Ready or Not? Preparing for FDA’s Implementation of FSMA · Cargill, Incorporated Steve...

Ready or Not?Preparing for FDA’s

Implementation of FSMA

Mary Lynn BedellVP, Food Law & Regulatory The Hillshire Brands Company

Larry LichterDirector, Global Supplier QualityMcCormick and Co., Inc.

Shirley BoydVP and Associate General CounselCargill, Incorporated

Steve ToeniskoetterModeratorFaegre Baker Daniels

Ready or Not?Preparing for FDA’s Implementation of FSMA

FSMA – The CliffsNotes® Version

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►Who/Where: facilities registered under 2002 BT Act, plus some more

►What:► Food safety plan (HACCP-like) for food and feed facilities► Increased inspections (risk-based), domestic and foreign► Increased FDA powers to suspend registration, detain product, force a

recall, inspect records, refuse admission to products, etc.► First significant on-the-farm powers for FDA (produce safety)► Focus on imported foods (FSVP and VQIP)► And so much more….

►Why: Last major revision 70+ years ago, new science, PCA.

FSMA Implementation – Effective Already

►Registration / suspension of registration (the “license”)► Increased authority to access records

► reasonable belief adulterated or misbranded►Mandatory recall authority►Whistleblower provisions►Refusal of admission to imported foods

► if refused admission to foreign facility►Lowered administrative detention standard►Prior Notice info re refusal of entry in other countries

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FSMA Implementation – Coming Soon

►FSMA signed into law Jan. 4, 2011

►Center for Food Safety v. Hamburg case► CFS filed to force FDA to comply with statutory

deadlines for regulations in FSMA and to follow APA► Court granted summary judgment for CFS,

set new schedule for regs.► FDA appealed, 9th Circuit denied emergency

appeal► FDA and CFS entered into consent decree

Feb. 2014, sets remaining deadlines

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Timeline for Remaining Significant Rules

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Rule Proposal Published

Deadline for Final Rule Notes

Preventive Controls (Human)

Jan. 16, 2013 Aug. 30, 2015 Revised proposal to be released Summer 2014

Preventive Controls (Animal)

Oct. 29, 2013 Aug. 30, 2015 Revised proposal to be released Summer 2014

Foreign Supplier Verification (FSVP)

July 29, 2013 Oct. 31, 2015

Produce Safety Standards

Jan. 16, 2013 Oct. 31, 2015 Revised proposal to be released Summer 2014

3rd Party Accreditation July 29, 2013 Oct. 31, 2015

Sanitary Transportation Feb. 5, 2014 March 31, 2016

Food Defense Dec. 24, 2013 May 31, 2016

Don’t Panic Just Yet

►Effective & compliance dates 1 – 3 years out

►Enforcement discretion

►Guidance coming► (including in some cases, industry- and commodity-specific)

►Another opportunity to provide input on proposed rules this summer

►A journey, not an event

►But your journey should already be underway

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Mary Lynn BedellVP, Food Law & Regulatory The Hillshire Brands Company

Preventive Controls for Human Foods

Preventive Controls for Human Foods

►New & Updated GMPs► Allergens► Defined “Environmental Pathogens”► Equipment and utensils

►Design and construction to preclude adulteration of foods

Record Keeping

►Establishment & Maintenance of Records Documenting:► Written Food Safety Plan► Monitoring of Preventive Controls► Corrective Actions► Verification Activities► Training

Mindset

►Plant personnel must be aligned.

►New requirements and responsibilities

►To make it all work, we have to rely on our plants to understand the significance and to be totally committed to the process.

Taste You Trust™

Taste You Trust™FSMA and the Inbound Supply Chain

Foreign Supplier Verification Program

May 14, 2014

Taste You Trust™

Today’s Discussion

Introduction

FSMA Foreign Supplier Verification Program

Conclusions

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Taste You Trust™

As the largest spice manufacturer in the world with $4.1B in sales and 35 plants and laboratories in 12 countries, we require the highest standards in food safety and quality.

McCormick’s Global Commitment to Food Safety

Taste You Trust™

ChinaChivesCelery SeedCinnamon/CassiaCorianderCumin SeedFennel SeedGingerGarlicOreganoRed PepperStar AniseSzechwan PepperTurmericWhite PepperSesame

MexicoAllspiceAnchor ChileOreganoVanilla BeansSesame

U.S.ACilantroGarlicMintParsleyOnion

CanadaCaraway SeedCorianderMustard

JamaicaAllspiceGinger

PeruPaprikaTurmeric Brazil

ClovesBlack PepperWhite Pepper

MoroccoCorianderFenugreekOreganoRosemaryThyme

NigeriaGinger

EgyptAniseBasilCarawayCilantroCorianderDill weedFennel seedMarjoramMint flakes

MadagascarClovesVanilla Beans

IndonesiaCinnamonClovesMaceNutmegVanilla Beans

(Bali, Java)Black pepper

(Lampung)White Pepper

(Mentor)

