HHS:PHS:FDA:CFSAN:OFS:DDEMP:MMPB:MST
5100 Paint Branch Parkway College Park, MD 20740-3835
M-I-15-3
June 29, 2015
TO: All Regional Food and Drug Directors
FROM: Milk and Milk Products Branch (HFS-316)
SUBJECT: Questions And Answers Received From The Field; Regional Milk Seminars; And FDA Training Courses Held During Fiscal Year 2013
Following are questions and answers received from the field; Regional Milk Seminars; and FDA training courses (Special Problems in Milk Protection, Milk Plant Sanitation and Inspection, Milk Pasteurization Controls and Tests, and Dairy Farm Sanitation and Inspection) held during fiscal year 2013.
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, Milk Regulatory/Rating Agencies, Laboratory Evaluation Officers and 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 FDA Web Site at http://www.fda.gov at a later date.
If you would like an electronic version of this document prior to it being available on the FDA Web Site, please e-mail your request to [email protected].
Robert F. Hennes, RS, MPH CAPT, U.S. Public Health Service Milk and Milk Products Branch
______M-I-15-3 1 June 29, 2015
1. PMO-Section 1; and Appendix L
Is rennet allowed as an ingredient in yogurt?
The following answer was provided by CFSAN’s Office of Nutrition, Labeling and Dietary Supplements (ONLDS):
No. Rennet is an enzyme and is not permitted by the Standard of Identities (SOIs) for yogurt as an ingredient; nor do any of the stayed provisions allow for the use of rennet in yogurt.
2. PMO-Section 1; and Appendix L
Must Vitamins A and/or D be added back to yogurt that has had milkfat partially or substantially removed in order to make “lower fat” yogurt products nutritionally equivalent to "full fat" yogurt?
The following answer was provided by CFSAN’s ONLDS:
No. As opposed to other SOI milk and milk products which must use the provisions of 21 Code of Federal Regulations (CFR) 130.10 and 21 CFR 101.62 when making nutrient content claims for fat, e.g. lowfat and nonfat; yogurt products with milkfat reduced still have their own separate SOIs as found in 21 CFR 131.203 for "Lowfat Yogurt" and in 21 CFR 131.206 for "Nonfat Yogurt". Both of these SOIs list vitamin addition as optional. In 2009, FDA proposed to revoke the lowfat yogurt and nonfat yogurt SOIs so that lower fat versions of yogurt would follow provisions of 21 CFR 130.10 and 21 CFR 101.62 (74 FR 2443). If this proposed rule is finalized as proposed, vitamin addition would be required to make the lower fat versions of yogurt nutritionally equivalent to “full fat” yogurt. However, the 2009 proposed rule has not been finalized.
3. PMO-Sections 1 and 4; and Appendix L
Does the SOI for Yogurt (21 CFR 131.200) allow for the addition of starch (corn, wheat or other) as an optional ingredient?
The following answer was provided by CFSAN’s ONLDS:
Yes. Starch (usually modified food starch) often is utilized as a stabilizer in food because of its ability to trap (bind) water; thus acting as a thickening or stabilizing agent. The SOIs for yogurts do provide for "Stabilizers" to be added, e.g. 21 CFR 131.200(d)(5), 131.203(d)(5) and 131.206(d)(5). Pectin is another example of a water-binding ingredient that is used in foods as a stabilizer in order to improve texture. If added the ingredient statement shall include starch as an ingredient. ______M-I-15-3 2 June 29, 2015
4. PMO-Sections 1 and 4; and Appendix L
A milk processor wishes to add “Tween” (Polysorbate 80) as an ingredient to a Grade "A" milk product and labeling the milk product "whipping cream". May Tween” (Polysorbate 80) be used as an ingredient in Grade “A” milk and/or milk products?
The following answer was provided by CFSAN’s ONLDS:
Yes. Polysorbate 80 is listed in 21 CFR 172.840 as a food additive permitted for direct addition to food for human consumption. If a SOI product allows for an emulsifier to be added as an optional ingredient, then the addition of Polysorbate 80 would be permitted provided that the specific usage rate cited for various products is met. 21 CFR 172.840 (c) (9) provides for Polysorbate 80 to be used as an emulsifier in whipped edible oil toppings; with a maximum usage rate of 0.4 percent of the weight of the finished whipped edible oil topping. The SOI for "whipping cream" found in 21 CFR 131.150 and 21 CFR 131.157 allows for emulsifiers to be added as an optional ingredient.
5. PMO-Sections 1 and 4; and Appendix L
a) A milk product is currently labeled as “Premium Egg Nog” and within the ingredient statement it lists “water” as an ingredient. Within the SOI for eggnog may water be added and still label the product “Egg Nog”?
The following answer was provided by CFSAN’s ONLDS:
According to the SOI for eggnog prescribed by 21 CFR 131.170, “eggnog” is the food containing one or more of the optional dairy ingredients specified in paragraph (b), one or more of the optional egg yolk-containing ingredients specified in paragraph (c), and one or more of the optional nutritive carbohydrate sweeteners specified in paragraph (d). In addition, one or more of the optional ingredients specified in paragraph (e) may also be added.
Water is not listed as one of the optional ingredients in paragraph (e); therefore, water cannot be used as an ingredient to make SOI eggnog with the following exceptions:
1) When water is used as a sub-ingredient for nutritive sweeteners in the liquid form in a way that is consistent with other applicable FDA regulations; and 2) When water is used to reconstitute nonfat dried milk (21 CFR 101.4(b)(3)) and the water used does not exceed the amount of water needed to
______M-I-15-3 3 June 29, 2015
reconstitute nonfat dried milk to single strength (21 CFR 101.4(c)) [FDA letter to IDFA, November 29, 2000].
b) Would this eggnog product meet the Definition of Milk Products contained within Section 1-Definitions of the PMO?
Yes. Grade “A” milk and milk products as defined in the PMO cover a range of milk and milk products and are not limited to milk and milk products that meet a SOI. Therefore, even if the milk and/or milk product does not meet the SOI for eggnog and could not be labeled as such, the milk and/or milk product would still meet the definition of Grade “A” Milk and Milk Products and could use a fanciful name, for example “Holiday Nog.”
Also, Section 4-Labeling of the PMO would not allow these eggnog products to use the term “Premium” before the fanciful name of the Grade “A” milk product.
6. PMO-Sections 1 and 4; and Appendix L
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%.
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:
Yes. 21 CFR 101.56 specifies the requirements for the nutrient content claim "light". "Light" is a relative claim and; therefore, the appropriate fat content of a food bearing a "light" claim depends on the fat content in its reference food. The reference food for “light whipped cream” is “whipped cream” as defined in 21 CFR 131.25. 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).
Product Fat level Heavy whipping cream ≥ 36% Light whipping cream 30% < 36%
Depending on the type of whipping cream used, "whipped cream" contains an amount not less than 30% milkfat. Therefore, the “Sugar Free Light Whipped Cream” product with 9.36% fat meets the requirements for the ______M-I-15-3 4 June 29, 2015
“light” claim because its fat is reduced by 50% or more (21 CFR 101.56) from the reference food, “whipped cream.” Certain other creams, such as "light cream" cannot be used as the reference food because "light cream" cannot be used to manufacture "whipped cream" as described in 21 CFR 131.25
7. PMO-Sections 1, 4, 6 and 7-Items 18r and 17p; and Appendices G and N; and FDA/NCIMS 2400 Forms
Does the PMO prohibit the freezing and storage of excess cow's milk once the season ends for seasonal on-farm producer/processors that dry off their herd; then thaw and pasteurize the cow's milk to extend their milk plant's production? The raw milk has been tested in accordance with Section 6-The Examination of Milk and/or Milk Products and Appendix N-Drug Residue Testing and Farm Surveillance of the PMO following milking and prior to freezing and subsequent storage.
No, not with this scenario as described above. With the freezing of raw milk, it shall be adequately handled, stored and protected at all times; and during the thawing process it shall be under controlled temperature conditions so that the raw milk does not exceed 45ºF (7ºC).
There are not any provisions in the FDA/NCIMS 2400 Forms for conducting official Section 6 regulatory testing of commingled raw milk or pasteurized milk and/or milk products that have been previously frozen. Also, it is not clear if there would be testing issues if frozen milk is commingled with non- frozen milk and then pasteurized.
They cannot label this frozen, thawed and pasteurized milk with the term "fresh".
NOTE: With this scenario as described above and the on-farm producer/processor meeting the requirement to test the raw milk prior to freezing in accordance with Section 6 and Appendix N of the PMO, additional Appendix N testing would not be required by the producer/processor when the raw milk is thawed and processed. Documentation shall be readily available to assure that the raw milk that was processed on a given day, utilizing previously frozen raw milk, was tested for Section 6 and Appendix N of the PMO prior to freezing.
8. PMO-Sections 1, 4 and 11; and Appendix L
May an IMS listed milk plant process, package and sell Grade “A” cream and also package and sell this same milk product labeled as “Manufactured Cream”?
______M-I-15-3 5 June 29, 2015
NOTE: The milk product is the same (cream separated from Grade “A” milk), the only difference is the cream is labeled as “Manufactured Cream” and does not have any Grade “A” designation on the container.
No. Cream is a standardized milk product defined in either 21 CFR 131.150 Heavy Cream, 21 CFR 131.155-Light Cream or 21 CFR 131.157-Light Whipping Cream. It is also included within the Definition of “Milk Products” of the PMO. If the cream is shipped in interstate commerce or shipped to an IMS Listed milk plant it is considered a Grade “A” milk product regulated under the PMO and the NCIMS Grade “A” Milk Safety Program. The product is “Cream” and shall be labeled as Grade “A”.
The CFR does not provide for the labeling of a milk product meeting one (1) of the SOIs for creams as “Manufactured Cream”. It would have to be labeled to comply with one (1) of the names of the milk products identified in 21 CFR 131.150-Heavy Cream, 131.155-Light Cream or 131.157-Light Whipping Cream.
9. PMO-Sections 3, 7-Item 12p, and 11; and Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program of the National Conference on Interstate Milk Shipments (PROCEDURES)-Section IV
a) When a milk plant, receiving station and/or transfer station changes legal ownership (not just a cosmetic name change), is the existing IMS listing for the previous ownership still valid, or is a new rating required to be conducted?
A new rating would be required. Section 3-Permits of the PMO states: "Permits shall not be transferable with respect to persons and/or locations." The new ownership would be required to submit an application for a permit to their Regulatory Agency. The Regulatory Agency shall notify the Rating Agency that such a change of ownership has occurred and the Rating Agency would request the removal of the milk plant from the IMS List. The Regulatory Agency would conduct an inspection of the milk plant, receiving station or transfer station, respectively; and if determined to be in compliance with the PMO, they would issue a new permit. At this time, the new ownership may submit a request to their Rating Agency for a rating if they wish to be on the IMS List.
b) If the previous milk plant ownership had a Regulatory Agency, in consultation with FDA, reviewed and accepted extended run(s) in place, would the new ownership be required to submit a complete new extended run(s) application including a current trial run(s) with samples to continue the operation of this previously accepted extended run(s)?
______M-I-15-3 6 June 29, 2015
Regulatory Agency acceptance of an extended run(s) is specific to equipment, process, milk and/or milk product(s), operating procedures and is issued to the ownership of the milk plant that originally submitted the extended run(s) application. If the new ownership wishes to utilize the previous ownership’s previously accepted extended run(s), along with the new ownership’s application for a permit submitted to the Regulatory Agency they shall include or have available for the Regulatory Agency’s review a copy of the extended run(s) application, protocol and acceptance documentation from the previous ownership. They shall inform the Regulatory Agency that they plan to utilize and follow the prior ownership’s previously accepted extended run protocol(s). During the routine Regulatory Agency quarterly inspections, Regulatory Agency personnel shall verify that the accepted extended run(s) protocol is being followed. If the new ownership cannot provide this extended run(s) documentation or they plan to utilize a new extended run(s) protocol, then they would be required to follow the requirements for an extended run(s) as cited within Item 12p-Cleaning and Sanitizing of Containers and Equipment of the PMO.
10. PMO-Section 4
Section 4 of the PMO requires that milk tank trucks transporting raw, heat- treated or pasteurized milk and/or milk products to a milk plant from another milk plant, receiving station or transfer station shall include a shipping statement containing specified required information. If all of this specified required information is provided on additional documentation, i.e. weight tickets, load manifests, etc. and provided as a part of the milk and/or milk product shipment to the receiving facility, would a “single” shipping statement or bill of lading containing all of the required specified information not be required. For example, a transfer station may combine/attach the weight tickets, load manifests, etc. from the milk tank truck(s) that directly transferred milk to another milk tank truck for shipment to a milk plant and include on those combined/attached documents the rest of the required information, such as seal numbers, milk tank truck identification number, etc. Would this be acceptable?
