Caballero B. (ed.) Encyclopaedia of Food Science, Food Technology and Nutrition. Ten-Volume Set

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resulted in a series of measures to promote world

food security. In December 1992, the first Inter-

national Conference on Nutrition (ICN) was held

in the FAO’s Headquarters in Rome. The confer-

ence was jointly sponsored by the FAO and the

WHO. At this conference, a World Declaration and

Plan of Action for Nutrition were unanimously

adopted, committing governments to prepare their

National Plans of Action for Nutrition containing

attainable goals and measurable targets based on

the principles and relevant strategies agreed at

theICN. World leaders assembled in Rome in Novem-

ber 1996 for the World Food Summit aimed at

renewing global commitment to the fight against

hunger. The FAO called the Summit in response to

widespread undernutrition and growing concern

about the capacity of agriculture to meet future food

needs.

0006 Besides being a major forum for the discussion of

food and agriculture matters, the FAO is an infor-

mation center collecting data related to its field of

work. It also acts as an adviser to governments,

being a useful source of independent advice on agri-

cultural policy and planning, on the administrative

and legal structures needed for development, and on

ways of ensuring that national development strategies

are directed towards rural development and the

alleviation of poverty and malnutrition. Its role as a

development agency should be highlighted: the FAO

gives direct, practical help in the developing world

through technical assistance projects in all areas of

food and agriculture (including fishery and forestry).

These field projects strengthen local institutions,

assist research and training, and develop and demon-

strate new techniques.

Food Security and Nutrition

0007 The idea of international action to achieve world food

security was launched by the FAO in early 1973. The

international undertaking in world food security

contains a set of general principles for stockholding,

special assistance to developing countries (including

aid to increase production), the exchange of informa-

tion, and arrangements for consultations. The con-

cept has developed further. Today, the objective of the

world food security concept is to ensure that all

people at all times have both physical and economic

access to the basic food they need. Its more specific

aims are related to production, with special emphasis

on low-income food-deficit countries, stability in the

flow of supplies, and the problems of access to avail-

able supplies on the part of needy nations and social

groups.

0008The search for policies that would cope with food

shortages and surpluses has been one of the main

threads in FAO history. Various activities contributed

to the preparation of such a policy, including the

following: expanding production, improving nutri-

tion, stabilizing prices, obtaining a fair return for

producers, and coping with famine.

0009Nutrition was a dominant theme at the Hot Springs

Conference, with the adoption of eight resolutions

dealing exclusively with various aspects of nutrition,

far more than on other subjects. There is no single

formula for curing malnutrition. The best approaches

vary, according to local and national circumstances.

The development of policies for food and nutrition

is largely a question of orienting sectoral activities

to have an impact on nutrition. Thus, from the mid-

1970s, the FAO worked closely with a number of

governments on the incorporation of nutritional

objectives into development plans.

0010A mass of information on every aspect of food and

agriculture (including production, supply, demand,

prices, and technology) is needed if government plan-

ners, traders, scientists, farmers, and technologists in

every country in the world are to make rational deci-

sions on planning, investment, marketing, research,

or training. The FAO provides that essential infor-

mation for food policy planning. For example, the

Global Information and Early Warning System for

Food and Agriculture monitors production condi-

tions and food supply prospects world-wide and

issues warnings when there are indications of trouble.

The role of world food surveys cannot be overempha-

sized in the assessment of world nutrition status. The

FAO prepares these surveys for collecting essential

data on the world’s food problems. These data are

analyzed and distributed to all member countries and

concerned bodies as reference data for the elabor-

ation of food policies at world or national levels. At

the time of writing, the latest survey is the sixth one,

published in 1996.

0011In addition to its tasks of collecting, analyzing and

disseminating information, advising governments on

food and agriculture (including fishery and forestry)

policy and planning, and providing opportunities for

governments to meet and discuss food and agriculture

problems, the FAO carries out a major program of

technical advice and assistance for the agricultural

community on behalf of governments and develop-

ment funding agencies. The FAO is involved at every

stage of agricultural development, from demonstrat-

ing new cultivation techniques to subsistence farmers,

to advising governments on how to achieve more

stable and equitable international trade in agricul-

tural commodities.

2588 FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS

Food Control

0012 In the past several decades, nations have experienced

extensive changes and faced new or greater problems

in assuring adequate national food security, trade,

and health. This trend is continuing for the following

reasons: intensification of farm production and the

centralization of food manufacturing; the develop-

ment of large urban markets remote from the agri-

cultural production areas; markets and consumer

demands for consistent supply of safe, uncontamin-

ated and good-quality food and food products; the

economic dependency of many countries on revenues

from agricultural food exports; and the rapid growth

in global food trade.

0013 Within the overall mandate of the FAO with regard

to production, distribution and marketing of food,

and for nutrition improvement, the necessity of

providing a safe, wholesome, and nutritious food

supply, and the protection of this supply from losses,

waste, deterioration, contamination, and adulter-

ation is implicit. It is interesting that the Hot Springs

Conference noted that the FAO would play a role in

insuring ‘protection of the public, through the

medium of pure-food laws, against impurities for

adulteration and against unfair competition and un-

desirable trade practices.’ It recommended that the

FAO should ‘assist governments to extend and im-

prove standards of nutrient content and purity of all

important foods.’ In view of this, the FAO has de-

veloped programs to assist governments to orient their

country policies and programs so as to include nutri-

tion improvement and food protection as specific

objectives.

