U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
FDA Prime Connection
Actions of the 1995 National Conf. on Interstate Milk Shipments
HHS,PHS,FDA,CFSAN,OFP,DCP,MSB
200 'C' Street, SW
Washington, D.C.
September 1, 1995
IMS-a-32
To: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
From: Milk Safety Branch, HFS-626
Subject: Actions of the 1995 National Conference on Interstate
Milk Shipments
The National Conference on Interstate Milk Shipments (NCIMS) was
held in St. Louis Missouri May 1-5, 1995. During the Conference,
the state delegates approved several changes to the Pasteurized
Milk Ordinance (PMO) and the related documents. FDA responded to
the NCIMS Executive Board on July 29, 1995 concerning each of the
problems passed during the 1995 Conference. FDA and the NCIMS
Executive Board concurred on the following changes unless otherwise
noted. These changes are effective September 12, 1995 unless
otherwise noted.
Some of the language as adopted by the delegates was modified in
order to maintain continuity with the present language and to
insure compatibility with other existing sections of the affected
document(s). The modifications have not changed the intent of the
voted actions. All page references to the documents are based on
1993 editions except for changes proposed to be made in the Draft
EML.
Deletions to the present document language is identified by
strikeout and additions are identified by underline text unless
otherwise noted.
*******
(DRAFT)EML Page 4, 9, 10, 24, 25, PMO Page 13, 44 and the
corresponding paragraph in the DMO
Proposal 264
On page 13 and 44 of the PMO add the following words as indicated:
...Assays of milk and milk products to which vitamin(s) A and/or D
have been added shall be made at least annually in a laboratory
which has been certified by the U. S. Food and Drug Administration
and which is acceptable to the regulatory agency., using test
methods acceptable to FDA and other official methodology which
gives statistically equivalent results to the FDA methods.
In the DRAFT EML insert the following on page 4, after the last
line of #4 and before the first paragraph:
For the purposes of certification of analysts for the
determination of vitamins A and D3 content of milk, the method of
analysis shall be the methods developed by FDA or other official
methodology which gives statistically equivalent results to the
FDA/LQAB methods.
In the DRAFT EML change the first paragraph following the title
SPLIT SAMPLE ANALYSIS as follows:
The Standard Plate Count (SPC), Petrifilm Aerobic Count (PAC),
Plate Loop Count (PLC), Direct Microscopic Somatic Cell Count
(DMSCC) Electronic Somatic Cell Count (ESCC), and Electronic
Phosphatase Count Fluorometer Phosphatase Method and vitamin A and
D3 result of each certified analyst shall fall within the limits
shown in Table 2.
Add the following after #5 on page 10:
6. Analysts certified for vitamin analysis shall meet the
acceptance limits (L1 and L2) and performance levels
shown in tables 2 and 3.
In the DRAFT EML modify TABLE 1 on page 24 as follows:
Procedure to No. of samples Product category and Duplicates
be evaluated to be examined recommended type
____________ ______________ ____________________ __________
Plate counts 8
Pasteurized cream,
Coliform 8 chocolate, skim and 1 each
Count homogenized
Phosphatase 8
___________________________________________________________________
Vitamins 8 Pasteurized, undet-
fortified ermined
products
___________________________________________________________________
Plate 6 Raw or 3
Counts pasteurized
___________________________________________________________________
Inhibitors 8 Raw and/or 4
pasteurized
___________________________________________________________________
Abnormal Milk 8 Raw milk 4
___________________________________________________________________
Modify Table 2 as shown with Proposal 265. (Double Underlined)
*******
(DRAFT)EML Pages 6 and 7
Proposal 262
Change page 6 and 7, beginning with paragraph 3 on page 6, as
follows:
NOTE: The strikeout and underlines were removed from this paragraph
as they appear in the DRAFT EML in order to clearly show the effect
of this proposal as submitted.
When a laboratory loses its accreditation because of lack of
certified analysts, or for some other reason, the State or
Federal Laboratory Evaluation Officer shall immediately notify
the milk laboratory involved, the State milk regulatory
agency, the State milk sanitation rating agency, the out-of-
state milk regulatory agencies where known customers are
located, the appropriate Food and Drug Administration Regional
Office and the Food and Drug Administration, Center for Food
Safety and Applied Nutrition, Office of Field Programs,
Division of HACCP, Laboratory Quality Assurance Branch by a
letter of notification to be dated within five working days of
receipt of the written request.
Upon Notice of withdrawal of accreditation, the certificate,
if issued shall be returned to the issuing State Laboratory
Evaluation Officer.
Additionally, the laboratory shall notify its customers in
writing, that it has been decertified totally or in part and
shall not represent itself as an official laboratory or
officially designated laboratory for those decertified
procedures under the Agreements of the NCIMS. A copy of the
generic notification must be sent to the laboratory evaluation
officer. Any laboratory which continues to accept samples for
official regulatory testing without NCIMS accreditation will
be decertified for 60 days in addition to the current
decertification period.
*******
(DRAFT)EML Pages 8 and 10 and PMO Pages 14 and 48
Proposal 144
(Note: The first changes referred to in proposal 144 were repeated
in proposal 265)
Change pages 14 and 48 of the PMO and the corresponding table in
the DMO follows:
Phosphatase***..............Less than 1 microgram per ml by the
Scharer Rapid Method (less than 500 milliunits/L by the
Fluorometric Fluorometer or Charm ALP Procedures) or equivalent.
Change Page 8, paragraph 1 of the DRAFT EML following the heading
SPLIT SAMPLE ANALYSIS as follows:
The Standard Plate Count (SPC), Petrifilm Aerobic Count (PAC),
Plate Loop count (PLC), Direct Microscopic Somatic Cell Count
(DMSCC), Electronic Somatic Cell Count (ESCC) and Fluorometer
Phosphatase Method Electronic Phosphatase Count result of each
certified analyst shall fall within the limits shown in Table 2.
Change page 8, last paragraph (# 2.) as follows:
2. Calculate the logarithmic mean for the Standard Plate Count,
Petrifilm Aerobic Count, Plate Loop Count, Direct Microscopic
Somatic Cell Count, Electronic Somatic Cell Count and
Fluorometer Method Electronic Phosphatase Count results of
each test sample; using a table of common logarithms, list the
logarithms of all analyst counts for a given sample.
Calculate the mean of the logarithms for the sample.
Change page 10, paragraph 1 (# 1) as follows:
1. Analysts certified to perform the Standard Plate Count,
Petrifilm Aerobic Count, Plate Loop Count, Direct Microscopic
Somatic Cell Count and Fluorometer Method Electronic
Phosphatase Count shall meet the acceptance limits and
performance levels shown in Tables 2 and 3.
This proposal also contained changes to Table 2 of the EML which
are included in Table 2 with Proposal 265.
*******
(DRAFT)EML Pages 10, 17, and 25
Proposal 265
Change page 8, the first paragraph under SPLIT SAMPLE ANALYSIS as
follows:
The Standard Plate Count (SPC), Petrifilm Aerobic Count (PAC),
Plate Loop Count (PLC), Direct Microscopic Somatic Cell Count
(DMSCC), and Fluorimeter Phosphatase Method Electronic Phosphatase
Count result of each certified analyst shall fall within the limits
shown in Table 2.
Change page 10, paragraph 3 (# 3) as follows:
3. Analysts certified to perform phosphatase tests shall detect
samples that contain residual phosphatase detectable by
appropriate official test methods. Analysts certified for
Electronic Phosphatase Count methods shall detect samples that
contain between 100 to 1000 mU within the specified limits in
table 2.
Change page 25, table 2 as follows (double underlined material from
Proposal 264):
TABLE 2
Test Rejection Limit 1 Rejection Limit 2
(L1) (L2)
______________________________________________________________
Plate 0.268* 0.179*
Counts
______________________________________________________________
Direct
Somatic 0.300* 0.200*
Cell Count
______________________________________________________________
Electronic
Somatic 0.212* 0.143*
Cell Count
______________________________________________________________
Vitamins 0.300 0.200
______________________________________________________________
Fluorometer 0.2810.300* 0.1870.200*
Electronic
Phosphatase
______________________________________________________________
*******
(DRAFT)EML Page 14
Proposal 263
Insert the following on Page 14 to establish a new second paragraph
in SECTION 5:
Upon initial evaluation and/or renewal, the laboratory, must
make application for evaluation upon a form provided by the
laboratory evaluation officer. The application will include
a statement indicating that participation in the laboratory
certification program is voluntary, that the laboratory agrees
to the provisions of the National Conference on Interstate
Milk Shipments and the procedures for the Evaluation of Milk
Laboratories, and that interference with or willful refusal to
permit evaluation will result in immediate suspension of the
evaluation and possible non-certification or decertification.
Change page 17 to establish the following new paragraph at the end
of SECTION 5:
If, at any time during any evaluation there is interference
with or willful refusal to permit evaluation, the laboratory
evaluation officer will serve notice that the laboratory will
not be certified or will be decertified until such time as the
laboratory agrees to abide by the voluntary certification
program. The laboratory may make reapplication by completing
the application form and stipulating that future interference
or refusals will result in non-certification or
decertification for thirty days.
