Progress on FSMA: Getting Down to Implementation

By: Michael R. Taylor

This is the second of two FDA Voice blogs about state listening sessions on updates to four of the rules proposed to implement the FDA Food Safety Modernization Act (FSMA).

It appears to me that people all over the country are rolling up their sleeves and preparing to make FSMA a reality.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.My team and I have just returned from visits to Georgia, North Carolina and Florida, states that are top producers of the fruits and vegetables that the world enjoys. We were there for listening sessions on the updates, or supplements, that FDA published in September to four proposed FSMA rules overseeing human and animal foods, both domestic and imported. Earlier in the month we visited California and Vermont for similar meetings.

When we visited states last year to discuss the FSMA rules that FDA originally proposed, beginning in January 2013, there were strong feelings that some aspects of our original proposals, such as the water quality standard, would be overly costly and not adequately adaptable to the range of production practices and conditions across the country. Farmers, manufacturers and importers want their foods to be safe, but they want rules that are as targeted as possible to risk and are practical to implement. We listened to their concerns, and we reviewed a wide range of written comments. They all formed the basis for the supplemental proposals that we issued in September, which have been well received.

During these most recent state visits, all of which were hosted by the heads of state agriculture departments, we heard continued support for FSMA and the need to implement it well, with mostly clarifying questions about the content of the rules. In fact, most of the discussion revolved around what has to be done once the rules take effect. We’re getting down to the nitty gritty of implementation.

Our day in Georgia began with breakfast with Commissioner of Agriculture Gary Black and Natalie Adan, director of the agriculture department’s Food Safety Division. The conversation centered on the importance of our partnerships with the states. FDA will be relying heavily on its state counterparts to provide training, technical assistance and compliance oversight.

There was also an appreciation, and a strong sense of priority, expressed by Commissioner Black and all of the state agriculture leaders, that the proposed FSMA rules will hold imported foods to the same standards as those produced in this country. That levels the playing field in the eyes of U.S. food producers, and it is also essential for food safety.

In all three Southern States, as well as in Vermont and California, there was some confusion about some of the specific terms of the proposed rules, especially the water quality and testing requirements. We are committed to providing clear guidance so that expectations are understood, as well as education, technical assistance and practical tools to facilitate compliance.

In North Carolina, we received a warm welcome from Agriculture Commissioner Steve Troxler who, as an elected official, has made food safety a campaign issue and a priority for his leadership and his department. In the listening session, Debbie Hamrick of the North Carolina Farm Bureau was very interested in how we will train our workforce to go out onto the farms, and how farmers will know how to meet the requirements. She offered to rent a bus and fill it with FDA officials and farmers to tour the area. Our reply: You’re on. She wants to work with us and we want to work with her.

We were also asked how we’re going to pay for all this and that brought up the critical issue of funding, which is a concern. It is urgent that FDA receive adequate funding for the training, technical assistance, state partnerships and import oversight that is essential for sound implementation of the FSMA rules beginning in late 2016 and 2017.

Florida was the final leg of this journey, which was fitting given Florida’s history of commitment to agriculture and food. Adam Putnam, the commissioner of agriculture, is a former U.S. congressman who had a leadership role in getting FSMA enacted. And Florida has been a pioneer in food safety, enacting seven years ago mandatory on-farm safety standards for the growing of tomatoes.

The listening session took place at the Gulf Coast Research and Education Center at the University of Florida’s Institute of Food and Agricultural Sciences. Driving there, we left the interstate highway to find ourselves suddenly in the midst of tomato fields, citrus groves and grazing cattle. We may think of Disney and spring training when we think of Florida, but agriculture is woven into the fabric of the state.

It was great to see Martha Rhodes Roberts, a long-time food safety leader in Florida, who moderated our listening session. As in Georgia and North Carolina, the Florida audience was a diverse mix of growers and people involved in various aspects of the food industry. The people we met in all three states appreciated both the changes we proposed in the supplemental rules and the continuing dialogue we are having on their implementation. They are ready now to get the job done.

I’d like to close with a reminder that the deadline for commenting on the four proposed supplemental rules for Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification Programs is Dec. 15. Visit our FSMA page on fda.gov for more information.

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

From Wariness to Welcome: Engaging New England on Food Safety

By: Michael R. Taylor

This is the first of two FDA Voice blogs about state listening sessions on updates to four of the rules proposed to implement the FDA Food Safety Modernization Act (FSMA).

