In November 2007, the Food and Drug Administration released the Food Protection Plan (FPP), an integrated strategy for protecting the nation’s food supply. The FPP addresses both food safety and food defense for domestic and imported products. FDA is working collaboratively across the agency to address the three core elements of protection: prevention, intervention and response. This summary provides an update on the accomplishments under the FPP in the first six-months and an overview of activities planned to begin now or in the near future.
Several key prevention initiatives have been started since November 2007. These began with outreach to explain and involve others in FDA’s Food Protection Plan. This outreach has involved multiple meetings with various foreign countries, state and local organizations, and industry and consumer groups. To further the interaction with federal, state and local partners, FDA announced a meeting to share information and develop strategies and future activities between federal, state, and local partners. As a cross-cutting activity, FDA has formed a Risk- Based Steering Committee with the charge of focusing FDA’s risk-based prevention, intervention and response activities to focus on the needs, processes, and timelines to ensure that a comprehensive risk-based approach is taken with regard to food protection. Specific risk-based prevention activities include FDA working in collaboration with states, universities and industry on a Tomato Safety Initiative. In an effort to increase foreign capacity and FDA’s presence beyond our borders, FDA has engaged with India and begun implementation of the China Memorandum of Agreement. The first bilateral meeting with China was held in Beijing in March, 2008.
FDA is working to improve the targeting of risk-based inspections and sampling to focus resources where they will have the greatest impact. FDA has completed a three-year plan to increase state inspections and will hire an additional 130 employees to conduct food field exams, inspections, and sample collections. FDA issued a Federal Register notice to solicit input on third-party certification programs and is interacting with a variety of industry groups to explore this further. FDA is working to develop better tools to identify food safety threats at the border, including the development of an advanced screening system. This system, known as PREDICT, was piloted on a small scale in recent months and the assessment of the pilot is currently under agency review. FDA has established a research coordinating committee to develop a collaborative research agenda that supports activities under prevention, intervention and response, such as mitigation strategies and rapid detection systems.
In order to improve the response to a threat to food safety, FDA is engaging with stakeholders to identify traceability best practices to be able to quickly identify where a contaminated product came from and where it has been distributed. FDA is working with states to improve response through Incident Command System training and is preparing to issue a Request for Applications for states interested in establishing Rapid Response Teams to enable rapid, localized response to incidents. In an effort to improve communication with the public, FDA developed templates for recall communication and presented them to FDA’s Risk Communication Advisory Board for input in March 2008.
1.1 Promote Increased Corporate Responsibility to Prevent Foodborne Illness
Outreach to States, Industry, and Other Stakeholders
FDA has undertaken several outreach activities in the last six months.
- FDA has begun working with state and local partners on developing a strategy for the implementation of the Food Protection Plan (FPP). The Commissioner announced that a 50-state meeting will be held on August 12-14, 2008 in St. Louis, Missouri to share information and develop strategies and future activities between federal, state, and local partners and FDA for the FPP, Import Safety Action Plan (ISAP), and Food and Drug Administration Amendments Act of 2007 (FDAAA).
- FDA issued a Federal Register Notice announcing a docket for stakeholder comment on the implementation of the FPP as part of a broad outreach plan. Docket number FDA-2008-N-0188, Food Protection Plan; Outreach Activities; Opportunity for Public Comment, can be found at www.regulations.gov.
- FDA issued a Federal Register Notice for a public meeting to solicit input on pet food labeling and standards for ingredients and processing of animal feed. Docket number FDA-2007-N-0442, Meeting Being Planned to Obtain Public Input for Ensuring the Safety of Pet Food, can be found at www.regulations.gov.
- 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. Docket number FDA-2008-N-0189-0001, Meeting to Present (1) Changes to the Animal Feed Safety System (AFSS) Project and (2) The Ranking of Feed Hazards According to the Risks They Pose to Animal and Public Health; Part 3: Swine Feed Example; Public Meeting, can be found at www.regulations.gov.
- FDA will be holding bilateral meetings in the next few months with Health Canada and the Canadian Food Inspection Agency, Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) and Mexico’s Secretary for Agriculture, Ranching, Rural Development, Fisheries, and Food Supply (SAGARPA).
Building in Safety Upfront by Identifying Best Practices and Standards
FDA is working with industry and stakeholders to identify and ensure the use of best practices for early prevention of food safety threats.
