REGULATORY COMPLIANCE - Food Safety News

REGULATORY COMPLIANCE - Food Safety News REGULATORY COMPLIANCE - Food Safety News

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3 rd Advanced Summit on FOOD SAFETY REGULATORY COMPLIANCE June 26-27, 2012 | Millennium Knickerbocker Hotel - Chicago, IL ❯ Reworking Food Safety Protocols and Compliance Programs in Response to New FSMA Requirements ❯ Minimizing Risk of Exposure to Government Enforcement, Product Scrutiny and Litigation Hear from these industry leaders Cargill ConAgra Herbalife H.J. Heinz J.M. Smucker Focus on China: ❯ Spotlight Address – The Evolution of Food Safety Law in China ❯ Food Regulation in China – Local Regulatory Enforcement Initiatives and High Risk Areas of Exposure for Food Operations NEW Interactive Working Groups June 25, 2012: A B Preventive Controls Post-FSMA: Risk-Based Internal Controls to Minimize and Prevent Hazards That Can Lead to Food Adulteration and Misbranding Foreign Supplier Verification Program and Food Imports Compliance ❯ How to Conduct Effective Risk-Based Screening of Foreign Suppliers and Ensure Adequate Certifications of Third Parties and Imported Food Media and Association Partners: Nestle Purina Petcare Sara Lee Target Whole Foods Gain in-depth guidance on how to update your internal controls post-FSMA in the following high risk areas: ✓ Expanded FDA access to company records ✓ Production and harvesting of fruits and vegetables ✓ Food defense – bioterrorism, intentional contamination and security controls ✓ Foreign supplier verification and food imports Learn how to minimize product exposure triggered by: ✓ Food Safety Law in Transition – How to Ensure Compliance with Evolving and Conflicting Federal, State and Local Regulatory Requirements ✓ Pathogens, Allergens and Food Contaminants – How to Test For, Measure, Control and Identify Pathogens, Allergens and Other Food Contaminants in Your Products ✓ Recalls – 5 Tips You Know Now You Wish You Had Known Then NEW interactive case study sessions: ❯ Inspections –How to Implement Effective Remediation and Corrective Action Plans Post-Inspection ❯ Point-Counter Point Debate – Examining the Scope of the FDA’s Regulatory Authority under FSMA ❯ Risk Assessment – A Corporate Approach to Conducting Effective Risk Assessments across Food Operations ❯ Third Party Auditors – Lessons Learned from the 2011 Cantaloupe Outbreak Sponsored by: Earn CLE Credits Conference Contributor: Register Now • 888-224-2480 • AmericanConference.com/food

3 rd Advanced Summit on<br />

FOOD SAFETY<br />

<strong>REGULATORY</strong> <strong>COMPLIANCE</strong><br />

June 26-27, 2012 | Millennium Knickerbocker Hotel - Chicago, IL<br />

❯ Reworking <strong>Food</strong> <strong>Safety</strong> Protocols and Compliance Programs in Response to New FSMA Requirements<br />

❯ Minimizing Risk of Exposure to Government Enforcement, Product Scrutiny and Litigation<br />

Hear from these industry leaders<br />

Cargill<br />

ConAgra<br />

Herbalife<br />

H.J. Heinz<br />

J.M. Smucker<br />

Focus on China:<br />

❯ Spotlight Address – The Evolution of <strong>Food</strong> <strong>Safety</strong><br />

Law in China<br />

❯ <strong>Food</strong> Regulation in China – Local Regulatory<br />

Enforcement Initiatives and High Risk Areas<br />

of Exposure for <strong>Food</strong> Operations<br />

NEW Interactive Working Groups<br />

June 25, 2012:<br />

A<br />

B<br />

Preventive Controls Post-FSMA: Risk-Based<br />

Internal Controls to Minimize and Prevent Hazards<br />

That Can Lead to <strong>Food</strong> Adulteration and Misbranding<br />

Foreign Supplier Verification Program and <strong>Food</strong><br />

Imports Compliance<br />

❯ How to Conduct Effective Risk-Based Screening<br />

of Foreign Suppliers and Ensure Adequate<br />

Certifications of Third Parties and Imported <strong>Food</strong><br />

Media and Association Partners:<br />

Nestle Purina Petcare<br />

Sara Lee<br />

Target<br />

Whole <strong>Food</strong>s<br />

Gain in-depth guidance on how to update your internal controls<br />

post-FSMA in the following high risk areas:<br />

✓ Expanded FDA access to company records<br />

✓ Production and harvesting of fruits and vegetables<br />

✓ <strong>Food</strong> defense – bioterrorism, intentional contamination and security controls<br />

✓ Foreign supplier verification and food imports<br />

Learn how to minimize product exposure triggered by:<br />

✓ <strong>Food</strong> <strong>Safety</strong> Law in Transition – How to Ensure Compliance with Evolving<br />

and Conflicting Federal, State and Local Regulatory Requirements<br />

✓ Pathogens, Allergens and <strong>Food</strong> Contaminants – How to Test For, Measure,<br />