*******
FDA 2400 Forms
Proposal 208
This Proposal requires that the QA/QC plan specified in the 2400
form be restricted to the state central laboratories.
*******
MMSR Page 2 and 6
Proposal 272
Make the following changes:
Section B.
1.a.(2) If milk is shipped to a non-listed plant, records
indicating actual testing must be provided or available for review.
When the state Grade A regulatory agency has determined adequate
documentation for compliance with this section exists the rating
agency may accept this documentation. The responsible rating
officer may at their discretion request records on the testing of
loads of milk that are sent to non-listed plants.
Section C.
1.a.2. If milk is shipped to a non-listed transfer station,
receiving station and processing plant, records indicating actual
testing must be provided and available for review. When the state
Grade A regulatory agency has determined adequate documentation for
compliance with this section exists the rating agency may accept
this documentation. The responsible rating officer may at their
discretion request records on the testing of loads of milk that are
sent to non-listed plants.
*******
MMSR Page 4 and form 2359k
Proposal 279
REVISE THE MMSR DOCUMENT, PAGE 4, ITEM 2.d (2), TO READ AS FOLLOWS:
(2) Compliance with drug residue, bacteria, somatic cell and
cooling temperature requirements is based on whether, at the time
of the rating, a dairy farm's supply meets the standards of Section
7 of the Grade A Pasteurized Milk Ordinance. Credit for each of
these categories bacteria, somatic cell, and cooling requirements
shall be given if no more than two of the last four sample results
exceed the limits: Provided that the last sample result is within
the limit. No credit is given for compliance with drug residue,
bacterial, somatic cell, and cooling temperature shall be given
when less than the required number of samples have been examined
during the preceding 6 months. For rating purposes, the preceding
6 months is considered to be the elapsed period of the month in
which the rating is made and the 6 months immediately preceding.
Dairy farms which have had a permit for less than 6 months at the
time of the rating, and for which the regulatory agency has not yet
examined the required number of samples shall be given credit:
Provided, that the last individual result is within the limits.
Modify FDA form 2359k to include the phrase "or drug residue" in
the column for bacterial counts.
*******
PMO Pages 4 and 32, Appendix L and the corresponding paragraphs in
the DMO
Proposal 326
Add the following at the end of the first paragraph in Definition
N:
...and suitable optional ingredients for protein, vitamin or
mineral fortification of milk products defined herein.2,3,4 Milk
products also include those dairy foods made by modifying the
federally standardized products listed in this Section in
accordance with 21 CFR 130.10 - Requirements for foods named by use
of a nutrient content claim and a standardized term.2,3,4
Add the following paragraph in Appendix L of the PMO on page 288
following Section 133.131 and in Appendix G of the DMO following
Section 131.3:
Section 130.10 Requirements for foods named by use of a nutrient
content claim and a standardized term.
(a) Description. The foods prescribed by this general definition
and standard of identity are those foods that substitute (see
Section 101.13(d) of this chapter) for a standardized food defined
in parts 131 through 169 of this chapter and that use the name of
that standardized food in their statement of identity but that do
not comply with the standard of identity because of a deviation
that is described by an expressed nutrient content claim that has
been defined by FDA regulation. The nutrient content claim shall
comply with the requirements of Section 101.13 of this chapter and
with the requirements of the regulations in part 101 of this
chapter that define the particular nutrient content claim that is
used. The food shall comply with the relevant standard in all other
respects except as provided in paragraphs (b), (c), and (d) of this
section.
(b) Nutrient addition. Nutrients shall be added to the food to
restore nutrient levels so that the product is not nutritionally
inferior, as defined in Section 101.3(e)(4) of this chapter, to the
standardized food as defined in parts 131 through 169 of this
chapter. The addition of nutrients shall be reflected in the
ingredient statement.
(c) Performance characteristics. Deviations from noningredient
provisions of the standard of identity (e.g., moisture content,
food solids content requirements, or processing conditions) are
permitted in order that the substitute food possesses performance
characteristics similar to those of the standardized food.
Deviations from ingredient and noningredient provisions of the
standard must be the minimum necessary to qualify for the nutrient
content claim while maintaining similar performance characteristics
as the standardized food, or the food will be deemed to be
adulterated under section 402(b) of the act. The performance
characteristics (e.g., physical properties, flavor characteristics,
functional properties, shelf life) of the food shall be similar to
those of the standardized food as produced under parts 131 through
169 of this chapter, except that if there is a significant
difference in performance characteristics that materially limits
the uses of the food compared to the uses of the standardized food,
the label shall include a statement informing the consumer of such
difference (e.g., if appropriate, ``not recommended for cooking'').
Such statement shall comply with the requirements of Section
101.13(d) of this chapter. The modified product shall perform at
least one of the principal functions of the standardized product
substantially as well as the standardized product.
(d) Other ingredients.
(1) Ingredients used in the product shall be those ingredients
provided for by the standard as defined in parts 131 through 169 of
this chapter and in paragraph (b) of this section, except that safe
and suitable ingredients may be used to improve texture, add
flavor, prevent syneresis, extend shelf life, improve appearance,
or add sweetness so that the product is not inferior in performance
characteristics to the standardized food defined in parts 131
through 169 of this chapter.
(2) An ingredient or component of an ingredient that is
specifically required by the standard (i.e., a mandatory
ingredient) as defined in parts 131 through 169 of this chapter,
shall not be replaced or exchanged with a similar ingredient from
another source unless the standard, as defined in parts 131 through
169 of this chapter, provides for the addition of such ingredient
(e.g., vegetable oil shall not replace milkfat in light sour
cream).
(3) An ingredient or component of an ingredient that is
specifically prohibited by the standard as defined in parts 131
through 169 of this chapter, shall not be added to a substitute
food under this section.
(4) An ingredient that is specifically required by the standard
as defined in parts 131 through 169 of this chapter, shall be
present in the product in a significant amount. A significant
amount of an ingredient or component of an ingredient is at least
that amount that is required to achieve the technical effect of
that ingredient in the food.
(5) Water and fat analogs may be added to replace fat and
calories in accordance with Section 130.10(c), (d)(1), and (d)(2).
(e) Nomenclature. The name of a substitute food that complies
with all parts of this regulation is the appropriate expressed
nutrient content claim and the applicable standardized term.
(f) Label declaration.
(1) Each of the ingredients used in the food shall be declared on
the label as required by the applicable sections of part 101 of
this chapter and part 130.
(2) Ingredients not provided for, and ingredients used in excess
of those levels provided for, by the standard as defined in parts
131 through 169 of this chapter, shall be identified as such with
an asterisk in the ingredient statement, except that ingredients
added to restore nutrients to the product as required in paragraph
(b) of this section shall not be identified with an asterisk. The
statement ``*Ingredient(s) not in regular -------------'' (fill in
name of the traditional standardized food) or ``*Ingredient(s) in
excess of amount permitted in regular --------------'' (fill in
name of the traditional standardized food) or both as appropriate
shall immediately follow the ingredient statement in the same type
size.
[58 FR 2446, Jan. 6, 1993]
Effective Date Note: At 58 FR 2446, Jan. 6, 1993 Section 130.10 was
added effective May 8, 1994.
*******
PMO Pages 9 and 38 and the corresponding section of the DMO
Proposal 329
Add a new #12 in Section 4. Labeling as follows:
12. Seal number on inlet and outlet.
*******
PMO Pages 11, 43 and 313, the Standards for the Fabrication of
Single Service Containers and Closures for Milk and Milk Products
(SSCC) Page 3, and where appropriate in Section 6 and Appendix N of
the DMO.
Proposal 126
Make the following modifications to Section 6 in Part I (page 11)
and Part II (Page 43)
During any consecutive six months, at least four samples of
raw milk for pasteurization shall be collected, in at least four
separate months, except when three months show a month containing
two sampling dates separated by at least 20 days, and delivered in
accordance with this section from each producer. These samples
shall be obtained under the direction of the regulatory agency or
shall be taken from each producer under the direction of the re-
gulatory agency. During any consecutive six months, at least four
samples of raw milk for pasteurization, ultra-pasteurization or
aseptic processing, collected in at least four separate months,
except when three months show a month containing two sampling dates
separated by at least 20 days, shall be taken by the regulatory
agency, from each milk plant after receipt of the milk by the plant
and prior to pasteurization, ultra-pasteurization or aseptic
processing. During any consecutive six months, at least four
samples of heat treated milk products, from plants offering such
products for sale, shall be collected in at least four separate
months, except when three months show a month containing two
sampling dates separated by at least 20 days, by the regulatory
agency. During any consecutive six months, at least four samples of
pasteurized milk, flavored milk, flavored lowfat milk, flavored
skim milk, each fat level of lowfat milk and each milk product
defined in this Ordinance, except aseptically processed, shall be
collected in at least four separate months, except when three
months show a month containing two sampling dates separated by at
least 20 days, from every milk plant, by the regulatory agency...
