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

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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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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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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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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What is FDA’s Universe?

– Media stories – New York Times

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• Reportable Food Registry Metrics• Figure 7 - Distribution of 229 Primary RFR Entries by

Food Safety Hazard

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What is FDA’s Universe?

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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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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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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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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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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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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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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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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