3M Food Safety and The Acheson Group present FSMA: How do I … · 2016-01-20 · Facilities that manufacture, process, pack, or hold food that is sold intrastate are also subject

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3M Health Care Academy

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3M Health Care AcademySM

3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series



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Host – Kevin Habas, 3M Food Safety

• Active in the Food Safety market for over 20 years; Currently

Global Scientific Marketing Manager; has held sales, marketing

and technical leadership roles at 3M and Ecolab

• Member of the International Association for Food Protection (IAFP)

since 1998, Global Food Safety Initiative (GFSI) TWG Global

Markets member and the Minnesota International Food

Technologists (IFT) affiliate member

• Founding member and treasurer of the recently formed MFPA –

local IAFP affiliate

• Certified SQF2000 Systems implementation



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Agenda

I. 3M Food Safety

II. The Acheson Group

III. FSMA presentation

IV. Question & Answer Session

V. FSMA presentation

VI. Question & Answer Session

VII. Closing comments



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4About 3M Food Safety

3M™ Petrifilm™ Plates

3M™ Clean -Trace™

Hygiene Monitoring Tests

Quality Indicator Testing

Pathogen & Toxin TestingHygiene MonitoringSample Handling / Media

3M™ Molecular Detection System

Every day and in more than 100 countries, 3M Food Safety products and

people help food and beverage processors maintain the highest food safety

standards and provide the highest levels of service and technical support.

• Over 30 Years in Food Safety Industry.

• Global Experience. Local support.

• Trusted by Top Food Companies, Validated

around the World.



+Melanie Neumann – J.D., M.S. EVP & Chief Financial Officer, The Acheson Group (TAG)

• Melanie has over 17 years experience advising food processors

• She has a Master’s degree in food which allows her to tackle the ever

changing global risks and food safety regulations

• She focuses her time on working with clients to prepare for FSMA and

other pending

• Her focus on the growing area of international food safety and TAG’s

increasing presence in China, Taiwan and other global markets is very

rewarding

• She has served as food law and intellectual property in-house legal

counsel for Hormel and Schwan’s, leading those companies through

numerous recalls and other crises

• Melanie also served as VP Crisis Management & General Counsel for a

global recall and crisis management firm



+FSMA: How do I comply? Webinar series

How to determine which

FSMA rules apply to you.

FSMA – What is it all about and

how do the rules fit together?

PC for Human Food – The

concepts from HACCP to

HARPC.

On Demand in October November 11, 2015

@ 1:00PM CST

December 18, 2015

@ 1:00PM CST



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7The Acheson Group

Global Food Safety Risk Management Firm

11 FTE’s

3 TAG Professional Advisors

Vast Network of Partners

Helps Companies Manage 3 Core Risk Management Strategies:

� Facility risk management/internal process controls

� Supply chain risk assessments/management programs

� Recall/Crisis preparedness and planning

� Regulatory compliance (e.g. FSMA, USDA, allergens)

� Recall/Crisis response

� Social Media

� Crisis communications strategies

� Complaint management practices

OPERATIONAL

RISK

REGULATORY

RISK

REPUTATIONAL

RISK



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8

Today’s Presentation:

Which Rules Apply to Me?



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9 Overview

� Rules are Finalizing---FSMA is “Getting Real”

� What Rules Apply to Me?

� Registration Requirements

� Exemptions

� Compliance Dates

� The Other Rules

� “TAG’s Take” – Industry Impact



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10



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11 The Seven Pillars of Prevention

� Preventive Controls for Human Food-Final

� Preventive Controls for Animal Food-Final

� Produce Safety

� Foreign Supplier Verification

� Third Party Accreditation

� Food Defense

� Sanitary Transport



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12 FSMA Status Summary – “The 7 Pillars”

Proposed Rule Final Deadline

PC- Human Food-Final September 17, 2015

PC- Animal Food-Final September 17, 2015

Produce Safety October 31, 2015

FSVP October 31, 2015

Third Party Accreditation October 31, 2015

Sanitary Transport March 31, 2016

Food Defense May 31, 2016



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13 Rules Enacted Upon Signing – All Apply!

� Inspection of records

� Suspension of registration

� Expanded administrative detention

� Authority to require import certificates

� Mandatory recall



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14 Facility Registration

� Does your facility manufacture, process, pack or hold food?

� Then you need to register unless exempt

� Facility registration is due November 16, 2015



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15

Does the Preventive Controls Rule

For Humans Apply to Me?



