Dairy

Sec. 527.100 Butter - Adulteration Involving *Insufficient* Fat *Content* (CPG 7106.05)

REGULATORY ACTION GUIDANCE:

The following represents criteria for direct reference seizure to the United States Attorney 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:

Print No.       Subs No.         Determinations
 Butter            Lot Sizes    Examined        Below 79.85%

Each Churn Mark 35cs or less          5               2
 Present Over 35cs    8               3

No Churn Marks 35 cs or less         12               4
 Present Over 35cs   20               7

 Bulk Butter (Tub or Cube)

Each Churn Mark 1 - 2 units         All               1
 Present 3 units      2               1
 Over 3 units         31

No Churn Mark 1 - 5 units           All1
 Present 6 - 14 units 52
 15 - 24 units        73
 25 - 150 units       83
 Over 150 units      144

*REMARKS (For Seizure 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 via EMS to CFSAN, Office of Field Programs, 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).

Issued: 10/1/80
Revised: 8/96

Sec. 527.200 Cheese and Cheese Products - Adulteration with Filth (CPG 7106.07)

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:

The sample of cheese products was processed from reject quality milk tested during an establishment inspection, even though filth is not found in the sample.

REMARKS:

Reject quality milk is determined as follows:

1. The sediment factor for 12 mg. and 6 mg. sediment pads exceeds 10. (Add the sum of the percentages for sediment pads graded as 12 mg. and 6 mg.),

or

2. The sediment factor for 12 mg. and 6 mg. sediment pads is 8 or more, determined as above, and the sediment factor for 12 mg., 6 mg., and 3 mg. sediment pads is 30 or more. (Add the sum of the percentages for sediment pads graded as 12 mg., 6 mg., and 3 mg.).

Cans of milk with 2 or more flies are considered reject as are cans of milk from which 6 mg. and 12 mg. sediment pads are obtained. sence of manure fragments, insects, insect fragments or rodent hairs must be established by laboratory examination *(using the method described in AOAC XV Ed. 952.21)* of some of the 3 mg., 6 mg., and l2 mg. sediment pads to confirm the classification and show that reject quality milk was used.

SPECIMEN CHARGE:

Article (cheese) (cheese product) adulterated (when introduced into and while in interstate commerce) (while held for sale after introduction into interstate commerce), within the meaning of 21 U.S.C. 342(a)(4), in that it has been prepared under insanitary conditions whereby it may have become contaminated with filth. It was processed from reject quality (filthy) milk.

NOTE: Only use direct reference citation authority when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.

*Material between asterisks is new or revised.*

Issued: 11/1/81
Revised: 3/95, 8/96

Sec. 527.225 Cheese - Misbranding Due to Moisture and Fat (CPG 7106.06)

REGULATORY ACTION GUIDANCE:

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

A. Cheddar, washed curd, colby, granular, swiss, gruyere, brick, samsoe, muenster, edam, gouda, monterey, high-moisture jack, asiago, cook, sap sago, gammelost, hard, semi-soft part-skim, pasteurized process, pasteurized blended and cold pack cheese (with nothing added), and mozzarella, represented as standardized cheese.

1. For High Moisture

a. If the average moisture of the vat, or lot if no vat numbers present, is at least 2 percentage points above the limit of the standard:

or

b. If no vat numbers present, moisture of two subdivisions is at least 4 percentage points above the limit of the standard, or moisture of one subdivision is at least 5 percentage points above the limit of the standard.

2. For *Insufficient Fat Content*

a. If the average fat of the vat, or lot if no vat numbers present, is at least 1.5 percentage points less than the limit of the standard:

or

b. If no vat numbers present, the fat of two subdivisions is at least 2.5 percentage points less than the limit of the standard, or the fat of one subdivision is at least 3.5 percentage points less than the limit of the standard.

NOTE: Duplicate moisture determinations should check within 0.2% and check analysis within 0.3%. Duplicate fat determinations on dry basis should check within 0.5% and check analysis within 0.6%.

B. Cottage Cheese, Dry Curd Cottage Cheese, and Low Fat Cottage Cheese represented as standardized.

1. For High Moisture

a. Cottage Cheese and Dry Curd Cottage Cheese. The average moisture is 81.0% or more.

b. Low Fat Cottage Cheese. The average moisture is 83.5% or more.

2. For *Insufficient Fat Content*

The average fat is 3.6% or less.