Control and Identify Pathogens, Allergens and Other <strong>Food</strong> Contaminants<br />

in Your Products<br />

✓ Recalls – 5 Tips You Know Now You Wish You Had Known Then<br />

NEW interactive case study sessions:<br />

❯ Inspections –How to Implement Effective Remediation and Corrective<br />

Action Plans Post-Inspection<br />

❯ Point-Counter Point Debate – Examining the Scope of the FDA’s Regulatory<br />

Authority under FSMA<br />

❯ Risk Assessment – A Corporate Approach to Conducting Effective Risk<br />

Assessments across <strong>Food</strong> Operations<br />

❯ Third Party Auditors – Lessons Learned from the 2011 Cantaloupe Outbreak<br />

Sponsored by:<br />

Earn<br />

CLE<br />

Credits<br />

Conference Contributor:<br />

Register Now • 888-224-2480 • AmericanConference.com/food


Since the passage of the <strong>Food</strong> <strong>Safety</strong> Modernization Act<br />

in January 2011, the FDA has been very busy…<br />

March 9, 2012 Domestic Facility Risk Categorization for FY 2012 was released, including<br />

guidance on the categorization of “high risk” food facilities<br />

March 1, 2012 Interim Final Rule on the Establishment, Maintenance, and Availability<br />

of Records became effective<br />

October 2011<br />

July 3, 2011<br />

Guidance issued on “What You Need to Know about Administrative<br />

Detention of <strong>Food</strong>s”<br />

Interim Final Rule on “Information Required in Prior Notice of Imported<br />

<strong>Food</strong>” became effective<br />

The above is only a sampling of the numerous implementing regulations and industry guidance<br />

that have been issued by the FDA in recent months since the passage of the <strong>Food</strong> <strong>Safety</strong><br />

Modernization Act – how is your company or client working to update company policies across<br />

departments in order to remain compliant under new and soon-to-be implemented regulations?<br />

Learn how new requirements under FSMA will impact your legal and<br />

business operations – prepare your business now.<br />

Back for a third successful installment, this annual forum has been developed to provide in-house<br />

food safety, regulatory and compliance officers and legal counsel with an opportunity to network<br />

and benchmark internal protocols and procedures in response to new regulatory requirements<br />

under the <strong>Food</strong> <strong>Safety</strong> Modernization Act. Featuring insights from a faculty of expert industry<br />

leaders and legal counsel who are on the cutting edge of implementation under the Act, ACI’s<br />

<strong>Food</strong> <strong>Safety</strong> Regulatory Compliance Summit will provide attendees with the most up-to-date<br />

information to aid you in your day-to-day practice.<br />

Take advantage of this opportunity to benchmark with your in-house peers and leading food<br />

attorneys as you are provided with the most up-to-date information on how key provisions<br />

under the <strong>Food</strong> <strong>Safety</strong> Modernization Act will impact your legal and business operations today,<br />

tomorrow and in the years to come.<br />

Also addressing the day-to-day, evergreen issues that in-house food safety, regulatory and<br />

compliance executives and legal counsel face on a day-to-day basis, this unique summit will also<br />

provide attendees with practical solutions to addressing your most pressing concerns surrounding:<br />

• preventive controls<br />

• foreign supplier verification<br />

• imported food<br />

Obtain the information you need from those on the leading edge of the food industry as<br />

you gather firsthand information and best practices you can take back to your company and<br />

implement throughout your food supply chain.<br />

Add value to your attendance by joining us at the NEW Interactive Working Group and<br />

Benchmarking Sessions focused on FSMA Regulation for Preventive Controls, Foreign Supplier<br />

Verification and Imported <strong>Food</strong>:<br />

Preventive Controls Post-FSMA: How to Establish Risk-Based Internal Controls that<br />

A<br />

Will Minimize and Prevent Hazards that can Lead to <strong>Food</strong> Adulteration and Misbranding<br />

B<br />

• inspections<br />

• records access<br />

• recalls<br />

Foreign Supplier Verification Program & <strong>Food</strong> Imports Compliance: How to Conduct<br />

Effective Risk-Based Screening of Foreign Suppliers and Ensure Adequate Certifications<br />

of Third Parties and Imported <strong>Food</strong><br />

Reserve space now for members of your food safety, regulatory, compliance and legal teams<br />

and use this event as your annual training! Register now by calling 888-224-2480, faxing your<br />

registration to 877-927-1563 or registering online at www.AmericanConference.com/food.<br />

