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As the September 19 deadline approaches for compliance by large food facilities with new preventive controls and Current Good Manufacturing Practice (CGMP) requirements under the Food Safety Modernization Act (FSMA), FDA released five chapters of a 14-chapter draft guidance to assist in compliance.

The non-binding draft document is now open for stakeholder comment and the agency promises to consider those in the final guidance and says it will release all 14 draft chapters by early 2018.

The first chapter deals with food safety plans and how a facility will control hazards. Other chapters discuss how to conduct a hazard analysis, common biological, chemical and physical hazards, implementing preventive controls, and monitoring, corrective actions and verification activities.

The agency also released two draft guidances dealing with preventive controls for animal food. One explores ways to comply with the rule’s CGMP requirements for animal food facilities and discusses the training of personnel, among other topics. The other document considers by-products of human food production used as animal food, including grain products and vegetable pulp. These also include foods such as potato chips, baked goods and pasta that are safe but considered the wrong size, shape, color or texture, explained Susan Mayne, director of FDA’s Center for Food Safety and Applied Nutrition, and Tracey Forfa, acting director of FDA’s Center for Veterinary Medicine, in an August 24 FDA Voice blog.

Producers of human food had been concerned that they would have to meet a whole new set of requirements for such by-products sent for use in animal foods. But by-products will only be subject to limited CGMPs to protect against contamination during holding and distribution, provided the human food facility complies with human food safety requirements and is not further processing the by-products for use as animal food, the draft guidance explains.

If the human food facility is further processing the by-products, it may comply with the requirements of either the human or animal food rule, as long as the food safety plan addresses how the facility will prevent or significantly minimize the hazards for the animal food that require a preventive control, the agency says.

“These draft guidances, and the others that we’re working on for the FSMA rules, will be further refined based on input we receive from the public … [W]e want to be sure that we’re all on the same page and these draft guidances will help get us there,” Mayne and Forfa noted.

The agency also issued a separate draft guidance to help businesses to determine whether their activities are covered by the definition of a “farm.”

FDA also released a final rule extending and aligning the compliance dates for certain provisions in four of the seven “foundational” FSMA rules — the CGMP and preventive controls rules for human and animal food, the Foreign Supplier Verification Programs (FSVP) rule, and the produce rule.

Human food companies other than small and very small businesses must be in compliance with the preventive controls and CGMP rule by September 19, 2016. Animal food companies other than small and very small businesses must be in compliance with the CGMP requirements under the animal foods rule by September 19, but they have an extra year to comply with the preventive controls requirements in the animal food rule.

The agency is allowing an extra two years for manufacturers to meet requirements for assurances by their customers who perform some needed food safety step.

The produce safety rule also clarifies the timeframe for agricultural water testing and offers considerable flexibility. Farms covered by the rule have two to four years to fulfill the testing requirement. For example, a farm that is not small or very small must begin sampling and testing untreated surface water no later than January 26, 2018. The relevant compliance date for the related microbial quality criteria is January 27, 2020. But the farm has discretion as to the number of samples included in an initial survey provided that the total is 20 or more samples. The samples must be taken over a period of at least two years and no more than four years, the agency says.

In other produce news, FDA is hiring 40 new consumer safety officers to help implement the FSMA produce safety rule. The safety officers will be working both in the United States and internationally, conducting inspections, investigations and providing technical assistance, the agency says.

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