Food Safety

FOOD SAFETY
Food safety refers to the proper food handling procedures applied during food preparation,
processing, storage, and distribution of the products you deal with in your food business. The
concern for the integrity of food safety lingers within all the parts of a food supply chain. The
concern for the food production life cycle starts from agriculture to packaging of finished
products and delivery to the consumer's table.
Controlling food safety requires knowledge about what could endanger its integrity and
stability. Food safety is negatively affected by contaminations along your food supply chain.
These contaminations can be caused by biological, chemical, physical, and radiological
hazards that can affect all key junctures of your operation. Without the proper management
and control of food safety, issues such as foodborne diseases and food-related injuries can
occur.
Food handling practices that can be applied to keep food products wholesome are what is
food safety made up of. All of the members of the food supply chain must comply with
established standards and legislation to maintain food safety. Proper handling and industrial
processes may include cooking at the right internal temperature to prevent undercooked meat,
preventing cross-contamination through proper segregation to prevent contact, storing foods
at proper refrigeration temperatures, and other critical control points that help render potential
infectious diseases ineffective.
Additionally, consumers also play a significant role when it comes to food safety. Customers
are expected to follow storage and processing directions for the products they purchase,
especially if these are raw materials. Participation of consumers towards food safety is also
seen through their demand for high-quality, safe products and voicing their complaints if
there are food safety issues.

Why is food safety important?
Recent data released by the World Health Organization have estimated that at least 600
million people all over the world become inflicted with foodborne illnesses after consuming
unsanitary food. Of these people, at least 420,000 people die every year. Economic progress
can become affected by productivity loss and medical expenses as a result of a foodborne
disease burden.
The majority of food safety issues are caused by pathogenic microorganisms such as bacteria
that cause food poisoning or food intoxication. They can cause mild to fatal health
consequences that include watery diarrhea, vomiting, abdominal pain, or even debilitating
infections and long-term diseases. The consequences of food safety issues may have fatal
outcomes for both food business owners and consumers.
Basic and everyday foods can easily become contaminated. Some examples of foods
involved in common illnesses include high-risk ingredients and any perishable food such
as eggs, poultry, fresh fruits, raw meat or deli meats, deli seafood salads, undercooked
seafood, ground meat, raw sprouts, and raw milk products. These ingredients can become
contaminated by intestinal pathogens such as bacteria and cause infection if preventive
measures are not applied.
Here are a few reasons why it is important to keep food safety controlled:
 Protection from foodborne illnesses and other food-related injuries. The main

objective of food safety is to protect consumers of food products from foodborne
diseases or injuries related to food consumption. Foodborne illnesses are a major
threat to food businesses and affect everyone all over the world as a result of
inadequate food safety. These effects are mainly caused by foodborne pathogens that
may include harmful bacteria, fungi, yeasts, parasites, or viruses. Additionally,
chemical substances, heavy metals, and excessive additives can also cause foodborne
illnesses and acute poisoning. Depending on the nature of your products, a pathogen
is expected to thrive with inadequate food safety control measures. Foodborne
infections and injuries can also arise as a result of physical hazards such as shards of
glass, pieces of metals, or any hard objects that have contaminated your food in
production. With proper food safety measures, you can assure that the food you serve
safe food and that the chance of infection is low.
 Reduced cost from food safety issues. Unsafe food with proven safety issues may be
deemed unfit for consumption and may merit being disposed of. Defective product
recalls cost companies more and will affect your profits and can even cause business
closure. The cost of food recalls is not only seen in terms of profits. If the food safety
issue has reached a widespread scale, you may be liable to pay for medical expenses
or lawsuits concerning damages. On the side of consumers, proper food safety
practices can reduce costly health care expenses from less risk of disease occurrence.
Consuming unsanitary food may lead to hospitalization and contribute to the cost of
health care.
 Reduce waste. Food products that have been proven to have food safety issues may
be subjected to disposal. Through the use of proper food safety practices, a food
business can cut waste as a result of a better food production process. Food safety
management systems are also designed to detect and control food hazards even before
they enter production which can lead to more waste if processed further.
 A better way of living. Any foodborne illness affects productivity in consumers.

Once afflicted, consumers will be able to function well and may even need
hospitalization in extreme cases. These events cause dramatic disruptions in everyday
activities. If food safety practices are applied both in a food service establishment and
at home, these cases can be prevented. Everyone can enjoy the delights that foods
bring and healthy life without the inconvenience and dangers of food safety hazards.
 Sustainable food production. Some food production practices have already received

backlash from different communities because of the negative effects they contribute
to the environment. Proper food safety practices include food manufacturing
processes that not only protect the consumer but also take into account the
environment. Practices such as reducing synthetic fertilizers that can leach into food
products are controlled under food safety legislation. In addition, food safety practices
include assurance of clean drinking water and the reduction of air, sewage, and other
environmental pollutants, which significantly contribute to the environment. These
practices go a long way. Contaminated water can easily affect all other ingredients
and enter the human body since water is a key ingredient in almost all processes.
 Safer food globalization. All laws about food safety are designed to protect
consumers from food safety issues. Adhering to these comprehensive guidelines
makes your products as competitive as possible, especially in the fast-paced
globalization of the food industry. With proper food safety management systems,
routes to a broader distribution channel become open for your food business.
GLOBAL AND LOCAL SCENARIO OF FOOD SAFETY
Global/ Pakistan health and nutrition burden

According to the economic survey there is consistent increase in the health budget each year.
Data revealed in economic survey 2017 demands solid food safety policy which will be
effective to decrease the public health burden of the country and will uplift the living
standard of the people. Public health burden of Pakistan is shown in graph 1. Public health
burden and GDP % is shown in graph 2.
A study was carried out to investigate the microbial load of fresh vegetables in Multan city.
Vegetables are grown near the cities by irrigating with sewage water. Sewage water is a
potential contaminator of these fruits and vegetables and contributing to the outbreak of food-
borne illness. These vegetables contained a higher microbial percentage of Staphylococcus
aureus, Pseudomonas aeruginosa, E. coli, Enterobacter spp. and Salmonella spp. to be 48%,
60%, 48%, 64%, and 8%. Another study indicated that eatables such as burger, chaana chart,
and fruit chart, and samosa have alarmingly high total coliform, S. aureus,
and salmonella spp. count. This microbial infestation has been propagated by the street
vendor preparing these eatables in non-hygienic and unsanitary conditions. Street vendors are
a major contributory to increasing food-borne illness.
Water is the basic necessity and required to sustain life. The importance of water has been
revealed in Holy Quran. Life has been created with water. Contaminated water is out
breaking gastrointestinal as well as chronic liver disease. The situation is more miserable in
the urban population rather than the rural population. Water is being contaminated by various
environmental and biological factors. Water horizon below the soil is being polluted by
synthetic fertilizers, pesticides, and herbicides. Intake of contaminated water is causing
foodborne illness. Among the food bore illness diarrheal problem is the overwhelming and
major contributor of infants’ mortality. E. coli, Citrobacter, Enterobacter, and Kiebsiella
species are the major contaminator of water among bacteria. In Pakistan, only 20 %
population has access to safe drinking water. Waterborne disease contributing to 80% of all
diseases and 33 % of all death.
Water is the basic necessity and required to sustain life. The importance of water has been
revealed in Holy Quran. Life has been created with water. Contaminated water is out
breaking gastrointestinal as well as chronic liver disease. The situation is more miserable in
the urban population rather than the rural population. Water is being contaminated by various
environmental and biological factors. Water horizon below the soil is being polluted by
synthetic fertilizers, pesticides, and herbicides. Intake of contaminated water is causing
foodborne illness. Among the food bore illness diarrheal problem is the overwhelming and
major contributor of infants’ mortality. E. coli, Citrobacter, Enterobacter, and Kiebsiella
species are the major contaminator of water among bacteria. In Pakistan, only 20 %
population has access to safe drinking water. Waterborne disease contributing to 80% of all
diseases and 33 % of all death.
Pakistan: Present scenario of food safety
Globalization and urbanization have increased the food demand for the population. Ensuring
the population health extensively needs food safety measures. Street vendors involved in the
eatable business and household have to be focused to create mass awareness of the food
chain, food born contamination, ways to prevent/reduce instant food contamination,
sanitation, and hygienic conditions. Globally food safety has got attention in Uruguay round
1995 during the international trade conference. Food regulations and standards are being
observed throughout the production, processing, and consumption chain to ensure food
safety. Punjab province has taken the initiative taking into consideration of food safety
importance formulated Punjab food Authority Act, 2011 which has been followed by KPK in
2014. Two provinces of Pakistan have an organization for the standardization and regulation
of food standards. Punjab Pure Food Rules cover about 104 food items with nine broader
categories. Food safety is not only a national need now. International trade prerequisite the
food safety measure for the export of the food items either raw or processed. ISO (The
International Organization for Standardization) is an international standard-setting body. It is
headquartered in Geneva, Switzerland, with 162 member countries. USA, EU, and the
majority of Gulf countries allow the import and export of eatables if have the food safety
certification. The government of Pakistan has adopted 22070 ISO Standards and developed
8857 Pakistan Standards. Food Standards are aligned with Codex Alimentarius Commission
and traceable with WHO.
Food safety technologies and policy
Production chain of fruit and vegetables should be critically evaluated by considering the
sources of infection. No innovative antimicrobial chemical available that could be applied
effectively and efficiently to remove pathogenic microbes (Plantation to production).
Contamination at production can multiply the microbial load, hence could increase its
pathogenicity. Washing of fruit and vegetables at production site in running water can
effectively reduce its pathogenic load and make it safer for human consumption. Disinfection
could also reduce the microbial up to the extent to make farm produce more safe and healthy.
Government and food safety regulatory organization should provide resources and technical
guidance to the producer to make their produce safe.
Food safety requirements for processing premises
Processing premises should opt appropriate location and design, equipment design, pest
control, waste management, sanitary measures. Personnel hygiene, appropriate handling,
packaging and storage and training of staff to ensure end product safety.
Food safety requirements related to processing
Food safety can ensure by proper food processing operations including use of food additives,
food preservatives, flavoring, antioxidants, antimicrobial agents to ensure the quality and
safety of processed food.
Food safety certification in Pakistan
Following are the organization involved in the food safety certification. The following
certification agencies should address the food safety issue at gross root level. Being
developing country our food business is predominately run by the street vendors.
Comprehensive action plan is needed to address the food vendors regarding their knowledge
about safe food, its handling and health hazards for using un safe food. SGS Pakistan (Pvt.)
Limited, Systems and Servicer Certification Supporting an organization’s aims and
objectives, an ISO 9001, ISO 22000 QMS documents the processes, procedures, and
responsibilities for achieving quality policies and objectives. Based on eight quality
management principles, the ISO 9001:2015 standard defines the way an organization operates
to meet the requirements of its customers and stakeholders including customer focusing,
leadership, and involvement of people, process approach, organizational context, continual
improvement, fact-based decision making and risk-based thinking.
Bureau Veritas Certification (BV Certification) enable organization compete in the global
food and beverage industry, players must demonstrate that their products, processes and
services meet the highest levels of safety, quality and responsibility, while keeping up with
evolving trends and market demands. Whether you are a food manufacturer, processor,
importer, supplier or retailer, stringent industry and regulatory standards, and complex,
globalized supply chains are making this an increasingly challenging task.
Certification Services Pakistan (CeSP) is a Conformity Assessment Body established to
provide certification, training and inspection services as per requirements of National and
International Standards like Quality Management System (QMS), Environment Management
System (EMS), Occupational Health and Safety Management System (OHSAS), Food Safety
Management System (FSMS) and Information Security Management System (ISMS), Halaal
Food Management System (PS 3733), personnel certification, product certification,
inspection services and/or any other field of certification emerging from time to time. CeSP
team includes qualified and competent management system auditors, trainers and support
staff committed to provide professional and value added services to its customers. Provincial
food authorities entrusts the following functions and responsibilities to regulates and
monitors the food business in order to ensure compliance by farmers, manufacturers,
distributors, importers and other stake holders in orders to provide safe food, formulate
standards, procedures, processes and guidelines in relation to any aspect of food including
food business, food labeling, food additive, and specify appropriate enforcement systems,
enforcement of food safety and quality standards, specify procedures and guidelines for
setting up and up-gradation of food laboratories, specify licensing, prohibition orders, recall
procedures, improvement notices and prosecution in the court of law, provides scientific
advice and technical support to the Government in matters relating to food safety,
establishment of food laboratories, organize training programme in food safety and standards,
promote general awareness regarding food safety and standards, certify food products/items
for export, forward and backward traceability of food items and surveillance including
collection, integration, analysis, interpretation and dissemination of data related to food and
nutrient intakes.
REGULATING FOOD SAFETY

In the U.S., food safety regulations may be declared by legislative bodies, such as Congress,
while state and local regulatory agencies handle the retail food segment and other food safety
issues through state legislative bodies or local town ordinances and bylaws. State and local
regulatory agencies may adopt or modify the federal standards. If they adopt the minimum
federal standards with changes, however, these changes must be more stringent than the
federal minimum standards.
The USDA and FDA, as mandated by Acts of Congress, regulate food safety interstate under
their respective statutory authorities, codified in the Code of Federal Regulations. Both the
FDA and USDA have provisions written into the acts that regulate their segment of the food
supply individually, yet they also have cooperative inspection programs that work together.
State Food Protection Programs, such as a state’s department of agriculture or public health,
are responsible for the enforcement of regulations adopted by state legislation.
Food safety legislation and regulation

The Food Act 2006 (the Act) is the main food safety legislation in Queensland and applies to
all Queensland food businesses. The objectives of the Act are to:
 ensure food for sale is safe and suitable for human consumption
 to prevent misleading conduct in relation to the sale of food
 to apply the Australia New Zealand Food Standards Code.
The Act manages food safety according to the level of risk that the food business presents to
the community. The higher the level of risk, the higher the level of food safety regulation.
There are other pieces of food safety legislation in Queensland that address food safety at a
different level of the food supply chain:
 Food Regulation 2016 (the Food Regulation)—prescribes details in relation to
licensable food businesses, display of licence details by mobile premises, isolation of
contaminants in food and fees for applications.
 Food Production (Safety) Act 2000—regulates the production of primary produce for:
o egg and egg products
o dairy produce
o meat and meat products (including pet meat and rendered products)
o seafood
o horticulture (see sprouts)
 Food Production (Safety) Regulation 2014—sits under the Food Production (Safety)
Act 2000 and sets out the Food Safety Schemes that business must implement.
Enforcement of the Act is a joint responsibility of Queensland Health and local government.
Enforcement of the Food Production (Safety) Act 2000 in Queensland is the responsibility
of Safe Food Production Queensland. The Act does not apply to therapeutic products
including dietary aids and supplements registered by the Therapeutic Goods Administration.
To determine if a product is a food or a medicine, the Food-Medicine Interface Guidance
Tool can be used.
Modern day food safety regulations were developed on sound scientific principles to protect
consumers from incidents of foodborne illness and death. In the modern information age of
24-hour news cycles and social media, expectations have changed drastically from 100 years
ago. Consumers are now aware of food safety incidents the minute they happen, sometimes
even before the implicated companies are informed.
Food represents one of the largest globally traded commodities and can pose a major safety
risk if not controlled. With globalization, the supply chain must be carefully monitored to
ensure imports meet food safety regulations and are free from tampering.
Governments around the world are acting swiftly to update and modernize their legislation.
Adopting industry-leading best practices, food safety regulations are increasingly outcome-
based and transparent. Governments are also seeking to harmonize their food safety
regulations across borders to keep the flow of goods moving seamlessly through the supply
chain.
Each government has a different interpretation of what constitutes risk for its citizens. But in
recent years, the United States and Canada have made sweeping changes to food safety
regulations with the Food Safety Modernization Act and the Safe Food for Canadians Act.
From Germany to New Zealand to China, governments have a vested interest in ensuring that
their food products are safe to eat and comply with food safety regulations.
Information on recent food safety regulations and regulatory bodies can be found below.
Click on the links for more details on domestic and foreign supply requirements:
United States
The Food Safety Modernization Act (FSMA): Published by the United States’ Food and
Drug Administration (FDA), the FSMA addresses how food safety is regulated. It allows the
FDA sweeping powers to monitor the private sector in regards to food safety issues.
Canada
The Safe Food for Canadians Act (SFCA): The SFCA was published by the Canadian Food
Inspection Agency (CFIA). It strengthens food safety rules, provides new ways for food
inspectors and laboratories develop to operate effectively, and keep consumers updated on
food safety issues.
Europe
The European Food Safety Authority (EFSA): The EFSA is the European Union (EU) risk
assessment body regarding food and feed safety. In close collaboration with national
authorities and in open consultation with its stakeholders, EFSA provides independent
scientific advice and clear communication on existing and emerging risks. EFSA is an
independent European agency funded by the EU budget that operates separately from the
European Commission, European Parliament and EU Member States.
Australia and New Zealand
Food Standards Australia New Zealand: A bi-national government agency, it develops and
administers the Australia New Zealand Food Standards Code. The Code lists requirements
for foods including additives, food safety, labelling and Genetically Modified foods.
Enforcement and interpretation of the Code is the responsibility of state and territory
departments and food agencies within Australia and New Zealand.
Argentina
The National Food Safety and Quality Service/ Servicio Nacional de Sanidad y Calidad
Agroalimentaria (SENASA): SENASA is an independent agency of the Argentine
government charged with surveillance, regulation and certification of products of animal and
plant origin. The agency is in charge of the prevention, eradication and control of diseases
and plagues. SENASA formally comes under the Secretariat of Agriculture, Livestock,
Fishing and Food, a division of the Ministry of Economy.
Brazil
Numerous agencies and Ministries share jurisdiction for ensuring the safety of the Brazilian
food supply. The Ministry of Agriculture, Livestock, and Food Supply (MAPA) and the
Ministry of Health (MS) – through its National Agency of Sanitary Surveillance (ANVISA) –
are the primary regulators of agricultural products. MAPA oversees and enforces a large
number of regulations pertaining to production, marketing, import and export of animal
origin products, fresh fruit and vegetables, alcoholic beverages, juices, grains, seeds, and
animal feed (including pet food). ANVISA enforces most of the regulations regarding
processed food products. MAPA and ANVISA’s regulations may be consulted on-line.
China
The China Food and Drug Administration (CFDA): CFDA was founded on the basis of
the former State Food and Drug Administration (SFDA). In March 2013, the regulatory body
was rebranded and restructured as the China Food and Drug Administration, elevating it to a
ministerial-level agency. The CFDA replaced a large group of overlapping regulators with an
entity similar to the Food and Drug Administration of the United States, streamlining
regulation processes for food and drug safety. The CFDA is directly under the State Council
of the People’s Republic of China, which is in charge of comprehensive supervision on the
safety management of food, health food and cosmetics and is the competent authority of drug
regulation in mainland China.
ESTABLISHING THE SAFETY OF FOOD COMPONENTS
A comprehensive food safety program is built on an effective and thorough food safety plan.
However, some companies may use a HACCP plan instead, which refers to “Hazard Analysis
and Critical Control Points.” Here’s a closer look at the difference between HACCP and food
safety plans and how both can promote food safety compliance:
HACCP Plans
HACCP plans are designed to preventively identify and address risks and hazards associated
with specific foods or production processes required by the FDA for the juice and seafood
industries. Their goal is to control the reasonably likely hazards, including microbiological,
physical, and chemical risks. HACCP plans can be streamlined and standardized across
facilities and departments with software that supports HACCP. There are seven core
principles of HACCP that together, promote ongoing food safety compliance:
Conduct a hazard analysis.
In this step, you must list the detailed steps involved in the processing and identify those in
which significant hazards are likely to occur. Then, focus on the hazards which can be
prevented, eliminated, or controlled through an effective HACCP plan.
Determine critical control points (CCPs).
CCPs are steps, points, or procedures at which actions can be taken to reduce a food safety
risk. Some examples include:
 Chilling
 Thermal processing
 Testing for metal contaminants
 Testing for chemical residue
 Establish critical limits.
Critical limits (CLs) are the minimum and/or maximum values to which physical, biological,
or chemical, measures must be controlled to reduce or completely eliminate a hazard. These
may include metrics such as weight, temperature, time, or other parameters controlled by
regulatory standards.
Establish monitoring procedures.
Food safety teams must also establish and adopt monitoring procedures to measure CLs at
each CCP in their process. The HACCP plan should also detail how the measurement will be
taken and when and by whom.
Establish corrective actions.
When a deviation in CLs occurs, corrective actions are used to address and prevent hazards.
This should include the identification and resolution of the issue itself as well as steps that
will be taken to prevent it from happening in the future.
Establish verification procedures.
Verification activities determine the validity of the HACCP plan and ensure operations are
running according to the plan. Food safety teams may use verification activities such as
reviewing records, auditing CCPs, calibrating instruments, and testing products.
Establish record-keeping and documentation.
Recordkeeping is a key component of any HACCP plan. While records detail all the
information about the plan for employees to reference, they can also be used as proof that
food was made safely during audits. Documentation should include the plant’s hazard
analysis, CCPs, CLs, monitoring system, corrective actions, recordkeeping procedures, and
verification activities.
Food Safety Plans
While the FDA does not require HACCP plans for all food groups, any companies that fall
under the FDA’s Food Safety Modernization Act (FSMA) must have a written food safety
plan for compliance with the Human Food Rule. A food safety plan encompasses HACCP
principles.
The FDA notes that a food safety plan “consists of the primary documents in a preventive
controls food safety system that provides a systematic approach to the identification of food
safety hazards that must be controlled to prevent or minimize the likelihood of foodborne
illness or injury. It contains a collection of written documents that describe activities that
ensure the safety of food during manufacturing, processing, packing, and holding.”
A food safety plan should include a hazard analysis, preventive controls, monitoring
procedures, corrective actions, and verification procedures like a HACCP plan. The FDA also
requires:
 Documented records illustrating how the plant is implementing the food safety plan
 A preventive controls qualified individual (PCQI) who designs or oversees the food
safety plan
 Signing and dating upon plan creation and every update made thereafter
 Reassessment of the plan at a minimum of two-year intervals

