JUNE 25, 2004
Good morning, Chairman Bilirakis and Members of the Subcommittee. I am Dr. Lester M. Crawford, Acting Commissioner of the Food and Drug Administration (FDA or the Agency), which is part of the Department of Health and Human Services (HHS or the Department). I am pleased to be here today with my colleague, Ms. Cathy Sauceda from Customs and Border Protection (CBP) in the Department of Homeland Security (DHS). Thank you for this opportunity to discuss FDA’s actions to implement the food safety provisions in Title III, Subtitle A - Protection of Food Supply - in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). I wish to thank the Members of this Subcommittee for your leadership in enacting this landmark legislation. This legislation represents the most fundamental enhancement to our food safety authorities in many years. As you know, it provided us with significant new tools to protect the nation’s food supply against the threat of intentional contamination and other food-related emergencies. Implementing these new authorities has been a top priority for FDA.
In my testimony today, I will first provide some background on HHS’ food safety responsibilities. Then, I will describe the many actions FDA has taken to implement the food safety provisions in the Bioterrorism Act.
HHS’ Food Safety Responsibilities
FDA is the Federal agency that regulates 80 percent of the nation’s food supply-everything we eat except for meat, poultry, and certain egg products, which are regulated by our partners at the United States Department of Agriculture (USDA). FDA’s responsibility extends to live food animals and animal feed. FDA is also responsible for ensuring that human drugs, human biological products, medical devices, and radiological products as well as veterinary drugs are safe and effective, and that cosmetics are safe. In addition, FDA is responsible for assuring that the health consequences of foods and medicines are accurately and honestly represented to the public, so that they can be used as effectively as possible to protect and improve the public health.
While FDA has the lead responsibility within HHS for ensuring the safety of food products, the Centers for Disease Control and Prevention (CDC) within HHS has an important complementary and non-regulatory public health role. As the lead Federal agency for conducting disease surveillance, CDC monitors the occurrence of illness in the U.S. attributable to the entire food supply. The disease surveillance systems coordinated by CDC, in which FDA participates, provide an essential early-information network to detect dangers in the food supply and to reduce foodborne illness. In addition, these systems can be used to indicate new or changing patterns of foodborne illness. Because CDC detects and investigates outbreaks of foodborne illness through its networks, CDC is able to alert FDA and USDA about implicated food products associated with an outbreak and works closely with the agencies to take protective public health action. In keeping with its agency mission, CDC also identifies, evaluates, and offers expert scientific opinion on the effectiveness of foodborne disease prevention strategies.
FDA contributes to the Foodborne Diseases Active Surveillance Network (FoodNet), the principal foodborne disease component of CDC’s Emerging Infections Program (EIP). FoodNet is a collaborative activity of CDC, FDA, the Food Safety and Inspection Service of USDA, and ten EIP sites, (California, Colorado, Connecticut, Georgia, New York, Maryland, Minnesota, Oregon, Tennessee, and New Mexico). Through this active surveillance system, these sites actively seek out information on foodborne illnesses identified by clinical laboratories, collect information from patients about their illnesses, and conduct investigations to determine which foods are linked to specific pathogens. This surveillance system provides important information about changes over time in the burden of foodborne diseases. These data help public health and food safety agencies evaluate the effectiveness of current food safety initiatives and develop future food safety activities. FDA provides both monetary support and technical expertise to the program.
In addition, just as FDA works with Federal, state, and local food safety counterparts, CDC works extensively with Federal, state, and local health departments to build their epidemiology, laboratory, and environmental health expertise in foodborne disease surveillance and outbreak response. All of these collaborations draw on and apply the unique expertise within HHS to address significant and emerging challenges to our food supply.
Implementation of Subtitle A of Title III of the Bioterrorism Act
Subtitle A of Title III of the Bioterrorism Act provides the Secretary of Health and Human Services with new authorities to protect the nation’s food supply against the threat of intentional contamination and other food-related emergencies. FDA is responsible for implementing these provisions. These new authorities improve our ability to act quickly in responding to a threatened or actual terrorist attack, as well as other food-related emergencies. Since this legislation was signed into law just over two years ago, FDA has been working hard to implement this law effectively and efficiently. Throughout this process, FDA has enjoyed close cooperation from our colleagues at CBP.
