I hope you will find the following information useful. This is meant to provide you with the needed information to make sound business decisions for the new year. If you choose to become a clent, I am happy to help you become compliant with FDA FSMA.
Food Safety Working Group 2011-12 Agenda and Beyond
The FSWG’s accomplishments to date represent a large down payment on a stronger food safety system that will deliver greater value, better prevent illnesses and more effectively promote the well-being of the American people.Building on those efforts, the FSWG will continue to strengthen the food safety system through increased prevention, enhanced surveillance, and faster response.It will do so in part through implementing the new FDA Food Safety Modernization Act (FSMA).
During 2010, the FSWG’s member agencies worked closely with the Administration, Congress, and key stakeholders on this critical legislation.The FSMA provides a new vision and mandate for the food safety system, focused on science-based prevention of food safety problems and risk-based targeting of public and private prevention efforts to get the most risk reduction “bang for the buck.”
To carry out this vision, Congress has directed FDA to establish new prevention oriented standards for the food industry, provided new inspection and enforcement tools to ensure high rates of compliance with those standards, and mandated the creation of a new system of import oversight so that imported food meets the same modern standards as domestically-produced food.FSMA also calls for FDA to work in close partnership with other federal agencies, to build a nationally integrated system of inspection and laboratory testing with state and local partners, and to work closely with foreign governments to improve import safety.In addition, Congress has directed CDC to strengthen and enhance public health surveillance and response systems in partnership with state and local health departments and to designate Centers of Excellence which will provide additional resources for frontline health professionals during outbreaks and conduct research and outreach activities regarding food safety.
The FSMA presents a significant opportunity and challenge for our food safety agencies.Implementation of this new legislation will be one of the highest priorities for the FSWG and its members over the next several years.
A. Greater Prevention
The federal food safety agencies will build on past prevention efforts and harness the new mandates of the FSMA to strengthen prevention of foodborne illness.
1. Pre-Harvest Food Safety
FSIS, FDA and CDC have a common interest in working with the scientific, agricultural and public health communities to solve the problem of infection and transmission of foodborne disease organisms at the point of livestock and fresh produce production.For example, while E. coli O157:H7 emerged as a hazard in beef in the early 1990s, the pathogen is now a significant cause of illness associated with fresh produce as well.While FSIS will continue implementing the FSWG recommendation to increase enforcement in beef facilities and FDA will issue rules for grower practices affecting produce safety, FSIS and its partner agencies at USDA will work with other federal agencies, producers, and scientists to discuss
how to minimize pathogen contamination in animal production.FSIS and other USDA agencies will take the lead in conducting a thorough review and assessment of pre-harvest activities in the industry and government and engage stakeholders to consider initiatives in the areas of research, incentives for technology development and adoption, and identification and dissemination of best practices.
USDA convened a public meeting in November among FSIS, the Animal and Plant Health Inspection Service (APHIS), and the Agricultural Research Service (ARS) to discuss how pre-harvest pathogen control strategies for animals presented for slaughter can reduce the likelihood that beef could become contaminated with Shiga toxin-producing E.coli, Salmonella, and other pathogens.The meeting featured presentations on the latest research, followed by workshop discussions that included a wide variety of stakeholder groups.After analyzing the public comments presented at the meeting, USDA intends to convene a second public meeting focused on pre-harvest pathogen control strategies for poultry.
FDA will require preventive food safety controls for food and feed facilities and produce.
2. Upcoming Preventive Control Standards
As mandated by the FSMA, FDA will issue new rules establishing preventive control requirements for produce growers, food and animal feed processing facilities, and food transporters, as well as to prevent intentional adulteration of food over the next one to three years.FDA has done significant outreach with stakeholders to prepare for the issuance of these rules.It held a series of three public meetings to inform interested parties of the agency’s current thinking regarding preventive controls, import oversight, and inspection and compliance and to solicit comment from stakeholders.The public meeting on preventive controls, in particular, gave stakeholders an opportunity to hear about FDA’s thinking on preventive controls for food and feed facilities and produce safety standards.This public meeting complemented the listening tours with farmers that FDA undertook in 2010 and 2011 in thirteen states to understand the complexities of the produce industry prior to developing a regulation.FDA is working towards a release of proposed regulations on preventive controls for food and feed facilities, produce safety standards, and a foreign supplier verification program to ensure that importers are verifying compliance with these standards for imported foods.FDA will work with USDA and other Administration partners to ensure that the final standards take into account the full diversity and complexity of these sectors.
