FDA Criminal and Civil Enforcement Strategies: Food and Drug Law Volume 3 of 12

Prior to , food defense and food safety program resources were usually separate in budgeting, program planning, and program goals and objectives. In the context of its oversight of ever-increasing imported food shipments, a spate of domestic and imported food outbreaks, and numerous other factors, the FDA has proposed the FPP as its strategic plan for marshaling all of its expertise, systems, capabilities, and capacities to prevent, intervene in, and respond to food-related threats.

This represents an increase of nearly FTEs, but no increase in funding. As context for the above FY projected resources and anticipated accomplishments, it is important to review food defense budgeting and staffing generally to date. As mentioned previously, at the start of the food defense initiative, the FDA and its federal and state counterparts had no food defense experts on staff and could not hire any because none existed except for physical security experts. Therefore, food defense expertise was developed by current food safety staff and scientists.

And as food defense and bioterrorism resources were appropriated, the FDA retrained and reclassified existing food safety professionals and staff to meet these obligations.

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This was done because, as food defense was receiving new funding, food safety funding was diminishing to the extent that FTEs and valuable expertise were being lost. Although some new staff were hired and trained over time, it was important for the FDA to retain its food safety expertise. For the near term, it redirected these resources to food defense research, training, education, risk communication, and compliance issues and problems.

So in essence, food defense and safety share resources. The agency has thereby maintained a dual focus in the face of dwindling resources, ensuring its ability to meet the full range of challenges to the food supply. From interviews with FDA officials, it appears that currently there are a small number of FTEs dedicated to food defense in the areas of prevention, intervention, and response. That same year, Congress passed the Bioterrorism Act of , 10 giving the FDA new authorities to better address threats from imported foods, to trace contaminated foods in distribution through record keeping, to detain contaminated foods in domestic commerce when deemed to be a serious danger to humans or animals, and to establish a database of all food producers worldwide so as to better target inspections and emergency response activities.

In , the administration reorganized to focus on domestic and border security functions, moving many domestic security programs from several departments to the new DHS. The FDA, along with its federal food safety counterparts, had to forge a new working relationship with DHS to achieve its food defense goals and objectives. A government—industry partnership—the Food and Agriculture Sector—allowed the FDA and other federal agencies to communicate, cooperate, and work more closely with regulated industry. The goal was to conduct vulnerability assessments and identify the key critical assets within the food and animal feed systems.

Even with dedicated participation by both government and industry members, however, the Food and Agriculture Sector effort has been only moderately successful. The most recognized achievement is development of the SPPA initiative. Although the efforts expended by all members of this partnership have generated some valuable outcomes and deliverables, the general sense from industry, states, and some federal officials is that the efforts did not yield corresponding value.

Since then, available resources have been applied in several instances to minimize the impact of food hazards in a rapid and effective manner. Bioterrorism record-keeping authority has been implemented to trace melamine-contaminated foods and animal feeds. In future budget and research planning, it will be even more important to assess relative risk in the areas of food defense and safety and to set priorities so the FDA can apply its core capacities and resources where most needed. However, combining food safety and defense priorities in a systematic and transparent process is necessary to fully integrate the components of the FPP.

Over the years, the FDA has received additional funding for its food defense and bioterrorism program and activities. The agency has applied these funds primarily by redirecting existing scientific, program, and technical personnel to the food defense program. In so doing, the FDA has preserved its core food safety capacity and expertise while focusing its priorities on food defense issues.

For example, the FDA embarked on an ambitious testing and research program; established appropriate facilities, such as BSL-4 laboratories; developed safety procedures for handling selected agents; established an expanded network of laboratory facilities FERN to gain surge capacity; and funded investigations for high-priority agents. Today, the agency is better equipped to respond to a chemical or microbial threat to the food supply.

At the same time, even the best planning efforts are limited by the inability to predict the future. Therefore, it is critical to retain functional expertise, capacity to act, and scientific knowledge to respond to both emerging food defense and safety events. The FDA may take enforcement action when a food or feed is found to be adulterated. Most of their initiatives are voluntary. Hence the food defense program, even at USDA with its authority to withhold its seal of approval, has been limited to issuing guidance and working with industry to encourage participation in food defense activities.

