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The seminar also will involve a detailed discussion of an acceptable Food Safety Plan to be developed by the companies which are covered by the Rule. Another element of the seminar will be the requirements for implementation of the Food Safety Plan, such as monitoring of compliance with the Plan, actions in response to issues found during monitoring, mitigation in the event of safety problems, training and recordkeeping. We also will discuss the resources to support industry compliance currently available or under development by FDA.

Learning Objectives:

Upon completing this course participants should:

  • Understand the background and basic food defense requirements of FSMA and the Food Defense Rule
  • Know which companies are and are not covered by the Food Defense Rule
  • Recognize the applicability of exemptions from coverage based on the size of a company and the type of food product
  • Identify the deadlines for compliance with the Rule applicable to their business
  • Understand the elements of an acceptable Food Safety Plan
  • Understand the actions which must be taken to implement the Plan
  • Be informed on the recordkeeping requirements of the Food Defense Rule
  • Recognize the FDA resources which have been established to help industry comply with the Rule
  • Understand the consequences of non-compliance
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

  • Plant owners or operators (domestic and foreign)
  • Personnel tasked with compliance with the Food Defense Rule
  • Regulatory compliance personnel
  • Plant security personnel

Topic Background:

For the first time, the Food Safety Modernization Act (FSMA), passed in 2013, required FDA to impose on food producers an obligation to draft and implement Food Defense Plans for defense of their food processes and products against terrorists compromising the safety of the food supply. In May 2016, FDA issued the final rule to implement the requirements of FSMA for FDA to require companies to develop and maintain Food Defense Plans to protect food against intentional adulteration. Food Defense and intentional adulteration of food in this context mean intentional contamination that could cause serious adverse health consequences to humans or animals, as determined by FDA in consultation with the Department of Homeland Security.

Pursuant to the FSMA mandate, on May 26,2016, FDA issued the final rule entitled Migration Strategies to Protect Food Against Intentional Adulteration (the Food Defense Rule). The Rule applies to all food facilities, domestic and foreign, which produce food for consumption in the United States and are therefore required to register with FDA under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food Defense Rule is subject to certain exemptions, which will be discussed in the seminar.

The Rule became effective July 26, 2016, but FDA extended the time for companies to comply. For very small businesses (averaging less than $10,000,000 per year in sales of human food), the compliance period is 5 years from publication of the Final Rule. Very small businesses also are able to comply through some requirements which are less onerous than for larger businesses. For small businesses (businesses with fewer than 500 employees but are not very small businesses) the Final Rule requires compliance 4 years after publication of the Rule.

Businesses that are not very small or small and do not qualify for any other exemptions have 3 years from publication of the Rule to comply. According to FDA, the Rule is primarily aimed at larger companies whose products reach many people. The Agency estimates that there are 3,400 covered firms that operate 9,800 facilities.

