DAY ONE
8:30 Registration Begins & Continental Breakfast
9:15 Co-Chair’s Opening Remarks
Adam M. EkonomonDirector, Regulatory law and Assistant General Counsel
The J.M. Smucker Company (Orrville, OH)
Tracey Phillips BeckVice President & Chief Operations Counsel
ConAgra Foods (Omaha, NE)
9:30 Food Safety Law in Transition: How to Ensure Compliance with Evolving and Conflicting Federal, State and Local Requirements Post-FSMATracey Phillips BeckVice President & Chief Operations Counsel
ConAgra Foods (Omaha, NE)
Ralph S. TylerPartner
Venable LLP (Washington, DC)
Former Chief Counsel, Food and Drug Administration
- Understanding how the FDA, USDA and local enforcement authorities are working collaboratively and separately to regulate food products post-FSMA
- Comparing and contrasting approaches to regulation and enforcement by FDA vs. USDA
- Update on regulatory initiatives undertaken as part of inter-agency cooperation efforts
- Deciphering regulatory requirements for food products in various states – how to stay abreast of regulatory and compliance requirements across jurisdictions
10:30 Morning Coffee Break10:45 Pathogen Control and Allergen Testing: How to Test For, Measure, Control and Identify Pathogens, Allergens and Other Food Contaminants in Your ProductsDawn WalterSenior Manager, Food Safety
Sara Lee Corporation (Downers Grove, IL)
- Contrasting allergens with pathogens and understanding the difference in how the two are regulated by the FDA vs. USDA
- Distinguishing allowable amounts of pathogens/contaminants for food products as regulated under FDA vs. USDA
- understanding how and why each agency treats the same contaminant/pathogen differently
- identifying “acceptable” levels of salmonella, e.coli, dioxins, GMOs, pesticides, antibiotics and other pathogens/contaminants
- Overview of new procedures for measuring and identifying contaminants in food products – what to test for and how to test for i
- What to do if a contaminant is found in your product –corrective measures vs. recal
- Current labeling issues surrounding allergens
- Lessons learned from recent high profi le food recalls involving
pathogens and allergens
11:30 Point-Counter Point Debate - The Evolution of FDA’s Authority to Regulate the Food Industry: Understanding Where FDA’s Scope of Authority under FSMA Begins and Ends
Gary Jay Kushner
Partner and Leader, Food and Agriculture Practice
Hogan Lovells (Washington, DC)
David Plunkett
Senior Staff Attorney, Food Safety Department
Center for Science in the Public Interest (Washington, DC)
During this point-counter point debate be engaged in a provocative, real-time discussion of FDA’s contemplated “expanded” authority under the Food Safety Modernization Act. Hear from counsel on both sides of this heated debate as they share with you perspectives on:
- The FDA’s authority to regulate the food industry under the FSMA – is the FDA acting outside the scope of its authority?
- How enforcement by the FDA is changing post-FSMA vs. pre-FSMA
- The new role of discretion under the FSMA
- How compliance with new FDA regulations and guidance can be a point of exposure – private litigation, reputational damage, etc.
