Preparing for the Food Safety Modernization Act

Agenda Introduction to the Food Safety Modernization Act (FSMA) Common Non-Conformances PrimusGFS SQF Global GAP Improvement Strategies

I Promise This Will Be Fun! HACCPFSMA GFSI

Food Safety Modernization Act The proposed rule states that Farms that pack or hold food from other farms are not subject to preventive controls rule. http://www.fda.gov/Food/GuidanceRegulation/FSMA/

Key Themes and Concepts The proposed rule states that Farms that pack or hold food from other farms are not subject to preventive controls rule.

Common Acronyms FSMA Food Safety Modernization Act HACCP Hazard Analysis and Critical Control Points HARPC Hazard Analysis and Risk Based Preventative Controls FSVP Foreign Supplier Verification Program PHF Potentially Hazardous Food RTE Ready to Eat RLTO Relatively Likely to Occur QAR Qualitative Assessment of Risk VQIP Voluntary Qualified Importer Program SAHCODHA Serious Adverse Health Consequences or Death of Humans or Animals

Prevention Mandatory Preventive Controls for Food Facilities Mandatory Produce Safety Standards Intentional Adulteration Standards Foreign Supplier Verification/Transport safety Preventive controls are not new in the food industry; many companies already employ them, and the FDA already requires them for foods such as juices, seafood, and shell eggs. But Congress has given the FDA an explicit mandate to use the tool more broadly. For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes: Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. Mandatory produce safety standards under which FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water. To prevent intentional contamination, FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points. As a preventive approach, Transport Safety is very important. This would ensure safety of food products during transportation for humans or for animals.

FSMA Implementation Dates The proposed rule states that Farms that pack or hold food from other farms are not subject to preventive controls rule.

Who is Affected by FSMA? Manufacturers and processors Farmers and growers Transporters Retailers Importers Laboratories Third party certification bodies Foreign governments The proposed rule states that Farms that pack or hold food from other farms are not subject to preventive controls rule.

Who is Exempt from this Rule? Juice and Seafood HACCP programs Low acid canned foods Alcoholic beverage processing Dietary supplement manufacture, processing or holding Storing raw agricultural products other than fruits and vegetables (Grain) Storing unexposed packaged food at ambient temperatures Farm: including farm activities that are covered by the proposed produce rule and certain low risk manufacturing/ processing, packing and holding activities conducted by small and very small businesses on farms for specific foods Modified requirements for Small (<500 employees) and very small businesses (TBD but >$250K, $500K , $1 million) A table outlining exemptions is provided to attendees in their workbooks on pages 28-29. The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. Facilities that are required to register include manufacturers, processors, warehouses, storage tanks and grain elevators

Qualified Individual Prepares and Manages the Food Safety Plan Validates Preventive Controls Reviews Records Determines Appropriate Corrective Actions Reviews Food Safety Plan QI prepares or oversees the FSP and can use a food safety team. A qualified individual would be required to prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records and conduct a reanalysis of the food safety plan (or oversee these activities). To be qualified, an individual would be required to successfully complete training in accordance with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system. 

FSMA Preventive Controls Hazard Analysis Preventive Controls Monitoring Corrective Actions Verification Reanalysis Documentation A Hazard Analysis that identifies and evaluates known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility. Preventive controls, would be required to be identified and implemented to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented. Preventive controls would be required to include, as appropriate: (1) process controls, (2) food allergen controls, (3) sanitation controls, and (4) a recall plan. The preventive controls required would depend on which, if any, hazards are reasonably likely to occur. It is unlikely that all possible prevention measures and verification procedures would be applied to all foods at all facilities. FDA believes a supplier approval and verification program is a risk-based and appropriate control to significantly minimize or prevent hazards from raw materials and ingredients that is consistent with current scientific understanding of food safety practices and is seeking comment on such a program. Monitoring procedures to provide assurance that preventive controls are consistently performed and records to document the monitoring. Corrective actions that would be used if preventive controls are not properly implemented. Facilities would be required to correct problems and minimize the likelihood of reoccurrence, evaluate the food for safety and prevent affected food from entering commerce when necessary. If specific corrective action procedures were not identified for the problem, or if a preventive control were found to be ineffective, the facility would also be required to re-evaluate the food safety plan to determine if modifications are needed. Verification activities to ensure that preventive controls are consistently implemented and are effective. Verification activities might include validation that the preventive controls are adequate for their purpose and are effective in controlling the hazard, activities to verify that controls are operating as intended and review of monitoring records. In addition, the proposed rule would require reassessment of the food safety plan at least every three years and at other times as appropriate. FDA recognizes that product and environmental testing programs are science-based verification activities that are commonly accepted in many sectors of the food industry and is seeking comment on these programs. FDA also is asking for comments regarding review of customer and other complaints as part of verification. Recordkeeping. Facilities would be required to keep a written food safety plan, including the hazard analysis. They also would be required to keep records of preventive controls, monitoring, corrective actions, and verification. 

