HHS:PHS:FDA:CFSAN:OFS:DDFPS:DEB:MST … Dairy and Egg Branch (HFS-316) SUBJECT: Questions And Answers Received From The Field; Regional Milk Seminars; And FDA Training Courses Held

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HHS:PHS:FDA:CFSAN:OFS:DDFPS:DEB:MST

5100 Paint Branch Parkway College Park, MD 20740-3835

M-I-09-3

May 29, 2009

TO: All Regional Food and Drug Directors

FROM: Dairy and Egg Branch (HFS-316)

SUBJECT: Questions And Answers Received From The Field; Regional Milk Seminars; And FDA Training Courses Held During FY 2008

Following are questions and answers received from the field; Regional Milk Seminars (Northeast, Central, Southeast and the joint Pacific/Southwest) and FDA training courses held during FY 2008.

In accordance with procedures established through the National Conference on Interstate Milk Shipments (NCIMS), if an answer to these questions results in a new understanding of a long-standing situation or installation, and the condition as it exists does not present an immediate public health hazard, reasonable judgment should be exercised and adequate time provided for modification and correction.

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Sanitation Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and also will be available on the CFSAN Web Site at http://www.cfsan.fda.gov at a later date.

If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to [email protected].

/ss/

CAPT Robert F. Hennes, RS, MPH

M-I-09-3 1 May 29, 2009

mailto:[email protected]

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QUESTIONS AND ANSWERS RECEIVED FROM THE FIELD;

REGIONAL MILK SEMINARS-

NE REGION-GLENN FALLS, NY (OCTOBER 23-25, 2007),

CENTRAL REGION-INDIANAPOLIS, IN (OCTOBER 30-NOVEMBER 1, 2007),

SE REGION-MOBILE, AL (NOVEMBER 13-15, 2007), and

PACIFIC/SW REGION-RENO, NV (APRIL 1-3, 2008);

AND

FDA TRAINING COURSES HELD DURING THE FY 2008-

FD577-SPECIAL PROBLEMS IN MILK PROTECTION COLUMBIA, MD (12/10-14/2007) and

FD577-SPECIAL PROBLEMS IN MILK PROTECTION MADISON, WI (8/4-8/2008)

1. PMO-Sections 1 and 3

Are independent warehouses marketing chains; such as Sam's Club, BJ's, Costco, etc., considered to be a “Milk Distributor” as defined in Section 1Definitions of the PMO and; therefore, required to be permitted per Section 3-Permits of the PMO?

No.

2. PMO-Sections 1 and 4; and Appendix L

May an anti-foaming/de-foaming agent be added to standardized “Milk” or chocolate milk and still be labeled as “milk” or “chocolate milk”?

The following answer was provided by CFSAN’s Office of Nutritional Labeling and Dietary Supplements ONLDS:

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No. The Standard of Identity for “Milk” (21 CFR 131.110) does not provide for the use of anti-foaming/de-foaming agents.


a) A Grade “A” milk product is labeled as "Sugar Free Light Whipped Cream" and is packaged in an aerosol can. This product was tested for milkfat and the results indicated that the milkfat was 9.36%. The product does not appear to meet the Standard of Identity for "Whipped Cream" as outlined in 21 CFR 131.25. This Standard states that, to use the unqualified name "whipped cream", the product must meet the Standard of Identity for part 131.150 (Heavy cream) and 131.157 (Light whipping cream), both of which require more than 9% fat, even if the fat is reduced by 50%.

The manufacturing plant is using the Standard of Identity for Light Cream, 21 CFR 131.155 and then making a "Light" claim by reducing the fat content by at least 50%. This Standard specifies a fat content of not less than 18% but less than 30%.

May a product labeled "Light Whipped Cream" contain 9% fat? The label bears all the required NLEA elements for a "light" claim, comparing their product to a leading brand and showing the reduction of fat and, in this case, calories also.

The following answer was provided by CFSAN’s ONLDS:

Per 21 CFR 131.25, whipped cream is the product made by whipping the cream that is described in 21 CFR 131.150 (heavy whipping cream) or 21 CFR 131.157 (light whipping cream). Depending on the type of whipping cream used, "whipped cream" contains an amount not less than 30% milkfat (light whipping cream contains 30 to 36% milkfat and heavy whipping cream contains greater than 36% milkfat). If this "whipped cream" is modified to bear a "light" claim to meet the requirements of 21 CFR 101.56, the fat content should be at least 50% lower than the appropriate reference food "whipped cream" made from either light whipping cream or heavy whipping cream. A fat content of 9% milkfat in "light whipped cream" would meet the requirements of 21 CFR 101.56 because this fat level would correspond to more than a 50% reduction compared to the fat content of either heavy whipping cream or light whipping cream. The label should also declare the percent fat reduction compared to the appropriate reference food.

It is not appropriate to use "light cream" as the reference food because "light cream" cannot be used to manufacture "whipped cream" as described in 21 CFR 131.25.

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b) It was stated in a) above that a "Whipped Cream" modified to bear a "Light" claim to meet the requirements of 21 CFR 101.56, must have a minimum fat content of 15% because the minimum fat content of the appropriate reference food "whipped cream" is 30%. Is there a maximum fat content for "whipped cream" modified to bear a "light" claim? If so where is it referenced in the CFR's?


Unlike a claim such as "low fat", "light" is a relative claim and; therefore, the appropriate fat content of a food bearing a "light" claim would depend on the content of fat in its reference food. In this case, the reference food "whipped cream" may contain fat at a range of 30% to greater than 36%. Whether the fat content in a "whipped cream" that bears a "light" claim is at an appropriate level would have to be determined based on the fat content of its reference food, "light whipping cream" or "heavy whipping cream". 21 CFR 101.56 specifies the requirements for the nutrient content claim "light".


a) When carbon dioxide (CO2) is incorporated into cottage cheese as a preservative agent, is a letter from the manufacturer of the CO2 required to be on file at the milk plant indicating compliance with the standards as set forth in the CFR?

CO2 is considered a GRAS substance under 21 CFR 184.1240 and the addition is governed by the conditions of use specified in the GRAS Regulation, 21 CFR 184.1240. The CO2 must be “Food Grade” or “USP”. This “Food Grade” determination may be accomplished by either a letter from the manufacturer stating that the CO2 is “Food Grade” or “USP” or properly identified as “Food Grade” or “USP” on it’s container.

b) Would a statement such as “Blended for the food and beverage industry” on the CO2 cylinder label be considered as proper identification that the CO2 is “Food Grade”?

No.


In the ingredients statement on a low fat yogurt product it states: “Low fat milk, milk whey, sugar, lactic cultures, and modified corn starch”. Does the Standard of Identity for yogurt provide for the addition of “milk whey”? Or is this part of the “stay” for the ingredients within the Standard of Identity for yogurt?

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The Standard of Identity for low fat yogurt provides for the use of "whey" for the purpose of increasing the nonfat solids content of yogurt. (Refer to 21 CFR 131.203(d)(1)) This is one of the “stayed” provisions; however, the “stay” is with respect to the restriction that only those ingredients listed in (d)(1) may be used for the purpose listed. The “stay” was in response to a request to permit other milk-derived ingredients for the purpose of increasing the nonfat solids content. ONLDS does not see an issue with the use of the ingredients (milk whey), which was included in the ingredients statement of this product.


a) May Omega 3's (EPA and DHA) be added to nonfat yogurt and still label the milk product as “nonfat yogurt”?


The Standard of Identity for nonfat yogurt in 21 CFR 131.206 would not allow for the addition of Omega-3 as Cod oil or any other fish oil and still label the product simply “nonfat yogurt”. However, the product in question is labeled “nonfat yogurt with Omega-3's EPA and DHA (FROM A PURE AND NATURAL FISH OIL SOURCE), which suggests that the manufacturer is intending to make a modified standardized nonfat yogurt as permitted under 21 CFR 130.10. Thus, from the perspective that the food in question is a 21 CFR 130.10 food, ONLDS offers the following comments:

The product as labeled, "Plain nonfat Yogurt with Omega-3's EPA and DHA (FROM A PURE AND NATURAL FISH OIL SOURCE)" is not acceptable because the term "with" implies that the food is a good source of Omega-3s. Because ONLDS has not established a daily value for Omega 3s, this is an undefined nutrient content claim, and thus not permitted. Further, if the manufacturer wants to make a statement about the quantity or amount of omega-3 in the food, they may do so under the provisions of 21 CFR 101.13(i). Such a statement could be “X grams of omega-3 fatty acids”.

The label cap for the product includes the "amount" statement "75 mg of EPA and DHA Omega-3 Fatty Acids" in the outside perimeter. The product would meet the requirements of 21 CFR 130.10 if this statement is included in the statement of identity to indicate that the product has been modified, i.e., "Nonfat Yogurt with 75 mg of EPA and DHA Omega-3 Fatty Acids".

Based on the legible portions of the label ONLDS is also providing the following label comments:

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• The statement "Taste and Odor-Free source of EPA and DHA Omega-3 Fatty Acids" that appears in the ingredient list after "Cod Oil" is intervening and should be removed.

• The nutrition label for this nonfat yogurt product lists total fat as "0g”. The listing of the "Cod Oil" ingredient is not accompanied by an asterisk that refers to a statement that indicates that the Cod Oil ingredient "adds a trivial amount of fat”, “adds a negligible amount of fat”, or "adds a dietarily insignificant amount of fat" (21 CFR 101.62(b)(1)(i)).

• Because this is a modified standardized food and Cod Oil is not an ingredient in regular nonfat yogurt, there must also be an asterisk after Cod Oil that refers to a statement that “ingredient not in regular nonfat yogurt” in accordance with 21 CFR 130.10(f)(2).

b) Would this yogurt product be considered Grade “A"?

Yes.


21 CFR Section 131.200 Yogurt

(a) Description. Yogurt is the food produced by culturing one or more of the optional dairy ingredients specified in paragraph (c) of this section with a characterizing bacterial culture that contains the lactic acid-producing bacteria, Lactobacillus bulgaricus and Streptococcus thermophilus…….All ingredients used are safe and suitable. Yogurt, before the addition of bulky flavors, contains not less than 3.25 percent milkfat and not less than 8.25 percent milk solids not fat, and has a titratable acidity of not less than 0.9 percent, expressed as lactic acid…...

What is FDA's definition of a bulky flavor? Does FDA consider French Vanilla a bulky flavor?


The Standards of Identity for yogurt, lowfat yogurt, and nonfat yogurt require a minimum milkfat content of 3.25% and a minimum milk solids not fat level of 8.25%, which in the case of yogurts made using bulky flavoring ingredients, are to be met on the basis of the yogurt mass prior to the addition of the bulky flavoring ingredients. FDA permitted this exclusion of bulky flavors in response to a comment to the proposed rule, in which FDA had not provided this specific exclusion. In the final rule that discussed this provision, FDA explained "adding bulky flavors to yogurts lowers the milkfat and milk solids not fat contents of the resultant food . . . there are not any recognized methods to separate all of the bulky flavoring material from yogurts. In addition, there is not a method to accurately determine the

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amount of milkfat and milk solids not fat in every sample of bulky flavored yogurt, lowfat yogurt, and nonfat yogurt. Therefore, the only practical way of determining the milkfat and milk solids not fat content of yogurts is to sample the yogurt, lowfat yogurt, or nonfat yogurt at the point of manufacture prior to the time the bulky flavoring material is added" (46 FR 9924 at 9930, January 30, 1981). FDA did not make specific allowances for the decrease in milkfat and milk solids not fat levels in the finished food for bulky added flavors. Rather, it required that yogurts meet the specified minimum levels prior to the addition of bulky flavoring ingredients.

