1. Critical Impact of Regulations to Food
Science and the Food Industry
Kathleen M. Sanzo, Esq.
ksanzo@morganlewis.com
DC-IFT / CFSA Meeting
November 13, 2012
November 13, 2012

2. Agenda
• Who cares about food safety and why?
• Importance of the Food Safety
Modernization Act (FSMA)
• Efforts to address Front of Package
Labeling
• What now? Four more years.
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3. Regulatory Landscape
• Who cares about food safety and why?
– Congress –
• Proposed legislation in 2012—S.216 – Enhance criminal penalties for
knowing and intentional misbranding and adulteration
• Oversight hearings on FMSA
• Budget Challenges
– FDA
– States
– Consumers/Consumer Advocacy groups
– Companies and Corporate Executives
– Plaintiffs’ lawyers
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4. What is FDA’s Universe?
• In 2011, FDA:
– Regulated ≈ $417B in domestic food
products, $49B foreign food products
– Regulated 167,000 US food facilities; 254,000
foreign food facilities
– Conducted 19,000 inspections of US
facilities, 995 foreign inspections (≈ 2.3% of
total)
– Spent $190M for inspections, including $25M
to states to conduct inspections
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5. What is FDA’s Universe?
• Staffed many foreign inspections posts
– China—13
– India—15
– Central/South America—14
– EU—2
– South Africa—2
– Middle East (Jordan)--2
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6. What is FDA’s Universe?
– Media stories – New York Times
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7. What is FDA’s Universe?
• Reportable Food Registry Metrics
• Figure 7 - Distribution of 229 Primary RFR Entries by
Food Safety Hazard
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8. Legislative Mandates Affecting
Food Safety Issues
• ACA requirements (2010 Healthcare Reform Bill)
– Nutrition labeling for vending machine food (PR April 6, 2011)
– Nutrition labeling of standard menu items in chain restaurants
and similar retail food establishments (PR – April 2011)
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9. Legislative Mandates Affecting
Food Safety Issues
• Food Safety Modernization Act (FSMA – 2011)
– Bi-annual registration (Now open as of Oct 2012)
– Preventative plans or HACCP systems for
processing, distribution, and holding food, including food
transport
– Contaminant-specific performance standards
– Increased, routine inspections on risk-based basis/re-inspections
(fees) (5 or 3 year cycle)
– Greater scrutiny of imported foods
• Supplier verification requirements (by June 2012)
• Possible certification of compliance of certain high risk imported food
• Expanded administrative detention for imported foods (July 3, 2011)
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10. More FSMA
– Mandatory food recalls, re-inspections (fees)
– Authority to suspend facility registration for
violations (July 3, 2011)
– Enhanced product tracking requirements (post
IFT pilot projects)
– Authority to request import certificates
– Enhanced records access (although lots of
restrictions around FDA authority)
– Accreditation of third party lab testing (June 2012)
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11. Rulemakings Delayed
• Four regulations at OMB for review and waiting on Fifth
– Produce rule – high risk
– Preventive Controls for Food
– Preventive Controls for Feed (will include GMPs similar to food)
– Foreign Supplier Verification (at OMB but waiting for Third Party
Certification)
– Third Party Certification –still being drafted
• FDA not fully enforcing yet, because all the rules are not
in place
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12. November 13, 2012 12

13. Front of Package Labeling
• Initiative on-going at FDA
• In interim FDA will take enforcement action
against labels that only tell the ―good news‖
or are not substantiated (e.g., claims on
foods for under 2 years)
• Note 17 Warning Letters to well known
brands (Nestle, Beechnut, Pom, Gorton’s) for
asserted misleading FOP labeling
• FDA looking for uniform and standard
industry approach and implementation plan
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14. Food for Thought—Four More
Years
• Continued reliance on private sector to improve
food safety record and supply chain management
• Continued development of and focus on food
science and risk assessment to prioritize
• Increased coordination with other government
authorities—especially foreign and state
authorities—to achieve legislative mandate
• Increased coordination with USDA to rationalize
resources and expertise and avoid possible
merging of 2 agencies in view of federal budget
constraints
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15. Food for Thought—Four More
Years
• Continued focus on compliance – issuance of more
Warning Letters/untitled letters more quickly
• Willingness to look to drug and device regulatory
models for systems control and CAPAs for food
• Increased reliance on responsible corporate officer
doctrine, individual liability
– U.S. v. Park (1975) principle of strict liability for senior officials
– Senior officials deemed responsible for violations of FFDCA without
knowledge of specific bad behavior or acts
– Violations of FFDCA are criminal
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16. Food for Thought -- Four More
Years
• Continued willingness to go to consent decrees
more quickly as result of violative behavior
• Consumer group and other third party (retailer)
support for greater FDA scrutiny and
enforcement action (e.g., peanut recall)
• Implication of reduced Congressional funding
for FDA food safety enforcement efforts
(e.g., recent House reduction of budget to
$750M, $200M less than requested)
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