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How the U.S. Food Safety Modernization Act Could Impact International Regulatory Practices


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Modernize an outdated U.S. food safety system, improve the government’s ability to decrease food-borne illnesses, and strengthen the authority of the Food and Drug Administration (FDA) to govern across the supply chain for both food and pet food. This is a significant statutory change in the food safety law with new FDA food safety that authorities have not seen since the passage of the Food Drug and Cosmetic Act in 1938. This Act is a major shift for the FDA from a reactive to preventive focus; it provides the FDA new authorities and responsibilities while also requiring industry to address new responsibilities.

Companies in the food chain, from “farm to table”, should respond to these new FSMA regulations — some already enacted and some that may be introduced over the next few
years — to improve their overall food safety programs. Impacted stakeholders include:

  • Growers/ producers
  • Ingredient suppliers
  • Processors/ packers
  • Distributors
  • Warehouses

Broad themes that apply across the value chain to support an enhanced food safety program include:

  • Mandatory written food safety plan with hazard analysis and preventive controls
  • Record keeping and records access
  • Facility registration, inspection and compliance
  • Effective response mechanisms for risks and recalls
  • Supplier verification programs, quality of imports / third-party certification
  • Food defense plans

The vast majority of the food supply chain — including U.S. trading partners — are uncertain about what in the new regulations for addressing preventative controls, performance standards, traceability requirements and user fees may require. Such definition may not be available until final regulations are published.

  • What impact will US food safety policy as a result of FSMA have on international trading partner’s food safety regulations and/or policies?
  • What will be the impact on supply chain logistics and in the global marketplace?
  • Define what Congress will do to support the implementation of FSMA in 2013 and beyond. Will FSMA be fully funded?
  • What will be the impact of FSMA on developing markets?
  • What is the impact of FSMA on small business owners and the work USAID supports in developing nations?

This paper provides stakeholders significant insight as to how they might approach FSMA in consideration of the how U.S. trading partners’ regulatory agencies are dealing with food safety in light of new legislation.

As used in this document, “Deloitte” means Deloitte & Touche LLP, a subsidiary of Deloitte LLP. Please see www.deloitte.com/us/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries. Certain services may not be available to attest clients under the rules and regulations of public accounting.

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