What a difference a year makes.

In August last year, my team and I visited New England to talk about the rules proposed in 2013 to implement FSMA. We were met with skepticism and some genuine fear that our produce safety proposals did not take full account of local growing practices and would both disrupt traditional practices and deter innovation. These weren’t easy conversations, but they proved instrumental in FDA’s decision to propose—on Sept. 29, 2014—updates, or supplements, to four of the proposed FSMA rules overseeing human and animal foods, both domestic and imported. These proposals include significant changes in the produce safety proposal and related elements of the preventive controls rules for food facilities.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.We weren’t quite sure what to expect when we flew to Vermont on Sunday, November 16, for a listening session the next day on the proposed supplemental rules. But the tenor of this visit was dramatically different, and very positive, beginning with the detour we took from our FSMA mission on Sunday to visit leading players in Vermont’s local food movement and artisanal cheese-making community.

Accompanied by Vermont Agriculture Secretary Chuck Ross, we first toured the Vermont Food Venture Center (VFVC) in Hardwick, a regional food hub that leases space to small food businesses, providing kitchen equipment, food storage and business consultations. The goal of this modern, well-equipped facility, as executive director Sarah Waring explained, is to strengthen Vermont’s local food network and agricultural economy.

We then toured Jasper Hill Farm in Greensboro, a renowned maker of artisanal cheeses.  We were welcomed by brothers Mateo and Andy Kehler, who have taken an innovative approach to making cheese, using both traditional methods and the latest technology. Their goal is to establish a network of local farms that supply the milk, with Jasper Hill aging and distributing the cheeses in an effort to support small dairy operations.

Our goal was to continue the dialogue we started this year with the cheese-making community to better understand, as food safety regulators, what goes into making artisanal cheeses. We learned a lot, tasted some great cheese, and left impressed by the community-oriented commitment at both VFVC and Jasper Hill Farm, and by their use of top-tier tools to strengthen Vermont’s local food system.

When we arrived back in Montpelier Sunday night, the setting was like something out of a postcard. This picturesque town, the nation’s smallest state capital, was dusted in the season’s first snow, which only accentuated its natural beauty and charm. We were happy to be there.

Monday morning we drove to the Vermont Law School in South Royalton for the FSMA listening session. This school, set in the rolling landscape of rural Vermont, is renowned for its commitment to sustainable environmental practices.

We saw familiar faces. Some had come to the meeting directly from their farm—through the snow. There were people from all over the Northeast—people who had participated in our series of listening sessions throughout New England in 2013. But this time, the response and dialogue were different. We heard acknowledgement and appreciation that we had addressed many of their concerns in our revised proposals by making the proposed rules more feasible, while still meeting our public health goals.

Much of the discussion focused on implementation of the rules, and, interestingly, some of the concerns echoed those we had heard in a November 6 listening session in Sacramento, CA, a place not only on the opposite side of the country but so different in its production systems. Many are finding the complexity of the proposed rules daunting, such as the technical underpinnings of the E.coli benchmark for water quality and the various boundary lines and exemptions that determine who is covered. We’ve always said that we wouldn’t take a “one size fits all” approach, which has contributed to making the rules more complicated. This only underscores our responsibility to explain the rules clearly and to provide education, technical assistance and guidance.

Secretary Chuck Ross said early and often that we need to educate before and as we regulate. And he’s right. I am struck anew by the importance of our partnerships with state leaders. Vermont’s Ross and California Secretary of Food and Agriculture Karen Ross have been invaluable in helping us develop these rules, as they will continue to be as we move towards implementation.

We were grateful for the participation in the listening session by food safety advocates Lauren Bush and Gabrielle Meunier, who each spoke of the devastating effects of foodborne illnesses. Lauren almost died after eating a salad contaminated by E.coli in 2006 and Gabrielle’s young son fought, and recovered from, a Salmonella infection in 2008 after eating tainted peanut butter crackers. Their stories underscore the underlying reason for the effort that so many are making to implement FSMA—to keep people safe.

Some participants expressed the view that even though we decided to defer, pending further study, our decision on an appropriate interval between the application of raw manure and harvest, some kind of interval is needed to protect crops from pathogens. Some suggested that the 90 to 120-day intervals set forth by the U.S. Department of Agriculture’s National Organic Program be adopted as an interim measure.

