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Special Edition Weekly: U.S. Food Safety Legislation
Implications of the New U.S. Food Safety Legislation
President Barack Obama signed the Food Safety Modernization Act on Jan. 4, 2011—nearly two years after a Salmonella outbreak linked to contaminated peanuts sparked renewed focus on the U.S. Food and Drug Administration’s (FDA) food-safety function. The new legislation gives the FDA the power to mandate recalls of contaminated food, requires most producers to maintain a safety plan and keep records showing that they follow the plans, and gives the agency more authority over food imports.
On Jan. 7, IFT held a forum in Washington, D.C. to discuss the implications of the new food safety legislation. The event, which attracted over 500 participants both in-person and via webcast, focused on product tracing, third-party certification, and preventive control plans, and featured the insights and perspectives of the following experts:
Background and Key Changes of the Food Safety Modernization Act
John Bode, OFW Law, kicked off the forum by providing the audience with some background on the Food Safety Modernization Act and the changes the industry can expect to see implemented by FDA immediately and in the next couple of years. Driven by the long list of major food recalls that the United States has experienced in recent years, Bode describes the Act as the most expansive change in food law since the 1938 Federal Food, Drug, and Cosmetic Act.
Bode continued by listing some of the provisions that can be expected to impact the food industry in the very near future. First, there will be increased frequency of inspections. However, as Bode explains, this is a very ambitious goal for the FDA and will be subject to the availability of appropriations. “It is difficult to imagine that FDA will get all the funding it needs,” said Bode.
Another major provision of the new Act involves import certification authority. The FDA may now require certification by an accredited third-party auditor for imported foods and facilities. While this will take effect immediately, Bode noted that there is no current system in place for accreditation of third-party auditors. (Third party certification is highlighted in more detail by Robert Brackett)
Similar to current rules, the Act immediately enables the FDA to expanded records access and mandatory recall authority if the company doesn’t initiate a voluntary recall.
Some provisions of the Act will take a little longer to implement and involve some major new requirements. All food facilities will soon be required to register biennially; current facility registration exists but is not kept up. In addition, a new requirement entails preventive control plans. The FDA is expected to issue regulation on this within 18 months. As Bode summarizes, registered facilities should have preventive control plans in place and these plans and all related records will be available to the FDA during inspections. There are some exemptions to this provision. Anthony Pavel discusses what will be required in the new preventive control plans.
For performance standards, the FDA plans to review and evaluate relevant health data every two years in order to determine the most significant foodborne contaminants. The agency will then issue contaminant-specific performance standards, which may include action levels.
Another provision of the Act details plans for the FDA to issue guidance and regulations to protect against intentional adulteration. The guidance, which will include model vulnerability assessment and examples of mitigation strategies and measures, is expected within the year. Foods at high risk of intentional adulteration must have preventive control plans.
A major issue with the recalls in recent years has been the speed at which the FDA has been able to trace the source of contamination. Therefore, the new Act focuses a lot on traceability. The FDA will establish a product tracing system that allows the agency to effectively track and trace food. The agency will be conducting pilot programs of the produce and processed food sectors within 180 days. As a part of the traceability efforts, the FDA will establish a list of high-risk foods and additional recordkeeping will be required for these foods. (David Acheson delves into the Act’s traceability provisions).
For imported foods, the Act contains a provision of regulatory significance. The provision states that all importers must have a foreign supplier verification program in place, stating that the food complies with FDA requirements. Once the regulations are in place, approximately in two years, companies offering food for import without a compliant verification program will be subject to injunction and criminal prosecution.
Overall, Bode explained that the Food Safety Modernization Act enables the FDA sweeping new enforcement authorities, including suspension of company registration, mandatory recalls, and broader access to records. While many details of the legislation have yet to be worked out, and there is not a specific timeline for promulgating regulations, Bode expects the Act to be “substantially implemented in three years.”
