Saturday 25 March 2017

FSMA FDA preventative controls CGMPs animal food feed

Proposed Preventative Controls and GMP Rule for Animal Food and Feed; Overview

The pet food and animal feed industry is set for sweeping changes under the newly proposed Preventative Controls and GMP rule. The US Food and Drug Administration (FDA) announced the new rule late Friday. It is one of a suite of proposed rules issued this year under the Food Safety Modernization Act (FSMA). At 405 pages the rule stands as one of the largest and is filled with new mandatory provisions for the industry. The proposed rule would modernize how animal food is manufactured, processed, packed, or held throughout the entire supply chain and minimize potential hazards in animal food. The proposed rule would require facilities develop a food safety plan. and to  follow current good manufacturing practices (GMPs).

 

Most animal food facilities have not been subject to GMPs and no animal food facility has been subject to preventive controls as put forth in this proposed rule. However, some animal food facilities, either individually or through feed industry associations, have implemented SOPs that are likely to be sufficient to satisfy a handful of the proposed requirements. The FDA in its analysis of the industry concluded the majority of facilities will need to make substantial changes if the proposed regulations are adopted. The annual cost of the new changes is estimated at $14,700-20,100 a year for small entities.

 

The preventive controls component of the rule addresses hazards specific to each facility while the GMP component addresses global controls.  GMPs are a familiar element for most FDA regulated facilities. Despite their long use on the human side, the FDA has not developed or required baseline controls for facilities manufacturing, processing, packing, and holding animal food.  The proposed animal food GMPs address similar safety requirements as those contained in the proposed rule to update the human food Current Good Manufacturing Practice (CGMP) regulations. These areas include:

  • Hygienic personnel practices and training;
  • Facility operations, maintenance, and sanitation;
  • Equipment and utensil design, use, and maintenance
  • Processes and controls; and
  • Warehousing and distribution.

The list is similar to the areas covered under the proposed Produce Safety rule. The GMP provisions of the proposed rule for animal food are not identical to the human food GMPs in the proposed rule for preventive controls for human food. The animal food GMPs, for example, would not address certain practices that don’t pertain to animal food, such as allergen cross-contact. The Agency is seeking comment on whether its thinking on GMPs, specifically that human and animal GMPs are similar, is appropriate.

This will not be the first time a segment of industry experiences a GMP mandate. It last occurred with a rule change in 2008 implement GMPs for the dietary supplement industry. The result has been a spike in 483s, warning letters, and other enforcement actions. The animal feed and food industry is likely to experience a similar rise in violations as the rule becomes effective.

 

Noticeably absent from the preventative controls component of the rule is supplier verification. The rule release prior to the animal feed and food rule, the Foreign Supplier Verification Program rule, specifically mandated supplier verification. It also sought comment on adding supplier verification into the preventative controls rule for human food (the sister rule to the preventative controls for animal feed rule). Despite this supplier verification is not mandated a part of a food safety plan for animal food and feed. The FDA does mention the need for supplier verification. It states in the rule its beliefe that “supplier approval and verification program is a risk-based and appropriate control to significantly minimize or prevent hazards from raw materials and ingredients that is consistent with current scientific understanding of food safety practices.” It goes on to note that while not included in the proposed requirements it is seeking comment on supplier verification. It may be that Office of Management and Budget once again stymied the FDA and struck out the provisions. The animal feed and food program is already costly, supplier verification activities would only add to those costs.

There is a great deal more to cover on the new rule. Stay tuned for additional updates this week.

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