IMPACT OF FOOD PROCESSING ON NUTRITIONAL QUALITY AND
FOOD SAFETY
Almost all food is processed in some way before it is eaten. Commercially, the main reasons
to process food are to eliminate micro-organisms (which may cause disease) and to extend
shelf life. Simply cooking or combining a food with other foodstuffs to create a recipe is also
considered a form of food processing. Whatever the case, the nutrient value of any food is
often altered by the processing.
Effects of processing and storage of food
Some vitamins are more stable (less affected by processing) than others. Water-soluble

vitamins (B-group and C) are more unstable than fat-soluble vitamins (K, A, D and E) during
food processing and storage.
The most unstable vitamins include:
 folate
 thiamine
 vitamin C.
More stable vitamins include:
 niacin (vitamin B3)

 vitamin K
 vitamin D
 biotin (vitamin B7)
 pantothenic acid (vitamin B5).
Processes affecting food nutrient content
A variety of things can happen during the growing, harvesting, storage and preparing of

food that can affect its nutritional content. Processes that expose foods to high levels of heat,
light or oxygen cause the greatest nutrient loss.
Fertilisers
Most plant crops are produced with the aid of fertilised soils. High use of nitrogen fertilisers
tends to reduce the vitamin C content in many fruit and vegetable crops. It does not seem to
make any difference to the plant’s nutrient value whether the fertiliser is organic or not.
Milling
Cereals such as wheat can be ground to remove the fibrous husks. The husks contain most of
the plant’s dietary fibre, B-group vitamins, phytochemicals and some minerals.
That is why products such as white bread are less nutritious than wholemeal varieties, even if
they have been artificially fortified with some of the nutrients that were lost after milling.
It is impossible to add back everything that is taken out, especially the phytochemicals. The
‘fibre’ that is added back to some products is often in the form of resistant starch, which may
not be as beneficial as the fibre removed.
Blanching
Before a food is canned or frozen, it is usually heated very quickly with steam or water. The
water-soluble vitamins, including vitamin C and B-complex, are sensitive and easily
destroyed by blanching.
Canning
Food is heated inside the can to kill any dangerous micro-organisms and extend the food’s
shelf life. Some types of micro-organisms require severe heat treatment and this may affect
the taste and texture of the food, making it less appealing. Preservatives are generally not
needed or used in canned foods.
Water-soluble vitamins are particularly sensitive to high temperatures. Many people believe
that canned foods are not as nutritious as their fresh counterparts, but this is not always the
case, as fresh food often deteriorates more rapidly than canned foods.
Freezing
The nutrient value of a food is retained when it is frozen. Any nutrient losses are due to the
processing prior to freezing and the cooking once the frozen food is thawed.
Pasteurisation
Pasteurisation involves heating liquid foods such as milk and fruit juices to specific
temperatures to destroy micro-organisms. The nutrient value of milk is generally unaffected.
In the case of pasteurised fruit juices, some losses of vitamin C can occur.
High pressure processing
This alternative preservation method subjects a food to elevated pressures, with or without
the use of heat to kill micro-organisms. This method has been used in foods such as fruit
juices. As heat is not required, this process impacts less on the vitamin content, flavour and
colour of foods.
Dehydrating
Drying out foods such as fruits can reduce the amount of vitamin C they retain, but it can also
concentrate other nutrients, particularly fibre in plant foods. Dehydrating food also makes
food products more energy dense, which may contribute to weight gain. If a dehydrated food
is reconstituted and cooked with water, further nutrients are leached out of the food and lost
in the cooking water.
Preparation of vegetables
Most vegetables are peeled or trimmed before cooking to remove the tough skin or outer
leaves. But most nutrients, such as vitamins, tend to lie close to the skin surface, so excessive
trimming can mean a huge reduction in a vegetable’s nutrient value.
Losing nutrients through cooking
Some vitamins dissolve in water, so you lose your vitamins to the cooking water if you prefer
to boil your vegetables. For example, boiling a potato can cause much of the potato’s B and C
vitamins to migrate into the boiling water. It is still possible to benefit from these nutrients if
you consume the liquid, for example, by turning the potato and the liquid into a soup.
Alternative cooking methods such as grilling, roasting, steaming, stir-frying or microwaving
generally preserve a greater amount of vitamins and other nutrients.
Benefits of cooking food
It would be inaccurate to say that cooking food always lessens the nutrient value. Cooking
can be advantageous in many ways, including:
 making the food tastier

 breaking down parts of vegetables that would otherwise be indigestible
 destroying bacteria or other harmful micro-organisms
 making phytochemicals more available, for instance, phytochemicals are more
available in cooked tomatoes than in raw tomatoes. (Phytochemicals are chemicals
produced by plants).
Preserving the nutrient value of vegetables
Some suggestions to retain the maximum nutrition in the foods you cook include:
 Store foods properly, such as keeping cold foods cold and sealing some foods in
airtight containers.
 Keep vegetables in the crisper section of the refrigerator.
 Try washing or scrubbing vegetables rather than peeling them.
 Use the outer leaves of vegetables like cabbage or lettuce unless they are wilted or
unpalatable.
 Microwave, steam, roast or grill vegetables rather than boiling them.
 If you boil your vegetables, save the nutrient-laden water for soup stock.
 Use fresh ingredients whenever possible.
 Cook foods quickly.
Ultra-processed foods
Ultra-processed foods and beverages are products formulated from industrial processes
and/or contain industrially derived ingredients.
The processing techniques used in ultra-processed foods differ from the more basic and
traditional methods described above. Industrial techniques include fractionation,
hydrogenation, hydrolysis, extrusion, moulding and pre-frying. Ultra-processed foods are
typically highly convenient and palatable, and tend to be high in added sugars, salt, oils
and fats. They also contain ingredients and additives that can’t usually be found in a home
pantry, such as artificial colours and flavours, emulsifiers, and inverted sugars.
Some common examples of ultra-processed foods include:
 carbonated soft drinks and energy drinks

 confectionary, biscuits, pastries
 sweetened breakfast cereals
 pre-prepared meat, cheese, pasta and pizza dishes
 sausages, burgers, hot dogs and other reconstituted meat products
 powdered and packaged ‘instant’ soups, noodles and desserts.
Ultra-processed food and health
Consumption of ultra-processed foods can lead to increased energy intake, resulting in weight
gain. A high proportion of ultra-processed foods in the diet is also linked to:
 obesity
 cardiovascular and metabolic diseases
 cancer
 gastrointestinal disorders
 depression.
The mechanisms explaining the association between consumption of ultra-processed foods

and chronic disease are still unclear. However it is likely explained in part by increased intake
of sugar, salt, fats and oils, increased energy intake due to their hyperpalatable nature, and the
displacement of meals prepared from nutritious unprocessed and minimally processed foods.
FOOD ADDITIVE
Legal burden for proof of

safety
The Food Additive Amendment of
1958 stipulates that man-
ufacturers (“petitioners”) must
satisfy the FDA’s safety cri-
teria prior to the marketing of a food
additive. The safety
standard is defined as “reasonable
certainty in the minds of
competent scientists that a substance
is not harmful under its
intended conditions of use.”
Although petitioners have a role
regarding data submitted, the FDA,
nonetheless, specifies or
at least suggests the necessary safety
criteria, including the
type and quantity of data necessary
to satisfy these criteria.
In addition to information on
chemistry and purity of the
ingredient, the FDA requires
information on intake, that is,
exposure as a consequence of
proposed uses within the diet-
ary matrix and relative to the specific
mechanisms of toxicity
of the ingredient. Clinical studies
may not be required. It is
important to recognize that the goal
of FDA is to ensure an
adequate margin of safety between
the expected concentra-
tion of the ingredient that produces
adverse effects in ani-
mals and the expected exposure to
the human population
including sensitive subpopulations
such as infants and the
elderly. Any additive that is intended
to have a technical
effect in food is deemed unsafe
under section 409 of the Act,
unless it conforms to the terms of its
approved use or to an
exemption for investigational use.
Any food that contains an
unsafe food additive is considered
adulterated under section
402(a)(2)(C) of the FFDCA.
safety
to have a technical
safety
to have a technical
Introduction
1. With the advent of food processing, food additives play an important role in providing a
safe food supply as well as meeting the consumers' need.
2. Food additive means any substance, either natural or synthetic, intentionally added to
food for a technological purpose in the processing, packaging, transport or storage of
such food. The technological functions of food additive include but not limited to the
following –
o enhancing the safety and quality by the inhibition of microbial growth;
o extending the shelf-life by protection against any oxidative deterioration;
o enhancing the flavour and odour;
o stabilising or retaining the colour; and
o improving the texture and consistency of a food, etc.
3. Food additive is not normally consumed as a food by itself and not normally used as a
typical ingredient of the food. The term does not include contaminants or substances
added to food for maintaining or improving nutritional qualities as well as seasonings
such as salts, herbs and spices.
4. There are many types of food additives and the commonly used ones include
preservatives, antioxidants, sweeteners, colouring matters, flavour enhancers, thickeners,
emulsifiers, etc.

safety
to have a technical
A list of approved food additives
for the European
Union (EU) can be found in the
following document
(https://www.fsai.ie/uploadedFiles/
Reg1129_2011.pdf).
Guide to safety assessment
(“the
Redbook”)
Principles of safety evaluation
The currently preferred approach to
safety assessment of
food additives is compiled in a
publication entitled Toxico-
logical Principles for the Safety
Assessment of Direct Food
Additives and Color Additives Used
in Food, commonly
known as “the Redbook” originally
published in 1982
(US FDA, 1982). Although attempts
to better harmonize
the agency’s testing guidelines
along international
approaches have occurred in past
revisions to the Red-
book,
5,6
the overall approach for safety
assessment of food
additives remains organized around
four basic principles.
These principals are also emphasized
in the safety assess-
ment guidelines typically applied to
pharmaceutical agents
and advanced in section S (safety)
by the International
Conference on Harmonization
(ich.org).
First, the agency presumes that
some toxicological
information is necessary for every
food additive. Second
safety
to have a technical
for the European
following document
Reg1129_2011.pdf).
(“the
Redbook”)
in Food, commonly
published in 1982
to better harmonize
along international
book,
5,6
assessment of food
(ich.org).
some toxicological
safety
to have a technical
for the European
following document
Reg1129_2011.pdf).
(“the
Redbook”)
in Food, commonly
published in 1982
to better harmonize
along international
book,
5,6
assessment of food
(ich.org).
some toxicological
safety
to have a technical
for the European
following document
Reg1129_2011.pdf).
(“the
Redbook”)
in Food, commonly
published in 1982
to better harmonize
along international
book,
5,6
assessment of food
(ich.org).
some toxicological
safety
to have a technical
for the European
following document
Reg1129_2011.pdf).
(“the
Redbook”)
in Food, commonly
published in 1982
to better harmonize
along international
book,
5,6
assessment of food
(ich.org)
Safety and Public Health Significance
1. The toxicity of food additives is generally low. The major food safety concern of food
additives is in fact due to their chronic exposure at levels above the safety reference.
2. The Joint Food Agriculture Organization / World Health Organization Expert Committee
on Food Additives (JECFA) is the international food safety authority responsible for
collecting and evaluating scientific data on food additives and allocate a safety reference
(i.e. acceptable daily intake (ADI)) to the food additives evaluated. JECFA also makes
recommendations on safe levels of use.
3. The ADI of a chemical is the estimate of the amount of a substance in food or drinking-
water, expressed on a body-weight basis, that can be ingested daily over a lifetime
without appreciable health risk. A dietary intake above the ADI does not automatically
mean that health is at risk. Transient excursion above the ADI would have no health
consequences provided that the average intake over long period is not exceeded as the
emphasis of ADI is a lifetime exposure.
4. A small proportion of the population may be intolerant to some food additives and may
have acute effects, e.g., small amount of sulphur dioxide may cause bronchoconstriction
and asthmatic reaction for certain people with allergic conditions.
Principles for Using Food Additives
1. The food additives being used should present no risk to the health of the consumer at the
levels of use.
2. The use of food additives is justified only when such use has an advantage, does not
present a hazard to health of and does not deceive the consumer, as well as serves one or
more of the following technological functions and needs, and only where these
objectives cannot be achieved by other means which are economically and
technologically practicable –
a. to preserve the nutritional quality of the food;
b. to provide necessary constituents for foods manufactured for groups of consumers
having special dietary needs;
c. to enhance the keeping quality or stability of a food or to improve its organoleptic
properties;
d. to provide aids in the processing, packaging, transport or storage of food, provided
that the additive is not used to disguise the effects of the use of faulty raw materials
or of undesirable (including unhygienic) practices of techniques during the course of
any of these activities.
3. All food additives shall be used under conditions of good manufacturing practice (GMP)
which include the following –
a. the quantity of the additive added to food shall be limited to the lowest possible
level necessary to accomplish its desired effect;
b. the quantity of the additive that becomes a component of food as a result of its use
in the manufacturing, processing or packaging of a food and which is not intended
to accomplish any physical, or other technical effect in the food itself, is reduced to
the extent reasonably possible; and
c. the additive is prepared and handled in the same way as a food ingredient.
Advice to the Trade
1. When formulating a food product, the food manufacturers are recommended to consider
the above "Principles for Using Food Additives" and avoid abuse of food additives.
2. Exercise due care in choosing food additives; add only the right type and right amount of
food additive which could serve the desired technological function to the food.
3. The trade should also take note of the regulatory requirement under the Public Health
and Municipal Services Ordinance, Cap. 132, regarding the use and labelling of food
additives.
4. Should there be any doubt on the use and labelling of food additives, seek advice from
food scientists or the authority.
5. The trade may also refer to the website of JECFA
(https://www.who.int/foodsafety/publications/jecfa/en/) for the safety evaluation and
specifications of food additives.
Advice to the Public
1. Buy foods from reputable sources.

