On November 6, 2007, the Interagency Working Group on Import Safety (Working Group), established by Executive Order 13439, issued an Action Plan for Import Safety:  A roadmap for continual improvement (Action Plan). The Action Plan is based on the principles of prevention, intervention, and response and contains 14 broad recommendations and 50 specific short- and long-term action steps to better protect consumers and enhance the safety of the increasing volume of imports entering the United States.

1. Prevention:  Prevent harm in the first place.  The U.S. government must work with the private sector and foreign governments to adopt an approach to import safety that builds safety into the manufacturing and distribution processes.  This effort will reduce the risks to consumers from otherwise dangerous imported products.
   
   
2. Intervention:  Intervene when risks are identified.  Federal, state, local and foreign governments, along with foreign producers and the importing community, must adopt more effective techniques for identifying potential product hazards. When problems are discovered, government officials must act swiftly, and in a coordinated manner, to seize, destroy or otherwise prevent dangerous goods from advancing beyond the point-of-entry. For foreign countries, taking steps to ensure the safety of products exported to the United States will benefit them by facilitating trade.
   
   
3. Response:  Respond rapidly after harm has occurred. In the event that an unsafe import makes its way into domestic commerce, swift actions must be taken to limit potential exposure and harm to the American public.

Since the release of the Action Plan, the FDA has collaborated with many partners to improve the safety of imported products. The following is a list of FDA accomplishments since issuance of the Action Plan.

Prevention

• Signed Memoranda of Agreement (MOA) with China. FDA signed two MOAs with China and held bilateral talks with the Chinese regulatory agencies to work towards creation of a certification program to help ensure items exported to the United States meet Department of Health and Humans Services (HHS) and FDA safety standards.  Additionally, these MOA’s provide a streamlined process for facilitating FDA inspections conducted in China.  This aspect of the agreement has already proven effective in giving FDA prompt access to conduct inspections.
• Issued Report on the Use of Standards. FDA issued its Annual Report on the Use of Standards by the Agency. This report describes the Agency’s involvement in standards setting activities during 2007.
• Expanded FDA’s International Outreach. FDA provided a briefing to Washington, DC-based foreign embassy personnel on FDA actions under the Action Plan and the FDA Food Protection Plan. Additionally, FDA discussed import safety with counterparts from Australia, New Zealand, the European Union, India, Vietnam, and several other countries.  These discussions support new capacity building, new bilateral agreements, and continued efforts to expand FDA’s foreign presence.
• Released Self-Assessment Tools for Industry. FDA worked domestically with industry to strengthen existing safety standards by releasing self-assessment tools for industry to minimize the risk of intentional contamination of food and cosmetics.
• Participated in Food and Agriculture Organization (FAO)/World Health Organization (WHO) Activities.  FDA participated in FAO/WHO activities to establish the Scientific Basis for International Standards and Guidance for Residues, Chemical Contaminants and Pathogens in Fresh Produce, Seafood, and Other Commodities. This included the completion of a risk assessment on Vibrio parahaemolyticus, which can cause gastrointestinal illness in humans.
• Participated in the Codex Alimentarius Commission (Codex) Activities to Promote International Food Safety Standards and Guidance Through Codex Alimentarius.  FDA provided the U.S. Delegate or Alternate delegate to 14 Codex Committees including those that developed standards in the areas of food hygiene, food additives, contaminants, nutrition, food labeling, biotechnology, and food import and export inspection and certification systems. 
• Participated in the WHO International Medical Products Anti-Counterfeiting Task Force (IMPACT). FDA provided the U.S. Delegate or Alternate delegate to the WHO IMPACT which aims to build coordinated action across and between countries in order to halt the production, trading and selling of counterfeit medical products around the globe. IMPACT is a coalition comprised of all the major anti-counterfeiting players, including: international organizations, non-governmental organizations, medicines regulatory authorities, enforcement authorities, associations representing pharmaceutical manufacturers, wholesalers, health professionals and patients.
