[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR120.3]
[Page 266-267]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 120 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS--Table of
Subpart A General Provisions
Sec. 120.3 Definitions.
The definitions of terms in section 201 of the Federal Food, Drug,
and Cosmetic Act, Sec. 101.9(j)(18)(vi), and part 110 of this chapter
are applicable to such terms when used in this part, except where
redefined in this part. The following definitions shall also apply:
(a) Cleaned means washed with water of adequate sanitary quality.
(b) Control means to prevent, eliminate, or reduce.
(c) Control measure means any action or activity to prevent, reduce
to acceptable levels, or eliminate a hazard.
(d) Critical control point means a point, step, or procedure in a
food process at which a control measure can be applied and at which
control is essential to reduce an identified food hazard to an
acceptable level.
(e) Critical limit means the maximum or minimum value to which a
physical, biological, or chemical parameter must be controlled at a
critical control point to prevent, eliminate, or reduce to an acceptable
level the occurrence of the identified food hazard.
(f) Culled means separation of damaged fruit from undamaged fruit.
For processors of citrus juices using treatments to fruit surfaces to
comply with Sec. 120.24, culled means undamaged, tree-picked fruit that
is U.S. Department of Agriculture choice or higher quality.
(g) Food hazard means any biological, chemical, or physical agent
that is reasonably likely to cause illness or injury in the absence of
its control.
(h) Importer means either the U.S. owner or consignee at the time of
entry of a food product into the United States, or the U.S. agent or
representative of the foreign owner or consignee at the time of entry
into the United States. The importer is responsible for ensuring that
goods being offered for entry into the United States are in compliance
with all applicable laws. For the purposes of this definition, the
importer is ordinarily not the custom house broker, the freight
forwarder, the carrier, or the steamship representative.
(i) Monitor means to conduct a planned sequence of observations or
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measurements to assess whether a process, point, or procedure is under
control and to produce an accurate record for use in verification.
(j)(1) Processing means activities that are directly related to the
production of juice products.
(2) For purposes of this part, processing does not include:
(i) Harvesting, picking, or transporting raw agricultural
ingredients of juice products, without otherwise engaging in processing;
and
(ii) The operation of a retail establishment.
(k) Processor means any person engaged in commercial, custom, or
institutional processing of juice products, either in the United States
or in a foreign country, including any person engaged in the processing
of juice products that are intended for use in market or consumer tests.
(l) Retail establishment is an operation that provides juice
directly to the consumers and does not include an establishment that
sells or distributes juice to other business entities as well as
directly to consumers. ``Provides'' includes storing, preparing,
packaging, serving, and vending.
(m) Shall is used to state mandatory requirements.
(n) Shelf-stable product means a product that is hermetically sealed
and, when stored at room temperature, should not demonstrate any
microbial growth.
(o) Should is used to state recommended or advisory procedures or to
identify recommended equipment.
(p) Validation means that 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.
(q) Verification means those activities, other than monitoring, that
establish the validity of the HACCP plan and that the system is
operating according to the plan.
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