0014 Food safety and quality start at the farm level and

continue throughout the processing and distibution

chain to storage and final preparation by the con-

sumer. Good agricultural, processing, distribution,

and marketing practices are essential to ensure con-

sumer protection. Now, more than ever, food control

programs are needed in order to assure that foods are

safe for consumption and are sold to the consumer on

fair terms; furthermore, such programs should help to

reduce food losses caused by improper handling or

spoilage of raw materials, prevent ‘dumping’ prac-

tices of shipping nonstandard (low-quality or con-

taminated) food products to countries that do not

have the capability of food control, and increase the

earnings of foreign currency necessary for the imple-

mentation of development plans. Food control,

including standards, is therefore an integrated part

of the programs developed by the FAO.

0015 Issues relating to food safety and food control

draw considerable public attention and represent an

important concern for governments, consumers, and

the industry alike. They need to be addressed at the

national level by adequate legislation, which should

be developed in cooperation with all interested

sectors and implemented efficiently.

0016The Economic and Social Department of the FAO,

and especially its Food and Nutrition Division (ESN)

are the main bodies responsible for the programs

oriented to guarantee food quality and safety and

consumer protection. Within this division, the Food

Quality and Standards Service focuses on activities in

the field of food control. These activities are imple-

mented through the Food Standards Group, which

provides the Secretariat for the Codex Alimentarius

Commission of the Joint FAO/WHO Food Standards

Program, and the Food Quality and Consumer Pro-

tection Group, which assists developing countries in

the formulation and development of effective food

control programs and gives scientific and technical

support to the Codex Alimentarius Commission.

Technical assistance provided by the FAO in food

control is based upon the fundamental elements that

all effective programs must consider:

0017a basic food law complemented by detailed regula-

tions that provide for correct hygienic practices in

food and agricultural production and processing,

the establishment of food standard and codes of

practice, the correct use of food additives, pesti-

cides, etc., and the proper use of labeling to avoid

consumer deception;

0018an effective administration of such laws and regu-

lations through an organization which includes

technical officers, inspectors, laboratory personnel

and compliance officers, together with the neces-

sary infrastructure to carry out their tasks ad-

equately;

0019a well-informed consumer, aware of the problems

related to food control, especially with respect to

good handling practices and storage; and

0020food producers, processors, and handlers who co-

operate with government agencies in assuring food

quality and safety.

0021In order to insure food security, facilitate trade and

protect consumers, the development of the following

activities receives special consideration from the

FAO:

0022support of developing countries in strengthening

their national strategies for quality and safety,

food control systems and contamination monitor-

ing programs;

0023preparation of food legislation, regulations, and

standards on a national, regional, or international

basis accordingly to meet changing consumer

demands (e.g., food irradiation, biotechnology),

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS 2589

new food ingredients (e.g., vegetable proteins), and

new food safety concerns (e.g., veterinary drug

residues, radionuclides); and

0024 technical assistance in training for food control

inspectorate and laboratory personnel and for

food control management staff. (See Legislation:

History; International Standards.)

Joint FAO/WHO Food Standards Program

Codex Alimentarius Commission

0025 The Hot Springs Conference noted the role of govern-

ment services in insuring the protection of the public.

It recommended that the FAO, when established,

should ‘consider the formulation and adoption of

international standards to facilitate and protect the

interchange of such products between countries, and

agree upon international methods of determination.’

0026 In 1958, work was begun by an FAO Committee of

Government Experts, in collaboration with the Inter-

national Dairy Federation, on the establishment of a

Code of Principles concerning Milk and Milk Prod-

ucts and compositional standards for milk products.

A further development that took place in 1958, and

which was to prove to be of great importance to both

the FAO and WHO in introducing an international

program for the elaboration of food standards, was

the creation of a body known as the Codex Ali-

mentarius Europaeus. In 1961, the Council of the

European Codex Alimentarius adopted a resolution

proposing that the work should be taken over by the

FAO and WHO. From that moment, matters moved

quickly, and the Codex Alimentarius Commission

was established in 1962 by the decision of the Con-

ference of the FAO and the Executive Board of the

WHO.

0027 The basic objectives were precisely those put

forward at Hot Springs: removal of nontariff trade

barriers caused by differing national food legislation,

insuring fair practices in international trade, and pro-

tection of the consumer against health risks and

fraud. The Commission assumed the role of an inter-

national forum for elaborating standards for foods

moving in international trade and for providing

guidance to countries wishing to create their own

national food laws and regulations.

0028 The Uruguay Round of Multilateral Trade Negoti-

ations concluded in Marrakesh in April 1994. It

established a new World Trade Organization (WTO).

Amongst the agreements were the Agreement on

the Application of Sanitary and Phytosanitary

Measures (the SPS Agreement) and the Agreement on

Technical Barriers to Trade (the TBT Agreement).

