FDA Is Preparing Guidances that Will Help Food Companies Prevent Foodborne Illness

By: Susan Mayne, Ph.D., and Tracey Forfa, J.D.

En Español

When we were drafting and seeking public comment on the rules that will implement the FDA Food Safety Modernization Act (FSMA), we promised that we would do whatever we could to help the regulated industry understand and meet the new requirements.

Susan Mayne

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

We meant what we said about “educating before and while we regulate,” since these new standards will ultimately transform the nation’s food safety system.

This month, we have taken important steps in fulfilling that promise with the release of three draft guidances that when finalized will help domestic and foreign food facilities meet the requirements of the preventive controls rules that became final in September 2015.

Those rules require hazard prevention practices in human and animal food processing, packing, and storage facilities. FSMA created the framework that holds manufacturers accountable for having a food safety plan, implementing it, verifying that it is working, and taking corrective action when it isn’t. Compliance dates are fast approaching for large food facilities. The human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs) and the animal food facilities must meet CGMPs by September 19, 2016. (The preventive controls rules have staggered compliance dates; smaller facilities have a year or more additional time to comply.)

One of the draft guidance documents covers ways to comply with the preventive controls requirements of the human food rule. Given the scope of that rule, we are prepared to issue only five draft chapters now, covering specific sections of the rule, but we will ultimately issue 14 chapters in all.

Tracey Forfa

Tracey Forfa, J.D., is Acting Director of FDA’s Center for Veterinary Medicine

These initial chapters cover basic information about establishing preventive controls in a human food facility. The first chapter is about the food safety plan in which a human food facility outlines how it has identified and evaluated its food safety hazards and how it will control hazards requiring preventive controls. The subsequent chapters provide direction on conducting a hazard analysis; understanding the biological, chemical and physical hazards that are commonly of concern; identifying and implementing the preventive controls that will significantly minimize or prevent hazards; and managing the preventive controls through such actions as monitoring, corrective actions and verification activities.

The other two draft guidances when finalized will help domestic and foreign facilities comply with key requirements in the Preventive Controls for Animal Food rule, which covers all animal food, including animal feed and pet food. One of those documents provides direction on ways to comply with the rule’s CGMP requirements, which are baseline food safety and sanitation standards for animal food facilities. This draft guidance also provides information on provisions related to the CGMP requirements, such as qualifications and training of personnel.

While CGMPs have long existed for the production of human food, this is the first time that most animal food producers will be subject to CGMPs. Concerns about incidents of food contamination that were sickening and killing pets were among the driving forces behind the enactment of FSMA.

The third draft guidance when finalized will help domestic and foreign food facilities whose by-products of human food production are used as animal food. Such by-products include grain products and vegetable pulp. They also include foods like potato chips, baked goods and pasta that are safe to eat but considered the wrong size, shape, color or texture.

Food producers required to meet food safety requirements for human foods had been concerned that they would have to meet a whole new set of requirements for such by-products. The draft guidance makes clear that the by-product will only be subject to limited CGMPs to protect it from contamination during holding and distribution, if the human food facility is subject to and in compliance with FDA’s human food CGMPs and all applicable human food safety requirements of the Federal Food, Drug, and Cosmetic Act and implementing regulations and is not further processing the by-products for use as animal food.

If the human food facility is further processing the by-products, the facility has a choice of complying with the requirements of either the human or animal food rule, as long as the food safety plan addresses how the facility will prevent or significantly minimize the hazards for the animal food that require a preventive control.

These draft guidances, and the others that we’re working on for the FSMA rules, will be further refined based on input we receive from the public. The comments we received on the proposed FSMA rules were important in helping us shape the final rules so we look forward to working with stakeholders in the same way on these documents.

Meeting the FSMA mandate involves cooperation between the FDA and the food industry. From the smallest food operation to the largest company, we want to be sure that we’re all on the same page and these draft guidances will help get us there.

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

Tracey Forfa, J.D., is Acting Director of FDA’s Center for Veterinary Medicine

Practical Applications of FDA Regulations for the Indian Food Industry

By: Dean Rugnetta

Dean RugnettaGlobalization of the food supply chain and advances in food processing technologies have led American consumers to develop a taste for a variety of foods and cuisines from different countries. Increasingly, U.S. grocery stores sell foods from Asia, Latin America, and many other parts of the world. Indian exporters have recognized this marketing opportunity, and FDA information shows an increase in U.S. imports from India over the past 10 years. A wealth of ready-to-eat Indian specialties can be found in cans and bottles on U.S. store shelves including Indian curries (a.k.a. gravies), canned sweets, pickled cucumbers, and Indian pickles (chopped fruits and vegetables marinated in brine).