Change Page 313 of Appendix N of the PMO and Appendix N of the DMO
as follows:
A. Monitoring and Surveillance.
Industry shall screen all bulk milk pickup tankers for beta
lactam drug residues. Additionally, other drug residues shall be
screened for by employing a random sampling program on bulk milk
pickup tankers. The random bulk milk pickup tanker sampling
program shall represent and include, during any consecutive six
months, at least four (4) samples collected in at least four (4)
separate months, except when three months show a month containing
two sampling dates separated by at least 20 days. Samples collected
under this random sampling program shall be analyzed as specified
by FDA. (See M-a-75).
Change Page 3 (C.3) of the Standards for the Fabrication of Single
Service Containers and Closures for Milk and Milk Products as
follows:
3. During any consecutive six months, at least four sample sets
shall be collected in at least four separate months, except
when three months show a month containing two sampling dates
separated by at least 20 days and analyzed at an official
laboratory, commercial laboratory or industry laboratory
approved by the state milk laboratory certifying agency
specifically for the examinations required under these
standards....
*******
PMO Pages 10, 11, 40 and 41 and creates New Appendix P, and Methods
of Making Sanitation Ratings of Milk Supplies (MMSR) Page 10
Proposal 209
Change pages 10 and 40 as shown:
3.4. Inspect each milk plant and receiving station at least once
every 3 months.
4.3. Inspect each transfer station and dairy farm at least once
every 6 months and
5. Inspect each dairy farm at least once every 6 monthsb.
Pages 11 and 41 (end of Section 5, insert the following footnote)
b Communities desiring to inspect dairy farms under a performance-
based inspection system should substitute the following language in
5. "5. Inspect each dairy farm as provided in Appendix P,
Performance-Based Dairy Farm Inspection System." (Addition of this
footnote will require resequencing the other existing PMO lettered
footnotes.)
Create a new Appendix P:
Note: The following is a new Appendix to the PMO. It is all new
material and is not designated as new by underlines.
Appendix P
PERFORMANCE-BASED DAIRY FARM INSPECTION SYSTEM
I. Preface
A performance-based inspection system is an option to
traditional routine inspection frequency (at least once every 6
months) on Grade A dairy farms. This option provides states with
a choice. For some states, inspecting every farm routinely twice
a year may provide effective regulatory oversight and make
efficient use of inspection resources. In other states, however,
an optional system which determines routine farm inspection
frequency based on producer milk quality and inspection performance
may be more desirable, equally effective, and make the most
efficient use of limited inspection resources. The overall
inspection effort devoted to a performance-based farm inspection
system may be more or less than the traditional inspection system
which requires a routine inspection at least once every 6 months
per farm.
II. Inspection Interval and Criteria
Grade A dairy farms will be categorized at least every 3
months using the immediately previous 12 months farm inspection and
milk quality data. The following criteria will be used to
categorize farms into 4 inspection intervals as defined below.
Minimum 1 year inspection interval (1 inspection each 12 months)
(All criteria below must have been met for the previous 12 months).
1. All SPC s 25,000
2. All SCC s 500,000
3. No temperature violations
4. No drug residue violations
5. No "critical control point" violations observed during farm
inspections
Dairy Farm inspection report items numbered:
10, 11-Cleaning and sanitizing of milk contact surfaces
16i-Significant drug violations
19-Significant cooling violations
6. No violation which creates a substantial risk of adulteration
or imminent health hazard
7. No more than 5 violations documented on any inspection sheet
8. No consecutive inspection violations on any inspection item.
9. No record of suspended permit, certification or license due to
inspection, milk quality or drug residue deficiencies.
10. Bacteriologically safe water supply at time of categorization
a. Farms in this category who are recategorized to a 6 month
inspection interval for a single violation of one milk quality
parameter (SPC > 25,000, SCC > 500,000 or temperature violation)
may be recategorized to the 1 year inspection interval if all 10
criteria listed above are met for the next 6 months.
Minimum 6 month inspection interval (1 inspection each 6 months)
(All criteria below must have been met for the previous 12 months).
1. May have 1 or more SPC > 25,000
2. May have 1 or more SCC > 500,000
3. No more than 1 warning letter issued due to non-compliance of
2 out of 4 previous official sample results for SPC and SCC
4. No temperature violations
5. No drug residue violations
6. No "critical control point" violations observed during farm
inspections
Dairy Farm inspection report items numbered:
10, 11-Cleaning and sanitizing of milk contact surfaces
16i-Significant drug violations
19-Significant cooling violations
7. No violation which creates a substantial risk of adulteration
or imminent health hazard
8. No more than 5 violations documented on any inspection sheet
9. No consecutive inspection violations on any inspection item.
10. No record of suspended permit, certification or license due to
inspection, milk quality or drug residue deficiencies.
11. Bacteriologically safe water supply at time of categorization
NOTE: Farms meeting the criteria for 1 year or 6 month inspection
intervals but with less than 12 months of farm inspection and milk
quality history (i.e. new farms) will be assigned to 6 month
inspection intervals.
Minimum 4 month inspection interval (1 inspection each 4 months)
(Any criteria below results in farm being placed into this
inspection interval for 12 months from the next recategorization).
1. More than 1 warning letter issued due to non-compliance of 2
out of 4 previous official sample results for SPC and SCC
2. Farm conditions which caused the regulatory agency to take
official regulatory action (i.e., warning letter, intent to
suspend, reinspection etc.)
3. 1 drug residue violation
4. "Critical control point" violations observed during farm
inspections
Dairy Farm inspection report items numbered:
10, 11-Cleaning and sanitizing of milk contact surfaces
16i-Significant drug violations
19-Significant cooling violations
5. Violation which creates a substantial risk of adulteration or
imminent health hazard
6. More than 5 violations on any inspection
7. Unsafe water supply at the time of categorization
Minimum 2 month inspection interval (1 inspection each 2 months)
(Any criteria below results in farm being placed into this
inspection interval for 12 months from the next recategorization).
1. More than 1 drug residue violation
2. Any farm suspended from the market by the regulatory agency
during the evaluation period (previous 12 months) for farm
conditions or milk quality violations except any reason other than
drug residue violations.
3. More than 1 incident where violative farm conditions or milk
quality parameters caused the regulatory agency to take official
regulatory action (i.e., warning letter, intent to suspend,
reinspection, etc.)
NOTE: The above guidelines for grade A farm inspection intervals
are not intended to prevent farm inspections at more frequent
intervals if in the judgement of the inspection staff more frequent
intervals are necessary.
Make the following changes in the MMSR:
On Page 10 of the 1993 MMSR in the Computation of Enforcement
Ratings section add a new "c", under 2. RAW MILK FOR PASTEURIZATION
ONLY as follows:
For farms inspected under the provisions of Appendix P the
following rating criteria applies:
1. At each 3 month categorization during the rating period, the
immediate previous 12 month producer records were used to determine
the proper categorization of individual producers into 12, 6, 4,
and 2 month inspection intervals.
2. Farms were recategorized properly every three months.
3. The due date for the next inspection is calculated from the
date of the last routine inspection, unless, the due date was
scheduled to occur before the recategorization. However, the due
date may be extended up to 30 days after the recategorization date
for producers assigned to a 2 month inspection frequency if the due
date was scheduled to occur before the recategorization date.
Change form 2359j, Report of Enforcement Methods, Part 1, No. 2
(example on Page 20, 1993 MMSR) as follows:
All producer dairy farms, inspected at least once every 6 months or
as required by Appendix P of the PMO.
*******
PMO Pages 11, 12 and 43
Proposal 205
Change paragraph 2 of Section 6 on pages 11 and 43 as follows:
NOTE: The double underlined words in this section are from proposal
126.
...During any consecutive six months, at least four samples of
pasteurized and aseptically processed milk, flavored milk, flavored
lowfat milk, flavored skim milk, each fat level of lowfat milk and
each milk product defined in this Ordinance, except aseptically
processed, shall be collected in at least four separate months,
except when three months show a month containing two sampling dates
separated by at least 20 days, from every milk plant, by the
regulatory agency...
Add the following at the end of the third paragraph in Section 6 on
pages 12 and 43:
Required drug residue tests shall be performed on aseptically
processed milk and milk products.
*******
PMO Page 36 and form 2359j
Proposal 280
This proposal provides for a change in the PMO and form 2359j
(Report of Enforcement Methods) to provide for Bulk Milk Pickup
Tanker inspection requirements. In addition to these changes it
requires the MMSR committee and the MSB to work together to prepare
a memorandum containing instructions for rating officers regarding
incorporation of the provisions of this proposal into IMS ratings.
This proposal also states these requirements become effective
September 1, 1996.
Amend Section III of the PMO, page 36, Administrative Procedures,
to read as follows:
ISSUANCE OF PERMITS.--Every milk producer, milk distributor, milk
hauler, bulk milk pick-up tanker*, and each milk plant, receiving
station and transfer station operator shall hold a valid permit...
* denotes a footnote at the end of Section 3 on page 37, and it
shall read as follows: The permit for a bulk milk pick-up tanker
may be issued to the responsible person for the bulk milk pick-up
tanker(s).
