US FSMA Final Rule on Animal Feed

Continuing with our US Food Safety Modernization Act (FSMA) article series, this article covers the final rule dealing with animal feed: “FSMA final rule for Preventive Control for Animal Food”.

Animal food (or feed, as more commonly referred to in the EU) is integral part of the food chain, influencing food safety of the final product. Rules for animal food safety are important part of the FSMA, with the final rule governing good manufacturing practices, hazard analysis and risk based preventive controls.

Details of the final rule are explained below.

What are the requirements of the rule?

(a). Current Good Manufacturing Practices must be established for facilities manufacturing animal food

- The FDA has considered unique aspects of animal food manufacturing industry and will also look to provide flexibility to different types of animal food facilities

- Facilities manufacturing human food but supplying by-products as animal food, no additional preventive controls are necessary to be implemented, apart from preventing physical and chemical contamination of the by-product supplied

- Facilities that further process the by-product by different operations can chose to implement CGMP rules for human or animal food but will need to conduct hazard analysis and implement preventive control standards if the hazards are recognized

- Facilities need not implement additional preventive control standards if they are qualified or are exempt as per the rule

(b). Covered facilities should establish and implement a food safety plan and include a systematic hazard analysis and implement preventive control

- A written food safety plan is mandatory under this provision of the rule

- Hazard analysis conducted should take into consideration predictable biological, chemical and physical hazards

- Preventive controls should be implemented wherever a hazard has been foreseen to achieve minimization or prevention of the risk

- The preventive controls should be regularly monitored and documented for effectiveness of implantation

- The preventive controls implemented should allow validation of the and also demonstrate effectiveness if corrective actions are taken

- Animal foods manufactured in facilities wherever hazards have been identified should also have a recall plan in place

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(c). Supply chain program of the manufacturer should be flexible, with compliance dates established

- Evaluation of the supply chain should be conducted on the principles of risk analysis

- Animal food manufacturing facilities should source their ingredients from “approved suppliers”; approved suppliers are those who will be evaluated by the manufacturers for supplier performance including hazard analysis, approved suppliers will also need to control identified hazards.

- If the hazard identified is controlled at the level of the suppliers, then the receiving facilities should disclose that the food is “not processed to control (identified hazard)” and obtain written assurance

- Separate compliance dates have been established such that a final facility will not be required to comply unless its suppliers are in compliance with the law

(d). “Farms” distinguished as primary and secondary by Preventive controls for Human food rule are not subject to comply with preventive controls rule if falling within the ambit of definition of “farm”

For more information on this, read this article.

(e). Feed mills associated with farms (having vertically integrated operations) are not covered by the rule

- The principle for excluding farms with integrated vertical operations from implementing the Preventive controls rule for animal food is that, they have now been placed under the definition of “farm”

- To cover certain identified gaps by exclusion of such facilities, the FDA in the future will frame a proposed rule so that these types of facilities implement practices as per cGMP

What is the compliance due date?

FSMA Feed

Compliance dates after publication of the final rule for the requirements of the supply chain program: 

  • Receiving facility is a small business and its supplier will be subject to CGMPs but not to preventive controls: six months after the receiving facility’s supplier is required to comply with the CGMP requirements of this rule. 
  • Receiving facility is not a small or very small business and its supplier will be subject to CGMPs but not to preventive controls: six months after the receiving facility’s supplier is required to comply with the CGMP requirements of this rule. 
  • Receiving facility is a small business and its supplier is subject to the preventive controls for animal food final rule: Three years after the rule’s publication date or six months after the supplier is required to comply with the rule, whichever is later. 
  • Receiving facility is not a small or very small business and its supplier will be subject to the preventive controls for animal food final rule: Two years after the rule’s publication date or six months after the supplier is required to comply with the rule, whichever is later. 

Assistance to the industry

Being a major law that will have long reaching impact on food safety, the FDA will publish guidance documents to help stakeholders understand and implement the provisions of the rule.

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Regulator outreach

  • Establishing a Food Safety Technical Assistance Network within the agency to provide a central source of information and a call center to support industry understanding and implementation of FSMA. 
  • Collaborating with the Food Safety Preventive Controls Alliance to establish training and technical assistance programs.

For Frequently asked questions and answers about FSMA and preventive control rules, see here.

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