are shipped and distributed. Responding quickly and Conclusions
effectively to food safety failures when they occur can prevent recalls
and further risk to consumers. In the science fiction story of “Dune,” the author Frank Herbert,
The USFDA’s New Era of Smarter Food Safety Blueprint outlines 1965 wrote: “One does not obtain food‐safety‐freedom by instinct alone.”
what the USFDA considers the most important aspects of food‐safety‐ Developing a food safety culture requires constant effort and hard
control procedures: technology‐enabled traceability, improved tools work. A successful FSC involves consistent planning, risk analysis
and approaches for prevention and outbreak response, new business and mitigation, training in all areas, traceable records, and an in‐
models and retail modernization, and food safety culture (U.S. Food depth review of successes and failures. For example, a successful
and Drug Administration, 2021e). In response to the need for approach involves maintaining a record of food recalls and the after‐
improved traceability in the food supply chain, the USFDA has issued action reports, as well as internal records and reviews of the near
the rule “Requirements for Additional Traceability Records for Certain misses that do not require formal recalls. Both sets of records are very
Foods” (U.S. Food and Drug Administration, 2022b). The purpose of valuable for conducting risk assessments and providing appropriate
this rule is to “help the USFDA rapidly and effectively identify recipi- prevention procedures.
ents of these higher risk foods to prevent or mitigate foodborne illness An FSC requires lasting commitment from all areas of the organiza-
outbreaks and address credible threats of serious adverse health conse- tion, driven by leadership, buy‐in by employees, and development of
quences or death.” This rule includes finfish, crustaceans, mollusks, training programs on HACCP, food safety, and traceability. Compli-
and bivalves in the Food Traceability List, meaning that primary sea- ance requires following cGMPs for cleaning and sanitation and routine

12
Blickem, E.R. et al.
self‐audits and includes hand washing, boot cleaning, clean smocks,
clean utensils and equipment, and creating a clean environment
including the floors, walls, and drains. Maintaining food safety
requires management reviews of cGMP audits and of sanitation check-
lists. “Never trust your memory more than a checklist (Wilson, 2022).”
An FSC is a learned set of functions involving the commitment of
leadership, the engagement of employees, and implementation and
reinforcement of training programs. Developing an FSC is a team
effort, and its success requires everyone’s involvement and emphasis.
The reasons for seafood recalls are varied; however, a well-imple-
mented FSC provides seafood companies the ability to control poten-
tial food safety failures, whatever the cause, and proactively
eliminate or reduce costly recalls of their products. A successful FSC
offers a seafood company the strong foundation required to prevent
or correct the loss of process control, and to develop procedures to pre-
vent food safety hazards that result in regulatory violative product
recalls.
Declaration of Competing Interest
The authors declare that they have no known competing financial
interests or personal relationships that could have appeared to influ-
ence the work reported in this paper.
Acknowledgments
The authors have worked in many parts of the seafood sector for
many years. This experience includes leading or serving on teams that
conducted seafood recalls and participated in the postrecall self‐
evaluations and risk analysis. They declare no conflicts of interest.
There was no funding agency. The authors contributed equally to this
manuscript. The authors wish to thank the administrators of the
USFDA recalls database and the individuals who provided the raw data
for the recalls. The Agency responses to our requests were always
prompt. The authors wish to thank the reviewers for the very valuable
comments and ideas to improve the manuscript.
References
Alfonzo, A., Gaglio, R., Francesca, N., Barbera, M., Saiano, F., Santulli, A., Matraxia, M.,
Rallo, F., & Moschetti, G. (2018). Influence of salt of different origin on the
microbiological characteristics, histamine generation and volatile profile of salted
anchovies (Engraulis encrasicolus L.). Food Control, 92, 301–311. https://doi.org/
10.1016/j.foodcont.2018.05.003.
American College of Healthcare Executives. (2017). Leading a Culture of Safety: A
Blueprint for Success. Retrieved from: https://www.osha.gov/sites/default/files/
Leading_a_Culture_of_Safety-A_Blueprint_for_Success.pdf Accessed September 26,
2022
Amit, S. K., Uddin, M., Rahman, R., Islam, S. M., & Khan, M. S. (2017). A review on
mechanisms and commercial aspects of food preservation and processing.
