Inspections, Compliance, Enforcement, and Criminal Investigations

Dairy Product Manufacturers (4/95)

 

GUIDE TO INSPECTIONS OF DAIRY PRODUCT MANUFATURERS

Note: This document is reference material for investigators and other FDA personnel. The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s).

TABLE OF CONTENTS

Raw Milk Receiving
 
Raw Storage
 
Processing
 
Additional Processing
 
Quality Control
 
7
Creameries
 
Equipment and Processing
 
Economic Violations
 
Butter Made From Interstate Cream
 
Sample Collection
 
Raw Materials
 
Equipment and Processing
 
Packaging
 
Controls
 
Personnel
 
Cleaning and Sanitizing
 
Sample Collection
 
MOU Countries
 
Sampling Decision
 
Sample Collection
 
Raw Materials
 
Definitions
 
Manufacturing and Processing
 
Sample Collection
 
Processing
 
Economics
 
Sample Collection
 
General
 
Processing
 
Quality Control
 
Sample Collection
 
Authority
 
References
 
Program Objectives
 
Program Operations
 
Compliance Program Status Reports
 
Miscellaneous Information
 

BACKGROUND

State and local regulatory agencies are responsible for the enforcement of sanitation requirements on dairy farms, in processing plants, dry milk plants, receiving and transfer stations (establishments where raw milk or cream is received for further transport). The Public Health Service has no legal jurisdiction in the enforcement of milk sanitation standards except on interstate carriers and milk and milk products shipped in interstate commerce. FDA's primary function under the Federal/State Milk Safety Cooperative Program (IMS Grade A products) is to provide technical assistance to the states in the implementation and enforcement of their milk regulations. This assistance is provided through the district and regional milk specialists and the Center for Food Safety and Nutrition's (CFSAN), Milk Safety Branch.

To assist states and municipalities in initiating and maintaining effective programs for prevention of milkborne diseases, the Public Health Service developed (in 1924) a model regulation known as the Standard Milk Ordinance for voluntary adoption by state and local milk control agencies. This model milk ordinance, now titled "Grade A Pasteurized Milk Ordinance" (PMO), also provides administrative and technical details as to satisfactory compliance with the ordinance. The ordinance is incorporated by reference in federal specifications, for procurement of milk and milk products served on interstate carriers, and is recognized by public health agencies and the milk industry as a national standard for milk sanitation.

FDA is responsible for direct inspectional coverage of all non-grade A products shipped in interstate commerce which include: Milk & Milk Products, Butter, Dried Milk Products, Cheese & Cheese Products, Ice Cream & Related Products (frozen desserts), Filled Milk & Imitation Milk Products.

In addition to applicable CFR references, the PMO can be used as an inspectional guide to cover specific operations in the dairy industry, including pasteurization equipment, packaging, quality control and record keeping requirements. Although the PMO does not have the force of regulations, it provides procedures and standards of general applicability that are acceptable to FDA. Deviations from the PMO can be listed as objectionable conditions if the procedures and standards in use at a firm are not deemed to be equivalent to those in the PMO.

This guide is basically an update of information published in the 1992 edition of the IOM regarding the inspection of dairy product manufacturers and milk safety state cooperative program. The guide covers both domestic and import inspectional information.

Since there is some overlap between USDA and FDA regarding milk safety, please review IOM 303 for procedures to follow when interacting with other government inspectors.

AUTHORITY

Public Health Service Act, as amended (P.L. 410), Sections 310, 311, 314, and 361.

Food, Drug and Cosmetic Act, as amended, Sections 201, 301-307, 401-409, 411, 701 - 709, 801.

Filled Milk Act, 21 U.S. C. Sections 61-64, enacted March 4, 1993

Federal Import Milk Act, 21 U.S.C Sections 141-149, adopted February 15, 1927.

REFERENCES

MILK AND MILK PRODUCTS

  1. Grade "A" Pasteurized Milk Ordinance,

    Recommendations of the United States Public

    Health Service/Food and Drug Administration.

    Current Revision

  2. 21 CFR Sections 1/10; 101; 108; 110; 113; 130; 131; 133; 173.310; and 178.1010.
  3. Grade A Condensed and Dry Milk Products And Condensed and Dry Whey (DMO). Current Revision.
  4. FDA Frozen Dessert Processing Guidelines

    (current edition).

  5. 3-A Sanitary Standards for Dairy Equipment.
  6. PMO, Part 1, Definition S; Attachment 4 for acceptable pasteurization times and temperatures; and Attachment 1 for pasteurizer evaluation.
  7. "3-A Accepted Practices for the Sanitary Construction, Installation, testing and Operations of HTST Pasteurizers"
  8. CPG 7119.05, Imported Milk and Cream
  9. CPG 7158.01, MOU with the National Conference on Interstate Milk Shipments Relating to Interstate Milk Shipments
  10. Federal Import Milk Act Regulations, 21 CFR, Part 1210.
  11. NCIMS Memorandums to supplement the PMO and related documents
  12. Regional/District Milk Specialists

BUTTER

  1. Grade "A" Pasteurized Milk Ordinance,

    Recommendations of the United States Public

    Health Service/Food and Drug Administration.

    Current Revision

  2. 21 CFR Sections 1/10; 101; 108; 110; 113; 131; 130; 133; 173.310; and 178.1010.
  3. 3-A Sanitary Standards for Dairy Equipment.
  4. PMO, Part 1, Definition S; Attachment 4 for acceptable pasteurization times and temperatures; and Attachment 1 for pasteurizer evaluation.
  5. "3-A Accepted Practices for the Sanitary Construction, Installation, testing and Operations of HTST Pasteurizers"
  6. Regional/District Milk Specialists

DRIED MILK AND WHEY

  1. Grade "A" Pasteurized Milk Ordinance,

    Recommendations of the United States Public

    Health Service/Food and Drug Administration.

    Current Revision

  2. Handbook 917, "Special Sanitation Suggestions for Dry Milk Manufacturers" by the American Dry Milk Institute, Inc.
  3. 3-A Sanitary Standards for Dairy Equipment.
  4. PMO, Part 1, Definition S; Attachment 4 for acceptable pasteurization times and temperatures; and Attachment 1 for pasteurizer evaluation.
  5. Grade A Condensed and Dry Milk Products and Condensed and Dry Whey (DMO) Current Revision.
  6. 21 CFR Sections 1/10; 101; 108; 110; 113; 130; 131; 133; 173.310; and 178.1010.
  7. "3-A Accepted Practices for the Sanitary Construction, Installation, testing and Operations of HTST Pasteurizers"
  8. NCIMS Memorandums to supplement the PMO and related documents.
  9. Regional/District Milk Specialists

CHEESE AND CHEESE PRODUCTS

  1. Grade "A" Pasteurized Milk Ordinance,

    Recommendations of the United States Public

    Health Service/Food and Drug Administration.

