[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR417.4]

[Page 636-637]
 
                  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 637]]

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.