[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR171.100]

[Page 25-26]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 171--FOOD ADDITIVE PETITIONS--Table of Contents
 
            Subpart B--Administrative Actions on Applications
 
Sec. 171.100  Regulation based on petition.


    (a) The Commissioner will forward for publication in the Federal 
Register, within 90 days after filing of the

[[Page 26]]

petition (or within 180 days if the time is extended as provided for in 
section 409(c)(2) of the Act), a regulation prescribing the conditions 
under which the food additive may be safely used (including, but not 
limited to, specifications as to the particular food or classes of food 
in or on which such additive may be used, the maximum quantity that may 
be used or permitted to remain in or on such food, the manner in which 
such additive may be added to or used in or on such food, and any 
directions or other labeling or packaging requirements for such additive 
deemed necessary by him to assure the safety of such use), and prior to 
the forwarding of the order to the Federal Register for publication 
shall notify the petitioner of such order and the reasons for such 
action; or by order deny the petition, and shall notify the petitioner 
of such order and of the reasons for such action.
    (b) The regulation shall describe the conditions under which the 
substance may be safely used in any meat product, meat food product, or 
poultry product subject to the Federal Meat Inspection Act (FMIA) (21 
U.S.C. 601 et seq.) or the Poultry Products Inspection Act (PPIA) (21 
U.S.C. 451 et seq.).
    (c) If the Commissioner determines that additional time is needed to 
study and investigate the petition, he shall by written notice to the 
petitioner extend the 90-day period for not more than 180 days after the 
filing of the petition.

[42 FR 14489, Mar. 15, 1977, as amended at 65 FR 51763, Aug. 25, 2000]