1. FDA Food Safety Modernization Act Primer on Act and the Final Rules June 8, 2016 Producer: Claire Carter Edited by: Afzal Bari Director: Afzal Bari

2. FSMA PRIMER 1 New Regulations Aim To Curb Incidences of Food Borne Illnesses in the U.S. Americans Who Are Affected by Food Borne Illnesses Annually June 8, 2016 | Claire Carter Sources: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016; NounProject, RockIcon 48 Million Get Sick 128,000 are Hospitalized 3,000 Die Food Safety Modernization Act Enacted: Signed into law on January 4, 2016 by President Obama Goal: To enable the FDA to act preemptively to ensure food safety rather than waiting for outbreaks to happen. Impacts: The FDA now has greater enforcement authority and more tools to enforce regulations on imported goods. Effort to Decrease Public Health Risk Annual Health Impacts

3. FDA Given Mandatory Recall Authority Under New Act June 8, 2016 | Claire Carter Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016. EnhancementDetails Preventive ControlsRequires comprehensive, prevention-based controls throughout the entire food system for the first time. Requires standards for the harvesting and production of food to be science-based Companies are now held accountable for preventing contamination of food stock Requires companies to develop plans to address contamination if it occurs, and an active plan in place to prevent contamination Inspection and Compliance Inspection is a key to holding companies accountable to the standard put forth. Improving current inspection protocol for maximal efficiency and effectiveness Apply the inspection resources in a risk-based manner Imported Food SafetyGreater oversight has been created for the 15% supply of the nation’s food stock that is imported. Authorizes the refusal of admission of food if deny FDA inspection Authorize requirement of certification of compliance with food-safety standards Requires importers to conduct supplier verifications and provides incentives for importers ResponseFDA for the first time has the authority to mandate a recall for all food products. Enhanced PartnershipsLegislation recognizes and further encourages partnerships across the federal, state, and local levels. Key Facts of the Food Safety Modernization Act FSMA PRIMER

4. 3 Regulations Aim to Improve Vulnerabilities in Processing and Distributing Seven Final Rules Under FMSA June 8, 2016 | Claire Carter Sources: Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016; NounProject, Yu Luck, Agne Alesiute, Creative Stall, Bettina Tan, ArtworkBean 1.Current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food 2.Current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals 3.Food supplier verification programs for importers of food for humans and animals 4.Standards for growing, harvesting, packing, and holding of produce for human consumption 5.Accredited third-party certification 6.Sanitary transportation of human and animal food 7.Mitigation strategies to protect food against intentional adulteration

5. FSMA is the Greatest Expansion of Power for Food Safety Initiatives FSMA PRIMER June 8, 2016 | Claire Carter Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016. Current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals Current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food Food supplier verification programs for importers of food for humans and animals Standards for growing, harvesting, packing, and holding of produce for human consumption Accredited third-party certification Sanitary transportation of human and animal food Mitigation strategies to protect food against intentional adulteration Sep. 2015 Nov. 2015 Implementation Progression of Final Rules of FMSA Analysis Dates for compliance are based off of when final rules were implemented Guidance for industry has been provided throughout the rulemaking process in addition to feedback on proposed rules for each of the seven that became final rules. Apr. 2016 May 2016

6. FSMA PRIMER 5 Regulations Aim to Improve Vulnerabilities in Processing and Distributing Mitigation Strategies to Protect Food Against Intentional Adulteration June 8, 2016 | Claire Carter Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016. General Purpose Create a food defense plan that requires risk-reducing strategies for processes in certain registered facilities Vulnerability assessments, mitigation strategies, and trainings and recordkeeping are all central elements to the rule The rule is to prevent widespread acts of adulteration, while smaller forms like actions by disgruntled employees are harder to avoid Applicability Coverage for this rule includes all domestic and foreign entities that are required to register as food facilities through the FDA Food Drug and Cosmetic Act Most smaller companies are exempted, meaning that there are about 3,400 registered firms that are covered operating about 9,800 food facilities The rule is to prevent widespread acts of adulteration, while smaller forms like actions by disgruntled employees are harder to avoid Dates for Compliance Very Small Businesses: Within five years of completion of final rule Small Businesses: Within four years of completion of final rule All Other Businesses: Within three years of completion of final rule

