The Role of Supply Chain Product Safety: A Study on

Food Safety Regulations

Elzbieta Trybus Gordon Johnson
California State University, Northridge, CA

Recent broadly publicized outbreaks of food-borne illnesses caused by E-coli and Salmonella have
increased public concerns on safety food and food suppliers. Assuring quality and food safety is,
however, critical to the entire supply chain. This paper has two objectives: to get a deeper
understanding of food safety issues in food supply chain management (SCM) and to discuss the role
of federal, state and local agencies in issuing regulations to prevent future outbreaks. As a result,
taxonomy of regulations for product safety is developed.

I. INTRODUCTION
During the last five years thousands of
products and processed food products have been
recalled due to contamination (and potential
contamination) of ingredients. Examples of these
recalls include ground beef, ground beef patties,
contaminated cookie dough, peanuts and peanut
derived products, pistachios, spinach, lettuce, dry
milk, contaminated toys and drywalls. Recalls of
contaminated food and food products have
reduced consumers confidence in the food
systems ability to deliver safe and high quality
products. The Center for Disease Control and
Prevention (CDC) estimated that food-borne
diseases cause about 76 million illnesses, more
than 325,000 hospitalizations and 5,000 deaths in
the United States every year (www.cdc.gov).
Food suppliers and food producers are
blamed for these diseases outbreaks. There are
many causes of food-borne disease outbreaks.
Some are related to an improper food
preparation, processing, products transportation
conditions, others to global outsourcing. The
United States imports food from more than 150
different countries through more than 300 ports
of entry.
Contamination of ground beef with E coli
0157:H7 has led to recalls involving millions of
pounds of ground beef: 21.7 million pounds of

beef patties in 2007 and more than 800,000

pounds of ground beef in 2009. Experts think that
more than 70,000 infections per year in the
United States are caused by E. coli 0157:H7
bacteria. A batch of Nestle Toll House
Refrigerated cookie dough contained bacterium
E. coli 0157:H7, causing 34 people to be
hospitalized after eating raw dough (Shepherd,
2009). Contamination of ground beef with E.
coli 0157:H7 resulted about hospitalization of 40
people and two deaths. Salmonella was detected
in products from Peanut Corporation of America
(PCA)s Georgia plant. Up to 9 deaths have been
linked to the peanut case (Schmit, 2009).
Tanimura and Antle Whole Head Romaine
Lettuce were recalled after salmonella was found
in a routine check (Donor, 2009).
Toys manufactured in China by Mattel
contained too much lead and were dangerous for
babies and little kids health (DeNoon, 2007).
Drywalls imported from China in 2002 caused
problematic health symptoms among many
homeowners and their families.
Costs of recalls are in millions of dollars
for the food industry; not including costs of lost
lives and patients hospitalizations. What need to
be done to reduce these risks? Regulators,
producers and retailers are mandated to improve
the quality of food products by redesigning
legislation and quality assurance programs. The

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The Role of Supply Chain Product Safety: A Study on Food Safety Regulations

US government and regulating agencies conduct

meetings and hearings to improve food safety
and quality in order to prevent and reduce the
number of food-borne disease cases.
The House approved the first major
changes to food-safety laws in 70 years, giving
new authority to the Food and Drug
Administration (FDA) to regulate the way food is
grown, harvested and processed. This Food
Safety Bill as reported by The Washington Post
(July 31, 2009) requires food manufacturers to
identify the particular risks they face, create
controls to prevent contamination, monitor those
controls to make sure they are working and
update these measures regularly. Such controls
have been mandatory for the seafood and juice
industries since the 1990s.
Since causes of contamination may occur
at any stage of the supply chain (SC) very often
the authorities, including, federal and state
agencies are unable to identify the origin of a
tainted food product. In such cases, food recalls
or warnings are applied to all suppliers, including
those who did not contribute to the
contamination.
The main purpose of this paper is to get a
deeper understanding of the causes of product
contamination, in particular food products and
discuss the role of federal and state agencies in
food safety regulations.