Yes. This required shipping statement may be a single document or may include multiple documents (weight tickets, load manifests, etc.) that are combined/attached as long as the documentation contains all of the Items specified in Section 4 of the PMO. All of the required documentation shall be available for review when requested by Regulatory Agency personnel, a Milk Sanitation Rating Officer (SRO) or a FDA Regional Milk Specialist (RMS).
______M-I-15-3 7 June 29, 2015
11. PMO-Section 4
M-a-49 states that packages containing nonfat dry milk cannot use two (2) grade designations, Grade “A” and the industry designation of “Extra Grade”, on the labels. The use of the two (2) grade designations on one (1) container of nonfat dry milk is misleading and; therefore, does not meet the labeling requirement of Section 4 of the PMO. Would this interpretation also apply to the two (2) grade designations labeling of other dry milk and milk products and/or dry whey and whey products, such as dried sweet dairy whey products?
Yes.
12. PMO-Section 4; and Appendix L
Are either of the terms “pasteurized” or “homogenized” required to be on the label of a Grade “A” milk or milk product? 21 CFR 131.110 states the terms may be used on the package label.
No. The terms "pasteurized" or “homogenized” are optional; however, the term "ultra-pasteurized" is required if the milk or milk product has been ultra- pasteurized.
NOTE: While 21 CFR 1240.61 requires all milk and milk products introduced into interstate commerce are to be pasteurized; that regulation also does not require the term "pasteurized" to be on the label.
13. PMO-Section 6
May the Regulatory Agency overrule the official laboratory testing results of official Section 6-The Examination of Milk and Milk Products of the PMO milk samples if they think the milk sample results to be erroneous?
A milk plant had several high counts in a row in which the milk and/or milk products were filled on different packaging machines and pasteurization systems that were collected on the same day. The high counts were found in sequential order as to how the sample were collected and submitted to the official laboratory. The first eight (8) samples were negative (<250 SPC) and the next eight (8) samples were all positive (> 42,000 SPC). The official laboratory reported that there were not any errors on their part but were also very surprised with the results.
Sample Collection: The Regulatory Agency shall have properly trained personnel that know how to properly collect and ship regulatory milk samples to the official laboratory.
______M-I-15-3 8 June 29, 2015
Laboratory Procedures and Methods: It would be expected that the official laboratory would have sufficient controls in place to assure their testing did not have any problems.
Conclusion: If the Regulatory Agency personnel did not have any issues with the milk samples when they were collected or the method of collection when they submitted the milk samples to the official laboratory; if the milk samples received in the official laboratory met their specifications; and if the required controls worked properly then the results would be considered official and actionable.
Based on meeting all of these criteria, the Regulatory Agency cannot overrule the official laboratory testing results.
14. PMO-Section 6; and Methods for Making Sanitation Ratings of Milk Shippers (MMSR)-Sections C and D; and Appendix A
A milk plant is producing whole “full fat” plain and flavored yogurts at various milkfat levels, i.e., 3.25%, 3.5%, 5% and 10%. Does Section 6 of the PMO require the sampling of each of these whole “full fat” levels for plain and flavored whole “full fat” yogurts as cited above for both plain and flavored whole "full fat" yogurts?
No. Whole “full fat” yogurt, which contains 3.25% milkfat or greater, would be considered as one (1) sampling category. Both plain and flavored whole “full fat” yogurt as described are required to be sampled. It is recommended that each different flavor of whole “full fat” yogurt at each milkfat level be sampled on a rotational basis within the single flavored whole “full fat” sampling category. It is also recommended that each plain whole “full fat” yogurt at each milkfat level be sampled on a rotational basis within the single plain whole “full fat” sampling category.
NOTE: If the Regulatory Agency elects to sample whole milk and/or milk products above 3.25% fat or greater on a rotational basis they shall comply with Section 6 of the PMO, in relationship to the required enforcement action when two (2) out of four (4) samples and three (3) out of five (5) samples exceed the standard. Therefore, all whole milk and/or milk products that are being sampled within this rotational system are affected by any warning letter and/or suspension of the permit enforcement action that would be required.
15. PMO-Section 6; M-a-98; and MMSR-Sections C and D; and Appendix A
Which of the laboratory tests cited in Section 6 of the PMO are required to be conducted on Ultra-Pasteurized (UP) Lactose Reduced Milk and Milk Products? ______M-I-15-3 9 June 29, 2015
M-a-98 identifies that Product Code #5-Ultra-Pasteurized Milk and Milk Products, which UP Lactose Reduced Milk would be classified and coded under, requires that Temperature, Bacteria, Coliform, Inhibitors and Vitamins testing be conducted. However, Product Code #19-Lactose Reduced Milk and Milk Products (Fluid), which only includes pasteurized (HTST and HHST) and not UP or aseptic processed, requires that Temperature, Bacteria, Coliform and Vitamins testing be conducted.
For UP Lactose Reduced Milk and Milk Products you would only be required to conduct tests that are common to both Product Code #5 and Product Code #19. In this case, for UP Lactose Reduced Milk and Milk Products, you would only be required to test for Temperature, Bacteria, Coliform and Vitamins since those are the only tests these two (2) Product Codes have in common.
NOTE: With the issuance of Revision #1 to M-a-98, these issues will be clarified and addressed under Product Code #5-Ultra-Pasteurized Milk and Milk Products.
16. PMO-Sections 6 and 7-Item 17p; Evaluation of Milk Laboratories (EML); and FDA/NCIMS 2400 Forms
Standard Methods for the Examination of Dairy Products (SMEDP) states to determine processing conditions in the manufacturing milk plant, that cottage cheese and similar cultured milk and milk product samples must be analyzed for coliform content within twenty-four (24) hours of manufacture. Are these cultured milk and milk products, including the ones cited within the temperature exceptions referenced in Item 17p-Cooling of Milk and Milk Products of the PMO, required to be analyzed for coliform content within twenty-four (24) hours of manufacture to be in compliance with Section 6 of the PMO and the applicable FDA/NCIMS 2400 Form?
No. Section 6 of the PMO does not specify a required time frame for the analysis of cottage cheese and similar cultured milk and milk products other than they must be collected while in the possession of the manufacturer. Also, the FDA/NCIMS 2400 Forms do not specify a required time frame. However, it is recommended that testing of cultured products be performed as soon as possible after collection.
17. PMO-Section 7
Section 7-Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products and Retort Processed after Packaged Low-Acid Milk and Milk Products of the PMO allows for bactofugation to be performed in the milk plant in which the milk and/or milk product is pasteurized, ultra-pasteurized, aseptically ______M-I-15-3 10 June 29, 2015
processed and packaged or retort processed after packaged. Is there any limitation on where the bactofugation process can occur? Is it required to be performed prior to the pasteurization, ultra-pasteurization, aseptic or retort processed, or can it be conducted after the milk or milk product is pasteurized, ultra-pasteurized or aseptically processed? A condensing/drying plant wants to perform the bactofugation process after pasteurization between the 1st and 2nd effects of an evaporator.
Bactofugation was added to the PMO at the 2007 NCIMS Conference. Proposal 220 was authored and submitted by FDA and was based on their review of the available literature and references addressing the use of bactofugation prior to any heat treatment pasteurization step. The intent of the wording addressing bactofugation in Section 7 of the PMO is directly related to that literature and references reviewed by FDA. With the current wording in the PMO, FDA would expect that bactofugation would be conducted in the milk plant in which the milk and/or milk is pasteurized, ultra-pasteurized, aseptically processed and packaged, or retort processed after packaging prior to any heat treatment pasteurization step.
There is concern that the use of bactofugation after the heat treatment pasteurization step presents the potential for post pasteurization contamination of the milk and/or milk products being processed. If a milk plant is considering using bactofugation in their process after the heat treatment pasteurization step they shall work with their Regulatory Agency, in consultation with FDA, to address the following issues and concerns:
What is the milk plant’s rationale for applying bactofugation after the heat treatment pasteurization step? Why must bactofugation be performed after the heat treatment pasteurization and why can’t it be performed by the currently accepted practice of prior to the heat treatment pasteurization step? What technical effect(s) in the finished milk and/or milk product will be achieved? What specific technical effect(s) will be achieved that could not be achieved when using the currently accepted practice of bactofugation prior to the heat treatment pasteurization step and the safety of the milk and/or milk product. What scientific information and data are available that address the potential for post pasteurization contamination of the milk and/or milk products. What assurances/controls will be in place to routinely evaluate and assess the safety of the bactofugation process and the finished milk and/or milk product?
______M-I-15-3 11 June 29, 2015
18. PMO-Section 7, Items 7r
Does the PMO prohibit a washer and/or dryer to be located in a restroom on a dairy farm?
No.
19. PMO-Section 7, Items 8r and 7p
a) FDA’s Milk and Milk Products Branch (MMPB) has received questions regarding the use and acceptability of reduced pressure zone (RPZ) water anti-siphon/backflow protection assemblies manufactured by the Watts Company and specifically addressing the 909 Watts RPZ (series), the 957 Watts RPZ (series) and the 994 Watts RPZ (series). These Watts RPZ series and other manufacturers with similar RPZ assemblies, e.g. Febco, Wilkins, etc., that utilize a spring controlled vent provided within the RPZ assemblies, are different in appearance from earlier models of RPZ devices that were constructed to provide a more readily observable vent opening to the atmosphere. Are these new models of RPZ assemblies and other manufacturers with similar RPZ assemblies acceptable as anti siphon/backflow protection devices when such protection is required within water systems utilized on Grade “A” dairy farms and in Grade “A” milk plants regulated under the PMO?
Watts Series 909
Watts Series 957
______M-I-15-3 12 June 29, 2015
Watts Series 994
Yes. These certified RPZ anti-siphon/back flow preventer assemblies have an opening to the atmosphere (vent) that will open when there is a failure of the valve(s) on either side of the atmospheric (vent) opening. These certified RPZ assemblies when installed and tested as recommended by the manufacturer or the applicable Water Control Authority are universally accepted for protection against back siphoning and back flow in high risk health hazard applications under State and local plumbing codes and are acceptable under the PMO. Acceptable RPZ assemblies need to be certified by at least one (1) of the following organizations for the specific level of health hazard identified on the Grade “A” dairy farm or in the Grade “A” milk plant:
American Society of Sanitary Engineering (ASSE), American Water Works Association (AWWA), American National Standards Institute (ANSI), University of Southern California - Foundation of Cross-Connection and Hydraulic Research (USC-FCCHR), Underwriters Laboratories Inc. (UL), Factory Mutual (FM), or National Sanitation Foundation (NSF).
NOTE: Double check valve assemblies that do not have a vent opening are NOT acceptable within the Grade “A” PMO for use on potable water lines within water systems utilized on Grade “A” dairy farms and in Grade “A” milk plants to provide the required protection against back siphoning or back flow.
Additional questions that are only related to these RPZ assemblies that utilize a spring controlled vent as cited in a):
b) If one (1) of these cited certified RPZ assemblies is installed and tested in accordance with the manufacturer’s installation/testing instruction manual associated with the specific RPZ assembly and the testing documented in a manner acceptable to the Regulatory Agency or applicable Water Control
______M-I-15-3 13 June 29, 2015
Authority, as warranted, would this be considered meeting the guidance addressed in a)?
Yes.
c) If the manufacturer’s testing procedures as cited in their installation/ testing instruction manual associated with the specific RPZ assembly specifies that a specifically trained or certified plumber is required to perform the tests, may the Regulatory Agency or applicable Water Control Authority, as warranted, allow any licensed plumber to test the RPZ assembly?
Yes. To be acceptable under the PMO, the testing and the individual performing the testing shall be acceptable to the Regulatory Agency or applicable Water Control Authority, as warranted.
d) Is written documentation required to be available to the Regulatory Agency, SRO or RMS for these RPZ assemblies to assure that they are meeting the requirements of the manufacturer’s installation/testing instruction manual associated with the specific RPZ assembly or applicable Water Control Authority regulations, as warranted?
Yes. Either a log book maintained by the dairy farm or milk plant operator or a tag attached to the RPZ assembly indicating the RPZ assembly number, location, date of testing, test results, any repairs conducted, and the person testing the assembly would be sufficient to meet this requirement.
e) If there is not any documentation available at the dairy farm or milk plant to indicate that the RPZ assembly(ies) has been tested as recommended by the manufacturer or the applicable Water Control Authority regulations, would this be considered a violation of the PMO? If so, where would this be debited on FORM FDA 2359a-Dairy Farm Inspection Report or FORM FDA 2359-Milk Plant Inspection Report, respectively?
Yes this would be considered a violation of either Item 8r or 7p, respectively. It would be debited on FORM FDA 2359a-Item 8(c)-five (5) point debit or FORM FDA 2359-Item 7(b), respectively.
f) How would the frequency of the required testing be determined and verified by Regulatory Agency personnel, SROs or RMSs?
