We all knew FSMA was a big deal when Congress passed it a little over four years ago. After a decade of illness outbreaks, import safety problems, and market disruptions that shook consumer confidence and imposed billions of dollars in costs on the food system, Congress mandated a paradigm shift to prevention — to establishing a modern system of food safety protection based not on reacting to problems but on preventing them from happening in the first place. That’s how we’ll achieve the food safety goals we all share — fewer illnesses, stronger consumer confidence in the system of protection, and a level playing field for American farmers and food companies. In addition to embracing these goals, Congress adopted a strong vision of how to achieve them. With broad input and support from industry and consumers alike, Congress said that a food safety system fit for the 21st century must be built on what the food industry itself has learned about how to make food safe and how to manage global supply chains, and it must harness the efforts of all food system participants — public and private, domestic and foreign — in a collaborative effort to see that those practical, effective, preventive measures are consistently followed. FDAinspector_406As big as that sounds — and it’s by far the biggest overhaul of the food safety system since the first national law was passed over a century ago — I don’t think any of us fully envisioned how much would have to be done and how much would have to change to make FSMA a success. The law itself spelled out the large number of regulations FDA must issue to establish the prevention framework. Indeed, FSMA made FDA responsible for some 50 specific deliverables in the form of rules, guidance for industry, new programs, and reports to Congress. FDA has been hard at work on these, with the major rules set to be final this year under court-ordered deadlines. You can see an inventory of what we’ve done since enactment of FSMA here on our FSMA web page. But we’ve learned that FSMA is about far more than new rules. It’s about how FDA changes fundamentally its approach to implementing food safety rules, including how FDA works with other governments and the food industry to achieve food safety success. That’s why FDA has devoted such huge effort over the past two years to rethinking every aspect of what will go into achieving high rates of compliance with the FSMA rules — for both home-grown and imported food — compliance that is essential to food safety and to achieving the level playing field on food safety that American consumers and industry both demand. For example, because we know that the vast majority of American farmers and food companies want to do the right thing on food safety and want to comply with the new rules, we are basing our FSMA implementation strategy on the principle of “educate before and while we regulate.” This means providing guidance and technical assistance to industry so they know what’s expected and are supported in doing it. It also means reorienting and retraining the FDA inspection and compliance workforce, as well as our state food safety partners, to work in this new way so we can provide consistent, high-quality oversight within the more technically sophisticated FSMA framework. We want to use the new FSMA framework to achieve good food safety results through collaborative effort, rather than focusing on the traditional enforcement approaches that were our main tool before FSMA was enacted. We will of course enforce vigorously when that’s what’s needed to protect consumers, but the goal is food safety, not enforcement cases. You can see a summary of this new compliance strategy here. The FSMA paradigm shift and the change needed to succeed are especially urgent and especially evident when it comes to imported food. The volume of imports is vast and growing, and the number of foreign manufacturing facilities registered to sell food in the United States is greater than the number of U.S. facilities. Safety problems with imported foods were one of the main drivers of FSMA’s enactment, and Congress recognized that the old system of relying almost entirely on FDA inspectors to detect and correct food safety problems by examining food at the border is drastically outmoded. Congress thus mandated a new import safety system that harnesses the capacity and responsibility of importers to manage their supply chains to ensure imports meet our new FSMA standards. And it directed FDA to increase its foreign presence through more foreign inspections and more engagement with foreign governments to leverage their food safety efforts. All of this of course costs money. The Congressional Budget Office (CBO) estimated that, to implement FSMA effectively, FDA would need a cumulative increase in its base funding for food safety of $583 million over the first five years following enactment. In those five years, FY 2011-2015, we’ve received much-appreciated base increases totaling $162 million, which have been crucial for getting FSMA implementation off the ground. During this period, FDA has made its own estimates of the FSMA funding need, as explained in a brief summary of the history and context of FSMA funding we recently posted. And we did this in full recognition of the fiscal challenges facing the government and with a commitment to be as targeted and cost effective as we can be. For example, we are not building a new system on top of the old but rather redeploying our current workforce and resources to implement FSMA and our new compliance strategy. We are prioritizing investments that leverage public and private resources and that support our industry and state partners in playing their food safety roles. And we are driving change within FDA to improve efficiency. This includes the Commissioner’s game-changing initiative to vertically integrate and streamline the collaboration between our experts and policymakers in headquarters and our field-based inspection and compliance workforce. The bottom line is that with program efficiencies we can gain, plus the FSMA funding increases FDA has received to date, enactment of the President’s request for a budget authority increase of $109.5 million for FY 2016 would make it possible for FDA to move forward in 2016 toward successful implementation of FSMA.¹ We think the request is modest in relation to the benefits FSMA promises for consumers and the food system and given what it takes to both revamp everything we’ve done in the past and take on such major new tasks as implementing the first-ever national standards for produce safety and building a new import safety system. And the request is modest in relation to CBO’s original estimate of FSMA funding needs. With the full $109.5 million in new budget authority, our total FSMA funding increases would still be less than half of what CBO estimated is needed for success. Finally, and crucially, FDA’s 2016 budget request reflects the unavoidable fact that the future is now when it comes to FSMA implementation. Let me explain what I mean by that. At the end of this year, we will have new FSMA rules — we are committed and we are under court order. By the end of 2016, we will begin overseeing their implementation, and we will do that in large part through legally mandated FSMA inspections of food facilities. Those inspections will happen. Thus, in terms of preparing for effective and efficient FSMA implementation, the future is here. If we invest properly in 2016 to prepare FDA and the industry for success, we will have success, in the form of better food safety, stronger public confidence, and a level playing field for U.S. farmers and food companies. If we don’t invest properly in 2016, food safety will suffer — people will get sick who wouldn’t otherwise — and the food industry will be disrupted — large and small operators alike — for lack of guidance and technical assistance for industry and lack of consistent, technically well-supported inspection by FDA and the states. That is what is at stake in FDA’s 2016 FSMA funding request. For additional information on key investments for implementing the FDA Food Safety Modernization Act, go here. ¹The President’s Budget requests $1.5 billion to support food safety, which includes $1.3 billion in budget authority — an increase of $109.5 million above 2015.

