The Food Safety Modernization Act

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 Food Safety Modernization Act (FSMA) enables the U.S. Food and Drug Administration (FDA) to better protect public health by strengthening the food safety system. The FSMA:

• Enables the FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur;
• Provides the 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;
• Gives the FDA important new tools to hold imported foods to the same standards as domestic foods; and
• Directs the FDA to build an integrated national food safety system in partnership with state and local authorities.

This Compliance Overview presents the FDA’s summary of FSMA Rules.

Links and Resources

• Preventive Controls for Human Food Fact Sheet and FAQs
• Mitigation Strategies to Protect Food Against Intentional Adulteration Fact Sheet and explanatory diagrams
• Sanitary Transportation of Human and Animal Food Fact Sheet, Implementation Fact Sheet and FAQs

Key New Authorities

• Prevention: the FDA will require comprehensive, science-based preventive controls across the food supply.
• Inspection and compliance: will provide the FDA with important new tools for inspection and compliance, including mandated inspection frequency, access to records and laboratory testing.
• Response: new response authority includes mandatory recalls, expanded administrative detention, suspension of registration, enhanced product tracing abilities and additional recordkeeping for high-risk foods.
• Imports:  new authorities include importer accountability, third party certification, certification for high risk foods, voluntary qualified importer program and the authority to deny entry
• Enhanced partnerships: the FSMA builds a formal system of collaboration with other government agencies, both domestic and foreign.

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 FSMA, as well as the modernized Current Good Manufacturing Practices (CGMPs) of this rule (unless an exemption applies).  It is important to note that 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 date 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.

Now larger animal food facilities have been required to comply with the preventive controls requirements since September 18, 2017, and facilities that are small businesses were required to implement the CGMPs by that date.

Because compliance dates are staggered by the size of the business, the next major compliance dates come in September 2018, when small businesses will also have to meet preventive controls requirements and very small businesses must implement the CGMPs.

This rule requires animal food facilities to have a food safety plan in place that includes an analysis of hazards to determine which ones need control and risk-based preventive controls to minimize or prevent those hazards.

Foreign Supplier Verification Programs (FSVP) for Food Importers

The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates begin May 30, 2017.

The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders. The FDA first proposed this rule in July 2013.

After input received during the comment period and during numerous engagements that included public meetings, webinars, and listening sessions, the FDA issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions included providing importers flexibility in determining appropriate verification measures based on food and supplier risks, while acknowledging the greater risk to public health posed by the most serious hazards in foods.

The final rule has elements of both the original and supplemental proposals, with the addition of greater flexibility in meeting certain requirements to better reflect modern supply and distribution chains. For example, importers can meet key FSVP obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as those importers review and assess the corresponding documentation.

The FDA is committed to helping importers comply with the FSVP requirements. In order to facilitate compliance, the FDA will provide guidance, outreach and training.

Mitigation Strategies to Protect Food Against Intentional Adulteration

The FSMA 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, 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.

The proposed rule was issued in December 2013. The changes in the final rule are largely designed to provide either more information, where stakeholders requested it, or greater flexibility for food facilities in determining how they will assess their facilities, implement mitigation strategies, and ensure that the mitigation strategies are working as intended.

In developing the rule, the FDA interacted with the intelligence community and considered vulnerability assessments conducted in collaboration with the food industry.

While acts of intentional adulteration may many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration is addressed in the final preventive controls rules for human and animal foods.

Proposed Rule on Laboratory Accreditation

The FDA is proposing to establish a program for the testing of food by accredited laboratories as required by the FSMA. The laboratory accreditation program, once established, will require that the testing of food in certain circumstances be conducted by laboratories that voluntarily become accredited under this program.

Laboratories that become accredited under this program will be required to follow model standards and will be subject to appropriate oversight. Establishing such a program will help the FDA ensure the safety of the U.S. food supply and protect U.S. consumers by helping ensure appropriate oversight of certain food testing that is of importance to public health. It will also ensure that the testing is done in accordance with appropriate model standards which will help produce consistently reliable and valid test results. 

Proposed Rule for Food Traceability

The FDA is proposing to establish additional traceability recordkeeping requirements (beyond what is already required in existing regulations) for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List. The proposed rule, “Requirements for Additional Traceability Records for Certain Foods” (Food Traceability Proposed Rule) is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and would implement Section 204(d) of the FSMA. The proposed requirements would help the FDA rapidly and effectively identify recipients of those foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death. The proposed rule will be available for public comment for 120 days following publication in the Federal Register.

