[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: 9CFR417.4]



[Page 634-635]

 

                  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. 417.4  Validation, Verification, Reassessment.



    (a) Every establishment shall validate the HACCP plan's adequacy in 

controlling the food safety hazards identified during the hazard 

analysis, and shall verify that the plan is being effectively 

implemented.

    (1) Initial validation. Upon completion of the hazard analysis and 

development of the HACCP plan, the establishment shall conduct 

activities designed to determine that the HACCP plan is functioning as 

intended. During this HACCP plan validation period, the establishment 

shall repeatedly test the adequacy of the CCP's, critical limits, 

monitoring and recordkeeping procedures, and corrective actions set 

forth in the HACCP plan. Validation also encompasses reviews of the 

records themselves, routinely generated by the HACCP system, in the 

context of other validation activities.

    (2) Ongoing verification activities. Ongoing verification activities 

include, but are not limited to:

    (i) The calibration of process-monitoring instruments;

    (ii) Direct observations of monitoring activities and corrective 

actions; and

    (iii) The review of records generated and maintained in accordance 

with Sec. 417.5(a)(3) of this part.

    (3) Reassessment of the HACCP plan. Every establishment shall 

reassess the adequacy of the HACCP plan at least annually and whenever 

any changes occur that could affect the hazard analysis or alter the 

HACCP plan. Such changes may include, but are not limited to, changes 

in: raw materials or source of raw materials; product formulation; 

slaughter or processing methods or systems; production volume; 

personnel; packaging; finished product distribution systems; or, the 

intended use or consumers of the finished product. The reassessment 

shall be performed by an individual trained



[[Page 635]]



in accordance with Sec. 417.7 of this part. The HACCP plan shall be 

modified immediately whenever a reassessment reveals that the plan no 

longer meets the requirements of Sec. 417.2(c) of this part.

    (b) Reassessment of the hazard analysis. Any establishment that does 

not have a HACCP plan because a hazard analysis has revealed no food 

safety hazards that are reasonably likely to occur shall reassess the 

adequacy of the hazard analysis whenever a change occurs that could 

reasonably affect whether a food safety hazard exists. Such changes may 

include, but are not limited to, changes in: raw materials or source of 

raw materials; product formulation; slaughter or processing methods or 

systems; production volume; packaging; finished product distribution 

systems; or, the intended use or consumers of the finished product.