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

FDA’s Science-based Approach to Genome Edited Products

By Robert M. Califf M.D., and Ritu Nalubola, Ph.D.

Recent scientific advances now make it possible to more efficiently and precisely alter the genome of plants, animals, and microorganisms to produce desired traits. These genome editing technologies are relatively easy to use and can be applied broadly across the medical, food and environmental sectors, with potentially profound beneficial effects on human and animal health. However, there are also potential risks ranging from how the technology affects individual genomes to its potential environmental and ecosystem impacts. Additionally, genome editing has raised fundamental ethical questions about human and animal life.

Genome editing technologies can be used to introduce, remove, or substitute one or more specific nucleotides (letters in the DNA code) at a specific site in the organism’s genome, and is achieved with the use of protein-nucleotide complexes. Several classes of these complexes exist, the most recent discovery is known as CRISPR/Cas9.

Research is currently underway that would use these technologies to:

  • Treat HIV, cancer or rare diseases by genetically altering specific types of cells;
  • Control or alter organisms that carry infectious diseases (for example, mosquitoes that are vectors of viruses/parasites causing dengue fever, Zika or malaria; or mice that transmit bacteria causing Lyme disease);
  • Improve the health and welfare of food producing animals, (for example, hornless cattle, pigs resistant to African swine fever or porcine reproductive and respiratory virus); and
  • Alter specific traits of food plants or fungi (for example, non-browning mushrooms).

Accompanying the enthusiasm about these promising technologies are questions about whether FDA is prepared to ensure the safety of regulated products that use this technology. Providing appropriate and balanced regulatory oversight for applications involving an emerging technology is not a new or unique challenge for FDA, but the potential breadth of applications and the fundamental nature of altering the genome call for the participation of multiple constituencies in considering the most effective regulatory policies to address any potential risks.

Robert Califf

Robert M. Califf, M.D., FDA Commissioner

Maintaining product-specific, risk-based regulation

Genome editing applications are relevant to three main FDA-regulated product classes. The specific regulatory approaches for each of these classes vary, reflecting differences in underlying statutory authorities. FDA is maintaining a product-focused, science-based regulatory policy, in accordance with specific legal standards applicable to each type of product and consistent with overarching U.S. Government policy principles.

Human medical products that apply gene editing to exert their therapeutic effect are regulated under our existing framework for biological products, which include gene therapy products. “Gene editing” here refers to non-heritable situations somatic cell gene therapy only, and not to heritable conditions (germ line gene therapy). The FY16 appropriations bill restricted use of federal funds “in research in which a human embryo is intentionally created or modified to include a heritable genetic modification.” FDA’s Center for Biologics Evaluation and Research (CBER) has a well-established program and policies in place to evaluate gene therapy products. Although different types of gene editing have potential clinical applications, currently only one type of gene editing, zinc finger nuclease- (ZFN) mediated, has been announced by their sponsors as being applied in clinical trials underway in the United States. Proposals for NIH-funded human gene therapy clinical trials are discussed and reviewed for scientific, clinical, and ethical issues by the NIH’s Recombinant DNA Advisory Committee (RAC). The RAC recently discussed (and did not find any objections to) the first clinical protocol to use CRISPR/Cas9-mediated gene editing. The potential for “off-target” effects such as insertions or deletions at unintended genetic loci has been identified by experts in the field as a key concern.

Similarly, FDA’s Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine have in place programs to adequately address foods derived from plants produced using genome editing and animals produced using genome editing. In these two product areas, we are issuing documents to clarify our current thinking and seek scientific information. With respect to foods derived from plants produced using genome editing, FDA has a longstanding program for foods derived from new plant varieties, including those developed by recombinant DNA (rDNA) techniques. We are requesting information on whether human and animal foods derived from genome edited plants pose additional risks compared to those from traditionally bred plants. FDA’s decades of experience providing oversight of foods from new plant varieties, coupled with scientific evidence and data received, will help inform our thinking on risk considerations going forward.

When animals are produced using genome editing, FDA has determined that, unless otherwise excluded, the portion of an animal’s genome that has been intentionally altered, whether mediated by rDNA or modern genome editing technologies, is a drug because it is intended to alter the structure or function of the animal and, thus, subject to regulation under our provisions for new animal drugs. We have updated our existing guidance for genetically engineered animals to include genome editing within its scope, and are issuing it in draft form for public comment. We are also seeking input on whether certain types of genome editing in animals pose low or no significant risk, and we may modify our regulatory approach based on this input.

