Overview of Part 117
Overview of Part 117 FDA’s Proposed Rule under FSMA Glenn Black, Ph D Director of Science Operations Grocery Manufacturers Association
www.gmaonline.org
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Agenda • • • •
Introduction Overview Key Takeaways Highlights of a Food Safety Plan
www.gmaonline.org
Introduction • FDA has proposed two new regulations under FSMA – Preventive Controls for human food – Produce Safety
• Comments due May 16, 2013 (120 days) • More to come Foreign Supplier Verification Animal Food Food Defense 3
www.gmaonline.org
Overview of Preventive Controls
• Proposed rule revise FDA’s current regulations in part 110 in two fundamental ways: 1. Add new provisions under section 103 of FSMA a. Hazard Analysis & Preventive Controls
2. Update and clarify cGMP’s (currently in part 110)
4
www.gmaonline.org
Registration
• To implement section 103(c) of FSMA, requires changes to current section 415 (FD&C Act) registration regulations: – Clarify definition of ‘facility’ – Clarify the scope of exemption for ‘farms’
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www.gmaonline.org
Key Takeaways 1. Proposed rule generally tracks the statute • Preamble traces origins of HACCP (examples)
2. FDA generally provides industry flexibility • Each facility to tailor food safety plan to its own circumstances
3. Validation of preventive controls key issue • FDA expects high level of scientific justification
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www.gmaonline.org
Key Takeaways (cont’d) 4. High emphasis on recordkeeping/FDA access • Keep records on-site at least 6 months • Always keep food safety plan on-site • Electronic records (Part 11) Exemption?
5. Updates to cGMPs (replacing 110) • • • •
Outgrowth of cGMP Modernization Initiative Changing language Removing specific performance standards Protection against cross contact
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www.gmaonline.org
Key Takeaways (cont’d) 6. Defines small and very small businesses • Small – less than 500 employees across the entire company (SBA definition) • Very small – either $250,000, $500,000, or $1,000,000 in annual sales of food (comments requested)
7. Compliance dates • 1 year for large businesses • 2 years for small businesses • 3 years for very small businesses ** All from date of publication of Final regulation 8
www.gmaonline.org
Food Safety Plan • Prepared (or preparation overseen) by “qualified individual” – Qualifications need to be defined • Requires the owner, operator or agent to have: A written Food Safety Plan: a. A hazard analysis (all considerations); b. Preventive controls (parameters/limits); c. Monitoring procedures; d. Corrective action procedures; e. Verification procedures (also Validation); and f. A recall plan. (Reanalysis every 3 yrs)
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www.gmaonline.org
Hazard Analysis • Identify and evaluate: “known or reasonably foreseeable hazards” for each type of food Severity of illness Foreseeable consumer use • Include a justification for conclusions reached E.g. Not reasonably likely to occur due to prerequisite program
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www.gmaonline.org
Preventive Controls • Identify and implement preventive controls for those hazards reasonably likely to occur • Preventive controls must include, as appropriate: – – – –
Process controls (traditional CCPs) Allergen controls (Cross contact & Labeling) Sanitation controls (Ready to Eat) Recall plan
– GMPs will be part of a more general food safety infrastructure (elements may overlap) 11
www.gmaonline.org
Recall Plan • Would be required to contain procedures for: – Notifying consignees and public – Conducting effectiveness checks – Disposing of recalled product
• FDA is requesting comment on whether it should require: – A recall plan to include procedures for notifying FDA – Mock recalls as a verification activity
12
www.gmaonline.org
Recordkeeping • New requirements would apply to all records required by new Part 117 • List of Required Records: written food safety plan monitoring of preventive controls corrective actions verification training for the qualified individual
13
www.gmaonline.org
Questions?
14
www.gmaonline.org
www.gmaonline.org
1
Agenda • • • •
Introduction Overview Key Takeaways Highlights of a Food Safety Plan
www.gmaonline.org
Introduction • FDA has proposed two new regulations under FSMA – Preventive Controls for human food – Produce Safety
• Comments due May 16, 2013 (120 days) • More to come Foreign Supplier Verification Animal Food Food Defense 3
www.gmaonline.org
Overview of Preventive Controls
• Proposed rule revise FDA’s current regulations in part 110 in two fundamental ways: 1. Add new provisions under section 103 of FSMA a. Hazard Analysis & Preventive Controls
2. Update and clarify cGMP’s (currently in part 110)
4
www.gmaonline.org
Registration
• To implement section 103(c) of FSMA, requires changes to current section 415 (FD&C Act) registration regulations: – Clarify definition of ‘facility’ – Clarify the scope of exemption for ‘farms’
5
www.gmaonline.org
Key Takeaways 1. Proposed rule generally tracks the statute • Preamble traces origins of HACCP (examples)
2. FDA generally provides industry flexibility • Each facility to tailor food safety plan to its own circumstances
3. Validation of preventive controls key issue • FDA expects high level of scientific justification
6
www.gmaonline.org
Key Takeaways (cont’d) 4. High emphasis on recordkeeping/FDA access • Keep records on-site at least 6 months • Always keep food safety plan on-site • Electronic records (Part 11) Exemption?
5. Updates to cGMPs (replacing 110) • • • •
Outgrowth of cGMP Modernization Initiative Changing language Removing specific performance standards Protection against cross contact
7
www.gmaonline.org
Key Takeaways (cont’d) 6. Defines small and very small businesses • Small – less than 500 employees across the entire company (SBA definition) • Very small – either $250,000, $500,000, or $1,000,000 in annual sales of food (comments requested)
7. Compliance dates • 1 year for large businesses • 2 years for small businesses • 3 years for very small businesses ** All from date of publication of Final regulation 8
www.gmaonline.org
Food Safety Plan • Prepared (or preparation overseen) by “qualified individual” – Qualifications need to be defined • Requires the owner, operator or agent to have: A written Food Safety Plan: a. A hazard analysis (all considerations); b. Preventive controls (parameters/limits); c. Monitoring procedures; d. Corrective action procedures; e. Verification procedures (also Validation); and f. A recall plan. (Reanalysis every 3 yrs)
9
www.gmaonline.org
Hazard Analysis • Identify and evaluate: “known or reasonably foreseeable hazards” for each type of food Severity of illness Foreseeable consumer use • Include a justification for conclusions reached E.g. Not reasonably likely to occur due to prerequisite program
10
www.gmaonline.org
Preventive Controls • Identify and implement preventive controls for those hazards reasonably likely to occur • Preventive controls must include, as appropriate: – – – –
Process controls (traditional CCPs) Allergen controls (Cross contact & Labeling) Sanitation controls (Ready to Eat) Recall plan
– GMPs will be part of a more general food safety infrastructure (elements may overlap) 11
www.gmaonline.org
Recall Plan • Would be required to contain procedures for: – Notifying consignees and public – Conducting effectiveness checks – Disposing of recalled product
• FDA is requesting comment on whether it should require: – A recall plan to include procedures for notifying FDA – Mock recalls as a verification activity
12
www.gmaonline.org
Recordkeeping • New requirements would apply to all records required by new Part 117 • List of Required Records: written food safety plan monitoring of preventive controls corrective actions verification training for the qualified individual
13
www.gmaonline.org
Questions?
14
www.gmaonline.org
