Basing Food Safety Standards on Science and Prevention

By: Margaret Hamburg, M.D.

Two of my highest priorities as FDA commissioner have been strengthening the scientific foundation of FDA’s regulatory decisions and ensuring the safety of an increasingly complex and global food supply.

Margaret Hamburg, M.D.That’s why I take such pride in FDA’s proposal of two rules that set science-based standards for the prevention of foodborne illnesses. One will govern facilities that produce food, and the other concerns the safety of produce.

The Preventive Controls for Human Food rule proposes that food companies—whether they manufacture, process, pack or store food— put in place controls to minimize and reduce the risk of contamination. The Produce Safety rule proposes that farms that grow, harvest, pack or hold fruits and vegetables follow standards aimed at preventing their contamination. 

These rules represent the very heart of the prevention-based reforms envisioned by the landmark FDA Food Safety Modernization Act (FSMA) and focus on preventing food safety problems before they happen.

These two rules are also part of a larger, ongoing reform effort, with other rules that set similarly high standards for imported and animal foods to be released in the near future.

In our interconnected world, FDA’s vigilance must extend globally. About 15 percent of our food is imported, and in some categories that percentage is much higher. For example, half of our fruits and a fifth of our vegetables come from abroad. We need a strategy that will address all of these complexities and challenges.

In drafting the proposed rules, FDA conducted extensive outreach and talked with key stakeholders, including farmers, consumer groups, state and local officials, and the research community. They build on existing voluntary industry guidelines and best practices for food safety, which many producers currently follow.

We want to continue to engage the public. So, I encourage Americans to review and comment on these rules, which are available for public comment for 120 days.

I believe this also showcases FDA’s adherence to solid science in its policy- and decision-making. The new draft rules recognize that the science of food safety is constantly evolving and that our oversight must take into account issues such as emerging disease-causing bacteria and new understandings of how hazards can be introduced into food processing.

FDA is committed to working with industry to provide the support they need, especially the smallest businesses. That’s why we are working with stakeholders through the Produce Safety Alliance, the Sprouts Safety Alliance, and the Preventive Controls Alliance to continue outreach efforts and to make educational and technical information readily available to industry.

Meeting the public health demands of a global marketplace. Bringing solid science to bear on our decision making. And safeguarding the well-being of American families with a prevention-focused food safety system. That’s FDA at work in the 21st century.

Margaret Hamburg, M.D., is Commissioner of the Food and Drug Administration

Succeeding on Produce Safety

By: Michael R. Taylor, J.D.

We get our fresh produce from all over the place – from the broad lettuce fields of Salinas, the smaller truck farms of North Carolina and Delaware, and the road side produce operations that dot Long Island. And just about everywhere in between.

But, as much as we all enjoy locally-grown produce bought at a nearby farmer’s market, our quest for abundant supplies of fresh fruits and vegetables year round has turned our eyes and our markets outward. We now import 50% of our fresh fruit and 20% of our fresh vegetables, with Mexico being our largest source of both. In fact, two-thirds of imported fresh vegetables and almost 30% of imported fresh fruit comes from Mexico.

Michael R. Taylor, J.D.I recently spent a day in Tubac, Arizona, participating in the America Trades Produce conference. Tubac is near Nogales, which is the site of the highest volume port of entry for produce coming into the United States from Mexico – sometimes over 1,000 truckloads per day.

The conference brought together people on both sides of the border with a stake in this trade – growers and shippers of produce, importers, federal and state officials from the United States, and our regulatory counterparts from Mexico. I went to the meeting to talk about FDA’s progress in implementing the Food Safety Modernization Act (FSMA), which will transform how we oversee the safety of fresh produce, whether grown in Mexico or the United States.

I came away with some strong impressions. First, food safety is a front-of-mind topic for the produce industry. Those trading across the border of course have trade concerns, such as avoiding logistical delays in entering goods at the port of entry. But the people I spoke with consider food safety central to their business. That’s why they wanted to hear from me about FSMA implementation and why the conference program included exercises using realistic scenarios to share knowledge about how to manage recalls and other food safety incidents.

Second, they know that managing problems after they occur is not nearly enough.  Significant outbreaks of illness affecting major produce commodities have harmed consumers and consumer confidence and cost millions in lost sales. That’s why many in the industry have invested in growing and handling practices they know can prevent contamination and illness. And it’s why they voice strong support for implementing FSMA, which will create a level playing field of modern, prevention-oriented standards to ensure wider adoption of sound food safety practices.

Finally, they want to get on with building the new import safety system mandated by FSMA. In addition to new produce safety standards, FSMA requires importers to have a verification program that provides assurances that the food they import is as safe as domestic produce, strengthens the private audit system, mandates more foreign inspection by FDA, and directs FDA to partner more closely with foreign governments to ensure food safety. These reforms respond directly to concerns reflected in a 2011 food-industry sponsored survey showing that only 50% of Americans have confidence in the safety of the food supply and 61% consider imported food less safe due to the lack of adequate government oversight.

Building the new import system can be a win-win for consumers and industry. By building in prevention and verification from the point of production, the system can make produce safer, bolster public confidence, and streamline the border entry process, which is crucial for the shelf life and quality of perishable fruits and vegetables.

People often say to me “You folks at FDA must really have your hands full implementing FSMA.”  That’s true, and even an understatement. The day in Tubac reminded me, however, why we’ll succeed. Modernizing the food safety system is a community effort.  We have broad common interests that motivate our individual and collaborative efforts.  By working together, we make success the only possible outcome.

Michael Taylor is Deputy Commissioner for Foods at FDA