Food Tracing
Delving into a major component of the Food Safety Modernization Act, David Acheson, Leavitt Partners, outlined the legislation’s requirements regarding traceability. In the conventional supply chain, each entity (grower, processor, manufacturer, etc.) in the process should be able to trace one step forward and one step back. In the new provision, this idea has not changed. However, as Acheson explained, the system needs to be more sophisticated and involve more stringent record requirements. Of course, there are many challenges to providing a successful traceability program, such as the complexity of distribution systems, supply chain unknowns, inconsistent recordkeeping, product name changes throughout the supply chain, different systems of tracking, and repacking of products.
Despite the challenges, traceability is of increasing concern for regulators because of their inability to determine where a food is moving in the supply chain. For example, Acheson describes the Salmonella Saintpaul outbreak in 2008. Due to the complex supply chain and insufficient recordkeeping, it took longer than necessary to determine the true source of contamination—tomatoes or peppers. This leads to increased consumer exposure to the contaminated food and broad industry damage.
In the new legislation, in order to eventually establish a product tracing system, the FDA must first develop pilot programs with the processed food sector and the produce industry within nine months. Within 18 months, the FDA must provide a report to Congress on recommendations for establishing more effective product tracing, including consideration of costs and benefits, feasibility of technologies for different sectors, and existing practices and international efforts that work.
In addition, the new law requires prior notice of rule making within two years to establish recordkeeping requirements for high-risk foods. To do this, the FDA needs to define high-risk products within one year based on known safety risks of a particular food, the likelihood of microbiological or chemical contamination, and the likelihood consuming the food will result in foodborne illness.
Overall, as Acheson explained, the regulators want a traceability system that is consistent, speedy, covers the entire supply chain, has electronic records, has interoperable systems, and covers domestic and imported foods. On top of that, the FDA wants the industry to develop the tools and to pay for the system. Acheson urged the audience and industry to see traceability as a food safety tool, not a burden. In fact, if a system is successful, it will quickly eliminate products, brands, or food categories as a source of foodborne illness. Acheson closed his presentation by urging the industry to engage with regulators, because the FDA will be looking for partners during the development process. This is an opportunity to offer insight and possible concepts as to what will work and what won’t.
Accreditation of Third-Party Auditors
Robert Brackett, Illinois Institute of Technology, spoke to the audience regarding the Food Safety Modernization Act’s provision for certification by an accredited third-party auditor for imported foods and facilities. The dramatic increase in imported foods and ingredients over the past decade has further stressed the FDA’s resources. Given this, there has been increasing interest in third-party audits. Accreditation is an important aspect of third-party audits, in order to ensure consumer confidence in the products. This is not a new idea, as audits have been accredited to private standards in the past (such as the Global Food Safety Initiative). In addition, the government has made recommendations for such accreditation and certification in reports since 2007.
In the new legislation, provision 307 sets out a plan to implement a system to provide for accredited audits of foods and facilities for imported products only. This would become part of a larger set of import regulations laid out in the Act, such as:
The third-party auditors are subject to some requirements. First, the records of regulatory audits will be made available to the FDA on request. In addition, the auditors must inform the FDA immediately if they discover conditions that could cause or contribute to a serious risk to public health. Brackett noted that in the new legislation there can be consequences for accredited third-party auditors. For example, an auditor can lose accreditation if he/she certifies a food that is linked to an outbreak of foodborne illness.
As Brackett commented, the establishment of a third-party audit system for certification of foods and facilities will not be quick or easy. The FDA has 24 months to establish a system for the recognition of accreditation bodies. Also, the FDA has to establish a user fee program, develop model accreditation standards, and institute a publicly-available registry of accreditation bodies and of accredited third-party auditors. But hopefully, in the end, the use of accredited third-party audits will benefit both the industry and consumers.