- FDA is working in collaboration with the State Health and Agriculture departments in Virginia and Florida, several universities, and the produce industry on a multi-year Tomato Safety Initiative. As part of the initiative, FDA has led assessments of grower practices focusing on the factors believed to be associated with contamination of tomatoes with Salmonella. FDA has conducted assessments in Virginia and completed two sets of assessments in Southern and Central Florida. FDA is in the process of analyzing the information in order to prepare a report on the assessments that can be shared with industry and other stakeholders.
- FDA has gathered input on animal feed best practices for preventive controls from industry groups including the National Grain and Feed Association, the American Feed Industry Association, the Pet Food Institute, and the Association of American Feed Control Officials (an organization of state feed control officials).
- FDA issued a draft Compliance Policy Guide (CPG) on Listeria monocytogenes. The CPG provides guidance for FDA staff on the agency’s enforcement policy for Listeria monocytogenes in ready-to-eat food. FDA issued a Federal Register Notice to solicit comment and held public hearings on the draft. Docket number FDA-2008-D-0058-0001, Draft Compliance Policy Guide Sec.555.320 Listeria monocytogenes, can be found at www.regulations.gov. FDA also issued draft guidance on controls that processors can use to minimize contamination of food with Listeria monocytogenes.
- FDA released self-assessment tools for industry to minimize the risk of intentional contamination of food and cosmetics.
- FDA issued a final rule entitled, “Substances Prohibited from Use in Animal Food or Feed.” This rule enhances the current Bovine Spongiform Encephalopathy (BSE) rule by prohibiting certain specified risk materials in all animal feed in addition to all of the original requirements. Docket number 2002-N-0031 can be found at www.regulations.gov.
FDA is working on developing, modifying and updating several food safety documents to address the current food safety vulnerabilities.
- FDA will issue a Federal Register notice to solicit input on possible modification of industry food safety guidelines for leafy greens and melons as part of FDA’s consideration of adopting the guidance.
- FDA will issue a Federal Register notice to solicit input on updating the 1998 Good Agricultural Practices (GAPs).
- FDA intends to publish a Final Rule on requirements to prevent Salmonella enteritidis contamination of shell eggs during egg production.
- FDA plans to release the 4th Edition of Fish and Fishery Products Hazards and Controls Guidance with updates to the previous editions to incorporate the current scientific and technical information regarding hazards associated with the harvest, processing, and storage of fish and fishery products.
- FDA is working on modernizing the Current Good Manufacturing Practices (GMPs) for human food. There have been changes in both the food industry and in the science of food safety that indicate a need for modernization.
- FDA will be querying key counterparts to identify best practices for import safety, including the use of third-party inspectors and reliance on certificates.
Increasing Foreign Capacity and Technical Assistance
FDA is building foreign capacity by engaging with foreign partners on both the FPP and ISAP. In addition, FDA is providing technical assistance to foreign countries to ensure the safety of imported food.
- A group from FDA attended the Food Safety Quadrilateral meeting with Canada, New Zealand and Australia in April 2008 to advance the FPP and ISAP. One of the proposals under consideration is the establishment of a rapid alert system to share information from any of the countries regarding potential significant public health problems found in food or feed.
- In response to finding unapproved drugs in Chinese aquaculture products, FDA conducted a review of aquaculture drug residue control procedures at thirteen Chinese firms that have been certified by the Chinese government as in compliance with the requirements of the import alert on Chinese aquaculture products. FDA plans to conduct verification audits of these firms in early July 2008.
- FDA was part of a Department of Health and Human Services delegation to Vietnam to discuss establishing a cooperative arrangement with the Ministry of Health covering food, feed, and medical products. An agreement with Vietnam was recently signed.
- FDA provided a briefing to Washington, DC based foreign embassy personnel on FDA actions under the FPP and ISAP.
- FDA is scheduling meetings with counterparts in Canada and Mexico to reinvigorate our bilateral relationships and to step up our collaborations to advance the work under the FPP and ISAP.
Expanding FDA Beyond our Borders
FDA has engaged with China and India on expansion of FDA presence beyond our borders.
- Implementation of the China Memorandum of Agreement (MOA) has begun. FDA has met their first set of deadlines by providing registration materials to the Chinese government, identifying points of contact for the MOA, and drafting the first five-year work plan.
- The first bilateral meeting with China was held in March 2008 in Beijing. The meeting focused on the relationship with the General Administration of Quality, Supervision, Inspection, and Quarantine (AQSIQ). There was verbal agreement to limit the present efforts in fulfilling the MOA to aquaculture (five species plus tilapia) and ingredients (wheat gluten, corn gluten, and rice protein).
- An FDA delegation visited Indian counterparts to discuss requirements for an FDA presence in India. Results are promising for future collaboration.
