FSMA Implementation: The Road Is Challenging, but the Company Is Extraordinary

By: Michael R. Taylor

As we begin 2016, it’s a good time to reflect on the extraordinary engagement we’ve had on food safety with the food-producing community and its continuing impact as we move forward to implement the FDA Food Safety Modernization Act (FSMA).

Michael R. TaylorIn August and September 2013, we took three important trips – to the Pacific Northwest, New England and Europe – to talk about the rules we had proposed earlier that year to implement FSMA.

What we learned on those trips made a huge impression, one that ultimately shaped more than just the rules. It had a profound effect on our understanding of the diverse global community of food producers, and opened our eyes to the food safety imperative that guides them.

More recently, we retraced our steps this November and December, making those journeys again to discuss the five FSMA rules that became final this fall — establishing preventive controls for human and animal food, setting produce safety standards, and strengthening oversight of imported foods.

First, some background. We had been traveling to farms since 2009, well before FSMA was signed into law in 2011, listening to and learning from farmers. The visits in 2013 were particularly important because FSMA had become law by then and we had specific proposals to discuss.

In the Pacific Northwest and New England, we focused on issues as different as the climate and geography of those regions. Growers who created lush farmland in the high desert regions of Idaho, Oregon and Washington using canal-fed irrigation systems were chiefly concerned about the agricultural water standards. In Vermont, Maine and New Hampshire, discussions centered on the impact of FDA’s plans on the local food movement and on farmers’ efforts to innovate and diversify.

There was a common theme, however: Growers have been understandably concerned about where we’re headed with these food safety regulations and how they will affect farms, especially those that have been in families for generations. So in 2013, with specifics on the table, there were some tough conversations about the merits of our proposals – and how they could be improved. In Europe, our discussions were primarily with our foreign regulatory counterparts, but also reflected uneasiness about the FSMA rules, particularly their impact on foreign trade.

The bottom line is that through these trips, our eyes were indeed opened to some realities. It became clear that we’d need to make changes for the regulations to work for the food industry while still protecting public health.

Fast forward to 2015. We saw familiar faces in our return to the Pacific Northwest and New England for public meetings in Portland, Oregon, on December 1, and in Brattleboro, Vermont, on December 14. These are people who were frank about their reservations and then rolled up their sleeves to work with us on finding solutions. And we did find solutions, building flexibility into the rules that give food producers and importers options and alternatives that still meet important safety criteria.

And in Europe, too, the conversation has turned to next steps. In early December we returned to Brussels and again met with our European Union regulatory counterparts. Europe has similar overarching food safety principles as the U.S. and the leaders we met want to leverage their resources and avoid duplication of effort. And we are looking into that now, beginning by comparing the public health protections in the European standards with those built into the FSMA rules.

The reception was enormously positive in all three places. We’re in a good place with the FSMA rules. Five of the seven rules we proposed have now been finalized, and we intend to publish final regulations on sanitary transportation and intentional adulteration in the spring. President Obama’s Fiscal Year 2016 budget request for FSMA implementation was close to fully funded, with FDA set to receive $104.5 million of the $109.5 million requested. This critical funding will enable us to maintain our momentum toward timely, comprehensive implementation.

We at FDA are gratified and grateful for what we’ve seen since we first took to the road in 2009. It’s clear that from the smallest farm to the halls of Congress, from local food centers to operations half-way around the world, there is a deep, shared commitment to produce safe food.

Without any doubt, there’s still a lot of hard work to be done, and we know some food producers are still apprehensive about the impact of our regulations on their livelihood. So, we will hit the road again beginning in January for more state and international meetings. We are committed to continuing the conversation and implementing FSMA in a practical way. Working together, we will create the modern food safety system envisioned by FSMA, one that makes every reasonable effort to prevent food safety problems and protect consumers and their families from foodborne illness.

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

Lessons Learned in Mexico about Food Safety – And Tomatoes

By: Stephen M. Ostroff, M.D.

En Español

As my colleagues at FDA can attest, I like to grow tomatoes in the summer. I often bring portions of the harvest to the office each week of the growing season. Though the total volume is modest, I still like to think of myself as an environmentally conscious and responsible “farmer.”

