Curtain goes up on DeLauro legislation: Food Safety Modernization Act

From the office of Rep. Rosa DeLauro:


Congresswoman Rosa L. DeLauro (Conn. -3) joined by Gabrielle Meunier, Mother of Salmonella Typhimurium victim; Jeff Almer, whose mother died as a result of salmonella poisoning and a S.T.O.P.-Safe Tables Our Priority member/victim advocate; and Caroline Smith DeWaal, Food Safety Director, Center for Science in the Public Interest, at a press conference on the peanut butter salmonella outbreak. DeLauro also introduced food safety reform legislation, the Food Safety Modernization Act, which would fix systemic problems in our food safety system by modernizing our food safety laws and establishing a separate Food Safety Administration headed by an expert in food safety within the Department of Health and Human Services.

The legislation enjoys the support of the Center for Foodborne Illness Research and Prevention; Center for Science in the Public Interest; Consumer Federation of America; Consumers Union; Food & Water Watch; The Pew Charitable Trusts; Safe Tables Our Priority; Trust for America’s Health (please click on the organization to view their endorsement).

“This salmonella outbreak represents the full-scale breakdown of a patchwork food safety system. And it should act as the final wake up call,” said DeLauro. “That is why, today, I am introducing the Food Safety Modernization Act to separate food safety regulation from drug and device approvals and to restore the balance that has long been missing at Health and Human Service.

Under the proposal, FDA would be split into an agency responsible for food safety (the Food Safety Administration) and another responsible for regulation of drugs and devices. This move creates an agency solely focused on protecting the public through better regulation of the food supply. The Food Safety Modernization Act would establish a farm-to-fork system for protecting foods that are currently regulated by FDA, which has jurisdiction over 80 percent of the food supply.

DeLauro also focused on the urgency for action, “With every recall the American people grow more concerned and the momentum for reform grows. For eight long years, our food safety system has been crippled by disinvestment, mismanagement, and a failure to meet its most basic regulatory responsibilities. True reform is going to require strong leadership from our president. I am confident, at last, that we have a government that understands its obligation to its citizens.”

In addition to the structural change, The Food Safety Modernization Act also updates food laws and would change the focus to preventing disease-causing contamination. The bill would utilize a modern approach to food safety by requiring food producers to: control health hazards in their operations; meet federal standards for preventing or removing contaminants and pathogens from food; and be subject to regular inspections by federal officials based on the risk profile of the products they produce. When prevention fails, the Food Safety Administrator would have sufficient enforcement authority, including authority to order recalls, seize unsafe food before it enters the market, and impose fines on companies that refuse to abide by the law.

“Together, we can act now to make it happen, transform the FDA, and begin a new movement that puts public health first,” DeLauro concluded. “At last, we can bring our current food safety system out of the past. It is about time.”

DeLauro - optimistic for change at FDA

From the office of Rep. Rosa DeLauro:

Washington, D.C. – Congresswoman Rosa L. DeLauro (Conn.-3) issued the following statement on a new report released by the Government Accountability Office (GAO), which continues to include federal oversight of food safety as “high risk” to the economy and public health and safety. The GAO has conducted the high risk series since 1990.

“In watching how the Food and Drug Administration has handled the recent salmonella outbreaks affecting peanut butter and peppers, it is no surprise that federal oversight of food safety continues to be included in the Government Accountability Office high-risk series.

“This report notes that ‘this fragmented federal oversight of food safety has caused inconsistent oversight, ineffective coordination, and inefficient use of resources.” As a result, it further substantiates the need to overhaul not only the structure of our food safety system, but also modernize our food safety laws and regulations – an avenue I will pursue when I reintroduce the Food Safety Modernization Act in the next few weeks.

“While food safety remains part of the high-risk series, I am optimistic, that working with the newly-installed Obama Administration, we can bring change to our food safety system. Together we will refocus our food safety system to once again prioritize public health.”

DeLauro will soon reintroduce, the Food Safety Modernization Act, which would not only modernize our food safety laws, but also restructure food safety efforts by splitting the FDA into two separate agencies – dividing the food safety responsibilities from the drug and device safety responsibilities.

DeLauro - salmonella should have jurisdiction of one agency

From the office of Rep. Rosa DeLauro:

Congresswoman Rosa L. DeLauro (Conn. -3) issued the following statement on the on-going investigation into a salmonella outbreak that has infected at least 388 people in 42 states since 3 September 2008. Because the source of the outbreak is unknown, it is unclear whether this outbreak falls under the jurisdiction of the Food and Drug Administration or the Department of Agriculture.