AustraliaPoppy Seed

ThailandLemongrassTurmeric

PakistanCumin SeedRed Pepper

VietnamBlack PepperWhite PepperCinnamonTurmeric

Anise SeedCumin Seed

IndiaBlack PepperCardamomCelery SeedCumin SeedDill SeedFennel SeedFenugreekGinger Red PepperTurmericVanilla BeansSesame

TurkeyAnise SeedBay LeavesCumin SeedFennel SeedOreganoPoppy SeedSage

AlbaniaOreganoRosemarySageSavoryNetherlands

Caraway SeedChervilPoppy Seed

SpainAnise SeedPaprikaRosemarySaffronThyme

FranceBasilChervilFennel SeedMarjoramRosemarySavoryTarragonThymeParsley

CroatiaSage

Guatemala/HondurasAllspiceCardamom

SeychellesCinnamon

Sri LankaBlack PepperCinnamonClovesComoros

Vanilla BeansCloves

MalaysiaCloves (Penang)Black Pepper

(Sarawak)White Pepper

(Sarawak)

RomaniaCoriander

CuminSaffron

West Indies (Grenada)MaceNutmeg

GermanyDill WeedParsley

HungaryPaprikaPoppy Seed

PolandPoppy SeedThyme

UgandaVanilla

Beans

TahitiVanilla

Beans

TongaVanilla

Beans

IsraelOreganoParsley

SPICES OF THE WORLD

Taste You Trust™

Spice Trade Background

Items primarily grown in developing countries

Crops are grown on small farms by 10’s to 100’s of thousands of farmers following farming practices that for the most part have not changed for centuries

Poor drying practices, handling and storage methods are typical

Taste You Trust™

A Global Sourcing Commitment to Food Safety

Most direct supply chain from “field to plate”

Farm

Collector

Processor

Shipper/Exporter

Agent

Importer/Dealer

Broker

McCormick

Exp

ort

Impo

rt

Customer

Fewer touch points reduce risk of contamination, ensure quality and

safety.

Allows us to work directly to impact product quality and innovation

Taste You Trust™34

“The Foreign Supplier Verification rule will require importers to verify that foreign suppliers are producing food in a manner consistent with U.S. standards. Under the proposed rule, in general, importers would be required to identify potential hazards associated with each food and verify that appropriate steps have been taken to adequately control those hazards”

-Margaret A. Hamburg, M.D. Commissioner of the US Food and Drug AdministrationPosted on July 26, 2013 by FDA Voice

Food Safety Modernization ActForeign Supplier Verification Program (FSVP)

Taste You Trust™

Food Safety Modernization ActForeign Supplier Verification Program (FSVP)What is FSVP:

Mandatory program Each importer must perform risk-based foreign supplier verification

activities for the purpose of verifying that the food imported by the importer is: Produced in compliance with the Food Safety Plan requirements Produced in compliance with produce safety regulations to be

promulgated by FDA Not adulterated or misbranded under 403(w) (undeclared allergens)

Foreign Supplier Requirements = US Supplier Requirements

Taste You Trust™3636

Responsible Party: Importer

US owner or consignee at time of entry; or US agent of foreign owner/consignee if no US owner/consignee as time of entry

Exemptions Seafood, juice and low-acid canned food already subject to FDA HACCP requirements

Considerations/Caveats FSMA acknowledges there will be differences among importers, types of imported food –

including the level of risk posed FDA has ability to establish other requirements if “necessary and appropriate to verify that

the food imported into the US is as safe as” food produced /sold in US

FSVP – FSMA § 301

Taste You Trust™

Supply Chain Control Know who your suppliers are (not just distributors) Verify they have a plan for assuring adherence to food safety requirements Establish a risk-based plan according to product type and facility history

Goal is to assure product is safe and not adulterated or misbranded (due to undeclared allergens)

Medium

Medium

MediumLow

Low

Low

High

High

Critical

Low Medium High

Low

Medium

High

Severity of Impact

Prob

abilit

y of

Occu

rrenc

e

Taste You Trust™

FSVP is an Ongoing Process Requiring…

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• Compliance Check: a review of the compliance status of foods and foreign suppliers

• Hazard Analysis: Importers would need to identify the hazards that are “reasonably likely to occur” for each type of food imported, and for each, the severity of the illness or injury if such a hazard were to occur.

• Verification Activities: Importers would be required to conduct activities that provide “adequate assurances” that the hazards identified as RLTO are adequately controlled.

• Corrective Actions: Importers would be required to review complaints they receive concerning the foods they import, investigate possible adulteration or misbranding, take certain corrective actions when appropriate, and revise their FSVPs when appropriate.

• Reassessment of the FSVP: Importers would be required to reassess their FSVPs within three years of establishing the FSVP and within three years of the last assessment.

