3M Food Safety and The Acheson Group present FSMA: How … · © 3M 2015. All Rights Reserved ... 3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series

© 3M 2015. All Rights Reserved

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



+Host – John Wadie, 3M Food Safety

� 3M Food Safety Marketing Manager for the U.S. Region

� Has held various sales and marketing leadership roles at 3M for over 25 years

� Active in the Food Safety market for over 8 years

� Active member of International Association for Food Protection (IAFP) and International Food Technologists (IFT)



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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.



+FSMA: How do I comply? Webinar series

FSMA – What is it all about and

how do the rules fit together?

PC for Human Food – The

concepts from HACCP to

HARPC.

How to build a food safety plan.

On Demand in November

December 18, 2015@ 1:00PM CST

January 5, 2016@ 1:00PM CST



+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 regulatory changes

• 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



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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’sToday’sToday’sToday’s Presentation:Presentation:Presentation:Presentation:

What Is It All About and What Is It All About and What Is It All About and What Is It All About and How Do The Rules Fit How Do The Rules Fit How Do The Rules Fit How Do The Rules Fit

TogetherTogetherTogetherTogether????



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9 OverviewOverviewOverviewOverview

� Rules are Finalizing---How Do they Connect?

� Connecting the Dots

� Case Studies/Examples of How the Rules Apply

� “TAG’s Take” – Industry Impact



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10



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11 FSMA Status FSMA Status FSMA Status FSMA Status Summary Summary Summary Summary –––– “The “The “The “The 7 Pillars”7 Pillars”7 Pillars”7 Pillars”

Proposed Rule Final Deadline Status

PC- Human Food-Final September 17, 2015 Final Rule Released

PC- Animal Food-Final September 17, 2015 Final Rule Released

Produce Safety October 31, 2015 To the Federal Register

FSVP October 31, 2015 To the Federal Register

Third Party Accreditation October 31, 2015 To the Federal Register

Sanitary Transport March 31, 2016 Proposed Rule

Food Defense May 31, 2016 Proposed Rule



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12 Reminder! And Basic Requirement!Reminder! And Basic Requirement!Reminder! And Basic Requirement!Reminder! And Basic Requirement!Facility Facility Facility Facility RegistrationRegistrationRegistrationRegistration

� 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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13 If I have to Register…….If I have to Register…….If I have to Register…….If I have to Register…….

� What are some examples of these rules applying…

� There are thousands of pages of regulations…

� Break it down for me…

� How do these fit together…?



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14 Dean’s Distribution CenterDean’s Distribution CenterDean’s Distribution CenterDean’s Distribution Center

“I am a distribution center that holds unexposed

packaged foods. I control temperatures and monitor

them but for quality reasons not safety reasons. Do I need

a modified food safety plan?”

“6 weeks out of the year I receive and hold lettuce and

tomatoes before the 4th of July holiday in crates with

exposed holes for one of my customers who uses it fresh

salad kits. Does that change anything?”



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15 Exemptions:Exemptions:Exemptions:Exemptions:

Warehouses Warehouses Warehouses 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



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16 Modified Requirements Modified Requirements Modified Requirements Modified Requirements ---- IIII

�Apply to a facility solely engaged in the storage of unexposed

packaged food that requires refrigeration with time/temperature

control to significantly minimize or prevent the growth of, or toxin

production by pathogens (117.206)

�The facility must conduct the following activities as appropriate to

ensure the effectiveness of the temperature controls:

�Establish and implement temperature controls adequate to

significantly minimize or prevent the growth of, or toxin

production by, pathogens;



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17 Modified Requirements Modified Requirements Modified Requirements Modified Requirements ---- IIIIIIII

�Monitor the temperature controls with adequate frequency to provide

assurance that the temperature controls are consistently performed;

� If there is a loss of temperature control that may impact the safety

of such refrigerated packaged food, take appropriate corrective

actions to:

� Correct the problem and reduce the likelihood that the problem will recur;

� Evaluate all the affected food for food safety

� Prevent the food from entering commerce, if you cannot ensure the affected

food is not adulterated



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18 Modified Modified Modified Modified Requirements Requirements Requirements Requirements ---- IIIIIIIIIIII

�Verify that temperature controls are consistently

implemented by:

� Calibrating temperature monitoring and recording devices

� Reviewing records of calibration within a reasonable time after

the records are created



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19Modified Modified Modified Modified Requirements Requirements Requirements Requirements ---- IVIVIVIV

� Reviewing records of monitoring and corrective actions taken to correct a

problem with the control of temperature within 7 working days (or PCQI

writes written justification to exceed 7 days) Establish and maintain the

following records:

� Records documenting temperature controls

� Affirmative demonstrating temperature is controlled

� Exception demonstrating loss of temperature control

� Records of corrective actions taken when there is a loss of temperature

control that may impact the safety of the food

� Records documenting verification activities



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20

Cindy’s Cookie CompanyCindy’s Cookie CompanyCindy’s Cookie CompanyCindy’s Cookie Company

“I make cookies that come out of an oven that are

open to the environment for approximately 50 feet

until packaged. Do I need to conduct environmental

monitoring under the Preventive Controls for Human

Food Rule?”



