The Food Safety Modernization Act

FSMA was signed into law with the objective of shifting focus from reaction to prevention and placing direct responsibility on businesses in the U.S. food and animal feed supply chain to self-identify, control and prevent hazards to human and animal food safety. Under FSMA, the FDA was given increased power to order food and feed recalls, and de-register or shut down food production and storage facilities if products pose a reasonable probability of causing a serious food safety outbreak.

Such dramatic actions would prevent companies (and their secured lenders) from selling off food products produced or stored in facilities that were subject to any possible contamination or food hazard. The law is intended to cause all businesses involved in the food chain (including their lenders) to be proactive and to assume direct responsibility for, and take meaningful affirmative steps to, improve food safety and mitigate risk.

Not only does FSMA affect U.S. food and animal feed producers, it also impacts ethanol manufacturing facilities; distributors, processors, importers and exporters of food and feed; foreign suppliers; storage facilities and warehouses; carriers and transporters of food and feed products; growers of fruits and vegetables; and supermarket and restaurant chains using central commissaries or storage facilities.

Processors of meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture, are not covered by FSMA. Several exemptions and delayed effective dates requiring compliance at various times during the period from 2015 through 2020 are provided for so-called Small and Very Small Businesses under the FSMA-related regulations.

FSMA comprises over 1,000 pages in the Federal Register, and the seven primary regulatory rules implemented under FSMA require more than 2,000 pages. It's no surprise that it took the FDA over four years to prepare the underlying regulations.

FSMA Rules

The seven primary FSMA Rules (Rules) cover topics such as Good Manufacturing Practices, Preventive Controls for Human Food and Animal Feed, the Sanitary Transportation of Food, the Intentional Adulteration or Third Party Auditor Accreditation Rule, the Foreign Supplier Verification Program and the Produce Safety Rule. The bundle of Rules requires businesses that produce, grow, manufacture, process, pack, store, transport, distribute and sell food products to prepare and implement written procedures for good manufacturing practices and food safety plans, including supply-chain verification programs.

Hazard Analysis

The Rules envision that companies will adopt a HARPC (Hazard Analysis Risk-Based Preventive Control) Plan, which must include features such as a hazard analysis, the identification of critical control points, the disclosure and documentation of food hazards, the adoption of preventive controls, and the monitoring and tracking of every product movement, taking corrective action and the implementation of verification procedures. With few exceptions, almost all U.S. food producers are required to register with the FDA bi-annually.

Hazard Control

Also required are written recall plans and supply-chain programs that mandate companies to incorporate steps to identify and control potential hazards arising outside their own manufacturing or processing facilities, but which could affect their food supply chain. Separate sanitary-practice obligations are also imposed on suppliers, loaders, carriers, warehouses, receivers and others involved in food-transportation operations. These regulations affect almost all food products transported within the United States by rail and truck, but exclude barge and air transportation, which are regulated by separate laws. Note that HARPC requires a self-reanalysis of each food-safety plan at least once every three years.

As a result of the new Rules, companies involved in cleaning, inspecting, loading, unloading and storing food products must take specific steps to avoid contamination and unsafe practices during transportation that would negatively affect food consumption. Truck and rail operators are required to prepare and implement written procedures for cleaning and inspecting trailers and rail cars. See “Process Control,” F. Tracy Schoenrock, Food Safety Magazine, October/November 2016. Carriers must maintain real-time measuring equipment and written logs to verify temperature controls during food transportation and storage. In turn, equipment manufacturers must ensure that the design, function and operation of their products eliminate the possibility of food contamination or adulteration at any point in the manufacture, storage, distribution, transport, sale or consumption of food or animal feed.

For example, the manufacturer of poorly designed food processing conveyor belts may face the shutdown of its factory, an impounding and recall of its equipment, and civil and criminal liability for its executives if the equipment design flaws caused or contributed to a food safety hazard or contamination, For the past several years, the FDA has expended a great deal of time and energy to provide training and educational programs and materials to the food and feed industry to enable compliance.