The frequency of testing would be determined by what is acceptable to the manufacturer’s installation/testing instruction manual associated with the specific RPZ assembly, which is acceptable to the Regulatory Agency or applicable Water Control Authority, as warranted. The frequency shall be evaluated and verified using documentation available at the dairy farm or milk plant respectively. ______M-I-15-3 14 June 29, 2015
20. PMO-Section 7, Items 8r and 7p; and MMSR-Sections B and C; and Appendix B
May multiple Watts 9D vent drain lines be directly connected to a single common drain line? The Watts 9D vent drain lines are the same diameter as the piping for the single common drain line. There would be multiple vent drain lines tied to a single common drain line that has a single air gap above the floor drain.
No, unless the single common drain line is equal to or exceeds the surface area of all the connected vent drain lines combined.
NOTE: On dairy farms this would be considered a Major (5 point) debit under Item 8r-Water Supply (Cross Connection) of the PMO.
21. PMO-Section 7, Items 8r and 7p; and MMSR-Sections B and C; and Appendix B
May over flow drain lines from several CIP tanks be directly connected to a single common drain line? The over flow drain line piping on each CIP tank overflow is the same diameter as the single common line drain. There would be multiple over flow drain lines tied to a single common drain line that has a single air gap above the floor drain.
The common drain line would be required to be evaluated to make sure that when all CIP tanks are over flowing that it cannot cause any of the CIP tank water inlets to become submerged.
NOTE: If a submerged inlet was identified on dairy farms this would be considered a Major (5 point) debit under Item 8r of the PMO.
22. PMO-Section 7, Item 9r
A dairy farm has a remote parlor where the sanitary milk pipeline back to the milkhouse is in part located outside. These sections, which included both the milk pipeline and the CIP return line, contained unprotected gasketed fittings and connections located outside exposed to the environment.
Are approved CIP milk pipelines as required in Item 9r-Utensils and Equipment Construction of the PMO allowed to have connections or fittings located outside that are not protected and are exposed to the environment?
No. Milk pipelines and CIP return lines installed as described above shall be either a continuous welded pipeline or provided with adequate means of protection or shielding, such as "dog housing", to protect the fittings and connections from contamination from the environment. Any welded pipeline ______M-I-15-3 15 June 29, 2015
regardless as to location shall have access points other than entrances and exits for inspection. It is preferred that all milk pipeline and CIP return line connections or fittings are made and accessible from within the milkhouse, milking barn, stable, or parlor.
23. PMO-Section 7, Items 10r and 11r
a) A dairy farm has a bottom filled farm bulk milk tank/silo that is emptied every other day. Is the valve of the farm bulk milk tank/silo required to be cleaned and sanitized between milkings?
Yes. Item 10r-Utensils and Equipment – Cleaning of the PMO requires that milk product-contact surfaces of all multi-use containers, equipment and utensils shall be cleaned after each usage. Item 11r-Utensils and Equipment – Sanitization of the PMO requires that milk product-contact surfaces of all multi-use containers, equipment and utensils shall be sanitized before each usage. In the scenario cited above, it would be expected that when the inlet sanitary pipeline (permanent mounted or flex hose) is disconnected following a milking that the valve be at least rinsed out with water to remove any milk solids and the valve capped. At the next milking, just prior to the inlet sanitary pipeline being connected to the valve, the valve shall be uncapped and the valve sanitized. This sanitization step may be accomplished by using a spray bottle, similar to how a bulk milk hauler/sampler would sanitize the valve just prior to attaching the unloading hose; flushing the valve with a sanitizing solution contained in a plastic bag; or any other means that is acceptable to the Regulatory Agency. The sanitizing solution used shall be at an appropriate concentration for the sanitizer that is being used, for an appropriate contact time, and the sanitizer shall be an EPA registered sanitizer.
b) Would there be a different answer if the farm bulk milk tank/silo is emptied after each milking?
Yes. When the farm bulk milk tank/silo is next emptied the valve and farm bulk milk tank/silo is required to be cleaned and sanitized prior to the next milking.
24. PMO-Section 7, Items 10r and 11r; and Appendix F
"Ox Ag Solution” is a 6,000 - 8,000 ppm Free Available Chlorine (FAC) solution made from mixing salt (Sodium Chloride) and water and then passing the mixture through an electronic cell. In most instances “Ox Ag Solution”, known generically as Anolyte, may be made on the dairy farm using a unit owned by the dairy producer. The dairy producer then dilutes the “Ox Ag Solution” and mixes it with different additives such as a
______M-I-15-3 16 June 29, 2015
detergent for washing systems with the “Ox Ag Solution” providing the needed chlorine for a chlorinated alkaline cleaning solution.
The manufacturer also states that the diluted “Ox Ag Solution” may be used to sanitize calf hutches, sick pens and maternity stalls, when used with laundry detergent to wash and sanitize drying towels, which are used to dry cows before applying the milking claw.
Would “Ox Ag Solution” be allowed for use on a Grade “A” dairy farm as cited above?
Yes. However, it would be a violation of Item 11r-Utensils and Equipment - Sanitization of the PMO to use this “Ox Ag Solution” for the sanitizing of dairy farm milking equipment.
25. PMO-Section 7, Items 14r
Dairy farms, including automated milking installations (AMIs), routinely filter raw milk entering the farm bulk milk tank/silo. This is sometimes accomplished using dual sock filters and filter canisters. When one (1) of the filter socks needs to be changed, the operator will switch from one (1) filter canister to the other by closing the inlet and outlet valves of the first filter canister and opening the inlet and outlet valves for the second filter canister. The soiled sock filter is removed from the first canister and the canister and sock filter holder are manually rinsed with water and/or a sanitizing solution, the filter is replaced and the canister is reassembled. This occurs while milk is flowing through the second canister and sock filter. During the milking operation, if the second filter needs to be changed, the process is reversed.
The full cleaning of the filter canisters and sock filter holders are not performed until the end of milking when the milking pipeline system is washed. The filter canisters and filter holders, with or without filters in place, are sanitized with the milk pipeline system before the next milking begins.
When the sock filter is changed during milking, there is only one (1) valve separation between raw milk in one (1) filter canister and water and/or sanitizing solution being manually applied in the other filter canister. Is this acceptable?
Yes.
26. PMO-Section 7, Item 15r
It was observed on a dairy farm that prescription (Rx) animal drugs that are labeled for use on dairy cattle are properly being labeled by the prescribing ______M-I-15-3 17 June 29, 2015
veterinarian with his/her name and address as required under Item 15r- Drug and Chemical Control of the PMO. Also on the label that is attached to the bottle by the veterinarian is the statement: "Use According to FDA Approved Label", would this be acceptable?
Yes, provided that the prescribing veterinarian is not prescribing this drug in an extra label use manner and the attached veterinarian’s label on the bottle does not obscure any of the information provided on the drug manufacturer’s label. If the attached veterinarian label covers the drug manufacturer’s label for the directions for use, prescribed withholding times, cautionary statements, or active ingredients, this would be considered a violation of Item 15(d)-five (5) point debit on FORM FDA 2359a-Dairy Farm Inspection Report.
27. PMO-Section 7, Item 15r
A homeopathic whey extract product is packaged as a drug in a sterile vial with a metal ring and rubber injection stopper. The manufacturer’s label directions for use are for oral use in calves. Because of how this homeopathic product is packaged as a drug for injection would this be considered a violation of the PMO?
Yes. Homeopathic products are unapproved new animal drugs and as this product is packaged as a drug for injection, CVM has the concern that this product will be actually injected and not administered orally as the label directs. This homeopathic product would be considered a violation of the PMO and would be a five (5) point debit marked under Item 15(d) on FORM FDA 2359b-Dairy Farm Inspection Report.
28. PMO-Section 7, Item 18r
A dairy farm is proposing to pass potable water, which may be well water, water from a rural supply or reclaimed water, through a plate heat exchanger against a recirculated freezing-point depressant solution to lower its temperature to as low as possible while remaining liquid. This cooled potable water will then proceeds through closed piping to a conventional water-to-milk plate heat exchanger (farm pre-cooler) to extract heat from the milk before the milk enters the farm bulk milk storage tank/silo/tanker. The theory behind this is that the low-30’s°F chilled water will be more effective at pre-cooling the milk than mid-50’s°F ground water. The potable water exiting this pre-cooler may be discharged to the drain; discharged for stock watering; or captured and reclaimed for reuse. The choice will be the option of the dairy producer. What would be the PMO requirements for this type of cooling system?
______M-I-15-3 18 June 29, 2015
The PMO does not differentiate between plate heat exchangers that are water-to-water, water-to-freezing point depressant or water-to-raw milk. Item 18r-Raw Milk Cooling of the PMO requires that the recirculated cooling water used in plate or tubular coolers or heat exchangers, is from a safe source and protected from contamination.
The recirculated freezing point depressant and other chemical additives shall be non-toxic under conditions of use. Propylene glycol and all additives shall either be U.S. Pharmacopeia (USP) Grade, Food Grade or Generally Recognized as Safe (GRAS) and properly protected from contamination. A freezing point depressant sample shall be collected and tested semiannually and shall comply with the bacteriological standards of Appendix G-Chemical and Bacteriological Tests of the PMO. If the potable water supply used is from a well and is discharged to the drain, the potable well water shall be collected and tested every three (3) years and shall comply with the bacteriological standards of Appendix G of the PMO. If the potable water supply used is from a rural water supply and is discharged to the drain, the rural water supply would not be required to be sampled and tested. If either potable water supply (well or rural water) is used and is discharged to stock watering, the line providing water to the stock tanks/troughs shall be installed with an appropriate air gap or back flow prevention device to prevent any potential cross connection between the discharged water and the water in the stock tanks/troughs. If either potable water supply (well or rural water) is used and is reclaimed it shall comply with the requirements of Appendix D-Standards for Water Sources, Section VI-Water Reclaimed from Heat Exchanger Processes or Compressors on Grade “A” Dairy Farms of the PMO. Samples shall be collected and tested semiannually and shall comply with the bacteriological standards of Appendix G of the PMO.
29. PMO-Section 7, Items 18r and 17p
M-I-13-6 (Question #51) relates to the use of glutaraldehyde in recirculated cooling water (sweet water) and it cites that the CFR does not specify chemicals that may, or may not, be used in dairy farm and milk plant recirculated cooling media systems. The answer also states:
“The safety of chemicals for use in Grade "A" dairy farm and milk plant recirculated cooling media systems under Items 18r-Raw Milk Cooling and 17p-Cooling of Milk and Milk Products of the PMO has been accepted if the chemical product(s) used is GRAS; if the chemical(s) is an EPA recognized sanitizer used at not more than 10% of the labeled strength; or if it can otherwise be shown to be safe for this use.”
______M-I-15-3 19 June 29, 2015
What would be considered to be acceptable and complete documentation for ingredients identified as GRAS or the use of a sanitizer; i.e. written verification provided to a milk plant by the chemical vendor on the vendor’s letterhead for a specific cooling media additive, to be determined to be in compliance with the statement above?
The chemical vendor’s documentation on the vendor’s letterhead to the milk plant shall include the following:
Cooling Media Chemical Additive:
The name of the product, including all of the ingredients contained within the product; and A citation that all of the ingredients in the product have been identified as GRAS.
NOTE: Upon request the vendor shall be able to provide documentation of the GRAS designation for each of the ingredients.
Sanitizer:
The sanitizer shall be an EPA registered sanitizer. The label on the sanitizer’s container shall have an EPA registration number, directions for use on food contact surfaces and the name and address of the manufacturer. EPA requires the directions for use to be in compliance with 40 CFR 180.940. All required information shall be on the label or tag attached to the container if the sanitizer is shipped in bulk to the dairy farm or milk plant. If the sanitizer does not have this information on the label or attached tag, than the sanitizer is considered an unapproved sanitizer and cannot be used.
NOTE: The operator of the dairy farm or milk plant would be responsible for assuring that the EPA registered sanitizer is not being used at more than 10% of the labeled concentration for use in the recirculated cooling water (sweet water).
30. PMO-Section 7, Items 10p, 11p, and 16p(C)
May the Alpha Laval Unique Vacuum Breaker Valve be used as the required air break (opening to the atmosphere) as cited within Item 16p(C) Pasteurizers Employing Regenerative Heating of the PMO in a HTST pasteurization system with a regenerator?
Yes. This device has a 3-A® Symbol. The 3-A® Symbol authorization is #835 and can be viewed at: http://www.3 a.org/Symbol/SymbolHolder_certificate.php?CertificateID=835. This vacuum ______M-I-15-3 20 June 29, 2015
breaker valve, as described in the 3-A® Symbol authorization, complies with Items 10p-Sanitary Piping and 11p-Construction and Repair of Containers and Equipment of the PMO; and if installed in accordance with the manufacturer’s installation instructions, the vacuum breaker valve complies with Item 16p(C) of the PMO.