Others inquired how the FSMA rules would affect them based on very individual scenarios. We asked them, and we’re asking everyone, to comment on the supplemental rules and include those scenarios for us to consider in drafting the final rules. We don’t want to create unintended harmful consequences.

The deadline for commenting on the four supplemental rules for Produce Safety, Preventive Controls for Human Food, Preventive Controls for Animal Food and Foreign Supplier Verification Programs is Dec. 15. Visit our FSMA page on fda.gov for more information.

Our Vermont trip was followed by state listening sessions in Georgia, North Carolina and Florida. I will be filing another FDA Voice blog on what we learned in those Southern states.

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

Partnerships Are the Key to Keeping Foods Safe Worldwide

By: Michael R. Taylor

The success or failure of our efforts to keep foods safe all over the world rests on the strength of our global partnerships and the work we can do together to verify that food safety standards are being met. That’s why, today, after two days of meetings in Beijing with Chinese regulators, I am speaking at the China International Food Safety and Quality Conference and Expo in Shanghai about meeting the food safety challenges that all nations face.

Mike Taylor speaks in China

Deputy FDA Commissioner Michael R. Taylor giving the keynote address at the China International Food Safety and Quality Conference and Expo.

No matter where we live, we all want to feed our families with the confidence that the foods we are enjoying are safe to eat. Food safety is thus a goal that transcends international borders, and the food supply has never been so global. In the United States, 15 percent of our food supply is imported from other countries, including nearly 50 percent of fresh fruit and 20 percent of fresh vegetables. And last year, the U.S. exported a record $136 billion in foods, feed and beverages.

Congress recognized this when it enacted the FDA Food Safety Modernization Act (FSMA) and established a new regulatory paradigm for food safety, drawing on widely accepted international practices. The paradigm is simple. No matter where food comes from, we will achieve the best food safety results if we define—in workable, science-based standards—the approaches to managing food safety systems that we know are effective in preventing food safety problems AND if we achieve high rates of compliance with those standards.

Verification is key to the success of the FSMA paradigm and our global understanding of how to make food safe. It is also key to the consumer confidence that makes robust trade in food possible. Verification begins with what food producers do in their operations to verify, on an ongoing basis, that they are successfully implementing proper controls to prevent safety problems. But verification is also a public responsibility and a challenge that all nations face in our global food system.

FDA Staff at China Event

From left, Christopher Hickey, director of FDA’s China offices, Deputy Commissioner Michael Taylor and Roberta Wagner, co-chair of FDA’s FSMA Operations Team Steering Committee, visiting the China Food and Drug Administration.

Domestically, we will use inspections and other means, including sampling and testing, to verify that private food safety management systems are working effectively to prevent problems. This is a shift from our historic focus on enforcement of adulteration standards, although we will continue to act swiftly and forcefully when violations are putting consumers at risk.

In FDA’s oversight of imported foods, FSMA’s new Foreign Supplier Verification Programs (FSVP) will make importers accountable to FDA for documenting that their foreign suppliers have taken preventive measures to help ensure the safety of their food products. And we will inspect importers to verify that they are doing their job with regard to FSVP.

But we know that is not enough. Congress also mandated that we work more closely with foreign governments to verify that food safety standards are being met, so we are investing heavily in new forms of partnership with major trading partners with the goal of relying on each other’s verification activities as an element of the overall assurance system.

A prime example and model for collaboration is our joint initiative with Mexico to build a full operational partnership on produce safety, based on a strongly shared commitment to food safety as a public health goal. We are working directly with SENASICA and COFEPRIS – the agencies in Mexico that are responsible for produce safety – to expand the sharing of information, personnel and best practices, and to improve laboratory and other technical harmonization. Our goal is mutual reliance on each other’s oversight work. This initiative includes an important public-private partnership component.

Another model for building verification partnerships is our pursuit of what we call “systems recognition agreements” with countries whose overall food safety systems are comparable to ours. We have one with New Zealand and are working on agreements with Canada and Australia.

We also believe that being present in foreign countries is important to our own verification work and to building partnerships with foreign governments. That’s why we have increased our foreign inspections and have FDA offices in China, India, Europe, and Latin America. China, with its size and complexity, poses unique challenges as we seek to build food safety partnerships, so we are working to increase our China-based staff as a way to improve verification and foster mutual understanding and confidence.