Our efforts to gather necessary scientific data aside, industry remains responsible for ensuring that its products meet all applicable requirements, including safety standards. FDA has historically made itself available to meet with developers and we encourage them to engage with us to help ensure they meet their statutory and regulatory obligations. And we will continue to provide technical advice and guidance for industry, as necessary.

Collaborating with Federal agencies

The White House Office of Science and Technology Policy (OSTP), FDA, the U.S. Environmental Protection Agency (EPA), and the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) initiated an effort in 2015 to ensure public confidence in the regulatory system for biotechnology products and improve the transparency, predictability, coordination, and, ultimately, efficiency of that system. After reviewing public comment to a docket and holding three public meetings, the agencies produced A National Strategy for Modernizing the Regulatory System for Biotechnology Products, to help ensure that the federal regulatory system is prepared to assess future biotechnology products, issued in September; and, earlier this month, a 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (CF Update), to clarify each agency’s role.

Ritu Nalubola

Ritu Nalubola, Ph.D., Senior Policy Advisor, FDA’s Office of Policy

APHIS is proposing to revise its regulation regarding genetically engineered organisms that may pose plant pest or noxious weed risks. As FDA, APHIS, and EPA formulate policies, there may be differences in approaches, reflecting differences in the scope of their authorities and the types of risks addressed. Under the CF Update, interagency coordination and cooperation will continue, including on appropriate terminology, identification of hazards, and approaches to addressing risks, within the constraints imposed by regulatory paradigms for different product areas.

FDA also has a longstanding collaborative relationship with the NIH office that oversees the RAC. FDA serves as a non-voting liaison on the committee, hears the discussions first-hand, and receives the written recommendations.  These recommendations may be considered during our overall review of investigational new drug applications (INDs) submitted to FDA.

Scientific engagement and horizon-scanning

Being ready to evaluate innovative emerging technologies is a top FDA regulatory science priority. FDA is co-sponsoring two studies, conducted by the National Academies of Sciences, Engineering, and Medicine (NASEM). Both are expected to be completed this year. FDA is also conducting its own horizon-scanning through its Emerging Sciences Working Group, an FDA-wide science-based forum, and opened a public docket to receive input on emerging technologies.

Working with international partners

Scientific advances do not adhere to national boundaries and therefore it is critical that we understand the evolving views of our international counterparts. Given the leadership role of the United States in biomedical and biological sciences, we cannot afford to fall behind in this exciting scientific frontier. As expected, international regulatory agencies, too, are currently working in this area. FDA’s CBER is an active member of the International Pharmaceutical Regulators’ Forum (and its Gene Therapy working group), which provides a forum for members to identify and exchange information on issues of mutual concern and undertake targeted regulatory cooperation activities.

Going forward

FDA is committed to fulfilling its mission to safeguard public health, while encouraging innovation and competitiveness. The actions we have taken to date, including release of the CF Update, National Strategy, and FDA’s documents – are steps in a series of ongoing activities. We will continue to collaborate with our federal and international partners, and actively communicate with stakeholders to help ensure confidence in FDA’s regulatory system. However, oversight provided by FDA is one aspect of broader governance necessary for safe and responsible research and development of genome editing applications. Moreover, the expansive scope of intentional genomic alterations using modern genome editing technologies has triggered debate on fundamental ethical and social issues, which will continue to influence public opinion and acceptance of genome editing applications. Even as FDA implements necessary steps for effective regulation to ensure the safety of products, the role of broader, inclusive public discussion involving multiple constituencies (e.g., scientists, developers, bioethicists, and public interest and community groups) to address the larger societal considerations should not be overlooked.

Robert M. Califf, M.D., is Commissioner of the Food and Drug Administration

Ritu Nalubola, Ph.D., is a Senior Policy Advisor in FDA’s Office of Policy

 

Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public

By: Susan Mayne, Ph.D., and Katherine Vierk, M.P.H.

Transparency in the actions we take as an agency, and our reasons for taking them, is an important value for FDA in its mission to protect public health.