Here’s what past attendees of<br />

ACI’s <strong>Food</strong> <strong>Safety</strong> Regulatory<br />

Compliance Summit have to say<br />

about this annual industry event:<br />

“My first ACI conference and I was<br />

very impressed.”<br />

Director of <strong>Food</strong> and Workplace<br />

<strong>Safety</strong>, Metz Fresh LLC<br />

“Very informative, speakers were<br />

knowledgeable.”<br />

Quality & Sanitation Manager,<br />

American Licorice Company<br />

“Very good experience.”<br />

Vice President, Tech Sales & General<br />

Counsel, Gilster-Mary Lee Corp.<br />

“Very insightful and relevant to current<br />

topics I deal with on a daily basis.”<br />

Global Procurement & Distribution<br />

Counsel, Whole <strong>Food</strong>s Market<br />

“This was my first ACI conference and<br />

I found it very informative and useful.”<br />

Regulatory Affairs Director,<br />

Kemin <strong>Food</strong> Technologies<br />

An Advanced Benchmarking<br />

Conference Designed for:<br />

<strong>Food</strong> Manufacturers, Retailers,<br />

Distributors, Suppliers, Servers and<br />

Restaurants counsel, directors and<br />

officers with the following titles:<br />

• <strong>Food</strong> <strong>Safety</strong><br />

• Quality Assurance/QA<br />

• Regulatory Affairs<br />

• Compliance<br />

• Government Affairs<br />

• Legal Counsel<br />

• Risk Management<br />

Attorneys practicing in the following<br />

areas and industries:<br />

• FDA Law<br />

• <strong>Food</strong> Law<br />

• <strong>Food</strong> & Beverage<br />

• Agribusiness & <strong>Food</strong> Regulation<br />

• Consumer Products<br />

Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/food


Day One - Monday, June 25, 2012<br />

Interactive Working Group and Benchmarking Session on FSMA Regulation<br />

for Preventive Controls, Foreign Supplier Verification and Imported <strong>Food</strong><br />

Curious to learn if your company is on the right path? Anxious to hear how other companies are preparing<br />

for FSMA-mandated preventive controls and new regulations governing imported food?<br />

By the date of this conference, it is expected that two key sets of regulations under FSMA addressing Risk-Based Preventive Controls under Title I<br />

and Foreign Supplier Verification and Imported <strong>Food</strong> under Title III will have been published. Highly anticipated by the industry given some of the<br />

new requirements outlined in the regulation, these interactive working group sessions have been specifically structured to provide an opportunity for<br />

in-house food safety, regulatory and compliance executives and legal counsel to benchmark current or contemplated internal controls and food safety<br />

plans with peers in a private, intimate setting. Learn what steps your colleagues are taking now to minimize the impact of the final regulations once<br />

published. Take advantage of this unique opportunity to gain real-time feedback and advice on how your company or client may want to go about<br />

structuring its internal preventive controls and policies for addressing imported food and foreign suppliers in light of points laid out in the <strong>Food</strong> <strong>Safety</strong><br />

Modernization Act.<br />

A<br />

9:30 am – 1:00 pm (Registration Begins at 9:00 am) 1:30 pm – 5:00 pm (Registration Begins at 1:00pm)<br />

Industry Benchmarking on Preventive Controls<br />

Post-FSMA: How to Establish Risk-Based Internal<br />

Controls that Will Minimize and Prevent Hazards<br />

That Can Lead to <strong>Food</strong> Adulteration and Misbranding<br />

B<br />

Interactive Working Group on Foreign Supplier<br />

Verification & <strong>Food</strong> Imports Compliance: How to<br />

Conduct Effective Risk-Based Screening of Foreign<br />

Suppliers and Ensure Adequate Certifications of<br />

Third Parties and Imported <strong>Food</strong><br />

Bradd Eldridge<br />

Director, Technical Services<br />

Abbott Nutrition (Chicago, IL)<br />

Dawn Walter<br />

Senior Manager, <strong>Food</strong> <strong>Safety</strong><br />

Sara Lee Corporation (Downers Grove, IL)<br />

Get ahead of the curve while learning from your peers what steps your<br />

company should be taking now to establish effective internal controls<br />

for documenting hazards and implementing preventive controls as<br />

required under Sec. 418 of the <strong>Food</strong> <strong>Safety</strong> Modernization Act. Hear<br />

