HHS:PHS:FDA:CFSAN:OC:DCP:MSB
5100 Paint Branch Parkway
College Park, MD 20740-3835
M-I-03-17
December 11, 2003
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Questions and Answers from FY'03 Regional Milk Seminars and Special
Problems in Milk Protection Courses
Following are questions and answers from Regional Milk Seminars and Special
Problems in Milk Protection Courses held in FY 2003.
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 a public health hazard, reasonable
judgment should be exercised, and adequate time provided for modification and
correction.
Copies of this memorandum are enclosed for distribution to Regional Milk
Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation
Officers and State Milk Sanitation Rating Officers in your region. This
memorandum should be widely distributed to representatives of the dairy industry
and other interested parties and will also be available on the FDA Web site at
http://www.cfsan.fda.gov at a later date.
/ss/ /ss/
Norris A. Robertson, Jr., CAPT Robert F. Hennes, RS, MPH, Chief
Milk Sanitation Officer Milk Safety Branch
Milk Safety Branch
QUESTIONS and ANSWERS
from the
SOUTHEAST REGION MILK SEMINAR-10/7-10/2002,
PACIFIC REGION MILK SEMINAR-11/19-21/2002
and the
FD 5107 SPECIAL PROBLEMS IN MILK PROTECTION COURSES- 7/14-18 (Rockford, IL) and
8/18-22/2003 (Statesville, NC)
1. PMO-Section 1 and Appendix L
Besides M-I-03-9, are there any additional references for Tolerances for
Residues of New Animal Drugs in Milk?
Another useful source is 21 CFR 556-"Tolerances for Residues of New Animal Drugs
in Food".
2. PMO-Sections I and 4; and Appendix L
May a mixture of non-fat milk solids and water be included as an ingredient in
reduced fat milk, lowfat milk, etc.?
No.
3. PMO-Sections 1 and 4; and Appendix L
May you "standardize" cream from 30% to 18% milkfat with water and still label
the final product as "cream"?
No. The standard of identity for cream does not provide for water as an added
ingredient.
4. PMO-Sections I, 4 and 7; and Appendix L
What is the difference between reconstituting and standardizing a dairy product?
Reconstituted or recombined milk and/or milk products mean those milk or milk
products, as defined in Section I of the PMO, which result from reconstituting
or recombining of milk constituents with potable water followed by legal
pasteurization. Standardizing a dairy product means adjusting the milkfat
content of milk by adding or removing cream or non-fat (skim) milk.
NOTE: Standardization of Grade "A" milk and milk products with other than Grade
"A" milk and milk products is prohibited under the PMO.
5. PMO-Sections 1, 4 and 7; and Appendix L
a. May carbon dioxide (CO2) be used in cottage cheese as a headspace filler,
during packaging, or be incorporated into the product? If so, what are the
labeling requirements?
Yes to both uses. Exemption for declaration of the CO2 in the food label
ingredient statement is dependent upon determination if the amount and usage of
the ingredient (CO2) meets the requirements set forth in CFR 21 part
100.100(a)(3) Food, exemptions from labeling, for incidental additives and
processing aids. When CO2 is used as a headspace filler, it is considered a
"processing aide" and would not require any additional labeling. If
incorporated directly into the product, it needs to be identified in the
ingredient statement by its common name followed by a parenthetical statement as
to its function, i.e., "preservative" or "extends shelf life". IDFA has
indicated that they are gathering information for FDA's consideration in
determining if the methods of purging the cottage cheese dressing and levels of
use of CO2 in finished packages of cottage cheese will meet the requirements for
an exemption from ingredient declaration. If that information is provided, FDA
will take it under consideration.
b. May CO2 be incorporated into bulk shipments of milk products? What
are the labeling requirements?
No. This is not allowed by the standard of identity for milk. The resulting
product could not be labeled as "milk."
6. PMO-Sections 1 and 6; and Appendixes L and O
Natural Vitamin A in whole milk is approximately 1,200 IU/qt. If Vitamin A
addition is claimed on the label, it needs to be at 2,000 IU/qt. Is this
because of a nutritional consideration?