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16Exemptions

� Alcoholic beverages and food produced at same so long as it is in

prepackaged form and constitutes less than 5% overall sales

� Pasteurized Milk Ordinance Regulated Facilities: Compliance date extended

to September 17, 2018 to allow the National Conference on Interstate Milk

Shipments to align with the preventative controls requirements

� Retail

� Restaurants

� USDA

� Seafood HACCP

� Juice HACCP

� LACF for Micro risks



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17Exemptions:

Primary Production and Secondary Activities Farms

An operation under one management in one general

(but not necessarily contiguous) physical location

devoted to the growing of crops, the harvesting of

crops, the raising of animals (including seafood), or

any combination of these activities.



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18 Exemptions:

Primary Production and Secondary Activities Farms

A secondary activities farm is an operation, not located on a primary

production farm, devoted to harvesting (such as hulling or shelling),

packing, and/or holding of raw agricultural commodities, provided that

the primary production farm(s) that grows, harvests, and/or raises the

majority of the raw agricultural commodities harvested, packed, and/or

held by the secondary activities farm owns, or jointly owns, a majority

interest in the secondary activities farm. A secondary activities farm may

also conduct those additional activities allowed on a primary production

farm.



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19 Exemptions:

Warehouses

�Solely engaged in the storage of unexposed packaged foods

�Solely engaged in the storage of Raw Agricultural Commodities

(RAC’s) - other than produce - intended for further processing

�Solely engaged in the holding and/or transportation of RAC’s

(other than produce)



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20 Qualified Facilities:Qualified Facilities:Qualified Facilities:Qualified Facilities:MixedMixedMixedMixed----Type FacilitiesType FacilitiesType FacilitiesType Facilities

� A small or very small business that is a farm mixed-type

facility is exempt from Prev. Controls Rule if the only

activities that it conducts are the low-risk activity/food

combinations listed in § 117.5(g) and (h)

� Drying/dehydrating; Boiling/evaporation of maple sap to make maple

syrup



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21Qualified Facilities:Qualified Facilities:Qualified Facilities:Qualified Facilities:

MixedMixedMixedMixed----Type Type Type Type Facilities Facilities Facilities Facilities

� A very small business that is a farm mixed-type facility, but does not

satisfy the criteria for the exemptions for only conducting low risk

activity/food combinations, is eligible for modified requirements as a

qualified facility

� “Qualified facility” that submits an attestation statement, are only

subject to modified requirements, and must register by July 1 of each

year. Additional requirements are listed for very small businesses to

be exempt, (< $1million in sales)



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22Compliance Dates for cGMP and PC

�Businesses with 500 + Full-Time Equivalent Employees

� September 19, 2016. Supply Chain Program has until the later of March 17, 2017,

or 6 months after a supplier is required to comply with the applicable rule

�Small Businesses (< 500 FTE Employees)

� September 18, 2017. Supply Chain Program has until the later of September 18,

2017, or 6 months after a supplier is required to comply with the applicable rule



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23 Compliance Dates for cGMP and PC

�PMO Businesses

� September 17, 2018. Supply Chain Program has until September 17,

2018

�Qualified Facilities (also Very Small Businesses)

� September 17, 2018. (Except compliance date is January 1, 2016 for

records to support the facility’s status as a qualified facility).

Attestation submissions by qualified facilities is December 7, 2018.

Compliance date for consumer notifications by qualified facilities is

January 1, 2020



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24TAG’s TakeTAG’s TakeTAG’s TakeTAG’s Take----Industry Industry Industry Industry ImpactImpactImpactImpact

� Intrastate Commerce:

� Facilities that manufacture, process, pack, or hold food that is sold intrastate are also subject

to the rules

� HACCP and GFSI Compliant Food Safety Plans recognized

� § 117.330. To the extent that an existing HACCP plan or GFSI-compliant food safety plan

includes all required information, a facility can use such plans to meet the requirements of

this rule

� Numerous GMP Updates! Examples:

� “Allergen cross-contact” new terminology =inadvertently introducing allergen to food

� New requirements for sanitation of non-food-contact surfaces of equipment, and sanitizing

portable equipment

� Now – FDA access to all food safety records with cause



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25 Required Records

� All records can be stored off site, with option of the written food

safety plan, as long as they are accessible within 24 hours of a request

for official review

� Food Safety Plan records do not need to be stored in one location or in “one

binder”

� Record retention begins after the applicable compliance date

� Records must document corrective actions, monitoring/verification of

preventive controls, and training

� Electronic records exempt from 21 CFR Part 11, however must be

equivalent to paper records and handwritten signatures



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26 Guidance Guidance Guidance Guidance Documents Documents Documents Documents

� The FDA is developing several guidance documents on subjects

that include:

� Hazard analysis and preventive controls

� Environmental monitoring

� Food allergen controls

� Validation of process controls

� A Small Entity Compliance Guide that explains the actions a small or

very small business must take to comply with the rule



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27 Industry AssistanceIndustry AssistanceIndustry AssistanceIndustry Assistance

�Plans for training and technical assistance are well under

way. They include:

� Establishing a Food Safety Technical Assistance Network within the

agency to provide a central source of information to support industry

understanding and implementation of FSMA.

