[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: 21CFR108.5]
[Page 205]
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. 108.5 Determination of the need for a permit.
(a) Whenever the Commissioner determines after investigation that a
manufacturer, processor, or packer of a food for which a regulation has
been promulgated in subpart B of this part does not meet the mandatory
conditions and requirements established in such regulation, he shall
issue to such manufacturer, processor, or packer an order determining
that a permit shall be required before the food may be introduced or
delivered for introduction into interstate commerce by that person. The
order shall specify the mandatory conditions and requirements with which
there is a lack of compliance.
(1) The manufacturer, processor, or packer shall have 3 working days
after receipt of such order within which to file objections. Such
objections may be filed by telegram, telex, or any other mode of written
communication addressed to the Center for Food Safety and Applied
Nutrition, Food and Drug Administration (HFS-605), 5100 Paint Branch
Pkwy., College Park, MD 20740. If such objections are filed, the
determination is stayed pending a hearing to be held within 5 working
days after the filing of objections on the issues involved unless the
Commissioner determines that the objections raise no genuine and
substantial issue of fact to justify a hearing.
(2) If the Commissioner finds that there is an imminent hazard to
health, the order shall contain this finding and the reasons therefor,
and shall state that the determination of the need for a permit is
effective immediately pending an expedited hearing.
(b) A hearing under this section shall be conducted by the
Commissioner or his designee at a location agreed upon by the objector
and the Commissioner or, if such agreement cannot be reached, at a
location designated by the Commissioner. The manufacturer, processor, or
packer shall have the right to cross-examine the Food and Drug
Administration's witnesses and to present witnesses on his own behalf.
(c) Within 5 working days after the hearing, and based on the
evidence presented at the hearing, the Commissioner shall determine
whether a permit is required and shall so inform the manufacturer,
processor, or packer in writing, with the reasons for his decision.
(d) The Commissioner's determination of the need for a permit
constitutes final agency action from which appeal lies to the courts.
The Commissioner will not stay a determination of the need for a permit
pending court appeal except in unusual circumstances, but will
participate in expediting any such appeal.
[42 FR 14334, Mar. 15, 1977, as amended at 54 FR 24891, June 12, 1989;
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
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