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The Food Safety Modernization Act (FSMA) passed by Congress in December 2010 and signed into law in 2011 is the most comprehensive food safety legislation in the U.S. since 1937.

“The law changes many of the regulatory structures designed to protect the public from foodborne illness, but mainly it updates the Food and Drug Administration’s (FDA) authority to regulate foods. Previously, the FDA only acted after a foodborne illness outbreak occurred. The FSMA enables the FDA to design measures that prevent foodborne outbreaks from occurring, proactively regulating the food industry,” reported the National Conference of State Legislators (NCSL).

While the FSMA was passed more than a decade ago, there are many aspects of the complicated legislation that are still being put into action.

“The broad scope of FSMA regulations across the entire food safety supply has required years to bring to fruition, and implementation is ongoing,” said Penn State Extension in 2021.

Rise in Foodborne Diseases Prompted FSMA Passage

A rise in foodborne diseases in the U.S., highlighted by a 2018 E. coli outbreak in romaine lettuce that resulted in illnesses across 16 states and an estimated $280 to $350 million economic blow to the food industry, spurred the FSMA legislation.

The FDA estimates that largely preventable public health foodborne diseases resulted each year in the U.S. in:

• 48 million people (1 in 6) are getting sick.
• 128,000 people were hospitalized.
• 3,000 people die each year.

“The FDA Food Safety Modernization Act (FSMA) is transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system,” explained the FDA.

Economic losses to growers, processors, shippers, and retailers also factored into the new protections.

“The FSMA was adopted in part as a response to the large numbers of people becoming sick from foodborne diseases and the heavy economic losses,” said the NCSL.

FSMA: 9 Major Rules to Ensure the Safety of the Food Supply

The FDA has finalized nine major rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food.

The FSMA rules are designed to make clear specific actions that must be taken at each of these points to prevent contamination.

Rules and related programs to the FSMA include:

• Agricultural Water: The FDA is proposing a revision to Subpart E of the FSMA Produce Safety Rule that would change the pre-harvest agricultural water requirements for covered produce (other than sprouts). The requirements in this proposed rule, if finalized, would replace the pre-harvest microbial quality criteria and testing requirements in the Produce Safety Rule with requirements for systems-based pre-harvest agricultural water assessments. These assessments would be used to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto produce or food contact surfaces and to determine whether corrective or mitigation measures are needed to minimize the risks associated with pre-harvest agricultural water.
  
  
• Accredited Third-Party Certification: The FSMA rule on Accredited Third-Party Certification was finalized in November 2015. The rule establishes a voluntary program for the accreditation of third-party certification bodies, also known as third-party auditors, to conduct food safety audits and issue certifications of foreign entities and the foods for humans and animals they produce. These requirements are intended to help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program. FSMA specifies two uses for certifications under this program:

o   Certifications may be used by importers to help establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review entry of food.

o   To prevent potentially harmful food from reaching U.S. consumers, the FDA can also require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.

• Food Traceability: The FDA final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule) establishes traceability recordkeeping requirements, beyond those in existing regulations, for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). The final rule is a key component of FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA). The new requirements identified in the final rule will allow for faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.

At the core of this rule is a requirement that persons subject to the rule who manufacture, process, pack, or hold foods on the FTL, maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.

The final rule aligns with current industry best practices and covers domestic, as well as foreign firms producing food for U.S. consumption, along the entire food supply chain in the farm-to-table continuum.

• Foreign Supplier Verification Programs (FSVP): The FSVP rule requires importers to perform risk-based foreign supplier verification activities to verify that:

o   The food is produced in a manner that provides the same level of public health protection as section 418 (concerning hazard analysis and risk-based preventive controls) or 419 (concerning standards for the safe production and harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs) of the FD&C Act (21 U.S.C. 350g and 350h), if applicable;

o   The food is not adulterated under section 402 of the FD&C Act (21 U.S.C. 342); and

o   The human food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)) (concerning food allergen labeling).