FDA did not discuss the types of flavoring ingredients that would be considered "bulky" in its rulemaking on yogurts. However, there is sufficient precedence on this issue in the rulemaking on ice cream. When FDA first adopted the Standard of Identity for ice cream and other frozen desserts, it discussed the characterizing ingredients that would be considered bulky. FDA explained that "the characterizing ingredients specified in findings 21, 22, 23, 24, 25, 26, and 29 are bulky; that is, they must be used in relatively large quantities in order to characterize the ice cream". The ingredients discussed in these findings are:

• chocolate, various kinds of cocoa, unpulverized residual material prepared by removing part of the fat from ground cacao beans or mixtures of these substances;

• fruits, including frozen, canned, dried fruits, pureed or comminuted; • fresh, canned, frozen, concentrated, or dried fruit juices; • coconut, shredded, comminuted, or other particles of varying sizes; • nuts, roasted or cooked in butter or fat, preserved in syrup; and • candy, cakes, cookies, cooked cereals, and glaceed fruits.

FDA excluded vanilla (vanilla beans derived substances or extracts), artificial vanilla flavorings, eggs or egg yolks, wines and other alcoholic beverages (including liqueurs), malted milk, and sweeteners in its categorization of "bulky" flavoring ingredients (FR pages 7126-7141, July 27, 1960).

ONLDS does not consider vanilla flavoring or sweeteners as “bulky flavors”. Therefore, yogurt flavored with vanilla must meet the milkfat and milk solids not fat requirements, after accounting for the weight of the flavoring or sweetening ingredients, i.e., on a finished food basis.


a) How should “Yogurt”, made with a blend of water buffalo milk and cow’s milk be properly identified on the label of the container?


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Yogurt is defined in part as a food produced by culturing one or more dairy ingredients (cream, milk, partially skimmed milk or skim milk) with a characterizing bacterial culture that contains the lacti acid-producing bacteria, Lactobacillus bulgaricus and streptococcus thermophilus (21 CFR 131.200(a)). Milk is defined in part as the lacteal secretion… obtained by the complete milking of one or more healthy cows (21 CFR 131.110). Consequently as the milk permitted in yogurt is limited to cow’s milk, a cultured product resembling yogurt which is made in part from water buffalo milk may not be labeled as just “yogurt”.

ONLDS would not object to a Statement of Identity that clearly distinguishes the product from the standardized food “yogurt” such as "Water Buffalo Milk and Cow’s Milk Yogurt" if the product is made from more buffalo milk than cow’s milk, or “Cow’s Milk and Water Buffalo Milk Yogurt” if the proportions are reversed. Additionally, "Yogurt Made from Water Buffalo and Cow's Milk" would clearly identify the source of the milk used to make the cultured product and would therefore be appropriate, as long as the entire Statement of Identity was presented together. Alternatively, ONLDS would not object to a statement of identity that adequately characterized the product without using the term “yogurt”, for example, “Cultured Dairy Product Made from Water Buffalo Milk and Cow’s Milk” or simply “Cultured Dairy Product” with “water buffalo milk” and “milk” so identified in the ingredient statement.

b) May the name of the this product be “Yogurt”, followed by a clear and non misleading statement such as “Made with a blend of water buffalo milk and cow’s milk”, or “Made with a blend of cow’s milk and water buffalo milk”?


No. The statement of identity cannot simply be “Yogurt”. The statement “made with a blend….” is not considered a part of the statement of identity. Please refer to the answer to a) above for the proper statement of identity.


a) The current yogurt regulations do not specifically state whether the minimum 8.25 percent milk solids not fat must be derived from the “optional dairy ingredients” or the “other optional dairy ingredients”. What if any restrictions apply to the use of “other optional dairy ingredients” to make up part of the 8.25 percent minimum milk solids not fat?


The current standards of identity for yogurt, lowfat yogurt, and nonfat yogurt (21 CFR 131.200(a), 131.203(a), and 131.206(a), respectively) require a minimum milkfat content of 3.25 percent and a minimum milk solids not fat content of 8.25 percent prior to the addition of bulky flavoring ingredients.

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The dairy ingredients listed as "other optional ingredients" in 21 CFR 131.200(d)(1), 131.203(d)(1), and 131.206(d)(1) may be used to increase the milk solids not fat levels above the minimum required 8.25 percent, not to meet this minimum level. FDA provided this clarification regarding the use of optional milk-derived ingredients to increase the milk solids not fat content in the final rule that established the yogurt standards. (Refer to 46 FR 9924 at 9927, January 30, 1981)

b) May any processing such as ultrafiltration (UF) be applied to the "optional dairy ingredients" (cream, milk or skim milk) in the yogurt manufacturing facility immediately prior to the culturing tank?

Basic dairy ingredients that are listed under "Optional dairy ingredients" in 21 CFR 131.200(c), 131.203(c), and 131.206(c) cannot be ultrafiltered. Neither the standards for yogurts nor the standard for milk or definition for cream provide for ultrafiltration of these basic dairy ingredients.

c) May UF milk be used either as an "optional dairy ingredient" (Question b) or as an “other optional dairy ingredient”?

UF milk cannot be used as a basic dairy ingredient. (Refer to the answer to b) above.) It is not listed as an "optional dairy ingredient" in 21 CFR 131.200(c), 131.203(c), and 131.206(c).

With respect to the use of UF milk under the provisions of "other optional ingredients" listed in 21 CFR 131.200(d)(1), 131.203(d)(1), and 131.206(d)(1), although the current Standards of Identity do not list UF milk within 21 CFR 131.200(d)(1), 131.203(d)(1), and 131.206(d)(1), due to a 1982 stay of these sections, FDA will not be able to take enforcement action against the use of UF milk that fits within the parameters of these provisions.

Currently, 21 CFR 131.200(d)(1), 131.203(d)(1), and 131.206(d)(1) of the yogurt Standards permit the use of concentrated skim milk, nonfat dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, and whey modified by partial or complete removal of lactose and/or minerals for the purpose of increasing the milk solids not fat content of yogurt above the minimum required 8.25 percent, provided the ratio of protein to total milk solids not fat of the food and the protein efficiency ratio of all protein present is not decreased as a result of adding these optional ingredients. However, in response to certain objections to the 1981 final rule, FDA stayed several provisions of the yogurt Standards, including 21 CFR 131.200(d)(1), 131.203(d)(1), and 131.206(d)(1) that restrict the type of milk-derived ingredients that may be used to increase the milk solids not fat content of yogurt to those listed in these sections. FDA has not held a public hearing to resolve these issues and these stayed provisions remain stayed. Therefore, at this time, FDA will not be able to take enforcement action against yogurt, lowfat yogurt, or nonfat yogurt that deviate from the Standards in the use of

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milk-derived ingredients other than those listed in section (d)(1) for the specific purpose of increasing the milk solids not fat content above the minimum 8.25 percent, provided the ratio of protein to total milk solids not fat of the food and the protein efficiency ratio of protein present in the food are not decreased as a result of the use of such ingredients.


If yogurt is being manufactured entirely from reconstituted NFDM and the NFDM used is derived from a powdered blend, which consisted of 95% NFDM and 5% functional dairy ingredient, could all of the functional dairy ingredient be non-Grade “A” assuming that a Grade “A” equivalent is not available?


Yes, provided that the function of the functional dairy ingredient used is for purposes other than to increase the solids or bulk of the yogurt and that the minimum 8.25% milk solids level is met before the addition of the functional dairy ingredient.


May water or the reconstitution of concentrated skim milk be utilized in the manufacturing of the standardized food “sour cream”? (The sour cream in question is made using 40% cream diluted with reconstituted condensed/concentrated skim milk to achieve a fat level of 18%.)


No. Based on the information provided, it appears that the ingredients used to produce this sour cream product are cream, concentrated skim milk, water, cultures, and stabilizers.

The Standard of Identity for sour cream in 21 CFR 131.160 states that sour cream is made by souring cream using certain cultures. Cream is defined in 21 CFR 131.3 as the liquid milk product high in fat that is separated from milk. This definition permits the use of certain specific substances to adjust the solids content of cream. Concentrated skim milk is one ingredient that can be used for this purpose. However, "reconstituted skim milk" or "water" is not listed among the ingredients that can be used to adjust the composition of cream. Therefore, ONLDS believes that the use of water or the reconstitution of concentrated skim milk does not fit within the provisions in part 21 CFR 131 for the manufacture of the standardized food "sour cream".

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Stabilizers may be used in sour cream for the purpose of improving texture as provided in 21 CFR 131.160(b)(1). The addition of "powders" would need to be evaluated based on the actual substances that are used.


May the cream that is used to make sour cream be standardized with reconstituted NFDM, which is made with the addition of water, if they label the finished product "Sour cream standardized with reconstituted milk" or some other accurate labeling?


Sour cream is a food made by souring pasteurized cream per 21 CFR 131.160. "Cream" is defined in 21 CFR 131.3(a) as the "liquid milk product high in fat separated from milk, which may have been adjusted by adding thereto: milk, concentrated milk, dry whole milk, skim milk, concentrated skim milk, or nonfat dry milk. Cream contains not less than 18 percent milkfat." Therefore, cream that is used to make sour cream can be adjusted in its milkfat content through the addition of skim milk. All ingredients used to make sour cream must be listed in the ingredient statement, including skim milk when used.

Reconstituted NFDM, which is made with the addition of water, is not listed among the ingredients permitted for adjusting the milkfat content of cream, as defined in 21 CFR 131.3(a). Therefore, "cream" that is used to make sour cream cannot be adjusted/standardized using reconstituted NFDM.


A company wishes to label their sour cream as "Naturally Cultured Sour Cream". They are inoculating their sour cream with Lacata coccus and Luconostoc cremoris cultures and there will not be any change in formulation. Is this an acceptable labeling practice for their sour cream, given the cultures they are using?


FDA ONLDS’ policy on the use of the term “natural” is that “natural” means that nothing artificial (including artificial flavors) or synthetic (including all color additives, vitamins, etc. regardless of source) has been included in or has been added to a food that would not normally be expected to be in the food. Additionally, we do not restrict the use of the term “natural” except on products that contain added color, synthetic substances and flavors as provided for in 21 CFR Section 101.22. Therefore, if all the ingredients used to make the product are derived by a natural process, we would not object to

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use of the term “natural” on the product label. On the other hand, if any of the ingredients used to make a product are synthetic, we would object to the use of the term “all natural” on the product label.