DeLauro will soon reintroduce, the Food Safety Modernization Act, which would split the FDA into two separate agencies – dividing the food safety responsibilities from the drug and device safety responsibilities.

“A frightening aspect of this salmonella outbreak is the jurisdictional limbo that has been created since the cause of the outbreak has yet to be determined. The involvement of both the Food and Drug Administration and the U.S. Department of Agriculture in this investigation is limited right now until the source, and jurisdiction, can be established.

“This jurisdictional limbo is potentially dangerous because it delays the investigation into an outbreak that began over four months ago, and any delays in these critical investigations can sicken more people.

“The scope of this recent salmonella outbreak is a reminder that reforming and modernizing our food safety laws should be a top priority in the new Congress. I look forward to working with my colleagues and the Obama Administration on achieving that goal.”

DeLauro - "so called reforms" of FDA

From the office of Rep. Rosa DeLauro, sliding across the inbox today:

Congresswoman Rosa L. DeLauro (CT-3) issued the following statement following the release of a report by the Food and Drug Administration on its implementation of the Food Protection Plan, which was announced in November 2007.

“While the FDA will contend that they are making progress on food safety, it is progress based on an outdated system and an outdated regulatory structure. Unfortunately, the recent situation involving melamine in baby formula demonstrates that significant work remains for the FDA.

“The long-term viability of these so-called reforms remains in doubt given that food safety will constantly be competing for attention and resources with medical product safety under the FDA.

“In order to achieve any real progress in protecting our food supply, the food safety responsibilities under the current FDA need to be detached and made a separate agency under the Department of Health and Human Services. It is only through this restructuring that the regulatory system will be provided with the expertise, management and resources focused exclusively on food safety to make legitimate reforms possible.”

Testimony - Jeff Levi

Here is the link to the testimony by Jeffrey Levi, Executive Director of Trust for America’s Health (TFAH), speaking at the House agriculture appropriations subcommittee hearing on the salmonella outbreak yesterday. Not much new here; the FDA is archaic, underfunded and slow to develop a strategic vision matched with resource requests. Here is one excerpt:


Our report finds that Congress has not provided the Food and Drug Administration with a modern, public health mandate to prevent foodborne illness; has not updated the agency’s legal tools to meet the challenges of a high-tech, globalized food supply; nor has it provided the funding stream necessary to carry out research and inspection. At the same time, the agency has not adequately expressed its resource needs as it moves forward with its Food Protection Plan.

Acheson - Ready to mandate traceability?

Go here for the testimony of David Acheson at the House agriculture appropriations subcommittee. His testimony has generated coverage from Reuters here, indicating that Rep. Rosa DeLauro was pressing Acheson on the issue of government mandated traceability. Here is what Acheson said in his testimony about traceability. From David Acheson's statement:


I would now like to describe some of our recent activities to improve product tracing of fresh produce. The ability to trace pathways of any food, including tomatoes and other fresh produce, through every point in the supply chain is crucial for limiting foodborne illness in an outbreak, for preventing future outbreaks, and for reducing the impact on the segments of the industry whose products were not associated with the illnesses. The pathways that fresh produce travels from field to consumer have become increasingly complex, with items sometimes changing hands many times in the supply chain.

FDA formed an internal multi-Center group to meet with external entities (such as industry, consumers, and Federal, State, local, and foreign governments) to better understand the universe of tracing systems that are currently in use or being developed. FDA has reached out to various organizations, including trade associations and consumer groups, to gain a better understanding of best industry practices for product tracing, including the use of electronic and other technologies that speed and enhance the tracing process and the use of systems that connect all the links in the produce supply chain. FDA is using this information to develop recommendations for the fresh produce industry to use to improve its internal tracing systems. We plan to hold two public meetings in the fall to further the exchange of information on available technology and best practices for enhanced product tracing.

We have been working extensively with States and the fresh produce industry to encourage incorporation of tracing procedures and technology. For example, FDA assisted the Florida Tomato Commission and the University of FloridaInstitute of Food and Agricultural Sciences in the development of Florida’s Tomato Best Practices Manual. This Manual incorporates Good Agricultural Practices, Good Handling Practices, and product tracing recommendations for industry. The Manual formed the basis of the State of Florida’s tomato safety rule.

