In December 2010, Congress enacted the Food Safety Modernization Act (FSMA), the most comprehensive food safety legislation 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.
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. Following a November 2018 E. coli outbreak in romaine lettuce, the agricultural sector lost more than $280 million, according to a report published by the University of California at Davis. Processors and shippers lost an estimated $20.6 million after pulling products from the supply chain and $37.3 million from products that couldn’t be harvested or sold. Grocery retailers lost an estimated $25.7 million due to price changes in romaine and having to pull the lettuce off their shelves.
The FSMA applies to all food facilities except meat, poultry and certain egg producers, which are regulated by the U.S. Department of Agriculture. Small businesses and farms are not subject to as extensive requirements as large food manufacturers and processors, but every food facility is covered in some manner. Food facilities that only sell within their state (or within 275 miles of their facility) and have less than $500,000 in annual sales are not covered by the FSMA. They do remain subject to state and local food safety laws.
The act primarily addresses regulatory gaps at the FDA and does not place a burden on the states. States are not required to perform any of its provisions nor does the law supersede state law. Food producers and processors will still have to follow state rules in addition to the new FDA requirements. Because the FDA has not promulgated its regulations, no case can be made that their rules conflict with any state rules. There may be a likelihood of duplication of efforts; however, between the state standards and the FDA requirements once the rules are promulgated.
State and local programs are mentioned often in the act. Section 110 of the FSMA requires the FDA to provide outreach to the state and local governments to build their food safety and food defense capabilities, which will include additional resources for state food safety programs. In addition, the FDA must work with states and local health programs to determine the best approach to addressing surveillance and tracing back of foodborne outbreaks.
Section 112, which addresses food allergy and anaphylaxis management, specifically asserts (in § 112(b)(3)) that nothing in that section should be construed to preempt state law.
However, although no specific state requirements exist, the law encourages the FDA to rely heavily on current state food safety and inspection programs, since a majority of the work currently is performed by state agencies. Section 205 (c ) requires the FDA to “develop and implement strategies to leverage and enhance the food safety and defense capacities of state and local agencies” regarding foodborne illness outbreaks, state laboratory capacity, carrying out inspection and enforce safety standards, to share information among agencies, and to improve the effectiveness of federal, state and local partnerships on food safety and defense. Section 209 provides for improving the training of state, local territorial and tribal food safety officials. Section 210 authorizes grants from the FDA to states and local governments to enhance food safety activities, build state laboratory capacities and build the infrastructure of state food safety programs.
Foodborne outbreaks, surveillance and inspection activities, and trace-back efforts all currently reside in the purview of state agencies, though funding often comes from a federal source. In-state sales of food products, such as sales at local farmers markets or other intrastate sales, remain under the purview of state government. Food produced on a farm and sold by the farm directly to a consumer is exempt (§ 204 (d)(6)(H)(I)), meaning any regulation of such activities must be done under state authority.
State departments of health are specifically mentioned. Section 399V-5 establishes Food Safety Integrated Centers of Excellence, which are to be housed in various state departments of health. These centers are to help other states and local departments of health through outbreak surveillance and investigations, analysis of the response, offering epidemiological and environmental training, and training and coordination of state and local agency staff. This effort will enhance state capabilities to identify and respond to a foodborne outbreak, though it will require states to maintain a food safety program within their health departments.
The Food and Drug Administration
The FDA has the primary role in ensuring the nation’s food supply is safe. Through its regulatory authority and extensive contracts with state and local food and health officials, the FDA is responsible for food safety in this country, with the exception of meat, poultry and egg safety requirements handled by the U.S. Department of Agriculture (USDA).
The FSMA provides the FDA with new authorities designed to achieve higher rates of compliance with prevention and risk-based food safety standards. It allows the agency to respond to and contain food safety problems when they arise. The law also directs the FDA to ensure imported foods follow the same standards as foods domestically produced.
Most importantly for states, it directs the FDA to build an integrated national food safety system in partnership with state and local authorities.