The Federal Food, Drug and Cosmetic Act (FFD&CA) requires, among other things, that a food bear on its label the common or usual name of the food. “Sour cream” or “cultured sour cream” is the common or usual name of the standardized food at 21 CFR 131.160. Therefore, the product should be labeled “sour cream” or “cultured sour cream,” regardless of whether the product is manufactured naturally or synthetically. However, although the common or usual name of the product you describe is “sour cream” or “cultured sour cream,” if the product is manufactured by a natural process, we would not object to the use of a statement such as “sour cream derived naturally,” “cultured sour cream derived naturally” or “natural” elsewhere on the product label.


a) A milk plant proposes to inject carbon dioxide (CO2) into condensed skim milk in one (1) milk plant and then ship the condensed skim to another milk plant to use the condensed skim to make cheese (probably a standardized variety). It appears the CO2 would act as a preservative of the condensed skim milk during transport. May CO2 be injected into condensed (concentrated) skim milk at all?


The Standard of Identity for concentrated milk (21 CFR 131.115) does not provide for the use of CO2 or other preservatives in concentrated or condensed milk. While the parent standard for concentrated milk does not permit the addition of preservatives, 21 CFR 130.10(d)(1) permits the use of safe and suitable ingredients to extend the shelf life so that the modified standardized product, in this case, condensed skim milk, is not inferior to its standardized counterpart, in this case, condensed milk. ONLDS does not have data or other information that would lead them to believe that CO2 or other preservatives are necessary to ensure that the shelf life of condensed skim milk is similar to that of condensed milk. Therefore, ONLDS believes that the use of CO2 as a preservative in condensed skim milk does not fit within the provisions of the standard in 21 CFR 131.115 or in 130.10.

NOTE: All substances added to foods must be safe and suitable for their intended use. While we recognize that CO2 is affirmed as GRAS under FDA regulation in 21 CFR 184.1240, ONLDS has not reviewed the safety aspects related to this specific use of CO2 in condensed skim milk.

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b) If yes, may the CO2 injected condensed skim be used to make cheese, either a standardized or a non-standardized variety? If yes, what would the labeling requirement be?


As stated above, ONLDS does not have any data or information at this time to suggest that CO2 used as a preservative is necessary to maintain the shelf life of condensed skim milk in a manner similar to that of condensed milk. Therefore, "condensed skim milk" cannot contain CO2 whether used as is or in another finished food such as cheese.


The CFR provides for nonfat dry milk (NFDM), condensed or concentrated skim milk to alternatively be listed as “skim milk” in the ingredients statement. If a skim milk product is fortified with NFDM, is the ingredients statement required to include NFDM? For example: "Skim milk, NFDM, vitamin A&D..." OR can it be “Skim milk, vitamins...".


21 CFR 101.4(b)(3) permits the collective declaration of various skim milk products that only differ in the amount of water in the ingredient. Thus, skim milk and NFDM may be declared simply as “skim milk” in the ingredients statement. Therefore, “Skim milk, vitamins…” would be appropriate.

16. PMO-Sections 1, 4 and 7, Item 16p; and Appendix L

A cheese/Grade “A” whey and lactose milk plant is adding a product that consists primarily of Phosphorous Pentoxide to the whey permeate after filtration and prior to the crystallizers and lactose dryer. The product is a liquid chelating agent that inhibits scaling and is being used with the intent that it is a processing aid.

NOTE: The Material Safety Data Sheet (MSDS) states that if ingested it causes gastrointestinal tract burns, etc.

May Phosphorous Pentoxide be considered a processing aid and be added to whey permeate after pasteurization?


Yes. Ingredients, including ingredients that may be considered processing aids, that are used to make a food have to either be prior sanctioned, an approved food additive or GRAS. There may be some allowance if it is regulated as a food contact substance. Otherwise, it would not be permitted

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to be used in a food. The fact that an ingredient may meet the provisions of a processing aid, which is primarily for purposes of labeling, does not supplant the fact that it must fall into one of the aforementioned three (3) categories.

Phosphorus Pentoxide is considered GRAS and if it meets the conditions for a processing aid it would not require labeling.

17. PMO-Sections 3 and 6; and Appendix E

The Regulatory Agency does not allow the laboratory to report any of the somatic cell counts in violation during accelerated sampling while the dairy producer has been issued a temporary permit. Is this an acceptable practice to only allow counts below 750,000 to be reported? What action should be taken?

Reporting only counts below 750,000 during this period is not an acceptable practice. By not reporting these results it would be considered as not meeting the accelerated sampling requirements of Section 3 of the PMO.

Following a somatic cell count suspension (three (3) out of the last five (5) samples exceeding the Standard), a temporary permit is issued after sampling indicates the milk is within the Standard prescribed in Section 7 of the PMO. At that point, samples shall be collected, tested and reported at a rate of not more than two (2) per week on separate days within a three (3) week period.

18. PMO, Section 4

Are there any objections to having a Farmers’ Promise medallion, which states, “*No Artificial Growth Hormone*” on the principal display panel and the following contextual statement, “*No Significant Difference Between Milk From Artificial Growth Treated Cows And Non-Treated Cows*” on the back panel of the label of a Grade “A” milk or milk product?


Consistent with FDA’s policy, ONLDS would not object to the Farmer’s Promise medallion on the front of the package and the contextual statement "no significant difference has been shown between milk derived from rbSTtreated and non-rbST-treated cows,” provided that there is nothing on the label or in the labeling that would suggest that the absence of artificial growth hormones would cause this milk to be superior.

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19. PMO-Section 4

May a milk or milk product have on their label the Certified American Humane Logo and the following associated statement, “Meets the Humane Farm Animal Treatment Program standards, which includes nutritious diet without antibiotics, or hormone, animals raised with shelter, resting areas, sufficient space, and the ability to engage in natural behaviors”?


The Certified American Humane logo and associated text are considered third party certifications and as long as the product meets the requirements under that program, ONLDS would not have a problem with the statements in regards to what the logo means.

20. PMO-Section 4

Would it be acceptable under Section 4-Labeling of the PMO to label a Grade “A” milk or milk product as “Super Fresh”?

No, with one exception, if Super Fresh™ was the trade mark name of the product.

21. PMO-Section 4

What are the labeling requirements for single-service plastic pouches used to package milk (i.e., 8 oz. and 10 oz.) and being sold only to school cafeterias or correctional institutions?


In a letter dated Oct 20, 1997 from John Foret, CFSAN's Office of Food Labeling, he addressed the labeling of 8 oz. plastic pouches of milk, juice, fruit drinks and similar products being sold only to school cafeterias and to correctional facilities.

Even though the letter provides for point-of-purchase posters (placards, counter signs, tags, loose-leaf binders, brochures, etc.) with all of the mandatory labeling information on them to be used in such settings; historically, in the dairy arena we have seen the following information ink jetted on the small plastic pouches (i.e., 8 oz. and 10 oz.) used for milk:

•Statement of identity (21 CFR 101.3); •Net quantity of content (21 CFR 101.105);

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•The identity (name and address or permit number) of the plant where pasteurized, ultra-pasteurized, or aseptically processed (PMO-Section 4); and •The words “Grade A” (PMO-Section 4).

The following information has then appeared either on the outer cardboard box, plastic over wrap bag or other container containing the pouches or on a poster placard, tag, counter sign, brochure, etc. located at the point-ofpurchase, i.e., at the school cafeteria:

•Ingredients statement (21 CFR 101.4); •If the milk or milk product bears a nutrient content claims such as “fat free”, “low fat” or “reduced fat”, than nutrition facts information must be provided on the label. For milk and milk products that are not sold directly to consumers at retail and are used in food service establishments, restaurants, schools, etc., this nutrition facts information can be provided on the label or may also be provided at these types of food establishments as a sign, poster placard or brochure.

NOTE: All labeling must also comply with the applicable requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004.

To summarize, all of the mandatory labeling may either be on the:

•Individual pouch itself; or •Part(s) as cited in the example above on the pouch and the remaining on the outer packaging (cardboard box, plastic over wrap bag, etc.); or •Part(s) as cited in the example above on the pouch and the remaining on a poster placard, tag, brochure, counter sign, etc. located at the point-of-purchase (school cafeteria); or •All on a poster placard, tag, brochure, counter sign, etc. located at the point-of-purchase (school cafeteria).

NOTE: No matter which approach is utilized all of the mandatory labeling requirements must be met in one manner or another and must be available at the point-of-purchase (i.e., school cafeteria).

22. PMO-Section 4; and Appendix L

A firm is purchasing five gallon bag-in-the-box containers of pasteurized milk to produce yogurt. The pasteurized milk has been processed, including fortification with vitamins A & D. The five gallon bag-in-the-box containers of pasteurized milk are being properly labeled. The receiving firm is repasteurizing the pasteurized milk that they receive during their yogurt processing.

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a) Is the packaged yogurt container required to indicate “vitamins A & D added” on the primary panel and on the ingredient statement?


Unless additional vitamins A & D are added in the process of making the yogurt, the vitamins A & D that were added to the milk will not need to be declared on the principal display panel of the yogurt; however, “vitamins A & D added” to the milk will need to be declared in the ingredient statement of the yogurt. Please note that the addition of vitamins A & D to milk make it a multi-ingredient food.

b) If the level of vitamins A & D in the pasteurized milk product purchased was only brought back to the standard level, i.e., the product was skim milk, would ”vitamins A & D added” be required to be declared in the ingredient statement on the packaged yogurt container?


Yes, they are still added ingredients to the skim milk and are required to be declared in the ingredient statement. Please note that skim milk is governed under 21 CFR 130.10 and as required by 130.10(b), nutrients added must be declared.

23. PMO-Section 4; and Appendix L

The following questions concerning pasteurized milk (batch and HTST) relate to M-I-08-7 (QUESTIONS AND ANSWERS FROM THE SOUTHEAST REGIONAL MILK SEMINAR AND FDA TRAINING COURSES HELD IN FY’07) (QUESTION #14)-5/7/2008.

May the term “Fresh” be used on the labeling for yogurt products?


Yes, “Fresh” may be used in the labeling of certain yogurt products. Yogurt is required to be pasteurized or ultra pasteurized prior to the addition of the bacterial culture. Therefore, we would not object to the term “fresh” on this product because it does not imply that the food is unprocessed or preserved. On the other hand, to extend the shelf life of yogurt, the yogurt may be heat treated after culturing. For this product, which has been treated to extend the shelf life, we would consider this to be a form of further preservation that would preclude the use of the term “fresh”.

a) From the response above, only batch or HTST pasteurized milk is provided for in the regulation to be labeled "Fresh"?

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Yes.

b) Therefore, pasteurized milk that is Ultra-pasteurized (UP) or aseptically processed and packaged (Ultra-High-Temperature (UHT)) cannot be labeled “Fresh”?

That is correct.

c) How much "manipulation" of the formula (ingredients) of a batch or HTST pasteurized milk is allowed before "Fresh" is inappropriate?

The type of processing or heat treatment determines whether "fresh" can be used on milk products, not the fat content or the ingredients (except preservatives).

d) May batch or HTST pasteurized whole milk that contains the addition of solids (NFDM, condensed, etc.), sweeteners, flavors, added fat (>3.25% products), calcium added, vitamin C added, be labeled “Fresh”?

Yes, provided none of the ingredients act as preservatives.

e) May batch or HTST pasteurized cream products (½ & ½, light cream, heavy cream, etc.) be labeled “Fresh”?