crisis management and restoration of consumer

evidence, and in Canada and Australia the policy
focus was on risk management and the
prevention of trade-threatening food safety
issues. Since the UK food industry is driven
primarily by domestic market, there were
practically no issues with food safety caused by
global SC. But Mad Cow Disease (the Bovine
Spongiform Encephalopathy, BSE) brought the
public attention to importance of food safety and
quality assurance. The 1990 Food Safety Act
requires buyers to take all reasonable steps to
ensure that food they receive from upstream
suppliers is safe. Also, upstream firms must
demonstrate to their downstream customers that
they are handling food correctly.
In Canada food safety is shared between
the Canadian Food Inspection Agency (CFIA)
and Health Canada (HC). In some cases food
safety and inspection standards are under
provincial jurisdiction. In Australia, state
governments were responsible for the
enforcement of food law. But to avoid different
standards across the country the Agriculture and
Resource Management Council of Australia and
New
Zealand
(ARMCANZ)
developed
Australian
Standards
for
processing
establishments servicing the domestic markets
(e.g. meats). In addition, national standards were
developed by the Australia-New Zealand Food
Authority (ANZFA).
Another study on food safety (Buelens et
al. 2003) emphasized the role of partnership in
SCM when improving food safety. The authors
found an impact of building trust in SC network,
improving technology for product traceability
and providing information required by
stakeholders in- and outside of the SC network
very crucial in improving safety of food
products.
Manning et al. (2004) analyzed quality
assurance (QA) model that drives both legislative
and customer compliance. This model requires
two elements: good manufacturing practice/good
agricultural practice (GMP/GAP), and a
benchmarking
protocol
that
measures

II. LITERATURE REVIEW

Food safety is everyones concern and
everyone has a role to play. Consumers, in
particular, are concerned with food safety, and
properties of food they buy and eat. Tools to
assure food safety and quality are important in
the entire SCM, when moving product from farm
to the table.
Introducing incentive structures for
changes in food safety legislation and in private
sector business strategies was discussed by
Hobbs et al. (2002) using three countries as
benchmarks: the UK, Canada and Australia. In
the UK the incentives were primarily related to

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performance in a quantitative way. Again, this

model refers to the European standards.
The food safety topics dont have full
recognition in SCM literature. In addition,
textbooks in SCM, like Simchi-Levi et al. (2008)
do not introduce quality issues in the SCM at all.
Other textbooks in SCM, including Burt et al.
(2003), Benton (2007), Jacobs and Chase
(2008), Webster (2008), Wisner (2008), and
Boyer and Verma (2010) expose readers to only
one chapter on quality tools without integrating it
into the SCM. In none of these textbooks food
chains are presented and their importance
discussed.
Controlling complex processes and also
regulations in food chain requires an integrated
approach and a responsible authority to oversee it
in order to protect and promote food safety
(Elmi, M. 2004).

The FDA has an Office of Criminal

Investigation as well. The FDA published the
Food Code to assist state and local governments
to regulate food safety. Usually, the FDA
inspects plants every 5 to 10 years. But in fact
FDA does only about half of all inspections
enforcing state agencies to perform them. This
may create some problems we will discuss later
using Peanut Corporation of America (PCA) in
Georgia as an example.

3.2. U.S. Department of Agriculture (USDA).

USDA inspects meat, poultry, and eggs.
The Food Safety and Inspection Service (FSIS) is
the public health agency in the USDA
(www.fsis.usda.gov). The USDA budget includes
inspection for wholesomeness of food, while
meat and poultry producers pay USDAs
Agricultural Marketing Service for quality
inspection (ex USDA Choice).
The legislation for these programs started with
the Federal Meat Inspection Act and the Poultry
Products Inspection Act, which affect interstate
and foreign commerce. Food sold only within the
state in which it is produced is regulated by the
state, but the FDA monitors state inspection
programs. In 1967 the Wholesome Meat Act
required state inspection to be at least equal to
the Federal inspection program. FDA and FSIS
collaborate to improve tracing of unsafe food
products.

III. THE ROLE OF FEDERAL, STATE AND

LOCAL HEALTH AGENCIES IN
IMPROVING FOOD SAFETY
This section will summarize the roles of
the different agencies in the United States in the
monitoring, reporting and enforcing food safety
standards.

3.1. Food and Drug Administration (FDA)

For more than 100 years, the FDA has
regulated the safety of components of the food
supply. The FDA is currently part of the
Department of Health and Human Services
(HHS) and consists of seven centers and offices
including Center for Food Safety and Applied
Nutrition Organization and Office of Regulatory
Affairs Organization (www.fda.gov). There are 3
elements of the Food Protection Plan:
A. Prevention, including risk assessment of
imported food
B. Intervention, including inspection and
surveillance. Sampling techniques are used to
screen imports
C. Response, including containment of illnesses
and communication to the media.