Yes.
7. PMO-Section 3 and Appendix B
a. If a bulk milk hauler/sampler has not been evaluated in the past two years,
does that hauler/sampler hold a valid license or permit?
Yes. Provided, the license has not expired, been suspended or been revoked.
b. If the initial license was issued recently, do they still hold a valid
permit?
Yes. An initial evaluation is required prior to issuing the initial permit or
license.
8. PMO-Sections 3 and 5; and Appendix B
Do milk tank trucks have to be clean before inspection and permit issuances?
It is recommended; however, it is at the Regulatory Agency's discretion.
9. PMO-Sections 3 and 6; Appendix N; and IMS-a-44 (Proposal 248)
M-a-86 (Rev. 3) doesn't specifically address which test kit can be used to test
a producer's reinstatement sample following a suspension for a positive drug
residue. Specifically, can an industry analyst run the screening test to clear
the producer before milk pick-up resumes? What test kit must be used to clear
the producer?
No. An industry analyst cannot run the screening test to clear the producer
before milk pick-up resumes. The producer's reinstatement sample is to be
analyzed at the Regulatory Agency's discretion by a certified industry
supervisor (CIS) or in a certified industry or Regulatory Agency laboratory by a
certified analyst, using the same test kit that was used to suspend the
producer's permit.
10. PMO-Sections 3 and 6; Appendix N; and M-I-96-10
May a producer's milk supply that is screened and confirmed positive, using the
Idexx Parallux be reinstated using the Charm SL?
No. The same test kit that suspended the producer's permit must be used to
reinstate the producer's permit.
11. PMO-Sections 3 and 6; and MMSR
Consider a farm that dries off (discontinues production) for an extended period
of time (60 days or more).
a. How would State Rating Officers and Regional Milk Specialists deal with the
lack of samples during ratings and check ratings?
Sampling should be conducted during the time the farm is in production.
b. Should the Regulatory Agency degrade such a farm during the dry period?
The PMO is silent on this issue. It is at the discretion of the Regulatory
Agency.
c. Does the Regulatory Agency carry the sample history forward through the
months where no product was available to sample?
Yes.
d. Should the Regulatory Agency conduct accelerated sampling at the beginning of
a new production cycle?
No. However, this is also at the discretion of the Regulatory Agency.
12. PMO-Sections 3 and 7; Appendix B; and IMS-a-44 (Proposal 108)
May a Grade "A" Interstate Milk Shippers (IMS) Listed plant unload milk from a
milk tank truck that was washed at a non-PMO permitted milk tank truck cleaning
facility?
No. Appendix B, Milk Tank Truck Standards, Item 5., Wash and Sanitize Record,
Sub-item a. of the PMO states: "The bulk milk hauler/sampler shall be
responsible for assuring that the milk tank truck has been properly cleaned and
sanitized at a permitted milk plant, receiving station, transfer station, or
milk tank truck cleaning facility. A milk tank truck without proper cleaning
and sanitizing documentation shall not be loaded or unloaded until the proper
cleaning and sanitization can be verified."
13. PMO-Section 4
What labeling is required on a Bill of Laden for bulk shipped heat-treated
blends of Grade "A" ingredients being shipped to an IMS plant for the
manufacture of Grade "A" dairy products?
The name of the Grade "A" heat-treated blend must include the proper identity of
the individual ingredients that make up the blend of Grade "A" ingredients.
14. PMO-Section 6; and Appendixes L and O
Is there some way to adjust/exempt small serving size, high fat products from
the requirement to add additional vitamin A, if the product already meets the
minimum of 2000 IU per quart? For example, does 21 CFR 130.10 (b) require the
addition of more vitamin A to non-fat half-and-half, even though one serving
(i.e., one or two tablespoons) is already near the maximum IU per quart of
vitamin A (4500 IU) as manufactured? Is there a danger of adding to vitamin
levels near toxic levels via the requirements of 21 CFR 130.10 (b)?
