Will New FDA Penalties Break Your Bank?

Pricey monetary penalties are just one of many concerns over the Congressional passage of the latest food safety regulations.


Significant Provisions Of House Bill 2749

The bill requires the food manufacturing, processing and logistics companies to be subject to additional fees, operational costs, harsh monetary penalties and severe criminal and civil penalties. Companies would also be responsible for additional recordkeeping and traceability requirements. Here is a look at some of the provisions of HR 2749.

Anyone who knowingly violates certain prohibitions—such as introducing adulterated or misbranded food into interstate commerce—can face up to 10 years imprisonment. Actions such as failing to register a facility or not conducting a hazard analysis constitute misbranding.

Each day a violation continues is considered a separate offence. For an unintentional violation for an individual, the fine is $20,000 per violation not to exceed $50,000 in a single proceeding. For a company committing an unintentional violation, the fine is $250,000 not to exceed $1 million. Individuals knowingly committing a violation would be subject to $50,000 per violation not to exceed $100,000; a corporation can be fined $500,000 per violation not to exceed $7.5 million.

Facilities handling food will be required to register annually with the Secretary of the Department of Health and Human Services, at an annual fee of $500.

Recordkeeping is required on all production, manufacture, processing, packing, transportation, distribution, receipt and holding of food. FDA would be empowered to search records without any evidence of a violation. Refusing records inspections would constitute adulteration.

Any person or company who produces, manufactures, processes, packs, transports or holds food will be required to establish a traceability system that will enable them to identify to the Secretary of HHS everyone along the supply chain within two business days.—A.T.

FDA e-Portal Collects Reports Of Dangerous Products

The FDA’s Reportable Food Registry began operation in early September. The FDA requires “responsible parties” to report within 24 hours any “reasonable probability that an article of food will cause severe health problems or death to a person or an animal.”

A reasonable party is any person who has to submit registration information to the FDA for a food facility that manufactures, processes, packs or holds food for human or animal consumption. Examples of reasons food should be reported include bacterial contamination, allergen mislabeling or elevated levels of certain chemical components.

Creating this portal is another initiative FDA is implementing to safeguard the country’s food supply. The Reportable Food Registry can be accessed at www.rfr.fda.gov. –A.T.

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