FDA Compliance Dates Looming for Food Companies

26 Aug 2016 --- The US Food and Drug Administration’s (FDA) Safety Modernization Act is making progress with the initial dates for compliance starting next month.

The government is opening a six-month public consultation period on drafts of guidance documents aimed towards helping large food companies meet new regulations. Some of the new rules have compliance dates that start in September.

While the major provisions of the FSMA rules are being implemented, the FDA has issued a final rule that extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules. These changes are part of the FDA’s strategy to ensure the regulations are as practical as possible without compromising on public health. 

The final rules addresses technical issues and better aligns compliance dates across the four rules. 

Meanwhile, the FDA also issues a new draft guidance to help industry to comply with the Preventative Controls for Human Food rule. Deadlines for compliance is just around the corner for large food companies that produce food for people and animals. 

Human food companies, with the exception of small businesses, have to comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food rule by September 19, 2016. 

Animal food companies have to comply by the same date and with preventative controls by September 18, 2017. 

The two CGMP and preventive controls rules - together with the five other foundational rules that will be implemented over the next several years to strengthen FDA oversight of produce, imported foods, sanitary transportation and intentional adulteration - will create the preventive and risk-based food safety system mandated by FSMA and reduce foodborne illness. 

The changes announced in the final rule impact the compliance dates for certain provisions in these four rules: the two CGMP and Preventive Controls rules for human and animal food, Foreign Supplier Verification Programs (FSVP), and Produce Safety. The changes include providing more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specific issues. 

A draft guidance has now been published and is open for public comment. It explains the FDA’s thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and also includes details about establishing a food safety plan. 

More chapters will be released as they are completed with all guidance published by early 2018.