U.S. Department of Health and Human Services.  HHS.gov  Secretary Mike Leavitt's Blog

Import Safety

Safety at the Speed of Life- Blog 7

Last week, I began a blog series on the importance of building safety into our global trade processes. I discussed the scope of our trading in the global markets, our response to the need for new tools and strategies and the importance of collaboration in implementing these new strategies. I would like to close this series by sharing one more story about safety, speed, and Olympic athletes. This one is a tale of devotion to the safety of our country and sheer speed on ice. It is about a true hero of the 2002 Olympic Winter Games — Derek Parra, a Mexican-American speed skater from San Bernardino, California.

Prior to the Games, Derek was an employee at Home Depot working in the flooring and electrical department. He is a regular guy who at the time would eat Fig Newtons the night before each race.

This regular guy represented our country during the 2002 Games in two monumental ways. In the opening ceremony, Parra was chosen as one of eight U.S. athletes who carried in the tattered flag that flew over the World Trade Center. In his book, Reflections on Ice, he wrote about this experience. Let me include an excerpt:

When it came time to begin the procession I touched the flag for the first time and felt a physical sensation unlike anything I had ever experienced. If it is possible to feel your soul being touched that is what I felt. As we carried the flag out before the capacity crowd and worldwide television audience the silence was deafening. I’ve never before heard such stillness. I was some place emotionally I had never been before; some place spiritually I didn’t know existed. While in this instance that flag represented so much death, it seemed also to stand for life, love and the hope of a nation.

I was there and he is right.

Powerful words about the safety of our homeland from a great Olympian.

A few days later, Parra fulfilled the hope of a nation by demonstrating that nice guys do finish first. He had a breathtaking and world-record-setting performance in the 1,500-meter race. In a stunning time of 1 minute 43.95 seconds, he bested the favorite skater from the Netherlands and captured gold for the United States.

Derek Parra carrying United States flag.
Derek Parra carrying United States flag.

After winning the race Parra said, “You give up so much, hoping for a moment like this, and it happens.”

He skated the perfect race. He embraced safety, mastered the ice, and skated at the speed of life. His fleet power made him at that moment the best in the world … ever.

In the next 12 to 24 months something far more significant than an Olympic gold medal is at stake. It is the future of product safety in the United States. There are two competing and divergent philosophies ready for battle. This battle is not entirely about safety; it is a surrogate battle about U.S. philosophy on trade.

I believe that opening world markets has brought enormous benefits to consumers — lower prices, greater variety, and more choice. We will achieve safety and speed by harnessing the power of consumers who rapidly and harshly punish those who produce poor products. The game plan is to develop high, science-based standards, demand absolute transparency, reward independent certification, and rigorously enforce high-risk products.

Others would have government inspect everything. They want to stop products at the border and increase point-of-entry government inspection. Not only does such a course mean higher costs and taxes, it means consumers would be denied timely access to an abundance of safe products at lower prices. Frankly, underneath their government-centric view lurks the spirit of protectionism and the illusion that they can use the inspection process to slow or reverse global trade.

If you care about the future of the United States in the global market, you have to weigh in here. Now is the time. This is the medal round.

In a global market there are three ways to approach change: You can fight it and fail; you can accept it and survive; or you can lead it and prosper.

We are the United States of America; let us lead.

Safety at the Speed of Life- Blog 6

I mentioned at the end of my previous post in this series on import safety that FDA’s role in global trade will be changing. FDA’s work is often underappreciated in this country. Nations around the world recognize FDA as the “gold standard” when it comes to food and drug safety. Under Commissioner Andrew C. von Eschenbach’s leadership, FDA is building on that “gold standard” by reaching out to new frontiers and globalizing the FDA.

FDA is opening an office in China with staff in three cities: Beijing, Shanghai, and Guangzhou. We are currently negotiating to do the same in India, with plans for additional FDA offices in multiple areas of Latin American, Europe, and the Middle East.

And we are changing how we do business. The traditional role of FDA as approver stands strong. How and where we do that is undergoing change.

The origin of all product standards, certification and inspection of goods does not need to start with FDA; it can start with the industry and in other countries as it did with shrimp.

This is a fundamental shift in government’s role. The 21st century role of FDA is as convener and arbiter as well as verifier and enforcer.

Will FDA be an aggressive enforcement entity? Yes. In fact, FDA’s enforcement resources will be better funded and more focused on the producers who have not demonstrated trustworthiness.

Will FDA be adopting safety standards as a regulator? Yes. But we will encourage industry to collaboratively develop standards for FDA to review. If they don’t meet the scientific rigor, we won’t accept them until they do.

While the United States is the largest economic player in the food and drug market, there are other nations with excellent systems in which we have great confidence. In the past, each nation has conducted separate inspections. The result is great redundancy as several countries inspect the same plant — for essentially the same things, while too much time lapses between visits.

We are going to change that.

I announced recently a policy initiative where FDA will work more closely with foreign regulators who have systems of inspection and regulation we trust. The principle will be collaborative information gathering, individual decision making.

As part of that effort, FDA has initiated a pilot project with our colleagues in the European Union and Australia to jointly plan, allocate, and conduct international pharmaceutical inspections. This will begin with inspections of active pharmaceutical ingredient manufacturing. These are the “starting products” of many of the medicines we all use.

Through this new collaboration, FDA and these trusted colleagues can spread our inspection net wider by leveraging our respective resources. We will be inspecting some, the Australians others, the European Union still others. We will then share information. This just makes good sense. Facilities will be inspected more often and we can all focus more resources on those products that present higher risk.

This is a very exciting vision: common standards, common certification, and shared inspections. Safer products. Lower costs.

