[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: 21CFR130.17]
[Page 293-295]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130 FOOD STANDARDS: GENERAL--Table of Contents
Subpart A General Provisions
Sec. 130.17 Temporary permits for interstate shipment of experimental packs
of food varying from the requirements of definitions and standards of
identity.
(a) The Food and Drug Administration recognizes that before
petitions to amend food standards can be submitted, appropriate
investigations of potential advances in food technology sometimes
require tests in interstate markets of the advantages to and acceptance
by consumers of experimental packs of food varying from applicable
definitions and standards of identity prescribed under section 401 of
the act.
(b) It is the purpose of the Food and Drug Administration to permit
such tests when it can be ascertained that the sole purpose of the tests
is to obtain data necessary for reasonable grounds in support of a
petition to amend food standards, that the tests are necessary to the
completion or conclusiveness of an otherwise adequate investigation, and
that the interests of consumers are adequately safeguarded; permits for
such tests shall normally be for a period not to exceed 15 months. The
Food and Drug Administration, or good cause shown by the applicant, may
provide for a longer test market period. The Food and Drug
Administration will therefore refrain from recommending regulatory
proceedings under the act on the charge that a food does not conform to
an applicable standard, if the person who introduces or causes the
introduction of the food into interstate commerce holds an effective
permit from the Food and Drug Administration providing specifically for
those variations in respect to which the food fails to conform to the
applicable definition and standard of identity. The test period will
begin on the date the person holding an effective permit from the Food
and Drug Administration introduces or causes the introduction of the
food covered by the permit into interstate commerce but not later than 3
months after notice of the issuance of the permit is published in the
Federal Register. The Food and Drug Administration shall be notified in
writing of the date on which the test period begins as soon as it is
determined.
(c) Any person desiring a permit may file with the Team Leader,
Conventional Foods Team, Division of Standards and Labeling Regulations,
Office of Nutritional Products, Labeling and Dietary Supplements, Center
for Food Safety and Applied Nutrition (HFS-822), 5100 Paint Branch
Pkwy., College Park, MD 20740, a written application in triplicate
containing as part thereof the following:
(1) Name and address of the applicant.
(2) A statement of whether or not the applicant is regularly engaged
in producing the food involved.
(3) A reference to the applicable definition and standard of
identity (citing applicable section of regulations).
(4) A full description of the proposed variation from the standard.
(5) The basis upon which the food so varying is believed to be
wholesome and nondeleterious.
(6) The amount of any new ingredient to be added; the amount of any
ingredient, required by the standard, to be eliminated; any change of
concentration not contemplated by the standard; or any change in name
that would more appropriately describe the new product under test. If
such new ingredient is not a commonly known food ingredient, a
description of its properties and basis for concluding that it is not a
deleterious substance.
(7) The purpose of effecting the variation.
(8) A statement of how the variation is of potential advantage to
consumers. The statement shall include the reasons why the applicant
does not consider the data obtained in any prior investigations which
may have been conducted sufficient to support a petition to amend the
standard.
(9) The proposed label (or an accurate draft) to be used on the food
to be market tested. The label shall conform in all respects to the
general requirements of the act and shall provide a means whereby the
consumer can distinguish between the food being tested and such food
complying with the standard.
(10) The period during which the applicant desires to introduce such
food into interstate commerce, with a statement of the reasons
supporting the
[[Page 294]]
need for such period. If a period longer than 15 months is requested, a
detailed explanation of why a 15-month period is inadequate shall be
provided.
(11) The probable amount of such food that will be distributed. The
amount distributed should be limited to the smallest number of units
reasonably required for a bona fide market test. Justification for the
amount requested shall be included.
(12) The areas of distribution.
(13) The address at which such food will be manufactured.
(14) A statement of whether or not such food has been or is to be
distributed in the State in which it was manufactured.
(15) If it has not been or is not to be so distributed, a statement
showing why.
(16) If it has been or is to be so distributed, a statement of why
it is deemed necessary to distribute such food in other States.
(d) The Food and Drug Administration may require the applicant to
furnish samples of the food varying from the standard and to furnish
such additional information as may be deemed necessary for action on the
application.
(e) If the Food and Drug Administration concludes that the variation
may be advantageous to consumers and will not result in failure of the
food to conform to any provision of the act except section 403(g), a
permit shall be issued to the applicant for interstate shipment of such
food. The terms and conditions of the permit shall be those set forth in
the application with such modifications, restrictions, or qualifications
as the Food and Drug Administration may deem necessary and state in the
permit.
(f) The terms and conditions of the permit may be modified at the
discretion of the Food and Drug Administration or upon application of
the permittee during the effective period of the permit.
(g) The Food and Drug Administration may revoke a permit for cause,
which shall include but not be limited to the following:
(1) That the permittee has introduced a food into interstate
commerce contrary to the terms and conditions of the permit.
(2) That the application for a permit contains an untrue statement
of a material fact.
(3) That the need therefor no longer exists.
(h) During the period within which any permit is effective, it shall
be deemed to be included within the terms of any guaranty or undertaking
otherwise effective pursuant to the provisions of section 303(c) of the
act.
(i) If an application is made for an extension of the permit, it
shall be accompanied by a description of experiments conducted under the
permit, tentative conclusions reached, and reasons why further
experimental shipments are considered necessary. The application for an
extension shall be filed not later than 3 months prior to the expiration
date of the permit and shall be accompanied by a petition to amend the
affected food standard. If the Food and Drug Administration concludes
that it will be in the interest of consumers to issue an extension of
the time period for the market test, a notice will be published in the
Federal Register stating that fact. The notice will include an
invitation to all interested persons to participate in the market test
under the same conditions that applied to the initial permit holder,
including labeling and the amount to be distributed, except that the
designated area of distribution shall not apply. The extended market
test period shall not begin prior to the publication of a notice in the
Federal Register granting the extension and shall terminate either on
the effective date of an affirmative order ruling on the proposal or 30
days after a negative order ruling on the proposal, whichever the case
may be. Any interested person who accepts the invitation to participate
in the extended market test shall notify the Food and Drug
Administration in writing of that fact, the amount to be distributed,
and the area of distribution; and along with such notification, he shall
submit the labeling under which the food is to be distributed.
(j) Notice of the granting or revocation of any permit shall be
published in the Federal Register.
(k) All applications for a temporary permit, applications for an
extension of a temporary permit, and related
[[Page 295]]
records are available for public disclosure when the notice of a permit
or extension thereof is published in the Federal Register. Such
disclosure shall be in accordance with the rules established in part 20
of this chapter.
(l) Any person who contests denial, modification, or revocation of a
temporary permit shall have an opportunity for a regulatory hearing
before the Food and Drug Administration pursuant to part 16 of this
chapter.
[42 FR 14357, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
46 FR 37500, July 21, 1981; 54 FR 24892, June 12, 1989; 59 FR 15051,
Mar. 31, 1994; 66 FR 17359, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001]
Back to Top
© 2007 Betterchem Corp.
|