how your peers at the forefront of the food industry are structuring their<br />

preventive control plans as they engage you in a thorough discussion<br />

of how to establish effective internal procedures and controls for<br />

identifying, testing for and monitoring the presence of various hazards<br />

in your products. Submit your preventive control plan in advance of the<br />

session for anonymous consideration and review by the panel during<br />

the working group. Topics to be discussed during this interactive and<br />

practical benchmarking session will include:<br />

• How to determine when procedures are adequate enough to<br />

“significantly minimize or prevent” the occurrence of hazards<br />

• Monitoring and auditing performance of adequate controls –<br />

are the controls effective?<br />

• Expected “assurances” – information to be included<br />

• Corrective action – when to take it<br />

• Verification and recordkeeping – what to keep, what the FDA<br />

will be looking for when they come knocking<br />

• Written plan, documentation, re-analysis<br />

Shirley Boyd<br />

Assistant General Counsel<br />

Cargill Inc. (Wayzata, MN)<br />

Nancy Husnik<br />

Senior Counsel, Law Department<br />

Target (Minneapolis, MN)<br />

Bruce Silverglade<br />

Principal<br />

Olsson Frank Weeda Terman Bode Matz PC (Washington, DC)<br />

During this interactive working group session, hear from senior-level<br />

in-house counsel and attorneys with expertise in food safety and<br />

import compliance as they share with you best practices and insights<br />

for preparing your company for impending regulations on imported<br />

food. Learn how your colleagues are structuring risk-based screening<br />

and auditing procedures to ensure that your foreign suppliers and third<br />

parties are updating their internal controls and food safety procedures<br />

to be in compliance with new provisions under Title III. Topics to be<br />

discussed during this interactive and practical session will include:<br />

• Reevaluating foreign suppliers to ensure their food safety protocols<br />

are in line with new requirements under Title III<br />

• Understanding required certifications and audit report submission<br />

requirements<br />

• Import re-inspection – how to handle this in practice<br />

• Inspection fees<br />

• Ensuring prior notice of imported food is recorded in accordance<br />

with FDA’s June 2011 Guidance for Industry addressing enforcement<br />

• Anticipating the FDA’s proposed regulations on third party<br />

auditing – what we can expect and when we can expect it<br />

Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/food


MAIN CONFERENCE | DAY ONE – Tuesday, June 26, 2012<br />

8:30 Registration Begins & Continental Breakfast<br />

9:15 Co-Chair’s Opening Remarks<br />

Adam M. Ekonomon<br />

Director, Regulatory law and Assistant General Counsel<br />

The J.M. Smucker Company (Orrville, OH)<br />

Tracey Phillips Beck<br />

Vice President & Chief Operations Counsel<br />

ConAgra <strong>Food</strong>s (Omaha, NE)<br />

9:30 <strong>Food</strong> <strong>Safety</strong> Law in Transition: How to Ensure<br />

Compliance with Evolving and Conflicting Federal,<br />

State and Local Requirements Post-FSMA<br />

Tracey Phillips Beck<br />

Vice President & Chief Operations Counsel<br />

ConAgra <strong>Food</strong>s (Omaha, NE)<br />

Ralph S. Tyler<br />

Partner<br />

Venable LLP (Washington, DC)<br />

Former Chief Counsel, <strong>Food</strong> and Drug Administration<br />

• Understanding how the FDA, USDA and local enforcement<br />

authorities are working collaboratively and separately to<br />

regulate food products post-FSMA<br />

• Comparing and contrasting approaches to regulation<br />

and enforcement by FDA vs. USDA<br />

• Update on regulatory initiatives undertaken as part of<br />

inter-agency cooperation efforts<br />

• Deciphering regulatory requirements for food products<br />

in various states – how to stay abreast of regulatory and<br />

compliance requirements across jurisdictions<br />

10:30 Morning Coffee Break<br />

10:45 Pathogen Control and Allergen Testing: How to<br />

Test For, Measure, Control and Identify Pathogens,<br />

Allergens and Other <strong>Food</strong> Contaminants in Your<br />

Products<br />

Dawn Walter<br />

Senior Manager, <strong>Food</strong> <strong>Safety</strong><br />

Sara Lee Corporation (Downers Grove, IL)<br />

• Contrasting allergens with pathogens and understanding the<br />

difference in how the two are regulated by the FDA vs. USDA<br />

• Distinguishing allowable amounts of pathogens/<br />

contaminants for food products as regulated under<br />

FDA vs. USDA<br />

- understanding how and why each agency treats the same<br />

contaminant/pathogen differently<br />

- identifying “acceptable” levels of salmonella, e.coli,<br />

dioxins, GMOs, pesticides, antibiotics and other<br />

pathogens/contaminants<br />

• Overview of new procedures for measuring and identifying<br />

contaminants in food products – what to test for and how<br />

to test for it<br />

• What to do if a contaminant is found in your product –<br />

corrective measures vs. recall<br />

• Current labeling issues surrounding allergens<br />

• Lessons learned from recent high profile food recalls involving<br />

pathogens and allergens<br />

11:30 Point-Counter Point Debate - The Evolution of<br />

FDA’s Authority to Regulate the <strong>Food</strong> Industry:<br />

Understanding Where FDA’s Scope of Authority<br />

under FSMA Begins and Ends<br />

Gary Jay Kushner<br />

Partner and Leader, <strong>Food</strong> and Agriculture Practice<br />

Hogan Lovells (Washington, DC)<br />

David Plunkett<br />

Senior Staff Attorney, <strong>Food</strong> <strong>Safety</strong> Department<br />

Center for Science in the Public Interest (Washington, DC)<br />

During this point-counter point debate be engaged in a<br />

provocative, real-time discussion of FDA’s contemplated<br />

“expanded” authority under the <strong>Food</strong> <strong>Safety</strong> Modernization<br />