Yes.

f) May batch or HTST pasteurized low fat, reduced fat, nonfat white or flavored milk products be labeled “Fresh”?

Yes.

24. PMO-Section 5; and Methods of Making Sanitation Ratings of Milk Shippers (MMSR)-Section D

a) How should industry inspectors, certified under the Certified Industry Inspection Program, within Section 5-Inspection of Dairy Farms and Milk Plants of the PMO be evaluated on State ratings and FDA check ratings? During State ratings or FDA check ratings, State Sampling Surveillance Officers (SSO) and Delegated Sampling Surveillance Officers (DSSO) certifications are evaluated to measure sampling compliance; similarly would it be appropriate to determine the certification status of Certified Industry Inspectors (CIIs) when evaluating PART I-Dairy Farms, Item 2-All dairy farms inspected at least once every six (6) months or as required in Appendix "P" of FORM FDA 2359j-Section B-Report of Enforcement Methods?

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Yes.

b) For example, if the CII's certification has expired would inspections performed by that person after the expiration date of his/her certification be accepted?

No.

c) A worse case scenario would be that a BTU's CII has not been certified in accordance with Section 5 of the PMO. With this scenario, would inspection credit be given for PART I-Dairy Farms, Item 2-All dairy farms inspected at least once every six (6) months or as required in Appendix "P" (15 points) on FORM FDA 2359j-Section B-Report of Enforcement Methods?

No.

d) Should this situation be evaluated during the State Program Evaluation (SPE) or just on each individual BTU State ratings or FDA check ratings?

For State Rating Officers they should evaluate this on all BTU State ratings. For FDA Regional Milk Specialists, this should be evaluated on both the SPE and on all BTU check ratings.

25. PMO-Section 6

If the two (2) bulk tanks/silos on a multiple tank/silo farm are not picked up and subsequently sampled and tested on the same date, what action should be taken by the Regulatory Agency if the sample result collected from tank/silo #1, on a given day, is acceptable and the sample result from tank/silo #2, which is collected the next day, is in violation?

The Regulatory Agency is responsible to identify which day or days results are to be considered official, i.e. the first day of the month or the first Monday of the month. If both of the samples are considered official regulatory samples by the Regulatory Agency, then both results would be recorded individually on the official regulatory producer ledger and if any appropriate enforcement action is warranted (two (2) out of the last four (4) or three (3) out of the last five (5) samples exceeding the standard) then such action would be required to be taken.

However if only one (1) of the samples results is considered official by the Regulatory Agency, then the results for that sample would be recorded on the official regulatory producer ledger and appropriate action taken as warranted.

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NOTE: Section 6 of the PMO requires that when multiple samples of the same milk are collected from the same producer from multiple tanks or silos on the same day, the laboratory results are averaged arithmetically by the Regulatory Agency and recorded as the official results for that day. This is applicable for bacterial (standard plate count), somatic cell count and temperature determinations only.

26. PMO-Section 6

If a milk plant's only source of milk or milk product is pasteurized product, i.e., pasteurized skim, ½ & ½, cream, etc. and it does not receive any other raw or heat-treated milk or milk products, is this pasteurized supply required to be sampled and tested at the receiving milk plant as the milk plant's commingled raw milk supply used for HTST, HHST, ultra-pasteurization, or aseptic processing in accordance with Section 6-The Examination of Milk and Milk Products of the PMO? If so, what standards would be utilized to determine compliance, the raw or pasteurized standards?

No, this pasteurized milk or milk product supply would not be required to be tested and sampled in accordance with Section 6 of the PMO as the milk plant’s commingled raw milk supply at the receiving milk plant.

27. PMO-Section 6 and Section 7, Item 5r

a) Is it acceptable to use a Ziploc bag as the sample collection container for the Anderson in-line sampler used on direct load farms, with or without a suitable shelter?

No.

b) Is anything other than the single-service bottle designed for the Anderson in-line sampling device acceptable at this time for this sampling device?

No.

c) If an unacceptable sample collection container, used with an approved in-line sampler, is observed on a State rating or FDA check rating, besides a sampling procedure issue, would it be considered a violation of the PMO?

Yes. It would be considered a violation of Item 5r-Milkhouse – Construction and Facilities, under a transportation tank that is used for the cooling and/or storage of milk on a dairy farm with or without a suitable shelter.

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28. PMO-Sections 6 and 7, Items 7p and 17p; and Appendix G

a) How many temperature control (TC) samples are required at a milk plant when samples of raw milk (from a number of silos), finished products, cooling media (sweetwater, glycol, etc.) and well water samples are collected?

If finished packaged milk products are collected first, may the TC sample for the finished packaged product be used for products collected from the silos, cooling media and well water samples? If all products are collected at the same location, separate TC samples must be collected for raw milk and finished milk products. All water samples delivered to the laboratory within six (6) hours and analyzed within eight (8) hours of the time the sample was collected, and the sample is not refrigerated, do not require a TC sample. All other water samples that exceed the required time frames, mentioned above, must be accompanied by a TC sample. Each cooler submitted to the laboratory must have the appropriate TC samples included for those products in that cooler.

The 17th Edition of Standard Methods For The Examination Of Dairy Products (SMEDP), Section 3.044, on page 74 requires such temperature control samples for the raw milk and finished milk products. This has also been required in previous Editions of the SMEDP.

b) What is the rationale for requiring separate TC samples for raw and pasteurized products if both samples are shipped in the same shipping container and the TC sample size meets the required volume?

The rule is a "one (1) size fits all" rule. What is meant by that statement is that storage and transportation were never meant to significantly alter the condition of the sample at collection but rather to "hold" it as collected so that it could be rapidly gotten to the lab for analysis. In order to cover all scenarios from rapid transport to those that take considerably longer, the rule was put in to provide for each required TC to accurately reflect the temperature of the sample it is paired with upon collection.

29. PMO-Sections 6 and 11; and MMSR-Section F

a) If a Grade “A” dry milk plant wishes to sell bulk Grade “A” raw, heat-treated or pasteurized cream must the dry milk plant be IMS Listed for these products (Product Codes #1, 3 and 4, respectively)?

Yes.

b) Is the Grade “A” bulk shipped heat-treated and pasteurized cream required to be sampled in accordance with Section 6 of the PMO?

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Yes.

30. PMO-Section 6; and Appendix B

The QMI in-line sampling device has been evaluated and accepted by the NCIMS for use on farms for in-line sampling with direct load milk tank trucks and for milk tank trucks hauling raw milk. May a Grade "A" milk plant utilize the approved QMI in-line sampling device for the sampling of bulk shipped raw, heat-treated or pasteurized milk and/or milk products (cream, skim milk, condensed skim milk, etc.) at the milk plant?

Yes, if acceptable to the Regulatory Agency.

NOTE: The studies for this in-line sampler were conducted using raw milk and the acceptance by the NCIMS was based on these studies. CFSAN’s Laboratory Proficiency Evaluation Team (LPET) states that from a technical point of view there should not be a problem with collecting raw, heat-treated or pasteurized milk or milk products, except possibly the more viscous products, for bulk shipment at the plant using this device as long as a sampling SOP protocol, acceptable to the Regulatory Agency, is developed and followed. Please refer to M-I-06-6 for an example of a suggested SOP for the use of this in-line sampler on a dairy farm.

31. PMO-Section 7

a) What test(s) is used to test sheep milk for the Somatic Cell Count?

Section 6 of the PMO cites under Administrative Procedures 6a (Non-Goat) either the Single Strip Direct Microscopic Somatic Cell Count (using the LW stain (blue and Canadian formulations)) or the Electronic Somatic Cell Count.

b) What is the somatic cell count (SCC) standard for raw sheep milk under the PMO?

The SCC standard for sheep milk is the same as bovine's milk - 750,000 per mL.

c) Finally, what Appendix N test should be used for sheep milk until such time that an approved test is available?

Until the validation studies for sheep milk, which are currently under way, are completed, a laboratory should use either one of the microbial-based drug residue detection tests (BsDA or Delvo) for drug residues in sheep milk.

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32. PMO-Section 7, Items 8r and 7p; and Appendix D; and MMSR-Appendix B

What would be considered the minimum acceptable distance/location (fifty (50) or one-hundred (100) feet) for a well to be located from a septic system drain field used for handling human waste?

Appendix D-Standards for Water Sources of the PMO provides criteria which is to be used in determining compliance with Items 8r-Water Supply (Dairy Farms) and 7p-Water Supply (Milk Plant). These guidelines specify the minimum distances allowable based upon general or basic soil formations for specific areas. Since human or animal excreta is considered to be a "point source" of contamination and a serious health hazard, individual wells serving milkhouses on Grade "A" dairy farms and for use in Grade "A" milk plants, which are inspected during a State Rating or PHS/FDA Check Ratings and are located within fifty (50) feet of contaminating sources such as cowyards, manure piles, septic systems, including drain fields, pit privies, sewage lagoons, cattle housing areas, feed lots, calf pens, etc., will be considered to be in violation of Item 8r or 7p, respectively.

Fifty (50) feet is not a concrete distance, it is a guideline. Any consideration of distances must take into account the soil structure, geologic conditions and other aspects, to determine acceptable minimum safe distances. Rather than rely strictly upon feet and distances, the only exceptions that will be made must be supported by qualifying documentation from the State Water Control Authority, which support a lesser distances for wells located in favorable (unconsolidated) soil formations. If the State has accepted the water supply on the basis of a sanitary survey, then that would be sufficient evidence for its acceptance on a State Rating or PHS/FDA Check Rating. (Refer to Table 10-Distance of a Well from Sources of Contamination in Appendix D and Appendix B-Table of Farm Water Supply Violation (Major-5 point debit) of the MMSR.)

33. PMO-Section 7, Items 9r and 11p

May State Regulatory personnel require that all new milk plant equipment being installed, including domestic and foreign manufacturers, have a 3-A Symbol on them?

That entirely depends upon the individual State’s dairy regulations. If the State’s dairy regulations require a 3-A Symbol on such equipment then the State can require it.

Items 9r and 11p of the PMO acknowledge the acceptability of equipment that meets 3-A Sanitary Standards that it complies with the sanitary design

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and construction standards of this Ordinance. However, it does not mandate the presence of a 3-A Symbol on all such equipment.

34. PMO-Section 7, Items 12r, 12p and 13p

Is a plate heat exchanger (cooler), installed in a horizontal position, on a dairy farm or in a milk plant, automatically considered a violation of the PMO and debited against the dairy farm or milk plant?

No. Each installation must be evaluated on a case-by-case basis to determine if the plate heat exchanger is self-draining or drainable. Individual manufacturers of plate heat exchangers have provided installation service bulletin guidelines to their installers instructing them how to properly install their plate heat exchangers in a horizontal position to provide an adequate means for the plate heat exchanger to properly drain.

35. PMO-Section 7, Items 14r and 15p(A); and Appendix H

a) May an air filter meeting the requirements for a coalescing air filter, as cited in Appendix H. Pasteurization Equipment and Procedures and Other Equipment, II. Air for Drying Equipment and Air Under Pressure – Direct Contact with Milk and Milk Products and Milk Product Contact Surfaces of the PMO, be considered the final air filter?

