[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 9CFR317.24]



[Page 183-184]

 

                  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.



[[Page 184]]



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 monitor 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 

establishments 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 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]