Both of these agreements are relevant in understanding

the international dimensions of food. The SPS Agree-

ment encourages the use of international standards,

guidelines, or recommendations where they exist and

identifies those of Codex (relating to food additives,

veterinary drugs and pesticides residues, contamin-

ants, methods of analysis and sampling, and codes

and guidelines of hygienic practices), as consistent

with provisions of the SPS. Thus, the Codex standards

serve as a benchmark for a comparison of national

sanitary and phytosanitary measures. The TBT Agree-

ment also recognizes international standards where

they exist. It requires that technical regulations on

traditional quality factors, fraudulent practices, pack-

aging labeling, etc. imposed by countries not be more

restrictive on import products than they are on prod-

ucts produced domestically.

0029Membership of the Codex Alimentarius Commis-

sion is open to all Member Nations and Associate

Members of the FAO and/or WHO. In 30 years, the

Commission has grown from the original 30 coun-

tries that were present at its First Session in 1963 to

165 member countries in 2001. The distribution of

Member Countries is as follows: Africa, 41; Near

East 19; Asia, 21; Europe, 40; Latin America and

the Caribbean, 31; North America, 2; Southwest

Pacific, 11. The Commission has an Executive Com-

mittee and 29 subsidiary bodies. All of these bodies,

like the Commission, are intergovernmental in char-

acter. The composition of the Executive Committee is

such as to insure an adequate representation of the

various geographical areas of the world to which the

members of the Commission belong. The Executive

Committee makes recommendations to the Commis-

sion regarding the general orientation of the program

of the work.

0030The main activities of the Commission have been

concerned with the development of international

world-wide standards for foods as well as other texts

on related matters, their publication in the Codex

Alimentarius, and the registration of acceptances by

member governments of standards. In addition, the

Commission, through its subsidiary bodies, is con-

cerned with the elaboration of advisory Codes of

Practice, which are adopted within the Codex. The

Commission determines priorities, and initiates and

guides the preparation of draft standards, whether by

its own subsidiary bodies or with the assistance of

other appropriate organizations.

0031During its lifetime, the Codex Alimentarius Com-

mission has elaborated more than 230 individual

commodity standards, 37 codes of hygienic and tech-

nological practices, and maximum residue limits for

pesticides covering more than 3000 potential pesti-

cide plant and animal combinations. The Codex Ali-

mentarius itself contains standards on the following:

2590 FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS

processed, semiprocessed, or nonprocessed food

products; raw materials used in manufacturing; label-

ing; nutrition information; food additives; contamin-

ants; pesticide residues; veterinary drug and hormone

residues in food; methods of analysis; sampling; codes

of practice; and guidelines and other recommenda-

tions. All the above have been published in 16

volumes of the Codex Alimentarius.

Labeling

0032 Food labeling is the primary means of communica-

tion between the producer and the consumer. One of

the most vexatious problems that exporters of food-

stuffs are likely to encounter is the wide disparity

between different countries’ requirements with regard

to labeling. The work of Codex in devising and issuing

a General Standard on the Labeling of Pre-Packaged

Foods must be regarded as a landmark, a major

achievement, in international recommendations for

food legislation.

0033 Codex has issued Guidelines for the production,

processing, labeling, and marketing of organically

produced foods. These guidelines set out the prin-

ciples of organic production at farm, preparation,

storage, transport, labeling and marketing stages,

and provide an indication of accepted permitted

inputs for soil fertilizing and conditioning, plant

pest and disease control, and food additives and pro-

cessing aids. For labeling purposes, the use of terms

inferring that organic production methods have been

used are restricted to products derived from operators

under the supervision of a certification body or

authority.

Nutrition Information

0034 Consumer demand for nutrition information is grow-

ing, stimulated by the media, whose interpret-

ation and presentation of the views of nutrition

scientists and on national policies are not always

balanced or accurate. Few consumers have any sys-

tematic training in nutritional matters or easy re-

course to reliable information sources. The natural

concern for the family health leads them to use the

media as their information source. The problem faced

by Codex was how to regulate it so that accurate and

balanced information could be presented without cre-

ating a rigid system. The Guidelines on Nutrition

Labelling have been issued to insure that nutrition

labeling is effective:

0035 providing the consumer with information about

a food so that wise choices can be made;

0036 providing a means for conveying information of

the nutrient content of a food on the label;

0037encouraging the use of sound nutrition principles

in the formulation of foods that would benefit

public health; and

0038providing the opportunity to include supplemen-

tary nutrition information on the label

Nutrition labeling should not describe a product or

present information that is in any way false, mislead-

ing, deceptive, or insignificant in any manner, to

insure that no nutritional claims are made without

nutrition labeling.

Food Additives

0039The use of food additives is becoming more important

in the production and world-wide distribution of

food. As the demand for variety increases, and with

it the desire to purchase goods from distant lands, the

importance of food additives will increase, rather

than diminish. None the less, this is a topic of great

consumer concern, and Codex has always treated it as

such through the Codex Committee on Food Addi-

tives and Contaminants (CCFAC). The CCFAC con-

siders technological needs on the one hand from

information supplied by Codex Commodity Commit-

tees. On the other hand, it applies safety consider-

ations based on the reports of the Joint Expert

Committee on Food Additives. The CCFAC follows

a risk-based approach to develop the General Stand-

ard for Food Additives, which includes a list of addi-

tives that can be used in accordance with Good

Manufacturing Practice and specific levels of use for

a number of additives for which an acceptable daily

intake (ADI) has been established.

