The Food industry is complicated. The supply-chain from growing through harvesting, formulating, processing, labeling, and manufacturing impacts everyone.

The terms and acronyms in the food industry can be overwhelming and it is often complicated to understand who governs food types each step of the way from farm to fork. Most food items are covered by the FDA (Food & Drug Administration), except the regulation of meats including beef, pork, lamb, poultry and egg products which are governed by the USDA (United States Department of Agriculture), yet game and exotic meats are governed by the FDA, a whole egg falls under the jurisdiction of the FDA, but once the egg leaves it’s shell it is no longer covered by FDA, it is covered by the USDA– confusing right. Once you have worked out who has regulatory jurisdiction over your food, the next step is to identify any special regulatory rules that may apply to your product or process. Here are a couple of examples: imported ingredients including raw agricultural products are covered under the Foreign Supplier Verification Program (FSVP) or if you are producing juice, you must implement a HACCP program specific to juice; acidified and low acid food also have specific regulations. The Code of Federal Regulation, which is the legislation that govern food in the US, is thousands of pages long and covers everything in the food industry including growing practices, clean and sanitary transportation, manufacturing, processing, food coloring, flavoring, packaging, labeling and much more. All food establishments, and especially farmers, must also comply with EPA regulations. Where the FDA and USDA function is to protect public health; the EPA’s charter is to protect the environment by regulating pesticides, chemical use, business impacts on the environment, etc.

Example: Using the State of CA

So far, we have discussed federal regulation and federal agencies. The food industries must also comply with state regulations. Typically, states regulate food processing, restaurants, food service and grocery stores. When applying for business permits, your local county or township typically requires proof you are complying with state and federal laws, such as providing a copy of your HARPC (Hazard Analysis Risk Based Preventive Controls) or HACCP (Hazard Analysis Critical Control Points) Plan. If you review the history of food borne illness outbreaks, the loss of life, permanently ill persons, and the associated costs to industry and healthcare, you will see why there was major regulatory reform that took place in the United States starting in the mid 1990’s. Regulators knew they could no longer allow a culture of reacting and investigating the source of food borne illness after people become sick, so they designed the regulation to promote a culture of proactively identifying and preventing hazards in growing, harvesting, shipping, storing, allergen management, product traceability and recall, intentional adulteration, packaging, labelling, manufacturing and processing of foods via the Food Safety Modernization Act, 2011 (FSMA). This regulatory reform gave the FDA more authority to inspect, shut down, fine, and prosecute employees, management, owners, and responsible persons who are not compliant and risking public health. As your food safety consultant, we ensure all our staff member and support staff are proficient in the regulation. We are trained and experienced in the following:


Produce Safety Rule

Agricultural water

  • Water quality - includes water used for cleaning of food contact surfaces or direct produce contact (including ice) during or after harvest, and for hand washing.
  • Water testing - the general approach to testing untreated water used for certain purposes.

Biological soil amendments

  • Raw manure - the applications of manure as a soil amendment and harvesting to minimize the risk of contamination.
  • Stabilized compost - Microbial standards that set limits on detectable amounts of bacteria.


Taking measures to prevent the introduction of dangerous microbes into or onto seeds or beans used for sprouting,

Domesticated and wild animals

The feasibility of compliance for farms that rely on grazing animals (such as livestock) or working animals for various purposes. It establishes the same standards for these animals as it does for intrusion by wild animals.

Worker training, health and hygiene

Taking measures to prevent contamination of produce and food-contact surfaces by ill or infected persons.

Equipment, tools, and buildings

Standards related to equipment, tools and buildings to prevent these sources, and inadequate sanitation, from contaminating produce.