2. Read the label of prepackaged food carefully in particular the ingredient list for food
additives added (if any) which you could accept.
3. People with allergic condition, such as asthma patients, may experience hypersensitive
reaction due to some food additives like sulphur dioxide and should be careful in
selecting food. Advice from medical professionals may be sought when necessary.
4. In choosing foods, avoid as far as practicable those which have abnormal colour, odour
and texture; stop consuming the food when it tastes abnormally.
5. Report any abnormalities of foods to the authority for investigation and other follow-up
actions.
6. Members of the public are advised to take a balanced diet so as to avoid excessive
exposure to food additives from a small range of food items.
FOOD IRRIDATION
INTRODUCTION
Food irradiation is the processing of food products by ionising radiation in order to control
foodborne pathogens, reduce microbial load and insect infestation, inhibit the germination of
root crops, and extend the durable life of perishable produce. According to the International
Atomic Energy Agency (IAEA), more than 50 countries have approved the use of irradiation
for about 50 different types of food, and 33 are using the technology commercially. The
positive list of irradiated products varies between countries but is often limited to spices,
herbs, seasonings, some fresh or dried fruits and vegetables, seafood, meat and meat
products, poultry and egg products. Despite the fact that irradiation has been used for decades
for food disinfection and satisfying quarantine requirements in trade, there is considerable
debate on the issue of health concerns over the consumption of irradiated food. These include
concerns over the toxicity of the chemicals generated and the change in nutritional quality of
food products after irradiation.
PRINCIPLES OF FOOD IRRADIATION

Ionising radiation and their sources
According to the Codex General Standard for Irradiated Foods, ionising radiations
recommended for use in food processing are: (I) gamma rays produced from the
radioisotopes cobalt-60 (60Co) and cesium-137 (137Cs), and (II) machine sources generated
electron beams (maximum level of 10 MeV) and X-ray (maximum level of 5 MeV).3
(I) Gamma rays produced from radioisotopes cobalt-60 and cesium-137
Cobalt-60 is produced in a nuclear reactor via neutron bombardment of highly refined cobalt-
59 (59Co) pellets, while cesium-137 is produced as a result of uranium fission. Both cobalt-60
and cesium-137 emit highly penetrating gamma rays that can be used to treat food in bulk or
in its final packaging. Cobalt-60 is, at present, the radioisotope most extensively employed
for gamma irradiation of food.
(II) Electron beams and X-ray generated from machine sources
A major advantage of machine-sourced ionising radiation is that no radioactive substance is
involved in the whole processing system. Powered by electricity, electron-beam machines use
linear accelerators to produce accelerating electron beams to near the speed of light. The
high-energy electron beams have limited penetration power and are suitable only for foods of
relatively shallow depth.
Electron beams can be converted into various energies of X-rays by the bombardment with a
metallic target. Although X-rays have been shown to be more penetrating than gamma rays
from cobalt-60 and cesium-137,4 the efficiency of conversion from electrons to X-rays is
generally less than 10% and this has hindered the use of machine sourced radiation so far.5
SAFETY OF IRRADIATED FOOD
Radiological safety
Irradiation process involves passing the food through a radiation field at a set speed to control
the amount of energy or dose absorbed by the food. Under controlled conditions, the food
itself should never come into direct contact with the radiation source.
At high energy levels, ionising radiation can make certain constituents of food become
radioactive. Studies showed that induced radioactivity was detected in ground beef or beef
ashes irradiated with X-rays produced by 7.5 MeV electrons. However, the induced activity
was found to be significantly lower than the natural radioactivity in food. Corresponding
annual dose is several orders of magnitude lower than the environmental background. The
risk to individuals from intake of food irradiated with X-rays generated by electrons with
nominal energy as high as 7.5 MeV is trivial. Studies carried out by IAEA showed that
increase in radiation background dose from consumption of food irradiated to an average
dose below 60kGy with gamma-rays from cobalt-60 or cesium-137, with 10 MeV electrons,
or with X-rays produced by electron beams with energy below 5 MeV are insignificant, and
best characterized as zero. Based on the experimental findings of WHO, FAO and IAEA,
Codex has set out the maximum absorbed dose delivered to a food should not exceed 10kGy
and the energy level of X-rays and electrons generated from machine sources operated at or
below 5 MeV and 10 MeV respectively, in part, to prevent induced radioactivity in the
irradiated food.
Microbiological safety
Two concerns that have been raised regarding the irradiation of microorganisms present in
food are the effect of the reduction in the natural microflora on surviving pathogens and the
potential for the development of radiation resistant mutants.
Ionising radiation significantly reduces the populations of indigenous microflora in foods.
There is concern that these "clean" foods would allow a more rapid outgrowth of bacteria of
public health concern, since the lower populations of indigenous microflora would have less
of an antagonistic effect on the pathogenic bacteria. It has also been hypothesised that
irradiated foods would be more amenable to the growth of foodborne pathogens if the food
was contaminated after irradiation. However, studies in irradiated chicken and ground beef
has illustrated that the growth rates of either salmonellae (chicken and beef) or Escherichia
coli O157:H7 (beef) were the same in both nonirradiated and irradiated meats suggesting that
the indigenous microflora in these products does not normally influence the growth
parameters of these bacteria.
The concern with radiation mutations is significant because ionising radiation has been
known for years to induce mutations. Induction of radiation-resistant microbial populations
occurs when cultures are experimentally exposed to repeated cycles of radiation. Mutations
developed in bacteria and other organisms can result in greater, less, or similar levels of
virulence or pathogenicity from parent organisms. Although it remains a theoretical risk,
there was no report of the induction of novel pathogens attributable to food
irradiation. Bacteria that undergo radiation-induced mutations are more susceptible to
environmental stresses, so that a radiation-resistant mutant would be more sensitive to
heating than would its nonradiation-resistant parent strain.
Toxicological safety
Toxicity studies in animals
The possible toxicological effects of consuming irradiated foods have been extensively
studied since the 1950s. Feeding trials involved a variety of laboratory diets and food
components given to human and different species of animals including rats, mice, dogs,
quails, hamsters, chickens, pigs and monkeys have been conducted to assess the toxicological
safety of irradiated foods.
Animal feeding trials conducted included lifetime and multi-generation studies to determine
if any changes in growth, blood chemistry, histopathology, or reproduction occurred that
might be attributable to consumption of different types of irradiated foods. Data from many
of these studies were evaluated by the Joint FAO/IAEA/WHO Expert Committee on the
Wholesomeness of Irradiated Food (JECFI). In 1980, JEFCI concluded that "Irradiation of
any food commodity up to an overall average dose of 10 kGy introduces no toxicological
hazard; hence, toxicological testing of food so treated is no longer required".The safety of
irradiated food was also supported by recent study with laboratory diets that had been
sterilised by irradiation. Several generations of animals fed diets irradiated with doses
ranging from 25 to 50 kGy, which is considerably higher than dose used for human foods,
suffered no mutagenic, teratogenic and oncogenic ill effect attributed to the consumption of
irradiated diets.
Human clinical studies
There have been relatively few trials performed on humans, the majority being carried out by
the US Army. The subjects were assessed by clinical examination and for cardiac
performance, haematological, hepatic and renal function. All studies have been short term.
No clinical abnormalities were discovered up to one year following the trials.
One of the best known human feeding trials is that performed in 1975 where 15 malnourished
children in India were fed a diet containing irradiated wheat at dose of 0.75 kGy. Increase in
the frequency of polyploidy and number of abnormal cells were observed during the course
of the trial. When the irradiated diet was discontinued, the abnormal cells reverted to a basal
level. The author attributed these observations to the consumption of the irradiated food.
However, when the report was examined more closely, it was found that only 100 cells from
each of the five children in each group were counted. The sample number was too small upon
which to base any conclusion.
A number of concerns regarding the impact of irradiated food on health have been raised.
Among these was the criticism of the design and execution of a number of in vitro studies
into toxicological safety. These studies used food juices, extracts and digests in mutagenic
studies using cells of mammalian, bacterial and vegetable origin and largely produced
negative effects. Some possible chromosome changes and cytotoxic effects were reported
but, as food contains many compounds that may interfere with the tests, the result were not
deem significant. There was also concern that when the WHO published its report on the
wholesomeness of foods irradiated at doses of above 10 kGy, five peer reviewed
publications, all of which were feeding trials reporting toxicological effects of irradiated
food, were disregarded. It also has been pointed out that all the animal studies were of much
too short duration to demonstrate carcinogenicity of irradiated food, which usually takes
several decades.
Chemical toxicological studies
The presence of several compounds, most notably 2-alkylcyclobutanones(2-烷基环丁酮) and
furan has generated some concerns about the safety of irradiated foods.
2-Alkylcyclobutanones
Irradiation of fat-containing food generates a family of molecules, namely 2-
alkycyclobutanones (2-ACBs), that result from the radiation induced breakage of
triglycerides. The 2-ACBs have been found exclusively in irradiated fat-containing food, and
have until now never been detected in non-irradiated foods treated by other food processes.
Thus, these compounds were considered to be unique markers for food irradiation. In
irradiated foods, level of 2-ACBs generated is proportional to the fat content and absorbed
dose. Depending on the dose absorbed, the concentration of 2-ACBs in irradiated food ranged
from 0.2 to 2μg/g of fat.
Previous study feeding rats daily with a solution of highly pure solution of 2-ACBs and
injected with a known carcinogen azoxymethane (AOM) showed that the total number of
tumours in the colon was threefold higher in the 2-ACB-treated rats than in the AOM
controls six months after injection. Medium and larger tumours were detected only in animals
treated with 2-ACB and AOM. This demonstrated that 2-ACBs found exclusively in
irradiated dietary fats may promote colon carcinogenesis in animals treated with a chemical
carcinogen. It does also suggest that the 2-ACBs alone does not initiate colon carcinogenesis.
However, it is worth noting that the amount of 2-ACBs consumed was much higher in this
study than that a human would consume in a diet containing irradiated food.
Furan
Furan is regarded as a possible carcinogen by the International Agency for Research on
Cancer. A number of studies have been performed on the effect of gamma irradiation on
furan levels in foods. There was evidence that level of furan increased linearly with
increasing irradiation dose and that both pH and substrate concentration affected the amount
of furan produced. Recent studies have also demonstrated low levels of furan were induced
by irradiation in fruits that had a high amount of simple sugars and low pH, such as grapes
and pineapples. However, the level of furan detected in irradiated foods purchased from
supermarket in the US were in general much lower than those in some thermal processed
foods.
PESTICIDES
HOW MUCH PESTICIDE RESIDUE IS ACTUALLY IN OUR FOOD?
Pesticide Residue Monitoring. The Food and Drug Administration (FDA), United States Department of
Agriculture (USDA), and many states have in place a pesticide residue monitoring program aimed at
detect- ing residues which exceed legal tolerances or for which there are no tolerances established; in
either case, food products containing illegal residues are subject to sei- zure and destruction. Each
year, FDA samples approximately one percent of the food supply, or about 20,000 fresh food
specimens grown domestically or imported. The majority of samples are derived from produce grown
in other countries. These fresh vegetables and fruits are subjected to chemical analyses that can
detect upwards of 268 pesticides or their metabolites.
The adjacent graphs summarize results from pesticide residue studies of imported and domestic
crops grown between 1987 and 1991. These FDA results are very comparable to the results obtained
from USDA and state pesticide residue monitoring programs. Such residue monitoring programs
provide only an overview of potential exposures to pesticide residues. They do not take into account
information on the effects of washing, peeling, and processing on pesticide residues, but provide
only crude estimates relative to the dietary intake of pesticide residues in food. However, the
monitoring programs do deliver a very important message to consumers: that pesticide label use
directions are being followed strictly by the agricultural community. Pesticide residues on the
majority of foods tested were within legal tolerances; and some foods were found to contain no
detectable residue. This important point clearly supports the public’s view that our farmers do have
the prerequisite knowledge to properly and correctly manage pesticides. This single fact gives
credence to federal and state regulatory decision makers who rely on the agricultural community to
follow label directions and precautions to minimize potential adverse impact on human health.
Total Diet Study. FDA does conduct a Total Diet Study which is a market basket approach that
analyzes pesticide residues after food has been prepared for eating. Foods are collected four times a
year from four geographical areas. A total of 267 food items are selected and prepared in institutional
kitchens. All of the foods are analyzed for pesticide residues after they are in table-ready or final food
form. The Total Diet Study yields the best insights into actual pesticide residue exposures and takes
into account the reduction of pesticide residues which occurs in the course of growing, handling,
shipping, processing, washing, peeling, and cooking. Over the last four years, approximately 55 out
of more than 200 pesticides have been detected in the Total Diet Study. The nine residues found
frequently in the 1989,1990, and 1991 total diet
studies are presented in Table 1. The total consumption of foods containing these residues can then
be used to estimate daily intake over a lifetime. For example, malathion was detected in
approximately twenty percent of the table-ready foods sampled. The residues found on specific food
items were multiplied by the amount of the food consumed. In the malathion example, children
between 6 and 11 months, young adults between 14 and 16 years, and older adults between the ages
of 60 and 65 consumed an average of 0.1, 0.08, and 0.04 micrograms per kilogram of body weight
per day, respectively, of this pesticide. Those exposure values were then compared to the RFD
criteria established by EPA and the World Health Orga- nization. The conclusion drawn from the total
diet studies is that pesticide residues being detected represent only one percent of the RFD and
generally are about 10,000 times lower than the NOAEL. FDA’s monitoring reveals that the “...levels
of pesticide residue found in the U.S. food supply are generally below safety limits set by the
Environmental Protection Agency.”
Circle of Poison. Foods imported from foreign countries into the United States are the subject of a
great amount of public debate and scrutiny from policymakers in Congress. The discussion involves
what has become known as the “Circle of Poison.” There are approximately 25 pesticides
manufactured in the United States that are neither registered for domestic use nor have food
tolerances established by EPA. These pesticides are sold for use in foreign agricultural production.
The vast majority of Circle of Poison candidate pesticides is comprised of pesticides that have not
been registered in this country since profits from their sale here could not justify the expense of
securing registration. As an example, U.S. manufacturers produce pesticides for export that may be
used on coffee or other tropical crops not grown in this country; and since they will not be used here,
U.S. registration is not required. These “unregistered” pesticides are very different from “banned”
chemicals that had a history of use in this country. It is also important to realize that many pesticide
bans were the result of other types of adverse effects (i. e., environmental, ecological, worker safety)
rather than food safety concern.
The debate centers on allowing foreign commodities from crops treated with these pesticides to
enter the United States on an import basis. Hence, the term “Circle of Poison.” FDA’s monitoring
efforts, although limited, indicate that only a small number of imported
AVERAGE RESIDUE REDUCTIONS DURING MARKETING AND PROCESSING
The following examples are approximate reductions. The actual values may vary dramtically, depending on the crop and also
on the amount of residue.
Shipping to percent
Supermarket Reduction
Peppers 14
Celery 86
Cabbage 86
Lettuce 87
Cucumbers 100
Tomatoes 100
Washing
Apples 14
Grapes 36
Peaches 73
Tomatoes 83
Trimming
Lettuce 89
Cabbage 93
Heating Potatoes
Baked 61
Boiled 68
Chipped 86
Beans
Canned 72
Frozen 92
commodities contained pesticide residues which exceeded established tolerances; likewise,
only a small number of foods were found to contain pesticide residues for which there were
no established tolerances.
Exposures to most illegal or violative residues are of no apparent toxicological significance.
The logical and widely held perceptions of legal residues as safe residues and illegal residues
as unsafe residues are not supported by scientific evidence. The purpose of tolerances is to
function as economic disincentives to pesticide misuse, regulate international trade, and
emphasize compliance with regulations. Therefore, in exploring the “Circle of Poison” issue
it is important not to focus on the presence of illegal residues but, instead, to identify specific
pesticide residues, examine toxicological information, and determine the quantity of residue
actually consumed in the human diet. Such information is essential to the logical assessment
of potential risk associated with consumption of foods containing trace residues.
INCIDENTAL CONTAMINATION IN FOOD
Emerging contaminants
At the same time, large new groups of as yet unregulated contaminants have attracted
attention. These groups of so-called “emerging contaminants (substances)” comprise various
compounds used in everyday life, such as human and veterinary pharmaceuticals, plasticizers,
and various industrial additives. Although often less persistent in the environment than
conventional contaminants, their continuous introduction might lead to negative effects.
Therefore, emerging contaminants belong to the most important chemical contaminants
currently found in the environment.
The term “emerging contaminants” does not necessarily solely cover newly developed
compounds. In fact, the term is used for at least three categories of compounds attracting the
concern of current environmental toxicologists and chemists. The first consists of compounds
that are newly introduced into the environment, e.g. industrial compounds that have only
recently been developed.
The second category comprises compounds that, although possibly around for longer times,
have only recently been detected in the environment. The analysis of emerging contaminants
is really challenging for analytical chemists, because of the diversity in chemical properties,
the complexity of matrices, and generally very low concentrations at which they are found –
usually to even low nanogram or picogram per liter levels. However, major advances in
chemical analytical technologies achieved last decades have widened the scope of
compounds that can be detected and identified enormously. Current techniques, such as liquid
chromatography coupled with tandem mass spectrometry, hyphenated chemical screening
techniques, and biological analysis methods (bioassays) now permit the routine analysis of all
kinds of polar organic chemicals, which could not be observed before with the gas
chromatographic approaches, that led to the early discovery of many persistent and non-polar
organic pollutants. Furthermore, instrumental sensitivity has improved enormously. Over the
last 40 years, a sensitivity gain of a factor 1000 to even 100,000 has been achieved thus
enabling the detection of most compounds at the concentrations in which they are indeed
present in the environment.
The third category emerging contaminants consist of compounds that, although possibly
known for a longer time, are only recently recognized as potentially causing adverse effects
on ecosystems or humans. This is, for example, the case with hormones
How long the contaminants keep their “emerging” status depends largely on the time needed
to assess their persistency and toxicity for humans and wildlife. This requires time and
resource-intensive studies on environmental fate and toxicological properties. As a result,
contaminants may keep their emerging status for several years
Classes of emerging contaminants
1. Endocrine disrupting compounds
The human endocrine system is comparable to that of animal vertebrates like fish. Therefore,
exposure to endocrine disrupting compounds might imply a certain health risk for humans
also. A link between environmental contaminants and reproductive health of humans has
been suggested in terms of declining sperm counts, increased incidences of other
reproductive disorders related with male infertility, testicular cancer, and breast cancer
however, a causal relationship has not been established
2. Pharmaceuticals
Pharmaceuticals are chemical compounds used for the diagnosis, treatment, or prevention of
diseases in humans and animals. It is impossible to imagine our modern Western society
without them; hundreds or thousands of different pharmaceuticals are currently used and
distributed including pain killers, antibiotics, anti-diabetics, β-blockers, lipid regulators (anti-
lipemics), anti-depressants, anti-epileptics, and X-ray contrast media. The use of
pharmaceuticals still rises due to increasing use to prevent instead of to cure diseases, due to
applying them as additives in food products and due to aging of population in Western-
European countries
Figure 3. Pharmaceuticals detected in surface water at an intake site of a drinking water
treatment plant along the River Meuse. Bezafibrate is used to treat elevated blood
concentrations of cholesterol (lipid regulator), ibuprofen is used as pain killer,
sulfamethoxazole as antibiotic, metoprolol as β-blocker (treatment of hypertension),
carbamazepin as anti-epileptic, other shown compounds are used as X-ray contrast media.
3. Illicit drugs, non-controlled drugs, and sweeteners
Using similar methodologies as for pharmaceuticals, it was demonstrated that our