• Published Draft Compliance Policy Guide (CPG) on Listeria Monocytogenes. FDA published a draft CPG on Listeria monocytogenes and held a public meeting to solicit public comment and encourage discussion on the CPG.
• Issued Draft Guidance for Industry on Control of Listeria Monocytognenes.  The draft guidance is intended to assist processors in controlling Listeria monocytogenes in the food processing environment during the manufacture of refrigerated or frozen, ready-to-eat foods. The draft guidance for industry, when finalized, will complement FDA’s current good manufacturing practices regulations.
• Issued Fresh-Cut Produce Guidance. FDA issued guidance on Fresh-Cut Produce to advise industry on how to limit contamination of fresh cut fruits and vegetables.
• Issued Amended Interim Final Rule on Use of Materials Derived from Cattle in Human Food and Cosmetics.  FDA issued an amended interim final rule that permits the agency to designate a country as not subject to certain bovine spongiform encephalopathy (BSE)-related restrictions upon written request and if the country demonstrates and provides supporting documentation that it’s current controls make such restrictions unnecessary. 
• Issued a Federal Register Notice for Food and Feed Third Party Certification Programs.  FDA issued a Federal Register notice that sought public comment on the existence and use of third-party certification programs to better understand how they can be used to help to ensure that food products are safe, secure, and meet FDA requirements.
• Provided Technical Assistance to China.  FDA provided training on regulatory requirements and technical assistance training to Chinese regulatory agencies.
• Hired Leadership for an FDA Office in China.  FDA received approval and has hired leadership for a new FDA office in China.
• Provided Technical Assistance to South Africa.  FDA’s Office of Cosmetics and Colors (OCAC) in the Center for Food Safety and Applied Nutrition participated in a U.S. Department of Agriculture/Foreign Agriculture Service workshop for South African regulators and industry representatives.  OCAC gave a seminar on regulatory requirements for marketing cosmetics in the United States, which included specific information on imports and labeling.
• Establishing an FDA Presence in India. An FDA delegation visited Indian counterparts to discuss requirements for an FDA presence in India.  Results are promising for future collaboration.
• Continued International Cooperation on Cosmetics Regulation (ICCR).  FDA continued to participate in ICCR activities, including strengthening the mechanisms for participating cosmetics regulatory authorities to keep each other apprised of emerging product-related safety issues.
• Issued a Federal Register Notice on Animal Feed Safety.  FDA issued a Federal Register notice for a public meeting to present changes to the Animal Feed Safety System project and the ranking of feed hazards according to the risk they pose to animal and public health. 
• Issued Final Rule on Substances Prohibited from Use in Animal Food or Feed.  FDA issued a final rule to expand protections against bovine spongiform encephalopathy (BSE) by prohibiting certain material in all animal feed that can carry the agent that causes BSE.
• Participated in HHS Delegation to Vietnam.  FDA accompanied an HHS delegation to Vietnam to discuss a cooperative arrangement with the Ministry of Health covering food, feed, and medical products.
• Establishing an FDA Presence in the Middle East.  The FDA Commissioner traveled to Jordan to explore expanding FDA”s presence in the Middle East.
• Coordinated Food Safety Exchange of Information.  FDA led the Security and Prosperity Partnership of North America Health Working Group with Canada and Mexico to coordinate and exchange information on food safety investigations and follow-up activities.
• Negotiated a Plan to Leverage Inspectional Resources.  The FDA negotiated a plan for leveraging inspectional resources of the European Union. The initial effort is to establish a pilot program to coordinate inspection planning.
• Protected American Consumers from Potentially Harmful Products.  Between November 7, 2007 and May 20, 2008, HHS/FDA refused admission of 8,543 entry lines, each line representing a distinct product type, that appeared to be adulterated, misbranded, processed under insanitary conditions, or unapproved new drugs. The refusal of these potentially harmful products prevented them from being distributed to the American public.

