FSMA: The Future Is Now

By: Michael R. Taylor

FDA is holding the “FDA Food Safety Modernization Act Public Meeting: Focus on Implementation Strategy for Prevention-Oriented Food Safety Standards.” The two-day national public meeting in Washington, D.C., began Thursday, April 23, 2015 with a panel discussion by top FDA leaders on the overarching philosophy and strategy. Participants: Michael Taylor, J.D., Deputy Commissioner for Foods and Veterinary Medicine; Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy; Melinda Plaisier, M.S.W., Associate Commissioner for Regulatory Affairs, Office of Global Regulatory Operations and Policy; Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition; Bernadette Dunham, D.V.M., Ph.D., Director, Center for Veterinary Medicine. Moderator: Kari Barrett, Advisor for Strategic Communications and Public Engagement, FDA

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

We’re Reinventing Ourselves to Keep Your Food Safe

By: Michael R. Taylor and Howard Sklamberg

Congress enacted the FDA Food Safety Modernization Act (FSMA) in response to dramatic changes over the last 25 years in the global food system. It grew out of an understanding that foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system. And FSMA was embraced by a public whose confidence in the food system was being eroded by a series of foodborne outbreaks.

Michael Taylor

Michael Taylor

The law directs a comprehensive overhaul of our food safety system, using three broad themes:

  • Advancing Public Health – by focusing on prevention of food safety problems through broad, consistent industry implementation of modern preventive practices.
  • Leveraging and Collaborating – by working in close collaboration with other government agencies (federal, state, local, tribal and foreign), the food industry and other stakeholders to make the best use of all available food safety resources.
  • Strategic and RiskBased Industry Oversight – including clear FDA guidance on standards; outreach and technical assistance to facilitate voluntary compliance; and the use of adaptable, risk-based inspection and compliance strategies that focus on public health outcomes and the effectiveness of overall systems of prevention.

Since January 2013, we have proposed seven new rules to establish the comprehensive framework of modern, prevention-oriented standards mandated by FSMA, covering the production and transportation of human and animal foods, whether produced in the U.S. or overseas. There is a lot of work to do to get these standards right, and we are very focused on that work.

Howard SklambergAt the same time, however, we must be laying the foundation for the next phase: effective and efficient implementation of the new standards. This requires fundamentally new approaches to collaboration and oversight to achieve high rates of compliance with FSMA’s prevention standards. And from a public health and public confidence standpoint, this is where the rubber meets the road.

We are thus pleased to be sharing with our partners and stakeholders a document that captures in broad, high-level terms our current thinking on strategy and guiding principles for implementing the produce safety rule, the preventive controls rules, and FSMA’s new import tool kit, after the final FSMA rules are issued in late 2015 and early 2016. We are making this available as the springboard for discussion with the entire food safety community.  And we know discussion is needed, because the strategy that will make FSMA a success requires significant change in how we at FDA do our work and how we work with our partners.

For example, FSMA calls for a national integrated food safety system that builds on FDA’s longstanding collaboration with state governments on food safety inspection and compliance, but we must take that collaboration to a new level, especially when it comes to the new and unique challenge of implementing the produce safety rule. We aspire to rely heavily on state agriculture departments and other state and tribal departments with on-farm food safety responsibility, taking advantage of their food safety commitment, their knowledge of local conditions and practices, and their local presence to deliver training, technical assistance and compliance oversight. But we have to work closely with our state partners to convert this aspiration to reality. That work includes finding the funding they will need to play an expanded role on produce safety and other areas of FSMA implementation.

FSMA is also helping drive internal governance change at FDA to be sure that all headquarters and field elements of our program are working seamlessly and efficiently to achieve our public health goals. You may have seen the memorandum that Commissioner Margaret Hamburg issued in February 2014 directing a more vertically integrated alignment of the program centers and the Office of Regulatory Affairs (ORA) working in particular areas, such as food safety and drug quality. This is aimed at increasing specialization across FDA, including the programs as well as frontline investigators and compliance officers. It is also intended to streamline interactions between ORA and Center experts so we can devise effective oversight plans, make well-informed judgments during inspections, and achieve timely corrective action when needed to protect consumers.

