Size Matters: Are You Ready For New FDA Rules?
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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowNew rules for food producers issued last month by the U.S. Food and Drug Administration will roll out in phases based on the size of the business. Compliance dates for some businesses begin as early as September 2016. Is your business ready?
On September 17, 2015, the FDA published the long-awaited final rules to establish requirements for current good manufacturing practices, hazard analysis and risk-based preventive controls for human and animal food as required by the Food Safety and Modernization Act (“FSMA”). These final rules also establish requirements for current good manufacturing practices and hazard analysis, and apply to domestic and foreign facilities that are required to register with the FDA and manufacture, process, pack, or hold human food, animal feed, or the ingredients used therein.
FSMA Preventive Controls for Human Food
Flexibility for Oversight & Management of Preventive Controls – The final rule will permit monitoring to be tailored to fit each particular preventive control.
Clarification of the Definition of a "Farm" – The FSMA definition of a “farm” was clarified and expanded to include a “secondary activities farm,” defined as an operation not located on a “primary production farm” that “is devoted to harvesting packing and/or holding raw agricultural commodities.”
Supply Chain Program Flexibility – The rule requires that a covered manufacturing/processing facility (“Facility”) have a risk-based supply chain program for those raw materials or ingredients for which the Facility has identified a hazard requiring a supply-chain applied control. However, those Facilities that control the hazard using preventive controls or who appropriately rely on a customer to control the hazard do not need to have a supply chain program for that hazard. Furthermore, a Facility will not be required to implement a preventive control when an identified hazard will be controlled by a subsequent entity in the supply chain, so long as the food is identified as one “not processed to control (identified hazard).”
Additional Binding Provisions Added to Current Good Manufacturing Processes ("CGMP") –Management is now required to ensure that all employees are qualified to perform their assigned duties, and receive training in the principles of good hygiene and food safety.
FSMA Preventive Controls for Animal Food
Establish CGMPs for Animal Food Production – The final rule establishes baseline CGMPs for animal food production that arguably provide greater flexibility than those related to human food. However, further processing of a by-product for use as animal food requires Facilities to process the by-product in compliance with CGMPs.
Covered Facilities Must Adopt a Written Food Safety Plan – The written Food Safety Plan must include the identification of all known or reasonably foreseeable biological, chemical, and physical hazards; the adopting of preventive controls; a plan for ensuring the efficacy of the preventive controls; and a recall plan in the event the Facility fails to prevent a hazard.
Supply Chain Flexibility – The animal food rule adopts substantially the same flexible supply chain program described above.
Exempts Vertically Integrated Feed Mills – Feed mills associated with farming operations in which the feed mill, animals, land and establishment are all owned by the same entity satisfy the definition of a “farm” and are generally not subject to the preventive controls for animal food final rule.
Exempts Bulk Grain Storing Facilities – Bulk grain storage facilities that do not process raw commodities into animal food are not subject to the Final Rule, but grain elevators with integrated feed mill operations are.
Compliance Dates
The final rules for preventive controls for both human food and animal food become effective on November 17, 2015. Businesses are required to be in compliance by September 17, 2016. However, “small businesses” (those with fewer than 500 full-time employees) are given until September 17, 2017 to comply with the preventive controls for human food final rule. “Very small businesses,” (those averaging less than $1 million per year in both annual sales of human food plus the market value of human food manufactured, processed, packed or held without sale) are given until September 17, 2018. Although they must have records to support their status as very small businesses by January 1, 2016.
“Businesses” have one year, “small businesses” have two years and “very small businesses” have three years to comply. A “very small business” is defined as one averaging less than $2,500,000 per year during the three year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed or held without sale. However, for each of those three business categories the compliance date for preventive controls is pushed out one year beyond the date of CGMP compliance.
The supply chain requirements will phase in as early as 18 months after the effective date to as late as three years after the rule’s publication date.
Aaron Grant is an attorney at Ice Miller.