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OCR for page 273
Appendix A
Current and Proposed Definitions of
Key Food Safety Terms
One of the important tasks of the committee was to establish the definitions
of food safety terms to be used throughout this report. Definitions of key food
safety terms from a variety of agencies and organizations were thoroughly
reviewed and are listed in Table A.1. To assure uniformity and consistency, the
committee decided to adopt most of the definitions published by the International
Commission on Microbiological Criteria for Foods (ICMSF, 2002), which are
widely accepted throughout the global food safety community. There are a few
terms that were specifically defined by the committee, one that was modified
from the ICMSF definition, one that was adopted from the Codex Alimentarius
Commission, and one that was used in a presentation to the committee (Personal
communication, R. Buchanan, Food and Drug Administration, February 5, 2002~.
These definitions are explained below.
A microbiological criterion defines the acceptability of a product or a food
lot, based on the absence or presence or number of microorganisms, including
parasites, and/or the quantity of their toxins/metabolites, per unit of mass, vol-
ume, area, or lot (CAC, 1997~. Microbiological criteria usually fall into three
categories and include microbiological standards, guidelines, and specifications.
Microbiological standards are used to determine the acceptability of a food
with regard to a regulation or policy. These standards are established by regula-
tory authorities and define the microbiological content that foods must meet to be
in compliance with a regulation or policy. Foods not meeting the standard are in
violation of the regulation or policy and are subject to removal from the market
(ICMSF, 2002~.
273
OCR for page 274
274
TABLE A-1 Definition of Terms
APPENDIX A
Committee
Term Consensus ICMSFa NRCb FDAC FSIS~
Appropriate
level of
protection
Control point
Criterion
The level of
protection
deemed
appropriate by
the country
establishing a
sanitary or
phytosanitary
measure to
protect human,
animal, or plant
life or health
within its
territory
Any step at
which biological,
chemical, or
physical factors
can be
controlled
A requirement
on which a
judgment or
. . .
decision can
be made
Critical control A step at which A point, step, or A point, s
point (CCP) control can be procedure in a procedure
applied and is food process at food prod
essential to which a control which cor
prevent or measure can be can be ap:
eliminate a food applied and at and, as a:
safety hazard or which control is a food sat
reduce it to an essential to hazard cat
acceptable level reduce an prevented
identified food eliminates
hazard to an reduced to
acceptable level acceptable
levels
OCR for page 275
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 2 75
FSIS~ NACMCFe Codexf
WTOg ECh
The level of
protection
deemed
appropriate by
the country
establishing a
sanitary or
phytosanitary
measure to
protect human,
animal, or plant
life or health
within its
territory
Any step at
which biological,
chemical, or
physical factors
can be
controlled
t, step, or
are in a
ocess at
control
e can be
. and at
control is
al to
an
ed food
to an
able level
A point, step, or
procedure in a
food process at
which control
can be applied
and, as a result,
a food safety
hazard can be
prevented,
eliminated, or
reduced to
acceptable
levels
A requirement
on which a
judgment or
. . .
decision can
be made
A step at which
control can be
applied and is
essential to
prevent or
eliminate a food
safety hazard or
reduce it to an
acceptable level
A step at which
control can be
applied and is
essential to
prevent or
eliminate a food
safety hazard or
reduce it to an
acceptable level
continued
OCR for page 276
276
TABLE A-1 Continued
APPENDIX A
Committee
Term Consensus ICMSFa NRCb FDAC FSIS~
Defect action Maximum level
level of natural or
unavoidable
defect in foods
for human use
that presents no
health hazard
Food safety A statement of A statement of
objective the maximum the maximum
(FSO) frequency frequency
and/or and/or
concentration concentration
of a hazard in a of a
food at the time microbiologica
of consumption hazard in a foo
that is at the time of
considered consumption
tolerable for that provides
consumers the appropriate
Maximum levels
of natural or
unavoidable
defects in foods
for human use
that present no
health hazard
OCR for page 277
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 2 77
FSIS~ NACMCFe Codexf WTOg ECh
urn levels
rat or
fable
in foods
can use
sent no
hazard
A statement of
the frequency or
concentration of
a microbiological
hazard in a food
appropriate for
consumer
protection
continued
OCR for page 278
278
TABLE A-1 Continued
APPENDIX A
Committee
Term Consensus
ICMSFa
NRCb FDAC
FSISd
Microbiological A criterion that
criterion defines the
acceptability of
a product or
food lot, based
on the absence
or presence or
number of
. .
