FDA Food Safety Modernization Act 2011 (FSMA)


FDA Food Safety Modernization Act 2011 (FSMA)

The Breakdown

• The US Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011.

• While the FDA missed many statutory deadlines in the release of rules, most of the larger significant rules have been released in draft form and public comment periods are closed while the FDA reviews these comments and finalizes the proposed rules. None of the final rules have yet to be released.

• FSMA enables the FDA to focus on preventing food safety problems rather than reacting to problems after they occur.

• FSMA provides the FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention and risk-based food safety standards, new tools to hold imported foods to the same standards as domestic foods, directs the FDA to build an integrated national food safety system in partnership with state and local authorities, and for the first time gives the agency mandatory recall authority.

From the FDA website:


• FSMA gives the FDA 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.

– Mandatory produce safety standards: The 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. It must also establish standards for soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area, and water.

– Authority to prevent intentional contamination: The 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.
Inspection and Compliance


• FSMA provides FDA with new tools for inspection and compliance, including:

– Mandated inspection frequency: 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 5 years of enactment and no less than every 3 years thereafter. Within one year of enactment, the law directs the FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years.

– Records access: The FDA will have access to records, including industry food safety plans and the records that firms will be required to keep while documenting the implementation of their plans.

– Testing by accredited laboratories: FSMA requires certain food testing to be carried out by accredited laboratories and directs the FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards.


• FSMA provides the FDA with tools to effectively respond when problems emerge despite preventive controls. New authorities include:

– Mandatory recall: FSMA provides the FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to do so.

– Expanded administrative detention: FSMA provides the 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: The 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.

– Enhanced product tracing abilities: The 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.

– Additional Recordkeeping for High Risk Foods: The 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.


• FSMA gives the FDA new authority to better ensure that imported products meet U.S. standards and are safe for U.S. consumers. New authorities include:

– Importer accountability: 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.

– Third Party Certification: FSMA establishes a program through which qualified third parties can certify that foreign food facilities comply with U.S. food safety standards.

– Certification for high-risk foods: The 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 US.

– Voluntary qualified importer program: The 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.

– Authority to deny entry: The FDA can refuse entry into the U.S. of food from a foreign facility if the FDA is denied access by the facility or the country in which the facility is located.

Enhanced Partnerships

• FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign. The following are examples of enhanced collaboration:

– State and local capacity building: FSMA provides FDA with a new multi-year grant mechanism to facilitate investment in State capacity and more efficiently achieve national food safety goals.

– Foreign capacity building: The FDA must 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: The FDA is explicitly authorized to rely on inspections of other Federal, State and local agencies to meet its increased inspection mandate for domestic facilities. FSMA also allows FDA to enter into interagency agreements to leverage resources with respect to the inspection of seafood facilities, both domestic and foreign, as well as seafood imports.

Our Position

• Stop Foodborne Illness is pleased that Congress has finally addressed the need for food safety reform within the FDA. FSMA is the most sweeping food safety legislation passed within the last 70 years.

• Although Stop is satisfied with the passing of FSMA, we believe it must be fully funded to work as designed. We also recognize that Congress’ capitulation to special interest groups through exemptions for certain food producers could seriously undermine the preventative nature of FSMA and leave millions of consumers exposed to unregulated foods.

Glossary & Acronyms

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