policy issues

FSMA Requirements & Compliance Deadlines for Animal Food Industry

FSMA-AFIA

Four of seven final rules within the Food Safety Modernization Act (FSMA) impact the animal food industry:

The largest of these rules is the first one, formally known as the “Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals,” published Sept. 17, 2015. This rule exempts some “farms,” as defined in the regulations, but otherwise impacts animal food manufacturers based on their size, with “large” firms defined as having over 500 employees, “small” firms defined as having fewer than 500 employees, and “very small” firms defined as those selling less than $2.5 million in animal food.

Although manufacturers that produce medicated feed have been in compliance with current good manufacturing practice (CGMP) regulations since the 1960s with the passage of 21 CFR Part 225, manufacturers that produced non-medicated feed or pet food did not have mandatory CGMPs. FSMA changed that by phasing in CGMPs for all animal food manufacturers.

Timeline for Compliance with CGMPs and HA/PC

Over the past several years, U.S. animal food manufacturers have been readying their facilities for compliance with the FSMA regulations. The table below shows when businesses were to comply with the CGMP rules as well as the hazard analysis and risk-based preventive controls (HA/PC) parts of the rule.

 

Business Size

Compliance Date for CGMPs & Related Requirements

Inspections for CGMPs Started

Compliance Dates for HA/PCs & 21 CFR 507.7

Inspections for HA/PCs Start

Large businesses (over 500 employees)

Sept. 19, 2016

Feb. 2017

Sept. 18, 2017

Oct. 2018

Small businesses (a business, including any subsidiaries and affiliates, employing fewer than 500 employees)

Sept. 18, 2017

Oct. 2017

Sept.17, 2018

Oct. 2019

Very small businesses (a business, including any subsidiaries and affiliates, averaging less than $2.5 million in animal food sales)

Sept. 17, 2018

Oct. 2018

Sept. 17, 2019, except for records to support its status as a very small business (Jan. 1, 2017)

Oct. 2020

 

The American Feed Industry Association has been gathering information from the Food and Drug Administration on the outcomes of these inspections to help its members better prepare for inspections. More information can be found on the AFIA member website.

For the latest updates on the Food Safety Modernization Act, visit the FDA’s website and sign-up for email updates