What is FSMA?

Food Safety Mordernization Act (FSMA)

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What is Food Safety Modernization Act (FSMA)?

In the United States, about 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention.  This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA) aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing food safety problems before they occur.

FSMA aims to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to problems when they occur.  FSMA also provides tools to hold imported foods to the same standards as domestic foods.

FDA’s New Food Safety Law

In-Depth Coverage: Food Import Requirements

FSMA requires comprehensive, science-based preventive controls across the food supply, including

  • Preventive Controls for Food Facilities: Food facilities that engaged in manufacturing, processing, packing, or holding food for consumption by human and animals in the United States are required to implement a written preventive control 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.   

  • Produce Safety Standards:  FDA enforces 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.  

  • Authority to Prevent Intentional Contamination: FDA has issued 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.  

  • Sanitary Transportation of Human and Animal Food:  FDA has issued the final rule to protect foods from farm to table by keeping them safe from contamination during transportation. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

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Inspection and Compliance

The FSMA provides FDA with tools to ensure compliance with requirements and respond effectively when problems occur, 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 the 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 records firms will be required to keep documenting the 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.  

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FDA’s Authoritative Response

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 the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by the 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 the 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:  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:  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.  

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In-Depth Coverage: Trade Remedies

FSMA Import Control

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.  Foreign Supplier Verification Program (FSVP)

  • Third Party Certification:  FSMA has established 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.

  • 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 has established 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:  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.

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