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FSMA Matters – Addressing Multi Agency Jurisdiction and Rules
Moderator: Joseph Corby; Executive Director; Association of food & Drug Officials (AFDO)
Panelists: Bob Hibbert; Attorney; Morgan Lewis
Dr. Charles Cook; Managing Partner; Country Fare Consulting LLC
Lowell Randel; VP for Regulatory Affairs for the Global Cold Chain Alliance (GCCA
Dr. Tracie Sheehan, Aryzta
What Guidance?
What Rule?
What Agency?
What Authority?
What Product?
Government Oversight of Food Manufacturing
• Federal and State Agencies• Varying Inspection & Reinspection Frequencies• Differing Regulations• Non-uniform Enforcement
The purpose of this panel is to identify and discuss those regulatory situations that cause confusion for food plant operations and to offer suggestions on these matters could be resolved.
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FOOD SAFETY SUMMIT: WHO REGULATES WHAT AND WHYMay 9, 2018Bob Hibbert
JURISDICTIONAL ISSUESType of Product
2
Sources:
Cattle, Sheep, Swine, Goats (Horses) and
Catfish (FMIA 21 U.S.C. 601 et sq.)
Chickens, Turkeys, Ducks, Geese, Guineafowl(PPIA 21 U.S.C. 451 et. seq.)
Game Animals – Deer, Rabbits, etc.,
Voluntary inspection (AMA 7 U.S.C. 1621 et seq.)
All Other Foods – FD&C Act (21 U.S.C. 301 et. Seq.)
TYPE OF PRODUCTDefining FSISAmenability
3
• Generally threshold is 2% cooked; 3% raw meat but …
• Product “not considered product of the meat” food or poultry indirectly…
• Regulations and ad hoc decisions
• What is a sandwich?
4
• Harvesting operations and carcass by carcass inspectors
• Processing operations and continuous inspection
• Restaurants and retail facilities –state and local control
• Honey Baked Ham v. Glickman (172 F. 3d 885 (1999))
JURISDICTIONType of Facility
Lets Fix This
5
• FDA / USDA Cooperative Agreement on Dual Jurisdiction Facilities, 1/30/2018
• Convergence of HAACP, HARPCand FSMA
• Next Generation of Food Products
• Single Food Agency?
THANK YOU© 2018 Morgan, Lewis & Bockius LLP
© 2018 Morgan Lewis Stamford LLC
© 2018 Morgan, Lewis & Bockius UK LLP
Morgan, Lewis & Bockius UK LLP is a limited liability partnership registered in England and Wales under number OC378797 and is
a law firm authorized and regulated by the Solicitors Regulation Authority. The SRA authorisation number is 615176.
Our Beijing and Shanghai offices operate as representative offices of Morgan, Lewis & Bockius LLP. In Hong Kong, Morgan Lewis operates through Morgan, Lewis & Bockius, which is a separate
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This material is provided for your convenience and does not constitute legal advice or create an attorney-client relationship. Prior results do not guarantee similar outcomes. Attorney Advertising.
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ROBERT G. [email protected]
THE FOOD INDUSTRY’S REGULATORY CONUNDRUMTHE INCONSISTENCIES
Who Regulates
What – How – When
for
Processors – Distributors - Retailers
Charles F. Cook Ph. D. Managing Partner Country Fare Consulting, LLC
FEDERAL STATUTES SIMPLIFIED • Food Drug & Cosmetic Act (and amendments)
• Federal Meat Inspection Act
• Poultry Products Inspection Act
• Egg Products Inspection Act
Food Products SHALL NOT BE
• Adulterated
• Misbranded
• Packed or held under insanitary conditions
May 2018
2
THE CONUNDRUM SIMPLY STATED IS:
How each regulatory Agency
• Federal
• State
• Municipal
Defines and Enforces• What is an adulterated food?
• What specifically constitutes misbranding of food?
• Insanitary conditions?
May 2018
3
AGENCY’S HISTORIC COURSE OF ACTION
• Each agency has promulgated regulations or codes or provided non enforceable guidance or directives defining their current understanding of adulterated food, misbranding or insanitary conditions
May 2018
4
This Photo by Unknown Author is licensed under CC BY-NC-ND
THE REGULATORY
PRODUCT CONUNDRUM
Which agency regulates which products?