Another recent example is the final guidance for fresh-cut produce, which FDA issued this year. The guidance includes a section on product tracing and a section on documentation and record keeping. FDA also provided industry its “Guide to Traceback of Fresh Fruits and Vegetables Implicated in Epidemiological Investigations,” which is used by our investigators.

Last month, FDA issued a Request for Applications to provide funding to six States to establish Food Protection Rapid Response Teams to investigate multi-state outbreaks of foodborne illness. Enhancing the infrastructure of State food protection programs and strengthening joint Federal/State responsiveness at a local level are an important way to protect consumers by expediting product tracing investigations.

We also are planning to host a workshop at the University of Maryland during 2009 to review the status of a product tracing study on tomatoes and dairy that the European Union is currently conducting. This review will allow FDA to incorporate relevant findings from the EU study in our decision making. The EU began its four-year product tracing study in 2007 with the goal of ensuring total product tracing of food and feed along the whole chain from production to consumption. As part of this effort, the EU is developing, testing, and evaluating two full pilot product tracing systems, including one for the tomato food chain. We will continue to work with Federal, State, local and international food safety partners and with industry to conduct research, develop educational outreach materials, and initiate other commodity-, practice-, or region-specific programs to enhance the safety of fresh produce.

DeLauro - Break up the FDA

Today's food safety hearing opens with a bang. Here is the press release from the office of Rep. Rosa DeLauro detailing her opening statement. Read on...

Washington, D.C. – Congresswoman Rosa L. DeLauro (CT-3), chairwoman of the House Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee, delivered the following opening statement during a subcommittee oversight hearing on food safety that examined the problems highlighted during the recent salmonella outbreak and analyzed the critical components that are necessary for an effective food safety system.

During the hearing, DeLauro called for the FDA to be split into two separate agencies – dividing the food safety responsibilities from the drug and device safety responsibilities – and announced that she plans to introduce legislation next week, the Food Safety Modernization Act, that would accomplish this goal. While the long-term solution should be the creation of an independent, single food safety agency, this interim step would establish the Food Safety Administration within the Department of Health and Human Services that would have responsibility for all food safety issues currently administered by FDA. The legislation also will address other critical components of an effective food safety system including traceability, process controls, inspections, and ensuring the safety of imported foods.

Below is the text of DeLauro’s opening statement (as prepared for delivery).

We are here today to examine the salmonella outbreak this year that sickened over 1,400 people across 43 states and the District of Columbia – providing yet further evidence that our current food safety system is broken. It fails to protect consumers from unsafe foods and has the capacity to harm producers and growers in the process.

Our goal this afternoon is not simply to rehash this summer’s Salmonella outbreak. We are looking for bigger answers – searching for the solutions that will allow us to avoid these breakdowns in the future.

Certainly, in recent months food safety has taken center stage like never before. I am encouraged to see many issues that have been on the back burner for years – such as traceability – finally make their way into the mainstream discussion.

Now, it is time to put those words into action. 76 million foodborne illnesses, 325,000 hospitalizations and 5,000 deaths occur each year because of unsafe foods. And their cost to our nation is great – $7 billion in economic losses annually.

A major outbreak’s impact lasts long after it has faded from the headlines. As Mr. Farr can attest, the spinach market still has not fully recovered from an E. coli outbreak two years ago. According to the California Department of Agriculture, spinach production in California is still approximately $60 million less than pre-outbreak levels.

And as Mr. Murray will discuss – and our colleagues from Florida and Georgia have seen this first-hand – the tomato industry now faces a similar struggle. FDA first implicated tomatoes as the potential source of this summer’s salmonella outbreak, before turning its attention to jalapeno and Serrano peppers. Now the FDA may be looking into the possibility that tomatoes caused the earlier infections and peppers were the source behind later cases of the outbreak.

What is most distressing, however, is that no one seemed to be in charge – no one is in charge. During a complex and constantly evolving food safety crisis, the public and the industry both looked to their government for guidance and assurance that the situation was under control. But with little leadership, the situation quickly got out of control and continued to threaten public health and consumer confidence for weeks.

With 15 different agencies responsible for administering 30 laws related to food safety, it is no wonder investigations are mismanaged, shortsighted, and stalled. To address these failings and prevent dangerous products from slipping through the cracks, I believe we need to create a single food agency.