Each sector is responsible for developing and implementing an SSP and providing sector-level performance feedback to DHS to enable assessment of national cross-sector CIKR protection program gaps. SSAs are responsible for collaborating with private-sector security partners and encouraging the development of appropriate information sharing and analysis mechanisms within the sector. HSPD-9 establishes a national policy to defend the food and agriculture system against terrorist attacks, major disasters, and other emergencies. The Food and Agriculture Sector has the capacity to feed and clothe people well beyond the boundaries of the nation.

The Sector is almost entirely under private ownership and is composed of an estimated 2. USDA is a diverse and complex organization with programs that touch the lives of all Americans every day. The FDA is responsible for the safety of 80 percent of all of the food consumed in the United States. While its mission is to protect and promote the public health, that responsibility is shared with federal, state, and local agencies; regulated industry; academia; health care providers; and consumers.

In addition, roughly , restaurants and institutional food service providers, an estimated , grocery stores, and other food outlets are regulated by state and local authorities that receive guidance and other technical assistance from the FDA. The Food and Agriculture Sector is dependent upon the Water Sec tor for clean irrigation and processed water; the Transportation Systems Sector for movement of commodities, products, and livestock; the Energy Sector for powering of the equipment needed for agricultural production and food processing; and the Banking and Finance, Chemical, Dams, and other sectors as well.

It is a central forum for introducing new initiatives for mutual engagement, evaluation, and implementation; issue resolution; and mutual education. This initiative included a series of assessments of the Food and Agriculture Sector in collaboration with private industry and state volunteers. SPPA assessments were conducted on a voluntary basis among one or more industry representatives for a particular product or commodity, their trade association, and federal and state government agricultural, public health, and law enforcement officials.

Between November and May , the teams completed 36 assessments in 28 states with industry partners, and identified generic protective measures or mitigation strategies that could be beneficial to many Sector industries. The first- and second-year status reports for the SPPA initiative are available at http: As part of its goal to improve preparedness, the Food and Agriculture Sector is committed to conducting tabletop exercises to demonstrate how government and industry can work together more effectively during a food contamination incident or a foreign animal or plant pest or disease outbreak.

The Sector will continue to host tabletop exercises that focus on response and recovery coordination among federal, state, tribal, local, and industry stakeholders. The FDA and USDA developed an online Food Defense Awareness training course targeting federal, state, and local regulators; local law enforcement; food program administrators; and industry. The goal of the course is to increase awareness of the potential for intentional adulteration of the food supply.

The course is available online at www. This initiative is intended to raise awareness among state and local government agency and industry representatives regarding food defense issues and preparedness. It is generic enough to apply to all aspects of the farm-to-table supply chain and is designed to spark thought and discussion with a variety of stakeholders.

ALERT identifies five key ways in which industry and businesses can decrease the risk of intentional food contamination at their facilities. To determine the extent to which selected food facilities maintain information required by the FDA in a food emergency. Beginning in , the FDA required certain food facilities to maintain records identifying the sources, recipients, and transporters of food products.

The purpose of these records is to allow the FDA to trace an article of food through each stage of the food supply chain—from a retail shelf back to a farm—if the FDA has a reasonable belief that a food product is adulterated and presents a serious health threat. Traceability is the ability to follow the movement of a food product through the stages of production, processing, and distribution.

Traceability includes both traceback and trace forward. Traceback is the ability to trace a food product from the retail shelf back to the farm. Conversely, trace forward is the ability to trace a food product from the farm forward to the retail shelf.

Traceability is often needed to identify the sources of food contamination and the recipients of contaminated food in product recalls and seizures. This study is based on two primary data sources: For the traceability exercise, we purchased 40 food products from different retail stores and attempted to trace them through each stage of the food supply chain back to the farm s or the border. We asked the facilities that handled the food product for information about their sources, recipients, and transporters, which we used in an effort to trace the product. We were able to trace 5 of the 40 products through each stage of the food supply chain; for most of the other products, we could identify the facilities that likely handled them.