� Collaborating with the Food Safety Preventive Controls Alliance to

establish training and technical assistance programs.

� Partnering with the National Institute of Food and Agriculture in the U.S.

Department of Agriculture to administer a grant program to provide

technical assistance to small and mid-size farms and small food

processors.



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29 Final Rule for Animal Food

� Manufacturing, processing, packing, and holding of finished products

that are intended to be fed to animals, including livestock, pets, and

other captive animals

� Manufacturing, processing, packing, and holding of ingredients that

may be used in animal foods

� Applies to domestic and imported foods

� Heavy focus on chemical and physical hazards, some microbiological

hazards



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30Human Food BHuman Food BHuman Food BHuman Food By----Products for Use as Animal FoodsProducts for Use as Animal FoodsProducts for Use as Animal FoodsProducts for Use as Animal Foods

�Human food by-products are not subject to animal food rule (except

for provisions for holding and distribution) if:

� Human food is produced in compliance with human food cGMPs and all

applicable food safety requirements

� Not further processed

� Shipping containers examined before use

� Must be held in a manner that protects against contamination

� Containers cleaned as necessary

� Must be accurately identified during holding

� Labeling that identifies common name must be attached when distributed



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31Qualified FacilitiesQualified FacilitiesQualified FacilitiesQualified Facilities

� Very small businesses are qualified facilities exempt from the full

requirements for hazard analysis and risk-based preventative controls

(some still have requirements)

� Average less than $2.5 Million/year in sales of animal food plus the market value

of animal food manufactured, processed, packed, or held without sale

� Requirements for a Qualified Facility are:

� Attestation the facility is a qualified facility, AND

� Attestation that hazards have been identified and that preventative controls have been

implemented and are being monitored, OR

� Attestation facility is in compliance with an applicable non-federal food safety law



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32 Proposed Produce Safety Rule

� Farms that grow, harvest, pack or hold most produce in raw or natural state (raw agricultural commodities)

� Farms and “farm” portions of mixed-type facilities

� Domestic and imported produce

� Farms with annual sales > $25,000 per year



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33 Proposed Food Defense Rule

� Impacts subset of companies registered with FDA

� Focused on those that are most likely targets

� Includes intrastate commerce

�$10M > Sales

�Focus is on insider, terrorist attack

� Intent is public health harm, also economic damage to the company

�Focus is on access, not specific to agent of concern

�Economically motivated adulteration is outside scope

� Expect to see it in final preventive controls rule



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34 Proposed Foreign Supplier Verification Program (FSVP)

� Shift the burden of ensuring safety of imported food to

importers

� Importers required to perform risk-based activities to verify

that food imported into the U.S. is to the same food safety

standards as those required of U.S. producers

� Aligns with Preventive Controls Rule for Humans



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35 Proposed Sanitary Transport Rule

� Impacts

� Shippers

� Carriers

� Receivers

� Includes USDA regulated foods

� Applies inter- and intra-state

� Includes food that enters the US via road or rail

� Includes human and animal food

� Estimated to cover 97% of food shipments and 83,609 firms



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36Where Do I Start?Where Do I Start?Where Do I Start?Where Do I Start?

� Develop a FSMA Team

� Create a FSMA Road to Compliance Plan

� Evaluate programs that will set you up for success

� Training

� Record Keeping

� Documentation of preventive controls, validation etc.

� Execute the Plan over the next year to hit the Compliance Date



+FSMA: How do I comply? Webinar series

How to determine

which FSMA rules apply to

you.

FSMA – What is it all about and

how do the rules fit

together?

PC for Human Food – The

concepts from HACCP to

HARPC.

On Demand in October November 11, 2015

@ 1:00PM CST

December 18, 2015

@ 1:00PM CST



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Thank you!

The Acheson Group

www.achesongroup.com

[email protected]

3M Food Safety

www.3M.com/foodsafety3

Kevin Habas

3M Food SafetyMelanie Neumann

The Acheson Group