NOTE: Duplicate moisture determinations should check within 0.2% and check analysis within 0.3%. Duplicate fat determinations and check analysis should check within 0.2%.

SPECIMEN CHARGE *(example for cheddar cheese)*:

Article misbranded when introduced into and while in interstate commerce within meaning of 21 U.S.C. 342(g)(1), in that it purports to be and is represented as cheddar cheese, a food for which a definition and standard of identity has been prescribed by Regulation (21 CFR 133.113) promulgated pursuant to 21 U.S.C. 341, and it fails to conform to such definition and standard, since 133.113(a) of such definition and standard requires that cheddar cheese contain not more than 39 percent of moisture, and that its solids contain not less than 50 percent of milk fat; whereas the article contains more than 39 percent of moisture and the solids of the article contain less than 50 percent of milk fat.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 3/95, 8/96

Sec. 527.250 Cheese and Cheese Products - Misbranding Involving Net Contents (CPG 7106.09)

REGULATORY ACTION GUIDANCE:

The following represents criteria for recommending legal action to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:

Net Weight

In packaged cheese when there is an average shortage of one percent or more substantiated by factory evidence of short weight practices, or two percent or more if factory evidence of short weight is not available.

NOTE: Caution must be observed to make sure that shrinkage has not occurred after interstate shipment.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 8/1/86, 3/95

Sec. 527.300 Pathogens in Dairy Products (CPG 7106.08)

BACKGROUND:

Over the past few years there has been an upsurge of incidents involving dairy products contaminated with pathogenic microorganisms. The most significant outbreaks have been Yersiniosis in Tennessee, Arkansas, and Mississippi in 1982; Listeriosis in Massachusetts in 1983 and in California in 1985; and Salmonellosis in Illinois in 1985. These incidents appear to be occurring with greater frequency and involving larger numbers of affected people. A number of deaths have been associated with these outbreaks.

This Compliance Policy Guide provides guidance for initiating legal action in cases involving products found to be improperly pasteurized, contaminated with pathogenic microorganisms, or prepared and packed under insanitary conditions.

REGULATORY ACTION GUIDANCE:

A. 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. Analysis of the dairy product demonstrates that one or more units is positive for Salmonella, Campylobacter jejuni, Campylobacter coli, Yersinia enterocolitica or Listeria monocytogenes and is confirmed;

or

2. Analysis of the product demonstrates that one or more of the subs has phosphatase values of 2.0 or more micrograms phenol per ml after subtraction of microbial phosphatase;

or

3. Analysis of the product is positive for staphylococcal enterotoxin and is confirmed.

SPECIMEN CHARGE:

Pathogens or staphylococcal enterotoxin:

Article adulterated (when introduced into and while in interstate commerce) or (while being held for sale after shipment in interstate commerce) within the meaning of 21 U.S.C. 342(a)(1), in that it contains (a pathogenic microorganism, namely (list the microorganism)), or (an added poisonous and deleterious substance, namely staphylococcal enterotoxin) which may render it injurious to health.

Phosphatase:

Article adulterated (when introduced into and while in interstate commerce) or (while held for sale after shipment in interstate commerce) within the meaning of 21 U.S.C. 342(a)(4), in that it has been prepared, packed or held under unsanitary conditions whereby it may have been rendered

health.

B. The following represents criteria for recommending legal action to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:

1. All Dairy Products

Analysis of the product demonstrates that one or more of the subs has phosphatase values between 1.0 and 2.0 micrograms phenol per ml after subtraction of microbial phosphatase.

2. Cheese and Cheese Products Only

a. Analysis of the cheese or cheese product demonstrates that one or more units have enteropathogenic E. coli levels greater than 1 X 10³ per gram of product;

or

b. Analysis of the cheese or cheese product demonstrates that one or more units have E. coli levels greater than 1 X 10⁴ per gram of product and a recent inspection demonstrates the existence of significant insanitary conditions.

NOTES:

1. Direct reference seizures must be based upon the procedures in BAM, 7th Ed.

2. A copy of direct reference seizure should be sent to HFS-605.

3. Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.

4. Products produced in a IMS listed plant which demonstrate any of the above criteria should first be referred to the appropriate State regulatory agency for follow-up. This would also include a non-IMS product manufactured in an IMS-listed plant. If the State fails to take appropriate action the District should proceed to initiate FDA legal action.

