[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR500.88]

[Page 14]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 500--GENERAL--Table of Contents
 
 Subpart E--Regulation of Carcinogenic Compounds Used in Food-Producing 
                                 Animals
 
Sec.  500.88  Regulatory method.

    (a) The sponsor shall submit for evaluation and validation a 
regulatory method developed to monitor compliance with FDA's operational 
definition of no residue.
    (b) The regulatory method must be able to confirm the identity of 
the marker residue in the target tissue at a minimum concentration 
corresponding to the Rm. FDA will determine the LOD from the 
submitted analytical method validation data.
    (c) FDA will publish in the Federal Register the complete regulatory 
method for ascertaining the marker residue in the target tissue in 
accordance with the provisions of sections 409(c)(3)(A), 512(d)(1)(I), 
and 721(b)(5)(B) of the act.

(Approved by the Office of Management and Budget under control number 
0910-0228)

[52 FR 49586, Dec. 31, 1987, as amended at 67 FR 78174, Dec. 23, 2002]