microorganisms,
including
parasites, and/or
the quantity of
their toxins/
metabolites, per
unit of mass
volume, area,
or lot
A
microbiological
criterion defines
the acceptability
of a product or
food lot, based
on the absence
or presence or
number of
A yardstick on
which a
judgment or
decision can be
made: a
microbiological
criterion will
stipulate that
a type of
. .
microorganism,
microorganisms,
including group of
parasites, and/or microorganisms
quantity of their or toxin
toxins/ produced by a
metabolites, per
unit(s) of mass,
volume, area
or lot
Microbiol
criteria ar
regulatory
standards,
are bench:
for evalua
test result
. .
microorganism
must either not
be present at all,
be present in
only a limited
number of
samples, or be
present as less
than specified
number or
amount in a
given quantity
of a food or
food ingredient
OCR for page 279
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 2 79
FSIS~ NACMCFe Codexf WTOg ECh
Microbiological
criteria are not
regulatory
standards, but
are benchmarks
for evaluating
test results
A
microbiological
criterion for
food-stuffs
defines the
acceptability of
a process,
product or food
lot based on the
absence or
presence, or
number of
microorganisms
and/or quantity
of their toxins/
metabolites, per
unit(s) of mass,
volume or area
continued
OCR for page 280
280
TABLE A-1 Continued
APPENDIX A
Term
Committee
Consensus ICMSFa
NRCb FDAC
FSISd
Microbiological An advisory An advisory
guideline microbiological
criterion used
to inform food
operators of the
microbiological
content that can
be expected in
food when best
practices are
applied
Microbiological Part of a
specification purchasing
agreement
between a buyer
and a supplier
of a food; such
criteria may be
mandatory or
advisory
according
to use
criterion used
to inform food
operators of the
microbiological
content that can
be expected in
a food when
best practices
are applied
Part of a
purchasing
agreement
A criterion that
often is used
by the food
industry or a
regulatory
agency to
monitor a
manufacturing
process.
Guidelines
function as alert
mechanisms to
signal whether
microbiological
conditions
prevailing at
critical control
points or in the
finished product
are within the
normal range
A
microbiological
criterion that is
between a buyer used as a
and a supplier purchase
of a food; such requirement
criteria may be whereby
mandatory or
advisory
according
to use
conformance
with it becomes
a condition of
purchase
between a buyer
and vendor of
a food or
ingredient; such
criteria may
be either
mandatory or
advisory
OCR for page 281
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 281
FSIS~ NACMCFe Codexf WTOg ECh
Criteria
included in
legislation or
regulations
which are
intended to
guide the
manufacturer
and help to
ensure good
hygienic
practice
continued
OCR for page 282
282
TABLE A-1 Continued
APPENDIX A
Committee
Term Consensus ICMSFa NRCb FDAC FSIS~
Microbiological A mandatory A mandatory A A criteria
standard microbiological criterion that is microbiological is part of
criterion that is incorporated criterion that is regulation
incorporated into a law or a part of a law, is a legal
into a law, ordinance ordinance or requireme
regulation, or administrative
ordinance regulation. A
standard is a
mandatory
criterion.