Contaminants

0040The term ‘contaminants’ is used to denote the pres-

ence in food of traces of undesirable elements of

substances, e.g., traces of lead, cadmium, polychlor-

inated biphenyls, or even radioactive fallout. The

CCFAC is responsible for establishing permitted

maximum or guideline levels for individual food

additives, for contaminants (including environmental

contaminants), and for naturally occurring toxicants

in foodstuffs and animal feeds. The establishment of

maximum levels for contaminants is a complex sub-

ject, and there are specific difficulties to address in

order to reach an agreement at the international level

in this area. Sometimes, the complete or updated risk

assessment is lacking, especially exposure assessment,

and there is a need to update the scientific informa-

tion. In addition, legislation in Member Countries

differs widely, especially between exporter and

importer countries, and it is difficult to come to a

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS 2591

consensus; there are also several technical problems

to be addressed, especially as regards methods of

analysis and sampling or inspection procedures.

Pesticide Residues

0041 The use of pesticides is essential in agriculture and

horticulture if crop yields are to be economically

viable and, indeed, if crops are to be successful. The

fact that residues can remain in the food is another

topic of considerable consumer and even wider

concern. There is well-justified concern that an unre-

stricted and uninformed use of these substances could

damage health. The Codex Committee on Pesticide

Residues, on the basis of the work of the FAO/WHO

Joint Meeting (Committee of Experts) on Pesticide

Residues (JMPR), has established maximum residue

limits (MRLs).

0042 Maximum Residue Limit (MRL) is the maximum

concentration of a pesticide residue (expressed as

milligrams per kilogram) recommended by the

Codex Alimentarius Commission to be legally per-

mitted in or on food commodities and animal feeds.

MRLs are based on Good Agriculture Practice data,

and foods derived from commodities that comply

with the respective MRLs are intended to be toxico-

logically acceptable.

0043 Codex MRLs that are primarily intended to apply

in international trade are derived from estimations

made by the JMPR as follows:

0044 toxicological assessment of the pesticide and its

residue; and

0045 review of residue data from supervised trials and

supervised uses including those reflecting national

food and agricultural practices. Data from super-

vised trials conducted at the highest nationally

recommended, authorized, or registered uses are

included in the review. In order to accommodate

variations in national pest control requirements,

Codex MRLs take into account the higher levels

shown to arise in such supervised trials, which are

considered to represent effective pest-control prac-

tices. Consideration of the various dietary residue

estimates and determinations both at the national

and international level in comparison with the

ADI should indicate that foods complying with

Codex MRLs are safe for human consumption.

Food Hygiene

0046 Poor food hygiene is a major cause of human illness.

Most hygiene problems are caused by faulty handling

of food and, in the case of processed or packaged

food, often occur after manufacture and packaging.

There are powerful reasons for the great attention

paid by Codex to food hygiene. In matters of hygiene,

it is especially true that good practices and economic

benefits go hand in hand. The establishment of effect-

ive good manufacturing practice as regards hygiene is

relatively simple in principle but is far from simple in

practice.

0047Codex has issued a Code of Practice and General

Principles of Food Hygiene. These General Principles

lay a firm foundation for insuring food hygiene. The

document follows the food chain from primary pro-

duction through to final consumption, highlighting

the key hygiene controls at each stage. It recommends

a Hazard Analysis and Critical Control Points

(HACCP)-based approach, wherever possible, to

enhance food safety. The HACCP system, which is

science-based and systematic, identifies specific

hazards and measures for their control to insure the

safety of food. HACCP is a tool to assess hazards and

establish control systems that focus on prevention

rather than relying mainly on end-product testing.

0048Principles for the establishment and application of

microbiological criteria for foods have been approved

by the Codex Alimentarius Commission. These prin-

ciples are intended to give guidance on the establish-

ment and application of microbiological criteria for

foods at any point in the food chain from primary

production to final consumption.

Current Issues

0049Matters related to biotechnology are at the center of

considerable debate in many countries and also at the

international level. In the framework of Codex, the

Commission decided to establish the Task Force on

Food Derived from Biotechnology, in order to insure

a comprehensive approach and to consider safety,

nutrition, and all relevant aspects of genetically

modified organisms (GMOs) and food produced

from GMOs.

0050Several food safety issues are related to animal

feeding, especially contamination of feed with myco-

toxins and other contaminants. This question drew

the attention of the media owing to the recent occur-

rence of contamination with dioxins in feeds, but

there are also several other issues, including the

Bovine Spongiform Encephalopathy. The Commis-

sion decided to establish a specific Task Force on

Animal Feeding to consider all aspects that can affect

food safety. Another important emerging issue in re-

lation to animal production is antimicrobial resist-

ance in bacteria, and in view of its complexity, it

should be addressed through a multidisciplinary

approach. It is currently under consideration by the

Committee on Food Hygiene and the Committee on

2592 FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS

Residues of Veterinary Drugs in Foods and is also

relevant to the work of the Task Force.

Future Directions

0051 The fundamental objective of the Codex Alimentar-

ius Commission is to establish sound internationally

agreed guidelines for national food control systems

based on the criteria of consumer health protection

and fair practices in trade, and taking into account

the needs and special concerns of all countries.