No adjustment or exemption is needed, as 21 CFR 130.10 (b) does not require the
addition of vitamins in amounts greater than those needed to restore vitamins
lost during the removal of the fat. Standardized foods that are modified to
make a nutrient content claim (i.e., non-fat half-and- half) must not be
nutritionally inferior to the traditional standardized food. For example, a
standardized food that is modified to make a non-fat or reduced fat claim must
have added amounts of fat-soluble nutrients in amounts needed to restore what is
lost due to complete or partial removal of fat. Amounts added greater than
those needed to simply restore lost amounts are not required for the non-fat or
reduced-fat food to be nutritionally equivalent to its traditional counterpart.
21 CFR 130.10 does not require the addition of more vitamin A to non-fat
half-and-half. When fat is removed from half-and-half to make a non-fat
half-and-half, fat-soluble vitamins that are incidentally lost along with the
removal of fat must be replaced only in amounts that are lost. Amounts over and
above those that are lost may be added, if a nutrient content claim, such as
"added" or "fortified" is made in accordance with 21 CFR 101.54.
The reference amount for "half-and-half" is 2 tbsp or 30 mL (21 CFR 101.12).
The vitamin A content of 2 tbsp of half-and-half is 106 IU (USDA Handbook 8).
Vitamin A must be added to bring the vitamin A levels of non-fat, reduced fat,
or low-fat versions of half-and-half to that found in regular half-and-half,
i.e., 53 IU/tbsp.
15. PMO-Section 6; Appendix N; and MMSR-Appendix, Part I, Dairy Farms, Product
Compliance
Why are there no PMO monetary (or equivalent) penalties for producers found to
have positive drug residues in Section 6 samples when no bulk milk pick-up
tankers are contaminated?
Though there is no direct monetary penalty addressed in the PMO, we do not agree
that there is not a penalty suffered by a producer found to have a positive drug
residue from a Section 6 sample. A confirmed positive drug residue result found
in a Section 6 producer sample requires enforcement action as set forth in
Appendix N of the PMO. The producer's permit is suspended and milk cannot be
shipped until a properly collected, representative sample indicates the
producer's milk is free of drug residues. In addition, the positive Section 6
sample is included in the count that may result in the initiation of action to
revoke the producer's permit after a third (3rd) violation in a twelve (12)
month period.
16. PMO and DMO-Section 6; and MMSR
If an antibiotic analysis is not performed on a sample of milk or not posted
with the results of an official monthly sample of milk, are standard plate count
(SPC), cooling temperature, coliform, or Direct Microscopic Somatic Cell Counts
(DMSCC) still valid tests?
SPC results are not valid when an antibiotic analysis is not performed on a raw
milk sample. SPC and coliform results are not valid when an antibiotic analysis
is not performed on a finished milk product sample. All other required milk
tests referenced in Section 6 of the PMO and DMO are valid and official and must
be treated as such, provided the test(s) itself is valid.
17. PMO-Section 6; IMS-a-44 (Proposal 234); and MMSR-Appendix
If a permitted facility has multiple tanks, which are sampled on the same day,
must the Regulatory Agency average the sample results?
Yes. When multiple samples of the same milk or milk products, except for
aseptically processed milk and milk products, are collected from the same
producer or processor from multiple tanks or silos on the same day, the
individual sample laboratory results are reported by the laboratory to the
Regulatory Agency. The Regulatory Agency arithmetically averages the individual
sample laboratory results and records this number as the official result for
that day. This is only applicable for bacteria (standard plate count and
coliform determination), somatic cell count and temperature determinations. If
this arithmetic average is not completed by the Regulatory Agency, it is a
records debit on enforcement ratings, as indicated in the Appendix of the MMSR
(Part I, Dairy Farms, Item 11, Sub-item c and Part II, Milk Plants, Item 10,
Sub-item c).
18. PMO-Section 6; IMS-a-44 (Proposal 234); and MMSR-Appendix
How would you average the bacterial counts on a farm with two separate bulk milk
storage tanks
(i.e., tank #1 has a bacteria count reported at <25,000 and tank #2 has a
bacteria count reported at 130,000)?