environment is also contaminated with drugs with predominantly non-medical applications. It
is estimated that up to 5% of the world population uses illicit drugs, like cocaine, heroin,
cannabinoids (hashish, marijuana), and amphetamine-like stimulants (such as ecstasy). In,
published a first systematic study on the presence of cocaine and its degradation product
benzoylecgonine in surface and waste water samples from the Italian river Po. The results
were interesting not only from an environmental but also from a societal-forensic point of
view; based on the measured concentrations, the authors calculated that cocaine consumption
in the area was considerably higher than estimated at that time. Since then, several studies
have investigated the presence of cocaine and other illicit drugs as cannabinoids,
amphetamins in surface and waste waters throughout Europe. In addition, also non-controlled
stimulatory compounds, such as caffeine from coffee, tea, and soft drinks and nicotine from
tobacco were often included in these investigations. Illicit and non-controlled drugs were
structurally found at nanogram per liter concentrations to low microgram per liter
concentrations in waste and surface waters. Degradation in sewage treatment plants varied
considerably between different drugs. The most frequently found compound was
benzoylecgonine, pointing to the use of cocaine . A Spanish study concluded that during the
production of drinking water from the Llobregat River illicit drugs were eliminated to
undetectable levels, whereas only traces of caffeine and degradation products of nicotine and
cocaine survived treatment.
One of the newest groups of emerging contaminants are artificial sweeteners. These
compounds are consumed in large volumes as low-calorie sugar alternatives in food and
drinks. Examples are acesulfame, saccharin, cyclamate, and sucralose. Some of them, such as
acesulfame, are heat-stable – and therefore used for baking purposes – and are very persistent
in liquids – and as such applied in soft drinks with long expiry dates. These properties,
combined with the fact that certain sweeteners are not degraded by the human body but
excreted unchanged, makes sweeteners the next class of compounds that proved to end up
widespread in surface waters after use.
4. Personal care products
Personal care products comprise active ingredients of cosmetics, toiletries, and fragrances.
They are applied as preservative or to alter odor, appearance, touch, or taste. In most cases,
personal care products are not meant for ingestion, but are applied directly on the human
body.
One group of personal care products consists of compounds used as fragrance, such as
polycylic musks. A second group comprises preservatives like parabenes applied in
shampoos, creams, and toiletries to prevent bacterial decay. Furthermore, disinfectants like
triclosan and clorophene are used on a large scale. Triclosan for example has been used for
decades in a wide variety of consumer products, ranging from toothpaste and hand soap to
toys and socks. In addition, compounds such as benzophenone in sun screen lotions that
block UV light have gained interest of environmental chemists and biologists. The last
examples mentioned here are alkylated siloxanes, compounds used in soaps, hair-care
products, etc. Personal care products enter the environment via sewage treatment effluent as a
result of showering, washing off, washing clothes, etc., but are also directly released in
surface waters by recreational activities as swimming and sunbathing. Personal care products
are observed regularly in effluents and surface waters worldwide. Some of them can
accumulate in exposed organisms. This was illustrated by our observation of triclosan and
clorophene in bile from bream in the Dutch River Dommel. Some personal care products are
suspected to have potentially adverse potencies, such as estrogenic hormone-like activity (UV
blockers, parabens), developmental toxicity (UV blockers), and extreme bioaccumulation
(musks).
5.Nanoparticles
Nanoparticles constitute a rapidly growing research area. They are extremely small in size
with diameters between 1 and 100 nm and have properties that differ from smaller
(molecules) or larger (bulk materials) particles of the same composition. Besides inorganic
compounds, such as titanium dioxide and nanosilver, and also organic compounds, such as
carbon nanotubes and “nano-C60” are examples of nanoparticles. They can be of natural
origin as well as manufactured and a wide variety of applications is foreseen or already
implemented, for example, in medicine and in food industries. Meanwhile, questions about
their environmental fate and possible human-health risks arise. Due to their small size, their
surface is relatively large and their chemical reactivity and biological activity remain
relatively high. Nanoparticles can enter the body and cells more easily than larger particles. It
is suggested that they might evoke inflammatory responses and DNA damage. However, very
little is as yet known about possible toxic properties of nanoparticles. Although currently
environmental data are scarce, techniques for the analysis of nanoparticles in environmental
samples are developing fast, and it is expected that monitoring data will become available
soon.
6. Flame retardants
Flame retardants are a class of chemicals that are widely used in plastics, textiles, and
furnishing foams, such as computers, televisions, clothes, and sofas to slow down
inflammation in the event of a fire. As such, they are supposed to have contributed
considerably to the reduction of fire risks. In the past, mainly polybrominated biphenyl and
polybrominated diphenyl ethers were used for this purpose. These compounds are structurally
similar to “conventional” contaminants as polychlorinated biphenyls, and likewise is their
behavior in the environment. Brominated flame retardants are structurally detected in tissues,
blood and breast milk of wildlife and humans. This is worrying, as convincing evidence has
been obtained last years that these compounds and their degradation products have several
potentially toxic properties, such as the ability to disrupt the thyroid, androgenic and
estrogenic hormone systems; toxicity for the nervous system and they might also be
carcinogenic. Because of their low solubility in water, they tend to sorb to sediments in rivers
instead of reaching high concentrations in water.
7. Complexing agents
Complexing agents are organic compounds that can bind metals. An example used in
common products as soap and toothpaste is EDTA. Other examples are 1H-benzotriazoles,
used as coating to protect metals in contact with fluids against corrosion, e.g. in engine
coolants, aircraft de-icers, or anti-freezing liquids, and for silver protection in dish washing
liquids. They are soluble in water, resistant to biodegradation and poorly removed in waste
water treatment. As a consequence, they have been found in surface and drinking water. One
complication of complexing agents is that, once emitted in the environment, they have the
ability to detach heavy metals from sediments and keep them dissolved in the aqueous phase.
This hampers the efficient removal of metals during drinking water production and,
moreover, enhances their bioavailability for aquatic organisms.
8. Pesticides
Pesticides, such as herbicides, fungicides, insecticides, plant growth regulators, bactericides,

and defoliants have been a topic of concern for surface water quality for decades. Extensive
use in agricultural practice and industrial emission during their production are important
sources of pesticides and their residues in the aquatic environment.
Is there a health risk related to emerging contaminants?
The above listing of emerging contaminants shows that numerous compounds used in
everyday life in Europe are released into the aquatic environment. Therefore, depending on
their fate in the environment and during drinking water preparation, there might be a
possibility that humans are exposed to emerging contaminants through drinking water
abstracted from contaminated surface waters. As a matter of definition, information about
related health risks is not yet sufficiently available for contaminants still in their “emerging”
stage and further research is warranted.
Risk assessment of emerging contaminants for humans includes assessment of the exposure
dose and assessment of the dose at which possible adverse health effects can occur. From the
latter, benchmarks representing safe doses that are assumed to be safe are derived.
Subsequently, the ratio between exposure dose and benchmark determines if there is a risk
related to the exposure.
1. Exposure assessment
The first step in risk assessment is to investigate the extent to which exposure takes place.
Typical for emerging contaminants are the low concentrations (nanograms to micrograms per
liter) in which they are detected in the environment. Acute toxicity for most of these
compounds is tested and observed only at relatively high doses, and not expected at low
environmental concentrations. However, the case of estrogenic hormones in the environment
disrupting the endocrine systems of fish has shown that exposure to low concentrations can
lead to subtle but severe adverse effects.
In contrast to fish and other aquatic organisms, exposure to emerging contaminants by direct
exposure to surface waters is only of minor importance for humans. More common exposure
routes for humans include oral administration (hormones, pharmaceuticals, illicit drugs), food
consumption (additives, non-controlled drugs, sweeteners, traces of contaminants in
vegetables and meat), direct application on the body (personal care products), exposure via
inhaled air and exposure to drinking water. Given the multiple routes, the relevance of
drinking water as exposure route depends on fraction drinking water contributes to the total
dose. The contribution of drinking water can differ between compounds and depends, for
example, on the concentrations in drinking water relative to those in other matrices, exposure
volumes, on efficiency of uptake after exposure.
For many contaminants, exposure via drinking water is estimated to be low compared to that
by other routes. For example, exposure assessments published for PFOA and PFOS in
Germany and for estrogenic hormones in the USA concluded that the contribution of drinking
water for the general population was only in the order of 0.7–2% of the total daily intake of
the general population. Another example is pharmaceuticals. In contrast to many known
polluting compounds, they are intentionally designed to exert at low concentrations a specific
biological effect in the body. Especially for this class of contaminants, effects might thus be
expected at low concentrations. Exposure to drinking water is likely life-long and may extend
to over 80 years. Using current environmental concentrations, the “worst case” assumption of
no removal at all during drinking water production, and an estimated consumption of 2 l of
water per day, it can be calculated that for most pharmaceuticals the dose that might be
obtained by life-long consumption of drinking water is lower than the dose obtained from a
single medical treatment with the same pharmaceutical. It is therefore often concluded that
traces of pharmaceuticals in drinking water likely do not represent an acute health risk
problem. However, although exposure assessment calculations do indicate the relative
significance of drinking water as exposure route, one should be aware that as such they do
not give an indication of the likeliness of adverse health effects other than the therapeutic
one.
2. Risk assessment
To assess the health risks of exposure to emerging contaminants via drinking water, doses (or
concentrations) determined in the exposure assessment step are compared with toxicity-based
benchmarks that represent estimates of exposure that are assumed to be safe. These
benchmarks are derived from toxicity data. Examples of such benchmarks are the acceptable
daily intake (ADI), provided by the World Health Organisation , and the Threshold of
Toxicological Concern (TTC) as proposed by an International Life Sciences Institute expert
group .Whether or not drinking water exposure exceeds these benchmarks indicates whether
the exposure may be associated with adverse health risks.
In applying such benchmarks for emerging contaminants in drinking water, several aspects
have to be taken into account. Vulnerability for certain effects might differ between gender,
and also during life stages, such as growth, pregnancy, or older age. As emerging
contaminants are not incidentally released in drinking water sources, but are continuously
present, exposure might continue life-long. Long-term effects might follow different
biological mechanisms and occur at much lower concentrations than acute effects. Therefore,
also possible other effects than the acute (therapeutic) one have to be investigated, as well as
the possible consequences of exposure to mixtures. Another important aspect is namely the
fact that in the environment more than one contaminant is present at the same time and
location. Real-life exposure seldom is to a single compound, but in general to a mixture.
Compounds in a mixture might act independently or might enhance or inhibit each other's
effects. Such combined behavior makes predictions of health risks of exposure even more
complex. exemplified the presence of more pharmaceuticals at the same time. In reality, the
composition of surface water is even more complex, as contaminants other than
pharmaceuticals – flame retardants, solvents, etc – can be detected in the same sample, as is
shown in the chromatogram showing the results of a screening analysis of a water sample
from the River Rhine in
Generally, toxicity benchmarks deal with mentioned aspects by applying safety factors to
estimated safety values, e.g. a factor 10 for sensitive populations as applied in the ADI.
Caldwell performed a risk assessment using ADI and TTC values for estrogenic hormones
potentially present in drinking water in the USA and concluded that they do not cause
adverse effects in the general US population even not in sensitive subpopulations
For most emerging contaminants, however, toxicological data are incomplete and therefore
benchmark values are not available. To deal with this problem, the TTC approach took as
starting point that even for compounds for which toxicity is not known in detail a safe
exposure could be estimated. The TTC distinguishes between classes of compounds, such as
genotoxic compounds (TTC = 0.15 μg/person/day) and several groups of non-genotoxic
compounds (with 1.5 μg/person/day as most strict TTC within the latter class.) Assuming a
daily drinking water consumption of 2 l and a contribution of 10% of the exposure by
drinking water, derived drinking water guidance limits from the TTC values of 10 ng/l for
genotoxic compounds and 0.1 μg/l for non-genotoxic compounds.
Although our toxicological knowledge keeps growing, the aspects mentioned show the
complexities we are confronted with and describe the uncertainties that still exist regarding
the assessment of potential health risks of emerging contaminants.
Dealing with emerging contaminants in drinking water sources
Surface waters have multiple stakeholders: industries, governments, drinking water

companies, and consumers. The quality of surface waters has to be protected to safeguard the
sustained use for all functions. This section discusses how governments and drinking water
companies deal with emerging contaminants in drinking water sources and shows the
necessity of involvement of various stakeholders.
1. The role of governments
Public water supply is regulated by international and national legislation. In Europe,

legislation given by the European Committee is becoming increasingly important. On the one
hand this is a positive development; emerging contaminants cross national borders and so
should measures to regulate them. On the other hand, international legislation implies a time-
consuming process and dealing with compromises. As a consequence, lists of regulated
compounds do not represent adequately the emerging contaminants we are faced with these
days, as many of the listed compounds are no longer in use or only in limited quantities as
soon as an act becomes operative.
Nowadays national legislation is often an implementation or a sharpening of the European

legislation. Concerning emerging substances, several European acts are of concern.
The Drinking Water Act 98/83/EEC describes the minimum quality requirements that apply
to drinking water. A number of substances are given specified requirements. Unfortunately,
concerning the previously mentioned substances hardly any of the emerging contaminants is
mentioned in this act.
The Water Framework Directive 2000/60/EC aims to safeguard the quality of European

surface and ground waters. It has as a general principle that standards for compounds should
be related to their eco(toxico)logical effects. Article 7 of the Directive explicitly links
improvement of water quality to drinking water aims. The protection level of surface and
ground water should be such that reliable drinking water can be prepared sustainably and that
it is aimed to enable reduction of the required level of purification treatment required in time.
A number of priority compounds are named, but in this list none of the here named emerging
substances is present.
From section 4, it is clear that numerous emerging contaminants have been produced and
applied in Europe for many years and sometimes in very high amounts. Yet there is
insufficient information on the hazards that they pose to human health and the environment.
To improve the protection of the human health and the environment, the European
Commission enforced the REACH Regulation (Registration, Evaluation, Authorization of
Chemicals; EC 1907/2006) in 2007. REACH gives a greater responsibility to manufacturers
to better and earlier assess hazards and risks of their produced compounds, and to identify
and implement measures to protect the humans and the environment. REACH thus provides a
legislative basis to investigate toxic properties of compounds before they are applied or
emitted into the environment instead of after their emerge as contaminants however the
potential of compounds to end up in drinking water is not considered in the investigations.
Besides legislation, also collaboration and discussion initiatives such as the International
Commission for the Protection of the Rhine (ICPR) and the International Meuse Commission
(ICM) aim to protect the sustainable use of surface waters. They provide a platform to discuss
and solve disputes between polluters upstream and users downstream a river.
2. The position of drinking water companies
Drinking water companies aim to produce safe and irreproachable drinking water at
reasonable costs. Application of the precautionary principle requires that, as long as health
risks related to long-term exposure to mixtures of low concentrations of all kinds of emerging
contaminants cannot fully be excluded, the produced drinking water should contain as less as
possible contaminants. Moreover, compounds (like MTBE), which are currently considered
not very toxic, are considered unwanted in principle.
Drinking water companies intensively monitor the quality of their sources and the
performance of the treatment processes. It appears that conventional treatment steps, suitable
for the removal of “conventional” contaminants, do not completely remove the often less
lipophilic and less environmentally persistent emerging contaminants. Drinking water
companies develop and introduce expensive and advanced treatment technologies to achieve
maximum purification of drinking water. Treatment and purification techniques have,
however, their technical limitations. Removal is not always 100%, is selective in nature and
advanced treatment methods may lead to the creation of other unwanted chemical
compounds. Therefore, preparation of chemically safe and irreproachable drinking water
should preferably be enabled by prevention of the emission of emerging contaminants in the
environment instead by technological improvements. To this aim, drinking water companies
endorse political measures to prevent pollution at the source and to counteract the current
shifting of responsibility for surface water quality from polluters to users like themselves.
This is done by the publication of the Danube, Meuse and Rhine Memorandum 2008,
collectively formulated by drinking water companies using these rivers as their sources
(International Association of Waterworks in the Danube Catchment Area et al. 2008). It
formulates the most important principles of sustainable use of surface waters necessary for
drinking water production and provides maximum concentrations of emerging contaminants
in surface waters that should not be exceeded. It was composed as aid and orientation for
politicians, governments, and policymakers in industry and water management.
RADIONUCLIDES IN FOOD
Radionuclides, whether man-made or natural in origin, are present in the environment. These
radioactive materials can contaminate food and can affect your health. Long-term
consumption of radiological contaminated foods can damage DNA, resulting in the mutation
of genes contained in the DNA and lead to cancer. When exposed, the degree of harm to
human health depends on the type and the dose of radionuclides. It is also critical to know the
radioactivity of the contaminated food. The food supply in Macao is mainly dependent on
imports. In 2011, the Fukushima nuclear power plant occurred radionuclides leaking incident
in Japan. Macao government has immediately taken measures to control the spread of risks
from imported Japanese foods, including of monitoring the quantity of radionuclide contained
in foods, then update the information and report to the public timely. Moreover, the
Administrative Regulation No. 16/2014 ‘Maximum Limits of Radionuclides in
Food’ regulates the maximum permissible limits of radioiodine-131 (131I), radiocaesium-134
(134Cs) and radiocaesium-137 (137Cs) in infant foods and other foods to safeguard food safety.
Radionuclides in Foods
The common radionuclides found in food are the naturally occurring radionuclides such as
Potassium-40, Uranium-238, Radium-226 and their associated progeny. The man-made
radionuclides can also be discharged into the environment following a major nuclear incident.
Iodine-131 is an immediate concern since it’s distributed over a large area and rapidly
transferred from contaminated feed into milk. Other radioisotopes that could be of long-term
concern if released are Cesium-134, Cesium-137, Strontium-90, Strontium-89 (Sr-89) and
Plutonium. They can remain in the environment for a long time.
FDA Guidance Levels for Radionuclides in Domestic and Imported Foods
In 1998, the U.S. Food and Drug Administration (FDA) released a document (63 FR 43402,
FDA 1998) titled “Accidental Radioactive Contamination of Human Food and Animal
Feeds: Recommendations to State and Local Agencies”. This document provides guidance to
State and local agencies in planning and execution of protective actions associated with
human food and animal feeds accidentally contaminated with radionuclides.
Table 1: Derived Intervention Levels (DIL, Bq/kg)

Radionuclide Group DIL (Bq/kg)
Strontium-90 (Sr-90) 160
Iodine-131 (I-131) 170
Cesium-134 + Cesium-137 (Cs-134, Cs-137) 1200
Plutonium-238 + Plutonium-239 + Americium-241 (Pu-238, Pu-239,
2
Am-241)
C3/6800 + C6/450 <
Ruthenium-103 + Ruthenium-106(a) (Ru-103, Ru-106) 1
(a) Due to large differences in daily intervention limits (DILs) for Ru-103 and Ru-106, the
individual concentrations of Ru-103 and Ru-106, the individual concentrations of Ru-103 and
Ru-106 are divided by their respective DILs and summed. The DIL for the Ruthenium group
is set at less than one.
Compliance Analysis of Radionuclides in Foods

Radiation DIL Detection Limit
Radionuclide Group Method
Type (Bq/kg) (Bq/kg)
EPA
Iodine-131 Beta, Gamma 170 20
901.1
EPA
Cesium-134 Cesium-137 Beta, Gamma 1200 10
901.1
EPA
Ruthenium-103 Ruthenium-106 Beta, Gamma 6800 450 50
901.1
Strontium-90 Beta 160 10 EPA 905
Plutonium-238/239,
Alpha 2 0.5 EPA 907
Americium-241
Listed Radionuclide Package (Alpha, Beta, Gamma)
Radionuclides listed above are usually contained in nuclear installations or used as a radiation
source in large enough quantities. They are those important for uptake into the food chain and
could be significant potential contributors to levels in foods.
Analysis of Radionuclides in Foods
EMSL Analytical, Inc.’s Radiochemistry Laboratory provides the analytical services for
radionuclides in foods: A. Gamma Emitters Analysis by Gamma Spectroscopy includes Cs-
134/137, Ru-103/106 and I-131.
B. Determination of Pu-238/239 and Am-241 by Alpha Spectroscopy.
C. Analysis of Strontium-90 by Beta Counting
Sampling Instructions
• Liquid samples are collected in a one-liter plastic or glass bottle.

