[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: 21CFR120.7]
[Page 268]
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. 120.7 Hazard analysis.
(a) Each processor shall develop, or have developed for it, a
written hazard analysis to determine whether there are food hazards that
are reasonably likely to occur for each type of juice processed by that
processor and to identify control measures that the processor can apply
to control those hazards. The written hazard analysis shall consist of
at least the following:
(1) Identification of food hazards;
(2) An evaluation of each food hazard identified to determine if the
hazard is reasonably likely to occur and thus, constitutes a food hazard
that must be addressed in the HACCP plan. A food hazard that is
reasonably likely to occur is one for which a prudent processor would
establish controls because experience, illness data, scientific reports,
or other information provide a basis to conclude that there is a
reasonable possibility that, in the absence of those controls, the food
hazard will occur in the particular type of product being processed.
This evaluation shall include an assessment of the severity of the
illness or injury if the food hazard occurs;
(3) Identification of the control measures that the processor can
apply to control the food hazards identified as reasonably likely to
occur in paragraph (a)(2) of this section;
(4) Review of the current process to determine whether modifications
are necessary; and
(5) Identification of critical control points.
(b) The hazard analysis shall include food hazards that can be
introduced both within and outside the processing plant environment,
including food hazards that can occur before, during, and after harvest.
The hazard analysis shall be developed by an individual or individuals
who have been trained in accordance with Sec. 120.13 and shall be
subject to the recordkeeping requirements of Sec. 120.12.
(c) In evaluating what food hazards are reasonably likely to occur,
consideration should be given, at a minimum, to the following:
(1) Microbiological contamination;
(2) Parasites;
(3) Chemical contamination;
(4) Unlawful pesticides residues;
(5) Decomposition in food where a food hazard has been associated
with decomposition;
(6) Natural toxins;
(7) Unapproved use of food or color additives;
(8) Presence of undeclared ingredients that may be allergens; and
(9) Physical hazards.
(d) Processors should evaluate product ingredients, processing
procedures, packaging, storage, and intended use; facility and equipment
function and design; and plant sanitation, including employee hygiene,
to determine the potential effect of each on the safety of the finished
food for the intended consumer.
(e) HACCP plans for juice need not address the food hazards
associated with microorganisms and microbial toxins that are controlled
by the requirements of part 113 or part 114 of this chapter. A HACCP
plan for such juice shall address any other food hazards that are
reasonably likely to occur.
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