Overview of FSMA Rules: Preventive Controls GA Watermelon Association September 19, 2016 Produce Food Safety Services GA Fruit & Vegetable Growers Association Deeper Dive of the Preventive Controls for Human Food Rule in Produce Packing Facilities David E. Gombas, Ph.D. September 16, 2016 First, Who s Under Which Rule? It depends on products, processes and ownership Primary Production Farm: 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, or any combination of these activities. Allows for activities performed for the safe or effective holding or packing of crops (washing, waxing, sorting, fumigating, repacking...) Secondary Activities Farm: An operation not located on a primary production farm devoted to harvesting, packing, and/or holding RACs. The primary production farm(s) that grow, harvest, and/or raise the majority of those RACs must own or jointly own a majority interest in the secondary activities farm First, Who s Under Which Rule? Limited manufacturing/processing is permitted on a farm All Farms: If all food processed is consumed on that farm or another farm under the same management Drying (e.g., grapes to raisins), ripening, packaging and labeling, when these activities do not involve additional manufacturing/processing Small or Very Small Farms (<$500K annual produce): Long list of activity/food combinations in 117.5(h) exempt from preventive controls (subpart C) and supplier controls (subpart G) e.g., cutting lemons and limes, pitting dried plums, chopping roasted peanuts First, Who s Under Which Rule? Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities: Guidance for Industry Provides numerous examples If you are not a farm (or retail or otherwise exempt, e.g., FSIS, seafood or juice HACCP), you are under Preventive Controls Applies equally to foreign and domestic facilities that pack, hold or manufacture/process foods intended for sale in the US (operations required to register with FDA) Modified requirements for qualified facilities, facilities solely engaged in the storage of unexposed packaged food, raw products that subsequently will be commercially processed ( kill step, written assurance) 1
When Must I Comply? It depends on processes and business size August 24, Federal Register, Final rule Fresh-cut and other processing facilities September 2016 C, 2017 B, 2018 A Facilities that would qualify as secondary activities farms except for ownership of the facility; facilities solely engaged in packing and/or holding activities on produce RACs; facilities that color RACs January 2018 C, 2019 B, 2020 A Same as Produce Safety dates (other than water) Good Manufacturing Practices (subpart B) Replaces current 21 CFR part 110 Includes all the same requirements (worker health and hygiene, facility and equipment condition, food contact surfaces cleanliness and sanitation, water quality and plumbing) plus training and prevention of allergen cross-contact Essentially the same requirements for packing and holding operations under Produce Safety rule (see 117.8) Special GMP provisions for human food by-products destined for animal food A very small: less than $1M annual human food sales and holding B small: fewer than 500 full-time equivalent employees C all others Qualified Individual a person who has the education, training, or experience (or a combination thereof) necessary to manufacture, process, pack, or hold clean and safe food as appropriate to the individual s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment. Preventive Controls Qualified Individual (PCQI) a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or is otherwise qualified through job experience to develop and apply a food safety system. Food Safety Preventive Controls Alliance Preventive Controls (subpart C) Written Food Safety Plan, with Written Hazard Analysis for biological (environmental), chemical, physical and economically motivated adulteration hazards Written Preventive Controls (sanitation, allergen, process, supply-chain) Written Monitoring procedures Written Corrective Action procedures Written Verification procedures Records of performance of above procedures Written Recall Plan Written Validation of Process Controls Reanalysis of Food Safety Plan Processor vs. Packhouse/Warehouse Fresh-cut, frozen, etc. clearly under PCHF Requirements for operations that only handle RACs less clear Specific steps necessary to ensure the safety of produce would generally be the same Hazard analysis vs. supplier-applied controls FDA guidance, PCQI training materials not yet available Where Do I Go for Guidance? published August 23, 2016 Chapter 1: The Food Safety Plan Chapter 2: Conducting a Hazard Analysis Chapter 3: Potential Hazards Associated with the Manufacturing, Processing, Packing, and Holding of Human Food Chapter 4: Preventive Controls Chapter 5: Application of Preventive Controls and Preventive Control Management Components 2
published August 23, 2016 Appendix 1: Potential Hazards for Foods and Processes Appendix 2: Food Safety Plan Forms Appendix 3: Bacterial Pathogen Growth and Inactivation Additional Guidances published August 24, 2016 Draft Guidance for Industry: Current Good Manufacturing Practice Requirement for Food for Animals Draft Guidance for Industry: Human Food By-Products for Use as Animal Food Future Guidance Coming Soon Chapter Six - Use of Heat Treatments as a Process Control Chapter Seven Use of Time/Temperature Control as a Process Control Chapter Eight Use of Formulation as a Process Control Chapter Nine Use of Dehydration/Drying as a Process Control Future Guidance Coming Soon Chapter Ten - Sanitation Controls Chapter Eleven Food Allergen Controls Chapter Twelve Preventive Controls for Chemical Hazards Chapter Thirteen Preventive Controls for Physical Hazards Chapter Fourteen Recall Plans Appendix 4 Sanitation and Hygienic Zoning Planned Guidances PC Rule for Human Food Facilities Environmental monitoring Supplier controls Validation of process controls Small Entity Compliance Guide that explains the actions a small or very small business must take to comply with the rule Industry Training - Alliances Produce Safety Alliance (PSA) Centered at Cornell University Developed a curriculum to train the farming community Sprout Safety Alliance (SSA) Centered at the Illinois Institute of Technology Developed a curriculum to train sprout growers Food Safety Preventive Controls Alliance (FSPCA) Centered at the Illinois Institute of Technology Developed curricula to train those that manufacture, process, hold and distribute human and animal food 3