• At least 500g of solid samples are collected in a one-quart or larger straight sided plastic or
glass container with a plastic or Teflon lined cap.
• An ice-cooler for the shipment of wet food samples such as meat, fish, milk and fresh
vegetables is preferred.
Human Health Effects of Radionuclides

Radionuclides exist in the nature, which make food and water have an opportunity to be
contaminated with trace amounts of radioactive substances. Compared to nuclear bomb
explosions and nuclear power plant incidents, the concentration and type of radionuclides
leaks in such human activities are relatively higher. Radioactive materials can be distributed
by the flows of wind, water and animals to farmlands, grasslands, rivers, lakes, oceans, etc.,
then entering into food chain. If human consume those food contaminated with radioactive
substances for a long time, the contaminants can accumulate and decay in our body; so, it
increases the risk of cancer induction and harms our health.

Specification for Radionuclides Limits in Food Enacted by International Standard and
Macao's Regulation
There were two large-scale nuclear power plant incidents in human history. That is,
Chernobyl in Ukraine in 1986 and Fukushima in Japan in 2011. Both caused a large amount
of high concentration of radionuclides leaks so that arouse worldwide public concerns. After
the first nuclear disaster, the Joint FAO/WHO Codex Alimentarius Commission enacted the
‘Guideline Levels for Radionuclides in Foods Contaminated Following a Nuclear or
Radiological Emergency’ to establish the maximum limits of baby foods and other foods for
use in the international food trade.

According to available data, not all radionuclides can enter human body and accumulate
through dietary intake. For instance, only very little amount of radioactive plutonium (Pu) is
absorbed by the gastrointestinal tract after eating the contaminated food. Most of this
radioactive substance is discharged from the body so it is unlikely to cause major health
hazards to humans.

In order to protect global public health, the FAO/WHO has analyzed public health data
and experiences regarding nuclear disasters over the years. They found that after consuming
the contaminated food, radioactive iodine (I) and cesium (Cs) can accumulate in human body
and be more likely to induce cancers. In particular, children are at higher risk of developing
illness than adults. In view of this, many countries use the maximum limits of radioiodine and
radiocaesium in foods as the regulatory standards to monitor the imported foods from nuclear
affected areas.

As a member of the World Trade Organization, Macao government took a reference
from the FAO/WHO standard to establish the Administrative Regulation No.
16/2014 ‘Maximum Limits of Radionuclides in Food’. Based on the local surveillance report
on food risks, the levels of radioactive iodine-131, caesium-134 and caesium-137 in baby
foods and other foods are regulated; moreover, all imported foods are treated on an the
principle of fairness to ensure food safety in Macao.

How does the Macao government regulate food imported from areas affected by nuclear
incidents?
Subsequent to the Fukushima nuclear accident in 2011, Macao has been conducting risk
assessment and monitoring of imported Japanese food products on an ongoing basis.
According to the government announcement dated 15 July, 2011, the inspection of
vegetables, fruits, milk and milk products imported from nine prefectures of Japan (Chiba,
Tochigi, Ibaraki, Gunma, Miyagi, Niigata, Nagano, Saitama and Tokyo Metropolis) has been
temporarily suspended. As for applications for the import of seafood and seafood products,
meat of livestock and their products from these prefectures, they will only be considered
unless provided with required supporting certificates and documents. The processing of all
applications for inspection of food products imported from Fukushima prefecture is
suspended temporarily.

On 4 October, 2019, the Administration Committee on Municipal Affairs of the
Municipal Affairs Bureau passed a resolution on the management measures applicable to the
import of Japanese food products into Macao. With the exception of Fukushima prefecture,
application for the import of Japanese food products into Macao from the nine other
prefectures (Chiba, Tochigi, Ibaraki, Gunma, Miyagi, Niigata, Nagano, Saitama and Tokyo
Metropolis) shall only be accepted when the statement on radiation monitoring and certificate
of origin issued by the Japanese authority are provided, in addition to meeting the existing
requirements on sanitary certificate(s) for import. Besides, the imported Japanese food
products are subject to inspection at the port of entry and shall only be allowed to enter
Macao after passing the inspection.

With regard to sales, the Department of Food Safety of the Municipal Affairs
Bureau and the Economic and Technological Development Bureau conduct joint inspection
of packaged food products available on the market regularly in order to monitor the
correctness of food labels and their information. Furthermore, no abnormality is detected in
the routine surveillance of the radionuclides levels in fresh and live food products imported
from Japan. If any food product is found to contain excessive permissible of radionuclides
which is stated on the standard of 'Maximum Limits of Radionuclides in Food', the
Department of Food Safety can take immediate actions depending on the severity and scope
of risks, such as removal from shelves, recall and sealing suspected food products so as to
prevent the spread of food hazards as well as protect residents’ health.

How to reduce the intake of food contaminated with radionuclides?
Macao has adopted effective measures for monitoring imported food products from
Japan, so the public should not be overly worried about radionuclides contamination of
imported food products. Moreover, most of the radionuclides released from nuclear incidents
precipitate the soil or waters surrounding the affected area in Japan, where is approximately
3,100 km away from Guangdong province. Since the drinking water and majority of fresh
meat and vegetables supplied to Macao come from China, all foods are subject to take dual
surveillance measures in both China and Macao. All of them have been passed rigorous
inspection for food safety. Hence, consumers can eat the food with peace of mind.

The food industry ought to declare the imported food which is subject to compulsory
sanitary and quarantine inspection in accordance with the law. They should place orders with
reputable suppliers. Upon receipt of food delivery, they should check whether the food
packaging is intact and there is adequate information on food labels, etc. When consumers
purchase Japanese packaged food products, they can pay attention to the (vender) and
(manufacturer) indicated on the food labels. The former is the address of business registration
for the company, i.e. office, but it is not the place of food manufacture. The latter specifies
the location of the food manufacturing or processing plants, which is usually expressed in
(identification number of manufacturing plant). If consumers have any doubts about the place
of origin or the quality of food product, we should not buy or consume it.
ASSESSING THE SAFETY OF GM FOOD CROPS
Scientists first discovered in 1946 that DNA can be transferred between organisms. It is now
known that there are several mechanisms for DNA transfer and that these occur in nature on a
large scale, for example, it is a major mechanism for antibiotic resistance in pathogenic
bacteria. The first genetically modified (GM) plant was produced in 1983, using an
antibiotic-resistant tobacco plant. China was the first country to commercialize a transgenic
crop in the early 1990s with the introduction of virus resistant tobacco. In 1994, the
transgenic ‘Flavour Saver tomato’ was approved by the Food and Drug Administration
(FDA) for marketing in the USA. The modification allowed the tomato to delay ripening after
picking. In 1995, few transgenic crops received marketing approval. This include canola with
modified oil composition (Calgene), Bacillus thuringiensis (Bt) corn/maize (Ciba-Geigy),
cotton resistant to the herbicide bromoxynil (Calgene), Bt cotton (Monsanto), Bt potatoes
(Monsanto), soybeans resistant to the herbicide glyphosate (Monsanto), virus-resistant squash
(Asgrow) and additional delayed ripening tomatoes. A total of 35 approvals had been granted
to commercially grow 8 transgenic crops and one flower crop of carnations with 8 different
traits in 6 countries plus the EU till 1996. As of 2011, the USA leads a list of multiple
countries in the production of GM crops. Currently, there are a number of food species in
which a genetically modified version exists. Some of the foods that are available in the
market include cotton, soybean, canola, potatoes, eggplant, strawberries, corn, tomatoes,
lettuce, cantaloupe, carrots etc. GM products which are currently in the pipeline include
medicines and vaccines, foods and food ingredients, feeds and fibres. Locating genes for
important traits, such as those conferring insect resistance or desired nutrients-is one of the
most limiting steps in the process.
GM Feed
The market share of GM products has rapidly increased from commercialization of the early
generation of GM crops in the 1990s. The major GM crops available in the market are
soybean (Glycine max L. Merr.) with 77% of the global area for individual crops (94.1
million hectares), maize (Zea mays L.) at 32% (59.7 million hectares), cotton (Gossypium
arboretum L.) at 80% (24.21 million hectares), and canola (Brassica napus L.) 30% (10.2
million hectares). The commercial use of transgenesis-delivered crops cultivars has also
recently expanded to more species including sugar beet (Beta vulgaris L.), papaya (Carica
papaya L.), squash (Cucurbita L.), eggplant Solanum melongena L.), potatoes (Solanum
tuberosum L.), and apples (Malus pumila and these products are already commercially
available in US. A meta-analysis including 147 food and feed crops, also has revealed that
the adoption of GM technology has decreased the use of chemical pesticides by 37%,
increased crop yields by 22%, and increased farmer profits by 68% . GM crops can be traded
as food and feed products. The products are classified as GM food, when the direct
consumers are mainly humans, and the products only intended for animal consumption are
regarded as GM feed. However, a range of GM crops, such as maize, soybean, and canola,
are used as both food and feed . Most GM crops available in the market, except for alfalfa
(Medicago sativa L. ssp. sativa) and creeping bentgrass (Agrostis stolonifera) have been
assessed as GM food, because they can be consumed by humans. On the basis of biomass,
between 70 to 90% of all GM crops, however, are estimated to be used in farm as animal
feed. In contrast to GM food crops, only a few types of GM forage products have been
commercially released. Alfalfa is an economically important legume forage mainly in
temperate regions. The first GM forage crop commercialized in US was the Roundup
Ready® Alfalfa from Forage Genetics International (Nampa, ID, US), which can be
categorized as a first generation transgenic. The herbicide-resistance trait was produced
through inserting two copies of an Agrobacterium-derived gene (cp4 epsps) of which
translational product (EPSPS; 5-enolpyruvylshikimate-3-phosphate synthase) contribute to
glyphosate-tolerance. Such insertion of the foreign gene allows post-emergence applications
of glyphosate-based herbicides for weed control.
Foods derived from GM crops
At present there are several GM crops used as food sources. As of now there are no GM
animals approved for use as food, but a GM salmon has been proposed for FDA approval. In
instances, the product is directly consumed as food, but in most of the cases, crops that have
been genetically modified are sold as commodities, which are further processed into food
ingredients.
Fruits and vegetables
Papaya has been developed by genetic engineering which is ring spot virus resistant and thus
enhancing the productivity. This was very much in need as in the early 1990s the Hawaii’s
papaya industry was facing disaster because of the deadly papaya ring spot virus. Its single-
handed savior was a breed engineered to be resistant to the virus. Without it, the state’s
papaya industry would have collapsed. Today 80 % of Hawaiian papaya is genetically
engineered, and till now no conventional or organic method is available to control ring spot
virus.
The NewLeaf™ potato, a GM food developed using naturally-occurring bacteria found in the
soil known as Bacillus thuringiensis (Bt), was made to provide in-plant protection from the
yield-robbing Colorado potato beetle. This was brought to market by Monsanto in the late
1990s, developed for the fast food market. This was forced to withdraw from the market in
2001as the fast food retailers did not pick it up and thereby the food processors ran into
export problems. Reports say that currently no transgenic potatoes are marketed for the
purpose of human consumption. However, BASF, one of the leading suppliers of plant
biotechnology solutions for agriculture requested for the approval for cultivation and
marketing as a food and feed for its ‘Fortuna potato’. This GM potato was made resistant to
late blight by adding two resistance genes, blb1 and blb2, which was originated from the
Mexican wild potato Solanum bulbocastanum. As of 2005, about 13 % of the zucchini grown
in the USA is genetically modified to resist three viruses; the zucchini is also grown in
Canada .
Vegetable oil
It is reported that there is no or a significantly small amount of protein or DNA remaining in

vegetable oil extracted from the original GM crops in USA. Vegetable oil is sold to
consumers as cooking oil, margarine and shortening, and is used in prepared foods. Vegetable
oil is made of triglycerides extracted from plants or seeds and then refined, and may be
further processed via hydrogenation to turn liquid oils into solids. The refining process
removes nearly all non-triglyceride ingredients. Cooking oil, margarine and shortening may
also be made from several crops. A large percentage of Canola produced in USA is GM and
is mainly used to produce vegetable oil. Canola oil is the third most widely consumed
vegetable oil in the world. The genetic modifications are made for providing resistance to
herbicides viz. glyphosate or glufosinate and also for improving the oil composition. After
removing oil from canola seed, which is ∼43 %, the meal has been used as high quality
animal feed. Canola oil is a key ingredient in many foods and is sold directly to consumers as
margarine or cooking oil. The oil has many non-food uses, which includes making lipsticks.
Maize, also called corn in the USA and cornmeal, which is ground and dried maize constitute
a staple food in many regions of the world. Grown since 1997 in the USA and Canada, 86 %
of the USA maize crop was genetically modified in 2010. and 32 % of the worldwide maize
crop was GM in 2011. A good amount of the total maize harvested go for livestock feed
including the distillers grains. The remaining has been used for ethanol and high fructose
corn syrup production, export, and also used for other sweeteners, cornstarch, alcohol, human
food or drink. Corn oil is sold directly as cooking oil and to make shortening and margarine,
in addition to make vitamin carriers, as a source of lecithin, as an ingredient in prepared foods
like mayonnaise, sauces and soups, and also to fry potato chips and French fries. Cottonseed
oil is used as a salad and cooking oil, both domestically and industrially. Nearly 93 % of the
cotton crop in USA is GM.
Sugar
The USA imports 10 % of its sugar from other countries, while the remaining 90 % is
extracted from domestically grown sugar beet and sugarcane. Out of the domestically grown
sugar crops, half of the extracted sugar is derived from sugar beet, and the other half is from
sugarcane. After deregulation in 2005, glyphosate-resistant sugar beet was extensively
adopted in the USA. In USA 95 % of sugar beet acres were planted with glyphosate-resistant
seed. Sugar beets that are herbicide-tolerant have been approved in Australia, Canada,
Colombia, EU, Japan, Korea, Mexico, New Zealand, Philippines, Russian Federation,
Singapore and USA. The food products of sugar beets are refined sugar and molasses. Pulp
remaining from the refining process is used as animal feed. The sugar produced from GM
sugar beets is highly refined and contains no DNA or protein—it is just sucrose, the same as
sugar produced from non-GM sugar beets.
Safety tests on commercial GM crops
The GM tomatoes were produced by inserting kanr genes into a tomato by an ‘antisense’ GM
method. The results show that there were no significant alterations in total protein, vitamins
and mineral contents and in toxic glycoalkaloids. Therefore, the GM and parent tomatoes
were deemed to be “substantially equivalent”. In acute toxicity studies with male/female rats,
which were tube-fed with homogenized GM tomatoes, toxic effects were reported to be
absent. A study with a GM tomato expressing B. thuringiensis toxin CRYIA (b) was
underlined by the immunocytochemical demonstration of in vitro binding of Bt toxin to the
caecum/colon from humans and rhesus monkeys.
GM maize
Two lines of Chardon LL herbicide-resistant GM maize expressing the gene of

phosphinothricin acetyltransferase before and after ensiling showed significant differences in
fat and carbohydrate contents compared with non-GM maize and were therefore substantially
different come. Toxicity tests were only performed with the maize even though with this the
unpredictable effects of the gene transfer or the vector or gene insertion could not be
demonstrated or excluded. The design of these experiments was also flawed because of poor
digestibility and reduction in feed conversion efficiency of GM corn. One broiler chicken
feeding study with rations containing transgenic Event 176 derived Bt corn (Novartis) has
been published. However, the results of this trial are more relevant to commercial than
academic scientific studies.
GM soybeans
To make soybeans herbicide resistant, the gene of 5-enolpyruvylshikimate-3-phosphate

