Every food manufacturer has its own controls in place to ensure that the food and beverages they produce don’t harm consumers. However, even the most discerning companies can mistakenly sell products that cause injury or illness. No food safety system can guarantee zero risk of failure.
At any point in production, food can become contaminated with bacteria, viruses, parasites, chemicals, undeclared allergens, or harmful materials such as glass or metal fragments. In the event that an unsafe food product leaves the control of the manufacturer or is in violation of safety legislation, the product must be removed from the market in what’s referred to as a recall. These recalls can be costly, with many leading to class-action lawsuits that easily fetch six figures or more.
Despite these facts, many food manufacturers are unprepared to mobilize quickly following an incident. To protect their consumers and avoid the costly fallout of food safety issues, it’s crucial for businesses to understand applicable legislation and chemical controls that can help them manage food and feed safety.
Food manufacturer safety legislation
Food and feed safety laws have been in place for decades and continue to improve with new information about product hazards and better systems of identifying and mitigating those hazards. Some of the most significant directives include the Food, Drug and Cosmetic Act (FDCA); Current Good Manufacturing Practices (CGMPs); and regulations for meat, poultry and processed egg products.
The Food Safety Modernization Act (FSMA) is the most recent addition and is the most sweeping change to food safety since the FD&C Act was passed. In 2011, the FSMA established a new regulatory framework that affects producers, importers, distributors, manufacturers and transporters of human and animal foods consumed in the United States. The FSMA moves beyond detection and response strategies to take a preventive approach, requiring hazard analysis of ingredients, materials and processes. In fact, several of the FSMA’s 41 sections require action from businesses that grow, produce, handle, hold or transport food and feed products:
1. CGMPs, hazard analysis and risk-based preventive controls for human and animal food (preventive controls)1 — The CGMPs guide companies in the safe production of food and feed products and set the expectation for Food and Drug Administration (FDA) requirements. The CGMPs cover areas such as design and construction of a food plant and maintenance of plant grounds, plant equipment, sanitary operations, facility sanitation, and production and process controls during the production of food. Most facilities that manufacture, process, pack or hold food for human consumption in the United States must establish a food safety system that:
a. Analyzes known or reasonably foreseeable biological, chemical and physical hazards
b. Implements preventive controls and a recall plan
c. Manages preventive controls through monitoring, corrective actions and verification
d. Updates and clarifies CGMPs for human food production
e. Inducts a qualified program overseer
For more information on CGMPs, click here.
2. Standards for the growing, harvesting, packing and holding of produce for human consumption (produce safety)2 — This rule establishes mandatory food safety practices for domestic and foreign farms that grow, harvest, pack or hold produce for consumption in the United States. Specific produce safety practices include, but are not limited to, the following:
a. Implementing raw manure application methods to minimize contact with covered produce during or after application
b. Establishing measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting
For more information on produce safety standards, click here.
3. Foreign Supplier Verification Program (FSVP)3 — Most entities importing food to the United States are required to develop, maintain and follow an FSVP, which helps ensure that foreign suppliers produce food in compliance with FDA standards for preventive controls and produce safety.
For more information on FSVPs, click here.
4. Sanitary transportation of human and animal food (sanitary transport)4— Unless exempt, most U.S. shippers, carriers, loaders and receivers must employ sanitary transport measures to ensure the safety of food during transportation. For instance, vehicles and equipment must be designed and maintained to prevent the adulteration of transported food. Additionally, shippers, carriers and receivers must utilize contamination prevention strategies, such as temperature control, to ensure food safety during transportation.
For more information, click here.
5. Focused mitigation strategies to protect food against intentional adulteration (food defense)5 — To help prevent terrorist attacks on the U.S. food supply, most FDA-registered food facilities must implement a food defense plan like the food safety plan under the preventive controls rule. Chiefly, the plan must include a vulnerability assessment of the potential impact on public health, degree of physical access to the product, and ability to successfully contaminate the product. It should also include mitigation strategies at each actionable process step to help provide assurance that vulnerabilities will be minimized or prevented.
For more information, click here.
6. Accreditation of third-party certification bodies to conduct food safety audits and to issue certifications (third-party accreditation)6 — The FDA is responsible for ensuring FSMA compliance. Leveraging its oversight capabilities, the FDA has mechanisms where private auditors need FDA accreditation to issue food safety certifications to foreign food facilities.