Not all facilities are required to maintain lot-specific information in their records, and those that are required to maintain lot-specific information are required to maintain it only if it exists. As a result, we were able to trace five of the specific products through each stage of the food supply chain. The facilities that handled each of these products were able to provide information about the specific product we purchased or were able to link that product to lot-specific information in their records.

For 31 of the 40 products, we were able to identify the facilities that likely handled the products. Most facilities that handled these products did not maintain lot-specific information in their records and could only estimate a range of deliveries from one or more facilities that may have included the product we purchased. As a result, we were not able to trace these specific products through each stage of the food supply chain.

In addition, these estimates may have included more facilities than those that actually handled the product or may not have included all of the facilities that handled the product. For example, for one product—a bag of flour—the storage facility did not know the exact farms that contributed to the product and, therefore, had to give us information about every farm that provided wheat during the previous harvest season.

For the remaining four products, we could not even identify the facili ties that likely handled them. In these cases, at least one facility in the food supply chain failed to provide any information about the potential sources of the products. Several factors prevented us from tracing the specific products through the food supply chain. Several factors limited our ability to trace the specific food products through each stage of the food supply chain. These factors included 1 processors, packers, and manufacturers not always maintaining lot-specific information as required; 2 other types of facilities not maintaining lot-specific information because it is not required; 3 retailers receiving products not labeled with lot-specific information; and 4 the mixing of products from a large number of farms.

These factors also affect the speed with which the FDA can trace specific food products through the food supply chain. Fifty-nine percent 70 of of the food facilities in our traceability exercise did not provide all of the required contact information about their sources, recipients, and transporters. Twenty percent did not provide all of the required information about their sources, 52 percent did not provide all of the required information about their recipients, and 46 percent did not provide all of the required information about their transporters. Facilities could not provide all required contact information for several reasons.

In some cases, managers had to look through large numbers of records—some of them paper based—for contact information. Additionally, some facilities did not have integrated record-keeping systems that linked sources and recipients to specific shipments or to transporters, and managers had to search separate systems to obtain the contact information. The FDA envisions establishing a new strategic framework for an integrated national food safety system.

In order to efficiently and effectively establish a fully integrated national food and feed safety system, the FDA must build and expand existing programs and relationships with its regulatory partners, specifically its federal, state, local, tribal, and territorial partners.

BUILDING A FOOD DEFENSE PROGRAM

Develop a National Work Plan that includes the inspections of food manufacturing and distribution facilities and the collection and analyses of compliance, surveillance, and environmental samples. Continue to develop uniform national standards for such subjects as manufacturing, inspections, and enforcement.

Build training courses and a certification program to be delivered to state, local, and tribal regulatory partners, and increase programmatic oversight and develop a more robust audit program. A system of this magnitude may require new authorizations such as multi-year budget authority for federal, state, local, tribal, and territorial regulatory partners and the authority to share non-public information with our regulatory partners when it is necessary to protect public health.

However, this request is necessary to begin building the framework for an integrated national food safety system. Furthermore, ORA is requesting funding in FY to continue building its workforce for more field food and feed work and support for the field food and feed work. In order to do so, ORA is requesting funding to continue hiring investigators, analysts, and support staff in order to continue to increase field and food work, such as:. The FMI is a trade association representing food retailers and wholesalers that develops and promotes policies, programs, and forums supporting its members and their customers in the areas of government relations, food safety and defense, public and consumer information, research and education, and industry cooperation.

According to Title 18 U. Codified as Title 21 U. Office of Inspector General. Traceability in the Food Supply Chain. Turn recording back on. National Center for Biotechnology Information , U. Appendix D The U. The tool rates seven factors that affect the desirability of a target: Criticality —public health or economic impact 2. Accessibility —physical access to target 3.

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Recuperability —ability of the system to recover from an attack 4. Vulnerability —ease of accomplishing the attack 5. Effect —amount of actual direct loss from the attack 6. Recognizability —ease of identifying target 7. Recurring themes included the need for better understanding of threat agent characteristics;. Information Sharing The Food and Agriculture Sector has made many attempts to find a suitable communication tool that fully supports its activities.

