[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: 40CFR451.3]

[Page 462]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 451_CONCENTRATED AQUATIC ANIMAL PRODUCTION POINT SOURCE
CATEGORY--Table of Contents
 
Sec. 451.3  General reporting requirements.

    (a) Drugs. Except as noted below, a permittee subject to this Part 
must notify the permitting authority of the use in a concentrated 
aquatic animal production facility subject to this Part of any 
investigational new animal drug (INAD) or any extralabel drug use where 
such a use may lead to a discharge of the drug to waters of the U.S. 
Reporting is not required for an INAD or extralabel drug use that has 
been previously approved by FDA for a different species or disease if 
the INAD or extralabel use is at or below the approved dosage and 
involves similar conditions of use.
    (1) The permittee must provide a written report to the permitting 
authority of an INAD's impending use within 7 days of agreeing or 
signing up to participate in an INAD study. The written report must 
identify the INAD to be used, method of use, the dosage, and the disease 
or condition the INAD is intended to treat.
    (2) For INADs and extralabel drug uses, the permittee must provide 
an oral report to the permitting authority as soon as possible, 
preferably in advance of use, but no later than 7 days after initiating 
use of that drug. The oral report must identify the drugs used, method 
of application, and the reason for using that drug.
    (3) For INADs and extralabel drug uses, the permittee must provide a 
written report to the permitting authority within 30 days after 
initiating use of that drug. The written report must identify the drug 
used and include: the reason for treatment, date(s) and time(s) of the 
addition (including duration), method of application; and the amount 
added.
    (b) Failure in, or damage to, the structure of an aquatic animal 
containment system resulting in an unanticipated material discharge of 
pollutants to waters of the U.S. In accordance with the following 
procedures, any permittee subject to this Part must notify the 
permitting authority when there is a reportable failure.
    (1) The permitting authority may specify in the permit what 
constitutes reportable damage and/or a material discharge of pollutants, 
based on a consideration of production system type, sensitivity of the 
receiving waters and other relevant factors.
    (2) The permittee must provide an oral report within 24 hours of 
discovery of any reportable failure or damage that results in a material 
discharge of pollutants, describing the cause of the failure or damage 
in the containment system and identifying materials that have been 
released to the environment as a result of this failure.
    (3) The permittee must provide a written report within 7 days of 
discovery of the failure or damage documenting the cause, the estimated 
time elapsed until the failure or damage was repaired, an estimate of 
the material released as a result of the failure or damage, and steps 
being taken to prevent a reccurrence.
    (c) In the event a spill of drugs, pesticides or feed occurs that 
results in a discharge to waters of the U.S., the permittee must provide 
an oral report of the spill to the permitting authority within 24 hours 
of its occurrence and a written report within 7 days. The report shall 
include the identity and quantity of the material spilled.
    (d) Best management practices (BMP) plan. The permittee subject to 
this Part must:
    (1) Develop and maintain a plan on site describing how the permittee 
will achieve the requirements of Sec. 451.11(a) through (e) or Sec. 
451.21(a) through (h), as applicable.
    (2) Make the plan available to the permitting authority upon 
request.
    (3) The permittee subject to this Part must certify in writing to 
the permitting authority that a BMP plan has been developed.