PROJECT NOTE | DECEMBER 2018

A REVIEW OF BEST FOOD SAFETY PRACTICES

International Experiences and Lessons for Bangladesh

ALEXANDER SAAK

1. INTRODUCTION

F oodborne illness caused by contamination and adulteration of food is an important public health concern in Bangladesh. While
there are no studies that quantify the full toll of food borne diseases on public health in Bangladesh, much of the high prevalence
of diarrhea among children and adults recorded during hospital visits is attributable to the consumption of unsafe food (WHO 2015,
Colombaru et al 2014). Non-compliance with hygienic practices that creates conditions for pathogen and microbial growth is common
in food production and handling throughout the food chain. For example, a study of raw seafood, fruits and vegetables sold in open
markets in Bangladesh finds that microbial and fungal counts in 15% of samples exceed and in 45% are close to the limits that are
considered safe for consumption (Feroz et al 2016). Khairuzzaman et al (2014) find the presence of high levels of common foodborne
pathogens in between 30% to 100% of street vended food in Dhaka. Other studies of microbiological quality of street foods in Bang-
ladesh also find that most foods are highly contaminated and that street vendors have little knowledge of and incentives to adhere to
hygienic food preparation and handling methods (Noor 2016).

A distinct source of hazard arises due to adulteration of food with harmful chemicals such as colorants and preservatives as well as
excessive pesticide and fertilizer use. Rahman et al (2015) provide a recent review of the studies conducted in Bangladesh that tested
food for adulteration. Tests conducted by the Institute of Public Health (IPH) and the World Health Organization (WHO) from 2001 to
2009 in Dhaka revealed that, on average, 50% of food, including up to 96% of some ready-to-eat food, was adulterated (Rahman et al
2005, Bangladesh Directorate General of Health Services 2012). This is consistent with findings in other studies. For example, in 2004
the Public Health Laboratory (PHL) of Dhaka City Corporation found that more than 76% of food items on the market were adulterated.
The analysis of the prevalence of food adulteration between 1995 and 2011 in Dhaka based on food testing conducted by PHL, Bang-
ladesh Standards and Testing Institution, and Consumers Association of Bangladesh in Nasreen and Ahmed (2014) reveals that 40-54%
of food was adulterated and that more than 35 food items were commonly adulterated. More recently, according to FAO, testing
fruits, vegetables, milk and milk-products in a government laboratory demonstrated that all of the tested food stuffs contained banned
pesticides that pose serious health hazards. The presence of toxic substances in these samples was about 20 times greater than that
set by the European Union. Evidence reported in these studies suggests that the degree of adulteration is rising alarmingly in an
epidemic manner (Parvez 2014, Robson 2014).

Contaminated and adulterated food poses significant threats to public health. Consumption of unsafe food can lead to spikes in short-
term food-borne illness while long-term exposure can increase birth defects and stunting among children as well as the incidence of
chronic diseases including cancer and kidney disorders (Majed et al 2016). Consumer health and food security in Bangladesh cannot
be achieved without improving the safety of food available in the domestic market. A functioning food safety system is also a pre-
condition for exporting of food to developed and many developing countries (Keiichiro et al 2015). In recent years, in partnerships
with FAO and WHO, Bangladesh has begun to make progress in raising awareness of food safety risks among consumers, educating
producers about food safety norms, strengthening the country’s laws and regulations related to food safety and their enforcement,
and creating institutional capacity to carry out a comprehensive risk analysis and implement a unified risk management approach to
food safety that focuses on the most important risks (FAO 2017).
 PROJECT NOTE | DECEMBER 2018

A REVIEW OF BEST FOOD SAFETY PRACTICES

International Experiences and Lessons for Bangladesh

ALEXANDER SAAK

The goal of this report is to identify best food safety practices that can inform policy makers in Bangladesh and other developing
countries by examining and synthesizing experiences in food safety systems and regulation as well as producer and consumer behavior
in low, middle, and high income countries. We begin by presenting the general objectives and principles of food safety regulation in
countries with mature food safety systems. Then we review government food safety regulatory systems in Denmark and the U.S. to
illustrate different approaches to organizing the implementation of food safety regulation. The food safety systems of both of these
countries were updated within the past 20 years (Denmark in 1997 and the U.S. in 2011), and as a result the two systems incorporate
modern best practices in food safety. The recent changes to U.S. food safety law are described in depth, as an example of a country
updating a food safety system that was developed over 80 years ago based on modern principles. We conclude by summarizing the
best practices and consider their potential to improve food safety in an emerging economy such as Bangladesh.

2. PRINCIPLES OF MODERN FOOD SAFETY REGULATORY SYSTEMS

The main goal of a food safety regulatory system is to protect consumer health and ensure that food is safe, wholesome, and properly
labeled. The design of many modern food safety systems is shaped by and incorporates the risk analysis, precautionary and transpar-
ency principles. This section reviews these principles and provides examples of their practical implementation.

2.1 Risk Analysis Principle

The principle of risk analysis in relation to food and feed regulation involves scientifically sound assessment, management, and com-
munication of risk (FAO/WHO 2011). Risk assessment provides information about food safety risks that is needed to make science-
based policy decisions. Risk management is the process of weighing policy alternatives in the light of results of a risk assessment and,
if required, selecting the appropriate actions necessary to prevent, reduce or eliminate the risk. In the risk management phase, factors
that influence policy decisions include the effectiveness and costs of risk reduction actions that can vary along the food supply chain
and depend on where the problem occurs as well as socio-economic and environmental impacts. Risk communication is the interactive
exchange of information and opinion throughout the risk analysis process among risk assessors, risk managers, consumers, feed and
food businesses, academics, and other interested parties. Box 1 presents three examples that illustrate how the risk analysis principle
can be expanded in scope and applied in practice in the case of the U.S.

