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In order to obtain an establishment number, a facility needs to be approved by USDA and FSIS to produce and sell products for human consumption. There are many guidelines and food safety measures that must be met in order to approve a facility and provide them an establishment number.

The following are some of the basic general requirements needed to be able to acquire and establishment number and to be able to have products produced with the “Benefit of Inspection”. (More information can be found on the FSIS website)

1. A HACCP Plan

HACCP is an acronym for Hazard Analysis Critical Control Point. Such a food safety “process control program” must be developed by someone formally trained in HACCP

2. A Sanitation Standard Operating Procedure (Sanitation SOP) for the cleaning of the facility and equipment.

3. A suitable facility where the walls, floors, and ceilings are cleanable, impervious to moisture, insects, vermin and meet other sanitary requirements as listed in Title 9 CFR 305, 307, 416, and 417 as they apply to your facility and the type of product you would like to produce.

4. Recall Plan

Being able to trace products from the use of ingredient to where the finished product is sent for distribution. Sometime referred to as one up and one back for trace-ability. Recall Plans Title 9 of the Code of Federal Regulations, Part 418 (9 CFR 418), requires that official establishments that produce meat and poultry products prepare and maintain written recall plans. Under this regulation, your plan must specify how you will decide whether to conduct a product recall and describe the procedures that you will follow if you decide that a product recall is necessary. In addition, the regulations require that your plan be available to the FSIS inspector for review upon request. FSIS recommends that processed egg products plants also develop and maintain recall plans, although they are not explicitly required to do so by the regulation. Each Recall Plan must have a Recall Team established. It’s recommended to have the people from multipole functional areas of your company so that different perspectives can be shards. Also, you will need a designated Recall Team Leader. Several examples can be found on the USDA website to help you make your own plan and meet the requirements.

5. Food Defense Plan

Food Defense is not the same as food safety. Food defense focuses on protecting the food supply form intentional contamination, with a variety of chemicals, biological agents or other harmful substances by people who want to do us harm. These agents could include materials that are not naturally-occurring or are not routinely tested for. An attacker’s goal might be to kill people or disrupt our economy. Intentional acts are generally not reasonable and are hard to predict.


To enhance your knowledge of the requirements, it is recommended that you become acquainted with the Federal Code of Regulations applicable to FSIS.  You should focus particularly on Title 9 CFR 305, 307, 416 and 417 that apply to facilities, sanitation and HACCP for red meat operations. For poultry operations listed in the 381 regulations under Title 9, you should refer to sub parts E and G in addition to all of the 416 and 417 regulations.

If you need assistance in developing your HACCP plan, you can view models of various HACCP plans on the FSIS Website. You can access these HACCP models by viewing “HACCP” in the A-Z index or using the FSIS public site search engine.

Finally, if you need supporting documents or more specialized help, you can reach out to the experts and tools including askFSIS available via the Small Plant Outreach. Contacts for State HACCP Contacts and Coordinators for each state are available on the FSIS Website and in Part 7.


I hope you found this article informative and helpful.  It is not meant to have all the details to set up your programs to be an approved establishment, but it should be used as a brief overview of some of the general requirements for a company to become qualified so you understand why it is important for the foods which we consume to be under the “Benefit of Inspection”.

If you have more questions or need help setting up your plans please feel free to reach out to me directly at www.servicecold.biz/services/expanded-service-offerings/ or email us at SST@ServiceCold.Biz .

Also, if you have any product on hold for possible Foreign Material we may be able to help using our X-Ray Inspection Services.

Thank you,

Chris Hetherman

Operating Partner

Service Cold Storage

Foreign Material Detecting Services using X-Ray Technology.