FSMA Proposed Rules for Preventive Controls and Fresh Produce Key Takeaways and Highlights Martin J. Hahn January 21, 2013

Agenda Introduction and Overview Summary of Preventive Control 10 Key Takeaways Highlights from Major Provisions Summary from the Produce Safety Proposed Rule Question and Answer Session

Introduction FDA has proposed two new regulations under FSMA Preventive Controls for human food Food Defense to come later Produce Safety Comments due May 16, 2013 (120 days) FDA says that more proposed rules are forthcoming

Overview of Preventive Controls Proposal Adds a new set of regulations implementing the Hazard Analysis and Risk-Based Preventive Controls provision of FSMA Updates and revises the cGMPs in Part 110 Includes several exemptions and modified requirements Includes a subpart on recordkeeping Would place everything in a new Part 117

10 Key Takeaways Proposed rule generally tracks the statute Hazard analysis; preventive controls; monitoring; corrective actions; verification; reanalysis; and recordkeeping FDA generally provides industry flexibility Each facility to tailor food safety plan to its own circumstances 3. FDA has tried to align proposal with HACCP Preamble traces origins of HACCP Repeated references to other government HACCP programs

10 Key Takeaways (continued…) 4. Testing/supplier verification not required (yet) FDA notes cost implications Economic analysis assumptions Nevertheless, FDA describes expectations in detail Requests comment on inclusion in final rule Need to read preamble and Appendix 5. Validation of preventive controls key issue FDA expects high level of scientific justification 6. Warehouse exemption Non-refrigerated warehouses – exempt Refrigerated warehouses – modified controls Frozen warehouses – based on reason for freezing

10 Key Takeaways (continued . . .) 7. High emphasis on recordkeeping/FDA access Keep records on-site at least 6 months Always keep food safety plan on-site Facility profiles (requested comment) Remote access (requested comment) Electronic records (Part 11) 8. Updates to cGMPs Outgrowth of cGMP Modernization Initiative Would replace Part 110 in its entirety

10 Key Takeaways (continued . . . ) 9. Defines small and very small businesses Small – less than 500 employees across the entire company (SBA definition) Very small – either $250,000, $500,000, or $1,000,000 in annual sales of food Compliance dates for Preventive Controls 1 year for large businesses 2 years for small businesses 3 years for very small businesses ** All from date of publication of Final regulation

Food Safety Plan Prepared (or preparation overseen) by “qualified individual” Signed and dated by owner, operator, or agent in charge initially and each time modified Would need to include: Hazard analysis Preventive controls Procedures for monitoring (including frequency), corrective actions, and verification Recall plan Would need to be written

Hazard Analysis Identify and evaluate “known or reasonably foreseeable hazards” for each type of food Proposal specifies categories of hazards to consider during identification Proposal specifies factors to consider during evaluation, including: Severity of illness Environmental pathogens in RTE foods exposed to the environment Foreseeable consumer use Determine which hazards are “reasonably likely to occur” Include a justification for conclusions reached

Preventive Controls Identify and implement preventive controls for those hazards reasonably likely to occur Preventive controls must include, as appropriate: Process controls Allergen controls Sanitation controls Other controls Recall plan Although FSMA identified cGMPs, supplier verification, and employee hygiene as preventive controls, the proposed rule does not

Preventive Controls continued . . . Process controls: procedures, practices, and processes performed on food Cooking, cooling, drying, acidifying, etc. Sanitation controls Would be required in certain situations Would need to include procedures for the cleanliness of food contact surfaces and the prevention of cross contact and cross contamination Allergen controls: procedures, practices, and processes to Protect food from cross contact during storage and use Ensure proper labeling

Preventive Controls continued . . . Preventive controls may be implemented at critical control points (CCPs), and also may be implemented at points other than CCPs Parameters associated with the control (the factors that must be controlled) would be required The maximum or minimum value or combination of values to which the parameter must be controlled This is similar to requiring critical limits at critical control points, but would apply to all preventive controls, whether at a CCP or another point

Recall Plan A written recall plan would be required Would be required to contain procedures for: Notifying consignees Notifying the public Conducting effectiveness checks Disposing of recalled product FDA is requesting comment on whether it should require: A recall plan to include procedures for notifying FDA Mock recalls as a verification activity