A serious potential health risk in canned and bottled foods

FDA’s regulations for processing shelf-stable or commercially sterile food — such as certain canned and bottled foods — were promulgated in the 1970’s in response to deaths related to botulism poisoning. Botulism is a muscle-paralyzing disease caused by a toxin made by the bacterium called Clostridium botulinum.  FDA’s regulations require that processors heat and/or formulate low acid canned foods and acidified foods in a manner that eliminates favorable growth conditions for such toxins.

The regulations also require that supervisors in plants that manufacture such products be trained in appropriate processing methods. In the United States, FDA collaborates with industry groups, academia and other stakeholders to offer “Better Process Control Schools,” which typically provide two to five days of training.

Better Process Control School in India

Better Process Control School Class Group Photo

Students attending Better Process Control School in India

India now has a Better Process Control School where supervisors at any of the 300 FDA-registered facilities can attend training on how to safely process low acid canned foods and acidified foods. The school was established in 2010 when FDA’s India Office partnered with FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and a local university in New Delhi, India. The school has convened three separate times since then, most recently this spring. The training helps local processors learn FDA’s regulatory requirements and fulfill a regulatory mandate. Processors that successfully complete the course receive a certificate.

The long-term goal of the training partnership in India is to establish a locally sponsored, self-sustaining class and demonstrates how FDA’s international outreach efforts are improving the safety of imported food products.

Dean Rugnetta is the Deputy Director of FDA’s India Office in New Delhi, India 

Links to other FDA Voice Blogs:

Addressing Global Challenges through Transatlantic Cooperation

By: Howard Sklamberg, J.D., Lou Valdez, and Donald Prater

Howard Sklamberg

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

On a recent trip to Brussels, our FDA delegation met with many of our European Union (EU) regulatory counterparts and stakeholders to discuss ways to strengthen our shared commitment to product safety and public health.  

Reflecting the broad scope of our transatlantic dialogue, we engaged on an array of issues, including supply chain safety, quality metrics, risk-based surveillance, data integrity, mutual reliance, and food safety systems.

Building on previous exchanges between FDA and the European Parliament (EP), we first met with Members of the Environment, Public Health and Food Safety Committee, known as ENVI.  ENVI Committee members visited FDA in 2013 and 2015 to share their perspective on how certain health-related topics are being addressed in the European Union. In addition, our FDA delegation exchanged views on recent trilateral cooperation with India and China on Good Clinical Practices and food safety and other approaches to cooperation on the international stage.

Lou Valdez

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

We then met with the head of the European Commission’s Directorate General for Health and Food Safety (DG SANTE), Director General Xavier Prats-Monné, and his colleagues.

We shared our observations on several topics, including:

  • How drug development has changed, including globalization of suppliers and distributors;
  • The challenges among regulatory bodies in keeping pace with risk-based allocation of inspection resources;
  • The complexity of the global supply chain and the need to collaborate on enforcement;
  • The significant progress being made on the Mutual Reliance Initiative (MRI);
  • Pharmaceutical GMP inspections; and
  • The interaction among FDA’s Europe, China, and India offices and regulatory counterparts in the EU and Governments of China and India.
Donald Prater

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

We then turned to food safety. Currently, the U.S. and the European Commission are working on a Food Safety Systems Recognition arrangement, a program that FDA has developed to increase regulatory cooperation and build toward reliance on the work of regulatory counterparts.

Such cooperation is facilitated through the reciprocal assessment of one another’s food safety systems to ensure the safety of foods produced under one another’s oversight. The United States already has an arrangement in place with New Zealand and recently signed one with Canada.

We also reviewed the Food Safety Modernization Act (FSMA) and discussed ways FDA and the European Commission can assist suppliers in the EU to better understand the FSMA requirements. Acknowledging that food safety standards are quite high in the United States and the EU, we discussed ways we can leverage the systems on both sides of the Atlantic to further protect consumers and more efficiently use our oversight resources globally.

FDA and EU Delegations in Brussels

A U.S. Food and Drug Administration (FDA) delegation met with many of their European Union (EU) regulatory counterparts in Brussels to discuss ways to strengthen the shared commitment to product safety and public health. Pictured from left to right are: Karin Kadenbach, Member European Parliament (MEP); Sandy Kweder, Deputy Director, FDA’s European Office; Lou Valdez, FDA’s Associate Commissioner for International Programs; Matthias Groote, MEP; Howard Sklamberg, FDA’s Deputy Commissioner for Global Regulatory Operations and Policy; and, Susanne Melior, MEP.

Next up were meetings on medical devices and cosmetics with the Directorate General for Internal Market, Industry, Entrepreneurship, and SMEs, also known as DG GROWTH.