- In April, the Commissioner traveled to Jordan to explore the possibilities of enhanced collaboration between FDA and Jordan.
- FDA is exploring an FDA presence in Latin America/Central America.
- FDA is developing the animal feed requirements criteria for animal feed products covered under the MOA with China.
1.2 Identify Food Vulnerabilities and Assess Risks
Identifying Food Vulnerabilities
Research has been conducted in a number of areas related to both food safety and food defense. A better understanding of the stability of contaminants in food leads to a better understanding of potential threats to food safety.
- FDA assessed and published data on the microbiological load of bagged, ready-to-eat produce. These findings suggest that in bagged, ready-to-eat lettuce, the microbial load may be relatively higher than expected. FDA published these findings in February 2008 in the Journal of Applied Environmental Microbiology. FDA is planning a follow-up study.
- FDA completed an Inter-Agency Agreement with the United States Department of Agriculture (USDA) and the Department of Homeland Security (DHS) to determine the survivability of Bacillus anthracis (anthrax) in processed liquid egg products, which include whole eggs, egg yolks, and egg whites. Further studies are being conducted to determine the role of lyzozyme in Bacillus anthracis inactivation.
- FDA developed an assay to assess the stability of two bioterrorism agents in high-risk foods. This assay can be used to assess other chemicals that may be used by terrorists to contaminate the food supply.
- FDA is researching new ways to conduct molecular epidemiological analysis of Salmonella newport. In addition, scientists have identified several natural plant bacteria that are effective in preventing Salmonella newport from contaminating commercial tomato fruit.
Developing Risk-Based Processes
FDA established a Risk-Based Steering Committee to focus on the needs, processes, and timelines to ensure that a comprehensive risk-based approach is taken with regard to food protection.
- FDA’s Office of Regulatory Affairs (ORA), Center for Food Science and Nutrition (CFSAN), and the Food Field Committee collaborated to develop and use a risk-based high priority list to create a FY 2008 work plan for the ORA field force.
- FDA’s Center for Veterinary Medicine established a team to enhance modeling capability for relative risk-ranking across programs.
- As part of the risk-based approach, FDA will use the information gathered during the FY 2008 risk-based inspections to assess the risk-ranking models and to determine which models need fine tuning and which additional models may need to be developed, and will work towards developing a system for relative risk ranking.
1.3 Expand the Understanding and Use of Effective Mitigation Measures
Expanding FDA Research, Development, and Evaluation
Several research projects on mitigation efforts are currently underway.
- FDA approved the use of cetylpyridinium chloride (CPC) as an antimicrobial agent applied in solution to raw poultry carcasses to prevent contamination with Salmonella or E. coli.
- FDA is using genetic analysis to identify hundreds of Salmonella strains from seafood imports. The analysis provides information that can be used to trace Salmonella outbreaks and implement surveillance programs to ensure food safety.
- FDA has established a research coordinating committee and is developing a collaborative and integrated FPP research agenda that will address research needs to support protection, intervention and response.
- FDA has initiated a collaborative multi-institutional study to reduce the risk of E. coli O157:H7, funded by USDA under the National Integrated Food Safety Initiative. The work will examine pathogen risk mitigation strategies for leafy greens from field to table.
- FDA plans to conduct research on the susceptibility of pathogens found in raw and processed meats and imported seafood to antimicrobial agents and mechanisms by which these pathogens develop a resistance to antimicrobial agents.
- FDA is partnering with outside partners on research, development and evaluation of mitigation tools. FDA established a Memorandum of Understanding with DHS and the Department of Justice (DOJ) to develop forensic tools to allow the identification and differentiation of individual strains of foodborne bacteria. This will assist in rapid identification of the source of contamination.
2.1 Focus Inspection and Sampling based on Risk
Expanding Field Capacity through Risk-Based Inspections and Sampling
Risk-based inspections allow FDA to focus resources where they will have the greatest impact.
- A targeted risk-based inspection of a canning facility identified cans with viable Clostridium botulinum spores and a recall was initiated. FDA initiated this inspection, along with inspections of other low acid canned food (LACF) manufacturers, following four cases of botulism in consumers in 2007. FDA increased inspection efforts to ensure that manufacturers of all types of LACF products are adhering to applicable FDA requirements. These actions illustrate the need for companies to operate under adequate preventive control systems.
- ORA has completed a 3-year plan for increasing state inspections.
- Based on the FY 2009 President’s Budget, FDA plans to conduct an additional 327 state contract food inspections in FY 2009 over the FY 2008 estimate.
