Cenza+ - Learning How to Abide by FDA Regulations Under the FSMA

Understanding the Impact of the FSMA to Food Manufacturing, Processing, & Distribution Companies

Bill S. 510, also known as the Food Safety Modernization Act (FSMA), strengthens how food safety is regulated, allowing the Food and Drug Administration (FDA) widespread new powers in regulating the private sector in the interest of food safety.

In practice, this measure ensures the FDA has the ability to protect the safety of the US food supply and therefore, protect public health. Extending the powers already granted to the FDA, this bill gives the agency power to access testing results and safety records—and even issue a mandatory recall, an action that was only voluntary prior to FSMA.

For the greater good, FSMA has significantly altered how private companies manufacture, process, distribute, import, export, and sell food. It’s crucial for food manufacturers and sellers to learn how to stay in compliance with guidelines established by the FSMA to produce safe food, avoid recalls or halted production.

Preventive Controls for Human Food

Under FSMA rules, food processors and manufacturers must have a written Food Safety Plan including a risk-based accounting for potential food safety issues. This rule is the Preventive Controls for Human Food Rule. Preventive measures are straightforward in design and intended to protect the food supply from unsanitary conditions, unsafe practices, and adulterated food.

Recall plans must be developed and would be enacted in situations where food could potentially be adulterated and cause illness, injury or death.

The FDA oversees and implements the FSMA Rules through monitoring and corrective actions where they see fit to protect public health. During an audit, the FDA will among other things:

Verify that preventative controls are capable of preventing food hazards via validated scientific evidence
Address major and minor deviations during the production process
Check for accuracy in calibration and monitoring
Review all records to ensure the sanctity and regularity of the monitoring process
Verify all ingredients are from approved manufacturers.
Confirm all employees are adequately trained and educated on the proper practices and carry out their jobs in a properly controlled environment.

Verification of Foreign Suppliers

Due to America’s international food importation practices, checks are in place to verify imported food’s compliance with US safety laws. All importers, if not exempt, must have a Foreign Supplier Verification Program (FSVP) enacted to keep foreign suppliers accountable for their consistency with public health protections in the US. Imported food and food ingredients coming into the US, for consumption in the US, must meet the same standards as foods produced in the United States.

Inspections and Third-Party Audits

Auditors can perform audits and certify food manufacturers are compliant with the FSMA rules. These audits assist the FDA in preventing potentially harmful products from reaching store shelves. Likewise, manufacturers who meet certain criteria can pay a fee and participate in the Voluntary Qualified Importer Program (VQIP), potentially granting them faster entry into the US markets.

Protection from Intentional Adulteration

The FSMA Rule, Mitigations Strategies to Protect Food Against Intentional Adulteration, addresses those efforts to protect food from intentional acts of adulteration where the intent is to cause wide scale public health harm, i.e. large numbers of acute illness or death. These dangerous acts could not only drastically harm public health, but could disrupt the US food supply and have severe economic impacts. Strict rules are in place for the food industry to evaluate their vulnerabilities followed by implementing mitigation strategies to minimize those vulnerabilities. This rule requires a Food Defense Plan be developed to include identification of vulnerabilities, mitigation strategies and management components such as monitoring, corrective action, verification, and record-keeping.

Get Help with Compliance from Paster Training, Inc.

Paster Training, Inc.'s consulting team provides various services to companies that manufacture, process, distribute, import, export, and sell food in the United States or overseas. The goal of their consulting division is to assure compliance with state and federal regulations, including the Food Safety Modernization Act (FSMA).

Their consultants have over 30 years of experience in the industry and regulatory fields. Many of their consultants were former members of local, state, and regulatory agencies. Their team is experienced with navigating the regulatory world.