In 2015, the former president of the now-bankrupt Peanut Corporation of America was sentenced to 28 years in prison. The company had sold tainted products and misled consumers about test results, causing a massive salmonella outbreak that killed 9 people and made hundreds more sick. The outbreak was magnified by the fact that the peanut products were used in other food products.
In response to the peanut scandal and several other outbreaks in the 2000s, President Barack Obama signed the Food Safety Modernization Act (FSMA) into law in 2011, giving the Food and Drug Administration (FDA) more power. Specifically, the agency could now take a proactive approach where it previously had a reactive mandate — it could only manage the outbreak of food borne illnesses after the fact.
For warehouses and other facilities that manage food, this regulatory change brought greater oversight. If you’re in the food business today, here are some tips for storing food in a warehouse in a way that keeps your customers healthy and your facility on the right side of the law.
How Do I Know If The Food Safety Modernization Act Applies To My Warehouse?
“The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary.”
If your facility falls into this category, you want to be fully compliant for the sake of your customers and because you don’t know when FDA inspectors may arrive. With a broader mandate from the FSMA, inspectors can do things like demand access to any records mandated by the FDA’s safety documentation guidelines. If food safety corrective measures haven’t been properly recorded, inspectors will move forward on the assumption that the corrective measure never happened.
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What Are My Legal Obligations As a Facility That Manages Food?
Here’s a general overview of your obligations for your knowledge. However, this information is not legal advice and is not a substitute for consulting with an attorney about how to adhere to regulations.
Generally speaking, the FDA wants to see that your facility takes a proactive approach to food safety. Your approach must be recorded on paper and implemented on the facility floor. Since the FSMA’s purpose is to make a system-level change, food management facilities need to demonstrate both to be considered compliant. One can’t exist without the other.
Provide Adequate Training and Education
All employees must have adequate education, training or experience to “manufacture, process, pack, or hold food,” and it’s the responsibility of management to ensure each employee is properly qualified for their assigned tasks. Previously, this provision in the Current Good Manufacturing Practices (CGMPs) was non-binding. Now, the FSMA has made it binding.
Since food management can include activities like producing, manufacturing, storing, packaging, and transporting food, figuring out exactly which training your employees need can be difficult. To help, the FDA has pointed business leaders to curricula offered by three FDA-funded alliances:
- Produce Safety Alliance (PSA)
- Food Safety Preventive Controls Alliance (FSPCA)
- Sprout Safety Alliance (SSA)
These alliances include government representatives from agencies like the FDA and United States Department of Agriculture (USDA). They also include representatives from state and local agencies, academia, and the food industry.
Furthermore, the FDA has a collaborative partnership with the USDA’s National Institute of Food and Agriculture for the National Food Safety Training, Education, Extension, Outreach, and Technical Assistance Program, a grant program to help make food safety training more accessible.
To recap, adequate training, education, and experience is now mandatory, so work with these organizations to ensure all of your employees are compliant. And, be sure to keep a proper record of your employees’ training.
Manage Allergen Cross-Contact
Thirty-five% of FDA food recalls are caused by undeclared allergens, making it the number one reason for a recall. These are allergens that unintentionally wind up in food products due to cross-contact. Keep in mind that cross-contact is not the same as cross-contamination. Cross-contamination is typically used in reference to foodborne illnesses whereas cross contact typically refers to allergens.
Foods that contain allergens like peanuts, soybeans, and eggs must carry labels warning consumers. So, it’s extremely important for food manufacturers and warehouses to prevent allergen cross-contact. With this in mind, the FSMA made the current good manufacturing practices around allergen cross-contact explicit.
Here are a few tips for storing food in a warehouse or manufacturing facility and avoiding allergen cross contact:
- Search for and source alternative products that taste the same as an allergen-containing food so that the allergen is not in the facility in the first place
- Purchase equipment where all components of the machinery are accessible and cleanable (e.g., equipment that uses sanitary design principles)
- Proper ventilation to prevent airborne allergen cross-contact
- Design an organized workflow based on traffic patterns within the facility to avoid the transfer of allergens from employee to employee, employee to materials, or material to employee
- Establish a dedicated location for products and ingredients that contain allergens
- Conduct inspections of materials from suppliers to ensure they don’t contain any undeclared allergens and obtain a letter of guarantee from suppliers
- Create clear protocols to manage spills or damaged packaging containing allergens
- Properly label pallets and other products containing allergens
- Use color coding to facilitate zone control within a warehouse facility
- Segregate cleaning equipment for exclusive use with allergen- or non-allergen-related equipment or areas
- Use standard operating procedures (SOPs) for sanitation to ensure the proper cleaning of surfaces
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Create a Food Safety Plan
Even if you don’t manufacture food, you are still required to create a food safety plan if you are a warehouse or distributor registered under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Your Food Safety Plan should contain a number of sections, most notably the following:
According to the Food Safety Preventive Controls Alliance, a hazard analysis is:
“The process of collecting and evaluating information on hazards and the conditions leading to their presence to determine which hazards are significant for food safety…”
A hazard analysis must be written even if no potential hazards are identified. While you do not have to create your hazard analysis in worksheet format - a narrative-style hazard analysis is acceptable - a worksheet does provide some structure. Here is one example that has been provided as a guideline from the FDA.