2.2 Precautionary principle

Mature food safety regulations in many countries such as the members of the EU also adhere to the precautionary and transparency
principles. The precautionary principle applies in circumstances where there are reasonable grounds for concern that an unacceptable
level of risk to health exists and the available supporting information and data are not sufficiently complete to allow for a comprehen-
sive risk assessment. When faced with these specific circumstances, decision makers or risk managers may take measures or other
actions based on the precautionary principle, while seeking more complete scientific and other data. Such measures have to comply
with the principles of non-discrimination and proportionality and should be provisional while more comprehensive information con-
cerning the risk is being gathered and analyzed.
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A REVIEW OF BEST FOOD SAFETY PRACTICES

International Experiences and Lessons for Bangladesh

ALEXANDER SAAK

BOX 1. EXAMPLES OF RECENT RISK ANALYSIS TOOLS AT FDA

There are several innovative food safety risk analysis tools that are currently being developed in the U.S. (by the U.S. Food and Drug
Administration and other agencies).

QPRAM is a virtual laboratory that is designed to predict and characterize risks from consumption of fresh produce that result from
specific behaviors and practices on farms and during the processing and consumption of crops. QPRAM tracks each unit of produce
and keeps a history of how, when, where, and by how much it was contaminated. The model can be used as a tool to optimize
interventions in real-world scenarios. In addition to predicting and helping prevent future contamination events, it can also be used
in real-world “trace-backs” to predict the likely point at which produce was contaminated, so that products can be identified and
removed from the market more quickly.

FDA-iRISK is an interactive tool that compares and ranks public health risks from multiple hazard/food combinations, to inform
FDA’s risk prioritization and resource allocation. This comprehensive risk assessment tool is designed to generate results relatively
quickly and can be accessed by the general public. FDA-iRISK allows risk assessors to construct, evaluate, and compare hazard/food
scenarios that may involve multiple hazards (both microbial and chemical), foods, process pathways, and populations. It can be
used to estimate the impact of various interventions applied at specific steps of the farm-to-fork continuum. A Web-based interface
linked to built-in mathematical functions and libraries of templates enables users across the world to share data and outcomes.
Impact can be expressed as number of illnesses and as a public-health metric (DALYs).

The Virtual Deli is a model that simulates, thousands of times per second, all the actions involved in preparation and serving of
sliced deli meats to customers, based on observational studies of real-world practices. It’s part of an interagency risk assessment
on Listeria monocytogenes in the retail setting and is designed to estimate at what points in the deli contamination is most likely
to occur and what interventions will be most effective in reducing contamination and illness. For example, the model can estimate
the potential effectiveness of separating slicers for meat and cheese or of other changes in practices.

Source: Risk Analysis at FDA: Food Safety. A science-based approach to policy decisions. FDA’s Fact Sheet, February 2011. ac-
cessed at https://www.fda.gov/downloads/Food/FoodScienceResearch/UCM267257.pdf

2.3 Transparency
Food safety and protection of consumer interests are of great concern to the general public, non-governmental organizations, profes-
sional associations, international trading partners and trade organizations. Therefore, transparency of decision-making is of para-
mount importance. The mechanisms that increase consumer confidence in the food safety regulation system include (i) effective
public consultations during the preparation, evaluation and revision of food and feed law, and (ii) obligation on public authorities to
inform the general public, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal
health.
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A REVIEW OF BEST FOOD SAFETY PRACTICES

International Experiences and Lessons for Bangladesh

ALEXANDER SAAK

3. GOVERNMENT FOOD SAFETY CONTROL SYSTEMS IN SELECTED COUNTRIES

National food safety systems differ in a number of dimensions including (1) activities and scope of responsibility, (2) the agency struc-
ture (a single agency or a coordinated system of multiple agencies), (3) approaches to registration of food businesses, (4) inspection
fees and scheduling, (5) monitoring of inspector performance; (5) sampling and testing procedures, (6) inspector training, and (7) the
extent of public disclosure of information related to inspections, outcomes, and regulatory actions. This section reviews the organiza-
tional elements of food safety control systems administered by governments of Denmark and U.S.

3.1 Food Safety Regulation in Denmark

An overview of the government food safety system in Denmark can be found in IFC (2010). This section outlines the key organizational
features of the Danish food safety system that are internationally recognized as best practices. Following the 1997 reform of Den-
mark’s food safety system, all food safety functions including inspections and control of food of animal origin are centralized under
the Danish Veterinary and Food Administration (DVFA). The DVFA reports to the Ministry of Food, Agriculture and Fisheries which is
responsible for regulation and control of food safety and maintaining laboratories that support research and analysis. In addition, to
DFVA, the Plant Directorate, and the Directorate for Fisheries also perform activities related to food safety. The Danish Plant Direc-
torate is responsible for inspections of companies and farms that are involved in production and distribution of seeds, animal feed,
plants, fruits and vegetables, and organic produce. The Danish Directorate for Fisheries is responsible for hygiene inspections at sea
and in fresh water (all vessels except freezing and cooking vessels), where fish are landed, at auctions, and on the premises of the first
buyer.

Before the reform, the inspection functions were distributed among the Ministry of Health and the Ministry of Fisheries and Munici-
palities. The dispersion of food safety activities across multiple agencies in the previous system resembles that in the current system
in the U.S. that will be reviewed in Section 3.2.

The Danish Veterinary and Food Administration

DVFA is responsible for ensuring the safety of food of animal origin, animal health and welfare, promotion of healthy eating habits
among the population, food quality and residues control, and compliance with organic food standards. To achieve its mission, DVFA
issues regulations, administers food and feed inspections, and provides information and advice to growers and processors.

Administrative organization and resources

DVFA’s inspections are performed through two regional centers comprised of 10 regional authorities. In addition to inspections, the
local authorities provide information about legislation and technical guidance to general public and firms. DVFA employs about 540
full-time employees, while each regional authority employs an average of 1,370 full-time employees. The regional authorities are
responsible for animal health, food of animal origin, imported animals (in collaboration with Customs Services), animal byproducts,
veterinary medicines (in collaboration with DVFA), veterinary medicines residues, food and food hygiene, imported food of plant
origin, herbicides and pesticides (in collaboration with Plant Directorate and DVFA), herbicides and pesticides residues, animal welfare,
restaurants and food retail.
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A REVIEW OF BEST FOOD SAFETY PRACTICES

International Experiences and Lessons for Bangladesh

ALEXANDER SAAK

In addition, there are two specialist research institutions affiliated with DVFA: the National Veterinary Laboratory and the National
Institute for Virus Research. Their main role is veterinary emergency service. The National Veterinary Laboratory’s mission is to prevent
and combat both livestock disease and food-borne human diseases originating in primary livestock production. The National Institute
for Virus Research prevents and combats viral infections in mammals, including viral infections originating outside Denmark. These
institutions serve both the government and the private sector. Each institution has a reference laboratory that provides services and
guidance to local private control laboratories. In collaboration with the accrediting authority, DVFA evaluates the laboratory’s work.

