FDA’s Proposed Rule under FSMA for Preventive Controls

Key Takeaways and Highlights Joseph A. Levitt, Partner Elizabeth Barr Fawell, Associate January 11, 2013

Agenda

• Introduction and Overview • 10 Key Takeaways • Highlights from Major Provisions • Key Points from the Produce Safety Proposed Rule • Question and Answer Session www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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10 Key Takeaways

1. Proposed rule generally tracks the statute

• Hazard analysis; preventive controls; monitoring; corrective actions; verification; reanalysis; and recordkeeping

2. 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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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

10. Compliance dates

• 1 year for large businesses • 2 years for small businesses • 3 years for very small businesses

** All from date of publication of Final regulation

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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•

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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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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) www.hoganlovells.com

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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) www.hoganlovells.com

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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 www.hoganlovells.com

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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)

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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) www.hoganlovells.com

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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 www.hoganlovells.com

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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 www.hoganlovells.com

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Produce Safety Proposed Rule

• Rather than issue standards for categories of produce considered high risk, the proposed rule would apply to almost all produce • The requirements focus on agricultural practices (not commodities), except: – Specific commodities rarely consumed raw (e.g., potatoes) – Produce subject to a kill step through commercial processing, so long as documentation kept (e.g., oranges for juice) – Produce that is not a raw agricultural commodity (and therefore is subject to Preventive Controls) www.hoganlovells.com

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Produce Safety Proposed Rule (continued…)

• Would set standards to control for 6 specific hazards – 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 www.hoganlovells.com

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And a little reminder…

• Be sure your company has renewed the registration of its facilities by January 31 st • 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) www.hoganlovells.com

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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!

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Questions?

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Contact Information

Joseph A. Levitt, Partner Hogan Lovells US LLP (202) 637-5759 [email protected]

Elizabeth Barr Fawell, Associate Hogan Lovells US LLP (202) 637-6810 [email protected]

www.hoganlovells.com

www.hoganlovells.com

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