The FSMA gives the FDA the mandate to design and implement a comprehensive, science-based system to prevent foodborne outbreaks. Much like the Hazard Analysis Critical Control Point (HACCP) plans the FDA requires of seafood and juice producers (and USDA requires of meat and poultry establishments), the FDA must promulgate rules requiring facilities to adopt a comprehensive hazards-management plan. Food processing, manufacturing, shipping and other regulated facilities must evaluate and prepare written analyses of known or reasonably foreseeable food safety hazards that could affect food manufactured, processed, packed, transported, or stored there (such as chemical hazards, pesticides, parasites, and allergens, whether unintentionally or intentionally introduced) at least once every three years (or more often if warranted). The facilities then must act on their analysis, implementing preventive controls to minimize or eliminate such hazards, monitor the effectiveness of such controls, take corrective actions as needed, and maintain documentation of the controls. Facilities under the HACCP requirements and facilities subject to the produce safety requirements provided by the FSMA are exempt from this requirement.
FSMA § 104 requires the FDA, in consultation with the USDA, to implement performance standards to determine the most significant food contaminants. The FDA must issue contaminant-specific and science-based guidance documents, action levels, or regulations to reduce the risk of serious illness or death, prevent adulteration of food, or prevent the spread of a communicable disease by food. These standards will apply to products and product classes (instead of to facilities). They are intended to help control risk factors in food, ensure acceptable processing controls, and enable the FDA to more quickly assess whether a food is safe and whether a facility should be inspected.
Section 105 of the FSMA addresses produce safety standards, requiring the FDA to establish science-based, minimum standards for safe production and harvesting of raw agricultural commodities, meaning fruits and vegetables. The FDA must provide sufficient flexibility in its regulations to account for different scales and types of production, to coordinate with the USDA and state agricultural agencies, and allow for states (or foreign) governments to request a variance based on local growing conditions.
The act requires the FDA to perform the following prevention-based controls:
- 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 and must address soil amendments (materials added to the soil such as compost), hygiene, packaging, temperature controls, animals in the growing area and water. These standards will address growing, harvesting, sorting, storage, hygiene, packaging, temperature controls, animal encroachment, and water concerns related to produce.
- 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.
Surveillance, Inspection and Compliance
Currently, food facilities (both foreign and domestic) must register with the FDA once, unless there is a relevant change in status then they must notify the FDA of this change. The FSMA increases registrations by requiring regular renewals every two years for food facilities (farms, restaurants, retailers and some other entities are exempt). In addition, §101 of the law eliminates the requirement that the FDA has a “reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death” before performing an inspection of records. If the FDA believes the food will cause “serious adverse health consequences or death” they may inspect records for foods in question and also foods likely to be infected if there is a reasonable belief of harm. They must notify the facility in advance of the inspection, however, as previously required.
The FSMA recognizes that preventive control standards improve food safety only to the extent that producers and processors comply with them. The act authorizes the FDA to provide oversight, ensure compliance with requirements and respond effectively when problems emerge. High-risk facilities, ones identified based on factors such as the processing particularly risky foods, a poor compliance history, the effectiveness of the facility’s hazards analysis and risk-based preventive controls, will be inspected more frequently.
Section 205 relates to food illness surveillance, defining it as the occurrence of two or more cases of a similar illness resulting from the ingestion of a certain food. States have traditionally conducted foodborne outbreaks, with assistance from the CDC. The act establishes a new surveillance system for outbreaks which could include coordinating and integrating federal, state, and local surveillance systems, improved sharing of information, public access to aggregate surveillance data and expanding system capacity.
FSMA provides the 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 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 firms will be required to keep documenting implementation of their plans. Farms and restaurants are exempt from these record-keeping requirements.
- Testing by accredited laboratories: The FSMA § 202 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.
Title II – Response
The FSMA provides the FDA with new tools to respond effectively when food health problems emerge despite preventive controls. These new authorities include:
- Mandatory recall: The FSMA § 206 provides the FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by the FDA. The FDA can impose a recall if 1) there is a reasonable probability that the food is adulterated or misbranded; 2) the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals, or 3) the responsible party has refused to voluntarily cease distribution and recall the products.
- Expanded administrative detention: The 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 the FDA uses to keep suspect food from being moved). The FDA may impose administrative detention if it has “reason to believe” that an article of food is “adulterated or misbranded.”
- Suspension of registration: The FDA can suspend registration of a facility if it determines that a food processed in that facility poses a reasonable probability of serious adverse health consequences or death, based on a determination that “food manufactured, processed, packed, received, or held by a facility registered … has a reasonable probability of causing serious adverse health consequences or death to humans or animals.” A facility under suspension is prohibited from importing food or introducing food into commerce.
- Enhanced product tracing abilities: FSMA § 202 directs the FDA to establish a system that will enhance its ability to track and trace both domestic and imported foods. In addition, the 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. The FDA must coordinate with USDA and state governments to assess product-tracing technologies.