Failure to
comply with it
constitutes a
violation of the
law, ordinance,
or regulation
and will be
subject to the
enforcement
policy of the
regulatory
agency having
jurisdiction
Monitor The act of The act of To conduct a Monitorin
conducting a conducting a planned consists o
planned planned sequence of observatic
sequence of sequence of observations or measured
observations or observations or measurement to taken to a
measurements measurements assess whether whether a
of control of control a process, point, is within
parameters to parameters to or procedure is establishe
assess whether assess whether under control critical lit
a CCP is under a CCP is under and to produce
control control an accurate
record for use
in verification
OCR for page 283
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 283
FSIS~ NACMCFe Codexf WTOg
Ech
A criterion that Criteria included
is part of a in legislation or
regulation; regulations
is a legal where failure to
requirement comply with
them can result
in rejection of
the food
duct a Monitoring To conduct a The act of
1 consists of planned conducting a
ce of observations or sequence of planned
actions or measurements observations or sequence of
ement to taken to assess measurements observations or
whether whether a CCP to assess measurements
ss, point, is within the whether a CCP of control
edure is established is under control parameters to
ontrol critical limit and to produce assess whether
produce an accurate a CCP is under
Irate record for control
for use future use in
ication verification
continued
OCR for page 284
284
TABLE A-1 Continued
APPENDIX A
Committee
Term Consensus ICMSFa NRCb FDAC FSIS~
Performance The required The required A public health
criterion outcome of a outcome of a goal that is
step, or step, or based on relating
combination of combination of the level of
steps, that steps, that stringency with
contributes to contribute to achieving some
assuring a food assuring a food level of control
safety objective safety objective over the public
is met is met health impact of
the hazard; it
requires being
able to
qualitatively or
quantitatively
relate the level of
hazard in a food
with its public
health impact
Performance The degree to The degree to Performar
standard which a step or which a step or standards
combination of combination of prescribe
steps in the steps in the objectives
production, production, levels of
processing, processing, performer
distribution, distribution, (such as
and/or and/or pathogen
preparation of preparation of reduction
a food must a food MUST standards
operate to operate to raw prods
achieve the achieve the establishn
required level desired level must achi~
of control over of control over
a hazard a hazard
OCR for page 285
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 285
FSIS~ NACMCFe Codexf WTOg ECh
ic health
at is
in relating
e1 of
Icy with
ng some
f control
e public
impact of
arc; it
s being
Lively or
atively
he level of
in a food
, public
impact
gree to
~ step or
ration of
~ the
Lion,
sing,
action,
rtion of
MUST
to
the
level
rot over
d
Performance
standards
prescribe the
objectives or
levels of
performance
(such as
pathogen
reduction
standards for
raw product)
establishments
must achieve
Defines the
expected level
of control at
one or more
steps in a
process:
establishing
and meeting
performance
standards can
be a means of
reaching public
health goals to
reduce
foodborne
illness; the
stringency of a
performance
standard should
be proportional
to the risk and
stated public
health goals
continued
OCR for page 286
286
TABLE A-1 Continued
APPENDIX A
Term
Committee
Consensus
ICMSFa NRCb FDAC
FSISd
Process criteria The control
parameters of
a step, or
combination of
steps, that can
be applied to
achieve a
performance
criterion
Processing The FSO minus
safety objective projected
pathogen
growth
Product
criterion
Public
health goal
Public health
objective
A parameter of
a food that can
be used to
assess the
acceptability
of a lot or
consignment
The desired
outcome
associated with
reducing the
burden of
. · .