Finally, we need the private sector to step up big-time to initiate, lead, and participate in the development of consensus-based standards and independent certification. You have a responsibility to your consumers and to the integrity of your industry.

I will conclude this series in my next entry, sharing my final thoughts on how, together, we have a unique opportunity to influence the future of product safety.

Safety at the Speed of Life- Blog 5

In my previous post in the series I began last week on the safety of imported products, I brought up the importance of collaborative skills in solving complex problems and working on global issues. In my 16 years of public service, every significant step of meaningful progress has come as a result of collaboration.

Collaboration does not eliminate tensions, but it minimizes them.

Collaboration does not take away hard choices, but it improves the acceptance of the decisions made.

Collaboration does not create instant success, but it has accelerated progress.

In the context of product safety, collaboration will not only be necessary for developing product standards, but in implementing many other parts of the plan as well.

Governments must collaborate with governments. Departments within governments — law enforcement, trade, border security and health agencies, for example — must collaborate with each other. Even competitors must cooperate in some circumstances.

And, in my judgment, a collaborative spirit, skill set, and commitment is a pre-requisite for leadership and success in the 21st century global marketplace.

When we presented our import safety plan to the President, I told him it would require additional money. The President committed to seeking additional funding. Congress has made a down payment that will support crucial steps, including expanding FDA’s international presence and improving its scientific and information technology infrastructure. But it will require sustained investment over the next several years to achieve long-term import safety.

Legislative action is also needed.

We need Congress to provide the FDA with authority to mandate third-party certification in certain high-risk categories when voluntary measures aren’t working.

Having laid out a long-term vision and strategy, I want to acknowledge that changes of this magnitude take time. Solutions take time to implement. But we have to keep steady pressure on the change pedal.

In the limited time left in this Administration, there are several things I plan to complete.

In the United States, our biggest trading partners are now Canada, China, and Mexico, in that order. Chinese products made up about one-sixth of all U.S. imports. Recognizing that, we have signed and begun to implement two landmark Memoranda of Agreement with the Chinese government: one concerning food and feed, and the other, drugs and medical devices.

These strong, action-oriented documents call for specific steps and set clear deadlines for achieving them. Once implemented, they will enhance the safety of scores of items the American people consume on a daily basis.

We recently signed a Memorandum of Understanding with the Vietnamese government. We are working with Indian authorities to support their pharmaceutical regulatory priorities. We have committed to share information and collaborate with our Mexican and Canadian partners on food and drug recalls. And we are developing an agreement with Central American governments that will improve product safety for consumers in the U.S. and abroad.

The role of FDA will change in regard to the issue of import safety. I will explain my vision for this role in more detail in my next entry.

Safety at the Speed of Life- Blog 4

As a continuation of my blog series on the safety of our product imports, I want to illustrate the change in our basic strategy by talking about the shrimp business. I was in Vietnam and Central America recently— both are big producers and exporters of shrimp. I met with representatives of the shrimp industry in both places.

We talked about the impact on their product when a shipment gets detained at our border. Delays create huge costs and often disrupt or even close affected businesses.

Members of the shrimp industry independently decided that they needed to develop a set of quality and safety standards, and a way to verify compliance with those standards. They did this because their consumers needed to know that their products were safe and of high quality. They developed a formal, voluntary collaboration that produced a set of industry standards and certification process.

A centerpiece of our new strategy is to encourage, leverage, and build upon such voluntary third-party efforts. We are not inventing a new concept. It already exists. And it works.

We observed independent certification being used in many sectors of the import world. Until now, we have not integrated this capacity for improvement into our regulatory responsibility. This needs to be a government-wide strategy; ultimately, it should apply to all product lines.

Since FDA has responsibility for the safety of a significant share of our imports, I would like to outline the way we are transforming the Food and Drug Administration to harness the power of this new vision.

In the future, products from those firms that have standards and certification processes that we trust will be given expedited entry and access to U.S. consumers. The FDA will be freed to focus its enforcement resources on those suppliers that don’t have certified products. FDA is establishing a pilot with the shrimp industry to help learn how to evaluate third-party certification programs, and implement them in the field.

So we are saying clearly: “We want you to have access to American consumer markets — we want to have access to yours. To do so, you need to meet American standards of quality and safety. If you can demonstrate through a process we trust, that your products meet the safety standards that we have mutually agreed upon, we’ll be your partners in speed.”

Can you see the linkage that connects speed and safety?

Speed is accomplished when trust has been established. Trust happens only with complete transparency. Transparency requires standards, and standards require collaboration.

This is a key point — a change born of the global market — collaboration is the new frontier of human productivity. I believe learning better collaborative skills is a requirement for success in this century. It is a proven method of solving complex problems, and it’s hard work. I want to write more about the importance of collaboration with other governments around safety in a global market, and I will pick up here in my next entry.

Safety at the Speed of Life- Blog 3

I ended my last post in this series by introducing the need to develop new tools and strategies to ensure the safety of the products we import for American consumers.

A year ago, President Bush directed a working group of his Cabinet to conduct a comprehensive review of our import safety practices. He appointed me Chair. Our review involved teams from throughout the federal government, with extensive help from the private sector. We conducted the most complete policy review ever on this subject by our government.

In my role as Chair, I visited ports and post offices, freight hubs and fruit stands, supermarkets and seaports. I listened, probed, toured, and took in the totality of America’s import system.

I met with leaders from India, Vietnam, People’s Republic of China, Australia, Mexico, Canada, El Salvador, Costa Rica, Panama, Nicaragua, Guatemala, Honduras, Singapore, the largest economies of the European Union and the European Commission to discuss import safety.