As the deputy commissioners for Foods and Veterinary Medicine (FVM) and Global Operations (GO), we share leadership responsibility, on the Commissioner’s behalf, for implementing these changes within FDA. To facilitate our efforts and share responsibility, we have created a new FVM Governance Board, which we co-chair and which includes as members: Michael  Landa, director of the Center for Food Safety and Applied Nutrition (CFSAN); Bernadette Dunham, director of the Center for Veterinary Medicine (CVM); and Melinda Plaisier, associate commissioner for Regulatory Affairs (ORA). This Board will help ensure that CFSAN, CVM, and ORA partner fully on major strategic decisions that affect successful implementation of FSMA’s new prevention paradigm.

This is the commissioner’s vision of an agency that works seamlessly across borders, both internal and external, when it comes to protecting public health.

Finally, the work of developing detailed plans for implementing the produce safety and preventive controls rules and the new import safety system is being done by teams of FDA employees overseen by the FSMA Operations Team Steering Committee. This steering committee is led by Roberta Wagner, CFSAN deputy director for regulatory affairs, and Joann Givens, ORA Central Region, acting regional food and drug director, and it will play a key role in the dialogue we will be seeking with our government partners and stakeholder community on our FSMA implementation plans. You’ll be learning about this team’s crucial leadership role in an upcoming FDA Voice blog.

We need your engagement in this important work. Together, we can build a modern food safety system that works well for the food system and for the consumers we all serve.

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

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Leave the Chocolate Out of Rover’s Celebrations

By: Bernadette Dunham, DVM, PhD, and Carmen Stamper, DVM

Holidays and chocolate seem to go together. For birthdays, anniversaries, Mother’s Day and many other holidays — chocolate is everywhere. But, there is someplace chocolate should never be, and that’s in your dog. Chocolate is toxic to dogs and can kill them. And since a lot of the chocolate treats might be the kids’, make sure to pass along the message to them to never give chocolate to Rover.

Here’s why chocolate is so dangerous for dogs:

Bernadette Dunham, DVM, PhD

Chocolate contains theobromine, a compound in the same family as caffeine.  In certain quantities, theobromine is toxic to dogs.  In general, the minimum toxic theobromine dose in dogs ranges from 46 to 68 milligrams/pound (mg/lb).  Half the dogs that consume 114 to 228 mg/lb or greater of theobromine will die. Lots of things can play a role in whether your dog will have a toxic reaction including the amount of chocolate your dog ate, your dog’s size, and whether your dog happens to be extra-sensitive to theobromine. One of the most important things in chocolate toxicity is the kind of chocolate your dog ate.  For instance:

  • Milk chocolate contains 44 mg of theobromine per oz.  (704 mg theobromine/lb milk chocolate)
  • Semisweet chocolate chips contain 150mg/oz. (2400 mg theobromine/lb semisweet chocolate)
  • Baking chocolate contains 390mg/oz. (6240 mg theobromine/lb baking chocolate)

Carmen Stamper, DVM

So, if we do the math, Rover is eyeing the ears and tail from a leftover chocolate bunny.  How much would he have to eat to get a 46 mg/lb dose of theobromine?  Depending on the type of chocolate, he’d have to eat:

  • 1 ounce per 1 pound of his body weight of milk chocolate bunny
  • 1 ounce per 3 pounds of his body weight of semisweet chocolate bunny, or
  • 1 ounce per 9 pounds of his body weight of baking chocolate bunny.

And, if Rover eats enough chocolate, he might show signs of chocolate toxicity:

Theobromine toxicity can cause a variety of signs ranging from mild to severe.  These signs can include vomiting, diarrhea, rapid heart rate, restlessness, hyperactivity, urinating more, muscle spasms and seizures.

If you think your dog has eaten chocolate call your veterinarian immediately! Only your veterinarian can determine the proper treatment for your pet.

Bernadette Dunham, DVM, PhD, is Director of FDA’s Center for Veterinary Medicine

Carmen Stamper, DVM, is on the Communication Staff of FDA’s Center for Veterinary Medicine

Les États-Unis et le Canada travaillent ensemble pour fournir un accès aux produits pharmaceutiques vétérinaires nécessaires

Publié le 12 décembre 2012

Par: Bernadette Dunham, D.V.M, Ph.D et Murray M. Lumpkin, M.D., M.Sc.


