[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2007]

From the U.S. Government Printing Office via GPO Access

[CITE: 9CFR417.2]



[Page 632-634]

 

                  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



[[Page 633]]



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 634]]



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]