The scale and complexity of global commerce amazed me. So did the need for change. We provided a comprehensive report to the President; the most important thing we said was this:

Mr. President,

We have a good system of product safety today, but it is not adequate for the future and we need a fundamental change in our strategy.

In the past we have stood at our borders attempting to apprehend products that don’t meet our expectations.

We cannot inspect our way to product safety without bringing trade to a standstill. Our new strategy must be to extend our borders and ensure that quality and safety are built into the products we import.

We will do this by rewarding producers that have products certified to meet our standards. Their goods will receive expedited entry into our country.

We will make clear to those who don’t that they can expect enhanced scrutiny.

You can read the report and the 50 specific recommendations we made at importsafety.gov. They are important, but the real transformation comes from the change in our basic strategy. I will share an example in my next entry of how a change in strategy can improve safety.

Safety at the Speed of Life- Blog 2

Yesterday, I began a blog series on the need to ensure the safety of imported products as global commerce expands the volume of imported products Americans enjoy.

This opening of world markets has brought enormous benefits to consumers: lower prices, greater variety, and more choice. Nowhere is this more evident than in the produce industry.

I met a produce manager named Dan in Detroit. I can remember his name because he told me he was “Dan the produce man.” He has been in the grocery business for three decades.

I asked him what has been the most significant change he has seen. He immediately responded with four words, “It’s what consumers want.”

It used to be a big deal each year when fresh peaches arrived. They would put up signs and place ads in the local paper. Not anymore.

Now he sells peaches almost every month of the year. During the winter, plums, nectarines, and grapes pour into this country from Latin America. We eat big, bright red strawberries in January without a second thought.

Americans walk into almost any produce department in the country and purchase what used to be seasonal items, at a reasonable price, any time of the year. It is the speed of life — our lives, our demands on an ever-growing global market.

It’s anything, anywhere, anytime.

My point is that as long as Americans want to enjoy fresh produce from around the world, buy needed medicines, wear low-cost clothing, drive foreign-made cars, use electronic products designed and built off our shores, purchase affordable furniture, and otherwise participate in the bounties of a global economy, our import system will become increasingly complex.

This is the value of global trade. The challenges we face are the result of a global market beginning to mature. Last year, the United States imported more than $2 trillion worth of products, an amount that exceeds the entire gross domestic product of France. This is approximately $6,500 for every man, woman, and child in the U.S.

These products were brought into the United States by more than 800,000 importers, through over 300 ports-of-entry. All projections indicate that this volume will continue to skyrocket over the coming years.

Just as the volume of trade has changed, so must the strategies to regulate safety. Simply scaling up our current inspection strategy will not work. This is not a problem unique to the United States. It is a fundamental challenge for all nations. We need to develop new tools and strategies equal to the new challenges we face. In my next post, I will share what we have done over the past year to assess and improve our strategy to ensure import safety.

Safety at the Speed of Life- Blog 1

Next month, the world will gather for the 29th Olympiad in Beijing, China. Those who participate and watch these games will be a part of the largest, most extraordinary collaboration of nationhood and humanity that exists in our world today.

Three out of every five people on the planet will watch as athletes from 200 countries join in this peaceful celebration of sport and personal achievement. It is a marvelous moment for mankind and a force for good in our world.

During my service as Governor of Utah, I witnessed, in a powerful way, the effort, strength, sheer talent, beauty, and grace of Olympic athletes. The setting was the 2002 Olympic Winter Games in Salt Lake City. It was the first major world gathering after September 11th.

The Olympic motto is three Latin words — “Citius, Altius, Fortius” — which mean “Faster, Higher, Stronger.” These words capture the spirit of the Olympic movement, a movement that dares people to break records and to achieve their personal best.

The first of the words in the Olympic motto has particular importance to the topic of my remarks on import safety. That word is citius. It means faster, swifter, quicker. It is the Olympic aspiration of speed. Speed is a value that is engrained in many Olympic athletes, but victory requires another virtue — safety.

Apolo Anton Ohno is arguably the finest short-track speed skater who has ever lived. Short-track speed skating is one of my favorite Olympic sports, a cross between ballet and roller derby. Short-track racers sprint around an oval track wearing helmets and skintight suits. The grace and swiftness of their movement is counterbalanced by some quite spectacular crashes that occur at high speeds.

During the 2002 Games, I watched the 1000-meter, medal-round race where five skaters participated, including Apolo Ohno and a very colorful Australian named Steven Bradbury. What Ohno and Bradbury had in common were colorful personalities. Ohno sported a signature goatee, and Bradbury displayed spiky blonde hair.

I spent time with both of them, and they are terrific guys. Ohno was the most likely to win, Bradbury the least. In fact, Bradbury’s presence in the medal round involved luck. He advanced from the first trial round because of a disqualification. He got through the second round because three skaters crashed. The skaters took their marks. The starter gun sounded. The skaters sprinted through the first straightaway and then fell into a ballet-like glide for eight laps, leaning in unison around each curve.

Going into the last turn of the final lap, Ohno and another skater were stride for stride. The crowd was on its feet. Suddenly, skates bumped, legs flared, and a domino collision left four skaters sprawled on the ice, each banging into the sideboards, just feet from the finish line.

Apolo_ohno_crashing_with_two_other_
Apolo Ohno crashing with two other speed skaters.

All but Steven Bradbury, who up to that point, was a distant fifth. He skated by the wreckage to victory as the first Australian to ever win a gold medal at the Winter Games.

As a side note, I spoke with Steven the next day in the athletes’ village. I wished him good luck in his next race, to which he replied, “You know mate, I think I’ve used all of my lucky charms.” We later joked that he was “slow enough to win the gold.”