Susan Mayne

Susan Mayne, Ph.D., is Director of the FDA’s Center for Food Safety and Applied Nutrition

That is why we are, for the first time, making public the data that FDA’s Center for Food Safety and Applied Nutrition (CFSAN) receives about adverse events related to foods, including conventional foods and dietary supplements, and cosmetics regulated by FDA. This is information that was once only available through Freedom of Information Act (FOIA) requests, but will now be easily available to researchers, consumers, and health professionals.

This first posting of data from CFSAN’s Adverse Event Reporting System (CAERS) includes data from reports submitted by consumers, medical professionals and industry from 2004 through September 2016. The term “adverse event” is an umbrella term for a number of poor outcomes, including bad reactions, illnesses or deaths. We plan to update this information quarterly to ensure that the public has the most current information available.

Katherine Vierk

Katherine Vierk, M.P.H., is the Director of the Division of Public Health Informatics and Analytics at FDA’s Center for Food Safety and Applied Nutrition

The goal of CAERS is to provide indications, or “signals” of potential hazards. FDA uses these adverse event reports to monitor the safety of foods, including conventional foods and dietary supplements, and cosmetics. This information can, and has, led to investigations of specific products, targeted inspections and product testing, import alerts, warning letters, and enforcement actions.

Examples of how adverse event data has been used to support multiple actions by FDA include recalls of HydroxyCut and OxyElite Pro dietary supplements, and investigations of cosmetic products, such as EOS lip balm and Brazilian BlowOut hair smoothing treatment.

A few caveats about CAERS: The data from the reports is what was reported to the agency. FDA has not necessarily determined that the events reported were actually caused by the product in question. And there often are gaps in the information provided, which should ideally include the product name, symptoms, outcome, consumer’s sex and age, and the date the adverse event was experienced.

Going forward, FDA intends to modernize the system to make reporting adverse events as user-friendly as possible. You can expect to hear more about that in about a year. But in the meantime we didn’t want to delay giving the public access to data we have. The CAERS data will be posted on fda.gov and is also available through OpenFDA, launched in 2014 to make it easier to access the agency’s publicly available information.

We’re hoping that this increased transparency will result in more detailed and complete reports that will help us to more rapidly identify red flags about a possible safety issue with products we regulate. Anyone can report a safety or quality issue with an FDA-regulated food (conventional foods and dietary supplements) and cosmetics. To do so, visit fda.gov.

Susan Mayne, Ph.D., is the Director of FDA’s Center for Food Safety and Applied Nutrition

Katherine Vierk, M.P.H., is the Director of the Division of Public Health Informatics and Analytics at FDA’s Center for Food Safety and Applied Nutrition

Trade Alert: FDA Issues New Import Data Requirements

By: Howard Sklamberg, J.D.

One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015.

Howard SklambergTo help meet that challenge in a way that benefits both government and the trade community, import entries of products regulated by FDA are submitted through an electronic system called the Automated Commercial Environment (ACE). A final rule published on November 29 in the Federal Register specifies certain data that must be submitted in ACE when an FDA-regulated product is offered for import into the United States. The effective date of the rule is December 29, 2016, 30 days from the date of publication.

The trade community helped us pilot ACE, which is operated by U.S. Customs and Border Protection (CBP), from August 2015 to May 2016. In July 2016, ACE became the sole CBP-authorized system for electronic submissions of entries that contain FDA-regulated products.

The rule also includes technical revisions to certain sections of FDA regulations:

  • The owner or consignee of an FDA-regulated product is now defined as the importer of record. This brings FDA regulations up to date with previous revisions to customs laws. (21 CFR 1.83 and 21 CFR 1005.2)
  • FDA will now directly provide a notice that an FDA-regulated product is to be sampled, rather than having to go through CBP to provide that notice. (21 CFR 1.90)
  • FDA may now provide written notices electronically to the importer of record about FDA actions to refuse FDA-regulated products and/or subject certain drug products to administrative destruction. (21 CFR 1.94)
  • The rule clarifies that FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule.

As a result of the more streamlined import process for FDA-regulated products provided by ACE, the rule is expected to lead to an efficient use of FDA and importer resources, and more effective enforcement of laws and regulations enforced by FDA.

