Some of the terms used in the PCAF rule are familiar, while some may mean something completely different from what you might think.
Use this page to navigate through some of the terminology used in the rule that might not be defined in the definitions listed in 21 CFR 507.3.
For all the relevant PCAF definitions, visit the Subpart A, §507.3 Definitions page on the e-CFR site.
A hazard, as defined by the FDA, is any biological, chemical (including radiological) or physical agent that has the potential to cause illness or injury in humans or animals. Similarly, a known or reasonably foreseeable hazard is a biological, chemical (including radiological) or physical hazard that is known to be, or has the potential to be, associated with the facility or the animal food.
A hazard requiring a preventive control is a known or reasonably foreseeable hazard for which a person knowledgeable about the safe manufacturing, processing, packing, or holding of animal food would, based on the outcome of a hazard analysis (which includes an assessment of the severity of the illness or injury to humans or animals if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls), establish one or more preventive controls to significantly minimize or prevent the hazard in an animal food and components to manage those controls (such as monitoring, corrections, or corrective actions, verification and records) as appropriate to the animal food, the facility, and the nature of the preventive control and its role in the facility’s food safety system.
Preventive Controls Qualified Individual (PCQI)
A Preventive Controls Qualified Individual (PCQI) is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that recognized under a standardized curriculum recognized as adequate by FDA, or is otherwise qualified through job experience to develop and apply a food safety system.
The following list are parts of the food safety plan that must be completed by or under the direction of the PCQI:
- Preparation of the food safety plan
- Validation of the preventive controls
- Determination that validation is not required
- Review of Records
- Reanalysis of the food safety plan
- Written justification for validation to be performed in a time frame that exceeds the first 90 days of production
- Written justification for review of records of monitoring and corrective actions within a time frame that exceeds seven (7) working days
- Determination that reanalysis can be completed and additional preventive controls validated as appropriate to the nature of the preventive control and its role in the facility’s food safety system, in a time frame that exceeds the first 90 calendar days of production.
Primary Production Farm
Primary production farm: an operation under one management in one general but not necessarily contiguous physical location devoted to the growing of crops, the harvesting of crops, the raising of animals, or any combination of these activities. Can conduct certain manufacturing, processing, packing, or holding activities of animal food as specified.
A qualified facility means (when including the sales by any subsidiary; affiliate; or subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate) a facility that is a very small business as defined in this part, or a facility to which both of the following apply:
- During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed, or held at such facility that is sold directly to qualified end-users (as defined in this part) during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; and
- The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation.
A qualified individual is a person who has the education, training, or experience (or combination thereof) necessary to manufacture, process, pack, or hold safe animal food as appropriate to the individual’s assigned duties. A qualified individual may be, but is not required to be, an employee of the establishment.
All individuals who manufacture/process/pack/hold animal food must be qualified to perform their assigned duties. This includes temporary and seasonal workers. They must have the education, training, experience, or a combination thereof, to complete duties in a way that results in safe food. They must also receive training on animal food hygiene and safety, including importance of employee health and personnel hygiene as appropriate.
Secondary Production Farm
Secondary activities farm: an operation not located on a primary production farm that is devoted to harvesting, packing, and/or holding raw agricultural commodities. May also pack or hold raw agricultural commodities, or manufacture/process, pack, or hold processed foods so long as all such food is consumed on that farm or another farm under the same management or the manufacturing/processing falls into limited categories.
A small business is a business employing fewer than 500 full-time equivalent employees. This includes employees of the entire business, not just the facility.
For example, though the NC State Feed Mill Education Unit typically employs 3 full-time employees, and about 10 part-time and student employees, our facility is considered a “large business” because we are owned by the state of North Carolina, which employs well over 500 FTE.
Very Small Business
A very small business is a business (including any subsidiaries and affiliates) 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 the animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm without sale).
For Additional Information
Marissa Herchler Cohen
NC State University
Cooperative Extension Service
Prestage Department of Poultry Science
234 D Scott Hall
Raleigh, NC 27695-7608