    Current Revision

  2. 21 CFR Sections 1/10; 101; 108; 113; 131; 133; 173.310; and 178.1010.
  3. 3-A Sanitary Standards for Dairy Equipment.
  4. PMO, Part 1, Definition S; Attachment 4 for acceptable pasteurization times and temperatures; and Attachment 1 for pasteurizer evaluation.
  5. "3-A Accepted Practices for the Sanitary Construction, Installation, testing and Operations of HTST Pasteurizers"
  6. Regional/District Milk Specialists
  7. Attachment 3, Summary of Specifications for Standardized Cheese and Cheese Products.

ICE CREAM AND RELATED PRODUCTS

  1. FDA's "Frozen Dessert Processing Guidelines."
  2. Grade "A" Pasteurized Milk Ordinance,

    Recommendations of the United States Public

    Health Service/Food and Drug Administration.

    Current Revision.

  3. 21 CFR Sections 1/10; 101; 108; 113; 131; 133; 173.310; and 178.1010.
  4. 3-A Sanitary Standards for Dairy Equipment.
  5. PMO, Part 1, Definition S; Attachment 4 for acceptable pasteurization times and temperatures; and Attachment 1 for pasteurizer evaluation.
  6. "3-A Accepted Practices for the Sanitary Construction, Installation, testing and Operations of HTST Pasteurizers"
  7. Regional/District Milk Specialists

FILLED MILK AND IMITATION MILK PRODUCTS

  1. Grade "A" Pasteurized Milk Ordinance,

    Recommendations of the United States Public

    Health Service/Food and Drug Administration.

    Current Revision

  2. 21 CFR Sections 1/10; 101; 108; 113; 131; 133; 173.310; and 178.1010.
  3. 3-A Sanitary Standards for Dairy Equipment.
  4. PMO, Part 1, Definition S; Attachment 4 for acceptable pasteurization times and temperatures; and Attachment 1 for pasteurizer evaluation.
  5. "3-A Accepted Practices for the Sanitary Construction, Installation, testing and Operations of HTST Pasteurizers"
  6. Regional/District Milk Specialists

MILK & MILK PRODUCTS

Refer to IOM Subchapter 530 for general instructions on conducting food inspections. The following are general inspectional instructions on all dairy products. Any differences will be included in the specific product sections.

Caution: Extreme care should be taken during these inspections to avoid possibility of product contamination. Always wear a clean lab coat or clean white coveralls when inspecting a dairy processing plant. Inspect the pasteurized product areas first and then the raw product handling areas. If it is necessary to return to the pasteurized product area, follow the firm's sanitation procedures. If the firm has no procedures in place, at a minimum sanitize your boots, wash your hands and change outer clothing.

Raw Milk Receiving

Raw milk should be protected from outside contamination. (PMO, Part II, Section 7, Item 5p). Receiving hoses should be clean, protected and cleaned daily after the last truck of incoming raw milk or cream has been received. (PMO, Part II, Section 7, item 12p and the 3-A Sanitary Standards).

Tank trucks used to transport raw milk should be constructed and operated to protect their contents from contamination and temperature extremes. (PMO, Part II, Section 7, item 20r). Tank trucks should be washed and sanitized after each use. (PMO, Part II, Section 7, Item 12p).

Single service articles are those having a milk contact surface, used in the processing of milk, and intended for one use only. Examples are certain pipeline gaskets, and woven milk filter material. (PMO, Part 1, Section 7, Item 11p). Single service items are replaced daily.

Raw Storage

The indicating and recording thermometers used on the raw milk storage tanks should comply with the requirements in Appendix H, Part IV, of the PMO. See Appendix H, "Indicating Thermometers used in Storage Tanks", and "Recording Thermometers Used in Storage Tanks".

Raw tanks are to be cleaned and sanitized when empty and emptied at least every 72 hours (PMO, Part II, Section 7, Item 12p). Tanks should be properly vented (PMO, Part II, Section 7, Item 5p).

Product must be maintained at 45F (7.2oC) or below prior to and after pasteurization. (PMO, Part II, Section 7, Standards).

Product in storage must be protected from external contamination (PMO, Part II, Section 7, Item 5p)

Processing

The firm's piping diagram should be reviewed and compared to the actual plant layout and all potential cross-connections found should be followed-up. No cross-connections are allowed between raw and pasteurized product or between CIP and product. (PMO, Part II, Section 7, Item 15p).

Pasteurizing, processing, cooling and packaging of milk and milk products should take place in a room separate from cleaning and sanitizing facilities for milk tank trucks, and other areas in which raw milk and raw milk utensils are handled. (PMO, Part II, Section 7, Item 5p).

The pasteurization process should be reviewed in detail. If a continuous process is used (HTST), a flow diagram showing each piece of equipment (i.e. pumps, valves, thermometers, etc.) and temperatures at each point of the process should be collected as an exhibit. Pasteurization must be performed following the time/temperature relationships as defined in PMO, Part 1, Definition S; or some other method reviewed and accepted by the agency Questions concerning the firm's pasteurization process may be directed to your district or regional milk specialist or the Milk Safety Branch.

Pasteurization shall mean the process of heating every particle of milk or milk product, in properly designed and operated equipment, to one of the temperatures given in the following chart and held continuously at or above that temperature for at least the corresponding specified time:

Temperature Time
*63oC (145oF)30 minutes
*72oC (161oF) 15 seconds
89oC (191oF) 1 seconds
90oC (194oF) 0.5 seconds
94oC (201oF) 0.1 seconds
96oC (204oF) .05 seconds
100oC (212oF) .01 seconds

*If the fat content of the milk product is 10% or more, or if it contains added sweeteners, the specified temperature shall be increased by 3oC (5oF). Note: See Attachment 4 for eggnog.

If vat (batch) pasteurization is used:

  1. The vat pasteurizer must comply with construction requirements. (PMO, Part II, Section 7, Item 16p (A)) as follows:
    1. Outlet valve is close coupled and leak detector type. (PMO, Part II, Section 7, Item 16p (A) (3)).
    2. Indicating, recording and air space thermometers comply with PMO, Part II, Section 7, Item 16p (A) and Item 16p(A)(1)(2).
    3. Inlet piping and valving shall be of proper construction (PMO, Part II, Section 7, Item 16p (A) (4)).
    4. Cover protecting product (PMO, Part II, Section 7, Item 16p (A)).
  2. A comparison of the pasteurizer indicting thermometer with the recording thermometer should ensure that the recording thermometer reads no higher than the indicating thermometer during the holding period. (PMO, Part II, Section 7, Item 16p (A)(5)).
  3. Verify the product is held at the minimum pasteurization temperature continuously for a minimum of 30 minutes. This time period does not include vat filling, preheating, emptying or cooling steps/times. (PMO, Part II, Section 7, Item 16p (A)(1)(c)).
  4. Determine if the air space between the top of the product and the underside of the vat cover is maintained at least 5oF (2.8oC) above required legal pasteurization temperature and recorded on the recording thermometer chart. If an air space heater is used, it should be of proper construction and it should be used throughout the holding time. (PMO, Part II, Section 7, Item 16p (1) and Item 16p (A)(2) and Appendix H, III, Figures 38 & 39).
  5. Review regulatory authority tests on pasteurization equipment for compliance with the specification as outlined in PMO, Appendix I, and PMO, Part II, Section 7, item 16p (E)(2). Verify that needed corrections were made. Regulatory authority (state/local) is responsible for testing equipment on a quarterly basis. Results should be recorded on form FDA 2359b or equivalent (PMO, Appendix M).
  6. Review pasteurization temperature recording charts for the necessary information (PMO, Part II, Section 7, Item 16p (E)(1)(a)).

