[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.12]

[Page 201-202]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--CONTINUED
 
PART 108--EMERGENCY PERMIT CONTROL--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 108.12  Manufacturing, processing, or packing without a permit, or in violation of a permit.

    (a) A manufacturer, processor, or packer may continue at his own 
risk to manufacture, process, or pack without a permit a food for which 
the Commissioner has determined that a permit is required. All food so 
manufactured, processed, or packed during such period without a permit 
shall be retained by the manufacturer, processor, or packer and may not 
be introduced or delivered

[[Page 202]]

for introduction into interstate commerce without the advance written 
approval of the Food and Drug Administration. Such approval may be 
granted only upon an adequate showing that such food is free from 
microorganisms of public health significance. The manufacturer, 
processor, or packer may provide to the Commissioner, for his 
consideration in making any such determination, an evaluation of the 
potential public health significance of such food by a competent 
authority in accordance with procedures recognized as being adequate to 
detect any potential hazard to public health. Within 20 working days 
after receipt of a written request for such written approval the Food 
and Drug Administration shall either issue such written approval or deny 
the request. If the request is denied, the applicant shall, upon 
request, be afforded a prompt hearing conducted in accordance with 
Sec. 108.5 (b) and (c).
    (b) Except as provided in paragraph (a) of this section, no 
manufacturer, processor, or packer may introduce or deliver for 
introduction into interstate commerce without a permit or in violation 
of a permit a food for which the Commissioner has determined that a 
permit is required. Where a manufacturer, processor, or packer utilizes 
a consolidation warehouse or other storage facility under his control, 
interstate shipment of any such food from the point of production to 
that warehouse or storage facility shall not violate this paragraph, 
provided that no further introduction or delivery for introduction into 
interstate commerce is made from that consolidated warehouse or storage 
facility except as provided in paragraph (a) of this section.