This illustrates an important lesson. In the Olympics, athletes will take extraordinary steps to achieve maximum speed, sometimes sacrificing safety. This produces both heroic results of victory and dramatic crashes.  Great sport, but dramatic crashes — when you are dealing with people’s health — are not an option — we must combine both speed and safety. 

An executive of a large American retail firm told me that one of its core values is represented by the phrase, “Speed is life.”  This connotes the need to be nimble, innovative, and responsive to the need for change in both business operations and consumer preferences.

Too frequently we see product safety problems resulting in unnecessary expense, sickness, injury, and even the loss of life. To the consumer the result is harmful, even tragic. To countries, companies and categories of products, the impact on a reputation can be devastating. In global commerce, as in the Olympics, things happen fast, they have to — but speed without safety carries great risk.

The unsettling stream of product safety problems we are experiencing are a reflection of the most profound changes in commercial patterns in human history — the globalization of trade. This week, I am beginning a blog series on the safety of product imports in a global market that demands speed. I will continue the series in my next post and discuss the impact of global commerce on the need to ensure the safety of imported products.

Central America

Written June 25, 2008

Yesterday, we held an all day session on product safety with representatives of the Central American countries and the Dominican Republic. We had Health Ministers from several of the countries and representatives of Agriculture and Commerce Ministries as well. I met with President Antonio Saca of El Salvador for about 30 minutes in advance of the meeting. He formally opened the meeting.

El_salvador062408_019_3
Secretary Mike Leavitt (2nd from left of those seated) listens as President Antonio Saca of El Salvador addresses attendees at the Product Safety Forum.

Our purpose was to begin a conversation with the participating nations on changing our collective strategy related to the safety of food. Central America and the Dominican Republic have become a major factor in U.S. food production. Collectively, these countries rank just behind Mexico and Canada in importation of food into the United States. A trip to the grocery store fruit and vegetable section will confirm that.

These countries properly fear any kind of import quality problem because it is seriously disruptive to their economy. The U.S. is 80% of their market. A situation like the melon problem we had in Honduras or the tomato situation in Mexico also damages their national brand.

In previous blogs, I have discussed our nation's strategic change. Our efforts are focused on preventing problems before they happen. Our best tactic to accomplish that is the establishment of quality standards and the continual monitoring of them through independent certification. I explain in my blog on the Red Pepper Principle, how implementing new practices can make crops attractive because of higher quality.

We had five panel discussions, all of which went well. Just before lunch, I asked the participants to consider an idea that I wanted to discuss during the afternoon. The idea was to create a U.S./ Central America/ Dominican Republic Memorandum of Understanding (MOU) on food and drug safety. Under this MOU, we would engage in regional capacity-building, joint standards-development, development of accreditation arrangements for certifiers and training at the Regional health-care Training center we have developed in Panama. I suggested that we identify a couple of product categories to start with. After lunch, the panel discussions began to center around the MOU idea. By the end of the session, we had devised a strategy to move the idea forward, with a goal of completing the MOU this fall. The meeting was a big success from my point of view. We didn’t conclude anything, but we were able to start a serious process. I still have a significant amount of work to do in making contact with other important players.

Dinner last night was terrific. Ambassador Charles Glazer and Mrs. Glazer invited a local mayor and two prominent business executives over. It was a chance for me to learn more about El Salvador. We talked about the challenges of local government and the upcoming national elections.

Mexico City Meetings

Written June 23, 2008

I’m writing from Mexico City tonight. I participated in a bi-lateral meeting with José Cordova, Secretary of Health, and members of his staff. We then had a working dinner that added Alberto Cardenas, Secretary of Agriculture, and Eduardo Sojo, the Secretary of Economy, and representatives of other Mexican national government agencies.

Secretary Cordova and I have a long list of things we are working on together. Most of them related to joint projects we are doing along the border.

Secretary Mike Leavitt and Secretary of Health for the United Mexican States Jose Angel Cordova.
Secretary Mike Leavitt and Secretary of Health for the United Mexican States Jose Angel Cordova.

Secretary Cardenas and I have known each other since 2003. Previously, he was Secretary of Environment and I headed the U.S. Environmental Protection Agency (EPA). It was the first time I met Secretary Sojo. Speaking of environmental issues, the air here is much better than I remember it. I joked with Secretary Cardenas that it was the result of the joint projects we had done on clean fuel while I was at EPA. I suspect the air isn’t always as good, but it is good to see some progress.

The evening meeting was devoted to a discussion of product safety. I won’t discuss the content of the meeting except to say it was focused on ways we can work together to assure safety of food and drug products that are produced in Mexico. I am going to Central America tomorrow for discussions with five governments on the same subject.

An obvious topic of conversation was the current situation with tomatoes. Tomatoes are Mexico’s biggest agricultural export to the U.S. Fresh fruit and vegetable exports to America accounted for $4.4 billion last year. As always, an incident in that sector of their economy has serious ramifications, and we are working with them to minimize impact, while putting safety first.

Secretary Leavitt speaking to Secretary Cordova during a bi-lateral meeting between U.S. and Mexican health officials.
Secretary Leavitt speaking to Secretary Cordova during a bi-lateral meeting between U.S. and Mexican health officials.

FDA is working non-stop to find the source of the salmonella outbreak that many states are experiencing right now. FDA has completed the trace-back for some of the tomatoes associated with the outbreak. The investigation has led them to certain farms in Mexico and Florida.

We have deployed a team to Mexico. They will conduct joint inspections with regulators in Mexico and Florida at the farms and other distribution points. Meanwhile, the FDA will continue to collect samples of tomatoes and conduct trace-back activities.

FDA is keeping a list of the areas that have not been associated with the outbreak. We added a long list of states within the United States and Mexico. It is on the FDA website.

