Food Safety

Principles and Challenges in Food Safety

Good day. I am delighted to have this opportunity to speak with you. My name is Eric Hargan, and I am the Acting Deputy Secretary of Health and Human Services. The Department of Health and Human Services is the Department within our federal government that leads the United States government's efforts to protect the health of Americans and provide essential services for vulnerable members of our society.

Health and Human Services is the largest civilian department in the United States government. More than 66,000 people work with us. It accounts for almost one out of every four dollars that the federal government collects in taxes nearly $700 billion. Health and Human Services, which is roughly equivalent to your Ministry of Health, Labor and Welfare, is actually several ministries in one. We protect the public health; conduct biomedical research; provide for the welfare of our elderly, disabled, and disadvantaged people; ensure the safety and efficacy of our medicines; and ensure the safety of approximately 80 percent of our food (the other 20 percent being under the control of the U.S. Department of Agriculture).

As the United States and Japan and mutual partners such as China trade a great deal of food with one another, I would like to focus my remarks today on current challenges in food safety.

Every night when we gather with our families to enjoy dinner, the last thing any of us wants to worry about is whether this meal will harm us. We trust that the farmers who grew our vegetables, the fishermen who caught our fish, the manufacturers who processed our food products are committed to selling us food that is safe. We also expect experts from our government and other regulatory agencies to inspect and protect our food. Daily, some people have come to believe something more: that every item of food is always 100 percent perfect.

Certainly, risks related to food like food-borne pathogens have decreased dramatically over the past decade. But risk can only be minimized, not eliminated. And when public expectations on risk are raised too high, unrealistic results are demanded, and governments scramble to fulfill public expectations. And when measured against a demand for perfection, for no risk, all human actions will come up short. This can result in low morale among providers and regulators, and can also lead to an inappropriate attempt to do everything. The attempt to do everything results in misallocation of resources, and under-resourcing of areas that are higher risk. This is the wrong approach, and this is why we try to remain evidence-based and risk-based in our approach to public health and safety.

However, when farmers, manufacturers, or regulatory agencies fail in their obligations, or consumers fail to understand specific risks when they are susceptible to food-borne illness, people can become sick or die. The obligations inherent in effective food safety regulation and education are therefore some of the most solemn that any government agency can have.

Over the past few days, I have had the opportunity to meet with members of your government, and have been impressed with their commitment to the health and well-being of the Japanese people and to the safety of the food you produce, eat, and trade. We both realize the magnitude of the trust our peoples have placed in us. I would like to share with you some of what I learned from the Japanese government as well as some of my experiences in the world of food safety regulation.

In the United States, as in Japan and many other countries, we have several regulatory bodies that oversee food safety. For example, the U.S. Department of Agriculture regulates packaged sandwiches made with meat and only one slice of bread. If the manufacturer puts a second piece of bread on the sandwich, the Food and Drug Administration which is part of Health and Human Services takes over. We at the Food and Drug Administration regulate cheese pizzas. But as soon as a manufacturer puts pepperoni on the pizza, the Department of Agriculture takes over.

Some people would prefer a single food regulatory agency. However, we see that trends in food-borne illness continue positive. So, in spite of the fact that the system might seem untidy, intellectually, it works. And when a system works, we should be hesitant to disturb. A radical reshaping of our food safety system would distract our agencies? to what effect? Continuing a structure with multiple agencies allows the leadership of food safety agencies to focus on their key job safety and not how to relate to new offices and organizations.

As our Food and Drug Administration part of my Department, as I mentioned regulates a preponderance of the food Americans eat, I would like to go into greater detail about its role in food safety.

It was a little over one hundred years ago, in 1906, that President Theodore Roosevelt signed our Pure Food and Drugs Act into law, foreshadowing the creation of our modern Food and Drug Administration. The Act provided for federal inspection of meat products, and forbade the manufacture, sale, or transportation of adulterated food products and poisonous patent medicines. Since then, FDA has played a central role in the work the American federal government does to protect our food supply against all threats.

Today, food is more inexpensive, healthier, and safer than any time in history. In 1929, almost 24 percent of a family's disposable income was spent on food. By 1970, that had dropped to almost 17 percent. In 2005, it had dropped to less than 12 percent. We also no longer have significant, long-lasting waves of food-borne illnesses, such as milk-sickness or typhoid. These are all amazing trends, and we encourage them as much as possible.

But these trends have unforeseen consequences. Let´s look at the trend for more inexpensive food. It is now cheap to produce low-cost, high-calorie foods with ingredients like high-fructose corn-syrup. In any other century, such a low-cost, high-calorie diet would be welcome. Even more, the elimination of food scarcity in large areas of the world would have been seen rightly as a miracle.