Bernadette Dunham, D.V.M, Ph.D., Director of FDA’s Center for Veterinary Medicine

La première revue et approbation simultanée d’un produit pharmaceutique vétérinaire par les États-Unis et le Canada marque un début encourageant à une collaboration visant à fournir un accès plus rapide aux médicaments vétérinaires nécessaires. Cette collaboration a pour but  d’éliminer les barrières commerciales et de réduire les frais pour les consommateurs, les organismes de contrôle et les fabricants.

Voici ce qui s’est passé: l’année dernière, le président Obama et le premier ministre du Canada Stephen Harper ont annoncé la création du Conseil de coopération réglementaire (RCC) entre les États-Unis et le Canada. Le conseil a pour but de mieux harmoniser plusieurs modalités réglementaires afin d’éliminer les exigences en double et de mieux partager les ressources réglementaires.

L’élimination des démarches faisant double emploi aura pour effet de réduire les frais et de permettre un accès plus facile aux produits  tout en encourageant le commerce et les investissements.

Murray M. Lumpkin, M.D., M.Sc., FDA Commissioner's Senior Advisor and Representative for Global Issues

Après la signature de l’accord de la création du conseil, un des premiers projets a été que les organismes de contrôle des produits pharmaceutiques des deux pays révisent simultanément les mêmes données d’efficacité pour l’approbation du nouveau produit vétérinaire d’Elanco, Comfortis, utilisé pour tuer les puces et empêcher les infestations de puces chez les chats. Cette action a culminé cette semaine par l’annonce que le Centre de médecine vétérinaire de la FDA et la Direction des produits pharmaceutiques vétérinaires du ministère de la santé du Canada avaient approuvé simultanément le produit.

Les organismes de contrôle des deux pays ont déterminé que plusieurs autres produits pharmaceutiques vétérinaires sont potentiellement admissibles pour revue par les deux pays selon le plan d’action du RCC.

À cause de la réussite de cette collaboration initiale, il est donc possible de continuer à améliorer l’efficacité de nos revues et à utiliser les ressources de nos revues pour améliorer l’accès à des produits sans danger et efficaces des deux côtés de la frontière.

Bernadette Dunham, D.V.M, Ph.D., est directrice du Centre de médecine vétérinaire de l’Administration des États-Unis pour les aliments et les produits pharmaceutiques.

Murray M. Lumpkin, M.D., M.Sc., est conseiller principal et représentant des questions globales du commissaire de la FDA.

U.S. and Canada Working Together To Provide Access to Needed Veterinary Drugs

en  français

By: Bernadette Dunham, D.V.M, Ph.D. and Murray M. Lumpkin, M.D., M.Sc.

Bernadette Dunham, D.V.M, Ph.D., Director of FDA’s Center for Veterinary Medicine

The first simultaneous review and approval of a veterinary drug by the United States and Canada marks a successful start to a collaboration aimed at providing quicker access to needed veterinary medicines. The collaboration is also intended to remove trade barriers and reduce costs for consumers, regulators and manufacturers.

Here’s the background: Last year, President Obama and Canada’s Prime Minister Stephen Harper announced the creation of the U.S.-Canada Regulatory Cooperation Council (RCC). The council’s goal is to better align several regulatory approaches, to remove duplicative requirements, and to better share regulatory resources.

Eliminating overlapping efforts is expected to result in reduced costs and more timely access to products while encouraging trade and investment.

Murray M. Lumpkin, M.D., M.Sc., FDA Commissioner's Senior Advisor and Representative for Global Issues


After the agreement to create the council was signed, one of the first projects was to have drug regulators in both countries simultaneously review the same effectiveness data for approval of Elanco’s new animal drug, Comfortis, used to kill fleas and prevent flea infestation in cats. That effort culminated in this week’s announcement that FDA’s Center for Veterinary Medicine and Health Canada’s Veterinary Drugs Directorate had simultaneously approved the drug.

Regulators in both countries have determined that several other veterinary drugs are also potentially eligible for simultaneous review by both countries under the RCC action plan.


Because of this successful initial collaboration, there is much potential opportunity going forward to continue to improve our review efficiency and the use of our review resources to improve access to safe and effective products on both sides of the border.

Bernadette Dunham, D.V.M, Ph.D., is Director of FDA’s Center for Veterinary Medicine.

Murray M. Lumpkin, M.D., M.Sc., is FDA Commissioner’s Senior Advisor and Representative for Global Issues.