Tomorrow, I’ll meet with U.S. businesses in Mexico City, tour a food processing plant, and give a diplomacy speech. One thing making this trip a little extra special is that my 18 year old son is accompanying me (at my expense). He is about ready to leave home for college and this is a way for us to have a little adventure together.

China - Blog IV

Thursday night I was scheduled to have dinner with my friend Gao Qiang, who until last year was China’s Minister of Health. He no longer has day-to-day management responsibility but continues to have significant involvement in health policy. He called to say he had meetings related to the earthquake so he needed to cancel our plans. I completely understood.

We were able to get together for a brief visit on Friday morning. He had only had two hours sleep the previous three nights. He said the entire government was focused on the rescue effort.

I was also able to spend time with Wan Gang, Minister of Science and Technology. We had met at the Third Strategic Economic Dialog last December but this was our first opportunity to spend time getting acquainted. We reviewed the existing relationship between HHS and the Ministry and laid out some areas where we have additional common interests.

During the middle of the day, I took a short break to attend a program at an International School on Internet Safety for Children. My wife Jackie volunteers full time for the ikeepsafe Foundation. The foundation has developed a book about internet safety using an Olympic Game theme and the book launch was held at the school. One of their sponsors has arranged to place several thousand copies of the book in schools.

The afternoon was spent in more meetings with government officials. I spent a productive hour with Minister Li and his Deputy Minister Wei. They reviewed with me plans they have to ensure food safety for the Olympics. It was rather extraordinarily detailed and well coordinated. The essence of the plan is if you touch any food during the Olympics as a restaurant, supplier, or processor, or transporter then you have to register and agree to certain standards. They have developed a tracking system that is the most elaborate thing I have ever seen. I can’t recount every component of the system but it includes GPS tracking of every truck carrying food, traceability of ingredients and an incident reporting system. I told Minister Li that if he could pull half of it off, his organization should be given a gold medal in food safety.

We also spoke at length about the progress on the implementation of our Memorandum of Agreement on food safety. We are making steady progress.

After our meeting, my good friend Vice Minister Wei arranged for us to see the Olympic park. What a treat that was. We went to a building where they display scale models of each venue. It was well presented. We then drove to several parts of the park so we could see the venues from close range. They are spectacular. The visit rekindled many of my Olympic feelings from 2002 when my home state of Utah hosted the Winter Olympic Games.

China will be stretched to manage the final preparations for the games and the earthquake recovery at the same time. It brought back memories of our Olympic preparations. The Olympics were only a few months after 9/11 hit. Suddenly the nature of the 2001 games changed. We would become the first major world gathering after the attack. Many were concerned that terrorists would use the Olympics as a target. We beefed up our security arrangements considerably during the final three months.

I rushed back to the Embassy to do a news conference. Regrettably, I was caught in Beijing traffic, which is simply unbelievable. I was about a half an hour late and that always makes me uncomfortable. The journalists were patient and seemed to understand the traffic problem. Most of their questions focused on import safety issues. There were 18 reporters there.

My final meeting of the day was dinner at Ambassador Sandy Randt’s home for members of my delegation. It was a terrific evening. Ambassador Randt has lived in the region for much of his professional career. He and his wife Sarah have been in China several times, starting in the 1970s. He also lived in Hong Kong for many years, speaks the language and is a terrific relationship builder. He is remarkably able and likeable; all good qualities for an Ambassador.

Our dinner conversation focused on China’s place in the next quarter century and a comparison of the unique challenges our respective countries face to maintain our economic momentum. We talked about the challenge of entitlement spending in the United States and the various disparities China will need to manage. It was an interesting conversation.

The best part of the evening was a conversation we had about music that we grew up with. Each of us named songs that took us emotionally back to our adolescence and the associated memories. My song was Strawberry Fields Forever, by the Beatles. It reminded me of sitting at a small drive-in on the outskirts of Loa, Utah where our ranch is located. I would go there on summer evenings to order food and play songs from the Juke box.

We all shared great memories. It was a terrific way to get to know each other.

Shanghai, China: Product and Food Safety

Written May 12, 2008

Well, this blog entry will break new ground for me. I'm writing it with my Blackberry while striding up and down on a stair stepper in a health club overlooking Shanghai, China. Before you jump to any conclusions about my accuracy with thumbs, be aware I'm going to send this draft to my colleague in Washington and have her clean up my double letters and typos. With the day’s schedule it is likely the best, perhaps only, opportunity I will have.

Yesterday, I gave a speech to about 800 representatives of manufacturing companies from around the world who supply a major retailer in the United States, the Target Corporation. It was a significant chance to once again send the message that if producers desire access to American consumers; they will have to meet American standards.

I spent the afternoon with a local office of the General Administration for Quality Supervision, Inspection, and Quarantine (AQSIQ), a rough equivalent of a Chinese Customs and Border Protection. This is the entity in the Chinese government with specific responsibility for the safety and quality of imported and exported food. The people I met with had spent a significant amount of time in the United States, and understood our processes reasonably well. A half day is long enough to learn some essential facts, but not enough to draw conclusions. Most seaports have a similar feel around the world. Actually, most of the large unloading cranes are made in Shanghai.

HHS Secretary Mike Leavitt joined by Chinese inspectors looks at chicken shipped from the U S  to the Port of Shanghai China's largest port
HHS Secretary Mike Leavitt joined by Chinese inspectors looks at chicken shipped from the U S to the Port of Shanghai China's largest port

Not surprisingly, the Chinese see our concerns about the safety of food imports differently than we do. They repeatedly mentioned they require certificates before goods are shipped out of China, and point out we don't. They also want us to accept AQSIQ certificates as proof of the safety for Chinese food exports to the United States. I won't take that on in a blog, but it does indicate why it is important to understand the perspective of others. One learns a lot being able to talk with people on the ground.