synthase from Agrobacterium was used. Safety tests claim the GM variety to be
“substantially equivalent” to conventional soybeans. The same was claimed for GTS
(glyphosate-resistant soybeans) sprayed with this herbicide. However, several significant
differences between the GM and control lines were recorded and the study showed
statistically significant changes in the contents of genistein (isoflavone) with significant
importance for health (and increased content in trypsin inhibitor.
Studies have been conducted on the feeding value and possible toxicity for rats, broiler
chickens, catfish and dairy cows of two GM lines of glyphosate-resistant soybean (GTS). The
growth, feed conversion efficiency, catfish fillet composition, broiler breast muscle and fat
pad weights and milk production, rumen fermentation and digestibilities in cows were found
to be similar for GTS and non-GTS. These studies had the following lacunae: (a) No
individual feed intakes, body or organ weights were given and histology studies were
qualitative microscopy on the pancreas, (b) The feeding value of the two GTS lines was not
substantially equivalent either because the rats/catfish grew significantly better on one of the
GTS lines than on the other, (c) The design of study with broiler chicken was not much
convincing, (d) Milk production and performance of lactating cows also showed significant
differences between cows fed GM and non-GM feeds and (e) Testing of the safety of 5-
enolpyruvylshikimate-3-phosphate synthase, which renders soybeans glyphosate-
resistant ,was irrelevant because in the gavage studies an E. coli recombinant and not the
GTS product were used. In a separate study , it was claimed that rats and mice which were
fed 30 % toasted GTS or non-GTS in their diet had no significant differences in nutritional
performance, organ weights, histopathology and production of IgE and IgG antibodies.
GM potatoes
There were no improvements in the protein content or amino acid profile of GM potatoes. In
a short feeding study to establish the safety of GM potatoes expressing the soybean glycinin
gene, rats were daily force-fed with 2 g of GM or control potatoes/kg body weight. No
differences in growth, feed intake, blood cell count and composition and organ weights
between the groups were found. In this study, the intake of potato by animals was reported to
be too low.
Feeding mice with potatoes transformed with a Bacillus thuringiensis var.kurstaki Cry1 toxin

gene or the toxin itself was shown to have caused villus epithelial cell hypertrophy and
multinucleation, disrupted microvilli, mitochondrial degeneration, increased numbers of
lysosomes and autophagic vacuoles and activation of crypt Paneth cells. The results showed
CryI toxin which was stable in the mouse gut. Growing rats pair-fed on iso-proteinic and iso-
caloric balanced diets containing raw or boiled non-GM potatoes and GM potatoes with the
snowdrop (Galanthus nivalis) bulb lectin (GNA) gene showed significant increase in the
mucosal thickness of the stomach and the crypt length of the intestines of rats fed GM
potatoes. Most of these effects were due to the insertion of the construct used for the
transformation or the genetic transformation itself and not to GNA which had been pre-
selected as a non-mitotic lectin unable to induce hyperplastic intestinal growth and epithelial
T lymphocyte infiltration.
GM rice
The kind that expresses soybean glycinin gene (40–50 mg glycinin/g protein) was developed
and was claimed to contain 20 % more protein. However, the increased protein content was
found probably due to a decrease in moisture rather than true increase in protein.
GM cotton
Several lines of GM cotton plants have been developed using a gene from Bacillus
thuringiensis subsp. kurstaki providing increased protection against major lepidopteran pests.
The lines were claimed to be “substantially equivalent” to parent lines in levels of
macronutrients and gossypol. Cyclopropenoid fatty acids and aflatoxin levels were less than
those in conventional seeds. However, because of the use of inappropriate statistics it was
questionable whether the GM and non-GM lines were equivalent, particularly as
environmental stresses could have unpredictable effects on anti-nutrient/toxin levels.
GM peas
The nutritional value of diets containing GM peas expressing bean alpha-amylase inhibitor
when fed to rats for 10 days at two different doses viz. 30 % and 65 % was shown to be
similar to that of parent-line peas. At the same time in order to establish its safety for humans
a more rigorous specific risk assessment will have to be carried out with several GM lines.
Nutritional/toxicological testing on laboratory animals should follow the clinical, double-
blind, placebo-type tests with human volunteers.
Toxicological Studies
The purpose of toxicological studies is to characterize intended changes and detect active
substances or compounds that could have unexpected toxic effects for non-targeted
organisms. All toxicity assessment for GM material should be performed based on a case-by-
case approach, considering the toxicological profile of new introduced substances. The
methods to assess the toxicity of a specific compound in the body, usually compromise the
use of animal studies, considering the target species and the critical effects. However, new
strategies to identify GM feed anti-nutrient or toxicants include research on the in-planta
metabolism pathway, such as “-omics” techniques that may generate a better understanding
of the complex pleotropic effects of new plant cultivars. Additionally, in vitro assays with
gastric enzymes, cultured cell lines, receptor proteins, and in vivo animal studies can be
performed.
High-throughput “-omics” profiling techniques, which involve the use of metabolomics,

transcriptomics, and proteomics, have been suggested as a nontargeted approach to detect
unintended effects in GM crops. Profiling studies using omics techniques include GM
glyphosate-tolerant soybean, where some specific metabolites were different compared with
the isogenic line and the results were explained by modifications in the regulation of the
shikimate pathway. Nevertheless, a GM stacked rice carrying the herbicide-resistant
gene bar and insect-resistance cry, was found substantially equivalent to its conventional
genetic breeding and natural genetic cultivars, when their proteome profiles were compared
A review of the safety assessment of GM crops using omics techniques, indicated that
transgenesis has less unintended impacts than conventional breeding. Another study showed
that there were more transcriptomic alterations in mutagenized plants than transgenic plants.
Several toxicological studies in GM feed using omics techniques, involve the analysis of
fungus or their secondary metabolites. For instance, mycotoxins, which are undesired
substances produced by crop-related fungus. In hybrids Bt maize, one of the principal
components of feeding formulas for livestock, plants experienced less fumonisin
concentration compare with its isoline. It was hypothesized that the reduction of fumonisins
was due to the pest reduction in the GM maize, since the fungus spore migration and
colonization may be facilitated with damages from insects. Therefore, it could be concluded
that GM corn can provide reductions in the risk of fumonisins contamination, but not
increment of toxicological risk for animals.
Similarly, in the transgenic high-energy perennial ryegrass, an evaluation of alkaloids,

secondary metabolites produced by endophytic fungus, found that the alkaloids concentration
in transgenic plants was same or lower compare with the isogenic line. The lower alkaloid
concentration could be partly attributed to higher growth of transgenic plants, which could
generate a dilution effect in the modulation of fungal biomass.
When performing in vivo studies, toxicology acute (14 days studies), subacute (28 days
studies), chronic (90 days studies), or specific toxicity (reproductive, mutagenicity, etc.)
assessment can be considered. In a chronic study feeding mice with crushed Bt cotton
seeds, cry genes and tnos promoter were detected only in intestinal tissue, while they were
not found in stomach, blood, liver, kidney, heart, and brain. In long term studies (>100 days),
no toxic effects were found in cattle and chickens fed with Bt maize. They concluded that
short fragments of plant chloroplasts (<200 base pairs) can be detected in blood lymphocytes
of cattle, but DNA fragments were not detected in other organs investigated (muscle, liver,
spleen and kidney). Similarly, some small changes in the metabolic profile of sheep fed
with Bt176-maize were found when compared with non-GE maize, according to the authors
such changes did not represent a health hazard. In pigs fed with Bt maize (MON810 event),
although all serum biochemistry parameters were within the normal reference interval for
pigs, small differences were reported. The authors concluded that the differences were the
result of a lower enzyme-resistant starch in the GM compare with the non-GM control.
Safety assessments of GM feeds should consider the maximum level present in any plant part
consumed by animals or in any by-product used as a feed ingredient, since the introduced
traits can express differently in the plant parts, affecting the concentration of novel proteins.
This can have implications in the level of exposure, selection of comparators and
determination of the novel protein concentration used in acute/sub-chronic toxicity studies.
In short, a case-by-case approach is also required for toxicological assessment of GM crops,

and the assessment procedure has not been standardized. A comparison with conventional
counterparts has been a common approach for GM food products, and a similar approach
may be used for forage products. A more cautious and stringent examination may be required
for GM feed, due to that a wider range of plant organs may be used for animal consumption
than those for human consumption, and storage conditions of the GM forage products may be
less uniformed and controlled than GM food.
HAZARD ASSOCIATED WITH NUTRITIONAL FORTIFICATION
A lively discussion about food fortification is presently taking place internationally. Different
countries, also within the European Union (EU), have different fortification regulations, a
situation that by many is considered to be a barrier to trade, and against EU free-trade
philosophy. Basically, two different attitudes to the question are apparent. The first is a
‘selective’ attitude, based on Codex Alimentarius principles, claiming that fortification
should not take place unless there is a documented need1, and the second is a ‘non-selective’
attitude, claiming that as long as there are no documented adverse health effects, fortifica-
tion regulations should be liberal2,3. The selective attitude comprises the historical approach,
where fortification of certain staple foods has been used as a means to alleviate deficiency
diseases in the general population; e.g. iodine in salt to alleviate goitre and vitamin D added
to margarine or milk to alleviate rickets. The selective approach has also of the discussions
and regulations been targeted, i.e. only meant for specific population groups, like iron added
to infant formula or flour to combat iron deficiency and anaemia. Recently, cereals fortified
with folic acid were introduced in the USA to reduce the prevalence of neural tube defects,
and the result is already measurable4,5. Both general fortification and targeted fortification
have been carefully regulated by the health and food authorities of the various countries and,
by and large, have been a blessing to consumers through their eradication of serious nutrient
deficiency diseases.
The ‘non-selective’ approach comprises all voluntary fortification by the food industry; that
is to say, the motivation is to increase the nutrient content of foods irrespective of there being
a documented need for it or not. All of the Nordic countries have in general been very
restrictive towards voluntary fortification, considering it unnecessary and potentially harmful.
Many other countries, like the USA, Britain, Switzerland and Belgium, have been more
liberal, allowing foods to be fortified voluntarily as long as harmful concentrations and
effects were avoided. Harmonising EU regulations implies making these two basically
different attitudes towards voluntary food fortification merge. In a joint effort to meet the
coming discussions, the Working Group on Diet and Nutrition under The Nordic Council of
Ministers initiated work with a discussion paper on the issue, which recently was published
as a report6. The present debate paper is based on, and is a continuation of, the Nordic report.
The most common arguments for and against voluntary, i.e. liberal, fortification practices are
presented and discussed, using a risk analysis model as a frame. This frame is also used when
discussing the possible impact of voluntary fortification on the total eating behaviour of
people. The paper does not discuss issues connected to two other aspects of the addition of
micronutrients to foods: restoration and standardisation
Exposure assessment (dietary intake)

To be able to evaluate the need for
fortification or food
supplements (vitamin and/or mineral
concentrates), and
estimate eventual negative health
outcomes of excessive
intakes, intake data for nutrients among
population groups
are necessary. To get a true estimate of
intake, they should
include nutrients provided not only by
food and drink, but
also by food supplements (vitamin and
mineral concen-
trates) and medications. The challenges
are formidable,
though, especially in countries with
liberal fortification
practices, because a good estimate of
nutrient intake
necessitates an updated database on the
nutrient content
of all brands of a food on the market,
and a dietary survey
method that will allow for brands to be
reported. Recent
EU directives on food additives
mandate all member states
to monitor their usage and
consumption
29 – 31
. In the wake
of this demand, simulation models
have been developed
to estimate food additive intake
32,33
. Similar methods have
been developed for assessing the
prevalence of nutrient
inadequacy
34
, and may prove useful when we want
to
estimate the true intake of
micronutrients, including the
contribution from fortified foods.
A way to get around the challenges
with dietary surveys
is to use biological markers of nutrient
intake. Unfortu-
nately, few such have been found to
date
35
.
Hazard characterisation
There are quite extensive variations
between vitamins and
minerals regarding the range between
the recommended
level of intake and the intake level that
gives rise to
adverse/toxic effects. For some
components this range can
be quite small, e.g. # 5-fold, whereas
for others the range
may be more than 100-fold. For
vitamins with a narrow
range and hence a greater risk of
excessive consumption
and adverse health effects, it is
necessary to be more
cautious from both scientific and
regulatory points of view.
However, larger ranges do not
necessarily imply
harmlessness, but simply that the
amount of data is limited.
Caution may be warranted also for
such micronutrients.
In an attempt to approach this problem,
we have, on the
basis of easily available information
from nutrition
textbooks and recommended intakes
18,23,24
, roughly
divided the vitamins and minerals into
three categories
(Table 4).
. Category A: Nutrients where the
range between
recommendations (or actual intakes)
and the upper
safe intake level is very narrow (# 5-
fold) and great
caution should be employed, for
instance, in regulatory
contexts (vitamins A and D, nicotinic
acid, folate and all
minerals).
. Category B: Upper safe intake level is
5–100 times
above recommendations.
Considerations should be
taken regarding side-effects or
interactions with other
components in the diet (vitamins B
6
,B
12
, C and E).
. Category C:
U p p e r s a f e i n t a k
e r a n g e i s v i r t u a
l l y
impossible to set, as no adverse or
toxic effects have
been observed even at . 100 times the
recommen-
dations (vitamin K, thiamin, riboflavin,
pantathenic acid
and biotin) and interactive effects have
hitherto not
been observed.
If liberal practices are advocated, it
may be useful to
have a classification like the above in
mind. If no safety
restrictions are applied, cases of
nutrient overloading due
to fortification may easily occur. It is
necessary to respect
the potential adverse effects of
micronutrients in category
A, and also be careful about the ones in
category B. New
information may eventually change
our views on
micronutrients in all categories,
necessitating changing of
categories.
concentrates), and
population groups
intake, they should
food and drink, but
mineral concen-
are formidable,
nutrient intake
nutrient content
reported. Recent
consumption
29 – 31
. In the wake
have been developed
32,33
inadequacy
34
to
intake. Unfortu-
date
35
.
the recommended
gives rise to
necessarily imply
we have, on the
from nutrition
18,23,24
, roughly
three categories
(Table 4).
range between
and the upper
fold) and great
minerals).
5–100 times
6
,B
12
, C and E).
. Category C:
l l y
toxic effects have
recommen-
pantathenic acid
hitherto not
been observed.
may be useful to
mind. If no safety
category B. New
our views on
categories.
concentrates), and
population groups
intake, they should
food and drink, but
mineral concen-
are formidable,
nutrient intake
nutrient content
reported. Recent
consumption
29 – 31
. In the wake
have been developed
32,33
inadequacy
34
to
intake. Unfortu-
date
35
.
the recommended
gives rise to
necessarily imply
we have, on the
from nutrition
18,23,24
, roughly
three categories
(Table 4).
range between
and the upper
fold) and great
minerals).
5–100 times
6
,B
12
, C and E).
. Category C:
l l y
toxic effects have
recommen-
pantathenic acid
hitherto not
been observed.
may be useful to
mind. If no safety
category B. New
our views on
categories.
xposure assessment (dietary intake)
concentrates), and
population groups
intake, they should
food and drink, but
mineral concen-
are formidable,
nutrient intake
nutrient content
reported. Recent
consumption
29 – 31
. In the wake
have been developed
32,33
inadequacy
34
to
intake. Unfortu-
date
35
.
the recommended
gives rise to
necessarily imply
we have, on the
from nutrition
18,23,24
, roughly
three categories
(Table 4).
range between
and the upper
fold) and great
minerals).
5–100 times
6
,B
12
, C and E).
. Category C:
l l y
toxic effects have
recommen-
pantathenic acid
hitherto not
been observed.
may be useful to
mind. If no safety
category B. New
our views on
categories.
To be able to evaluate the need for fortification or food supplements (vitamin and/or mineral
concentrates), and estimate eventual negative health outcomes of excessive intakes, intake
data for nutrients among population groups are necessary. To get a true estimate of intake,
they should include nutrients provided not only by food and drink, but also by food
supplements (vitamin and mineral concentrates) and medications. The challenges are
formidable, though, especially in countries with liberal fortification practices, because a good
estimate of nutrient intake necessitates an updated database on the nutrient content of all
brands of a food on the market, and a dietary survey method that will allow for brands to be
reported. Recent EU directives on food additives mandate all member states to monitor their
usage and consumption29 – 31. In the wake of this demand, simulation models have been
developed to estimate food additive intake32,33. Similar methods have been developed for
assessing the prevalence of nutrient inadequacy34, and may prove useful when we want to
estimate the true intake of micronutrients, including the contribution from fortified foods. A
way to get around the challenges with dietary surveys is to use biological markers of nutrient
intake. Unfortu- nately, few such have been found to date35.
There are quite extensive variations between vitamins and minerals regarding the range
between the recommended level of intake and the intake level that gives rise to adverse/toxic
effects. For some components this range can be quite small, e.g. #5-fold, whereas for others
the range may be more than 100-fold. For vitamins with a narrow range and hence a greater
risk of excessive consumption and adverse health effects, it is necessary to be more cautious
from both scientific and regulatory points of view. However, larger ranges do not necessarily
imply harmlessness, but simply that the amount of data is limited. Caution may be warranted
also for such micronutrients.
In an attempt to approach this problem, we have, on the basis of easily available information
from nutrition textbooks and recommended intakes18,23,24, roughly divided the vitamins
and minerals into three categories (Table 4).
. Category A: Nutrients where the range between recommendations (or actual intakes) and
the upper safe intake level is very narrow (#5-fold) and great caution should be employed, for
instance, in regulatory contexts (vitamins A and D, nicotinic acid, folate and all minerals).
. Category B: Upper safe intake level is 5–100 times above recommendations.

