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

A New Partnership with Canada on Food Safety

By: Caroline Smith DeWaal

With a shared border that is more than 5,500 miles long, Canada and the United States have a lot in common — including a shared food supply. So it is no surprise that Canadian food safety agencies and the U.S. Food and Drug Administration (FDA) have signed a “systems recognition arrangement” to mark an important new food safety partnership.  Notably, this is only the second arrangement of this type. The first was signed in December 2012 between FDA and New Zealand’s food safety authority.

Caroline DeWaalSystems recognition not only allows FDA to better plan its oversight of high risk foods, it also increases our reliance on regulators in other parts of the world that have demonstrated they provide a similar system of food safety protection. This is one tool that we use to help ensure that consumers have confidence that their food is safe, whether produced in the U.S. or elsewhere.

Under this arrangement between FDA and Canadian food safety authorities signed on May 4, 2016, FDA recognizes that Canada operates a national food safety control system with regulatory programs comparable to ours. A major advantage of this arrangement is that it allows FDA to be more risk-based in its oversight of imported food.

With systems recognition in place with Canada and New Zealand, FDA can plan more wisely its overall inspection activities, including foreign facility inspections, import field exams, and import sampling. In this reciprocal arrangement, both countries benefit.  Systems recognition advances cooperation and confidence building between our two regulatory systems and it paves the way for sharing information related to food safety.

Systems recognition is a very high bar to reach. Why? For one, the strength of food safety regulatory systems varies widely around the globe. At FDA, systems recognition is an option for countries with domestic food safety systems that have preventive, risk-based programs in place. We understand that any country can have a food safety incident.

For systems recognition to work well, we want to know that the country’s regulatory authorities have the ability to swiftly track down the source of a foodborne illness and take action to stop contaminated food in its tracks –and to follow up to prevent such events from happening again. While systems recognition arrangements are entirely voluntary for the two countries that enter into them, they mark a high degree of trust in participating countries’ abilities to both prevent and respond to food-related outbreaks and contamination events. Following a rigorous review, we are confident that Canada has systems in place to accomplish this.

Before entering into a systems recognition arrangement with Canada, FDA undertook an evidence-based assessment of Canada’s domestic food safety system. We used the International Comparability Assessment Tool (ICAT) to evaluate all aspects of the system, from the regulatory foundation, to the training, inspection, and compliance programs, to the investigation of outbreaks and trackbacks to find contaminated food sources. Onsite reviews were an important part of the assessment process; those reviews allowed FDA to see first-hand how Canada implements the programs they’ve described in the ICAT and Canada conducted a similar review of the way FDA operates its food safety programs.

Systems recognition is intended to facilitate discussions that lead to a continuous improvement process for regulators on both sides of the border. For example, in recent years, new legislation was adopted in each country that emphasizes preventive control systems and import safety: The FDA Food Safety Modernization Act became law in 2011 and the Safe Food for Canadians Act was passed in 2012. As our respective food safety systems, regulatory frameworks, programs and oversight continue to improve, we are committed to this partnership with Canada for the benefit of consumers on both sides of the border.

Caroline Smith DeWaal is the International Food Safety Policy Manager on the International Affairs Staff at FDA’s Center for Food Safety and Applied Nutrition

Protecting Trade in Safe Food is a Global Concern

By: Sharon Mayl and Debbie Subera-Wiggin

Protecting consumers from contaminated foods is a global concern—as well as a key FDA priority. This was clear to us when we attended a World Trade Organization (WTO) conference in Geneva earlier this spring to provide outreach on FDA’s new food safety regulations.

Debbie Subera-Wiggin, left, and Sharon Mayl at the World Trade Organization meeting in Geneva.

Debbie Subera-Wiggin, left, and Sharon Mayl at the World Trade Organization meeting in Geneva.

This was the 65th meeting of the WTO’s Committee for Sanitary and Phytosanitary Measures (SPS), an important body that provides a forum for the discussion of food safety and animal and plant health issues that affect the international food trade. While enhancing free trade is WTO’s focus, members understand the importance of facilitating trade in safe food products.