Registration of Food Facilities
Section 305 of the Bioterrorism Act requires registration of foreign and domestic food facilities that manufacture, process, pack, or hold food for consumption by humans or animals in the U.S.. Thanks to this provision, FDA will have, for the first time, a roster of foreign and domestic food facilities that provide food for American consumers. In the event of a potential or actual terrorist incident or an outbreak of foodborne illness, the registration information will help FDA to quickly identify, locate, and notify the facilities that may be affected.
On October 10, 2003, FDA and CBP jointly published an interim final regulation to implement the registration requirement. This regulation became effective on December 12, 2003. We have provided two public comment periods that allowed a total of 105 days for interested parties to comment on certain provisions in the interim final rule. We currently intend to publish the final rule in the spring of 2005 after considering all the timely comments we have received.
FDA’s electronic registration system became operational on October 16, 2003, which allowed facilities almost two months to register with FDA before the regulation became effective. We worked hard to develop an electronic system that is easy to use. The system is available 24 hours a day, seven days a week, to anyone with access to the Internet. We are also providing technical assistance to persons who need help with the registration process. The electronic system will provide the facility with its registration number nearly instantaneously upon successful completion of the registration process. While facilities are not required to register electronically, FDA strongly encourages facilities to use the electronic system to register. Although it will take longer for facilities that register by mail to receive their registration numbers, registration by paper also is relatively easy to accomplish. As of June 24, 2004, 208,277 facilities have registered. This includes 98,896 domestic and 109,381 foreign facilities.
Our goal has been to phase-in enforcement of the registration rule in a manner that ensures a smooth transition with minimal effect on commerce. Last December, FDA published two Compliance Policy Guides that stated our intention to focus initially on educating industry about how to comply with the new registration requirement. For domestic facilities, FDA expects it typically would discover a registration violation during a routine inspection and would enforce the registration provision as appropriate in each situation. Circumstances that could merit regulatory action include a continuing failure to register or a threat to the food supply associated with food from an unregistered facility. In addition, FDA may consider the failure to register as an additional charge in an enforcement action that is based on other statutory violations. Regarding foreign facilities, Section 305 states that food from a foreign facility that is required to register, but has not done so, must be held at the port of entry until the facility is registered. Accordingly, FDA is enforcing the registration requirement for manufacturers and shippers through the prior notice interim final rule, which I will discuss in a moment. In most cases, the failure of a facility, domestic or foreign, to be registered is a violation that can be readily corrected. As mentioned above, electronic registration may be accomplished with minimal effort. Thus, the ability to remedy a failure to register is relatively straightforward for both domestic and foreign facilities.
Prior Notice of Imported Food Shipments
Section 307 of the Bioterrorism Act requires the submission to FDA of prior notice of food, including animal feed, that is imported or offered for import into the U.S. This advance information enables FDA, working closely with CBP, to more effectively target inspections at the border to ensure the safety of imported foods before they move into the U.S. On October 10, 2003, FDA and CBP jointly published an interim final rule to implement this provision. This regulation became effective on December 12, 2003. We recently reopened and extended the public comment period on the Prior Notice Interim Final Rule for an additional 60 days. Comments will be accepted through July 13, 2004. Interested parties will have had a total of 165 days to comment on the provisions. We currently intend to publish the final rule in March 2005. Since December 2003, we have been receiving approximately 150,000 notifications each week about articles of food being imported or offered for import into the U.S.
FDA and CBP worked collaboratively to ensure the new regulations promote a coordinated strategy for border protection. Thanks to this collaboration, prior notice may be submitted electronically either by licensed brokers using CBP’s Automated Commercial System (ACS) or by anyone using FDA’s Prior Notice System Interface. FDA’s and CBP’s systems are linked together. Regardless of which system a submitter uses to transmit the prior notice to FDA, the notices submitted are reviewed in the same timeframes and in accordance with the same procedures.