Group photo of FDA and Mexico Officials and Tomato Growers

From left to right:
Rafael Ávila Julio Mexico-SENASICA-Branch Chief)
Joaquín Rivera Quiroz (Mexico-SENASICA-International Affairs)
SENASICA staff member
Edmundo Garcia (FDA-Regional Director for Latin America)
Mary Lou Valdez (FDA-Associate Commissioner for International Programs)
Stephen Ostroff (FDA- Acting Commissioner)
Sandra Cruz (FDA- Assistant Regional Director for Latin America)
Silvia Rojas Villegas ( Mexico- SENASICA- Director for Food Safety, Aquaculture, and Fisheries)
Jorge Martínez Lambarry (Mexico- General Director Binatur Invernaderos)
Angel Covarrubias Domínguez (Mexico – SENASICA’s staff)
Selma Koekoek (Food Safety Manager – Binatur Invernaderos).

So I was glad to spend some time on food safety issues last month while in Mexico attending the 10th International Summit of Heads of Medicines Regulatory Agencies. In addition to summit activities, I spent time with FDA staff in our Latin America Office and with our regulatory counterparts in Mexico charged with keeping foods safe. In the process, I gained a new appreciation for the partnership we have with Mexico to enhance food safety and to minimize the potential for contamination of fresh produce.

Which brings me back to tomatoes.

Representatives of the Mexican National Service for Agro-Alimentary Public Health, Safety and Quality (SENASICA) accompanied me and other FDA staff on a tour of Bionatur Invernaderos de Mexico, a state-of-the-art tomato-growing operation located in Jocotitlan Estado de Mexico, about 75 miles outside of Mexico City.

While most people think of growing tomatoes as an activity that requires soil, tomatoes can also grow using an alternative substrate and the addition of water, sunshine, and nutrient solutions. Bionatur Inveraderos is among the largest users of this technology, known as hydroponics, in the world. It’s an enormous, state-of-the-art operation, with eight 25-acre greenhouses on the 200-acre farm. And the results are very impressive, with row after row of enormous plants that dwarf my back-deck efforts.

Hydroponic tomatoes

Rows of tomatoes at Bionatur Invernaderos de Mexico, a state-of-the-art tomato-growing operation located in Jocotitlan Estado de Mexico, about 75 miles outside of Mexico City.

For me, there’s a real value to FDA visiting farms of all kinds to see first-hand the importance growers place on producing safe fruits and vegetables and the pride they have in their work, no matter what the size of the operation. Just as in the United States, produce is grown on all different kinds of farms in Mexico, from those using the latest technology to traditional operations that have been in hard-working families for generations. What the U.S. and Mexico also have in common is our mutual commitment to the safety of produce grown on our nations’ farms, which is especially important as the food supply continues to become more global.

For example, while the United States is a leading producer of tomatoes, Mexico is currently the 10th largest in the world. And in the last decade, tomato trade between the U.S. and Mexico has grown considerably — and is likely to continue to expand as global supply chains further diversify.

In light of these trends, assuring the safety of these imports is paramount. That’s why we work closely with our Mexican food safety counterparts: SENASICA and the Federal Commission for the Protection of Sanitary Risk (also known as COFEPRIS). Last year, our three agencies signed The Produce Safety Partnership, which specifically aims to promote the safety of fresh and minimally processed agricultural products in both countries.

SENASICA has a voluntary Risk Reduction System for Contamination (SRRC) program to ensure that fruits and vegetables grown in Mexico are produced in optimal sanitary conditions to reduce the risk of contamination.

Food safety requires everyone’s participation — including farms, facilities, regulatory agencies, and consumers. As we implement the FDA Food Safety Modernization Act (FSMA), we are working closely with our Mexican regulatory counterparts, as well as other nations and international stakeholders, to make sure that they have the understanding, information, and training necessary to meet these important new food safety standards.

FDA’s Latin America Office, with staff located in San Jose, Costa Rica; Santiago, Chile; and Mexico City, will be instrumental in this FSMA outreach as we rely heavily on the Latin American region to ensure the availability of fresh produce year round.