This vacuum breaker valve shall be installed per the manufacturer’s specifications as follows:
It shall be mounted at least twelve (12) inches above the highest raw milk in the HTST pasteurization system on the top of a horizontal pasteurized milk pipeline between the outlet of the regenerator or cooler section and the nearest point downstream open to the atmosphere; The vent/CIP line discharge port shall be open to the atmosphere twelve (12) inches above the highest raw milk in the HTST pasteurization system; Any drain line installation shall include provisions for the effective cleaning of the drain line; and All associated piping as installed, including the drain line, shall comply with Items 10p and 11p of the PMO.
31. PMO-Section 7, Item 11p
a) M-I-08-7 (Question #37) provides information regarding the construction and cleanability of sintered stainless steel spargers used to introduce gasses into milk and/or milk products. Because these sintered stainless steel spargers cannot be effectively cleaned and sanitized, they are required to be single use. Would this single use limitation also apply to plastic spargers used for the same purpose?
Yes.
b) Is it acceptable to autoclave and reuse sintered stainless steel or plastic spargers?
No. Because of their construction, sintered stainless steel and plastic spargers cannot be effectively cleaned and autoclaved and are required to be single use.
32. PMO-Section 7, Items 11p and 12p; and Appendix J
The Regulatory Agency is responsible to collect the official samples of containers from form/fill/seal packaging machines located in milk plants as required within Appendix J-Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products of the PMO. Where and how is this required sampling evaluated during ratings and check ratings of a milk plant in which form/fill/seal packaging machines are located? ______M-I-15-3 21 June 29, 2015
They would be evaluated during the review of the Regulatory Agency’s milk plant’s container sampling records under Items 11p and 12p of the PMO.
33. PMO-Section 7, Item 11p; and Appendix J
A powder blending facility is filling 12 oz. form fill plastic pouches with nonfat dry milk (NFDM) and other dry milk powders. Is the plastic film used to form the 12 oz. pouches required to come from an IMS listed source or are all condensed and/or dried milk and milk products exempt from that requirement?
Item 11p, Administrative Procedures #11 of the PMO exempts all paper, plastics, foil, adhesives, and other components of containers used in the packaging of milk or milk products that have been condensed and/or dried from meeting the requirements of Appendix J of the PMO. Containers used to package milk or milk products that have been condensed and/or dried shall be non-toxic, free from deleterious substances and comply with the requirements of the Federal Food, Drug and Cosmetic Act (FFDCA).
Therefore, the 12 oz. form fill plastic pouches as used in your question or other containers that package condensed and/or dried milk and/or milk products are not required to be from an IMS Listed single-service container/closure manufacturing facility.
34. PMO-Section 7, Item 11p; and Appendix J-Section D, Item 20
Single-service container/closure manufacturing plants are utilizing colorants and resin additives that have certification letters (Food Contact Surfaces (FCS) Notification (FCN)) stating the product complies with FDA. Is this acceptable for the colorant/resin to be used in the production of single- service items in IMS Listed single-service container/closure manufacturing plants in place of stating the colorant/resin complies with 21 CFR 174-178?
Yes. Proposal 214 from the 2011 NCIMS Conference incorporated the FCN process into Section D-Fabrication Plant Standards, Item 20-Identification and Records within Appendix J of the PMO and reads: "materials complies with the requirements of 21 CFR Parts 174-178 ..." This replaced the previous wording of only citing "21 CFR Parts 175-178 ...". 21 CFR 174 Indirect Food Additives: General, was added to the PMO in order to reference the newer FCN acceptance found in 21 CFR 174.5 that FDA has been using and would be acceptable under the PMO to determine compliance with Appendix J, Section D, Item 20 of the PMO.
NOTE: A FCN is an effective premarket notification for FCS that has been demonstrated to be safe for their intended use. The FCN shall include the FCS, the notifier, the manufacturer of the FCS, the intended use, the limitations on the conditions of use for the FCS and its specifications, the ______M-I-15-3 22 June 29, 2015
effective date, and its environmental decision. Under section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348 (h)(2)(C)) a FCN is only effective for the manufacturer or supplier identified in the FCN. Persons who market a FCS based on an effective FCN must be able to demonstrate that the FCN is effective for their FCS. All persons who purchase a FCS manufactured or supplied by a manufacturer or supplier identified in an effective FCN may rely on that FCN to legally market or use the FCS for the use that is the subject of the FCN, consistent with any limitations in that FCN.
35. PMO-Section 7, Item 11p; and Appendix J-Sections C and D
Questions relating to the IMS listing and use of single-service ceramic (clay) pots as a packaging container for Grade “A” milk and/or milk products.
a) What Material Code would be utilized to list ceramic (clay) pots as a single-service packaging container for Grade “A” milk and/or milk products?
At the current time list them under Material Code 8-Glass. FDA’s MMPB will evaluate this situation to determine if a specific Material Code for “Ceramic” needs to be added to FORM FDA 2359d-Report of Certification (Fabrication of Single-Service Containers and Closures for Milk and Milk Products) at a later date if the manufacturer or other manufacturers choose to continue to be listed for a period of time.
b) Appendix J, Item 20-Identification and Records of the PMO requires that the fabrication plant shall have on file information from suppliers of raw materials, waxes, adhesives, sealants, coatings and inks indicating that the material complies with the requirements of 21 CFR 174-178. What 21 CFR 174-178 requirements would apply to the use of ceramic (clay) pots used as single-service packaging containers for Grade “A” milk and/or milk products?
The glaze that is used as a component of the packaging container materials shall be non-toxic and free of intentionally added lead or cadmium where migration of the lead or cadmium to food cannot be ruled out. The food- contact surface shall not contain significant levels of naturally occurring lead, cadmium, or other substances of toxicological concern as unintended contaminants, where migration of the contaminant to food cannot be ruled out. Any component substance of the ceramic pots (e.g., components of a glaze) reasonably expected to migrate to the food that is not authorized under FDA regulations for its intended use would require a submission for FDA premarket approval as an indirect food additive in the form of a FCN or a threshold of regulation (TOR) exemption, if it is not GRAS, or prior sanctioned for this use. If the ceramic food-contact surface is coated with a resinous or polymeric coating, usage of the coating could be authorized if it ______M-I-15-3 23 June 29, 2015
complies with the identity and specification requirements of 21 CFR 175.300-Resinous or Polymeric Coatings. All coatings shall also comply with 21 CFR 174.5-Indirect Food Additives. The manufacturer may seek further guidance from the FDA CFSAN Office of Food Additive Safety (OFAS): (240) 402-1200 or Fax: (301) 436-2973.
c) Do the FDA Compliance Policy Guides (CPGs) 545.400-Pottery (Ceramics); Import and Domestic (Maximum Cadmium Levels) and 545.450-Pottery (Ceramics); Import and Domestic (Maximum Lead Levels) apply to these single-service ceramic (clay) pots?
No. These two (2) CPGs are specific to tableware and do not apply to packaging container materials.
d) Are the food-contact surfaces of the single-service ceramic (clay) pots required to be glazed to be acceptable under the PMO?
Yes.
e) May cardboard dividers be used to separate the single-service clay pots during packaging and shipment if the cardboard dividers meet the bacteriological standard of Appendix J of the PMO and are in compliance with 21 CFR 174-178.
Yes, provided that the cardboard dividers, which are classified as single use articles, are not reused in any fashion by either the manufacturing facility or the milk plant that is utilizing the single-service ceramic (clay) pots.
36. PMO-Section 7, Items 11p and 14p; and Appendix J
a) A milk plant wishes to make traditional Greek yogurt by using strainer bags to strain out the whey. If the strainer bags are single-service and handled in a sanitary manner during storage and use would the use of these strainer bags meet the intent of the PMO?
Yes. The strainer bags shall be constructed of non-toxic material as required in Item 11p of the PMO and shall be handled, stored and protected as required in Item 14p-Storage of Single-Service Containers, Utensils, and Materials of the PMO.
b) Would these single-service strainer bags be required to come from an IMS Listed source?
No.
______M-I-15-3 24 June 29, 2015
NOTE: The answers to a) and b) above would also apply if a milk plant chooses to use cheese cloth as a single-service article to strain out the whey in their production of traditional Greek yogurt.
37. PMO-Section 7, Item 12p
A milk plant is utilizing electronic records for documenting the required cleaning and sanitizing of multi-use containers, utensils and equipment. If during the course of a rating or check rating, the electronic records cannot be accessed or produced what should a SRO or RMS do?
If by the time that the rating or check rating of the physical inspection of the milk plant has been completed and records still are not able to be accessed or provided to the SRO or RMS, then Item 12p(a)-Containers, Utensils and Equipment Effectively Cleaned; 12p(b)-CIP Cleaning Requirements of Ordinance in Compliance; Records Complete; and 12p(c)-Approved Sanitization Process Applied Prior to Use on FORM FDA 2359-Milk Plant Inspection Report shall all be debited.
38. PMO-Section 7, Item 12p; and Appendix H-Sections IV and V
Item 12p of the PMO provides for the use of electronic cleaning records that comply with the applicable provisions of Appendix H, Sections IV and V of the PMO for temperature recording devices, with or without hard copy. Are these electronic cleaning records required to be 21 CFR 11 compliant?
No.
39. PMO-Section 7, Item 12p; and Appendix J
Appendix J of the PMO requires that during any consecutive six (6) months, at least four (4) sample sets of containers shall be collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days, and that they be analyzed at an Official, Commercial or Industry Laboratory approved by the Milk Laboratory Control Agency. An IMS listed single-service container manufacturing facility produces containers seasonally and would not be able to meet the four (4) out of six (6) month PMO sampling frequency requirement. For this situation, when should samples be collected and tested to be in compliance with the PMO?
Sample sets of containers shall be collected and tested during each of the months of production to be considered in compliance with the PMO.
______M-I-15-3 25 June 29, 2015
40. PMO-Section 7, Item 12p; and Appendix J-Section C
How should a final assembled single-service container and closure, a five (5) gallon container/pail with a lid that includes a gasket as a component part in the lid, be sampled and tested under Appendix J, Section C-Bacterial Standards and Examination of Single-Service Containers and Closures of the PMO?
The gasket is considered a component part and shall come from an IMS listed source. During any consecutive six (6) months, at least four (4) sample sets shall be collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days, and analyzed at an Official, Commercial or Industry Laboratory approved by the Milk Laboratory Control Agency specifically for the examinations required within Appendix J of the PMO. The containers/pails with the lids attached shall be sent to the laboratory in a closed pre-filled condition. The laboratory testing the submitted four (4) sample sets shall conduct their testing procedures in the following manner:
If the lid can be opened and then re-sealed by the laboratory aseptically or if possible to aseptically inject with a suitable syringe/needle apparatus, then a rinse solution can be introduced into the pail/container and the rinse method test can be performed; or If the rinse method test is not appropriate, then the laboratory will remove the lid and perform swab testing of all milk and/or milk product contact surfaces, i.e., the inner side of the lid, gasket and container/pail.
NOTE: The component parts i.e., lid, container/pail, or gasket, shall not be sent to the laboratory separately. It shall be tested as it will be used to hold milk and/or milk product.
41. PMO-Section 7, Item 12p; and MMSR-Preface
A plant in the U.S. manufactures 64 oz. glass refillable milk bottles and they ship the multi-use glass bottles to a plant in Canada that prints the multi-use glass bottles and then drop ships the multi-use bottles back to milk plants in the U.S. As the multi-use glass bottles are not single-service and are refillable; whereas, the milk plant is responsible for sanitizing and washing the multi-use glass bottles prior to filling. Is the multi-use glass bottle manufacturing plant and/or the printing plant required to be IMS Certified/Listed under the NCIMS Grade “A” Milk Safety Program?
No. Neither plant is required to be IMS Certified/Listed because these are multi-use glass bottles.
______M-I-15-3 26 June 29, 2015
42. PMO-Section 7, Items 15p(A) and 15p(B)
a) May a caustic rinse followed by a clear water rinse, which is considered a “caustic short wash”, be conducted after processing manufacturing grade milk and/or milk product and before processing Grade “A” milk and/or milk products on the same pasteurization system, provided both are process as Grade “A”?
Yes. When a “caustic short wash” is used, Item 15p(B), Administrative Procedures #1 of the PMO requires that during processing, including CIP operations, pipelines and equipment used to contain or conduct milk and/or milk products shall be effectively separated from tanks or circuits containing cleaning and/or sanitizing solutions.
b) With the scenario in a) above would a full CIP be required?