Considerations should be taken regarding side-effects or interactions with other components
in the diet (vitamins B6, B12, C and E).
. Category C: Upper safe intake range is virtually impossible to set, as no adverse or toxic
effects have been observed even at .100 times the recommendations (vitamin K, thiamin,
riboflavin, pantathenic acid and biotin) and interactive effects have hitherto not been
observed.
If liberal practices are advocated, it may be useful to have a classification like the above in
mind. If no safety restrictions are applied, cases of nutrient overloading due to fortification
may easily occur. It is necessary to respect the potential adverse effects of micronutrients in
category A, and also be careful about the ones in category B. New information may
eventually change our views on micronutrients in all categories, necessitating changing of
categories.
xposure assessment (dietary intake)
concentrates), and
population groups
intake, they should
food and drink, but
mineral concen-
are formidable,
nutrient intake
nutrient content
reported. Recent
consumption
29 – 31
. In the wake
have been developed
32,33
inadequacy
34
to
intake. Unfortu-
date
35
.
the recommended
gives rise to
necessarily imply
we have, on the
from nutrition
18,23,24
, roughly
three categories
(Table 4).
range between
and the upper
fold) and great
minerals).
5–100 times
6
,B
12
, C and E).
. Category C:
l l y
toxic effects have
recommen-
pantathenic acid
hitherto not
been observed.
may be useful to
mind. If no safety
category B. New
our views on
categories.
Risk characterization
As adverse health effects/toxicity from too high intakes of vitamins and minerals is normally
only possible through the consumption of multiple fortified foods or food supplements,
groups at risk of excess intake will be high consumers of fortified foods and supplements. A
number of countries, e.g. Britain, Switzerland and Belgium, have years of experience with
rather liberal fortification practices. Apparently, no signs of adverse health effects have been
reported in recent years as having connection to fortification practices in these countries.
However, as frank toxicity is not expected, negative health effects may be difficult to reveal,
they may be subtle and indirect. Because our normal dietary survey methods are limited and
considered a very inexact science, and the situation is not being made easier with fortified
foods, the true impact of micronutrients from the diet, both fortified and non- fortified, will
perhaps only be understood when adequate biomarkers for nutrient intake and status have
been found. Meanwhile, the best tool we have is to compare thorough consumption data with
the upper safe level of intake. Such an exercise has been done in the development of upper
levels in the Nordic countries18, by the EU21 and by the National Academy of Science in the
USA
SAFETY AND QUALITY RESEARCH PRIORITIES IN THE FOOD

INDUSTRY
Research priorities
Although a number of frameworks for hazard assessment, risk management, and testing
methods are applicable for safety assessment of cell-cultured meat and seafood products,
gaps remain in understanding some of the novel aspects of cell-cultured meat and seafood
products that may affect safety.
The following research topics address the safety information data gaps identified in this
review. Many of these areas of research will require collaboration between academic,
nonprofit, government, and industry groups to support development of methods that are
reasonable to sufficiently demonstrate safety and to ensure that the research and outcomes are
representative of realistic products. As part of the workshops, input was sought to understand
the importance of these research topics from an industry perspective. Participants were asked
to vote for their top priorities; these results are listed in Supplement 2.
 Evaluation of the inputs (e.g., growth factors, antibiotics, scaffold, novel inputs), as
compared to conventional foods:
 ∘ Identification of the types of inputs and concentrations used in the product;
 ∘ Determination of where in the process the inputs are used;
 ∘ Assessment of the efficacy of the removal steps;
 ∘ Evaluation of the safety of the residues for use in food.
 Determination of the significance of health status of the source animal in relation to
potential for disease propagation in vitro.
 Confirmation that cell-cultured products are less susceptible to contamination than
conventional foods.
 Assessment of the range of genetic modification approaches and outcomes that affect
safety:
 ∘ Identification of novel metabolites or expression products;
 ∘ Evaluation of the potential for DNA to be transferred to gut or environmental microbes;
 Development of industry-wide standards for safe residue levels of common inputs.
 Evaluation of the comparative approach for the safety assessment of the final product:
 ∘ Development of methods for comparative nutritional analysis.
 Development and validation of animal-free safety testing methods;
 ∘ Development of digestion and microbiome safety assessments with regard to inputs of
concern such as growth factors.
 Assessment of whether there are any novel allergens in the final product.
 Assessment of whether media recycling concentrates hazardous inputs/residues.
 Evaluation of environmental effects of waste products and determine appropriate
disposal.
 Evaluation of whether any novel food processing techniques affect safety of the final
product.
METHODS TO MANAGE AND ASSESS SAFETY

Manufacturing process safety
Cell-cultured meat and seafood safety depends on a manufacturing process designed with
product safety in mind and an assessment of the final product. This section describes
practices and protocols from related fields that can be translated to the cell-cultured
manufacturing context as part of creating safe, consistent, high-quality products.
1. Good Manufacturing Practice

Good Manufacturing Practice (GMP) relates to the overall “good housekeeping” principles
intended to prevent a hazard from occurring and is a set of widely applied food production
practices that describe appropriate design and construction of facilities, sanitary operations
and maintenance, and production and process controls that ensure reliable results and safe
production of food. GMPs and standard operating protocols from the food, feed, meat and
seafood, and pharmaceutical and medical fields can be applied to cell-cultured meat and
seafood manufacturing to ensure consistent quality and safety of the product. In addition,
Good Hygiene Practices (GHPs) are essential in the food supply and can be audited alongside
GMP compliance. GHPs extend beyond industrial food manufacture into the service industry,
such as catering, hotels, and restaurants
2. Good cell culture practice

Also applicable to cell-cultured meats and seafoods are concepts from Good Cell Culture
Practice (GCCP). These principles are typically applied to in vitro systems for basic research,
medicines, and pharmacology to maximize the reliability of cell and tissue products but some
aspects are relevant for handling and management of cell-cultured meat and seafood. GCCP
sets minimum standards and provides recommendations for in vitro work to prevent
contamination and ensure quality of the final product. Among other relevant
recommendations, GCCP suggests working with aseptic techniques and avoiding antibiotic
use, developing standard operating procedures, and controlling the quality of media
supplements and other inputs. Documentation is emphasized; maintaining a detailed record of
all procedures can provide information on what potential contaminants or hazardous inputs
may be present in the final product, which can support targeted screening for potentially
harmful impurities and contaminants. The standards set by GCCP is likely prohibitive for
food; however, development of “food-grade” GCCP based on existing guidelines may be a
good next step.
3. Code of hygienic practice
Until the relationships between source animal health and final food product are understood
for cell-cultured products, guidance regarding the health of food animals or recommendations
related to the use of animal-derived materials for medical procedures may be useful. A code
of hygienic practice already exists for animal food production, which includes procedures for
herd management to maintain animal health and prevention of animal disease. Animals used
as source animals for xenotransplantation (i.e., use of live cells, tissues, or organs from an
animal source in a human recipient) are recommended to be healthy and reside in specific
pathogen-free closed herds with health screening programs. These programs track and
monitor infectious diseases, and documentation of animal health history is required. This
proactive approach can be especially useful where there are no validated screening tests to
detect endogenous pathogens. This is the case, for example, for prion-associated diseases,
such as BSE where diagnosis can only be made in a postmortem examination of brain tissue.
Active herd/flock management and documentation, along with monitoring and screening of
source animals for potential infectious disease, will lower the risk of culturing affected cells.
Similarly, isolation of animal-derived components of cell media (e.g., BSA, trypsin, collagen,
etc.) from low-risk animals reduces the chance of contamination .
4. Hazard and risk management systems

Management systems can help prevent or minimize hazards and manage specific risks within
a process. This review identifies some potential biological and chemical hazards; as more
data are developed and manufacturing processes evolve, other hazards (e.g., physical) and
associated risks (i.e., the likelihood that a hazard poses a significant safety issue) can be
assessed. Systems to manage food safety risk such as Hazard Analysis and Critical Control
Point (HACCP), Hazard Analysis and Risk-Based Preventative Controls (HARPC), Food
Safety Plan development, and other risk-based preventative controls programs may be
applied to cell-cultured meat and seafood processes. In each approach, a systematic review is
performed for each step of the manufacturing process to identify every possible hazard or
source of contamination. A control or procedure is introduced to prevent, eliminate, or
minimize each hazard based on its risk. In many countries, a risk prevention system is a
regulatory standard or law and is often considered essential to achieving greater market
access. Detailed documentation of each process step and identification of potential hazards
can help identify the impurities and contaminants that warrant examination in the final
product. This review delivers a first step toward hazard identification, recognizing that it is
premature to conduct a generalized risk assessment.
5. Input materials and equipment selection

Input material selection and control provides a second example where more general
frameworks can be supplemented with practices from specific fields. Cell culture materials
can be selected to comply with current GMP and food-grade specifications. The selection and
management of equipment, disposables, and cleaning agents made of food-safe materials will
limit the amount of toxic extractables and leachables migrating into the product. Standardized
tests for such contaminants to ensure quality and safety can be drawn from the
biopharmaceutical, medical device, and cosmetics industries, where much has already been
established related to testing regimes for process-related contaminants and residue
measurement.
6. Contaminant control
Every new cell line can be cultivated in a quarantine incubator and verified that they are
pathogen free. Microbiological controls and testing derived from practices involving stem
cells or in vitro practices can be applied throughout the manufacturing process. Many
methods exist to evaluate and reduce contamination from infectious agents introduced via
equipment, handling, material inputs, or processes where cultures are exposed to the air. A
system of daily observation and regular screening of cultures, media, and equipment using
standard protocols can be adapted from those provided in regulatory guidance or
pharmacopeial standards. Investment in rapid microbiological testing and implementation of
effective controls and procedures to limit contamination is essential. Viruses and other
undesirable agents can be reduced or removed from serum and final products through heat
inactivation, irradiation, or filtration. In addition, cells intended for banking may be screened
for bacteria, yeast, fungi, prions, and viruses to prevent unintentional propagation in future
batches.
BIOSOLID RECYCLING & FOOD SAFETY ISSUES
The municipal and septic wastewater treatment process produces both a solid and a liquid
waste stream. The solid residues are referred to as sludge. Biosolids are sludges that have
been treated to a standard suitable for beneficial reuse. That is, stabilised organic solids
derived totally or in part from wastewater treatment processes which can be managed safely
to utilise beneficially their nutrient, soil conditioning, energy or other value.
The term biosolids does not include untreated wastewater sludges, industrial sludges or the
product produced from the high temperature incineration of sewage sludge. It should also be
noted that many other solid waste materials are not classified as biosolids, eg animal
manures, food processing or abattoir wastes, solid inorganic wastes, and untreated sewage or
untreated wastes from septic systems/sullage wastes.
Biosolids can contain significant quantities of organic matter and plant nutrients, and as such
are viewed as a valuable resource for the agricultural, horticultural and municipal sectors.
Potential risks of biosolids applications
Misconceptions over high levels of heavy metals, other pollutants and potentially harmful
pathogens create concerns about the potential adverse impact of land application. Most
people lack the technical knowledge needed to understand how nutrients move through soil,
the technical issues surrounding potential risks, and the general practice of applying
biosolids. It is true that potential exists for toxic materials in biosolids, which are highly
variable in quality. Consequently, the EPA developed risk-based standards for controlling the
use and disposal of biosolids.
Disease causing organisms
One health risk with the land application of biosolids is the potential exposure to pathogens
(disease causing organisms). Organisms in this category include, but are not limited to,
bacteria, protozoa, viruses and viable helminth ova. Pathogens can be eliminated by treating
biosolids prior to land application using one or more of the many available treatment
technologies for control of pathogens and vectors.
Toxic chemicals
A perceived risk is that the biosolids may contain chemicals that are directly toxic in small
concentrations or doses. Most pollutants can be considered toxic or harmful at certain
concentrations or doses, such high concentrations have rarely been found in biosolids.
Common foods or products, such as salt or aspirin, are safe at normal levels but are also toxic
at certain high doses. The same concept is true for biosolids (Tables 2 and 3).
Table 2
Guide for interpretation of toxicity data
Ratings Relative Probable lethal oral dose of the pure chemical for
toxicity a 150 pound human adult
supertoxic 6 a taste to 7 drops
extremely toxic 5 7 drops to a 1 teaspoon
very toxic 4 1 teaspoon to 1 ounce
moderately 3 1 ounce to 1 pint (1 pound)

toxic
slightly toxic 2 1 pint to 1 quart (2 pounds)
practically 1 more than one quart

nontoxic
Table 3
Toxicity of some common chemicals
Chemical Toxicity1 rating
Strychnine 6
Caffeine 4
Antifreeze 3
Aspirin 3
Cayenne pepper 3
Table Salt 3
Sugar 1
Biosolids2 1
1
See Table 2.
2
Based on the highest concentration of most toxic chemicals in municipal sewage sludge.
Natural background levels in the environment
Most of the metals found in biosolids occur naturally in soil, water and air media
Quantities of metals found in soils, water and air are called background levels. These
background levels vary from place to place in various media. The amount of metals added by
the annual land application of biosolids is small compared to the background levels in some
soils One acre of land contains about 1,000 dry tons of soil 6 to 8 inches deep. If 2 dry tons of
biosolids are incorporated into 1 acre of soil, the annual addition of zinc would increase the
soil level of zinc by only 1 or 2 percent for a low metals biosolid (Table 4).
Table 4
Quantity of metals in Missouri soils and biosolids
Element Soils pounds per acre foot Biosolids pounds per dry ton
Arsenic 18 0.01 to 0.08
Chromium 108 0.02 to 24
Copper 26 0.09 to 10.4
Lead 40 0.08 to 1.9
Nickel 28 0.02 to 0.07
Zinc 98 0.34 to 26
Biosolids use in crop production

Numerous research studies, in both the laboratory and field, have shown that there are no
short-term risks to agricultural field crops when biosolids are applied at recommended rates
based on nitrogen content. However, in the long term, metals will accumulate in the soil to
the point that crop uptake of them will increase. With the approval of research scientists,
cumulative loading rates (in pounds per acre) of metals have been established in order to
protect the long-term productivity of the soil and assure that crops will be suitable for food-
chain use. These loading rates are based on the soil's ability to retain metals in an immobile
form and on maintaining proper soil pH. The same reactions in the soil that protect crops will
also protect groundwater supplies.
Biosolids fed to cattle
Researchers have fed biosolids directly to beef and dairy cattle at 10 percent to 20 percent of
their diet with no negative health results. Other research studies also show that there is not a
significant health risk to beef or dairy cattle from consuming feed grown on biosolids
amended soils. The use of best management practices will reduce the potential for direct
ingestion of biosolids while grazing cattle on biosolids-amended pastures.
Storm water runoff
Research has been conducted on pollutant levels in storm water runoff from land application
sites. Since most biosolids are adsorbed onto soil particles, it is important to minimize soil
erosion and sediment transport. Biosolids that are surface-applied must be able to infiltrate
into the soil surface. Biosolids that are applied during frozen or saturated soil conditions risk
being transported off-site if storm water runoff occurs before the soil dries. Intense storm
water runoff occurs several times each year at random intervals in Missouri. Runoff can be
controlled when recommended best management practices are followed.
EPA risk assessment
In 1988 the EPA conducted the National Sewage Sludge Survey, which sampled municipal
sludges from 200 cities across the nation and tested for about 400 different pollutants. Most
of these pollutants were found at very low levels. The EPA used this survey information and
national research data to select pollutants for the risk assessment under the 40 CFR 503 rules.
The EPA risk assessment looked at 14 possible pathways that land application of biosolids
could impact the environment (Table 5).
Table 5
Exposure pathways for biosolids land application
Exposure pathway Description
1. Sludge-soil-plant- Consumers in regions heavily affected by land application.

human
2. Sludge-soil-plant- Farmland converted to home garden use.

gardener
3. Sludge-soil-child Farmland converted to future residential use, and child-
ingested soil.
4. Sludge-soil-plant- Farm households eating a major portion of meat products

human from animals fed crops grown on sludge-amended soils.
5. Sludge-soil-animal- Farm households eating a major portion of meat from

human animals grazing on sludge-amended soil.
6. Sludge-soil-plant- Livestock eating food or feed grown on sludge-amended soil.

animal toxicity
7. Sludge-soil-animal Livestock ingesting soil while grazing.

toxicity
8. Sludge-soil-plant Crops grown on sludge-amended soils.

toxicity
9. Sludge-soil-soil biota Soil biota living in sludge-amended soils.

toxicity
10. Sludge-soil-soil Animals eating soil biota.

biota-predator
11. Sludge-soil-airborne Tractor operator exposed to dust.

dust-human
12. Sludge-soil-surface Water quality criteria for all beneficial uses of surface water.
water-fish-humans
13. Sludge-soil-air- Farm households breathing fumes from any volatile

human pollutants in sludge.
14. Sludge-soil-ground Farm households drinking water from wells.

