SGS Informs On: Current Good Manufacturing Practices (cGMP) Finalized by USFDA

The USFDA has begun finalizing the rules that make up the Food Safety Modernization Act (FSMA). Publication of the first two of seven rules targets production and storage of human and animal food.

Farfield, NJ, January 06, 2016 --( Finalized US FDA Rules Apply to Food Operations

On September 17, 2015 the United States Food and Drug Administration (US FDA) published the final rules for the Current Good Manufacturing Practices (cGMPs) and Preventive Control for Human and Animal foods. These are the first two of the seven major Food Safety Modernization Act (FSMA) rules to be finalized.

Human Food: Preventive Controls and cGMPs

Every facility must have a written food safety plan that includes a hazard analysis, preventive controls, a supply-chain program, recall plan, procedures for monitoring, corrective action procedures and verification procedures. Hazard analyses must consider known or reasonably foreseeable biological, chemical (including radiological) and physical hazards, whether natural, unintentionally introduced or intentionally introduced for economic gain. Preventive controls are process, food allergen, sanitation and supply chain controls with a recall plan. Verification will include the validation of preventive controls, the verification of monitoring and corrective action, the calibration of verification monitoring and equipment, as well as product testing and environmental monitoring for items required, such as ready to eat foods, and record reviews. The food safety plan is to be revisited every three years, or more frequently if necessary. The supply chain program involves use of approved suppliers by the receiver, determining appropriate supplier verification procedures based on the hazards, then conducting and documenting the verification. This verification can be an onsite audit, sampling and testing, or a review of the relevant food safety records. The verification activity, and its frequency, will be based on the hazard and on supplier performance.

Facilities storing unexposed food are exempt from preventive control requirements, except if time/temperature control monitoring is a requirement; in this case, corrective actions and verification of the temperature controls must be performed. Very small businesses, defined as operations with less than $1 million USD in sales of human food that manufacture, process, pack or hold food without sale, have modified preventive control requirements. These very small businesses are to attest either that they meet these qualifications; or, if not, which hazards have been identified and the preventive controls implemented and monitored; or that the facility is in compliance with non-federal food safety law.

Animal Food: Preventive Controls and cGMPs

There are now cGMPs for animal food operations, covering personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, holding and distribution, and the holding and distribution of human food by-products for use as animal foods. These are less strict in nature than the human food requirements and many are designated as “if necessary.” Requirement for training is a cGMP for animal food.

The preventive control requirements are the same as the human food program.

Very small businesses, defined here as operations with less than $2.5 million USD in sales of animal food that food manufacture, process, pack or hold food without sale, have modified preventive control requirements, are to attest either that they meet these qualifications, which hazards have been identified and the preventive controls implemented and monitored, or that the facility is in compliance with non-federal food safety law.

Exemptions from the Preventive Control Rules

These rules do not apply to farms (primary production and secondary activities) and retail establishments. A primary production farm is an operation under one management, in one general location which raises crops, harvests crops and/or raises animals. These farms can pack or hold raw agriculture commodities (RACs) of their own, or others’. They can manufacture/process, pack or hold processed food as long as all such foods are consumed on the farm, another farm of the same management, or this manufacturing processing falls into limited categories. A secondary activities farm is not located on a primary production farm, but is devoted to harvesting, packing and/or holding RACs. The primary production farm (or farms) that grow, harvest and/or raise the majority of the RACs must own, or jointly own, a majority interest in the secondary farm activities. There are some exemptions and modified requirements for certain facilities.

Modified Requirements for Preventive Control Rules

Seafood and juice facilities that adhere to the HACCP regulations and those involved in the manufacturing, processing, packing and holding of dietary supplements and/or alcoholic beverages at certain facilities are exempt. Low acid canned food, for microbiological hazards only, is exempt as those regulations already cover this hazard. Grain elevators and warehouses that store only RACs intended for further distribution or processing are also exempt.

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James Cook
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Food Scientific and Regulatory Affairs Manager