Change 2359J, Page 2, Part 1, Item #11, from 10 points to 5 points.
On form 2359J Page 2, Part 1, add a new Item #12 as follows:
Ord
No. Sec Item# Insp # Compl % Compl Wt. Credit
___________________________________________________________________
11 Records 10 5
systematically
maintained
and current
___________________________________________________________________
12 All bulk milk 5
pickup tankers
permitted and
inspected at
the required
frequency
___________________________________________________________________
This proposal also provides for the following:
1. Item 12 may be pro-rated utilizing the professional judgement
of the rating officer, based upon those bulk milk pick-up tankers
used within the last 30 days to haul the milk from the randomly
selected farms on a rating.
2. Prorating may be based, but not limited to the following
guidelines:
a. Are the bulk milk pick-up tankers permitted under the
direction of a regulatory agency?
b. Does this regulatory program allow for necessary enforcement
action against individual bulk milk pick-up tankers?
c. Are bulk milk pick-up tankers inspected at the minimum
required frequency and are these evaluations forwarded to the
appropriate regulatory agency in a timely manner?
3. A copy of the current bulk milk pick-up tanker inspection
report shall be stored in a manner acceptable to the regulatory
agency.
~THIS PROPOSAL BECOMES EFFECTIVE ON SEPTEMBER 1, 1996.~
*******
PMO Page 45 and the corresponding paragraph in Section 6 of the DMO
Proposal 221
Change #1 under Laboratory Techniques.-- as follows:
1. Standard plate count at 32oC (agar or petrifilm method).
*******
PMO Page 45 and the corresponding paragraph in Section 6 of the DMO
Proposal 222
Change #3 under Laboratory Techniques-- as follows:
3. Coliform test with solid media or petrifilm method at 32oC
for all milk and milk products, and Petrifilm High Sensitivity
Coliform count method for all milk and milk products except
unflavored whole, low fat and skim milk.
*******
PMO Page 45 and the corresponding paragraph in the DMO.
Proposal 252
Change #4 under Laboratory Techniques.-- as follows:
4. Disc assay methods for drugs specified in Appendix G, page
195. In addition, Beta lactam methods which have been
independently evaluated or evaluated by FDA and have been found
acceptable by FDA for detecting drug residues at current safe or
tolerance levels shall be used for each drug of concern.
*******
PMO Page 55Proposal 101
Change Item 5r #16 on page 55 as follows:
16. The milkhouse is equipped with a wash-and-rinse vat having at
least two compartments. Each compartment must be of sufficient
size to accommodate the largest utensil or container used. The
cleaning-in-place vat form milk pipelines and milk machines may be
accepted as part of the two compartment vat. Provided, that the
cleaning in place station rack, in or on the rack and the milking
machines inflations and appurtenances are completely removed from
the vat during the washing, rinsing and/or sanitizing of other
utensils and equipment. Where mechanical cleaning/CIP systems
eliminate the need for handwashing of equipment, the presence of
the second wash vat compartment may be optional, if so determined
by the State Regulatory Agency, on an individual farm basis.
*******
PMO Page 83 and the corresponding location in Item 15p
Administrative Procedures of the DMO
Proposal 116
This Proposal was not concurred with by the FDA, however the
following alternate wording was mutually agreed upon during
discussion with the NCIMS Executive Board on July 29, 1995.
Change page 83 Item 15p., Administrative Procedures 15p(a)3. b. of
the PMO and in the appropriate corresponding location in the DMO as
follows:
b. If the area is not completely enclosed or doors of the
unloading area are open during unloading, a suitable filter is re-
quired for the manhole or air inlet vent and suitable protection
must be provided over the filter material either by design of the
filter holding apparatus or a roof or ceiling over the area. When
weather and environmental conditions permit, manhole openings and
covers of milk tank trucks may be opened outdoors for the short
period of time necessary for the collection of samples for animal
drug residue screening and bacterial quality analysis. Direct
connections from milk tank truck to milk tank truck must be made
from valve to valve or through the manhole lid. Provided, that all
connections are made ferrule to ferrule and adequate protection is
provided for the air vent.
*******
PMO Page 84 and the appropriate location in the DMO
Proposal 117
At the end of Section 7, Item 15p., Administrative Procedures, Item
15p(A) add the following:
13. In the case of separating non-Grade A and Grade A products,
a water rinse after processing non-Grade A and prior to Grade A is
adequate separation, provided both are processed as Grade A and raw
and pasteurized products are kept physically separated.
*******
PMO Pages 96 and 100
Proposal 137
Change page 96, h(2) as indicated:
(2) When culinary steam is in introduced directly into the milk
or milk product, automatic means (e.g., stand-alone and/or PLC-
based ratio control system) shall be provided to maintain a proper
temperature differential between incoming and outgoing milk to
preclude dilution with water.
Change page 100, f(1) as indicated:
(1) When culinary steam is in introduced directly into the milk
or milk product, automatic means (e.g., stand-alone and/or PLC-
based ratio control system) shall be provided to maintain a proper
temperature differential between incoming and outgoing milk to
preclude dilution with water.
*******
PMO Pages 41, 58, 73 and 106
Proposal 110
Add the following at the end of Section 7 item 8r Administrative
Procedures #7 on page 58:
7. ..... in a laboratory acceptable to the regulatory agency.
To determine if water samples have been taken at the frequency
established in this section, the interval shall include the
designated period plus the remaining days of the month in which the
sample is due.
Add the following at the end of Section 7 item 7p Administrative
Procedures #7 on page 73:
7. ..... in a laboratory acceptable to the regulatory agency.
To determine if water samples have been taken at the frequency
established in this section, the interval shall include the
designated six month period plus the remaining days of the month in
which the sample is due.
Change page 106, Section 7 item 16p(E) 2. as follows:
2. EQUIPMENT TESTS AND EXAMINATIONS.--The regulatory agency shall
perform the indicated tests on the following instruments and
devices initially on installation; and at least once each 3 months
and the remaining days of the month in which the equipment tests
are due thereafter; and whenever any alteration or replacement is
made which may affect the proper operation of the instrument or
device. Provided, that the holding time test shall be conducted at
least every 6 months and the remaining days of the month in which
the equipment check is due.
Change page 41 in the Administrative Procedures of Section 5 of the
PMO and in the appropriate location in the DMO as follows:
ADMINISTRATIVE PROCEDURES
INSPECTION FREQUENCY.--For the purposes of determining the
inspection frequency for dairy farms and transfer stations the
interval shall include the designated six month period plus the
remaining days of the month in which the inspection is due.
For the purposes of determining the inspection frequency for milk
plants and receiving stations the interval shall include the
designated three month period plus the remaining days of the month
in which the inspection is due.
One bulk milk pickup tanker inspection every 12 months, or hauler
pickup and sampling procedures inspection each 24 months, or one
producer inspection every 6 months or one plant inspection every 3
months is not a desirable frequency, it is instead a legal minimum.
Milk haulers, dairy farms and milk plants experiencing difficulty
meeting requirements should be visited more frequently. Inspections
of dairy farms shall be made at milking time as often as possible
and of milk plants at different times of the day in order to
ascertain if the processes of equipment assembly, sanitizing,
pasteurization, cleaning and other procedures comply with the
requirements of this Ordinance.
*******
PMO Page 130
Proposal 259
Change paragraph 2., Equipment Requirements.-- of the Evaluation of
Hauler and Operations
e. Calibrated pocket thermometer certified for accuracy every
6 months, accuracy + or - .5xC (1xF) 1xC (2xF).
*******
PMO Pages 163 and 164
Proposal 105
Change Pages 163 and 164 in the PMO, and the appropriate pages in
Appendix D of the DMO as follows:
V. WATER RECLAIMED FROM THE
CONDENSING OF MILK
AND MILK PRODUCTS
Condensing water from milk evaporators and water reclaimed from
milk and milk products may be reused in a milk processing plant.
Acceptable uses of this water fall into three general categories:
1. Reclaimed water which may be used for all potable water
purposes including the production of culinary steam.
2. Reclaimed water which may be used for limited purposes
including the production of culinary steam.
3. Use of reclaimed water not meeting the requirements of this
section.
Condensing water from milk evaporators and water reclaimed from
milk or milk products shall comply with the following requirements:
Reclaimed water to be used for potable water purposes, including
the production of culinary steam, shall meet the following
requirements:
The paragraphs numbered 1 through 12 remain the same.
On page 164 make the following changes beginning at the third
paragraph:
Condensing water from milk evaporators and water reclaimed from
milk or milk products may be used for the following limited
applications;
1. Pre-rinsing of the product surfaces where pre-rinses will not
be used in food products; and
2. Cleaning solution make-up water; provided that for either use,
items # 3-11 of this section are satisfied, and:
Reclaimed water may be used for limited purposes including:
1. Production of culinary steam.
2. Pre-rinsing of the product surfaces where pre-rinses will
not be used in food products.
3. Cleaning solution make-up water.
Provided that for these uses items #3-11 of this section are
satisfied and:
The paragraphs lettered a. through d. remain the same.
and modify the last paragraph to read as follows:
Recovered water not meeting the requirements of this section may
be used as boiler feed water for boilers not used for generating
culinary steam or in a thick, double walled heat exchanger.