Utilize Appendix H of the PMO and 3-A Accepted Practices for the Sanitary Construction, Installation, Testing and Operation of HTST Pasteurizers for evaluation of high-temperature short-time (HTST) or higher-heat short-time (HHST) systems. A flow diagram showing each piece of equipment in those systems, and temperatures at each point of the process should be collected as an exhibit.

Determine the time-temperature used for pasteurization and the cut-in/cut-out temperature for each pasteurization unit. (PMO, Part I, Definition S).

Check construction of the HTST pasteurization unit. (PMO, Part II, Section 7, item 16p(B) and Attachment 1):

  1. Holding tube should slope continually upward at least 1/4 inch per linear foot. (PMO, Part 11, Section 7, Item 16p(B)(2)(d)).
  2. Properly installed and maintained flow diversion device (FDD), divert line and leak detect line. (PMO, Part II, Section 7, Items 16p (B)(2)(b)).
  3. Recorder-controller should be present and properly installed and under regulatory seal.* (PMO, Part II, Section 7, Item 16p (B) (1)(2)).
  4. If a positive displacement timing pump is used, it should be sealed* at its maximum flow rate by a regulatory agency. (PMO, Part II, Section 7, Item 16p(B)(2)(f)).

    * Note: sealed is defined as any acceptable means which shall prevent alteration of the mechanism which controls public health parameters of time, temperature, pressure. Normally this will consist of a hard cover "box" or plate which is rendered tamper evident by means of wire thread with lead crimps. Said lead crimps shall have the identifying mark of the regulatory authority imprinted upon them.

  5. If milk to milk regenerator is used, it should comply with PMO, Part II, Section 7, item 16p(D) and Attachment 2.

    The vacuum breaker should be installed in the proper location and 12 inches above the highest raw milk in the system. (PMO, Part II, Section 7, item 16p(D) and Attachment 2).

    If a booster pump is used, proper controls should be in place covering its operation, i.e., it should be located between the constant level tank and the inlet to the raw milk section of the regenerator. There should be pressure gauges and adequate pressure controls installed to insure at least 1 lb. greater pressure on the pasteurized side than on the raw side at all times. (PMO, Part II, Section 7, Item 16p (D)).

  6. The balance tank should be of proper design and construction. (PMO, Part II, Section 7, Item 16p (D)).
  7. All public health controls (see below) should be properly sealed. See definition of "sealing" above. (PMO, Part II, Section 7, Item 16p(B)(2)(c)(f) and item 16p (d)(9)).
    1. recorder controller
    2. flow promoting devices (mag meters, timing pumps)
    3. flow diversion controls
    4. differential pressure controllers.
  8. The recording thermometer should read no higher than the indicating thermometer during processing. Temperatures must agree within 1oF but in no case can the recording thermometer read higher than the indicating thermometer.

With permission of management, when system is in forward flow, actuate manual divert switch and observe operation. (PMO, Appendix I, Test 5, (5)).

  1. The flow diversion device (FDD) should move to divert position.
  2. The frequency pen should go to the divert position.
  3. The booster pump should stop operating.
  4. The pasteurizer side pressure should remain higher than the raw side at all times.

Review state regulatory tests of HTST pasteurization units to determine if proper tests have been completed at the required frequency. Document any deficiencies in frequency or testing. Corrections should have been made as needed. The regulatory authority is required to conduct tests quarterly, except for "holding time" which is conducted semi-annually. Results should be recorded on FDA form 2359 b or equivalent (PMO, Appendix M). Tests must be conducted in accordance with PMO, Appendix I.

Review the recording charts for the following information: (PMO, Part II, Section 7, item 16p(E)(1)(b)).

  1. Date
  2. Chart # if more than one used during a product day
  3. Name or number of pasteurization unit
  4. Cut-in and cut-out temperature recorded at the beginning of the run, with a reference mark
  5. Indicating thermometer temperature at a given time or reference point as indicated on chart
  6. Position of FDD (Forward Flow or Diverted Flow) recorded by mechanical "event" pen on the thermal limit controller
  7. Amount and identification of each product noted on the chart
  8. Record of and reason for each unusual occurrence if any
  9. Signature or initials of operator
  10. Name of plant
  11. Record of Quality Control

If the continuous pasteurization system utilizes a magnetic flow meter based timing system, refer to PMO, Section 7, 16p and Appendix H and I, for specific guidance. If the pasteurization system public health safeguards are under any degree of computer control please contact the regional/district milk specialist or the Milk Safety Branch for specific guidance.

Additional Processing

Determine the vitamin fortification of the products being processed. Review results of the required annual vitamin assay. (PMO, Part I, Section 6, and PMO Appendix O).

Review vitamin usage logs which record actual and estimated vitamin usage. Compare and note discrepancies. Document the point of addition and method of Vitamin A and D addition.

Determine whether all ingredients are added before the pasteurization process to assure complete pasteurization. Verify that culture media is properly pasteurized in appropriate equipment prior to addition.

Observe the handling practices during addition of dry ingredients to milk and milk products. Contamination of the milk or milk product may occur through contact with the outside of the dry ingredient container.

Determine whether the pasteurization times and temperatures comply with the comparable times and temperatures for similar dairy products, see the definition of pasteurization under "Processing" above, Attachment 4 and PMO, Part I, Definition S.

If steam is used directly in products or on product-contact surface, determine the following: (PMO, Part II, Section 7, item 16p (B)(2)(d)(8)(9)(10) and item 21p (B)(g)(h) and item 16p(C)(2)(e)(f) and PMO Appendix H, III).

  1. Boiler water treatment compounds should comply with 21 CFR 173.310
  2. If direct injection into product, steam should be properly filtered, piped and trapped. (PMO, Appendix H, IV).

If air under pressure is used in contact with the product or directed at product-contact surface, determine the following (PMO, Appendix H, figures 34,37,38 &39):

  1. It is properly filtered before compression.
  2. Oil and moisture are properly removed after compression.
  3. There is a single-service final filter immediately prior to use.
  4. A sanitary check valve is located downstream from the final filter to prevent product from contaminating the filter and air piping.

Determine if product and ingredients are properly protected from environmental contamination at all times:

  1. Check for excessive condensation from ceilings and from overhead pipes and equipment.
  2. Covers on tanks and vats
  3. Caps on lines when not in use.

