a. All "processors"
b. All importers
a. Every "processor" must conduct a hazard analysis to determine whether they have likely food safety hazards that they must control.
a. Where hazard analysis reveals need, every "processor" must have a written HACCP plan that's specific to location and kind of product.
b. HACCP plan must ID:
ii. Critical control points to control hazards that can occur both inside & outside the processing plant. (HACCP PRINCIPLE #2)
iii. Critical limits (i.e., safe operating parameters) for the ccp's. (HACCP PRINCIPLE #3)
iv. Monitoring procedures. (HACCP PRINCIPLE #4)
v. Corrective action plans, if any. (HACCP PRINCIPLE #5)
vi. Verification procedures to: (HACCP PRINCIPLE #6)
vii. Recordkeeping system to document monitoring, corrective actions, certain verification procedures. (HACCP PRINCIPLE #7)
c. Signing/dating: Plan must be signed/dated by a senior firm official. This must occur initially, upon modification, and at least annually.
Processors may either...
a. Follow corrective action plans they have developed in advance,
or
b. Do the following:
a. Verifying the HACCP plan: Processors must reassess adequacy of their HACCP plan at least annually or whenever a significant change occurs.
b. Verifying ongoing activities:
a. Monitoring and similar records must state the name & location of the processor, date & date, signature/initials of person making the record.
b. Records retention: processors must store records for 1 to 2 years, depending on type of record and type of product (i.e., shelf-life).
c. Plans, HACCP records, & sanitation records, must be available to FDA inspectors for review and copying. Consumer complaints are not available, but the consumer complaint SOP is available.
d. All plans & records in possession of FDA are deemed to be not available for public disclosure per FOIA regulations. Exceptions: 1) previously disclosed or abandoned materials; 2) discretionary disclosure in accordance with FDA's FOIA regulations.
a. For each processor, certain enumerated HACCP functions must be performed by an individual who has been trained in HACCP through course materials or who through job experience that has provided knowledge equivalent to a course. The course must be at least equivalent to a standard curriculum recognized as adequate by FDA.
b. The enumerated functions are:
c. Processors have a choice: they may either obtain training for one or more of their own employees, or they may hire trained independent contractors to perform these functions.
a. Monitoring/Recordkeeping. Processors must monitor and keep records in 8 enumerated areas of sanitation. Processors may establish their own monitoring frequencies. This monitoring and recordkeeping may be part of the processor's HACCP system or in a parallel system outside the HACCP plan. FDA has access to these records. The regulations recommend that processors have a sanitation SOP for the 8 enumerated areas, but it is not required.
a. Importers must verify that their overseas suppliers follow HACCP. There are two ways to verify:
a. Controlling the origin of molluscan shellfish (i.e., properly classified waters) is most important preventive control for most hazards. Thus, the HACCP plans of processors of molluscan shellfish must include how this control is being performed, including how processor are only obtaining shellfish:
a. Botulism is a significant likely hazard for this type of product if not sufficiently controlled. Thus, the HACCP plans of processors of smoked fish must include how they are controlling this hazard to ensure zero toxin production in the product for a time slightly beyond the shelf life of the product.
a. The industry has two years to obtain training, write HACCP plans, install HACCP systems, engage in sanitation monitoring, etc. FDA is preparing to conduct voluntary, "dry run" HACCP inspections during this two year period. Full, mandatory implementation must occur by the end of this period.
Hypertext updated by dms/ear 2001-AUG-15