*******
PMO Page 164
Proposal 123
Add the following at the end of Appendix D:
VI. WATER RECLAIMED FROM HEAT EXCHANGER PROCESSES
Potable water utilized for heat exchange purposes in plate or other
type heat exchangers or compressors on grade A dairy farms may be
salvaged for the milking operation if the following criteria are
met:
1. The water shall be stored in a storage vessel properly
constructed of such material that it will not contaminate the water
and be designed to protect the water supply from possible
contamination.
2. The storage vessel shall be equipped with a drain and access
point to allow for cleaning.
3. No cross-connection shall exist between this supply and any
unsafe or questionable water supply or any other source of
pollution.
4. There are no submerged inlets through which this supply may be
contaminated.
5. The water shall be of satisfactory organoleptic quality and
shall have no off flavors or odors.
6. The water shall comply with the bacteriological standards of
Appendix G, page 195.
7. Samples shall be collected and analyzed prior to initial
approval and semi-annually thereafter.
8. Approved chemicals, such as chlorine, with a suitable retention
period, may be used to suppress the development of bacterial growth
and prevent the development of tastes and odors.
9. When chemicals are added, a monitoring program for such added
chemicals shall be in effect and such chemicals shall not add
substances that will prove deleterious to the use of the water or
contribute to product contamination.
10. If the water is to be used for the sanitizing of teats or
equipment (backflush systems), approved sanitizers, such as iodine
may be added by an automatic proportioning device located
downstream from the storage vessel but prior to its end-use
application.
*******
PMO Page 185
Proposal 206
Make the following change to Table 11 in Appendix E:
Date Confirmed Enforcement action as applied to a
Somatic Cell standard of 750,000 per ml.
Counts per
ml.
___________________________________________________________________
7/10/93 500,000 No action required
__________________________________________________________________
8/15/93 600,000 No action required
__________________________________________________________________
10/01/93 800,000 Violative; No action required
__________________________________________________________________
11/07/93 900,000 Violative; Written notice to
producer, 2 of last 4 counts exceed
standard
__________________________________________________________________
11/14/93 1,200,000 Violative; Suspend permit.
Issue temporary permit after
farm inspection sampling
indicates the milk supply is
within the limits prescribed in
Section 7; Begin accelerated
sampling schedule.
__________________________________________________________________
11/28/93 700,000 No action required
__________________________________________________________________
12/07/93 700,000 No action required
__________________________________________________________________
12/11/93 550,000 No action required
__________________________________________________________________
12/14/93 650,000 No action required
__________________________________________________________________
12/21/93 600,000 Permit fully reinstated; No action
required
__________________________________________________________________
*******
PMO Page 195, Private Water Supplies, and the appropriate
corresponding paragraph in Appendix K of the DMO.
Proposal 218
Criteria.--An MPN (Most Probable Number of coliform organisms) of
less than 1.1 per 100 ml, when ten replicate tubes containing 10
ml, or when five replicate tubes containing 20 ml are tested using
the multiple tube fermentation technique, or less than 1 per 100 ml
by the membrane filter technique, or less than 1 per 100 ml when
using an MMO-MUG technique (The MMO-MUG technique is not acceptable
for recirculated cooling water). 100 q 2.5 ml water will be used
for this analysis. Any sample producing a bacteriological result
of TNTC--Too Numerous To Count--(greater than 200 total bacterial
colonies per 100 ml) or confluent growth by the membrane filter
technique, or a bacteriological result of Turbid by the multiple
Tube Fermentation (Most Probable Number - MPN) technique, without
coliform present shall have a subsequent heterotrophic plate count
of less than 500 colonies/ml in order to be deemed satisfactory.
Findings shall be reported as present or less than 1 per 100 ml
(absent) for coliform organisms.
*******
PMO Page 198 and the corresponding language in Appendix K of the
DMO
Proposal 211
Add the following:
Bacillus stearothermophilus Disc Assay--
Qualitative Method
NOTE: Bacillus stearothermophilus disc assay analysis performed to
fulfill the provisions of Section 7 of the PMO must be capable of
detecting at least 4 of 6 beta lactam drugs at or below FDA
reference levels. See the Bacillus stearothermophilus disc assay
FDA 2400 procedure form(s) for details related to this analysis.
This Proposal included a provision that it would not be implemented
until an implementation date was mutually agreed between the NCIMS
Executive Board and the FDA. This has not been done. When an
implementation date is established it will be included in future
memoranda from the FDA.
~NO IMPLEMENTATION DATE HAS BEEN ESTABLISHED FOR THIS PROPOSAL~
*******
PMO Pages 208, 210 and 211 and the corresponding paragraphs in
Appendix L of the DMO
Proposal 139
Change Page 208 as follows:
Recent developments in the design of HTST pasteurizing systems
have introduced the use of magnetic flow meter based timing systems
with centrifugal pumps to be used as replacements for positive
displacement timing pumps with a fixed or sealed speed below the
required holding time .
2. Those employing an A-C variable frequency motor speed control
for the centrifugal timing pump. In this case, the timing pump may
be centrifugal or positive displacement type.
Change Page 210 and 211 as follows:
8. When an A-C variable frequency motor speed control is used
on the centrifugal timing pump, the control valve is not needed as
the flow rate of product through the system is controlled by feed-
ing the signal from the magnetic flow meter to a controller which
in turn varies the A-C frequency to the pump motor, thus
controlling the flow rate of product through the system. With
these A-C variable frequency systems, a sanitary product check
valve is needed, in the sanitary milk pipe line to prevent a
positive pressure in the raw milk side of the regenerator whenever
a power failure, shutdown or flow diversion occurs.
9. When a regenerator is used with large systems, it will be
necessary to bypass the regenerator during start-up and when the
flow diversion device is in the diverted flow position. Care
should be taken in the design of such bypass systems to assure that
a dead-end does not exist. A dead-end could allow product to remain
at ambient temperature for long periods of time and allow bacterial
growth in the product. Caution should also be observed with such
bypass systems and any valves used in them so that raw milk product
will not be trapped, under pressure in the raw regenerator plates,
and not have free drainage back to the constant level tank when
shutdown occurs.
10. Most systems will utilize a dual stem flow diversion device
and will be using the centrifugal timing pump during the CIP
cleaning cycle. All public health controls, required of such
systems, must be applicable. When switching to the CIP position,
the flow diversion device must move to the divert position and must
remain in the diverted flow position for at least 10 minutes,
regardless of temperature, and the booster pump cannot run during
this 10 minute time delay.
11. All systems shall be designed, installed and operated so that
all applicable tests required by Section 7, Item 16p(E) (See
Appendix I, pages 223 through 255) can be performed by the
regulatory agency, at the frequency specified. Where adjustment or
changes can be made to these devices or controls, appropriate seals
shall be applied after testing so that changes cannot be made
without detection.
12. Except for those requirements directly related to the physical
presence of the metering pump, all other requirements of the Grade
A Pasteurized Milk Ordinance are applicable.
PLACEMENT OF COMPONENTS--Individual components in the magnetic flow
meter based timing systems shall comply with the following
placement condition:
1. The centrifugal timing pump shall be located downstream from
the raw milk regenerator section, if a regenerator is used.
2. The magnetic flow meter shall be placed downstream from the
centrifugal timing pump. There shall be no intervening flow
promoting components between the centrifugal timing pump and the
meter.
3. The control valve, used with the constant speed centrifugal
timing pump, shall be located downstream of the magnetic flow
meter.
4. The centrifugal timing pump, the magnetic flow meter, the
control valve, when used with the constant speed centrifugal timing
pump system, and the sanitary product check valve, when used with
the A-C variable frequency motor speed control system, shall all be
located upstream from the start of the holding tube.
5. All flow promoting devices, which are upstream of the flow
diversion device, such as centrifugal timing pumps (constant speed
or A-C variable frequency motor control types), booster pumps,
stuffer pumps, separators and clarifiers shall be properly
interwired with the flow diversion device so that they may run and
produce flow through the system at sub-legal temperatures, only
when the flow diversion device is in the fully diverted position,
when in product run mode. Separators or clarifiers which continue
to run, after power is shut off to them, must be automatically
valved out of the system, with fail-safe valves, so that they are
incapable of producing flow.
6. There shall be no product entering or leaving the system
(i.e., cream or skim from a separator or other product components)
between the centrifugal timing pump and the flow diversion device.
*******
PMO Pages 225 and 226
Proposal 141
Change Procedure #1, 3, 5, 6 and 7 of Test 2 as follows:
1. Adjust the recording pen to read exactly as the previously
tested indicating thermometer, in the temperature range for the
pasteurization process being used after a stabilization period of
5 minutes (two minutes for electronic recording thermometers) at a
constant temperature. The water bath shall be rapidly agitated
throughout the stabilization period.
3. Immerse the sensing element of the recorder in boiling water
for not less than 5 minutes (two minutes for electronic recording
thermometers).
