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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 527.100 Butter - Adulteration Involving Insufficient Fat Content

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to the *Division of Compliance Management and Operations (HFC-210)* and for direct citation by District Offices:

  1. The average of the fat determinations, by both original and check analysis, on the number of subdivisions shown in the following table is below 79.85%;

    or
  2. The number of individual fat determinations by both original and check analysis meets or exceeds the figures in the right hand column of the following table:

 

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  Lot Sizes No. Subs Examined No. Determinations Below 79.85%
Print Butter
Each Churn Mark Present
 35cs or less
 5 2
Over 35cs 8 3
No Churn Mark Present 35 cs or less 12 4
Over 35cs 20 7
Bulk Butter (Tub or Cube)
Each Churn Mark Present

1 - 2 units

 

 All 1
3 units 2 1
Over 3 units 3 1
No Churn Mark Present 1 - 5 units All 1
6 - 14 5 2
15 - 24 units 7 3
25 - 150 units 8 3
Over 150 units 14 4


*REMARKS: (For Seizures Only)

If there is reason to believe that a lot was packed under the supervision of, or certified by the U.S. Department of Agriculture, submit the following information *by e-mail* to CFSAN, Office of *Compliance*/Division of Enforcement (HFS-605) and await reply before proceeding:

Sample Number Date of Shipment
Article Involved Dealer
Amount of Lot Shipper
Codes Analytical Conclusions

SPECIMEN CHARGE:

Article adulterated when introduced into and while in interstate commerce, within the meaning of 21 U.S.C. 342(b)(2) [Sec. 402(b)(2) of the Food, Drug, and Cosmetic Act], in that a product containing less than 80% by weight of milk fat has been substituted for butter, a product which should contain not less than 80% of milk fat as provided by the Act of March 4, 1923 (21 U.S.C. 321a).

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 8/96, 5/05

Updated: 11/29/05

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