[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
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 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

[[Page 202]]

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.