Is it Something My Pet Ate?

By: Bernadette Dunham, D.V.M., Ph.D.

As a practicing veterinarian I saw first-hand that pets tend to eat odd things, from foreign objects such as stones, fish hooks or sewing needles with thread…to car antifreeze, sometimes with unfortunate outcomes. However, when it comes to the main staple of our pet’s nutritional diet we usually turn to commercially produced pet food that we reach for on the store shelves. 

Millions of pets consume pet food without any problems, but once in a while, as is the Bernadette Dunham, D.V.M., Ph.D.case with human food, bacteria or chemicals may contaminate pet food or pet treats and our pets may get ill. If you think your pet may have become ill from eating pet food or pet treats then I have some important steps for you to follow:

First, call your veterinarian! It is important that your pet receive prompt medical attention. Your veterinarian will most likely ask if your pet vomited, had diarrhea, or was acting lethargic and how soon any of these signs appeared after eating.

Second, while your veterinarian will tend to your pet’s condition, you or your veterinarian can help FDA’s Center for Veterinary Medicine (CVM) investigate your pet’s illness. You or your veterinarian can electronically report cases of animal illness associated with pet foods through the Safety Reporting Portal, or by calling the FDA Consumer Complaint Coordinators in your state.

But before you log-on or pick up the phone, here’s what we need to know:

  • What kind of pet do you have?  Is it a dog, cat, rabbit, fish, bird, or other species?
  • What is the age, weight, and breed of your pet? Is she pregnant or spayed? Is he neutered?
  • How much of the suspected pet food does your pet normally eat at each feeding — and how much has already been eaten from that package?
  • How long has your pet been eating the suspected pet food? Did the signs of illness appear following feeding a new or partially used container of the food?
  • How much of the product do you still have?
  • Also, did any other pets in your household eat the same product? Did they become ill too, or were they unaffected?
  • What other foods or treats does your pet eat?
  • Did your ill pet spend time outside unsupervised (back to they eat odd things) and why do you suspect the pet food caused the illness?
  • Does your pet have any current or previous health problems, and do you give your pet any other food, treats, dietary supplements, or drugs?

The condition of your pet is paramount to determining what happened and why, but also necessary is the information provided on the pet food package. If you transfer dry pet food into other containers for easier handling, please save the original packaging until the pet food has been consumed. FDA will want to know the exact name and the description of the product as it is stated on the label. The type of container such as box, bag, can, or pouch can be useful information as well.

FDA’s investigators will be looking for the lot number, which identifies in which plant your pet’s food was manufactured, and when. Is there a best by, best before, or an expiration date on the package? This, along with the UPC code, or bar code, and the net weight are facts useful to FDA’s investigators. It may also help for you to let us know when and where you purchased the pet food, and how the food was stored, prepared, and handled.

Pet owners should also call the pet food manufacturer to report a suspected pet food illness in their pet. The contact information will be printed on the package.

Like any scientific investigation, there are numerous questions to consider and your ability to provide the information to your veterinarian and to FDA’s CVM is most essential in helping to determine what happened. It is very much like putting on Sherlock Holmes’ thinking cap to solve a mystery.

FDA brings a multitude of resources to pet food investigations. As we evaluate the circumstances that led to your pet’s illness, a variety of FDA experts join forces to solve the puzzle. Investigators with expertise in proper manufacturing practices, plus food and feed safety, examine the manufacturing plants, warehouses and the trucks used for shipping the pet food. They are supported by scientists and other experts at FDA headquarters who can help them determine what might have caused a pet food or pet treat problem.

When a pet food is suspected of causing illness in animals, samples of the food might be sent to FDA laboratories and perhaps FDA’s Forensic Chemistry Center where scientists perform original research to identify any possible contaminants or other hazardous materials in the product.

In addition, CVM has established a veterinary response laboratory network (Vet-LRN), which assists in the investigation by examining samples from pets that have become ill. Vet-LRN works with your veterinarian and the collaborating network laboratories whenever clinical or tissue samples are needed to help diagnose the problem with the pet food.

FDA is committed to the health and well-being of your pet and by working together, you, your veterinarian, and FDA can not only respond to, but more importantly prevent any pet food-borne illness from happening again.  Thank you!

Dr. Bernadette Dunham is the Director of FDA’s Center for Veterinary Medicine