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

2. 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

3. 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

4. 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

5. 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, :30 am to 5:30 pm
April 24, :30 am to 12:30 pm

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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)

13. 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

14. 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

15. 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)

16. 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)

17. 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

18. Additional Elements in Registration – Email Address
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 the owner, operator, or agent in charge to confirm the registration
Unclear whether FDA would routinely to confirm registration
FDA seeks comment as to whether registrants should be allowed to request that FDA only use communications in emergency situations

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. Questions/Discussion
Miriam J. Guggenheim Covington & Burling LLP One CityCenter, 850 Tenth Street, NW, Washington, DC T |