Sandler Trade LLC Helps Embassies Unpack Food Safety Modernization Act’s Proposed FDA Regulations

To implement the Food Safety Modernization Act (FSMA) that was passed in 2011 the Food and Drug Administration (FDA) has published four proposed regulations that subject foreign food producers to U.S. food production standards and puts the onus on U.S. importers to certify that these standards have been met.

The proposed rules, comprising hundreds of pages, have Washington experts abuzz and scrambling to understand, explain, and comment. The FDA has posted useful summaries and Qs and As (see — and while these are very useful, you will likely have more questions). We found that there is a great need to dive into the details of the proposed regulations, create order out of the chaos, and present governments and traders a clear outline of what it all means for their products. Our experts have done just that.

Sandler Trade LLC is assisting our clients understand the upcoming producer, exporter, and importer obligations. We are helping clients present the information in an accessible format to their government and trade association, and to understand what they can do to influence the final outcomes and to prepare for compliance. Starting preparations now will help ensure that exports will not be disrupted.

Projects that Sandler Trade LLC has already worked on include:

  • Prepared a PowerPoint presentation that concisely explains new FSMA requirements and key elements of the proposed FDA regulations, relevant deadlines for comment, and steps governments and industries should be taking to prepare.
  • Assisted our clients assess likely impacts and prepare submissions for FDA.
  • Provided updates and will hold seminars to educate governments and exporters.

The following are the proposed regulations, and the deadlines for public comment:

  1. Preventative Controls Regulations (September 16)
  2. Produce Safety Regulation (November 26)
  3. Foreign Supplier Verification Program Regulation (November 26)
  4. Accreditation of Third Parties to Audit and Certify (November 26)

It’s difficult to unpack the four proposed regulations and to get to the bottom line: How will this affect foreign food producers, and their U.S. customers? What do these rules mean, and how can companies prepare themselves for compliance?

Imagine you are a relatively small foreign food producer who sells food products to the United States with no safety issues. While you may be doing everything right, U.S. importers will soon need to CERTIFY that you are doing everything right. U.S. importers, under the Foreign Supplier Verification Program, will need to collect important information about foreign food producers’ compliance with the Preventative Controls Regulations and Produce Safety Regulations, which outline food safety best practices. Importers will need to know what questions to ask and foreign producers will need to be prepared to demonstrate and prove compliance. The new rules will apply to many foreign firms that manufacture, process, pack, or hold human food. These firms will be required to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, identify monitoring procedures, record monitoring results and specify what actions will be taken to correct problems that arise. Importers will need to be satisfied that imported products are in compliance. On occasion, FDA will evaluate safety plans and inspect facilities to verify compliance.

The way forward is NOT to be discouraged, but to understand what’s coming and to begin preparations. Foreign governments and foreign producers and exporters all need to engage the FDA. Sandler Trade LLC has already begun these preparations on your behalf, and our clients are ahead of the game. Contact us If you want to learn more about the proposed regulations, would like to purchase our PowerPoint overview (which can be personalized to your needs and interests), or would like to submit comments to FDA. Understanding how these regulations will affect exporters and small producers is especially important for Embassies, trade associations and trading companies. Sandler Trade LLC stands ready to assist you.

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