Agriculture & Food Security, 6(1), 1–22. https://doi.org/10.1186/s40066-017-
0130-8.
Bernard, H., Höhne, M., Niendorf, S., Altmann, D., & Stark, K. (2014). Epidemiology of
norovirus gastroenteritis in Germany 2001–2009: Eight seasons of routine
surveillance. Epidemiology & Infection, 142(1), 63–74. https://doi.org/10.1017/
S0950268813000435.
Blickem, E. R., Bell, J. W., Baumgartel, D. M., & DeBeer, J. (2022). An analysis of tuna
recalls in the United States, 2002 through 2020. Journal of Food Protection, 85(1),
60–72. https://doi.org/10.4315/JFP-21-254.
Boxman, I., Dijkman, R., Verhoef, L., Maat, A., Van Dijk, G., Vennema, H., & Koopmans,
M. (2009). Norovirus on swabs taken from hands illustrate route of transmission: A
case study. Journal of Food Protection, 72(8), 1753–1755. https://doi.org/10.4315/
0362-028X-72.8.1753.
Center for Disease Control and Prevention. (2019). Vibrio Species Causing Vibriosis.
Retrieved from: https://www.cdc.gov/vibrio/index.html Accessed April 9, 2022.
Centers for Disease Control and Prevention. (2022). Vaccines by Disease. Retrieved
from: https://www.cdc.gov/vaccines/vpd/vaccines-diseases.html Accessed March
26, 2022.
Cliver, D. O. (1994). Viral foodborne disease agents of concern. Journal of Food
Protection, 57(2), 176–178. https://doi.org/10.4315/0362-028X-57.2.176.
Daniels, N. A., Ray, B., Easton, A., Marano, N., Kahn, E., McShan, A. L., II, ... Angulo, F. J.
(2000). Emergence of a new Vibrio parahaemolyticus serotype in raw oysters: A
prevention quandary. Journal of the American Medical Association, 284(12),
1541–1545. https://doi.org/10.1001/jama.284.12.1541.
13
Journal of Food Protection 86 (2023) 100090
de Graaf, M., van Beek, J., & Koopmans, M. P. (2016). Human norovirus transmission
and evolution in a changing world. Nature Reviews Microbiology, 14(7), 421–433.
https://doi.org/10.1038/nrmicro.2016.48.
Deloitte Insights. (2021). The Social Enterprise In A World Disrupted. Deloitte Global
Human Capital Trends. Retrieved from: https://www2.deloitte.com/content/dam/
insights/us/articles/6935_2021-HC-Trends/di_human-capital-trends.pdf Accessed
September 30, 2022.
Federal Food, Drug, and Cosmetic Act. (1938). 21 U.S.C.§342 Adulterated Food. Sec.
402(a)(4). Retrieved from: https://www.govinfo.gov/content/pkg/COMPS-973/
pdf/COMPS-973.pdf Accessed October 1, 2022
Federal Register. (1975). 40CFR§141. National Interim Primary Drinking Water
Regulations. Fed. Regist.40:59566. Retrieved from: https://www.loc.gov/item/
fr040248/ Accessed October 1, 2022.
Federal Register. (1977). 21CFR§101.4. Food Labeling, Food; designation of
ingredients. Fed. Regist. 42:14310. Retrieved from: https://www.loc.gov/item/
fr042050/ Accessed May 27, 2021.
Federal Register. (1979a). 21CFR§108. Emergency Permit Control-Final Rule. Fed.
Regist. 44:16204. Retrieved from: https://www.loc.gov/item/fr044053/ Accessed
May 8, 2021.
Federal Register. (1979b). 21CFR§110. Current Good Manufacturing in Manufacturing,
Processing, Packing or Holding Human Food. Proposal. Fed. Regist. 44:33238.
Retrieved from: https://www.loc.gov/item/fr044112/ Accessed May 14, 2021.