Two FSMA rules that became final this month are particularly important to Mexican farmers growing produce destined for American consumers. The Produce Safety rule establishes science-based safety standards for both domestic produce farms and those in other countries that export to the U.S. And the Foreign Supplier Verification Programs (FSVP) rule requires importers to ensure that their foreign suppliers meet U. S. safety standards.

It is clear to me that Mexico also shares another quality with the U.S. and other nations: It has the academic capital and capacity to engage in both high tech and traditional farming, and to successfully meet these new safety standards designed to prevent foodborne illness.

While there are differences in our systems, technologies, and environments, the U.S. and Mexico both want consumers to be confident in the safety of their food. By working together, we can achieve that goal.

Stephen M. Ostroff, M.D., is Acting Commissioner of Food and Drugs

A Mother’s Loss, an Advocate’s Example, Fuel Our Mission to Keep Foods Safe

By: Michael R. Taylor

For the many people in government, and elsewhere, who have been working on implementation of the FDA Food Safety Modernization Act (FSMA), this has been a week for reflection, celebration, and anticipation. I got to experience all three in the 24 hours I spent this week at the 2015 Food Safety Consortium in Schaumberg, Illinois.

Michael R. TaylorTuesday night I joined the many friends and supporters of the public health organization STOP Foodborne Illness in honoring Nancy Donley for her 22 years of ‎relentless advocacy for improving food safety. She is driven by the memory of her 6-year-old son Alex, who suffered greatly before he died in 1993 after eating a hamburger contaminated with E. coli O157:H7.

This was a time for reflection. Nancy and the many others in the STOP network who have shared their excruciating stories of pain and loss have made it simply unacceptable for those producing food to do anything less than their best to prevent these tragedies from happening.

Nancy, as much as any single person, has catalyzed fundamental change in our food safety culture toward making food safety a central business value for food companies and shifting government oversight toward a model that ensures accountability for minimizing contamination by pathogens.

Nancy has inspired me and many others to see food safety as the deeply personal, primary value it is, and to act accordingly.‎

STOP also honored Walmart’s Frank Yiannas as a STOP Food Safety Hero for his pioneering work to define and instill food safety culture as a primary value in the food industry.

Reflections on Nancy’s and Frank’s contributions are the backdrop for a bit of celebration. Not because the culture change Nancy inspires and the food safety success we seek are complete — far from it. But we are on our way.

The three FSMA rules FDA issued last week to improve produce safety and strengthen oversight of imports, coupled with the preventive controls rules we finalized in September, create a powerful and comprehensive new framework for the prevention of foodborne illness. This framework will be completed next year with final rules on food transport and intentional adulteration. The rules are the product of enormous effort by teams of FDA experts and by the many government, industry and consumer partners whose input has been so important in shaping the rules.

At the conference Wednesday morning, I shared some of these reflections and the sense of celebration and gratitude we are experiencing at FDA. I got some positive nods and no push back, but it was clear that the food safety professionals at this gathering are focused on the future, anticipating the challenges and changes FSMA will bring.

So are we at FDA. We see challenges galore, but also a huge opportunity to fulfill a vision that Nancy and STOP rightfully insist be the guide for our food safety work and our food safety culture.

Food safety is a primary value for many in the food system. It must be so for all.

Science-based prevention is the organizing principle for many food production systems. It must be for all. 

And a spirit of common cause and collaboration on food safety, which has begun to take root in so many positive ways, must be the foundation for all the work ahead to successfully implement FSMA.

So, this week, let’s celebrate where we are as we anticipate and build the future.

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

Forging the Path Forward toward Global Food Safety

By: Camille Brewer, M.S., R.D., Donald Prater, D.V.M., and Leigh Verbois, Ph.D.

Camille Brewer

Camille Brewer, M.S., R.D., Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine.

These are exciting times for global food safety. In the last few years, China, Europe and the United States – three countries and regions of the world with complex food systems – have begun adopting sweeping modernization of their food safety laws and regulations. This is significant given these three countries together provide nearly half of the world’s foods!

China, Europe and the United States have a long history of partnering to help make sure that the food traded between us meets the robust food safety standards our consumers expect.

For many years, we’ve held regular meetings under our agreements with one another to talk through important issues affecting the safe production of both domestically consumed and internationally traded food.