Inspections

Denmark and the U.S. (as typical of mature food safety systems) adopt the same approach regarding the role of the private industry
in ensuring food safety. The official control and inspection of food and animals in Denmark (and the U.S.) is based on the principle that
companies and primary producers are responsible for ensuring that regulations are observed and followed. The companies and pro-
ducers must have self-inspection programs with systematic action plans (similar to hazard analysis and critical control points (HACCP)
plans) that ensure that statutory requirements regarding the handling and treatment of foodstuffs are respected (general food safety
requirements, food additives, packaging and labeling) and that the foodstuffs do not pose a risk to human health under normal use.
The self-inspection program must be organized in accordance with the principles of the HACCP system. The self-inspection programs
of individual companies must be approved and registered by the authorities. Food industry companies and companies handling non-
food animal products are required to implement self-inspection programs in accordance with the EU, national, and applicable legisla-
tion from other countries. Primary producers and companies that transport livestock must have a self-inspection program in place to
ensure compliance with the regulations on animal welfare, animal care, and livestock health.

The Administration relies on mobile teams to insure cooperative relationships with inspection offices including joint checking of ac-
counts and other internal documents. The inspection offices perform multiple functions. Official inspectors provide information to
producers on how to implement regulations. They also register and conduct pre-market inspections of food business operators, slaugh-
ter and processing facilities as well as inspections of animals, labeling and documentation related to traceability of live animals. In-
spectors also perform border control of imports/exports of live animals, foodstuff s and non-food products of animal origin at 15
border posts. Inspection offices also conduct sampling and testing of food and ensure that inspections are risk based consistent with
the risk analysis principle. Inspectors are also responsible for tracing the source of the problem throughout the food chain and have
the authority to impose penalties including shutting down of production and banning products from the marketplace.

Frequency of inspections, outcomes, and fees

As in other mature food safety systems, the food safety authorities maintain a register of all regulated facilities. In 2016, there were
approximately 5,000 facilities that produce food of animal origin for export and local consumption, 50,000 food and feed producing
establishments, and 70,00 registered food retail outlets and restaurants.
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A REVIEW OF BEST FOOD SAFETY PRACTICES

International Experiences and Lessons for Bangladesh

ALEXANDER SAAK

Inspections conducted by regional food authorities are typically unannounced although advanced warnings are possible. During an
inspection visit, the inspector usually takes samples of raw materials, semi-finished goods, packaging, or additives. There are no stand-
ard prescribed values for fees and fines. Fines are often determined by the fine values set during similar prior cases. There are four
sanction instruments: warnings (no legal status but important for risk ranking), enforcement notice (ban, required correction, training,
and consultancy), administrative fine (prescribed when it is the first time and not a serious problem), and reporting to police for
prosecution (complicated or repeated frauds).

Consistent with the risk analysis principle the targeting of inspections is based on risk. Inspection frequency drops as the level of risk
decreases or if there have been no hygiene or safety problems during four visits within the same year. Such establishments are called
“elite” and receive fewer inspections. One third of all food and feed producing establishments have “elite” status.

In the DVFA’s scheme for determining a facility’s general risk level, each facility is classified in one of six risk groups, based on seven
risk factors (microbiological and chemical). Depending on classification, retailers are visited by an inspector anywhere from 3 to 0.2
times per year, while wholesalers are inspected from 7 times to 0.5 times per year.

Transparency and public disclosure

Denmark has unique system of disclosing the outcomes of inspections to the public through “smiley” report cards whereas the ex-
pression reflects the overall compliance with food safety norms. The scheme was introduced in 2001 and is now one of the most well-
known public food safety schemes. Now smiley reports are posted in all supermarkets, groceries, bakeries, butchers, greengrocers,
kiosks, restaurants, hospital kitchens, elderly homes, and outdoor food vendors. Information is available online about the status of
inspection reports and the general public is informed at various retail points about the results of the “Smiley” campaign. The European
food and feed recall site offers a monthly report and information based on the Rapid Alert System that is easily accessible to the
general public.

Sampling programs

During inspection visits, inspectors take samples of raw material, additives and semi-finished material and send them for analysis to
laboratories affiliated with the DVFA. To ensure comprehensive coverage and risk-based implementation, the annual sampling plan
takes into account the projected annual production of food and feed subject to testing and adjusts in response to the emergence of
new pathogens and threats from known pathogens. DFVA’s inspectors take annually about 60,000 samples of various contaminants
and components, with about a third taken at the regional level. Also, the Danish Plant Directorate analyzes about 1000 samples annu-
ally. Eight (3 in Denmark and 5 in the EU) laboratories carry out the national plan for monitoring and control of chemical residues in
food.

Ensuring quality of inspections

Inspection activities encompass monitoring, sampling, auditing, and actions in case of non-compliance. There are internal audit sys-
tems for control of quality of inspection work in all directorates. Regional offices monitor inspector effectiveness and accuracy by
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A REVIEW OF BEST FOOD SAFETY PRACTICES

International Experiences and Lessons for Bangladesh

ALEXANDER SAAK

checking samples of their reports to evaluate clarity, uniformity of approach, and consistency with legal requirements. Regional Vet-
erinary and Food Control Authorities are responsible for the hiring, training and payment of inspectors. The training of all food and
veterinary inspectors, and inspectors of food of animal origin and feed is mandatory. The Danish Plant Directorate has a training
scheme for all inspectors under its authority. DVFA coordinates and carries out on-going training programs for inspection personnel
from various agencies. Veterinarians receive classroom training in veterinary public health and food inspection as part of their veteri-
nary degree course of study. When applying for an inspector position, veterinarians receive on-the-job training by visiting the regulated
establishments and production facilities. Veterinary technicians, who often have experience as slaughterhouse workers, are educated
at the Danish Meat Trade College. Their course consists of 14 weeks of theoretical training and seven weeks of practical training.
Ongoing training needs are determined and scheduled by the official veterinarian or the head veterinarian through consultation with
the Regional Veterinary and Food Control Authority. Special emphasis is placed on HACCP, Sanitation Standard Operating Procedures
and supervisory training. A yearly performance conference for each DVFA employee is required by Danish law.