Working with the WTO Secretariat, the U.S. Mission in Geneva and the Office of the United States Trade Representative, we shared information about the FDA Food Safety Modernization Act (FSMA) rules that aim to help ensure the safety of foods exported to the United States. It was exciting to look out at the audience and see public health and trade officials from more than 33 countries and international organizations seeking to learn more about the new food safety regulations.

The United States has been a member of the WTO, which has 162 member nations and observer organizations, since 1995. Under the auspices of this SPS Committee, U.S. trade and regulatory agencies, including FDA, work with governments worldwide on trade issues related to food safety. Their work includes ensuring that the regulations of each nation support the rights and obligations of WTO agreements.

FDA incorporates these obligations into our regulatory process, specifically to ensure that our regulations are risk- and science-based, are created through a transparent process, and are equitable to both domestic and foreign producers, while protecting public health. The WTO SPS Committee is an ideal international venue for sharing information on FDA’s food safety rules.

Our job during this meeting was to share insights on three of the new FSMA rules — in particular, produce safety, foreign supplier verification programs, and accredited third-party certification.

We were very impressed by the interest that the countries’ representatives had in these rules. More than 50 representatives even skipped their lunch to participate in the outreach session and many returned that evening, after the main session closed, to continue the discussion!

WTO members are interested in understanding and meeting the regulatory requirements in FSMA rules so that they can continue to ship safe products to the U.S. Several of the participants expressed their government’s support for working cooperatively with us to strengthen food safety controls.

We left the outreach session with a better understanding that our trading partners are highly motivated to put mechanisms in place that will help their producers and manufacturers comply with the FSMA rules and contribute to robust trade partnerships.

Sharon Mayl, J.D., is a Senior Advisor for Policy in FDA’s Office of Food and Veterinary Medicine; Debbie Subera-Wiggin is a Consumer Safety Officer on the International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition.

Strengthening Partnerships: FDA’s China Office Engages in Key Outreach with Chinese Provincial FDA, Academia, and Industry

By: S. Leigh Verbois, Ph.D.


Dú mù bù chéng lín, dān xián bù chéng yīn

‘A single tree makes no forest, one string makes no music.’

“A single tree makes no forest, one string makes no music.”This old Chinese proverb inspired FDA’s China Office, as members of our staff embarked on a five-day trip to meet with provincial FDA regulators, industry, and academia in China’s Yangtze River Delta region.

FDA Staff with Zhejiang FDA

FDA Staff Meets with Zhejiang FDA
Hangzhou, China
Front Row, Left to Right: Gang Wang (FDA China Office), Bo Ju (Zhejiang FDA), Yuanchang Shao (Zhejiang FDA), Leigh Verbois (FDA China Office), Jue Chen (Zhejiang FDA), Chiang Syin (FDA China Office), William Sutton (CDRH),
Back Row, Left to Right: Jinfeng Liang (Zhejiang FDA), Wenhua Zheng (Zhejiang FDA), Yini Ye (Zhejiang FDA), Lixin Shen (Zhejiang FDA), Nicole Taylor Smith (FDA China Office), Lixia Wang (FDA China Office)

The Yangtze River Delta region is an economic area that encompasses the Shanghai municipality, Zhejiang and Jiangsu provinces. The commercial epicenter, which accounts for 20 percent of China’s gross domestic product, is home to a significant number of FDA-regulated medical product manufacturers.

We traveled more than 3,300 kilometers (1,980 miles) to meet with key leaders and experts to strengthen partnerships, share information, and build the foundation for future cooperative engagement. Our first stop was Shanghai, where I had the great fortune to be able to address hundreds of students and faculty at East China University of Science and Technology’s School of Pharmacy and China Pharmaceutical University.

My message to the students was that they are the future leaders who will be in charge of the next generation of pharmaceutical innovation and data integrity.

In Shanghai, we also had the opportunity to sit down with U.S. Embassy Consul General Hanscom Smith to compare notes and to talk about current FDA priorities underway in the region.