We were welcomed by Carlo Pettinelli, Head of the Directorate for Consumer, Environmental and Health Technologies, and we discussed the key objectives of the Medical Device Single Audit Program (MDSAP) of the International Medical Device Regulators Forum (IMDRF). Mr. Pettinelli acknowledged the importance of MDSAP, and indicated that the European Commission would continue to provide coordination and communication to support the engagement of EU Member States in the program.

We also set aside time for discussion with key industry stakeholders representing medical products – primarily drugs and devices, including, the American Chamber of Commerce Healthcare Committee to the EU and the European Federation of Pharmaceutical Industry Association (EFPIA). There we reviewed FDA’s Pharmaceutical Quality and MRI initiatives.

Our trip concluded with a media roundtable and a briefing to the Deputy Chief of Mission and staff at the U.S. Mission to the European Union. Our FDA Europe Office is based at the USEU and provides critical support to U.S. Ambassador Anthony Gardner.

Throughout all our meetings, one theme was crystal clear: Transatlantic cooperation is vitally important to address the challenges and opportunities of a globalized marketplace.  By carefully evaluating and understanding each other’s regulatory systems, there is tremendous potential to better allocate our resources based on risk, and improve the safety of food, medical products, cosmetics, and other products around the world.

Howard Sklamberg, J.D., is the Deputy Commissioner for Global Regulatory Operations and Policy

Mary Lou Valdez is the Associate Commissioner for International Programs

Donald Prater is Director of FDA’s Europe Office

The United Nations Sustainable Development Goals: Efficient and effective regulatory systems are the tide that raises all boats

By: Mary Lou Valdez, M.S.M., and Kristin Wedding

Lou Valdez

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

Do you think it’s possible to ensure healthy lives and promote well-being for all people of all ages by 2030? That’s just one of the United Nations 17 Sustainable Development Goals (SDGs), which the world’s leaders agreed to in September 2015. And, FDA has an important role in supporting these goals.

On June 23-24, 2016, we had the opportunity to participate in the National Academies of Science, Engineering, and Medicine’s Forum on Public-Private Partnerships for Global Health and Safety (PPP Forum). The two-day workshop focused on engaging the private sector and developing partnerships to advance health and the SDGs.

Good health and well-being are linked to many of the SDGs, including zero hunger, ending poverty, economic growth, industry, innovation and infrastructure, and reduced inequalities. But what, you might ask, are FDA’s potential contributions as a regulatory agency in achieving the SDGs?

Regulatory Systems and the SDGs: the Challenges

Kristin Wedding

Kristin Wedding is International Policy Analyst in FDA’s Office of International Programs

Strong functioning regulatory systems for food and medical products are at the nexus of public health, economic development, trade, and investment. Within our public health mission, effective regulatory systems often are a necessary precursor for economic development and growth, including private sector investment. Conversely, the absence of effective regulatory systems is an underlying threat to achieving many of the SDGs. For example:

  • unsafe food contributes to malnutrition and jeopardizes food security (Goal 2);
  • lack of access to safe and effective medical treatments exacerbates chronic diseases (Goal 3), and impedes people from getting and keeping a job (Goal 8).
  • illness hampers children’s learning and school attendance (Goal 4), and often disproportionately impacts girls (Goal 5); and,
  • insufficient access to clean water and sanitation (Goal 6) results in the death of more than 1,000 children each day from preventable diarrheal diseases.

Regulatory Systems and the SDGs: the Opportunities

At the workshop, FDA chaired an expert panel on the critical role of regulatory systems and PPPs in promoting global public health, economic development, and sustainable investments to achieve the SDGs. We were joined by Dr. Juergen Voegele of the World Bank, Dr. Rajeev Venkayya of Takeda Pharmaceuticals, and Dr. Dan Hartman of the Bill & Melinda Gates Foundation.

Despite our diversity, we sent a unified message that regulatory systems are essential drivers for the success and sustainability of global health investments to meet the SDGs. It is the responsibility of all of us – as stakeholders, donors, and partners – to make our investments matter.

UN Panel Discussion

Panel discussion at National Academies of Science, Engineering, and Medicine’s Forum on Public-Private Partnerships (PPPs) for Global Health and Safety: A Workshop on Engaging the Private Sector and Developing Partnerships to Advance Health and the Sustainable Development Goals (SDGs).
Mary Lou Valdez, M.S.M, Associate Commissioner for International Programs, FDA, and Juergen Voegele, Ph.D., Senior Director, Agriculture Global Practice, The World Bank.

FDA participates in a number of global partnerships aimed at strengthening regulatory systems, including the World Bank-led Global Food Safety Partnership (GFSP) the PPP Forum, as well as our work with multilateral institutions such as the World Health Organization.

We look forward to continuing the discussion about future pathways for collaboration and action in demonstrating the critical roles regulatory systems play in the attainment of the SDGs. The public health of U.S. citizens – and others around the globe – can benefit from our efforts now and in the future.

