[Code of Federal Regulations]
[Title 9, Volume 2, Parts 200 to end]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR317.24]

[Page 176-177]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS--Table of Contents
 
                           Subpart A--General
 
Sec. 317.24  Packaging materials.

    (a) Edible products may not be packaged in a container which is 
composed in whole or in part of any poisonous or deleterious substances 
which may render the contents adulterated or injurious to health. All 
packaging materials must be safe for their intended use within the 
meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as 
amended (FFDCA).
    (b) Packaging materials entering the official establishment must be 
accompanied or covered by a guaranty, or statement of assurance, from 
the packaging supplier under whose brand name and firm name the material 
is marketed to the official establishment. The guaranty shall state that 
the material's intended use complies with the FFDCA and all applicable 
food additive regulations. The guaranty must identify the material, 
e.g., by the distinguishing brand name or code designation appearing on 
the packaging material shipping container; must specify the applicable 
conditions of use, including temperature limits and any other pertinent 
limits specified under the FFDCA and food additive regulations; and must 
be signed by an authorized official of the supplying firm. The guaranty 
may be limited to a specific shipment of an article, in which case it 
may be part of or attached to the invoice covering such shipment, or it 
may be general and continuing, in which case, in its application to any 
article or other shipment of an article, it shall be considered to have 
been given at the date such article was shipped by the person who gives 
the guaranty. Guaranties consistent with the Food and Drug 
Administration's regulations regarding such guaranties (21 CFR 7.12 and 
7.13) will be acceptable. The management of the establishment must 
maintain a file containing guaranties for all food contact packaging 
materials in the establishment. The file shall be made available to 
Program inspectors or other Department officials upon request. While in 
the official establishment, the identity of all packaging materials must 
be traceable to the applicable guaranty.
    (c) The guaranty by the packaging supplier will be accepted by 
Program inspectors to establish that the use of material complies with 
the FFDCA and all applicable food additive regulations.
    (d) The Department will mmnitor the use of packaging material in 
official establishments to assure that the requirements of paragraph (a) 
of this section are met, and may question the basis for any guaranty 
described under paragraph (b) of this section. Official establishments 
and packaging suppliers providing written guaranties to those official 
establishments will be permitted an opportunity to provide information 
tm designated Department officials as needed to verify the basis for any 
such guaranty. The required information will include, but is not limited 
to, manufacturing firm's name, trade name or code designation for the 
material, complete chemical composition, and use. Selection of a 
material for review does not in itself affect a material's 
acceptability. Materials may continue to be used during the review 
period. However, if information requested from the supplier is not 
provided within the time indicated in the request--a minimum of 30 
days--any applicable guaranty shall cease to be effective, and approval 
to continue using the specified packaging material in official 
establishments may be denied. The Administrator may extend this time 
where reasonable grounds for extension are shown, as, for example, where 
data must be obtained from suppliers.
    (e) The Administrator may disapprove for use in official 
establishmelts packaging materials whose use cannot be confirmed as 
complying with FFDCA and applicable food additive regulations. Before 
approval to use a packaging material is finally denied by the 
Administrator, the affected official establishment and the supplier of 
the material shall be given notice and the opportunity to present their 
views to the Administrator. If the official establishment and the 
supplier

[[Page 177]]

do not accept the Administrator's determination, a hearing in accordance 
with applicable rules of practice will be held to resolve such dispute. 
Approval to use the materials pending the outcome of the presentation of 
views or hearing shall be denied if the Administrator determines that 
such use may present an imminent hazard to public health.
    (f) Periodically, the Administrator will issue to inspectors a 
listing, by distinguishing brand name or code designation, of packaging 
materials that have been reviewed and that fail to meet the requirements 
of paragraph (a) of this section. Listed materials will not be permitted 
for use in official establishments. If a subsequent review of any 
material indicates that it meets the requirements of paragraph (a), the 
material will be deleted from the listing.
    (g) Nothing in this section shall affect the authority of Program 
inspectors to refuse a specific material if he/she determines the 
material may render products adulterated or injurious to health.

[49 FR 2235, Jan. 19, 1984. Redesignated at 55 FR 49833, Nov. 30, 1990]