• Meat sandwich (2 slices of bread and meat)
• Meat sandwich (2 slices of bread and meat) crimped edges
• Hot dog in a bun
• Bagel dog
• Catfish processing
• Seafood processing
• Shrimp cocktail sauce platter
• Meat based reaction flavor
Example
Plant produces bagel dogs and hot dog in a bun. Which agency regulation or guidance does the facility follow?
May 2018
5
LET’S LOOK AT THE HISTORY
Traditional plants produced products under either USDA or FDA jurisdiction
To-Day
A plant may manufacture or store products regulated by:
FDA – Preventive Controls
FDA – Seafood HACCP
USDA – Meat, poultry, catfish HACCP
Additionally
Plants are required to conform to GFSI standards as required by customers
GFSI Standards not the same as Regulatory Standards May 2018
6
A REAL EXAMPLE
A plant produces RTE Pizza made
on same production line
Schedule is: Day 1 –
Cheese Pizza Day 2 –
Meat Pizza
Day 3 –Shrimp Pizza
QUESTION
Day 1 – Does plant have to comply with
FDA draft guidance on Control of Listeria
Monocytogenes in Ready-To-Eat food
Day 2 – Comply with FSIS Codified
Regulations of Listeria Rule
Day 3 – FDA Codified
Seafood HACCP Regulation
Requirements and Responses
Differ
May 2018
7
HOW AGENCY’S DEFINE INSANITARY CONDITIONS
• FDA
• The persistent presence of food pathogens in environment – does not differentiate between RTE or NRTE production areas
• The presence of L. monocytogenes on not RTE foods
• USDA
• Presence of L. monocytogenes on exposed food contact surfaces
• SSOP non-conformances
• Physical inspection by Agency Inspectors
May 2018
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SUPPLIER APPROVAL
• FDA – Supply Chain Preventive Control
• USDA – Pre-requisite program in HACCP
Different Requirements
May 2018
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And the list of inconsistencies goes on and frustration mounts
May 2018
10
BEST WAY TO ASSESS FDA’S CURRENT THINKING
Review 483’s which are based on inspectors observations that they feel may be a violation of FDCA and related acts which are clear, specific and significant
May 2018
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WHAT IS THE SOLUTION?
Single Food Agency like most of the
developed countries
Won’t happen – Politics
• Harmonized Regulations and Requirements
• A Great Example
• FDA Food Code
May 2018
12
FSMA Matters – Addressing Multi Agency Jurisdiction and Rules: An Industry Perspective
Lowell Randel
Global Cold Chain Alliance
Worldwide Membership
1,064 Facilities 78 Countries
FT3
347 Companies
45.9 Billion FT3 395 Suppliers
Food Security166 million
pallets
290 billion lbs. of
perishable food stored in
member warehouses
each year
95 billion lbs. perishable food in storage on any
given day
Contribution to the Economy
Annual revenue generated by the warehouse industry.
4.7 BillionUSD
$
Contribution to the Workforce
people employed annually on a Full Time basis (FTEs)
Permanent (W2) Employees
Contract or Temporary Employees
37,000
Who has jurisdiction?
Potential Agency Involvement
STATE HEALTH DEPTS
STATE AG DEPTS
STATEDOTs
International Agencies/ Regulations Also Apply
Increased Impact of “Private” Regulations
Application of FSMA
• FSMA interrelates with many of these Federal, State, International and “Private” regulations
• Creates a very complex situation for facilities that are subject to many different regulations and inspections
• Leads to confusion and audit fatigue
Real World Examples
• Warehouse stores meat, poultry, seafood, fruits & vegetables, juice and prepared foods.
• Warehouse blast freezes and tempers meat for domestic and export.
• Warehouse imports and exports various seafood items and does light processing.
• Warehouse stores and mixes juice concentrates
• Warehouse stores animal feed and rendered product
What food safety regulations apply? (Doesn’t include other types of regs)
• FSMA• Preventive Controls for Human Food• Preventive Controls for Animal Food
• Sanitary Transportation of Food
• Foreign Supplier Verification (maybe)• Food Defense
• FDA Juice HACCP
• FDA Seafood HACCP
• FSIS• Inspections for tempering
• Export certifications• Catfish inspection
• APHIS• Receive, hold and export animal by-products
• AMS• Export Verification program
• NOAA• Seafood inspection
• State health, agriculture and transportation regulations
• International requirements for export
Example of Jurisdictional Complexity
• Consider a shipment of beef from packing plant to 3rd Party Warehouse with mixed product
• Role of USDA, FDA, State agencies?