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21 Environmental MonitoringEnvironmental MonitoringEnvironmental MonitoringEnvironmental Monitoring

� As appropriate to the facility, the food, and the nature

of the preventive control.

� Environmental monitoring would be required� Where RTE product is exposed to the environment prior to packaging and

the packaged food does not s not s not s not receive a treatment that would significantly

minimize an environmental pathogen that could contaminate the food when

it is exposed.

� Routine testing does not have to be conducted by an

accredited lab, the test method must be scientifically

valid, and results do not need to be sent to the FDA



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22

Chase’s Cheese Co.Chase’s Cheese Co.Chase’s Cheese Co.Chase’s Cheese Co.

“My hazard analysis identified Listeria monocytogenes

(LM) as a hazard requiring a preventive control in soft

cheese. The hazard will be controlled by my supplier of

soft cheese.

Am Am Am Am I required to have a recall plan for the soft cheeseI required to have a recall plan for the soft cheeseI required to have a recall plan for the soft cheeseI required to have a recall plan for the soft cheese?”?”?”?”



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23 Recall Plan Requirements: 117.139

A Recall Plan is required for each food with a hazard requiring a preventive control

Must be in writing

• Describe procedures for :

• Directly notifying the direct consignees of the food being recalled,

• including how to return or dispose of the affected food;

• Notify the public about any hazard presented by the food when appropriate

• to protect public health;

• Conduct effectiveness checks to verify that the recall is carried out; and

• Appropriately dispose of recalled

• food—e.g., through reprocessing, reworking, diverting to a use that does

• not present a safety concern, or destroying the food.



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24

Rick’s Right-On Repacking Inc.

Will the Preventative Controls for Human Food Rule apply for a

repackaging operation of food that is not exposed?

Will my company need to follow the Intentional Contamination Rule

once that is final?



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25

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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26

Oranges R Us

I am a subsidiary of a vertically integrated co-op that harvests

and packs oranges.

Am I exempt from having to comply with the Preventive Controls

Rule for Human and/or Animal food?

If so, what requirements apply to me?



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27Exemptions: Primary Production and Secondary Activities Farms

Primary Production Farm is 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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28 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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29

Deanna’s Dynamite Dietary Supplements

My company produces solely dietary supplements.

Does the Preventive Controls Rule for Humans or other FSMA

rules apply to dietary supplement ingredient manufacturers

that are already in compliance with 21 CFR Part 111?



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30

Dean’s Chips and Dips

I buy black pepper from a broker who acquires

it from a supplier in India.

I use the black pepper on potato chips and dips

What do I need to do to be sure I am compliant with FSMA?



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31

Subpart G – Supply Chain Program (Preventive Control Requirement)

The receiving facility must establish and implement a risk-based supply-chain program for

those raw materials and other ingredients for which the receiving facility has identified a

hazard requiring a supply-chain-applied control

Exceptions

• Importer that is in compliance with FSVP

• Food for research

Program must be written

When applied by an entity other than the receiving facility’s supplier, the facility must:

• Verify the supply-chain-applied control; or

• Obtain documentation of an appropriate verification activity from another entity, review and

assess the entity’s applicable documentation, and document that review and assessment



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32

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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33

Tim’s Transportation Services

If I am exempt from the Preventive Controls Rule for Human/Animal Rules

will I need to comply with other FSMA Rules like the Sanitary

Transportation Rule?



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34TAG’s TakeTAG’s TakeTAG’s TakeTAG’s Take----Industry Industry Industry Industry ImpactImpactImpactImpact

� Won’t have a lot of time with Guidance documents –Q1 2016

� “FSMA Phase 2”

� Implementation

� Food Safety Culture

� Performance Metrics

� Compliance History

� Intrastate Commerce:

� Facilities that manufacture, process, pack, or hold food that is sold

intrastate are also subject to the rules



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35Further Guidance on How The Rules “Fit”Further Guidance on How The Rules “Fit”Further Guidance on How The Rules “Fit”Further Guidance on How The Rules “Fit”

� The FDA is developing several guidance documents on:

� 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

� NOT UNTIL Q1 2016!

� UNTIL THEN “READ THE PREAMBLE” –aka read the comments/responses for

guidance



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36

REMINDERS-Compliance 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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37

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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38



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39Where 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

FSMA – What is it all about and

how do the rules fit together?

PC for Human Food – The

concepts from HACCP to

HARPC.

How to build a food safety plan.

On Demand in November

December 18, 2015@ 1:00PM CST

January 5, 2016@ 1:00PM CST



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Thank you!Thank you!Thank you!Thank you!

The Acheson Groupwww.achesongroup.comwww.achesongroup.comwww.achesongroup.comwww.achesongroup.cominfo@[email protected]@[email protected]

3M Food Safetywww.3M.com/foodsafetywww.3M.com/foodsafetywww.3M.com/foodsafetywww.3M.com/foodsafety

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3John Wadie

3M Food SafetyMelanie Neumann

The Acheson Group

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3M Food Safety and The Acheson Group present FSMA: How … · © 3M 2015. All Rights Reserved ... 3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series