As Dr. Hartman so aptly noted during the panel session, in this time of globalization “efficient and effective regulatory systems are the tide that raises all boats.”

Mary Lou Valdez, M.S.M., is FDA’s Associate Commissioner for International Programs

Kristin Wedding is International Policy Analyst in FDA’s Office of International Programs

Charting a Path Forward on Food Safety, Nutrition and Animal Health

By: Stephen Ostroff, M.D., Susan Mayne, Ph.D., and Tracey Forfa, J.D.

Stephen Ostroff, M.D.

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

At FDA, we need to be prepared for the opportunities and challenges of today as well as those of tomorrow, and the FDA Foods and Veterinary Medicine Program’s new Strategic Plan for fiscal years 2016-2025 helps us to do just that.

Our new Strategic Plan makes it clear that we must have an overarching and risk-based approach that encompasses our broad portfolio of responsibilities. The plan organizes this work under four key goals: food safety, nutrition, animal health and organizational excellence.  Whether it’s chemical safety, dietary supplements, cosmetics, genetic engineering, nutrition labeling, antimicrobial resistance, review of animal drugs, or ensuring that we have the right technologies to identify hazards in the commodities we regulate—all of these issues impact the public health.  FDA is a public health agency first and foremost—and that is where our focus will be, using the core principle of science and tools such as regulation and guidance, research, and outreach and education to get us there. This fall, we’ll be issuing a broad implementation plan which will highlight specific actions under these four goals.

Susan Mayne

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

Over the past several years we’ve made a lot of progress in a number of key areas. We have been very focused on developing the implementation framework for the Food Safety Modernization Act (FSMA), an enormous undertaking to modernize our preventive approach to food safety, and that work will continue. At the same time, we’ve made great headway on nutrition, modernizing the Nutrition Facts label, publishing draft, voluntary targets for reducing sodium in various foods, and making a final determination that partially hydrogenated oils are no longer “generally recognized as safe.”  We’ve addressed the impact of animal agriculture on antimicrobial resistance by phasing out the use of medically important antimicrobials for production use and bringing remaining uses under the direction of veterinarians. And whole genome sequencing has helped us to identify the sources of foodborne illness outbreaks with speed and precision.

Tracey Forfa

Tracey Forfa, J.D., is Acting Director of the FDA’s Center for Veterinary Medicine

One important lesson we learned from our work on FSMA that we can apply moving forward is the importance of transparency and active stakeholder engagement. We transformed the way we do business, and it helped to make our work on FSMA successful. Sometimes, our perspectives may differ from those of our stakeholders, but the important thing is that we seek common areas of alignment to solve problems. We plan to use this approach more broadly.

It’s important that our plan stays current. It will be updated to reflect emerging science, technology, innovation, and trends in globalization. It will keep pace with emerging hazards and risks in the products we regulate. That is why we are establishing an open docket. Comments can be submitted at any time, so that we can consider them and update the plan at least every two years.

We encourage you to take a look at the plan and let us know what you think. We will have plenty of opportunity for discussion in the months and years to come as we work to improve the public health together.

Read the Foods and Veterinary Medicine (FVM) Program’s Strategic Plan Fiscal Years 2016–2025

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

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

Tracey Forfa, J.D., is Acting Director of the FDA’s Center for Veterinary Medicine

Registration of Food Facilities: A Key Link in the Safety Chain

By: Erwin C. Miller, M.S.

The FDA’s mission to protect consumers from unsafe food follows different paths. The seven rules that have been finalized since last fall to implement the 2011 FDA Food Safety Modernization Act (FSMA) will require food producers, importers, and transporters to take science- and risk-based actions to help prevent the contamination that leads to foodborne illness.

Erwin MillerToday, the agency finalizes another rule to implement FSMA, one that updates the requirements for the registration of domestic and foreign food facilities that manufacture, process, pack, or hold food for consumption in the United States, whether for people or for animals. Under the final rule, additional information will be required that will ultimately support the FDA’s ability to respond quickly to food-related emergencies and that will also help the agency more efficiently use the resources it has for inspections.

The registration rule also will affect establishments located on farms and “farm-operated businesses” by expanding the definition of a “retail food establishment,” which is not required to register as a food facility. The expansion of this definition would allow the inclusion of sales directly to consumers at roadside stands, farmers markets, Community Supported Agriculture (CSA) programs and other such direct-to-consumer platforms in determining an establishment’s primary function and thus whether it meets the definition of a retail food establishment. Congress, through FSMA, directed FDA to amend this definition. (Under the final rule, a farm-operated business is a business managed by one or more farms and that conducts manufacturing/processing not on the farm.)