Food Safety Preventive Controls Alliance The FSPCA Preventive Controls for Human Food course is the standardized curriculum recognized by FDA Successfully completing this course is one way to meet the requirements for a preventive controls qualified individual. Preventive Controls Qualified Individual A qualified individual who has successfully completed training in the development and application of riskbased preventive controls At least equivalent to that received under a standardized curriculum recognized as adequate by FDA Or be otherwise qualified through job experience to develop and apply a food safety system. Oversees or performs Preparation of the Food Safety Plan Validation of the preventive controls Review of records Reanalysis of the Food Safety Plan FSPCA Human Food Curriculum Content 2.5 day Face to Face Course with Exercises Throughout Exercises Model Foods Introduction to Course Food Safety Plan Overview GMPs and Prerequisite Programs Biological Food Safety Hazards Chemical, Physical and Economically Motivated Food Safety Hazards Preliminary Steps Resources for Preparing a Food Safety Plan Hazard Analysis and Preventive Control Determination Process Preventive Controls Food Allergen Preventive Controls Sanitation Preventive Controls Supplier Preventive Controls Verification and Validation Procedures Record keeping Procedures Recall Plan Regulation Overview http://www.iit.edu/ifsh/alliance/ For course availability & Participant Manual Teaching models Simple, with format consistent with curriculum Currently available Peanut butter Cold pressed energy bar Broccoli, carrot, pecan salad Black pepper Ready to cook entrée Sliced tomatoes Leafy greens salads Models in development Produce packinghouse Cheeses Other frozen foods What If I have a HACCP Plan? Element HACCP Plan Added in Food Safety Plan Hazard analysis Preventive controls Parameters and values Monitoring Corrective actions or Corrections Verification Biological, chemical, physical CCPs for processes Critical limits Required for CCPs Corrective actions For process controls Also consider radiological, environmental and economically motivated adulteration (food safety only) Process CCPs + controls at other points that are not CCPs Parameters and minimum/maximum values (= Critical limits for process controls) Required as appropriate for preventive controls Corrective actions or corrections, as appropriate As appropriate for all preventive controls; supplier verification required when supplier controls a hazard Records For process As appropriate for all preventive controls controls Recall plan Not required Required when a hazard requiring a preventive control is identified The FSMA Technical Assistance Network and What It Means for You 4
Technical Assistance Network Launched FDA s FSMA Technical Assistance Network on September 10, 2015 Provide technical assistance to industry, regulators, academia, and consumers regarding FSMA Address questions related to FSMA rules, programs, and implementation Submit inquiries via the web form or by mail To submit a question about FSMA, visit www.fda.gov/fsma and go to Contact Us 26 Auto-Response With Case Number Inquiry (2500 character limit) --None Other Preventive Controls-Animal Food Preventive Controls-Human Food Produce Safety Foreign Supplier Verification Program (FSVP) Accredited Third-Party Certification (3 rd Party) Sanitary Transportation for Human and Animal Food Voluntary Qualified Importer Program (VQIP) Intentional Adulteration FDA s Food and Cosmetic Information Center (FCIC)/Food Safety Modernization Act (FSMA) Technical Assistance Network (TAN) has received your inquiry. Your inquiry has been assigned case number 00000000. Please retain this case number and reference it in future correspondence regarding this inquiry. We will respond to your inquiry as soon as possible. However, response times may vary, due to public health priorities and the high volume of inquiries we receive. We strive to provide the public with accurate and current information. Thank you for contacting FDA s FCIC/FSMA TAN. FDA's Food and Cosmetic Information Center (FCIC)/ Food Safety Modernization Act (FSMA) Technical Assistance Network (TAN) will respond to your web inquiry as soon as possible. However, response times may vary, due to public health priorities and the high volume of inquiries we receive. We strive to provide the public with accurate and current information. Thank you for contacting FDA's FCIC/ FSMA TAN. **Please do not reply to this email box. If you would like to submit a follow up question or need clarification to this inquiry, please visit http://cfsan.force.com/inquirypage and reference this inquiry s case number. 27 FDA FSMA Technical Assistance Network Inquiries September 10, 2015 through July 8, 2016 248 198 280 169 12 7 Preventive Controls for Human 66 Food Produce Safety Standards 318 873 Preventive Controls for Animal Food Other Foreign Supplier Verification Programs Sanitary Transportation of Food Accredited 3rd Party Certification Intentional Adulteration Voluntary Qualified Importer Program FSMA Technical Assistance Networks Preventive Controls Scientific & Technical Questions from Industry submit a web form at: www.iit.edu/ifsh/alliance Land Grant Universities Extension Specialists FSMA Regulation & Policy Interpretation Questions submit a web form at: www.fda.gov/fsma International Partners CVM CFSAN KMS ORA OIP PSA SSA Produce Scientific & Technical Questions from Industry Land Grant / Extension Specialists International Partners States/ NASDA FDA NIFA/ National & Regional Centers 5
31 32 Summary Know which rule your operation is under Under Preventive Controls (unless exempted): minimum requirements are GMPs, a written hazard analysis and a PCQI Packinghouses that only handle RACs should draw from the provisions of the produce safety rule to guide the hazard analysis Training is required and available Several useful FDA Guidance chapters have been published and more are coming FDA and FSPCA Technical Assistance Networks (TAN) are available for specific questions (but don t forget your trade associations are also good resources) Preventive Controls for Human Food Qualified Individual Trainings Specific for packinghouses, cooling operation and others who pack and/or hold raw agricultural products October 4 6 Orlando, FL November 7 9 Fresno, CA November 14 16 Salinas, CA For details and to register go to http://www.unitedfresh.org/events programs QUESTIONS Brenden St. John Georgia Fruit and Vegetable Growers Association bstjohn@producefoodsafetyservices.com 6