The laboratory will report the individual sample results to the Regulatory
Agency, as specified by the laboratory 2400 form, and in the case of a reported
value of <25,000, the laboratory will make the actual number known to the
Regulatory Agency upon request. In this example we will assume that the
laboratory reported an actual number of 23,000. The Regulatory Agency is
responsible for obtaining these results and calculating the arithmetic average
of the two results (23,000 + 130,000 = 153,000/2 = 76,500) for the official
sample result. The arithmetic average [76,000] will be reported to the producer
and recorded on the producer's ledger sheet, as the official sample result for
that sampling event. The estimated number of <25,000 cannot be averaged.
19. PMO-Section 6; IMS-a-44 (Proposal 166); and SMEDP
Does the multi-use red rubber sample septum meet the requirements of the single
use style septum for the collection of samples in a plant?
Yes. There is a septum that has several spots/circles where a needle can be
inserted. As long as each of these spots/circles is used only once and the
septum is sanitized prior to each use, then this is acceptable.
20. PMO-Section 6; and M-I-02-8
If there are not any validated laboratory tests available for some pasteurized,
condensed or dry milk products, do you still have to take samples?
Yes. Applicable coliform and temperature determinations are still required.
21. PMO-Section 6; and 2400 Series Forms
What is the name of the new Somatic Cell Count (SCC) testing instrument "flow
cytrometry" mentioned along with the Bactoscan?
It is Delta Instruments, Somascope MKII, and comes in two speeds (300 and 500
samples per hour).
22. PMO-Section 6; and SMEDP
In regard to coliform testing of cultured products, SMEDP, 16th Edition states:
"Samples of cultured or acidified cottage cheese, sour cream, yogurt and milk
products must be plated within 24 hours after manufacture to obtain meaningful
results." Section 6 of the PMO, under Laboratory Techniques, differs from the
SMEDP, yet the Regulatory Agency requires coliform testing on these products
regardless of how long it has been since they have been manufactured. How
should these samples be marked on laboratory worksheets: "IMS" or not or
"official" or not?
The laboratory worksheets should be marked "IMS" and "official" since the PMO
requires that coliform testing be done. The SMEDP is a guidance document used
by the NCIMS.
23. PMO-Section 7
Is it acceptable for a milk tank truck cleaning facility to be located on a
Grade "A" dairy farm?
Yes. Provided, it meets all the applicable requirements of the PMO.
24. PMO-Section 7, Item 5r
a. On a farm, if a single milking is directly loaded into a milk tank truck and
delivered to a plant and is subsequently cooled at the plant, how long can that
milk be held at the farm without being cooled?
Milk that is directly loaded into a milk tank truck may not be held without
being cooled. Item 5r, Administrative Procedure 16(d) of the PMO states: "An
accurate, accessible temperature recording device shall be installed in the milk
line downstream from an effective cooling device, which cools the milk to below
7°C (45°F)." Therefore, the temperature of the milk must be at 7°C (45°F) or
below prior to being loaded into the milk tank truck.
b. What temperature must direct load milk be at when delivered to the plant?
The required temperature is 7°C (45°F) or less.
25. PMO-Section 7, Item 5r
On a Grade "A" dairy farm, can a utensil wash vat constructed of fiberglass or
Nalgene be used in a mechanically cleaned system?
Yes. A utensil wash vat can be constructed of fiberglass or Nalgene, if it is in
good repair and the construction materials are non-toxic under the conditions of
use. Utensil wash vats should be relatively smooth and be of sufficient size to
accommodate the largest utensil or container that is washed manually. When
utensil wash vats deteriorate to a condition of poor repair, i.e., excessive
corrosion, separated seams, etc., which hampers their intended use and
cleanability, then Item 5r would be debited.
26. PMO-Section 7, Item 8r
Is plate cooler discharge water that is directly connected to the potable water
system without an appropriate back-flow prevention device installed on the
potable water line an 8a or 8c debit?
It is a cross-connection; therefore, a violation of Item 8r, and is debited on
Item 8c of Form FDA 2359a "Dairy Farm Inspection Report".
