Your Input is Bringing Change to Food Safety Rules

By: Michael R. Taylor

Michael R. TaylorYou spoke. We heard you.

We began 2013 with the proposal in January of two rules required by the FDA Food Safety Modernization Act: the Produce Safety Rule and Preventive Controls for Human Food. The former would set science-based standards for the produce industry while the latter would set safety requirements for food facilities.

We were determined from the beginning to be transparent in our processes and to engage all stakeholders in the work of crafting final regulations that would work across the broad spectrum of food-producing operations. An unparalleled outreach effort followed the proposal of these rules. My team and I traveled across the country and around the world to discuss these food-safety requirements with the people who would be most affected, including farms of varying types and sizes.

In our travels, we saw first-hand how everyone is committed to food safety.  We especially spent a lot of time talking to farmers, both those who are smaller and work the land their family has owned for generations, and those who oversee large, diverse operations. We have heard concerns that certain provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.

And because of the input we received from farmers and the concerns they expressed about the impact of these rules on their lives and livelihood, we realized that significant changes must be made, while ensuring that the proposed rules remain consistent with our food safety goals.

For that reason, we are planning to revise language in the proposed rules affecting farmers and plan to publish it in the Federal Register for public comment by early summer. These include changes to sections covering water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities (such as a farm that has a food-processing operation), and procedures used to withdraw the qualified exemption to these requirements for certain farms. As we consider the comments we’ve received, we may decide to include other changes for public comment. We recognize that completing these rules is essential to protecting the public health and are committed to completing them as quickly as possible.

We always knew that the rules governing farmers would be complex, in part because of the incredible diversity in the size and nature of farming operations. The standards we set must accommodate that diversity and be feasible to implement.

In our efforts to get first-hand information about how these rules would work in the real world, we visited nearly 20 states, Europe and Mexico; toured small and large farms and met with farmers across the country; met with the Amish, organic producers and other groups deeply involved in farming; collaborated with officials from other federal and state public health agencies; and held many public meetings. We also met with coalitions of consumer groups and other stakeholders. Our outreach work has been focused on ensuring that we never took our eyes off the ultimate goal: Keeping the food that you and your family eat safe.

We believe that this decision to change  these proposed rules—in response to the careful consideration of many people involved in supplying our food—is critical to fulfilling our commitment to getting them right. I urge you to review these changes when they are ready and let us know what you think.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

In Vermont, Innovation Advances Local Food Systems

This is the seventh in a series of blogs by Deputy FDA Commissioner Michael Taylor on his multi-state tour to see agricultural practices first-hand and to discuss the produce-safety standards and preventive controls rule that FDA is proposing as we implement the Food Safety and Modernization Act of 2011 (FSMA). 

By: Michael R. Taylor

Innovation was the theme of our day in Vermont on Wednesday, Aug. 21. We visited food operations that have developed enterprising ways to make the most of local produce markets and to expand the options available to both growers and entrepreneurs.

Mad River Food Hub owner Robin Morris, right, gives a tour of the food distribution and processing facility.

Our first stop was at the Mad River Food Hub in Waitsfield. Food hubs are all about connecting small farms with markets. They distribute locally grown foods in a way that would otherwise be difficult for the owner of a small farm.

Owner Robin Morris has also provided space for the use of small food businesses. People who want to make and sell food but do not have their own facility rent space at Mad River, using the industrial kitchen, cutting room and other facilities there.

It’s an enterprising way to provide a critical service and is a central part of the economic model of a local food system. Small-scale entrepreneurs can get a start in a licensed facility, while keeping costs at a manageable level.

Robin is doing this as a business but also as way to give back to the local food system, whose broad, community-oriented values he strongly embraces. Robin and his team are very tuned in to food safety and part of the service they provide is to support the use of safe practices. Even though many of these small businesses are likely to be exempt from certain requirements under the proposed FSMA rules, they know they also have to meet their customers’ food-safety expectations, and Robin’s team helps them do that.

Later we stopped at Intervale Food Hub in Burlington for a great discussion with Travis Marcotte, Sona Desai and others who are playing leading roles in the food hub movement nationally. In addition to deepening our knowledge of the diverse food hub business models in New England and elsewhere, we had a great lunch in their big old red barn.

Mike Taylor in the hydroponic greenhouse with David Hartshorn, right, owner of Hartshorn Farm.

One of the most interesting stops on our trip was at the Hartshorn Farm in Waitsfield, where owner David Hartshorn has invested in a hydroponic facility in addition to his traditional organic farming operation. Hydroponics is a kind of agriculture that does not use soil – the plants are grown in nutrient-enriched water.

With one hydroponic greenhouse so far, David has a very high-tech system for growing lettuce with amazing efficiency. He estimates that he can grow as much lettuce in one-quarter of a hydroponic acre as he could on 10 acres of farmland. And crops could be grown all year round this way. Such diversification can help keep growers on the land, with real potential for growth. And you’ve got to love David’s entrepreneurial spirit!

Unlike the conversations in Maine and New Hampshire earlier this week, the conversations in Vermont were less about concerns that the federal government will roll over local growers with its proposed regulations, although the “don’t squash the little guy” message still came through.

This day was more about showing FDA how Vermont is using smart and creative tools to make local growers and food producers successful. What they are doing here is truly impressive and bodes well for the robust and highly diverse local food systems in New England.

Our last stop on Aug. 22 was in Massachusetts, where we received a warm reception from a key state partner—Greg Watson, commissioner of the Massachusetts Department of Agricultural Resources.

Commissioner Watson and his colleagues joined us at a listening session at the Plainville Farm in Hadley. More than 150 growers and other stakeholders attended this session and expressed many of the concerns we’ve heard in the other states about the potential impact of these proposed regulations on their operations and on their very livelihood.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

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