The registration of food facilities has long been considered a key component of food safety. The September 2001 terrorist attacks highlighted the need to enhance the security of the infrastructure of the United States, including the food supply. Congress responded by enacting the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (called the Bioterrorism Act). This law directed the FDA to require food facilities that manufacture, process, pack, or hold food for consumption in the United States to register with the agency.

Nine years later, FSMA required that facilities renew their registrations biennially, among other new registration requirements. The biennial renewal requirement was effective upon enactment of FSMA, and the final rule codifies this and other registration requirements. The final registration rule also requires some new information, including the type of activity conducted for each category of food product and certain email address information to help expedite communication between the facilities and the agency. In addition, the final rule establishes mandatory electronic registration (with the availability of a waiver process) beginning January 4, 2020.

Facilities also will be required to provide a unique facility identifier (UFI) number as part of the registration process. This will allow the FDA to verify the facility-specific address associated with the UFI and help the agency ensure the accuracy of the registration database in a way that has not been possible under the current system. FDA plans to issue a guidance document to support compliance with the UFI requirement. Food facilities will be required to provide a UFI beginning October 1, 2020.

Together, the requirements in the final rule will be invaluable in providing the FDA with more accurate information about facility locations and information about the activities within facilities—thus aiding investigators in responding to foodborne illness outbreaks or earthquakes, floods, or other disasters. The final rule will also help the agency identify high-risk facilities and ensure that personnel with the proper training are dispatched to conduct an inspection.

While there is no fee for registration, some in the food industry submitted comments stating that certain aspects of the proposed rule would be too burdensome. In response to these comments, the agency has postponed the requirement for mandatory electronic registrations and the submission of a UFI to 2020 to ensure that facilities have ample time to comply.

The next biennial registration period will be October 1 through December 31, 2016. The FDA is committed to working with the food industry to facilitate implementation of this rule and address any questions that arise.

Erwin C. Miller, M.S., is the Chief for the Data Systems Integration Branch in FDA’s Center for Food Safety and Applied Nutrition

FDA Takes Action against Zika Virus

By: Robert M. Califf, M.D., and Luciana Borio, M.D.

Zika virus was first identified in 1947 in Uganda and for decades only sporadic cases and a few outbreaks were recognized in a number of locations, including parts of Africa, Asia, and the Pacific. Since 2015, the situation has changed dramatically, with 48 countries and territories reporting a first outbreak of Zika virus as of July 2016. In the United States, cases of Zika virus disease acquired by the bite of an infected mosquito have only been reported in U.S. territories; to date, cases of Zika virus infection reported in the continental United States have involved travelers and in some instances their sexual contacts. However, given the number of Zika cases among travelers visiting or returning to the United States and the increased mosquito activity in the summer months, we expect that imported cases could result in local spread of the virus in some areas of the United States.

Robert Califf

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

The FDA is taking important steps to rapidly respond to the Zika virus outbreak. We are engaged with our partners across the U.S. Government, the private sector, and the international community—including the World Health Organization and ANVISA (the Brazilian Health Regulatory Agency)—to help minimize the impact of this outbreak.

Protecting Tissues and the Blood Supply

One of the FDA’s first actions was to take important steps to help protect the safety of the blood supply. The FDA issued guidance in February 2016 recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, were potentially exposed to the virus, or have had a confirmed infection. The guidance also recommends that areas with active Zika virus transmission, like Puerto Rico, obtain whole blood and blood components from areas of the United States without active virus transmission unless a blood donor screening test for Zika virus is used. Because there were no blood donor screening tests available for Zika virus at the time, HHS arranged for and funded shipments of blood products from the continental U.S. to Puerto Rico to ensure an adequate supply of safe blood for residents until a blood donor screening test became available. The FDA worked closely with developers in a highly accelerated time frame to make available an investigational test for blood screening in March 2016. The availability of this investigational test, which has been in use in Puerto Rico since early April, has allowed blood establishments to safely collect blood in areas with active Zika virus transmission. A second investigational blood screening test was made available in June 2016. Together, these tests have also enabled blood donor screening to be put in place in areas of the United States where local virus transmission is anticipated, but not yet detected, helping to maintain the safety of the blood supply.

Dr. Lu Borio

Luciana Borio, M.D., is FDA’s Acting Chief Scientist

Zika virus also poses a risk for transmission by human cells, tissues, and cellular and tissue-based products (HCT/Ps) such as corneas, bone, skin, heart valves, and semen used for medical, surgical, or reproductive procedures. Because of this risk, the FDA issued guidance recommending that donors of HCT/Ps be considered ineligible if they were diagnosed with Zika virus infection, were in an area with active Zika virus transmission, or had sex with a male with either of those risk factors, within the past six months.

