46:9 19-077-E (REG. 02) EMERGENCY ACTION IN EFFECT 04/12/19—09/02/19

15.01.15.02

.02 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Animal” means cattle, swine or poultry.

(2) Elevated Risk.

(a) “Elevated risk” means a risk that is significantly higher than that present under normal or standard operating conditions.

(b) “Elevated risk” does not include a risk typically or frequently present under normal or standard operating conditions.

(3) “Medically important antimicrobial drug” means any drug from a class of drug or derivative of a class of drug that is:

(a) Made from a mold or bacterium that kills or slows the growth of other microbes, specifically bacteria; and

(b) Either:

(i) Used in human beings or intended for use in human beings to treat or prevent disease or infection; or

(ii) Listed in Appendix A of the federal Food and Drug Administration’s Guidance for Industry #152, including critically important, highly important, or important antimicrobial drugs.

(4) “Prophylaxis” or “Prophylactic” means the prevention of disease or infection in the absence of documented clinical signs of disease or infection.

(5) “Regular Pattern” means administering a medically important antimicrobial drug twice or more on the same animal or group of animals:

(a) For the same purpose or condition; or

(b) For a prophylactic purpose in the absence of an elevated risk of contracting a disease or infection, including:

(i) In correspondence with a particular life stage of an animal, such as in ovo, at birth or hatch, or at weaning;

(ii) As an ongoing management strategy or tool, such as in correspondence with a particular age or weight of an animal, particular time of the week, month, or year, or particular season; or

(iii) When moving animals from one location to another.