[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR177.1]

[Page 277-278]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 177--ISSUANCE OF FOOD ADDITIVE REGULATIONS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 177.1  Scope and applicability.


    (a) This part establishes procedures for the establishment, 
modification, or revocation by the Administrator of food additive 
regulations under section 409 of the Federal Food, Drug, and Cosmetic 
Act (FFDCA), 21 U.S.C. 348, for food additives which may result in 
pesticide residues in or on processed food or otherwise affect the 
characteristics of such food.
    (b) Part 178 of this chapter contains procedures for filing 
objections and requests for hearings under FFDCA section 409(f) on food 
additive regulations or petition denials issued under this part. Part 
179 of this chapter contains rules governing formal evidentiary hearings 
under FFDCA section 409(f).
    (c) Part 180 of this chapter contains regulations establishing 
tolerances, or exemptions from the necessity for a tolerance, for 
pesticide residues on raw agricultural commodities under FFDCA section 
408. If the use of a pesticide chemical in the production, storage, or 
transportation of a raw agricultural commodity (RAC) in conformity with 
such a tolerance or exemption results in the presence of a pesticide 
residue in or on processed food made from the RAC, FFDCA section 
402(a)(2)(C) provides that such pesticide residue shall not be deemed 
unsafe for the purposes of FFDCA section 409 (despite the absence of a 
food additive regulation regarding such residue on the processed food) 
if the residue in or on the RAC has been removed to the extent possible 
in good manufacturing practice and the concentration of such residue in 
the processed food when ready to eat is not greater than the tolerance 
prescribed for the RAC. However, a food additive regulation would be 
required if the level of the pesticide residue in the processed food 
when ready to eat exceeded the level permitted in the ``parent'' RAC by 
the tolerance established under FFDCA section 408. In addition, if a 
pesticide residue in or on a processed food results from the application 
of a pesticide during or after processing, the food would be unsafe

[[Page 278]]

within the meaning of FFDCA section 409 unless a food additive 
regulation permitted that residue in or on the processed food.