  • flutterby

    “level playing field for farmers and food companies” is mentioned twice in this article. On what planet? FSMA puts a disproportionate burden on small farms and will cause many growers to quit farming altogether. I guess you mean a level playing field for the giant farms that remain.

    • grifty

      Its really not that hard to comply. I say this having been directly involved.

      • Kula Farmer

        Yea, sure if you dont mind spending thousands of dollars, hundreds of hours, and endless meddling by the government bureaucrats

  • J T

    “Level playing field” how? The Mexican/South American importers are still going to be sending us produce highly contaminated with their fecal colliforms and Salmonella. In fact, we will be getting MORE contaminated produce, because the already-clean American growers are going to be going out of business due to the unnecessary increased costs from FSMA. More and more of our food will be imported from countries where you can’t even drink the tap water. If the tap water will make you sick, just think about the quality of water they are spraying on their fields. Those countries don’t have modern waste management systems in the majority of their growing areas, so food-borne illness diseases are extremely common. Those diseases then get imported to unsuspecting consumers here in the USA.

    • Sansher

      I agree with you on the lax Mexican standards. and about the infected un tested/ regulated water systems there. Also the crazy Chinese and Pacific Rim practices. believe me I check the origin and buy accordingly, because relying only on the cost of something can be misleading.

  • RED

    I too am “involved” overseeing the Quality Control and Safety programs of very large / medium and small Ag. accounts. Depending upon your type of operation, many of the Ag companies are facing significant “challenges” and costs to comply with mandates that are still not yet finalized. Others who say they are “ready” have had to re-direct significant funds for often redundant or frivolous programs not well suited to their operation. Yes, they have recourse, but that too is expensive! Prevention of food borne illness is not a new government idea; it has existed in the private market and has historically been quite effective in many Ag operations. It could certainly be expanded however.

    I note that the author likes to use the term “Invest”….we have heard this euphemism before!

    While effective “food safety” programs are indeed a high priority, we must be vigilant to make certain that this does not turn into just another opportunity to “grow govenment” with underworked, overpaid government employees and their attending bloated salary and benefit packages…… all on the backs of the already overtaxed citizenry.

    An in depth disclosure of the internal FSMA safeguards in place or proposed to prevent governmental abuse and the corruption of chrony-capitalism (which is actually communism) might be instructive and well received……and we should have open forum comment sessions for public evaluation and feedback as well.

    • bat

      Is Red a certain character with the initials L. B.?

      • RED


  • Ramrod

    RED’s comment characterized government employees as “underworked, overpaid..with bloated salary and benefit packages”. But he did not cite reliable public statistics to support these characterizations. If true, these allegations should be substantiated with citations to recognized, published and peer-reviewed evaluations by neutral evaluators. Otherwise, like other prejudicial generalizations they should be taken with a large grain of salt. Persons with actual first-hand experience with government food-safety employees should compare these allegations to their own observations and reach their own conclusions.

    • RED

      Stating that we have to keep a watchful eye on the bureaucracy
      does not require statistics. It requires careful observation and collection of data to generate those statistics. Time will tell.

  • sky35

    The FDA’s own scientists long ago warned of the dangers of GMOs, but the FDA maliciously supports the poisoning of infants and children through their promotion of Monsanto’s evil agenda of spreading Glyphosate GMOs. Around here they are more accurately known as the Fraud and Death Advocates. They DO NOT protect our health, but they do protect Monsanto’s ability to cause long-term health damage to hundreds of millions of people.

  • Kula Farmer

    I find This amuzing
    “For example, because we know that the vast majority of American farmers and food companies want to do the right thing on food safety and want to comply with the new rules”

    You can stuff your new rules