Evaluate Water Supply (PMO, Appendix D, PMO, Part II, Section 7, item 7p and item 17p):

  1. Construction of wells (if applicable)
  2. Proper analysis conducted semi-annually (if applicable)
  3. Check for submerged inlets
  4. Check for cross-connections between potable water and: product, CIP system(s), boiler water feed tank, i.e. non-potable water or cooling media, i.e. sweetwater, glycol, and tower water.
  5. Determine if sweetwater and glycol systems are properly constructed, protected and tested.
  6. Condensing water and water reclaimed from milk and milk products used in accordance with Appendix D of the PMO.

Evaluate HVAC System (PMO, Part II, Section 7, item 4p):

  1. Determine air flow throughout plant
  2. Determine if the source of the air is filtered

Cleaning and Sanitizing (PMO, Appendix F and PMO, Part II, Section 7, Item 12p.)

CIP System should be properly constructed (PMO, Part II, Section 7, item 10p, 11p):

  1. No submerged water inlets.
  2. Recorder probe located in proper position (PMO, Part II, Section 7, item 12p (2)(b)).
  3. No cross-connection between CIP and product (PMO, Part II, Section 7, item 15p (B)).
  4. Air valves, including the FDD, are pulsated during CIP cycle.

Charts (PMO, Part II, Section 7, item 12p (2)(c)) should be:

  1. Accurate as to time of day;
  2. All circuits washed daily or as required by use; and,
  3. Cycles are complete (no short cycles).
  4. Properly labeled with the date and plant identification.

Manually Cleaned Items should all be disassembled, cleaned and sanitized daily.

An inspection should be scheduled to determine if equipment is clean. Schedule your inspection to be present after clean-up and prior to start-up. Disassemble the following cleaned equipment to check on adequacy of cleaning (note - have plant personnel disassemble the equipment if at all possible):

[NOTE: Have plant personnel disassemble the following equipment and evaluate for construction and cleanliness.]

  1. Plug valves
  2. Air valves
  3. Fillers
  4. Vacuum breakers
  5. Metering valves
  6. Pumps
  7. Check-valves
  8. Air filter
  9. Gasketed lines
  10. Plate Heat Exchangers
  11. Flow Diversion Device

Inspect for cleanliness all available storage and processing vessels:

  1. Silo tanks
  2. Pasteurized storage tanks
  3. Vat pasteurizers
  4. Processing vats
  5. Balance tanks
  6. Transport tankers

Note: These items can be checked throughout the inspection after they have been washed. Always check raw silo tanks when they are available, otherwise product will be placed into tank, and it may not be available for 72 hours.

Packaging

Since post-pasteurization contamination is the most common cause for contaminated dairy products, conduct a thorough review of the packaging process while in operation, including:

  1. Excess grease and excess lubricant
  2. Presence of overhead shielding above open containers prior to or after filling.
  3. Presence of condensate which may have access to open containers prior to or after filling.
  4. Containers and caps originate from an approved source (see IMS Quarterly Listing).
  5. Temperature of the product never exceeds 45oF prior to packaging.
  6. CIP solution completely drained prior to packaging.
  7. No cross-connections between raw piping and storage vessels and packaging equipment.

Quality Control

The firm should have quality control procedures for inspection of equipment that is cleaned in place as well as for equipment that is hand cleaned.

Verify that all farm bulk tanker trucks unloading raw milk at the plant are screened for beta lactam drug residues prior to processing the raw milk.

Compare quality control test results with finished product standards:

  1. Standard plate count
  2. Coliform
  3. Drug Residues
  4. Phosphatase
  5. Vitamin testing
  6. Temperature

What action is taken if samples are found out of limits?

Review results of official state samples, if taken.

BUTTER

Refer to IOM Subchapter 530 for general instructions on food inspections. During butter inspections place major emphasis on filth and decomposition in cream and/or milk as well as plant sanitation. Additionally, verify that butter is made from pasteurized cream or other milk products.

Some of the guidance below is only applicable to certain inspectional situations. Consult with your regional/district milk specialist or Milk Safety Branch to determine applicability to firm being inspected.

Creameries

If filthy cream is being used or if plant insanitary conditions result in demonstrable contamination of the cream, collect exhibits from in-line filters, clarifiers, dump screens, flies floating in vat cream, etc. Explain the exhibits with reference to the probable amount of cream involved, whether it was the same cream you examined, and what churn numbers are related to the exhibits. Identification of butter sampled with cream tested should be clearly and positively made.

Verify the cream quality control program practiced by the creamery on both cream purchased from individuals as well as cream pooling stations.

Evaluate equipment cleanup procedures. Poor cleanup indicators include mold in or about butter printer, milkstone buildup, and failure to remove sanitary product seals from continuous churns.

Fully document any insanitary condition noted with appropriate photographs, exhibits, etc.

Equipment and Processing

Evaluate the pasteurization equipment to assure adequate milk/cream pasteurization. See PMO, Part II, Section 7, Item 16p (A)(B). Give special attention to the flow diversion device and the thermal limit controller as well as the timing device in the system.

Economic Violations

Review firm records for butterfat analysis and report disposition of any low fat churns and excessive overruns. Excessive overruns are lots of product to which too much air has been incorporated.

Butter made from interstate cream

If the creamery receives cream from interstate sources, but does not ship the butter interstate, seizure action will only be considered if the butter contains 10% or more of filthy or decomposed interstate cream.

Trace the cream into a specifically identified churn (or churns).

Sample Collection

Sample by churns if marked. Identify each subdivision with corresponding churn mark and the determination to be made. Seal each jar individually.

If the lot is readily available for re-sampling, preliminary samples of fewer subdivisions may be collected where special circumstances so dictate. Collection reports and records should arrive at the laboratory with or ahead of the sample.

For filth

If bulk (tub or cube), use butter trier and take cores at points equidistant around the circumference or at the edge or corners of the cube. Insert trier diagonally from a point at the edge or corner through the center to the bottom of the opposite side. Give the trier a full turn and withdraw. Beginning at the pointed end of the trier, place 3-inch length of butter in clean, dry glass jars. Use the last inch to plug the hole.

Wipe the trier before drawing each core.

If filth only is to be determined, the sample need not be refrigerated. The same subdivisions may be used for WIA-butyric acid determinations.

For fat and moisture

Collect subdivisions of 1/2 pound or 1 print, if in 1-lb prints. It is preferable to collect separate subdivisions for this determination. Sample must be refrigerated. In the case of 1-lb. or larger solid prints, deliver entire print in person if laboratory is easily accessible otherwise submit entire print in dry glass jars. If desired, opposite quarters or portions of the print equivalent to at least 1/2 lb. may be cut and submitted for fat determination.

Glass jars should be clean and dry, and cylindrical in shape. They must not have porcelain or absorbent lined caps.

If tub or cube butter, use a butter trier in the manner previously described.