China Pharmaceutical University (CPU)

China Pharmaceutical University (CPU)
Nanjing, China
CPU Faculty and Students attending Dr. Leigh Verbois’s Presentation on “CDER’s Novel Drug Approvals and Priorities”

The team then rode a high speed bullet train to Nanjing to meet with Jiangsu FDA, the regional regulator. This type of information sharing between the provincial FDA and the FDA China Office supports our shared mission of assuring that medical products produced in China meet U.S. safety standards.

On day three, we traveled again by bullet train to Suzhou where we partnered with China’s Association for Medical Device Industry to hold a two-hour, town hall meeting with almost 200 of China’s big device manufacturers that export products to the United States.

Working with FDA’s Center for Devices and Radiological Health (CDRH), our team provided information on Unique Device Identification (UDI) requirements. In the greater China region, it is estimated that there are nearly 4,000 medical device establishments affected by these requirements.

Hangzhou, China

Hangzhou, China
One of the many bridges in Hangzhou to symbolize “Building Bridges” between the FDA China Office and our Chinese stakeholders

The next morning, we headed for Hangzhou. After about two hours by train, we arrived in Hangzhou ready to meet with provincial FDA officials. Our meeting focused on specific ways we could collaborate on future medical device and drugs outreach, and more effectively share information.

The final day of our weeklong journey started with an industry roundtable focused on pharmaceuticals, held in partnership with Zhejiang FDA. As fellow regulators, we joined together to engage in substantive discussion with representatives from major manufacturers located in the Zhejiang, Jiangsu, and Shanghai regions, many of whom were interested in recent data integrity efforts in China. The FDA team then boarded our last train back to Shanghai for a final meeting with local officials that focused on our mutual priorities, as well as ways to expand and leverage efforts going forward.

The team flew back to Beijing feeling very satisfied that we accomplished much and clearer than ever that continued collaboration with Chinese regulators, industry and academia will help to ensure that medical products manufactured for the U.S. market are safe and effective. After all, one tree alone does not make a whole forest.

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

Border Crossings: Working With Partners to Verify the Safety of Imported Produce

By: Michael R. Taylor

One of the vivid images that sticks with me from my tenure at FDA is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States‎, many loaded full with fresh produce. I was told by our FDA team that, during the busy season, as many as 1,500 produce trucks enter the United States there daily, and Nogales isn’t even the busiest port of entry on the 2,000-mile U.S.-Mexico border.

Michael R. TaylorThat visit to Nogales was in the early phase of our food safety modernization initiative at FDA‎, but it had a lasting effect on me. It drove home the degree of difficulty we would face in fulfilling the produce safety vision embodied in the FDA Food Safety Modernization Act (FSMA).

With 50 percent of our fresh fruit and 20 percent of our vegetables coming from growers in other countries, the challenge was not only to establish produce safety rules that would be effective and workable across the hugely diverse produce sector, but also to verify with reasonable confidence that those standards are being met consistently, every day, regardless of where the produce is grown.

‎The FSMA produce ‎safety rule is now on the books, but implementation and the task of achieving and verifying compliance is just getting started. We know that success will take an enormous amount of education, training, and technical assistance to support the vast majority of farmers who will want to comply.

It will take a concerted effort by government and industry alike to verify that compliance is happening. And all of that demands active public-private collaboration and partnership to meet high consumer expectations.

‎‎Within the United States, this means working with our state government partners to build state produce safety programs that will provide our primary interface with U.S. growers on all aspects of produce safety. We will also work with growers and their customers to strengthen the reliability of private audits as a source of verification that can complement, but never replace, the essential role of government inspection.

‎But what about those 1,500 truckloads coming into Nogales daily from Mexican farms? How do we verify their compliance?

‎The answer is this: only by using every tool in our import tool kit‎, and, of course, by building partnerships.

‎I’m writing this while en route to Tubac, Arizona, for the annual Spring Policy Summit of the Fresh Produce Association of the Americas (FPAA). FPAA represents those producing and trading fresh produce across the U.S.-Mexico border. For good business reasons, FPAA and its members focus heavily on ensuring the safety of that huge volume of food.

