REGULATORY COMPLIANCE - Food Safety News
REGULATORY COMPLIANCE - Food Safety News REGULATORY COMPLIANCE - Food Safety News
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
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- Page 4 and 5: MAIN CONFERENCE | DAY ONE - Tuesday
- Page 6 and 7: DAY TWO - Wednesday, June 27, 2012
- Page 8: 3 rd Advanced Summit on FOOD SAFETY
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 />
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process your request.<br />
Questions about CLE credits for your state? Visit our online CLE Help Center at<br />
www.americanconference.com/CLE<br />
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Each year more than 21,000 in-house counsel, attorneys in private<br />
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© 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 />
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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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