Preventive Controls
A new important requirement in the Food Safety Modernization Act entails preventive control plans. Anthony Pavel, K&L Gates, ended the forum on Jan. 7 with a discussion on the changes to preventive control plans in the new legislation. As Pavel explained, most companies have HACCP plans already in place. These are going to provide a good basis for the new preventive control plans but there will be some additions and changes that need to be made. First, there will need to be a Hazard Analysis, which identifies all known or reasonably foreseeable hazards in a written analysis.
In addition, as a part of the plan, preventive controls need to be outlined. These include:
Verification is the next part of the preventive control plan, and, according to Pavel, this part goes beyond the current HACCP and may be difficult to implement. Here, the owner/operator/agent must verify that preventive controls are adequate to control hazards, including environmental and product testing. Also, this step involves verifying the owner is conducting monitoring, making appropriate decisions about corrective actions, and conducting periodic re-analysis of the plan. Pavel noted that with this plan, there is increased emphasis on final product testing, which creates a large burden for the industry.
Recordkeeping is a vital part of the preventive plan. The plan must be written and records must be maintained for a minimum of two years. In addition, records must be made “promptly available” upon oral or written request by the FDA. Lastly, there is a requirement to re-analyze the hazard analysis and preventive control plans at least every three years. However, any significant change that creates a reasonable potential for new hazard warrants the need to immediately re-analyze the plans.
It should be noted that there are some exemptions to the new preventive control plans. These include facilities subject to current HACCP or other requirements, such as seafood, juice, fresh produce, dietary supplements produced under Part 111, and low-acid canned food.
Special Edition Weekly: U.S. Food Safety Legislation
Implications of the New U.S. Food Safety Legislation
President Barack Obama signed the Food Safety Modernization Act on Jan. 4, 2011—nearly two years after a Salmonella outbreak linked to contaminated peanuts sparked renewed focus on the U.S. Food and Drug Administration’s (FDA) food-safety function. The new legislation gives the FDA the power to mandate recalls of contaminated food, requires most producers to maintain a safety plan and keep records showing that they follow the plans, and gives the agency more authority over food imports.
On Jan. 7, IFT held a forum in Washington, D.C. to discuss the implications of the new food safety legislation. The event, which attracted over 500 participants both in-person and via webcast, focused on product tracing, third-party certification, and preventive control plans, and featured the insights and perspectives of the following experts:
- John Bode, OFW Law
- David Acheson, Managing Director, Leavitt Partners
- Robert E. Brackett, Illinois Institute of Technology
- Anthony T. Pavel, Partner, K&L Gates
Background and Key Changes of the Food Safety Modernization Act
John Bode, OFW Law, kicked off the forum by providing the audience with some background on the Food Safety Modernization Act and the changes the industry can expect to see implemented by FDA immediately and in the next couple of years. Driven by the long list of major food recalls that the United States has experienced in recent years, Bode describes the Act as the most expansive change in food law since the 1938 Federal Food, Drug, and Cosmetic Act.
Bode continued by listing some of the provisions that can be expected to impact the food industry in the very near future. First, there will be increased frequency of inspections. However, as Bode explains, this is a very ambitious goal for the FDA and will be subject to the availability of appropriations. “It is difficult to imagine that FDA will get all the funding it needs,” said Bode.
Another major provision of the new Act involves import certification authority. The FDA may now require certification by an accredited third-party auditor for imported foods and facilities. While this will take effect immediately, Bode noted that there is no current system in place for accreditation of third-party auditors. (Third party certification is highlighted in more detail by Robert Brackett)
Similar to current rules, the Act immediately enables the FDA to expanded records access and mandatory recall authority if the company doesn’t initiate a voluntary recall.
Some provisions of the Act will take a little longer to implement and involve some major new requirements. All food facilities will soon be required to register biennially; current facility registration exists but is not kept up. In addition, a new requirement entails preventive control plans. The FDA is expected to issue regulation on this within 18 months. As Bode summarizes, registered facilities should have preventive control plans in place and these plans and all related records will be available to the FDA during inspections. There are some exemptions to this provision. Anthony Pavel discusses what will be required in the new preventive control plans.