HARPC for Facilities FSMA Section 103 Hazard Analysis and Risk-Based Preventive Controls (HARPC) Evaluate Food Safety Hazards Identify and Implement Preventive Controls Monitor Controls Maintain Monitoring Records Conduct Verification Activities Based on FDA’s outreach efforts and public comments, the FDA is proposing revisions to its proposed rule on 4 rules (human foods, animal foods, produce safety and FSVP) that are more flexible and less burdensome in key areas. The FDA is accepting comments for 75 days after the publication date. No additional comments are being accepted on the original proposed rule. The FDA will accept comments on the revised provisions while continuing to review comments already received on the original proposed rule. The comment period opened September 29, 2014. Under the Hazard Analysis and Risk Based Preventive Control plan for human and animal foods, each covered facility would be required to prepare and implement a written food safety plan, which would include A Hazard Analysis that identifies and evaluates known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility. The plan should include Preventive controls, which would be required to be identified and implemented to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented. Preventive controls would be required to include, as appropriate: (1) process controls, (2) food allergen controls, (3) sanitation controls, and (4) a recall plan. Monitoring procedures to provide assurance that preventive controls are consistently performed and records to document the monitoring will need to be maintained and kept for each PC plan. Verification activities to ensure that preventive controls are consistently implemented and are effective will need to be carried out for each Preventive Control Plan (PCP). Verification activities might include validation that the preventive controls are adequate for their purpose and are effective in controlling the hazard, activities to verify that controls are operating as intended and review of monitoring records. In addition, the proposed rule would require reassessment of the food safety plan at least every three years and at other times as appropriate. Recordkeeping is key for the PCP. Facilities would be required to keep a written food safety plan, including the hazard analysis. They also would be required to keep records of preventive controls, monitoring, corrective actions, and verification.

What is the difference between HACCP and HARPC? HACCP vs HARPC What is the difference between HACCP and HARPC? Mention: Under HACCP: The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan. Impact of raw materials Ingredients Likely end use Categories of consumer concern Epidemiological evidence Codex: Analyze all raw materials, ingredients. List all hazards that may be reasonably expected to occur at each step including primary production, processing, manufacture and distribution until the point of consumption. Under HARPC: A potential biological, chemical, physical or radiological hazard that might be associated with the facility or the food (not used in Codex HACCP) Raw materials Flagged ingredients (allergens) Condition, function, design of facility and equipment/ environmental pathogens in RTE Others listed in “describe the product” FMSA: A Hazard Analysis that identifies and evaluates known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility.

HACCP Plan HACCP Plan HACCP + Elevated PRPs= HARPC Plan Prerequisite Programs/ GMPs HACCP Plan Prerequisite Programs/ GMPs Elevated Prerequisite Programs HACCP + Elevated PRPs= HARPC Plan This is an important conceptual graphic. The background emphasizes that management commitment is crucial and the driving force for food safety management systems to work. The slide is animated and divided into 2 halves. The left side of the slide (will appear on first click) shows the existing HACCP systems as they exist and the right half (will appear on second click) shows how the situation would be under HARPC. ON the 3rd click the HACCP plan on the right side will change to HARPC Plan. The following are the key points from this graphic: Most food companies already have HACCP and PRPs PRPs support HACCP PRPs may not be as tightly controlled with record keeping and monitoring requirements etc as HACCP and sometimes are seen as a “second tier” control HARPC is all about looking more holistically at your risk (using the food safety plan approach) During the HARPC process it is likely that all your HACCP systems are controlling risks that are RLTO But – some of your PRPs may be also controlling risks that are RLTO and it is those risks that are currently under PRPs that need to move into a HARPC concept and be given extra weight and included in your food safety plan Thus the final food safety plan will likely consist of all your HACCP programs and some PRPs (which ones will depend on what you do –e.g. make sandwiches and salads etc). Your remaining PRPs will continue to be important to control for GMPs and other background food safety good practices