Ingredient / Processing Step
C = chemical, including radiological
P = physical
Are any potential food safety hazards requiring preventive control?
Justify your decision for column 3
Table: Potential framework for Hazard Analysis provided (Source: FDA)
Examples of potential food hazards are:
- Pathogens commonly associated with particular foods that your warehouse or facility manages
- Process-related hazards such as a broken chopping blade that introduces metal fragments into food
- Equipment that’s difficult to clean and may inadvertently introduce allergens or foodborne illnesses to foods
- Use of shelf-life increasing packaging materials that may introduce specific pathogens
Generally speaking, warehouse managers should consider the following categories when brainstorming potential hazards:
- Intrinsic Factors (Commonly known hazards associated with specific products before and after processing)
- Processing Procedures
- Microbial Content of Food
- Facility Design
- Equipment Design and Use
- Employee Health, Hygiene, and Education
- Storage Conditions
- Intended Use and Users (e.g., if the food will be heated up by consumers)
Once potential hazards are identified and you’ve decided there is a need for preventive controls, you must put those controls in place. Preventive controls could include process controls, food allergen controls, sanitation controls, or supply chain controls, for example.
These preventive controls must be both documented and implemented. The documentation must address the following types of controls:
- Rules around operations like refrigerating, cooking and acidifying foods
- Parameters and values such as critical limits
Food Allergen Controls
- Documented procedures for receiving food from suppliers, processing food, cleaning equipment, ensuring proper ventilation, proper labeling of foods containing allergens, segregation of allergen-containing foods from non-allergen-containing foods
- Rules around cleaning of the facility and equipment, providing adequate time for machine cleaning between product processing changeovers, guidelines for properly cleaning equipment with hard-to-reach components
Supply Chain Controls
- Guidelines around verifying a supplier’s adherence to safety standards
- Creating a risk-based supply chain program
- Documented plan detailing how a company will manage a recall on a tainted product, including steps for notifying consignees and the public
Monitoring and Oversight
Once preventive controls have been put in place, warehouse managers also have to document their plans to monitor and oversee them. This includes specific actions:
- Corrective Actions
An example of a monitoring activity is ensuring that a heat process kills pathogens by checking temperatures. Monitoring activities must be documented or inspectors will move forward as if they’ve never happened.
General Tips on Storing Food In a Warehouse
As you research your obligations as a food storage facility, remember that you can’t take general tips for storing food in a warehouse at face value. The law puts the responsibility on the business to identify the specific risks associated with its facility since not every facility manages the same types of food products. For instance, a facility that exclusively manages allergen-containing foods won’t need to list undeclared allergens as a potential hazard since all of their products will be properly labeled.
Once you understand your responsibilities under the Food Safety Modernization Act, you’ll have the context to better understand and apply general tips for storing food in a warehouse.
In addition to food storage and preparation tips shared above, consider how things like your facility infrastructure and inventory management practices play a role in food safety compliance.
During construction or maintenance of your warehouse, regularly inspect your facility to ensure the following issues don’t exist:
- Windows or window frames containing holes
- Leaky foundation, walls, or roof
- Rodent burrows in area surrounding the building
- Rodent tracks around your building
- Standing water, trash, or weeds near your facility’s perimeter
- Damage to your exterior or interior (e.g., cracks, open pipes)
- Chemicals stored near food storage areas
If you’re storing food in your facility, purchase a warehouse management system (WMS) with easy lot tracking or lot traceability. First in, first out (FIFO) is incredibly important in a food storage warehouse environment. This allows a warehouse and other supply chain partners to identify the specific lot that a batch of any good came from. If there are any recalls, supply chain partners can identify exactly which products contain tainted goods.
Managing Food in a Warehouse Requires Proper Attention and Care
Warehouse management for food products carries a higher risk than other non-consumable products. For starters, poor food management in warehouses can potentially be deadly. Plus, poor food safety practices can put a company out of business and lead to possible criminal charges for executives.
With the introduction of stronger legislation in the form of the FSMA and the magnified risk of tainted food due to today’s global supply chains, it’s important for warehouses and distribution facilities to understand their obligations under the law, put Current Good Manufacturing Practices into place, and proactively manage risks through proper monitoring and documentation.
Written by Ruthie Bowles
Ruthie is a content marketing consultant for Logiwa. Her specialties include small business development and inventory management.