3.3. Center for Disease Control and

Prevention (CDC)
Center for Disease Control (CDC), an
agency within the U. S. Department of Health
and Human Services (HHS), is not a food and
safety regulatory agency but works closely with
the food safety regulatory agencies, in particular
with the U.S. Food and Drug Administration
(FDA) and the Food Safety and Inspection
Service (www.cdc.gov).
Food illnesses which affect many states at
the same time require CDC assistance to
the
states. Examples are widespread outbreaks
affecting a large number of people. CDC can lead

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investigations of the cause of a food borne

illness. Included in the CDC is the National
Institute for Occupational Safety and Health,
which investigates illnesses from pesticides and
other chemicals. This agency also studies why
farmers have higher incidences of skin diseases
and brain cancer.

chemical, or mechanical hazard. Applications

include toys, cribs, power tools, cigarette
lighters, and household chemicals.
After recalls of lead contaminated toys in
2007 President George W. Bush signed the
Consumer Product Safety Improvement Act of
2008 on August 2008. This Act regulates
childrens product safety and provides changes in
the Product Safety Commission. It sets regulation
standards for new levels of acceptable lead
content and mandates a documentation of testing.
It imposes new and more severe penalties and
fines onto companies that break newly regulated
standards. It also mandates a reduction in the
total lead content that can be used in childrens
products. CPSC mandates that childrens toys are
tested by a third party testing facility
(www.cpsc.gov).

3.4. Import Safety

Multiple government agencies are
involved in import safety. For example, the US
Customs and Border Protection agency inspects
food imports.
The National Oceanic and
Atmospheric Administration (NOAA), within the
Department of Commerce, operates the fee-based
Seafood Inspection Program. At the request of
the US seafood importer of the foreign seafood
facility, NOAA audits the facility to ensure that it
complies with the hazard Analysis Critical
Control Point (HACCP) Quality Management
Program. Also the Department of Agriculture
(USDA) works with foreign exporters to ensure
that fruits and vegetables are free from
agricultural pests and diseases prior to export to
the U.S.A. Coordination between agencies has
been a difficult issue. In 2006 the Security and
Accountability For Every Port Act required an
electronic interface among agencies to address
the issue of different computer systems. In 2007
the Secretary of Health and Human Services
chaired a committee to improve import safety
(www.importsafety.gov).

IV. EXAMPLES OF SYSTEM FAILURES

AND INEFFICIENCIES
The USA system of multiple agencies and
organizations responsible for food safety was
criticized as being inefficient. Dr. Samuel Earl
Fox from the School of Public Health at Johns
Hopkins University (BMJ 2003, report) raised an
issue that food safety regulations are out of date,
inflexible and erratically enforced. The Peanut
Corporation of America (PCA) case in Georgia
and Nestle Cookie Dough case are good
examples of this critique.

3.5

Consumer Product Safety Commission

(CPSC)
The US Consumer Product Safety
Commission created in 1972 is charged with
protecting the public from unreasonable risks of
injuries caused by consumer products. The
Consumer Product Safety Act of 1972 gave the
CPSC control over 15,000 products for which the
commission has the power to create safety
standards and push for recalls if there is a risk of
harm or death to consumers. Under extremes
circumstances the commission can even issue a
ban on a product. Risks include fire, electrical,

4.1. Peanut Butter Case

In 2008 CDC identified first multistate
cluster of Salmonella infection. Through
epidemiologic investigation the outbreak was
traced to peanut butter and peanut butter paste
manufactured in the Peanut Corporation of
America (PCA) located in Blakely, Georgia. In
2001 FDA investigated the production process
and the use of duct tape. The FDA paid the State
of Georgia to send their inspectors to visit PCA
in 2006 and 2008. PCA passed the state
inspections. After the recall, the FDA visited
PCA with strong criticism of the cleanliness of