27. PMO-Section 7, Item 8r
Does a potable waterline feeding a plate cooler require a backflow preventer?
Not at the current time.
28. PMO-Section 7, Items 9r, 10r and 11r
May a vacuum trap be located directly on top of the receiver jar?
Yes. Provided that all areas of the vacuum trap and associated piping from
which liquids may drip, drain or be drawn into milk or milk products or onto
milk product contact surfaces meet product contact surface requirements for
construction, materials and finish, and are maintained clean and are sanitized
prior to each use.
29. PMO-Section 7, Item 12r
On a farm, can a receiver jar be located in a pit in a utility room?
Yes. The utility room must be maintained in compliance with the requirements
for the milking area, including construction and cleanliness, and the pit must
have adequate drainage and access.
30. PMO-Section 7, Item 12r
Is there a debit if a vacuum trap's lid is not weighted properly and does not
properly close when the trap is located in the milking parlor or milking barn?
What about when the trap is located in the milkroom?
Yes. This would be a violation no matter where it is located. Such an opening
to the vacuum trap may allow insects, rodents and other contaminants direct
access to the receiver jar.
31. PMO-Section 7, Item 15r
Is it a violation if a drug has a manufacturer's label on the bottle, which
states the drug's active ingredient and trade name, but the veterinarian's label
has another manufacturer's trade name for the same exact drug? For example,
Flunixin Meglumine, Trade Name Vedegesic, is on the manufacturer's label;
however, Banamine is on the veterinarian's label.
If the drug has all the PMO required labeling information and is stored
correctly, it would not be a violation of the PMO.
In the case of Vedegesic or other generic Flunixin products, i.e., horse
approval only, it would have to be properly extra-labeled by a veterinarian for
either lactating or non-lactating animals.
In the case of Banamine, Rx with beef approval labeling, if it is intended for
calves and non-lactating cows, it can be stored on the non-lactating shelf with
only the prescribing veterinarian's name and address on the container. If the
Banamine is intended for lactating cows, a full Extra Label Use (ELU) label is
required.
Technically, the veterinarian should identify the drug Flunixin or Flunixin
Meglumine on the over label.
32. PMO-Section 7, Item 15r
Is the storage of a syringe or a drug bottle in the hand washing fixture a debit
under Item 15b?
Yes.
33. PMO-Section 7, Item 15r
What is the meaning of the term "bulk" drugs?
United States v. Algon Chemical Inc., 879 F.2d 1154 (3d Cir. 1989) states:
"...bulk drug is an active ingredient (in unfinished form) intended for
manufacture into finished dosage form drug products." Refer to 21 CFR 207.3 (a)
(4). Bulk drugs (or "bulk drug substances") may be supplied in various size
containers and may or may not meet USP standards.
34. PMO-Section 7, Item 15r
a. Is CVM doing any work on Homeopathic Medicines?
No. FDA is not reviewing any homeopathic drugs at this time and currently, there
are not any FDA approved homeopathic drugs for veterinary use. Homeopathic
drugs found on dairy operations must comply with the drug labeling and storage
requirements of Item 15r of the PMO.
b. Does a valid client veterinarian relationship make this legal or allowed?
No. Technically, a veterinarian's participation in the use of homeopathic
drugs has no bearing on this issue. The legal or approved status of
homeopathic drugs is an FDA responsibility under the Federal Food, Drug and
Cosmetic Act (FFD&C Act).
35. PMO-Section 7, Item 18r; and Appendix H
What records are required for farm bulk milk tanks that store temperature
information, then print the data at a later date?
Section 7, Item 18r, Administrative Procedure 3(g) of the PMO states: "A
recording thermometer and/or any other device that meets the intent of these
Administrative Procedures and technical specifications and is acceptable to the
Regulatory Agency can be used to monitor/record the bulk tank temperature."