But there has been a cost to our solution in the developed world to the age-old problem of food scarcity, and we have swung to the other end of the pendulum. Now, as I noted, it costs American consumers less to buy technologically sophisticated yet nutritionally suspect processed food than it does to buy an equivalent amount of calories of fresh meat or vegetables. So it makes more economic sense for people on limited budgets to eat unhealthy foods instead of healthy foods. Is it a coincidence that we are facing a so-called epidemic of overweight and obesity?

In addition to a new focus on obesity, there is also a consumer trend towards healthier foods. Scientists and researchers are continuously learning more about biology and nutrition, and this knowledge has been increasingly matched by a desire for natural, healthy foods. Take spinach, for example. Two or three decades ago, the only way most Americans might eat spinach was if it had been boiled into a green, tasteless mass. Now, our more health-conscious consumers instead want the freshest, most delicate leaves of baby spinach. But while baby spinach might make an excellent salad and is an excellent source of nutrients, it is also, in rare situations, an excellent carrier of E. coli. In fact, the less processed a food is, the more likely it will convey pathogens, as we saw in an E. coli outbreak on spinach in the United States last year.

The relatively free market in food has allowed not only the elimination of food scarcity from large parts of the world, but also the ability to bring fresh, healthful foods from all over the world to local supermarkets in the developed world. This is another milestone. All this has happened while the major categories of food-borne illness have been eliminated or put into serious decline. And food, both healthful and not so healthful, has become cheaper and cheaper.

This access to cheap calories and now, increasingly, less-expensive healthful food is, I believe, one of the great public health achievements of our time. It is the continuation of the green revolution launched decades ago.

However, the side effects of this, from a rise in obesity to a greater traffic in food across borders, have resulted in calls for substantially greater regulation of food. And over-regulation that raises the cost of food will reduce access to food (and even more so, healthful food) for our most vulnerable populations. This cannot be allowed to happen. We must make sure that, while we continue to improve our efforts in food safety, we do not begin over-regulation and roll back decades of improvements and our public health and our lifestyle.

These calls for greater regulation are most understandable in the area of food safety. Our people have grown alarmed about recent outbreaks in spinach, scallions, and peanut butter last year. In some sense, food safety agencies are victims of their own success in scientific and technological advances. For example, we know a great deal more than we used to about toxicity levels for chemicals, bacteria, and other contaminants and methods to keep food safe from them.

Our methods to keep food safe from pathogens are becoming even more refined as are our abilities to trace disease outbreaks back to their food-borne sources. Our ability to collect and process information keeps growing. In fact, I suspect that the better we become at tracing outbreaks, the more food-based outbreaks we will find. This won?t be because farmers and manufacturers are being less careful. This will be because we more proficient at identifying the outbreaks and their cause more quickly and with a greater degree of certainty.

These improvements in tracing outbreaks emphasize one of the goals of my trip to share ideas and best practices on food safety protocols with my international colleagues. Allow me to explain.

In 1937, a drug called sulfanilamide was used to treat streptococcal infections. As a powder, it was safe and effective. But some consumers wanted to purchase the drug in a liquid form. A Tennessee-based company found that sulfanilamide would dissolve in diethylene glycol, and produce a liquid that looked, smelled, and tasted just fine.

Unfortunately, they didn´t also test to see how safe the new formulation was even though diethylene glycol, typically used in antifreeze, is highly toxic. In total, more than 100 people were killed by the diethylene glycol over the course of this disaster.

The very next year, Congress passed the 1938 Federal Food, Drug, and Cosmetic Act. That act remains the basis for how the Food and Drug Administration within our Department still regulates these products.Even so, just last year, more than 100 people in Panama died after consuming medicine that contained diethylene glycol rather than the glycerin shown on the label. And earlier this year, we discovered toothpaste that contained diethylene glycol in the United States. Fortunately, the product was pulled from our country´s shelves in time. All of this toothpaste was imported from China. This provoked one public health expert to ask me: Why are we still facing problems like diethylene glycol that we solved seventy years ago? Are we importing problems we solved years ago? Of course, diethylene glycol is an area where there is some disagreement among national regulators of how much is too much. But, regardless of scientific disagreement on the level of toxicity, we should all agree that the Panamanian situation should not ever be repeated.

In this light, it is heartening to see the continuing efforts of Chinese regulators to assess their industries and exports. We are assisting and encouraging them in these efforts that are addressing problems that arise in every large market. And China is one of the largest.