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the plant. The FDA also criticized the PCA

policy of retesting so that the second test might
come back negative. FDA advocated that product
be destroyed after one positive result.
King Nut peanut butter produced by PCA
was not sold directly to consumers but was
distributed to institutions, food service providers,
food manufacturers and distributors in many
states and countries. Kellogg bought PCA
Peanut Paste for its sandwich crackers. Kellogg
sent its employees to visit the PCA plant but did
not do an audit. Both King Nut and Kellogg
hired an auditor, AIB International, who rated
PCAs plant as Superior. However, AIB gives
98% of companies a Superior or Excellent
rating (Schmit, 2009). PCA paid AIB for the
audit and was given one month notice before the
next audit. Critics of the status quo use this as an
argument for a new FDA policy.
Nestle sent its employees to PCAs plant
and rejected PCA as a supplier due to inadequate
cleaning and cross contamination. Nestle did not
send report to the FDA as it is not mandated by
government agencies to report inadequacies in
supplier procedures. Deibel Labs told PCA that
6% of its samples tested positive for salmonella,
but this also was not reported to FDA. Another
issue was cross contamination, when salmonella
from raw nuts is next to roasted nuts. Raw and
roasted nuts must be separated to avoid this
problem. Problems at the PCA plant in Georgia
included duct tape, which can harbor insects and
a leaky roof, which implies salmonella from bird
droppings could get into the plant. Inadequate
cleaning was a pervasive problem for PCA. More
than 2833 peanut containing products produced
by a variety of companies were recalled by PCA.
Some members of Congress advocate that
positive test results of food contamination should
be reported to FDA. William Hubbard, former
FDA Associate Commissioner, said third party
auditors have a conflict of interest or are not well
trained.

4.2. Nestle Cookie Dough Case

In 2009 health officials identified Nestle
Toll House cookie dough as a potential source of
E. coli outbreak. Initially investigators from the
US Government were not able to find
contamination inside the factory or on the
equipment at the Nestle plant in Virginia. David
Acheson, Assistant Commissioner for Food
Safety in the FDA, said this raises the likelihood
that it was an ingredient (Layton 2009). Cookie
dough is made from eggs, milk, butter/margarine,
flour, and chocolate. Nestle restarted cookie
dough production July 7, 2009 with new supplies
of eggs, margarine, and flour, along with a
different label containing a warning not to eat
raw cookie dough.
Recalls issued by a manufacturer or
mandated by a government agency damage
firms reputation, cost lives and lead to
bankruptcy, as it happened to the PAC.
In September 2009 the FDA launched
http:/www.foodsafety.gov with recall bulletins.
The United States Senate will vote this year on
the Food Safety Act, already passed by the
House of Representatives. This bill would give
the FDA the power to issue recalls (Huget, 2009)
since the current law (passed in 1938) only
allows the FDA to request voluntary recalls. The
new bill also requires FDA inspections yearly
(Klein, 2009).
V. ANALYSIS OF TYPICAL CAUSES IN
SELECTED PRODUCTS
CONTAMINATION CASES
As pointed in the previous section there
are situations where finding causes of
contamination is not easy and is taking more time
and resources than expected. Contamination of
lettuce could be caused by human error at the
farm, transportation and handling, or storage.
As an illustration of non-biological causes,
lettuce grown in southeast California contained
perchlorate, a rocket fuel additive (Danelski,
2003).
A Nevada facility contaminated the
Colorado River, whose water irrigated fields of

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lettuce in Imperial, Riverside, and San

Bernardino Counties.
Contamination of toys manufactured in
China was caused by using inappropriate paint
provided by a supplier who did not comply with
the quality standards. Investigations revealed that
the cause of this contamination was lead in paint.
Millions of toys were recalled in 2007 when it
was discovered that kids and babies were sick
because of playing with these toys.
Another example is drywalls from China used in
increased amounts after Hurricane Katrina, have
been discovered to be toxic. Sulfuric compounds
within the drywall have had a corrosive effect,
leading to a damage of copper plumbing pipes,
electrical outlets, air-conditioning coils, and other
metallic utilities and furnishings. The sulfur in
these walls emits a rotten-egg smell, allegedly
resulting in nausea, headaches and respiratory
problems. Hundreds of residents in Florida,
Louisiana, and Virginia have been complaining
of noxious gases emitted by Chinese drywalls.
We will summarize typical causes of
contamination by using a 5Ms method also called
cause-and-effect diagram or fish-bone diagram
developed by Ishikawa in Japan. This quality
management tool classifies possible causes into
materials, methods, manpower, machines, and
Mother Nature causes. Below a list of possible
causes is presented.
1. Materials: types of fertilizer, water used for
irrigation and later for cleaning, pesticides,
ingredients, containers and packaging
materials.
2. Methods: documentation and employee
training,
procedures
for
harvesting,