FDA will continue to provide assistance to filers working to properly submit the required data. Some of the measures we have instituted:

  • We are offering telephone meetings with importers, customs brokers, and other stakeholders, in real-time, while they are filing entries in ACE. Request a meeting by emailing ACE_Support@fda.hhs.gov.
  • An ACE Support Center is staffed 24/7. Reach FDA staff by email at ACE_Support@fda.hhs.gov or by phone at a domestic toll-free line (877-345-1101) or a local/international line (571-620-7320).
  • Upon request, FDA will assist in a filer’s first ACE submission, or for filers who import various commodities, FDA will assist with every first submission of a particular commodity.
  • Additional assistance for general import operations and policy questions, including FDA product codes and entry requirements, is available via email at FDAImportsInquiry@fda.hhs.gov or by calling 301-796-0356.

ACE replaces the Automated Commercial System, an older electronic submission system. Additionally, ACE provides an efficient single window for importers. Prior to the development of ACE, importers of products regulated by multiple government agencies could in some cases be required to submit information more than once.

ACE has already shown promise in accomplishing the dual goal of protecting public health while also serving the needs of the trade community by facilitating a more efficient review for admissibility of compliant products. FDA processing times for both automated and manual review have already been substantially reduced, by approximately 75% and 93% respectively, compared with the agency’s processing times in the previous system.

The ACE system serves to protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being offered for import that may be associated with a greater public health risk.

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Visit to West Coast Farmers and Processors Finds Shared Commitment to Food Safety

By: Stephen Ostroff, M.D.

Most people, even if they live in cities or suburbs, understand that there are many types of farms. But to really appreciate how different farms can be, you have to get out there and see it for yourself. By visiting farms in different parts of the country, you see first-hand the food safety challenges that are unique to a region. Farms are different sizes, grow a variety of crops and don’t follow the same growing and harvesting practices. There’s a varied amount of rainfall by region and season, and irrigation methods differ by crop and location. And so, while farmers confront some of the same issues, there can be real differences in the challenges they face.

What produce farmers and other food producers have in common is that they face new federal standards for the production of safe food. Seven foundational rules to implement the FDA Food Safety Modernization Act (FSMA) were finalized by May of this year. These include the produce safety rule, which establishes enforceable safety standards for the production and harvesting of most fruits and vegetables on farms in the United States and foreign farms that produce these commodities for the United States. They also include the preventive controls for human food rule, which establishes safety standards applicable to food facilities, including those that process fruits and vegetables.

I, along with my colleagues at FDA and state counterparts, visited the farmlands of the Pacific Northwest and California earlier this fall to get a sense of how growers, packers, processors and other stakeholders are getting ready to meet the new standards that apply to them. In September, we visited apple orchards and packing houses in Washington and berry growers in Oregon. We toured irrigation systems and met with stakeholders who included growers, water resources groups and tribal representatives.

FSMA West Coast Farm Tour

Parreira Almond Processing Company: Dr. Ostroff, left, and manager Paul Parreira Jr. at the almond hulling and shelling facility in Los Banos, CA.

In October, we visited stone fruit, table grape, citrus, and lettuce and strawberry fields in northern California. We toured an almond hulling and shelling operation in a visit coordinated by the Almond Alliance of California, and held a roundtable discussion about California’s water supply with farmers, representatives of industry associations and others. We visited a major processor of salad items. We finished the trip with an early-morning visit to the Golden Gate Produce Terminal in San Francisco, a trove of organic and conventional produce, as well as specialty and ethnic foods.

Produce farms have not been regulated like this before – it’s new territory for both the farming community and for FDA. We were asked many questions and received a great deal of feedback about the new regulations. But we found a strong commitment to providing consumers with safe fruits and vegetables and to moving forward in a collaborative fashion. For our part, I think it’s incumbent on FDA to protect public health without requiring a lot of unnecessary steps or measures that don’t achieve that goal.

These trips also highlighted the fact that that many food producers and industry associations have already invested a lot of time and effort in food safety measures. In some instances, what they have put in place goes beyond what is required under FSMA. In both trips, we saw farmers, other food producers, and industry associations stepping up to address past safety issues, including by developing their own on-farm standards and implementing audits to verify that those standards are met. Some developed treatment protocols and funded research to fill data gaps. These efforts will make it much easier to meet the new federal standards.

FSMA West Coast Farm Tour

Wenatchee (WA) Reclamation District: Manager Rick Smith, center, shows Dr. Ostroff, right, and colleagues an open irrigation canal system.