Enhancing Food Safety: The Role of the Food and Drug Administration.

Crossroads and the Future Industry interviews suggested that the Food and Agriculture Sector must transform itself to sustain active participation in the future. Registration of Food Facilities This authority requires food manufacturers, processors, holders, and distributors to register each facility, not company, with the FDA. Record Keeping Record keeping requires each domestic food manufacturer, processor, holder, or distributor to retain records of incoming ingredients and supplies and of outgoing products. Inspectional Activities and Industry Training The FDA performs 10, food inspections annually, conducted by its own workforce and through state contracts.

FDA Research As has been discussed, FDA scientists, economists, and others were instrumental in designing and shaping the risk assessment tools used for setting food defense priorities and targeting FDA resources most effectively. The four major areas of interest are development of methods for the detection of biological and chemical agents in foods,.

The food defense components of the plan are as follows: The FDA will improve its ability to protect American consumers and strengthen the safety and security of the food supply chain by working with domestic and foreign industry to develop new control measures for all levels of food production and processing. The FDA will also verify that these control measures are effective when implemented. The FDA will strengthen food safety by improving the science on which regulatory decisions and enforcement rely. The agency will conduct risk analysis, modeling, and evaluation to improve risk-based decision making so it can better target resources to high-risk foods.

The FDA will work with the food industry, consumer groups, and federal, state, local, and foreign partners to identify and generate the additional data needed to improve understanding of food vulnerabilities and risks. This information will be used to strengthen food safety and defense. The FDA will expand state capacity to perform risk-based inspections by increasing the number of cooperative agreements and partnerships with states. The agency will also invest in high-volume laboratories for better sample analyses and faster testing. The FDA proposes establishing a new strategic framework for an integrated national food safety system.

To achieve this objective, the FDA must build new and expand existing programs and relationships with its federal, state, local, tribal, and territorial regulatory partners. This will allow the FDA to increase information sharing and improve the quantity and quality of food safety data it receives from its food safety partners.

The FDA will conduct research in high-priority areas, such as reducing the risk of E. The agency will speed its response to outbreaks by developing and validating technologies for subtyping pathogens and developing, evaluating, and deploying rapid detection tests. Working with its federal and state partners, the FDA will develop a Pet Event Tracking Network for early reporting of contaminated feed. The FDA will conduct research designed to limit the adverse health effects of intentional and unintentional contamination of food.

The FDA will upgrade and integrate the information technology systems it uses to screen, sample, detain, and take enforcement actions against imported products. This effort includes developing and validating an accurate database of registered foreign facilities as well as designing and using risk-based software algorithms for import targeting.

The FDA will improve the speed and effectiveness of its response to contamination by strengthening its ability to collect and analyze information necessary to trace products during a food emergency. The agency will also collaborate with state veterinary diagnostic laboratories to ensure more timely and accurate reporting and analysis of feed contamination. The FDA will aggressively strengthen its response to food-related events by instituting a more robust incident command system that fully integrates modern incident command principles into its emergency operations.

The agency will also improve how it communicates with the public about food-related emergencies to ensure that such communications better meet the health and information needs of consumers. Develop and apply a mechanism for prioritizing combined food defense and safety risks and generating a single ranked listing of food protection priorities for purposes of strategic, long-range planning. Generates resources to support FDA oversight of food safety: Prevents food safety problems before they occur: Requires foreign and domestic food facilities to have safety plans in place to identify and mitigate hazards.

Safety plans and food facility records would be subject to review by FDA inspectors and third-party certifiers. Sets a minimum inspection frequency for foreign and domestic facilities. Each high-risk facility would be inspected at least once every 6 to 12 months; each low-risk facility would be inspected at least once every 18 months to 3 years; and each warehouse would be inspected at least once every 5 years.