Do not add moisture adhering to the outside of the trier. Report whether the product is firm or leaky. If the product is hard, heat the trier until the temperature can just be borne by the hand. If it is very hard, place cubes or tubs in tempering room for 24 hours.

Three average trier fulls will usually provide slightly more than the 1/2 pound required for the subdivision. NOTE: A churn mark is an identification of each batch made.


BUTTER SAMPLE SCHEDULE

(Number of subs required)

over 3 units
WIA & Butyric Acid Filth Fat & Moisture
Min. Amt each Sub 1 lb
(453 gm)
1 lb
(453 gm)
8 oz
(225 gm)
Print Butter,
Each Churn Mark of
1-35 cases
(30 lbs)*
1** 5 5
Over 35 cases 1** 8 8
No Churn Marks
(30 lbs)*
1-35 cases 12 12 12
Over 35 cases 12 20 20
Bulk Butter(Cube-Tub) Each Churn, Mark of
1-2 units 1** All All
3 units 1** 2 2
1** 3 3
No Churn Marks 1-5 units All All All
6-14 units 5 5 5
15-24 units 7 7 7
25-150 units 8 8 8
Over 150 units 8 14 14

Prints for Net Weight

Weigh 50 prints equally distributed from not more than 12 cases in lot. If short eight, sample as for fat.

*If a lot or mark contains fewer cases than the number of subs specified, collect 1 sub from each case with one or more additional subs per case to provide the minimum number of subs required.

**Collect two-pound subdivisions to provide 1/2 lb. for WIA and Butyric Acid Test, 1/2 pound for 702(b) requirements and 1 lb. for butyric acid isolation exhibit.

Fully document any insanitary conditions noted with appropriate photographs, exhibits, etc.

DRIED MILK AND WHEY

See IOM Subchapter 530 for guidelines on conducting food inspections.

The guidance in this section is applicable to other dried whey products, i.e., cheese, butter, whey, caseinate, etc. Before initiating the inspection, refer to IOM 311 for information on the MOUs with USDA regarding NFDM plants.

NOTE: If management of the firm requires employees to shower and change clothes prior to entering certain areas of the plant, comply with the firm's policy. If the firm furnishes employees disposable clothing for these areas, it should be used.

Raw Materials

Evaluate the source and nature of the water supply and any subsequent treatment. (DMO, Part II, Section 7, item 7p)

Be alert for careless handling of powdered ingredients (vitamins, flavors, etc.) which may contribute to product contamination.

Obtain sources of Vitamins A & D and other optional ingredients.

Determine how long milk is held prior to and after pasteurization. Record milk holding temperatures. Raw and pasteurized milk should be maintained at 45oF or less after pasteurization. Condensed milk should be held at 45oF or less, but it can be held up to 1 hour at 45oF - 135oF or two hours at 135oF - 165oF.

All whey for condensing is maintained at a temperature of 45oF or less; or 145oF or greater until processed. Condensed whey shall be cooled during the crystallization process to 45F or less within 18 hours of condensing.

All pasteurized milk and milk products, pasteurized whey and condensed milk products except those to be immediately dried, are cooled immediately in approved equipment to a temperature of 45oF or less. All pasteurized milk and milk products, pasteurized whey and condensed milk products shall be stored at a temperature of 45oF or less and maintained there at until further processing. If surge tanks or balance tanks are used between the evaporator and the drier, such tanks shall hold the product at a temperature of 150oF or more, or shall be completely cleaned at a minimum of once every 4 hours of operation or less. Exception: acid type whey with a titratable acidity of 0.40% or above, or a pH of 4.6 or below. (DMO, Part II, Section 7, item 17p).

Equipment and Processing

Evaluate the pasteurization equipment to assure adequate product pasteurization. See PMO, Part II, Section 7, Item 16p (B). Specifications are defined in "3-A Accepted Practices for the Sanitary Construction, Installation, testing and Operations of HTST Pasteurizers". Give special attention to the flow diversion valve and the thermal limit controller (recording thermometer). It must be checked and sealed by authorized regulatory officials. Check the vacuum breakers and positive shut-off valves in the lines between the pasteurizer and evaporators. Check for evidence of milk leaking from the pasteurizer, piping and other processing equipment.

Evaluate equipment construction characteristics for assurance that static accumulations are controlled, particularly in fluid milk drying and conveying equipment, sifters, rollers, drum, sanitizers.

Determine if equipment is constructed and maintained to protect the product from dust and environmental contamination.

Equipment used for the manufacturer of dried dairy products should not be used in drying other products unless effectively cleaned and sanitized prior to the drying of the dairy products.

Preheaters and hotwells should be fitted with tight covers when in use.

Spray dryers should be a continuous discharge type, easily cleanable and should be cleaned and inspected at least daily.

Rollers and collectors should be located in a room separated from other operations to prevent airborne contamination.

Conveying equipment such as augur ends, bucket elevators, etc., should be cleaned at least daily to prevent accumulation of static material.

Sifter screens should be easily removable and maintained in a clean condition.

Evaluate air filtration system and determine the air flow throughout the plant. Consider the following:

  1. The quality and source of intake air.
  2. Is the air recycled, filtered? How? Are the filters reusable or disposable?
  3. Air for cooling powder may pass over refrigerated coils and pick up dust or powder contaminants.
  4. Proximity of air exhaust to air intake.
  5. Air temperature at critical points, i.e., entering and leaving drying chamber.
  6. Potential for plumbing backflow. For example, can water used to produce vacuum be back siphoned into the plant's water supply?

Plant air supply systems should provide clean, adequately filtered air for all post-pasteurization processing rooms in which the finished product is exposed to the air, i.e. instantizing and packaging rooms. Clean, adequately filtered air should be supplied to product dryers, product coolers, dry product handling equipment and instantizing equipment. The air supply system should be maintained in a clean, sanitary, and efficient operating condition including changing or cleaning of filters as often as necessary. Filters should be tightly fitted or sealed in frames to avoid air by-pass.

Plant forced air intakes should be properly located to prevent the entrance of airborne contaminants.

Air exhausts from buildings or equipment should be so constructed as to prevent back-flow of air or material when not operating.

The moisture exhaust should be so arranged to control back-flow of air, material or condensation . Drainage should be conducted away from the product.

If the air for cooling powder is mechanically cooled, refrigeration units should be maintained in a clean condition.

Be alert for condensate formation throughout the plant and for optimum moisture and temperature conditions conducive to Salmonella growth in static material. Proper safeguards should be taken to prevent condensation from entering the product.

Evaluate the handling and treatment of the condenser cooling water. Small amounts may be drawn into the systems during operation. If cooling water is circulated over a cooling tower, evaluate the potential for Salmonella and other bacterial contamination. Cooling water utilizing a cooling tower may not be used directly for cooling of product in a plate heat exchanger or other mechanical system where product may be contaminated. Condensing water for evaporator must be from a safe source unless the evaporator is constructed and operated to preclude contamination of such equipment or its contents by condensing water; or by water used to produce vacuum. (DMO, Appendix A.)

