Food Safety Regulatory Compliance

Wednesday, June 15 to Thursday, June 16, 2011

The Sutton Place Hotel, Chicago, IL

DAY ONE – JUNE 15, 2011INTERACTIVE WORKING GROUP SESSION

9:00 am – 12:30 pm (Registration Begins at 8:30 am)A Debunking the Food Safety Modernization Act: Deciphering Implementation Timelines and New Requirements – What to Prepare For and When

Scott MacIntire
Director, Chicago District Office
U.S. Food and Drug Administration (Chicago, IL)

Gary Jay Kushner
Partner and Leader, Food and Agriculture Practice
Hogan Lovells (Washington, DC)
Former Vice President and General Counsel, American Meat Institute
Former Staff Counsel for Scientific Affairs, Grocery Manufacturers of America

Cited as being the most comprehensive food legislation passed in decades, once fully implemented the Food Safety Modernization Act will put into place several procedural requirements and food safety protocols that will greatly impact day-to-day operations for food manufacturers and companies within the food distribution and supply chain.

During this practical and interactive session, attendees will be brought up to speed on new and revised requirements under the Food Safety Modernization Act as well as effective and proposed dates for implementation of key provisions. Learn who will be impacted and when as well as what you need to do now in order to be compliant.

Title I - Prevention of Food Safety Problems

• Records access – outlining which types of records are accessible by the Government and under what circumstances
• Registration of food facilities – delineating which facilities are subject to the new requirements
  
  • suspension of registration
• Hazard Analysis and Risk-Based Preventive Controls – evaluating new requirements and expectations – what has changed from HACCP?
• Produce safety standards – an overview
• Understanding the implications of strategies and programs to be developed –
  
  • national agriculture and food defense strategy
  • Food and Agriculture Coordinating Councils
  • food transportation, safety and security
  • food allergy and anaphylaxis management
  • new dietary ingredients

Title II Detection & Response to Food Safety Problems

• Overview of FDA inspection targets for domestic and foreign facilities and ports of entry and the impact on the industry
• Evaluating laboratory accreditation standards
• Outlining food tracing and tracking enhancements, particularly applicable to “high risk foods”
• Surveillance systems – understanding how data will be collected and analyzed
• Mandatory recall authority – understanding how data submitted to the RFR may lead to a mandatory recall
• Understanding when administrative detention of food will be permitted
• Defining decontamination and disposal standards
• Lessons learned from the Reportable Food Registry

Title III - Imported Food

• Deciphering new requirements for food importers to conduct risk-based foreign supplier verification
• Understanding required certifications and audit report submission requirements
• Inspection of foreign food facilities – when and how
  
  • evaluating the effect of an inability to inspect
• Assessing the pros and cons of utilizing an accredited third party auditor – significance of conflicts of interest
• Outlining new employee protections for whistleblowers – are your current policies up to date?

Whether you are new to the field or a seasoned veteran seeking specific information on changes to be implemented under the Food Safety Modernization Act, you will find this workshop invaluable for getting up to speed while also maximizing your opportunity to engage in the advanced discussions that will be the hallmark of the main conference

CONFERENCE DAY ONE – JUNE 15, 20111

2:30 Registration for Main Conference Begins

1:00 Conference Co-Chairs’ Opening Remarks

Jorge Hernandez
Senior Vice President, Food Safety and Quality
U.S. Foodservice (Chicago, IL)

Tracey Phillips Beck
Vice President and Chief Operations Counsell
ConAgra Foods (Omaha, NE)

FOCUS ON LEGISLATIVE ENHANCEMENTS TO HACCP UNDER THE FSMA

1:15 How to Update and Ensure Effective Risk-Based Food Safety Controls

Daniel Forrest Shaw
Vice President, Deputy General Counsel
H.J. Heinz Company (Pittsburgh, PA)

Tim Haley
Director of Regulatory Affairs
Bush Brothers & Company (Knoxville, TN)

John Batz
Director, Quality and Food Safety
Malt-O-Meal Company (Lakeville, MN)

• Evaluating how proposed revisions implementing Hazard Analysis and Risk-Based Preventive Controls modify HACCP plans already in place
  
  • outlining the types of hazards that must be evaluated and revisiting your food safety plan to ensure it addresses “foreseeable” hazards
  • crafting a food security analysis – what to look at and what to do with the information discovered
  • understanding Government expectations for 
    • required “assurances” and records of monitoring
    • when corrective action plans are required
• How to minimize risk exposure created by cross-contamination
• Minimizing triggers for re-analysis of your food safety plan
• Defining modified requirements for “qualified” and “small” entities