• How/when does FSMA apply?
How to Navigate?
• First step: know which regulations apply
• Understand who is enforcing them
• Understand how they interrelate
• Develop relationships with regulators
• Important for agencies to be transparent and communicate
• Where do “private” regs fit in? Can they help simplify the situation – or make it more complex…?
• Engage consultants, if needed
• Utilize industry association resources
Summary
• FSMA adds complexity to an already crowded regulatory landscape
• The trend towards more “private regulations” will have an increasing impact
• Companies, and agencies, must focus on communication and transparency to minimize conflicts
Food Safety SummitSession 10: FSMA Matters –
Addressing Multi Agency Jurisdiction and Rules
Tracie Sheehan, Ph.D.
Our Food Safety Fundamentals are Aligned around the World
• We all want to assure safe food!• The vast majority of our food industry wants to protect
the consumer, protect their brand and protect their company through internal policies, external and internal audits, testing of food, environment, ingredients, packaging, and monitoring of any complaints
• The Global Food Safety Initiative (GFSI) has driven harmonization of third party food safety audits with continuous improvement in audit criteria
• The World Health Organization (WHO) wants to improve the safety of water and food around the world
Are we eating in a Safer Food World?
• Food supply chains now cross multiple national borders. Good collaboration between governments, producers and consumers helps ensure food safety.
• An estimated 600 million – almost 1 in 10 people in the world fall ill after eating contaminated food and 420,000 die every year……
• However that means that 7.2 billion people survive and thrive each year due to SAFE food intake!
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We all have a role to play to improve life expectancy in the world through safer food
"CIA – The World Factbook Life Expectancy At Birth". 2017-06-03.
5
Our Food Safety Fundamentals are Aligned in the United States
• We all want to assure safe food!• US National government agencies (FDA, FSIS, CDC) want to
ensure safe food through inspections, mutual recognition of equivalent country regulations, import monitoring, and surveillance of foodborne outbreaks
• US State Inspectors want to ensure safe foods for their state and support FDA in their inspections and because they have more inspectors
• US Local Health Department inspectors focus on restaurants as well as local food manufacturing
Comparison of Major US Food Safety Regulations, Presidential Party in Power & Life Expectancy
Are there opportunities for improved food safety oversight?
• Real examples of multiple inspectors in the same facility:• Facility #123 gets quarterly inspections from the local health
department, twice a year inspections by the state’s department of agriculture and annual inspections by FDA
• Facility #456 gets no inspections from any regulatory agency for 5 years
• Possible Solution:• Have each agency load their inspection with corrective actions
received into an FDA database by FDA registration number• FDA could better allocate resources to the facility that hasn’t been
visited in 5 years• Caveat – for states approved to inspect on behalf of FDA, it would
count as a completed inspection and for local health departments, it could count as an “unqualified inspection” so FDA would go every other year.
Are there opportunities for improved food safety oversight?
• Real examples of multiple inspectors in the same facility at the same time:
• Meat Pizza (FSIS) vs. Cheese Pizza (FDA)
• Open sandwiches (FSIS) vs. Closed sandwiches (FDA)
• Catfish (FSIS) vs. All other fish (FDA)
• Possible Solutions:• Resolve FSIS vs. FDA jurisdictional differences to eliminate multiple inspectors in the
same facility and use those inspectors for facilities inspected less frequently
• Pizza – one agency
• Sandwiches – one agency
• Fish and Catfish – one agency
• Combine agencies for efficiency and collaboration…
if Canada can do it so can the US!
Are there opportunities for improved food safety oversight?
• Real Example• Food tampering threat event at a facility – as a result FDA, OCI, Homeland Security,
and police showed up in FSIS regulated facility and all agencies expected to be the lead agency for investigation, employee interrogations, sample collection and testing
• Possible Solution• Designate lead agency for crisis situations before they happen
• Train facilities on who to call in the event of a suspected issue
Let’s work together for a safer food world!
• Mutual Global Food Safety System Recognition
• US FDA recognizes Australia, Canada, New Zealand….who is next?
• Global Webinars on Food Safety Regulations
• Regulatory recognition of Global Food Safety Initiative (GFSI) third party audits for supplier approval
• Support CODEX on food safety requirements for global trade