5. For milk products in liquid form (e.g., whole milk, lowfat milk), only those products that are labeled as being pasteurized are to be analyzed for phosphatase. Heat dried dairy products (e.g., nonfat dry milk, casein) are not expected to contain phosphatase and therefore should not be analyzed for phosphatase.

6. Criteria for E. coli are applicable only to cheese and cheese products because other dairy products would not be expected to contain significant levels of E. coli.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 7/1/83, 8/1/86, 3/95, 8/96

Sec. 527.350 Eggnog; Eggnog Flavored Milk - Common or Usual Names (CPG 7106.02)

BACKGROUND:

Standards of identity have not been promulgated for either eggnog or eggnog flavored milk.

The U.S. Public Health Service published in June 1966, after discussion with the Food and Drug Administration, definitions for "eggnog" and "eggnog flavored milk" for the benefit of communities interested in regulating them under the terms of the 1965 Recommended "Grade "A" Pasteurized Milk Ordinance." These definitions are incorporated in the *1993* revision of the "Ordinance" and are enforceable by those States and local authorities who have, by regulation, adopted the code.

POLICY:

Definitions for "eggnog" and "eggnog flavored milk" given in the "Grade "A" Pasteurized Milk Ordinance," *1993* Edition, are as follows:

Eggnog - Eggnog is a milk product consisting of a mixture of milk or milk products of at least 6.0 percent butterfat, at least 1.0 percent egg yolk solids, sweetener, and flavoring. Emulsifier and not over 0.5 percent stabilizer may be add.

Eggnog Flavored Milk - Eggnog flavored milk is a milk product consisting of a mixture of at least 3.25 percent butterfat, at least 0.5 percent egg yolk solids, sweetener, and flavoring, Emulsifier and a maximum of 0.5 percent stabilizer may be added.

The terms "eggnog" and "eggnog flavored milk" are each considered to be the common or usual name for the products so defined.

In the absence of a standard of identity, the definitions given in the Grade "A" Pasteurized Milk Ordinance will serve as compliance guides for the identity of "eggnog" and "eggnog flavored milk." A food represented as such should meet the compositional requirements of the definitions. If not otherwise adulterated or misbranded, such food is considered to be in compliance with the Federal Food, Drug, and Cosmetic Act.

The addition of yellow color may serve to adulterate the products under 403(b) of the Act since the use of such color would make the article appear to contain more egg yolk than it actually contains.

Labels of these foods should bear a statement of ingredients listed by their common or usual names in order of decreasing predominance in compliance with 21 CFR^a.

^a 21 CFR 101.4(a)

*Material between asterisks is new or revised.*

Issued: 12/3/73
Revised: 10/1/80, 3/95

Sec. 527.400 Whole Milk, Low Fat Milk, Skim Milk - Aflatoxin M₁ (CPG 7106.10)

BACKGROUND:

Aflatoxins are a group of chemically related toxins produced as natural by-products during the growth of certain common molds. The aflatoxins are designated as B₁, B₂, G₁, and G₂. These compounds are demonstrated liver toxins and liver carcinogens. Aflatoxin B₁ is considered the most potent of this group. They are potential contaminants of several commodities including corn. If a particular corn crop is stressed, for example, by drought or insect attack it is susceptible to mold growth and aflatoxin contamination.

A metabolite of aflatoxin B₁ *that* is produced during normal biological processes of animals ingesting the toxin is chemically similar to B₁ and has been designated as aflatoxin M_1. *The aflatoxin M₁, though less potent than B₁, has been shown to cause liver cancer in certain animals.* Because the M₁ metabolite may occur in the milk of dairy cattle ingesting feed contaminated with aflatoxin B₁, exposure of these animals to aflatoxin contaminated feed should be minimized.

As a result of adverse weather conditions, insect damage and possibly other undetermined factors, the 1977 corn crop grown in the southeastern United States was severely affected by growth of aflatoxin producing molds. *The Agency conducted surveys in the southeastern states to determine the incidence of aflatoxin M₁ contamination of fluid milk products. The results of these surveys showed that aflatoxin contamination of milk in at least four southeastern states was a potentially serious public health hazard. The Commissioner therefore established a 0.5 parts per billion (ppb) action guideline for aflatoxin contamination of fluid milk products in 1977.