Taste You Trust™

How will the FDA drive implementation of FSVP?

OPTION ONE• Singular approach to all suppliers• Initial Audit and subsequent

audits required at least annually to adequately verify control

• Other means of verification also specified

OPTION TWO• Importer selects activity to

adequately verify control

• Verification activity to be selected by importer based on risk assessment

Companies with established vendor programs use a variety of tools to verify controlStrategic partnerships Supplier relationship developmentCore values alignment Product inspection testing

Product performance measurements (foreign matter, metal, etc.) Processing records inspection (unannounced)

Audits

Taste You Trust™

Food for thought … The spice supply chain is somewhat unique

Spices are typically grown on very small farms with complex supply chains.

We encourage the FDA to allow for differentiation of Spices imported as a raw agricultural commodity (RAC) versus those imported as ready to use (RTU). An Inability to account for this will imperil the supply of spices to the US.

For RAC’s hazards are controlled by the finished product manufacturer in the US. As such, there should be no requirement to conduct any supplier verification activities when importing spices into the Unites States for processing

For RTU, verification requirements should apply to the foreign facility where the food is processed for sale to US customers

Option 2 is logical to effectively achieve the verification objective. Programs already exist –do not need to reinvent.

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Taste You Trust™

Thank You

© 2014 Cargill, Incorporated. All rights reserved.The FBD May Food & Ag Conference 2014CONFIDENTIAL. This document contains trade secret information. Disclosure, use or reproduction outside Cargill or inside Cargill, to or by those employees who do not have a need to know is prohibited except as authorized by Cargill in writing.© 2013 Cargill, Incorporated. All rights reserved.

Accreditation of Third Party Auditors

www.cargill.com

© 2014 Cargill, Incorporated. All rights reserved.The FaegreBD May Food & Ag Conference 2014

Overview

• Objective – competence and independence of auditors doing audits relied on for importation of foods

• Elements – FDA recognize accrediting bodies (ABs) – ABs evaluate and accredit third party auditors (TPAs)– TPAs audit and certify that foreign facilities meet

FSMA req’ts– TPA certification required for VQIP and Section 303

import certification (MIP)


From 78 Fed. Reg. 45783 (July 29, 2013)


Two Categories of Audits• Regulatory

– Used to determine eligibility for VQIP and MIP

– May be used to satisfy FSVPrequirements

• Consultative– To determine compliance with FD&C

Act and industry standards and practices– Used for internal purposes only

• Missing??– FSVP/DSVP


Regulatory Audit Requirements• Audit must include:

– Onsite assessment– Records review– Environmental or product sampling and analysis

where appropriate• Auditor must FDA immediately if auditor discovers a

condition that could “cause or contribute to a serious risk to the public health”

• Submit audit to FDA and AB• Conduct monitoring if concerns that facility is not in

compliance


Areas of Concern• Application?

– VQIP and MIP only– FSVP also?

• Standard for auditors reporting serious observations – Class 1 recalls only – Class 2 recalls too?

• Mandatory Reporting – VQIP and MIP only?

© 2014 Cargill, Incorporated. All rights reserved.The FaegreBD May Food & Ag Conference 2014CONFIDENTIAL. This document contains trade secret information. Disclosure, use or reproduction outside Cargill or inside Cargill, to or by those employees who do not have a need to know is prohibited except as authorized by Cargill in writing.© 2013 Cargill, Incorporated. All rights reserved.

Recordkeeping and Records Access

www.cargill.com


New Recordkeeping Requirements

•Hazard Analysis and Preventive Controls

•Foreign (and Domestic) Supplier Verifications

•Food Defense Plans • “High Risk” Foods


FDA Records Access Today• FDA may

– Inspect a facility (or vehicle) in which food is manufactured, processed , packed or stored

– Examine all pertinent equipment, finished and unfinished materials, containers and labeling

– Collect samples of finished products, WIP, raw materials, packaging and labeling

– Review and copy records detailing interstate shipment– If FDA has a reasonable belief that food is adulterated, access

manufacturing, packing, storage, transportation, importation and other records


Records Access Tomorrow• Food Safety Plan and all related records

– Hazard analysis– Preventive controls (including validation, monitoring, corrective

action and verification)– Training

• Foreign Supplier Verification Program (and records to establish food produced to FSMA reqt’s)

• Food Defense Plans – Vulnerability assessments – Mitigation strategies (including validation, monitoring, corrective

action and verification)

• Additional “traceability” records for “High Risk” foods


Areas of Concern• Time and cost• Documentation expectations – paper and electronic (21

CFR 11)• Storage location v. accessibility• Productive and efficient inspections• Remote access• Freedom of Information Act (FOIA)• Consultative audits• Customer requests for records

Ready or Not? Preparing for FDA’s Implementation of FSMA · Cargill, Incorporated Steve...

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