1. Planning a Smart Path to Part 117 Implementation
MSU Food Law Current Issues, July 12, 2016
Charles M. Breen
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2. It’s not rocket science, but does require work.
Write a Plan for the Food Safety Plan
Purpose
Goals
Resources available
Resources needed
DOCUMENT what you did
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3. 21 CFR 117 PC-HF Minimum Syllabus from Preamble and Rule:
Summary of the Major Provisions of the Rule
Proposed Exemptions From the New Requirements for Hazard Analysis and Risk-Based Preventive Controls
Table 53 – Compliance Dates for the Requirements of Part 117 Other Than the Requirements for a Supply-Chain Program
Subpart F – Requirements Applying to Records That Must Be Established and Maintained
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4. 21 CFR 117 PC-HF
Assign responsibilities – with enough authority to accomplish tasks
Identify current food safety plans and certifications
Send one or more to PCQI training
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5. 21 CFR 117 PC-HF Priority items: Revised GMPs – do you still comply?
Hazard analysis
Controls in place
Controls needed
What records do you need and to review?
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6. 21 CFR 117 PC-HF Priority items: Recall plan Supply chain program
Provision of assurances
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7. Revised GMPs – do you still comply?
Everybody with food safety responsibilities must be qualified to do their job to produce safe food.
Employees need to know tasks, food hygiene, and personal hygiene.
Individual Training at specified frequencies must happen, and records kept.
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8. Revised GMPs – do you still comply?
Supervisors must have training and/or experience to be qualified to supervise food safety responsibilities and respond to employees reporting safety and hygiene issues
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9. Revised GMPs – do you still comply?
Major emphasis: prevention of allergen cross-contact
“[A]llergen cross-contact” appears 34 times in revised Part 117 GMPs
“[A]llergen cross-contact” is not used in 21 CFR 110
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10. Revised GMPs – do you still comply?
Making ready-to-eat (RTE) food and not know it?
117.3 Ready-to-eat food (RTE food) means any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards.
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11. Hazard Analysis Chemical (including radiological) Microbiological
Physical
Allergens are a chemical hazard
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12. Hazard Analysis Iterative analysis for each product
1. All food safety hazards
2. Hazards that could cause harm
3. Hazards known or reasonably foreseeable
Number 3 requires preventive control(s)
NB: Quality is not a food safety factor.
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13. Hazard Analysis 3. Hazards known or reasonably foreseeable
Product history
Recalls, import alerts, regulatory actions
New information
Consumer disregard of cooking instructions
Pathogen appearance in new food matrix
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14. For hazards requiring control(s)
What’s already in place?
Is validation information available?
Is performance verified?
How often is the control monitored?
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15. For hazards requiring control(s)
What’s already in place?
FDA recognizes many firms have adequate controls and produce safe food
Identify what is already under control
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16. For hazards requiring control(s)
Is validation information available?
Scientific or technical data to show a control is capable of eliminating or minimizing a hazard
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17. For hazards requiring control(s)
Is performance verified?
Information and data that a control is doing the job adequately to control hazard
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18. For hazards requiring control(s)
How often is the control monitored?
Facility to decide how often to monitor (and record) performance
Some controls will need frequent monitoring, others less
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19. What new records do you need?
Know what you have and supplement as needed
Existing records do not need to be duplicated
Original or true copies, permanent, recorded when monitored, timely review
Electronic records do not need to be Part 11 compliant
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20. Recall Plan Assignment of responsibilities Notify direct consignees
Notify consumers if Class 1
Account for and properly dispose of recalled product
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21. Supply Chain Program Know what hazards exist for a food
Know who in supply chain controls hazard
Verify if your supplier controls hazards
Document receipt or sale if hazards controlled downstream (Assurances)
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22. Assurances
Assurances given regarding hazard control are legally binding
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23. Thank You

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