The Law of the Foreign Supplier Verification Program Rule

Course Code: FSC 851

Credits: 3 credits

This course provides students with the knowledge and understanding to implement the requirements of the “Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals” regulation of the 2011 U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA). The course materials provide an understanding of the key requirements for the development and implementation of an FSVP. Record keeping systems are emphasized that meet the regulatory requirements to import foods into the USA. Our course has an administrative overtone, providing an understanding of the legislative and regulatory processes through an in-depth look at the relationship between the FDA, industry, consumer interest groups, and scientific communities.

The learning objectives of this course are to enable students to:

  • Summarize the Food Safety Modernization Act (FSMA) and to understand why it was introduced.
  • Understand the history and development of FDA’s Foreign Supplier Verification Programs (FSVP) Rule.
  • Discuss the major provisions of the FSVP Rule.
  • Analyze problems, barriers, and factors affecting FSVP implementation.
  • Examine the current issues in food import law focusing on the FSVP Rule.
  • Identify implementable record keeping requirements.
  • Evaluate FDA’s limitations under FSMA and the FSVP.
  • Recognize the critical role laws and regulations play in protecting import food.
  • Explore the intersection of science and law in relation to import food safety.
  • Define the future challenges and opportunities impacting FSVP.

The course syllabus is subject to change each semester but generally covers the following topics:

  • Overview of FSMA
  • The FSVP process
  • FSVP requirement overview
  • Who must comply?
  • How to develop and implement a FSVP plan
  • Preventive controls and the Produce Safety Rule
  • Foods that cannot be consumed without control of hazards
  • Foods whose hazards are controlled after importation
  • Corrective actions and investigations
  • Importer identification at entry
  • Foreign supplier performance, food risk, and corrective actions
  • Record keeping
  • FDA oversight
  • Dietary Supplements
  • US importers of Canadian foods
  • Very small importers and food from certain small suppliers
  • Analysis of economic and environmental impact
  • Understanding the changing landscape of FSVP regulations
  • Countries with comparable or equivalent safety systems
  • Compliance dates
  • Executive Order 13175
  • Best practices for compliance with FSVP regulations

Schedule:

This course is offered in the first half of the summer semester of even-numbered years only (mid-May to late June).

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