12:30 Networking Luncheon
1:45 Food Inspections: Assessing Risk Factors for Government Targets and How to Minimize Downstream Liability Exposure Arising Out of “Surprise” Inspections
Adam M. Ekonomon
Director, Regulatory law and Assistant General Counsel
The J.M. Smucker Company (Orrville, OH)
Sarah L. Brew
Leader, Food Litigation & Regulation Practice Group
Faegre Baker Daniels LLP (Minneapolis, MN)
- Overview of what types of facilities have been most susceptible to inspections over the past year –
- identifying if your facility could be fl agged as “high risk” for the purpose of inspections under Sec. 421
- understanding how facilities are targeted for inspection under the new PREDICT system (Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting) factors considered
- manufacturer’s history with the FDA
- lab test results
- weather conditions
- Deciphering the timelines for the inspection of “high risk” vs. “non-high risk” facilities
- Lessons learned from recent industry inspections – eggs, sprouts, restaurants
- Preparing effective internal controls and procedures for a “surprise” inspection
- ensuring your books are in order
- training staff on what types of behavior are viewed as cooperative vs. uncooperative
- how to respond to an investigator’s request
- distinguishing a valid investigation from a fishing expedition – how to instruct your staff to react to each
2:45 Mock Case Study: How to Implement Effective Remediation and Corrective Action Post-Inspection
Jason R. Klinowski
Freeborn & Peters LLP (Chicago, IL)
During this session be engaged in a live mock case study as Jason guides you through a comprehensive discussion of how to take swift and appropriate corrective actions post-inspection. Topics to be discussed during this session will include:
- How to respond to Form 483 observations
- Documenting corrective steps and ensuring compliance with new procedures outlined post-inspection
- Handling food re-labeling issues for products identified during inspection
- Lessons learned from the Dominguez Foods detention and seizure
3:30 Afternoon Refreshment Break
3:45 Preparing for New Standards in Produce Safety: How to Re-Adjust Food Safety and Compliance Protocols to Minimize Liability Risk and Comply with Anticipated Regulations for the Safe Production and Harvesting of Fruits and Vegetables
Alicia K. White
Global Procurement and Distribution Transactional Counsel
Whole Foods Market (Austin, TX)
Leslie T. Krasny
Partner, Keller and Heckman LLP (San Francisco, CA)
General Counsel, Produce Marketing Association
Hear from senior food safety and regulatory affairs executives and legal counsel as they discuss with you current FDA proposals addressing standards for produce safety under Sec. 419 of the Food Safety Modernization Act. Topics to be addressed by this session will include:
- Impact of the proposed regulations on “small” and “very small” businesses – how to determine if raw agricultural products produced by your facility are “low risk”
- Factors relative to the growing and harvesting of produce that will be regulated – soil, hygiene, packaging, temperature and water
- Hazards to be addressed by the regulation – naturally occurring, unintentionally introduced, intentionally introduced
- Prioritization of the applicability of the regulation – assessing the risk level of produce and agronomic practices based on “known safety risks”
- Overview of exemptions for direct farm marketing
- Examination of current industry-led food safety proposals for the produce industry - Produce Traceability Initiative (PTI)
- Finished product testing –
- identifying legal obligations for ensuring your company’s due diligence obligations are met
- how often should testing be informed
- when is sampling OK, what to look for
- what to do with the results
* By the date of this event, it is expected that rule making for comment on standards for produce safety will have issued. The content of this session will be updated to address the regulation under Sec. 419 in its current form as published by FDA.
4:45 Risk Assessment Case Study: A Corporate Approach to Conducting Effective Risk Assessments across Your Food Operations
Daniel Forrest Shaw
Vice President, Deputy General Counsel
H.J. Heinz Company (Pittsburgh, PA)
- Identifying what your self-assessment process needs to accomplish
- Tips for outlining when, how often and by whom should risk assessments be conducted?
- Ensuring an efficient process for addressing consumer and product complaints
- Evaluating whether or not your company is utilizing sustainable business practices to prevent downstream litigation
- how to detect and address behavior that can open the door to class/mass action litigation
- understanding the difference between regulatory action and company behavior that can trigger consumer fraud litigation vs. personal injury litigation
- Ensuring key members in each department – legal, marketing and regulatory – are clear regarding what the reporting structure is for compliance infractions
5:15 Conference Adjourns to Day Two
DAY TWO
9:15 Co-Chairs’ Remarks
9:30 China Spotlight Address: The Evolution of Food Safety Law in China – Overview of Local Food Safety Regulations and New Requirements for Food Operations in China
Representative
U.S. Food and Drug Administration* (Beijing, China)
Hear from a representative from the U.S. FDA’s China Office as you are provided with an in-depth overview of the current status of food regulation in China. Gain an on-the-ground perspective into what regulatory challenges food and ingredient manufacturers in China have been facing as well as insights into what steps U.S. food manufacturers should be taking to ensure that food products imported from China are manufactured in compliance with US federal regulations and new provisions under FSMA.