Summary of advantages of Danish food safety agency

A consolidated food safety system in Denmark offers the following advantages:

• A reduction in inspection overlap and more effective implementation of risk-based inspections. In a fragmented system such as the
one in U.S. that will be considered in the next Section, one inspection can be performed by different inspectors from FDA and FSIS. In
Denmark, this overlap is avoided, as one inspector (or a team of inspectors) completes the inspection of a single facility.

• Uniform public disclosure of compliance through the “smiley approach” is effective in raising food safety and food safety awareness.

• The enforcement of food safety regulations is more consistent, which improves the food safety system’s effectiveness.

• Communications between inspectors and inspectees are streamlined and the respective responsibilities are defined more clearly.

• As in the U.S., the primary responsibility for complying with food safety standards and self-inspection is on food producers and
providers.

3.2 Food Safety Regulation in the USA

Public food safety system in many countries are more fragmented than the one in Denmark (Johnson 2016). Typically, two or more
central government agencies oversee food safety activities in different food sectors such as animal-sourced and processed foods. In
addition, central agencies that are responsible for food safety frequently delegate field inspections to local agencies or hire third-party
food safety audit firms to conduct inspections. Here we consider an example of a relatively fragmented - but generally considered to
be highly effective - food safety system in the U.S. Although, as will be described below, the U.S. approach exhibits certain inconsist-
encies in the treatment of food products that pose similar risks to food safety, the U.S. consumers enjoy some of the safest food in
the world (Roberts 2016). While dispersion of food safety activities among multiple federal agencies is frequently viewed as inefficient,
the vertical element of the hierarchy where multiple local agencies are contracted by a central agency is typically less subjected to
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A REVIEW OF BEST FOOD SAFETY PRACTICES

International Experiences and Lessons for Bangladesh

ALEXANDER SAAK

criticisms. The latter organizational feature arises naturally as central governments in large countries (including the central govern-
ment in Bangladesh) typically have limited capacity to enforce food safety regulations at the local level. Many of the deficiencies in
how food safety is regulated in the U.S. arise due to various historical events as well as management costs and disruptions that would
arise as a result of significant changes in the current organizational structure (Note 2007).

Although there have been several legislative proposals to consolidate the food safety, labelling, inspection and enforcement functions
into a single food safety agency, the U.S. food safety system remains highly fragmented with responsibilities for oversight distributed
among multiple government agencies. This fragmentation has its roots in the historical evolution of food safety regulation in the US,
and implies problems of duplication and inefficient resource allocation. In general, a centrally organized food safety system is prefer-
able to a fragmented structure. The two main government agencies responsible for food safety control in the U.S are the Food and
Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) within the US Department of Agriculture (USDA). These
two agencies lead and coordinate the government food safety system that involves a network of 15 federal agencies (including FDA
and USDA) and state and local health agencies. The federal food safety agencies that regulate interstate and international trade derive
their authority from over 30 laws from the 1938 Federal Food, Drug and Cosmetic Act that continues to act as a basis for food laws
today to 2011 Food Safety Modernization Act that only recently fully went into effect. At state and local levels, the intrastate food and
agricultural businesses are regulated by state governments and local health boards that can supplement national laws with their own
regulations and inspection systems.

While the food laws require food manufacturers and distributors, and most recently produce growers, to employ a variety of measures
to ensure that their products are safe and properly labeled, the laws also empower the agencies to take necessary actions to keep
unsafe or misbranded regulated food products out of the marketplace.

3.2.1 Regulation of Food (Except for Meat and Poultry): Food and Drug Administration

The FDA oversees 80% to 90% of the US food supply (it is not responsible for most meat and poultry, processed eggs and some fish
products, which are regulated by the USDA). This includes domestically produced and imported produce, dairy and processed foods
as well as all seafood and shellfish and some fish products (in cooperation with National Oceanic and Atmospheric Administration and
local agencies). The FDA’s mission is to ensure the safety of the food supply and protect and promote public health. To achieve this
goal, the FDA engages in the following activities. First, the FDA sets scientifically justifiable standards for preventing foodborne illness
in order to ensure the safety of food, including fresh produce, food additives and dietary supplements, consumed by humans. Second,
the FDA regulates the safety of animal feed and the safety and effectiveness of animal drugs, including the safety of drug residues in
human food derived from animals. Third, the FDA is responsible for protection of the food and feed supply from intentional contami-
nation. The fourth area of responsibility is ensuring that food labels are truthful and contain reliable information consumers can use
to choose healthy diets.

The agency ensures compliance with food safety standards and regulations through its own field inspection workforce that conducts
inspections of manufacturers or processors of products that are regulated by the FDA (including food processing facilities; dairy farms;
animal feed processors; foreign manufacturing and processing sites; imported products at the border). The FDA also coordinates and
provides funding to state and local regulatory inspection agencies to conduct inspections, offers technical support to health agencies
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A REVIEW OF BEST FOOD SAFETY PRACTICES

International Experiences and Lessons for Bangladesh

ALEXANDER SAAK

and industry, and hires third-party contract inspectors (to certify of foreign food facilities and laboratory testing of imported food
products). 1

However, the state agencies are primarily responsible for carrying out food safety inspections of most food manufacturing facilities
(other than meat slaughter and processing plants) and food retailers and service providers. The FDA cooperates with over 400 state
agencies and works with the states to set the safety standards for food establishments and commodities and evaluates the states’
performance in upholding these and other federal standards.