water-human
The EPA risk assessment evaluated the health risk to the general population as well as to a
highly exposed individual, such as a person who would have direct contact with biosolids
land application sites for a lifetime. The aggregate health risks to the U.S. population from all
biosolids land application is much lower than many other common activities in our everyday
lives. The aggregate health risks per one million (1,000,000) persons is less than one person
for biosolids land application compared to 42 persons for motor vehicle accidents (Table 6).
Table 6
The relative risks of activities
Annual risk of death per one million population
Smoking 1 pack per day 277
Motor vehicles accident 42
Alcohol consumption (light drinkers) 5
Eating peanut butter (4 tbsp. per day) <1
Biosolids land application (all exposure pathways) <1
SYSTEMATIC FOOD SAFETY MANAGEMENT
A food safety management system (FSMS) is a group of procedures, practices, and principles
that manage food safety, control food safety hazards, and ensure safe and high-quality food.
Additionally, they conduct a hazard analysis of risk factors to all parts of the food process,
which reduces these risks to an acceptable level. A food safety system is a legal requirement
that businesses must implement to meet food safety regulations and ensure regulatory
compliance.
However, a food safety management system is also a helpful tool that businesses can use to
evaluate their current food safety measures. As a useful Tool, food safety systems assess
whether a company adequately controls food safety hazards and ensures that food continues
to be safe to eat.
Any food business or food industry must implement a food safety management system to
mitigate foodborne hazards and ensure the continued safety of our food. Thus, small caterers,
food manufacturers, large businesses, and even businesses making ready-to-eat food will
have tailor-made food safety management systems with food safety management systems at
every stage of the food chain—the overall level of food safety increases.
There are several methods a business can use to build a food safety management system. One
such system that companies have their FSMS based on is a Hazard Analysis Critical Control
Points plan (or HACCP plan.)
HACCP is an international method that ensures that food is safe to eat as it is one example of
a food safety management system. This is primarily undertaken by identifying potential
hazards and introducing control measures to control food safety risks and actively prevent
foodborne illness.
Risk factors to food safety include chemical, physical, and microbiological threats. All three
of these risk factors are accounted for and managed in any food safety system. A failure to do
so can result in severe food-borne illnesses for consumers.
We will discuss the principles of the Hazard Analysis Critical Control Point shortly. But first,
let’s discuss four other critical components of a food safety management system.
Importance of a Food Safety Management System
Food safety procedures are essential to ensure sufficient control of the risks associated with
the food process. Therefore, reducing foodborne hazards and foodborne illnesses is a central
goal of any food safety management system.
Why is this important? Failure to ensure safe practices can cause a foodborne illness. Should
your business be associated with unsafe procedures, customers will avoid your shop, resulting
in a loss of sales and revenue. Incoming lawsuits can also follow due to a food standards
agency investigation.
Therefore, prioritizing safer food practices through implementing a food safety management
system is essential to maintain customer confidence in your business.
Prerequisite programs
Prerequisite programs are composed of a wide range of different plans that aim to establish
safe and sanitized conditions for food businesses. These programs encompass some of the
most basic food handling practices, such as basic food hygiene and minimum food
operations.
Although voluntary and does not require stringent monitoring, prerequisite programs are
essential for food businesses. Operations included in these programs are very simple and
must be observed every day.
Some of the most common prerequisite programs include:
o Sanitation standard operating procedures

o Sanitation design principles
o Proper layout of your food business (e.g., one-direction flow, easy-to-clean
walls, and availability of handwashing facilities)
o Food safety posters and reminders
o Air and water controls
o Employee training on food hygiene
o Effective pest control program
o Proper waste management
HACCP
The Hazard Analysis Critical Control Point system or HACCP is a systematic food
management system that aims to analyze hazards and establish control measures to minimize
them to acceptable levels. The HACCP program is the most widely known food safety plan
all over the world. It is used as a standard for higher food safety systems as it encompasses all
essential tasks to control hazards and keep customers safe from potential food risks.
The establishment of a HACCP plan in a food business depends on the requirement of the
concerned government agency regarding the nature of your business.
HARPC
Under the U.S. Food Safety Modernization Act of 2011 (FSMA), food businesses in the U.S.
food industry were mandated to establish a risk-based preventive control program in place of
a HACCP plan. This program is known as the Hazard Analysis and Risk-based Preventive
Controls system or HARPC. This food safety system aims to address food safety hazards
before they even occur. The scope of the HARPC system is broader than other food safety
management systems and uses risk-based data to establish preventive controls.
ISO
The International Organization for Standardization or ISO is a non-governmental

organization that establishes food quality and safety standards and management systems for
the food industry. This organization has established several different levels of requirements
and standards for food safety management systems. One of the most notable requirements
published by the organization is ISO 22000. This international standard lays out the most
critical food safety standards that a food business must have. It incorporates elements of the
HACCP system and other versions of ISO standards, such as the ISO9001.
IMPACT OF FOOD SAFETY ON WORLD TRADE ISSUE
Food safety regulations and standards can impede trade and significantly affect the ability of
developing countries to access markets, particularly in industrialized countries. In extreme
cases, countries are denied access to export markets; their exports may be banned from other
countries because they fail to meet food safety standards, or the costs of compliance may be
too high. Outright bans are mostly used as temporary measures when acute food safety issues
are identified. Even when exporters can comply with food safety requirements, their
competitiveness relative to other exporters may be diminished because of their relatively high
compliance costs. Both macro- and microeconomic effects of food safety regulations can be
extremely damaging for export-oriented countries. In developing countries compliance with
food safety may require action by both governments and individual exporters. Introducing
certification procedures would be a government action, for example, while improving
hygiene and other value addition processes in processing facilities would be a private action.
Most of the effects of food safety requirements on trade stem from government regulation. It
is increasingly recognized that voluntary food safety standards can also impede trade.
Exporters may comply voluntarily with established standards because customers require it or
to meet food safety regulations. If such standards are widely applied they in effect become
mandatory within a product market, exporters may have little or no choice but to comply.
Standard setting and increased quality assurance can have positive effects in individual
commodity markets. Voluntary quality assessment and standardizing accompanied with use
of certified varieties and declaring them in sales have increased the sales value in
commodities. There are good examples of this for instance in potato retail sales.
The regulations in developed countries certainly have implications for developing country
food producers and processors, and can increase the costs of exporting. During the last
decade developing countries’ exports of fresh and minimally, only post harvest processed
products have increased markedly, and include
vegetables, roots, tubers and fruits. The developing country exporters frequently face
difficulties in meeting the increasingly stringent food safety regulations imposed by
developed countries. Technical assistance, investments by producers, and new policies in
developing countries has however helped the developing-country exporters maintain market
access.
The food system is also changing in developing countries themselves, not least because new
food safety standards required by developed countries shape also expectations among
urbanized consumers in the developing countries. Also, the food processing and preparation
has tended to move outside the household as economies develop. Supermarket chains
increasingly dominate urban food retailing in middle-income areas, creating new supply
chains, and thus also creating new income opportunities.
Meeting food safety standards has to be seen as a part of successfully developing export
markets and opportunity for the food producing enterprises. Food safety issues have to be
seen as important to their ability to participate in and benefit from trade. The developing
countries should have enough assistance in technical issues regarding food safety and food
exports within the current WTO context.
But the benefits from food safety improvement will only be captured if policymakers in
developing countries understand both food safety risks and their impact on public health, and
the synergies between development of the domestic food system and food export industries.
In addition, developing countries must establish processes for food safety policy that are
inclusive, in that they take into account the interests of many different groups; transparent, in
that they use verifiable information, relate decisions to evidence-based rationales, and
communicate those rationales in a widely accessible manner and in a timely way; and
competent, in that they are based on the best available information about the magnitude and
distribution of benefits and losses.
Efforts to meet food safety standards in export markets must be judged also by whether such
efforts generate economic gains for the domestic industry or create positive spillovers for
food safety in the domestic food system. The global nature of the food supply and food
security will also require developed countries to consider how they might better assist
developing countries to address food safety issues.
FOOD SAFETY CHALLENGES IN 21st CENTURY
1. A growing nutritional crisis
The world has made substantial progress in reducing hunger and undernutrition in the past 25
years. Global rates of hunger have fallen and now affect around one in ten people and the
percentage of children who are chronically undernourished has declined to around one in
four. Such progress means less suffering, lower mortality rates and improved life chances for
hundreds of millions of families and their children.
However, despite these gains, malnutrition in all its forms currently affects one in three
people worldwide, far beyond the 795 million who experience hunger on a daily basis. And
the situation is rapidly getting worse. Over the next 20 years, multiple forms of malnutrition
will pose increasingly serious challenges to policy makers:
 Today, the prevalence rates of overweight, obesity and diet-related chronic diseases
such as diabetes and hypertension are increasing in every region and most rapidly in
low- and middle-income countries. In sub-Saharan African men, the growth rate of
overweight and obesity now exceeds that
for underweight. For South Asian women, the prevalence of overweight and obesity is
almost the same as the prevalence
of underweight. In China, the combined rate of overweight and obese adults is
projected to rise to over 50% by 2030.
 Nearly a quarter of all children aged under five years
of age today are stunted, with diminished physical and mental capacities. Less than a
third of all young infants in 60 low- and middle-income countries are meeting the
minimum dietary diversity standards needed for growth. And undernourished mothers
are having babies who will be left with life-long impairments.
• More than 2 billion people lack vital micronutrients (e.g., iron, zinc, vitamin A) which
affects their health and life expectancy. For example, in low- and middle-income countries,
over half
of the young women and adolescent girls surveyed are not meeting their micronutrient needs.
By 2050, the estimated impact of elevated carbon dioxide on the zinc content of grains,
tubers and legumes, could place 138 million people at new risk of zinc deficiency – with 48
million in India alone.
The proportion of the world that is suffering from diet-related malnutrition is increasing. It
now stands at just over 1 in 3. This ratio will move towards
1 in 2, if current trends continue
Looking to the future, if the direction of current policies remains the same, (i.e. business as
usual) then estimates suggest that by 2030, the number of overweight and obese people will
have increased from 1.33 billion in 2005 to 3.28 billion, around one third of the projected
global population. This is a major concern as no country to date has successfully reversed
growth in obesity once it has been allowed to develop. At the same time, there will still be
653 million calorie-deficient people (down from 795 million in 2015). Most of the reductions
in calorie insufficiency will come from Asia, while Africa will see a levelling off. But if
nothing is done, Asia and Africa will still be grappling with significant levels of
undernutrition in 14 years’ time.
Together, these facts offer up a formidable warning to policy makers. Immediate and decisive
action is needed to address the challenges that they pose to avert the profound consequences
for the health of populations, health care costs and economic growth.
2. Malnutrition represents the number one risk factor in the global burden of disease
The impacts of malnutrition are huge. An estimated 45%

of deaths under age five are linked to undernutrition and suboptimal breastfeeding alone is
responsible for almost 12% of total deaths3, mostly in low-income countries. Malnutrition
has many causes and a low-quality diet is one of them.
Malnutrition associated with diets that are not nutritious or safe represents the number one
risk factor in the global burden of disease. These low-quality diets contain insufficient
calories, vitamins and minerals or contain too many calories, saturated fats, salt and sugar.
The risk that poor diets pose to mortality and morbidity is now greater than the combined
risks of unsafe sex, alcohol, drug and tobacco use.
Poor nutrition amplifies the health consequences of diseases such

as HIV/AIDS, malaria and measles. In economic terms, across Africa and Asia, the estimated
impact of undernutrition on gross domestic product (GDP) is 11% every year — more than
the annual economic downturn caused by the global financial crisis of 2008–10.
3. Food systems are not delivering healthy diets
Today’s food systems are too focused on food quantity and not enough on quality. They are
not helping consumers to make healthy and affordable food choices consistent with optimal
nutrition outcomes. In fact, the trend is in the opposite direction. The multiple forms of
malnutrition will not diminish unless policy makers and private sector business leaders work
together to reshape food systems in ways that will advance the goal of healthier diets for all.
The risk that poor diets pose to mortality and morbidity is now greater than the combined
risks of unsafe sex, alcohol, drug and tobacco use
Over recent decades, agricultural productivity has risen, food trade has increased and the
once ever-present threat of famine has receded in most parts of the world. This means many
people have better diets than before. But the rate of increase of intake of foods that
undermine diet quality has been increasing even faster. For example, in 2000, sales of ultra-
processed foods and beverages in the upper-middle- income countries were one-third of those
in the high-income countries. Fifteen years later, they were more than half. So while there
have been dietary improvements, the net result is still low-quality diets.
As this report shows, rising incomes alone will not improve the quality of people’s diets. As
incomes increase, food scarcity diminishes but the cost of many nutritious foods remains high
and the ability to purchase foods that do not support high- quality diets increases. Currently,
income growth is a double- edged sword when it comes to improving diets.
4. The importance of a food system approach
Policy makers need to ensure that all parts of food systems work together to deliver high-
quality diets. This means thinking well beyond agriculture to also consider the many
processes and activities involved in food production, processing, storage, transportation,
trade, transformation and
In the longer term, food systems will be subject to major stresses... Population growth,
climate change and increased competition for natural resources are notable examples. This
amounts to a change in mindset and a fundamental shift in approach. Whatever progress is
made towards food security, unless foods reach people in a form that is nutritious and
affordable, the problem of poor quality diets will not be solved.
Food systems are changing rapidly with important consequences for changing diets. The food
chains that supply consumers are growing longer, with global trade increasing the distance
between production and consumption, as well as the diversity of foods available to
consumers. Value and power in food systems is shifting towards the middle of these food
chains, with agricultural produce becoming ingredients for processed products. Decisions by
large agri-businesses, manufacturers and retailers are playing a growing role, relative to the
public sector, in the availability, affordability, safety and desirability of foods. Policy makers
need to ensure that food system changes like these contribute to, and do not detract from,
high-quality diets.
The bottom line is that food systems are failing us. Those who would benefit from consuming
more animal source foods, fruits, vegetables and pulses often find them unaffordable. Others
who need to reduce their consumption of red meat may be unable to switch to other sources
of flesh-based food such as fish.
In the longer term, food systems will be subject to major stresses resulting from important
external influences
(Population growth, climate change and increased competition for natural resources are
notable examples. But others such as income growth, urbanization and globalization
of diets are likely to have mixed effects – with both positive and negative consequences for
diets. It is essential that policy makers think through the consequences of all of these drivers
of change for their own food systems.
The good news is that there are many ways in which policy makers can reshape food systems.
Extending policy action beyond agriculture to the entire food system opens up many
opportunities to improve the consumer’s ability to access food that is safe, nutritious and
affordable. The full Foresight report provides detailed guidance on the many options
available to policy makers to allow them to act now on their own food systems, to help
address diet quality-driven malnutrition crises in their countries.
Specific priorities for action
Policy makers and other key decision makers need to work throughout the food system to
effect diet change. The full report provides guidance together with advice on promising
evidence-based policy actions to improve diets.
While most actions will depend heavily on local contexts, the following are universally
applicable:
1. Focus food and agriculture policies on securing diet quality for infants and
young children. These are woefully inadequate in many countries. Improved policy
choices are needed which recognize the centrality of high-quality diets for the
youngest.
2. Improve adolescent girl and adult women’s diet quality as a priority in all policy
making that shapes food systems. Women are particularly vulnerable to the health
impacts of low-quality diets because of their higher nutrition requirements and
because of their disempowerment in some cultures.
3. Ensure that food-based dietary guidelines (FBDGs) guide policy decisions to
reshape food systems. FBDGs are largely absent in low-income countries (present
only in 2 out of 31) and limited in lower middle-income countries (12 out of 51).
They are needed to inform and to influence food policies around the world.
4. Animal source foods (e.g. dairy, eggs, fish and meat) provide important
nutrients. Policy support for these foods should be pragmatically evidence-based
rather than driven by ideology. Infants, children, adolescents and women of
reproductive age living in low-income contexts will find it extremely hard to meet
nutrient requirements in the absence of these foods. At the same time, some groups in
low-income contexts are consuming levels of these foods in excess of recommended
levels.
5. Make fruits, vegetables, pulses, nuts and seeds much more available, more
affordable and safe for all consumers. They offer considerable benefits in terms of
diet quality. There are opportunities throughout the food system to overcome supply-
side barriers to make them available, affordable
and appealing. Public policy can also incentivize greater investment in the
infrastructure required to produce, store and transport these foods.
6. Make policies which regulate product formulation, labelling, advertising,

promotion and taxes a high priority. These are needed to create disincentives for
companies to allocate resources to forms of processing that undermine diet quality.
Policies to educate consumers of the adverse health effects of consuming these
products more than occasionally are also needed.
Failure to take decisive actions now will lead to very serious health and economic impacts for
all in society, but especially for women, infants
and young children. These impacts will reverberate throughout the life cycle and across
generations
7. Improve accountability at all levels. Governments committed to reshaping food systems

toward healthy diets need to set targets and publish transparent scorecards of their results.
Private sector actors should acknowledge their far-reaching roles in defining food
environments – and the nutritional quality of foods and other products that they promote to
consumers. Civil society organizations need to monitor the performance of others.
8. Break down barriers associated with the longstanding division of jurisdictional

responsibilities within many governments – between agriculture, health, social
protection and commerce. These can fundamentally impede integrated action across food
systems, inhibit the effective allocation of resources and create barriers that inhibit access to
data.
9. Institutionalize high-quality diets through public sector purchasing power. Food

provided in schools, hospitals, across the armed forces and in the prison system should
be of the highest dietary benefit to the diet, consumer. This approach has the potential to
shape the norms around foods that contribute to high-quality diets and incentivize suppliers
and contractors to align their value chains accordingly.
10. Refocus agriculture research investments globally to support healthy diets and good
nutrition Global and national public research organizations (and their funders) must
rebalance their priorities to reflect a priority focus on high-quality diets. Much more
investment in research on fruits and vegetables, animal source foods, legumes, nuts and
seeds is urgently required. Better national-level and subnational data are needed on
consumer food prices, food safety, food loss and waste. The Access to Nutrition Index that
assesses the conduct and performance of companies should be strengthened at the country
level.

Food Safety

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Food Safety

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FOOD SAFETY

 Protection from foodborne illnesses and other food-related injuries. The main

 A better way of living. Any foodborne illness affects productivity in consumers.

 Sustainable food production. Some food production practices have already received

Global/ Pakistan health and nutrition burden

REGULATING FOOD SAFETY

Food safety legislation and regulation

Conduct a hazard analysis.

Determine critical control points (CCPs).

 Testing for metal contaminants

 Testing for chemical residue

 Establish critical limits.

Establish monitoring procedures.

Establish verification procedures.

Establish record-keeping and documentation.

Food Safety Plans

 Reassessment of the plan at a minimum of two-year intervals

Effects of processing and storage of food

Some vitamins are more stable (less affected by processing) than others. Water-soluble

The most unstable vitamins include:

More stable vitamins include:

 niacin (vitamin B3)

Processes affecting food nutrient content

A variety of things can happen during the growing, harvesting, storage and preparing of

High pressure processing

Losing nutrients through cooking

Benefits of cooking food

 making the food tastier

Preserving the nutrient value of vegetables

Some common examples of ultra-processed foods include:

 carbonated soft drinks and energy drinks

Ultra-processed food and health

The mechanisms explaining the association between consumption of ultra-processed foods

Legal burden for proof of

Legal burden for proof of

1. Buy foods from reputable sources.

PRINCIPLES OF FOOD IRRADIATION

HOW MUCH PESTICIDE RESIDUE IS ACTUALLY IN OUR FOOD?

AVERAGE RESIDUE REDUCTIONS DURING MARKETING AND PROCESSING

INCIDENTAL CONTAMINATION IN FOOD

Classes of emerging contaminants

1. Endocrine disrupting compounds

3. Illicit drugs, non-controlled drugs, and sweeteners

Using similar methodologies as for pharmaceuticals, it was demonstrated that our

4. Personal care products

Pesticides, such as herbicides, fungicides, insecticides, plant growth regulators, bactericides,

Is there a health risk related to emerging contaminants?

Surface waters have multiple stakeholders: industries, governments, drinking water

1. The role of governments

Public water supply is regulated by international and national legislation. In Europe,

Nowadays national legislation is often an implementation or a sharpening of the European

The Water Framework Directive 2000/60/EC aims to safeguard the quality of European

2. The position of drinking water companies

FDA Guidance Levels for Radionuclides in Domestic and Imported Foods

Table 1: Derived Intervention Levels (DIL, Bq/kg)

Compliance Analysis of Radionuclides in Foods

Analysis of Radionuclides in Foods

• Liquid samples are collected in a one-liter plastic or glass bottle.

Human Health Effects of Radionuclides

ASSESSING THE SAFETY OF GM FOOD CROPS

Foods derived from GM crops

Fruits and vegetables

It is reported that there is no or a significantly small amount of protein or DNA remaining in