Donald Prater

Donald Prater, D.V.M., Director of the Europe Office in the FDA’s Office of International Programs.

We’ve also worked together for decades in venues like the Codex Alimentarius Commission to set global standards for food safety. Up until now, discussions between us have largely happened with only two of our three governments in the room.

On November 2, our three countries and regions met in Beijing to take this cooperation to the next level within our more globalized food safety system. We discussed ways the three of us will work together as a group to improve the safety of the food products our countries manufacture and trade.

Leigh Verbois

Leigh Verbois, Ph.D., Director of the China Office in FDA’s Office of International Programs.

Our countries recognize that by gaining deeper knowledge about each other’s food safety systems and sharing timely information for better regulatory decisions and actions, we can move closer to the reality of global regulatory cooperation and alignment. We can also increase our confidence in the food we feed our families, whether it is produced in the United States, the European Union or China.

In the United States, the FDA recently rolled out the first two final rules to implement the landmark FDA Food Safety Modernization Act (FSMA) of 2011, and will release additional final rules this month.

In 2015, China updated its China Food Safety Law of 2009 to better clarify regulatory responsibility, increase penalties for the adulteration of food making it unsafe to eat, emphasize industry accountability, and improve traceability of food supply chains. In 2014, the European Union rolled out Smarter Rules for Safer Food, regulations that streamline the legal framework for food safety.

Trilateral Meeting

Participants representing the U.S., China, and Europe meet to discuss how the three countries and regions will collaborate and cooperate to improve food safety.

With China, the EU and the United States in agreement on our food safety collaboration, we will begin taking action! A first step is setting a meaningful agenda for a meeting before the summer of 2016.

We will be engaging food safety experts and focusing on closer cooperation through technical and scientific exchanges or workshops. These workshops will bring together experts to discuss food safety challenges.

Trilateral handshake photo

From L-R: Mr. Michael Scannell, Director of Food & Veterinary Office, Directorate-General Health and Food Safety-European Commission; Dr. Leigh Verbois, Director of the China Office, United States Food and Drug Administration; and Mr. BI Kexin, Deputy Director-General for Import and Export Food Safety Bureau (AQSIQ) – People’s Republic of China, shake hands at the conclusion of the meeting.

Among the many topics to consider are our respective new food safety laws and regulations, approaches to preventing food safety hazards during manufacturing, and the importance of recordkeeping.

Through collaboration with our Chinese and European colleagues, the FDA will develop a better understanding of our various approaches to keeping food safe.

This type of common understanding is essential in our increasingly globalized world since food safety knows no borders.

 

 

Camille Brewer, M.S., R.D., is Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine.

Donald Prater, D.V.M., is Director of the Europe Office in the FDA’s Office of International Programs

Leigh Verbois, Ph.D., is the Director of the China Office in FDA’s Office of International Programs

FDA Invests in Innovative Ways to Communicate to Hispanics

By: Gloria Sánchez-Contreras, M.A.

En Español

National Hispanic Heritage Month–celebrated annually from September 15 to October 15—gives Americans a great opportunity to celebrate the histories, cultures, and contributions of Hispanic Americans whose roots are in Spain, Mexico, the Caribbean, and Central and South America.

Gloria Sanchez-ContrerasAt FDA, we join in this celebration as we continue to use innovative ways to reach Hispanics as part of our mission to protect the public health. To achieve this goal, FDA uses media strategies that are culturally and linguistically tailored to Hispanics, who, according to research, are avid users of online and social media.

There are 54 million people of Hispanic origin in the United States, making them the nation’s largest ethnic or racial minority group, with 17 percent of the nation’s total population, according to the U.S. Census Bureau. The United States has the second-largest population of Spanish-speaking residents in the world, ahead of Colombia and Spain, and second to Mexico, a recent study by the Instituto Cervantes shows.

These statistics cannot go unnoticed. FDA recognizes the importance of connecting with this growing and diverse segment of our population. Consequently, we have increased our online consumer information in Spanish and developed a variety of bilingual communications strategies to reach and engage all Hispanics.