Based on FDA’s current assessment, the timeframes in the interim final rule for submitting prior notice are the least amount of time that FDA needs to meet our statutory responsibility to receive, review, and respond to the prior notice submission. They take into account different modes of transportation. The regulations require prior notice at least two hours in advance of arrival by land via road, at least four hours in advance of arrival by air or land via rail, and at least eight hours in advance of arrival by water. The staggered prior notice submission timeframes allow FDA reviewers to expedite their review of shipments with shorter transport times without negatively affecting the review times of shipments with longer transport times.
FDA and CBP are committed to further increasing integration of our agencies’ respective advance notice requirements with a goal of: (1) achieving a uniform, integrated system; (2) building on current operational procedures; and (3) implementing the law with minimal disruption to current entry practices. Toward this goal, on April 4, 2004, FDA and CBP issued a plan, “Joint FDA-CBP Plan for Increasing Integration and Assessing the Coordination of Prior Notice Timeframes.” The plan describes the process by which FDA and CBP intend to increase integration and examine whether we could amend the timeframe requirements in FDA’s prior notice interim final rule to be the same as those in CBP’s advance electronic information rule. The plan was issued with an initial 30-day comment period, which FDA has extended for an additional 60-day period that ends July 13, 2004.
Although the interim final rules became effective December 12, 2003, FDA and CBP issued a Compliance Policy Guide that explains our intention to focus initially on educating affected firms and individuals about the new prior notice requirement while gradually phasing in enforcement of the prior notice interim final rule. This phase-in period will end August 12, 2004, at which time full enforcement will begin.
While we cannot physically inspect every shipment, it is important to note that every shipment that contains FDA-regulated products that is entered for consumption or warehouse storage through CBP’s ACS is electronically reviewed by FDA’s Operational and Administrative System for Import Support to determine if the shipment meets identified criteria for physical examination or sampling and analysis or warrants other review by FDA personnel. This electronic screening allows FDA to concentrate its limited inspection resources on high-risk shipments while allowing low-risk shipments to proceed into commerce.
With the new prior notice requirement, specific information mandated by the Bioterrorism Act must be submitted to FDA before the imported food arrives in the U.S. This not only allows the electronic system to review and screen the shipments for potential serious threats to health (intentional or otherwise) before food arrives in the U.S., but it also allows FDA staff to review prior notices of those products flagged by the systems as presenting the most significant risk and determine whether the shipment should be held for further investigation. FDA worked very closely with CBP in developing this screening system.
In addition, FDA has been actively working with the analysts at CBP’s National Targeting Center to utilize their Automated Targeting System as an additional tool to enhance the Agency’s ability to focus attention on those imported foods that may pose a serious threat to public health. We anticipate that the use of FDA’s and CBP’s screening systems will enable both agencies to effectively target shipments posing the greatest risk in order to further focus our border inspection efforts.
In developing the interim final rules to implement the registration and prior notice requirements, FDA carefully considered all the comments received during the public comment periods and strived to develop provisions that were consistent with the Bioterrorism Act and that achieve its objectives while minimizing the impact on trade to the extent feasible. FDA and CBP have conducted extensive domestic and foreign outreach to explain the rules to consumers and the food industry. FDA has been commended by numerous parties throughout the world for what many describe as an unprecedented level of outreach.
Section 303 of the Bioterrorism Act gives FDA new authority to administratively detain any article of food for which the Agency has credible evidence or information that the food presents a threat of serious adverse health consequences or death to humans or animals. This authority is self-executing and provides an added measure to ensure the safety of the nation’s food supply. Section 303 also requires FDA to provide by regulation procedures for instituting on an expedited basis certain enforcement actions against perishable foods subject to a detention order. On June 4, 2004, FDA published a final rule to implement this section. The rule includes procedures for detaining an article of food, expedited procedures for detaining perishable foods, and the process for appealing a detention order.
Maintenance and Inspection of Records for Foods
Section 306 of the Bioterrorism Act authorizes FDA to have access to certain records when the Agency has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. It authorizes the Secretary to publish regulations to establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food. On May 9, 2003, FDA published a proposed rule to implement this section. We have received approximately 200 comment letters that we have carefully considered. We intend to issue a final rule in the near future. When finalized, the recordkeeping regulation will enhance FDA’s ability to track and contain foods that pose a threat of serious adverse health consequences or death to American consumers from accidental or deliberate contamination of food.