I'm not going to get into a travel log, but there are a couple of observations worth making. This is an amazing city: incredibly vibrant and modern.

The Chinese are serious city-builders. They do infrastructure faster than anybody in the world, I think. They can just throw so many people at projects, and exercise such absolute social control, that they can move in a way that gives them a significant comparative advantage. In making that statement, I do not discount the negative environmental compromises, or the impact on human beings, but they have a clear set of priorities, and when they decide to move, things happen.

For example, they are building 150 miles of subway within the city in the next two years. Compare that to Boston’s Big Dig.

They decided to build a deep-water port about 18 miles off the shore of Shanghai on some islands. In order to get the goods from the port to the mainland, they needed a causeway. It will take them three years to build the causeway. It would take more than three years in the United States just to scope the work.

I was at the port when the earthquake struck. It was felt in the upper floors of our hotel, but not at the port. I visited the area of the earthquake last December. I am checking in at the White House to see if there are ways I can be helpful on behalf of the United States, and when I meet with the Minister of Health later today [Wednesday, May 13], I will express my condolences from all Americans for the loss of life here.

The disasters here and in Burma are frightening examples of how vulnerable we are as human beings.

Today, I'll visit a hospital and school of traditional medicine, and meet with a large group of students. Tomorrow, I'll meet with American businesses in Shanghai to discuss product safety, before I leave for Beijing.

Viet Nam – Blog III

Following on yesterday’s blog, here are some additional observations about my recent trip to Viet Nam.

Observation two: While they maintain a communist structure of government, Viet Nam is obviously devoted to being part of the global market economy. As people vote with their dollars, markets are highly democratic. It seems clear they have found a way to reconcile the ideology. They have attained status in the World Trade Organization and seem highly motivated to come into conformance on global economic standards.

When I visited with a group of shrimp farmers, we discussed market conditions, world prices and the demands of entrepreneurship. Clearly, the government plays a different role in their business than it does in a democracy. These were small businessmen, looking to find niches in a market where they could optimize their opportunity.

Dinner with Shrimp Farmers
Dinner with Shrimp Farmers

Observation Three: The Vietnamese government seems to understand the importance of protecting the made in Viet Nam brand. They are proud of the fact that it is beginning to show up more places. We discussed openly how quickly a brand that is not known well can be damaged by adverse quality events. We agreed during our talks to develop a working group to develop MOUs, similar to what we have done with China, which will allow our regulatory agencies to work interoperability, even though we have different systems of government.

Viet Nam is drafting new framework laws for food and drug safety so this is an opportune time to work with them. We agreed to move on aggressive time frames.

Observation Four: The business environment has a frontier quality to it. There appears to be opportunity everywhere, but you would have to have a high tolerance for the type of bureaucratic and political uniqueness that accompanies a country in transition. I had lunch with members of the American Chamber of Commerce. I sat next to Tony Foster, a Chicago based businessman who is building several businesses in Viet Nam. He is actually married to a Vietnamese physician who now lives in Chicago.

One of his businesses is a company providing international telephone services, and from his short description, he appears to have taken advantage of a need Viet Nam had for telephone capacity. As part of his willingness to invest in telephone infrastructure, his company was granted status that, for a time, gave him a comparative advantage in the market.

At the Port of Saigon, the Port executive told me they had contracted with a Seattle company to build a new Port. I know little about it, but presumably the company will invest money and bring expertise, earning a return from Port fees and securing an early position in a growing enterprise. I observed a similar arrangement in southern India.

As we boarded the plane to Ho Chi Min City, our Ambassador, Michael Michalak, introduced me to a private equity fund manager specializing in Viet Nam investments who was also boarding. There are obviously unique challenges investing right now, but with a populations growing rapidly in number and prosperity, Viet Nam is an intriguing marketplace.

Viet Nam still has state control of most of the key industry groups, and they have been slow to give up control. State owned enterprises make up 37% of their GDP. The government owns and controls industries like banking, energy, air travel, and health care.

Observation Five: Reduction of poverty is a primary social goal of the government and they seem to be succeeding to some extent. In 1993 58 percent of the nation’s population was in poverty. Today it is only 15 percent.

They will have to do substantially better in basic areas like education, health care system, etc. However, they seem to know where the problems are.

The Vietnamese government has a goal to be a country with middle income. They also aspire to be considered an industrialized country by 2020. It feels like, to me, that the Vietnamese and Chinese have similar approaches to planning. They also have the ability to compel things done that democracies require more time to finesse.

Observation six: Personal freedom is still mixed. Freedom of religion has dramatically improved the past few years and the churches are full.

However, freedom of speech is not as good. The embassy told me there are many situations in recent years where people have been imprisoned for speaking out against the government.

Viet Nam - Blog I

An Overview

The final three days of my trip to Southeast Asia were spent in Viet Nam. This was a follow up trip to my October 2005 visit. I focused on three issue areas: HIV/AIDS, Avian Influenza and the safety of imports. Meeting the new health minister was a priority as well.

As a general overview, I arrived in Hanoi on Tuesday night, the 15th of April. I spent Wednesday the 16th of April there working. On Thursday, I flew to Ho Chi Min City, where I spent the day working, and then on Friday, I was able to go out into the countryside, which always turns out to be a highlight.

In Hanoi, I visited the Ministries of Health and Agriculture; spoke to the American Chamber of Commerce; spent an hour interacting with students and faculty at the Hanoi School of Public health; and then met with Prime Minister Nguyen Tan Dung. In the evening, my new friend, Nguyen Quoc Trieu, the Minister of Health, held a banquet that none of our delegation will ever forget. This was not your routine diplomatic gathering. It was a party, full of personalities, music and bonding.

