Preventive Controls for Animal Food

Craig Doan is an Account Executive with Impact Washington who has 30+ years in the food industry and academics specializing in food safety, food processing, and food product innovation.

The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food rule is final, and compliance dates for some businesses began in September 2016.

Below are the key requirements and compliance dates.

Current Good Manufacturing Practices (CGMP’s) Established for Animal Food Production:

The FDA has finalized baseline CGMP standards for producing safe animal food that take into consideration the unique aspects of the animal food industry and provide flexibility for the wide diversity in types of animal food facilities.

Processors already implementing human food safety requirements, such as brewers, do not need to implement additional preventive controls or CGMP regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except to prevent physical and chemical contamination when holding and distributing the by-product.

Further processing a by-product for use as animal food (e.g., drying, pelleting, heat-treatment) requires companies to process the by-product in compliance with CGMPs to ensure the animal food’s safety and to make sure that the processing does not introduce hazards to the animal food. The company can choose to follow either the human food or animal food CGMPs when further processing the by-product. In addition, unless they are a qualified facility or otherwise exempt from subpart C (hazard analysis and preventive controls), the facility needs to assess its process and determine whether there are any hazards that would require a preventive control. A facility that appropriately determines through its hazard analysis that there are no hazards requiring a preventive control would document such a determination in its hazard analysis but would not need to establish preventive controls.

Covered Facilities must establish and implement a Food Safety System that includes and analysis of hazards and risk-based Preventive Controls (PC).  The rule sets requirements for a written Food Safety Plan that includes:

Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).

Preventive controls (PC): These measures are required to ensure that hazards requiring a PC will be minimized or prevented.

Oversight and management of preventive controls: The final rule provides flexibility in the steps needed to ensure that preventive controls are effective and to correct problems that may arise (Monitoring, Verification, and Corrective actions and corrections).

Recall plan: Every facility that produces animal food with a hazard requiring a preventive control must have a recall plan.

Supply chain Program is more flexible, with separate compliance dates established: The rule mandates that an animal food manufacturing/processing facility have a risk-based supply chain program for those raw materials and other ingredients for which it has identified a hazard

requiring a supply-chain-applied control. Animal food facilities that control a hazard using preventive controls, or who follow requirements applicable when relying on a customer to controls hazards, do not need to have a supply-chain program for that hazard.

Animal food facilities are responsible for ensuring that raw materials and other ingredients with a supply-chain-applied control are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose raw materials or other ingredients are subject to verification activities before being accepted for use. (Approved suppliers are those approved by the facility after a consideration of factors that include a hazard analysis of the food, the entity that will be controlling that hazard, and supplier performance.)

A facility will not be required to implement a preventive control when an identified hazard will  be controlled by another entity in the distribution chain, such as a customer or other processor.  The receiving facility will have to disclose that the food is “not processed to control (identified hazard)” and obtain written assurance from its customer regarding certain actions that customer agrees  to take.

Separate compliance dates have been established for the supply-chain program provisions so that a food facility will not be required to comply with the supply-chain program provisions before its supplier is required to comply with the preventive controls for animal food rule or the produce safety rule.

The definition of a “Farm” is clarified in the Preventive Controls for Human Food Final Rule to cover two types of farm operations.  Operations meeting the definition of “Farm” are not subject to the PC rule.

Primary Production Farm: This is an operation under one management in one general, but not necessarily contiguous, location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities.

Secondary Activities Farm: This is an operation not located on the Primary Production Farm that is devoted to harvesting, packing, and/or holding raw agricultural commodities. It must be majority owned by the Primary Production Farm that supplies the majority of the raw agricultural commodities that are harvested, packed, or held by the Secondary Activities Farm.

Feed Mills associated with farms (Vertically Integrated operations).  Not covered.

Feed mills associated with fully vertically integrated farming operations (i.e., farms where the feed mill, animals, land, and establishment are all owned by the same entity) generally meet the definition of a farm and are therefore not subject to the PC for Animal Food final rule.

The FDA remains concerned that not having these operations subject to the PC for Animal Food final rule leaves a gap in the protection of human and animal health because these feed mill operations manufacture significant amounts of animal food.

The FDA intends to publish a proposed rule in the future that would require some feed mill operations that currently are part of a farm to implement the current good manufacturing practices established by the PC for Animal Food rule.

Compliance Dates

Businesses have a staggered number of years after publication of the final rule to comply, based on business size. In addition, there will be staggered compliance between the CGMP requirements and the Preventive Control Requirements:

 

Business Size

CGMP

compliance date

PC

compliance date

 

Business other than small and very small September 2016 September 2017
Small business (a business employing fewer than 500 full-time equivalent employees)

 

 

September 2017

 

September 2018

Very small business (a business averaging less than $2,500,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm without sale).

 

 

 

 

September 2018

 

September 2019,

 

except for records to support its status as a very small business (January 1, 2017)

 

 

Impact Washington will be hosting FSPCA Preventive Controls for Animal Foods in Washington State

These 2 day courses are taught by a FSPCA certified lead instructor and fulfills FDA requirements for FSMA Preventive Control Qualified Individual Training (PCQI) for Animal Food.  The classes are led by an instructor with feed regulatory experience, has attended the FSPCA lead instructor training, and holds an Alliance Lead Instructor Certificate.

Locations & Dates:

Kennewick, WA March 29 & 30 2017.

Bothell, WA June 5 &5, 2017

Spokane, WA August 21 & 22, 2017

Questions?  Email us at Cdoan@impactwashington.org

References

  1. Federal Register:  regulations.gov
  2. Frequently Asked Questions http://www.fda.gov/Food/GuidanceRegulation/FSMA/ ucm247559.htm#PC_Rules
  3. FDA Food Safety Modernization Act fda.gov/fsma
  4. FDA’s FSMA Technical Assistance Network http://www.fda.gov/Food/GuidanceRegulation/FSMA/ ucm459719.htm
  5. FDA http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM461884.pdf

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