FDA has also recently established a National Food Safety Preventive Controls Alliance and an industry-oriented food safety training program to assist the US food industry in complying with regulations promulgated in response to FSMA legislation.The objectives of the National Food Safety Preventive Control Alliance include:
••To provide food facilities in the US with the resources to be in compliance with the preventive control component of FSMA.
••To assist the FDA to disseminate the science and technical elements relevant to the hazard analysis and preventive controls aspects of FSMA legislation to the US food industry.
••To assist the US food industry, particularly the small and medium-sized companies, to be compliant with the FSMA legislation.
For egg safety, FSIS is developing a proposed rule to address food safety risks in the egg products industry and will require Hazard Analysis and Critical Control Point (HACCP) systems in every establishment that produces egg products.By applying new standards, the egg product industry will be expected to comply with a system similar to that for meat and poultry products.FDA will continue to implement its prevention-based regulations for shell eggs.
3. Retail Food Safety
The federal agencies participating in FSWG have several proposed rules and other initiatives underway that will have a significant impact on retail food safety.For instance, within the coming year, FDA will improve retail food safety by encouraging more uniform state adoption of FDA’s recommended standards for retail food safety, strengthening state and local inspection programs, and increasing the presence of certified food safety managers in retail facilities in accordance with its Retail Food Safety Action Plan.FSIS will publish a new regulation to revise its inspection procedures to ensure they are better focused on public health protection.FDA, FSIS and CDC are working on a risk assessment on Listeria monocytogenes that specifically addresses retail practices.In preparation for this risk assessment, a Federal Register notice requesting scientific data was published and the agencies held a public meeting.In addition the agencies are working through CDC’s Environmental Health Specialists Network (EHS-Net) program and engaging in collaborative research with industry and academic partners to develop supporting data.
FDA will improve retail food safety by:
1. Encouraging more uniform state adoption of FDA standards;
2. Strengthening state and local inspection programs; and
3. Increasing the presence of certified food safety managers in retail facilities.
B. Enhanced Surveillance and Compliance
1. Domestic Inspection and Compliance
Under the FSMA, FDA will be modernizing its approach to food safety inspection to take advantage of the preventive control framework and make better use of scarce inspection resources.The primary focus will shift from looking for problems in food safety facilities and correcting them after the fact to verifying that facility operators are implementing well-planned and documented systems for preventing problems.This approach is more effective and efficient because it helps ensure that proper practices are being observed on a continuing basis.
FDA will also begin using the new administrative enforcement powers granted by the FSMA to prevent food safety problems.This includes administratively detaining products that have been produced under sub-standard conditions that jeopardize safety and suspending the registration and thus ability to operate facilities whose food products are putting consumers at risk due to inappropriate practices.When necessary, FDA will also use its new power to mandate recalls of foods that are contaminated or linked with illness outbreaks.
2. Import Safety
FDA will focus on implementing the new import safety tool kit Congress created with the enactment of FSMA.Under the new system, food importers will be responsible for providing documented assurances to FDA that the food they import has been produced under the same prevention-oriented standards as domestic food.FDA will be able to verify the adequacy of the assurances by examining the importer’s records and selectively examining import shipments.FDA will also support and supplement the efforts of importers by establishing an accredited third-party certification program, working with foreign governments and assessing the adequacy of food safety oversight and practices in countries exporting to the United Sates, and conducting inspections of foreign food facilities.Finally, FDA will implement a system to expedite entry of food shipments for importers that have especially well-documented systems to ensure safety.
FSIS has been working to further define its risk-based methodology for audits of equivalent countries allowed to export product to the U.S.FSIS will publish a document that details a performance-based approach to audits of foreign countries and point-of-entry re-inspections.This documentation will ensure that foreign equivalence audits continue to move in the direction of a risk-based approach and focus resources in an effective and efficient manner.
Federal agencies will continue working to ensure that foreign governments have the technical expertise and understanding of U.S.requirements that they need to be effective food safety partners.
3. Foodborne Illness Surveillance and Incident Investigation
As funding becomes available, CDC will maintain, upgrade and expand the PulseNet, and other subtyping networks, with more participants and next-generation methods to make outbreak detection and investigation faster and more robust for more pathogens.For example, CDC is developing new methods to deploy in state health department laboratories that will rapidly identify and subtype the important non-O157 Shiga toxin-producing E. coli, such as the one that caused a large and deadly outbreak in Germany in 2011.FoodCORE will evaluate the impact of enhanced outbreak response activities so that the most successful methods can be adopted by other state and local health departments.The proportion of foodborne illness that can be attributed to specific food commodities will be estimated based on reported foodborne outbreaks.In addition, CDC will launch a new FoodNet case-control study of risk factors for infection with non-O157 Shiga toxin producing E. coli and will complete a study of risk factors for developing hemolytic uremic syndrome among persons with E. coli O157:H7 infections.
