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FSMA for Small Businesses: Tailoring Compliance for Success 

 July 2, 2024

By  Rachel Montgomery

The Food Safety Modernization Act (FSMA) has transformed the landscape of food safety regulations in the United States. Aimed at preventing foodborne illness outbreaks, FSMA mandates a science-based approach to ensuring food safety throughout the entire food supply chain. While these regulations are essential for public health, achieving FSMA compliance can pose significant challenges, particularly for Small Businesses within the food industry.

This article delves into the unique obstacles faced especially by Small Businesses in complying with FSMA. We’ll explore practical solutions and guidance to help them navigate the complexities of the regulations and tailor a food safety plan that safeguards consumers while considering the realities of their business size and structure.

What is considered a Small Business under FSMA?

SME’s (Small or Midsize Business Entities) can mean different sizes in different regulations and country to country.   FDA describes a Small Business as a business with fewer than 500 full-time equivalent employees.   In planning the implementation of FSMA regulations, FDA recognized the special needs of Small Businesses and provided phased-in compliance dates for FSMA Rules.  Although these phase-in dates have passed, FDA has provided several guidance documents specific to Small Businesses. You can find those guidance documents on the FDA website; the small entity compliance guide for human food is one example: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-what-you-need-know-about-current-good-manufacturing-practice-hazard

Challenges Faced by Small Businesses in FSMA Compliance

Here are some of the main hurdles Small Businesses encounter when implementing FSMA:

  • Resource Constraints: A Small Business often operates with tighter budgets and smaller teams compared to larger food corporations. Allocating sufficient resources for staff training on FSMA requirements, conducting thorough hazard analyses, and maintaining comprehensive recordkeeping systems can pose a significant financial and logistical burden.
  • Navigating Regulatory Complexity: FSMA regulations are extensive and intricate, encompassing various preventive control measures, supply chain management standards, and recordkeeping requirements. For businesses unfamiliar with food safety regulations, deciphering and implementing these guidelines can be overwhelming.
  • Adapting Existing Infrastructure: Adapting current processes and infrastructure to meet FSMA requirements can be challenging, especially for facilities with limited space or outdated equipment. Upgrading equipment or redesigning production lines to meet stricter sanitation protocols or hazard mitigation measures might necessitate significant upfront investments.

Tailoring FSMA Compliance for Small Businesses: Practical Steps to Success

Despite the challenges, achieving FSMA compliance is not only required by law but also essential for the long-term success of any Small Business in the food industry. Here are some practical steps and considerations to guide Small Business on their FSMA compliance journey:

  • Focus on High-Risk Areas: Conduct a thorough hazard analysis that identifies and prioritizes the most significant hazards specific to your products, ingredients, and processes. FSMA allows for a risk-based approach, so focus your initial preventive control efforts on mitigating the most critical risks. This targeted approach allows you to allocate your limited resources efficiently.   A PCQI, a Preventive Controls Qualified Individual, is required to conduct the hazard analysis and develop and implement a food safety plan.  Considered to be the most practical approach to becoming a PCQI is taking a course that provides a certificate of completion issued by FSPCA.  Note:  The word Certificate is used rather than the words Certified or Certification because FSPCA emphasizes that Certificate is the proper term.)
  • Embrace Free Resources: The FDA, recognizing the challenges faced by SMEs, offers a wealth of free resources to aid in FSMA compliance. Their website provides a comprehensive library of guidance documents, training materials, and informative webinars. Leveraging these resources is a cost-effective way to gain a clear understanding of the requirements and best practices for implementing FSMA in your specific operation. 
  • Remember to Enlist Help from Suppliers:  Your suppliers of equipment, supplies, and services are other resources that can provide expertise you may not have in-house.  Enlist their help since they have a vested interest in your business and helping it succeed and grow.
  • Seek Expert Guidance: Consider consulting with qualified food safety professionals. These experts can provide tailored advice on developing and implementing FSMA-compliant food safety plans, hazard analysis, and preventive control measures. While there might be associated costs, their expertise can save you time, resources, and ensure you’re on the right track towards compliance. 
  • Technology Can Be Your Ally: Explore cost-effective software solutions designed for the food industry. These solutions can streamline recordkeeping, automate monitoring procedures, and facilitate employee training on FSMA regulations. Technology can be a powerful tool for Small Businesses to manage compliance tasks efficiently without overburdening limited staff. 
  • Interactive PCQI training courses provide opportunities to hear and discuss best practices from other companies:   Technology and other approaches to save money on compliance are often best practices participants from other companies readily discuss and industry-experienced lead instructors have made use of in their own manufacturing and supply chain operations.  Thus, look for training courses that provide full interaction throughout the course, not only with an industry-experienced lead instructor, but with the other participants, both altogether and in small groups in break-out sessions.

Additional Tips for Small Businesses Navigating Compliance: 

Building a Culture of Food Safety is crucial for long term compliance, and Food Safety Culture is essential for Small Businesses with limited resources.

  • Invest in Employee Training: A well-trained workforce is the cornerstone of any effective food safety program. A business must implement training programs that educate all employees on proper hygiene practices associated with their particular duties. A food safety plan including hazard identification and implementation procedures must be developed by a PCQI, with specialized training.  Small businesses can benefit by having multiple PCQI’s to share the duties; employees feel empowered by the knowledge, which enhances commitment to the Food Safety Program and Culture.   Moreover, management investment and personal participation in regular refresher courses ensures employees stay up-to-date and reinforces the importance of food safety in your company culture.
  • Open Communication is Key: Foster a culture of open communication where employees feel empowered to report any potential food safety concerns. Regularly address employee questions and concerns to create a collaborative environment focused on preventing foodborne illness outbreaks.
  • Network with Other Small Businesses:  Connect with other small food businesses in your area or industry. Sharing best practices, challenges, and resources can be invaluable in navigating the complexities of FSMA compliance. Collaborate and learn from each other’s experiences to find cost-effective solutions and build a stronger support network. Fully interactive PCQI training via platforms such as Zoom can jump start communication with others in industry to learn best practices.

Conclusion By understanding the unique challenges that they face, and adopting a tailored approach, Small Businesses can achieve FSMA compliance without compromising their business viability. Investing in food safety not only protects consumers but also strengthens brand reputation and consumer confidence, ultimately contributing to the long-term success of your small sized food business

About the author

Mrs. Montgomery is an FSPCA Lead Instructor for PCQI Human Food, PCQI Animal Food and Foreign Supplier Verification Programs (FSVP) courses with over 30 years experience as a food safety executive in large-scale manufacturing. Montgomery offers virtual training spread over multiple shorter days to fulfill the hours required yet allow team members more time to absorb the training and also stay in touch with their work teams. Montgomery is the Principal of Simple Compliance Solutions, LLC and a Registered Microbiologist (National Registry of Certified Microbiologists).

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