Exemptions – who does the rule apply to? Training: Produce Safety Alliance

Transportation Companies

Sanitary Transportation

Vehicles and transportation equipment - the design and maintenance of vehicles and transportation equipment to ensure that it does not cause the food that it transports to become unsafe. Transportation operations - The measures taken during transportation to ensure food safety, such as adequate temperature controls, preventing contamination of ready to eat food from touching raw food, protection of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact, i.e., the unintentional incorporation of a food allergen. Training - personnel in sanitary transportation practices and documentation. Records - Maintenance of records of written procedures, agreements, and training. Training – FDA

Wash, Pack, Process, Manufacture, Store, and Some Producers of Food Supplies

Good Manufacturing Practices and Preventative Controls Rule

Food Safety Plan

Hazard Analysis – identification of known or reasonably foreseeable biological, chemical, and physical hazards. Preventive Controls - hazards requiring a preventive control will be significantly minimized or prevented and help ensure that the food is not adulterated.
  • Process controls - procedures that ensure the control parameters are met.
  • Food Allergen controls - written procedures the facility must have and implement to control allergen/s.

Sanitation controls - procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards. Oversight and management – a facility must make sure that the controls are being met.

  • Monitoring - assurance that preventive controls are consistently performed.
  • Corrections – identify and correct problems
  • Corrective actions – documentation of corrected problems
  • Verification – scientific validation
Supply Chain Program - a risk-based analysis of your entire supply chain. Recall Plan – the ability to identify and your products and recall them in the event of an adverse food safety issue. Training: HACCP Certified (International HACCP Alliance), Preventive Control Qualified Individuals (Food Safety Preventive Controls Alliance)

All Segments of the Food Chain

Intentional Adulteration

Food Defense Plan

Vulnerability assessment - Identification of vulnerabilities such as ability to contaminate the product or have physical access to the product. Mitigation strategies - How identified vulnerabilities will be eliminated or controlled. Mitigation strategy management components - Defines the mitigation strategy. Monitoring - Creating and implementing procedures, including:

  • Corrective actions and
  • Verification tasks

All Segments of the Food Chain

Food Traceability

Under FDA’s “New Era of Smarter Food Safety” initiative, the food traceability requirements are focusing on specific risk-based food types, defining a critical food event that must be tracked and key data element and how these records must be provided to the FDA in the event of a food safety outbreak.

Food Traceability List – A risk based ranking model for upcoming increased food traceability requirements. Critical Tracking Events – defines the steps in the food chain process that requires specific actions and tasks occur for:

  • Growing – additional requirements for sprouts
  • Receiving – defining the “first receivers” responsibilities
  • Creating – creating food versus transforming food definitions and impact of foods on the Food Traceability List.
Transformation – defining what is a transformed food, lot code and tracking requirements. Shipping - defines responsibilities within each step of the transportation process. Traceability Program Records – FDA requirements for record keeping, availability of records and format.

Importers of Food, Ingredients and Supplies

Foreign Supplier Verification Program (FSVP)

Importers are required to conduct risk-based activities to verify the food they are importing has been grown, manufactured, processed, packaged etc. to standards like the US.

Scope – defines who is responsible party or the importer is, under the rule. Hazard Analysis – the importer is required to identify the risks associated with the food and ensure proper supplier controls are in place to prevent, eliminate or control the hazard, throughout the food chain. Evaluation of Supplier Performance - The importer must evaluate:

  • The hazard analysis must be evaluated by a Qualified Individual (QI) as defined by the FDA.
  • Procedures, processes and practices for safety of food
  • Food safety history of the supplier
  • Storage and transportation practices

Supplier Verification – Verification activities may vary depending upon the risks previously identified but may include:

  • Onsite Audits of the supplier’s facility
  • Sampling and testing
  • A review of the supplier’s relevant food safety records

Corrective Actions – the obligations of the importer in the event of an adverse food safety issue. Exemptions and Modified Standards – some food categories and company size and functions can result in modified or exempt requirements.

Navigating regulations, special rules and programs can be tricky, our job is to stay up to date with our evolving industry and be your partner to ensure your food is safe and the brand you worked so hard to build remains unscathed. Call or click here to schedule a free consultation today!