Supporting Diagnostic Development

The ability to accurately detect and diagnose Zika virus infection is critical for a robust response to this public health threat. The FDA is actively working with manufacturers to support their diagnostic development programs, helping to ensure that their tests are properly validated before they are used to inform patient care. This collaboration has been very successful, and since the beginning of the year, we have authorized the use of five diagnostic tests for Zika virus under FDA’s Emergency Use Authorization authority—four tests to diagnose active infection and one test to assess whether individuals who may have recently been exposed to Zika were actually infected. This test is especially important for women given the link between Zika virus infection and microcephaly and other poor pregnancy outcomes in babies of mothers who were infected with Zika virus during their pregnancy.

Strategies to Suppress Mosquito Population

FDA—as well as our colleagues at EPA— are reviewing the use of innovative strategies to help suppress the population of virus-carrying mosquitoes to help mitigate the threat of vector-borne epidemics, such as Zika virus, which is thought to spread to people primarily through the bite of an infected Aedes aegypti mosquito.

Recently, the FDA released for public comment a draft environmental assessment (EA) submitted by Oxitec, Ltd. (Oxitec). The EA assesses the potential environmental impacts of a proposed field trial of the company’s genetically engineered (GE) Ae. aegypti mosquitoes. The FDA also released for public comment a preliminary Finding of No Significant Impact (FONSI) agreeing with the conclusion in Oxitec’s draft EA that the proposed field trial of the company’s GE mosquitoes would not result in significant impacts on the environment.

The goal of the proposed field trial is to determine whether released Oxitec GE mosquitoes will mate with local wild-type Ae. aegypti and suppress their population at the release site. The FDA is reviewing the thousands of comments received during the public comment period before determining whether to finalize the EA and FONSI or prepare an environmental impact statement (EIS). Oxitec will not proceed with the field trial of the GE mosquitoes until FDA issues its final EA and FONSI or EIS. Oxitec’s GE mosquitoes are one possible approach that could be incorporated into an integrated vector control program to help mitigate the threat of vector-borne epidemics; however, it is too early to say with any certainty whether such an approach would be successful.

Facilitating Medical Product Development

There are currently no vaccines or treatments for Zika virus that have been shown to be safe and effective. Facilitating the development and availability of vaccines is one of the highest priorities for the FDA and the international community. The FDA continues to actively engage with commercial and government developers, including the NIAID and BARDA, to advance the development of investigational vaccines for Zika virus as soon as possible. We are also working with ANVISA to assist in their efforts to expedite the development of vaccines for Zika virus. As was recently reported, a commercial company announced plans to begin evaluating the first investigational Zika virus vaccine in a Phase I clinical study.

Unfortunately, during outbreak situations, fraudulent products claiming to prevent, treat or cure a disease almost always appear. FDA is monitoring for fraudulent products and false product claims related to Zika virus and will take appropriate action to protect consumers when necessary.

More than 120 FDA staff from across the Agency are  responding to the Zika virus outbreak, working together to address the complex range of issues that this evolving epidemic continues to present in order to protect and promote the public health, both domestically and abroad. This type of teamwork exemplifies the capacity of people at FDA to rally together to solve problems, often with little explicit credit other than the satisfaction of meeting the mission of promoting and protecting the public health. There are many fundamental scientific questions that need to be addressed with respect to Zika virus, and our scientists are working to help answer some of these questions in our own laboratories. We stand ready to use our expertise and authorities to the fullest extent to help facilitate the development and availability of products that may help mitigate the Zika virus outbreak.

Visit our Zika response web page for more information, including the latest Zika virus response updates from FDA.

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

Luciana Borio, M.D., is FDA’s Acting Chief Scientist

A Tale of 3 Countries: Applying FSMA Standards Globally

By: Stephen Ostroff, M.D., and Camille Brewer, M.S., R.D.

Over the past two months, we have been part of FDA delegations visiting three very diverse countries—Canada, China and Mexico—to discuss food safety. As we are doing in the United States with the FDA Food Safety Modernization Act (FSMA), each country we visited is addressing their national food safety objectives in unique and creative ways.  And each has committed to taking a strong role in supporting compliance with the new food safety regulations mandated by FSMA.

Stephen Ostroff, M.D.

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

Looking at how these nations are different – and how they are the same – opens a window on the challenges and opportunities presented by FSMA implementation on a global scale. The seven foundational FSMA rules are now final and they will have a profound effect on foreign food producers that want to export their products to the United States.

We visited Canada on May 10 and 11 for public meetings on FSMA in Toronto and Ottawa. Canada is modernizing its own food safety system under the Safe Foods for Canadians Act, which, like FSMA, places a strong emphasis on preventive controls. Our nations have a strong interest in achieving as much convergence as possible on food safety standards.