Federal Register. (1979c). 21CFR§113. Thermally processed low-acid foods packaged in
hermetically sealed containers -Final Rule. Fed. Regist. 44:16215. Retrieved from:
https://www.loc.gov/item/fr044053/ Accessed May 8, 2021.
Federal Register. (1979d). 21CFR§114. Acidified Foods. Fed. Regist. 44:16235.
Retrieved from: https://www.loc.gov/item/fr044053/ Accessed March 25, 2021.
Federal Register. (1995). 21CFR§123. Fish and fishery products. (HACCP). Fed. Regist.
60:65197. Retrieved from: https://www.govinfo.gov/content/pkg/FR-1995-12-18/
pdf/95-30332.pdf Accessed March 25, 2021.
Federal Register. (2010). 21CFR Part 1. Implementation of Sanitary Food Transportation
Act of 2005. Fed. Regist. 75:22713. Retrieved from: https://
www.govinfo.gov/content/pkg/FR-2010-04-30/pdf/2010-10078.pdf Accessed
May 31, 2021.
Federal Register. (2015a). 9CFR§300, 441, 530. Mandatory Inspection of Fish of the
Order Siluriformes and Products. Fed. Regist. 80:75590-75630. Retrieved from:
https://www.govinfo.gov/content/pkg/FR-2015-12-02/pdf/2015-29793.pdf
Accessed July 1, 2022.
Federal Register. (2015b). 21CFR§117. Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Human Food (cGMPs). Fed. Regist.
80:56145. Retrieved from: https://www.federalregister.gov/documents/2015/09/
17/2015-21920/current-good-manufacturing-practice-hazard-analysis-and-risk-
based-preventive-controls-for-human Accessed May 25, 2021.
Federal Register. (2016). 21CFR§1 & 11, Subpart O. Sanitary Transportation of Human
and Animal Food. Final Rule. Fed. Regist. 81:20092. Retrieved from: https://
www.govinfo.gov/content/pkg/FR-2016-04-06/pdf/2016-07330.pdf Accessed May
31, 2021.
Fiore, A. E. (2004). Hepatitis A transmitted by food. Clinical Infectious Diseases, 38(5),
705–715. https://doi.org/10.1086/381671.
Food Industry Association. (2020). Undeclared Allergens Continue to be the Leading
Cause of U.S. Food Recalls. Retrieved from: https://www.fmi.org/blog/view/fmi-
blog/2020/11/19/2020-undeclared-allergens-continue-to-be-the-leading-cause-of-
u.s.-food-recalls#:~:text=For%20many%20years%20now%2C%20undeclared,by%
20undeclared%20or%20misbranded%20allergens. Accessed March 25, 2022.
Food Safety News. (2021). Publisher’s Platform: Starbucks. Retrieved from: https://
www.foodsafetynews.com/2021/11/publishers-platform-starbucks-offer-hepatitis-
a-vaccinations-to-all-present-and-future-employees-and-i-will-agree-to-consult-
with-you-for-1-00-and-conflict-marler-clark-from-being-on-the/?utm_source=Food
+Safety+News&utm_campaign=f3fb443ba3-RSS_EMAIL_CAMPAIGN&utm_
medium=email&utm_term=0_f46cc10150-f3fb443ba3-40293183 Accessed
November 20, 2021.
Freitas, C., Glatter, T., & Ringgaard, S. (2020). The release of a distinct cell type from
swarm colonies facilitates dissemination of Vibrio parahaemolyticus in the
environment. ISME Journal, 14(1), 230–244. https://doi.org/10.1038/s41396-
019-0521-x.
Gawande, A. (2010). The Checklist Manifesto: How to get things right. New York: Picador.
Gecan, J. S., Bandler, R., & Staruszkiewicz, W. F. (1994). Fresh and Frozen Shrimp: A
Profile of Filth, Microbiological Contamination, and Decomposition. Journal of Food
Protection, 57(2), 154–158. https://doi.org/10.4315/0362-028X-57.2.154.
Herbert, F. (1965). DUNE. Philadelphia: Chilton Book Company.