The big challenge for the growers in the drought-stricken Western states is water. The drought makes it difficult for growers to predict from month to month and season to season how much water will be available, where it will come from, and what it will cost. Therefore, many had questions regarding the produce safety rule’s water quality standards.

Our state regulatory partners in Washington, Oregon, Idaho and California brought members of the produce community together to meet us and discuss these issues. I am so grateful for their active involvement in making FSMA a success. Karen Ross, secretary of the California Department of Food and Agriculture, Lisa Hanson, interim director of the Oregon Department of Agriculture, Derek Sandison, director of the Washington State Department of Agriculture, and Pamela Juker, representing the director of the Idaho State Department of Agriculture, are strong voices for agriculture and food safety in the West, and we value their partnership and continued input. Both they and their staffs understand the farmers and have long-standing relationships with them. Through recently announced produce safety cooperative agreements with FDA, we will be partnering with each of these states and 38 others to implement the new produce safety rule.

We also had the opportunity to visit farms that have been in families for generations. These farmers take great pride in their work and are determined to keep their food safe but still have questions about how to they can comply with the new requirements. The take-home lesson for us was the need to provide adequate education and training and clear guidance that will help these farmers comply with FSMA. Farmers are looking for this and we’re making sure that we can fill these needs.

There was also a lot of discussion about making sure that the information we provide can be understood by people working on farms who are not native English speakers. There is a great deal of diversity in these regions, including the Hmong-American farmers of California’s Central Valley.

So there’s a lot of work ahead of us, and together we will roll up our sleeves to get it done. We went to see farmers and other food producers, and met a lot of talented people who grow and process the food we eat. We found an incredible diversity in the food that is produced, but a shared commitment to having the safest possible food supply.

Stephen Ostroff, M.D. is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

SCORE at Six Months: Meeting the Challenge of Complex Recalls

By: Stephen Ostroff, M.D., and Howard Sklamberg, J.D.

When a potentially contaminated food is on the market, time is of the essence to keep people from becoming ill. Yet there are times when it is difficult to determine what actions should be taken. This can happen when we do not have enough information to reach a clear decision.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

To better address these situations, in April FDA established a team of senior leaders that is brought in to make decisions in the most challenging cases. The team is called SCORE, which originally stood for Strategic Coordinated Outbreak Response and Evaluation, but it soon became clear that the scope of its work is broader than outbreaks. The team looks at cases in which recalls and other actions may be needed, even when there are no reports that people have fallen ill. So SCORE now stands for Strategic Coordinated Oversight of Recall Execution.

And we’re happy to report that SCORE is already making a difference, helping to overcome obstacles and streamlining processes to get potentially harmful foods off the market as soon as possible to reduce further consumer exposure.

In the last six months, SCORE has reviewed and directed operations in cases that include flour contaminated with peanut protein, (a major food allergen), facilities contaminated with Listeria monocytogenes, pistachios in which Salmonella was detected, and baby food that was not manufactured in compliance with infant formula regulations. All of these cases resulted in recalls and announcements issued by the firms and FDA.

Howard Sklamberg

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

SCORE was launched, in part, in response to concerns raised by the Department of Health and Human Services’ Office of the Inspector General about FDA’s ability to ensure that companies initiate voluntary recalls in a prompt and effective manner. While FDA staff were already helping to facilitate thousands of prompt and successful voluntary recalls, we recognized the need for an enhanced response in certain, more complex cases.

In the cases brought to the team, we believe that SCORE has helped determine the right course of action and shorten recall timeframes, getting the products off the market faster. SCORE has helped improve tactical planning, leading to additional inspections and sampling assignments, and to getting the word out to more consumers about potentially dangerous products. In one case, FDA suspended a food facility’s registration after a reinspection and additional sampling requested by SCORE showed continued contamination. Suspension of registration effectively shuts a facility down until FDA determines that there is no longer a reasonable probability that foods produced there will cause serious illnesses or death.

We set individual deadlines and got prompt results in these, and other, instances. FDA staff are seeing these actions as a model for their efforts going forward.

FDA has been evolving over the past few years into an agency that speaks with one voice in its oversight of food safety. SCORE’s membership includes leaders from within the directorates of Foods and Veterinary Medicine and Global Regulatory Operations and Policy, in addition to the Office of the Chief Counsel. The spectrum of expertise covers inspections and investigations, compliance and enforcement, policy, legal, communications, outbreak response and, most important, science.