One of the most important strategies we use is to make sure that messages created for Hispanics speak to them effectively. We consider Hispanics’ informational needs, lifestyles, and cultural health beliefs both when creating new messaging and when translating messaging from English to Spanish.

For example, we know Hispanics respond better when communications are in their primary language – which can be English or Spanish – and when communications use images that relate to them. We do this by employing a bilingual and bicultural team that reviews messaging for cultural competence and adapts translations to ensure they are culturally sensitive and in plain language.

In addition to our English-language communications, we have developed strategies to reach out to Spanish-speaking Hispanics online. Our Consumer Updates and drug safety communications are regularly translated into Spanish. We share Spanish-language information through our social media channels, including Twitter, Facebook, Pinterest, and YouTube.

In addition, we also have a complete Web section in Spanish for consumers (www.FDA.gov/ArticulosConsumidor), a press room (“Comunicados de Prensa”), and a central page (www.FDA.gov/Espanol) that links to a variety of Spanish-language content developed across the Agency’s product centers and offices.

These are exciting times, and it is a privilege to lead some of these efforts for our agency. The Office of External Affairs works diligently across FDA to share important and timely public health news with Latino consumers, stakeholders, media, and community organizations. And during Hispanic Heritage Month—and all the months of the year–we want Hispanics to know that FDA is a trusted source of consumer information.

Gloria Sanchez-Contreras, M.A., is a Bilingual Public Affairs Specialist and the Spanish-Language Communications Lead in FDA’s Office of Media Affairs.

A Quarter Century of Groundbreaking Science: The Forensic Chemistry Center

By: Stephen M. Ostroff, M.D.

This month marks the 25th anniversary of our Forensic Chemistry Center (FCC) in Cincinnati, Ohio. I recently joined former and current administrators and staff of this lab—one of FDA’s many incredible field laboratories—at an event celebrating this milestone.

Acting FDA Commissioner, Stephen Ostroff, M.D.One thing is clear: The last quarter-century has been a period of tremendous success at the FCC. FCC scientists use their scientific analysis and original research to investigate the physical and chemical characteristics and effects of adulterants on products regulated by the Agency, including chemical fingerprinting of poisons, glass, pharmaceuticals, food products and product packaging materials. By analyzing physical samples they can identify counterfeits, trace the origin of a pathogen or solve a crime.

In short, they are the CSI of FDA.

The commitment, expertise, and curiosity of FCC scientists have helped FDA overcome many scientific challenges, and made an extraordinary difference in the lives and safety of millions of Americans. Time and again the sophisticated analyses of puzzling substances by our scientists—often using innovative, esoteric methods, and groundbreaking research, along with the development of new processes and procedures—have made a critical difference in FDA’s ability to investigate and enforce–and protect the American public.

FCC Anniversary group photo

Former and current administrators and staff of the Forensic Chemistry Center (FCC) in Cincinnati, Ohio, at an event celebrating the 25th Anniversary. From left to right: Paul Norris, Director, Office of Regulatory Science; Steve Solomon, Deputy Associate Commissioner for Regulatory Affairs; Dr. Ostroff, Acting Commissioner of Food and Drugs; Phil Walsky, Deputy Director, Office of Criminal Investigations; Fred Fricke, former Director of FCC; and, Duane Satzger, Director of FCC.

FCC’s work has paved the way for passage of important laws, legal prosecutions, and consumer protection activities like recalls. And it has helped strengthen international relationships and advance international cooperation to ensure product quality and consumer safety.

Just a few highlights of FCC’s important efforts include:

  • In the 1990s, the lab supported some of FDA’s early work evaluating nicotine, which was recently cited in the proposed rule to deem additional tobacco products subject to the agency’s tobacco product authorities;
  • In 2001, after 22 people died in the Croatian Republic after receiving dialysis using certain devices, FCC’s analysis identified the presence of a toxic performance fluid in those devices that resulted in their recall by the manufacturers;
  • FCC investigated numerous illnesses and deaths of cats and dogs during 2007-8, which led to the determination that the pet food was adulterated with melamine and related compounds;
  • FCC’s investigation and analysis following the death of cattle in Washington State helped the FBI rule out the possibility that it was caused by terrorism;
  • Following the deaths of a number of infants in India who had been given the measles vaccine, FCC investigated the vaccine’s manufacturing process and discovered that the cause was not, as initially feared, a vaccine of poor quality. Instead the children had received pancuronium bromide, a muscle relaxant, which had been packaged in vials with similar size and shape to the vaccine, rather than the vaccine itself. This discovery was communicated to the Indian government, leading to a critical change in their immunization practices; and,
  • FCC developed a method for examining the sea animals impacted by the Deepwater Horizon oil spill, which helped determine when the seafood would be safe to consume.

