Mixing Kentucky Spirits with Food Safety to Protect Spent Grains Used to Feed Animals

By: Jenny Murphy, M.S.

“Spent grains” is the general term for the remnants of corn, rye, barley and other grains used to make alcoholic beverages. While they are a byproduct of human-food production, spent grains have a long history of being used as a valuable source of nutrients to feed many animal species. They also have been the subject of ongoing concerns among beverage distillers and brewers over the past few years as the FDA drafted rules that will implement the FDA Food Safety Modernization Act (FSMA).

Jenny Murphy holding spent grains

Jenny Murphy, a consumer safety officer in FDA’s Center for Veterinary Medicine (CVM), with handful of dried spent grain at the Wild Turkey distillery. In background, from left: Shannon Jordre, a consumer safety officer in CVM’s Division of Compliance, Jim Sanders, Distillery Manager at the Wild Turkey Distillery, Steve Barber, director of FDA’s Cincinnati District Office, and Jennifer Erickson, a regulatory policy analyst in CVM’s Office of Surveillance and Compliance.

Those concerns brought an FDA team to the rolling hills of central Kentucky this month to visit distilleries and a craft brewery and to meet members of the distilled spirits and brewers industry. The team was led by Stephen Ostroff, M.D., who was then FDA’s deputy commissioner for foods and veterinary medicine and who is now the acting FDA commissioner. I represented the agency’s Center for Veterinary Medicine (CVM) because of the connection between spent grains and animal health.

Congress included language in FSMA to exempt most alcoholic beverage manufacturing facilities from most of the FSMA requirements. But every day these manufacturers produce tons of spent grain, which are commonly used as animal food rather than being discarded in a landfill. Whether or how spent grains would be regulated under FSMA has been a point of some uncertainty for industry.

Based on the information available at this time, FDA considers the potential animal food safety hazards associated with spent grains from the alcoholic beverage industry to be minimal. The agency has assured these manufacturers that they will only be required to ensure that the byproducts are properly labeled and kept safe from contamination while they are held for distribution if these conditions are met: They continue to follow current good manufacturing practice (CGMP) requirements for human food in the production of their alcoholic beverages, and the resulting spent grains are not further processed. If the grains are further processed, such as by drying, they must follow CGMP requirements, with the flexibility to follow either the human food or animal food CGMPs.

But we have been encountering some confusion among brewers and distillers about these CGMP requirements for human and animal foods and how they would apply to spent-grain products. We wanted to reach a greater level of understanding on both sides, and what better place to do that? Kentucky is, after all, the birthplace of bourbon, according to the Kentucky Distillers Association. Recognized by Congress as a distinctively American product, bourbon is a $3 billion industry in Kentucky that generates 15,400 jobs. Kentucky also has a growing craft beer brewing industry.

containers of wet spent grain

Adam Watson (center), managing member and brewer at Against the Grain Brewery in Louisville, shows the visitors the containers of wet spent grain waiting for pickup outside the brewery.

We were a large group – about 20 participants from FDA’s headquarters and district office, the Kentucky Department of Agriculture, the state Division of Regulatory Services based at the University of Kentucky, and industry, including the Distilled Spirits Council and Brewers Association. Over the course of two days, we visited the Woodford Reserve, Wild Turkey, Jim Beam’s Booker Noe plant and Clermont distilleries, as well as the Against the Grain brewery.

This opportunity for education and outreach was extremely productive for all involved. FDA participants were able to allay many concerns and provide clarity about the framework for the CGMPs that the distillers and brewers are expected to meet for both human and animal food. And the distillers and brewers opened their doors, bringing us into their world in a way that was very informative and instructive. There is no substitute for actually seeing how these beverages are produced and how the spent grains are handled.

Although the basic processes are the same, each of the distillers and brewers we visited approaches its work somewhat differently. When it comes to spent grains, there are some operations that simply hold the grain and others with more elaborate processes to distribute the grain because of the large volume produced. We learned distinctions in terminology as the distillers showed us a variety of spent grain products, including wet and dry grains, syrups and cakes.

FDA engaged in this kind of outreach when the FSMA rules were taking shape. Now that the regulations are becoming a reality, we believe these conversations are just as important to help food producers understand what’s expected and avoid any misunderstandings. For FDA, these exchanges help us better understand what, if any, challenges industry may be facing as they strive to meet these new requirements.

