1. A. The Department incorporates by reference the United States (U.S.) Code of Federal Regulations (CFR) 2023 Title 21 Food and Drugs, Chapter I Food and Drug Administration (FDA), Department of Health and Human Services, Subchapter B Food for Human Consumption, Part 117, Subparts A, B, and F, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.

2. B. An applicant shall complete the application in R9-8-908 when engaged in:

   1. 1. Food manufacturing, or
   2. 2. Wholesale food distribution.
3. C. A manufactured food facility may not use marijuana, as defined in A.R.S. § 36-2850, as an ingredient in human foods.
4. D. A manufactured food facility license issued according to this Article is non-transferable.

5. E. The Department incorporates 21 CFR § 117, Subpart A in whole, unless otherwise specified:

   1. 1. 21 CFR § 117.1, Applicability and status;
   2. 2. 21 CFR § 117.3, Definitions in part;
   3. 3. 21 CFR § 117.4, Qualifications of individuals who manufacture, process, pack, or hold food;
   4. 4. 21 CFR § 117.5, Exemptions in part;
   5. 5. 21 CFR § 117.7, Applicability of subparts C, D, and G of this part to a manufactured food facility solely engaged in the storage of unexposed packaged food;
   6. 6. 21 CFR § 117.8, Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities; and
   7. 7. 21 CFR § 117.9, Records.
6. F. In 21 CFR § 117.3, the Department shall not use the definition of “calendar day.”
7. G. In 21 CFR § 117.3, the Department shall not use the definition of “facility” or “qualified facility.”

8. H. In 21 CFR § 117.3, the definition of “farm” as defined in 21 CFR § 1.227 is as follows:

   1. 1. “Farm” means:

      1. a. A primary production farm that is under the operation of one management in one general, physical location devoted to the growing of crops, the harvesting of crops, the raising of animals, including seafood, or any combination of these activities; and
      2. b. A secondary activities farm devoted to harvesting, packing, and holding of raw agricultural commodities, provided that the primary production farm that grows, harvests, and raises the majority of the raw agricultural commodities harvested, packed, and held by the secondary activities farm owns, or jointly owns, a majority interest in the secondary activities farm.

   2. 2. “Farm” includes operations that do the following:

      1. a. Packs or holds raw agricultural commodities;
      2. b. Packs or holds processed food; or
      3. c. Manufactures or processes food, provided that all food used is consumed on that farm or another farm under the same management.

9. I. In addition to the requirements in 21 CFR § 117.3, the following definitions apply:

   1. 1. “Additive” means the same as “food additive” or “color additive” in A.R.S § 36-901.
   2. 2. “Administrative completeness review time-frame” means the same as in A.R.S. § 41-1072.
   3. 3. “Adulterated” means possessing one or more of the conditions enumerated in A.R.S. § 36-904.
   4. 4. “Applicant” means a person or business organization requesting approval to operate a manufactured food facility.
   5. 5. “Application” means information provided to a regulatory authority from an applicant requesting licensure for a manufactured food facility.
   6. 6. “Approved Supplier” means a provider of food items, raw ingredients, or food additives obtained from an acceptable source determined by the regulatory authority or of the food regulatory agency that has jurisdiction based on a determination of conformity with principles, practices, and generally recognized standards that protect public health and is considered GRAS according to the FDA.
   7. 7. “Aseptic processing of food” means the filling of a commercially sterilized cooled product into pre-sterilized containers, followed by aseptic hermetical sealing, with a pre-sterilized closure, in an atmosphere free of microorganisms.
   8. 8. “Business organization” means the same as “entity” in A.R.S. § 10-140.
   9. 9. “Calendar day” means each day, not including the day of the act, event, or default from which a designated period of time begins to run, but including the last day of the period unless it is a Saturday, Sunday, or legal holiday, in which case the period runs until the end of the next day that is not a Saturday, Sunday, or legal holiday.
   10. 10. “CFR” means the Code of Federal Regulations.
   11. 11. “Class 1 recall” means a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
   12. 12. “Class 2 recall” means a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
   13. 13. “Class 3 recall” means a situation in which the use of or exposure to a violative product is not likely to cause adverse health consequences.

   14. 14. “Consumer” means a person who:

       1. a. Is a member of the public,
       2. b. Takes possession of food,
       3. c. Is not functioning in the capacity of an operator of a food establishment, and
       4. d. Does not offer the food for resale.
   15. 15. “Department” means the Arizona Department of Health Services.
   16. 16. “FDA” means the United States Food and Drug Administration.
   17. 17. “GRAS” means Generally Recognized as Safe.