Produce Rule Sec. 105. Standards for Produce Safety Agricultural Water Soil Amendments Health and Hygiene Hazards in the growing area (Animals) Equipment, Tools and Facilities Sprout Production Enhancements Section 105: standards associated with identified routes of microbial contamination of produce, including: (1) agricultural water; (2) biological soil amendments of animal origin (3) health and hygiene (4) animals in the growing area and (5) equipment, tools and buildings. The proposed rule includes additional provisions related to sprouts.

Sanitary Transport Sec. 111. Sanitary Transportation of Food Sanitary transportation practices Documentation This rule addresses implementation of the Sanitary Food Transportation Act of 2005, which requires persons engaged in food transportation to use sanitary transportation practices to ensure that food is not transported under conditions that may render it adulterated. The rule is still being developed but how the rule addresses the transport of harvested product from the fields is still to be determined. The goal of the proposed rule on the sanitary transportation of human and animal food is to prevent practices that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food during transportation. The proposed rule addresses the sanitary transportation of both human and animal food traveling via motor or rail vehicle by establishing criteria for the safe transportation of food. Specifically, the proposed rule would establish requirements for: vehicles and transportation equipment, transportation operations, information exchange, training, records, and waivers.

Import Safety Importer accountability Third Party Certification 18 Import Safety Importer accountability Third Party Certification Certification for High Risk Foods Voluntary Qualified Importer Program (VQIP) Authority to Deny Entry The FSMA gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include: Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. Certification for high risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S. Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.

Steps to FSMA Compliance Farm: including farm activities that are covered by the proposed produce rule and certain low risk manufacturing/ processing, packing and holding activities conducted by small and very small businesses on farms for specific foods Modified requirements for Small (<500 employees) and very small businesses (TBD but >$250K, $500K , $1 million) A table outlining exemptions is provided to attendees in their workbooks on pages 28-29. The proposed rule on preventive controls for human food would apply to facilities that manufacture, process, pack or hold human food. In general, with some exceptions, the new preventive control provisions would apply to facilities that are required to register with FDA under FDA’s current food facility registration regulations. Facilities that are required to register include manufacturers, processors, warehouses, storage tanks and grain elevators

Inspection and Compliance Mandated inspection frequency (At least every 3 years if high risk) Records Access Potential Testing of Products Mandated inspection frequency: based on risk, for food facilities and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years. Records access: FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans. Testing by accredited laboratories: The FSMA requires certain food testing to be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards.

Regulatory Response Mandatory Recall Expanded Administrative Detention Suspension of Registration Record Retention

Foreign Supplier Verification Program Importers will be required to develop, maintain and follow FSVP for each food imported Requirements vary based on Type of food product Category of importer (small, very small) Nature of the hazard identified in food Who controls the hazard Foreign Supplier Verification Program (FSVP). All importers must establish and follow an FSVP, unless otherwise exempted. An importer of food under the proposed FSVP regulations is the U.S. owner or consignee of the food at the time of entry, or, if there is no U.S. owner or consignee at the time of entry, the U.S. agent or representative of the foreign owner or consignee. Under the proposed FSVP regulations, an importer would be required to develop, maintain, and follow an FSVP for each food it imports. The requirements will vary depending upon the type of food product that is being imported, category or the size of the import business, nature of the hazard identified in the food product being imported, and ‘who’ is responsible for controlling the hazards (manufacturer or somebody else). Written documentation is key and the importer should have the documentation available.