Hernández-Cabanyero, C., & Amaro, C. (2020). Phylogeny and life cycle of the zoonotic
pathogen Vibrio vulnificus. Environmental Microbiology, 22(10), 4133–4148. https://
doi.org/10.1111/1462-2920.15137.
International Nuclear Safety Advisory Group. (1988). Basic safety principles for nuclear
power plants (Safety Series No. 75. INSAG–3). London, England: Her Majesty’s
Stationery Office. Retrieved from: https://www.nrc.gov/docs/ML0906/
ML090650543.pdf Accessed September 27, 2022.
Johnson-Weider, M. (2017). Muddying the Waters: Catfish Inspection Authority
Transitions to the Food Safety and Inspection Service. Journal of Food Law &
Policy, 13(2). Retrieved from: https://scholarworks.uark.edu/jflp/vol13/iss2/8
Accessed 8 July 2021. 8.
Kaur, G & Ellison, J. P. (2018). FDA Issues First Mandatory Recall order, Exercising
FSMA Authority Over Food Products Containing Kratom. Retrieved from: https://
www.thefdalawblog.com/2018/04/fda-issues-first-mandatory-recall-order-
exercising-fsma-authority-over-food-products-containing-kratom/ Accessed March
15, 2022.
Blickem, E.R. et al.
Lago, J., Rodríguez, L. P., Blanco, L., Vieites, J. M., & Cabado, A. G. (2015).
Tetrodotoxin, an extremely potent marine neurotoxin: Distribution, toxicity,
origin, and therapeutical uses. Marine Drugs, 13(10), 6384–6406. https://doi.org/
10.3390/md13106384.
Lemon, S. M., Ott, J. J., Van Damme, P., & Shouval, D. (2018). Type A viral hepatitis: A
summary and update on the molecular virology, epidemiology, pathogenesis, and
prevention. Journal of Hepatology, 68(1), 167–184. https://doi.org/10.1016/j.
jhep.2017.08.034.
Letchumanan, V., Chan, K. G., & Lee, L. H. (2014). Vibrio parahaemolyticus: A review on
the pathogenesis, prevalence, and advance molecular identification techniques.
Frontiers in Microbiology, 5, 1–13. https://doi.org/10.3389/fmicb.2014.00705.
Love, D. C., Lane, R. M., Davis, B. J., Clancy, K., Fry, J. P., Harding, J., & Hudson, B.
(2019). Performance of cold chains for Chesapeake Bay farmed oysters and modeled
growth of Vibrio parahaemolyticus. Journal of Food Protection, 82(1), 168–178.
https://doi.org/10.4315/0362-028X.JFP-18-044.
Mol, S., & Coşansu, S. (2022). Seafood safety, potential hazards, and future perspective.
Turkish Journal of Fish and Aquatic Sciences, 22(6). https://doi.org/10.4194/
TRJFAS20533.
Narzary, Y., Das, S., Goyal, A. K., Lam, S. S., Sarma, H., & Sharma, D. (2021). Fermented
fish products in South and Southeast Asian cuisine: Indigenous technology
processes, nutrient composition, and cultural significance. Journal of Ethnic Foods,
8(1), 1–19. https://doi.org/10.1186/s42779-021-00109-0.
National Fisheries Institute. (2019). NFI’s Annual Top 10 List. Retrieved from: https://
aboutseafood.com/press_release/top-10-list-offers-a-look-back-in-time/ Accessed
September 29, 2022.
National Oceanic and Atmospheric Administration. (2023). Global Wild Fisheries.
Retrieved from: https://www.fishwatch.gov/sustainable-seafood/the-global-picture
Accessed February 22, 2023.
National Shellfish Sanitation Program (NSSP). (2020). Guide for the Control of
Molluscan Shellfish (2019 Revision). Retrieved from: https://www.
fda.gov/media/143238/download Accessed 2 October 2021
Onofrio, M. D., Egerton, T. A., Reece, K. S., Pease, S. K., Sanderson, M. P., Jones, W., III,
Yeargan, E., Roach, A., DeMent, C., Wood, A., Reay, W. G., Place, A. R., & Smith, J.
