Why Food Safety Regulations Are Especially Complex for Smaller Manufacturers
In a landscape marked by increasing consumer expectations and regulatory scrutiny, food safety is more critical for food manufacturers than ever. With various regulatory bodies, shifting compliance protocols, and complex supply chains—it can be difficult for small and medium-sized (SMB) food manufacturers to keep up.
Today, there are various nuanced laws that span different local, state, and federal initiatives. Principally, however, food manufacturers are beholden to the U.S. Food & Drug Administration (FDA) and its legislation. In recent years, FDA regulations have changed considerably, adapting to a global economy by prioritizing prevention instead of reactionary management. These changes are laid out in the Food Safety Modernization Act (FSMA).
For SMBs food safety isn’t just a regulatory requirement; it's the cornerstone of business. It's how SMBs protect their customers, maintain their reputations, and grow their business. Noncompliance can result in far-reaching consequences—from customer illness to legal action.
Yet SMBs must navigate the complexity of the FSMA and overlapping regulations with fewer resources and smaller teams, making it more difficult not just to get the job done, but to optimize and streamline the process.
FSMA and the Foundations of Modern Food Safety Compliance
The FSMA was developed in response to the 48 million people in the U.S. who get sick from foodborne diseases each year. Signed into law by President Barack Obama in 2011, FSMA gives the FDA new authority over how foods are grown, harvested, and processed.
Since then, nearly every aspect of the U.S. food system has been impacted in a shift to prevention through preventative controls across the food supply instead of a reactionary approach.
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What Is FSMA and Why Does It Matter?
For the first time ever, the FSMA mandates that the FDA enact controls across the entire food supply—including pet food and animal feed. It established preventative controls for food facilities, new produce safety standards, hazard analyses that account for radiological hazards, and additional regulations against intentional contamination of foods.
These more stringent and mandated guidelines impact SMBs significantly, because they created changes to inspection frequency (usually based on risk), allow the FDA to access all records, frequently require testing by accredited laboratories, and allow for visual inspection of the facilities and swabbing of the environment. When it comes to compliance, SMBs face the same protocols as much bigger companies—which has often made navigating food safety a full-time job.
Non-compliance can result in new punishments, including: mandatory recall, administration detention, suspension of registration, and additional tracing and record keeping for high-risk foods.
How FSMA Defines “Small” and “Very Small” Businesses
“Small” and “very small” businesses are exempt from some requirements of prevention as laid for in the FSMA. Small businesses employ fewer than 500 full-time equivalent employees, and very small businesses are those that average less than $1M in sales annually.
These exemptions are subject to change as the company grows or as regulations evolve. What’s more, there are different rules for different types of food, so there may be different standards, even for small and very small businesses.
Core FSMA Rules Every SMB Should Understand
There are six foundational rules laid out in the FSMA that illustrate the major shift from responding to foodborne outbreaks to preventing them. These also extend to animal food, as part of the Preventive Controls for Animal Food (PCAF) rule, written into the final version of the FSMA. As such, any facilities handling animal food should also sit up and take notice.
These are essentials for every SMB to understand:
Food Traceability Rule
This mandates enhanced traceability and record-keeping for specific foods on the Food Traceability List, allowing for more rapid and effective tracing during outbreaks. While the compliance deadline has been extended several times, the FDA has most recently proposed that it take effect July 20, 2028.
Prevention Controls for Human Food (PCHF)
This rule requires food facilities to register with the FDA and create and implement a written food safety plan.
Produce Safety Rule
The Produce Safety Rule sets minimum standards for growing, harvesting, packing, and holding of fruits and vegetables.
Foreign Supplier Verification Programs (FSVP)
The FSVP states that importers are responsible for ensuring that foreign-produced foods they bring into the U.S. meet U.S. food safety standards.
Intentional Adulteration Rule
This rule requires facilities to develop a “food defense plan” to protect against intentional contamination intended to cause widespread harm.
Sanitary Transportation Rule
The Sanitary Transportation Rule requires shippers, loaders, carriers, and receivers to use sanitary practices to prevent contamination.
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The Food Traceability Rule: What Small Manufacturers Need to Know
The Food Traceability Rule represents the most robust change to operations for most food manufacturers. As part of a long and complex supply chain, SMB manufacturers must now account for the entirety of the chain with detailed records. The rule applies to manufacturers, processors, packers, and holders of foods on the Food Traceability List, as well as those containing any ingredients on the list. The rule mandates the establishment of a traceability plan, with the assignment of traceability lot codes and key data elements that must be kept for two years and available to the FDA within 24 hours of a request, along with a timeline of critical tracking events.
