FSMA: How Sweeping Reform of Food Safety Laws Will Impact ... · CGMPs and Preventive Controls Rule...
Transcript of FSMA: How Sweeping Reform of Food Safety Laws Will Impact ... · CGMPs and Preventive Controls Rule...
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FSMA: How Sweeping Reform of Food Safety Laws Will Impact Your Business
Jason Sapsin Faegre Baker Daniels
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FSMA: How Sweeping Reform of Food Safety Laws will Has Affect Affected your Business
Attorney-Client Privilege
Jason Sapsin, Counsel Faegre Baker Daniels LLP
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Agenda
Section 1: FSMA background, structure and goals
Section 2: Compliance and Implementation
Section 3: Enforcement metrics and predictions (?)
Attorney-Client Privilege
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Background, Structure and Goals
Attorney-Client Privilege
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But first . . .
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But first . . .
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Background, Structure and Goals
Pre-FSMA: FDA’s food safety efforts criticized as uneven and reactive
Attorney-Client Privilege
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• Enacted in 2011
• Covers entities which manufacture, process, store or transport food products (intra/interstate)
• Major “reform” effort
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Background, Structure and Goals
Proactive v. Reactive • Focus on prevention • Risk-based analysis
Proactive v. Reactive
• Recall/Detention • Rulemaking/Guidance • Fines and fees
More FDA authority
• Inspections • Recordkeeping • Imports
More industry requirements
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Background, Structure and Goals
• Pre-FSMA: • No minimum inspection frequency • Years between inspections • Reactionary
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Background, Structure and Goals
• Post FSMA • Administratively detain / seize food • Mandatory administrative recall • Perform in-depth inspection of facility • Take documents • Revoke facility registration
ü No registration = illegal to ship product into interstate commerce • Compulsory fines and/or fees • Refuse to allow import of products
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Background, Structure and Goals
• What Actually is FSMA? – Preventive Controls Rule – Supply-Chain Program – Foreign Supplier Verification Program – Sanitary Transportation – Food Defense
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FSMA Implementation
Rule Final Rule Published
CGMPs and Preventive Controls Rule (Human and Animal Food)
Sept. 17, 2015
Supply-Chain Program Sept. 17, 2015
Third-Party Certification Nov. 27, 2015
Foreign Supplier Verification (FSVP) Nov. 27, 2015
Produce Safety Rule Nov. 27, 2015
Sanitary Transportation of Food April 6, 2016
Food Defense May 27, 2016
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Compliance and Implementation
Attorney-Client Privilege
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Areas of Focus: • Personnel
• Plant and grounds
• Sanitary facilities and controls
Preventive Controls Rule: CGMPs
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Areas of Focus: • Equipment and utensils
• Manufacturing operations (e.g., labeling, materials inspections)
• Warehousing and distribution
Preventive Controls Rule: CGMPs
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Preventive Controls Rule: Food Safety Plan
• All FDA Registered Facilities must develop and implement a written Food Safety Plan that includes:
ü Hazard Analysis
ü Preventive Controls
ü Monitoring Procedures
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Preventive Controls Rule: Food Safety Plan
• All FDA Registered Facilities must develop and implement a written Food Safety Plan that includes:
ü Corrective action procedures
ü Verification procedures
ü Recall plan
ü Supply chain program
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Preventive Controls Rule: Food Safety Plan
Food Safety Plan must be developed and overseen by a Preventive Controls Qualified Individual (PCQI)
– Relevant job experience and/or completed training for food safety program
– Training must be recognized as adequate by the FDA
– PCQI develops and implements food safety plan at facility
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Preventive Controls Rule: Basics of HARPC
For Every Product Manufactured, Company MUST
– Evaluate hazards – Develop a written hazard analysis – Validate preventive control
• Justify why/how it will control hazard – Monitor preventive control to
ensure it is working
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Preventive Controls Rule: Basics of HARPC
For Every Product Manufactured, Company MUST
– Verify preventive control is effective • Review monitoring records • E.g., finished product testing
– Corrective Actions • Additional controls implemented if
preventive control is not effective at minimizing/eliminating hazard
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How Does HARPC Differ From HACCP?
• Congress recognized use of HACCP elsewhere, but did not use that language in FSMA
• HACCP is a good start – CGMPs – Prerequisite programs
• Biggest difference: Preventive Controls vs. CCPs
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HARPC: Identifying Hazards
Step 1: Identify any known or reasonably foreseeable hazard:
Biological Chemical (pesticides) Environmental
Physical Radiological Intentional or accidental
Allergens Unapproved food or additives
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Primary Contaminants
• Pathogens: – Salmonella – E. coli O157:H7, other STECs – Listeria monocytogenes – Norovirus
• Foreign Objects (plastic, metal, glass, etc.) • Mycotoxins (grains) • Undisclosed allergens • Naturally-occurring (pits, mold,
yeasts, etc.)
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HARPC: Identifying Hazards
Step 1 (cont.): Specific areas required to be considered:
– Food formulation – Condition, function and design of facility and equipment – Raw materials and ingredients – Transportation practices – Manufacturing/processing procedures, including sanitation and
hygiene – Packaging and labeling activities – Storage and distribution – Intended or reasonably foreseeable use
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HARPC: Identifying Hazards
Step 2: Identify PC Hazards: • For each PC Hazard, one or more
preventive controls must be identified and implemented – Preventive controls are specific
to the facility and the product – FDA makes clear that preventive
controls need not be CCPs
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HARPC: Preventive Controls
• Preventive controls may include: – CGMPs – SOPs – Hygienic zoning – Environmental sampling and
controls – Allergen controls and labeling
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HARPC: Ensure Preventive Controls Are Working
• Validation – Can the control measure be effective at controlling the
hazard?