Act. Hear from counsel on both sides of this heated debate as<br />

they share with you perspectives on:<br />

• The FDA’s authority to regulate the food industry under<br />

the FSMA – is the FDA acting outside the scope of its<br />

authority?<br />

• How enforcement by the FDA is changing post-FSMA<br />

vs. pre-FSMA<br />

• The new role of discretion under the FSMA<br />

• How compliance with new FDA regulations and guidance<br />

can be a point of exposure – private litigation, reputational<br />

damage, etc.<br />

12:30 Networking Luncheon<br />

FOCUS ON INSPECTIONS<br />

1:45 <strong>Food</strong> Inspections: Assessing Risk Factors for<br />

Government Targets and How to Minimize<br />

Downstream Liability Exposure Arising Out<br />

of “Surprise” Inspections<br />

Adam M. Ekonomon<br />

Director, Regulatory law and Assistant General Counsel<br />

The J.M. Smucker Company (Orrville, OH)<br />

Sarah L. Brew<br />

Leader, <strong>Food</strong> Litigation & Regulation Practice Group<br />

Faegre Baker Daniels LLP (Minneapolis, MN)<br />

• Overview of what types of facilities have been most<br />

susceptible to inspections over the past year –<br />

- identifying if your facility could be flagged as “high risk”<br />

for the purpose of inspections under Sec. 421<br />

- understanding how facilities are targeted for inspection<br />

under the new PREDICT system (Predictive Risk-Based<br />

Evaluation for Dynamic Import Compliance Targeting)<br />

factors considered -<br />

- manufacturer’s history with the FDA<br />

- lab test results<br />

- weather conditions<br />

Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/food


• Deciphering the timelines for the inspection of “high risk”<br />

vs. “non-high risk” facilities<br />

• Lessons learned from recent industry inspections – eggs,<br />

sprouts, restaurants<br />

• Preparing effective internal controls and procedures<br />

for a “surprise” inspection<br />

- ensuring your books are in order<br />

- training staff on what types of behavior are viewed<br />

as cooperative vs. uncooperative<br />

- how to respond to an investigator’s request<br />

- distinguishing a valid investigation from a fishing<br />

expedition – how to instruct your staff to react to each<br />

2:45 Mock Case Study: How to Implement Effective<br />

Remediation and Corrective Action Post-Inspection<br />

Jason R. Klinowski<br />

Freeborn & Peters LLP (Chicago, IL)<br />

During this session be engaged in a live mock case study as Jason<br />

guides you through a comprehensive discussion of how to take<br />

swift and appropriate corrective actions post-inspection. Topics<br />

to be discussed during this session will include:<br />

• How to respond to Form 483 observations<br />

• Documenting corrective steps and ensuring compliance<br />

with new procedures outlined post-inspection<br />

• Handling food re-labeling issues for products identified<br />

during inspection<br />

• Lessons learned from the Dominguez <strong>Food</strong>s detention<br />

and seizure<br />

3:30 Afternoon Refreshment Break<br />

3:45 Preparing for New Standards in Produce <strong>Safety</strong>:<br />

How to Re-Adjust <strong>Food</strong> <strong>Safety</strong> and Compliance<br />

Protocols to Minimize Liability Risk and Comply<br />

with Anticipated Regulations for the Safe Production<br />

and Harvesting of Fruits and Vegetables<br />

Alicia K. White<br />

Global Procurement and Distribution Transactional Counsel<br />

Whole <strong>Food</strong>s Market (Austin, TX)<br />

Leslie T. Krasny<br />

Partner, Keller and Heckman LLP (San Francisco, CA)<br />

General Counsel, Produce Marketing Association<br />

Hear from senior food safety and regulatory affairs executives<br />

and legal counsel as they discuss with you current FDA proposals<br />

addressing standards for produce safety under Sec. 419 of the<br />

<strong>Food</strong> <strong>Safety</strong> Modernization Act. Topics to be addressed by this<br />

session will include:<br />

• Impact of the proposed regulations on “small” and “very<br />

small” businesses – how to determine if raw agricultural<br />

products produced by your facility are “low risk”<br />

• Factors relative to the growing and harvesting of<br />

produce that will be regulated – soil, hygiene, packaging,<br />

temperature and water<br />

• Hazards to be addressed by the regulation – naturally<br />

occurring, unintentionally introduced, intentionally<br />

introduced<br />

• Prioritization of the applicability of the regulation – assessing<br />

the risk level of produce and agronomic practices based on<br />

“known safety risks”<br />

• Overview of exemptions for direct farm marketing<br />

• Examination of current industry-led food safety proposals<br />

for the produce industry - Produce Traceability Initiative (PTI)<br />

• Finished product testing –<br />

- identifying legal obligations for ensuring your company’s<br />

due diligence obligations are met<br />

- how often should testing be informed<br />

- when is sampling OK, what to look for<br />

- what to do with the results<br />

* By the date of this event, it is expected that rulemaking for<br />

comment on standards for produce safety will have issued. The<br />

content of this session will be updated to address the regulation<br />

under Sec. 419 in its current form as published by FDA.<br />

4:45 Risk Assessment Case Study: A Corporate<br />

Approach to Conducting Effective Risk<br />

Assessments across Your <strong>Food</strong> Operations<br />

Daniel Forrest Shaw<br />

Vice President, Deputy General Counsel<br />

H.J. Heinz Company (Pittsburgh, PA)<br />

• Identifying what your self-assessment process needs to<br />

accomplish<br />

• Tips for outlining when, how often and by whom should<br />

risk assessments be conducted?<br />

• Ensuring an efficient process for addressing consumer<br />

and product complaints<br />

• Evaluating whether or not your company is utilizing<br />

sustainable business practices to prevent downstream litigation<br />

- how to detect and address behavior that can open the<br />

door to class/mass action litigation<br />

- understanding the difference between regulatory action<br />

and company behavior that can trigger consumer fraud<br />

litigation vs. personal injury litigation<br />

• Ensuring key members in each department – legal,<br />

marketing and regulatory – are clear regarding what<br />

the reporting structure is for compliance infractions<br />

5:15 Conference Adjourns to Day Two<br />

“My first ACI conference and I was very impressed.”<br />

Director of <strong>Food</strong> and Workplace <strong>Safety</strong>, Metz Fresh LLC<br />