Administrative Procedure 3(c) states: "Recording thermometer charts shall be
maintained on the premises for a period of a minimum of six (6) months and
available to the Regulatory Agency." Administrative Procedure 3(h) states: "The
recording thermometer charts shall properly identify the producer, date, and
signature of the person removing the chart." Therefore, bulk tanks that store
temperature information must be capable of printing the required information, as
cited above, at a frequency and time period acceptable to the Regulatory Agency
and at any time the Regulatory Agency requires this information.
36. PMO-Section 7, Item 18r; and IMS-a-44 (Proposal 118)
After a bulk milk hauler/sampler calibrates the bulk tank-recording thermometer,
where should the results be recorded?
Section 7, Item 18r, Administrative Procedure 3(b) of the PMO requires that the
results shall be documented in a manner acceptable to the Regulatory Agency.
37. PMO-Section 7, Item 8p
Is it acceptable for hand washing fixtures to drain to the floor in a milk
processing room?
Yes.
38. PMO-Section 7, Item 12p
Once raw milk storage tanks or silos have been cleaned, will re-sanitizing
restart the "72 hour" window?
No. The time restarts when milk enters the milk storage tank or silo following
proper cleaning and sanitization.
39. PMO-Section 7, Item 12p; and Appendix H
What are the requirements for cleaning charts, if the traditional circular
charts are not being used?
Section 7, Item 12p, Administrative Procedure 2 of the PMO contains these
requirements.
40. PMO-Section 7, Item 15p(A); and Appendix L
Is it legal to standardize the protein content in Grade "A" non-fat dry milk
(NFDM)?
No. The standard of identity for NFDM does not provide for this.
41. PMO-Section 7, Item 15p(B); and IMS-a-44 (Proposal 130)
What are acceptable alternatives to using pasteurized water for pushing or
flushing pasteurized product?
The acceptable alternatives to using pasteurized water include using water that
has undergone an equivalent process found acceptable by the Food and Drug
Administration (FDA) and the Regulatory Agency or that has undergone a hazard
evaluation and safety assessment of the specific water supply and application
involved. Should treatment be necessary, a protocol acceptable to the
Regulatory Agency, in consultation with FDA, must be followed to ensure the
water will not compromise the safety of the product.
NOTE: In virtually all applications, some additional treatment of potable water
will be necessary.
42. PMO-Section 7, Item 16p(B); and Appendix H
On a HTST System, is it acceptable to use a computer program or software switch
for the "Product", "Inspect" or "CIP" mode switch?
Yes. Provided it meets the applicable requirements of Appendix H, Part V.,
"CRITERIA FOR THE EVALUATION OF COMPUTERIZED SYSTEMS FOR GRADE 'A' PUBLIC HEALTH
CONTROLS" of the PMO.
43. PMO-Section 7, Item 16p(B); and Appendixes H and I
When testing a two-speed HTST system, must a salt test also be performed on the
low speed?
Yes. If a plant processes a product requiring a minimum holding time longer
than 15 seconds, i.e., eggnog at 25 seconds, and the HTST system has "dual set
points" to allow processing at the low speed, the timing of the HTST System must
also be tested at the low speed.
44. PMO-Section 7, Item 16p(D)
What is the correct procedure for measuring the height of a vacuum breaker on a
HTST system twelve (12) inches (30.5 cm) above the highest raw milk in the
system?
Measure twelve (12) inches (30.5 cm) from the top of the highest raw line or
vessel to the bottom of the horizontal pasteurized pipeline downstream from the
regenerator and/or cooler section, which the vacuum breaker may be located or on
which the vacuum breaker and its connecting vertical pipeline are connected.
45. PMO-Appendix B
When a tanker exceeds 72 hours between uses, the PMO requires it to be
re-sanitized. Does it need to be re-sanitized at a permitted milk tank truck
cleaning facility?
Yes.
46. PMO-Appendix J; and IMS-a-44 (Proposal 164)
Plant "A" manufactures a metal collar, spring and check ball, which will become
components of a spray nozzle for aerosol "Whipped Cream" cans.
Plant "B" fabricates the plastic portion of the spray nozzle and assembles the
plastic and metallic portions into the finished spray nozzle. Do Plants "A" and
"B" need to be listed?