This team is in its infancy but the results it has achieved thus far signal an integrated approach to food recalls that will help ensure a swift response no matter what obstacles arise. The arrival of the compliance dates for the FDA Food Safety Modernization Act rules overseeing the safety of domestic and imported foods are putting additional food safety controls in place to help reduce food contamination. And the work of SCORE and its colleagues will continue.

SCORE’s goals for the next year include identifying and closing gaps that slow the process of determining whether a food is a threat to public health or interfere with identifying the right actions to take in response to potential contamination. Our ultimate goal is to continue to improve our ability to protect consumers from contaminated food.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine, and Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

Making Sure ‘Healthy’ Means What It Says on Food Packages

By: Douglas Balentine, Ph.D.

With final rules on the Nutrition Facts label published, consumers soon will see an updated label on food packages that makes the calories and serving sizes of products easier to see and that gives them additional nutrition information, such as added sugars, vitamin D, and potassium.

Doug BalentineThe marketplace is teeming with rows and rows of foods – some new and some not; some healthier than others. Even for the well informed, choosing what to buy is challenging, especially if you want to choose a healthy diet for you and your families.

We know that many consumers use the Nutrition Facts label, especially when they are buying a food for the first time. Often, there are also a lot of other terms on food packages such as “healthy,” “low in fat,”or “good source.” We also know that many just don’t have the time to consider the details of nutrition information on every package they purchase. In fact, most purchase decisions are made quickly, within three to five seconds.

That’s why we’re looking at how we define the claim “healthy.” Companies can use this and other claims on the front of packages of foods that meet certain criteria to help consumers quickly identify nutritious choices.

As our understanding about nutrition has evolved, we need to make sure the definition for the “healthy” labeling claim stays up to date. For instance, the most recent public health recommendations now focus on type of fat, rather than amount of fat. They focus on added sugars, which consumers will see on the new Nutrition Facts label. And they focus on nutrients that consumers aren’t getting enough of, like vitamin D and potassium. By updating the definition, we hope more companies will use the “healthy” claim as the basis for new product innovation and reformulation, providing consumers with a greater variety of “healthy” choices in the marketplace.

We have started to consider the criteria or terms for an updated definition of “healthy” but don’t have all the answers. As a first step, we are asking for public input on a range of questions about what “healthy” should mean from a nutrition perspective and how consumers understand and use “healthy” food label claims.

For example, what current dietary recommendations should be reflected in the definition of “healthy”? What are the public health benefits of defining the term “healthy”? What do consumers expect of foods that carry a “healthy” claim? What factors and criteria should be used for the new definition of “healthy”? We are also planning to hold public forums to get additional input and inform us of what a broad range of stakeholders and consumers think. This may take some time, but we want to get it right.

While we are working on the “healthy” claim, we also will begin evaluating other label claims to determine how they might be modernized. We want to give consumers the best tools and information about the foods they choose, with the goal of improving public health. And, we will also engage with industry to explore other ways to encourage companies to change their products to have better nutrition profiles. The end result will be more healthy dietary choices for consumers, and that is a worthy goal.

Douglas Balentine, Ph.D., is Director, Office of Nutrition and Food Labeling at FDA’s Center for Food Safety and Applied Nutrition

First Major FSMA Compliance Dates: Landmarks and Learning Experiences

By: Stephen Ostroff, M.D., and Howard Sklamberg, J.D.

The phrase “where the rubber meets the road” is one that comes up in conversations about different subjects, from athletics to academics, when carefully laid plans are put to a crucial test. That’s where we are today with the arrival of the first major compliance dates under the regulations developed by FDA to implement the FDA Food Safety Modernization Act (FSMA).

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

This is the day when larger businesses must comply with certain new standards under the preventive controls rules for human and animal food, two of the main rules developed to drive down the incidence of foodborne illnesses in our country. Larger human food facilities must meet preventive controls and modernized Current Good Manufacturing Practice requirements (CGMPs); larger animal food facilities must meet CGMPs. (The human and animal food rules have staggered compliance dates; animal food businesses have additional time to meet the preventive controls standards, as do smaller producers of human foods.)