We are also happy to be engaged in serious talks with our Chinese counterparts and raising our levels of communication with them. Especially in this time of global trade, fast travel, and instantaneous communication, health officials from all across the world have a duty to improve how we work and share information with one another.

Fortunately, the United States and Japan enjoy a strong friendship that includes a long-standing, cooperative relationship on health and food issues. Officials from our government work closely with their counterparts at the Japanese Ministry of Health, Labor, and Welfare, the Ministry of Agriculture, Forestry and Fisheries, and the Food Safety Commission. We exchange information on regulatory problems, clinical reviews of products, and inspection reports.

We are working together on an international effort to bring drugs, biologics, and devices to the market more efficiently. And we are working with the Japanese Food Safety Commission on issues such as beef safety. For example, just last month we agreed to make our mutual beef inspections more efficient an agreement that I would like to thank my Japanese colleagues for. I am looking forward to continuing this fruitful and effective relationship on food safety issues.

I also hope that we can work together to improve food safety in Chinese exports. We in the U.S. have had a great deal of difficulty this year in exports from China, including the diethylene glycol I mentioned earlier, vegetable protein laced with melamine, and, most recently, seafood.

Two weeks ago, we issued a country-wide import alert on certain types of Chinese farm-raised, or aquacultured seafood contaminated with antimicrobial drugs. These import alerts are based on evidence of problems in food safety, and our criteria for getting out of an alert is for the importing company to show FDA that the food is safe to go into commerce in the United States. Each shipment of certain types of aquacultured seafood are held subject to FDA being satisfied that it does not contain the drugs of concern. In order for a company to avoid having their product held they have to take several steps. It would have to provide documentation that:

• One, at least five consecutive entries have been allowed to proceed following third-party, such as a government inspection authority, testing showing that the products do not contain the prohibited residues,
• Two, that an inspection of the processor was conducted in accordance with FDA´s seafood regulations, and
• Three, that the processor is in compliance with all Chinese government requirements for exporting aquacultured seafood.

We welcome actions taken by the Chinese. In recent weeks the Chinese government have taken specific actions in China and closed 180 food factories after inspectors found industrial chemicals being used in products in a variety of foods.

In return, our Secretary has become personally involved, and has established meetings with the Chinese. By the December Strategic Economic Dialogue in Beijing, we expect to have two memoranda of understanding, one on drugs and devices and one on food and feed. We are committed to high-level meetings from now until December in order to get this done. It is important to gain a mutual understanding of the way forward on resolving these problems. And despite any more issues that may crop up, we are committed to going ahead with our meetings. It is not unreasonable to want certifiably safe food from one?s trading partners.

These import problems are just one of the challenges we as food safety regulators face. Among the other challenges are:

• Increasing amounts of food imports;
• The increased globalization of the food supply;
• The increased complexity of food distribution;
• Changing consumer expectations of safety;
• New farming, manufacturing, and processing practices;
• Infrastructure that has not kept pace with the increasing complexities;
• The rising threat of terrorist attacks;
• The challenges in tracking food rapidly when problems do arise; and
• Changing consumer preferences in types of food.

In response to these challenges, we at the Department of Health and Human Services are working on a new food safety plan. We hope to issue it in the next six to eight weeks. It will be organized around the key principles of prevention, intervention, and response, and will take a farm-to-table approach that considers both domestic and imported food and feed and will integrate food safety with food defense. An important backdrop to this will be the need to find the resources to implement this plan. The following are some of the elements we expect to be in the plan, although there are other elements we are still formulating.

Prevention
Through the plan, we anticipate working with industry to develop food safety plans to identify vulnerabilities and how they can be mitigated or prevented.

Intervention
We plan to increase and enhance our risk-based inspection and sampling regime, and to implement new rapid-screening methods for identifying pathogens or contaminants in food. We want to be able to detect problems on the local level.

Response
We expect to increase our collaboration with foreign governments. We will also leverage the power of modern information technology to enable our laboratories to communicate rapidly with one another, handle surges in food testing, and more precisely track the origin and destination of intentionally and unintentionally contaminated foods, feed, and food ingredients.

In conclusion, never before has food been as safe, healthful, and inexpensive as we now enjoy it. By the same token, never before have we faced so many challenges when it comes to maintaining food safety. But with friends like I have found with my Japanese counterparts, I am confident that we will be able to prevent most possible food safety crises, respond effectively to any that do occur, and recover rapidly to restore consumer confidence in the safety and quality of the products we grow and manufacture. Thank you.