• Laboratory Accreditation for Analyses of Foods (LAAF): The FSMA final rule on Laboratory Accreditation for Analyses of Foods (LAAF) establishes a laboratory accreditation program for the testing of food in certain circumstances. Under the LAAF program, FDA will recognize accreditation bodies (ABs) that will accredit laboratories to the standards established in the final rule (referred to as LAAF-accredited laboratories).

The final rule specifies eligibility requirements that ABs and laboratories wishing to participate in the program will need to satisfy, as well as procedures for how the FDA will manage and oversee the program. In certain circumstances, owners and consignees will be required to use a LAAF-accredited laboratory for food testing. FDA will maintain an online public registry listing recognized accredited bodies and LAAF-accredited laboratories.

The establishment of the LAAF program is intended to improve the accuracy and reliability of certain food testing through the uniformity of standards and enhanced FDA oversight of participating laboratories.

• Mitigation Strategies to Protect Food Against Intentional Adulteration: The FSMA's final rule is aimed at preventing intentional adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism targeting the food supply. Such acts, while not likely to occur, could cause illness, death, and economic disruption of the food supply absent mitigation strategies. Rather than targeting specific foods or hazards, this rule requires mitigation (risk-reducing) strategies for processes in certain registered food facilities.

• Preventive Controls for Human Food: Generally, domestic and foreign food facilities that are required to register with section 415 of the Food, Drug, & Cosmetic Act must comply with the requirements for risk-based preventive controls mandated by the FDA Food Safety Modernization Act (FSMA) as well as the modernized Current Good Manufacturing Practices (CGMPs) of this rule (unless an exemption applies).  It is important to note that the applicability of the CGMPs is not dependent upon whether a facility is required to register.

This rule, which became final in September 2015, requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.

Compliance dates are staggered, based on the size of the business, with separate dates for the requirements of the supply chain program. Training, education, and technical assistance are available for those covered by this rule.

• Preventive Controls for Animal Food: The second major compliance dates for the FSMA Preventive Controls for Animal Food rule arrived in September 2017. The final rule was published in September 2015 and larger animal food facilities were required to comply with the Current Good Manufacturing Practice (CGMP) requirements by September 2016.

• Produce Safety: The Produce Safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part of the agency’s ongoing efforts to implement the FDA Food Safety Modernization Act. The final rule went into effect on January 26, 2016.

• Sanitary Transportation of Human and Animal Food: The FSMA rule on Sanitary Transportation of Human and Animal Food is now final, advancing FDA’s efforts 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. The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law. Specifically, the FSMA rule establishes requirements for vehicles and transportation equipment, transportation operations, records, training and waivers.
  
  
• Voluntary Qualified Importer Program (VQIP): The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the United States for participating importers. Both consumers and importers will benefit from this program. Participating importers will be able to import their products to the U.S. with greater speed and predictability, avoiding unexpected delays at the point of import entry. Consumers will also benefit from the importer’s robust management of the safety and security of their supply chains. To participate, importers must meet eligibility criteria and pay a user fee that covers costs associated with the FDA’s administration of the program.

The Latest News on the FSMA

The FSMA is constantly evolving with the latest news in 2023 as:

• FDA Concludes Voluntary Pilot Program to Evaluate Alignment of Third-Party Food Safety Standards with FSMA Rules: For the pilot, the FDA selected and assessed third-party food safety standards for alignment with the requirements in the Preventive Controls for Human Food or Produce Safety rules. Although the specific elements of the third-party food safety standards and the FSMA implementing regulations may not be identical, a finding of alignment indicates that the relevant technical components of the PC Human Food or Produce Safety rules have been addressed.
  
  
• Small Entity Compliance Guide (Requirements for Additional Traceability Records for Certain Foods): This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule.
  
  
• Guidance for Industry (Transition from Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption): This document communicates FDA’s current thinking on how, when the COVID-19 public health emergency expires, qualified exempt farms may transition away from those temporary policies and back to the qualified exemption eligibility criteria as established in the Produce Safety Rule.
  
  
• Guidance for Industry (Foreign Supplier Verification Programs for Importers of Food for Humans and Animals): This guidance provides questions and answers to facilitate importers’ understanding of the FSVP requirements.