IFDA Food Safety Meeting Regulatory Update Miriam J. Guggenheim May 28, 2015

Agenda FSMA Implementation Update FDA’s Proposal to Amend Facility Registration Rule FDA Guidance on Mandatory Food Recalls Avian Flu Impact on Egg Production FDA Determination on GRAS Status of PHO Vermont GE Labeling Law Menu Labeling Rules

2015 FSMA Final Rules Preventive controls for human food – August 30 Preventive controls for animal feed – August 30 Foreign supplier verification – October 31 Produce safety standards – October 31 Accreditation of third party auditors – October 31

2016 FSMA Final Rules Sanitary Transportation of Food – March 31, 2016 Intentional Adulteration – May 31, 2016 Compliance dates generally 1 year after final rule for large businesses

You are cordially invited FSMA Public Meeting You are cordially invited What: Focus on Implementation Strategy for Prevention- Oriented Food Safety Standards Where: Washington Marriott Hotel at Metro Center When: April 23, 2015 - 8:30 am to 5:30 pm April 24, 2015 - 8:30 am to 12:30 pm

FDA Strategy for Implementation FDA will put out guidance as well as final rules Early period will focus on education, training, of both inspectors and industry FDA will “educate before it regulates” States an intention for constructive dialogue with industry Particularly regarding imports, FDA wants to help importers assess compliance of foreign suppliers Importance of IT infrastructure (but challenges) FDA aims to leverage state resources Funding issues? FDA not yet deep into implementation of 2016 rules

FDA Strategy for Implementation – Inspections Inspectors will be food-specific, and inspections will be targeted and risk based FDA considering two-tiered inspections Assess adequacy of plans at the corporate level Assess implementation at facility level Inspectional violations would be ranked based on risk/public health impact Again, in early stages of implementation, more about education than enforcement

Hazard Analysis and Risk-Based Preventive Controls (HARPC) – Recap Must identify/evaluate known or reasonably foreseeable hazards that may be associated with a facility Must identify and implement validated preventive controls to significantly minimize or prevent identified hazards Must monitor and verify that preventive controls are effective Verification activities include environmental and finished product testing programs Must take corrective action when needed Must document all, including your food safety plan, and retain for 2 years Records are available to FDA, not just during inspection

HARPC Supplemental Proposal – Definition of Risk Proposal would define “significant hazard” as: [A] known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would, based on the outcome of a hazard analysis, establish controls to significantly minimize or prevent the hazard in a food and components to manage those controls (such as monitoring, corrections or corrective actions, verification, and records) as appropriate to the food, the facility, and the control IFDA suggested instead: a known or reasonably foreseeable hazard for which there is a reasonable probability, based on experience, illness data, scientific reports, or other information relevant to the food or the facility, that severe illness or injury will occur in the absence of its control

HARPC Supplemental Proposal Domestic supplier verification Would apply only to manufacturers receiving raw materials, not to warehouses and distributors handling finished food products IFDA supported non-applicability to distributors Product testing Would apply only “as appropriate to the facility, the food, and the nature of the preventive controls IFDA appreciated, but urged express exemption/clarification for distributors Environmental monitoring Required only if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard, “as appropriate to the facility, the food, and the nature of the preventive controls

Modified HARPC Requirements for Warehouses FDA proposed rule would exempt from ambient warehouses “solely engaged in the storage of packaged foods that are not exposed to the environment” Still subject to general GMPs Exemption would not apply to the storage of produce in vented crates IFDA urged exemption Facilities storing foods requiring time and temperature controls to limit pathogen growth would be subject to limited requirements to ensure such controls

Foreign Supplier Verification Program Proposal “Importer” defined as: the person in the United States who has purchased an article of food that is being offered for import into the United States or if no such purchaser exists, the consignee at the time of entry Importer must implement a written FSVP providing “adequate assurances” that foreign suppliers are producing food in compliance with the requirements of the FDCA, including FSMA Written FSVP must be prepared by a “qualified individual” No FSVP required where importers or customers accomplish the same ends through the HARPC rule (i.e., have a supplier verification program)

FSVP – Hazard Analysis Importers must conduct a hazard analysis for most types of imported food to determine hazards reasonably likely to occur and the severity of the illness or injury from that hazard Can review foreign suppliers’ hazard analysis Can use third party auditors In considering the risks associated with the supplier and imported food, the importer would need to consider: the hazard analysis conducted by the foreign supplier the entity that will be controlling the identified hazards the foreign supplier’s food safety procedures, processes, and practices the foreign supplier’s compliance with relevant FDA regulations, evidenced by import alerts or warning letters the foreign supplier’s food safety performance history, including testing and audit results; and other factors such as transportation and storage considerations

