Following extensive outreach with the stakeholder community and publication of four notices of proposed rulemaking, on September 10, 2015, the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) issued the much anticipated Final Rules amending regulations governing Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food Final Rule) and adding regulations specific to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Base Preventive Controls for Food for Animals (Preventive Controls for Animal Food Final Rule).
The Final Rules are significant because they represent the culmination of FDA’s efforts to impose a preventive, rather than a reactive, approach to food safety regulation, while also acknowledging the need for flexibility.
The Preventive Controls for Human Food Final Rule is significant in three ways:
- First, the Final Rule clarifies the definition of “farm,” which is central to determining whether certain entities must register as a food facility. Food facilities that must register with FDA must also comply with the new requirements for hazard analysis and risk-based preventive controls, but farms are excluded from the definition of food facilities. The Preventive Controls for Human Food clarified (and expanded) the definition of “farm.” The Final Rule distinguishes between two types of farm operations—“primary production farm” and “secondary activities farm.” Notably, a secondary activities farm must be majority owned by the primary production farm that supplies the raw agricultural commodities harvested, packed, and/or held by the secondary activities farm. This expanded definition enables some operations that were previously considered “off-farm” to benefit from inclusion in the farm definition and thus gain exemption from some of the FSMA rules, including the Preventive Controls for Human Food Final Rule.
- Second, the Final Rule mandates that covered facilities establish certain hazard analysis and risk-based preventive controls, including requirements for a written food safety plan, hazard analysis (e., identification of reasonably foreseeable hazards associated with each type of food manufactured, processed, packed, or held at the facility), and preventive controls management (i.e., procedures for monitoring, corrections, corrective actions, validation, and verification). The Final Rule introduces some flexibility by acknowledging that “a facility must take into account the nature of the preventive control and the facility’s food safety system when considering which activities are appropriate for that facility.”
- Third, the Final Rule re-designated as a separate subpart those provisions applying to supply chain programs. The FDA acknowledged in its Final Rule the reality of modern distribution chains, and therefore will not require a manufacturing/processing facility to implement a preventive control where the hazard requiring the preventive control will be controlled by another entity in the distribution chain. However, covered facilities must still ensure that human food products are received only from approved suppliers, and must further assess and document the supplier’s own documentation of its verification activities.
In addition to adopting the preventive control requirements outlined above, the Preventive Controls for Animal Food Final Rule is distinctly significant in two ways:
- First, the Final Rule establishes for the first time Current Good Manufacturing Practices (CGMPs) for animal food production, with a particular focus on the following areas: personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, holding and distribution, and holding and distribution of human food by-products for use as animal food. Notably, human food facilities must follow only the specific CGMPs for the holding and distribution of human food by-products for use as animal food. However, if human food facilities further process a by-product for use as animal food, these same facilities are required to comply with the CGMPs outlined in the Final Rule, but may choose to follow either the human or animal CGMPs.
- Second, the Final Rule further highlights that feed mills that are part of fully vertically integrated farming operations are not required to register as food facilities, and therefore need not comply with the new hazard analysis and preventive control requirements. The FDA reasoned that it needs additional information to help inform the scope of any requirements, and that the FDA will seek comment in future rulemaking on how best to subject vertically integrated feed mills to food safety requirements.
Attention to the requirements set forth in these Final Rules is critical because the time frame for compliance by some businesses is somewhat strict. The earliest expected compliance date with the human food preventive control requirements for some businesses (i.e., businesses other than small businesses) is September 2016. Similarly, for these same businesses, the earliest expected compliance date with animal food CGMP requirements is September 2016, with the earliest anticipated compliance with preventive control requirements set for September 2017.
The practical effect of the Final Rules is that covered entities must now devote substantial time and resources to establishing food safety plans and hazard analysis and preventive control procedures within a relatively short time frame. Nevertheless, the hope is that the FDA will adopt an individualized approach to enforcement, recognizing that food safety programs and hazard analysis and preventive control management procedures must be individually tailored and account for the diversity in types of human and animal food facilities.
*Blake Walsh is admitted only in Tennessee. His practice is supervised by principals of the firm admitted in the District of Columbia.