alsease In
society
A measurable
population-based
target for
maintaining or
improving health
The control
parameters of
a step, or
combination of
steps, that can
be applied to
achieve a
performance
criterion
The FSO minus
projected
pathogen
growth
A parameter of
a food that can
be used to
assess the
acceptability
of a lot or
consignment
OCR for page 287
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 287
FSIS~ NACMCFe Codexf WTOg ECh
continued
OCR for page 288
288
TABLE A-1 Continued
APPENDIX A
Committee
Term Consensus
ICMSFa NRCb FDAC
FSISd
Tolerable level The level of
of risk risk proposed
following
consideration of
the public
health impact,
technological
feasibility,
economic
implications,
and that which
society regards
as reasonable in
the context of,
and in
The level of
risk proposed
following
consideration of
public health
impact,
technological
feasibility,
economic
implications,
and that which
society regards
as reasonable in
the context of,
and in
comparison with, comparison with,
other risks in other risks in
everyday life everyday life
Validation
Obtaining
evidence that
the elements of
the Hazard
Analysis and
Critical Control
Point (HACCP)
plan are
effective
Obtaining
evidence that
the elements of
the HACCP
plan are
effective
Element of
verification
focused on
collecting and
evaluating
scientific and
technical
information to
determine
whether the
HACCP plan,
when properly
implemented,
will effectively
control the
identified food
hazards
The scion
and techn:
process fc
determinist
that the C
and assoc:
critical lit
are adequ
and suffix:
to control
likely haz
OCR for page 289
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 289
FSIS~ NACMCFe Codexf WTOg ECh
at of
action
1 on
ng and
sing
Be.
arc and
al
Action to
one
r the
P plan,
Properly
rented,
ectively
the
ed food
The scientific
and technical
process for
determining
that the CCPs
and associated
critical limits
are adequate
and sufficient
to control
likely hazards
The element of
verification
focused on
collecting and
evaluating
scientific and
technical
information to
determine if the
HACCP plan,
when properly
implemented,
will effectively
control the
hazards
Obtaining
evidence that
the elements of
the HACCP
plan are
effective
continued
OCR for page 290
290
TABLE A-1 Continued
APPENDIX A
Committee
Term Consensus ICMSFa NRCb FDAC FSIS~
The application
of methods,
procedures,
tests, and other
evaluations, in
addition to
monitoring, to
determine
compliance
with the
HACCP plan
Zero tolerance Lay audience
perception of
the absence of
a hazard that
cannot be
scientifically
assured, but is
operationally
defined as the
absence of a
hazard in a
specified
amount of food
as determined
by a specific
method
The application
of methods,
procedures,
tests, and other
evaluations, in
addition to
monitoring, to
determine
compliance
with the
HACCP plan
Those activities,
other than
monitoring,
that establish
the validity of
the HACCP
plan and that
the system is
operating
according to
the plan
a ICMSF = International Commission on Microbiological Criteria for Foods (ICMSF, 1997, 1998,
2002).
b NRC = National Research Council (NRC, 1985).
c FDA = Food and Drug Administration (FDA, 1995, 2001).
d USDA = U.S. Department of Agriculture (USDA, 1996).
e NACMCF = National Advisory Committee on Microbiological Criteria for Foods (NACMCF,
1997, 2002).
f Codex = Codex Alimentarius Commission (CAC, 1997).
g WTO = World Trade Organization (WTO, 1995).
h EC = European Commission (EC, 1999).
OCR for page 291
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 291
FSIS~
NACMCFe
Codexf WTOg ECh
activities,
Ian
ring,
;ablish
City of
.CCP
id that
Em iS
:lg
ng to
Those activities,
other than
monitoring,
that determine
the validity of
the HACCP
plan and that
the system is
operating
according to
the plan
The application
of methods,
procedures,
tests, and other
evaluations, in
addition to
monitoring, to
determine
compliance
with the
HACCP plan
997, 1998,
NACMCF,
OCR for page 292
292
APPENDIX A
Microbiological guidelines are usually established by a regulatory authority,
industry trade association, or a company to indicate the expected microbial content
of a food when best practices are applied. Food companies use microbiological
guidelines as a basis to design their control systems. These guidelines are advi-
sory in nature and may not lead to rejection of a food (ICMSF, 2002~.
Microbiological specifications are used by buyers of a food or ingredient to
reduce the likelihood of purchasing a product that may be of unacceptable safety
or quality. Microbiological specifications can define the microbiological limits
for an ingredient so that when it is used, the final product will meet all the
requirements for safety and quality. Buyers throughout the food system establish
microbiological specifications for materials they purchase. In most cases, specifi-
cations are advisory and the materials are sampled periodically. When microbio-
logically sensitive ingredients are purchased, each incoming lot may be sampled
and tested (ICMSF, 2002~.
