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As part of its continuing implementation of the Food Safety Modernization Act (FSMA), on October 31, the FDA announced the availability of a draft guidance document titled “Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA” (Guidance).

The Guidance is meant to provide industry with more information on the content of the disclosure statements required by four of the seven foundational FSMA rules. Additionally, it identifies the types of documents that would and would not be appropriate vehicles for such disclosure statements.

The four relevant foundational FSMA rules are:

  1. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Human PC Final Rule)[1]
  2. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Animal PC Final Rule)[2]
  3. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Product Safety Final  Rule)[3]
  4. Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (FSVP Final Rule)[4]

On September 19, the FDA Foods and Veterinary Programs held a webinar to discuss FDA’s recent issuance of the preventive controls hazard analysis and risk-based draft guidance (Draft Guidance), which became available for public comment on August 24, 2016.1 The Draft Guidance provides the first five chapters of a 14-part guidance designed to help businesses comply with the Preventive Controls for Human Food Final Rule2 by the compliance date of September 19, 2016.

The Draft Guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls, and includes discussions on establishing a food safety plan, what a hazard analysis entails, appropriate preventive controls for certain food categories, monitoring, corrective actions based on a hazard analysis, verification, and records requirements.

On August 24, the US Food and Drug Administration (FDA or Agency) issued a final rule (Final Rule) that extends and clarifies the compliance dates for a limited subset of Food Safety Modernization Act (FSMA) requirements in four of the seven foundational rules part of FDA’s FSMA implementation.1 The four rules include

  • Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (Preventive Control Rules) for Human and Animal Foods;2
  • Foreign Supplier Verification Programs (FSVP);3 and
  • Produce Safety.4

On July 14, FDA issued a final rule amending the requirements for the registration of food facilities (Final Rule).1 The Final Rule was issued as part of the implementation of the Food Safety Modernization Act (FSMA) to help improve the accuracy of the food facility registration database.

Background of FSMA

FSMA, enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.

On May 27, the US Food and Drug Administration (FDA or Agency) published a final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (Final Rule).1 The Final Rule is part of FDA’s implementation of the Food Safety Modernization Act (FSMA) and requires food facilities to prepare and implement a food defense plan, conduct a vulnerability assessment, and implement mitigation strategies with food defense monitoring procedures to minimize or prevent significant vulnerabilities.

The Final Rule applies to both domestic and foreign facilities required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is targeting larger businesses with this Final Rule because its purpose is to protect the food supply against individuals or organizations with intent to cause large-scale public health harm.

On January 4, 2011, US President Barack Obama signed the Food Safety Modernization Act (FSMA).[1] The law’s aim is to shift the focus on food safety from responding to problems to preventing them. FSMA accomplishes this by providing new enforcement authorities to the FDA to help it achieve higher rates of compliance through risk-based, prevention-oriented safety standards to better respond to and contain problems when they do occur. The law also contains important new tools to better ensure the safety of imported foods and encourages partnerships with state, local, tribal, and territorial authorities.

Since 2013, the FDA has published in the Federal Register those FSMA-required regulations that provide the framework for the law’s preventive-oriented approach. On April 6, 2016, the FDA published the final rule on Sanitary Transportation of Human and Animal Food (Final Rule).[2] The Final 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. Because of limitations in the laws, the requirements do not apply to transportation by air or ship. As compared to the proposed rule[3], the Final Rule made some notable changes to the scope of covered entities and the definition of “transportation operations” and added clarifying language to the new requirements.

For a more detailed analysis, please see our LawFlash on the sanitary transportation of human and animal food Final Rule.

The FDA is planning a webinar on April 25 from 11:00 a.m. to 12:00 p.m. eastern time to present key pieces of the Final Rule. More information on the webinar can be found on the FSMA website.


In late October, the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), along with state and local officials investigated an outbreak of E. coli infections linked to food served at a major fast-casual restaurant chain. Much of the underlying information documenting the outbreak has been derived from an advanced laboratory technique called “whole genome sequencing” (WGS). This is a fairly new instrument in the CDC toolbox. WGS reveals the complete DNA make-up of an organism, thereby enabling health officials to better understand variations both within and between potentially pathogenic species. Such information can then be compared with clinical isolates from sick patients, and, if they match, there may be a reliable link established between the illness and the pathogen. This new technique has the potential to define the scope of a foodborne illness outbreak more quickly and ideally will help to prevent additional cases. Traditionally, this analysis has been done via a process known as pulse-field gel electrophoresis (PFGE). But PFGE has a shortcoming in that it is unable to differentiate between related species of organisms, which can be critical when health officials are trying to delineate the specific source of the outbreak, and want to know whether to recall a product or not.

The FDA has issued two important final rules that will implement requirements of the Food Safety and Modernization Act (FSMA):

  • Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food
  • Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Animal Food

Both rules will require manufacturers and other elements of the food chain to evaluate, implement, and document the effectiveness of science-based preventive food safety programs.

On June 5, the Food and Drug Administration (FDA) published its Draft Guidance for Voluntary Qualified Food Importer Program (the Draft Guidance). A copy of the Draft Guidance can be found here.

A central goal of the Food Safety Modernization Act (FSMA) is to establish a proactive focus on preventing food safety problems rather than relying on a reactive approach. In this context, FSMA required FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers that maintain a high level of security and safety in their supply chains as part of FSMA’s Quality Assurance Program. Along the same lines, FDA has issued the Draft Guidance to establish and provide guidance regarding the Voluntary Qualified Importer Program (VQIP).

FDA asserts that the VQIP will benefit both consumers and industry. Industry will benefit because qualified importers will receive expedited review, resulting in their product getting to market faster. Consumers will benefit because food safety protections will be strengthened by requiring high levels of security and safety for VQIP members. On the other side of the coin, the program will help FDA and consumers identify importers that do not participate in the VQIP as potentially more likely to present a food safety public health risk.

What recourse do businesses have when their products are incorrectly identified as the source of a foodborne illness outbreak? For the time being, it appears that the answer to that question is “very little.” In a recently dismissed lawsuit concerning FDA’s 2008 warnings linking tomatoes to a Salmonella outbreak in New Mexico and Texas, which proved to be wrong, a federal court held that the government’s error did not constitute a regulatory “taking” under the Fifth Amendment, even though the warnings had significant financial impact on the marketplace. Despite the court’s decision, and its impact on prospective regulatory takings claims, a compensation provision under the Food Safety Modernization Act (FSMA) provides a potential avenue of recourse for farmers, and it is likely that litigants will test this compensation theory in the future.