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More guidance offered on feed-related FSMA rules

AFIA urges FDA to use regulatory discretion because of short time frame between guidance release and compliance dates.

As the implementation of the Food & Drug Administration’s Food Safety Modernization Act (FSMA) continues, the agency issued two draft guidances on Aug. 24 to assist the industry with implementation of the Preventive Controls for Animal Food rule and another draft guidance to assist businesses in determining whether the activities they perform fit within the “farm” definition.

Two of the draft guidances are meant to assist domestic and foreign companies in complying with Current Good Manufacturing Practice (CGMP) requirements and with human food byproduct requirements under the FSMA Preventive Controls for Animal Food Rule.

Draft Guidance for Industry #235 - Current Good Manufacturing Practice Requirements for Food for Animals is intended to help facilities that manufacture, process, pack or hold animal food for consumption in the U.S. comply with CGMP requirements in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations and holding and distribution. The guidance also includes information on training and related recordkeeping. The CGMPs required under the Preventive Controls for Animal Food rule are flexible in order to address the diversity of facilities and animal foods, the wide range of animal food activities and the potential safety risks posed by some animal foods.

Richard Sellers, senior vice president of public policy and education for the American Feed Industry Assn., said the release of the FDA draft guidance document on CGMPs is “very welcomed, but very late.”

He added that, historically, a guidance of this type is used both by industry and FDA field staff to determine the requirements of specific rules. “Clearly, this was not the case here,” he said.

"The compliance date for firms with more than 500 employees is Sept. 19 -- less than one month away -- for CGMP compliance. Industry needs adequate time to review this document and determine if their facilities are in compliance with FDA's interpretation of this rule as explained in this document. The tardy nature of the guidance makes this task nearly impossible to achieve,” Sellers said.

Sellers urged FDA to be more timely in it is release of these important documents and to use regulatory discretion in inspections for several months to come as firms match their facilities CGMPs to the agency’s expectations.

Draft Guidance for Industry #239 - Human Food By-Products for Use as Animal Food will assist facilities that manufacture, process, pack or hold human food and then subsequently provide the human food byproducts for use as animal food in determining which requirements in the Preventive Controls for Animal Food rule apply to their human food byproduct. Common examples of human food byproducts used for animal food include wheat middlings, grain products from grain milling and vegetable pulp.

FDA plans to hosting a webinar later in September to discuss these draft guidance documents in more detail.

Draft Guidance for Industry for Classification of Activities as Harvesting, Packing, Holding or Manufacturing/Processing for Farms & Facilities is aimed at helping food businesses determine which of the FSMA rules apply to their operations.

In general, businesses that perform activities only within the “farm” definition are not subject to the FSMA Preventive Controls for Human Food or Animal Food rules. Instead, when their activities involve covered produce, farms may be subject to the FSMA Produce Safety rule. Facilities conducting activities that are outside the farm definition generally need to register with FDA as food facilities (unless other exemptions apply, such as the exemptions for retail food establishments and restaurants) and may be subject to the FSMA Preventive Controls for Human Food or Animal Food rules. Farms, including those subject to the Produce Safety rule, are not required to register with FDA as food facilities. The draft guidance includes several examples of hypothetical operations.

All three draft guidance documents will be available for public comment starting Aug. 25, 2016. FDA will consider all comments received during the periods designated in the Federal Register notices before completing final versions of the guidances.

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