We had the opportunity to explain that the recently signed systems recognition arrangement with Canada does not create a “green lane” for foods shipped to the United States. Instead, it is a reciprocal regulatory cooperation tool that will foster greater risk-based targeting of resources and will foster cooperation in many areas, such as risk assessment and research. The systems recognition arrangement with Canada, signed on May 4, affirms that while our countries’ domestic food safety systems are not identical in all aspects, they currently do achieve a comparable degree of food safety protection.

In addition, considerable interest was expressed in the Voluntary Qualified Importer Program (VQIP), which does provide facilitated entry for food shipments to the United States.

Camille Brewer

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

In late April, our public and private meetings in Mexico strengthened what has become a true partnership between our two countries. In 2014, we started the Produce Safety Partnership with the National Service for Agro Alimentary Health, Safety and Quality (SENASICA), and the Federal Commission for the Protection from Sanitary Risks (COFEPRIS)—our regulatory partners in Mexico—to help prepare growers and packers there to comply with the FSMA requirements. This flagship program forms the basis for extensive collaboration on produce issues.

Mexico continues to modernize and strengthen its own regulatory regime for food safety. Our strong and growing relationship with the Mexican government is a model for partnerships we’d like to forge with other nations. One of our central FSMA themes is working closely with foreign governments that share our food safety goals, and whose own food safety efforts can contribute to the safety of imported food. Our FDA office in Mexico helps to build and sustain our mutual food safety goals.

This is a priority for both Mexico and the United States because of the large volume of produce we trade and the importance of produce safety from a public health and confidence standpoint. Much of the produce we eat in the U.S. is grown in Mexico, including produce that would otherwise be hard to find in the winter months. A lot is at stake for both sides, and our meetings in Mexico reinforced our shared commitment to food safety.

A week before the Mexico trip, we traveled to Beijing for a FSMA public meeting and meetings with our regulatory counterparts in China—the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), the China Food and Drug Administration (CFDA), and the China National Center for Food Safety Risk Assessment (CFSA). China also has new food safety laws. The interest in meeting FSMA requirements is so intense that the public meeting was shared across China by webinar, with more than 5,200 participants in government agencies, academic institutions, and industry.

There were meetings with Chinese officials about issues of mutual interest and strategic importance, in addition to subjects unique to China, such as the regulation of ceramic tableware and traditional Chinese medicine.

Like FDA, government regulators in China have been working to refine the food-safety infrastructure based on new laws. The sheer vastness of the country and the rapid pace of economic development and change  are key factors that government officials are taking into account as they refine their laws to control and monitor food production.

Progress is being steadily made and the FDA Office in China continues to work effectively with Chinese authorities to identify points of synergy. The visit culminated in a meeting of representatives of China, the European Union and FDA to discuss core food safety principles and other subjects.

So you can see our partnerships take on different forms. What we learned in our travels to Mexico, China and Canada is that each nation has a strong resolve to make their food supply safer for their own citizens and for export to other nations.

We will continue traveling to countries willing to partner with us in this mission. No matter where you live, no matter where you govern, everyone wants safe food.

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

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

Globalization and FDA’s New Partnerships to Ensure Product Safety

By: Howard Sklamberg

Globalization is posing challenges for public health. For FDA, part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.

Howard SklambergIn fiscal year 2015, there were more than 34 million shipments of FDA-regulated products into the United States, up from just 15 million shipments a decade ago. These products are handled by 130,000 importers, and are manufactured, processed, or packaged at more than 300,000 foreign facilities.

We know this global trade expansion has ramifications for our nation’s public health. We also know we cannot be the inspectors for the world. Hence, we need to effectively direct our resources in a risk-based manner as we grapple with this tremendous volume of imported goods.

How? One way is to identify foreign regulators whom we can rely upon to partner with in verifying that safety standards are being met and then construct an approach that will meet the requirements of multiple regulatory jurisdictions. We are currently engaged in three innovative programs that meet this challenge.

The Medical Device Single Audit Program

The Medical Device Single Audit Program, or MDSAP, is an international approach to the auditing and monitoring of the manufacture of medical devices to ensure their safety and efficacy. This audit program will allow a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Currently, five nations – Australia, Brazil, Canada, Japan, and the U. S. – are participating in the MDSAP Pilot. It began 18 months ago and will run through the end of 2016. The program’s goals include:

  • Enabling regulatory oversight of medical device manufacturers’ quality management systems;  and,
  •  Promoting more efficient use of regulatory resources through work-sharing and mutual acceptance among regulators.

Mutual Recognition Agreements

In 2014, FDA launched the Mutual Reliance Initiative (MRI), a strategic collaboration between the FDA and the EU Member States. The goal of the program is to determine if the FDA and EU can agree to recognize each other’s drug Good Manufacturing Practice (GMP) inspections, a potentially time-saving approach.

