FDA Final FSMA Preventive Control Rules
On September 17, 2015, the Food and Drug Administration 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 apply to domestic and foreign facilities that manufacture, process, pack, or hold human food, animal feed, or the ingredients used therein and are required to register with the FDA under the agency’s existing regulations implements by the Bioterrorism Act.
FSMA Preventive Controls for Human Food
The main thrust of the final rule for Preventive Controls for Human Food is unchanged from prior versions; that is, a shift to Hazard Analysis and Risk-Based Preventive Controls. Food manufacturers and processors required to register with the FDA are tasked with identifying their significant hazards with the potential to cause illness in humans and animals and developing a Food Safety Plan to control those hazards. Ongoing monitoring and record keeping related to the Food Safety Plan is also mandated. While the main thrust of the rule has not changed, the final rule does have some important clarifications and additions discussed below.
Flexibility for Oversight & Management of Preventive Controls – Rather than take a “one size fits all” approach to monitoring hazards, the final rule will permit monitoring to be tailored to fit each particular preventive control. An example provided by the FDA is that the monitoring of the actual temperature values used in a heat process designed to kill pathogens would be more frequent and extensive than the simple record keeping of preventive maintenance activities used to minimize metal hazards.
Clarification of the Definition of a “Farm” – The FSMA definition of a “farm” was clarified and expanded to include a “secondary activities farm,” which is defined as an operation not located on a “primary production farm” that “is devoted to harvesting packing and/or holding raw agricultural commodities.” The “secondary activities farm” must be majority owned by the “primary production farm” that supplies the majority of the raw agricultural commodities harvested, packed, or held by the “secondary activities farm.”
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, such as a customer or processor, so long as the food is identified as one “not processed to control (identified hazard).” Additionally, the Facility must have obtained written assurance from the subsequent entity regarding the actions to be taken to control the hazard down the line. A Facility may also shift the responsibility for conducting supplier verification activities to another entity in the supply chain, such as a broker or distributor, so long as the Facility reviews and assesses that entity’s documentation of the supplier verification.
Additional Binding Provisions Added to Current Good Manufacturing Processes (“CGMP”) – Formerly non-binding provisions, such as those related to employee education and training, are now binding. Management is now required to ensure that all employees involved in manufacturing, processing, packing or holding food are qualified to perform their assigned duties. These employees must also receive training in the principles of good hygiene and food safety, including employee health and hygiene.
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. With that said, animal food processors already implementing human food safety requirements do not need to implement additional preventive controls or CGMP regulations when supplying a by-product for animal food, except to the extent needed to prevent physical or chemical contamination of the by-product. Further processing of a by-product for use as animal food, however, does require Facilities to process the by-product in compliance with CGMPs. In such a scenario, the Facility can elect to follow either the animal food or human food CGMP.
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 designed to minimize or prevent the identified hazards; a plan for ensuring the efficacy of the preventive controls through monitoring and verification; and, finally, a recall plan in the event the Facility fails to prevent a hazard to its animal food.
Supply Chain Flexibility – The animal food rule adopts substantially the same flexible supply chain program described above in the Human Food section.
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. The FDA, however, has expressed an intent to publish a future proposed rule that would require some vertically integrated feed mills to adopt the CGMPs established by 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, e.g. grain elevators, are not subject to the Final Rule. Grain elevators with integrated feed mill operations, however, remain subject to CGMP requirements.
The final rules for preventive controls for both human food and animal food become effective sixty (60) days after publication – on November 17, 2015. Businesses are required to be in compliance with the final rule one year after publication – September 17, 2016. However, “small businesses” (those with fewer than 500 full-time employees) are given two years to comply with the preventive controls for human food final rule – until September 17, 2017. “Very small businesses,” defined as those businesses 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 three years – until September 17, 2018 – to comply, although they must have records to support their status as very small businesses by January 1, 2016.
Compliance dates for animal food are similar, although slightly more complex. The general date of CGMP compliance is one year for “businesses,” two years for “small businesses,” and three years for “very small businesses.” For the purposes of the preventive controls for animal food final rule, 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. For each of those three business categories, however, the compliance date for preventive controls is pushed out one year beyond the date of CGMP compliance (e.g. a “small business” has three years to comply with establishing preventive controls).
Finally, the supply chain requirements will phase in over a period starting as early as 18 months after the effective date (for a receiving business other than a small or very small business whose supplier will not be subject to human food preventive controls rule) to as late as three years after the rule’s publication date or six months after the supplier is required to comply with the rule, whichever is later, for a small business with a supplier that is subject to the preventive controls for animal food final rule.
While the final rules are not substantially different than the earlier published proposed and supplemental rules, the final rules do start the clock running on Facilities to shift from a more reactive food safety regime to a more preventive, and arguably more onerous, outlook. Facilities are encouraged to familiarize themselves with the rules and begin preparing to implement the rules’ requirements as soon as practicable.
This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader must consult with legal counsel to determine how laws or decisions discussed herein apply to the reader's specific circumstances.