The preventive controls rules were the first two of seven foundational FSMA rules to become final starting in September 2015. Human food facilities are required to have a food safety system in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent those hazards. The standards that animal food facilities must meet mark the first time that CGMPs have been broadly required for the safe production of animal food.

FSMA was signed into law in 2011 in the wake of mounting concerns by consumers and lawmakers about outbreaks of foodborne illness that kill thousands of people and animals every year. What followed was an unprecedented effort by FDA to involve the diverse landscape of food safety stakeholders, including growers, manufacturers, importers, distributors, consumer groups, and academic institutions, in the formulation of rules that are practical, flexible and effective for the food industry at home and abroad while protecting the public from contaminated food.

Howard Sklamberg

Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Since FSMA was enacted in 2011, we have literally traveled the world to get input on the rules we proposed in 2013 and early 2014 to implement the law. FDA teams have been involved in approximately 600 engagements, including public meetings, webinars, listening sessions, farm tours, visits to manufacturing plants and extensive presentations and meetings with various stakeholder groups.

As a result of these conversations, we made significant changes in September 2014 to four of the FSMA proposed rules, including the preventive controls rules, to make them more feasible and, ultimately, more effective.

So what happens now? This is a new chapter for all of us. FDA is focusing on providing the support that companies need to comply with the new requirements with education, training and technical assistance. We will be looking at how facilities are working to comply with the new food-safety standards and protect consumers from unsafe food. Of course, our mandate is to protect public health and, when necessary, the agency will act swiftly to do so.

The conversations we had with stakeholders in creating the rules will continue as we move further into the implementation phase with the preventive controls and other rules. We will be sharing our thinking on how requirements should be met in guidance documents and asking for the public to continue to provide feedback. If necessary, changes will be made; aspects of the rules will be fine-tuned. This first wave of compliance dates is important to the entire spectrum of FSMA implementation; the lessons learned will be invaluable in the years ahead when smaller food facilities are held to the new standards.

So today, the rubber meets the road. But these compliance dates aren’t the beginning of the end of our work to make FSMA a reality. They’re the end of the beginning. The partnership that FDA has forged with food producers of all kinds, and with its state, local, tribal and international regulatory partners, will ultimately protect consumers for generations to come.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

On Dauphin Island, FDA Scientists Work to Keep Seafood Safe

By: Capt. William Burkhardt III, Ph.D.

On a barrier island in the Gulf of Mexico, two dozen scientists and staff in the FDA’s only marine research laboratory have one common goal: to keep consumers safe from contaminated or unsafe seafood.

I am the director of the FDA’s Gulf Coast Seafood Laboratory (GCSL) on Dauphin Island, Alabama, where we detect chemical and biological hazards and work to reduce the likelihood of illness associated with seafood. In early August, the agency invited U.S. Rep. Robert Aderholt to tour the facility and see our work first-hand. Rep. Aderholt represents Alabama’s Fourth Congressional District and chairs the House Appropriation Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.

Gulf Seafood Lab

Robert Hayes Aderholt feeds crabs at the Gulf Coast Seafood Laboratory as his father, U.S. Rep. Robert Aderholt, and biologist Kathy El Said look on.

At the GCSL, we use the latest technology to detect and identify things that can potentially contaminate seafood. There are drug and chemical residues that may be present from the use of antibiotics and other chemicals in aquaculture production. There are also petrochemicals from off-shore drilling.

There are marine biotoxins that occur naturally, such as harmful algal toxins that go up the marine food chain and eventually get into fish. There are bacteria that occur naturally in marine waters, such as vibrios, that can cause serious, even deadly, illnesses. And there are viruses, such as the norovirus, in marine water that are ingested by shellfish.

We routinely test a wide array of samples from public and private sources, and work closely with FDA’s compliance and enforcement teams in and out of the country so that action can be taken when appropriate.

Our scientists are often brought in when a natural or man-made disaster threatens to contaminate fish or an outbreak is tied to seafood. We’re involved right now in the response to an outbreak of hepatitis A in Hawaii tied to imported scallops, providing microbiological support to identify the virus that has sickened more than 200 people.

Group photo at Gulf Seafood Lab

U.S. Rep. Robert Aderholt (front row, center) poses with FDA’s team at the marine research laboratory. Also in the front row are lab director Capt. William Burkhardt III (left) and William Jones, deputy director of FDA’s Office of Food Safety (right).