On Thursday I did media interviews, traveled to Ho Chi Min City, and toured the seaport in the same way I have many American ports; working to understand their role in the safety of imported products. I then visited a clinic our HIV/AIDS money supports, which is setting up the nation’s first methadone clinic as a way of assisting in the prevention of HIV/AIDS, and then met with the party leaders of the city.

Friday morning early, we drove into the countryside about three hours. Seafood is one of the biggest trade items between the U.S. and Viet Nam. I wanted to get a sense of the processes and sophistication levels in that industry, in a similar way as I was able to in India. The three hour drive by itself was worth the effort of going. I saw many different kinds of communities along our route in varying degrees of change.

I visited a large seafood processor and had a two hour discussion over lunch with a group of shrimp growers, a regulator and fellow who appears to have a job similar to an extension agent. I then went to meet with a group of chicken growers in a rural residential area along with public health people. We talked avian influenza.

Mike Leavitt at fish farm in Viet Nam

At fish farm in Viet Nam

In the evening, we had a reception at our hotel and picked up the midnight flight for a connection in Tokyo for D.C. These trips are non-stop events. By the time I get to the end of the week, I’m usually feeling exhausted, but greatly enriched. This was a successful mission, but I’m ready to get back into a normal routine. With the time zone changes, different beds most nights, and fifteen hour days, the last seven days feels like one continuous day.

I was able to keep better control of my diet and exercise routines this trip. Both usually take a hit on these forced marches. I think I got exercise all but two mornings and with only one major banquet, didn’t do any serious caloric damage. It’s a small victory in my long fight to stay healthy.

Having provided this overview of the trip, over the next few days I’ll post a series of observations I have as a result of the trip.

Honduras Cantaloupe

FDA recently placed an Import Alert on cantaloupe coming into the United    States from Agropecuaria Montelibano, a  major Honduran grower and packer. This action was taken after the Centers for  Disease Control and Prevention (CDC) determined fruit from the company was  associated with outbreaks of Salmonella Litchfield in 16 states. 

Watching these things unfold is fascinating. Each situation is like a mystery being solved by investigators at FDA and CDC. The investigators are often referred to as disease detectives because their techniques are a blend of scientific skill and detective shoe leather. 

The investigators piece together extensive interviews with affected people until they can find a common thread tying them together. When there are cases across 16 states that can be difficult. Once they find what is  causing it, they have to track the product back through an intricate system of  distributors, import brokers and suppliers. When the product comes from outside the United States, it is even more complicated.

An Import Alert has cascading consequences. Not only does it  affect consumers, but it immediately changes the livelihood of thousands of farm workers, processors and shippers and in many cases the viability of  companies and the way an entire nation’s products are perceived. As a result we  have to take these things very seriously. 

The cantaloupe problem is complicated further by the fact that Honduras  is in the middle of their season. There is fruit in process and still on the  vine. 

I spoke twice with Honduran President Manuel Zelaya Rosales who asked that I meet with his Agriculture, Health and Commerce Ministers the  next day in Washington.  Of course, I agreed. The envoys flew all night; their plane touched down at 5:30 a.m. for an 8:30 a.m. meeting with me and FDA Commissioner Andy Von  Eschenbach.   

The three Ministers were most cooperative and understanding  of the situation. They pledged their full cooperation, asking only that we move  with all speed to find the solutions. Knowing what is at stake both in terms of human health, economics and our friendship with Honduras, I committed we would  have a team on the ground by the next day.   

The next morning a team of people from FDA and CDC left for Honduras.  As I write this over the weekend they are in the fields where we suspect the contaminated fruit originated.  We agreed at the meetings  with the Ministers that our team would work side by side with their  regulators to get at the bottom of this as quickly as possible. We have put FDA labs on notice that we want to make this a priority. Hopefully, we can get to the bottom of this quickly and help the producing company remedy any problem.

Import Safety Agreements with the Chinese Government

Under assignment from President Bush, I have devoted considerable time and a lot of HHS resources over the past six months to an Import Safety Working Group. I was chairman of the 12-person group which represented all the relevant parts of the U.S. government.

The working groups concluded that our country has a good system of import safety, but it is inadequate for the future. In September, we laid out a strategic framework for the future. In November, we issued an implementation plan with 50 specific recommendations in 14 different categories.

Throughout the period of our work, Chinese products have been under substantial media scrutiny because of a series of negative incidents involving their pet food, aquaculture products, tooth paste and toys with lead paint. It was evident to both our countries that these events were warning signs that required a policy response.

In the summer of 2007, I began working with Chinese officials to develop binding memorandums of agreement on how we can work together to assure their products meet U.S. standards. I asked Andy von Eschenbach, Commissioner of the FDA, to assemble a technical team. I assigned my Chief of Staff, Rich McKeown, to represent me in the negotiations. Vice Premier Wu Yi of the Chinese government received a similar assignment from President Hu to organize a team.

The work between the Chinese and American negotiating teams spanned six months and involved four different rounds of meetings. They were rigorous and spirited. However, in the end, two agreements were produced. One agreement is on food and animal feed. The second is focused on drugs and medical devices. I believe these two agreements contain a framework which will have a profound impact not just on the importing relationships between the U.S and China, but also on the relationships we have with other nations.

I want to enumerate five of the many important conclusions I have reached during this period.

Lesson 1: The import safety problem is the natural consequence of a maturing of the global marketplace. These issues have been slowly ripening for several years now. It is a direct reflection of the profound growth in the amount of trade between nations. Our systems are not designed for the pressure they are under. We are inventing tools to deal with new problems. Scaling the old way up is an inadequate response.

