[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.140]

[Page 159]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 14_PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
 
              Subpart H_Color Additive Advisory Committees
 
Sec.  14.140  Establishment of a color additive advisory committee.


    The Commissioner will establish a color additive advisory committee 
under the following circumstances:
    (a) The Commissioner concludes, as a matter of discretion, that it 
would be in the public interest for a color additive advisory committee 
to review and make recommendations about the safety of a color additive 
on which important issues are pending before FDA and for interested 
persons to present information and views at an oral public hearing 
before a color additive advisory committee.
    (b) There is an issue arising under section 721(b)(5)(B) of the act 
concerning the safety of a color additive, including its potential or 
actual carcinogenicity, that requires the exercise of scientific 
judgment and a person who would be adversely affected by the issuance, 
amendment, or repeal of a regulation listing a color additive requests 
that the matter, or the Commissioner as a matter of discretion 
determines that the matter should, be referred to a color additive 
advisory committee.
    (1) Paragraph (b) does not apply to any issue arising under the 
transitional provisions in section 203 of the Color Additive Amendments 
of 1960 relating to provisional listing of commercially established 
colors. A color additive advisory committee to consider any such matter 
will be established under paragraph (a) of this section.
    (2) A request for establishment of a color additive advisory 
committee is to be made in accordance with Sec.  10.30. The Commissioner 
may deny any petition if inadequate grounds are stated for establishing 
a color additive advisory committee. A request for establishment of a 
color additive advisory committee may not rest on mere allegations or 
denials, but must set forth specific facts showing that there is a 
genuine and substantial issue of fact that requires scientific judgment 
and justifies a hearing before a color additive advisory committee. When 
it conclusively appears from the request for a color additive advisory 
committee that the matter is premature or that it does not involve an 
issue arising under section 721(b)(5)(B) of the act or that there is no 
genuine and substantial issue of fact requiring scientific judgment, or 
for any other reason a color additive advisory committee is not 
justified, the Commissioner may deny the establishment of a color 
additive advisory committee.
    (3) Establishment of a color additive advisory committee on the 
request of an interested person is conditioned upon receipt of the 
application fee specified in Sec.  14.155.
    (4) Any person adversely affected may request referral of the matter 
to a color additive advisory committee at any time before, or within 30 
days after, publication of an order of the Commissioner acting upon a 
color additive petition or proposal.