Food Safety Program Requirements for 2019 and Beyond

As we settle into the new year, we find ourselves thinking about what’s to come in the food safety arena. 2018 saw some high-profile food recalls, including the nationwide warning about romaine lettuce just days before Thanksgiving. While the industry responds to threats like these, many manufacturers speculate about what they can expect food safety program requirements to look like in 2019 and beyond. Here, we’re offering some expert insight to help you get clarity on the subject and prepare your company for the most imminent movements in food safety.

Present Challenges in Food Safety and Production

Data from the Centers for Disease Control and Prevention reveal that each year, about 48 million people in the U.S. – that’s one in six! – get sick from foodborne diseases. 128,000 of those are hospitalized, and 3,000 suffer a fatality. Those are some grim numbers in such an advanced society, and they represent a significant public health burden – one that is largely preventable. So what specific challenges to food safety and production are impeding successful prevention efforts in the industry today? For starters:

  • Environmental changes: The Stop Foodborne Illness organization cites some prime contributors to food safety risk as a result of climate change, including factors like bacterial adaptation, mold and mycotoxin growth, soil contamination, water contamination, and animal disease. These elements impact the safety of foods from the very beginning phases of the food chain, and unless they are properly detected and mitigated, they can cause serious ramifications for manufacturers down the line.  
  • Economic pressures: As the economy ebbs and flows, the food chain is affected in many ways. The latest data from the U.S. Census of Agriculture, for example, shows that the overall number of farms is decreasing, while the average size of those farms is increasing. Generally speaking, the bigger the farm, the greater its distribution. So, as farm numbers decline and farm sizes grow, there are inevitable threats to your manufacturing operation with regard to supplier data management and inspection. This makes it more important than ever to ensure that your process for receiving raw and fresh food evolves accordingly.
  • Resource constraints: Every food company is challenged to ensure food safety while ensuring profitability. When food safety processes are not modernized and streamlined for efficiency, a facility’s resources can become maxed out. In order to meet budget requirements, some organizations even decide to cut back on the manpower needed to effectively implement a robust food safety plan. This naturally introduces greater risks for contamination, adulteration and subsequent foodborne illness.

As these and other challenges heighten the risk of recalls and consumer health incidents, the government continues to focus on regulations that require food brands and manufacturing companies to prioritize prevention. Here’s a glimpse into how this is expected to play out.  

Implications of FSMA in 2019 and Beyond

The Food Safety Modernization Act, which was enacted in 2011, continues to roll out based on specific compliance dates for various types and sizes of businesses. Accordingly, food companies are expected to be in full compliance with the prevention and risk mitigation mandates outlined under FSMA law.

Here are some of the FSMA regulations you can expect to see the FDA continuing to enforce in 2019:    

  • Third-Party Certification: This rule establishes a voluntary program for the accreditation of third-party certification bodies 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.
  • Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food: 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 FDA Food Safety Modernization Act as well as the modernized Current Good Manufacturing Practices of this rule. 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.
  • Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: 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. Covered facilities must follow Current Good Manufacturing Practices for animal food production. Some animal food facilities need a supply-chain program to address hazards in raw materials and other ingredients.
  • Sanitary Transportation of Human and Animal Food: 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. It 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. Specifically, it outlines requirements for vehicles and transportation equipment, transportation operations, records, training, and waivers.

Some of the approaching FSMA compliance dates for 2019 include final rules on:

  • Mitigation Strategies to Protect Food Against Intentional Adulteration: This 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 or economic disruption of the food supply absent mitigation strategies. Rather than targeting specific foods or hazards, this rule requires risk-reducing strategies for processes in certain registered food facilities.
  • Produce Safety: This rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. Key requirements address agricultural water; biological soil amendments; sprouts; domesticated and wild animals; worker training as well as health and hygiene; and equipment, tools, and buildings.
  • Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals: This 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. An importer is defined as the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent.

In addition to these FSMA rules, expect to see continuing efforts related to the following FDA programs and standards:

  • Voluntary Qualified Importer Program (VQIP): This 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. Participants are able to import their products to the U.S. with greater speed and predictability, avoiding unexpected delays at the point of import entry. Consumers also benefit from the importer’s 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 a cost associated with the FDA’s administration of the program.
  • FDA Food Code: Published by the FDA, this model assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating the retail and food service segment of the industry (restaurants and grocery stores, as well as institutions such as nursing homes). Local, state, tribal and federal regulators use the FDA Food Code as a model to develop or update their own food safety rules and to be consistent with national food regulatory policy.
  • FDA Data Dashboard: In 2009, President Obama issued the Memorandum on Transparency and Open Government, instructing agencies to take specific actions to implement the principles of transparency, participation, and collaboration. To that end, the FDA has since published various data sets to include compliance data, and has explored several methods to display it, increase usability and improve the overall user experience. The Data Dashboard is designed to support the understanding, accountability, and analysis of public FDA data through easy-to-use, visually accessible, customizable and understandable graphics. The underlying data used to generate the dashboard graphs are based upon transparency data sets and other data already available to the public. The current datasets and data include the Inspection Database and selected data elements from the compliance, enforcement and import-related information on

Across the U.S. Border

The United States’ neighbors to the north have also rolled out food safety program requirements that brands and manufacturing companies should be aware of, both now and in the future. The Safe Food for Canadians Acts (SFCA) consolidates the authorities of the Fish Inspection Act, the Canada Agricultural Products Act, the Meat Inspection Act and the food provisions of the Consumer Packaging and Labelling Act.

Specifically, it requires that:

  • Food businesses have preventive controls in place. Whether importing food into Canada or making food for export or to be sold interprovincially, most businesses are mandated to understand and control potential food safety hazards by implementing controls related to:
    • Manufacturing, processing, treating, preserving, grading, packaging or labeling food to be exported or sent across provincial or territorial borders
    • Growing or harvesting fresh fruits or vegetables to be exported or sent across provincial or territorial borders
    • Handling fish on a conveyance to be exported or sent across provincial or territorial borders
    • Slaughtering food animals from which meat products are derived to be exported or sent across provincial or territorial borders
    • Storing and handling a meat product in its imported condition for inspection by the Canadian Food Inspection Agency (CFIA)
    • Importing food
    • Documenting food safety controls in a preventive control plan (PCP)
  • Certain food businesses acquire appropriate licensing from the Canadian Food Inspection Agency to conduct one or more activities related to food, including manufacturing, processing, treating, preserving, grading, packaging and labeling.
  • Certain food businesses track the movement of their food in the supply chain – forward to the immediate customer and back to the immediate supplier. This includes requirements for traceability-specific documentation and product labeling.

New Year, New Approach to Food Safety Risk and Compliance

There’s no way around the food safety program requirements your organization faces this year and beyond. Nor should there be. Because at the end of the day, comprehensive food safety protects your brand from recalls and health incidents that can severely threaten your reputation, your relationship with consumers and the long-term profitability of your company.

It’s better to focus on a food safety intelligence and automation solution that can support your company in streamlining processes, improving food quality, reducing recall risk AND complying with the latest regulations in the evolving realm of food production. Comprehensive software brings immeasurable value to your food safety, data analysis, regulatory and auditing efforts by saving on time, costs and inaccuracies.

As you continue seeking smarter, more effective ways to facilitate food safety, mitigate risk and meet compliance obligations, use our free ROI calculator to determine how automating your environmental monitoring program can potentially save you time and money.

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