The Food Safety Modernization Act, commonly referred to as FSMA, was created to facilitate a preventive rather than reactive approach to foodborne illnesses and food safety. Preventable foodborne illness and its consequences are a significant public health problem and a threat to the economic well-being of the food system globally.
FSMA is the responsibility of the Food and Drug Administration (FDA) and is identified under Title 21 Code of Federal Regulations (CFR) Part 117. FDA Food Safety Modernization Act (FSMA) information can be found on the web at the following address: https://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm.
This site has six drop down subject headers. Investigation into these subject headers will be a valuable tool in learning more about the FDA views, guidelines and policies relative to FSMA implementation. This article will focus on selected rules that may apply to grain processors associated with production, storage and distribution of food products into or within the United States.
Seven major rules have been identified by the FDA to facilitate implement of FSMA. It is understood that ensuring food safety is a shared responsibility among participants in the global supply chain. The FSMA rules are designed to make clear specific actions that must be taken within the supply chain to prevent contamination.
The seven rules identified in this article provide a brief review of Preventive Controls (Human Food), Foreign Supplier Verification Program (FSVP) rule, Accredited Third-Party Certification, Sanitary Transportation Rule, and Intentional Adulteration. For each rule there are exemptions and compliance dates based on the size of the business.
The current compliance dates or changes may be found at https://www.fda.gov/food/guidanceregulation/fsma/ucm540944.htm. As indicated earlier, training, education, and technical assistance are available for those covered by the various rules.
Preventive Controls Rules
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 FSMA as well as the modernized Current Good Manufacturing Practices (CGMPs) 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.
The rule 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. Focus is placed on known or reasonably foreseeable biological, chemical, and physical hazards related to foods in the facility. For each identified hazard, the Food Safety Plan must determine whether the hazard requires preventive controls and, if so, outline preventive controls to minimize or prevent that hazard.
Food Safety Plans are flexible to suit the processing system and typically include a listing of Food Safety Team members and product flow diagrams as background information. Hazard analysis is a required element in which biological, chemical or physical hazards are identified and evaluated. Those hazards that may result in serious adverse health consequences or death to humans or animals (SAHCODHA) require preventive controls. Preventive control types include Process, Food Allergen, Sanitation, Other Preventative Controls (Pre-Requisite Programs) and Supply Chain, and are based on Hazard Analysis. In addition, a recall plan must be developed if any hazard identified requires a preventive control, and implementation procedures outlined including verification, validation, monitoring and corrective action. The development of a Food Safety Plan must be carefully documented and reviewed as a whole at least once every three years.
Only those issues with SAHCODA status should be included in the FSMA Food Safety Plan. Inclusion of extraneous quality issues or items covered under prerequisite programs such as CGMPs and other food safety programs create documentation requirements that become burdensome. More importantly, they become subject to review and scrutiny upon inspection. It is advisable to only address those items clearly identified as SAHCODA hazards.
Other food safety programs, such as HACCP, ISO 22000, or BRC, do not satisfy the requirement of having an FDA Food Safety Plan. A Preventive Controls Qualified Individual (PCQI) must create or oversee the development of a facility’s Food Safety Plan, including a written Hazard Analysis on which the Food Safety Plan is based. Both the Food Safety Plan and Hazard Analysis must be maintained physically on site. The Preventive Controls Qualified Individual (PCQI) may or may not be an employee of the facility but be someone who has “successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system.” In addition to preparation of a Food Safety Plan, the PCQI is expected to perform or oversee validation of the preventive controls, records review and re-analysis of the Food Safety Plan.
The Preventive Controls Rules also require covered facilities to approve their raw material and ingredient suppliers when the receiving facility has identified a hazard requiring a preventive control. In approving suppliers, facilities must consider multiple factors, including the supplier’s performance (i.e., compliance with FDA regulations, including FDA warning letters, Import Alerts, etc.). Facilities can use the FDA’s public databases or a third-party tool to monitor a supplier’s status.