When the Deepwater Horizon oil rig exploded in 2010, spilling an estimated 4.9 million barrels of oil into the Gulf of Mexico, we staffed sampling locations. A year after that spill, we allayed the concerns of fishermen participating in the Alabama Deep Sea Fishing Rodeo tournament, billed as the largest fishing tournament in the world. FDA’s Office of Regulatory Affairs set up a mobile laboratory in our parking lot and together we tested samples that fishermen brought in, working round-the-clock for two weeks. We were able to assure the fishermen that there was no oil or dispersants in their fish.

In 2005, we were heavily involved in the response to Hurricane Katrina, in which there were concerns that chemicals would be swept into the Gulf and then into the fish. We deployed staff to sample crabs, shrimp and other seafood and send them by courier back to our labs. Ultimately, we found some elevated levels of bacterial contamination, but that dissipated relatively quickly during the time in which the area was closed to fishing.

We are also invited by other countries to assist in emergency response. For example, six years ago we traveled to Chile after an earthquake there and used our technology to detect norovirus in the drinking water.

When Haiti was hit with a cholera outbreak in 2010, we responded in collaboration with the Centers for Disease Control and Prevention. Our tests found cholera in seafood collected from Port au Prince. These findings were used to tighten recommendations on the movement of ballast water in and out of ships to minimize transmission of the outbreak.

We work with the seafood industry to find practical solutions to common problems. For example, we’re working with oyster fisherman to identify strategies to control bacterial (vibrio) growth. And we’ve advised barracuda fishermen to avoid certain parts of the Caribbean where the fish are vulnerable to biotoxins.

As I showed Rep. Aderholt around our labs, it was a good opportunity to reflect on the important work we do here and the impact we have. Whether it’s in the United States or overseas, we want to be known as a group of scientists that helps people everywhere enjoy seafood safely.

Capt. William Burkhardt III, Ph.D., is the Director of FDA’s Division of Seafood Science and Technology

FDA Cooperative Agreements with States to Advance Food Safety

By: Stephen Ostroff, M.D.

Today, the FDA is honoring an important commitment by awarding millions of dollars to the states that will help implement the new produce safety rule mandated by the FDA Food Safety Modernization Act (FSMA) to protect consumers from foodborne illness.

Stephen Ostroff, M.D.In FSMA, Congress envisioned a strong partnership between the FDA and the state agencies that have a greater understanding of the growing and harvesting practices in their areas. Many have longstanding relationships with farmers and produce associations.

To support this partnership, the FDA is awarding $21.8 million in cooperative agreements to 42 states in support of their work to help implement the new produce rule. These funds will provide states with the resources they need to develop a produce safety system, considering the specific and unique needs of their growers for education, outreach, and technical assistance.

The funding for each state is based on the estimated number of farms in the state that grow produce covered by the FSMA rule.  The goal is to provide resources that will enable the states to develop a multi-faceted, multi-year plan that includes an assessment of their produce safety landscape, including an evaluation of existing state authorities to implement a produce safety program and ways to develop a strong outreach and education program with growers.

The produce safety rule, which became final in November 2015, establishes science-based standards for the safe growing, harvesting, packing, and holding of fruits and vegetables. State leaders were key partners as the produce provisions were being developed, providing valuable input on how to make the requirements as practical and flexible as possible for growers while still protecting public health.

The cooperative agreements build on a foundation laid long before the produce rule became final. Enacted in 2011, FSMA included several important provisions aimed at strengthening the National Integrated Food Safety System so that the more than 3,000 state, local, and tribal government agencies involved in food safety are fully integrated in FDA’s work to fulfill FSMA’s mandate.

We have been steadily building this system, and in our FY2017 budget request we have asked Congress for an additional $11.3 million in new budget authority to further support the development of state produce safety programs.

In 2014, the FDA entered into a five-year cooperative agreement with the National Association of State Departments of Agriculture (NASDA) that brought together state partners to collaboratively plan implementation of the produce safety rule. The framework developed by NASDA will guide and inform states as they work on their own regulatory programs.

The cooperative agreements are part of a long-term strategy to strengthen this working partnership with the states. We’re in this together and the FDA will continue to support its state partners as we work to make the vision of a preventive and risk-based food safety system a reality.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine