There is no doubt that managing imports is FDA’s most vexing problem in the new millennia.  At a meeting of the Council on Foreign Relations recently, Commissioner Hamburg said, “In recent years in this country, we have experienced events– some clearly deliberate and some unintended–with serious implications for health and safety, as well as for trade, commerce, and the economy: ranging from contaminated heparin (a blood thinning drug), counterfeit glucose monitor strips and surgical mesh, to melamine-tainted vegetable protein and dairy products, salmonella in peppers, to name just a few.  And, the world is poised for even further globalization.”  

Members of Congress were also concerned about imports as they considered the FDA Food Safety Modernization Act.  After melamine-tainted protein from China caused deaths and illnesses in dogs and cats all over the country, both the House and the Senate held hearings on the issues surrounding imports.  The same year, contaminated drugs and toothpaste caused numerous deaths and illnesses, both in the United States and other countries, and there have been recurrent outbreaks linked to fruits and vegetables imported into the United States.

Congress found that FDA’s oversight of imports was inadequate, relying heavily on a border inspection program that checked less than two percent of incoming foods at the border.  Unlike the food safety program at the U.S. Department of Agriculture (USDA), FDA lacked the authority or the ability to develop agreements with foreign countries to ensure safety.  Instead, importers could flood the U.S. with sometimes substandard products, because FDA lacked effective programs to prevent this from occurring.

Giving FDA new tools to manage imports was a driving force behind the enactment of the FSMA.  Several new tools, like inspection and certification, originate in the country of origin. Others, like the Foreign Supplier Verification Program, will hold U.S. importers accountable.  This article will review several of the import provisions, including inspections and certification.  Other components of the new import program will be reviewed in a later article.

The Mandate to Inspect Foreign Facilities Is Not Achievable Without Dramatically Increasing FDA Funding

While compromises were made in the frequency of domestic inspection to achieve passage of the food safety legislation, the mandates for inspection of foreign facilities only grew stronger, reflecting the strong desire among members of Congress to improve FDA’s oversight of imports.  The final bill contains a foreign facility inspection requirement that requires FDA to “inspect not fewer than 600 foreign facilities,” in the year following passage of the Act.  In 2009 (the last year with complete data), FDA conducted 210 foreign facility inspections, so while it is ambitious, the goal of 600 inspections by next January is not out of reach.

The “out-of-reach” clause follows, however.  The law goes on to require FDA to “at least” double foreign facility inspections in each of the next five years. For the mathematically inclined (or budget minded) here is mandate: FDA would conduct 1,200 foreign facility inspections in 2012; 2,400 in 2013; 4,800 in 2014; 9,600 in 2015; and 19,200 in 2016.  This is indeed an extraordinary – if not impossible – goal.  And with the current costs for foreign facility inspections estimated at just under $25,000 per inspection, this provision is unlikely to be achieved in the current budget climate. 

Unless Congress fully funds the new legislation, FDA will be hard pressed to meet the letter of this mandate.  But given the other tools in the bill, it can still meet the spirit of the requirement, perhaps with a more sustainable outcome, using other provisions in the Act. 

Increasing the Role of Foreign Governments

Under our laws, USDA is charged with the safety of all meat and poultry products sold in the U.S.   When it comes to imported products, USDA doesn’t inspect every foreign meat or poultry plant that imports to the U.S.  Instead that agency relies on foreign governments to conduct inspections and certify that the products coming from approved plants meet our safety standards.  USDA regularly audits the foreign inspection programs, and even visits some foreign plants, to provide oversight and assurance that the foreign programs are capable of enforcing our standards.  In addition, USDA checks incoming meat and poultry at the border, including intensive checks on nine percent, as a verification of the foreign program’s effectiveness. Foreign government export certification has long been in use in the meat sector for approving products from other countries.

While it is not possible to exactly replicate the USDA program at FDA, the new law gives FDA some useful tools that can be used to design a more effective system for policing imports.  Prompt implementation of these provisions is vital, especially in the absence of full funding for foreign inspections.  Section 305 of the Food Safety Modernization Act, called Building Capacity of Foreign Governments with Respect to Food Safety, calls on FDA to develop a plan including bilateral and multilateral “arrangements and agreements” that give responsibility to the exporting country to ensure the safety of food. The plan includes provisions for mutual recognition of inspection records, secure electronic data sharing and multilateral acceptance of laboratory methods and testing and detection techniques.  These are the essential elements of a system that would allow FDA to utilize inspections conducted by other countries to ensure the food shipped to the U.S. meets our standards.  

Certification of Imports

The bill also contains authority for FDA to require certification for different foods or all food coming from certain countries as a condition of admission to the U.S.  The legislation provides for a range of options for the certifications or assurances, including shipment-specific certificates, or a listing of approved facilities.  Certification will be dependent on a number of factors, including the known safety risks associated with the food or with the country, territory or region of its origin, or findings that the governmental programs are not adequate to ensure that the food meets U.S. standards.

Certification can be done by either a foreign national government or an entity that is accredited by the Secretary as a third party auditor.  More on third party certification will be discussed in a later article that will cover this topic and the Foreign Supplier Verification Program specifically.

Certification builds on the Prior Notice requirements for imports that were included in the 2002 Bioterrorism Act.  This provision requires all importers to notify FDA when they are shipping foods to the U.S., including what port of entry they will reach.  The new law also allows for the electronic submission of certifications, which could be done along with the prior notices. 

Envisioning a Future of Safer Imports 

Clearly, the safety of imported foods was a major driver both for Congress and for consumers in supporting the Food Safety Modernization Act.  While this portion of the new law is the most complex, it is built upon existing tools and concepts that have been used in other sectors fo
r many years.  While th
e intensive program for inspecting meat and poultry can’t be duplicated for FDA regulated foods, developing a group of trusted foreign governments to provide safety assurances is a new regulatory model that will improve upon FDA’s current practice in reviewing imports.

Last week, Commissioner Hamburg concluded her remarks at the Council on Foreign Relations with the following prescription for change:

“What I envision for the future is a public health safety net for consumers around the world that is created, supported, and maintained by a global alliance of regulators.  Some of the work for this is already underway and has been for several years, as regulators around the world have begun to collaborate.  But these efforts need to be taken to the next level.  We must ask ourselves how we can weave our various efforts into a coherent global system of oversight and safety.”

The effort to modernize the Food and Drug Administration’s (FDA) food safety program began in the late 1990s, following several very large outbreaks linked to raw oysters and imported berries. One outbreak involved berries tainted with Hepatitis A that were processed into a dessert served by the school lunch program, and underscored for consumers our vulnerability. That outbreak sickened over 250 consumers in five states, many of whom were school children.  

The first bill titled, “The Consumer Food Safety Act of 1998,” was filed in April of that year by Representative Frank Pallone, with 29 cosponsors, including both Representative Henry Waxman and Representative Rosa DeLauro. While it was a relatively simple bill compared to what finally passed Congress late last year, the legislation contained many of its essential elements, including both registration and process controls.  

In 2001, when Congress was grappling with the aftermath of the attack on the World Trade Center, concerns were raised by then-Secretary of Health and Human Services Tommy Thompson that our food supply could become a target. In fact, Thompson told Congress that he was most concerned about food as a target because inspections were not adequate. In response, Congress included a number of food provisions in the Bioterrorism Response Act of 2002, along with $100 million for improvements in inspection and counterterrorism programs. The agency was given authority to register domestic and foreign facilities, detain suspect food items, require prior notice on all imported food shipments, and also required “one up/one down” traceability.  

The FDA Food Safety Modernization Act significantly improves the registration provision and adds records access requirements that will be critical to preventing future outbreaks. While registration of food facilities doesn’t sound like a program that will give teeth to the new FDA Foods program, in fact, when coupled with suspension, it gives FDA a powerful new enforcement tool. To understand why, let’s back up and look at the history of the issue. 

Prior to 2002, FDA inspectors went into the field not knowing who exactly they should be inspecting. An Inspector General report once noted that FDA inspectors would refer to the Yellow Pages of the local phone book to find food plants in an area. The registration provision was adopted by Congress in order to give the agency a comprehensive list, with names, addresses and contact information for the food plants under its jurisdiction. While the 2002 Bioterrorism Act provided a first step for registration, its implementation by FDA was lackluster, and the database of food plants soon became out-of-date.

The initial registration provision under the Bioterrorism Act required registrants to “notify the Secretary in a timely manner of changes to [registration] information,” and required FDA to compile and maintain an up-to-date list of registered facilities. The new Act is more specific and requires food facilities to re-register between October and December of each even numbered year beginning in 2012.   

Authority to suspend the registration of a food facility is perhaps one of the most important enforcement tools the new law grants FDA. It allows the agency to effectively shut down a food facility that is associated with an outbreak of serious foodborne illness. A facility under suspension cannot import, export, or ship food until the business takes corrective action.  This provision becomes effective no later than 180 days after enactment of the law or earlier, if regulations are issued by FDA.   

The new authority artfully shifts the legal burden between industry and the agency to create incentives for businesses to comply with food safety requirements, while giving the agency real teeth to address non-compliance. To keep FDA from overreaching, the authority to suspend a facility resides with the Commissioner, and businesses are provided an opportunity to contest the suspension within two days of its issuance.  

The Commissioner can reinstate the registration when the evidence shows that adequate grounds do not exist for its continuation. Thus, a facility can submit a corrective action plan for FDA’s approval, and once approved, it can begin shipping product again. Suspension authority will be an effective enforcement tool if properly implemented. This provision gives FDA a significant new tool to go along with its broad responsibility to protect the public from unsafe food.   

Another treasure in the Act is the records access provisions. To gain access to corporate records under the 2002 Bioterrorism Act, FDA needed evidence of adulteration as well as a serious risk to health or life. It also required that record requests be in writing.  This delayed access to critical corporate records during outbreak investigations like one involving peanut butter and led the agency to ask Congress to relax the adulteration requirement. Additionally, the Bioterrorism Act only allowed FDA to access records for the food under investigation, preventing inspectors from following leads to other food lines within the same facility.  

The new law gives FDA clear authority to access a facility’s written food safety plan, together with monitoring and test results, during its regular inspections of the food plant. These records must be made available to “a duly authorized representative of the Secretary upon oral or written request.” This will greatly aid the FDA in improving the effectiveness of its inspections. No longer will the agency be doing a simple inspection, reflecting only its findings during the time inspectors are in the plant. Through a random review of records for different days or even weeks, FDA can transition to conducting inspections that reflect activities in the plant over a longer time frame. And during an investigation of an outbreak, the FDA Food Safety Modernization Act provides clear authority to expand an inquiry to other food lines within a facility, provided there is a reasonable belief the food processed on them is affected in the same way as the food under investigation. 

The FDA never realized the full benefit of new authorities to oversee and enforce food safety laws it gained in the 2002 Bioterrorism Act. The Food Safety Modernization Act takes lessons learned from a decade of outbreak investigations to give the agency tools for protecting public health. The agency will need to move forward rapidly on regulations to put muscle in and reap the full value of these tools. 

———-

U.S. Food and Drug Administration photo

With the signing of the historic FDA Food Safety Modernization Act, President Obama and Congress have adopted the first comprehensive overhaul of the food safety program at the Food and Drug Administration.  This overhaul will replace the reactive legal structure under which FDA responded to problems–adulterated or misbranded foods already on the market–with a preventive mandate.  The new structure gives FDA much greater oversight over the food industry, including requiring facilities to register every two years, to develop new food safety plans, and to provide the agency with test results.  The bill also gives greater incentives for the industry and importers to implement strong food safety programs, so that one bad actor is less likely to have an adverse impact on an entire segment of the industry, which is what happened to spinach growers a few years ago. 

The new program will take several years to roll out; even longer to become fully effective.  In a series of articles, CSPI will give FDA-watchers a timeline for implementation of the new law, with emphasis on speed and priorities, highlighting things with the greatest consumer and industry impacts. 

In this first installment, we will focus on several little known provisions that complement the mandatory recall provision. This has been widely touted as one of the biggest victories for consumers, though it may see little use if the food industry is careful and compliant with FDA’s requests for voluntary recalls.   

Mandatory recall is one of the few provisions of the Modernization Act that goes into effect immediately. The provision will likely reduce the length of time that FDA spends in negotiating voluntary recalls with the companies involved.  And delays in recalls can have serious consequences.  Consumers are often the last to know when there is a problem with the food supply, and too often they are not alerted until the food is already being sold, which means that it could already be on their shelves or in their family’s dinner. 

Second, the legislation requires FDA to develop by this coming April a consumer-friendly website to help identify food that is subject to a recall.  That website should provide searchable, product-specific information for consumers, as well as information about the status of the recall (ongoing, completed, etc).  The current FDA recall search engine is cumbersome and not useful to consumers looking for brand names or other key terms. 

Third, in a two-step process, the legislation requires grocery stores to provide notices about recalls to customers when they are shopping.  FDA will first identify for grocery stores “conspicuous locations” for posting such notices, and in 18 months, food companies will be required to give grocery stores notices to post.  Currently consumers receive little or no in-store messaging, which leaves many standing in the grocery store wondering about a current recall and whether something they purchased last week was involved.  The Secretary’s list of conspicuous locations for notice will include targeted recall information at the point of purchase, and may extend to other types of notification, such as via text, phone or email of a recall.   

While the overall goal of the FDA Food Safety Modernization Act is to prevent food from becoming contaminated in the first place, these provisions will provide some immediate consumer benefits before the other components come on-line. 

Next installment —  New teeth in the law:  Registration, suspension and records access