FDA issues final FSMA preventive controls regulations for human and animal food

FDA issues final FSMA preventive controls regulations for human and animal food

AHPA Update

Published: Wednesday, September 16, 2015

The Food and Drug Administration (FDA) last week released two final Food Safety Modernization Act (FSMA) regulations with sweeping new requirements for manufacturers of human food and animal feed. 
Compliance dates for these final rules begin as soon as September 2016 for some larger businesses and will be phased in over two years for smaller businesses. The final rule reflects FDA's attempt to enact tough measures to prevent foodborne illnesses, but also provide sufficient flexibility to accommodate the needs of a highly diverse, global food production system.
"AHPA greatly appreciates that FDA accepted many of the industry's suggestions in the final language and provided flexibility for industry to decide how best to adequately meet the requirements," said AHPA President Michael McGuffin. "The next step is to ensure that the companies that are subject to the new regulations have the information and resources they need to implement these requirements without significantly disrupting their operations."
AHPA has been actively involved in the FSMA rulemaking process and has submitted more than 400 pages of comments to FDA to regarding draft FSMA regulations. AHPA's comments on the Preventative Control Rules  were aimed at ensuring that the vast majority of entities impacted by the regulations would be able to easily understand and implement required provisions to ensure compliance. AHPA will continue to analyze the rules and provide members with compliance resources.

Learn more about FSMA from FDA officials at AHPA's 2015 Botanical Congress on Oct. 9 in Las Vegas.
Exempted Farms
AHPA continues to analyze the final rules, but an initial review indicates that the major provisions that define "farm," "packing" and "holding" were modified to address industry concerns raised by AHPA and other organizations. FDA exempts many farms from the rule with its expanded and clarified definition of "farm." However, many farms will still be subject to the produce safety rule that is expected to be finalized by the end of October.
The definition of a farm in the final rule is clarified to cover two types of farm operations. Operations that fit these definitions are not subject to the preventive controls rule.
Primary Production Farm: An operation under one management in one general (but not necessarily contiguous) location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or any combination of these activities. This kind of farm can pack or hold raw agricultural commodities such as fresh produce and may conduct certain manufacturing/processing activities, such as dehydrating grapes to produce raisins and packaging and labeling raisins.

The final rule includes, a change to expand the definition of "farm" to include packing or holding raw agricultural commodities (such as fresh produce) that are grown on a farm under a different ownership. The final rule also includes within the "farm" definition companies that solely harvest crops from farms.
Secondary Activities Farm: An operation not located on the Primary Production Farm that is devoted to harvesting, packing and/or holding raw agricultural commodities. It 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.
According to FDA, the definition for a Secondary Activities Farm was provided, in part, so that farmers involved in certain formerly off-farm packing now fit under the definition of "farm," as the packing is still part of the farming operation. In addition to off-farm produce packing operations, another example of a Secondary Activities Farm could be an operation in which nuts are hulled and dehydrated by an operation not located at the orchard before going to a processing plant. If the farmer that owns the orchards and supplies the majority of the nuts is a majority owner of the hulling/dehydrating facility, that operation is a Secondary Activities Farm.
Risk-Based Preventive Controls
According to FDA's summary of the rule for Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, facilities that are subject to the regulations must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. This includes a written food safety plan that covers:
Hazard analysis: What are the known or reasonably foreseeable biological, chemical, and physical hazards that occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).
Preventive controls: Measures that are required to minimize or prevent hazards, including process, food allergen, and sanitation controls, as well as supply-chain controls and a recall plan.
Oversight and management of preventive controls: 
o Monitoring: to provide assurance that preventive controls are consistently performed.
o Corrective actions and corrections: to quickly identify and correct a minor, isolated problem that occurs during food production.
o Verification: to ensure that preventive controls are consistently implemented and effective. 
FDA notes that the final rule makes the supply-chain more flexible. The final rule also establishes separate compliance dates for the supply-chain program provisions so that a food facility will not be required to comply with the supply-chain program provisions before its supplier is required to comply with the preventive controls for human food rule or the produce safety rule.
The rule mandates that a manufacturing/processing facility must have a risk-based supply chain program for raw material and other ingredients that it has identified a hazard that requires a supply-chain control. 
Facilities that use preventative controls for a hazard or rely on a customer to control the hazard, do not need to have a supply-chain program for that hazard. Food facilities are responsible for ensuring that foods are received only from approved suppliers, or (on a temporary basis) from unapproved suppliers whose materials are subject to verification activities. (Approved suppliers are those approved by the facility after a consideration of factors that include a hazard analysis of the food, the entity that will be controlling that hazard, and supplier performance.)
A facility will not be required to implement a preventive control when an identified hazard will be controlled by a subsequent entity such as a customer or other processor. Another entity in the supply chain, such as a broker or distributor, can conduct supplier verification activities, but the receiving facility must review and assess that entity's documentation of the verification of control of the hazard.
Updated Current Good Manufacturing Practice (cGMP)
FDA notes that the final rule does not include nonbinding provisions. Some of the previously nonbinding provisions, such as education and training, are now binding so management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. These employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.
FDA's longstanding position that cGMP requirements address allergen cross-contact is made explicit in the final regulatory text.


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