N.M. Admin. Code § 20.10.2.11

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

Section 20.10.2.11 - HEMP FACILITY REQUIREMENTS

A. After the effective date of this part and unless otherwise provided, it is illegal to operate a hemp facility which does not meet the requirements of this section.

B. Adoption of 21 CFR 117 Subparts A, B, and F. Except as otherwise provided, Subparts A, B, and F of the United States code of federal regulations, title 21, part 117 are hereby adopted and incorporated in their entirety.

C. 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 regulatory authority for official review and copying upon oral or written request.

D. Omissions. The following provisions are omitted from the incorporated subparts of 21 CFR 117:

(1) 117.1;

(2) 117.5;

(3) 117.7;

(4) 117.8;

(5) 117.310;

(6) 117.315(d);

(7) 117.325; and

(8) 117.335.

E. The current 21 CFR 111 and United States federal food, drug, and cosmetic act, title 21, chapter 9 are hereby adopted as a technical reference and interpretation guide.

F. Hemp and Hemp Product Source and Hemp Product Transportation.

(1) Hemp facilities shall not receive hemp without a hemp harvest certificate issued by NMDA or a person approved by the regulatory authority verifying the hemp being transported has a THC concentration of not more than three-tenths of one percent (0.30%) on a dry weight basis.

(2) Hemp facilities shall not receive hemp-derived material, hemp extract, or hemp finished product unless:

(a) it is received from an NMED permitted hemp facility or a person approved by the regulatory authority;

(b) it is accompanied by a hemp transportation manifest; and

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

G. Records and Traceability.

(1) Hemp facilities shall implement the approved record keeping system at all times and shall maintain traceability records for a period of two years.

(2) Hemp facilities shall maintain all shipping records and records of receipt for all hemp products for a period of two years, including but not limited to:

(a) Hemp harvest certificate;

(b) Hemp transportation manifest;

(c) Date of receipt; and

(d) Certificate of analysis, if hemp finished product.

H. Hemp facilities shall maintain the operational plans and recall plan, accepted by the regulatory authority, onsite during all hours of operation and shall make them available for review by the regulatory authority.

I. The final disposition of all unused hemp product and residual solvents shall be conducted as approved by the regulatory authority in Subsection C of 20.10.2.8 NMAC.

J. The permit holder shall be responsible to ensure the security of, and limit access to, hemp-derived material with a THC concentration of greater than three-tenths of one percent (0.30%).

N.M. Admin. Code § 20.10.2.11

Adopted by New Mexico Register, Volume XXX, Issue 15, August 13, 2019, eff. 8/1/2019, Amended by New Mexico Register, Volume XXXI, Issue 02, January 28, 2020, eff. 1/28/2020