With most deadlines having passed from the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) ramped up efforts this year in enforcing the new regulations. Whether it be through inspection violations or warning letters, FDA sought to fully implement FSMA regulations. See some of the year’s highlights below.
FDA Began More Actively Enforcing FSMA regulations
FDA’s inspection data reported 289 citations to importers without an FSVP, up from 108 the previous year. FDA also cited hundreds of facilities for having issues with their Hazard Analysis and Risk-Based Preventive Controls (HARPC) Food Safety Plans. These citations ranged from failing to have a HARPC Food Safety Plan, not identifying hazards that require a control, or not having a Preventive Controls Qualified Individual (PCQI) write the plan as required.
With most of the deadlines having passed, some several years ago, it should be expected that FDA will continue to enforce these rules more heavily.
FDA Removed 20% of Food Facility Registrations after Renewal Period
FSMA requires food facilities to renew their FDA registration between October 1 and December 31 of every even numbered year. FDA routinely removes facilities from its database that fail to renew. FDA removed over 47,000 companies at the beginning of 2019.
FDA considers registrations that are not renewed to be expired. Having an expired registration prohibits a facility from selling and distributing their products in the United States. The next renewal period will take place between October 1 and December 31 of 2020.
Intentional Adulteration Deadline Passed
Under FSMA, facilities must designate a Qualified Individual to develop mitigation strategies to protect food from intentional adulteration via a Food Defense Plan. The deadline for facilities with more than 500 full-time equivalent employees to comply passed on July 26, 2019. Businesses with less than 500 full time equivalent employees must comply by July 26, 2020.
FDA released a guidance to assist facilities in creating their Food Defense Plans. The guidance supplies several methods to streamline the process of creating a plan.
FDA Announced Higher Re-Inspection Fees
This year, FDA announced they would raise the fee for re-inspections conducted in 2020. Although there is no fee for routine inspections, FSMA gives FDA authority to collect fees when FDA re-inspects a facility due to compliance issues. The fee for foreign facilities increased to $301/hr and $258/hr for domestic facilities.
FDA Issued Warning Letters for Preventive Controls and FSVP Violations
This year, FDA started issuing warning letters to companies with compliance issues in regards to FSMA violations, most frequently involving Preventive Controls and FSVP. When the deadlines first passed for these regulations, FDA offered a grace period in which they sought to educate facilities as to what would be expected of them regarding these new rules. However, it is clear that FDA is shifting from the educational phase to enforcement.
A warning letter is an official message from FDA citing a compliance violation. Generally, facilities have 15 business days to respond with solutions to the violations. Expect more of these letters to be issued for FSMA violations in 2020.
Final Preventive Controls Deadline Passed
The last of the Preventive Controls deadlines (for very small animal food facilities) passed this year. With all the deadlines having passed, it will now be expected for facilities to comply with Preventive Controls rules, and any deviation can result in regulatory action from FDA.
The overall theme of 2019 was increased enforcement of FSMA regulations. Registrar Corp offers many FSMA related services including HARPC Food Safety Plan development or review and FSVP assistance. We will continue to keep the food industry updated and respond to the changes in FDA regulations ahead. To receive 2020 updates by email, subscribe to our blog. For assistance with FDA regulations, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.