“Very informative, speakers were knowledgeable.”<br />

“Quality & Sanitation Manager, American Licorice Company<br />

”<br />

Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/food


DAY TWO – Wednesday, June 27, 2012<br />

9:15 Co-Chairs’ Remarks<br />

FOCUS ON CHINA<br />

9:30 China Spotlight Address: The Evolution of <strong>Food</strong><br />

<strong>Safety</strong> Law in China – Overview of Local <strong>Food</strong><br />

<strong>Safety</strong> Regulations and New Requirements for<br />

<strong>Food</strong> Operations in China<br />

Representative<br />

U.S. <strong>Food</strong> and Drug Administration* (Beijing, China)<br />

Hear from a representative from the U.S. FDA’s China Office<br />

as you are provided with an in-depth overview of the current<br />

status of food regulation in China. Gain an on-the-ground<br />

perspective into what regulatory challenges food and ingredient<br />

manufacturers in China have been facing as well as insights into<br />

what steps U.S. food manufacturers should be taking to ensure<br />

that food products imported from China are manufactured<br />

in compliance with US federal regulations and new provisions<br />

under FSMA.<br />

10:15 <strong>Food</strong> Regulation in China: Update on Local<br />

Enforcement Initiatives and High Risk Areas of<br />

Exposure for China <strong>Food</strong> Operations and Imports<br />

Fang He<br />

Partner<br />

June He Law Offices (Beijing, China)<br />

• Best practices for U.S. companies when importing food<br />

from China<br />

• Examining food products most at risk and what U.S.<br />

companies can do to work with Chinese ingredient and<br />

food suppliers and manufacturers to ensure food safety<br />

• How to obtain appropriate certifications and verifications<br />

from suppliers in China<br />

11:00 Morning Coffee Break<br />

11:15 Customs Spotlight Address: An Inside Look into<br />

How U.S. Customs Monitors <strong>Food</strong> Importation<br />

Valerie M. Neuhart*<br />

Director, Import <strong>Safety</strong> and Interagency Requirements<br />

U.S. Customs and Border Protection<br />

U.S. Department of Homeland Security (Washington, DC)<br />

11:45 Interactive Panel Session: 5 <strong>Food</strong> Recall Tips You<br />

Know Now You Wish You Had Known Then<br />

Susan M. Denigan<br />

Vice President & General Counsel<br />

Nestle Purina Petcare Company (St. Louis, MO)<br />

Madeleine M. McDonough<br />

Co-Chair, Agribusiness & <strong>Food</strong> <strong>Safety</strong> Practice<br />

Shook, Hardy & Bacon L.L.P. (Washington, DC)<br />

During this interactive session hear from a diverse panel of legal<br />

counsel and food safety experts as they share with you some of<br />

their most valuable lessons learned from recent industry recalls.<br />

Please come prepared with questions as ample time will be<br />

provided for Q&A with the panel as well.<br />

12:30 Ensuring <strong>Food</strong> Defense to Meet New Government<br />

Expectations Post-FSMA: How to Incorporate<br />

Bioterrorism, Intentional Contamination and<br />

Security Controls into Your <strong>Food</strong> <strong>Safety</strong> Plan<br />

Robert E. Brackett, PhD<br />

IIT Vice President and IFSH Director/Co-Director,<br />

National Center for <strong>Food</strong> <strong>Safety</strong> and Technology<br />

(Bedford Park, IL)<br />

Sarah Roller<br />

Chair, <strong>Food</strong> and Drug Law Practice<br />

Kelley Drye & Warren LLP (Washington, DC)<br />

• Knowing what your food defense plan should accomplish<br />

• Document recordation and retention – what types of<br />

information should be documented and recorded<br />

• Security and sensors – where and how to monitor<br />

• Distinguishing appropriate measures to address intentional<br />

contamination vs. bioterrorism<br />

1:15 Networking Luncheon<br />

2:30 Third Party Auditor Case Study: How to Prepare for<br />

New FSMA Provisions Addressing Accreditation of<br />

Third Party Auditors and Minimize Downstream<br />

Liability - Lessons Learned from the Cantaloupe<br />

Outbreak of 2011<br />

Alan Maxwell<br />

Partner<br />

Weinberg Wheeler Hudgins Gunn & Dial LLC (Atlanta, GA)<br />

Illustrating the grave consequences than can arise out of a<br />

company’s sole reliance on third party audits, the cantaloupe<br />

outbreak of 2011 provides a prime example of the type of<br />

situation that Sec. 808 of the <strong>Food</strong> <strong>Safety</strong> Modernization Act<br />

