FASTER Act Puts Allergens Back in the Spotlight

FASTER Act Puts Allergens Back in the Spotlight

Denis Storey
July 30, 2021

Aug. 5 Webinar: “Get Ahead of Sesame Allergen Disclosure Enforcement”

Register Now

Aug. 5 Webinar: “Get Ahead of Sesame Allergen Disclosure Enforcement”

TraceGains is teaming up with FARE CEO Lisa Gable to host a webinar exploring the FASTER Act and how food and CPG companies can best prepare.

Register Now

On April 23, 2021, President Joseph Biden signed the Food Allergy Safety, Treatment, Education and Research (FASTER) Act of 2021 into law. Lawmakers drafted this landmark legislation to add sesame to the federally recognized list of known allergens and streamline the practice of labeling new allergens as they emerge.

The FASTER Act requires food and beverage manufacturers to label finished goods made with sesame to identify it as an allergen on the packaging. Manufacturers frequently use sesame in products with labels that read “natural flavors” or “natural spices,” making it difficult for consumers to understand product labels at retail locations.

In addition, the new law establishes a risk-based scientific process and framework for ascertaining additional allergens covered by the Federal Food, Drug, and Cosmetic Act.

The U.S. Senate passed the FASTER Act with unanimous approval after earning overwhelming bipartisan support in the U.S. House of Representatives. 

This legislation marks the first time since 2004 that lawmakers have added a new allergen to the Food Allergen Labeling and Consumer Protection Act (FALCPA) and is the most significant legislation to emerge from Washington since the Food Safety Modernization Act (FSMA).

FSMA updated multiple essential food and beverage regulations. Still, allergen controls and the revised Good Manufacturing Practices (GMPs) that support them could arguably be some of the most important. For example, FSMA’s Hazard Analysis and Risk-Based Preventive Controls (HARPC) Rule goes so far as to define label requirements and elevate undeclared allergens as hazards to be controlled.

With the entire food industry shifting from reacting to foodborne diseases to actively preventing them, here's what you need to know.

Allergen Risks

A food allergy is a reaction to a naturally occurring protein in a food or ingredient. In the United States, the Food and Drug Administration (FDA) identifies eight primary allergens that account for up to 90% of all food allergies. This list, aptly titled “The Big 9,” includes milk, eggs, fish, shellfish, nuts, peanuts, wheat, soybeans, and now sesame. 

Most allergies cause a mild reaction, but in about 18% of cases, allergens can cause anaphylaxis, a systemic response causing breathing passages to swell and blood pressure to nosedive. In the worst cases, this can lead to death.

Allergens can be life-threatening to corporations as well. Recalls can have disastrous impacts on companies, as the economic costs associated with customer communication, product removal and disposal, damages, and legal fees can bankrupt a company in record time. All of this can be caused by human error, mislabeling, or accidental cross-contamination.

Undeclared Allergen

Undeclared allergens remain the leading cause of recalls in the United States and the FDA identifies them as  a “hazard.” Regulated under the HARPC Rule, manufacturing facilities must identify undeclared allergen hazards in their food safety plans that are “reasonably likely to occur” and document the processes to mitigate them proactively. Consider cross-contamination when drafting a food safety plan, including contingencies for cross-contamination.

Undeclared allergens don’t just pose an issue for the company; they also pose problems for suppliers. If a company receives an ingredient that could include a potential allergen or has a potential for cross-contamination, the supplier’s food safety plans also should be addressed. Visibility to suppliers to determine their level of control over potential hazards within their facilities, or cross-contamination, should be of utmost importance.

Allergen Practices

FSMA’s most impressive effort to improve allergen safety belongs to GMPs within HARPC. In total, upwards of 30 allergen controls are identified across every stage of the process: from cross-contact with handling, storage, and use, to sanitation practices and shop-floor cleaning procedures. As a result, GMPs can be found at every step, from receipt to labeling and mislabeling to the final product. In the end, companies must document and follow the appropriate operating procedures to ensure allergens are declared appropriately when a product leaves your dock.

Hazard Analysis

Manufacturers must consider specific hazards when assessing a food safety plan for hazard analysis and preventive controls. Before a complete hazard analysis, identify controlled allergens. Recommended practices include:

  • Create a flow diagram:

    • Identify product and traffic patterns.

    • Assess potential cross-contact opportunities.

    • Develop appropriate controls.

  • Develop controls for cross-contact points: Focus on equipment and facility design.

  • Map employee traffic: Assign workstations, identify shared areas such as washrooms and break rooms, and evaluate uniforms/cleanroom smocks for contamination.

Preventive Controls

Allergen controls are essential at every step of the food manufacturing process. At a high level, standard controls to be documented include:

  • Procurement: What allergens are being purchased?

  • Receiving: What protective requirements are in place to stop cross-contamination in transit?

  • Storage: Materials in storage should be stacked with allergens in mind.

  • Production controls: Changeover procedures need to be followed before changing to a product with a dissimilar allergen content.

During packaging, employees should ensure they’re applying the appropriate label or container.

  • Changeover procedures: Raw materials should be limited in production locations to only necessary stations.

  • Monitoring and verification of preventive controls: Employee education is essential for a successful cross-contamination control program to be effective.

  • Written corrective action procedures: Effectively communicate corrective actions to the individuals who identify the issues.

  • Validation of the effectiveness of the controls: Validate the program and practices with scientific proof that the program and procedures effectively prevent cross-contamination.

Food Allergy Research & Education (FARE) is the leading global food allergy advocacy organization and the largest private investor of food allergy research in the world. TraceGains is teaming up with FARE CEO Lisa Gable to host a webinar exploring the FASTER Act and how food and CPG companies can best prepare. Discover how your business can remain proactive with food allergen disclosures, learn new strategies for managing allergen risk, and get tips for preventing mislabeling incidents. Register today so you don’t miss out on this exciting new webinar.