Examine the inspection, sampling and cleanout ports on the evaporator for buildup of static material and avenues for airborne contaminants.

Evaluate product flow through the plant and determine whether there is unnecessary product movement between areas which may increase the likelihood of cross-contamination.

Observe procedure for incorporating Vitamin A & D and other optional ingredients into the product. Review the volume control records on the use of vitamins. Compare the usage with products produced. Review the records of vitamin testing if products produced are vitamin fortified.

Packaging

Observe and evaluate the packaging operation to determine:

  1. The suitability of finished product containers.
  2. Storage of unused containers.
  3. Container cleaning, if applicable.

Evaluate the safeguards and precautions in the filling and packaging areas to avoid product contamination, i.e., the method of final weight adjustment and the sanitary handling of packaging containers at this point.

Topping off to obtain proper net weight should be conducted in a sanitary manner using clean utensils and equipment and using fresh dry milk which is protected from airborne contamination.

The contents of damaged containers of dry milk should be reconstituted, re-pasteurized, and processed if intended for food use and if no visible extraneous material was introduced into the product.

Controls

Determine quality control specifications for raw materials, i.e., bacterial load, antibiotics, pesticides, butterfat, sediment, etc.

Evaluate sampling, test procedures and results of incoming raw milk, pasteurized milk, base powder, and other ingredients. Residual phosphatase activity is the test commonly used to indicate the pasteurization effectiveness. False positive phosphatase results may be found when pasteurized milk is held at 50oF - 93oF, pasteurization temperatures exceed 163oF and salt such as magnesium chloride is added after pasteurization.

Ascertain scope of Salmonella testing of water supply, and the air supply, at critical processing points, in the plant environment, and in finished products.

Determine the qualifications of laboratory personnel, adequacy of laboratory equipment, and record keeping procedures.

Determine if production lots are quarantined until completion of finished product analysis.

Personnel

Observe employee habits and dress, particularly, use of special clothing while handling or contacting in-process materials and equipment surfaces that contact the product. Consider the following:

  1. Whether employees change into clean (sanitized, sterilized, etc.) clothing prior to entering the drier for cleaning or other purposes.
  2. Gowning procedures.
  3. Shower requirements.
  4. Storage and handling of clothing prior to issuance.
  5. Hair protection.
  6. "No smoking" practices in the storage, processing and packaging of milk and milk products.
  7. Accessibility of hand washing facilities to processing and packaging areas.

Determine plant policy on visitors and personnel traffic through processing and storage areas. Observe practices from the standpoint of introducing contamination on clothing and shoes, i.e., agricultural workers, those handling pets or other animals, etc.

Cleaning and Sanitizing

Evaluate cleaning methods (CIP, vacuum, compressed air, etc.) for all raw ingredient, in-process, and dried milk contact equipment, i.e., pumps, valves, tanks, lines, belts, conveyors, air filtering bags, packaging machines, etc. Determine if cleaning and sanitizing procedures are available to employees in writing.

Observe scheduled plant and equipment cleanup including plant start-up and shut down procedures. The evaluation should consider the following:

  1. Separate cleaning equipment should be used exclusively for the drying system and should be stored properly.
  2. Frequency of cleaning.
  3. Equipment suitability, including smooth impervious construction, easily accessible for cleaning, etc.
  4. Degree of employee supervision.

Determine the identity, strength, and use of sanitizing agents. Proper use requires flushing these agents from the system.

Verify that box dryer(s) are being sanitized as described in the DMO.

Determine the disposition of powder and dust collected during plant cleanup. Milk powder recovered from bag collectors and other places in the instantizing process (other than "fines" which are recirculated) may be fed back into the system, but, unless rehydrated and pasteurized prior to recycling, this may be a source of bacterial build-up and recontamination. If used for animal feed, it should be adequately handled, stored and protected to prevent contamination.

Sifter tailings should not be used for food purposes and should be disposed of in a manner that would preclude contamination of plant facilities or finished products.

Instantizing equipment should be disassembled sufficiently to render all product contact surfaces accessible to cleaning and sanitizing on regular basis.

Sample Collection

Use aseptic techniques when collecting samples. Do not routinely sample dry milk products labeled with a USDA shield unless used as a raw material, and there is reason to suspect contamination or adulteration, or a direct observation of contamination was made during inspection or investigating a consumer complaint.

Investigational Sample

Use aseptic technique and include open and closed controls as part of your sample (see IOM 426).

In every plant inspected collect in-line factory samples where conditions exist which may harbor Salmonella or where Salmonella or other bacterial contamination is suspected (see IOM Sample Schedule, Chart 1).

Possible suspect areas include: static and encrusted material in drier and around windows in pneumatic systems, static material and tailings from sifter, static material from and around air bags on filling machines, static or residue in, on, or near exhausts or intake vents, and any area or point where powder, dust, and moisture collect to form conditions to support bacterial growth.

Always "bracket" each piece of equipment to pinpoint contamination source.

Collect samples of finished materials. If firm has not operated for several days, sample the first lots produced after resumption of operations.

Always include as one of your in-line subs the first material through the dryer.

Minimum sub-sample size is 100 grams (4oz.), if that amount is available.

Include 30 4oz. subs of dried milk produced on the day of the inspection and 30 4oz. subs of dried milk from a previous day's production.

Official Sample

Bacteriological (ALWAYS USE ASEPTIC TECHNIQUE) - 30 4oz subs in duplicate or 30 retail size containers (minimum sub size is 4oz.).

If sample is collected from bulk, include open and closed controls.

Filth & Composition

  1. Retail Containers - Sample the square root of the number of containers in the lot but not less than 6, nor more than 18 in duplicate (minimum sub size is 8 oz.).
  2. Bulk Containers - Collect samples from bulk containers using aseptic technique. Sample the square root of the number of containers in the lot but not less than 6, nor more than 18 in duplicate (minimum sub size is 8 oz).

When the product is packed in barrels or other bulk containers: remove the head; composite 6 trier fulls from each container for each subsample; place in a sterile, clean, dry container. Take each trier full with a trier long enough to reach the bottom of the container. Insert trier straight down at points 2 inches from the edge of the semicircular surface as follows:

o

B

             o

             D

o

F                    Co

             o

             E

A

o

Bagged Materials

Composite 6 trier fulls using aseptic techniques taken straight down from top to bottom at equidistant points grouped around the center of the bag.

Sample the square root of the number of containers in the lot but not less than 6, nor more than 18 in duplicate. (Minimum sub size i 8 oz.)

Economic, Standards

  1. Composition - See section 2b. above, Filth and Composition, for sample size.
  2. Vitamin Determination - Sample only fortified NFDM products that provide at least 500 USP units (IUs) of Vitamin A and 100 USP units (IUs) of Vitamin D, in 8 ozs. of reconstituted product.
    1. Retail Packages - Collect 12 - 1 lb. intact retail packages in duplicate of the same code.
    2. Bagged Material & Bulk - Aseptically collect 12 - 1 lb. subs in duplicate from 12 different containers in the lot.