7. FSMA PRIMER 6 Rule Sets Regulations to Minimize Contamination Risk In Transit Sanitary Transportation of Human and Animal Food June 8, 2016 | Claire Carter Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016. General Purpose Expands upon the Sanitary Food Transportation Act (SFTA) to ensure that food safety risks are minimized during transit Properly refrigerating good, adequately cleaning vehicles, and properly protecting food are essential actions included in the regulations Vehicle transportation equipment must meet certain standards before transporting goods and adequate temperature controls, cross-contamination, and training in sanitary practices with written records of procedures, agreements, etc. Applicability Applies to shippers, receivers, loaders, and carriers who transport food by rail or motor vehicle into the United States regardless of whether the food is for interstate commerce Does not apply to shippers who simply deliver through U.S. without supplies entering the U.S. market Food intended for international distribution is covered by the rule until it reaches a port or border of the U.S. Dates for Compliance Small Businesses (Employ fewer than 500, revenue less than $27.5 million): Within two years of completion of final rule All Other Businesses: Within one year of completion of final rule

8. FSMA PRIMER 7 Voluntary Accreditation Allows for Expedited Entry for Certain Foods Accredited Third Party Validation June 8, 2016 | Claire Carter Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016. General Purpose This rule creates a voluntary program for the accreditation of third-party auditors to conduct food safety evaluations and issue certifications of foreign facilities and the foods that are produced for humans and animals Certifications can be used by importers to establish Voluntary Qualified Importer Program (VQIP) status, which allows for the expedited review and entry of food into the U.S.; Certifications can be used to prevent harmful food from reaching consumers in the U.S. the FDA can require that an import be verified by a third party certification body Accreditation bodies are foreign government bodies or agencies Applicability The mandatory import certification authority cannot apply to alcoholic beverages manufactured by foreign facilities nor meat, poultry, and egg products that are subject to USDA oversight at time of import Accreditation bodies recognized by the FDA are foreign governments/agencies or a private third party Third-party certification bodies are required to perform unannounced facility audits and alerting the FDA is there are any threats to public health Dates for Compliance This rule went into effect as soon as it was passed with the FDA encouraging accreditation bodies to apply immediately, and certification bodies should seek accreditation as soon as FDA approved accreditation bodies begin accepting applications

9. FSMA PRIMER 8 Water Quality Standards Included in First Rule for Growing and Harvesting of Produce Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption June 8, 2016 | Claire Carter Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016. General Purpose For the first tie, creating a science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption This includes standards for approaching water quality based on the presence of E. coli in both untreated water and agricultural water used on the crops Risk assessments will also be conducted by the EPA to determine a threshold for applications of manure and how many days in between said application for safe levels of bacteria. Applicability Coverage differs depending on whether sprouts are involved because sprouts have frequently been involved in recent outbreaks, however, these regulations do not apply to raw agricultural commodities Farm workers who handle covered produce or surfaces that contact food and their supervisors are the only individuals responsible for receiving training in health and hygiene practices. Food grains, foods rarely consumed raw, and produce for on-farm consumption are exempt from these regulations Dates for Compliance Very Small Businesses: Within four years of completion of final rule (three years for activities involving sprouts) Small Businesses: Within three years of completion of final rule (two years for activities involving sprouts) All Other Businesses: Within two years of completion of final rule (one year for activities involving sprouts)