No. Neither a “caustic short wash” nor a full CIP would be required. A water rinse would be considered adequate separation and the raw and pasteurized milk and/or milk products are kept physically separated as cited under Item 15p(A), Administrative Procedures #15.
NOTE: If both grades of milk and/or milk products are not being processed as Grade “A” utilizing the same pasteurization system, then a full CIP, including a sanitization step, would be required.
43. PMO-Section 7, Item 15p(B)
a) M-b-354, issued 1/28/2008, addresses Sudmo mixproof valves used for the separation of cleaning solutions from milk and/or milk products, which were equipped with control tops of an older style manufactured by Burkert Fluid Control Systems. New Sudmo mixproof valves are being equipped by Sudmo with a new style control top that is also being manufactured by Burkert Fluid Control Systems. Does M-b-354 cover both of these Sudmo mixproof valves
No. M-b-354 only covers the Sudmo mixproof valve with the older style control top, as was submitted and reviewed. A change in the control top would require an additional review and a supplement to M-b-354.
b) The new Sudmo mix proof valve with the newer style Burkert Fluid Control Systems control top has a 3-A® Symbol authorization granted under 3-A® Sanitary Standards for Double-Seat Mixproof Valves, Number 85-. Would these new Sudmo mixproof valves with the newer style Burkert Fluid Control Systems control tops be considered to be in compliance with the PMO?
______M-I-15-3 27 June 29, 2015
Yes.
44. PMO-Section 7, Item 15p(B)
a) M-b-359, issued 6/29/2009, addressing Tuchenhagen mixproof valves used for the separation of cleaning solutions from milk and/or milk products, which were equipped with Tuchenhagen control tops. A milk plant engineer would like to replace the Tuchenhagen control top with the Burkert Fluid Control Systems control top on these Tuchenhagen valves that were previously reviewed and accepted under M-b-359. Would M-b-359 cover such a replacement of the control top?
No. A change in the control top would require an additional review and a supplement to M-b-359.
b) If a milk plant replaces the Tuchenhagen control top with a Burkert Fluid Control Systems control top would the original 3-A® Symbol authorization for the Tuchenhagen valve with the Tuchenhagen control top still be valid?
No. 3-A® SSI has informed FDA that the 3-A® Symbol authorization would be considered invalidated because the control top had been changed from the one (1) reviewed and verified during their current 3-A® Symbol authorization.
NOTE: Tuchenhagen has also informed FDA that such a change would invalidate their warrantee.
45. PMO-Section 7, Item 15p(B)
In relationship to Questions 43 and 44 above, how can Regulatory Agency personnel, SROs and RMSs determine if a control top for a 3-A® mixproof valve with a 3-A® Symbol authorization is actually the control top that was reviewed and verified during the mixproof valve’s current 3-A® Symbol authorization?
3-A® SSI has issued a guidance bulletin for their certified conformance evaluators (CCEs), requiring that the control top be identified by the Model Type and also any required program details to sufficiently allow an inspector, SRO or RMS to assure the model is correct and the top is capable of meeting the stem position sensing sensitivity. This information is to appear on the 3-A® Symbol authorization. If the mixproof valve had been granted a 3-A® Symbol authorization for compliance with 3-A® Sanitary Standard 85-## before this requirement goes into effect and the control top is identified, Regulatory Agency personnel, SROs and RMSs may seek documentation from the mixproof valve manufacturer that the identified control top was in use and included on the mixproof valves that were last
______M-I-15-3 28 June 29, 2015
reviewed and granted a 3-A® Symbol authorization for compliance with 3-A® Sanitary Standard 85-##.
Compliance with 3-A® Sanitary Standard 85- for the mixproof valve and control top in use may also be established by documenting that the valve(s) and their control top(s) comply with all required testing as specified within D14-Additional Requirements to Separate Milk and Milk Products from Cleaning and Sanitizing Solutions (with or without seat-lift cleaning) of 3-A® Sanitary Standard 85-##.
46. PMO-Section 7, Item 15p(B)
Is there an official definition for pasteurized water within the PMO?
There is not a specific definition within Section 1 of the PMO; however, Item 15p(B), Administrative Procedures 2 of the PMO provides an operational definition of pasteurized water. Administrative Procedures 2 requires that pasteurized water shall:
a. Meet at least the minimum times and temperatures provided for in the definition of Pasteurization within the PMO in equipment that may not meet Item 16p-Pasteurization and Aseptic Processing and Packaging of the PMO; or b. Meet the requirements found in Appendix H, Section IX-Accepted Process for the Creation of Pasteurized Equivalent Water – Ultraviolet Light (UV) Disinfection of Water of the PMO; or c. Have undergone an equivalent process found acceptable by FDA and the Regulatory Agency; or d. Have undergone a hazard evaluation and safety assessment of the specific water supply and application involved and has undergone an additional treatment to destroy or remove bacteria acceptable to the Regulatory Agency, in consultation with FDA, to ensure the water will not compromise the safety of milk or milk products. Supporting information shall be submitted to and approved by the Regulatory Agency.
47. PMO-Section 7, Item 15p(B)
Item 15p-Protection from Contamination, Administrative Procedures 15p(B)2.d of the PMO describes requirements to produce pasteurized equivalent water and requires that the milk plant shall submit supporting information to the Regulatory Agency for their review and approval. The supporting information that is required to be submitted is described in 15p(B)2.d(1) through (5). Item 15p(B)2.d (5) requires "Documentation that the source water shall meet or exceed the EPA Safe Drinking Water Bacteriological Standards. Safety Assessment comparison of samples from the facility’s water source, pasteurized water, and proposed equivalent ______M-I-15-3 29 June 29, 2015
water. Water samples shall be collected daily for two (2) weeks following approval of the initial installation and every six (6) months thereafter; and”.
a) Does Item 15p(B)2.(5) mean that when testing pasteurized equivalent water for bacteria, the milk plant’s water would be initially tested for bacteria to see if it meets the EPA Standards, then the pasteurized water would be tested for bacteria as the control and those results would be compared to the bacterial results from the pasteurized equivalent water?
Yes.
b) Must the bacterial results for the pasteurized equivalent water indicate that they are comparable (substantially the same) to the bacterial results for the pasteurized water (control)?
Yes.
c) A milk plant has elected to only test for E. coli to compare the milk plant’s water, pasteurized water and pasteurized equivalent water. All of the results for all of the different waters tested are the same at <1 CFU for E. coli. Is this enough bacteriological data for making the required comparison?
No. The milk plant shall perform additional bacteriological tests that can provide more differentiation and demonstrate whether the results for the pasteurized equivalent water are comparable to the results for the pasteurized water and that both test results are lower than similar bacterial test results for the milk plant’s source water.
NOTE: Historically, Regulatory Agencies have utilized coliform and often bacterial counts. Whatever standards or testing methodology are used, they shall be acceptable to the Regulatory Agency, in consultation with FDA, and shall be able to demonstrate that the proposed pasteurized equivalent water will not result in a compromise to the safety of the milk or milk product exposed to this water.
d) Water samples are required to be collected daily for two (2) weeks following the approval of the initial installation. May milk plant personnel collect these required samples?
Yes.
NOTE: All supporting information provided to the Regulatory Agency shall include water test results comparing the milk plant’s water source, pasteurized water and proposed pasteurized equivalent water daily for two (2) weeks following initial installation and every six (6) months thereafter. ______M-I-15-3 30 June 29, 2015
48. PMO-Section 7, Item 15p(B)
Previously accepted pasteurized equivalent water proposals have utilized a .1 micron filter. Would the utilization of a .2 micron filter be acceptable under a previously accepted pasteurization equivalent water proposal?
No. Item 15p, Administrative Procedures, 15p(B)2.d of the PMO provides for a hazard analysis and safety assessment of the specific source water supply, the application involved and the specific process to be applied. Whether this, or any other technology and/or criteria would be acceptable to the Regulatory Agency is dependent upon that individual hazard analysis and safety assessment and on the supporting information and data provided to and found acceptable by the Regulatory Agency, in consultation with FDA.
49. PMO-Section 7, Item 16p
A milk plant plans to install pressure differential controllers on the heater and cooling sections of HTST and HHST pasteurization systems. Failure to maintain at least a 69 kPa (10 psi) difference in each of these sections will cause the pasteurization system to divert. The milk plant has stated that the monitoring and control functions will not be in the “public health control” programmable logic controller (PLC) but will cause the system to divert and have to go through a complete CIP and sterilization/sanitization cycle before returning to processing.
NOTE: The current 3-A® Accepted Practice for continuous flow pasteurization systems provides guidance regarding pressure controls for the cooling section; however, within the PMO these pressure controls for the cooling section are not required.
a) Are the operational controls for these pressure differential controllers on the heater and cooling sections required to be located in the “public health control” PLC?
No. However, the Regulatory Agency shall evaluate these additional operational controls that are added to the HTST/HHST pasteurization systems to determine that the legal pasteurization process cannot be compromised.
b) Should the Regulatory Agency take regulatory action against a milk and/or milk product that has not met the milk plant’s standards for these additional operational controls on their HTST and/or HHST pasteurization systems?
______M-I-15-3 31 June 29, 2015
As long as the legal public health controls fully comply with the PMO requirements and the legal pasteurization process is not compromised, the Regulatory Agency would not be required to take regulatory action.
c) If installed, are the additional operational controls required to be operational for all milk and/or milk products?
No. That decision is left to the milk plant.
d) Is the Regulatory Agency required to test these additional operational controls during the routine quarterly HTST/HHST equipment tests?
No.
50. PMO-Section 7, Item 16p
May powdered (dry) cocoa and powdered (dry) cane sugar be added after pasteurization if they meet the "provided" language cited in Item 16p of the PMO?
Item 16p of the PMO lists ingredients which shall be added prior to pasteurization, including cocoa and cocoa product. It also describes criteria for ingredients which may be added after pasteurization: “Provided, ingredients which may be added after pasteurization are those flavoring ingredients and other ingredients which have been found to be safe and suitable and which include: …”
Powdered (Dry) Cocoa-No.
Cocoa and cocoa products have a history of being contaminated with Yersinia sp., and have been implicated in illness outbreaks when they were added after pasteurization. Cocoa and cocoa products have NOT been found to be safe and suitable for addition after pasteurization, and shall NOT be added after final pasteurization.
Powdered (Dry) Sugar-Yes.
Dry sugars and salt are included in the listing of ingredients permitted for addition after final pasteurization.
51. PMO-Section 7, Item 16p(A)
a) Is the use of a radiant heating element as the source for the required air space heating within a batch (vat) pasteurizer acceptable within 3-A® Sanitary Standard for Non-Coil Type Batch Pasteurizers, Number 24-03
______M-I-15-3 32 June 29, 2015
which became effective July 6, 2010, and Item 16p(A)-Batch Pasteurization, of the PMO?
Yes, provided that Section E1.15 “Air Space Heating” of 3-A® Sanitary Standard 24-03 is met and compliance has been validated by the Regulatory Agency.
NOTE: The Regulatory Agency may use the requirements of Section E1.15 and validation data per Appendixes J and K of 3-A® Sanitary Standard 24 03 and the applicable PMO requirements related to material, construction, cleanability, etc. to review and accept, or reject, the use of a radiant heating element for air space heating.
b) Would this also be true for the C. van’t Reit batch pasteurizers that use an internal radiant heating element to provide the air space heating as well as an extra paddle located above the normal product level on the agitator shaft that is required to be operating in the air space to provide adequate air movement so that the air temperature one (1) inch above the milk or milk product remains equal to or greater than the temperature indicated on the air space thermometer for compliance with Section E1.15 of 3-A® Sanitary Standard 24-03?
Yes.
NOTE: This batch (vat) pasteurizer claims 3-A® compliance and claims to be acceptable under the PMO based on 3-A® compliance. However they have elected not to obtain a 3-A® Symbol authorization. Therefore, compliance with the PMO shall be based on individually evaluating all of 3 A® Sanitary Standard 24-03 as well as the applicable PMO requirements. If these batch (vat) pasteurizers are equipped with variable speed agitators the validation required by Section E1.15 of 3-A® Sanitary Standard 24-03, shall be performed with the agitator at the slowest operational speed to verify that the extra paddle on the agitator shaft will adequately move the air in the air space in such a manner that the air temperature one (1) inch above the milk or milk product remains equal to or greater than the temperature indicated on the air space thermometer. During operation, if the extra paddle intended to provide this air movement is submerged in milk or milk product, it would be considered in violation of Item 16p(A) of the PMO.
