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FDA Issues Final Regulations on Preventive Controls for Human and Animal Food

The Food and Drug Administration has issued separate final rules setting forth preventive controls for human and animal food, and affected companies will face compliance dates that begin as early as September 2016. Containing elements of both the original and supplemental proposals, these rules require human and animal food facilities to develop and implement written food safety plans that indicate the possible problems that could affect the safety of their products and outline steps they would take to prevent or significantly minimise the likelihood of those problems occurring. An FDA press release states that these rules constitute "the first step in putting greater emphasis on the prevention of foodborne illness, holding imported food to the same food safety standard as domestically produced food, and developing a nationally integrated food safety system in partnership with state and local authorities."

Both rules create new requirements for domestic and foreign facilities required to register with the FDA as a food facility to establish and implement a food safety system that includes an analysis of known or reasonably foreseeable biological, chemical and physical hazards and risk-based preventive controls. According to the FDA, these rules provide flexibility in the steps needed to ensure that preventive controls are consistently implemented and effective and that problems are timely identified and corrected.

In addition to maintaining a food safety plan, performing a hazard analysis and instituting preventive controls for the mitigation of any identified hazards, registered food facilities will also be required to monitor their controls, conduct verification activities to ensure the controls are effective, take appropriate corrective actions, and maintain records documenting these actions. The first step of a hazard analysis involves hazard identification, which must consider known or reasonably foreseeable hazards, including biological, chemical and physical hazards. The hazard analysis must consider hazards that may be present in the food because they occur naturally, are unintentionally introduced or are intentionally introduced for purposes of economic gain. Economically motivated adulteration that affects product integrity or quality but not food safety is outside the scope of these rules.

Both rules also mandate that a manufacturing/processing facility have a risk-based supply chain programme for those raw materials and other ingredients for which it has identified a hazard requiring a supply chain applied control. Covered facilities are responsible for ensuring that raw materials or foods are received only from approved suppliers or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use. Another entity in the supply chain, such as a broker or distributor, may conduct supplier verification activities, but the receiving facility must review and assess that entity's documentation of the verification of control of the hazard. Facilities that control a hazard using preventive controls, or that follow requirements applicable when relying on a customer to control hazards, do not need to have a supply chain programme for that hazard.

The human food rule modernises the FDA's long-standing current good manufacturing practice regulations regarding the manufacturing, processing, packing or holding of human food, and the animal food rule creates new CGMP regulations that specifically address the manufacturing, processing, packing and holding of food for animals.

Operations defined as farms are not subject to either rule, and the definition of "farm" is clarified to cover two types of operations. A primary production farm is an operation under one management in one general but not necessarily contiguous location devoted to the growing of crops, the 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 (including those grown on a farm under different ownership) and may conduct certain manufacturing or processing activities. A secondary activities farm is 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 that it harvests, packs or holds. The FDA notes that primary production and secondary activities farms conducting activities on produce covered by the produce safety rule will be required to comply with that rule.

Compliance dates are staggered over several years. For the human food rule, very small businesses will have three years to comply, small businesses will have two years and all other businesses will have one year. For the animal food rule, very small businesses will have three years to comply with the CGMP requirements and four years to comply with the preventive control requirements, small businesses will have two years and three years, respectively, and all other businesses will have one year and two years, respectively. In both cases, timeframes for compliance with the supply chain programme requirements will vary depending on the size of the receiving facility and the controls to which its supplier is subject.

The FDA emphasises that the final rules are the result of extensive engagement with stakeholders and address numerous concerns as well as flexibility and clarification requests with the goal of making the regulations as practical and protective of public health as possible. The agency adds that once the seven FSMA rules are finalised next year "they will work together to systematically strengthen the food safety system and better protect public health."

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