   18. 18. “Imminent health hazard” means a significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on:

       1. a. The number of potential injuries, and
       2. b. The nature, severity, and duration of the anticipated injury.
   19. 19. “Inspection report” means a document used to record the compliance status of a manufactured food facility and convey compliance information to the licensee at the conclusion of an inspection.
   20. 20. “License” means the document issued by the regulatory authority that authorizes a person to operate a manufactured food facility.

   21. 21. “Licensee” means an entity that:

       1. a. Is legally responsible for the operation of a manufactured food facility, such as the owner, the owner’s agent, or other person as documented; and
       2. b. Possesses a valid license to operate a manufactured food facility.
   22. 22. “Manufactured food facility” means the location, including any applicable building structures, in which manufactured food operations and wholesale food distribution occur.

   23. 23. “Manufactured food operation” means a commercial operation:

       1. a. That derives any percentage of their gross sales from the manufacturing, packaging, labeling, or storing of food for human consumption for wholesale to other business entities, such as food establishments and retailers; and
       2. b. If providing food directly to a consumer, must also comply with A.A.C. Title 9, Chapter 8, Article 1 Food Establishments.
       3. c. A manufactured food operation does not include a marijuana establishment as defined in A.R.S. § 36-2850 or a nonprofit medical marijuana dispensary as defined in A.R.S. § 36-2801; and
       4. d. A manufactured food operation does not include an Arizona Cottage Food registrant as described in A.R.S. § 36-136(H)(4)(g) and § 36-136(H)(13).
   24. 24. “Overall time-frame” means the same as in A.R.S. § 41-1072.
   25. 25. “Person” means the same as in A.R.S. § 41-1001.
   26. 26. “Public health nuisance” means an act, condition, or thing, as specified in A.R.S. § 36-601, or any practice contrary to the health laws of this state that is harmful to the health of the public.
   27. 27. “Regulatory authority” means the Department or a public health services district, local health department, Department of Environmental Services, or Department of Environmental Quality that carries out delegated functions, powers, and duties on behalf of the Department through a delegation agreement.
   28. 28. “Retail” means the sale of a product directly to a consumer.
   29. 29. “Substantive review time-frame” means the same as in A.R.S. § 41-1072.
   30. 30. “Warehouse” means a manufactured food facility for the storage or reshipment of food products, where no manipulation of food products occurs.
   31. 31. “Wholesale food distribution” means the sale of manufactured food items to be retailed by others.
   32. 32. “Written notice” means a message or order in written, typed, or printed characters sent or otherwise proved to have been received via standard mail or email.
10. J. In 21 CFR § 117.3, the Department shall not use the definition of a “very small business.”

11. K. The regulatory authority may inspect manufactured food facilities regulated in this Article related to the following:

    1. 1. Acidified foods,
    2. 2. Low-acid canned foods,
    3. 3. Aseptic processing of foods,
    4. 4. Seafood, or
    5. 5. Juice.

12. L. Manufactured food facilities related to the following are exempt from the requirements in this Article:

    1. 1. Dietary supplements,
    2. 2. Bottled water, and
    3. 3. Infant formulas.

13. M. The following food products under the Arizona Department of Agriculture jurisdiction are exempt from this rule:

    1. 1. Egg inspection requirements found in A.R.S. Title 3, Chapter 5 and A.A.C. Title 3, Chapter 2, Article 9.
    2. 2. Meat and poultry inspection requirements found in A.R.S. Title 3, Chapter 13 and A.A.C. Title 3, Chapter 2, Article 2.
    3. 3. Dairy and dairy products inspection requirements in A.R.S. Title 3, Chapter 4 and A.A.C. Title 3, Chapter 2, Article 8.
14. N. Spirituous liquor, as defined in A.R.S. § 4-101, produced on the premises licensed by the Arizona Department of Liquor Licenses and Control is exempt from requirements in this Article, as specified in A.R.S. § 36-136.

Historical Note

Adopted effective October 9, 1998 (Supp. 98-4). Section expired under A.R.S. § 41-1056(E) at 8 A.A.R. 2056, effective March 31, 2002 (Supp. 02-2). New Section made by final rulemaking at 32 A.A.R. 488 (February 27, 2026, Issue 9), effective April 6, 2026 (Supp. 26-1).