0052 The new recognition and status that Codex stand-

ards, guidelines, and other recommendations acquired

under the WTO Agreement on the Application of

Sanitary and Phytosanitary Measures (the SPS Agree-

ment) also brought new challenges and responsibil-

ities, including the need to insure that its standards

and related texts are based on scientific principles and

meet the needs and mandate of the organization. The

WTO Agreement on Technical Barriers to Trade is

also of great relevance, given the significance of the

provisions pertaining to product description, label-

ing, packaging, and quality descriptors for consumer

information and fair practices in trade. Although

quality provisions are fundamentally driven by the

market, the CAC has an important role in insuring

that provisions relating to quality are sound and

based on the criteria of essentiality and do not consti-

tute disguised barriers to trade.

See also: Legislation: History; International Standards;

Codex

Further Reading

Codex Alimentarius Commission (1989) Codex Alimentar-

ius Commission Procedural Manual, 7th edn. Rome:

Food and Agriculture Organization/World HealthOrga-

nization.

FAO (1976) Guidelines for Developing an Effective Na-

tional Food Control System. FAO Food Control Series

No. 1, WHO Food Control No. 1. Rome: Food and

Agriculture Organization.

FAO (1985) FAO, The First 40 Years. Rome: Food and

Agriculture Organization.

FAO (1987) Introducing Codex Alimentarius. Rome: Food

and Agriculture Organization.

FAO (1988) FAO, What it is, what it does. Rome: Food and

Agriculture Organization.

FOOD AND DRUG ADMINISTRATION

A Miller and T Nordenberg, FDA’s Center for

Food Safety and Applied Nutrition, Maryland,

MD, USA

Historical Introduction

0001 The Food and Drug Administration (FDA) is an Ex-

ecutive Branch agency within the US Department of

Health and Human Services (HHS). Its regulatory

obligations include overseeing the safety of about

80% of the domestically produced and imported

food in the USA – specifically, all food except meat,

poultry, and processed eggs.

0002 Long before the federal government of the USA

began to regulate the country’s food and drug prod-

ucts, individual states had made independent efforts

to regulate them. But despite the threat of punishment

for selling adulterated and mislabeled foods, the state

laws, including the first-of-its-kind Massachusetts

food and drug law passed in 1785, proved unsuccessful

in preventing the marketing of violative food

products.

0003It was not until 1906 that the first federal Pure

Food and Drug Act was enacted, which made it a

federal crime to sell mislabeled or adulterated food,

drink, and drugs intended for interstate commerce.

This cornerstone legislation of the future Food and

Drug Administration was passed following the 1905

publication of Upton Sinclair’s provocative novel The

Jungle, which exposed the unsanitary conditions in

American meatpacking plants, and the public crusade

of Dr. Harvey Wiley, the chief chemist of the US

Department of Agriculture (USDA) in the late 1800s

and early 1900s, to reform the food and drug laws to

protect consumers from harmful preservatives and

adulterants.

0004Wiley, who came to be known as the ‘Father of the

Pure Food and Drugs Act,’ was appointed as the first

administrator of the landmark 1906 legislation. Under

Wiley’s leadership, the staff at the USDA’s Bureau of

Chemistry improved upon existing scientific methods

FOOD AND DRUG ADMINISTRATION 2593

for analyzing food and refined legal procedures and

inspection methods helpful in enforcing the law.

0005 The first separate federal food and drug agency was

established in 1927, and took the name ‘Food and

Drug Administration’ in 1931. While the 1906 law

laid the agency’s foundation, Congress has continued

to update the act over the years, ultimately assigning

FDA responsibility for assuring the safety of most US

food products. The Federal Food, Drug, and Cos-

metic Act, signed into law by President Franklin D.

Roosevelt in 1938, remains the basic food and drug

law of the USA. Three amendments to the 1938 law

had important implications for food regulation: the

Miller Pesticide Amendment in 1954, the Food

Additives Amendment in 1958 (which includes the

‘Delaney Clause’), and the Color Additive Amend-

ments in 1960.

0006 Despite the legal amendments, the overall goal of

the federal food law has remained constant: protect-

ing US consumers from adulterated and misbranded

food products, whether they are produced domestic-

ally or imported into the USA. It is the Food and Drug

Administration’s responsibility to implement the food

and drug laws to protect and promote the health and

economic interests of the American public.

0007 Recent statistics from the Centers for Disease

Control and Prevention illuminate the enormity of

this challenge: foodborne illness, according to CDC,

causes approximately 76 million illnesses, 325 000

hospitalizations and 5000 deaths each year in the

USA. And in their quest to improve the safety of

the US food supply, food scientists and regulators

continue to be faced with ever-changing hurdles: for

example, US consumers are eating more seafood,

fresh produce (especially imported produce), and

more ready-to-eat foods, as well as more foods pre-

pared at restaurants and institutional settings such

as nursing homes and hospitals. Also, up to 25% of

the US population is considered ‘at risk’ for food-

borne illness. Vulnerable populations include preg-

nant women, children, the elderly, and those who

are immunocompromised. But perhaps the most

perplexing challenge of all comes from evolving bac-

teria such as new strains of Escherichia coli (E. coli)

0157:H7.