No. A coalescing filter, and associated moisture trap, if used, is normally installed on a main air supply line that serves multiple points of application. Final filters are required to be located in the air line upstream from, and as close as possible to, the individual points of application.

b) If used, what is required in order to meet the requirements of Appendix H of the PMO for coalescing filters?

Air systems that generate pressures in excess of one (1) bar, i.e., 103.5 kPa (15 psi), shall be provided with a means to remove the moisture. The removal of moisture may be achieved by condensation and coalescing filtration or absorption, or equivalent, to prevent moisture in the system.

If an air storage tank is required or used, the coalescing filter must be located after the air storage tank. If an air storage tank is not required or used, the coalescing filter must be located after the compressing equipment, unless a drier is being used to remove the moisture, in which case, a coalescing filter would not be required. NOTE: In a system with an air storage tank, only one (1) coalescing filter is required and it must be located after the air storage tank. (Refer to the Figure addressing a Central Compression-Type Air Supply in Appendix H of the PMO).

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The coalescing filter must be accessible for examination, cleaning and for the replacement of the filter media.

A means shall be provided to measure the differential pressure across the coalescing filter. This may be as simple as a fitting on each side of the coalescing filter where gauges may be installed when the milk plant wishes to check these pressures.

The base of the coalescing filter housing must be provided with a means to remove condensed liquid from the housing. This is normally an automatic or manual drain valve.

36. PMO-Section 7, Item 15r

a) What is FDA’s position on the labeling of homeopathic nutritional supplements used on dairy animals?

FDA cannot find any justification for regulating veterinary homeopathic drugs any differently from other animal drugs subject to the FFD&CA. M-I-06-5 (Current Information Addressing Item 15r-Drug and Chemical Control Of The Grade “A” Pasteurized Milk Ordinance) requires that homeopathic drugs found on dairy operations must comply with the drug labeling and storage requirements of Item 15r of the PMO. b) Do they need to be properly labeled with adequate directions for use, withholding times, etc.?

Yes, if animal health claims are stated on the label.


A firm is selling a dietary supplement with the words homeostasis and homeotherapeutic on the label. Does a homeopathic medicine have to say “homeopathic” on the label to be a homeopathic medicine?

No. A homeopathic medicine does not need to say homeopathic on the label to be considered an unapproved animal drug. With any animal health claims made, the labeling and storage requirements of Item 15r of the PMO must be complied with. The term “Homeotherapeutic” is a drug claim.


Regarding the drug labeling requirements for a pharmacy dispensing a prescription (Rx) medication on the order of a veterinarian, could a catalog supply company be considered a pharmacy, so we would expect to see their name and address on the label of an Rx drug?

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Catalog companies may be a pharmacy if they are registered as a pharmacy to dispense medicine in the State on the order of a licensed Veterinarian.


The following question and answer is provided for guidance in relationship to M-I-08-6 (FDA Approval For The Use Of Baytril® 100 (Enrofloxacin) Injectable Solution For The Treatment Of Bovine Respiratory Disease (BRD) In Dairy Cattle Replacement Heifers Less Than Twenty (20) Months Of Age), which was issued March 28, 2008.

Baytril® 100 has recently been approved and labeled for dairy replacement heifers less than twenty (20) months of age (M-I-08-6). How will this new approved animal drug be evaluated during farm inspections, State ratings and FDA check ratings concerning the animal drug labeling and storage requirements of Item 15r-Drug and Chemical Control of the PMO?

Baytril® 100 cannot be extra-labeled for use in female dairy cattle twenty (20) months of age and older by anyone, including veterinarians.

This new approved and labeled animal drug product can be stored with the non-lactating drugs to comply with Item 15r of the PMO, which requires that drugs intended for the treatment of non-lactating dairy animals are segregated from those drugs used for lactating animals. Separate shelves in cabinets, refrigerators or other storage facilities satisfy this Item.

Baytril® 100 is a prescription (Rx) product. To comply with Item 15r labeling requirements of the PMO it shall be properly labeled to include the name and address of the veterinary practitioner dispensing the product or if the drug is dispensed by a pharmacy on the order of a veterinarian, the labeling shall include the name of the prescribing veterinarian and the name and address of the dispensing pharmacy, and may include the address of the prescribing veterinarian. The label shall also include:

a. Directions for use and prescribed withholding times; b. Cautionary statements, if needed; and c. Active ingredient(s) in the drug product.

Unapproved and/or improperly labeled drugs are not used to treat dairy animals and are not stored in the milkhouse, milking barn, stable or parlor. Drugs are stored in such a manner that they cannot contaminate the milk or milk product-contact surfaces of containers, utensils or equipment.

NOTE: Old labeled product will be in the field for a period of time until existing stocks are depleted. The old label states that the drug is specifically prohibited for use in cattle intended for dairy production or calves to be

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processed for veal. This included all classes of cattle on a dairy operation, including calves reared as dairy cow replacements, heifers, lactating and non-lactating (dry) cows, and bulls maintained for breeding purposes. The old label restricted the use of Baytril® 100 to treat BRD only in cattle maintained for beef production, i.e., beef or dairy breed feedlot steers, bulls, and heifers.

If old label product, labeled as not to be used to treat cattle intended for milk production, is found stored on the non-lactating shelf it is not to be debited under Item 15 on FORM FDA 2359a-Dairy Farm Inspection Report during farm inspections, State ratings and FDA check ratings, provided the name and address of the prescribing vet are identified on the label.


Baytril® 100 (enrofloxacin) has received FDA approval for the treatment of Bovine Respiratory Disease (BRD) in dairy replacement heifers less than 20 months of age and per M-I-08-6 it cannot be extra-labeled for lactating cows. What about Baytril® A-180 (danofloxacin) that is currently labeled for beef cattle only? Is there any change for this product?

M-I-06-5 states: "Baytril® 100 and A180 are specifically prohibited for use in cattle intended for dairy production or calves to be processed for veal. This includes all classes of cattle on a dairy operation, including calves reared as dairy cow replacements, heifers, lactating and non-lactating (dry) cows, and bulls maintained for breeding purposes."

Now that Baytril® 100 is approved for replacement heifers it can be stored on the non-lactating shelf; however it cannot be extra-labeled for cattle 20 months and older. Baytril® A180 is not approved for replacement heifers so the language in M-I-06-3, cited above, still applies to this product.


What are the PMO labeling requirements for Lidocaine (Rx), which is a local anesthetic?

Lidocaine is an Rx drug so to be in compliance with Item 15r of the PMO the drug shall be properly labeled to include the name and address of the veterinary practitioner dispensing the product or if the drug is dispensed by a pharmacy on the order of a veterinarian, the labeling shall include the name of the prescribing veterinarian and the name and address of the dispensing pharmacy, and may include the address of the prescribing veterinarian. In fact to comply with their own State veterinary licensing and practice acts, veterinarians are supposed to label all Rx drugs.

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If medications approved for dairy cattle are used on other species of dairy animals, are the extra labeling requirements required?

Yes.


Would Uddermint, a topical cream made from concentrated Japanese peppermint oil and which is rubbed on the udder to heat the udder and improve circulation be considered a topical and exempt under Item 15r of the PMO?

Uddermint is not an approved drug. Technically it is not exempt under Item 15r because it's neither a topical antiseptic nor a wound dressing. FDA’s Center for Veterinary Medicine (CVM) has not objected to its marketing as a bag balm type product in the past. It is not legal for the firm to make drug claims on the labeling such as for the treatment of mastitis.

Technically since it is not an approved drug, not a topical antiseptic nor a wound dressing it should not be used or stored on dairy farms; however, for this product (Uddermint), we would consider it like most bag balms and not debit it on State Ratings and Check Ratings.


May a dairy producer use an udder and teat topical ointment that contains colloidal silver on dairy animals? The topical ointment contains a minimal amount of colloidal silver as a preservative.

No. Using such a topical ointment on dairy animals may cause some of the silver to end up in the milk.

45. PMO-Section 7, Items 18r

GEOTHERMAL RECIRCULATED GLYCOL COOLING WATER SYSTEM The recirculated cooling water system described below was encountered during a routine Grade “A” dairy farm inspection.

OVERVIEW OF THE SYSTEM: The system is operating in a very similar manner to a typical geothermal residential or commercial heating/cooling loop system. In this system, the plate cooler replaces the coils that would be used for the temperature exchange in a forced air or baseboard heating system. The system is operated under pressure with a water circulation pump, expansion tank, pressure gauge and ground loops connected to a copper manifold system. The piping used in the system is Pex water tubing.

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The glycol used does not appear to be food grade but has a recommended use on the label for food cooling systems. The terms “USP” and/or “FOOD GRADE” were not included on the label.

The construction of this cooling system is not like a traditional recirculated cooling water system that we normally see on a Grade “A” dairy farm because it uses the earth to cool the cooling media rather than a compressor or ice bank. This cooling system would still be classified as a recirculated cooling water system and; therefore, it must meet the PMO requirements for such recirculated cooling water systems, including an acceptable food grade glycol, cooling media protection and semiannual testing.

a) May non-food grade piping/fittings be used in this geothermal recirculated glycol cooling water system?

Yes. Any acceptable water piping materials may be used. The PMO does not specify food grade materials for water piping within recirculated cooling water systems.

b) The system showed thirty (30) lbs. pressure. May this be classified as a pressurized system?

Yes. Most traditional recirculated cooling water systems are under pressure at the heat exchange surface. The cooling water is pushed through the plates or tube, rather than drawn through.

c) Are non-visible below ground loops, such as is utilized in this geothermal recirculated glycol cooling water system an approved method of cooling the recirculated glycol water cooling media?

Yes.

d) What type of construction must the circulation pumps for this type of system be made of?

The PMO does not specify the type of construction as long as the recirculated water is “protected from contamination”.

e) Is the glycol that is used in this system required to be labeled as food grade (“USP” and/or “Food Grade”)?

Yes. If this PMO requirement cannot be verified, Item 18-Cooling would be considered in violation and 18(b) would be debited on FORM FDA 2359aDairy Farm Inspection Report.

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46. PMO-Section 7, Items 7p and 16p(A)

A producer handler is planning to purchase an older used vat pasteurizer and would like to heat the milk or milk product in this vat using the following system:

Plant water will be heated indirectly in a boiler and recirculated from a storage tank, which is a farm bulk milk tank used for this purpose only, into the jacket of a vat pasteurizer. Water from the jacket of the vat will be sent back to the jacket and/or stored in the bulk milk tank and reheated in the boiler as needed. Pasteurized milk will be pumped hot from the vat to a plate heat-exchanger for cooling.

May this be done, if so under what conditions?

The jacket of the older used vat pasteurizer may contain a build up of rust infused with unknown chemicals and other materials. There is no practical way to effectively remove this build up or to verify that it has been removed. Therefore, water that has been through this vat jacket may be recirculated back to the farm bulk milk tank (storage tank) provided it is dedicated to the vat pasteurizer and isolated from the milk plant’s potable water system, but such water may not be circulated back to the boiler. Doing so, would be considered a violation of Item 7p-Water Supply, Section 7 of the PMO, which prohibits cross connections between safe water and unsafe or questionable water.

