Critical Impact of Regulations to Food Sciene and the Food Industry

  • 158 views
Uploaded on

 

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads

Views

Total Views
158
On Slideshare
0
From Embeds
0
Number of Embeds
1

Actions

Shares
Downloads
11
Comments
0
Likes
0

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide

Transcript

  • 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, 2012November 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.November 13, 2012 2
  • 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’ lawyersNovember 13, 2012 3
  • 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 inspectionsNovember 13, 2012 4
  • 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)--2November 13, 2012 5
  • 6. What is FDA’s Universe? – Media stories – New York TimesNovember 13, 2012 6
  • 7. What is FDA’s Universe? • Reportable Food Registry Metrics • Figure 7 - Distribution of 229 Primary RFR Entries by Food Safety HazardNovember 13, 2012 7
  • 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)November 13, 2012 8
  • 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)November 13, 2012 9
  • 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)November 13, 2012 10
  • 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 placeNovember 13, 2012 11
  • 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 planNovember 13, 2012 13
  • 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 constraintsNovember 13, 2012 14
  • 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 criminalNovember 13, 2012 15
  • 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)November 13, 2012 16