was drafted to avoid. During this interactive case study panel,<br />

hear from counsel experienced in representing companies during<br />

high profile food outbreak events, as they outline for you –<br />

• What steps companies can and should consider taking now<br />

to minimize downstream liability that can arise out of laterdetermined<br />

faulty findings by a third party auditor<br />

• How to audit the auditor – how to ensure that your third<br />

party auditor is following government-mandated food<br />

safety regulations<br />

• How Sec. 808 of the FSMA will impact corporate screening<br />

procedures of third party auditors – what will be required,<br />

what to look for<br />

• Pros and cons of utilizing third party auditors vs. in-house<br />

auditors – does due diligence require the use of third party<br />

auditors<br />

• Steps to take to ensure the integrity of the audit and its<br />

findings<br />

• Delineating liability between the auditor and the audited –<br />

with whom does liability lie<br />

* Denotes Invited Speaker at the Time of Print<br />

Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/food


3:00 Responding to FDA’s Increased Access to Records:<br />

How to Re-Think Record Retention Protocols<br />

and Collect Data in a Manner That Will Minimize<br />

Exposure to Government Enforcement or<br />

Downstream Litigation<br />

Nancy Husnik<br />

Senior Counsel, Law Department<br />

Target (Minneapolis, MN)<br />

Mark Mansour<br />

Partner<br />

Akin Gump Strauss Hauer & Feld LLP (Washington, DC)<br />

• Knowing what types of records are accessible to the<br />

Government and under what circumstances<br />

• Understanding how far up and down the manufacturing,<br />

distribution and supply chain the record production<br />

obligation extends<br />

• Tips for effectively documenting-<br />

- testing and inspection results<br />

- instances of non-conformance<br />

- written plans and reanalysis<br />

- your internal food safety and regulatory compliance<br />

procedures vs. those of companies within your supply<br />

and distribution chain<br />

• How to comply with reportable food registry requirements<br />

without creating a roadmap for Government enforcement<br />

or litigation exposure – what to report and when<br />

3:45 GRAS and Emerging Issues Surrounding New<br />

Guidance on the Use of New Dietary Ingredients<br />

Cameron Smith<br />

Senior Director, WW Regulatory,<br />

Government and Industry Affairs<br />

Herbalife (Torrance, CA)<br />

• Determining when a premarket safety notification is<br />

required for a dietary supplement containing a new<br />

dietary ingredient (NDI)<br />

• Defining what qualifies as a NDI<br />

• Overview of the procedures for submitting a NDI<br />

notification – what should be included in a NDI notification<br />

• Understanding the types of information FDA will be<br />

looking for when evaluating the safety of a dietary<br />

supplement containing a NDI, and what should be<br />

included in a NDI notification<br />

• Evaluating when a particular substance may be marketed<br />

as a dietary ingredient in a dietary supplement<br />

4:15 Conference Concludes<br />

“Very insightful and relevant to current topics I deal with<br />

on a daily basis.”<br />

Global Procurement & Distribution Counsel, Whole <strong>Food</strong>s Market<br />

“This was my first ACI conference and I found it very informative<br />

and useful.”<br />

Regulatory Affairs Director, Kemin <strong>Food</strong> Technologies<br />

Continuing Legal Education Credits<br />

CLE<br />

Credits<br />

Accreditation will be sought in those jurisdictions requested by the<br />

registrants which have continuing education requirements. This<br />

course is identified as nontransitional for the purposes of CLE<br />

accreditation.<br />

ACI certifies that the activity has been approved for CLE credit by the New<br />

York State Continuing Legal Education Board in the amount of 11.5 hours. An<br />

additional 4.0 credit hours will apply to participation in workshop A and B.<br />

ACI certifies that this activity has been approved for CLE credit by the State Bar<br />

of California in the amount of 9.25 hours. An additional 3.5 credit hours will<br />

apply to participation in workshop A and B.<br />

You are required to bring your state bar number to complete the appropriate<br />

state forms during the conference. CLE credits are processed in 4-8 weeks after<br />

a conference is held.<br />

ACI has a dedicated team which processes requests for state approval. Please<br />

note that event accreditation varies by state and ACI will make every effort to<br />

process your request.<br />

Questions about CLE credits for your state? Visit our online CLE Help Center at<br />

www.americanconference.com/CLE<br />

Global Sponsorship Opportunities<br />

With more than 500 conferences in the United States, Europe, Asia Pacific,<br />

and Latin America, American Conference Institute (ACI) provides a diverse<br />

portfolio devoted to providing business intelligence to senior decision makers<br />

who need to respond to challenges spanning various industries in the US and<br />

around the world.<br />

As a member of our sponsorship faculty, your organization will be deemed as<br />

a partner. We will work closely with your organization to create the perfect<br />

business development solution catered exclusively to the needs of your practice<br />

group, business line or corporation.<br />

For more information about this program or our global portfolio of events,<br />

please contact:<br />

Wendy Tyler<br />

Head of Sales, American Conference Institute<br />

Tel: 212-352-3220 x5242 | Fax: 212-220-4281<br />

w.tyler@AmericanConference.com<br />

American Conference Institute:<br />

The leading networking and information<br />

resource for counsel and senior executives.<br />

Each year more than 21,000 in-house counsel, attorneys in private<br />

practice and other senior executives participate in ACI events – and<br />

the numbers keep growing.<br />

Guaranteed Value Based on Comprehensive Research<br />

ACI’s highly trained team of attorney-producers are dedicated, full-time, to<br />