52. PMO-Section 7, Item 16p(B); and Appendix I
Item 16p(B)-High-Temperature-Short-Time (HTST) Continuous-Flow Past eurization, Administrative Procedures 2.h.2. of the PMO requires that when culinary steam is introduced directly into the milk and/or milk product, automatic means, i.e., stand-alone ratio controller and/or PLC-based ratio control system, shall be provided to maintain a proper temperature dif ______M-I-15-3 33 June 29, 2015
ferential between the incoming and outgoing milk and/or milk product to preclude adulteration with water.
a) On HHST pasteurization systems that inject steam into the milk and/or milk product and a stand-alone ratio controller is used, is there a requirement for that ratio controller to have a chart to document the proper temperature differential for the Regulatory Agency to review to assure that the milk and/or milk product is not adulterated with the water from the steam being injected?
No.
b) If a recording chart is not required, how would Regulatory Agency personnel, SROs and RMSs monitor and verify that the ratio controller is working appropriately?
The Regulatory Agency is responsible to assure that the milk and/or milk product is not adulterated with water. Documentation of this temperature differential at the ratio controller shall be provided by any means and time frames acceptable to the Regulatory Agency. The milk plant shall provide this information upon request to the Regulatory Agency, SRO or RMS for their review.
53. PMO-Section 7, Item 16p(B); and Appendix I
Item 16p(B), Administrative Procedures 2.b.(6) of the PMO requires that the flow diversion device (FDD) be located downstream of the holding tube and that the flow control sensor be located not more than 46 centimeters (18 inches) upstream from the FDD. Appendix I-Pasteurization Equipment and Controls – Tests, Test 5.6-Response Time (FDD) of the PMO requires that the FDD response time shall not exceed one (1) second. In some pasteurization systems when they are in forward flow and cooling down and when the milk and/or milk product cools down past the cut-out set point, if the FDD uses the full one (1) second to close, our calculations indicate that milk and/or milk product may make it through and out of the FDD forward flow port for up to .79 seconds before the FDD can fully close.
Shouldn't the PMO require the flow control sensor to be located further upstream on the holding tube and require a time delay before forward flow can be achieved to prevent raw milk and/or milk product from being pushed through the FDD when the pasteurization system goes into forward flow, or require the FDD to be moved to after the regenerator or cooling sections and sequence logic be required for start-up and after a FDD divert?
No. The current PMO requirements are adequate to assure the safety of the pasteurized milk and/or milk product. ______M-I-15-3 34 June 29, 2015
Rational: When a pasteurization system diverts because of temperature, the milk and/or milk product passing through the FDD during the allowable maximum one (1) second that it takes for the FDD to fully seat will be very close to the cut-out set point; which is determined by the processor, but cannot be below the minimum pasteurization temperature of 161°F (72°C). In addition, there is sanitary piping between the forward flow port of the regenerator or cooling section and within the first section(s) of the regenerator in which pathogen kill continues. Also, the response time of typical FDDs that are generally used on larger pasteurization systems that can operate fast enough to raise this as a question is very short, approximately .1 second. Finally, it is very difficult to seal holding times and cut-out temperatures at exactly the legal minimums. Therefore, Regulatory sealing normally takes place at times and cut-out temperatures above the legal minimums such that milk and/or milk product moving through the FDD has been subjected to legal pasteurization temperatures and/or times. Considering these factors, as a practical matter, milk and/or milk product moving out of the FDD forward flow port during the FDD movement will have received a pathogen kill sufficient to render the pasteurized milk and/or milk product safe.
54. PMO-Section 7, Item 16p(B); and Appendix I
A milk plant has installed the Tri Clover (Alfa Laval) 762-227 FDD, which is covered by M-b-330, issued 6/6/1997, as a replacement for the FDD on their HTST pasteurization system that is connected to an evaporator. The manufacturer’s instructions for the valve assembly test are to remove the valve body, unscrew the stem from the bottom and place a gap gauge in between the stem and actuator. They have requested permission to modify the valve stem so that they can conduct the valve assembly test without removing the valve body from the housing. They are asking if they can flatten two sides of the stem where the stem and actuator meet (point that is within the open yoke) to enable them to use an open end wrench to loosen the stem so that the gap gauge can be placed for the test. Would this be acceptable?
No. FDA has concerns about allowing a milk plant to alter the construction and manufacturer’s testing procedures of a FDD that has been officially issued an M-b based on FDA’s reviewed and acceptance of the construction and testing procedures submitted by the manufacturer of the FDD.
NOTE: With this modification to the construction and testing procedures for the Tri Clover (Alfa Laval) 762-227 FDD, M-b-330 would be null and void. Also, if this FDD has a 3-A® Symbol authorization and has been field modified, that 3-A® Symbol authorization would be null and void.
______M-I-15-3 35 June 29, 2015
55. PMO-Section 7, Item 16p(C); and Appendices H and I
Does the PMO prohibit the use of multiple constant level tanks with individual booster pumps to feed a raw regenerator of a pasteurization system through a common raw differential pressure controller located prior to the inlet of the raw regenerator?
No. However, each of the constant level tanks and each of the booster pumps shall meet all of the applicable criteria required within Item 16p(C) and Appendix H of the PMO and shall be tested as required in Appendix I of the PMO. An evaluation of the configuration, safeguards and testing of each individual installation shall be performed by the Regulatory Agency and shall be reviewed and evaluated during ratings and check ratings.
56. PMO-Section 7, Item 16p(C); and Appendix I
Please clarify Appendix I, II-Test Procedures, Test #9.2.3-Interwiring of the Pressure Differential Controller with the FDD in an HHST Continuous Flow Pasteurization System of the PMO. Procedure 3c. states that the test light should turn off when the pasteurized pressure is at least 14 kPa (2psi) higher than the raw product pressure. Should this not read the contrary and as follows: “The test light should turn off when the pasteurized pressure is at least 14 kPa (2 psi) lower than the raw product pressure.”
No. This existing wording in the 2011 PMO and what is being added to the 2013 PMO is correct.
Item 16p(C), Administrative Procedures 1 of the PMO requires that regenerators shall be constructed, installed and operated so that pasteurized milk or milk product in the regenerator will automatically be under greater pressure than raw milk or milk product in the regenerator at all times. The text that was cited specifies that the booster pump shall de energize when the pasteurized side product pressure becomes less than 14 kPa (2 psi) greater that the raw product pressure.
NOTE: The test light turning off indicates when the booster pump has been de-energized.
57. PMO-Section 7, Item 17p
Item 17p of the PMO makes the following statement:
“All pasteurized milk and milk products, except the following, shall be cooled immediately prior to filling or packaging, in approved equipment, to a temperature of 7ºC (45ºF) or less, unless drying is commenced immediately after condensing: ______M-I-15-3 36 June 29, 2015
1. Those to be cultured; …”
a) Does the statement "Those to be cultured;" include pasteurized milk and/or milk products that are intended to be cultured and set in the cup, e.g. "cup set", where culture incubation takes place after filling and capping, thus the pH of these milk and/or milk products (yogurt) may be above 4.8 at the time of filling?
For Example: Milk at 7ºC (45ºF) or less is pasteurized, cooled to a temperature suitable for culture growth, cultured on the fly going to the filler, reheated, filled at this warm incubation temperature, incubated in the sealed consumer package, sent through a blast cooling tunnel, and then into the cooler.
Yes. It would also include pasteurized milk and/or milk products that are cultured and set in a vat, tank or vessel, cooled to 7ºC (45ºF) or less and then packaged.
NOTE: In a conventional “vat set” process, milk product is brought to incubation temperature and culture is added in the vat, incubated in the vat and at the right stage of acidity development (approximately pH 4.6) the milk product is agitated and cooled to 7ºC (45ºF) or less to halt further fermentation, and then sent to the filler.
b) Do the remaining exemptions cited in Item 17p of the PMO (2-Cultured Sour Cream; 3-Acidified Sour Cream; 4-All Yogurt Products; 5-Cultured Buttermilk; and 6-Cultured Cottage Cheese) only include pasteurized milk and/or milk products that are cultured and set in a processing vat, tank or vessel, "vat set", prior to filling and; therefore, are required to meet the specific pH and/or temperature and/or container size criteria when the products are filled at temperatures above 7ºC (45ºF)?
No. This would also apply to “cup set” cultured milk and/or milk products and would require that these cultured milk and/or milk products meet the specific exemption requirements cited in Item 17p of the PMO for the applicable cultured milk and/or milk product.
58. PMO-Section 7, Item 17p
a) What is the intent of M-I-13-4 (Clarification of a Milk Plant’s and a Regulatory Agency’s PMO Requirements Related to the Temperature Exceptions Cited in Item 17p-Cooling of Milk and Milk Products and the Sampling Requirements of These Specifically Identified Milk and Milk Products in Item 17p as Addressed in Section 6-The Examination of Milk and Milk Products of the Grade “A” Pasteurized Milk Ordinance (PMO))?
______M-I-15-3 37 June 29, 2015
This M-I is FDA's official guidance provided to the SROs and RMSs of how FDA expects them to look at and evaluate, with potential debiting of their observations, the temperature exemptions cited within Item 17p of the PMO. This is how SROs and RMSs are to be trained and certified under the Grade "A" Milk Safety Program. It is FDA’s responsibility to provide such information to Regulatory and Rating Agencies, Industry and RMSs in order to assure uniformity among SROs, RMSs and IMS listed shippers.
b) Item 17p of the PMO provides for a temperature exception of being cooled immediately prior to filling or packaging to a temperature of 45ºF (7ºC) or less for milk and milk products "to be cultured". Would “to be cultured” cup-set and/or vat-set milk and milk products also need to undergo the verification requirements cited in M-I-13-4 when they go from the incubator to the cooler or does it really only apply to the "specifically identified milk and/or milk products" addressed in M-I-13-4?
M-I-13-4 only applies to the specific identified milk and milk products cited in M-I-13-4 and does not address the temperature exceptions cited for “to be cultured” milk and/or milk products in Item 17p of the PMO.
c) If a milk plant is using the yogurt temperature exception in Item 17p of the PMO, and yogurt is cooled down to 45ºF (7ºC) or less within several hours after filling and the milk plant does not push the twenty-four (24) hour requirement for the pH to be 4.60 or below after filling or the ninety-six (96) hour exception to cool down to 45ºF (7ºC) or less after filling, is the milk plant required to continue to monitor and document the related critical factors once it is verified that the milk plant’s equipment, practices, procedures, protocols, etc., cool the product down quickly and have not been changed?
Yes; however, if any of the milk plant’s equipment, practices, procedures, protocols, etc., change, i.e., the yogurt is palletized in a different configuration or placed in a different location in the cooler or a new cooler entirely, etc., then the documentation supporting the temperature exception would be required to be re-verified by the Regulatory Agency.
NOTE: The milk plant is required to continue to monitor and document the critical factors associated with the specific milk and/or milk product cooling temperature exception cited in Item 17p of the PMO after their initial verification.
d) Is a paper review of records that the milk plant keeps of every batch of milk and/or milk product the only information that is required to be considered by the Regulatory Agency when they conduct a routine inspection to re-verify the specific milk and/or milk product’s cooling temperature exception methods? ______M-I-15-3 38 June 29, 2015
No. The required Regulatory Agency’s verification of a specific milk and/or milk product’s cooling temperature exception method shall include a review of the milk plant’s records and shall also include physical verifications as needed initially and then during every routine regulatory inspection.
59. PMO-Section 7, Item 17p; and Appendix H
a) A milk plant is making flavored milks using a flavoring slurry that contains skim milk powder, which is being maintained at a temperature greater than 7°C (45°F) and plans to hold the flavoring slurry for over four (4) hours; what are the parameters for this flavoring slurry?
The temperature shall be maintained at 66°C (150°F) or greater or the tank and/or vessel(s) used to blend and hold the flavoring slurry shall be emptied and cleaned after each four (4) hours of operation.
b) A milk plant is making flavored milks using a flavoring slurry that contains skim milk powder, which is being maintained at a temperature greater than 7°C (45°F) and less than 66°C (150°F) for less than four (4) hours . Are there any temperature requirements within that range for the flavoring slurry as long as the time does not exceed four (4) hours?
No.
c) What temperature parameters would be required if the cocoa powder flavored slurry is rehydrated with hot water at ~90°C (194°F) rather than with skim milk before being added directly to the batch tank?
While there are not any specific temperature requirements/limitations addressed in the PMO for this flavored water slurry, the formula and process shall be evaluated by FDA to verify that the flavored slurry does not result in an unacceptable volume of added water to the milk and/or milk product that are being processed.
60. PMO-Section 7, Item 18p; and Appendix J
______M-I-15-3 39 June 29, 2015
Question pertaining to the above image:
a) Are threads allowed to be used in the product contact area of a single- service container and/or closure as shown in the image above?
Yes.
b) If threads are allowed in a single-service container and/or closure, would the threads be required to be of a specific design, i.e. sanitary design?
Yes.
c) Concerning the stainless steel fill pipe noted in the above image with the threads, which is attached to the threaded single-service container/closure (tote), can it be CIP/COP cleaned? Or would the stainless steel fill pipe be required to be autoclaved?