It is an extraordinary record. And it’s meant so much to FDA—and the nation—over the past 25 years. But the anniversary and success of this one lab also underscores the remarkable work done by all of FDA’s laboratories across the country. These labs and the districts in which they are located are the critical front line eyes and ears of FDA. And they are the springboard for excellent science.

Good science is fundamental to the mission of FDA. We need it to make good regulatory decisions. It’s what the public expects and deserves. By being able to handle and apply the science of today and anticipate the science of tomorrow we can be more flexible and adaptive, and support innovation.

Having seen the impressive and important work our labs are doing, I’m more committed than ever of the need to invest in better facilities and the best support. We must maintain state-of-the-art laboratories and research facilities, and attract, hire, and retain the best scientists to work in them. First-rate regulatory science requires first-rate scientists working in first-rate facilities.

It’s why I’ve made this a priority for FDA. And why we will put it high on our list of subjects for discussion with Congress as they shape future budgets for the Agency.

The scientists in FDA’s field laboratories are among the unsung heroes of FDA’s work to protect the public health. So let me congratulate and thank those at the FCC and across FDA on the milestone occasion of the 25th anniversary of the Forensic Chemistry Center.

Stephen M. Ostroff, M.D., is Acting Commissioner of the U.S. Food and Drug Administration

Destroying Certain Imported Drugs: A New Rule to Protect Patients

By: Howard Sklamberg and Melinda K. Plaisier

Recently, FDA published the final rule implementing section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA). This new rule, which will take effect on October 15, 2015, provides FDA with an administrative process for the destruction of certain drugs refused admission to the United States. Why is this important? These drugs can pose a serious public health risk to consumers in the United States.

Howard Sklamberg

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

On July 9, 2012, President Obama signed FDASIA into law. Title VII of FDASIA provides FDA with important new tools to help the agency better protect the integrity of the drug supply chain. One of those new tools is in section 708, which grants FDA the authority to use an administrative procedure to destroy a drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that was refused admission into the United States.

The majority of refused drug products subject to FDA’s new destruction authority come into the United States via international mail. Some of these mail parcels may include one or more drugs that are unapproved, adulterated, and/or misbranded, including counterfeit drugs and drugs that purport to be dietary supplements.

These drugs can pose a serious public health threat to consumers in the United States because they:

  • might not contain the active ingredient that patients need for treatment of their disease;
  • might have too much or too little of an active ingredient;
  • might contain the wrong active ingredient; and/or
  • might contain toxic ingredients.
Melinda Plaisier

Melinda K. Plaisier, FDA’s Associate Commissioner for Regulatory Affairs

In addition, drugs that are represented and sold as dietary supplements can contain hidden or deceptively labeled active pharmaceutical ingredients, some at levels much higher than those found in FDA-approved drugs. Such products can cause harm and have been associated with serious adverse events for consumers. Other purported dietary supplements, although they may not contain harmful ingredients, are promoted to prevent or treat serious diseases but have not been proven safe and effective for that purpose.

Prior to this rule, drugs imported via an International Mail Facility (IMF) that were refused admission because they appeared to violate the law were generally sent back to the U.S. Postal Service (USPS) for export. There has been little deterrence to prevent sellers from sending drugs that violate the law or resending previously refused drugs into the United States via the IMFs to circumvent import regulatory systems.

In fact, some of the parcels returned by USPS were resubmitted for entry into the United States by the sender, with the sticker indicating prior refusal by FDA still attached and visible. This new rule allows FDA to better deter such importation by having an administrative process in place to destroy a refused drug. Rather than returning the drugs to the sender, these drugs will be destroyed. Compared to the volume of entries at IMFs, the agency has limited on-site resources. By deterring violative imports and re-entry attempts, this new process will allow the agency to more effectively focus its limited resources.