Today’s FDA: Mission and Organization

0008 Along with setting the standards and ensuring the

safety of over 75% of the food consumed in the

USA, FDA is responsible for ensuring the safety of

animal feed and drugs and all human medications and

vaccines, blood products and tissues for transplant-

ation, medical devices, devices that emit radiation,

and cosmetics.

0009Of the five product-oriented centers that regulate

these areas, the Center for Food Safety and Applied

Nutrition (CFSAN) carries out the mission of ensur-

ing that food products in the USA are safe, nutritious,

wholesome, and properly labeled. CFSAN regulates

all food products sold in interstate commerce, except

meat, poultry, and processed egg products, which fall

under the authority of the US Department of Agricul-

ture. Products made and sold entirely within a single

state are regulated by that state.

0010FDA’s responsibilities cover an estimated $240 bil-

lion worth of domestic food shipments and $15

billion worth of imported foods, from the point

of production or entry into the USA to the point of

sale. About 46 000 food establishments are listed in

the agency’s ‘Official Establishment Inventory’ of

regulated companies. These figures do not include

the 600 000 or so restaurants and institutional

food-service establishments, nor do they include the

roughly 235 000 grocery stores and other food outlets

in the USA. These are regulated by state and local

authorities to whom the FDA’s CFSAN provides

guidance and technical assistance in the form of a

Model Food Code published every other year. FDA

also has regional retail specialists who provide tech-

nical assistance to state and local governments.

0011Since 1992, CFSAN has been organized into prod-

uct-oriented offices, including the Office of Plant and

Dairy Foods and Beverages, the Office of Seafood, the

Office of Food Additive Safety, and the Office of

Nutritional Products, Labeling and Dietary Supple-

ments. Other offices that provide support to the prod-

uct-based offices (as well as to agency stakeholders)

include the Office of Field Programs, the Office of

Scientific Analysis and Support, the Office of Applied

Research Skills and Safety Assessment, the Office of

Constituent Operations, and the Office of Manage-

ment Systems. In addition to these offices involved in

food regulation, CFSAN also has the agency’s office

of colors and cosmetics.

0012Two additional CFSAN component offices play

crucial cross-cutting roles, including coordination of

agency efforts: the Food Safety staff was formed

after President Clinton’s announcement in 1997 of a

national initiative to enhance food safety. The FSI

staff focuses on meeting the mandate of reducing

foodborne disease to the greatest extent possible,

and the Office of Science advises CFSAN’s director

and other senior managers on applying the best

science available to major issues.

0013The nearly 900 CFSAN employees have spe-

cialized training in diverse scientific and other discip-

lines. Employees include chemists, microbiologists,

biologists, toxicologists, food technologists, path-

ologists, pharmacologists, nutritionists, dietitians,

2594 FOOD AND DRUG ADMINISTRATION

physiologists, environmental health specialists, gen-

eticists, molecular biologists, mathematicians, sani-

tarians, economists, risk assessors, lawyers, and

educators.

0014 While CFSAN experts play the lead role in food

safety, the premarket review of food and color

additives, the chemical safety of food and dietary

supplements, food labeling, and nutrition, three

other FDA centers also play integral roles in food

safety:

0015 The Center for Veterinary Medicine is responsible

for ensuring that animal drugs and medicated feeds

are safe and effective, and that people can safely

consume food produced from treated animals.

0016 The Office of Regulatory Affairs (ORA) conducts

food safety inspections in production plants, col-

lects and analyzes food samples, and monitors

imports for compliance with US requirements.

ORA’s district offices across the nation conduct

‘field assignments’ to assess whether imported and

domestically produced food products are in com-

pliance with FDA’s regulations; remove violative

products from the marketplace; provide data on

food products for consideration in regulation and

policy development; follow up on consumer com-

plaints; assure that recalled or detained products

are removed from distribution channels; and par-

ticipate in investigations when FDA-regulated food

is associated with illness.

0017 The National Center for Toxicological Research

undertakes scientific research and testing in sup-

port of FDA’s mission.

0018 Complementing FDA’s regulatory responsibilities

are the food-related functions of other federal agen-

cies – notably, the Centers for Disease Control and

Prevention (CDC) and the National Institutes of

Health (NIH) within HHS, the USDA’s Food Safety

and Inspection Service, and the US Environmental

Protection Agency (EPA). FDA works closely with

these and other federal agencies, such as the US De-

partment of Commerce’s National Marine Fisheries

Service, the US Department of Treasury’s Bureau of

Alcohol, Tobacco and Firearms, the US Customs

Service, the US Federal Trade Commission, the US

Department of Defense, and others.

0019 Pursuant to Presidential Order, these agencies have

developed a framework to eliminate jurisdictional

overlaps and fill potential gaps. A number of initia-

tives have integrated food-safety regulation among

federal agencies and their state and local counter-

parts, and uniform data collection and reporting

systems are being developed to enable the three levels

of government in the USA to function as a national

food-safety system.

0020While the agencies have varying approaches to food

regulation under their distinct authorizing statutes,

they communicate extensively with each other and

abide by a series of formal agreements setting forth

the agencies’ respective food safety and nutrition roles.

0021FDA also collaborates extensively with state and

local authorities, including the Association of Food

and Drug Officials and state, county, and city health

and agricultural departments.

0022Increasingly, the agency is also taking advantage

of the specialized expertise that outside food-safety

partners can contribute. Two academic–industry–

government consortia exemplify such collaboration:

0023National Center for Food Safety and Technology.