L. (2021). Spatiotemporal distribution of phycotoxins and their co-occurrence
within nearshore waters. Harmful Algae, 103. https://doi.org/10.1016/j.
hal.2021.101993 101993.
Oregon State. (2002). Compendium Of Fish And Fishery Product Processes, Hazards,
And Controls. Chapter 4: Dried Fish and Fishery Products. Retrieved from: https://
seafood.oregonstate.edu/sites/agscid7/files/snic/compendium/chapter-4-dried-
fish.pdf Accessed March 28, 2023.
Penn State Extension. (2020). Understanding FSMA: HACCP, HARPC and the Preventive
Controls for Human Food Rule. Retrieved from: https://extension.psu.edu/
understanding-fsma-haccp-harpc-and-the-preventive-controls-for-human-food-rule.
Accessed July 8, 2021.
Pérez-Reytor, D., Jaña, V., Pavez, L., Navarrete, P., & García, K. (2018). Accessory toxins
of Vibrio pathogens and their role in epithelial disruption during infection. Frontiers
in Microbiology, 9, 2248. https://doi.org/10.3389/fmicb.2018.022.
Pflug, I. J. (2010). Science, practice, and human errors in controlling Clostridium
botulinum in heat-preserved food in hermetic containers. Journal of Food Protection,
73, 993–1002. https://doi.org/10.4315/0362-028X-73.5.993.
Schein, E. H. (2016). Organizational Culture and Leadership. Jossey-Bass, ISBN-10,
1119212049.
Sea Grant, Delaware. (2020). Seafood Regulatory Oversight. Retrieved from: https://
www.seafoodhealthfacts.org/printpdf/sustainability-regulations/seafood-
regulatory-oversight Accessed September 26, 2022.
Self, R. L., McLendon, M. G., Lock, M. C., & Hu, J. (2021). Analysis of decomposition in
23 seafood products by liquid chromatography with high-resolution mass
spectrometry with sensory-driven modeling. Food Science & Nutrition, 9(5),
2658–2667. https://doi.org/10.1002/fsn3.2223.
Shamshak, G. L., Anderson, J. L., Asche, F., Garlock, T., & Love, D. C. (2019). US seafood
consumption. Journal of the World Aquaculture Society, 50(4), 715–727. https://doi.
org/10.1111/jwas.12619.
Shaw, F. L. (2016). Norovirus isn’t rocket science: Wash your freakin’ hands. Retrieved
from: https://www.foodsafetynews.com/2016/10/norovirus-isnt-rocket-science-
wash-your-freakin-hands/ Accessed September 26, 2022.
Strom, M. S., & Paranjpye, R. N. (2000). Epidemiology and pathogenesis of Vibrio
vulnificus. Microbes and Infection, 2(2), 177–188. https://doi.org/10.1016/S1286-
4579(00)00270-7.
Trainer, V. L., Sullivan, K., Le Eberhart, B. T., Shuler, A., Hignutt, E., Kiser, J., Eckert, G.
L., Shumway, S. E., & Morton, S. L. (2014). Enhancing shellfish safety in Alaska
through monitoring of harmful algae and their toxins. Journal of Shellfish Research,
33(2), 531–539. https://doi.org/10.2983/035.033.0222.
Twedt, R. M., Novelli, R. E., Spaulding, P. L., & Hall, H. E. (1970). Comparative
hemolytic activity of Vibrio parahaemolyticus and related vibrios. Infection and
Immunity, 1(4), 394–399. https://doi.org/10.1128/iai.1.4.394-399.1970.
Twiner, M. J., Rehmann, N., Hess, P., & Doucette, G. J. (2008). Azaspiracid shellfish
poisoning: A review on the chemistry, ecology, and toxicology with an emphasis on
human health impacts. Marine Drugs, 6(2), 39–72. https://doi.org/10.3390/
md6020039.
U.S. Congress. (2004). Food Allergen Labeling and Consumer Protection Act of 2004,
Public Law 108–282. Retrieved from: https://www.fda.gov/media/
77570/download Accessed September 26, 2022.