A performance standard is the degree to which a step or combination of steps
in the production, processing, distribution, and/or preparation of a food must
operate to achieve the desired level of control over a hazard (Personal communi-
cation, R. Buchanan, Food and Drug Administration, February 5, 2002~. The
term performance standard does not appear anywhere in the U.S. Department of
Agriculture Pathogen Reduction/Hazard Analysis and Critical Control Point
Final Rule (USDA, 1996), but was incorporated from regulations used in other
industries.
It should be noted that the committee defined a food safety objective as a
statement of the maximum frequency and/or hazard in a food at the time of
consumption that is considered tolerable for consumer protection. This is broader
and less restrictive than the ICMSF definition of the term because it includes
microbiological, chemical, and physical hazards. It should also be noted that the
committee changed the word "acceptable" to "tolerable" because contamination
of food is seldom acceptable; it cannot be deemed "appropriate" either.
A public health objective is a measurable population-based target for main-
taining or improving health, while a public health goal is the desired outcome
associated with reducing the burden of disease in society.
The committee defined the term zero tolerance as the lay audience percep-
tion of the absence of a hazard that cannot be scientifically assured but is opera-
tionally defined as the absence of a hazard in a specified amount of food as
determined by a specific method.
REFERENCES
CAC (Codex Alimentarius Commission). 1997. Hazard Analysis and Critical Control Point System
and Guidelines for its Application. Annex to CAC/RCP 1-1969, Rev. 3-1997. Rome: CAC.
OCR for page 293
CURRENT AND PROPOSED DEFINITIONS OF KEY FOOD SAFETY TERMS 293
EC (European Commission). 1999. The Evaluation of Microbiological Criteria for Food Products of
Animal Origin for Human Consumption. Online. Available at http://europa.eu.int/comm/food/
fs/sc/scv/out26_en.pdf. Accessed March 14, 2003.
FDA (Food and Drug Administration). 1995. Procedures for the safe and sanitary processing and
importing of fish and fishery products; Final rule. Fed Regist 60:65095-65202.
FDA. 2001. HACCP procedures for the safe and sanitary processing and importing of juice: Final
rule. Fed Regist 66:6137-6202.
FSIS (Food Safety and Inspection Service). 1996. Pathogen reduction; Hazard analysis and critical
control point (HACCP) systems; Final rule. Fed Regist 61:38805-38855.
ICMSF (International Commission on Microbiological Specification for Foods). 1997. Establish-
ment of microbiological safety criteria for foods in international trade. World Health Stat Q
50:119-123 .
ICMSF. 1998. Potential Application of Risk Assessment Techniques to Microbiological Issues Re-
lated to International Trade in Food and Food Products. J Food Prot 61: 1075-1086.
ICMSF. 2002. Microorganisms in Foods 7. Microbiological Testing in Food Safety Management.
New York: Klewer Academic/Plenum Publishers.
NACMCF (National Advisory Committee on Microbiological Criteria for Foods). 1997. Hazard
analysis and critical control point principles and application guidelines. J Food Prot 61: 1246-
1259.
NACMCF. 2002. Final. Response to the Questions Posed by FSIS Regarding Performance Standards
with Particular Reference to Ground Beef Products. Online. FSIS, U.S. Department of Agricul-
ture. Available at http://www.fsis.usda.gov/OPHS/nacmcf/2002/rep_stand2.pdf. Accessed
March 12, 2003.
NRC (National Research Council). 1985. An Evaluation of the Role of Microbiological Criteria for
Foods and Food Ingredients. Washington, DC: National Academy Press.
USDA (U.S. Department of Agriculture). 1996. Pathogen reduction; Hazard analysis and critical
control point (HACC) systems; Final rule. Fed Regist 61:38805-38989.
WTO (World Trade Organization). 1995. Agreement on the Application of Sanitary and
Phytosanitary Measures (SPS). Geneva: WTO.
Representative terms from entire chapter:
safety terms
