FSMA: How Sweeping Reform of Food Safety Laws Will Impact ... · CGMPs and Preventive Controls Rule (Human and Animal Food) Sept. 17, 2015 Supply-Chain Program Sept. 17, 2015 Third-Party

Produced by

FSMA: How Sweeping Reform of Food Safety Laws Will Impact Your Business

Jason Sapsin Faegre Baker Daniels

Produced by

1

FSMA: How Sweeping Reform of Food Safety Laws will Has Affect Affected your Business

Attorney-Client Privilege

Jason Sapsin, Counsel Faegre Baker Daniels LLP

Produced by

Agenda

Section 1: FSMA background, structure and goals

Section 2: Compliance and Implementation

Section 3: Enforcement metrics and predictions (?)


Produced by

3

Background, Structure and Goals


Produced by

The image cannot be displayed. Your computer may not have enough memory to open the image, or the image may have been corrupted. Restart your computer, and then open the file again. If the red x still appears, you may have to delete the image and then insert it again.

But first . . .

Produced by

But first . . .

Produced by


Pre-FSMA: FDA’s food safety efforts criticized as uneven and reactive


Produced by

•  Enacted in 2011

•  Covers entities which manufacture, process, store or transport food products (intra/interstate)

•  Major “reform” effort

Produced by


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

Produced by


•  Pre-FSMA: •  No minimum inspection frequency •  Years between inspections •  Reactionary

Produced by


•  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

Produced by


•  What Actually is FSMA? – Preventive Controls Rule – Supply-Chain Program – Foreign Supplier Verification Program – Sanitary Transportation – Food Defense

Produced by

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

Produced by

13

Compliance and Implementation


Produced by

Areas of Focus: •  Personnel

•  Plant and grounds

•  Sanitary facilities and controls

Preventive Controls Rule: CGMPs

Produced by

Areas of Focus: •  Equipment and utensils

•  Manufacturing operations (e.g., labeling, materials inspections)

•  Warehousing and distribution

Preventive Controls Rule: CGMPs

Produced by

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

Produced by


•  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

Produced by


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

Produced by

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

Produced by

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

Produced by

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

Produced by

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

Produced by

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.)

Produced by


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

Produced by


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

Produced by

HARPC: Preventive Controls

•  Preventive controls may include: –  CGMPs –  SOPs –  Hygienic zoning –  Environmental sampling and

controls –  Allergen controls and labeling

Produced by

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?

Produced by

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.”

Produced by

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!

Produced by

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

Produced by

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

Produced by

32

Supply Chain Program


Produced by

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”).

Produced by

Supply-Chain Program: Affects on Suppliers

•  Supplier Verification Activities

•  Verification activities

based on nature of hazard, where it is controlled and supplier performance

Produced by

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

Produced by

36

Foreign Supplier Verification Program


Produced by

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

Produced by

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

Produced by

39

Sanitary Transportation


Produced by

Sanitary Transport Rule

Transportation Operations

Shipper Carrier Receiver Loader

Produced by

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

Produced by

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.

Produced by

Sanitary Transportation Guidelines

•  Prevent food safety issues during food transport

•  Manufactures/processors/distributors transporting food will be required to use sanitary transportation practices

Produced by

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

Produced by

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

Produced by

46

Enforcement and Implementation


Produced by

Industry readiness estimate (EAS, March 2016)

Produced by

FDA Implementation Strategy

•  “Facilitate Industry Compliance”

•  Regulator training

•  “Education before Regulation”

•  Non-FDA oversight schemes

48

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

49

September, 2016

Joann Givens

Produced by

Recent enforcement

50

Produced by

Recent enforcement

51

Produced by

Recent enforcement

52

Produced by

THANK YOU

53 Attorney-Client Privileged

Jason W. Sapsin, JD, MPH Faegre Baker Daniels [email protected] (303) 607-3652

Documents

FSMA: How Sweeping Reform of Food Safety Laws Will Impact ... · CGMPs and Preventive Controls Rule (Human and Animal Food) Sept. 17, 2015 Supply-Chain Program Sept. 17, 2015 Third-Party