Foreign Supplier Verification Program Rule
The FSVP 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 FDA regulatory requirements. An importer as defined by the FDA must evaluate the risks posed by foods it supplies by determining potential hazards associated with each food, as well as by evaluating the supplier’s performance (i.e., FDA compliance history) to approve a supplier. Importers must then implement an FSVP for each approved supplier and each food imported from that supplier. The rule gives importers the flexibility to choose appropriate verification activities for each food and supplier while acknowledging the greater risk to public health posed by the most serious hazards in foods. Examples of potential verification activities include annual onsite audits of a supplier’s facility, sampling and testing a supplier’s products, or reviewing a supplier’s food safety records. Importers can meet key FSVP obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances if those importers review and assess the corresponding documentation.
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 United States with greater speed and predictability, avoiding unexpected delays at the point of import entry. Consumers also will benefit from the importers’ 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. Beginning Jan. 31, 2018, applications for VQIP were accepted.
Accredited Third-Party Certification
The Accredited Third-Party Certification 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:
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.
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.
Third-party certification bodies accredited under this program are required to perform unannounced facility audits and to notify the FDA upon discovering a condition that could cause or contribute to a serious risk to the public health. An accredited third-party certification body could be a foreign government or other third-party entity or individual. There are two kinds of audits that accredited third-party certification bodies can perform as part of the program: consultative and regulatory. In both kinds, auditors will examine compliance with applicable federal food safety requirements.
A consultative audit is conducted in preparation for a regulatory audit and is for internal use. In addition to compliance with federal standards, a consultative audit also considers how the facility meets industry standards and practices. The results of a consultative audit may remain private, but a certification body is required to report to the FDA if a consultative audit reveals issues that may pose a serious risk to consumer health.
Only a regulatory audit can be the basis for certification. When a certification body conducts a regulatory audit, it must provide the FDA with a full report on the results of its inspection.
Sanitary Transportation Rule
The Sanitary Transportation Rule is designed to ensure product is loaded and shipped in clean containers that have a documented cargo history. The container must be cleaned if the previous cargo poses a threat for the next cargo.
The four entities addressed by this rule include the shipper, loader, carrier and receiver. Grain producers are exempt from the sanitary transportation rule but all others in the supply chain must comply. Grain elevators connected to or co-located with feed mills, ethanol plants, corn wet mills and dry milling operations must comply.
Intentional Adulteration Rule
The Intentional Adulteration Rule applies to all facilities required to register with the FDA as a food facility, unless covered by an exemption. The purpose of the rule is to protect food from a person or group of people who are intentionally doing something to the food to either cause illness or death on a large scale. It requires facilities to develop and implement a written Food Defense Plan that assesses vulnerabilities within the facility, identifies a mitigation strategy for each vulnerability, and identifies monitoring procedures to ensure effectiveness of the mitigation strategies. A PCQI must prepare a facility’s Food Defense Plan. The first compliance date for Protecting the Food Supply from Intentional Adulteration, such as Acts of Terrorism, is July 26, 2019.
There are several main components to a food defense plan. First, facilities must conduct a vulnerability assessment, which means finding the points in their processes that pose the greatest risk for intentional adulteration. Second, facilities must put in place mitigation, or preventive, strategies to address these vulnerabilities. Third, a system must be put in place for food defense monitoring, food defense corrective action, and food defense verification, which together ensure the system is working as intended to address the vulnerabilities. Fourth is recordkeeping. Finally, there are training requirements. Personnel, and their supervisors, working at the most vulnerable points in a facility are required to take food defense awareness training and to have the education, training, or experience to properly implement mitigation strategies. In addition, preparing the food defense plan, conducting vulnerability assessments, identifying mitigation strategies, and engaging in reanalysis activities must be done or overseen by personnel with additional training or experience.
The Food Safety Preventive Controls Alliance’s (FSPCA) Intentional Adulteration Subcommittee is developing food defense training resources for industry and inspectors alike. Training will include a combination of online and instructor-led formats and is expected it to be ready by summer 2018.