FDA issues final rule on preventive controls for human food

AFP Correspondent

WASHINGTON (Oct. 13, 2015) — The final rule on human food preventive controls, mandated by the Food Safety and Modernization Act, was published in the Federal Register on Sept. 17. The compliance dates are staggered over several years.
This rule, “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food,” establishes food safety requirements.
The rule applies to facilities that manufacture, process, pack or hold human food and are required to register as a food facility. It does not apply to establishments not required to register.
The first step for the mandated food safety plan — hazard identification — must consider biological, chemical and physical hazards. Preventive controls measures must ensure that the process, food allergen, sanitation and supply hazards will be minimized or prevented.
The oversight and management of the preventive controls includes several steps. Monitoring to assure consistency such as temperatures to kill pathogen, corrective actions to reduce likelihood of recurring problems or to prevent the food from entering commerce, and verification to ensure effectiveness such as tests, must be implemented and recorded. A recall plan is also required.
The rule clarifies the definition of a “farm.” Operations defined as farms are not subject to the preventive controls rule. In general, this preventive controls rule exception applies to establishments classified as a farm and which do not process food.
A primary production farm, under one management, is devoted to growing and harvesting crops, or raising animals.
This kind of farm, FDA indicates, can pack or hold raw agricultural products such as fresh produce and may conduct certain manufacturing/processing such as dehydrating grapes to produce raisins and packaging and labeling raisins.
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 harvested, packed, or held by the secondary activities farm. An example is an off-farm produce packing operation.
Both the primary production and secondary activities farms which conduct activities on produce covered by the Produce Safety Rule will be required to comply with that rule, not the Preventive Controls Rule.
The Produce Safety Rule should be issued by Oct. 31.
This preventive controls rule mandates a risk-based supply chain program for a manufacturing/processing facility. However, if a customer controls hazards, and if the facility obtains assurances of those controls, the facility does not need a supply chain program for that hazard.
Also, if another entity, such as a customer or another processor, controls the hazard, the facility must disclose it and obtain written assurance.
Another entity, such as a broker or distributor, can conduct supplier verification activities, but the receiving facility must review and assess the documentation.
Management must ensure the employees are qualified for their assigned duties, both for the current good manufacturing practices and the preventive controls. This requirement includes education and training in food hygiene and food safety.
Exemptions apply to some processors of certain low-risk foods, such as acid fruits.
The staggered compliance dates for very small businesses averaging less than $1 million per year is three years, except those businesses must support their status by January 1, 2016.
To allow time for the Pasteurized Milk Ordinance changes to its safety standards, businesses subject to PMO also have three years to comply.
Small businesses with fewer than 500 full-time equivalent employees have two years; all other businesses have one year.
The compliance dates for the supply chain program varies from six months to two years, depending on business size and whether the supplier is complying with the preventive controls or the produce safety rule.
FDA’s website,, includes a link to the final rule. Several guidance documents are being developed on hazard analysis, environmental monitoring, allergen and validation of process controls, plus a small entity compliance guide.
FDA’s Food Safety Technical Assistance Network provides specific information on the rule. The link to their ‘web form’ can be accessed on their website under the heading ‘How to contact FDA about FSMA.’
In addition, the Preventive Controls Alliance is developing a training course and distance education modules.
Additional information will be forthcoming on specific hazards, controls, exemptions, the PMO, requirements for qualified personnel and recordkeeping, and training opportunities.