- FDA is considering additional targeted assignments to other segments of the LACF industry in light of findings of viable Clostridium botulinum spores at a canning facility.
- FDA will hire and train at least 161 new FTEs to conduct food safety work. The Office of Regulatory Affairs will hire at least 130 new FTEs to conduct food field exams, inspections, and sample collections. The Center for Food Safety and Applied Nutrition will hire at least 29 FTEs and the Office of Crisis Management will hire at least two new FTEs using FY 2008 appropriated dollars.
- Based on the FY 2009 President’s Budget, in FY 2009, ORA will conduct an additional 20,000 food import field exams above the FY 2008 performance goal.
Ensuring Import Safety though Voluntary Third-Party Certification Programs
- FDA issued a Federal Register Notice for Food and Feed Third-Party Certification Programs. The notice seeks public comment on the existence and use of third-party certification programs to better understand how they can be used help to ensure that food products are safe, secure, and meet FDA requirements. Docket Number FDA-2008-N-0183-001, Third-Party Certification Programs for Foods and Feeds, can be found at www.regulations.gov.
- FDA is exploring current existing third-party certification programs to gain a better understanding of the general attributes of such programs to ensure certification is reliable.
2.2 Enhance Risk-Based Surveillance of Imported Foods at the Border
Advancing Screening Technology at the Border
- FDA is working to develop better tools to identify food safety threats at the border. Under contract to FDA, New Mexico State University is developing a prototype system for improving electronic screening, using open-source intelligence, of imported products offered for entry into the U.S. The evaluation of the prototype system, PREDICT (Predictive Risk-Based Evaluation of Dynamic Import Compliance Targeting), has been completed and the final pilot evaluation document is currently under review.
- FDA plans to publish the Prior Notice of Imported Foods Final Rule by the end of 2008.
2.3 Improve the Detection of Food Systems “Signals” that Indicate Contamination
Deploy New Rapid Detection Tools to Identify Pathogens
FDA is developing new methods for rapidly and accurately identifying contaminants in food.
- FDA has 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.
- FDA microbiologists received training at CDC’s Salmonella Reference Laboratory on a new molecular method for rapidly and accurately identifying Salmonella serovars. The instruments have been purchased by both CFSAN and ORA laboratories.
- FDA has developed a method for detecting mycotoxins in distiller’s grains.
The FDA is working on developing several detection tools that are expected to be complete in 2008, including:
- Method for detecting melamine and cyanuric acid in various feeds and feed ingredients.
- Method for detecting antibiotics of concern in distiller’s grains.
- Method for detecting prohibited proteins in animal feeds.
3.1 Improve Immediate Response
Enhancing Traceability Capabilities for More Rapid and Precise Product Tracking
FDA is working to enhance traceability capabilities because the ability to quickly identify where a contaminated product came from and where it has been distributed is essential for a rapid response to a foodborne illness outbreak.
- FDA is currently engaging in dialogue with industry and other stakeholders on current traceability models and standards to identify best practices for traceability.
- FDA plans to develop guidance for traceability best practices to ensure fast and effective recalls.
Collaborating with States on Response Efforts
FDA is working in conjunction with States to improve response to food safety threats.
- FDA has completed four Incident Command System training courses that have included State representatives.
- FDA has developed an additional Farm Investigation Course for federal, state, and international investigators. Training was held in February 2008.
- FDA issued a Request for Applications (RFA) for funding to establish state Rapid Response Teams to investigate foodborne illness outbreaks, perform trace backs of implicated foods and evaluate data from investigations to identify trends. Six states will be awarded cooperative agreements in FY 2008; an additional three States will be awarded funding in FY 2009.
3.2 Improve Risk Communications to the Public, Industry, and Other Stakeholders
Improving Recall Communication
- FDA developed templates for recall communications and presented them to the FDA Risk Communications Advisory Committee for input in March 2008.
- FDA is currently exploring the use of multiple and targeted channels to quickly alert consumers of a threat to food safety.
Since the implementation of the Food Protection Plan in November 2007, FDA has been working to further build the foundations of a strong food safety system based on prevention, intervention and response. FDA has collaborated with stakeholders to improve preventive controls, signed agreements with foreign countries to ensure the safety of imported food, begun research on novel detection and mitigation methods, and provided training to improve response. FDA will continue to work collaboratively with foreign, federal, state, and local government partners, Congress, industry, consumer organizations, public health officials and others to ensure the full implementation of the Food Protection Plan and to ensure that America’s food supply remains safe.