Under the final rule, FDA will provide the owner or consignee of the refused drug with written notice and an opportunity to appear and introduce testimony to the agency prior to the destruction. If the drug is destroyed, section 708 provides that the owner or consignee is responsible for the costs of storage and disposal of the drug. However, FDA generally does not intend to pursue recovery of storage and disposal costs against individual consumers who seek to import a drug for their own personal use that is then refused and destroyed.

By enabling FDA to destroy certain drugs, this important action will allow FDA to continue to protect and promote public health.

You can look up the current status of any FDASIA deliverable and sign up to receive Title VII updates using FDASIA-TRACK.

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

Melinda K. Plaisier is FDA’s Associate Commissioner for Regulatory Affairs.

Welcoming FDA’s New Overseas Leaders: FDA’s Foreign Posts Provide a Vital Resource for Consumer Protection

By: Howard Sklamberg and Mary Lou Valdez

Howard Sklamberg

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

It’s simple but true: relentless global commerce and interaction demand a globalized FDA. That’s why we’ve made determined efforts – sometimes with great difficulty – to place our professionals around the world in the key countries and regions that produce FDA-regulated food and medical products.

The Vital Role of FDA’s Overseas Offices

Our foreign offices add an unsung, yet vital, element to the Agency’s global work. FDA posts in China, Europe, India, and Latin America, in close cooperation with FDA Centers and the Office of Regulatory Affairs, help to strengthen our ability to protect public health. Our foreign posts assist by:

  • Increasing our knowledge and appreciation of the global regulatory landscape;
  • Facilitating collaboration with foreign regulators to strengthen evidenced-based approaches to product safety and quality; and
  • Helping manufacturers in other countries to understand FDA standards and regulations.

Equally important, placing investigators in a top-exporting nation allows us to get to a site more quickly in a public health emergency or investigate indications of violations that could imperil public health.

Recent Accomplishments

The Latin America Office has deepened FDA’s ties with the regulatory partners in the 44 nations and territories comprising that vast region. For example, Mexican regulators have followed up on FDA inspection results and have taken immediate actions against firms and products that violate U.S. and Mexican law. Through a 2014 bilateral Statement of Intent, our Latin America Office is helping to implement a Produce Safety Partnership with Mexico, which is vital inasmuch as nearly one-third of FDA-regulated food products we eat are either grown in or transported through Mexico.

Lou Valdez

Mary Lou Valdez, FDA’s Associate Commissioner for International Programs

Thanks to the work of our China Office, FDA signed two Implementing Arrangements in late 2014 with our Chinese food and drug regulatory counterparts: the China Food and Drug Administration and the Administration of Quality Supervision, Inspection and Quarantine. The arrangements expand the number of in-country investigators and significantly increase FDA’s ability to perform inspections of firms that manufacture FDA-regulated products. We also work closely with Chinese officials to help strengthen the Central/Provincial inspectional roles to ensure product quality and safety and better secure supply chains.

The India Office regularly engages with Indian regulators and industry. India is a major source of generic drugs imported to the United Sates and, as such, we work closely with them on pharmaceutical quality. India also is the 7th largest supplier of food to the United States – principally shrimp, spices, and rice. Recently the India Office played a key role in coordinating a Memorandum of Understanding on Food Safety that FDA signed with the Export Inspection Council of India. The India Office also hosts a number of workshops to increase understanding of U.S. requirements such as records management with industries interested in exporting their products to the U.S.

The Europe Office has continued to enhance FDA’s partnership with the European Medicines Agency (EMA), with whom we actively share data, information, and technical expertise. Since 2009, FDA and EMA have strengthened collaboration through the exchange of dedicated liaison officers and by engaging in mutual scientific interests in such areas as advanced medical therapies, biosimilar medicines, blood products, orphan products, and veterinary medicines. In addition, Europe Office professionals have briefed nearly a dozen European Union (EU) nations on the landmark Food Safety Modernization Act, and have also analyzed more than 150 audit reports from the EU’s Food and Veterinary Office to bring FDA expertise to food facility site selection.