5. Remove the sensing element from the boiling water and immerse
in water at a temperature within the testing range for the
pasteurization process being used. Allow a 5-minute (two minutes
for electronic recording thermometers) stabilization period for
both indicating and recording thermometers. Compare readings of
0.5xC (1xF) plus or minus, the indicator thermometer reading.
6. Remove sensing element from the bath, at operating
temperatures, and immerse in melting ice for not less than 5
minutes (two minutes for electronic recording thermometers).
7. Remove sensing element from the ice water and immerse in water
at a temperature, within the testing range, for the pasteurization
process being used. Allow a 5-minute (two minutes for electronic
recording thermometers) stabilization period for both indicating
and recording thermometers. Compare readings of 0.5xC (1xF), plus
or minus, the indicator thermometer reading.
*******
PMO Page 242 and the corresponding paragraph in Appendix F of the
DMO
Proposal 130
l. For all gear driven timing pumps; and for those homogenizers
used as timing pumps when the measured holding time for water is
less than 120% of the legal holding time, repeat procedure 'k'
using milk. For those homogenizers used as timing pumps repeat
procedure `k' using milk when the measured holding time for water
is less than 120% of the legal holding time.
*******
PMO Page 307 and Form 2359K
Proposal #278
This proposal will require several of the "r" items in Section 7 to
be modified and/or renumbered, will modify the Dairy Farm
Inspection Sheet, and will require changes in FDA form 2359K Status
of Raw Milk For Pasteurization. A summary of these changes follow:
~THE IMPLEMENTATION DATE FOR THIS PROPOSAL IS JANUARY 1, 1997 FOR
RATINGS AND CHECK RATINGS. REGULATORY AGENCIES MAY BEGIN USING THE
NEW FARM INSPECTION FORM 2359A AT THEIR DISCRETION.~
ADJUSTMENTS TO FARM SHEET POINT VALUES
# of
Item # Points
___________________________________________________________________
1 5 & 5 10 points divided evenly between abnormal
milk and DMSCC
___________________________________________________________________
2a 1 decreased by 1
___________________________________________________________________
2e 2 moved to 19h, increased by 1
harborage problems with birds, rodents or
insects.
___________________________________________________________________
2f 1 decreased by 1 and relabeled 2e
___________________________________________________________________
3 3 increased by 1
___________________________________________________________________
4 3 increased by 1
___________________________________________________________________
6 4 increased by 1
7 4 decreased by 1
8 2 Minor water violation
5 Major water violation (Maximum of 5 points
for #8)
___________________________________________________________________
9 4 increased by 1
___________________________________________________________________
13 moved under 16a including Administrative
Procedures
___________________________________________________________________
14 5 increased by 2, relabeled #13
___________________________________________________________________
15 moved under 3a, Administrative Procedures
only
___________________________________________________________________
16a-g 3 increased by 1, relabeled #14a/g
___________________________________________________________________
16h/i 2 & 7 relabeled #15b/e (Maximum debit of 7
points
___________________________________________________________________
17 2 decreased by 1, relabeled #16
___________________________________________________________________
18 1 decreased by 1, relabeled #17
___________________________________________________________________
19 relabeled #18
___________________________________________________________________
20 deleted from farm inspection sheet
___________________________________________________________________
21a&b 3 relabeled #19a&b
___________________________________________________________________
21c&d 2 relabeled #19c&d
___________________________________________________________________
21e&f 2 relabeled #19e&f
___________________________________________________________________
21g 2 increased by 1, relabeled #19g
___________________________________________________________________
FOLLOWING IS A FARM INSPECTION FORM THAT REFLECTS THESE CHANGES:
ZDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDD?
3 3
3 The revised Dairy Farm Inspection 3
3 Report may be obtained through the 3
3 Food and Drug Administration, Milk 3
3 Safety Branch (HFS-626), 200 C Street, 3
3 S.W., Washington, DC 20204. 3
3 3
@DDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDDY
PMO Page 315 and the corresponding paragraph in Appendix N of the
DMO
Proposal 241
Add the following as the last paragraph in Appendix N:
One year after test(s) have been evaluated by FDA and accepted by
the NCIMS for a particular drug or drug family, other unevaluated
tests are not acceptable for screening milk. The acceptance of
evaluated tests does not mandate any additional screening by
industry with the evaluated method.
NOTE: The last paragraph in Appendix N of the 1993 PMO beginning
"Industry may employ other methods ...." was a printing error and
should be removed (see M-I-94-2).
*******
PMO page 317, 318, 319 and 320
Proposal 121
Make the following changes as indicated in Appendix O:
1. Page 317, left column, first paragraph change to read:
"Vitamin fortification can be accomplished by the addition of
vitamins at many different points in the processing system,
preferably after separation, including. These range from addition
to the raw tanker before unloading, to the silo tank, to the
pasteurizing vat (for vat pasteurization), to the HTST balance tank
or and on a continuous basis into the pipeline after
standardization and prior to pasteurization in accordance with the
manufacturer's recommendations."
"... must be installed so as to be activated only when the unit is
in forward flow. The addition of vitamins must be accomplished
prior to pasteurization and in accordance with the manufacturer's
recommendations."
2. Page 317, left column, change to read:
"When a vitamin metering pump(s) is used with an HTST unit or an
HHST unit, the pump(s) must be installed so as to be activated only
when the unit is sending product in forward flow."
3. Page 317, left side, modify the 3rd paragraph as follows:
If vitamins are added in the proper amount, before separation and
standardization, and the product is separated and standardized,
then the low fat product will tend to be under fortified and the
high fat product over fortified. To reduce this effect, it has
been found that if the vitamin concentrate used is in an evaporated
milk carrier, the separation of the vitamins to the fat or cream
phase is minimized. Water soluble vitamin concentrates can
minimize this problem if vitamins are added before separation.
Processors who use this procedure should perform confirmatory
assays to ensure proper fortification levels of each product.
4. Page 318, right column, add a new (3) and change the existing
(3) to (4), (4) to (5) and (5) to (6).
(3) Written procedures and training should be provided to all
employees responsible for vitamin fortification for each product to
be fortified. These procedures should focus on product start up
and product change over.
5. Page 318, right column, old #4 which is the new #5, add the
following at the end of the existing wording:
(5)4. "... cleaning procedure after use. For batch addition, use
only accurate, calibrated measuring devices, such as plastic
graduated cylinders, or pipettes. Measuring devices should be
sized to the amount of concentrate added, i.e. if 8 ml. is added,
a 10 ml. graduated cylinder would be appropriate. Measuring
devices should be rinsed with the product being fortified to insure
no residual concentrate is left.
6. Page 318, right column, renumber (6) to (7) and change to read:
(76) "Check meter calibration regularly including both the pump and
the tubing by determining delivery rate accuracy. Use only
properly calibrated tubing for peristaltic pump systems and replace
tubing regularly."
7. Page 318, right column, change old #7 and new #8 as follows:
(87). Use insulated vessels, such as thermos jugs, for holding
diluted concentrates to maintain temperatures of 4.4xC. (40xF) or
below. Storage vessels used for supplying vitamin concentrate to
metering pumps should be emptied on a regular basis. A regular
systematic cleaning and sanitizing schedule must be maintained for
these vessels, pumps and tubing.
8. Page 318, right column, add a new (9).
(9) Vitamin concentrates should be stored and held in accordance
with the manufacturer's recommendations for maximum shelf life.
9. Page 318, right columns, renumber existing (8) to (11) and add
a new (10).
(10) Vitamin metering pumps should be interwired with the flow
divert and recycle valves to prevent operation during divert and/or
recycle flows.
10. Page 319, top of page, left column, add a new (12) as follows.
(12) Care must be taken when reprocessing reclaimed product so
vitamin A and/or D levels do not exceed the label claims by more
than 150%."
11. (NEW) Page 318, left column, eliminate paragraph 1, 2 & 3 and
replace with the following:
"The best point for injection of the vitamin is ahead of the
homogenizer, which in most cases is a point of low pressure. This
allows the homogenization process to distribute the vitamin(s)
throughout the milk. A positive displacement type pump must be
used. Otherwise negative pressures at the point of injection can
create problems. A small vacuum can result in relatively large
volumes of vitamin concentrate being drawn into the milk system in
a very short time period.
Simple, single speed HTST systems running one product, for example,
homogenized vitamin D milk, would work very well with one metering
pump. More complex systems having two or more operating speeds and
running products to which both vitamin D and vitamins A & D are
added, require more than one pump and valve arrangement. See
Figure 41 for an example of such an arrangement.
To avoid the need for two pumps or the constant adjusting the pumps
where both vitamin D and vitamin A & D concentrates are used in the
same HTST systems, the vitamin D concentrate can be diluted with
water or skim milk so that it can be fed into the system at the
same rate as the vitamin A & D concentrate. Regulatory personnel
should be notified for their approval if this procedure is used.
Provisions should be made to keep these solutions at 4.4xC (40xF)
or less during the fortification process. Extreme care should be
taken to make precise measurements. Small errors in measurements
and calculation can have a major effect on the final concentration
in the finished product. Containers and equipment used for
dilution should be cleaned and sanitized daily, or more frequently,
if necessary."