No. We have previously accepted the use of spray nozzles that are made from
safe materials to be manufactured in an unlisted source, if they are submerged
in a sanitizing solution and drained just prior to being fitted onto the can. If
the spray nozzle is to be applied without this sanitizing solution rinse, it
and all component parts must come from listed sources.
47. PMO-Appendix N; M-a-86 (Revision 3); and IMS-a-44 (Proposal 248)
Is the following scenario possible under M-a-86: A bulk milk pick-up t
anker load of milk is found to be presumptive positive with Test A, and the same
bulk milk pick-up t
anker load of milk is confirmed as a screening positive load with Test B. The
producer trace back of the producers on that same bulk milk pick-up tanker is
performed with Test C?
Yes. Provided, the tests are approved and listed in the latest revision of
M-a-85 and are equivalent as listed in the latest revision of M-I-96-10.
48. DMO-Section 7, Preamble; MMSR; and M-I-86-16
In a cheese plant that is IMS Listed for Grade "A" whey and whey products, where
does the IMS listing start? At receiving or at the point where the curd and
whey are separated?
An IMS Listing would start at receiving and would also involve everything up to
the point where the whey and curd are separated, including the pasteurization or
heat-treatment of the raw milk for cheese making and any pasteurization of
starter culture. The listing would continue on through the processing, handling
and packaging of the whey and whey products.
Section 7 of the DMO states: "Whey shall be from cheese made from Grade "A" raw
milk for pasteurization provided in the PMO. Whey used in the manufacture of
Grade "A" condensed and dry whey shall be produced in a cheese plant that
complies with Items 1p, 2p, 3p, 4p, 5p including the requirements in Footnote g,
6p, 7p including the requirements in Footnote h, 8p, 9p, 10p, 11p, 12p, 13p,
14p, 15p, 17p, 20p, 21p and 22p as provided in the PMO.
Whey shall be from: 1. Cheese made from Grade "A" raw milk for pasteurization,
which has been pasteurized prior to use in accordance with Item 16p of the PMO;
or 2. Cheese made from Grade "A" raw milk for pasteurization, which has been
heat-treated to a temperature of a least 64°C (147°F) and held continuously at
that temperature for at least 21 seconds or to at least 68°C (153°F) and held
continuously at that temperature for at least 15 seconds, in equipment meeting
the pasteurization requirements provided in the PMO. Provided, that this
requirement shall not be construed as barring any other heat treatment process
which has been recognized by the United States Public Health Service/Food and
Drug Administration to be equally efficient in the destruction of staphylococcal
organisms and which is approved by the State Regulatory Agency."
49. MMSR-Item C
During a rating, are pasteurization chart violations pro-rated?
Yes.
50. MMSR-Form FDA 2359i
Is Block Three (3) of the 2359i for the home State of the firm or that State in
which the rating takes place? For Example: Wisconsin Bulk Tank Unit (BTU) of
Illinois Plant-does WI or IL go in Block Three (3)?
Block Three (3) is for the State conducting the rating, and under which the
BTU's Listing will be shown in the IMS List. In the example, Wisconsin would be
the State listed in Block Three (3).
51. MMSR-Form FDA 2359j
Should Regional Milk Specialists (RMS's) and State Rating Officers (SRO's) be
using the Report of Milk Sanitation Rating [Form FDA 2359j, Page One (1)]?
RMS's often provide, in the form of a cover letter or written report, this same
information to the State. In this case, the use of this form is optional.
SRO's should use this form or provide similar information in a written report.
52. MMSR-Form FDA 2359j, Dairy Farms-Part I and Appendix, Part I., Dairy Farms,
Product Compliance
If a farm milk sample is not taken within 21 days after a warning letter is
issued, what is debited under the enforcement rating?
That farm will be pro-rated, unless a single farm BTU, under Item 10, "Permit
Issuance, Suspension, Revocation, Reinstatement, Hearings, and/or Court Actions,
Taken as Required," on Dairy Farms, Part I, on Form FDA 2359j (Page 2), "Report
of Enforcement Methods".
M-I-03-17 1 December 11, 2003