Located near Chicago, this joint effort of FDA, the

Illinois Institute of Technology, and food com-

panies focuses on the safety of food processing

and packaging technologies. Established in 1988,

the center has contributed to significant improve-

ments in the safety of sprouts and fresh juice prod-

ucts, for example, and to the development of

alternative commercial sterilization procedures

such as ultra-high-pressure processing.

0024Joint Institute for Food Safety and Applied Nutri-

tion. Established in 1996 with the University of

Maryland, this program provides the foundation

for partnerships with other academic institutions,

private industry, consumer and trade groups, and

international organizations. The integrated

academic and regulatory science program focuses

on research in the areas of food safety, risk assess-

ment, human nutrition, and animal health and

production.

0025FDA has also established an extramural grant pro-

gram to support research in topical areas that include

produce safety, egg safety, antimicrobial resistance,

methods to detect foodborne viruses in foods, and

research on food service, transportation and con-

sumer practices.

0026By helping FDA to stay on the cutting edge in

science, such collaborations ultimately support FDA

in making well-founded regulatory decisions. To im-

prove the safety of the food supply globally, FDA has

undertaken cooperative research with institutions in

other countries, as well.

FDA’s Regulatory Role

0027FDA is charged with enforcing the Federal Food,

Drug, and Cosmetic Act (FFDCA), which prohibits

the distribution within the USA, or importation into

the country, of any adulterated food (a food contain-

ing ‘any poisonous or deleterious substance which

may render it injurious to health’)ormisbranded

FOOD AND DRUG ADMINISTRATION 2595

food (a food whose labeling ‘is false or misleading in

any particular’).

0028 To ensure that the food industry knows specifically

what is expected of them, all of the agency’s regula-

tions are published in the US government’s official

daily bulletin, the Federal Register, pursuant to a

process called ‘notice and comment’ rulemaking.

Before finalizing certain policies, standards, and

guidelines, FDA publishes a proposed approach in

the Federal Register. The proposal contains details

of the proposal and its intent, and an invitation to

the public to provide written comments for agency

consideration.

0029 While 90 days is the standard period for receiving

comments, the period is often extended to 180 days or

longer when needed. On some issues, the agency has

received as many as half a million comments. After

careful analysis of all comments, appropriate sugges-

tions are incorporated into the final version of a new

regulation. The final regulation is accompanied in the

Federal Register by a point-by-point discussion of all

significant suggestions or criticisms and an explan-

ation of the basis on which they were accepted or

turned down.

0030 This notice-and-comment rulemaking process is an

essential element of FDA’s fair and transparent ad-

ministrative procedure, which enables the public to

know how a decision was made, believe in its integ-

rity, and have confidence that it is fair and based in

science.

0031 From the perspective of enforcing the FFDCA and

related regulations, the agency’s role can be divided

into premarket and postmarket regulatory responsi-

bilities. The premarket system focuses primarily on

the safety of food additives and requires that the

person or corporation requesting FDA’s approval

of an additive provide scientific evidence before

marketing to support its safety. The requirement

covers direct additives, such as a new nonnutritive

sweetener, and indirect additives, such as a com-

ponent of plastic bottles that can migrate into food.

(Noncarcinogenic indirect food additives whose mi-

gration into food is likely to be trivial, however, are

candidates for abbreviated review by FDA.)

0032 The premarket approval requirement is waived

altogether in certain cases – for example, when a

substance is generally recognized by the scientific

community to be safe – that is, deemed ‘generally

recognized as safe,’ (GRAS). The procedure for a

determination that a substance is GRAS has become

much simpler under a recent proposed rule allowing

‘voluntary notification’ of GRAS status.

0033 FDA’s postmarket food-related activities involve

primarily compliance and surveillance activities,

during processing and in the marketplace. The

agency’s system of inspection and enforcement places

priority on food at high risk of microbiological

contamination (such as infant formula, ready-to-eat

foods, and seafood).

0034Unlike in its premarket actions, in its postmarket

activities, FDA bears the burden of proving that a

food is adulterated (or misbranded) under the

FFDCA or related regulations. The agency can collect

evidence of adulteration through its inspections, la-

boratory analyses, and other sources of information.

0035If a food is determined to be violative, it can be

seized or the manufacturer enjoined from producing

it. Also, FDA can seek civil and criminal penalties

against those who willingly introduce noncompliant

foods into interstate commerce. Violative products

are sometimes voluntarily recalled by the manufac-

turer, not by FDA, which backs the legal authority to

order a product’s recall.

0036Products imported into the USA are necessarily

handled differently than domestically produced prod-

ucts, because it is generally not feasible for FDA

inspectors to inspect the facility where an imported

food was produced. In the case of imported foods, if a

product appears to be adulterated or is being

examined as part of a routine surveillance inspection

of imported products, it can be detained or placed

under bond while samples are evaluated.

0037If the product is determined to be adulterated

under the FFDCA, it is refused entry into the country.

Foreign manufacturers or importers with a history of

contamination problems may be placed on ‘auto-

matic detention,’ which requires the importer to pro-

vide an independent laboratory analysis showing that

the product is free of any hazard. Sometimes, a prod-

uct from an entire region may be considered to have

an excess risk of adulteration, in which case, each lot

of food seeking entry in to the USA must be tested

before being admitted.

