May 24, 2022

Volume XII, Number 144

Advertisement
Advertisement

May 23, 2022

Subscribe to Latest Legal News and Analysis
Advertisement

Terrorism Regulations Finish FDA's FSMA Implementation

The U.S. Food and Drug Administration (FDA) recently released the last of its rules crafted to enforce the Food Safety Modernization Act (FSMA). These most recent rules aim to prevent the intentional adulteration of food in the supply chain. The FDA is specifically concerned about stopping insiders who could use their access to facilities to launch terrorist attacks resulting in wide-scale harm to the public health. 

These rules shift the focus from responding to a contamination after it occurs to industry prevention. In addition, they are also a reminder that FDA’s overall mandate under FSMA is to transfer compliance obligations onto industry and hold it accountable for its responsibility to produce safe human and animal food, rather than FDA taking on this duty exclusively. In order to accomplish this goal, each of the FSMA rules, including the intentional adulteration rule, will require industry to implement written policies and procedures that comply with extensive regulations. 

Now that FDA has implemented the intentional adulteration regulations, the following is a complete listing of the compliance programs companies must implement involving the production, handling, packaging, importing, and distribution of human and animal food (unless an exemption applies):

  • Preventative Controls for Human and Animal Food
  • Compliance program addressing monitoring, verification, corrective actions, and recalls.
  • Produce Safety
  • Compliance program addressing water quality standards and overall produce safety.
  • Foreign Supplier Verification Program
  • Compliance program that verifies foreign suppliers comply with FDA regulations and ensures they maintain the same level of public health protection and food safety as in the United States.
  • Sanitary Transport
  • Compliance program that addresses vehicles, cleaning and inspecting, and employee training.
  • Intentional Adulteration
  • Compliance program labeled as a food defense plan, designed to prevent terrorist or other attacks through the food supply, including vulnerability assessments.

The deadlines for when companies will be expected to have finalized their written compliance programs vary by rule, company size, and sales, but some take effect as early as 2017. It should be noted that some of these compliance programs potentially could take companies years to develop, draft, and implement depending on the complexity of their supply chain and product diversity. 

© Copyright 2022 Armstrong Teasdale LLP. All rights reserved National Law Review, Volume VI, Number 191
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement

About this Author

Ryan Fournier, International Attorney, Armstrong Teasdale Law Firm
Associate

Ryan, a member of the firm’s International practice group, represents domestic and foreign companies of all sizes on a wide range of international law matters. These include: U.S. Customs and Border Protection laws and regulations; the Foreign Corrupt Practices Act; compliance reviews and audits; licensing and compliance matters involved in the export of U.S. products under the Export Administration Act and Regulations (EAA/EAR); the Arms Export Control Act and Regulations (AECA/ITAR); Foreign Assets Control Regulation; free trade agreements; sanctions programs; boycott and anti-boycott...

314.259.4712
F. Scott Galt, Armstrong Teasdale, Global Trade Lawyer, International Compliance Attorney
Partner

As a member of the firm’s International practice group, Scott understands that government actions increasingly affect companies involved in the global trade of goods and services. To manage those added risks associated with overseas transactions, Scott handles international corporate compliance issues and global transactions for foreign and domestic companies in a wide variety of industries. His knowledge of local legal requirements, including domestic import and export regulations and national data protection laws in many countries, helps organizations enhance their...

314.259.4709
Scott Kozak, Agriculture, Food and Health and Securities Regulation, Armstrong
Partner

Scott Kozak is the founder and co-founder of two of the firm's practice groups:  Agriculture, Food and Health and Securities Regulation and Litigation. He is also a member of the firm’s Complex Commercial Litigation team. A skilled trial lawyer, he focuses on, securities, products liability, toxic tort, complex commercial and environmental litigation. 

Products Liability. Scott has handled a wide range of products liability cases and as a member of the Agriculture, Food and Health group, defends...

314-259-4714
Advertisement
Advertisement
Advertisement