U.S. Congress. (2005). Sanitary Food Transportation Act of 2005. Public Law 109-59,
Stat. 1911. Retrieved from: https://www.govinfo.gov/content/pkg/PLAW-
109publ59/pdf/PLAW-109publ59.pdf Accessed September 26, 2022.
14
Journal of Food Protection 86 (2023) 100090
U.S. Congress. (2021). Food Allergen Safety, Treatment, Education and Research of
2021, Public Law 117–11. Retrieved from: https://www.congress.gov/117/plaws/
publ11/PLAW-117publ11.pdf. Accessed September 26, 2022
U.S. Department of Agriculture. (2020). Inspection of Siluriformes. Retrieved from:
https://www.fsis.usda.gov/inspection/inspection-programs/inspection-
siluriformes Accessed September 26, 2022.
U.S. Food and Drug Administration. (2005a). CPG Sec 540.250 Clams, Mussels, Oysters,
Fresh, Frozen or Canned - Paralytic Shellfish Poison. Retrieved from: https://www.
fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-540250-
clams-mussels-oysters-fresh-frozen-or-canned-paralytic-shellfish-poison Accessed
September 26, 2022.
U.S. Food and Drug Administration. (2005b). CPG Sec 540.590 Fish - Fresh and Frozen,
as Listed - Adulteration by Parasites. Retrieved from: https://www.fda.gov/
regulatory-information/search-fda-guidance-documents/cpg-sec-540590-fish-fresh-
and-frozen-listed-adulteration-parasites Accessed 26 September 2022.
U.S. Food and Drug Administration. (2005c). CPG Sec 540.650 Uneviscerated Fish
Products that are Salt-cured, Dried, or Smoked (Revised). Retrieved from: https://
www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-
540650-uneviscerated-fish-products-are-salt-cured-dried-or-smoked-revised
Accessed September 26, 2022.
U.S. Food and Drug Administration. (2005d). CPG Sec 555.425. Foods, Adulteration
involving hard or sharp foreign objects. Retrieved from: https://www.fda.gov/
regulatory-information/search-fda-guidance-documents/cpg-sec-555425-foods-
adulteration-involving-hard-or-sharp-foreign-objects Accessed September 26, 2022.
U.S. Food and Drug Administration. (2005e). Quantitative Risk Assessment on the
Public Health Impact of Pathogenic Vibrio parahaemolyticus in Raw Oysters.
Retrieved from: https://www.fda.gov/media/77879/download. Accessed
September 26, 2022.
U.S. Food and Drug Administration. (2009). CPG Sec. 540.370 Fish and Fishery Products
– Decomposition. Retrieved from: https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/cpg-sec-540370-fish-and-fishery-products-
decomposition Accessed September 26, 2022.
U.S. Food and Drug Administration. (2010). Draft guidance for industry: questions and
answers regarding the Reportable Food Registry as established by the Food and
Drug Administration Amendments Act of 2007 (Edition 2). Pub. L. 110-085.
Retrieved from: https://www.fda.gov/media/79130/download Accessed
September 26, 2022.
U.S. Food and Drug Administration. (2012). Bad Bug Book, Foodborne Pathogenic
Microorganisms and Natural Toxins. Second Edition. Retrieved from: https://www.
fda.gov/food/foodborne-pathogens/bad-bug-book-second-edition Accessed
September 26, 2022.
U.S. Food and Drug Administration. (2016). CPG Sec 540.275 Crabmeat – Fresh and
Frozen – Adulteration with Filth, Involving the Presence of Escherichia coli.
Retrieved from: https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/cpg-sec-540275-crabmeat-fresh-and-frozen-adulteration-filth-
involving-presence-escherichia-coli Accessed September 26, 2022.
U.S. Food and Drug Administration. (2017). Full Text of the Food Safety Modernization
Act (FSMA). Sec. 211. Improving the reportable food registry. Retrieved from:
https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-
safety-modernization-act-fsma#SEC211 Accessed September 26, 2022.