Water from this system, including water from the boiler, which is fed by the potentially contaminated water, must not be used for any plant purposes that require a “safe water supply” as addressed in the PMO, including uses such as CIP make up, etc. Piping in this system, including the boiler, to which the potentially contaminated water returns, must not be cross connected to the safe water supply.

47. PMO-Section 7, Item 12p

Does the PMO set an upper limit on the length of time for an extended run, for example seventy-two (72) hours?

No, the PMO does not limit extended runs to seventy-two (72) hours or provide an upper limit on the length of time for the extended run. However, prior to accepting any period of time for any extended run, the Regulatory Agency must review and accept, in consultation with FDA, supporting information as noted in Item 12p-Cleaning and Sanitizing of Containers and Equipment, Administrative Procedure #1 of the PMO that supports their decision to establish an extended run time period.

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48. PMO-Section 7, Item 12p; and Appendix F

What is the proper procedure for the separation of Grade “A” and non-Grade “A” milk and milk products during a dryer operation? What is considered a separation? Is a shake down of the bag house, blow down of the cyclones and main chamber adequate? Does it need to be a complete CIP, bag change, etc. or does just the wet side need to be CIP’d?

Item 12p. Cleaning and Sanitizing of Containers and Equipment of the PMO states: “Drying equipment, cloth-collector systems, packaging equipment and multi-use dry milk products and dry whey storage containers are cleaned at intervals and by methods recommended by the manufacturer and approved by the Regulatory Agency.” It also states: “Cloth-collector systems and all dry product-contact surfaces downstream from the dryer shall be sanitized or purged at intervals and by methods recommended by the manufacturer and approved by the Regulatory Agency.”

II. Evaporating, Drying and Dry Product Equipment Cleaning, #3-Wet Cleaning of Dryers within Appendix F. Cleaning and Sanitizing of the PMO stipulates that it is necessary to "thoroughly clean" the dryer if ungraded milk or milk product is ran through the dryer prior to Grade “A” milk or milk product. Under #4-Dry Cleaning within this same Section of Appendix F it provides recommended cleaning methods. The system should be properly shut down; any milk product removed from the drying system; and followed by a manual dry cleaning (brushing or vacuuming) of the dryer. For the old "box type" dryers this may be accomplished by using manually brush down and sweeping methods and all nozzles must be removed and cleaned.

It would be advised that the milk plant(s) employ the methods of cleaning as recommended by the manufacturer of the drying system. In all cases it must be acceptable to the State Regulatory Agency.

NOTE: As to "How much flush (purge) material" they need to run prior to Grade "A" product, it will depend on the type of equipment they are operating, its design and the milk plant’s dry cleaning process, etc. It's the milk plant’s responsibility to prove to the Regulatory Agency that their flush (purge) is adequate to remove the preceding processed non-Grade "A" materials. This should be a part of the milk plant’s written protocol they submit to the Regulatory Agency for the acceptance of their flushing (purging) protocol.

49. PMO-Section 7, Item 12p; and Appendix H

May a twenty-four (24) hour recording device be used in place of a seven (7) day recording chart on raw milk storage tanks/silos that store product longer than twenty-four (24) hours in a milk plant and fulfill the requirements of Item

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12p-Cleaning and Sanitizing of Containers and Equipment, Administrative Procedures #1 of the PMO?

No. Item 12p of the PMO specifically requires a seven (7) day temperature recording device, which complies with the specifications of Appendix H of the PMO.

50. PMO-Section 7, Item 12p; and Appendix J

Item 12p, Administrative Procedures #8.e., and Appendix J of the PMO state that single-service glass containers must be labeled with wording to designate "single-service use only". Does this mean that the glass container must be embossed with "single-service use only" or can it be painted on the container or would a sticker be adequate?

The wording "Single-service use only" must be embossed, painted, stenciled or otherwise permanently marked on the single-service glass container. The use of a sticker is not acceptable.

51. PMO-Section 7, Item 12p; and EML

Cleaned and sanitized empty multi-use glass milk containers are required to be sampled and tested under the PMO. Once the multi-use glass containers have been tested at the IMS-Listed laboratory may the containers be returned to the plant for reuse?

Yes.

52. PMO-Section 7, Item 15p(A)

Does the PMO require that a cover be in place over the pistons of a homogenizer that has water spraying over the pistons for lubrication?

No.


Are air blow lines considered to be an avenue for a cross connection between raw and pasteurized products if the air supply is coming from a common source and the air lines are connected to both raw and pasteurized tanks or lines?

Historically we have not considered common air lines that are used for both raw and pasteurized applications to constitute a raw to pasteurized cross connection. Item 15p(A) of the PMO requires that for each application of air under pressure, which is used for the agitation or movement of milk or milk

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products, or is directed at a milk or milk product-contact surface, in which a milk product has the potential for entering the air line, be equipped with a sanitary check valve. If a check valve fails, the application is considered in violation of Item 15p(A).


Item 15p(A) of the PMO allows for connecting water lines to tanks or manifolds using a fail-safe valve and check valve.

a) Would it be possible to locate the sanitary check-valve before the fail-safe valve if the fail-safe valve was close-coupled to the tank or valve cluster (safe water→sanitary check valve→fail-safe valve→close-coupled to the tank or valve cluster)?

Yes, this would be an acceptable alternative, provided that both the pipe and any fittings located after the sanitary check valve and the sanitary fail-safe valve are of sanitary construction. In addition, the entire assembly, including the sanitary check valve, the sanitary piping, and the sanitary fail-safe valve, must be cleaned and sanitized whenever the tank or valve cluster, to which the sanitary fail-safe valve is close coupled to, is cleaned and sanitized.

b) Would it be possible to eliminate the sanitary check-valve before the fail-safe valve if the fail-safe valve was close-coupled to the tank or valve cluster?

No. A fail-safe valve will close upon the loss of air or power but will not respond to a reversal of flow through it when it is programmed to be open. Without the sanitary check valve, the milk or milk products could enter the non-sanitary piping back to the back flow preventer.

c) May a sanitary ball check be used for the sanitary check valve required within this Proposal?

Yes.

55. PMO-Section 7, Item 15p(A); and Appendix H

The following questions relate to Figure 44. Culinary Steam Piping Assembly for Airspace Heating or Defoaming in Appendix H. Pasteurization Equipment and Procedures and Other Equipment, III. Culinary Steam – Milk and Milk Products of the PMO:

a) Is this the only acceptable design for culinary steam or just an acceptable design? In other words, if all of the required components are there but not necessarily in the same order, would that be acceptable?

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The equipment identified with an asterisk (*) within Figure 44 depicts that the equipment is required. Figure 44 also identifies equipment in a numerical order that has been shown to work effectively to produce clean, dry culinary steam. A different equipment arrangement that has been accepted by the State Regulatory Agency and FDA as being equally effective in the production of clean, dry culinary steam would also be acceptable.

b) Figure 44 requires sanitary piping downstream of the auxiliary water trap (#s 8 and 9), but it also requires stainless steel piping after the filtering device. This is kind of confusing as stainless steel tends to be sanitary piping. Does this mean that the piping after the filtering device has to be stainless steel but the body of the water trap (#s 8 and 9) may be constructed of something else?

All of the equipment that will be in contact with the steam, after the filtering device, are required to be stainless steel and are available in stainless steel design and construction. The equipment cited and located before #10 are not normally of a sanitary design or construction. The purpose of requiring stainless steel construction of this equipment is not to require them to be cleanable but to assure that any corrosion after the filtering device does not contaminate the steam.

Beginning at and downstream from #10, all piping, fittings and similar steam contact surfaces must be of a sanitary design and construction and must be cleanable.

c) Does everything have to be stainless steel after the filtering device, including all threaded fittings, until after the water trap (#s 8 and 9) and there after all fittings and equipment have to be of a sanitary design and construction?

Yes. (Refer to the answer provided in b) above.)

d) May the filtering device be a sanitary 3-A approved steam filter and be located after the water trap (#s 8 and 9)?

No. The drawings included with 3-A Practice 609 (3-A ACCEPTED PRACTICES FOR A METHOD OF PRODUCING CULINARY STEAM) and Figures 42 and 43 for Culinary Steam Piping Assembly for Steam Infusion or Injection of the PMO show the condensation trap (Figure 42-#5 and Figure 43-#3) as an attachment to the bottom of the filtering device (Figure 42-#10 and Figure 43-#2), not before the filtering device. In the 3-A drawing and in Figure 42 of the PMO, the filtering device is shown after the control valve (#7-Steam Pressure Regulating (Reducing) Valve) and the pressure gauge (#6). Because this location is acceptable for culinary steam for direct infusion and injection, FDA would not object to placing the

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filtering device in this location in the culinary steam piping assembly for a vat pasteurizer. In this case, the steam contact surfaces downstream of the filtering device must be stainless steel and the piping starting with #10 and downstream must be of a sanitary design, construction and cleanable stainless steel.

56. PMO-Section 7, Item 15p(B)

Within the requirements of the PMO for continuous flow higher-heat-shortertime (HHST) pasteurization of milk and milk products, may a milk plant run condensate from culinary steam through their steam block barriers during production and steam through these barriers during cleaning and sanitizing?

The requirements of the PMO addressing the acceptability of condensate, as opposed to steam, circulating in steam block barriers varies with the specific application. The PMO identifies three (3) applications that involve steam block barriers:

1. To separate sterilized or sanitized surfaces from those that are not sterilized or sanitized. In this case, the PMO would allow the use of condensate in these steam block barriers under the same conditions that FDA’s Low Acid Canned Foods (LACF) program accepts their use. What follows reflects LACF's current thinking regarding the use of condensate in these steam block barriers:

• The simplest usage might be a steam trace on a static joint, such as where two (2) piping systems are joined. In such an application, steam is passed through the trace during the cleaning and/or sterilization cycle and then the steam valve is partially closed to the point that only condensate from the steam flows through the trace. This is acceptable as the condensate is sterile having been condensed from steam. In fact, it is desirable because it reduces the chance that product will burn onto the joint causing future sanitation and sterilization problems. The product side of such a static joint is typically under higher pressure than the steam trace when condensate is flowing through it so any leakage would be into the steam condensate and this should not compromise sterility. In fact, product mixed with condensate might be more noticeable and alert the operator to a need to repair the joint.

• When steam is used as a barrier to contamination on a rotating or reciprocating shaft, such as a filler or pump shaft, the use of condensate is not appropriate. We would expect a steam barrier on such joints.

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• On the backside of a physical barrier, condensate would be acceptable. For example, if the condensate is on the back side of the bellows, in a bellows type valve, it is the bellows that form the barrier, not the condensate.

• If there are specific LACF applications that are not addressed by the above text, FDA will consider these on a case-by-case basis under the LACF requirements.

2. To provide an option to the PMO requirement involving a complete physical break between the equipment and circuits used to conduct milk or milk product and tanks or circuits containing cleaning and/or chemical sanitizing solutions.

The principles of operation for this option depend on the detection of a temperature drop that indicates the presence of liquid in the steam block barrier. This can be accomplished by using a signal (alarm) generated based on the detection of a temperature drop to shut down the cleaning pumps, etc. This option can only be effective if steam is circulating through the steam block barrier during the time the alarm is required to be active. This would be required when cleaning solution is on one (1) side of the steam block barrier and product is on the other side.