Internal administrative organization of food safety competencies

The FDA’s unified food program is carried out under the leadership of Office of Foods by the Center for Food Safety and Applied
Nutrition, the Center for Veterinary Medicine, and the foods-related portion of the Office of Regulatory Affairs. Within the Center for
Food Safety and Applied Nutrition the responsibilities for initiation of proposals to reduce food safety risks, setting standards for
domestically produced and imported food and dietary supplements, and providing technical guidance to the industry and state and
local inspection agencies are split between the Office of Food Safety and Office of Food Additive Safety. Regulation of manufacturing
and distribution of animal drugs, animal feed, and veterinary devices is carried out by the Center for Veterinary Medicine.

3.2.1.1 Inspections

Inspections of domestic and foreign food manufacturing facilities

FDA routinely inspects food facilities, often in partnership with state regulatory agencies. The frequency is based on the type of facility,
the type of food processed or handled at the facility, and the public health risk associated with the product. If a facility is found to
need some corrective actions, follow-up inspections are conducted to review the implementation of the corrections. In 2012, there
were 172,969 active domestic food and feed facilities and 285,977 active foreign food and feed facilities that were registered with the
FDA. More than 1,300 FDA’s inspectors (full-time staff years) conducted field activities such as food and feed inspections and investi-
gational activities, which amounts to 290 facilities (domestic and foreign) per inspector. As shown in Table 1, this represents a signifi-
cant decline compared to the historical number of FDA’s inspectors. There were approximately 51,300 domestic food facilities that
were subject to inspection in 2004 - 2008.

Table 1: The number of FDA inspectors, 2003 - 2012

2003 2005 2007 2009 2012

3,167 2,943 2,569 3,019 1,300

1 For a description of FDA’s contracting arrangements with third party certifiers see McAllister (2012).
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ALEXANDER SAAK

Historical inspection rates and outcomes

Since 2004 FDA inspected, on average, less than 29% of food facilities each year, and the number of inspected facilities gradually
declines over time. 56% percent of food facilities were operating for at least 5 years without an FDA inspection. The percentage of
facilities that were not in compliance with food safety standards is typically less than 4% and decreases over time. The reporting, risk-
classification system and registry compilation procedures changed since 2011. In 2012, FDA and the states under contract with FDA
inspected (or attempted to inspect) 14% of registered domestic food facilities and FDA inspected 0.5% of foreign food facilities. Note
that although the share of inspected facilities declines over time, the rate of decline is slower for high-risk facilities that pose the
greatest potential risks to food safety.

Table 2: Domestic Food Facilities Subject to FDA Inspection

Number of Food Facilities Number of Food Facilities In- Percentage of Food Facili-
spected ties Inspected

Total High-risk Total High-risk Total High-Risk

2004 59,305 8,102 17,032 6,241 29% 77%

2005 61,930 8,330 15,773 5,547 25% 67%

2006 62,929 8,347 14,547 5,664 23% 68%

2007 65,520 8,568 14,339 5,535 22% 65%

2008 67,819 8,667 14,966 5,460 22% 63%

2011 172,969 22,235 24,462 11,007 14% 50%

Source: Office of Inspector General Analysis of FDA data, 2009 and 2013.

The number of high-risk animal feed manufacturing firms was estimated to be between 8,000 and 10,000 firms but many of these
establishments were not subject to regulation and inspection. The Center for Veterinary Medicine inspects approximately 10% of high-
risk feed facilities each year.

Inspections of food Imports

In 2012, FDA examined 1.9% of food and feed import lines (entries of products into the U.S.). Electronic screening as well as special
alerts based on evidence such as a history of violations determine which products pose the greatest risk and, therefore, should be
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ALEXANDER SAAK

physically examined. The Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) information technol-
ogy system used data analytics from the entire life cycle of a product to better identify and target high-risk products before they enter
the country. The average cost of physically inspecting or sampling a line of imported food was approximately $160 per field exam and
approximately $3,100 per sample analyzed.

Inspections of local food service providers

Inspections and licensing of restaurants and grocery stores and other food service providers are typically handled by local and county
health departments. However, FDA serves as a scientific and technical consultant to state and local regulatory agencies by publishing
the FDA Food Code, which sets forth model provisions for keeping food safe in restaurant, cafeteria, and institutional food operations.
Most states adopt these model provisions as legal requirements applicable to restaurants and food-service establishments within their
jurisdictions. The following case study illustrates.

3.2.1.2 Food Safety Modernization Act (FSMA)

The 2011 FDA Food Safety Modernization Act (FSMA) (i) introduces more stringent food safety requirements, (ii) shifts the focus of
federal regulators from responding to contamination to preventing it, (iii) provides FDA with new enforcement and inspection author-
ities, and (iv) includes more components of the food supply chain (such as on-farm food safety). For example, all foreign suppliers are
now subject to the same standards as the domestic producers and processors they supply and food safety regulation of fresh produce
for the first time extends to the farm level. The new food law affects the activities of the FDA (not USDA or other agencies involved in
food safety activities).

Table 3: Summary of FSMA and its impacts

Pre-FSMA Post-FSMA
Approach to risk man- Emphasis on monitoring ex post out- Emphasis on risk analysis and prevention
agement comes (product quality and illness out- along the food chain
breaks)
Inspections and infor- FDA is responsible for all inspections, FDA expands scope and frequency of in-
mation gathering scope of inspections is limited to pro- spections, allows for accredited third-
cessing and distribution party audits of foreign production facili-
ties, collects reportable food events infor-
mation from industry and public health of-
ficials
Enforcement Voluntary recalls Mandatory recalls

New inspection, regulatory actions, and reporting programs

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Until FSMA, the emphasis of federal inspection programs was on detecting legal violations and constructing judicial enforcement cases.
Due to concerns about the low frequency of food safety inspections that left many firms uninspected for several years, the goal of
FDA is now to ensure that firms are consistently implementing the modern preventive measures mandated by FSMA. New enforce-
ment authorities allow for food to be detained, the suspension of food facility registration and the ability to issue a mandatory product
recall. All food facilities are required to renew their registration every other year. An electronic system through which industry must
and public health officials may submit reports concerning a reportable food or compliance violations, known as reportable food reg-
istry, has been established to enhance the exchange and provision of information.