At the core of this proposal is a requirement for those who manufacture, process, pack or hold foods on the Food Traceability List (FTL) to establish and maintain records containing Key Data Elements (KDEs) associated with different Critical Tracking Events (CTEs).  While the proposed requirements would only apply to those foods on the FTL, they were designed to be suitable for all FDA-regulated food products. The FDA would encourage the voluntary adoption of these practices industry-wide.

Coverage

With some exceptions listed below, this rule applies to both domestic and foreign companies that are required to register with the FDA as food facilities under the Federal Food, Drug, and Cosmetic (FD&C) Act.

This rule is designed to primarily cover large companies whose products reach many people, exempting smaller companies. There are 3,400 covered firms that operate 9,800 food facilities.

It does not cover farms.

Key Provisions

While this is the first time that companies are required to create a food defense plan, the FDA has taken an approach similar to Hazard Analysis Critical Control Point (HACCP) system, an approach adopted by industry for the identification, evaluation and control of food safety hazards. The FSMA rules advance and strengthen those safeguards.

Each covered facility is required to prepare and implement a food defense plan. This written plan must identify vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions and verification. A reanalysis is required every three years or when certain criteria are met, including mitigation strategies that are determined to be improperly implemented. 

Vulnerability assessment: This is the identification of vulnerabilities and actionable process steps for each type of food manufactured, processed, packed or held at the food facility. For each point, step, or procedure in the facility’s process, these elements must be evaluated:

• The severity and scale of the potential impact on public health. This would include such considerations as the volume of product, the number of servings, the number of exposures, how fast the food moves through the distribution system, potential agents of concern and the infectious/lethal dose of each; and the possible number of illnesses and deaths.
• The degree of physical access to the product. Things to be considered would include the presence of such physical barriers as gates, railings, doors, lids, seals and shields.
• The ability to successfully contaminate the product.

Mitigation strategies: These should be identified and implemented at each actionable process step to provide assurances that vulnerabilities will be minimized or prevented. The mitigation strategies must be tailored to the facility and its procedures.

• The final rule removes the distinction between “broad” and “focused” mitigation strategies. The original proposal only required “focused” mitigation strategies because “broad” mitigation strategies, such as a fence around the entire facility, did not protect specific points from being attacked by an insider.
• The final rule recognizes that a mitigation strategy, applied in a directed and appropriate way to protect the actionable process step from an insider attack, would sufficiently minimize the risk of intentional adulteration.

Mitigation strategy management components: Steps must be taken to ensure the proper implementation of each mitigation strategy. In each of these areas of food defense, the facilities are given more flexibility in the final rule to establish the actions most appropriate to their operation and product.

• Monitoring:Establishing and implementing procedures, including the frequency with which they are to be performed, for monitoring the mitigation strategies.
• Corrective actions: The response if mitigation strategies are not properly implemented.
• Verification: Verification activities would ensure that monitoring is being conducted and appropriate decisions about corrective actions are being made.

Training and recordkeeping: Facilities must ensure that personnel assigned to the vulnerable areas receive appropriate training; facilities must maintain records for food defense monitoring, corrective actions, and verification activities.

Compliance Date

This rule is a first of its kind, so education and outreach is critical. Additionally, the FDA recognizes that many of the food facilities covered by this rule will also be meeting the requirements of other FSMA rules. Therefore, the FDA is providing a longer timeline in the final rule for facilities to comply with the intentional adulteration rule.

• Very Small Businesses—a business (including any subsidiaries and affiliates) averaging less than $10,000,000, adjusted for inflation, per year, during the three-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale (e.g., held for a fee). These businesses would have to comply with modified requirements within five years after the publication of the final rule.
• Small Businesses—a business employing fewer than 500 persons would have to comply four years after the publication of the final rule.
• Other Businesses—a business that is not small or very small and does not qualify for exemptions would have to comply three years after the publication of the final rule.
  
  

Exemptions

• A very small business. While exempt, the business would be required to provide to the FDA, upon request, documentation to demonstrate that the business is very small.
• The holding of food, except the holding of food in liquid storage tanks
• The packing, re-packing, labeling or re-labeling of food where the container that directly contacts the food remains intact
• Activities that fall within the definition of “farm”
• Manufacturing, processing, packing, or holding of food for animals
• Alcoholic beverages under certain conditions
• On-farm manufacturing, processing, packing, or holding by a small or very small business of certain foods identified as having low-risk production practices. The exemption applies if such activities are the only activities conducted by the business subject to the rule. These foods include certain types of eggs, and certain types of game meats.
  
  

Sanitary Transportation of Human and Animal Food

The FSMA rule on Sanitary Transportation of Human and Animal Food is now final, advancing the FDA’s efforts to protect foods from farm to table by keeping them safe from contamination during transportation. The earliest compliance dates for some firms begin one year after publication of the final rule in the Federal Register.

