United States FDA – Food Safety Modernization Act (FSMA)
The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. The law provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur.
To cover the entire food system, FSMA has divided the covered areas into the following 7 rules (now final):
- Preventive Controls for Human Food
- Establish Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
- Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
- Mitigation Strategies to Protect Food Against Intentional Adulteration
- Accredited Third-Party Certification
- Sanitary Transportation of Human and Animal Food (STHAF)
For the first time, FDA will have a legislative mandate to require comprehensive, science-based preventive controls across the food supply. This mandate includes:
Mandatory preventive controls for food facilities: Food facilities are required to implement a written preventive controls plan. This involves:
(1) evaluating the hazards that could affect food safety,
(2) specifying what preventive steps, or controls, will be put in place to significantly minimize or prevent the hazards,
(3) specifying how the facility will monitor these controls to ensure they are working,
(4) maintaining routine records of the monitoring, and
(5) specifying what actions the facility will take to correct problems that arise. (Final rule due 18 months following enactment)
Mandatory produce safety standards: FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables. Those standards must consider naturally occurring hazards, as well as those that may be introduced either unintentionally or intentionally, and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water. (Final regulation due about 2 years following enactment)
Authority to prevent intentional contamination:FDA must issue regulations to protect against the intentional adulteration of food, including the establishment of science-based mitigation strategies to prepare and protect the food supply chain at specific vulnerable points. (Final rule due 18 months following enactment)
Inspection and Compliance
The FSMA recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. Therefore, it will be necessary for FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge. FSMA provides FDA with important new tools for inspection and compliance, including:
Mandated inspection frequency: The FSMA establishes a mandated inspection frequency, based on risk, for food facilities and requires the frequency of inspection to increase immediately. All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years.
Records access: FDA will have access to records, including industry food safety plans and the records firms will be required to keep documenting implementation of their plans.
Testing by accredited laboratories: The FSMA requires certain food testing to be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards. (Establishment of accreditation program due 2 years after enactment)
The FSMA recognizes that FDA must have the tools to respond effectively when problems emerge despite preventive controls. New authorities include:
Mandatory recall: The FSMA provides FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA.
Expanded administrative detention: The FSMA provides FDA with a more flexible standard for administratively detaining products that are potentially in violation of the law (administrative detention is the procedure FDA uses to keep suspect food from being moved).
Suspension of registration: FDA can suspend registration of a facility if it determines that the food poses a reasonable probability of serious adverse health consequences or death. A facility that is under suspension is prohibited from distributing food. (Effective 6 months after enactment)
Enhanced product tracing abilities: FDA is directed to establish a system that will enhance its ability to track and trace both domestic and imported foods. In addition, FDA is directed to establish pilot projects to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or control a foodborne illness outbreak. (Implementation of pilots due 9 months after enactment)
Additional Recordkeeping for High Risk Foods: FDA is directed to issue proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack, or hold foods that the Secretary designates as high-risk foods. (Implementation due 2 years after enactment).
The FSMA gives FDA unprecedented authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include:
Importer accountability: For the first time, importers have an explicit responsibility to verify that their foreign suppliers have adequate preventive controls in place to ensure that the food they produce is safe. (Final regulation and guidance due 1 year following enactment)
Third Party Certification: The FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards. This certification may be used to facilitate the entry of imports. (Establishment of a system for FDA to recognize accreditation bodies is due 2 years after enactment)
Certification for high risk foods: FDA has the authority to require that high-risk imported foods be accompanied by a credible third party certification or other assurance of compliance as a condition of entry into the U.S.
Voluntary qualified importer program: FDA must establish a voluntary program for importers that provides for expedited review and entry of foods from participating importers. Eligibility is limited to, among other things, importers offering food from certified facilities. (Implementation due 18 months after enactment)
Authority to deny entry: FDA can refuse entry into the U.S. of food from a foreign facility if FDA is denied access by the facility or the country in which the facility is located.
The FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign. In doing so, the statute explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve our public health goals. The following are examples of enhanced collaboration:
State and local capacity building: FDA must develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies. The FSMA provides FDA with a new multi-year grant mechanism to facilitate investment in State capacity to more efficiently achieve national food safety goals.
Foreign capacity building: The law directs FDA to develop a comprehensive plan to expand the capacity of foreign governments and their industries. One component of the plan is to address training of foreign governments and food producers on U.S. food safety requirements.
Reliance on inspections by other agencies: FDA is explicitly authorized to rely on inspections of other Federal, State and local agencies to meet its increased inspection mandate for domestic facilities. The FSMA also allows FDA to enter into inter-agency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.
Additional partnerships are required to develop and implement a national agriculture and food defense strategy, to establish an integrated consortium of laboratory networks, and to improve foodborne illness surveillance.
The content on this page has been referenced from the FDA website to maintain accuracy. To view full FSMA documentation on the law, exemptions, enforcement, compliance, etc. we encourage you to visit the FDA FSMA website
Do These New Rules Apply to My Company?
FDA legislative mandate to require preventive controls across the entire food supply chain from farm to table.
It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it. Visit the FDA website for detailed information on all things FSMA.
What are the major elements of the FDA Food Safety Modernization Act?
The elements can be divided into five key areas:
- Preventive controls – For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply to prevent or significantly minimize the likelihood of problems occurring.
- Inspection and Compliance – The legislation recognizes that inspection is an important means of holding industry accountable for its responsibility to produce safe food. FDA is committed to applying its inspection resources in a risk-based manner and adopting innovative inspection approaches.
- Imported Food Safety – FDA has new tools to ensure that imported foods meet U.S. standards and are safe for our consumers. For example, for the first time, importers must verify that their foreign suppliers have adequate preventive controls in place to ensure safety, and FDA will be able to accredit qualified third party auditors to certify that foreign food facilities are complying with U.S. food safety standards.
- Response – For the first time, FDA has mandatory recall authority for all food products. FDA expects that it will only need to invoke this authority infrequently since the food industry largely honors our requests for voluntary recalls. The agency has other new authorities that are also in effect: expanded administrative detention of products that are potentially in violation of the law, and suspension of a food facility’s registration.
- Enhanced Partnerships – The legislation recognizes the importance of strengthening existing collaboration among all food safety agencies—U.S. federal, state, local, territorial, tribal and foreign–to achieve our public health goals. For example, it directs FDA to improve training of state, local, territorial and tribal food safety officials.
How are the preventive controls rules different from the Hazard Analysis and Critical Control Points (HACCP) system?
The Hazard Analysis and Critical Control Points systems that many FDA-regulated manufacturers have in place are the foundation of the preventive controls regulations. Although there are similarities between the FSMA preventive controls requirements and the HACCP system, not every provision is identical. For example, in HACCP systems, controls are applied at critical control points (CCPs), whereas preventive controls include controls at CCPs or controls other than those at CCPs that are appropriate for food safety.
For how long are records required under the new law’s “Hazard Analysis and Risk-Based Preventive Controls” provision (FSMA section 103/Food Drug and Cosmetic Act (the FD&C Act) section 418) required to be kept?
This section of the new law contains a provision (FD&C Act section 418(g)) requiring that certain records established under that section be kept for at least two years.
Where can I find more frequently asked questions on FSMA?
Please visit the FDA Website on FSMA here.