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Top 5 Regulatory Compliance Risks: Food & Beverage Industry

Food Services

Top 5 Regulatory Compliance Risks: Food & Beverage Industry


Since Congress introduced the Food Safety Modernization Act (FSMA) in 2011, compliance with the law by the food and beverage industry has shifted from responding to reports of foodborne illnesses to prevention.  


The FSMA applies to all food manufacturers required to register under the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition to the FSMA, OSHA compliance requirements and the Current Good Manufacturing Practices (CGMP) raised the regulatory compliance bar as it applies to the food and beverage industry.


Food and beverage manufacturers face non-compliance fees, penalties, and potential recalls from the U.S. Food and Drug Administration (FDA) if they do not provide adequate food safety protection at their manufacturing plants and for their employees. 


The following briefly describes the five types of regulatory compliance standards and the fees and penalties for food and beverage industry non-compliance.

Risk #1: HARPC Analysis Compliance 

Hazard Analysis and Risk-Based Preventive Controls (HARPC) were first announced in the Preventive Controls Rule of the FSMA. HARPC compliance requires that each food and beverage industry manufacturer prepare a hazard analysis in written form.

What Does the Hazard Analysis Entail?

The hazard analysis must include the manufacturer’s preventive controls and its procedures for:


·         Monitoring the implementation of preventive controls

·         Setting forth corrective action procedures

·         Verification of procedures for corrective action

·         Identifying the manufacturer’s recall plan. 


HARPC compliance requires manufacturers to designate a qualified individual to oversee its preventive controls and procedures. The selected individual must receive relevant FDA training. Each manufacturer’s facility must maintain its own HARPC plan.

Risk #2: HARPC’s Recordkeeping Requirements

The types of records each manufacturing facility needs to keep are:


·         A record of the preventive controls for each hazard as well as verification that the procedures control the hazard

·         Records indicating that the manufacturer performs the preventive controls on a consistent basis 

·         Records verifying a full account of corrective actions taken

·         Records showing suppliers’ approval and verification


Manufacturers must retain all HARPC records in their original form for at least two years after preparation, including the signatures of the person completing the activity.  

Risk #3: CGMP Compliance

One of the impacts of FSMA was to update the CGMP to include employee training as a mandatory requirement. This is true primarily in the food industry, but CGMPs also apply to manufacturers of beverages, pharmaceuticals, cosmetics, medical devices, and diet supplements.


CGMPs help ensure consistency in procedures that improve products created in a safe environment for employees. The following are examples of critical employee training points:


·         Employers adopt detailed, step-by-step procedures

·         Follow the established procedures faithfully

·         Document all regulatory compliance steps in a timely manner

·         Validate standard operating procedures

·         Follow all quality and safety procedures for both equipment and in facility management

·         Maintain all equipment and facilities to ensure safety and regulatory compliance

·         Demonstrate job competence of employees

·         Ensure cleanliness in both employee self-care and in facilities maintenance

·         Make sure safety protocols are built into every product’s creation

·         Conduct regularly scheduled audits of compliance procedures and protocols


The FDA recommends that CGMPs include monitoring of critical safety controls such as:


·         Humidity

·         PH

·         Flow rate

·         Time

·         Temperature

Risk #4: FSMA’s Sanitary Transportation Compliance Requirement

The final FSMA rule establishes the mandatory requirements for food and beverage manufacturers in relation to:


·         Vehicles and transportation equipment

·         Transportation operations

·         Records and record retention

·         Employee training

·         Waivers, where the waiver will not result in food being transported in an unsafe manner for humans or animals

Risk #5: OSHA Compliance

In many industries, OSHA requires employee footwear that meets the standards established by the American Society for Testing and Materials (ASTM) and the American National Standards Institute (ANSI). Some employers pay for employee personal protection equipment (PPE), including protective footwear. Employees may bear the cost of their PPE if they are allowed to take the work footwear off-site. 


The OSHA footwear standards are not required in the food and beverage industry but they come highly recommended. This recommendation led to a growth in corporate footwear programs to control the costs of providing employee PPE. Corporate safety footwear programs help employers reduce costly accidents caused by inadequate footwear. They also emphasize a strong corporate culture of caring for the safety of their employees.

The Consequences of Non-Compliance

Non-compliance with FSMA does not often result in outlandish fees. Manufacturers may receive a bill for hourly re-inspection of an employer’s facilities and documentation that the employer fixed the problems identified during the first inspection. The big stick under FSMA comes when an FSMA inspection demonstrates that the manufacturer’s food contamination rises to the level that requires an expensive food recall. Naturally, other consequences may occur, such as buyers and suppliers may reconsider doing business with a company that does not take food safety seriously.


OSHA violations, however, foreshadow significantly higher costs.  Less serious violations may just result in a warning citation. Serious violation penalties add up to $13,000 per violation. Repeated violations may result in penalties as high as $136,000. OSHA maintains multiple citations as a permanent part of the company’s safety record.


A corporate safety footwear program is a critical step in keeping employees safe and meeting the requirements set forth by OSHA, reducing companies’ exposure to footwear-related workplace accidents and the associated costs of being non-compliant. Speak to a safety expert to learn more about Shoes For Crews’ corporate safety footwear solutions.