U.S. Food and Drug Administration. (2018a). FDA Finalizes Guidance on Mandatory
Recall Authority. Retrieved from: https://www.fda.gov/food/cfsan-constituent-
updates/fda-finalizes-guidance-mandatory-recall-authority Accessed September
26, 2022.
U.S. Food and Drug Administration. (2018b). Index of Compliance Policy Guides.
Retrieved from: https://fda.report/media/75894/Compliance-Policy-Guides-Index.
pdf Accessed September 26, 2022.
U.S. Food and Drug Administration. (2020). 21CFR§113. Thermally processed low-acid
foods packaged in hermetically sealed containers. Retrieved from: https://www.
accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=113&
showFR=1 Accessed September 26, 2022
U.S. Food and Drug Administration. (2021a). 21CFR§7. Enforcement Policy Retrieved
from: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-7
Accessed September 26, 2022.
U.S. Food and Drug Administration. (2021b). CPG Sec 540.525 DRAFT: Scombrotoxin
(Histamine)-forming Fish and Fishery Products – Decomposition and Histamine
(CPG 7108.24) Retrieved from: https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/cpg-sec-540525-draft-scombrotoxin-histamine-
forming-fish-and-fishery-products-decomposition-and Accessed September 26,
2022.
U.S. Food and Drug Administration. (2021c). Fish And Fishery Products Hazards and
Controls Guidance (June 2021). Retrieved from: https://www.fda.gov/media/
80637/download Accessed September 26, 2022.
U.S. Food and Drug Administration. (2021d). Interstate certified shellfish shippers list.
Retrieved from: https://www.fda.gov/media/152017/download Accessed October
2, 2021
U.S. Food and Drug Administration. (2021e). New Era of Smarter Food Safety. Retrieved
from: https://www.fda.gov/food/new-era-smarter-food-safety Accessed March 15,
2021.
U.S. Food and Drug Administration. (2022a). Evaluating the Public Health Importance
of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food,
Drug, and Cosmetic Act: Guidance for FDA Staff and Stakeholders. Retrieved from:
https://www.fda.gov/media/157637/download Accessed November 10, 2022.
U.S. Food and Drug Administration. (2022b). FSMA Final Rule on Requirements for
Additional Traceability Records for Certain Foods. Retrieved from: https://www.
Blickem, E.R. et al. Journal of Food Protection 86 (2023) 100090

fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements- Wilson, J. E. (2022). Firefighter/Paramedic. personal communication.

additional-traceability-records-certain-foods Accessed January 10, 2023.
Virginia Department of Health. (2018). Norovirus Infection Fact Sheet. Retrieved from:
https://www.vdh.virginia.gov/epidemiology/epidemiology-fact-sheets/norovirus-
infection/?pdf=1056 Accessed September 26, 2022.
Wang, Z., de Jager, L. S., Begley, T., & Genualdi, S. (2022). Large volume headspace GC/
MS analysis for the identification of volatile compounds relating to seafood
decomposition. Food Science & Nutrition, 10(4), 1195–1210. https://doi.org/
10.1002/fsn3.2751.
Washington State Department of Health. (2018). Shellfish Poisoning: Paralytic, Domoic
Acid, or Diarrhetic Retrieved from: https://doh.wa.gov/sites/default/files/legacy/
Documents/5100//420-077-Guideline-ShellfishPoisoning.pdf Accessed November
10, 2022.
[seadart86@yahoo.com]
Wright, A., Goodrich, R. M. Hubbard, M. A. & Schneider, K. R. (2015). Preventing
Foodborne and Non-foodborne Illness: Vibrio parahaemolyticus. Retrieved from:
https://nifa.usda.gov/sites/default/files/resource/Preventing-Foodborne-Illness-
Vibrio-pharahaemolyticus.pdf. Accessed September 26, 2022.
Yeung, P. M., & Boor, K. J. (2004). Epidemiology, pathogenesis, and prevention of
foodborne Vibrio parahaemolyticus infections. Foodborne Pathogens and Disease, 1(2),
74–88. https://doi.org/10.1089/153531404323143594.
Yiannas, F. (2009). Food safety culture: Creating a behavior-based food safety management
system. New York: Springer.

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