IMPORTED DRIED MILK PRODUCTS FROM MOU COUNTRIES

MOU Countries - See CPG reference for products and attributes.

Australia CPG 7156f.01

Belgium CPG 7156g.01

Denmark CPG 7156h.01

France CPG 7156j.02

Ireland CPG 7156.01

Netherlands CPG 7156n.01

New Zealand CPG 7156e.01

Norway CPG 7156o.01

Sweden CPG 7156c.03

Sampling Decision

Districts will attempt to telephone the Center for Food Safety & Applied Nutrition only once per day for all sampling decisions.

Sampling decisions will be made only for "Human Use" certified lots.

Contact the Center MOU Audit Monitor at 202-205-5042 and provide the following information for each certified lot offered for entry:

  1. Country of Origin.
  2. Product.
  3. Entry Date.
  4. Lot Number.
  5. Lot Size (# of containers & weight/container).
  6. Sample Number and sampling date when required.

If the District suspects that a certified lot does not comply with the certificate and has decided to sample, notify the Center Monitor of the reason for this decision.

Certified lots not designated for sampling are to be released without delay, unless the lot was sampled for some other reason than those attributes specifically covered by the MOU.

Sample Collection

Collect each sample (thirty 100 gram subsamples) in accordance with the IOM SAMPLE SCHEDULE CHART 1 - SALMONELLA SAMPLING PLAN.

Include on the FDA-713, the attribute to be analyzed (e.g. Salmonella, phosphatase, penicillin) as appropriate.

CHEESE AND CHEESE PRODUCTS

In addition to the instructions and information provided in IOM Subchapter 530 regarding food inspections, direct attention to the following areas when conducting inspections of cheese producers.

Although cheese standards allow the use of unpasteurized milk provided the cheese is aged at not less than 35oF for 60 days (longer for some cheese), utilization of unpasteurized milk should be considered potentially hazardous. In the past, use of unpasteurized milk was justified on the belief that the curing process inactivated all pathogens. However, some pathogenic bacteria such as Listeria may not always be inactivated. When unpasteurized milk is used, give special emphasis to in-depth evaluation of quality control and product handling at all points from the milk producers to packaging and storage. Post-pasteurization contamination must be given close scrutiny.

Pasteurized

When used to describe a dairy ingredient, means that every particle of such ingredient shall have been heated in properly designed and operated equipment to one of the temperatures specified in the table below and held continuously at or above the temperature for the specified time or other time/temperature relationship which has been demonstrated to be equivalent thereto in microbial destruction:

Temperature Time
145oF 30 mins.
161oF 15 secs.
191oF 1 sec.
194oF 0.50 sec.
201oF 0.10 sec.
204oF 0.05 sec.
212oF 0.01 sec

Note: products with greater than 10% fat and or added sweeteners shall be pasteurized at 5oF higher.

Heat treatment

A process in which dairy products such as milk, cream, whey, etc., are subjected to heat at less than a time/temperature relationship necessary to achieve pasteurization. No standard time/temperature has been established for the process. Heat treatment is used to control undesirable bacteria which might compete with the starter cultured, or if uncontrolled, cause foodborne illnesses and/or poor quality cheese (e.g. gassy cheese or off flavors).

Positive phosphatase test results do not always indicate a milk pasteurization problem. The phosphatase test is not specific to bovine phosphatase, but may detect phosphatase from other sources such as vegetative cells, mold, etc. which is more heat resistant than bovine phosphatase. Deviations from the normal phosphatase reaction expected in pasteurized products sometimes occur when HTST pasteurization temperatures exceed 163oF and/or salts such as magnesium chloride are added after pasteurization,

[Note: Some of the guidance furnished below is only applicable to certain inspectional situations, consult with your regional/district milk specialist or the Milk Safety Branch to determine applicability to firm being inspected.]

Raw Materials

Most firms now receive milk in bulk. All milk must meet the following quality standard: less than 1 million Somatic Cell Count (SCC); less than 1,000,000 STD Plate Count (commingled milk).

Manufacturing and Processing

Evaluate filtration and clarification steps. These procedures affect cheese quality by removing sediment, debris, body cells from the cow's udder (somatic cells), some bacteria, etc.

Using blacklight, check for milkstone on the equipment. A milkstone buildup indicates improper cleaning.

Evaluate the pasteurization process and equipment. Refer to Milk and Milk Products section of this guide as well as PMO, Part II, Section 7, item 16p for detailed guidance.

Field test for Phosphatase of Milk

Conduct a phosphatase test on pasteurized milk using the method furnished with the field phosphatase test kit. This field test is applicable to milk only; not to cheese or curd because of interfering substances. Be sure reagents are satisfactory by conducting tests in the District's Laboratory on 0.5% raw milk in pasteurized milk and on pasteurized milk before use in the field.

High temperature short-time (HTST) pasteurized products found negative for phosphatase when sampled immediately after pasteurization may yield positive results after a short period of storage without refrigeration This phosphatase reactivation phenomenon may occur under any one of the following conditions:

  1. Storage of pasteurized products at temperatures between 50oF to 93oF.
  2. HTST pasteurization above 163oF.
  3. The addition of such salts as magnesium chloride to milk or cream after pasteurization.

Collect plant samples of cheese if field phosphatase test cannot be made on the milk.

Evaluate the quality control program. Determine what follow-up is made on patrons whose milk is high in sediment. Ascertain the duties of the field man, determine whether his primary job is to have filtered milk delivered to the plant or to improve the sanitary conditions under which the milk is produced.

Check the firm's quality control records for drug residues in milk. Verify that every farm tanker truck of raw milk has been sampled and tested for beta lactam drug residues prior to processing. If milk found to contain drug residues has been used, determine the ultimate disposition and follow up.

Quality control records should also be checked for abnormal milk (e.g., somatic cell counts over 1 million per ml.). When bacteria counts exceed 1,000,000 per ml., determine the disposition of the milk.

Review cheese make records and determine if all critical times, temperatures and pH readings were recorded. Vats showing slow acid development indicate a high potential for excessive staphylococcal growth and concurrent enterotoxin production. Consider sampling the cheese, whey, whey cream, whey butter, etc. for staph. enterotoxin.

If cheeses are being made which may, in lieu of pasteurization, be aged for a specific time and minimum temperature, and the plant has elected this option, or if aging is required regardless of pasteurization, check storage practices including the following:

  1. The date stamping procedure, and the accuracy of date stamped on cheese.
  2. Labeling practices to insure that uncured cheese made from raw or unpasteurized milk is labeled to indicate what further curing or processing is necessary.
  3. The existence of an agreement with the storage warehouse for proper storing and handling of uncured or unaged cheeses, if the warehouse is not operated by the cheese manufacturer.

