[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR417.2]

[Page 629-631]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 417_HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
--Table of Contents
 
Sec. 417.2  Hazard Analysis and HACCP Plan.

    (a) Hazard analysis. (1) Every official establishment shall conduct, 
or have conducted for it, a hazard analysis to determine the food safety 
hazards reasonably likely to occur in the production process and 
identify the preventive measures the establishment can apply to control 
those hazards. The hazard analysis shall include food safety hazards 
that can occur before, during, and after entry into the establishment. A 
food safety hazard that is reasonably likely to occur is one for which a 
prudent establishment would establish controls because it historically 
has occurred, or because there is a reasonable possibility that it will 
occur in the

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particular type of product being processed, in the absence of those 
controls.
    (2) A flow chart describing the steps of each process and product 
flow in the establishment shall be prepared, and the intended use or 
consumers of the finished product shall be identified.
    (3) Food safety hazards might be expected to arise from the 
following:
    (i) Natural toxins;
    (ii) Microbiological contamination;
    (iii) Chemical contamination;
    (iv) Pesticides;
    (v) Drug residues;
    (vi) Zoonotic diseases;
    (vii) Decomposition;
    (viii) Parasites;
    (ix) Unapproved use of direct or indirect food or color additives; 
and
    (x) Physical hazards.
    (b) The HACCP plan. (1) Every establishment shall develop and 
implement a written HACCP plan covering each product produced by that 
establishment whenever a hazard analysis reveals one or more food safety 
hazards that are reasonably likely to occur, based on the hazard 
analysis conducted in accordance with paragraph (a) of this section, 
including products in the following processing categories:
    (i) Slaughter--all species.
    (ii) Raw product--ground.
    (iii) Raw product--not ground.
    (iv) Thermally processed--commercially sterile.
    (v) Not heat treated--shelf stable.
    (vi) Heat treated--shelf stable.
    (vii) Fully cooked--not shelf stable.
    (viii) Heat treated but not fully cooked--not shelf stable.
    (ix) Product with secondary inhibitors--not shelf stable.
    (2) A single HACCP plan may encompass multiple products within a 
single processing category identified in this paragraph, if the food 
safety hazards, critical control points, critical limits, and procedures 
required to be identified and performed in paragraph (c) of this section 
are essentially the same, provided that any required features of the 
plan that are unique to a specific product are clearly delineated in the 
plan and are observed in practice.
    (3) HACCP plans for thermally processed/commercially sterile 
products do not have to address the food safety hazards associated with 
microbiological contamination if the product is produced in accordance 
with the requirements of part 318, subpart G, or part 381, subpart X, of 
this chapter.
    (c) The contents of the HACCP plan. The HACCP plan shall, at a 
minimum:
    (1) List the food safety hazards identified in accordance with 
paragraph (a) of this section, which must be controlled for each 
process.
    (2) List the critical control points for each of the identified food 
safety hazards, including, as appropriate:
    (i) Critical control points designed to control food safety hazards 
that could be introduced in the establishment, and
    (ii) Critical control points designed to control food safety hazards 
introduced outside the establishment, including food safety hazards that 
occur before, during, and after entry into the establishment;
    (3) List the critical limits that must be met at each of the 
critical control points. Critical limits shall, at a minimum, be 
designed to ensure that applicable targets or performance standards 
established by FSIS, and any other requirement set forth in this chapter 
pertaining to the specific process or product, are met;
    (4) List the procedures, and the frequency with which those 
procedures will be performed, that will be used to monitor each of the 
critical control points to ensure compliance with the critical limits;
    (5) Include all corrective actions that have been developed in 
accordance with Sec. 417.3(a) of this part, to be followed in response 
to any deviation from a critical limit at a critical control point; and
    (6) Provide for a recordkeeping system that documents the monitoring 
of the critical control points. The records shall contain the actual 
values and observations obtained during monitoring.
    (7) List the verification procedures, and the frequency with which 
those procedures will be performed, that the establishment will use in 
accordance with Sec. 417.4 of this part.
    (d) Signing and dating the HACCP plan. (1) The HACCP plan shall be 
signed and dated by the responsible establishment individual. This 
signature

[[Page 631]]

shall signify that the establishment accepts and will implement the 
HACCP plan.
    (2) The HACCP plan shall be dated and signed:
    (i) Upon initial acceptance;
    (ii) Upon any modification; and
    (iii) At least annually, upon reassessment, as required under Sec. 
417.4(a)(3) of this part.
    (e) Pursuant to 21 U.S.C. 456, 463, 608, and 621, the failure of an 
establishment to develop and implement a HACCP plan that complies with 
this section, or to operate in accordance with the requirements of this 
part, may render the products produced under those conditions 
adulterated.

[61 FR 38868, July 25, 1996, as amended at 62 FR 61009, Nov. 14, 1997]