Monitoring Establish and implement written procedures for monitoring preventive controls Would include frequency of monitoring activities FDA does not specify monitoring frequency, but states that monitoring must be performed at sufficient frequency to ensure that the preventive controls are being performed consistently Monitoring activities would be: Documented Subject to verification activities, including records review by a qualified individual within a week after the records are created

Corrective Actions Establish and implement written corrective action procedures to be used if the preventive controls are not properly implemented, including procedures to: Identify and correct a problem to reduce the likelihood it will recur Evaluate all affected food for safety Prevent affected food from entering commerce if its safety cannot be assured Take the same steps AND reanalyze the food safety plan if either specific corrective action procedures have not been established or a preventive control is ineffective Corrective actions would need to be documented and subject to verification and records review

Verification Validation Express requirement in the proposed rule Conducted by a qualified individual Before the plan is implemented (or within the first 6 weeks of production if necessary); following reanalysis as needed Would include collecting and evaluating scientific and technical information Food allergen controls, sanitation controls, and the recall plan would not need to be validated

Verification continued… Monitoring Verify that monitoring is being conducted, such as through observation or independent tests Corrective Actions Verify that appropriate decisions are being made Verification Verify that the preventive controls are consistently implemented and are effective Calibration Establish and implement written procedures for the frequency of calibrating process monitoring and verification instruments

Verification continued… Internal Records Review Conducted or overseen by qualified individual Review monitoring and corrective action records within a week after they were made Review calibration records within a reasonable time Consumer Complaints Proposal would not require review of consumer complaints as a verification activity, but FDA seeks comment on this issue Documentation All verification activities would need to be documented

Verification continued . . . Reanalysis of the plan would be required At least every three years Whenever a significant change is made in the activities at the facility affecting the hazard analysis Whenever a preventive control is found ineffective Whenever a preventive control is not properly implemented and there was no established corrective action procedure Whenever the facility becomes aware of new information about potential hazards As mandated by FDA in response to new hazards and developments in scientific understanding

Qualified Individual Qualified individual(s) would need to do or oversee: Preparation of the food safety plan Validation of preventive controls Review of records for implementation of preventive controls and appropriateness of corrective actions Reanalysis of the food safety plan Qualification would be either through education/training or experience Applicable training would be documented, including type, date, and person trained

Recordkeeping New requirements would apply to all records required by new Part 117 FDA is proposing to require facilities to establish and maintain records documenting Written food safety plan Monitoring of preventive controls Corrective actions Verification activities Training for qualified individuals

Recordkeeping continued… Records would need to be: Originals, true copies, or electronic records Contain actual values and observations Be accurate, indelible, and legible Be created concurrently with performance of the activity documented Be as detailed as necessary to provide history of the work performed Include: Name and location of the facility Date and time of activity documented Signature/initials of person performing the activity Where appropriate the identity of the product and production code

Recordkeeping continued… Location: Retained for 2 years, but off-site storage permitted after 6 months if records can be provided within 24 hours Food safety plan must always remain on-site Electronic records considered on-site if accessible Electronic records: FDA proposes requiring compliance with Part 11, but seeks comment on whether an exemption is appropriate (as with BT Act) Disclosure: Records would be subject to disclosure under the FOIA

Records Access Records would be required to be made “promptly available to a duly authorized representative” “upon oral or written request” FDA states this is consistent with its HACCP regulations, which require records be available for review and copying FDA seeks comment on whether to explicitly require facilities to send records to the agency and whether they should be required to be submitted electronically FDA seeks comment on whether to require the submission of “facility profiles” (products, hazards, and preventive controls)

Warehouses Exempt: Facilities solely engaged in the storage of Non-refrigerated packaged food not exposed to the environment Raw agricultural commodities (other than fruits or vegetables) intended for further distribution or processing Modified Requirements: Facilities that store refrigerated packaged food that requires time/temperature control for safety (TCS)

Refrigerated Warehouses FDA expects the warehouse to learn whether a particular food requires time/temperature control for safety from the manufacturer, the label, or the scientific/technical literature Rare for a frozen food to be a TCS food Modified requirements: Establish and implement temperature controls Monitor temperature controls Take corrective actions Verify that temperature controls are implemented consistently (through calibrating devices and reviewing records) Document monitoring, corrective actions, verification activities