The challenge of implementing the FSMA food safety paradigm on a global scale is huge, but I’m convinced from all the dialogue we’ve had around the world that we are on the right track. We have a long way to go, of course, but I have no doubt we’ll get there with the continued collaboration and commitment of our trading partners.

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

Getting it Right on Spent Grains

By: Michael R. Taylor

Since the March 31 close of the comment period on FDA’s proposed animal feed rule, we’ve received a lot of questions and comments about so-called spent grains. Spent grains are by-products of alcoholic beverage brewing and distilling that are very commonly used as animal feed.

Michael TaylorTo add to the picture, spent brewer and distiller grains are just a subset of the much broader practice of human food manufacturers sending their peels, trimmings, and other edible by-products to local farmers or feed manufacturers for animal feed uses rather than to landfills. One industry estimate is that 70 percent of human food by-product becomes food for animals.

We’ve heard from trade groups and members of Congress, as well as individual breweries raising concerns that FDA might disrupt or even eliminate this practice by making brewers, distillers, and food manufacturers comply not only with human food safety requirements but also additional, redundant animal feed standards that would impose costs without adding value for food or feed safety.

That, of course, would not make common sense, and we’re not going to do it.

In fact, we agree with those in industry and the sustainability community that the recycling of human food by-products to animal feed contributes substantially to the efficiency and sustainability of our food system and is thus a good thing. We have no intention to discourage or disrupt it.

We also believe the potential for any animal safety hazard to result from this practice is minimal, provided the food manufacturer takes common sense steps to minimize the possibility of glass, motor oil or other similar hazards being inadvertently introduced, such as if scraps for animal feed were held in the same dumpster used for floor sweepings and industrial waste.

We understand how the language we used in our proposed rule could lead to the misperception that we are proposing to require human food manufacturers to establish separate animal feed safety plans and controls to cover their by-products, but it was never our intent to do so. In fact, we invited comment on practical ways to address by-products in keeping with their minimal potential risk.

We will take the necessary steps to clarify our intent in the rules themselves so there can be no confusion. As we previously announced, this summer we plan to issue revised proposals for comment on several key FSMA issues and we will include changes consistent with the points I’ve outlined in this blog.

Our door at FDA has been wide open to stakeholders at every step of the FSMA process. We have learned a lot through active, two-way dialogue with those who have concerns about what we propose or ideas about how we can achieve our food safety goals in the most practical way. We hope and fully expect that dialogue to continue.

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

FDA Uses New Authorities To Get OxyElite Pro Off the Market

By: Daniel Fabricant, Ph.D. 

As the head of the office that oversees dietary supplements, it is my responsibility to ensure that the dietary supplement products on the market — which are used by more than 180 million Americans daily — do not cause harm.

This is not an easy job because FDA’s authority to regulate dietary supplements is very different from the agency’s authority to regulate drugs and medical devices prior to their marketing. Adding to the challenge is the fact that there are more than 85,000 dietary supplement products and no requirement for product registration.

Just recently we had a case that illustrates both the limits of FDA’s authority to regulate supplements and the promise of new enforcement tools provided by the FDA Food Safety Modernization Act (FSMA). Dozens of people were suffering acute liver failure or non-viral hepatitis so severe that several needed liver transplants, and one died. These people, by and large, had been healthy.

The illnesses were linked to certain OxyElite Pro dietary supplement products made by Texas-based USPLabs. Certain OxyElite Pro products and a second product, VERSA-1, contain a new dietary ingredient that has not been shown to be safe for use by consumers. This ingredient, aegeline, is a synthetic version of an alkaloid that exists, in natural form, in a tree that grows in parts of Asia.

This is the second time in little more than a year that USPLabs has produced supplements containing a new dietary ingredient that lack a history of use or other evidence of safety. In the previous case, the company added a stimulant called DMAA (dimethylamylamine) to OxyElite Pro and to a similar product, Jack3D. We were alerted to the addition of DMAA through more than 100 reports of illness, including six deaths, among people who used the products.

Consumers may look at a capsule or tablet, the forms in which many supplements are sold, and not realize our limitations in regulating dietary supplements. In October 1994, the Dietary Supplement Health and Education Act expressly made supplement manufacturers responsible for ensuring that their products are safe. Under this law, manufacturers do not need FDA approval before selling dietary supplements. The burden is generally on FDA to prove that a supplement is unsafe before any actions can be taken to restrict its use or remove it from the market.