In order to improve prevention and surveillance efforts, food safety programs need additional and new information on contributing factors and environmental antecedents of foodborne illness outbreaks.Currently, this information is lacking.A national voluntary environmental assessment information system could provide food-safety program managers with an information resource that could fill this gap.As a way to foster wider use of environmental assessments of farms and facilities to identify possible pathways of contamination, the National Voluntary Environmental Assessment Information System (NVEAIS) will be launched next year.CDC, as the lead agency, will continue to work with FSIS, FDA, state EHS-Net sites, and membership of the Conference for Food Protection to develop and implement the system.Information collected through NVEAIS will be used to establish a detailed characterization of food vehicles and monitor food vehicle trends, identify and monitor contributing factors and their environmental antecedents, and provide a basis for hypothesis generation regarding factors that may contribute to foodborne outbreak events.With this information, food safety programs and the food industry will have data to guide the planning, implementation and evaluation of foodborne illness prevention activities.
With support from FDA, FSIS, the National Park Service and EHS-Net states, CDC has also developed a virtual-world training program on how to conduct foodborne illness outbreak environmental assessments.This training program will be one of several requirements for participation in NVEAIS.
Food importers will be responsible for providing documented assurances to FDA that the food they import has been produced under the same prevention-oriented standards as domestic food.
4. Product Tracing
FSIS relies heavily on records maintained by industry to identify trace back and trace forward on FSIS-regulated products associated with foodborne illness and other food safety incidents. Retail records are a critical component in trace back and trace forward activities, and are essential to quickly and effectively determine source product and ensure controls are enhanced by affected product manufacturers (e.g., official establishment, retail, foodservice).Yet, recent outbreak investigations were impeded by poor retail records.
1 FSIS will propose a rule to enhance access to records to facilitate trace back in case an illness or outbreak is associated with ground beef from retail stores. FSIS will also develop compliance guidelines that retailers can use to meet FSIS trace back and trace forward activities, and additional guidance for investigators focused on activities at the retail level.
As mandated by the FSMA, FDA will consider information gathered through pilot tests of approaches to effective product tracing in other food categories, work with the food industry to foster innovative approaches to improve tracing, and improve its internal systems for tracing food products to their origin.
1. To illustrate, FSIS’s Office of Public Health Science investigated 16 cases of foodborne illness implicating raw ground beef products manufactured at retail in 2007-2008.Of the 16, only 9 retail operations kept production logs (e.g., grinding logs) sufficient for trace back and trace forward activities. Of the 9, 5 resulted in a recall.
CDC will maintain, upgrade and expand the PulseNet and similar networks with next-generation methods to make outbreak detection and investigation faster and more robust for more pathogens.
C. Improved Response
1. Outbreak Response
By all accounts, the government response to recent multistate outbreaks has been effective in swiftly reducing risks and saving lives.Our new systems were put to the test with the recent Listeria outbreak in cantaloupes.Enhanced surveillance, coordinated by CDC, and a rapid, multistate response were critical in controlling the outbreak.Close collaboration between FDA, CDC and the state of Colorado resulted in quick identification and recall of the contaminated cantaloupes of the source of the contaminated cantaloupes, enabling consumers to be advised quickly to avoid the contaminated food, and helping to prevent further exposures, illnesses, and deaths.
Within a week of FDA issuing a press release announcing the single source of contaminated cantaloupes and that the cantaloupes were recalled, FDA had a multi-disciplinary team on the ground conducting an environmental assessment to better understand how the contamination occurred.Updates on the recall and sub-recalls are posted on FDA’s website to ensure consumer awareness.
We continue to dedicate resources and expertise to learn all that we can from these outbreaks, in order to identify risks in advance of future outbreaks.FDA evaluates information, including environmental and product samples used to determine the root-cause of how whole cantaloupe became contaminated with Listeria.It is clear that we have already realized positive gains from our investment to develop an improved system.For instance, the funding we provided to the state of Colorado to improve surveillance for foodborne illnesses through its participation in the FoodNet active surveillance system, a program sponsored by CDC, FDA, and USDA was instrumental in enabling officials in Colorado to quickly recognize the outbreak of listeriosis cases and conduct interviews to help identify the most likely food associated with the illnesses.