For performance standards, the FDA plans to review and evaluate relevant health data every two years in order to determine the most significant foodborne contaminants. The agency will then issue contaminant-specific performance standards, which may include action levels.
Another provision of the Act details plans for the FDA to issue guidance and regulations to protect against intentional adulteration. The guidance, which will include model vulnerability assessment and examples of mitigation strategies and measures, is expected within the year. Foods at high risk of intentional adulteration must have preventive control plans.
A major issue with the recalls in recent years has been the speed at which the FDA has been able to trace the source of contamination. Therefore, the new Act focuses a lot on traceability. The FDA will establish a product tracing system that allows the agency to effectively track and trace food. The agency will be conducting pilot programs of the produce and processed food sectors within 180 days. As a part of the traceability efforts, the FDA will establish a list of high-risk foods and additional recordkeeping will be required for these foods. (David Acheson delves into the Act’s traceability provisions).
For imported foods, the Act contains a provision of regulatory significance. The provision states that all importers must have a foreign supplier verification program in place, stating that the food complies with FDA requirements. Once the regulations are in place, approximately in two years, companies offering food for import without a compliant verification program will be subject to injunction and criminal prosecution.
Overall, Bode explained that the Food Safety Modernization Act enables the FDA sweeping new enforcement authorities, including suspension of company registration, mandatory recalls, and broader access to records. While many details of the legislation have yet to be worked out, and there is not a specific timeline for promulgating regulations, Bode expects the Act to be “substantially implemented in three years.”
Food Tracing
Delving into a major component of the Food Safety Modernization Act, David Acheson, Leavitt Partners, outlined the legislation’s requirements regarding traceability. In the conventional supply chain, each entity (grower, processor, manufacturer, etc.) in the process should be able to trace one step forward and one step back. In the new provision, this idea has not changed. However, as Acheson explained, the system needs to be more sophisticated and involve more stringent record requirements. Of course, there are many challenges to providing a successful traceability program, such as the complexity of distribution systems, supply chain unknowns, inconsistent recordkeeping, product name changes throughout the supply chain, different systems of tracking, and repacking of products.
Despite the challenges, traceability is of increasing concern for regulators because of their inability to determine where a food is moving in the supply chain. For example, Acheson describes the Salmonella Saintpaul outbreak in 2008. Due to the complex supply chain and insufficient recordkeeping, it took longer than necessary to determine the true source of contamination—tomatoes or peppers. This leads to increased consumer exposure to the contaminated food and broad industry damage.
In the new legislation, in order to eventually establish a product tracing system, the FDA must first develop pilot programs with the processed food sector and the produce industry within nine months. Within 18 months, the FDA must provide a report to Congress on recommendations for establishing more effective product tracing, including consideration of costs and benefits, feasibility of technologies for different sectors, and existing practices and international efforts that work.
In addition, the new law requires prior notice of rule making within two years to establish recordkeeping requirements for high-risk foods. To do this, the FDA needs to define high-risk products within one year based on known safety risks of a particular food, the likelihood of microbiological or chemical contamination, and the likelihood consuming the food will result in foodborne illness.
Overall, as Acheson explained, the regulators want a traceability system that is consistent, speedy, covers the entire supply chain, has electronic records, has interoperable systems, and covers domestic and imported foods. On top of that, the FDA wants the industry to develop the tools and to pay for the system. Acheson urged the audience and industry to see traceability as a food safety tool, not a burden. In fact, if a system is successful, it will quickly eliminate products, brands, or food categories as a source of foodborne illness. Acheson closed his presentation by urging the industry to engage with regulators, because the FDA will be looking for partners during the development process. This is an opportunity to offer insight and possible concepts as to what will work and what won’t.
