Day 1 - Monday, September 29, 2014

7:30
Registration Begins and Continental Breakfast
8:30
Co-Chairs’ Opening Remarks
8:45
FSMA Update – How to Navigate These Rules to Prepare Your Company for the Long Haul
10:15
Coffee Break
10:30
Key FDA Initiatives Your Company Should Address – Why, When and How?
11:30
California’s Proposition 65 – Update on this Critical Proposition Which Drives the Food Products Market Nationwide
12:00
FDA Keynote Address: FDA Enforcement and Labeling Updates
12:30
During your networking luncheon, take the opportunity to sit with and ask questions of subject matter experts on the following topics affecting your daily operations:
1:45
Product Labeling – How to Make Sure Your Product Labels Comply with Government Requirements
2:45
Marketing and Advertising – How to Structure Your Marketing Campaigns using “Natural,” “Gluten-Free,” “Organic” “Non-GMO”
3:45
Refreshment Break
4:00
Health Claim Substantiation Pop Quiz! – Understanding the Regulatory Requirements for Making Health Claims
4:45
Town Hall Wrap Up – Food “Addiction” Theories: Is Sugar/Salt/Fat the New Nicotine?
5:30
Boot Camp Adjourns to Day Two

Day 2 - Tuesday, September 30, 2014

8:30
Co-Chairs’ Opening Remarks
8:35
USDA Updates – Understanding Dietary Guidelines, Food Safety and Other UDSA Initiatives
9:30
Food Safety – Preventing Adulteration and Contamination that Could Lead to Unsafe Products and Costly Litigation
10:30
Coffee Break
10:45
Food Inspections – What to Do Before, During, and After an Inspection
11:45
USDA Keynote: FSIS Update and New and Proposed Regulations
12:05
Networking Luncheon – Sub-Industry Roundtable (produce, meat, dairy, beverages, etc.)
1:20
Mock Session – Drafting a Food Safety Plan from A to Z
2:15
Record Keeping – How to Effectively Retain and Maintain FDA and USDA Compliance Documentation that Stands Up to Government Scrutiny
3:00
Refreshment Break
3:15
Recalls and Traceability – Interactive Produce Case Study
4:15
GMO Legislative Updates – How the States are Taking the Lead on Genetically Modified Food Labeling and the Implications for Food Companies
5:15
Boot Camp Wrap Up: Checklist for a Proactive FDA and USDA Compliance Program
5:30
Conference Ends

Day 3 - Wednesday, October 1, 2014

9:00
A Practical Guide to FSMA Section 103 – Deep Dive into Hazard Analysis and Risk-Based Preventive Controls
1:30
Food Imports – How to Decipher and Apply FSMA’s Foreign Supplier Verification Program, Voluntary Qualified Importer Program, and USDA’s Proposed Country of Origin Labeling Rule

Day 1 - Monday, September 29, 2014

7:30
Registration Begins and Continental Breakfast
8:30
Co-Chairs’ Opening Remarks

Speakers

Alicia K. White
Senior Procurement, Facilities and Operations Counsel
Whole Foods Market Legal Team (Austin, TX)

Richard Wegener
Partner
Faegre Baker Daniels (Minneapolis, MN)

8:45
FSMA Update – How to Navigate These Rules to Prepare Your Company for the Long Haul

Speakers

Sarah Roller JD, RD, MPH
Partner, Food & Drug Law Practice – Chair
Kelley Drye & Warren LLP (Washington, DC)

Daniel R. Dwyer
Partner
Kleinfeld, Kaplan and Becker, LLP

This session will get you up to speed on FSMA implementation, provide an overview of key developments, and examine practical steps that companies can take to ensure they are taking steps to implement these FSMA rules in ways that offer the greatest value for their business for the long haul.

  • Hazard Analysis and Risk-Based Preventive Controls
  • Produce Standards
  • Sanitary Transportation
  • Foreign Supplier Verification Program
  • Third-Party Certifications and Food Safety Audits
  • Recordkeeping and Record Access
  • Enforcement Authorities

10:15
Coffee Break
10:30
Key FDA Initiatives Your Company Should Address – Why, When and How?

