Regulations

Food safety regulations, in particular the FSMA (Food Safety Modernization Act), play a vital role in ensuring the safety and quality of food consumed by both humans and animals. Meeting food safety regulations is a fundamental requirement for all operators in the food industry. Resources are available to help you meet the standards and get the training and certifications needed.

Food Safety Modernization Act Rules and Regulations

The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama in 2011. It helped transform the US food safety systems by focusing on prevention rather than response to food-borne illness. It plays a foundational role in the way foods are grown, harvested, and processed.

To help producers prepare for FSMA standards, Penn State Extension has a range of resources, in both Spanish and English, provided by experts in the areas of feed and food safety.

Preventive Controls for Human Food

The Preventative Controls Rule of the FSMA regulations focuses on prevention of food-borne illness. It requires all human food processing facilities to have a Qualified Preventive Control individual who is ultimately responsible for developing and implementing Hazard Analysis and Risk-Based Preventive Controls for Human Foods.

Any training provided for employees involved in developing and implementing HACCP systems, as part of the FSMA regulations, has to meet FDA requirements for Preventive Controls Qualified Individuals. Penn State Extension provides training on how to meet these requirements in its Preventive Controls for Human Foods Certification Workshop.

Preventive Controls for Animal Food

FSMA regulations apply not just to human food but to animal food too. Facilities processing food for animals also must have a written food safety plan, prepared by Qualified Preventive Control Individuals.

A food safety system established and implemented by manufacturers and processors of animal feed has to be developed by industry professionals with FDA approved credentials. If you have someone in your organization about to take on the role, Preventive Controls for Animal Food Workshop meets FDA requirements.

Foreign Supplier Verification Program (FSVP)

The Food Safety Modernization Act covers not only US produce, but food that may have been imported from other countries. The aim is for imported foods to meet the same safety standards as those grown or processed on US soil.

Several regulations cover FDA regulated foods that are grown, manufactured, or processed outside the US. They include the Product Safety Rule, the Preventive Controls for Human Foods Rule, and the Preventive Controls for Animal Foods Rule.

The Foreign Supplier Verification Program (FSVP) Rule also plays an important part in the process. Importers are required to verify food imports have been produced in accordance with applicable US safety standards. FDA credentials are required for anyone involved in the development and implementation of the FSVP. A Foreign Supplier Verification Workshop is another resource that’s available in this section.

Sanitary Transportation of Human and Animal Food

Food safety is crucial throughout the supply chain, and the FDA has made the Sanitary Transportation Rules to prevent food safety risks when human and animal food is being transported. Anyone working in the food transportation industry, such as shippers, carriers, loaders, and receivers, should understand the regulations, be able to recognize hazards, follow basic safety procedures, and be able to implement best practices. The Sanitary Transport of Human and Animal Food online course meets FDA training requirements.

Food Defense

The FSMA is made up of several rules that have the ultimate goal of improving food safety in the US. One of the more recent additions to the set of rules is the FDA rule Mitigation Strategies to Protect Against Intentional Adulteration or IA rule. It applies to food companies that are involved in the production, transport, storage, or distribution of food for sale to the public.

The aim of the rule is for food companies with more than $10,000,000 in annual sales to establish control measures to prevent or minimize intentional contamination of food. In order to meet this aim, companies have to develop a Food Defense Plan that assesses operations for vulnerable points and then develops and implements mitigation strategies.