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