Refusing, impeding, or delaying an inspection would be prohibited. Requires demonstrating safety for food imports: Creates a fast-track import process for food meeting security stan dards: Directs the FDA to develop voluntary safety and security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing. Requires safety plans for fresh produce and certain other raw agricultural commodities: Directs the FDA, in coordination with USDA, to issue regulations for ensuring the safe production and harvesting of fruits and vegetables and other raw agricultural commodities, such as mushrooms.

Directs HHS to issue trace-back regulations that enable the Secretary to identify the history of the food in as short a time frame as prac ticable, but no longer than 2 business days. Prior to issuing such regulations, the Secretary would be required to conduct a feasibility study, public meetings, and one or more pilot projects.

There would be exemptions for certain foods or facilities. Requires labels on all processed food to indicate the country in which final processing occurred. Requires country-of-origin labeling for all produce. Requires the FDA to establish a program for recognizing laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Requires laboratories to send certain test results directly to the FDA. Provides strong, flexible enforcement tools: Provides the FDA new authority to issue mandatory recalls of tainted foods.

Strengthens penalties imposed on food facilities that fail to comply with safety requirements. Advances the science of food safety: Directs the Secretary to enhance foodborne illness surveillance systems so as to improve the collection, analysis, reporting, and usefulness of data on such illnesses. Requires the Secretary to provide greater coordination among federal, state, and local agencies. Allows the FDA to charge a fee to cover the cost of additional inspections of facilities that previously committed a violation of the act related to food. Enhances oversight of the safety of new infant formulas: Requires that the manufacturer of a new infant formula submit certain safety information regarding new ingredients.

Grants the FDA additional time to review such new ingredients. Allows the Secretary to prohibit or restrict the movement of harmful food products: If the Secretary, after consultation with the governor of a state, determines there is credible evidence that an article of food presents an imminent threat, he or she can prohibit or restrict movement of that food in the state or portion of the state. Creates an up-to-date registry of importers: Requires all importers of foods to register with the FDA annually and pay a registration fee.

Requires unique identification numbers for facilities and importers: To improve the accuracy of data and the ability of the FDA to identify parties involved in a crisis situation more quickly, creates unique identification numbers for all food facilities and importers. Provides protection for whistleblowers that bring attention to important safety information: Prohibits entities regulated by the FDA from discriminating against an employee in retaliation for assisting in any investigation regarding any conduct the employee reasonably believes constitutes a violation of federal law.

It provides a means to identify sector elements and systems that are critical to key state commodity chains or food distribution systems,. Tabletop Exercises As part of its goal to improve preparedness, the Food and Agriculture Sector is committed to conducting tabletop exercises to demonstrate how government and industry can work together more effectively during a food contamination incident or a foreign animal or plant pest or disease outbreak.

In addition, the act needs to specify that the food safety plan and the implementation records must be made available to FDA inspectors. Finally, the act should state that if a facility fails to satisfy these requirements for preventive controls based on hazard analysis and risk, any food produced,. The committee discussed the possibility of recommending mandatory testing for pathogens. However, it concluded that the FDA should address this complex issue on a case-by-case basis, pursuant to the overall risk-based food safety management approach proposed in this report.

The FDCA needs to be amended to require the FDA to periodically issue enforceable, risk- and science-based performance standards for pathogens and other contaminants significant to public health. The agency should be required to use a risk-ranking approach to prioritize the development and issuance of those standards.

A process for making decisions about what, when, and how to inspect is essential for an efficient food safety system. In Chapter 3 , the committee recommends that the FDA use a risk-based approach to make decisions and allocate resources. In Chapter 8 , the committee specifically calls for a review and update of FDA inspection processes so they are consistent with a risk-based approach. Although the FDA is already thinking through its decision-making process for the conduct of inspectional activities, the committee concluded that this is one key area that requires a congressional mandate.

The committee also believes, however, that the law should establish minimum standards for the frequency and intensity of inspection of all food facilities, regardless of their risk ranking.

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Moreover, the committee believes it is important to maintain some element of randomness in the scheduling and targeting of inspections. In contrast, with respect to prescription drugs, nonprescription drugs intended for human use, and restricted devices, the FDCA provides the FDA with broad access to records bearing on whether the products are adulterated, misbranded, or otherwise in violation of the act. The committee believes that Congress needs to give the FDA similarly broad access to records in food facilities.

