Introduction to Proposed Rules for FSVP

Filed in Uncategorized by on February 5, 2013

On July 26, 2013, the U.S. Food and Drug Administration (“FDA”) proposed regulations for the Foreign Supplier Verification Program (“FSVP”) as mandated by the Food Safety Modernization Act (“FSMA”) of 2010. In this video, Benjamin England, Founder and CEO of FDAImports.com, provides an overview of the proposed FSVP regulations and their implications for both importers and foreign suppliers.

Stay tuned – we’ll be posting more videos and blogs explaining FSVP and its implications in the coming weeks. To learn more about the impact these regulations will have on your business, or to work with FDAImports.com on writing and submitting comments on the proposed FSVP rules, contact us today.

Video Transcript:

Hi, my name is Ben England. I’m the founder and CEO of FDAImports.com. You’re watching this video on FSVP.com. FSVP stands for the Foreign Supplier Verification Program. We created this website as a place where we can provide information to you, to the public, and to our clients information about what FDA is doing in implementing the Foreign Supplier Verification Program under the Food Safety Modernization Act. And the FDA has been busy.

On July 26, Friday, FDA published the proposed rule that’s designed to implement the Foreign Supplier Verification Program under the FSMA. Now FDA was supposed to issue these regulations quite some time ago, and you can see why it took them a while. It turns out it’s not so easy to implement this provision.

There are some things about it we wanted to talk about early – sort of high-level issues – and then over time this website will have more and more detailed information about how the government will be implementing this program.

So to start, FSVP, specifically, has to do with FDA’s requirement, under the FSMA, to propose a regulation whereby importers of food would be required to verify that their foreign suppliers are in compliance with US law. There’s a few specific provisions that the importer must pay attention to; for instance, the Hazard Analysis and Risk-Based Preventive Control proposed regulation, as well as the Standards for Produce Safety proposed regulation. Those regulations came out earlier in the year, in January, and there’s been sort of an ongoing process of comments, and FDA has again extended the comment period for those two regulations because of how they relate to the Foreign Supplier Verification.

But essentially, importers of food now will be required to verify that their foreign suppliers are in compliance with HARPC, and the Standards for Produce Safety, and verify that the food is not otherwise adulterated under the law, or misbranded with respect to, for instance, some allergen labeling (which could have some food safety implications). Now this seems like something that most people would agree is a wise idea, and I happen to be one of those people. It turns out that most people in the industry, the food industry, already perform these kinds of reviews, but not to the level of detail that FDA is proposing in the regulation.

You might find in the near future, particularly if you’re an importer, that some companies may start coming to you – some consultants, some law firms, some professionals, some qualified individuals, may come to you and try to sell you a Foreign Supplier Verification plan for $49.99, in three easy installments, plus shipping and handling. At this point, it’s not time to buy an FSVP. It is time to think about what it is you’re doing that already is designed to ensure compliance with US law, and how you can know what your foreign suppliers are doing, but there is no rule yet. It’s a proposed regulation, it’s not in effect, and it’s not enforceable. So I don’t want you to run off and try to find an FSVP, or try to actually build one yet, because nobody knows what the requirements are going to be, so I don’t want you to fall into that.

There’s some things you can do right now, though. If you read this regulation, you’ll see hundreds of times that FDA talks about comments. This is the time for you to comment to the government and tell FDA what you think the rule will do to you – what it will do to your business, what it will do to the supply chain, whether it will actually enhance or improve the safety of imported food. That’s important for you to provide that information, because FDA believes certain things about this regulation. And it turns out that it may or may not accomplish what FDA thinks it’s supposed to accomplish, so you need to tell them that.

We at FDAImports.com, we write comments for companies, we help them think through the issues that are specific to their companies in order to provide comments to the government, and we could certainly help you with that. And some places you’ll find to be thinking about the issues will be right here at FSVP.com. We encourage you to stay tuned – again, I’m Ben England, thank you for listening, at FSVP.com and at FDAImports.com.

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