developing the content and scope of our conferences based on comprehensive<br />

research with you and others facing similar challenges. We speak your language,<br />

ensuring that our programs provide strategic, cutting edge guidance on practical<br />

issues.<br />

Unparalleled Learning and Networking<br />

ACI understands that gaining perspectives from – and building relationships<br />

with – your fellow delegates during the breaks can be just as valuable as the<br />

structured conference sessions. ACI strives to make both the formal and informal<br />

aspects of your conference as productive as possible.<br />

© American Conference Institute, 2012<br />

Register now: 888-224-2480 • Fax: 877-927-1563 • AmericanConference.com/food


3 rd Advanced Summit on<br />

FOOD SAFETY<br />

<strong>REGULATORY</strong> <strong>COMPLIANCE</strong><br />

June 26-27, 2012 | Millennium Knickerbocker Hotel - Chicago, IL<br />

❯ Reworking <strong>Food</strong> <strong>Safety</strong> Protocols and Compliance Programs in Response to New FSMA Requirements<br />

❯ Minimizing Risk of Exposure to Government Enforcement, Product Scrutiny and Litigation<br />

NEW Interactive Working Groups &<br />

Benchmarking Sessions - June 25, 2012:<br />

A<br />

B<br />

Preventive Controls Post-FSMA: How<br />

to Establish Risk-Based Internal Controls<br />

to Minimize and Prevent Hazards That<br />

Can Lead to <strong>Food</strong> Adulteration and<br />

Misbranding<br />

Foreign Supplier Verification Program<br />

and <strong>Food</strong> Imports Compliance: How to<br />

Conduct Effective Risk-Based Screening<br />

of Foreign Suppliers and Ensure Adequate<br />

Certifications of Third Parties and<br />

Imported <strong>Food</strong><br />

PRIORITY SERVICE CODE<br />

.717L12_INH<br />

ATTENTION MAILROOM: If undeliverable to addressee, please forward to:<br />

<strong>Food</strong> <strong>Safety</strong>, Regulatory Affairs, Compliance, Legal<br />

REGISTRATION FORM Registration Fee<br />

The fee includes the conference‚ all program materials‚ continental breakfasts‚<br />

lunches and refreshments.<br />

Payment Policy<br />

Payment must be received in full by the conference date. All discounts will be<br />

applied to the Conference Only fee (excluding add-ons), cannot be combined<br />

with any other offer, and must be paid in full at time of order. Group discounts<br />

available to individuals employed by the same organization.<br />

Cancellation and Refund Policy<br />

You must notify us by email at least 48 hrs in advance if you wish to send<br />

a substitute participant. Delegates may not “share” a pass between multiple<br />

attendees without prior authorization. If you are unable to find a substitute,<br />

please notify American Conference Institute (ACI) in writing up to 10 days<br />

prior to the conference date and a credit voucher valid for 1 year will be issued<br />

to you for the full amount paid, redeemable against any other ACI conference. If<br />

you prefer, you may request a refund of fees paid less a 25% service charge. No<br />

credits or refunds will be given for cancellations received after 10 days prior to<br />

the conference date. ACI reserves the right to cancel any conference it deems<br />

necessary and will not be responsible for airfare‚ hotel or other costs incurred<br />

by registrants. No liability is assumed by ACI for changes in program date‚<br />

content‚ speakers‚ or venue.<br />

CONFERENCE CODE: 717L12-CHI<br />

YES! Please register the following delegate for the 3rd Advanced Summit on <strong>Food</strong> <strong>Safety</strong> Regulatory Compliance<br />

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FEE PER DELEGATE Register & Pay by May 4, 2012 Register & Pay by June 1, 2012 Register after June 1, 2012<br />

Conference Only $1995 $2095 $2295<br />

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I cannot attend but would like information on accessing the ACI publication library and archive<br />

*ELITEPASS is recommended for maximum learning and networking value.<br />

ACH Payment ($USD)<br />

Please quote the name of the attendee(s) and<br />

the event code 717L12 as a reference.<br />

For US registrants:<br />

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Address: 800 6th Avenue, New York, NY 10001<br />

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Non-US residents please contact Customer Service<br />

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✃<br />

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American Conference Institute is pleased to offer our delegates a limited<br />

number of hotel rooms at a preferential rate. Please contact the hotel directly<br />

and mention the “ACI <strong>Food</strong> <strong>Safety</strong> Regulatory Compliance” conference to receive<br />

this rate:<br />

Venue: Millennium Knickerbocker Hotel<br />

Address: 163 East Walton Place, Chicago, IL 60611<br />

Reservations: 800-621-8140<br />

Incorrect Mailing Information<br />

If you would like us to change any of your details please fax the label on<br />

this brochure to our Database Administrator at 1-877-927-1563, or email<br />

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