3. The use of sequential steam blocks as a part of a double steam block based flow diversion system that will function as an alternative to the traditional dual stem flow diversion device that is normally required in a continuous flow pasteurization system.


What is the definition of “Pasteurized Water”? Must this water run through a pasteurizer or can it be laboratory pasteurized water?

Pasteurized water as specified in Item 15p(B)2 of the PMO, is water that has been processed through a pasteurizer at times and temperatures, which meet at least the minimum times and temperatures for milk identified in the definition of Pasteurization contained in the PMO. If the water is heated in other than a legal pasteurization system, adequate documentation must be available to indicate that the water has been subjected to the minimum times and temperatures required for milk pasteurization.


Is a block-and-bleed valve arrangement required to be position detectable or electronic position detectable as cited in Item 15p(B) of the PMO?

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Item 15p(B)1.b.(2) specifies that both valves, and valve seats in the case of single-bodied double seat valves, are position detectable and capable of providing an electronic signal when not properly seated in the blocked position.

The intent of this language is to require that the position detectable valve seats must be "capable of providing an electronic signal when not properly seated in the blocked position". Based on the technology that is currently available, position detectable for this application is electronic position detectable or it would not be capable of providing the required electronic signal.


May the principles cited within Question #13 from M-I-86-16 (Q’s & A’s from the Advanced Milk Specialists Training Course In Lexington, KY (Feb. 1986)) and illustrated in M-I-87-3 (Supplementary Information Re: M-I-86-16, Question 13 (Constant Level Tank Drawings)), be used to prevent a cross connection between raw and pasteurized milk or milk products in a tank or vessel used to blend pasteurized product with unpasteurized product?

Yes. The piping must be installed in compliance with the text contained in Question #13 from M-I-86-16 and the drawings provided in M-I-87-3. This would effectively prevent a cross connection between raw and pasteurized products and would be considered to be in compliance with Item 15p.(B)-Protection From Contamination of the PMO.

For your reference, Question #13 from M-I-86-16 is provided below:

13. P.M.O. – Section 7, 15p, 16p

Q. What are the specific requirements for the connections of lines returning product to the constant level tank [divert line (16p), leak escape line (16p) and recirculation line (15p)]?

A. Each must be a separate line and must terminate above the maximum flood level of the constant level tank and must be protected from back siphonage. Protection against back siphonage may be accomplished by providing a vertical gap of at least two times the diameter of the inlet pipe between the inlet pipe and the flood level of the constant level tank. A satisfactory maximum flood level may be the rim of the constant level tank or may be accomplished by providing an overflow outlet below the rim. The overflow outlet must have a diameter equal to or greater than twice the diameter of the largest inlet pipe connected to the constant level tank. With an overflow outlet, the flood rim is the highest point of the opening inside the constant level tank. Under no

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circumstances can the lines terminate below the normal operating product level of the vessel.”


The following questions relate to pasteurized water or an equivalent process found acceptable by FDA and the State Regulatory Agency or shall have undergone a hazard evaluation and safety assessment of the specific water supply and application.

a) Who may collect the water samples required for two (2) weeks as cited under Item 15p(B), Administrative Procedures #2.e.?

The water samples and testing referred to are part of the supporting information that is required following the approval of the initial installation by the Regulatory Agency. As to who may actually collect these samples, that would be the decision of the Regulatory Agency.

b) What laboratory may analyze the samples for compliance with this requirement?

Any laboratory acceptable to the Regulatory Agency.


May reclaimed white milk from plant flushes, which utilize only milk and not water to push the milk, from filler change overs, etc., be collected and stored in a tank over night; and then separated, restandardized, pasteurized and packaged as a Grade "A" milk or milk product the next day? This firm processes only white milks.

Yes, provided that the milk or milk product complies with the Standard of Identity for the specific milk or milk product processed and the sanitary handling and cooling criteria of Section 7, Item 15p(B), Administrative Procedures #4.

62. PMO-Section 7, Item 15p(B); and Appendixes H and L

May raw or heat-treated cream received in milk tank trucks be burst rinsed with culinary steam to remove the remaining cream from the milk tank trucks? If so, what are the requirements?

Yes, the cream may be flushed directly to a storage silo/tank if the milk plant condenses, concentrates or dries the cream, or if the milk plant takes other appropriate actions to prevent the dilution or adulteration of milk with added water from the use of the culinary steam. An example might include the use

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of a system or process designed, constructed and controlled that manually or automatically prevents the addition of water or which diverts the condensed steam (water) and cream mixture to a separate tank or vessel and captures the mixture for further processing. The efficacy of this system should be verifiable if challenged.

NOTE; The culinary steam used must be in compliance with Section III-Culinary Steam – Milk and Milk Products, Appendix H, of the PMO.


May a RO/UF membrane system be located on the dairy farm premise?

Yes. However, the separate facility on the farm premise in which the RO/UF membrane system is installed must be permitted as a milk plant.


Within Item 16p of the PMO, are RO/UF system thermometers and divert valves required to be tested and calibrated? If so, how often? Do you need to record the FDD event on a chart recorder?

The PMO does not address records, diversion valve testing nor thermometer calibration methods and frequency for the RO/UF membrane systems cited under Item 16p of the PMO. The thermometers must be accurate when checked and the divert valve must divert when required.


If sweet whey (pH 4.7 or higher) is pasteurized prior to entering an RO system, and if the resulting concentrated whey is cooled, handled and stored as required in the PMO, is the sweet whey required to be repasteurized prior to entering a condenser system within the same milk plant?

No.

66. PMO-Sections 7, Item 16p

May pasteurized cream be added to a pasteurized yogurt product and sold without being re-pasteurized?

Yes, pasteurized milk and milk products may be blended together without an additional pasteurization step, as long as they have been pasteurized and packaged at the same plant in which initial pasteurization took place. In other words, pasteurized cream at Plant A could be added to a pasteurized cultured product at Plant A without re-pasteurizing the blended products.

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A concern would arise when pasteurized cream from Plant A is shipped to Plant B for addition to pasteurized milk or milk product(s) and the blended milk or milk product is not re-pasteurized at the site of packaging. In these cases, the pasteurized cream from Plant A must be re-pasteurized at Plant B prior to, or after adding to the Plant B pasteurized milk or milk product. The one exception, provided in the PMO to this requirement, is that cottage cheese, dry curd cottage cheese and reduced fat or lowfat cottage cheese may be transported in sealed containers in a protected, sanitary manner from one (1) milk plant to another for creaming and/or packaging.


Is it acceptable to coat the Digital Reference Thermometer (DART) probes with Teflon?

No. If the manufacturer wants to make such a design/construction change, which can change the performance of the probes, they would need to submit the probe and supporting data and have it reviewed as the original DART submission/acceptance was reviewed.


May the legal holding tube on an HTST/HHST system be insulated (shielded, covered or enclosed)?

Yes, it may be insulated (shielded, covered or enclosed) to reduce heat loss as long as the holding tube is accessible for inspection and the slope can readily be determined, by either visual means or the removal of the shield, cover, or enclosure.


Is a flow promoting device, such as a pump or a homogenizer without an unrestricted recirculation line, allowed down stream from the pasteurized side of a regenerator and the pasteurized side pressure sensor if means are provided to prevent negative pressure between the pasteurized side of the regenerator and the inlet to the pump or homogenizer? The means to prevent this negative pressure is normally accomplished by a properly installed and located vacuum breaker.

Yes.


May a positive displacement type timing pump have a by-pass line installed that is used solely for CIP purposes?

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Yes, provided that the by-pass line is physically removed during the processing of milk and/or milk products.


With an HHST system, the Flow Diversion Device (FDD) may be located after the cooler section. Where is the Safety Thermal Limit Recorder (STLR) temperature sensor required to be located on an HHST system?

The pasteurization indicating thermometer and the temperature sensor for the STLR must always be at the end of the holding tube regardless of the FDD location.

72. PMO- Section 7, Item 16p(D)

May a HTST system use tower water as the cooling media in the cooling section of the HTST system when this cooling section utilizes double plates with an intervening gasketed atmospheric gap?

No.

73. PMO-Section 7, Item 16p(D)

Would a pump located after the vacuum breaker at the end of an HTST pasteurization system be considered a violation of Item 16p(D) of the PMO?

No.

74. PMO-Section 7, Item 16p(D), Appendix I, Section II (Test 9.3.2)

There are homogenizer (timing pump) based HTST systems where "Lockout" safety switch boxes are interwired with the homogenizer and are usually located adjacent to the homogenizer. When conducting equipment Test #9.3.2-Booster Pump - Interwired With the Timing Pump, it has been observed that the booster pump is not wired through these “Lock-out” safety switch boxes and that the booster pump can be energized when the timing pump is de-energized through the “Lock-out” safety switch boxes. Is the booster pump required to be de-energized in all cases where the timing pump cannot run, including the “Lock-out” safety switch boxes?

Yes. The use of “Lock-out” safety switch boxes are acceptable, provided that the booster pump is hard wired through the “Lock-out” safety switch box and that the booster pump is in compliance with all of the applicable PMO testing criteria

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75. PMO-Section 7, Item 16p(E); and Appendix H

May a batch (vat) pasteurizer utilize electronic data collection, storage and reporting as cited in Appendix H. V. of the PMO in lieu of conventional recording charts, including the airspace and indicating thermometer readings?

Yes. They must meet the requirements of Item 16p(E) and Appendix H, V.Criteria for the Evaluation of Electronic Data Collection, Storage and Reporting of the PMO.


The following question relates to Item 17p-Cooling of Milk and Milk Products and water from an open, evaporative cooling tower used to cool water in an intermediate cooling media loop that will be subsequently used to cool product. If a plate type or double/triple tube type heat exchanger is used to exchange heat between the water from the open tower and the water in the intermediate cooling media loop it must be protected by an Isolation System to assure that there is no possibility of contamination of the intermediate cooling media loop water by the tower water. Within, Administrative Procedures #11 of the PMO, does this require differential pressure controller testing every six (6) months or quarterly?

This differential pressure controller testing would be required to be conducted by the Regulatory Agency upon installation; every six (6) months thereafter; and following any repair or replacement.


a) May the temperature of flavored milk ingredients in a slurry water mixture exceed 45°F (7°C) prior to blending with milk?

Yes.

b) May the temperature of flavored milk ingredients in a slurry milk mixture exceed 45°F (7°C) prior to blending with milk?

No.


May the pressure differential on a water-to-water cooling tower system be controlled through a PLC or must it be wired in a conventional manner via an independent pressure differential controller?

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It may be controlled through a PLC, provided the requirements of Appendix H, VI. CRITERIA FOR THE EVALUATION OF COMPUTERIZED SYSTEMS FOR GRADE "A" PUBLIC HEALTH CONTROLS of the PMO are satisfied and it can be visually determined if and/or when the pressure differential is not being met.


Other than the exemption for cottage cheese, may other milk products, such as cultured products, be transported to another IMS facility to be filled into final packaging, or be re-packaged?

No, this is a violation of Item 18p. Bottling, Packaging and Container Filling of the PMO.


Are the vehicles that distribute packaged milk and milk products from a permitted storage facility or “Milk Distributor” covered under Item 21p-Vehicles?