The agency issued such regulations in The FDA has access to these records under the same standard applicable to all records sought under. When confronting a food safety emergency, the FDA can often depend on state governments to use their embargo authority to stop the distribution and sale of the adulterated food. In communications with the committee, the FDA maintained that it should be given the power to order a company to recall an adulterated food when necessary to protect the public health.

The bills currently under consideration in Congress give the FDA the power, subject to specified procedures, to issue a cease distribution order and a subsequent recall order when there is a reasonable probability that a food will cause serious adverse health consequences or death. In most instances, the FDA does not need mandatory recall authority to fulfill its food safety mission.

Food companies almost always cooperate with FDA-requested recalls, and even when companies resist, the agency. A claimant for a detained article may appeal the detention order, and the commissioner must, after providing an opportunity for an informal hearing, confirm or terminate the order within 5 days of when the appeal is filed FDCA h 4 A. Indeed, the voluntary recall process is normally so efficacious that the FDA rarely uses its mandatory authority even in those areas in which it possesses such authority.

For example, although the FDA has had mandatory recall authority over medical devices since , the committee learned that the agency has invoked this power only ten times, and never since Nonetheless, the committee concludes that there may be rare circumstances, involving uncooperative food distributors, in which the FDA needs the power to formally order a party to cease distribution of an article of food and recall it.

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Congress thus needs to amend the statute to provide the FDA with such authority with respect to foods that are adulterated under section of the FDCA and may cause serious health consequences or death. To ensure that the existence of mandatory recall authority does not undermine the carefully honed and highly effective voluntary system already in place, Congress should require the FDA to always provide the party in question an opportunity to cease distribution and recall an article voluntarily according to terms prescribed by the agency before it issues an order. If the party refuses to proceed voluntarily, the FDA should then have the power to order the party to cease distribution immediately, but the party should, except in instances of imminent danger, be given an opportunity for an expeditious informal hearing before the FDA modifies the order to mandate recall.

Section d 2 exempts from the reporting requirement any party that detects the adulteration prior to the transfer of the food to another party and corrects the adulteration or destroys the food. The committee believes this safe harbor ought to be extended to parties that detect adulteration even after transfer of the food to an immediately subsequent party as long. Pursuant to these statutes and implementing regulations, FSIS permits imports of meat, poultry, and egg products only from countries it has certified as having inspection systems that ensure that exported food products meet American food safety standards.

The FDCA does not require the FDA to make a similar country-by-country equivalence determination, and the committee does not believe that such an approach would be practicable for the agency, which has jurisdiction over a much more global and diverse imported food supply relative to FSIS.

Nonetheless, in administering a risk-based food safety system, the FDA might decide to review the regulatory systems of some or all of the nations that export food to the United States. The committee also concluded that, rather than dramatically increasing inspectors in foreign countries, the FDA should use a risk-based approach to prioritize inspections at the border see Chapter 3.

Despite the dramatic developments in food production and distribution that have occurred since the enactment of the FDCA, the main statutory provisions under which the agency carries out its food safety mission remain largely unchanged. These provisions are broad. The agency is often reluctant to take action without an explicit mandate to do so, and those actions it does take in the absence of express statutory authorization are vulnerable to court challenge. Congress should consider amending the FDCA to provide explicitly and in detail the authorities the FDA needs to fulfill its food safety mission.

The following are the most critical areas in which Congress should enact amendments: Not Merely a Collection of Words 2nd edition. Food and Drug Law Institute. Food and Drug Administration. Procedures for the safe and sanitary processing and importing of fish and fishery products. Federal Register 60 Procedures for the safe and sanitary processing and importing of juice. Federal Register 66 Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases.

Although it is not solely responsible for ensuring the safety of the nation's food supply, the U. Food and Drug Administration FDA oversees monitoring and intervention for 80 percent of the food supply. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks.

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The Role of the Food and Drug Administration , a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management.