Food Safety Regulatory Compliance

DAY ONE – JUNE 15, 2011 INTERACTIVE 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 confl icts 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 fi nd 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 confence.

JUNE 17, 2011 ADVANCED INTERACTIVE BENCHMARKING & WORKING GROUP SESSIONS

9:00 am – 1:00 pm (Registration Begins at 8:30 am)

B Auditing & Monitoring Compliance within the Food Manufacturing, Distribution and Supply Chain: Best Practices for Probing & Correcting Weak Spots in Your Compliance Protocols

Mark Mansour
Partner
Akin Gump Strauss Hauer & Feld LLP (Washington, DC)

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

In a perfect world, your food safety and regulatory compliance departments would be able to say without a doubt that all companies included within its manufacturing, distribution and supply chain are 100% compliant with company-established and more importantly, FDA-mandated food safety compliance protocols. In reality, this is often not the case.

Designed to provide a practical forum for benchmarking with your peers regarding how to best audit and monitor compliance throughout the manufacturing, distribution and supply chain, this intensive, hands-on session will provide you with a rare opportunity to brainstorm and benchmark your internal compliance and audit programs with those of your peers as you are guided through a discussion of the following points:

• Identifying what your self-assessment and auditing process needs to accomplish – knowing what you are looking for and how to identify it within your own corporate operations
• Understanding when there is a duty to “investigate” suspected violations
• How to recognize weak points in the operations of those included within your product manufacturing, distribution and supply chain
  • detecting what types of behavior can open the door to product contamination and/or adulteration
• Discussing when, how often and by whom should risk assessments should be conducted
• Conducting the audit – what to look for and when to stop looking
• Handling knowledge or suspicion of potential regulatory violations and assessing the potential risk and liability exposure of a suspected violation
• Ensuring key members in each department – legal, marketing and regulatory – are clear regarding what the reporting structure is for compliance infractions
• Taking corrective action once it is discovered that those you do business with are not utilizing good manufacturing and business practices
• Addressing consumer claims and product complaints – knowing what your process is and the process of those with who you do business and how the process is working?
• Record maintenance and preservation – deciding whether or not to retain certain documents
• Common internal audit pitfalls that should be avoided

1:30 pm – 5:00 pm (Registration Begins at 1:00 pm)

C Anatomy of a Recall: A Step by Step Analysis to Minimize Liability Exposure & Prevent Common Pitfalls that Can Lead to Downstream Litigation

Dean N. Panos
Co-Chair, Products Liability and Mass Tort Defense Practice
Jenner & Block LLP (Chicago, IL)

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

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

Nancy Husnik
Senior Counsel
Target Corporation (Minneapolis, MN)

The food industry has been witness to more than its fair share of product recalls over the past few years. From peanut butter to fresh fruits and produce to eggs and organic beef, it seems no sector of the food industry has been un-touched by a recall in recent years. Still, as internal food safety regulatory compliance programs continue to evolve and companies more closely examine supply chain and distribution processes for efficiency and effectiveness, there is no question that the recall execution process is an area of constant improvement within the food industry.

Structured as a step-by-step examination of a mock scenario, this advanced working group session will walk you through the execution of a real-life recall from start to fi nish as you issue spot with a group of your peers, best practices for effi ciently and quickly executing a recall. Topics of discussion during this session will include:

• Making the decision to recall – when and how – balancing time pressure and a less than complete set of data and information
• How to effectively remove products from the market place
• Working with state and federal government to streamline your recall process post-incident
• Preserving business and customer relationships during a high publicity food recall incident
• Identifying and correcting compliance mishaps that led to the recall
• Anticipating and preparing for downstream litigation that will arise as the result of a recall – from customers and from within the supply chain
• Lessons learned and revisiting your GMP compliance in light of recent food recalls

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