A multi-use stainless steel fill pipe, which may have threads as shown in the image, shall be of sanitary design and shall be cleanable, including any threads, and shall be properly cleaned after each use and at least once each day used and sanitized prior to its next use. The stainless steel fill pipe with threads would not be required to be autoclaved.
61. PMO-Section 7; and Appendixes B and N
Raw sheep milk samples, collected from a dairy farm, that have previously been frozen are allowed to be tested for Appendix N of the PMO, if the samples are collected in accordance with the sampling requirements cited in Appendix B-Milk Sampling, Hauling and Transportation, V. Requirements for the Sampling of Raw Sheep Milk that has been Frozen Prior to Being Tested For Appendix N Drug Residue of the PMO. Would the frozen sheep milk sample(s) require a Temperature Control (TC) sample?
No.
NOTE: Appendix N testing for drug residues shall be performed in the 0.0°C to 4.5°C temperature range. A means to determine the temperature of the thawed frozen sample(s) prior to testing shall be provided. A subsampling of the same sample or one (1) of a group of thawed frozen samples could provide this means.
It is not permissible to test frozen raw milk samples for bacteria or somatic cells.
______M-I-15-3 40 June 29, 2015
62. PMO-Section 11; and Procedures-Section IX
Would a BTU that is IMS listed under the NCIMS International Certification Program (ICP) be allowed to ship milk to a Grade “A” milk plant in the U.S.?
Yes. BTUs that are IMS listed under the ICP are provided the same privileges as an IMS listed BTU located in the U.S. The BTU would also be required to have a valid Federal Import Milk Act (FIMA) permit to import milk into the U.S.
63. PMO-Appendix B, Section I
Proposal 108 that was passed at the 2013 NCIMS Conference added to Appendix B, I-Milk Sampling and Hauling Procedures, Evaluation of Bulk Milk Hauler/Sampler Procedures, Item 2-Equipment Requirements of the PMO a new sub-item i. states: “Single service sanitary towels shall be provided for farm bulk milk tanks with a measuring rod”. Would you clarify what the term “single service sanitary towels” refers to? Does it mean individual chemically treated sanitizing wipes or single service paper towels, like normally used for hand washing on a dairy farm?
The use of the word "sanitary" was not meant to infer "chemically treated sanitizing wipes". Clean, single use "paper towels" that would normally be used to wipe your hands dry is all that is required. The reason this wording was added into Appendix B was to make it clear that the bulk milk hauler/sampler is required to have single service sanitary towels in case the dairy producer does not have single service paper towels available, either they ran out of single service sanitary towels or the dairy producer has switched to the use of an approved hand drying device.
These individual single service sanitary paper towels shall be properly protected from contamination while being stored in the cab of the milk tank truck and shall be properly handled by the bulk milk hauler/sampler while they are brought into the milkhouse and used for the wiping of the measuring rod during the measuring procedure. If the paper towels are carried into the milkhouse in a pocket of the bulk milk hauler/sampler’s clothing or a previously used paper towel is used during the measuring procedure this would be considered a violation of Item 14-Sample Collection – Precautions and Procedures, i-Do not contaminate milk during the measuring process on FORM FDA 2399a-Bulk Milk Hauler/Sampler Evaluation Report.
64. PMO-Appendix I
A State has asked for guidance with a new HTST timing device that is being developed by a company within their State. This new HTST timing device ______M-I-15-3 41 June 29, 2015
would start the holding tube pasteurization timing as soon as the valve to introduce the electrolyte from the injection device into the holding tube is moved. The State will conduct comparisons between the existing accepted HTST timing device (Lumenite) and this new HTST timing device to furnish data to a Regional Dairy Equipment Review Committee and FDA regarding the accuracy of this new HTST timing device.
Appendix I, Test 11.1-HTST Pasteurizers, Procedure 3 states that an electrode shall be placed at the beginning of the legal holding tube. This new HTST timing device would not have such an electrode. If this new HTST timing device is found to produce accurate holding time measurements acceptable to the State and FDA, would new language be required to be added to Appendix I of the PMO?
No. In order for the State’s comparison findings to be accepted nationwide, the comparison would be required to be validated through a Regional Dairy Equipment Review Committee working in cooperation with FDA. If there is consensus that the new HTST timing device will produce accurate pasteurization holding time measurements, it would be acceptable for use nationally and would be conveyed through the issuance of an M-b.
65. PMO-Appendix J, Sections A, B and C
At Plant 1, the polystyrene plastic roll stock is made into a single layer extruded sheet that is then rolled. This polystyrene plastic roll stock is then sent to Plant 2, a yogurt milk plant, where the polystyrene plastic roll stock is then connected to a packaging machine(s). As the polystyrene plastic roll stock is unrolled it is heated to soften the polystyrene plastic roll stock and it is formed into yogurt containers (cups), either by vacuum being applied to the exterior of the container (cup) molds or air is blown into the interior of the container (cup) molds, the formed containers (cups) are then filled and a paper label is applied to the outside of the newly formed and filled containers (cups).
a) Would Plant 1 that extrudes the sheets of polystyrene, rolls the polystyrene plastic sheets and ships the polystyrene plastic roll stock to Plant 2 where they are thermoformed to make yogurt containers (cups), filled and labeled have to be IMS Listed?
Yes.
b) At Plant 1, would the polystyrene plastic roll stock be considered a finished single-service product and be required to be sampled and tested or would the polystyrene plastic roll stock be considered a component part that would not be required to be sampled at Plant 1?
______M-I-15-3 42 June 29, 2015
It would be treated like a component and would not be required to be sampled at Plant 1, the manufacturing plant, and tested.
c) Would the formed polystyrene containers (cups) be required to be sampled at Plant 2, the container forming, filling and labeling milk plant, and tested?
Yes. Samples of the final molded empty containers (cups) with lids applied shall be collected directly from the forming/packaging machine(s) in order to detect possible contamination of the containers (cups) after molding and prior to packaging.
Please refer to M-I-05-4 (Question #38) for a related question and answer.
66. PMO-Appendix J, Sections A and C
Plastic film roll-stock shrink wrap labels are pre-printed on the interior side of the plastic film (the side that touches the exterior surface of the container) at a plant and then the pre-printed plastic film roll-stock shrink wrap labels are shipped directly to either:
A milk plant where the pre-printed plastic film roll-stock shrink wrap labels are applied to the outside of single-service plastic containers and the plastic containers are filled; or To another plant, where the pre-printed plastic film roll-stock shrink wrap labels are applied to the outside of single-service containers with the printed surface contacting the exterior surface of the plastic container. Plastic containers are then stacked together (nested), packaged and shipped to a milk plant where the plastic containers are filled.
Does a plant that produces the pre-printed plastic film roll-stock shrink wrap labels that are sold directly to either a milk plant or other plant that applies the pre-printed plastic film roll-stock shrink wrap labels to the outside of single-service plastic containers required to be IMS Listed?
No.
NOTE: Previously issued Qs/As have already stated that the plant cited in the second bullet above that handles the single-service containers and applies the pre-printed plastic roll-stock shrink wrap labels, packaging them and shipping them to a milk plant shall be IMS Listed. This IMS Listed facility for this specific operation shall also have documentation available that the pre-printed plastic roll-stock shrink wrap labels comply with the requirements of 21 CFR 174-178 and the bacteriological standards of Section C of Appendix J of the PMO.
______M-I-15-3 43 June 29, 2015
67. PMO-Appendix J, Section D-Item 20
Single-service containers are manufactured in a plant in the U.S. and the containers are then shipped to a plant in Canada or a different plant in the U.S. that is labeling the containers.
NOTE: Labeled containers may be distributed from the labeling plant or shipped back to the manufacturing firm for distribution. Which plant is required to be identified by either the name or city of the plant or assigned plant code on the outer wrapping or carton as required under Item 20 Identification and Records of Appendix J of the PMO?
The identification of the manufacturing plant by both the name or city (to include State, Providence, Country, etc., if applicable) of the plant or assigned plant code shall appear on the outside of the outer wrap or carton, and it is recommended that the identification of the labeling firm also appear on the outside of the outer wrap or carton identifying it as the labeling firm.
NOTE: All of the plants involved are required to be IMS listed.
68. PMO-Appendix N
Appendix N Scenario: An on-farm producer/processor has two (2) farm bulk milk tanks/silos located in the milkhouse, which are both being utilized by the adjacent milk plant as their raw milk holding tanks/silos. The milk plant is an Appendix N screening lab only and samples and tests individually each raw milk holding tank/silo each day before processing and the test results revealed that one (1) of the two (2) raw milk holding tanks/silos was positive for Beta lactams.
a) May the milk in the negative tank be processed?
No. The negative tank/silo contains milk from an identified confirmed positive dairy producer from a confirmed positive tank/silo from that dairy farm on the same day’s production. Documented evidence cannot be derived or provided as proof that none of the positive residue milk from the one (1) positive tank/silo was also not present in the negative tank/silo. This is the same rationale and approach that was used in addressing M-I-12-9 (Question #72) related to the sampling and testing of multi-compartment bulk milk tank trucks to eliminate the potential to dilute antibiotic adulterated milk with safe milk in either another compartment of a multi-compartment bulk milk tank truck or another tank/silo for a producer/processor.
b) May the milk plant clear their next day’s milking on their own using their Appendix N screening laboratory or is it required that a State or other IMS
______M-I-15-3 44 June 29, 2015
certified Appendix N milk laboratory clear the next day’s milking prior to processing?
An Appendix N screening laboratory cannot confirm or clear any milk samples for drug residues. This is an official regulatory action so it is required to be conducted in an IMS accredited Appendix N laboratory by a certified analyst.
69. PMO-Appendix N
a) When a milk plant receives raw skim milk from another milk plant that conducted the raw milk sampling and testing of the raw milk in accordance with Appendix N of the PMO, is the receiving milk plant required to sample and test the received shipment of raw skim milk for drug residues prior to further processing?
If the raw skim milk was not commingled with untested raw milk prior to its shipment, then the receiving milk plant would not be required to re-test the raw skim milk. Documentation of this raw milk testing and the results shall be included either on the bill of lading or attached to the bill of lading for the raw skim milk shipment.
b) With this scenario above, if the shipment of milk was pasteurized skim milk, would the receiving milk plant be required to sample and test the pasteurized skim milk for drug residues?
No. The only required drug residue testing for pasteurized milk and/or milk products is included in Section 6 (four (4) in six (6) months) of the PMO. This required sampling and testing conducted by the Regulatory Agency is for official regulatory purposes.
NOTE: The raw milk that was utilized in making the pasteurized skimmed milk is required to be tested in accordance with Appendix N of the PMO prior to processing at the milk plant that received the raw milk utilized in processing the pasteurized skim milk...
70. PMO-Appendix N; and MMSR-Section C
Would the following situation be considered to be “not in substantial compliance” in regards to Appendix N of the PMO and Section C-Rating Methods for Milk Plants, Receiving Stations and Transfer Stations of the MMSR while conducting the records review during a milk plant rating or check rating?
A milk plant has either misplaced and/or lost several months of Appendix N testing records. Records do not exist for a period of time to show that ALL ______M-I-15-3 45 June 29, 2015
and/or ANY raw milk tank truck loads received at the milk plant were tested per Appendix N prior to processing. This is NOT the most recent month, but is during the six (6) months before the rating or check rating.
Yes. Per Section C, Item 1 of the MMSR, "If the milk plant, receiving station or transfer station is not in substantial compliance, a rating/listing audit or check rating/FDA audit is not to be completed and the Rating Agency shall immediately withdraw the IMS certification."
71. PROCEDURES-Sections III and IV
a) If a company builds a new milk plant and is simply moving all activities to that new location does the new milk plant at the new location need to be rated by the State for their IMS listing or can the existing listing from the old milk plant just be transferred?
A new IMS listing is required for the new milk plant at the new location. Just like a permit, an IMS Listing is not transferrable with respect to location.
b) Is a listing tied to a particular address?
Yes. Because this is a new and different milk plant at a different location, the permit issued for the old milk plant at the old location is no longer valid. This new milk plant must have a valid permit issued based on an inspection of the conditions and procedures observed at the different milk plant at this different location. The old milk plant’s permit would no longer exist under this scenario; whereas, the existing IMS listing based on the conditions and procedures observed at the old milk plant would no longer be considered a valid IMS listing.
When production ceases at the old milk plant the Regulatory Agency shall notify the Rating Agency to request FDA to remove the milk plant at the old location from the IMS List. After the new milk plant has been issued a valid permit and has requested an IMS Listing, the Rating Agency can conduct a rating as required by Section IV-Oversight and Responsibilities of the PROCEDURES for the listing of any new interstate milk shipper. Normally the Regulatory and Rating Agencies coordinate these activities so that there will be very limited or not any interruption in the production and shipment of milk and milk products during this transition.