Our next step is to take the knowledge we acquired and the lessons we learned and use them to help shape training for regulators and outreach to this industry in support of our shared commitment to keep both human and animal foods safe.

Click here to view FDA’s flickr album from this month’s visit to Kentucky.

Jenny Murphy, M.S., is a consumer safety officer in FDA’s Center for Veterinary Medicine

Talking Across International Borders About FSMA

By: Michael R. Taylor

Michael R. TaylorAll countries face the challenges presented by a food supply that is increasingly global, and consumers rightfully expect that the food they eat is safe no matter where it comes from. We all have the same goals: safe food, consumer confidence, and efficient and effective oversight to reach those goals.

With that in mind, our partnerships with foreign food producers and our regulatory counterparts in other countries are increasingly important. As we get closer to releasing the final rules that will implement the FDA Food Safety Modernization Act (FSMA), we are reaching across borders to ensure that our international stakeholders have the information and training they need to meet these new standards.

The need for this international outreach is a message that came through loud and clear at a public meeting this April on FSMA implementation. The feedback from agricultural attaches, overseas business owners, and representatives from governments worldwide was that they want to hear more about what to expect, and how to prepare for what’s ahead.

To address these concerns, we invited representatives of foreign embassies and other international stakeholders to attend a roundtable discussion on June 23, 2015. In the attached video, you’ll see both the optimism and concerns that surfaced during the meeting at FDA’s Center for Food Safety and Applied Nutrition in College Park, Md.


On June 23, 2015, FDA held a meeting of representatives of foreign embassies and international stakeholders involved in implementation of the FDA Food Safety Modernization Act (FSMA). This is the fifth video blog in which the people who will be helping to make FSMA a reality share their insights on challenges, opportunities and next steps. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)


One sentiment, expressed at the meeting, was: “The United States isn’t the only country concerned about food safety.” From FDA’s perspective, we’re counting on that as we build the partnerships we’ll need to help ensure the safety of foods all over the world. We will join forces with agriculture and public health officials in other countries, international industries and associations, multilateral organizations, and academia to address the unique needs of foreign food producers who must comply with the new FSMA regulations.

We’re operating under the premise that the vast majority of food producers, both foreign and domestic, want to ensure the safety of their foods. We will be relying on our international partners to help us find ways to provide solid verification that the FSMA standards are being met.

The earliest compliance dates will be a year after we publish the first final rules this summer. In the meantime, we are working with our public and private partners to develop training for domestic and international food producers. These partners include the U.S. Department of Agriculture, grower and local food system groups, and the Food Safety Preventive Controls and Produce Safety alliances, whose members include the FDA, local and state regulatory agencies, the food industry, and academia.

We are committed to making FSMA implementation as open and transparent a process as possible. The April public meeting and the June roundtable discussion were just two steps in that process. But they were important steps because both provided open and frank conversations.

We’ve got a long road ahead. We’ve long worked with other countries as trading and regulatory partners. Now, we aspire to be food safety partners, working together and supporting each other when problems arise. These partnerships ultimately will benefit consumers all over the world.

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

Looking at the Road Ahead for FSMA

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this last of four video blogs, they share their insights on next steps as FDA moves from rule-making to implementation. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the third: Voices of FSMA: The Challenges We Face.)

Thinking About FSMA Issues

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this third of four video blogs, they share their insights on the challenges ahead as FDA moves from rule-making to implementation. The next blog focuses on next steps. (The first video is Voices of FSMA: The Road to Implementation; the second: Voices of FSMA: The Opportunities Ahead; the fourth: Voices of FSMA: Moving Forward.)

Continuing the Conversation About FSMA

Implementation of the FDA Food Safety Modernization Act (FSMA) involves people at all segments of the food supply chain, from farm to table. On April 23-24, 2015, FDA held a public meeting in Washington D.C. to discuss its plans to implement FSMA rules designed to build a food safety system that focuses on prevention and risk. The meeting drew hundreds of people in person and thousands joined the webcast. They included consumers, growers, manufacturers, importers, advocates, state and federal government officials, and representatives from other nations. And in this second of four video blogs, they share their insights on the opportunities that FSMA makes possible for the global food safety system. The next blogs focus on challenges and momentum. (The first video is Voices of FSMA: The Road to Implementation; the third: Voices of FSMA: The Challenges We Face; the fourth: Voices of FSMA: Moving Forward.)