Integration of federal and state food safety networks

Historically the challenge to integration has been the differing approaches to food safety adopted in federal and state agencies as well
as the potential lack of uniformity and consistency between laboratories and methods of analysis and sampling. FSMA mandates that
the federal and state authorities achieve greater integration and adopt national food and feed regulatory programs to ensure a con-
sistent approach to inspection. Laboratories undertaking regulatory controls are to be accredited to ISO 17025 relating to the general
requirements for the competence of testing and calibration laboratories and to adopt consistent methods of analysis. It will therefore
be easier to exchange information and as such to identify trends and improve reactions to foodborne incidents.

New Food Safety Rules under FSMA

I. Produce Safety Standards

The rule applies to fruits and vegetables for human consumption that are raw agricultural commodities, and sets stand-
ards for the growing, harvesting, packing and holding of such produce to minimize the risk of serious adverse health
consequences or death. This regulation affects both international and domestic produce growers, in that it establishes
science-based standards focused on the growing, harvesting, packing and holding of produce on-farms. The key provi-
sion areas include agricultural water quality standards and testing, standards for using raw manure and compost, train-
ing, control of domestic and wild animals, equipment, tools, buildings, sanitation as well as worker health and hy-
giene. This on-farm produce safety regulation is significant in that FDA will now put in place an enforceable implementing
regulation which explicitly articulates on-farm standards of conduct for the safe growing, harvesting, packing and holding
of fresh produce.

II. Preventive Control of Human Foods

This rule focuses on preventing problems that cause human foodborne illness. This rule establishes the following require-
ments: Hazard Analysis and Critical Control Points plant – a written plan that specifies risk-based preventive controls
against economic adulteration and pathogen contamination, food allergen, cross-contamination and sanitation controls,
a recall plan, monitoring procedures, and corrective actions. The exempted activities include: certain low risk activities
such as process qualified on farm packing and holding. This rule applies to domestic and foreign facilities that manufac-
ture, process, pack or hold food sold in the U.S.
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III. Foreign Supplier Verification Program

This rules holds importer accountable for complying with the U.S. food safety regulations. Importers are responsible for
conducting risk-based foreign supplier verification activities and ensuring that imported food is not adulterated and is
produced according to FDA’s preventive control requirements and produce safety standards. High risk foods must be
certified by a third-party certifier (including foreign government agencies) accredited by the FDA. The FDA has the au-
thority to deny entry and maintains the registry of foreign food facilities.

IV. Preventive Controls for Animal Feed

This rule extends human food requirements to include the implementation of good manufacturing practices (CGMP)
rules that are applicable to animal food producers. The scope of regulation is now expanded and includes feed mills
associated with farms.

V. Accredited Third-Party Certification

This rules establishes that qualified third parties can certify foreign (not domestic) food facilities as being in compliance
with US food safety standards. The audit report must be made available to FDA. A third-party auditor must immediately
notify FDA of any serious risk to public health or if food is refused elsewhere and consider existing international standards
and accreditation bodies when developing applicable standards.

VI. Mitigation against Intentional Adulteration

This rule addresses intentional adulteration where the intention is to cause large-scale public health harm. This regulation
targets manufacturing processes within a facility that are most likely to be vulnerable, rather than specific foods or haz-
ards. It applies to domestic and foreign food facilities that manufacture, process, pack or hold food, and additionally
requires that managers prepare a food defense plan and conduct necessary staff training.

VII. Transportation

The goal of this rule is to prevent practices in transport that create food safety risks such as not maintaining the integrity
of the cold chain by proper refrigeration, inadequate cleaning and not properly protecting the food. This rule applies to
shippers, receivers, and carriers of food by road or rail and to exporters shipping food to US. Additional requirements
include vehicle and transport equipment and operation requirements, Information exchange, training, records.

A summary of changes

The new approach to food safety under the FSMA can be summarized as follows.

• The focus of FDA regulators is shifted from responding to contamination to one of prevention. Food facilities are required to evaluate
hazards in their operations, implement and monitor effective measures to prevent contamination and to have a corrective action plan
to implement as necessary.
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• FDA’s oversight authority is expanded as FDA is now authorized to (a) increase the frequency of its inspections and (b) allocate
resources to inspect facilities according to the facilities’ known risks, with high risk facilities being inspected more frequently.

• FDA will regulate on-farm food safety practices related to microbial contamination across the wide range of heterogeneous produce
firms.

• Interagency collaboration in various areas such as inspections, seafood safety

and food import is now required by law. However, FSMA does not apply to the federal food safety system as a whole as it excludes
many of the USDA’s responsibilities.

3.2.2 Safety of Meat and Poultry: Food Safety and Inspection Service

FSIS regulates the safety, wholesomeness, and proper labeling of most domestic and imported meat and poultry and their products
sold for human consumption, comprising roughly 10%-20% of the U.S. food supply. In carrying out its responsibilities under these acts,
FSIS places inspectors in meat and poultry slaughterhouses and in meat, poultry, and egg processing plants. FSIS also conducts inspec-
tions of warehouses, transporters, retail stores, restaurants, and other places where meat, poultry, and egg products are handled and
stored.

Federal continuous inspections of domestically produced meat and poultry

Meat and poultry animals and products undergo continuous (i.e., 100%) inspection. FSIS inspects all meat and poultry animals to look
for signs of disease, contamination, and other abnormal conditions, both before and after slaughter (“antemortem” and “postmor-
tem,” respectively), on a continuous basis—meaning that no animal may be slaughtered and dressed unless an inspector has examined
it. One or more federal inspectors are on the line during all hours the plant is operating. Processing plants visited once every day by
an FSIS inspector are legally considered to be under continuous inspection. FSIS’s inspectors monitor operations, check sanitary con-
ditions, examine ingredient levels and packaging, review records, verify food safety plans, and conduct statistical sampling and testing
of products for pathogens and residues during their inspections

Federal inspections of imported meat and poultry

FSIS is responsible for certifying that foreign meat and poultry plants are operating under an inspection system equivalent to the U.S.
system before they can export their product to the U.S. Meat and poultry imports are 100% visually inspected (process-based, docu-
mentation, labeling), although physical inspections of imports may be more random. FSIS conducts evaluations of foreign meat safety
programs and visits establishments to determine whether they are providing a level of safety equivalent to that of U.S. safeguards. In
order to ship meat or poultry to the U.S. a foreign plant must be approved by FSIS.

