[Code of Federal Regulations]
[Title 9, Volume 2]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.24]

[Page 271-272]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
     CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION OF PRODUCTS--Table of Contents
 
                           Subpart A--General
 
Sec. 318.24  Compliance procedures for meat derived from advanced meat/bone separation machinery and recovery systems.

    (a) The product resulting from the separating process shall not have 
a calcium content exceeding 0.15 percent or 150 mg/100 gm of product 
within a tolerance of 0.03 percent or 30 mg, as prescribed in 
Sec. 301.2(rr)(2) of this subchapter.
    (b) To verify the calcium content in meat derived from advanced 
meat/bone separation machinery and recovery systems, a compliance 
program consisting of the following parameters shall be followed by 
manufacturers of meat defined in Sec. 301.2(rr)(2) of this subchapter.
    (1) An analysis of a sample of at least 1 pound from each lot shall 
be performed by the operator of the establishment or his or her agent. 
For purposes of this paragraph, a lot shall consist of the meat derived 
from advanced meat/bone separation machinery and recovery systems, 
designated as such by the operator of the establishment or his or her 
agent, from the product produced from a single species of livestock in 
no more than one continuous shift of up to 12 hours. Individual results 
from the chemical analyses shall be compared to the calcium limit, 
prescribed in paragraph (a) of this section, in order to demonstrate 
compliance. If compliance is not demonstrated, that is, if any single 
analytical result is more than 0.18 percent,\1\ \2\ before product from 
a production lot that is still at the establishment or one that is 
subsequently produced can be considered to be in compliance, at least 
three samples from that production lot shall be taken and analyzed for 
calcium, either separately, or, at the option of the establishment, as a 
composite (i.e., combining the three samples for analysis). The average 
of the results or the composite result must be less than or equal to 
0.15 percent. Taking three samples from each subsequently produced lot 
and analyzing them in order to demonstrate compliance shall continue 
until five consecutive lots have mean or composite results less than or 
equal to 0.15 percent. If the statistical evidence indicates that a 
production lot is not in compliance with the calcium limit, as 
prescribed in Sec. 301.2(rr)(2) of this subchapter, the lot must be 
labeled as MS(S) and meet all of the requirements for MS(S) in 
Sec. 319.5 of this subchapter.
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    \1\ The value 0.18 percent was derived by multiplying by 3 the 
expected analytical standard deviation obtained by FSIS laboratories on 
the approved chemical procedure for measuring calcium which uses 
Ethylenediaminetetraacetic acid (EDTA) as provided in the ``Official 
Methods of Analysis of the AOAC International'' (formerly the 
Association of Official Analytical Chemists), 15th Ed. (1990).
    \2\ Individual or an average of results shall be rounded to the 
nearest 0.01 percent calcium.
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    (2) The management of the establishment must maintain records to 
support the validity of the calcium content (as a measure of bone 
solids) to assure the

[[Page 272]]

process is in control. Such records shall be made available to the 
inspector or any other duly authorized representative of the Agency upon 
request. (Recordkeeping requirements were approved by the Office of 
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Management and Budget under control number 0583-0095.)

[59 FR 62561, Dec. 6, 1994]

Subparts B-F [Reserved]