10. FSMA PRIMER 9 Uniform Standard Established for Hazard Analysis for All Types of Food Imported Food Supplier Verification Programs for Importers of Food for Humans and Animals June 8, 2016 | Claire Carter Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016 General Purpose To create a program that requires importers, to whom the rule applies, verify that the foreign suppliers are meeting the same requirements for production quality, ensure the food is not adulterated, and finally, is properly labelled for allergens. Create a uniform standard for conducting a hazard analysis for each type of food that an importer brings into the U.S. Ensure that supplier verifications are being conducted either by the importer or a third party, including annual on site audits or sampling and testing or reviews of the suppliers food safety records. Establishment of the FDA FSMA Food Safety Technical Assistance Network which will help in all aspects of FSMA implementation. Applicability Dietary supplements may be exempt if they comply with Current Good Manufacturing Practices, and in almost all will be exempt from completing the hazard analysis requirement. Modified requirements are in place for foods from foreign suppliers who reside in a country whose food safety system has been recognized as comparable to that of the U.S. Juice, fish, and fishery products that comply with FDA’s Hazard Analysis and Critical Control Point regulations are exempt as are all foods for research, evaluation, personal consumption, alcoholic beverages, imported for future export, low-acid canned food, and certain meat, poultry, and egg products regulated by USDA. Dates for Compliance for Activities Not Involving Sprouts 18 months after publication of final rule

11. FSMA PRIMER 10 Definition of Farm Expanded to Accommodate Certain On-Site Processing or Holding and Packing Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food June 8, 2016 | Claire Carter Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016. General Purpose Requiring that covered facilities establish and implement a food safety system-one that includes an analysis of hazards and risk-based preventive controls along with oversight and management techniques for these preventive controls The rule clarifies the definition of a farm because farms are exempt from preventive controls Updates and clarification within the Current Good Manufacturing Practices are updated; nonbinding provisions are not included and education and training provisions that were previously binding are now nonbinding Applicability Coverage does not apply to anything that falls under the following definitions of a farm; Primary Production Farm: An operation that falls under one management in one general area that is dedicated to growing and harvesting of crops, raising of animals or any of combination of these activities including certain manufacturing/processing activities like dehydrating grapes to produce raisins Secondary Activities Farm: An operation that is not located on the Primary Production Farm (PPF) but is majority owned by the PPF and is devoted to harvesting, packing and/or holding raw agricultural commodities Dates for Compliance Very Small Businesses: Within three years of completion of final rule Small Businesses: Within two years of completion of final rule All Other Businesses: Within one year of completion of final rule

12. FSMA PRIMER 11 Only Feed Mills Operated By a Third Party Are Subject to Preventive Controls, Others are Part of “Farm” Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals June 8, 2016 | Claire Carter Source: U.S. Food and Drug Administration, “Food Safety Modernization Act,” 2016; U.S. Food and Drug Administration, “FSMA Rules & Guidance for Industry,” 2016. General Purpose Establishing Current Good Manufacturing Practices (CGMP’s) which have been determined based on the unique aspects of the animal food industry while providing flexibility to accommodate the multiple varieties of animal food facilities Requiring that covered facilities establish and implement a food safety system-one that includes an analysis of hazards and risk-based preventive controls along with oversight and management techniques for these preventive controls Mandating that every facility that produces animal food that requires a preventive control have a recall plan Applicability Coverage does not apply to anything that falls under the following definitions of a farm; Primary Production Farm: An operation that falls under one management in one general area that is dedicated to growing and harvesting of crops, raising of animals or any of combination of these activities. A provision was included to allow for a feed mill to be considered part of the farm even if only the poultry stock is operated by a third party. Secondary Activities Farm: An operation that is not located on the Primary Production Farm (PPF) but is majority owned by the PPF and is devoted to harvesting, packing and/or holding raw agricultural commodities Feed mills that are part of vertically integrated operations are not covered under this rule either Dates for Compliance Very Small Businesses: Three years for CGMP compliance and 4 years for Preventive Control (PC) compliance Small Businesses: Two years for CGMP compliance, three years for PC compliance All Other Businesses: One year for CGMP compliance, two years for PC compliance