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• The US and other countries require daily inspection for analyze a HACCP program and identify safety or quality
many high-risk processing facilities such as processed meat, problems. Additionally, inspectors must have a wide variety of
poultry, and egg products. skills in order to inspect premises, collect samples, conduct an
• Many governments worldwide use random or periodic overall evaluation, understand and apply food legislation,
inspection to check for unsanitary conditions that could collect evidence, and handle HACCP audits.
lead to adulteration as well as to verify a food facility’s food
safety system.
The Frequency of Inspections
When food-related disease outbreaks or other food crises
occur, government agencies can be subject to significant Inspections can be daily (as some countries require for meat
criticism. Some governments may practice a reactive approach and poultry) or periodic. In either case, to maximize consumer
to inspection, when, for example, they send inspectors to in- confidence, Codex guidance recommends that inspection or
spect facilities in response to an outbreak or contamina- other appropriate controls should extend to all stages of
tion event linked to foods from a similar type of facility. production, manufacture, importation, processing, storage,
Several governments are working to identify and define the transportation, distribution, and trade.
components of a risk-based inspection system for periodic For periodic inspections, managers should apply principles
inspections. Under a risk-based inspection system, food fa- of risk to ensure an adequate frequency of inspection is
cilities are inspected regularly on a schedule that reflects the maintained, i.e., foods and facilities should be evaluated to
likely risk to consumers from the type of food produced, not ensure high-risk foods are inspected more frequently than
just in response to outbreaks. Consultation with all stake- those presenting a low risk.
holders on the elements of the inspection system can help to Codex outlines a number of components to consider when
inform those both inside and outside of government. assessing the risk of imported foods, many of which apply
equally well to domestic products:
• Laboratory systems that provide the ability to sample and Government Enforcement
test foods and facilities for specific contaminants.
Government actions often begin after an inspection reveals
• Active foodborne outbreak surveillance systems to inform
problems in a food establishment, or may occur in response to
regulators about the foods most likely to cause illness.
an outbreak of illness linked to a food. Government agencies
• Utilization of state, provincial, or potentially private in-
may utilize a multistep approach to ensure compliance. For
spectors to augment the national management scheme.
example, they may begin by issuing notices of deficiencies and
conducting reinspections to check on a business’s corrective
actions. If problems are not corrected or the noncompliance is
Enforcement especially egregious, the agency may issue a warning letter.
If the product has been shipped to distributors, a business may
The role of enforcement is to provide deterrence and to pro- be asked to voluntarily withdraw or recall the adulterated or
mote the use of best practices. Government sanctions are the misbranded product. Agencies also publicize their findings
primary means of enforcing food safety standards. However, through a public health warning and through formal ad-
private lawsuits can also serve to promote compliance. En- ministrative procedures.
forcement is important to deter noncompliance in countries Some agencies may utilize more direct approaches such as
where market forces alone do not provide sufficient incentive detaining suspect food or levying civil monetary penalties. If
for businesses to produce safer food. the food is subject to continuous inspection or requires ap-
Important government enforcement tools include: proval by government inspectors before being marketed, the
agency may withdraw inspectors, which effectively shuts down
• Detention: An order, typically issued by a government au-
the business until it demonstrates that it has come into
thority, to temporarily hold a shipment of food so that it
compliance.
cannot enter commerce pending a more thorough
Governments may also take firms or individuals to court to
examination.
seize unsafe food or issue an injunction that stops the firm
• Seizure: The government takes unsafe food, which may
from manufacturing or distributing their products. The gov-
occur without compensating the owners, to prevent it from
ernment may seek criminal sanctions if appropriate. Pros-
reaching consumers. Seizures may require a court order.
ecution may target the person who was in a position of
• Injunction: An agency may seek a court ordered injunction
responsibility, regardless of whether that person intended to
to stop a food establishment from producing or distributing
commit a crime. Punishments can include a fine, prison,
food.
or both.