FOCUS ON INSPECTIONS

2:15 FDA Spotlight Address: Outlining Priorities for Increased Inspections under the FSMA and Inspectors’ Expectations On-Site

Scott MacIntire
Director, Chicago District Office
U.S. Food and Drug Administration (Chicago, IL)

2:45 Afternoon Refreshment Break

3:00 Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should Government Come Knocking

Dan Caudill
President
Caudill Seed Company Incorporated (Louisville, KY)

Kenneth Odza
Partner
Stoel Rives (Seattle, WA)

• Discussing how FDA will prioritize, fund and educate inspectors in order to enforce new provisions under the FSMA
• Preparing effective internal controls and procedures for a “surprise” inspection
  
  • ensuring your staff is clear about what types of behavior are viewed as cooperative vs. uncooperative
  • how to respond to an agent’s requests
  • outlining senior management’s role during inspections
  • distinguishing between valid investigations and fishing expeditions and how your staff should react to each
• Preparing your books for inspection
• Knowing what’s going on in your food facilities – assigning responsibility for food tracking and country of origin labeling
• Defining what qualifies as a “high-risk” vs. “non high-risk” facility and how this classification will impact susceptibility to inspection
• Post-inspection —
  
  • outlining corrective steps for problems identified during inspection
  • handling food re-labeling issues for products identified as adulterated during inspection

4:00 The Reportable Food Registry One Year Later: How to Report Events While Minimizing Exposure to Government Investigation or Private Litigation

Shirley Boyd
Vice President & Associate General Counsel
Cargill, Incorporated (Minneapolis, MN)

Ricardo Carvajal
Director
Hyman, Phelps & McNamara PC (Washington, DC)
Former Associate Chief Counsel, U.S. FDA

• Revisiting what notifi cation duties apply when —
  
  • more than one “responsible party” is involved
  • there are multiple immediate previous sources or subsequent recipients
• Lessons learned from action taken by the FDA in response to information reported in the RFR – what to report and when
  
  • maintaining an appropriate balance between disclosure and reporting
  • ensuring each department understands what qualifies as reportable behavior
• Evaluating the future impact of RFR reporting on facility registration revocation – understanding how a reported event may trigger revocation

FOCUS ON GFSI AND SQF CERTIFICATION

4:45 How to Prepare For and Achieve SQF Certification: A Guide to Meeting Food Safety Requirements and Addressing Compliance Hurdles

LeAnn Chuboff
Technical Director
Safe Quality Food Institute (Arlington, VA)

During this special case study session, LeAnn Chuboff will guide you through a thorough discussion of how to achieve critical SQF certification under current GFSI requirements. Take note as she discusses common defi ciencies often encountered during SQF audits while also providing you with best practices for resolving key issues in order to achieve certification. Come prepared with your most pressing questions as LeAnn addresses the following points of discussion:

• Requirements for certifi cation under SQF Safe Quality Food Codes 1000 and 2000, Level 2 and Level 3
• Meeting the challenges of compliance with the SQF food quality standard – where to begin and end when addressing food handling, preparation and processing
• Compliance transferability – evaluating whether or not compliance under one of the GFSI standards will suffi ce to meet other state, federal and local food safety and regulatory compliance requirements
• Audit harmonization – how to identify the programs in your own food safety audit to meet expectations under the SQF standard
• Ensuring delivery of third party certifi cation of compliance - how to ensure that companies within your supply and distribution chain are also compliant with the applicable food safety quality standard required by the retailer – ingredient suppliers, farmers, etc.
• Overview of commonly encountered stumbling blocks to achieving SQF certification

5:30 Conference Adjourns to Day Two

CONFERENCE DAY TWO – JUNE 16, 2011

9:00 Co-Chairs’ Remarks FOCUS ON FOOD IMPORTS POST-TITLE III

9:15 How to Obtain Crucial Import Certifi cations and Documentation to Meet New FSMA Import Protocols

Scott MacIntire
Director, Chicago District Office
U.S. Food and Drug Administration (Chicago, IL)

William J. Friedman
Of Counsel
Covington & Burling LLP (Washington, DC)

Qing Cong
Partner
June He Law Offices (Beijing, China)

• Understanding what level and type of documentation will now be required for import certification
• Examining new requirements for food importers specific to the import verification program
• Domestic FDA embargo authority – knowing when and how it can be triggered
• How the FDA (and other US regulatory agencies) monitor food import/export activity outside the US
• Complying with new records maintenance requirements and minimizing exposure created by increased FDA access to records
• Taking the appropriate steps to insulate your company from liability when importing food products
• Analyzing unique issues related to contamination and food supply chain safety when products (or ingredients) are manufactured abroad
• Ensuring foreign product manufacturers, marketers and ingredient suppliers are adjusting their current food safety and security measures in response to new requirements under the FSMA