Here we break it down a bit more.
What Are Key Data Elements?
Key data elements include food information (including a description and quantity), dates of specific events like harvest or packing, locations of packing sites, harvest sites, and receiving location, and the business information of any businesses involved in the supply chain.
What Are Critical Tracking Events?
Critical tracking events are key points in a food’s supply chain, which include: harvest, cooling (reducing a raw food’s temperature before it's packed), initial packing, first land-based reception, shipping, receiving, and transformation (AKA, slicing, cutting, commingling, repacking, or relabeling).
What’s on the Food Traceability List?
The list includes many foods, but emphasizes high-risk foods such as leafy greens, soft cheeses, nut butters, eggs, shellfish, and produce like tropical fruits, tomatoes, cucumbers, and peppers. A complete list is available on the FDA’s website.
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Other Critical Regulatory Areas for SMB Food Producers
Beyond the FSMA, there are other regulatory areas for food producers to pay attention to, covering sanitary transportation, traceability, labeling, allergens, and more.
Labeling and Allergen Disclosure
The FDA requires food manufacturers to provide a clear ingredient list, nutritional information, and the presence of any major allergens under laws like the Food Allergen Labeling and Consumer Protection Act. Failing to meet these requirements can result in lawsuits and product recalls that create reputational damage.
USDA Oversight (Meat, Poultry, Egg Products)
When it comes to certain items like meat, poultry, and eggs, oversight shifts from the FDA to the USDA. The USDA has different inspection requirements, which are usually continuous at facilities that handle these products to ensure that strict food safety and sanitation standards are met. Labeling for these products may also be different, requiring prep-approval labels before they can enter the market.
OSHA and Environmental Safety Regulations
PSHA sets standards for employee protection, including the proper use of cleaning chemicals, personal protective equipment, and training to prevent accidents in production areas. In addition to OSHA requirements, businesses are responsible for managing waste disposal and complying with environmental health inspections that address sanitation and potential contamination risks.
Compliance Challenges for Smaller Teams and How to Overcome Them
For many SMBs, staying compliant isn’t just about effort—it's about the struggle to do so with limited resources. Unlike larger manufacturers with dedicated compliance teams, smaller operators often rely on one person, or a piecemeal team of different employees to get the job done. These individuals often use manual, paper-based systems that make recordkeeping and audits very cumbersome. Additionally, training gaps can emerge when staff turnover is high or when compliance updates aren’t communicated effectively. Both of these scenarios leave employees feeling unsure about what needs to be done or how to do it.
In addition to these challenges, SMBs also face budgetary constraints. When retailers and distributors demand costly third-party certifications as a condition of doing business—a practice that is increasingly common—the regular strain of staying compliant intensifies. These challenges can make regulatory maintenance and compliance feel overwhelming, especially for businesses that would like to scale operations.
Meeting these challenges is tough, but a simple pathway to improvement is by investing in tools that streamline processes and eliminate unnecessary manual work related to compliance.
How Tools like BruceAI Simplify Compliance Workflows
With tools like BruceAI, SMB food manufacturers can transform compliance from a tedious burden to a streamlined, mostly automated process. Tools like this enable auto-generation of key supplier and compliance documentation by ingesting inputs like questionnaires and document checklists, then extracting critical metadata like expiration dates or audit findings to keep files structured and audit-ready.
BruceAI even continuously monitors supplier data and traceability logs, sending alerts or flagging missing records or nonconformance before these issues turn into major audit crises. As a result, teams spend much less time chasing paperwork and more time on value-add work, all while maintaining a compliance environment that is always inspection-ready.
Final Thoughts: Staying Ahead of Regulations in a Resource-Limited Environment
Regulatory compliance in food manufacturing isn’t a one-and-done task, it’s an ongoing commitment that evolves alongside new rules, allergens, and standards. For SMB manufacturers, the key to long-term success lies in being proactive: building systems that not only meet today’s requirements but can also adapt to tomorrow’s challenges.
Staying ahead of regulations not only protects consumers, but it strengthens trust with key partners—from retailers to distributors. Tools like BruceAI act as a strategic advantage in the journey to proactive compliance, helping teams maintain audit-ready records, streamlining documentation, and monitoring compliance without adding headcount. By embracing smart automation, small businesses can turn compliance into a key advantage.
Ready to simplify your workflows? Start your free trial of BruceAI today.