Back to Top

Intervention

• Collaborated on an Inter-Agency Agreement to Determine the Survivability of Bacillus Anthracis (causative agent of anthrax). FDA entered into an agreement with the U.S. Department of Agriculture and the Department of Homeland Security to determine the survivability of Bacillus anthracis in processed liquid egg products, which includes whole eggs, egg yolks, and egg whites.
• Established a Memorandum of Understanding (MOU) to Develop Forensic Tools. FDA entered into a MOU with the Department of Homeland Security to develop forensic tools to allow the identification and differentiation of individual strains of food borne bacteria.  
• Modernized FDA’s Mission Accomplishments and Regulatory Compliance Services (MARCS). The MARCS program manages the integration, re-engineering, and enhancement of the legacy systems that support FDA field activities. MARCS was recently upgraded to include International Mail Courier information collection and photographic capture of parcels and contents.
• Enabled Single Sign-On for Import Systems.  The FDA enabled a single sign-on capability for the Field Accomplishments and Compliance Tracking System and the Operational and Administrative System for Import Support.  By not having to log on to multiple systems, it will be easier for Agency staff to use these systems in accomplishing their work. 
• Improved Interagency Interaction. Representatives from Customs and Border Protection, Department of Justice, U.S. Department of Agriculture, Department of Commerce, Consumer Protection Safety Commission, FDA, Environmental Protection Agency, and Department of Transportation held a series of meetings to identify ways to improve upon agency interaction during the cargo clearance process and to maximize the sharing of critical data among agencies. 
• Developed a Platform for Rapid Detection of Pathogens in Food. FDA developed a rapid detection method using flow cytometry to identify E. coli and Salmonella in food. This system is being used in poultry processing facilities to detect and prevent bacterial contamination during food processing.
• Approved the Use of Cetylpyridinium Chloride (CPC) as an Antimicrobial Agent.  FDA approved CPC as an antimicrobial agent applied in solution to raw poultry carcasses to prevent contamination with Salmonella or E. coli.
• Developed a Cell-Based Cytotoxicity Assay. FDA developed a cell-based cytotoxicity assay to assess the biological activity of the bioterrorism agents, ricin and abrin, in infant formulas, fruit juices and yogurt. This assay can be used to assess other chemicals that may be used by terrorists to contaminate the food supply.
• Developed a Flow Cytometry Based System. In collaboration with outside parties, FDA developed a flow cytometry based system which uses probes to identify bacteria according to genus, species, or serotype (e.g. differentiating normal E. coli from E. coli O157), depending on the level of specificity desired.  This system has been successfully commercialized and is being used in poultry processing facilities to detect and prevent bacterial contamination.
• Employed a New Detection Method for Salmonella. FDA is using genetic analysis to identify hundreds of Salmonella enterica strains from seafood imports. The analysis provides information that can be used to trace more quickly outbreaks of Salmonellaenterica and implement surveillance programs to ensure the safety of imported seafood.
• Developed a New Detection Method for Mycotoxins. FDA developed a method to detect mycotoxins in distiller’s grains.
• Portable X-Ray Fluorescence (XRF) Devices. FDA has developed the analytical capabilities using handheld XRF devices to detect lead and other heavy metals in a variety of products and media. More than 80 elements can be rapidly screened that could be extended to the field and used in remote sites outside the laboratory.  To date a cadre of investigators and analysts has been trained to screen a variety of products.
• Upgraded eLEXNET Portal Collaboration and User Interface Tools. FDA has upgraded the Electronic Laboratory Exchange Network (eLEXNET) user interface to more effectively provide information and stimulate interactive information exchange amongst users.  eLEXNET is a seamless, integrated, web-based information network that allows health officials at multiple government agencies engaged in food safety activities to compare, share and coordinate laboratory analysis findings.  This network provides the necessary infrastructure for an early warning system that identifies potentially hazardous foods and enables health officials to assess risks and analyze trends.
• Developed a Real-Time Polymerase Chain Reaction Assay for the Detection of Salmonella and E.coli in multiple food matrices. FDA developed a method which was AOAC International validated to rapidly screen large numbers of samples for Salmonella and E.coli in 24 hours. FDA has also developed a method to rapidly screen large numbers of samples within 30 hours.
• Issued a Compliance Program for Select Imported Biologic Regulated Products (CP 7342.007).  FDA issued a comprehensive compliance program for select biologic imports (http://www.fda.gov/cber/cpg/7342007.htm).  The new compliance program gives the Field comprehensive instructions for reviewing import entries of select biologic products.  It outlines what regulatory requirements apply and what steps to take if a product does not comply.
• Expedited Entry of Stem Cells for Transplantation. The FDA, Customs and Border Protection, and the National Marrow Donor Program entered into an agreement for expedited entry of hematopoietic stem cells for transplantation.  Hematopoietic stem cells are used for transplantation into immuno-compromised individuals, particularly those individuals who have cancer and require donated stem cell transplant material as part of their treatment protocol.
• Responded to Adverse Events Associated with Heparin.  After discovering an increase in adverse reactions to certain heparin sodium products, FDA designed, validated, and publicized test methods for analyzing heparin for contamination. FDA began inspections of domestic and foreign facilities and suppliers to determine the presence and cause of the contamination, map the supply route of contaminated products, and gauge the inspected firms' compliance with current good manufacturing practices.  Working relationships developed through the Memoranda of Agreement with China helped speed and facilitate HHS/FDA visas and inspections in responding to the heparin crisis.  HHS/FDA was joined in the facilities by representatives from the Chinese State Food and Drug Administration and continues to have conversations with them as they conduct their testing so that any findings are shared.
• Completed PREDICT Pilot. The PREDICT prototype for improved, risk-based electronic screening of imports was pilot tested using seafood entries at five ports in metropolitan Los Angeles.  The test was successful.  Using PREDICT, the "hit rate" of violative findings for field exams increased to 7.0% from 3.7%.  For samples, the violation rate increased to 19.3% from 14.4%.  FDA is now expanding the prototype to include automated database lookups with regards to marketing status, and to add more types of products for PREDICT screening.

Back to Top

Response

• Collaborated with States. FDA held a conference call with the State Commissioners of Agriculture and Health to discuss collaboration between the states and the Agency regarding food safety.  The FDA Commissioner announced that a 50-State meeting will be held to develop implementation strategies for the implementation of the Food Protection Plan, the Action Plan, and the FDA Amendments Act (FDAAA) between federal, state, and local partners
• Issued Federal Register Notices for Pharmaceutical Serialization, Track and Trace, and Authentication. FDA published two Federal Register (FR) notices pursuant to section 913 of the FDA Amendments Act of 2007 to seek public comment on standards for pharmaceutical serialization, track and trace, and authentication, as well as to seek public comment on technologies used for track and trace and authentication of pharmaceuticals.  Track-and-trace technologies can be used as anti-counterfeiting and anti-diversion tools by tracking a product throughout the supply chain.
• Developed a Recall Template.  FDA developed a template for public notification of recalls and presented it to the FDA Risk Communications Advisory Committee. 
• Issued a Request for Applications for states interested in establishing Food Hazard Rapid Response Teams (RRT). The goal of developing and sustaining an RRT is in concert with long-term goals to enhance the food inspection and foodborne illness response programs, to increase the ability to inspect and obtain compliance for firms in their jurisdiction involved in the processing, manufacturing, distribution, transportation and warehousing of food, verify compliance with the State laws and regulations, good manufacturing practices, food defense, and other food protection requirements.

Back to Top