FSVP Requirements: Activities Compliance Review of Foods and Suppliers Hazard Analysis (Biological, Chemical and Physical) Supplier Verification Activities Corrective Actions (if needed) Periodic Reassessment of the FSVP Importer Identification at Entry Recordkeeping Compliance Status Review: Such review would need to include any FDA warning letters, import alerts, and requirements for certification issued by the FDA under section 801(q) of the Food, Drug, and Cosmetic Act (FD&C Act). Hazard Analysis: Importers would be required to analyze the hazards associated with each food they import. The hazard analysis would identify the hazards that are reasonably likely to occur for each type of food imported, and evaluate the severity of the illness or injury if such a hazard were to occur. Under the revised proposed rules, radiological hazards will be classified under chemical hazards. Supplier Verification Activities: Importers would be required to conduct activities that provide adequate assurances that the hazards identified as reasonably likely to occur are adequately controlled. Verification activities could include: onsite auditing of foreign suppliers; periodic or lot-by-lot sampling and testing of food; and periodic review of foreign supplier food safety records; or other appropriate risk-based procedures. Verification activities applicable to all FSVPs, regardless of identified hazards, include maintaining a written list of foreign suppliers from which food is imported, and establishing and following adequate written procedures for conducting verification activities. Corrective Actions: Importers would be required to review complaints they receive concerning the foods they import, investigate the cause or causes of adulteration or misbranding in some circumstances, take appropriate corrective actions, and revise their FSVPs when they appear to be inadequate. Periodic Reassessment of the FSVP: Importers would be required to reassess their FSVPs within three years of establishing the FSVP or within three years of the last assessment. However, importers would have to reassess the effectiveness of their FSVP sooner if they become aware of new information about potential hazards associated with the food. Examples of such information might include information on changes to the source of raw materials or to product formulation. Importer Identification: Importers would be required to obtain a Dun and Bradstreet Data Universal Numbering System (DUNS) number for their company and to ensure that, for each food product offered for importation into the United States, their name and DUNS number are provided electronically when filing for entry with Customs and Border Protection. Recordkeeping: Importers would be required to keep certain records, including those that document compliance status reviews, hazard analyses, foreign supplier verification activities, investigations and corrective actions, and FSVP reassessments.

Third Party Certification Programs Tool for importers to obtain needed assurances under FSVP Participate in the VQIP to expedite movement of food Can be required by FDA to accompany high-risk foods Another mandate for safety of imported foods is third party certification. Third party certification program is a tool for importers to obtain assurances to meet their obligations for the Foreign Supplier Verification program (sec 301). This is a way for the importers to participate in the voluntary qualified importer program to expedite movement of food through the import process (sec 302). Third Part Certification might become a requirement by the FDA to accompany high- risk foods (sec 303).

Enhanced Partnerships Reliance on inspections by other agencies: Federal, State and local agencies to meet its increased inspection mandate for domestic facilities. Foreign capacity building: The law directs FDA to develop a comprehensive plan to expand the capacity of foreign governments and their industries. One component of the plan is to address training of foreign governments and food producers on U.S. food safety requirements. State and local capacity building: FDA must develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies. The FSMA provides FDA with a new multi-year grant mechanism to facilitate investment in State capacity to more efficiently achieve national food safety goals. Inspection by Other Agencies International Capacity Building Improved Foodborne Illness Surveillance

So what are our collective challenges?

PrimusGFS Documentation NCs Source: Azzule PrimusGFS v2.1

PrimusGFS Documentation NCs

PrimusGFS Facility NCs

PrimusGFS Facility NCs

SQF Document Certification Re-Certification Surveillance Interesting to note which NCs occur in every certification scenario: 2.5.7.1 – Internal Audits Specifically a routine internal inspection program shall be implemented and documented 2.4.5.4 – Incoming goods and services Specifically approval should be based on performance Source: SQFI

SQF Facility 6 Mo Surveillance Certification Re-Certification Which NCs occur in every cert scenario? 11.2.13 – Cleaning and Sanitation (*This clause has 8 subparts) 11.7.5 – Control of Foreign Material 11.2.3 – Walls, Partitions, doors, and Ceilings 11.2.12 – Equipment, Utensils, and Protective Clothing Source: SQFI

SQF Quarterly Report Minor Major Critical Source: SQFI

GlobalGAP IFA v4.0 Food Safety Related

How to improve your GFSI performance?

How to improve your GFSI performance? How do you measure the success of your Program? Key Performance Indicators (KPIs) Internal Audit Findings 3rd Party Audit Score Customer Complaints Sanitation Performance Maintenance Program Review Training Program Performance

How to improve your GFSI performance? Do you have a strong TEAM? Do you have the right hierarchy? Are the right people in the right positions? Proper balance of personality types Do employees communicate well? Do you have a commitment to excellence that is humane? How is your employee turnover in key positions?

How to improve your GFSI performance? Focus on Fundamentals This is Food you produce Keep your process simple and try not to do too much Use data to guide your decisions

Thank You Greg Komar NSF Agriculture gkomar@nsf.org www.nsf.org