At this meeting, my colleagues and I will be discussing implementation of the foreign supplier verification program (FSVP) final rule, which places new responsibility on importers to ensure the safety of the food they import. This responsibility includes ensuring and verifying that their foreign suppliers use processes and procedures that meet U.S. safety standards. The result is that importers’ private verification efforts will help ensure the public health. At the same time, they are accountable to FDA.

FSVP is the regulatory linchpin of FSMA’s historic paradigm‎ shift for imported food from reaction at the border to accountability for prevention at the point of production. But Congress recognized that FSVP alone is not enough. FSMA also mandates that FDA conduct more foreign inspections and work more closely with foreign governments to ensure the safety of imported food.

‎So‎ also gathering in Tubac are our regulatory colleagues from the two Mexican agencies responsible for produce safety on the farm (SENASICA) and after the produce leaves the farm (COFEPRIS).

In 2014, we formed the US -Mexico Produce Safety Partnership, through which we are collaborating with our Mexican colleagues – much the way we do with our state partners – on education and technical assistance, inspection and compliance, and response to outbreaks. We’ll be reviewing our progress and discussing our challenges in a partnership working group meeting and sharing our government perspectives with FPAA, which has formed its own working group to collaborate with the government effort.‎

‎This degree of collaboration on food safety is unprecedented‎. But it is necessary because neither government nor industry alone can provide the level of verification FSMA envisions and consumers demand.

And it is possible because of the deep alignment of strategic interests ‎on food safety that exists among industry, government and consumers. We all have a huge stake in seeing that modern preventive practices are being used consistently to make produce safe. That is the foundation for real partnership. We all have different roles to play, but we all have the same goal.

‎That’s why we are gathering in Tubac. And, that’s why I’ll be traveling to Mexico City in April with Dr. Stephen Ostroff, my successor at FDA when I leave the agency in June, to work with our Mexican colleagues and the Mexican industry on FSMA implementation. That’s why we’re holding a public meeting in Washington today to discuss import safety with consumer, industry, and foreign stakeholders.

‎And it’s why hundreds of my FDA colleagues are working tirelessly with partners across the food system to prepare for FSMA implementation. I’m grateful for the opportunity I’ve had to work with so many people dedicated to food safety.  I think we are all fortunate that Steve Ostroff and other leaders across the food system have their hands on the helm.

And I am confident that we are on the way to success in fulfilling the FSMA vision, from the farms of Vermont and California to that line of trucks at Nogales.

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

A FSMA Update for our Stakeholders in India

By: Howard Sklamberg

Rice at India Spice Market

Deputy Commissioner Howard Sklamberg, Dr. Mathew Thomas, FDA India Office Country Director, and Ritu Nalubola, Ph.D., Senior Policy Advisor, Office of the Commissioner, observing different varieties of rice offered at a whole produce and spice market near Mumbai, India

In an effort to complement our conversations about the FDA Food Safety and Modernization Act (FSMA) in the United States, FDA is reaching out to our international partners and stakeholders to discuss implementation of this historic food safety law.

I recently visited India, accompanied by Andrew Stephens from the Office of Food and Veterinary Medicine, and Ritu Nalubola, Ph.D., with the Commissioner’s Office of Policy. We had extensive discussions with our regulatory counterparts in the Indian government and with key food industry officials.

Spice Market near Mumbai, India

A Mumbai spice wholesaler describing a range of spices available to Deputy Commissioner Howard Sklamberg and Dr. Mathew Thomas, FDA India Office Country Director, at a whole produce and spice market near Mumbai, India

India is the seventh largest supplier of food to the United States. The Indian food products that end up on the dinner tables of Americans every night — including shrimp, spices, and rice — reflect the increasing globalization of our country’s food supply.

Many of these goods come from any of India’s 29 states, produced by thousands of different companies. Such dispersion and volume makes FDA’s close engagement with our Indian counterparts necessary, especially on the export-related parts of FSMA.

Our most recent trip to India follows a similar trip in March 2015 when Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine, joined me to introduce FSMA to a wide variety of Indian stakeholders.

