[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2007]

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

[CITE: 9CFR331.5]



[Page 363-364]

 

                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS

 

     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 

                               AGRICULTURE

 

 PART 331_SPECIAL PROVISIONS FOR DESIGNATED STATES AND TERRITORIES;

 

Sec. 331.5  Criteria and procedure for designating establishments with operations which would clearly endanger the public health; disposition of products; 

          application of regulations.



    (a) An establishment preparing products solely for distribution 

within any State shall be designated as one producing adulterated 

products which would clearly endanger the public health, if:

    (1) Any meat or meat food product prepared at the establishment is 

adulterated in any of the following respects:

    (i) It bears or contains a pesticide chemical, food additive, or 

color additive, that is ``unsafe'' within the meaning of sections 408, 

409, or 706 of the Federal Food, Drug, and Cosmetic Act or was 

intentionally subjected to radiation in a manner not permitted under 

section 409 of said Act; or if it bears or contains any other added 

poisonous or added deleterious substance which may render it injurious 

to health or make it unfit for human food; or

    (ii) It consists in whole or in part of any filthy, putrid, or 

decomposed substance or is for any other reason unsound, unhealthful, or 

unwholesome or otherwise unfit for human food (for example, it was 

prepared from meat or other ingredients exhibiting spoilage 

characteristics; or it is, or was prepared from, a carcass affected with 

a disease transmissible to humans and its condemnation would be required 

under part 309 or 310 of the Federal Meat Inspection regulations (9 CFR 

parts 309, 310) at federally inspected establishments; or it is a ready-

to-eat pork product which has not been treated to destroy trichinae as 

prescribed in Sec. 318.10 of this subchapter for products at federally 

inspected establishments); or

    (iii) It has been prepared, packed or held under insanitary 

conditions whereby it may have become contaminated with filth or may 

have been rendered injurious to health (for example if insects or vermin 

are not effectively controlled at the establishments, or insanitary 

water is used in preparing meat or meat food products for human food); 

or

    (iv) It is, in whole or in part, the product of an animal that died 

otherwise than by slaughter; or

    (v) Its container is composed, in whole or in part, of any poisonous 

or deleterious substance which may render the contents injurious to 

health; and

    (2) Such adulterated articles are intended to be or are distributed 

from the establishment while capable of use as human food.

    (b) When any such establishment is identified by a Program Inspector 

as one producing adulterated product, which would clearly endanger 

public health under the criteria in paragraph (a) of this section, the 

following procedure will be followed:

    (1) The Program Inspector will informally advise the operator of the 

establishment concerning the deficiencies found by him and report his 

findings to the appropriate Regional Director for the Program. When it 

is determined by the Regional Director that any establishment preparing 

products solely for distribution within any State is producing 

adulterated products for distribution within such State which would 

clearly endanger the public health, written notification thereof will be 

issued to the appropriate State officials, including the Governor of the 

State and the appropriate Advisory Committee, for effective action under 

State or local law to prevent such endangering of the public health. 

Such written notification shall clearly specify the deficiencies deemed 

to result in the production of adulterated products and shall specify a 

reasonable time for such action under State or local law.

    (2) If effective action is not taken under State or local law within 

the specified time, written notification shall be issued by the Regional 

Director to the operator of the establishment, specifying the 

deficiencies involved and allowing him ten days to present his views or 

make the necessary corrections, and notifying him that failure to 

correct such deficiencies may result in designation of the establishment 

and operator thereof as subject to the provisions of titles I and IV of 

the Act as though engaged in commerce.



[[Page 364]]



    (3) Thereafter the Program Inspector shall survey the establishment 

and designate it if he determines, in consultation with the Regional 

Director, that it is producing adulterated products, which would clearly 

endanger the public health, and formal notice of such designation will 

be issued to the operator of the establishment by the Regional Director.

    (c) Products on hand at the time of designation of an establishment 

under this section are subject to detention, seizure and condemnation in 

accordance with part 329 of this subchapter: Provided, That products 

that have been federally inspected and so identified and that have not 

been further prepared at any nonfederally inspected establishment may be 

released for distribution if the products appear to be not adulterated 

or misbranded at the time of such release.

    (d) No establishment designated under this section can lawfully 

prepare any products unless it first obtains inspection or qualifies for 

exemption under Sec. 303.1 of this subchapter. All of the provisions of 

the regulations shall apply to establishments designated under this 

section, except that the exceptions provided for in Sec. 331.3 of this 

part shall apply to such establishments.