Lesson 2: Collaboration is necessary within governments as well as between governments. Different countries have different systems of government and different views of import challenges and priorities. Likewise, different parts of governments see import safety with different perspectives. For example, a border protection agent views this as a law enforcement challenge. A public health official sees it as a health problem and, naturally, a trade negotiator wants to know how it will affect commerce.

Lesson 3: Different perspectives, economic systems and regulatory regimes must be bridged by common goals, international standards and interoperable systems. The standardization of cargo containers across the world is a proper metaphor. By adopting standard-sized containers, the shipping community has made it possible for cargo to be handled efficiently in any nation. There is no substitute for the hard, messy work of collaboration in developing them.

Lesson 4: Transparency is trust’s seed. In a global market, speed is life. Anything that slows the flow of goods down, including unnecessary inspections, damages competitiveness. Competitiveness and safety can co-exist only when one knows who to trust. Transparency brings trust; trust brings speed; speed wins in a global market.

Lesson 5: Continuous improvement is necessary. The agreements we signed with the Chinese are frameworks and will require continued work at many layers of government and industry. There is a Chinese saying, “A man who would move a mountain starts by moving small stones.”

Import Safety Report

A good share of my week has been spent in activities related to a report for the President on the safety of imports. Every few days it seems another significant recall is announced.  It has become a matter of real focus for consumers and policy makers.

It is my observation that issues like this slowly ripen because of bigger and more fundamental shifts in economic or social practices. Concern over the safety of imports is not unique to the United States.  Last week I hosted the health ministers of the G7 countries plus Mexico and the European Union.  Every country represented is dealing with import safety concerns. 

What are the underlying economic and social changes causing this sudden concern?  Import safety concerns represent the natural maturing process of a global market.  They represent an early warning that we need to adapt our systems and thinking to accommodate a new set of challenges.  The old ways do not protect us adequately from the new risks. 

I was assigned by the President to chair a government-wide review of our practices related to imports of all kinds.  The working group included 10 other cabinet members and the heads of the Food and Drug Administration and Consumer Product Safety Commission. 

I’ve previously reported on some of my experiences doing this review.  Today, I want to provide you access to the report.  I think it has been well crafted.  It contains 50 specific recommendations in 14 categories, all crafted to fill in detail to the Strategic Framework we provided the President eight weeks ago.

In keeping with my goal of making these postings shorter (and the fact that I’m out of time today) I will provide some additional observations later.  In the meantime I would value your reactions.

Finishing the Import Safety Report- Written Friday, September 7th, 2007

The safety of imported products has been in the news frequently. I’m in the final stages of preparing a report for President Bush on the subject. In July he appointed me Chair of a Cabinet Task Force on Import Safety. He asked us to report back within 60 days. I’ll provide him with a strategic framework this week.

The week after the President signed an executive order creating the Task Force, I organized a team of people from 12 different parts of the federal government and assigned them to analyze current authority and practices. As their work progressed, I hit the road.

Experience has taught me that if I spend enough time talking with people actually doing the work, my understanding of the problems improves rapidly and consistent themes begin to emerge. I’ve been in seaports, post offices, food manufacturers, wholesalers, retailers, at checking stations, freight handlers at border crossings. When the themes raised by those working on the front lines match the conclusions of those doing analysis in Washington, it gives me confidence our work product will be solid. Clearly, that is the case on this task.

Yesterday, (Thursday, September 6th) was spent at a seaport in Charleston, South Carolina. I wanted to see an interagency working group called Project Seahawk. The co-location of various agencies like FDA, USDA and the Customs and Border Protection has produced remarkable improvements in efficiency.

I met up old friend, J.P. Suarez in Orlando Florida, mid day Thursday. We worked together when I headed the EPA. J.P. is now Senior Vice President of Corporate Compliance for Wal-Mart. He brought some of his colleagues who have responsibilities for product safety. We walked through one of their large stores and talked about the challenges with import safety related to all kinds of products. Walmart and other major retailers now require rigorous inspections at every stage of production.

Mike Leavitt examining toy

Late in the afternoon I met a terrific couple, Migdale and Clara La Rosa in Miami. Some FDA inspectors introduced me to them as they taught me more about the inspection on seafood.

Both Migdale and Clara come from Cuban emigrant families. They could see an opportunity to live the American dream. They bought a truck and began distributing freight for a single customer. Eleven years later, they run La Rosa Logistics, Inc in Miami. They now have 23 employees and a dozen trucks.

La Rosa Logistics is a freight forwarder. Many of their customers are wholesale fish distributors. Rather than maintaining refrigeration facilities, and delivery trucks, they hire La Rosa to do those things for them. When a shipment of fish comes from Chile or Honduras, La Rosa picks it up at the airport, checks the product freshness and quality, then delivers to the distributor’s customers.

Clara runs the front office. Migdale oversees the operation in the warehouse. Around the office there are pictures of their four children who reflect the combined attractiveness of their parents.

By law, shippers have to inform border officials of their intent to present goods at the border. As the shipment approaches, FDA inspectors decide which packages or containers they need to inspect. If one of those packages is to be processed by La Rosa, FDA notifies them it needs to be held. If FDA doesn’t tag it for inspection, La Rosa still tests the fish in essentially the same way the FDA would. When I asked why they perform tests not required by law they pointed out that delivery of poor product is a failure their customers won’t tolerate. The survival and prosperity of their business depends on product safety.

Inspection is a critical part of keeping imports safe. However, the amount of products is so large we will never inspect it all. We have to create a system of standards and verification so quality is built in.

www.importsafety.gov