Yes.

81. PMO-Appendix B, Section I

What material must the sampling dipper storage container be constructed of?

It shall be constructed of a non-toxic material and the storage container shall be in good repair

82. PMO-Appendix D, Section V

Under Category I. Used for Potable Water Purposes, #2. of Section V. Water Reclaimed From Milk And Milk Products And From Heat Exchangers and Compressors, Appendix D. Standards for Water Sources of the PMO it addresses samples shall be collected daily for two (2) weeks for bacteriological analysis.

a) Who may collect these water samples that are required daily for two (2) weeks as cited within this Section?

As to who may actually collect these samples, that would be the decision of the Regulatory Agency; however, the required semi-annual samples must be collected by the Regulatory Agency.

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b) What laboratory may analyze these samples?


Under Category I. Used for Potable Water Purposes, #3. of Section V. Water Reclaimed From Milk And Milk Products And From Heat Exchangers and Compressors, Appendix D. Standards for Water Sources of the PMO it addresses the testing of the water for turbidity.

a) What tests may be used to calibrate the electrical conductivity (EC) meter so that it remains in correlation with an organic content of less than 12 mg/L as required?

Either the chemical oxygen demand or permanganate-consumed test may be used.

b) Who may collect these turbidity samples?

Milk plant personnel may collect these turbidity samples as needed to verify the calibration of the EC meter. The Regulatory Agency may also take samples to verify this EC meter calibration.

c) What is the role of the Regulatory Agency in regard to the calibration of the EC meter?

The Regulatory Agency should check the milk plant’s calibration records and verify the calibration or ask milk plant personnel to verify the calibration as often as necessary to assure that the required calibration is being maintained.

d) What laboratory may analyze the samples for compliance with this requirement?


Under Category I. Used for Potable Water Purposes, #13. of Section V. Water Reclaimed From Milk And Milk Products And From Heat Exchangers and Compressors, Appendix D. Standards for Water Sources of the PMO it addresses water reclaimed from heat exchange in a raw milk heat exchanger.

Does this require the quarterly differential pressure controller testing on the reclaimed water system?

Yes, if the water is intended for Category I use. This differential pressure controller testing would be required to be conducted by the Regulatory

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Agency upon installation; quarterly thereafter; and following any repair or replacement.

83. PMO-Appendix H, Section I

Under Section I. HTST Pasteurization, Pressure Relief Valves, Located Within HTST, HHST, and Aseptic Processing Systems of the PMO it addresses the installation of a sight glass if sanitary piping is returning milk or milk products from the pressure relief valve directly back to the constant-level tank. Is the sight glass now required on all installations or only those with a pressure relief valve located downstream from the holding tube in HTST systems?

A sight glass is only required on HTST systems in which the pressure relief valve is located downstream from the holding tube and the sanitary piping from the pressure relief valve returns milk or milk products directly back to the constant-level tank.

84. PMO-Appendix H, Section V

The following questions relate to Section V. Criteria For The Evaluation Of Electronic Data Collection, Storage and Reporting of Appendix H. Pasteurization Equipment And Procedures And Other Equipment of the PMO.

a) How long are electronic records that are gathered under this Section required to be kept by the milk plant for Regulatory Agency review?

Electronic records must be stored for the same period of time as their analogous paper records.

b) What experience is needed for in-house programmers that develop systems for the electronic data collection, storage and reporting for use in their own milk plant?

Section V. Criteria For The Evaluation Of Electronic Data Collection, Storage and Reporting of Appendix H. Pasteurization Equipment And Procedures And Other Equipment of the PMO does not address specific experience requirements for the programmers, either in-house or otherwise. The systems and the program that are developed must meet all of the requirements of this Section.

c) How can we be assured that the continuity of information transfer to new programmers and to the milk plant engineer is being met?

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This continuity of information transfer is being provided through the required written user guide, which addresses five (5) areas of documentation, and bears the name of the identified milk plant representative assigned to administer this procedure. Additional information required upon the initial installation is that reports shall bear the signatures of both the vendor of the system and the identified milk plant representative to verify visually the accuracy of the reports for seven (7) consecutive days. Also, a written record shall be maintained by the milk plant identifying any changes or updates to the system or program.

85. PMO-Appendix I, Section II (Test 2)

Is the water bath temperature cited in Test 2. Recording Thermometers – Temperature Accuracy, Procedure #1, within Appendix I of the PMO for HHST pasteurizers required to be performed at processing temperatures or at the temperature that the cut-in/cut-out is set?

The water bath temperature is to be set at the pasteurization temperature, not the processing temperature.

86. PMO-Appendix I-Section II (Test 14)

Are the pressure sensing elements identified in Test 14. Setting of Control Switches for Differential Pressure Across the Injector within Appendix I of the PMO required to be calibrated?

No.

87. PMO-Appendix I-Section II (Test 15)

a) Is a sign posted at the main entrance to a milk plant, which indicates that no hand-held devices are allowed, negate the requirement for the quarterly completion of pasteurization equipment Test #15-Electro-Magnetic Interference from Hand-Held Communication Devices?

Regardless of a sign being posted or not, if hand-held communication devices are not used in the milk plant, Test #15 does not apply.

b) In regards to the answer provide to a) above, does this apply only to milk plants in which Test #15 has never been conducted because they do not use hand-held communication devices, or to milk plants in which Test #15 resulted in an adverse reaction on the system, so the “fix” is a sign on the main door?

It only applies in a milk plant in which hand-held communication devices are not used. In a milk plant in which hand-held communication devices are

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used, a “radio free zone” is not an acceptable permanent alternative to requiring a milk plant to conduct Test #15 as required and to identify and correct the installation concerns that cause hand-held communication devices to compromise the electronic control device’s public health safeguards of continuous flow pasteurization and aseptic processing systems and which cause the public health alarms and/or controls within those systems to fail equipment Test #15.

(Refer to M-I-03-13 (Question #60) and M-I-04-10 (Question #50) for additional information).

88. PMO-Appendix J, Section C

If a sample container set of four (4) containers is tested using the rinse test, how many “SPC positive” containers are needed to declare the sample set is “violative”?

If two (2) or more of the four (4) containers tested in the sample set indicate results greater than fifty (50) SPC, then the sample set is considered violative.

NOTE: All single-service containers and closures shall be free of coliform organisms to be considered non-violative.

89. PMO-Appendix J, Section D, Item 15

Resin pellets are shipped in rail cars and in large totes. In both cases there are plastic/rubber liners that are used to contain the resin. Should these liners be considered when evaluating resin handling and storage?

No.

90. PMO-Appendix J, Section D, Item 20

Is the addition of calcium carbonate polyolefin concentrate to resin for the manufacture of single-service items acceptable? It is proposed to be added to strengthen the plastic containers by using less resin to make the individual containers by increasing wall stiffness and reduce warpage.

Yes. The single service manufacturing facility is required to have a letter from the manufacturer or supplier specifying that the calcium carbonate concentrate is generally recognized as safe (GRAS) and approved for use in direct food contact packaging under 21 CFR 177.1520-Indirect food additives and 184.1409-Direct and indirect food substances affirmed as generally recognized as safe.

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NOTE: In regards to the other parts of 21 CFR addressed in Appendix J of the PMO, specifically 21 CFR 175-Indirect food additives: adhesives and components of coating and 21 CFR 176-Indirect food additives: paper and paperboard components, this concentrate is intended to be added into polyolefins and are comprised of polyolefin and calcium carbonate. As such, they are not regulated by either of the 21 CFR parts cited in this NOTE.

91. PROCEDURES GOVERNING THE COOPERATIVE STATE-PUBLIC HEALTH SERVICE/FOOD AND DRUG ADMINISTRATION PROGRAM OF THE NATIONAL CONFERENCE ON INTERSTATE MILK SHIPMENTS (PROCEDURES)-Section III; and MMSR-Section B

How many IMS listed BTUs may a single dairy farm be included in?

One (1). Provided, that with a single dairy farm where there are two separate owners with separate permits, two separate herds, and two separate bulk milk tanks the individual owners/permits may be listed in separate BTUs.

92. PROCEDURES-Section IV

The following question is in reference to the following documents included in M-I-03-12 (Supplement 1)-Updated State Program Evaluation Report General Guidelines And Format And The Addition Of Minimum State Program Evaluation Requirements And Criteria and State Program Evaluation Resolution Process, issued 3/6/2007: “NCIMS Minimum State Program Evaluation Requirements and Criteria”, dated May 11, 2006, and “Sample Size Estimates for the Number of Files to be Reviewed by the Total Number of Files and 95% Confidence Level-(Farms, Receiving Stations, Transfer Stations, Milk Plants, Bulk Milk Hauler/Samplers, Industry Plant Samplers, Dairy Plant Samplers, Milk Tank Trucks, etc.)”.

Where it lists the number of files to be reviewed, is there a restriction to evaluating only the number of files cited in the Table or should the actual number of files that were reviewed during all of the check ratings conducted during the State Program Evaluation review period be used to calculate the compliance percentages for the Minimum State Program Evaluation Requirements and Criteria?

For Example: If a State has 526 permitted Grade "A" dairy farms, is there a restriction to only evaluate 55 files? Or, if 87 farms are check rated during the SPE period, should all 87 farm records be used to calculate the compliance percentages?

The actual number of farm files (records) that were included in the check ratings (87 farms in this example) shall be used, as long as this number of

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files meets the minimum number of files required as cited in the Table. Remember, the minimum number of files as cited in the Table, is the minimum number of files that must be reviewed if your check rating farm numbers (files) had not met that number of files reviewed during the time period of the State Program Evaluation.

93. MMSR-Section B

Industry field staff has requested that they drive for ratings and check ratings. Industry field staff would like to have an advanced notice (3 to 4 days) to prepare dairy producers for ratings and check ratings. Is this an acceptable practice for a safe milk supply? Would this be considered prenotification?

This is not an acceptable practice and it would be considered prenotification.

94. MMSR-Section F; and FORM FDA 2359i-Interstate Milk Shipper’s Report

What Product Code number should be cited on Form FDA 2359i-Interstate Milk Shipper’s Report for dried milk protein concentrate?

Product Code #22-Dried Milk and Milk Products

95. GENERAL INFORMATION

Which Federal Agency regulates or issues guidelines on the levels of radiation in food/milk? Would that be EPA or FDA?

FDA regulates the levels of radiation in milk and other foods, just as they do for other food additives or pesticides. 21 CFR 179 provides general provisions for irradiating food and gives conditions for the irradiation and labeling requirements. If there was a need to set limits on the radiation remaining in the food, FDA would notify EPA and provide rationale for establishing the limit, EPA would develop the science to support the limit being proposed, and FDA would take it through the rule making process. As it is, if there were a case where it was thought that milk or food was harmful due to radiation, the conditions and levels would be determined and referred to a Health Hazard Evaluation Board (HHEB). Regulatory decisions would than be made depending on the decisions from that board.

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HHS:PHS:FDA:CFSAN:OFS:DDFPS:DEB:MST … Dairy and Egg Branch (HFS-316) SUBJECT: Questions And Answers Received From The Field; Regional Milk Seminars; And FDA Training Courses Held

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