The recommended point for metered injection of vitamin concentrate
is after separation and prior to homogenization. This allows the
homogenization process to distribute the vitamins throughout the
milk. A positive displacement metering pump and a check valve for
in-line injection are recommended. The check valve will prevent
contamination of the vitamin concentrate with milk.
When vitamin A, A & D or D concentrates are injected by metering
pumps, separate positive pressure pumps with separate delivery
tubing and check valves are recommended. (See Figure 41 for an
example of such an arrangement.) Pumps should be calibrated based
on the product flow rate of the continuous pasteurization system.
If flow rates change for different milk products, additional
vitamin pumps may be needed. Adjusting calibration of vitamin
metering pumps is not recommended without verifying the adjusted
calibration is accurate. Calibration checks of vitamin metering
pumps should be done on a routine basis.
12. Page 319, left column, under "TESTING METHODS" delete the
existing paragraph and replace with a new paragraph.
"The Association of Official Analytical Chemists (AOAC), Fifteenth
Edition, 1990, recommends a liquid chromatography method for
vitamin D. The Carr-Price Method is recommended by AOAC for
vitamin A. Other methods for vitamin A include fluorescent
spectrophotometry (See Journal of Dairy Science, Volume 58, page
558) and liquid chromatography methods. Most plant quality control
laboratories are not equipped to perform these analyses."
Test methods used for the detection of vitamin A and/or D should be
those acceptable to the Food & Drug Administration or other
official methodology which gives statistically equivalent results
to the FDA methodology. Vitamin analysis should be conducted in
laboratories certified by the Food & Drug Administration and
acceptable to the regulatory agency.
13. Page 319, right side, bottom of page, delete the words,
"Natural Levels"
14. Page 320, left side, add a new paragraph after, "....to assure
that levels are within good manufacturing practices."
Vitamin concentrate potency degrades with time. Concentrates
should be stored in accordance with manufacturer's recommendation
to maintain label potency. Vitamin concentrate potency should be
verified by the vitamin supplier.
*******
SSCC Page 2 & 9
Proposal 143
Make the following change on page 2:
5. "Plastic molding, forming, extrusion, and laminating resins"
means:
a. Resins or an intimate admixture of resins with other
ingredients which meet the requirements of the Federal
Food, Drug and Cosmetic Act as amended and;
b. Plastic composed solely of clean cuttings or regrind,
provided they have been handled and maintained in a
sanitary manner.
This definition shall not preclude the use of recycled plastic
material when it complies with a protocol which has been reviewed
and accepted by the Food and Drug Administration.
6. "Regrind" means that clean plastic material which is trimmed
from the container or closure, and imperfectly formed
containers or closures which result from the manufacture of
single-service containers and closures, provided it is
handled in a clean, sanitary manner. This may be in its
trimmed or molded form and ground in a suitable grinder
within the plant. It shall not include any material,
container or closure which comes from an unapproved plant
source or has been used as a container for any product, or
whose source, chemical content and treatment is unknown, or
which may have poisonous or deleterious material retained in
the plastic,which migrates to the food at levels exceeding
regulatory limits. Regrind may be, when transported from one
approved plant to another, provided it is will be shipped in
suitable, clean, sealed, properly labeled containers. This
definition shall not preclude the use of regrind plastic
material when it complies with a protocol which has been
reviewed and accepted by the FDA.
7. "Production scrap" means that material which remains from
the manufacture of single-service containers or closures
which has been handled or treated in such manner that it
does not comply with the definition for "broke and trim" or
"regrind", but may be collected for recycling. into non-food
contact products. It may contain material such as
containers or trim that have fallen on the floor.
Make the following changes on Page 9
16. EQUIPMENT AND MATERIALS FOR CONSTRUCTION OF CONTAINERS AND
CLOSURES
a.-d. No change.
e. Containers, resin and flashing on the floor and floor
sweepings of production materials are prohibited from being
reused. This shall not preclude the use of these materials
when it complies with a protocol which has been reviewed and
accepted by the FDA.
reletter e. and f. to f. and g. respectively.
*******
Procedures Page 5
Proposal 305
In Section III H. add the following new paragraph after the
existing paragraph:
If a BTU scores less than 90, a re-survey shall be conducted after
written notification from an authorized representative of the BTU
to the rating agency that the BTU is in substantial compliance. A
re-rating shall be completed in no more than 15 days from the date
of receipt of the notification. If the re-rating is less than 90,
the next re-rating shall begin in no less than 15 days from the
date of notification by the state rating agency and at the
discretion of the rating agency.
~THE IMPLEMENTATION DATE FOR THIS PROPOSAL IS AUGUST 1, 1995.~
*******
Procedures Page 8 and 16
Proposal 324
In Section V, A. insert a new paragraph #5 and renumber the
existing paragraphs #5-7 to become #6-8 as follows:
5. When an existing rating is no longer valid because a listed
milk plant, receiving station and/or transfer station permit
is revoked, the state shall within 5 days request FDA to
remove the listing.
In Section VII, C. add the following new paragraph:
6. If a state milk sanitation rating agency fails to request
removal of a milk plant, receiving station and/or transfer
station from the IMS list as provided for in section V A 5
FDA shall after 5 days provide this information to all
receiving states.
*******
Procedures Page 11
Proposal 330
Add the following at the end of #5:
5. For action to be taken if the PHS/FDA check rating indicates
listed rating not justified, refer to Section VII.C. For
the purpose of these Procedures and all related forms, the
terms "listed rating", "official rating" and "published
rating" shall mean the most recent survey rating, which is
accompanied by written permission by the shipper to publish,
and submitted to the PHS/FDA Regional Office by the State
milk sanitation rating agency.
*******
Procedures Page 12
Proposal 237
This Proposal was not concurred with by the FDA, however the
following alternate wording was mutually agreed upon during
discussion with the NCIMS Executive Board on July 29, 1995.
Change Section VI, E. 1 and 2 as follows:
E. Laboratory Evaluations
1. The PHS/FDA shall evaluate and approve laboratory
facilities and procedures of State laboratory approval
agencies to assure compliance with FDA-2400 series
evaluation forms and where appropriate, the latest
edition of Standard Methods for the Examination of
Dairy Products and Official Methods of Analysis of the
Association of Official Analytical Chemists (AOAC).
2. 2. The PHS/FDA shall periodically check survey milk
laboratories of participating states to assure
compliance with FDA-2400 evaluation forms and where
appropriate, the latest edition of Standard Methods for
the Examination of Dairy Products and Official Methods
of Analysis of the Association of Official Analytical
Chemists (AOAC). Check surveys conducted during
recertification of Laboratory Evaluation Officers shall
be submitted but it shall be the option of the LEO
whether or not the survey is submitted for official
action regarding laboratory status.
*******
Procedures Page 12
Proposal 328
Add to Section VI, RESPONSIBILITIES OF THE PHS/FDA a new item "G"
as follows:
G. After each Conference and/or request by the NCIMS Executive
Board, the FDA shall incorporate editorial updates into the
Pasteurized Milk Ordinance (PMO), the Dry Milk Ordinance (DMO), the
Standards for the Fabrication of Single Service Containers and
Closures (SSCC), the Methods for Making Sanitation Ratings and the
Evaluation of Milk Laboratories (EML) in accordance with the
guidelines to be developed jointly by PHS/FDA and the NCIMS
Executive Board.
*******
Procedures Page 15 and 16
Proposal 319
Change Section VII C.2.(c.) as follows:
2. Pasteurization Plants, Receiving Stations and/or Transfer
Stations
c. Withdrawal of Certification
When check rating data indicate that the sanitation compliance
rating of the pasteurization plant, receiving station and/or
transfer station requires a withdrawal of certification, the
State Rating Agency, upon written recommendation of the
PHS/FDA, shall immediately withdraw current certification of
the shipper and notify such shipper, the PHS/FDA, and all known
receiving States thereof, in accordance with Section V.A.4.
In case of withdrawal, a new rating shall be made in not less
than thirty (30) days and not to exceed sixty (60) days, unless
the State Rating Agency has reason to believe a new rating
within a lesser time period, but in no event in less than
fifteen (15) three (3) days, would result in an acceptable
rating. The effective date for action shall be determined from
the date of the letter of notification by the State Rating
Agency. Such letter to be dated within five (5) working days
following the date of the official notification.
~THE IMPLEMENTATION DATE FOR THIS PROPOSAL IS AUGUST 1, 1995.~
*******
Procedures Page 21 and 22 (Constitution)
Proposal 310 and Proposal 335
Changes from Proposal 310 are identified by a single underline and
changes from Proposal 335 are identified by a double underline.