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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introduction to the provisions of FSMA with respect to the risk of intentional contamination of the food supply
    • Overview of the Food Defense Rule
      • Hazard Analysis Critical Control Point (HACCP)-type approach
    • The meaning of intentional adulteration in the context of FSMA and the Food Defense Rule
    • Businesses covered by the Food Defense Rule
      • Meaning most
    • Exemptions from coverage
      • Very small business, but documentation of very small status required
      • Holding of food, except in liquid storage tanks
      • Packing, repacking, labeling or relabeling for food where the container that directly contacts food remains intact
      • Activities that fall within the definition of “farm”
      • Manufacturing, processing, packing, or holding of food for animals
      • Alcoholic beverages under certain conditions
      • On-farm manufacturing, processing, packing of holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the Rule. These foods include types of eggs and certain types of game meat
    • Deadlines for compliance
      • Vary with size of business
    • Consequences of non-compliance
      • Prohibited acts under FD&C Act
      • FD&C Act is a strict liability criminal statute
Day 02(8:30 AM - 4:30 PM)
  • FDA requirements for the elements of a Food Defense Plan Covered facilities must have a written Food Defense Plan, which must include the following elements
    • Vulnerability Assessment
      • Conduct or have conducted a vulnerability assessment for each type of food manufactured, processed, packed, or held at your facility using appropriate methods to evaluate each point, step, or procedure in your food operation to identify vulnerabilities and actionable process steps
      • An actionable process step means a point, step, or procedure in a food process where a significant vulnerability exists and at which mitigation strategies can be applied and are essential to significantly minimize or prevent the significant vulnerability
    • Mitigation Strategies
      • Identify and implement mitigation strategies at each actionable process step to provide assurances that the significant vulnerability will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated under the FD&C Act
    • Monitoring
      • Establish and implement written procedures, including the frequency with which they are to be performed, for food defense monitoring of the mitigation strategies
    • Corrective Actions
      • Establish and implement written food defense corrective action procedures that must be taken if mitigation strategies are not properly implemented.
    • Food Defense Verification
      • Verification that defense monitoring is being performed according to the Plan
      • Verification that appropriate decisions about food defense corrective actions are being made
      • Verification of reanalysis
        • Reanalysis of the Food Defense Plan, as a whole, at least once every 3 years
        • Reanalysis if there is a significant change in operations, upon new information about potential vulnerabilities
        • Reanalysis on finding that a mitigation strategy is not properly effective
  • Qualifications of individuals who perform activities with respect to the Food Defense Plan
    • Company must ensure that each individual who performs activities with respect to the Plan is a qualified individual
    • Qualified individual means a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity under the Plan, as appropriate to the individual's assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.
  • Recordkeeping
    • The Food Defense Plan must be retained onsite at the facility covered by the plan
    • Existing records may be used in meeting the FDA recordkeeping requirements, but all documents used as part of the Plan must be maintained onsite
    • Other records may be maintained onsite if available within 24 hours
    • All records required by the Food Defense Rule must be retained at the facility for at least 2 years after they were prepared
  • FDA resources to assist industry compliance
    • FDA has established an Intentional Adulteration Subcommittee with the Food Safety Preventive Controls Alliance to develop food defense training resources for industry and regulators
    • FDA intends to publish guidance documents on issues such as conducting a vulnerability assessment, identifying and implementing mitigation strategies, and writing procedures for food defense monitoring, corrective actions, and verification
    • Tools currently available on FDA's website
      • Mitigation Strategies Database is an online, searchable listing of mitigation strategies that can be applied to different steps in a food operation
      • The FDA FSMA Food Safety Technical Assistance Network is operational and provides a central source of information to support industry understanding and implementation of FSMA. Questions submitted online or by mail will be answered by information specialists of subject matter experts.
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Ralph Simmons

Ralph Simmons
Chairman and President, Ralph A. Simmons LLC

Ralph A. Simmons has over 35 years of experience in FDA regulation of food, and related products such as direct food additives, and food-contact substances. This experience has included the representation of companies with FDA-regulated products and experience as a senior policy advisor within FDA. The experience in FDA included work on regulations to implement FSMA.

Mr. Simmons has extensive experience in working with FDA on FSMA regulations and regulations in related areas, such as direct food additives and food-contact substances. This experience has included representing industry in negotiations with FDA, which avoided having food-contact material suppliers being registered under FDA’s program of registration of food facilities, located domestically and internationally.

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Frederick R. Weisman Art Museum

Frederick R. Weisman Art Museum

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This living history museum commemorates the establishment of a fort here in the wilderness in 1819 by Col. Josiah Snelling and his troops, who opened the area for homesteaders. Costumed guides are the focus of a living history reenactment during the summer months, re-creating the activities of everyday army life during the 1820s.

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Mississippi River Visitor Center

Located inside the entrance to the Science Museum of Minnesota , the Mississippi River Visitor Center is operated by the National Park Service and designed to educate visitors about the Mississippi National River & Recreation Area. Park rangers can assist travelers with planning outdoor excursions, including canoe and riverboat trips, hiking, biking, and birding. If you're at all outdoorsy, it's worth a stop.

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Hands-on exhibits introduce visitors to natural history, science, and technology in this massive museum. Highlights include the Human Body Gallery, navigating a virtual towboat down the Mississippi River, and a collection of fossils and prehistoric specimens. In warm months check out EarthScapes Mini Golf, a new activity designed to teach earth surface dynamics. There's also an Omnitheater.

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University of Minnesota

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