Speakers

Lawrence Reichman
Partner
Perkins Coie LLP (Portland, OR)

In the context of a constantly evolving regulatory environment, this session will guide you through the significant regulatory changes to date including:

  • Understanding FDA’s Nutritional Labeling guidelines
  • Discussing FDA’s tentative determination that PHOs are not GRAS
  • Outlining FDA’s Draft Social Media Guidance
  • Update on “Gluten Free”
  • Dissecting FDA’s final guidance requiring Investigational New Drug Applications for clinical research involving foods and dietary supplements

11:30
California’s Proposition 65 – Update on this Critical Proposition Which Drives the Food Products Market Nationwide

Speakers

Rebecca Cross
Partner
BraunHagey & Borden LLP (San Francisco, CA)

  • Discussing recent enforcement trends
  • How to respond to a Prop 65 Notice of Violation
  • Defending a Prop 65 action – the latest on exposure and naturally occurring defenses
  • Brainstorming creative settlement strategies
  • Incorporating Prop 65 into you compliance programs

12:00
FDA Keynote Address: FDA Enforcement and Labeling Updates

Speakers

Lynn Szybist (Invited)
Supervisor
Food and Drug Administration (College Park, MD)

12:30
During your networking luncheon, take the opportunity to sit with and ask questions of subject matter experts on the following topics affecting your daily operations:

During your networking luncheon, take the opportunity to sit with and ask questions of subject matter experts on the following topics affecting your daily operations:

✓ Inspections
✓ Recalls
✓ GMOs
✓ Product Labeling
✓ Class Action Litigation
✓ California Food Laws
✓ Marketing and Advertising

1:45
Product Labeling – How to Make Sure Your Product Labels Comply with Government Requirements

Speakers

Angela Agrusa
Partner
Liner LLP

  • Understanding the regulatory landscape applicable to food labels
    • 21 CFR parts 100-199
    • FDCA Chapter IV
    • Fair Packaging and Labeling Act of 1966
  • Distinguishing the role of the FDA and USDA in approving information listed on a product label
  • Understanding the scope of authority of FSIS and AMS concerning product labels
  • Distinguishing labels approvable under the prior label
  • Approval system vs. under generic label approval
  • Defining the product “label”
    • front-of-pack, information panel, package insert
    • label requirements – contents, ingredients, allergens
    • how to list information posted on website and advertisements
  • How to avoid allegations of misrepresentation and misbranding

2:45
Marketing and Advertising – How to Structure Your Marketing Campaigns using “Natural,” “Gluten-Free,” “Organic” “Non-GMO”

Speakers

Richard Wegener
Partner
Faegre Baker Daniels (Minneapolis, MN)

“Natural,” “Organic,” “Sustainable,” “Fresh,” “Gluten-Free,” and “Grass-Fed” are claims that are causing companies to come under attack in various regulatory and judicial forums. Come prepared to ask questions on how to optimize your marketing efforts without exposing your company to litigation.

  • “All Natural” Definition – Guidance on how to structure your claims
  • Understanding the development of industry consensus standards and the role of self-regulation
    • Learnings from relevant case law: Trader Joe’s, Kashi, Frito-Lay, Ben & Jerry’s
  • Understanding the latest from the Washington regulatory landscape
  • Recent FDA warning letters
  • Complying with the Organic Food Production Act

3:45
Refreshment Break
4:00
Health Claim Substantiation Pop Quiz! – Understanding the Regulatory Requirements for Making Health Claims

  • What are the different types of beverage product claims?
  • What are the regulatory requirements for making each type of claim?
  • When can information provided on a food product label be classified as “optional information”?
  • Under what circumstances a health claim that has been cleared through FDA’s pre-market clearance procedures can be deemed
    • unauthorized under the FDCA?
    • an unapproved new drug specifically in the context of disease prevention claims?
  • What type and quantity of evidence is sufficient to meet FDA and FTC expectations for product claims?

4:45
Town Hall Wrap Up – Food “Addiction” Theories: Is Sugar/Salt/Fat the New Nicotine?

Moderator

Kurt D. Weaver
Partner
Womble Carlyle Sandridge & Rice, LLP (Raleigh, NC)

In recent years, food and beverage companies have been the target of lawsuits and taken much of the blame for the obesity epidemic in America. Some consumer groups and class action plaintiffs are likening food and beverage companies to the tobacco companies of old by saying that manufacturers are making foods and beverages with “addictive” ingredients like high fructose corn syrup, salt, and fat. In this new and interactive “town hall” you will have the opportunity to hear the opinions of your peers and voice your thoughts on this controversial hot topic.

  • Understanding the addiction hypothesis: Salt, sugar (high fructose corn syrup), fat
  • How are these ingredients in food being compared to nicotine in tobacco?
  • How is the defense of self control now weakened by this food addiction hypothesis?

