N.M. Admin. Code § 16.8.6.10

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.8.6.10 - EDIBLE AND TOPICAL CANNABIS MANUFACTURER REQUIREMENTS

A. Adoption of 21 CFR 117 . Except as otherwise provided, Subpart F and the sections, specified in paragraphs 1-7 of this subsection, of Subparts A and B of the United States code of federal regulations, title 21, part 117 are hereby adopted and incorporated in their entirety:

(1) 117.3 Definitions;

(2) 117.20 Plant and grounds;

(3) 117.35 Sanitary operations;

(4) 117.37 Sanitary facilities and controls;

(5) 117.40 Equipment and utensils;

(6) 117.80 Processes and controls; and

(7) 117.110 Defect action levels and Subpart F.

B. Modifications. Except as otherwise provided, the following modifications are made to the incorporated subparts of 21 CFR 117 :

(1) 117.301: All records required by this part are subject to all requirements of this subpart;

(2) 117.315(c): Offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. Electronic records are considered to be onsite if they are accessible from an onsite location; and

(3) 117.320: All records required by this part must be made promptly available to the division for official review and copying upon oral or written request.

C. Omissions. Except as otherwise provided, the following omissions are made to the incorporated subparts of 21 CFR 117 :

(1) 117.310;

(2) 117.315(d);

(3) 117.325;

(4) 117.335; and

(5) The following terms are omitted from section 117.3 Definitions:

(a) Allergen;

(b) Food;

(c) Food-contact surfaces;

(d) Lot;

(e) Manufacturing/processing; and

(f) Packing.

D. Adoption of food code parts 4-5, 4-6 and 4-7. Except as otherwise provided, parts 4-5, 4-6, and 4-7 of the 2017 United States food and drug administration model food code is hereby adopted and incorporated in its entirety.

E. Modifications. Except as otherwise provided, the following modifications are made to the incorporated subparts of the 2017 United States food and drug administration model food code, 4-603.12 Precleaning:

(1) Food or cannabis product debris on equipment and utensils shall be scraped over a waste disposal unit or garbage receptacle or shall be removed in a warewashing machine with a prewash cycle.

(2) If necessary, for effective cleaning, utensils and equipment shall be pre-flushed, presoaked, or scrubbed with abrasives. Ethyl alcohol (ethanol) or isopropyl alcohol (isopropanol) are acceptable for pre-flushing or presoaking.

F. Omissions. Except as otherwise provided, the following omissions are made to the incorporated subparts of the 2017 United States food and drug administration model food code:

(1) 4-502.12;

(2) 4-502.13(B);

(3) 4-502.14;

(4) 4-602.11(A)(1);

(5) 4-602.11(B);

(6) 4-602.11(D)(3); and

(7) 4-602.11(E)(2)-(3).

G. Cannabis Product Ingredient Source.

(1) Ingredients shall be received from sources as specified in 7.6.2 NMAC.

(2) Cannabis products, ingredients, and edible or topical cannabis finished products intended for human consumption shall be transported under conditions that will protect against allergen cross-contact and against biological, chemical (including radiological), and physical contamination of the cannabis products, ingredients, and cannabis finished products, as well as against deterioration of the cannabis products, ingredients, and cannabis finished products and the container in accordance with the New Mexico Food Service Sanitation Act and the New Mexico Food Act.

H. The current 21 CFR 111 and United States Federal Food, Drug, and Cosmetic Act, Title 21, Chapter 9 and 7.6.2 NMAC are hereby adopted as a technical reference and interpretation guide.

N.M. Admin. Code § 16.8.6.10

Adopted by New Mexico Register, Volume XXXII, Issue 23, December 14, 2021, eff. 12/2/2021, Adopted by New Mexico Register, Volume XXXIII, Issue 19, October 11, 2022, eff. 10/11/2022