Local inspections of meat and poultry and agreements with local agencies

27 states operate their own meat and/or poultry inspection programs. FSIS ensures that the states’ inspection programs are equivalent
or stricter than its own inspection program. Plants processing meat and poultry under state inspection can market their products only
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within the state. If a state chooses to discontinue its own inspection program, or if FSIS determines that it does not meet the agency’s
equivalency standards, FSIS starts inspecting plants that were previously state-inspected. FSIS also has cooperative agreements with
more than two dozen states under which state inspection personnel are authorized to carry out federal inspection in meat and/or
poultry plants. Products from these plants may travel in interstate commerce.

Inspection rates

There are about 6300 regulated meat and poultry facilities under USDA’s jurisdiction, which is much smaller than that under FDA’s. In
2015, FSIS’s inspectors conducted inspections in 6,339 establishments and state inspectors performed inspections under federal in-
spectors’ supervision in 350 plants. As in the case of FDA, much of the FSIS’s work is conducted in cooperation with federal, state, and
municipal agencies, as well as private industry.

3.2.3 Budgets for food safety programs and inspection costs

Although FDA is responsible for a considerably greater share of the U.S. food supply, its budget for federal food safety activities (that
covers most food other than meat and poultry) is about a third less than that of FSIS (that only covers meat and poultry), reflecting
the higher risk associated with meat and poultry relative to other foods. Under FSMA the FDA’s budget for food safety activities has
begun to increase including funding through industry-paid user fees.

In 2015, FDA had 3,700 personnel engaged in food safety related activities compared with 8,900 at FSIS. The differences in the number
of staff at each agency reflects the requirements and nature of inspections of different food products. FDA inspection involves primar-
ily inspection of facilities, review of records and documentation, and sampling and testing for contamination. Although all plants over-
seen by FSIS are visited daily, inspections of meat and poultry conducted by FSIS operate differently in slaughter and processing plants.
FSIS’s inspectors examine all meat and poultry animals at slaughter on a continuous basis, requiring that at least one federal inspector
is on the line during all hours the plant is operating. Inspection at processing plants does not require an FSIS inspector to remain
constantly on the production line or to inspect every item. Instead, inspectors are on site daily to monitor the plant’s adherence to
the standards for sanitary conditions, ingredient levels, and packaging and to conduct statistical sampling and testing of products.

In 2012, FDA had a budget of $145.2 million for inspection of domestic facilities and $34.7 million for FDA inspection of foreign facilities
or, respectively, 0.03% and 0.07% of the value of domestically produced and imported food regulated by FDA. These expenditures
include appropriations used to inspect facilities that manufacture food for human consumption and post-market inspections con-
ducted for FDA’s Center for Veterinary Medicine, with the exception of veterinary drug inspections. FDA allocated $18.6 million (13%
of its budget for domestic inspections) to state agencies, through contracts, to perform domestic inspections on its behalf. These
figures do not include the cost of inspections at the border (i.e., sampling and field examinations) since this function is not performed
in registered facilities, nor does it include costs for functions such as laboratory analyses or criminal investigations. In 2012, the average
inspection costs were $15,500 per high-risk domestic food facility inspection, $9,200 per non-high-risk domestic food facility inspec-
tion, and $23,600 per foreign high-risk food facility inspection. In addition to the risk level, the cost of doing an inspection is affected
by such factors as the size of the facility (the number of employees and square footage), the complexity or level of automation of the
manufacturing process, and the volume and number of different products produced at the facility.
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4. ORGANIZATION OF PUBLIC FOOD SAFETY REGULATION: BEST OPERATIONAL

PRINCIPLES
High quality of inspections: training and modern technology

A food safety system cannot be effective without a high level of expertise in implementing food safety regulations. This requires on-
going training of all inspection personnel. To implement risk-based inspections, inspectors and their supervisors need to exercise
considerable discretion in deciding which facilities to visit and scheduling of inspections and re-inspections. Inspector training varies
depending on the types of inspections to be performed. Specialized courses need to be developed depending on whether an inspector
oversees animal slaughter or processing facilities, imported food at a border entry, or food service establishment.

In effective food safety agencies, inspectors provide concrete advice to the food enterprises on ways to improve future audits and,
therefore, the level of food safety at the enterprise. For example, in a study of food safety inspections of small processors in the US,
Buckley (2015) finds that state inspectors took a collaborative, assistive approach which appeared to benefit processor operations and
improve compliance.

In their study of regulatory inspections by FDA, Macher et al (2011) find evidence of substantial inspector heterogeneity. Outcomes
of inspections depended on the investigator-specific factors such as the amount and type of training received by investigators, time
on-the-job, and the level of the accumulated knowledge and experience of an investigator. There is also evidence that training of
inspectors and improvements in inspection technology can enhance objectivity of inspections. For example, Jin and Lee (2014) show
that a small innovation in inspection technology – adoption of the handheld digital device to record violations during restaurant hy-
giene inspections - substantially increased the rate of detection of violations and increased restaurant compliance efforts as well as
reduced restaurant-related foodborne disease outbreaks.

Risk-based inspections and sampling

The Codex Alimentarius (WHO and FAO 2007) codifies a risk-based approach as the best practice for food safety regulations. As Hoff-
mann and Harder (2010) state: “A consensus has emerged among nations about the basic components of an effective food safety
system based on modern science and management practices. In shorthand, the vision is of a farm-to-fork, risk-based, scientifically
supported safety control system.”

Although prioritization of the limited inspection capacity based on risks posed to consumers seems uncontroversial, even mature food
safety systems such as the one in the U.S. continue to rely on a mix of risk-based and non-risk-based approaches to inspections. For
example, FDA adopts a risk-based approach such that inspection rates vary depending on the level of risk associated with a food
product. However, FSIS’s inspectors examine all animals before slaughter and all processing plants that it regulates. As FSIS’s inspec-
tions are continuous, it necessarily allocates similar efforts and resources to inspecting low-risk and high-risk meat and poultry plants
and food processing facilities. A frequently cited example compares inspection rates by FDA and FSIS at facilities producing pizzas with
cheese and pepperoni toppings. FDA regulates production lines at the facilities producing cheese pizza and inspects them once every
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5 years. FSIS regulates production lines at the facilities producing pepperoni pizza and inspects them daily. Both types of pizza are
generally considered low risk foods as the process of cooking eliminates foodborne pathogens.