• Monitoring
• Verification – Is the control measure working on an ongoing basis?
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HARPC: What Happens if a PC is impractical?
If Company (or Company’s Supplier) cannot control for the hazard, it must obtain annual written assurances that customer is “manufacturing, processing, or preparing the food in accordance with applicable food safety requirements.”
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Record Keeping Requirements
• Written plan and records must be kept for 2 years
• Reanalysis every 3 years unless significant change in process • Records must be provided to FDA on request • If it’s not documented it didn’t happen!
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Preventive Controls Rule: CGMP Compliance Dates
Business Size CGMP Compliance Date for Human Food
CGMP Compliance Date for Animal Food
Other Businesses September 19, 2016 September 19, 2016
Small Businesses* September 18, 2017 September 18, 2017
Very Small Businesses** September 17, 2018 September 17, 2018
* Human & Animal Food: Fewer than 500 full time employees ** Human Food Very Small Business: > $1,000,000 avrg annual sales **Animal Food Very Small Business: > $2,500,000 avrg annual sales
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Preventive Controls Rule: HARPC Compliance Dates
Business Size HARPC Compliance Date for Human Food
HARPC Compliance Date for Animal Food
Other Businesses September 19, 2016 September 18, 2017
Small Businesses* September 18, 2017 September 17, 2018
Very Small Businesses** September 17, 2018 September 17, 2019
* Human & Animal Food: Fewer than 500 full time employees ** Human Food Very Small Business: > $1,000,000 avrg annual sales **Animal Food Very Small Business: > $2,500,000 avrg annual sales
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Supply Chain Program
Attorney-Client Privilege
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Supply-Chain Program
• Manufacturing/processing facilities must have a risk-based supply-chain program to ensure control of hazards in raw materials and other ingredients when the control is applied before receipt (“supply-chain applied control”).
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Supply-Chain Program: Affects on Suppliers
• Supplier Verification Activities
• Verification activities
based on nature of hazard, where it is controlled and supplier performance
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Supply-Chain Program: Compliance Dates
Business Size Supply-Chain Compliance Dates Receiving facility not small business + Supplier is subject to Preventive Controls Rule or Produce Safety
6 months after supplier is required to comply with Preventive Controls or Produce Safety
Receiving facility not small business + Supplier not subject to Preventive Controls Rule or Produce Safety
March 17, 2017
Small business receiving facility + Supplier is subject to Preventive Controls Rule or Produce Safety
Later of: September 18, 2017 OR 6 months after supplier is required to comply with Preventive Controls or Produce Safety
Small business receiving facility + Supplier not subject to Preventive Controls Rule or Produce Safety
September 18, 2017
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Foreign Supplier Verification Program
Attorney-Client Privilege
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Foreign Supplier Verification Program • Importer = Owner of food/
feed item when enters U.S. or, if none, U.S. agent/representative of foreign owner
• Records must be kept for
two years, produced upon request
• Compliance by May 2017
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Foreign Supplier Verification Program
• Importer required to verify food was produced in compliance with FSMA requirements (Preventive Controls and Produce Safety Rules)
• Conduct evaluation of food risk and supplier performance • Verification of foreign suppliers includes:
• Annual on-site audits of supplier’s facility • Product sampling and testing • Review of foreign supplier’s food safety records
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Sanitary Transportation
Attorney-Client Privilege
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Sanitary Transport Rule
Transportation Operations
Shipper Carrier Receiver Loader
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Sanitary Transport Rule: Outline and Highlights
• Who is Covered? – Domestic shippers and – Domestic loaders and – Domestic receivers and – Domestic carriers who – Transport food in U.S. by rail or truck in intra or
interstate commerce
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Sanitary Transport Rule: Outline and Highlights
• Shippers in other countries who: – Ship food directly to the U.S. (from
Canada or Mexico) by motor or rail – Ship food directly to the U.S. by ship
or air, and arrange for the transfer of intact containers onto motor or rail carriers for transport within U.S.
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Sanitary Transportation Guidelines
• Prevent food safety issues during food transport
• Manufactures/processors/distributors transporting food will be required to use sanitary transportation practices
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Sanitary Transport Rule
• Rule builds on safeguards initially envisioned in the 2005 Sanitary Food Transportation Act
• Prevent transportation practices that create food safety risks, such as:
– Cleaning vehicles between loads – Checking incoming load conditions – Failure to implement and maintain temperature controls – Failure to protect food in adequate containers – Failure to coordinate and exchange information between actors
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Sanitary Transportation: Compliance Dates
Business Size Sanitary Transportation Compliance Dates
Other Businesses 1 year — April 6, 2017
Small Businesses* 2 years — April 6, 2018
* Businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts
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Enforcement and Implementation
Attorney-Client Privilege
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Produced by
Industry readiness estimate (EAS, March 2016)
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FDA Implementation Strategy
• “Facilitate Industry Compliance”
• Regulator training
• “Education before Regulation”
• Non-FDA oversight schemes
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Produced by
FDA Implementation Strategy
• FSMA Alliance: Public/Private training partnership
• Technical Assistance Network
• Focus on education does NOT mean no enforcement
• Looking for evidence of anticipatory action
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September, 2016
Joann Givens
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Jason W. Sapsin, JD, MPH Faegre Baker Daniels [email protected] (303) 607-3652