As an incremental step toward that goal, next week I plan to introduce the Food Safety Modernization Act, creating a Food Safety Administration within the Department of Health and Human Services with responsibility for all food safety issues currently administered by FDA. While, maintaining the USDA’s independent, food safety responsibilities, the new law would establish a Commissioner of Food Safety and Nutrition Policy – a presidential appointment requiring advice and consent of the Senate – to lead the new Food Safety Administration.

It is time to create a streamlined federal agency focused exclusively on protecting our food supply. Instead of having to balance food safety with competing priorities, it would allow food safety experts and researchers to do their jobs.

To be sure, our ultimate goal must remain an independent, single food agency, but I believe that in order to begin fixing our broken system, we must act now and this is the best way forward. The Food Safety Modernization Act will address traceability, process controls, inspections, and imports. We have further to go, to be sure, but with this first step, we will have come a great distance – allowing food safety experts and researchers to do their jobs, provide increased oversight and fulfill their regulatory responsibility.

A recent GAO report outlined the critical components that are necessary for an effective food safety system, including traceback procedures, cooperative arrangements between public health officials, and mandatory recall authority. I believe that these measures could be implemented most effectively under a system governed by a singe food safety agency. While there has been movement on food safety reform, we are not there yet.

Finally, it is worth noting that the GAO report highlighted other nations’ effective “farm-to-fork” approach to food safety. If we want to see similar success and restore our own country’s gold standard for food safety we must also focus on the entire food supply chain, place primary responsibility for food safety on producers, and ensure that food imports meet equivalent safety standards.

We know what is at stake – today we will hear about the consequences of our inaction – and the opportunity to embrace tangible reforms. It is time to show we have learned these hard lessons and make public health our top priority. We cannot afford to wait any longer.

Thank you.

Another Chinese food scandal

Defective Chinese baby formula hasn't hit the shores of America, but China' s lax food safety system is getting another workover by Rep. Rosa DeLauro:

Washington, D.C. – Congresswoman Rosa L. DeLauro (CT-3), chairwoman of the Agriculture – Food and Drug Administration Appropriations Subcommittee, issued the following statement about the announcement that a second baby in China had died in connection with melamine-tainted baby formula. In recent months over 1,200 babies have been sickened – more than 340 infants remain hospitalized, including 53 in serious condition.

“With the death of another Chinese baby from melamine-tainted baby formula, it is clear that the Chinese have a non-functioning regulatory system for ensuring the safety of foods and drugs. It was almost 18 months ago that the Chinese government pledged to improve oversight of its food safety regulations following the discovery that China was the source of melamine-tainted pet food. It now appears that this was an empty promise.

DeLauro - FDA hopelessly out of touch

Just slid across the inbox, from Rep. Rosa DeLauro:

New Haven, CT – Congresswoman Rosa L. DeLauro (CT-3), chairwoman of the Agriculture, Food and Drug Administration Appropriations Subcommittee, issued the following statement amid reports that jalapenos, which have been connected to the recent Salmonella outbreak that sickened 1,400 people, have been a source of repeated problems. In fact peppers and chilies were the top Mexican crop rejected by border inspectors for the last year.

These recent revelations regarding the salmonella investigation will be raised during a food safety oversight hearing to be held by the Agriculture –FDA Appropriations Subcommittee when Congress returns in September. The hearing will also analyze the critical components that are necessary for an effective food safety system.

“Through the course of this salmonella outbreak and subsequent investigation, we continue to witness the systemic problems within the FDA that causes the agency to ignore crucial evidence that could have minimized or prevented this particular outbreak. We have seen the same issues arise in previous food-borne illness outbreaks, and it demonstrates that the FDA lacks the agility to anticipate and adeptly respond to incidents, and it fails to follow-through when presented with critical findings.

“Based on this recent information involving pepper shipments from Mexico being rejected at the border, the agency's leadership appears to lack accountability and is hopelessly out-of-touch. Despite the pepper shipments being repeatedly sent back because of filth and disease and dried peppers being included in a 2006 list of high-risk foods deserving greater attention, the FDA just last week indicated that peppers are not typically problematic. Since the start of 2008, ten percent of the 88 shipments turned away were contaminated with salmonella and eight percent of the 158 intercepted shipments had salmonella. Instead of acting on this information, the FDA chose to ignore it.

“This outbreak reinforces why we must urgently reform our food safety system to include traceback procedures, cooperative arrangements between public health officials, and mandatory recall authority, with the ultimate goal of creating a single food safety agency.”