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IMS-a-32: Actions of the 1995 National Conference on Interstate Milk Shipments

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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:

  1. 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
be evaluated
No. of samples
to be examined
Product category and
recommended type
Duplicates
Plate counts 8    
Coliform
Count
Phosphatase
8 Pasteurized cream,
chocolate, skim and
homogenized
1 each
  8    
Vitamins 8 Pasteurized,
fortified
products
undetermined
Plate
Counts
6 Raw or
pasteurized
3
Inhibitors
Counts
8 Raw and/or
pasteurized
4
Abnormal
Milk
8 Raw Mild 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:

  1. 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:

  1. 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
(L1)
Rejection Limit 2
(L2)
Plate
Counts
0.268* 0.179*
Direct
Somatic
Cell Count
0.300* 0.200*
Electronic
Somatic
Cell Count
0.212* 0.143*
Vitamins 0.300 0.200
Fluorometer
Electronic
Phosphatase
0.2810.300* 0.1870.200*

(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 ompliance with this section exists the rating agency may accept this documentation. The responsible rating officer may at their iscretion 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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).
  5. 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.
  6. 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:

  1. 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:

  1. 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:

  1. 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:

  1. 4. Inspect each milk plant and receiving station at least once every 3 months.
  2. 3. Inspect each transfer station and dairy farm at least once every 6 months and
  3. 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

  1. 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.
  2. 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
      1. 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:

No. Ord
Sec
Item# Insp# Compl% Compl Wt. Credit
11 Records
systematically
maintained
and current
    10 5    
12 All bulk milk
pickup tankers
permitted and
inspected at
the required
frequency
    5    

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:
    1. Are the bulk milk pick-up tankers permitted under the direction of a regulatory agency?
    2. Does this regulatory program allow for necessary enforcement action against individual bulk milk pick-up tankers?
    3. 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:

  1. 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:

  1. 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:

  1. 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:

  1. 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:

  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.

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:

  1. ..... 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:

  1. ..... 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:

  1. 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
Somatic Cell
Counts per
ml.
Enforcement action as applied to a
standard of 750,000 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
12/21/93 650,000 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.

  1. 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:

  1. 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 feeding 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.
  2. 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.
  3. 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, egardless of temperature, and the booster pump cannot run during his 10 minute time delay.
  4. 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 hall be applied after testing so that changes cannot be made without detection.
  5. 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.
  1. Immerse the sensing element of the recorder in boiling water for not less than 5 minutes (two minutes for electronic recording thermometers).
  1. 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.
  2. 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).
  3. 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

  1. 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

Item # # of
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 elabeled #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:

The revised Dairy Farm Inspection Report may be obtained through the Food and Drug Administration, Milk Safety Branch (HFS-626), 200 C Street, S.W., Washington, DC 20204.

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 hese 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 dded, 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 itamin 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 hould 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:

  1. "Plastic molding, forming, extrusion, and laminating resins" means:
    1. 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;
    2. 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.

  1. "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 hich 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.
  2. "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

  1. 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:

  1. 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:

  1. 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:

  1. 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. 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:

  1. 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 rom 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 CIMS 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 anitizing solution just prior to the time of milking and shall be ry 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:

  1. 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 wide ly 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