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

Transcription

1 This image cannot currently be display ed. 3M Health Care Academy 3M Health Care Academy SM 3M Food Safety and The Acheson Group present FSMA: How do I comply? Webinar series

2 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)

3 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

4 4About 3M Food Safety 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. Quality Indicator Testing 3M Petrifilm Plates Over 30 Years in Food Safety Industry. Sample Handling / Media Hygiene Monitoring Pathogen & Toxin Testing Global Experience. Local support. Trusted by Top Food Companies, Validated around the World. 3M Clean -Trace Hygiene Monitoring Tests 3M Molecular Detection System

5 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, 1:00PM CST January 5, 1:00PM CST

6 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

7 7 The Acheson Group OPERATIONAL RISK Global Food Safety Risk Management Firm 11 FTE s 3 TAG Professional Advisors Vast Network of Partners REGULATORY RISK 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 REPUTATIONAL RISK Regulatory compliance (e.g. FSMA, USDA, allergens) Recall/Crisis response Social Media Crisis communications strategies Complaint management practices

8 8 Today s Presentation: What Is It All About and How Do The Rules Fit Together?

9 9 Overview 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 11FSMA Status Summary The 7 Pillars Proposed Rule Final Deadline Status PC-Human Food-Final September17, 2015 FinalRule Released PC-AnimalFood-Final September17, 2015 FinalRule 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

12 12 Reminder! And Basic Requirement! 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

13 13 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?

14 14 Dean 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 4 th of July holiday in crates with exposed holes for one of my customers who uses it fresh salad kits. Does that change anything?

15 15 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

16 16 Modified Requirements - I 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 ( ) 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;

17 17 Modified Requirements - II 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

18 18 Modified Requirements - III 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

19 Modified Requirements - IV 19 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

20 20 Cindy 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?

21 21 Environmental 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 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

22 22 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 I required to have a recall plan for the soft cheese?

23 23 Recall Plan Requirements: 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.

24 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?

25 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

26 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?

27 27 Exemptions: 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.

28 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 farmowns, 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.

29 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?

30 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?

31 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

32 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

33 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?

34 34 TAG s Take-Industry Impact Won t have a lot of time with Guidance documents Q 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

35 35 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

36 36 REMINDERS-Compliance Dates for cgmp and PC Businesses with 500 Full-Time Equivalent Employees September 19, 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, 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

37 37 Compliance Dates for cgmp and PC PMO Businesses September 17, Supply Chain Program has until September 17, 2018 Qualified Facilities (also Very Small Businesses) September 17, (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, Compliance date for consumer notifications by qualified facilities is January 1, 2020

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39 Where Do I Start? 39 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

40 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, 1:00PM CST January 5, 1:00PM CST

41 This image cannot currently be displayed. This image cannot currently be displayed. 3M Health Care Academy Thank you! The Acheson Group 3M Food Safety Melanie Neumann The Acheson Group John Wadie 3M Food Safety 3