72. PROCEDURES-Section III; and MMSR-Section A
a) May an International Certification Program (ICP) Third Party Certifier’s (TPC’s) SRO be under contract with a State to perform ratings within that State?
______M-I-15-3 46 June 29, 2015
Yes. However, the SRO would be performing these ratings as an agent of the State and not the ICP TPC.
b) May a TPC contract directly with a State to conduct ratings or single- service container/closure facility audits?
No.
c) May a single-service container/closure manufacturing facility, located in a U.S. State, directly pay a TPC’s SRO, under contract with the State, to perform a single-service listings provided the State directs the work?
No. A TPC’s SRO is acting as an agent of the State Regulatory Agency. They have a contract with the State and the State would be required to pay for the work that is contracted for with the TPC SRO.
73. PROCEDURES-Section III; and MMSR-Section A
A SRO by definition is not to have direct responsibility for the routine regulatory inspection and enforcement or regulatory auditing of the shipper to be rated or listed. Are SROs allowed to evaluate new equipment for their State? The SRO would not give final approval or disapproval, but would evaluate and give their opinion to the Dairy Program Manager. The Dairy Program Manager would make the final determination of the equipment’s compliance with the PMO and sign the State’s approval/disapproval letter.
FDA’s MMPB would not see an issue with a SRO assisting in the review and evaluation of new equipment as cited above.
74. PROCEDURES-Section IV
a) Is a State required to send out a notification letter to all known receiving States when an IMS listed shipper is listed for six (6) months with an Enforcement Rating of less than 90?
Yes.
Section IV-Oversight and Responsibilities, B-State Responsibilities, 1-State Ratings, d. of the Procedures states:
d. When a certified interstate milk shipper's supply, raw or pasteurized, changes status because of degrading, permit revocation, significant change in number of producers, or change in the Sanitation Compliance or Enforcement Rating to less than ninety percent (90%), the shipping State shall immediately notify all known receiving States and the appropriate PHS/FDA Regional Office. ______M-I-15-3 47 June 29, 2015
b) What action is required of the receiving States that are notified of this Enforcement Rating of less than ninety percent (90%)?
No action is required. This required notification is to inform the receiving State(s) that a rerating or reinspection, respectively, will be required to be conducted within six (6) months of the rating with the Enforcement Rating of less than ninety percent (90%) or the BTU or milk plant will be withdrawn from the IMS List. The notification is more of a heads up to the receiving State(s) to make them aware that this BTU or milk plant has the potential to be withdrawn from the IMS List in the next six (6) months.
75. PROCEDURES-Section IV; and MMSR-Section C
a) A milk company sets up a separate production operation for yogurt in the same building used for fluid milk production utilizing basically all separate equipment. May they request and receive separate IMS Listings for each operation as two (2) separate PMO entities?
No. This is one (1) milk plant with a single IMS Listing that produces yogurt and other PMO fluid milk and/or milk products.
b) When may milk plants that produce different Grade “A” milk and/or milk products with different operations performed within the same building be provided the opportunity to have separate IMS Listings?
1. Milk plants that produce both pasteurized and/or ultra-pasteurized Grade “A” milk and/or milk products and condensed and/or dried Grade “A” milk and/or milk products, with the stipulation that both operations shall have separate permits issued by the Regulatory Agency. 2. Milk plants that produce both pasteurized and/or ultra-pasteurized Grade “A” milk and/or milk products and aseptically processed and packaged Grade “A” low-acid milk and/or milk products. 3. Milk plants that produce both pasteurized and/or ultra-pasteurized Grade “A” milk and/or milk products and retort processed after packaged Grade “A” low-acid milk and/or milk products. 4. Milk plants that produce pasteurized and/or ultra-pasteurized Grade “A” milk and/or milk products, aseptically processed and packaged Grade “A” low-acid milk and/or milk products, and retort processed after packaged Grade “A” low-acid milk and/or milk products.
76. PROCEDURES-Section V
Section V-Qualifications and Certifications, D-Milk Sanitation Rating Personnel, 10 of the Procedures states:
______M-I-15-3 48 June 29, 2015
“To be re-certified, a certified SRO shall have during the three (3) year period attended at least one (1) PHS/FDA Regional Milk Seminar, attended at least one (1) training course, which includes the auditing of milk plant HACCP Systems and NCIMS listing, if applicable, and attended at least one (1) PHS/FDA training course on “Special Problems in Milk Protection” or other training judged by PHS/FDA to be equivalent and appropriate.”
If a SRO is going to retire prior to the expiration date of his/her current valid SRO certificate would the SRO be required to meet the SRO re-certification requirements cited above?
No, because their certification will not expire prior to their upcoming retirement. However, the SRO and the State or TPC, if applicable, need to be aware that if the SRO were to wish to conduct ratings after the expiration date of his/her current SRO certification and the SRO has not met the requirements for re-certification cited above that FDA would not accept any ratings conducted by the SRO until the SRO met the initial SRO certification requirements, including a Regional Milk Seminar, attendance at a HACCP course, if applicable, and attendance at a Special Problems course or one (1) that was determined by FDA to be equivalent, etc..
NOTE: This would also apply to a LEO that is going to retire prior to the expiration date of his/her current valid LEO certificate and the applicable requirements which are to be met for LEO re-certification.
77. PROCEDURES-Section V
a) When a RMS is conducting the initial certification of a SRO or SSO, how many candidates may be certified at one time?
One (1).
b) When a RMS is conducting the recertification of a SRO or SSO, how many SROs or SSOs may be certified at one (1) time?
Multiple. This number should be determined based on the number of SROs or SSOs that the RMS feels comfortable with recertifying at one (1) time to make sure that they can appropriately and adequately evaluate each and every SRO and/or SSO.
c) When a FDA certified SSO is conducting the initial certification of a delegated Sampling Surveillance Officer (dSSO), how many candidates may be certified at one (1) time?
One (1).
______M-I-15-3 49 June 29, 2015
d) When a FDA certified SSO is conducting the recertification of a dSSO, how many dSSOs may be certified at one (1) time?
Multiple. This number should be determined based on the number of dSSOs that the FDA certified SSO feels comfortable with recertifying at one (1) time to make sure that they can appropriately and adequately evaluate each and every dSSO.
78. PROCEDURES-Section V; and EML-Section 3
May a Regulatory Agency or Laboratory Control Agency, as applicable, request the removal of one (1) of their FDA certified Laboratory Evaluation Officers (LEOs) if they deem that the individual is not conducting the work as an LEO properly?
Yes. All Regulatory or Laboratory Control personnel involved in the Grade “A” Milk Safety Program work at the discretion of their Regulatory Agency or Laboratory Control Agency, as applicable. If the Regulatory Agency or Laboratory Control Agency, as applicable, feels that an individual is not representing the Grade “A” Milk Safety Program appropriately or effectively, the Regulatory Agency or Laboratory Control Agency can remove them from performing those duties. Based on such action, the Regulatory Agency or Laboratory Control Agency, as applicable, would then provide official notification to FDA to remove the individual’s FDA certification. Before FDA could revoke the LEO’s certification, they would have to following Section V-Qualifications and Certification, H-The Hearing Procedure for Revoking the Certification of a SRO, SSO, or LEO of the Procedures.
NOTE: This would also apply to a SRO and/or SSO. The Regulatory Agency may request FDA to remove the individual’s FDA certification as a SRO and/or SSO.
79. MMSR-Section F
Currently, what is the maximum number of Product Codes that a milk plant can be listed for on the IMS List when submitting the rating information utilizing the electronic version of FORM FDA 2359i-Interstate Milk Shipper’s Report through the FDA web site?
Fifteen (15) different Products Codes.
80. EML-Section 1; and FDA 2400 Forms
The following questions or concerns are regarding the use of the recently approved Charm EZ Reader (M-I-13-2). ______M-I-15-3 50 June 29, 2015
a) May a laboratory purchase and begin using the new Charm EZ Reader?
Yes. While laboratories may contact Charm Sciences and arrange the purchase of the EZ Reader, at the time this question was asked, the current NCIMS/FDA 2400 Form only allowed an equivalent reader to the Pearl/ROSA readers; therefore, the new EZ Reader could only officially be used in the “read only” mode until a revised NCIMS/FDA 2400 Form incorporating the alternative “incubate and read” mode was approved. The NCIMS/FDA 2400 Form has now gone through the usual NCIMS approval process and has been released for its use by LEOs and laboratories. The Charm EZ Reader can now be used in both the “read only” and “incubate and read” modes. In addition to the NCIMS/FDA 2400 Form, Charm can provide a protocol on the use of their various approved readers.
b) Will LEOs need to conduct an on-site survey or send split samples for an analyst to become certified or approved to use the EZ Reader?
No. Since the EZ Reader will be used in conjunction with currently approved M-a-85 drug test kit methods it will not be necessary for certified and approved analysts to be surveyed or conduct split samples. However, laboratories MUST inform their LEO that the EZ Reader has been obtained and that analysts have undergone the training that Charm intends to offer. The EZ Reader may only be officially used for methods for which analysts are currently certified or approved. Conditional certification or approval of new analysts or methods to be used with the EZ Reader will require an on- site evaluation or split samples as determined by the LEO.
c) Once officially in place what happens if an initial positive result is obtained with an EZ Reader?
If an initial positive is found with an EZ Reader then the completion of the presumptive testing to determine if the sample is presumptive positive or not MUST be done with the EZ Reader. It will be acceptable to complete the bulk milk pickup tanker confirmation and producer trace back with the EZ Reader as long as the analyst is certified and follows the pre-arranged protocol established with the State.
d) If a screening laboratory uses an EZ Reader will the confirming laboratory have to also use an EZ Reader? No. The Pearl/Rosa readers and the EZ Reader have been demonstrated to be equivalent. Confirming laboratories will not have to replace their readers if someone else uses the new EZ Reader, as long as the confirming laboratory reader (Pearl or ROSA) is capable of performing the same or equivalent test. As long as the kits are equivalent then it does not matter which reader is used.
______M-I-15-3 51 June 29, 2015
e) Is switching between readers allowed during testing?
Switching between readers is not allowed within a testing process, e.g., presumptive testing, confirmation testing, producer trace back, or Section 6 of the PMO testing. Switching may only occur between the presumptive positive stage and bulk milk pickup tanker confirmation, or between the bulk milk pickup tanker confirmation and producer trace back.
f) Will a laboratory be required to purchase the EZ Reader when it becomes available?
No. As long as Charm provides and continues to support the Pearl and other ROSA Readers, laboratories will not be required to purchase the EZ Reader to replace their current reader. Should a reader become non functional the reader will need to be replaced with any approved reader available. At this point, there is NO sunset date on the Charm Pearl Reader. Charm will continue to produce and provide Pearl Readers.
g) Can the color coded strips made for the EZ Reader be read on the Pearl or ROSA Readers?
Yes; however, the reverse is not true. EZ compatible test strips are color coded by assay type. The EZ Reader WILL NOT read or run non-color coded strips. The color coding is detected by the EZ Reader and used to select the correct channel/test for the strip that is inserted. Also, incubated strips are not to be read using multiple readers. For example, an incubated strip is read on one (1) reader to get the official result. If the laboratory has a second reader, regardless of type, the strip is not to be read using the second reader.
h) May the EZ Reader be substituted as a heater and reader?
Yes; however, to do this officially it will require a FDA 2400 Form modification. Users should be aware that the EZ Reader only has a single slot to insert a strip so it can only run one (1) test at a time in the “read only” or in the “incubate and read” modes. The EZ Reader can be used in conjunction with external heating blocks when set in the “read only” mode to only read incubated color coded strips. Depending on the desire or need of a laboratory, the EZ Reader can be used in the “incubate and read” mode. In this case, the EZ Reader serves as both the heater block and reader. There could be situations where a laboratory may wish to use a combination of both modes. For instance, the daily performance monitoring could be conducted in the “read only” mode. Then for routine testing, the EZ Reader could be set to the “incubate and read” mode to generate test results. An Appendix N example could be when a Charm3 SL3 test is performed with the EZ Reader in the “incubate and read” mode. If an initial positive is ______M-I-15-3 52 June 29, 2015
determined, then the laboratory would have the option to continue in this mode or switch to the “read only” mode for the follow-up presumptive testing to determine whether the sample is presumptive positive or not. In this case of using the “read only” mode, the controls and duplicate samples would be incubated using one (1) or more external incubators. The EZ Reader would prompt the analyst sequentially through the necessary steps to take. The EZ Reader can be set up according to the needs of the laboratory to give prompted follow-up bulk milk pickup tanker and producer trace back confirmations.
______M-I-15-3 53 June 29, 2015