While continuous inspections are feasible in some cases such as visual inspections of animal carcasses, the frequency of sampling and
testing of food is constrained by laboratory and personnel capacity. For example, the FDA’s PREDICT technology varies the frequency
of sampling of food products based on the presence of warning signs. Such indications include non-conformities in documentation,
history of violations or poor performance of a particular domestic firm or producer, or notification of food safety risks associated with
a certain product placed through the international Rapid Alert System or a regional system.

From farm-to-fork approach and traceability

The “farm-to-fork” approach ensures compliance with food safety regulations and traceability of products throughout the entire food
value chain. Even some of the mature food safety systems only recently have fully adopted this approach. For example, in the U.S.
under the 2011 FSMA, FDA now regulates on-farm food safety practices with respect to microbial contamination during the production
of raw fruits and vegetables. Under the FSMA Preventative Controls Rule, FDA also regulates domestic and foreign food processing
and storage facilities and inspects their compliance with HACCP plans. Furthermore, FSMA also contains provisions for the FDA’s reg-
ulation of intermediary transportation and food retail and service providers to ensure compliance with temperature, humidity, atmos-
pheric and handling food safety norms.

Traceability requires that food and feed businesses – including growers, processors, transportation intermediaries, retailers, and im-
porters – ensure that all foodstuffs, animal feed and feed ingredients can be traced through the entire food chain. Each business must
be able to identify its supplier and which businesses it supplied. This is known as the ‘one step-backward, one-step-forward’ approach.
This allows food safety authorities to trace the movement of food products all the way back up the production chain – including live
animals, animal-based products or plants are involved - whenever there is a significant outbreak of animal disease or food poisoning
affect consumers. For example, in the EU the traceability and risk-management functions are carried out by TRACES (Trade Control
and Expert System), an electronic system of border controls and certification for traded goods.

Early warning and foodborne-disease surveillance system

In order to protect consumers from food that does not comply with safety rules, effective food safety systems operate a rapid early
warning system. For example, in the EU the rapid warning system spots whether foodstuffs contain banned substances or excessive
amounts of high-risk substances, such as residues of veterinary medicines in meat or carcinogenic colorings in food. When a threat is
spotted, alerts go out across the EU. Blocking a single batch may be all that is needed, but all shipments of a particular product from
a farm, factory or port of entry will be stopped if necessary, and products delivered to warehouses and retail outlets may be recalled.

Similar systems exist or are being developed in other countries with mature food safety systems. For example, the U.S. Active Food-
borne Disease Surveillance System relies on collaboration of multiple agencies to conduct population-based active surveillance of most
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common bacterial foodborne pathogens and determine - through a series of surveys of laboratories, physicians, and the population -
the magnitude of diarrheal illnesses and the proportion of these illnesses that are attributable to foods.

Transparency

To increase transparency of operations and performance and accountability of inspectors, many governments rely on a central register
of food and agricultural enterprises. A central register provides data necessary to evaluate aggregate performance of an inspectorate,
improve design of risk-based inspection programs, and reduce duplication of inspections.

Public disclosure of outcomes of government food safety audits and testing also enhances the effectiveness of regulation of food
safety. In the U.S., for example, public disclosure of outcomes of testing for pathogen contamination in poultry plants by a government
food safety agency led to significant improvements in their subsequent performance (Ollinger et al 2017). In the case of China, Mol
(2014) finds evidence of greater disclosure of information pertaining to food safety in supply chains that are oriented towards export
rather than domestic markets and suggests that more food chain transparency would be beneficial.

Unified administrative structure

The majority of high-income countries have, at least to some extent, consolidated their food safety systems (GAO 2005). Concentrating
food safety inspection authority in a single agency (for example, the Danish food safety system) has important benefits when com-
pared to a food safety system where responsibilities for oversight of different food sectors and products are dispersed among multiple
agencies (e.g., the U.S. food safety system). A single agency system yields improvements in several areas of food safety operations:

• Improved service delivery by providing a single contact for consumer and industry clients

• More consistent and timely enforcement of food safety laws and regulations

• Reduced overlap in inspections

• Clearer responsibilities and reduced gaps in oversight.

• Streamlined communications

• Increase coordination among entities involved in food safety activities

• Frequency of inspections can be more effectively based on risk

• Improved accountability and transparency of inspection process and disclosure of outcomes

• Unified position when dealing with international organizations or trade partners

• Improved information systems

• Reduced average inspection costs due to more effective sharing of resources

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Harmonization of food safety standards and inspection procedures

Food safety is also enhanced through the harmonization of laws, regulations and standards between and among trading partners. For
example, the U.S. FDA recognizes food safety systems of New Zealand, Canada and Australia as comparable to each other in food
safety laws and regulations, inspection programs, response to food-related illness and outbreaks, compliance and enforcement and
laboratory support. Mutual recognition allows to (i) better coordinate regulatory efforts to help ensure food safety including taking
into account exporting country’s inspections when prioritizing one’s own domestic and foreign facility inspections and import sam-
pling, (ii) improve responses to outbreaks of foodborne diseases, and (iii) promote international trade and scientific collaboration.

Note that the countries that participate in these mutual recognition arrangements have mature food safety systems. A country that is
in the process of establishing a food safety authority such as Bangladesh can begin by ensuring that its food safety standards and
inspection procedures satisfy the internationally accepted practices established by the Codex Alimentarius and the 1995 SPS agree-
ment (Agreement on the Application of Sanitary and Phytosanitary Measures) and other WTO (World Trade Organization) require-
ments (Unnevehr and Hoffman 2015). This will allow exporters with effective food safety management systems to access international
markets and may increase food safety of the domestically produced and imported food as well.

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Alexander Saak was a Research Fellow at IFPRI at the time of writing this paper. He is currently employed by the Internal Revenue
Authority of the United States Government.

INTERNATIONAL FOOD POLICY RESEARCH INSTITUTE

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