The law made an exception for “new dietary ingredients” (i.e., dietary ingredients not marketed in the United States before Oct. 15, 1994). Before supplements containing these new dietary ingredients – vitamins, minerals, herbs and other substances – can be sold, a manufacturer or distributor must provide FDA with information establishing their safety when used under the conditions recommended or suggested in the product labeling. USPLabs should have informed FDA of its plans to add aegeline to its dietary supplements, and it should have established the safety of aegeline in its products. Neither of those things happened.

We do not have the authority to evaluate and approve dietary supplements before they are sold to consumers. However, in this case we were able to invoke new enforcement authorities provided by FSMA to remove them from the market.

Key provisions under the new food safety law – mandatory recall and administrative detention – now play a critical role in allowing FDA to act quickly and decisively. We can now order a recall when there is a reasonable probability that an article of food is adulterated or misbranded under certain sections of the Federal Food, Drug, and Cosmetic Act and there is also a reasonable probability that the articles of food will cause serious adverse health consequences or death to people or animals. 

We also have the authority to administratively detain a food or dietary supplement to prevent its distribution if the agency has reason to believe the product is adulterated or misbranded.

We invoked our recall authority and warned USPlabs that FDA might order it to stop distributing the involved OxyElite Pro dietary supplements if the company did not stop distribution on its own and conduct a voluntary recall. USPLabs agreed to voluntarily recall the OxyElite Pro products and destroy all lots of the products, including remaining warehouse stock, which had an estimated value of $22 million. We will supervise the destruction of these products.

My colleagues and I will continue to use our new authorities, as appropriate, to make sure that the supplements you take will not put you in the hospital. We are committed to keeping you and your family safe, using every tool at our disposal.

Daniel Fabricant, Ph.D., is Director of FDA’s Division of Dietary Supplement Programs

We’re Partnering with Mexico to Keep Foods Safe

By: Michael R. Taylor 

En Español

Food safety is an issue that crosses borders. The reality of this global marketplace is that consumers, industry and governments worldwide are in this together. 

Deputy Commissioner Michael Taylor (on r) and Dr. Ricardo Cavazos, General Director of Economic and International Affairs at the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)

With that in mind, my team and I traveled to Mexico City on Oct. 29, 30 and 31 to discuss the rules that FDA has proposed this year to help ensure the safety of both domestic and imported foods. 

We said at the beginning of our efforts to implement the 2011 FDA Food Safety Modernization Act (FSMA) that we would send FDA delegations to Canada, Mexico, Europe and China to strengthen partnerships with officials there to help accomplish our safety goals. Working with our government partners in the U.S. and abroad is important in making sure that implementation is successful. This trip was the last of these journeys, and it was a great experience. 

Why is a partnership with Mexico important? Because it is one of the United States’ top trading partners. A lot of the produce we eat in the U.S. is grown there, including fruits and vegetables that would otherwise be hard to find in the winter months. 

What we learned in meetings with SENASICA and COFEPRIS – two key food safety agencies in the Mexican government – is that we’re all on the same page when it comes to food safety. We share with Enrique Sanchez Cruz, director general of SENASICA, Mikel Arriola, federal commissioner of COFEPRIS, and their able staffs a commitment to protect our citizens from the contaminated foods that cause so many preventable illnesses each year. 

And there is much we can do to help each other. For example, our counterparts in Mexico have a great deal of data to share based on microbiological sampling of foods and inspections. And, like us, they base their food-safety priorities on risk: What are the greatest potential hazards? We came away with a much deeper understanding of their work in this area. 

One of the key messages we got from our Mexican colleagues was that they are eager and committed to working with us to implement FSMA, and this motivates us to take our partnership to a new level. The benefits will be mutual, as FSMA and Mexico’s own food safety initiatives promise to elevate standards and improve practices on both sides of the border. 

At a public listening session on our FSMA proposals attended by representatives of major commodity groups, the sentiments were much the same. They want to be engaged with us in this important work. 

We envision partnerships with our foreign counterparts as being multi-faceted, including data sharing, recognition of inspection reports, multilateral sharing and acceptance of laboratory methods, and training of government and industry on U.S. food safety requirements, and where appropriate, cooperating under trade agreements. 

We know food safety is more a journey than a destination, and the road we are on with Mexico will have its bumps and seem long at times. But, thankfully, we are on the road together, and we will get there. 

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