[Code of Federal Regulations]
[Title 40, Volume 29]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR451.2]

[Page 461]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 451_CONCENTRATED AQUATIC ANIMAL PRODUCTION POINT SOURCE
CATEGORY--Table of Contents
 
Sec. 451.2  General definitions.

    As used in this part:
    (a) The general definitions and abbreviations in 40 CFR part 401 
apply.
    (b) Approved dosage means the dose of a drug that has been found to 
be safe and effective under the conditions of a new animal drug 
application.
    (c) Aquatic animal containment system means a culture or rearing 
unit such as a raceway, pond, tank, net or other structure used to 
contain, hold or produce aquatic animals. The containment system 
includes structures designed to hold sediments and other materials that 
are part of a wastewater treatment system.
    (d) Concentrated aquatic animal production facility is defined at 40 
CFR 122.24 and Appendix C of 40 CFR Part 122.
    (e) Drug means any substance defined as a drug in section 201(g)(1) 
of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321).
    (f) Extralabel drug use means a drug approved under the Federal 
Food, Drug and Cosmetic Act that is not used in accordance with the 
approved label directions, see 21 CFR part 530.
    (g) Flow-through system means a system designed to provide a 
continuous water flow to waters of the United States through chambers 
used to produce aquatic animals. Flow-through systems typically use 
rearing units that are either raceways or tank systems. Rearing units 
referred to as raceways are typically long, rectangular chambers at or 
below grade, constructed of earth, concrete, plastic, or metal to which 
water is supplied by nearby rivers or springs. Rearing units comprised 
of tank systems use circular or rectangular tanks and are similarly 
supplied with water to raise aquatic animals. The term does not include 
net pens.
    (h) Investigational new animal drug (INAD) means a drug for which 
there is a valid exemption in effect under section 512(j) of the Federal 
Food, Drug, and Cosmetic Act, 21 U.S.C. 360b(j), to conduct experiments.
    (i) New animal drug application is defined in 512(b)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C 360b(b)(1)).
    (j) Net pen system means a stationary, suspended or floating system 
of nets, screens, or cages in open waters of the United States. Net pen 
systems typically are located along a shore or pier or may be anchored 
and floating offshore. Net pens and submerged cages rely on tides and 
currents to provide a continual supply of high-quality water to the 
animals in production.
    (k) Permitting authority means EPA or the State agency authorized to 
administer the National Pollutant Discharge Elimination System 
permitting program for the receiving waters into which a facility 
subject to this Part discharges.
    (l) Pesticide means any substance defined as a ``pesticide'' in 
section 2(u) of the Federal Insecticide, Fungicide, and Rodenticide Act 
(7 U.S.C. 136(u)).
    (m) Real-time feed monitoring means a system designed to track the 
rate of feed consumption and to detect uneaten feed passing through the 
nets at a net pen facility. These systems may rely on a combination of 
visual observation and hardware, including, but not limited to, devices 
such as video cameras, digital scanning sonar, or upweller systems that 
allow facilities to determine when to cease feeding the aquatic animals. 
Visual observation alone from above the pens does not constitute real-
time monitoring.
    (n) Recirculating system means a system that filters and reuses 
water in which the aquatic animals are produced prior to discharge. 
Recirculating systems typically use tanks, biological or mechanical 
filtration, and mechanical support equipment to maintain high quality 
water to produce aquatic animals.

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