Be ready: FDA pet food inspection deferral ending (Part 2)

FDA has provided much flexibility to the animal food industry for implementing FSMA, but as deadlines approach pet food manufacturers must be ready to test their compliance and readiness.

(Sergey Dudyrev |
(Sergey Dudyrev |

In this second part of a three-part series, pet food manufacturers will learn the steps to test the readiness of their hazard analysis.

Part 1: Food safety plan readiness

Part 3: Preventive controls readiness

The U.S. Food and Drug Administration (FDA) has provided much flexibility to the animal food industry for implementing the Food Safety Modernization Act (FSMA). The question facility owners, operators or agents in charge should be asking is, “Are we now ready for FDA inspections considering these still relatively new and complex requirements?”

The Preventive Controls for Animal Food rule was published in September 2015, three years prior to the date official inspections begin. In the meanwhile, FDA has truly held up its promise to “educate” before “regulating,” demonstrating flexibility in listening to the animal food industry’s request for staggered compliance dates for CGMPs (Current Good Manufacturing Practices) and preventive controls. Then, in another accommodating move, FDA delayed routine inspections of CGMPs and preventive controls.

Inspections begin

Despite FDA's accommodating approach, FDA has emphasized all along that its job is to protect public health and that it will rely on its new tools and authorities to protect human and animal consumers by keeping food with actual and potential hazards out of the marketplace, and the industry must not lose sight of that authority, nor overlook that the FSMA Preventive Controls for Animal Food regulation can be dauntingly complex in detail. Even if you have diligently read the regulation, including the lengthy preamble, taken Food Safety Preventive Controls Alliance (FSPCA) training and have studied all the guidance documents FDA has issued to date, something may have been missed in your approach to compliance. Use the example questions below as a quick test of the readiness of your hazard analysis.

Hazard analysis — test your readiness

  1. Does your hazard analysis include adequate justification where you determined that a preventive control was not required for a hazard?  

Whether or not your risk analysis determined that there was a hazard requiring a preventive control, clear justification of your yes or no answer is required, particularly if you concluded that no preventive control was needed. Ensure your justification is written as clearly and with enough detail as possible to help you recall your rationale and explain to FDA personnel arriving at your facility on and after September 18, 2018. 

  1. Have you indicated in your hazard analysis that you have considered radiological hazards as well as economically motivated adulteration (EMA)?  

Some animal food facilities have voluntarily implemented HACCP (Hazard Analysis Critical Control Point) for a number of years, but one of the distinct differences between HACCP and the hazard analysis for preventive controls is that radiological hazards must be considered. Consider not only radiation, which may be present naturally in an area, but nuclear power facilities and the impact of a natural disaster affecting such a facility on your animal food operations and products. 

EMA is also a new factor that must be given consideration in a hazard analysis under the Preventive Controls Rule. EMA hazards do not apply to intentional adulteration to cause harm, or to economically motivated actions without a hazard, but to ways to increase profit, which results in hazards. The toxic chemical melamine used to cause an increase in nitrogen level and a false protein test result which led to illness and deaths of pets consuming dog treats is a well-known example of EMA. Lead compounds used in spices represent another example. 

The good news is that a facility does not have to consider all possibilities for EMA, but FDA has indicated that facilities can limit their consideration of this type of hazard to those with a pattern of economically motivated adulteration which has occurred in the past.

  1. Did you use the Appendix E — Aid to Identifying Animal Food Hazards, in Preventive Controls for Animal Food Draft Guidance as an aid when you conducted your hazard analysis? 

Keep in mind that FDA has provided tools to assist the industry in conducting hazard analyses; these tools represent FDA’s current thinking and undoubtedly will be a reference when FDA begins inspections. In the January 2018 Preventive Controls for Animal Foods Guidance, FDA provided tables of hazards covering 10 categories of animal foods. FDA indicated that they did not list all possible animal foods or hazards, but that the tables of hazards are intended as a starting point for a facility identifying known or reasonably foreseeable hazards.    

  1. If you are producing canned food, have you performed a hazard analysis for chemical and physical hazards?  

Although low acid canned foods under 21 CFR Part 113 do not need a hazard analysis for biological hazards, they are not totally exempt from the Preventive Controls Rule; the chemical and physical hazards must be evaluated.

  1. Did you list toxins from microorganisms as biological or chemical hazards?

Mycotoxins are produced by live organisms, fungi, so it may seem they could fall under biological hazards. However, the preventive controls regulations include them as chemical hazards.

The above questions are not a complete and comprehensive test of your hazard analysis, but are intended to challenge your understanding of some of the details of implementation and help you ensure your readiness. For more information on the details of compliance, FDA has provided a number of educational tools, notably the curriculum developed with the FSPCA, and the FSPCA training courses available. 

FDA has indicated that these courses provide a background and foundation in not only the regulation but also in the scientific principles on which the regulation was based. Look also to the comprehensive guidance documents provided during 2016, 2017 and 2018, easily accessed on the FDA website, and to FDA’s technical assistance network, which fields questions on the regulation.

Rachel Montgomery is an FSPCA Lead Instructor with over 30 years’ experience as a food safety executive in large-scale manufacturing. Montgomery is the Principal of Simple Compliance Solutions LLC and a registered microbiologist. 

Page 1 of 59
Next Page