On that trip, we explained that FSMA mandates a food safety system that is preventive, rather than reactive. FSMA requires that foreign food producers meet U.S. safety standards.

A variety of spices in India

A selection of spice offerings at a whole produce and spice market near Mumbai, India

At that time, we also signed a Memorandum of Understanding (MOU) with the government of India to engage in regulatory, scientific, and public health protection matters related to food products.

Building upon our 2015 trip, and upon the great work of FDA’s India office, our recent meetings focused on three FSMA rules of vital significance to India stakeholders: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; and Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications. The overview my FDA team provided was very useful to our Indian counterparts, many of whom have been engaged with FDA’s India Office in learning the details of the new mandates for exporters.

Howard Sklamberg speaking at the World Spice Congress in India

Deputy Commissioner Howard Sklamberg delivering remarks on FDA’s final FSMA rules at the World Spice Congress in Ahmedabad, India

I finished my trip with remarks to the World Spice Congress. As I noted there, the food system grows more global and trade-driven every year, which means we grow more dependent every year on collaboration and real partnership between government and industry across national boundaries.

We all have three goals: We want food to be safe. We want consumers to have confidence. And we want food safety and consumer confidence to enhance trade between nations. FSMA will help us achieve all three.

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

Strengthening our Regulatory Relationships in India

By: Mathew T. Thomas and Dean Rugnetta

India’s economic expansion is in part due to the tremendous growth in the pharmaceutical industry. The United States is a large consumer of medical products, and India is one of the largest suppliers of its drug products. And our important work together remains an FDA priority.

Investigator Daniel Roberts

Investigator Daniel Roberts (FDA India Office) and an Indian Regulator sharing inspectional approaches for current good manufacturing practices for pharmaceuticals during the workshop in Ahmedabad

We are working with our counterparts in the Indian government to ensure the medical products manufactured there, especially those for export to the U.S., meet FDA’s safety and quality requirements. FDA established an office in India in 2008, in part to promote government-to-government interactions like these and to keep pace with rapid developments and innovations in the pharmaceutical sector.

In November 2015, representatives from FDA’s India Office, our Center for Drug Evaluation and Research (CDER), Office of Regulatory Affairs (ORA), and Office of International Programs (OIP), partnered with the India Government’s Central Drug Standards Control Organization (CDSCO), to share inspectional techniques and guidance for conducting current good manufacturing practices of pharmaceutical facilities.

Carmelo Rosa and Denise DeGiulio

Carmelo Rosa (CDER), Denise DiGiulio (CDER), and an Indian Regulator discuss Quality By Design guidance with the workshop participants in Ahmedabad

Training sessions were provided in two cities (Ahmedabad and Bengaluru) for about 200 Indian regulators representing CDSCO and some of the State drug control agencies. The training was an example of the cooperation by both agencies to increase knowledge and skills, thereby contributing to the health and welfare of citizens in both countries.

The collaboration resulted in representatives from both agencies learning more about the regulatory perspectives of the other – and doing so first-hand. It was clear from the interactions that the Indian inspectors had extensive knowledge of FDA and of the international techniques for conducting inspections. The FDA representatives at the sessions benefited from input regarding the differences between FDA and Indian legislation and regulations. And as new inspectors comprised the majority of attendees, there was the opportunity for learning on both sides.

FDA Workshop Team in India

FDA Workshop Team in Bangaluru. Front Row – Denise DiGiulio (CDER), Carmelo Rosa (CDER), Leslie Ball (Office of International Programs), Mathew Thomas (India Office), Thomas Cosgrove (CDER), Thomas Arista (ORA). Back Row: Shiva Prasad (India Office), Daniel Roberts (India Office), Solomon Yimam (India Office)

Senior officials from the Government of India attended both events and affirmed their goals of ensuring patient safety and of collaborating with FDA to make sure that products from India are safe and meet appropriate quality standards.

FDA and Government of India regulators will continue leveraging knowledge and strengths to ensure patient safety in India and product quality of FDA-regulated pharmaceuticals.