10:15 Food Regulation in China: Update on Local Enforcement Initiatives and High Risk Areas of Exposure for China Food Operations and Imports
Fang He
Partner
June He Law Offices (Beijing, China)
- Best practices for U.S. companies when importing food from China
- Examining food products most at risk and what U.S. companies can do to work with Chinese ingredient and food suppliers and manufacturers to ensure food safety
- How to obtain appropriate certifications and verifications from suppliers in China
11:00 Morning Coffee Break
11:15 Customs Spotlight Address: An Inside Look into How U.S. Customs Monitors Food Importation
Valerie M. Neuhart*
Director, Import Safety and Interagency Requirements
U.S. Customs and Border Protection
U.S. Department of Homeland Security (Washington, DC)
11:45 Interactive Panel Session: 5 Food Recall Tips You Know Now You Wish You Had Known Then
Susan M. Denigan
Vice President & General Counsel
Nestle Purina Petcare Company (St. Louis, MO)
Frank C. Rothrock
Partner
Shook, Hardy & Bacon L.L.P. (Irvine, CA)
During this interactive session hear from a diverse panel of legal counsel and food safety experts as they share with you some of their most valuable lessons learned from recent industry recalls. Please come prepared with questions as ample time will be provided for Q&A with the panel as well.
12:30 Ensuring Food Defense to Meet New Government Expectations Post-FSMA: How to Incorporate Bioterrorism, Intentional Contamination and Security Controls into Your Food Safety Plan
Robert E. Brackett, PhD
IIT Vice President and IFSH Director/Co-Director,
National Center for Food Safety and Technology
(Bedford Park, IL)
Sarah Roller
Chair, Food and Drug Law Practice
Kelley Drye & Warren LLP (Washington, DC)
- Knowing what your food defense plan should accomplish
- Document recordation and retention – what types of information should be documented and recorded
- Security and sensors – where and how to monitor
- Distinguishing appropriate measures to address intentional contamination vs. bioterrorism
1:15 Networking Luncheon
2:30 Third Party Auditor Case Study: How to Prepare for New FSMA Provisions Addressing Accreditation of Third Party Auditors and Minimize Downstream Liability - Lessons Learned from the Cantaloupe Outbreak of 2011
Alan Maxwell
Partner
Weinberg Wheeler Hudgins Gunn & Dial LLC (Atlanta, GA)
Illustrating the grave consequences than can arise out of a company’s sole reliance on third party audits, the cantaloupe outbreak of 2011 provides a prime example of the type of situation that Sec. 808 of the Food Safety Modernization Act was drafted to avoid. During this interactive case study panel, hear from counsel experienced in representing companies during high profile food outbreak events, as they outline for you –
- What steps companies can and should consider taking now to minimize downstream liability that can arise out of later determined faulty findings by a third party auditor
- How to audit the auditor – how to ensure that your third party auditor is following government-mandated food safety regulations
- How Sec. 808 of the FSMA will impact corporate screening procedures of third party auditors – what will be required, what to look for
- Pros and cons of utilizing third party auditors vs. in-house
- auditors – does due diligence require the use of third party auditors
- Steps to take to ensure the integrity of the audit and its findings
- Delineating liability between the auditor and the audited – with whom does liability lie
3:00 Responding to FDA’s Increased Access to Records: How to Re-Think Record Retention Protocols and Collect Data in a Manner That Will Minimize Exposure to Government Enforcement or Downstream Litigation
Mark Mansour
Partner
Akin Gump Strauss Hauer & Feld LLP (Washington, DC)
- Knowing what types of records are accessible to the Government and under what circumstances
- Understanding how far up and down the manufacturing, distribution and supply chain the record production obligation extends
- Tips for effectively documenting
- testing and inspection results
- instances of non-conformance
- written plans and reanalysis
- your internal food safety and regulatory compliance procedures vs. those of companies within your supply and distribution chain
- How to comply with reportable food registry requirements without creating a roadmap for Government enforcement or litigation exposure – what to report and when
3:45 GRAS and Emerging Issues Surrounding New Guidance on the Use of New Dietary Ingredients
Cameron Smith
Senior Director, WW Regulatory,
Government and Industry Affairs
Herbalife (Torrance, CA)
- Determining when a premarket safety notification is required for a dietary supplement containing a new dietary ingredient (NDI)
- Defining what qualifies as a NDI
- Overview of the procedures for submitting a NDI notification – what should be included in a NDI notification
- Understanding the types of information FDA will be looking for when evaluating the safety of a dietary supplement containing a NDI, and what should be included in a NDI notification
- Evaluating when a particular substance may be marketed as a dietary ingredient in a dietary supplement
4:15 Conference Concludes
Conference Details