Food Regulation’s Scientific

Underpinnings

0038FDA has a longstanding commitment to supporting

and participating in scientific research that can

inform regulatory decision-making and contribute to

a safer food supply. Agency scientists have, for

example, developed a state-of-the-art polymerase

chain reaction technique to allow them to detect

Cyclospora cayetanensis, a protozan parasite on pro-

duce. The pathogen was associated with foodborne

illness from imported raspberries into the USA and

Canada in 1996 and 1997. Meanwhile, advances in

molecular biology have also improved scientists’ abil-

ity to detect foodborne viruses such as Hepatitis A

and Norwalk-like viruses associated with illnesses

2596 FOOD AND DRUG ADMINISTRATION

from produce and seafood, water, or sick food

workers.

0039 For another example, a team of scientific experts,

including FDA scientists, has devised methods to

reduce the microbiological hazards associated with

seed sprouts, which are an increasingly popular ingre-

dient in the American diet and, beginning in 1995,

were linked with a rising incidence of foodborne

disease outbreaks. Specifically, researchers evaluated

a number of rapid tests that can be used to determine

the safety of the irrigation water used to grow

sprouts. These tests, conducted on the water after

contacting the growing seeds and sprouts, can point

to contaminated batches of sprouts early in the

process.

0040 Recently, another team of FDA scientists demon-

strated that surface heating of fruit is an effective

method to improve apple juice safety by reducing

the numbers of microorganisms, including E. coli

0157:H7. A model was developed that showed that

there is minimal penetration of heat below the surface

of apples during use of the inactivation technique.

0041 FDA’s research is aimed at understanding and con-

trolling a wide variety of potential hazards in the food

supply, be they microbiological contaminants or

other threats, including chemical contaminants, pesti-

cide residues, or heavy metals. A variety of scientific

tools are employed to help ensure that policy devel-

opment and regulatory decisions are based on sound

scientific principles.

0042 While the agency has conducted risk and safety

assessments on chemical hazards for several decades,

today, FDA also conducts risk assessments to charac-

terize the likelihood and severity of human health

risks posed by microbial contaminants. Recently,

FDA has undertaken quantitative microbial risk

assessments to evaluate the public health impact of

Listeria monocytogenes, Vibrio parahaemolyticus,

and foodborne pathogens associated with the use of

antimicrobials in food-producing animals, which can

prove hazardous to people if resistant bacteria are

transferred to them from the animals.

0043 Two surveillance tools offer additional examples

of how FDA takes advantage of modern scientific

capabilities in fulfilling its public health mission:

0044 National Antimicrobial Resistance Monitoring

System. This system, implemented by FDA, CDC,

and USDA, tracks whether certain bacteria are be-

ginning to lose susceptibility to antimicrobial drugs

by acquiring antibiotic resistance genes. This ob-

jective scientific information can guide people’s use

of antibiotics in food animals so as to avoid poten-

tially devastating human health consequences in

the long term.

0045PulseNet. Using high-speed internet connections

and computer algorithms that can compare

pulsed-field gel-electrophoresis patterns, or DNA

‘fingerprints,’ of foodborne bacteria, can rapidly

and reliably link sporadic cases of foodborne illness

to larger foodborne outbreaks. The collaborative

project among FDA, CDC, and USDA was used in

1998 to support a swift response from FDA that

minimized harm from a Shigella outbreak by

quickly linking cases of infections in Minnesota,

Massachusetts, California, and Canada to fresh

parsley from a single farm.

0046Manufacturers themselves play a critical role in

assuring that hazards are minimized at the site of

food production. A key to achieving the safest

product possible is the Hazard Analysis and Critical

Control Point (HACCP) system, which identifies the

critical steps in the food-production process where

contamination is most likely to occur, and puts into

place controls and limits to address the threat.

0047FDA has incorporated HACCP principles for many

years in its guidance documents and regulatory pro-

grams, starting with the 1979 low-acid canned-food

regulations. FDA implemented mandatory HACCP

for domestic and imported seafood products in 1997

and, in January 2001, finalized the HACCP rule for

fruit and vegetable juices.

0048FDA also has incorporated HACCP principles into

its Model Food Code, a guidance document that

serves as a model policy for state, territorial, and

municipal and local agencies that license and inspect

food service establishments, retail food stores, and

food-vending operations in the USA. Recently, FDA

has been working with the National Conference for

Interstate Milk Shipments to develop a fluid milk

HACCP pilot program.

Beyond Contaminants: Nutrition and

Dietary Supplements

0049Besides dealing with pathogenic microorganisms and

other issues of contamination or adulteration, FDA is

responsible for other food and health issues such as

nutrition and dietary supplements.

0050The system of nutritional labeling regulation dra-

matically changed in the USA with the passage of the

Nutrition Labeling and Education Act (NLEA) of

1990, which required standardized nutrition labeling

for most foods (except fresh meat and poultry) and

authorized the use of nutrient content claims and

FDA-approved health claims.

0051The FDA published final rules in 1992 and 1993,

implementing the NLEA provisions. Under these

regulations (and under parallel regulations from the

FOOD AND DRUG ADMINISTRATION 2597