In Article IV, Section 5, Subd.1, 2 and 3 delete references to
"Local Health Authority" as a category for election to the NCIMS
Board of Directors as follows:
SECTION 5. The membership of the Board shall be selected as
follows:
Subd. 1. Group I -- Eastern States
The Eastern states are Connecticut, Delaware, Florida,
Georgia, Maine, Maryland, Massachusetts, New Hampshire, New
Jersey, New York, North Carolina, Pennsylvania, Puerto Rico,
Rhode Island, South Carolina, Vermont, Virginia, West
Virginia and all states east of Group II including the
District of Columbia. and a A total of four (4) members
shall be selected for election from this area (one member
from a State rating agency, one member from industry, one
member from a State enforcement agency, plus one member from
either a local health authority, If a qualified member from
a local health authority is not available, a one member from
either a State rating or State enforcement agency may be
selected), and one member (at large) from the Public Health
Service/Food and Drug Administration to be appointed by the
Commissioner of the Food and Drug Administration.
Subd. 2. Group II -- Central States
The Central States are Alabama, Arkansas, Illinois, Indiana,
Iowa, Kentucky, Louisiana, Michigan, Minnesota, Mississippi,
Missouri, Ohio, Tennessee and Wisconsin. A total to fur (4)
members shall be selected for election from this area (one
member from a State rating agency, one member from industry,
one member from a State enforcement agency, plus one member
from either a local health authority If a qualified member
from a local health authority is not available, a one member
from either, a State rating or State enforcement agency may
be selected]), plus one member (at large) from an
educational institution and one member (at large) from a
laboratory. The at-large members need not live or be
employed in Group II.
Subd. 3. Group III -- Western States
The Western States are Alaska, Arizona, California,
Colorado, Hawaii, Idaho, Kansas, Montana, Nebraska, Nevada,
New Mexico, North Dakota, Oklahoma, Oregon, South Dakota,
Texas, Utah, Washington and Wyoming. all states west of
Group II and a A total of four (4) members shall be selected
for election from this area (one member from a State rating
agency, one member from industry, one member from a state
enforcement agency, plus one member from either a local
health authority, If a qualified member from a local health
authority is not available, a member from either a State
rating or State enforcement agency may be selected), plus
and one member (at large) from the U.S. Department of
Agriculture to be appointed by the Secretary of Agriculture.
In the case of participating U.S. Trust Territories, non-
U.S. countries or political subdivision thereof, each U.S.
Trust Territory, non-U.S. country or subdivision thereof
shall be assigned to Group I, Group II, or Group III by the
NCIMS Executive Board.
*******
Procedures Page 29
Proposal 333
Change Article X, Section 4, Subd. 2. as follows:
Each State, or other entity listed in Subd.3. of this Section,
shall be entitled to one (1) full vote in the delegate business
meeting, or two (2) one-half (1/2) votes.
*******
Procedures Page 29
Proposal 334
Change Article X, Section 4 as follows:
...Each voting delegate at the biennial or special meeting of the
Conference may cast a vote only for his/her own State. Delegates
and/or alternates will not be allowed to vote at a NCIMS from a
state which fails to honor the reciprocity provisions set forth in
Section 1-A paragraphs 2 and 3 of the Procedures Governing the
Cooperative State-Public Health Service/Food and Drug
Administration Programs for Certification of Interstate Milk
Shippers.
*******
The following proposals were passed without reference to a
document:
Proposal 132
The technical committee of the NCIMS in cooperation with the Milk
Safety Branch will conduct a study to determine whether electronic
digital test thermometers may be used under the provisions of
Appendix I.
*******
Proposal 138
This proposal directs the NCIMS Chairman to name a committee to be
assigned the task of preparing updated language for the PMO to
allow dairies to move into the computer era with greater ease,
emphasizing computer technology and removing obstacles that could
prevent them from incorporating computers into the controls for
their processing equipment while maintaining public health
protection.
*******
Proposal 210
This proposal directs the NCIMS Chairman to name a committee to
study the current hauling and transportation practices used for
Grade "A" milk and milk products, present a report to the NCIMS
Executive board and make recommendations, if necessary to the 1997
NCIMS Conference.
*******
Proposals 217, 225, 226, 227, 228, 229, 230, 231, 232, 233, 234,
235, 236, 254 and 260
These proposals were passed as submitted and sent to the laboratory
committee to be reviewed and implemented according to a protocol
which provides for evaluating laboratory related proposals and
modifying laboratory forms.
*******
Proposal 219
This proposal provides for the following:
1) Request the FDA to develop performance criteria for positive
controls to be used with each drug residue screening test,
after this criteria has been accepted by the Laboratory
Committee, and
2) Request the FDA Laboratory Quality Assurance Branch (LQAB)
routinely select samples of positive controls, and analyze them
to establish whether they meet the criteria accepted by the
Laboratory Committee, and
3) Provide that the LQAB notify the manufacturers of the positive
control and the test kit manufacturers that require the use of
those controls that fail to meet the NCIMS standards, and
request the manufacturers to submit a plan to correct the
situation and prevent its recurrence, and
4) If a firm fails to submit a plan in a timely manner (ie. 30
days), LQAB will notify the NCIMS through it's Laboratory
Committee of that fact, and
5) The NCIMS Laboratory Committee may request FDA to issue
memoranda which will notify the participating states that the
subject firm's control samples do not meet the NCIMS standard,
and may not be used in NCIMS monitoring or regulatory drug
residue screening programs.
*******
Proposal 250
Requests the Laboratory Committee to:
1. Consider research done at Langston University E. (Kika) de la
Garza Institute for Goat Research which supports findings that
goat milk standards or a correction factor must be used with
Fossomatic cell counts on goat milk, and
2. Make a recommendation to the Executive Board on that issue.
*******
Proposal 251
Provides that the NCIMS Laboratory Committee evaluate studies of
drug screening tests for goat (or other species) milk and make
recommendations to the NCIMS Executive Board related to the results
of their evaluation of these studies.
*******
Proposal 258
Extends the time limit for raw milk samples used for bacteria tests
and taken in accordance with the existing PMO requirements to an
universal sample aged less than 48 hours.
*******
Proposal 266
This proposal provides that both the Foss instrument and Bentley
Somacount 300 meet the Flow cytometry/optoelectronic classification
referred to as a somatic cell confirmatory or screening test
referred to in paragraph 3 page 46 of the PMO.
*******
Proposal 277 TABLED
FDA agreed to work to address the concerns stated in this problem
in order to expedite investigations and/or other actions to be
taken when violations of the FD&C Act which are not covered by the
PMO are observed.
~BECAUSE THIS PROPOSAL WAS TABLED THERE IS NO IMPLEMENTATION DATE.~
*******
Proposal 321
This proposal requested the NCIMS Executive Board to investigate a
Pennsylvania program which provides for the use of "Grade AA" on
fluid milk products and rule whether this practice is a violation
of the conference agreement on reciprocity.
*******
Proposal 325
Requests the NCIMS Chairman appoint a committee to explore Proposal
325 and develop a recommendation that can be implemented by the
Board prior to the 1997 NCIMS Conference.
*******
Proposal 336
This proposal directed the Council 3 Chairman to appoint a
committee of Council 3 members and the submitter of the proposal to
develop a resolution in which the conference urges FDA to provide
a uniform comprehensive computer data base system for
implementation by the states and industry and that the FDA provide
a grant or grants to facilitate the development of such a system.
*******
FDA DID NOT CONCUR ON THE FOLLOWING PROPOSALS:
NOTE: Proposals 116 and 237 were originally not concurred by the
FDA, however alternate wording was mutually agreed n by the FDA and
NCIMS Executive Board on July 29, 1995.
Proposal 125
This Proposal would have changed Section 7 item 14r of the PMO as
follows:
Milking shall be done in the milking barn, stable or parlor. The
flanks, udders, bellies and tails of all milking cows shall be free
from visible dirt. All brushing shall be completed prior to
milking. The udders and teats of all milking cows shall be clean
and dry before milking. Teats shall should be treated with a
sanitizing solution just prior to the time of milking and shall be
dry before milking. Wet hand milking is prohibited.
Public Health Reason.-- .... Application of sanitizing solutions
to the teats followed by thorough drying just prior to the time of
milking is highly recommended. This practice has the advantage of
giving an additional margin of safety.....
ADMINISTRATIVE PROCEDURES
#4 Udders and teats of all milking cows are clean and dry before
milking. Teats shall be clean and dry before milking. Teats shall
be cleaned, treated with a sanitizing solution and dry just prior
to milking.
FDA would like this Proposal to be referred to the 1997 NCIMS
Conference to allow additional parties the opportunity to offer
comments.
*******
Proposal 315
This proposal would have changed Section 4 of the PMO as follows:
9. No reference shall be made with regard to the use or non-use
of rBST or rBGH on any dairy product.
FDA is willing to work with the NCIMS to discuss other options to
address this issue.
*******
All proposals which change documents will be incorporated into the
next edition of the document as they are updated.
Copies of this memorandum are enclosed for distribution to District
Milk Specialists, state milk regulatory agencies, State Laboratory
Evaluation Officers and State Milk Rating Officers in your region.
This memorandum is also available on the FDA FDA Prime Connection
computer bulletin board system, and should be widely distributed to
representatives of the milk industry and other interested parties.
Joseph M. Smucker
Acting Chief, Milk Safety Branch, HFS-626
Division of Cooperative Programs
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
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