Testing and Supplier Verification Although expressly mentioned in the statute, testing and supplier verification are not being required as preventive controls/verification activities, likely due to cost But the proposed rule contains extensive discussion of the value of such programs, key attributes, and FDA’s expectations for such programs FDA seeks comment on whether to impose requirements in these areas and extent of any final requirements (Read preamble and Appendix Carefully)

Revisions to cGMPs In general, FDA proposes: Clarifying that certain provisions require protection against cross contact of food in order to address allergens That provisions directed to preventing contamination of food and food contact surfaces include preventing contamination of food packaging materials as well Deleting certain provisions containing recommendations Modernizing and updating the language FDA is requesting comment on whether: It should mandate employee training It should require, rather than recommend, certain provisions (e.g., cleaning non-food-contact surfaces)

Other Exemptions/Modified Requirements “Qualified facilities” Very small businesses Certain low-risk on-farm activities Dietary supplements Alcoholic beverages Foods subject to seafood or juice HACCP Farms Microbiological hazards addressed by the LACF regulation (note, only micro hazards—and no exemption for acidified foods)

Legal Authority FDA cites the FFDCA, FSMA, and the PHS FSMA states that failure to comply with Preventive Controls is a prohibited act Proposed rule states that failure to comply with cGMPs and/or FSMA will be considered in determining whether food is adulterated or in violation of the PHS Preventive Controls requirements would apply to intrastate activities Whether each provision of FDA’s proposal in within the bounds of its statutory authority warrants close review

Produce Safety Proposed Rule FSMA requires FDA to establish requirements for “high risk” product FDA concludes all produce presents comparable risks and are “high risk” The proposal would cover any food that falls within the definition of “raw agricultural commodity,” unless exempt The definition of produce includes any fruit or vegetable including almonds, peanuts, and walnuts, but exempts cereal grains such as wheat, barley, rye, field corn, any many otherss

Exemptions from the Rule Produce rarely consumed raw The regulation contains a complete list of “produce” Peanuts are included on this list and specifically excluded Produce for personal consumption by the farmer who grew it Produce that is not a raw agricultural commodity Produce that meets the following three criteria Produce receives commercial processing that reduces pathogens of public health significance You have records documenting the recipient of the produce will indeed process it You are subject to record keeping and other enforcement requirements (FDA identifies almonds and walnuts as examples of products that would meet the above exemption)

Produce Safety Rule What are the potential food safety hazards when raising produce? Worker Training and Health and Hygiene Agricultural Water Biological Soil Amendments Domesticated and Wild Animals Equipment, Tools, and Buildings Sprouts Generally, more like cGMPs than HACCP Compliance date is two years (more for small and very small businesses) after passage (water is an additional two years)

Worker Training & Hygiene Personal cleanliness No communicable diseases Washing hands, with running water, soap, and dry afterwards Avoid contact with animals

Water Inspection of water system at beginning of season Treat with EPA approved pesticides when necessary Testing of water quality Establishment of water quality standards depending on use Testing at the beginning and every 3 months

Soil “Amendments” Establishes detail requirements regarding compost quality Prohibits most use of human waste Identifies treatments that can be used for soil amendments from animal waste Establishes application intervals (0 days, 45 days, 9 monhts)

Wild and Domestic Animals Restricts use of lands used for grazing by domestic animals Addresses “animal intrusion” by wild animals

Growing, Harvesting, Packing, & Holding Segregate produce from excluded products Cannot harvest visibly contaminated products Don’t contaminate produce during harvest Prohibits use of dropped produce Addressing packaging materials

Equipment, Buildings, Tools Establishes minimum requirements for buildings and equipment Pest control Toilet facilities Hand washing facilities Presence of domesticated animals Sewage disposal Trash disposal Plumbing

And a little reminder… Be sure your company has renewed the registration of its facilities by January 31st Check on your co-manufacturers and suppliers, too! If they have not renewed their registrations, they likely will be cancelled by FDA (which prohibits them from importing product) and then will require re-registration (new number)

Conclusion FDA responded in part to several of industry’s concerns The proposed preventive controls requirements warrant close review The absence of proposed requirements for testing and supplier verification pose special challenges Economic assessment will be very important  Lots of work ahead!

Questions?