The European Office plays a key role in the Mutual Reliance Initiative (MRI), an important FDA-EU endeavor to evaluate our comparable regulatory frameworks for inspections of manufacturers of human pharmaceuticals to determine if we can rely on each other’s inspectional information. The MRI has led to FDA accompanying EU officials on audits of three EU nations. The Europe Office also managed an EU audit of FDA’s oversight of the Active Pharmaceutical Ingredient (API) manufacturers within the U.S. That exchange led to the EU relying on our oversight, and allowing U.S.-made APIs into the European market.

New Leaders at Our Overseas Posts

We can look confidently toward the future and the roles our foreign posts can play in support of the FDA mission globally. It is with an eye on that future that we are marking “a changing of the guard” as we welcome new Office Directors and Deputy Directors to FDA foreign offices.

We extend a warm welcome to:

China Office

Leigh Verbois, Ph.D., Director 

Europe Office

Donald Prater, D.V.M., Director

India Office

Mathew Thomas, M.B., B.S., Director

Latin America Office

Edmundo Garcia, Director, Director

Capt. Philip Budashewitz, Deputy Director

We also share our deepest gratitude as we say good-bye to an outstanding group of foreign post directors who are moving on to new opportunities: Christopher Hickey, Ph.D., (former Director, China Office), Carl Sciacchitano (former Acting Director, India Office), Michael Rogers (former Director, Latin America Office), and Bruce Ross (former Deputy Director, Latin America Office).

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

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

FDA, From a Distance

By: Claudia Heppner, Ph.D.

It is a great honor for me, as a European, to be working for FDA. I am one of the two Locally Employed Staff (Foreign Service nationals) currently working in FDA’s Europe Office in Brussels, Belgium.

Claudia HeppnerI came to this position after serving for 12 years in the European Food Safety Authority (EFSA), which is the European Union (EU) institution that provides independent scientific advice on existing and emerging food safety issues.

Before joining EFSA, I worked with the Secretariat of the EU’s Scientific Committee on Food. I’ve also worked for a multinational company in Belgium and the United Kingdom in the areas of pesticides product discovery and product development, including genetically-engineered plants.

With seven months at FDA under my belt, I enjoy and receive a great deal of satisfaction from my challenging new duties. Together with my colleagues, I am analyzing the range of science and policy issues under discussion in the EU’s decision-making framework. These EU issues span the breadth of FDA-regulated products and may sound familiar to some: updating and streamlining the food safety system; rapid access to innovative medicines; biotech, nanotech, novel foods, mobile and e-health; and, implementation of new legislation on tobacco and electronic cigarettes.

The EU has a complex environment for decision making, involving the “three pillars” (the European Commission, the European Parliament, and the Council of the EU) along with EU organizations that are counterparts to FDA such as the European Medicines Agency, EFSA, and various EU scientific committees.

In addition, each EU Member State (countries that are members of the EU) has its own national law-making bodies and regulatory organizations.

Only the European Commission can propose an EU law. The preparatory steps include: concept papers; a roadmap describing the timeline and significant events; impact assessments examining potential economic, social and environmental consequences; and public consultations.

I quickly learned that the European system is quite different from the legislative process and the notice-and-comment rule making system in the United States. In the Europe Office, we look at each step along the way in the EU decision-making process as a potential opportunity for strategic engagement.

Recently, I wrote a paper that analyzed what the EU is doing to strengthen food regulatory systems in Africa, China, and India. I was struck by the possibilities of what could be achieved through FDA and EU cooperation to help assure the safety of foods shipped to the United States and Europe and to improve public health around the world.

I feel fortunate to be working at FDA and to have the opportunity to broaden my professional horizons. I enjoy the dual focus on science and policy, working on medical product issues as well as foods issues, and observing how a non-EU organization like FDA works.

I look forward to continued learning and to the possibility of contributing to both the U.S. public health and – through FDA’s engagement with the EU – the EU public health.

Claudia Heppner, Ph.D., is a Senior Policy Analyst in FDA’s Europe Office

Find out more about FDA’s Europe Office

Talking Across International Borders About FSMA

By: Michael R. Taylor

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

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

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

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


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


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

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

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

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

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

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