[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.12]
[Page 206-207]
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
[[Page 207]]
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.
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