This rule is one of seven foundational rules proposed since January 2013 to create a modern, risk-based framework for food safety. 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 builds on safeguards envisioned in the 2005 Sanitary Food Transportation Act (SFTA). Because of illness outbreaks resulting from human and animal food contaminated during transportation, and incidents and reports of unsanitary transportation practices, there have long been concerns about the need for regulations to ensure that foods are being transported in a safe manner.

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.

Changes from the Proposed Rule

The proposed rule opened for public comment on February 5, 2014. The FDA made changes throughout the rule in response to public comments, as it has for the other FSMA rules that have become final in the last seven months. For additional information on key changes that have been made in the final rule, please see Key Changes in the FSMA Final Rule on Sanitary Transportation of Human and Animal Food.

Coverage

With some exceptions, the final rule applies to shippers, receivers, loaders and carriers who transport food in the United States by motor or rail vehicle, whether or not the food is offered for or enters interstate commerce.

It also applies to persons, e.g., shippers, in other countries who ship food to the United States directly by motor or rail vehicle (from Canada or Mexico), or by ship or air, and arrange for the transfer of the intact container onto a motor or rail vehicle for transportation within the U.S., if that food will be consumed or distributed in the United States.

The rule does not apply to exporters who ship food through the United States (for example, from Canada to Mexico) by motor or rail vehicle if the food does not enter U.S. distribution.

Companies involved in the transportation of food intended for export are covered by the rule until the shipment reaches a port or U.S. border.

Key Requirements

Specifically, the rule would establish requirements for:

• Vehicles and transportation equipment: The design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe. For example, they must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.
• Transportation operations:The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen.
• Training:Training of carrier personnel in sanitary transportation practices and documentation of the training. Carriers covered by the rule are required to provide food safety training to transportation operations personnel when the carrier and shipper agree that the carrier is responsible for sanitary conditions during transport. See the FDA Training Module.
• Records:Maintenance of records of written procedures, agreements and training (required of carriers). The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.
  
  

Waivers

The Sanitary Food Transportation Act (SFTA) allows the agency to waive the requirements of this FSMA rule if it determines that the waiver will not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.

The FDA has published three waivers for businesses whose transportation operations are subject to Federal-State or local controls. They include:

• Businesses that hold valid permits and are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program, only when engaged in transportation operations involving bulk and finished Grade “A” milk and milk products.
• Businesses that are permitted or otherwise authorized by the regulatory authority to operate a food establishment that provides food directly to consumers (including restaurants, retail food establishments, and nonprofit food establishments, as defined in 21 CFR 1.227), only when engaged in transportation operations as:
  • Receivers, whether the food is received at the establishment itself or at a location where the authorized establishment receives and immediately transports the food to the food establishment;
  • Shippers and carriers in operations in which food is transported from the establishment as part of the normal business operations of a retail establishment, such as:
    • delivery of the food directly to the consumer(s) by the authorized establishment or a third-party delivery service or
    • delivery of the food to another location operated by the authorized establishment or an affiliated establishment where the food is to be sold or served directly to the consumer(s).
  • Businesses that are appropriately certified and are inspected under the requirements established by the Interstate Shellfish Sanitation Conference’s National Shellfish Sanitation Program (NSSP), only when engaged in transportation operations involving molluscan shellfish in vehicles that are permitted by the State NSSP certification authority.

These waivers were published after being described in the proposed and final Sanitary Transportation of Human and Animal Food rule. The FDA considered comments on the waivers and found that the waivers would not result in the transportation of food under conditions that would be unsafe for human or animal health, or contrary to the public interest.

Related notices: Federal Register Notice: Waivers from Requirements of the Sanitary Transportation of Human and Animal Food Rule

Compliance Dates

Recognizing that businesses, especially small businesses may need more time to comply with the requirements, the compliance dates are adjusted accordingly.

• Small Businesses - businesses other than motor carriers who are not also shippers and/or receivers employing fewer than 500 persons and motor carriers having less than $27.5 million in annual receipts would have to comply two years after the publication of the final rule.
• Other Businesses - a business that is not small and is not otherwise excluded from coverage would have to comply one year after the publication of the final rule.

Exemptions

• Shippers, receivers, or carriers engaged in food transportation operations that have less than $500,000 in average annual revenue
• Transportation activities performed by a farm
• Transportation of food that is transshipped through the United States to another country
• Transportation of food that is imported for future export and that is neither consumed nor distributed in the United States
• Transportation of compressed food gases (e.g. carbon dioxide, nitrogen or oxygen authorized for use in food and beverage products), and food contact substances
• Transportation of human food byproducts transported for use as animal food without further processing
• Transportation of food that is completely enclosed by a container except for food that requires temperature control for safety
• Transportation of live food animals, except molluscan shellfish