If successful, we could rely upon EU experts to inspect facilities within their own borders, a more practical way of overseeing the large number of drug manufacturing sites outside of the United States. And it would be similarly more practical if the EU relied on FDA experts to inspect facilities within the United States.

Both the EU and the FDA are in the process of evaluating each other’s processes. The EU has visited several of FDA’s district offices in the United States and one drug laboratory and evaluated the work they do. The FDA has a different challenge since each country in the EU has at least one inspectorate, and in Germany, each state has their own inspectorate. To date, FDA has observed eight audits – in Sweden, Greece, Croatia, Germany, Hungary, Italy, the Czech Republic, and the United Kingdom – and will continue to observe audits of other Member States this year and in 2017.

Food Safety Systems Recognition

Preventing problems at relevant points along the global food supply chain can be a daunting job. FDA is soliciting help by leveraging foreign food safety systems that are similar to our own.

The agency’s Systems Recognition program determines whether another country has comparable regulatory programs and public health outcomes to what we have in place in the U.S.

A major advantage of Systems Recognition is that it allows FDA to be more risk-based in its oversight of imported food and we can more wisely plan our overall inspection activities, including foreign facility inspections, import field exams, and import sampling.

Thus far, we’ve completed: New Zealand and the U.S. signed a Systems Recognition Agreement (in 2012) and recently another agreement was signed with the Canadian Food Inspection Agency.

What’s Next? 

The three initiatives I’ve briefly outlined represent the best of FDA innovation and expertise in grappling with the increasing amount of imported FDA-regulated products. Our work will focus on a continued careful reliance on trusted foreign partners; a move away from duplicative work; more risk-based inspections; better data; and the minimization of public health risks globally.

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

Marking the Beginning of a New Era in Food Safety

By: Stephen Ostroff, M.D.

The promises embodied in the FDA Food Safety Modernization Act (FSMA) add up to this: The foods that we eat and serve our families must be as safe as we can make them.

Stephen Ostroff, M.D.These promises mandate that food be produced, packed and transported with an awareness of potential hazards and a commitment to taking whatever systematic steps are necessary to eliminate or greatly reduce any risks. They envision a world in which families can share foods produced halfway around the world, knowing that they are held to the same rigorous safety standards as those produced in the United States.

The past nine months have seen the finalization of the seven rules that make FSMA’s promises a reality – for both domestic and imported foods. The last of those rules, one that adds protections against intentional adulteration, became final on May 27. Together, and individually, these rules represent a paradigm shift from simply responding to outbreaks of foodborne illness to preventing them from happening in the first place.

There’s a lot of work to be done in the implementation phase. But even as we look forward, it’s important to recognize that getting to this point with rules that are final is a spectacular achievement, and that many deserve the credit.

Members of Congress joined together to pass FSMA in 2010 because of widespread concern over multistate outbreaks, and lawmakers like Sen. Jerry Moran of Kansas and Rep. Rosa DeLauro of Connecticut have been unwavering in their support since then. Consumers, such as activists in STOP Foodborne Illness, who became sick themselves or who lost loved ones to contaminated food, put their sorrow aside and became champions for the greater good. Public policy organizations like the Pew Charitable Trusts have been steadfast partners throughout the rulemaking and budget processes.

The food industry mobilized to help FDA find the most effective, practical ways to implement these regulations. We worked with national associations that include the Grocery Manufacturers Association and groups with a more regional focus, such as the New England Farmers Union. Farmers, manufacturers, distributors, retailers and many others whose livelihood is directly affected by these rules brought their concerns to the table and worked with us to make the rules as feasible as possible.

We found dedicated partners in other government agencies at the federal, state and international levels. Leanne Skelton of the U.S. Department of Agriculture has been part of the FDA team. The National Association of State Departments of Agriculture is playing an important role in helping FDA meet the challenges of implementing the produce safety rule. State agriculture leaders like Chuck Ross in Vermont, Katy Coba in Oregon and Steve Troxler in North Carolina became a bridge between FDA and the food producers in their states. Our regulatory counterparts in other nations, such as SENASICA and COFEPRIS in Mexico, have joined the fight to increase food protections worldwide.

The people of FDA, under the leadership of Michael R. Taylor, worked tirelessly to find the right intersection between science and policy; to develop innovative and practical solutions to complex challenges; and, to engage in open and meaningful discussions with the many communities within the diverse food supply system. I recently succeeded Mike as deputy commissioner, and I want to acknowledge the importance of his dedication to public health and food safety.

The FDA teams who drafted and revised the rules worked in tandem with teams laying the groundwork for eventual implementation. They have traveled the nation, and the world, to meet with food producers and government officials. They have worked 24/7 on these rules since FSMA became law.

The road ahead towards full implementation of FSMA is a long one. There are miles to go, but thanks to the commitment and hard work of all those who are making this journey, we will keep the promises of FSMA.

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