Mathew T. Thomas is the Director of FDA’s India Office in New Delhi, India

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

A Closer Look at Tea and Rice: FDA Brings FSMA Outreach to Japan

By: Camille Brewer, M.S., R.D., and Sema Hashemi, M.S.

Our delegation of FDA experts traveled to Tokyo and Osaka in the first week of February to hold seminars on our new final rules under the FDA Food Safety Modernization Act (FSMA). These rules will require that foods exported to the United States be produced in a manner that provides the same level of public health protection as that required of U.S. food producers.

FSMA outreach delegation and Ambassador Caroline Kennedy

The FSMA outreach delegation met with Ambassador Caroline Kennedy (center). The delegation members (from left) are: Sema Hashemi, Jess Paulson (from the U.S. Department of Agriculture), Jenny Scott, Samir Assar, Bruce Ross, Camille Brewer, Jeffrey Read, and Brian Pendleton.

We were delighted to see first-hand how receptive the Japanese government and industry have been, both in embracing FSMA’s principles and in bringing a more intense focus on preventive controls and supply chain management. Exports of agricultural, as well as fish and fishery products, to the United States are at a record high. The U.S. is Japan’s second highest export market, and key exports include rice, tea, soy products, confectionary and specialty products. The Japanese food industry is keenly interested in increasing exports to the U.S. and representatives expressed a strong commitment to fostering an understanding of and compliance with our food safety regulations. Throughout our visit, we were reminded of the important link between market growth and maintaining a strong reputation for safe exports.

Interest in FSMA is high. Public seminars in Tokyo and Osaka drew nearly 400 and 200 participants, respectively, our largest FSMA international outreach audiences to date. As a reference document for participants, the Japan External Trade Organization (JETRO) prepared a 315-page manual with translations of key FSMA regulations and FDA presentations for each participant.

JETRO, a government-related organization, has facilitated and delivered numerous informational programs for industry on FSMA since the passage of the law. During our outreach meeting, JETRO also delivered a one-hour FSMA overview, which effectively set the stage for more detailed FDA presentations that followed. These proactive efforts achieved a much greater understanding among participants and more productive interactions during our limited time together.

Our meetings with Japanese government colleagues in the Ministry of Agriculture, Forestry, and Fisheries (MAFF), as well as the Ministry of Health, Labour, and Welfare (MHLW), allowed us to take a step back and discuss ways in which the our governments can work collaboratively to promote food safety. It was clear to us that these ministries are very eager to collaborate closely with FDA to help ensure that Japan’s food exports to the U.S. meet FSMA’s high standards of safety for food production. We are looking forward to further discussions with our Japanese colleagues as FSMA implementation continues.

Our delegation received many thoughtful and detailed questions on how FSMA would apply to Japan’s food exports to the U.S., particularly to green tea and rice — as two foods particularly important to Japanese identity and tradition. Indeed, our delegation learned a great deal about the various steps in the production of both commodities. FDA and the Japanese ministries all committed to exchange more detailed information on traditional production methods for these commodities. They represent valuable case studies on how FSMA operates to ensure prevention-based oversight of the entire food supply chain, including those unique to a culture or community.

U.S. Ambassador to Japan Caroline Kennedy graciously set aside some time to discuss FSMA international outreach activities and food safety issues with our delegation. She was very pleased to hear of Japan’s detailed preparations for these FSMA seminars and the goodwill shown to FDA’s delegation. Ambassador Kennedy stressed the importance of the relationship between the United States and Japan in the area of agricultural trade, agreeing that future dialogue on FSMA would only serve to strengthen these close ties.

We leave Japan with many fond memories of the warmth and hospitality provided by our Japanese hosts. They honored us not only with their kindness but also with the meticulous preparation and education on FSMA that we could see had taken place in advance of our arrival. We move forward more confident than ever in Japan’s strong commitment to food safety and to ensuring that foods exported to the United States will be produced under the effective prevention-based systems that FSMA envisions for food supply chains around the world.

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

Sema Hashemi, M.S., is Director of the Office of Regional and Country Affairs within FDA’s Office of International Programs

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