# Title 7 — Agriculture Commissioner

## Article 7-16 — Commercial Feed

## Chapter 7-16-10 — Drugs and Additives in Feed

### § 7-16-10-01. Drugs and additives in feed.

1. Prior to approval of either a registration application or approval of a label for commercial feed
which contains additives, or both, the distributor may be required to submit evidence to prove
the safety and efficacy of the commercial feed when used according to the directions
furnished on the label.
2. Satisfactory evidence of safety and efficacy of a commercial feed may be:
a. When the commercial feed contains such additives, the use of which conforms to the
requirements of the applicable regulation in title 21, Code of Federal Regulations, or
which are "prior sanctioned" or "informal review sanctioned" or "generally recognized as
safe" for such use.
b. When the commercial feed is itself a drug as defined in subsection 7 of North Dakota
Century Code section 4.1-41-01 and is generally recognized as safe and effective for the
labeled use or is marketed subject to an application approved by the food and drug
administration under section 512 of the Federal Food, Drug, and Cosmetic Act.
c. When one of the purposes for feeding a commercial feed is to impart immunity, the
constituents imparting immunity have been approved for the purpose through the federal
Virus, Serum, and Toxins Act of 1913 as amended.
d. When the commercial feed is a direct fed microbial product and:
(1) The product meets the particular fermentation product definition;
(2) The microbial content statement as expressed in the labeling is limited to the
following: "Contains a source of live (viable) naturally occurring microorganisms."
This statement shall appear on the label; and
(3) The source is stated with a corresponding guarantee expressed in accordance with
these rules.
e. When the commercial feed is an enzyme product and:
(1) The product meets the particular enzyme definition defined by the association of
American feed control officials; and
(2) The enzyme is stated with a corresponding guaranteed expressed in accordance
with these rules.
History: Effective July 1, 2020.
General Authority: NDCC 4.1-41-20
Law Implemented: NDCC 4.1-41-06