5:30
Boot Camp Adjourns to Day Two

Day 2 - Tuesday, September 30, 2014

8:30
Co-Chairs’ Opening Remarks
8:35
USDA Updates – Understanding Dietary Guidelines, Food Safety and Other UDSA Initiatives

Speakers

Martin Hahn
Partner
Hogan Lovells

  • Discussing the 2015 Dietary Guidelines and its implications for processed meats
  • Understanding FSIS’s regulatory update on Salmonella
  • Outlining USDA’s Country of Origin labeling rule and how it will affect your imports

9:30
Food Safety – Preventing Adulteration and Contamination that Could Lead to Unsafe Products and Costly Litigation

Speakers

Allyson Wilcox
Assistant General Counsel
Beam Brands (Deerfield, IL)

Trent Taylor
Partner
McGuireWoods LLP (Richmond, VA)

  • Defining “adulteration” and “adulterants” under the FDCA and the Federal Meat Inspection Act
    • Poisonous or deleterious substances
    • Added vs. non-added substances
    • Chemical contaminants and carcinogens
    • Filth and extraneous materials
    • Pesticides, Metals
  • STECs – update on new USDA regulation amending the Federal Meat Inspection Act to add six serotypes of E. coli to the list of prohibited “adulterants” under the Act
  • Contrasting allergens and pathogens and understanding the difference in how the two are regulated by the FDS vs. USDA
  • Update on the Reportable Food Registry and how the FDA has used information

10:30
Coffee Break
10:45
Food Inspections – What to Do Before, During, and After an Inspection

Speakers

Karnail Mudahar
Deputy District Manager, Food Safety and Inspection Service, Office of Field Operations
USDA Chicago District

Frederick Branding
Partner
Olsson Frank Weeda Terman Matz PC. (Washington, DC)

  • Knowing what the Government will be looking for during an inspection
  • How to prepare your records and employees for an inspection
  • How to handle a “surprise” inspection
  • How to respond to agent’s requests on-site
  • Distinguishing a valid investigation from a fishing expedition and how your staff should react to each
  • Formulating a Form 483 response post-inspection
  • How to manage internal and external communications and PR associated with a Government inspection
  • Taking corrective actions post-inspection

11:45
USDA Keynote: FSIS Update and New and Proposed Regulations

Speakers

Karnail Mudahar
Deputy District Manager, Food Safety and Inspection Service, Office of Field Operations
USDA Chicago District

12:05
Networking Luncheon – Sub-Industry Roundtable (produce, meat, dairy, beverages, etc.)

During your networking luncheon, take the opportunity to network with your peers from the same sub-industry and brainstorm issues affecting your business:

✓ Meat
✓ Produce
✓ Dairy
✓ Beverages
✓ Baked Goods

1:20
Mock Session – Drafting a Food Safety Plan from A to Z

Speakers

Janet Raddatz
Vice President - Quality & Food Safety Systems
Sargento Foods Inc. (Plymouth, WI)

Nathan A. Beaver
Partner
Foley & Lardner LLP

Expert speakers will lead you through the drafting of a mock safety plan from start to finish. You will learn a step-by-step approach to this critical component of food safety in your company. Ask questions, provide input, and come away with an effective food safety plan.

  • Determining the “must have elements” for your food safety plan
  • Monitoring your food safety plan
  • Identifying corrective actions to be taken
  • Verification of your food safety plan
  • Understanding the role of “Qualified Individuals”

2:15
Record Keeping – How to Effectively Retain and Maintain FDA and USDA Compliance Documentation that Stands Up to Government Scrutiny

Speakers

Martin Hahn
Partner
Hogan Lovells

  • Key record keeping requirements and common areas of non-compliance
  • What happens if you don’t have the required records to present to FDA or USDA
  • Who should keep your records, and when to delegate to a third party
  • What types of records should be created to comply with FSMA
  • Identifying where relevant records are kept
  • Review of sample relevant records
  • Which records should be retained in hard copies vs. electronic copies

3:00
Refreshment Break
3:15
Recalls and Traceability – Interactive Produce Case Study
4:15
GMO Legislative Updates – How the States are Taking the Lead on Genetically Modified Food Labeling and the Implications for Food Companies

Speakers

Trenton H. Norris
Partner & Head, Consumer Protection Practice
Arnold & Porter LLP (San Francisco, CA)

  • Fed billHR4432 – Safe and Accurate Food Labeling Act
  • 522 in Washington State
  • Prop 37 in California
  • Bill HB112 in Vermont
  • Bill LD718 in Maine
  • Federal Bill: Genetically Engineered Food Right-to-Know Act

5:15
Boot Camp Wrap Up: Checklist for a Proactive FDA and USDA Compliance Program

Participants will walk away from this Boot Camp with a printed checklist of things to do to build or maintain a proactive compliance program. Don’t wait until the government comes knocking at your door – use these strategies to avoid the mistake that can get you in trouble.

5:30
Conference Ends