Intentional Adulteration Rule

Under the Intentional Adulteration Rule, foreign and domestic companies that manufacture, produce, process, pack or hold large quantities of food destined for U.S. consumption are required to prepare and implement food-defense plans that self-assess their own vulnerability for food contamination in their facilities, institute mitigation strategies and verify the effectiveness of those strategies. Under FSMA, food-defense plans are designed to protect against the intentional adulteration of food while food-safety plans are meant to protect against unintentional contamination of food. Compliance dates for the Adulteration Rule occur in July 2019 for all businesses other than Small Businesses (fewer than 500 full-time employees) and in July 2020 for Small Businesses.

Foreign Supplier Verification Program

The Foreign Supplier Verification Program (FSVP) is intended to ensure that all food imported into the United States is produced in accordance with FSMA food safety standards. U.S. food importers are required to verify that their foreign food suppliers are growing and manufacturing food products in accordance with FSMA's Preventive Controls and Produce Safety Rules. In turn, importers are obligated to conduct their own hazard analyses, evaluate food contamination risks, conduct annual audits of supplier facilities, review foreign supplier food-safety records and implement any required corrective actions. An FSVP must be prepared for each foreign food supplier selling into the United States.

Produce Safety Rules

The Produce Safety Rules (PSR) were promulgated under FSMA to regulate the farming activities of growers of fresh produce. Typically, fresh produce comprises fruits and vegetables, which would also be deemed “farm products” as such term is used under the Uniform Commercial Code (UCC). The PSR establish minimum U.S. standards for growing, harvesting, packing and storing fruits and vegetables. Each facility in the food-processing chain is subject under FSMA to inspections, hazard analysis, preventive control requirements and specific equipment standards. Growers and producers must also prepare and implement written standards for employee hygiene and provide training regarding food safety to meet the requirements of FSMA. Certain small farms and producers are exempt, however, under these Rules.

Obligations and Responsibilities

The new Rules and accompanying regulations greatly increase the obligations, responsibilities and risks of all affected businesses in the U.S. food and feed industry. Commentators suggest that FSMA directly increases the regulation of the production, processing, distribution and sale of 80% of all domestic and imported foods. FSMA's primary objective — to prevent food contamination by implementing proactive measures — requires most U.S. food producers, distribution centers, food importers and exporters, packagers, carriers, transportation and shipping companies, equipment manufacturers and supermarket chains to allocate substantial resources to record-keeping, training, product information, labeling and tracking systems, auditors, food safety personnel and legal staff.

Under FSMA, food executives are legally accountable for safety and contamination, similar to the Sarbanes-Oxley rules. As would be expected, FSMA contains whistle-blower provisions and employee retaliation protections to ensure that companies are complying proactively with the Rules. Each Rule and regulation under FSMA has a “domino” effect throughout the food chain. It requires companies to adopt a variety of safe practices and procedures and, in an effort to limit their own risk, to demand that all their suppliers, including equipment manufacturers and distributors, do the same. FSMA requires all compliance documentation of each covered business to be retained for at least two years, and to be accessible within 24 hours after any FDA request.

Action Required

The final Rules under FSMA were not adopted until 2015 and 2016, and the respective effective dates for compliance purposes depend on whether the affected entity is a large company, a small company or in some cases, a very small company. The latest regulatory effective dates are currently scheduled to occur in 2020.

Although the timeline for the effective date of the Rules varies based on the size of the food company, most companies have already taken substantial steps to comply. By being proactive in adopting safe food processing operations, such companies hope to protect their reputation and business from the negative publicity and possible financial disaster arising from the sale of contaminated food and non-compliance with FSMA. They want to have good practice systems and processes in place as soon as possible, which must identify all possible safety hazards, verify the food safety steps that need to be taken and prepare food recall plans.

We conclude this discussion in next month's issue.

*****
Michael A. Leichtling is counsel at Sills Cummis & Gross P.C. in New York. Reach him at [email protected].