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5 Frequently Asked Questions About the Food Safety Modernization Act

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The Food Safety Modernization Act (FSMA) created in 2011 by the Food and Drug Administration (FDA) is old news to the food processing industry. However, because the required compliance dates were years away from the time FSMA was created in 2011, the implementation of FSMA has seemed like a distant to-do.

That is no longer the case. Many food facilities across the U.S. were required to comply with FSMA by September 2016, and deadlines for other food facilities are around the corner in September 2018 – so if you haven’t done so already, it’s time to get down to business.

Read on for the top frequently asked FSMA questions to make sure you understand your required changes. And for even more on this topic, download our Special Report on FSMA.

What is FSMA?

Created by the FDA, FSMA was signed into law on Jan. 4, 2011 and is one of the largest food safety laws created in more than 70 years. Its goal is to ensure the U.S. food supply is safe by encouraging a preventive – rather than reactive – approach to contamination.

What is the Preventive Controls for Human Food rule?

FSMA’s Preventive Controls for Human Food rule is the product of the FDA’s outreach to industry and consumer groups; the agency’s federal, state, local and tribal regulatory counterparts; academia; and other stakeholders. The rule highlights four key requirements that food manufacturing facilities must meet to be compliant with the FDA.

What are the four key requirements of FSMA’s Preventive Controls for Human Food rule?

Facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. A written food safety plan is required and must cover: (a) hazard analysis, (b) risk based preventive controls, (c) oversight and management of preventive controls including monitoring, corrective actions and completed steps, and (d) verification that the preventive controls are working. The written food safety plan must address a Hazard Analysis and Risk Based Preventive Controls (HARPC) approach, rather than the Hazard Analysis and Critical Control Points (HACCP) approach that many facilities have used for years. At first glance, HARPC may seem no different from HACCP, but HARPC leads facilities to more carefully analyze hazards and threats by requiring that preventive controls be in place before any identified hazard arises.

What is the deadline for all adjustments to be made?

Depending on the type of food business in question, the deadline for compliance with FSMA could have been be as early as September 2016 or they could be as late as September 2018:

  • Very small businesses averaging less than $1 million per year in annual sales of human food: September 2018

  • Business subject to the Pasteurized Milk Ordinance: September 2018

  • Small business with fewer than 500 full-time employees: September 2017

  • All other businesses: September 2016

What types of facilities are exempt from having to shift their approach from HACCP to HARPC as part of adjusting for FSMA?

There are six types of food facilities that are exempt from shifting their approach from HACCP to HARPC to comply with the final FSMA rule:

  • Food companies under the exclusive jurisdiction of the U.S. Department of Agriculture

  • Companies that are subject to FDA’s new Standards for Produce Safety authorities

  • Facilities that are subject to and comply with FDA’s seafood and juice HACCP regulations

  • Low acid and acidified canned food processors

  • Companies defined as “small” or “very small” businesses

  • Companies with a previous 3-year average product value of less than $500,000

For actionable steps that will help you get ready for FSMA at your facility, click below to download our Special Report on FSMA. If you’d like to have a free consultation after reading through our special report, schedule one with Orkin.


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