procedures for food processing, cleaning and

sanitation, and transportation.
3. Machines: machines used in harvesting, food
processing, air conditioning, and equipment
for transportation.
4. Manpower: farmers, workers trained in using
methods and machines, workers empowered
to stop the process if there is a problem,
consumers who may need special warnings
and instructions how to use the product.
5. Environment (or Mother Nature): weather
conditions, unexpected disasters including
hurricanes, fires, flood, and earthquakes but
also buildings and storages.
In table 1 we summarize root causes in cases
discussed in this paper.
Thus, the main causes of contaminated
product were materials used in the processes,
machines processing food products, methods and
environment. All these causes and errors should
be removed from the system before product goes
to the consumer. Managers need to provide better
supervision and working structures in the
existing SCM. SCMs.

VI. CONCLUSIONS
Our paper indicates that regulations on food
safety do not work in the way they were
originally designed. It takes time for designated
agency to detect the cause of product
contamination. The responsibility of educating
managers, producers, and consumers about the
transmission of food-borne diseases is the
important task for food safety experts. Managers
in food industry should use all available tools to
prevent food contamination and work toward

TABLE 1: IDENTIFICATION OF ROOT CAUSES OF PRODUCT CONTAMINATION

CASE NAME
Nestle Cookie Dough
Peanut butter
Lettuce
Toys (supplied to Mattel)
Toxic Walls

ROOT CAUSE(S)
Materials (raw eggs), policies
Methods, machines, environment
Material (water used in irrigation)
Materials, methods, testing
Materials (toxic ingredients)

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achieving full compliance with existing and

future food standards and regulations.
Also, quality must be incorporated into the
SCM courses. Cost-benefit analysis of preventing
contamination and implementing necessary
techniques, including better product traceability
should be performed. The main problem, in this
case, is data availability and dissemination of
reports by CDC. The last CDC surveillance
report was published in November of 2006 and
summarizes years 1998 to 2002.

Elmi, M., Food Safety: Current Situation,

Unaddressed Issues and the Emerging
Priorities. Journal of East Mediterranean
Health, 2004, 10(6).
Foster, S.T. Managing Quality: Integrating the
Supply Chain, Prentice Hall, 2010.
Huget, J., Food Borne Illnesses, Washington
Post, September 29, 2009.
Jacobs, F.R. and Chase, R.B., Operations and
Supply Management: The Core, McGrawHill, 2008.
Klein, E., When Good Foods Goes Bad,
Washington Post, September 30, 2009.
Layton, L., E Coli Confirmed in Nestle
Samples, Washington Post, June 30, 2009.
Manning, L. Baines, R.N., and S.A. Chadd,
Quality Assurance Models in the Food
Supply Chain, British Food Journal, 108(2),
2006.
Simchi-Levi, D., Kaminsky, H., and E. SimchiLevi, Designing and Managing the Supply
Chain, McGraw-Hill, 2008.
Schmit, J., Broken System Hid Peanut Plants
Risks, USA Today, April 27, 2009.
Vollmann, T.E., Berry, W.L., Whybark, D.C.,
and F. R. Jacobs, Manufacturing Planning
and Control for Supply Chain Management,
McGraw-Hill, 2005.
Webster, S., Principles and Tools for Supply
Chain Management, McGraw-Hill, 2008.
Wisner, J. D., Tan, K. C., Leong, G. K.,
Principles of Supply Chain: A Balanced
Approach, South Western Cengage Learning,
2008.

VII. REFERENCES
Benton, W.C., Purchasing and Supply Chain
Management, McGraw-Hill/Irvin, 2007.
Beulenes, A. J. M., Broens, D., Folstar, P., and
G. J. Hofstede, Food Safety and
Transparency in Food Chains and Networks:
Relationships and Challenges, Food Control,
16(6), 2005.
Boyer, K.K., and R. Verma, Operations and
Supply Chain Management for the 21
Century, South Western, 2010.
Burt, D.N., Dobler, D.W., and S.L. Starling,
World Class Supply Management: The Key
to Supply Chain Management, McGraw-Hill,
2003.
Danelski, D., Growing Concerns, Riverside
Press Enterprise, April 27, 2003.
DeNoon, D.J., Fischer-Price Toy Recall: What
to Do, WebMD Health News, 2007,
http://www.webmed.com/parenting/news/200
70802/toy-recall-what-parents-should-know.
Deprez., E.E., Chinas Latest Tainted Export:
Toxic Drywall, Business Week, July 13,
2009.

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