Accreditation of Third-Party Auditors
Robert Brackett, Illinois Institute of Technology, spoke to the audience regarding the Food Safety Modernization Act’s provision for certification by an accredited third-party auditor for imported foods and facilities. The dramatic increase in imported foods and ingredients over the past decade has further stressed the FDA’s resources. Given this, there has been increasing interest in third-party audits. Accreditation is an important aspect of third-party audits, in order to ensure consumer confidence in the products. This is not a new idea, as audits have been accredited to private standards in the past (such as the Global Food Safety Initiative). In addition, the government has made recommendations for such accreditation and certification in reports since 2007.
In the new legislation, provision 307 sets out a plan to implement a system to provide for accredited audits of foods and facilities for imported products only. This would become part of a larger set of import regulations laid out in the Act, such as:
- Foreign Supplier Verification: Importers will be required to verify that imported food and food ingredients are produced in accordance with U.S. laws and regulations. Verification may include monitoring records, lot-by-lot certification for compliance, and on-site inspections.
- Volunteer Qualified Importer Program: FDA will provide for expedited entry of products from qualified importers who participate in the program. Participation is voluntary.
- Third-Party Certification: FDA now has the authority to require third-party certification for imported foods or ingredients depending on type, history, or region. Third parties may be foreign governments or private auditors who meet accreditation requirements.
- Laboratory Accreditation: FDA will be required to recognize accreditation bodies to accredit laboratories. Would require the use of accredited laboratories when FDA has designated an identified or suspected food safety problem.
The third-party auditors are subject to some requirements. First, the records of regulatory audits will be made available to the FDA on request. In addition, the auditors must inform the FDA immediately if they discover conditions that could cause or contribute to a serious risk to public health. Brackett noted that in the new legislation there can be consequences for accredited third-party auditors. For example, an auditor can lose accreditation if he/she certifies a food that is linked to an outbreak of foodborne illness.
As Brackett commented, the establishment of a third-party audit system for certification of foods and facilities will not be quick or easy. The FDA has 24 months to establish a system for the recognition of accreditation bodies. Also, the FDA has to establish a user fee program, develop model accreditation standards, and institute a publicly-available registry of accreditation bodies and of accredited third-party auditors. But hopefully, in the end, the use of accredited third-party audits will benefit both the industry and consumers.
Preventive Controls
A new important requirement in the Food Safety Modernization Act entails preventive control plans. Anthony Pavel, K&L Gates, ended the forum on Jan. 7 with a discussion on the changes to preventive control plans in the new legislation. As Pavel explained, most companies have HACCP plans already in place. These are going to provide a good basis for the new preventive control plans but there will be some additions and changes that need to be made. First, there will need to be a Hazard Analysis, which identifies all known or reasonably foreseeable hazards in a written analysis.
In addition, as a part of the plan, preventive controls need to be outlined. These include:
- How to prevent the hazards listed in the analysis
- Sanitation procedures
- Employee hygiene training
- Environmental monitoring program
- Food allergen control program. According to Pavel, this an area of increasing interest for the FDA since the largest cause of recalls is undeclared allergens. The agency wants to get this under control.
- Recall plan
Verification is the next part of the preventive control plan, and, according to Pavel, this part goes beyond the current HACCP and may be difficult to implement. Here, the owner/operator/agent must verify that preventive controls are adequate to control hazards, including environmental and product testing. Also, this step involves verifying the owner is conducting monitoring, making appropriate decisions about corrective actions, and conducting periodic re-analysis of the plan. Pavel noted that with this plan, there is increased emphasis on final product testing, which creates a large burden for the industry.
Recordkeeping is a vital part of the preventive plan. The plan must be written and records must be maintained for a minimum of two years. In addition, records must be made “promptly available” upon oral or written request by the FDA. Lastly, there is a requirement to re-analyze the hazard analysis and preventive control plans at least every three years. However, any significant change that creates a reasonable potential for new hazard warrants the need to immediately re-analyze the plans.
It should be noted that there are some exemptions to the new preventive control plans. These include facilities subject to current HACCP or other requirements, such as seafood, juice, fresh produce, dietary supplements produced under Part 111, and low-acid canned food.