FSVP Proposal – Verification Activities First, review the compliance status of a food and a foreign supplier before importation FDA said would make a “one stop shop” to facilitate review of, e.g., warning letters, 483s, etc. Where no hazard is identified, no additional verification required Where a hazard is identified: but controlled by the importer, the importer must document, at least annually, that it has adequate procedures to control the hazard but controlled by the importer’s customer, the importer must obtain “written assurances,” at least annually, that the customer is controlling the hazard but controlled by the supplier, the rule would require certain verification activities Importers would need to conduct at least one on-site audit of a supplier when they determine that a hazard that could cause serious adverse health consequences or death exists

FSVP Proposal Importers will need to establish and follow written procedures to ensure they obtain food from “approved” foreign suppliers But don’t need to maintain a list FDA intends to release draft guidance at the time of a final rule, and final guidance in advance of compliance date IFDA comments: Need better definition of “importer” that doesn’t mix terms of art FDA should recognize role of distributors – often not the right party to conduct FSV activities Concern about significant hazard definition Urged 30-month compliance period (rather than 18 months)

FDA Proposal to Amend Food Facility Registration Rule Released on April 9; comments due June 8 Goals: Codify/implement FSMA provisions relating to facility registration Enhance “utility” of registration FDA gets many bogus/false/incorrect/incomplete registrations that impede the utility of the database Logistical provisions: Must register electronically starting January 4, 2016 Must renew every 2 years between October 1 and December 31 Failure to renew is both a prohibited act and results in cancellation of registration Must update registration with any changes or cancel registration within 30 days (shortened from 60)

Must Identify Type of Activity Conducted at the Facility Ambient human food storage warehouse/holding facility Refrigerated human food warehouse/holding facility Frozen human food warehouse/holding facility Interstate conveyance caterer/catering point Contract sterilizer Labeler/relabeler Manufacturer/processor Farm mixed-type facility Packer/repacker Salvage operator (reconditioner) Animal food warehouse/holding facility Other activity

Additional Elements in Registration – Email Address Email address of: owner, operator, or agent in charge of the facility contact person of the facility If a third party registers on behalf of the facility, FDA will email the owner, operator, or agent in charge to confirm the registration Unclear whether FDA would routinely email to confirm registration FDA seeks comment as to whether registrants should be allowed to request that FDA only use email communications in emergency situations

Additional Elements in Registration – D-U-N-S® Number FDA proposes that registrations must include D-U-N-S numbers for each facility (not just one for the company) D-U-N-S number could be obtained at no cost through a system that would be directly linked from the facility registration system FDA’s goal is to enable the agency to verify the facility-specific address to facilitate efficient inspections Again, to address the problem of bad data in the system If object to D-U-N-S number, FDA requests comments on other facility identifiers the agency could use

FDA Guidance on Mandatory Food Recalls Standard: FDA determines there is a reasonable probability that the food is adulterated or misbranded, and that it will cause serious adverse health consequences or death Procedure: FDA will provide responsible party with an opportunity to voluntarily recall If company doesn’t, FDA can mandate recall FDA will issue press release Evidence FDA might consider to determine whether standard is met: inspection observations RFR data consumer/trade complaints lab testing epidemiological data

Avian Flu Impact on Egg Production Avian flu reportedly has cut industrial egg product production (including liquid, frozen, and powdered eggs) by 25% Prices reportedly up by almost 240% in the last month Flu expected to continue to spread until temperatures in affected region remain above 80 degrees for a sustained period Some egg alternatives, but formulation/labeling issues Currently, only Canada can export egg products into the US Industry asking USDA to allow temporary imports from other countries

Update on FDA Determination re GRAS Status of PHOs Kummerow lawsuit FDA deferral June 1, 2015 GMA’s FAP for low level PHO uses Late May 2015 FDA’s final determination on PHO GRAS status By June 15, 2015

Vermont GE Labeling Law GE labeling law enacted April 20, 2015 Will go into effect July 1, 2016 GMA lawsuit – Court refused to enjoin law

Menu Labeling Rules Applies to restaurants and “similar retail food establishments” with 20 or more locations doing business under the same name and offering substantially the same menu items Those selling “restaurant-type food” – for immediate human consumption Calories must be declared on restaurant menus for “standard menu items” Other nutrition information must be available upon request Vending machine rule – requires vending machine operators who own or operate 20 or more machines to provide calorie declarations

Questions/Discussion Miriam J. Guggenheim Covington & Burling LLP One CityCenter, 850 Tenth Street, NW, Washington, DC 20001 T +1 202 662 5235 | mguggenheim@cov.com www.cov.com