- 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 the secretary designates as high-risk foods.
Title III – Imports
Imported foods have generally not been subject to the same rigorous standards as domestic food. The FSMA changes that concept, ensuring foreign grown and processed foods are as safe as foods produced domestically. The act gives the FDA unprecedented authority to ensure imported products meet U.S. standards and are safe for consumers. New authorities include:
- Importer accountability: For the first time, importers have an explicit responsibility to verify their foreign suppliers have adequate preventive controls in place to ensure the food they produce is safe. Section 301 establishes the Foreign Supplier Verification Program (FSVP) that requires each importer to perform foreign supplier verification to ensure each of its suppliers produce foods employing processes and procedures “including reasonably appropriate risk-based preventative controls” that are documented in a written plan and designed to prevent adulteration and reduce hazards as required by other relevant provisions of the Food, Drug and Cosmetic Act (FDCA). The FDA must draft regulations that may include requirements such as monitoring records, lot-by-lot certification of compliance, annual on-site inspections, checking the hazards analysis and risk-based preventive control plan of the foreign supplier, or periodically testing and sampling shipments of these foods. Importers would maintain import-verification records for at least two years and make them available to the FDA upon request. Importing food without an FSVP is prohibited. (Facilities in compliance with the HACCP, such as seafood and juices, are exempt from this provision.)
- Third Party Certification: FSMA § 307 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 through the Voluntary Qualified Importer Program (VQIP) (§ 302) or the import certification process (§ 303). Third parties may be foreign governments, foreign cooperatives or other parties the FDA deems appropriate. The FDA must either identify accrediting bodies that can provide this service or provide this service themselves. The FDA is to audit the performance of these third party accreditors every four years.
- Certification for high-risk foods: Section 303 authorizes the FDA to require high-risk imported foods (based on health consequences) be accompanied by a credible third-party certification (by an agency, representative of the foreign government, or auditor accredited under the act) or other assurance of compliance as a condition of entry into the U.S.
- Voluntary qualified importer program: Section 302 requires the FDA to establish a Voluntary Qualified Importer Program (VQIP) for importers that provide for expedited review and entry of foods from participating importers. Eligibility of the VQIP is limited to importers offering food from certified facilities, importers doing business with foreign suppliers that have a good compliance history and practices, importing from countries with a regulatory system that can ensure compliance with the U.S. food safety standards, importing foods with a limited risk of intentional adulteration, or other factors the FDA may include for VQIP eligibility.
- Authority to deny entry: The FDA can deny certain foods produced at a foreign facility entry into the U.S. if the FDA is refused access by the facility or the country in which the facility is located. It also has new authorities to prevent foods being smuggled into the U.S.
Perhaps the most relevant section of the FSMA is the section on enhanced partnerships. The FSMA relies on current food safety policies and programs to implement its provisions. It enhances the current system by building a formal system of collaboration with other government agencies, both domestic and foreign. The statute explicitly recognizes that all food safety agencies need to work together in an integrated way to achieve the public health goals the FSMA seeks. Enhanced collaboration with other governments include:
- State and local capacity building: Section 110 directs the FDA to develop and implement strategies that leverage and enhance the food safety and food defense capacities of state and local food and health agencies. The FSMA provides the FDA with a multi-year grant mechanism to facilitate investment in state capacity to more efficiently achieve the food safety goals of the law.
- Foreign capacity building: Section 306 and 307 of the law directs the 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. The FDA must develop a comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments and their respective food industries that export foods to the US, including bilateral and multilateral agreements on food safety, provisions for electronic data sharing, provisions for mutual recognition of inspection reports, laboratory methodologies, and detection techniques. The FDA must devise a program to train foreign governments and food producers on U.S. requirements for safe food. The agency must make a recommendation on whether and how to harmonize its requirements with requirements found under the Codex Alimentarius (an international food code standard). The act allows the FDA to enter into agreements with foreign governments to facilitate inspections of foreign facilities.
- 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. The FSMA also allows the 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.
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.
FSMA § 107 imposes many new user fees on food facilities. Fees will now be levied for:
- Reinspection of domestic facilities, foreign facilities and importers, following findings of non-compliance related to food safety requirements.
- Noncompliance with food recall orders that result in the FDA performing part or all of the recall (e.g., technical assistance, follow-up effectiveness, public notifications).
- Voluntary Qualified Importer Program to cover administrative costs.