Chemical controls for food and feed safety
In food manufacturing, the use of various chemicals is not only common, it’s necessary. Maintenance, sanitation and laboratory chemicals are fundamental components of clean and productive facilities. In addition, pesticides are often used to control risks related to various pests and disease carriers that may be present in food.
However, while necessary for the smooth operation of a plant, certain chemicals have the potential to contaminate food products at any point during processing, packaging, transportation and production if they aren’t managed properly. In order to protect consumers from such hazards and avoid potential liability concerns, food manufacturers need a chemical program that complies with the Occupational Safety and Health Administration’s Hazard Communication Standard (HCS) and industry standards. These programs should account for the items listed below:
- Chemical approval teams — Businesses should designate one or more members to serve as a chemical approval team to evaluate chemical purchase requests and give purchase approval.
- Approved chemicals master list — Businesses should develop a master list of all approved chemicals. It should identify the name, manufacturer, intended use, locations of use and departments authorized for use. The list should be divided into categories, such as boiler and water treatment, pesticides, herbicides, laboratory, janitorial, sanitation and maintenance.
- Controlled storage areas — Controlled storage areas restrict chemical access to authorized personnel using electronic keypads or badges, padlocks or key locks. Some companies incorporate security cameras to keep digital records of personnel entering and exiting these areas.
- Chemical container labels and usage records — Chemical container disposal protocols should be implemented, and chemical label instructions should be followed for appropriate procedures. For example, some pesticide labels state that the container needs to be punctured and triple-rinsed before disposing.
- Proper disposal method for chemicals — Chemical container disposal protocols should be implemented, and chemical label instructions should be followed for appropriate procedures. For example, some pesticide labels state that the container needs to be punctured and triple-rinsed before disposing.
- Chemical spill containment procedures — Chemical spills may occur in the storage area or during usage. According to OSHA’s HCS, the safety data sheet must detail accidental release measures, such as personal precautions, personal protective equipment, emergency procedures, and methods and materials for containment and cleanup. Spill containment devices and materials should be present in chemical storage areas, and authorized personnel should know how to use them. See OSHA’s HCS for further information on spill containment.
- Chemical usage, storage and application training — It’s important that all personnel understand that mishandling chemicals creates a risk to themselves and the food or feed being produced. All personnel should receive general chemical training on company protocols.
Have a food recall plan in place
A food recall occurs when a product is believed to be unsafe for consumers and the responsible party — whether it’s the original manufacturer or distributor — takes corrective action (e.g., the product is removed from distribution or retail stores).
A recall is one of the most effective methods for containing products that are in violation of FDA laws. Often, recalls are performed voluntarily, as manufacturers and distributors of food products have a responsibility to ensure the public’s well-being. Failing to take the appropriate actions following a product issue not only jeopardizes the health of your customers and your reputation, but it can also lead to warning letters, injunctions, fines and prosecution.
Per the FD&C Act, recall strategies are developed either by FDA officials for FDA-requested recalls or by the recalling organization for voluntary recalls. In general, recall strategies should be customized for each individual recall to account for differences in food hazards. Additionally, recall strategies should take the following into consideration:
- The results of health hazard evaluations
- How easy or difficult it will be for members of the supply chain or consumers to identify the affected product
- How obvious the adulteration or misbranding of the product is to the consumer
- The current availability of the affected product on the market
- How the organization will continue to make essential products available to consumers
Specific recall strategies will differ by organization and the specific hazards that an adulterated or misbranded food presents.
Other food safety best practices
Beyond understanding applicable legislation, implementing a thorough chemical program and preparing for a recall, a number of general food safety considerations should be kept in mind7:
- Create a food safety plan — A food safety plan outlines an organization’s food safety objectives. It contains a collection of written documents, which describe activities that ensure the safety of food during manufacturing, processing, packing and holding. This plan should take expertise from safety, management, production, logistics, quality and other professionals into account. For more information on food safety plans, click here.
- Involve employees — Employees should be trained on common food safety issues. Additionally, it’s beneficial to gather employee feedback on how internal policies and procedures can be updated to further improve food safety protocols.
- Monitor your progress — Food safety is an ongoing concern. As such, it’s important for firms to conduct regular audits, ensuring that food safety is practiced throughout the organization. If issues are discovered during your audits, it’s important to address them quickly and provide refresher training to employees as needed.
Food and feed safety issues can have dire consequences for companies, the food supply chain and, ultimately, the consumer. When ensuring public safety, effective planning and management can make all the difference. What’s more, with the proper plan in place, your business can survive the financial burden of a full-scale recall. For more information related to food safety and manufacturing, click here.