Pasteurized process cheeses are required to be heated during preparation to a temperature not less than 150oF for not less than 30 seconds. Report time and temperature of this process if applicable. (21 CFR 133).

Sample Collection

Samples should be held and shipped under refrigerated conditions.

Coat or reseal the holes or surface of any cheese exposed by sampling to prevent spoilage by mold. Use the following formula for sealing compound:

Paraffin.........3 oz.

Beeswax..........3 oz.

White Petrolatum..6 oz.

or:

By mixing and heating white petrolatum and paraffin (1:1).

Cheese is practically always coded with the vat (or vat series) numbers or initial and date of manufacture. Each subsample should represent one such code (vat). Record the code number on the subsample jar. Seal each sub separately.

List distribution for the collection of Official Samples for regulatory consideration if the plant is operating under insanitary conditions, likely to result in a filthy product.

Investigational

Filth and Sanitation

Collect in-plant samples,sediment pads, and other evidence necessary to document insanitary practices and the receipt and use of filthy milk.

There are usually one or more in-line filters in addition to the dump tank screen which will remove gross material. Clarifiers or modified separators are sometimes in the line. Samples of this gross filth and the entire in-line filters are excellent exhibits. Filters and clarifier sludge can be preserved for laboratory examination by shaking with 25 cc. of perchloroethylene in a quart jar. Report the amount of milk which an exhibit represents. Do not take sediment tests after pasteurization as it could lead to criticism that your action contaminated the milk.

Bacteriological Contamination

During inspections collect in-line and finished product samples as necessary to document suspected or observed bacteriological problems.

If inspectional evidence indicates slow acid formation, collect a 1/4 pound sample aseptically from each vat of cured cheese available (with a maximum of 5 vats) immediately prior to removal of the cheese from the vat for hooping and pressing. If possible, collect sample before cheese curd is salted. Staphylococci die rapidly after cheese has been pressed and for this reason sample only freshly made cheese.

Cottage cheese, baker's cheese, cream cheese, Neufchatel cheese or other unripened cheese would be collected if staphylococcal or other bacterial contamination is suspected.

NOTE: Immediately after collection, refrigerate between 32oF and 40oF., but do not freeze. Submit sample promptly so that analysis for staphylococci can be started, within 48 hours of the completion of the cheese-making process, since the staphylococcal count may change rapidly in the period of time following sample collection. In no case should this time period for submission of the samples exceed 96 hours. Submit the vat samples as separate subdivisions under one investigational sample number. Identify and handle these samples separately from any other samples collected to demonstrate plant conditions.

Food Additives, Color Additives and Pesticides

Instructions for sampling is found in the IOM or as follows:

  1. Food Additives
    1. Investigational

      Restrict sampling during inspections to instances where there is a clear-cut food additive violation. Since no single sampling schedule is feasible for all additives and foods containing them, collect a representative sample of both the violative additive and the finished food.

    2. Official

      Collect Official Samples in instances where there is a clear-cut additive violation. No single sampling schedule is feasible for all additives and foods containing them. As a general rule, collect a representative sample of the same amount of finished food as would be required for a filth analysis.

  2. Color Additives - Two pounds taken at random from the lot (see IOM Sample Chart 9).
  3. Pesticides - See IOM Sample Schedule Chart 3 - Pesticides.

Official

Cheese may be taken with trier, or by cutting wedges, whichever is least objectionable to the dealer. Also, the entire sub may be taken from one cheese, or distributed among several cheeses of the same code, whichever is least objectionable to the dealer. Do not include more than 1 vat number or code in a single subdivision.

Filth or Phosphatase

Each subdivision should consist of at least 1/2 pound exclusive of claimant's portion. Collect a number of cheese (cheddar, wheels, longhorns, etc.) but not less than 6 nor more than 12 subdivisions.

For Bacteria

Collect 10-8 oz subs in duplicate using aseptic technique.

For standards

Cheddar, Similar Type Semi-Hard and Hard Cheese

Follow the official AOAC method in sampling cheese. This specifies that: "When cheese can be cut, take narrow, wedge-shaped segment reaching from outer edge to center. When not permissible to cut cheese, take sample with cheese trier. If only one plug can be obtained, take it perpendicular to the surface of cheese at point one-third distance from edge to center extending either entirely or halfway through. When possible draw three plugs, one from center, one near outer edge and one midway between other two. Use about 3/4 inch of rind portion or core to reseal hole." This amount will be sufficient for moisture and fat analysis and 702(b) requirements.

Place cores in suitable size (4 oz.) straight edge ointment jars and immediately close to avoid drying. Wedges may be placed in suitable jars or polyethylene bags which are tightly sealed. (Polyethylene bags are not to be used for cheese sampled for fat and moisture determinations unless the sample can be held under refrigeration until submitted to the laboratory.)

 
Number of cheeses Cores Sabsamples
MinMax
10 or less 1 3 1
11 - 30 2 6 2
31 - 50 3 9 3
51 - 75 4 12 4
76 - 100 5 15 5
101- 150 6 18 6
151- 200 7 21 7
201- 300 8 24 8
301- 400 9 27 9
Over 400 10 30 10

Cheddar cheese is practically always coded with the vat designation and date of manufacture. If possible, each subsample should represent one such code (vat). Record on the subsample jar, full information.

Cottage Cheese and Creamed Cottage Cheese

Sample size includes 702(b) portion. Use aseptic technique when sampling from bulk.

Commercial Bulk Containers

The official AOAC method requires that the commercial bulk containers be first stirred thoroughly for at least five minutes with a dairy stirrer (a 5 1/2" perforated concave metal disk attached to a 27" metal rod as a handle. The sample (one quart) is taken promptly from the top layer of the mixed cottage cheese. Sample the square root of the number of bulk containers in lot.

Large Bulk Containers, Holding Vats, Mixing Bins

When the lot to be sampled cannot be thoroughly mixed with a dairy stirrer, mechanical mixing is necessary. Determine the firm's normal mixing procedure and whether they are willing to mix the cottage cheese so that a representative sample can be obtained. If they re not, collect at least eight (8) 1 quart subs from various portions or layers.

Retail Sized Containers

It is necessary that this schedule be followed to insure a representative sample.

Size of Lot - up to 50 cases, if container net weight is equal to or less than 340 grams (12 oz) collect 24 containers, two subs from each of 12 cases. If container size is more than 340 grams, collect 12 containers, on sub from each of 12 cases.

Size of Lot - More than 50 cases. If net weight is equal to or less than 340 grams (12 oz), collect 48 containers, two subs from each of 24 cases. If net weight is greater than 340 grams (12 oz), collect 24 containers, one sub from each of 24 cases.

Food Additives, Color Additives, and Pesticides

See IOM 535.3, 535.4, 536.1, and 570.

Sample Shipment

Take precautions to assure that samples are properly refrigerated during shipment and arrive at the laboratory promptly and in good condition.

Imports - Follow IOM Chapter 6 - Imports.

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