Authority to Commission Other Federal Officials to Conduct Inspections
Section 314 of the Bioterrorism Act authorizes the Secretary to commission other Federal officers and employees to conduct examinations and investigations. Pursuant to this new authority, FDA and CBP have signed a Memorandum of Understanding to commission CBP officers to conduct examinations on FDA’s behalf at ports where FDA may not currently have staff or to augment FDA staff in the enforcement of FDA’s prior notice requirements. This unprecedented FDA-CBP collaboration significantly strengthens our ability to secure the border while ensuring the movement of legitimate trade. In accordance with this new authority, FDA has already commissioned over 8,150 CBP officers. The Agency will continue to explore use of this authority with other agencies as a tool to further improve efficiencies.
Authority to Mark Articles Refused Admission into U.S.
Section 308 authorizes the Secretary to require the marking of refused food (other than food required to be destroyed). This provision is intended to prevent unsafe foods that have been refused entry into the U.S. from entering U.S. markets via the practice of “port shopping.” This is a practice by which importers send goods that have been refused entry at one port to a different port in the hope of obtaining admission for the refused goods. Obviously, this practice puts American consumers at risk. Before passage of the Bioterrorism Act, FDA had published a proposed rule to require the marking of refused food. This proposal was withdrawn in light of the new and additional statutory requirements. We are considering a new rulemaking to implement Section 308.
Protection Against Adulteration of Food
Section 302 of the Bioterrorism Act contains numerous provisions intended to increase protection against adulteration of food. One of the requirements in this section is for the Secretary to give high priority to increasing the number of inspections of food offered for import. Thanks to a fiscal year 2002 supplemental appropriation, FDA received counterterrorism funds that enabled us to hire additional staff, most of whom were hired to address food safety issues, primarily at the border. With these additional employees, we have more than doubled the number of ports that have an FDA presence from 40 to 90 ports. We have increased by more than six-fold the number of food examinations at the border.
In compliance with another requirement in this section, on October 16, 2003, we submitted a report to Congress, “Testing for Rapid Detection of Adulteration of Food,” about the research that is underway to develop tests and sampling methodologies to rapidly detect adulterated food. FDA has commenced more than 90 different research projects to develop tests and sampling methodologies to increase the detection of adulterated food. A number of the research projects are designed specifically to develop tests suitable for inspections of foods at ports of entry. For example, commercially available test kits are currently being analyzed for a variety of food matrices to evaluate their suitability for use in the field at ports of entry. We are in the process of preparing the second annual report on our research activities.
Also pursuant to a requirement in Section 302, HHS provided a report to Congress on assessments of the threat of the intentional adulteration of food.
In conclusion, thanks to the new authorities provided by the Bioterrorism Act along with HHS’ other food safety activities, the nation’s food safety system is stronger than ever before. As you might imagine, it has been a tremendous undertaking for FDA to implement the provisions in the Bioterrorism Act in such a short period of time. We are proud of our accomplishments and will continue our efforts to implement the Bioterrorism Act in an efficient and effective manner. We are thankful to Congress for these new authorities that will serve to bolster the safety of our food supply.
In addition to the new authorities provided to us in the Bioterrorism Act, I would like to briefly mention some other activities in which FDA has been involved to ensure the safety and security of our nation’s food supply. We have enhanced coordination with our partners in Federal, state, and local governments, academia, and industry. To minimize the risk that food will be subject to tampering or other malicious actions, we have issued guidance for the food industry on the security measures it may take. We are also working with DHS to carry out our Sector-Specific Agency responsibilities under Homeland Security Presidential Directive 7/Critical Infrastructure Identification, Prioritization, and Protection for food other than meat, poultry, and egg products. FDA has embarked on an ambitious research agenda throughout the Agency to address potential terrorist threats. To increase laboratory surge capacity, FDA has worked closely with CDC and USDA to expand the Laboratory Response Network by establishing the Food Emergency Response Network. Through this aggressive and collaborative program, FDA has made significant progress in strengthening the safety and security of the nation’s food supply.
Thank you for this opportunity to discuss our efforts to implement the food safety provisions of the Bioterrorism Act. I look forward to continuing to work with you and would be pleased to respond to any questions.
Last Revised: July 2, 2004