• Civil penalties: A government agency may impose civil
Governments can enlist food establishments to enforce
fines administratively or go through the courts. Civil pen-
standards. For example, the Food Safety Act of 1990 in the
alties provide a flexible response targeted at restoring
United Kingdom provides a due diligence defense to en-
compliance with food safety requirements.
courage food establishments to take responsibility for their
• Criminal penalties: The government may prosecute indi-
products. A person who can prove he took all reasonable
viduals or firms, seeking court ordered fines and/or prison
precautions and exercised due diligence to avoid the com-
sentences. Statutes normally specify the criminal penalties
mission of the offense can escape conviction. One result of
for specific violations.
having the due diligence defense available has been the
Other authorities that are useful in enforcing food laws emergence of private food safety standard setting and certifi-
include: cation bodies.
throughout the food chain that can affect food safety. Ad- Plunkett D and DeWaal CS (2008) Who is responsible for the safety of food in a
vancements in food safety practices over time have changed global market? Government certification v. Importer accountability as models for
assuring the safety of internationally traded foods. Food and Drug Law Journal
the scope and purpose of inspections and have put more
63: 657–664.
emphasis on prevention rather than enforcement. Safe Food International (2005) Food Safety Guidelines Endorsed by WHO and FAO.
http://safefoodinternational.org/guidelines.html (available in English, French,
Spanish).
United States v. Dotterweich, 320 US 327 (1943).
US Department of Agriculture (2012) Food Safety and Inspection Service Directives.
See also: Food Safety Assurance Systems: Audits of Food Safety 8000 Series: Compliance Evaluation and Enforcement. http://www.fsis.usda.gov/
Management Systems; Documentation and Record Keeping; Hazard regulations_&_policies/8000_Series-Compliance_Evaluation_&_Enforcement/
Analysis and Critical Control Point System (HACCP): Principles and index.asp
US Food and Drug Administration (2011) Regulatory Procedures Manual. http://
Practice. Institutions Involved in Food Safety: FAO/WHO Codex
www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/
Alimentarius Commission (CAC). Public Health Measures: default.htm#_top
Challenges of Developing Countries in Management of Food Safety; US Food and Drug Administration (2012) Investigations Operations Manual. http://
Challenges of Industrialized Countries in Food Safety Management; www.fda.gov/ICECI/Inspections/IOM/default.htm
Food Control and Public Health Laboratories; Fundamentals of Food Vapnek J and Spreij M (2005) Perspectives and guidelines on food legislation, with
a new model food law. FAO Legislative Study 87. http://www.fao.org/legal/
Legislation; Modern Approach to Food Safety Management: An legstud/ls87/ls87e.pdf
Overview
Relevant Websites
Further Reading
http://www.cspinet.org/
Buzby JC, Frenzen PD, and Rasco B (2001) Product liability and microbial Center for Science in the Public Interest.
foodborne illness. Economic Research Service/USDA 799: 1–41. http://www.codexalimentarius.net/web/index_en.jsp
Codex Alimentarius (2009) Food Import and Export Inspection and Certification Codex Alimentarius.
Systems, 4th edn. Rome, Italy: World Health Organization/Food and Agriculture http://ec.europa.eu/food
Organization of the United Nations. European Commission, Food Safety – From the Farm to the Fork.
DeWaal CS (2007) Food protection and defense: Preparing for a crisis. Minnesota http://www.fao.org/ag/agn/agns/
Journal of Law, Science and Technology 8: 187–198.
Food and Agricultural Organization of the United Nations, Food Quality and
DeWaal CS (2007) Food safety and security: What tragedy teaches us about our
Standards Service.
100-year old food laws. Vanderbilt Journal of Transnational Law 40: 921–935.
http://safefoodinternational.org/mission.html
DeWaal CS and Plunkett D (2009) Building a Modern Food Safety System for FDA
Safe Food International.
Regulated Foods. Washington, DC: Center for Science in the Public Interest.
DeWaal CS and Robert N (2005) Global and Local: Food Safety around the World. http://www.fda.gov/Food/
Washington, DC: Center for Science in the Public Interest. http:// US Food and Drug Administration.
safefoodinternational.org/international_report_051905.pdf http://www.fsis.usda.gov/
DeWaal CS and Guerrero Brito GR (2005) Safe Food International: A Blueprint for US Department of Agriculture, Food Safety and Inspection Service.
Better Global Food Safety. Food and Drug Law Journal 60(3): 393–405. http://www.who.int/foodsafety/en/
Food and Agriculture Organization/World Health Organization of the United Nations World Health Organization, Food Safety.
(2003) Assuring Food Safety and Quality: Guidelines for Strengthening National
Food Control Systems. http://www.who.int/foodsafety/publications/capacity/en/
Englsih_Guidelines_Food_control.pdf