The Agency routinely monitors milk and milk products for aflatoxin contamination. It has generally been observed that the incidence and levels of aflatoxin M₁ contamination varies with the extent of aflatoxin contamination of the corn crop for a particular year.*

REGULATORY ACTION GUIDANCE:

The following represents criteria *that should be considered when deciding whether to* recommend legal action to CFSAN/Office of Field Programs/Division of Enforcement (HFS-605):

The original and check analysis show that the sample contains greater than 0.5 ppb aflatoxin M₁ and the identity of aflatoxin M₁ is confirmed by the chemical derivative test.

METHODOLOGY:

Samples of fluid milk products collected for aflatoxin M₁ analysis shall consist of not less than 10 pounds composited from not less than 10 units or portions of units randomly selected from a given lot. In the case of bulk units, the composite 10 pound sample may be drawn directly from bulk fluid storage after adequate mixing of the contents and flushing of the sampling valve.

Prior to analysis, the total sample shall be mixed in a manner to provide analytical samples that are representative of the composite. Duplicate aliquots of the well mixed sample shall be analyzed by *one of the methods for aflatoxin M₁ in dairy products described in AOAC Official Methods of Analysis (1990) 15th edition, sections 974.17, 980.21 and 986.16. Confirmation of the aflatoxin identity shall be by the method described in section 980.21.*

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 3/95, 8/96

Sec. 527.450 Milk and Milk Products Containing Penicillin (CPG 7106.03)

BACKGROUND:

Prior to the adoption of the cylinder plate method as the official method for detection of penicillin in milk products, states were using the Disc Assay procedure. This resulted in situations where the state's results were negative for inhibitory substances while FDA's test using the unofficial cylinder method were positive for penicillin. Regulatory action was not considered appropriate in these circumstances.

Since that time FDA adopted the Cylinder Plate Method as the official assay for the detection of penicillin in milk and milk products. FDA's Division of Federal-State Relations informed the State Health Officers, State Agriculture Commissioners, State Dairy Officials, and State Laboratory Directors of our decision to adopt the more sensitive cylinder plate method as official and requested that they proceed as soon as possible to adopt that method as their official analytical assay for the detection of penicillin in milk and milk products. Some states have complied with this request. Since the adoption of the Cylinder Plate Method we have consistently advised inquirers that while they may use other methods as preliminary tests, products found to be positive by the official method would be considered actionable.

POLICY:

Milk and milk products containing penicillin are adulterated within the meaning of Section 402(a)(2)(D) of the Federal Food, Drug, and Cosmetic Act in that they contain a new animal drug which is unsafe. Such milk and milk products may be subjected to reconditioning however, any reconditioning process will be considered and approved on a case by case basis by FDA. Products will be released subject to analysis by FDA using the most sensitive method (official method) for penicillin detection.

Milk and milk products containing penicillin which have satisfactorily passed through a reconditioning process and have been released by FDA may be used for human food or as a component of other food products.

Issued: 10/1/80

Sec. 527.500 Malted Milk (CPG 7106.01)

BACKGROUND:

No standard of identity has been established for malted milk. A definition for malted milk was published in Food Inspection Decision (F.I.D.) 170, issued March 31, 1917 and the same definition was included in S.R.A., F.D. No. 2, Revision 5, issued in November 1936. This definition was adopted as a guide in enforcing the Food and Drugs Act of 1906:

Malted Milk

The product made by combining whole milk with the liquid separated from a mash of ground barley malt and wheat flour, with or without the addition of sodium chloride, sodium bicarbonate and potassium bicarbonate, in such a manner as to secure the full enzymatic action of the malt extract, and by removing water. The resulting product contains not less than 7.5 percent of butterfat and not more than 3.5 percent of moisture.

After enactment of the Federal Food, Drug, and Cosmetic Act of 1938, malted milk was among the foods exempted from label declaration of ingredients requirement for labeling of non-standardized foods. The exemption was based on the expectation that standards would soon be established. However, no standard was established and on September 17, 1959, the exemption was terminated. In lieu of a standard the revised definition that appeared in Service and Regulatory Announcement, F.D. No. 2, Revision 5, November 1936, has been used as a guide.

Trade Correspondence (TC-297) issued May 7, 1940 included the following:

"An investigation which we made some years ago showed that malted milk drinks as served at soda fountains normally contain at least 0.5 ounce of malted milk in 10 fluid ounces of beverage. We believe that if you retain the name 'Chocolate Flavored Malted Milk Drink' for your product, the manufacturing formula should be revised so that the finished beverage will contain at least 0.5 ounce of malted milk in 10 fluid ounces of beverage. ***"

POLICY:

In the absence of a standard of identity the definition published in S.R.A., F.D. No. 2, Rev. 5, November 1936, will serve as a compliance guide for the identity of malted milk.

