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

Transcription

1 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 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

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 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

6 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, 1:00PM CST December 18, 1:00PM CST

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 spresentation: Which Rules Apply to Me?

9 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

10 10

11 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

12 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

13 13 Rules Enacted Upon Signing All Apply! Inspection of records Suspension of registration Expanded administrative detention Authority to require import certificates Mandatory recall

14 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

15 15 Does the Preventive Controls Rule For Humans Apply to Me?

16 16 Exemptions 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

17 17 Exemptions: 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.

18 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 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.

19 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)

20 20 Qualified Facilities: Mixed-Type 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

21 21 Qualified Facilities: Mixed-Type 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)

22 22 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

23 23 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

24 24 TAG s Take-Industry Impact 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 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

25 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

26 26 Guidance 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

27 27 Industry 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.

28 28

29 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

30 30Human Food By-Products 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

31 31 Qualified 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

32 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

33 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

34 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

35 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

36 Where Do I Start? 36 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

37 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, 1:00PM CST December 18, 1:00PM CST

38 Thank you! The Acheson Group 3M Food Safety Melanie Neumann The Acheson Group Kevin Habas 3M Food Safety 3