FDA has also recruited a Chief Medical Office/Director of Outbreaks, who will lead a new Coordinated Outbreak Response and Evaluation (CORE) Network within FDA to ensure rapid and effective emergency response and more systematic follow up investigations, in collaboration with CDC and other agencies.Future prevention efforts will be created based on lessons from past outbreak experiences.CDC will continue to evaluate the best methods in FoodCORE Sentinel Sites and will promote best practices among all local and state health departments.
FDA will work with the food industry to foster innovative approaches to improve tracing, and improve its internal systems for tracing food products to their origin.
The FSIS will propose a rule to enhance our ability to identify outbreaks associated with ground beef from retail stores.
2. Data Analysis
In April 2011, FSIS launched the Public Health Information System (PHIS) to help respond more rapidly to current and potential food safety threats.PHIS, which will strengthen FSIS detection and response to foodborne hazards, will be a flexible, user-friendly, and web-based application that replaces many of FSIS’ legacy systems, such as Performance Based Inspection System (PBIS) and the Automated Import Information System (AIIS), automates paper-based business processes, and can be modified to accommodate changing needs.PHIS uses a systems approach to food safety.Through its predictive analytics component, PHIS will integrate FSIS’ data streams.This function will support a data-driven approach to FSIS inspection, auditing, and scheduling and result in a comprehensive, timely, and reliable data-driven inspection system.
Once fully implemented, PHIS will revolutionize the agency’s ability to utilize data in real time to inform all aspects of its domestic inspection, import inspection, and export activities.
This system will make the Agency and its employees more accountable, and allow FSIS to collect more information about the U.S.domestic and international food safety systems, which produce FSIS-regulated products.Using multiple data sources, PHIS will allow analysts to identify trends that will provide the agency with the capability to adjust domestic and import inspection and sampling.As a result, FSIS will be in a position to better identify food safety risks and detect problems before they reach consumers and result in outbreaks and recalls.PHIS will enable alerts for imported product to be triggered by real time data monitoring and will automate FSIS’ risk-based approach to foreign country audits and re-inspection.In addition, work will continue under the Data Analysis and Integration Group (DAIG) at FSIS to coordinate the agency’s data collection, analysis, and integration activities across all program areas.Also, the FSIS, FDA and CDC have established the Interagency Food Safety Analytics Collaboration (IFSAC) group to develop and share analytical methods, common terminology, and standards of practice.The IFSAC will address key issues such as foodborne illness attribution.
D. Consumer Education
Consumers play a key role in the farm-to-table approach to food safety.They are the last step where food can be contaminated to a level that could cause harm and where proper handling can minimize the risk of harm.Consumer education will therefore continue to be an important part of prevention, as well as the target for information during a food recall or outbreak to identify and prevent use of products that should not be consumed.The FSWG agencies will focus on three areas for improving consumer education:
••elevating interagency and community-based partnerships for food safety education;
••expanding the science base and reach of consumer education; and
••strengthening risk communication related to foodborne outbreaks and recalls.
Using sophisticated data collection and analysis, FSIS will better identify food safety risks before they reach consumers.
A central element of the vision laid out by the FSMA is that no one agency, level of government or private sector initiative can succeed in meeting today’s food safety challenges alone—collaborative action and effective partnerships are vital.Food safety presents many challenges for the entire food system, public and private, and from farm-to-table.Meeting the challenges across organizational lines within government and between government and the private sector is the vision of the FSWG, and the members of the FSWG are committed to fulfilling it.
Many ongoing partnership efforts are outlined in this report.Future efforts will involve the many instances in which FSMA mandates inter-agency collaboration and coordination among federal agencies on such topics as produce safety, preventive controls in food facilities, intentional adulteration standards, technical assistance for small growers and facility operators, and improving surveillance of foodborne illness.
The partnership efforts will also focus heavily on strengthening the capacity of state and local agencies and integrating federal, state and local efforts for a more effective and efficient food safety system, as well as collaborating with foreign governments of import safety.
Finally, government must continue to partner with the food industry and consumers to ensure food safety.Industry bears the primary burden and responsibility to produce safe food, and has vast experience and expertise in doing so.Consumers are also critical partners in the food safety system and in ensuring better outcomes.To be successful, government must further enlist the effort, expertise and perspectives of all stakeholders through systematic outreach and active listening.The FSWG and its members are committed to fostering and maintaining that partnership to sustain and enhance our current system, and continue to provide one of the safest food supplies in the world.