10:15 Deciphering when “Reasonable Probability” Triggers the FDA’s New Mandatory Recall Authority & Measuring the Impact on Day-to-Day Business Operations

Nancy Husnik
Senior Counsel
Target Corporation (Minneapolis, MN)

Jorge Hernandez
Senior Vice President, Food Safety and Quality
U.S. Foodservice (Chicago, IL)

Gary L. Yingling
Partner
K&L Gates LLP (Washington, DC)

Panel Moderator
Shawn K. Stevens
Member
Gass Weber Mullins LLC (Milwaukee, WI)

• Understanding when “reasonable probability” exists that a product is adulterated or misbranded and will cause serious adverse health consequences or death
• Considering the implications of an FDA mandated recall vs. a voluntary one
• How to prepare for the “informal hearing” held during the mandatory recall process – identifying what information should be divulged
• Minimizing the impact on your business of a vacated or modified order – effectively communicating with your distribution/supply chain and customers
• Identifying what information should be included in required periodic reports to be submitted in accordance with a mandatory recall

11:30 Morning Coffee Break

11:45 Responding to Government Inquiries, Investigations and Warning Letters: Successful Strategies for Mitigating Downstream Litigation Exposure

Douglas Besman
Senior Counsel, Head of Litigation
Nestle USA, Inc. (Solon, OH)

Frederick H. Degnan
Partner
King & Spalding LLP (Washington, DC)
Former Associate Chief Counsel for Foods and Associate Chief Counsel for Enforcement, U.S. FDA

• Managing the liability risk associated with increased government access to company records and filings
• Understanding what types of behavior can trigger negative attention from the government
• Responding to increased cooperation between federal, state and local agencies
• Creating a food safety plan that won’t later act as a roadmap for regulators
• Developing a strategy to address publicity issues that arise as the direct result of government action

12:45 Networking Luncheon

FOCUS ON MARKETING & ADVERTISING CLAIMS

2:00 Bulletproofing Your Compliance Program to Address High Risk Target Areas for Enforcement

Edward Shin
Senior Corporate Counsel
Welch Foods Inc. (Concord, MA)

Bruce Strothers
Marketing Counsel
The Coca-Cola Company (Atlanta, GA)

• Identifying compliance weak spots in your marketing and advertising program
• Detecting behavior that may open the door to government enforcement vs. consumer fraud litigation
• Preventing non-compliance in various promotional platforms specifically when food products are being marketed to children
• Update on current enforcement trends in food and beverage marketing and advertising - product claims, labeling, claim substantiation

3:00 Using Traceability and Effective Recordkeeping to Ensure Accountability and Minimize Liability throughout the Distribution and Supply Chain

Sarah Brew
Partner
Faegre & Benson LLP (Minneapolis, MN)

Latasha Grinell
Litigation and Employment Counsel,
Dean Foods (Dallas, TX)

• Best practices for tracing a product from the processing plant through the distribution system to the final destination
  
  • how your internal programs should differ from a universal system-wide tracking program
  • creating an accountability chain for your product – from origin to destination
• Ensuring proper shipment records are retained
• Allocating risk and responsibility through indemnity provisions and insurance requirements
• Utilizing certificates of analysis, audits, product certifications and other methods to manage upstream accountability
• Auditing compliance with internal food accountability and reporting programs and re-adjusting your tracking procedures and compliance in response to your findings

4:00 Afternoon Refreshment Break

4:15 Legislative and Caselaw Update: Examining the Current Status of Proposition 65 Cases and National Legislation Concerning Emerging Chemicals of Concern

Leslie T. Krasny
Partner
Keller Heckman (San Francisco, CA)

Meg Villarreal
Senior Manager, Government & Industry Relations
Del Monte Foods (San Francisco, CA)

• Outlining compliance requirements under Proposition 65 - best practices for ensuring compliance with and minimizing your exposure to Prop 65 litigation
• Identifying science and policy-based approaches to most effectively preventing a targeted substance from being listed
• Lessons learned from recent cases and successful defense strategies
• Recent developments with OEHHA, the agency charged with administering Proposition 65
• Emerging chemicals of concern (BPA, acylamide, PhIP, PAHs, benzene and others)

5:00 Conference Conclude

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Location:
The Sutton Place Hotel
Chicago, IL