Issued: 10/1/80
Revised: 8/96

Sec. 527.600 Use of DDVP *(dichlorvos)* Strips in Milkhouses and Milkrooms (CPG 7106.04)

BACKGROUND:

On January 24, 1972, the Pesticide Regulation Branch of EPA registered the label of DDVP strips for use in milkhouses and milkrooms.

EPA registration policy is "these strips should not be used where exposed food is present, either in food service or in food processing plants. However, we would not construe milkrooms to involve exposed food since modern installations in most dairy facilities keep the milk continuously under careful mechanical control and do not involve any exposure of the product."

"Data has been adduced to support the opinion that the milk in milkhouses or milkrooms does not pick up residues of DDVP under conditions of use of the strips (none by a method reported to be sensitive to a 0.01 ppm). Even if minute but non-detectable residues were incurred, they would be covered by the DDVP tolerance in milk of 0.02 ppm. This tolerance was established on December 1, 1970."

POLICY:

Therefore, it is now the policy of the Food and Drug Administration in its Interstate Milk Shippers Program and its other food programs not to object to the use of DDVP strips in milkhouses and milkrooms when used in accordance with the label directions *approved by EPA. *

No change has been made in regard to the use of such DDVP strips in kitchens, restaurants, or other areas where food is prepared or served. The use of such strips should still be prohibited in these instances.

*Material between asterisks is new or revised.*

Issued: 8/26/76
Revised: 10/1/80, 8/96

Sub Chapter 530

Dietary Supplements

Sec. 530.400 Vitamin Products for Human Use - Low Potency (CPG 7121.02)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for recommending legal action to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605):*

Actionable if deficiency found in excess of 20 percent in one of more (where multivitamin produce involved) nutrients.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 3/95

Sec. 530.500 Wheat Germ Containing Non -Wheat Germ Tissue (CPG 7121.03)

REGULATORY ACTION GUIDANCE:

The following represents the criteria for recommending legal action to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605):*

The wheat germ contains an average of 15% or more, by weight, non wheat germ tissue.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 10/89, 3/95

Sub Chapter 535

Edible Oils

Sec. 535.100 Oleomargarine - Misbranding Due to *Insufficient* Fat (CPG 7113.01)

REGULATORY ACTION GUIDANCE:

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

The average fat content by both original and check analysis is *below* 79.85%.

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 via EMS or FAX to CFSAN/Office of Field Programs/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:

The article was misbranded while introduced into, while in, and is misbranded while held for sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 343(g)(1) in that it purports to be and is represented as oleomargarine, a food for which a definition and standard of identity has been prescribed by regulation (21 CFR 166.110) promulgated pursuant to 21 U.S.C. 341 and it fails to conform to such definition and standard, in that Section 166.110(a) of such definition and standard provides, among other things, that oleomargarine contain not less than 80 percent fat as determined by the method prescribed in such definition and standard, whereas, the article contains less than 80 percent fat.

*Material between asterisks is new or revised.*

Issued: 11/7/79
Revised: 10/1/80, 11/22/88, 3/95, 8/96

Sub Chapter 537

Egg Industry

Sec. 537.100 Eggs and Egg Products - Frozen - Adulteration Involving Decomposition (CPG 7107.02)

REGULATORY ACTION GUIDANCE:

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

1. If examination of the frozen eggs or frozen egg products by a qualified egg examiner shows two or more cans contain decomposed eggs;

and

2. At least two subsamples, but all subsamples if more than two *are* examined, from cans classed as decomposed have direct microscopic counts of 5,000,000 or more *bacterial cells per gram when analyzed by AOAC 940.37, 15 Ed*.

REMARKS:

If all cans in the lot are examined, recommend seizure only of the cans found to *contain* decomposed *eggs*.

If there is reason to believe that the lot of egg products was packed under the supervision of or certified by the U.S. Department of Agriculture, *submit* the following information *via EMS or FAX* to CFSAN/Office of Field Programs/Division of Enforcement (HentsFS-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(a)(3) in that it consists wholly or in part of a decomposed substance by reason of presence therein of decomposed eggs.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 3/95, 8/96