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| TO: | All Regional Food and Drug Directors |
| FROM: | Milk Safety Team (HFS-626) |
| SUBJECT: | Questions and Answers from FY'04 and FY'05 FD3105-Dairy Farm Sanitation and Inspection Courses and from FY'05 Regional Milk Seminars and Check Ratings |
Following are questions and answers from FD3105-Dairy Farm Sanitation and Inspection Courses held in FY'04 and FY'05 and FY'05 Regional Milk Seminars and Check Ratings.
In accordance with procedures established through the National Conference on Interstate Milk Shipments (NCIMS), if an answer to these questions results in a new understanding of a long-standing situation or installation, and the condition as it exists does not present an immediate public health hazard, reasonable judgment should be exercised and adequate time provided for modification and correction.
An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Rating Officers in your region. The electronic version should be widely distributed to representatives of the dairy industry and other interested parties and also will be available on the FDA Web Site at http://www.cfsan.fda.gov at a later date.
If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to .
| /ss/ | /ss/ |
| Norris A. Robertson, Jr., Milk Safety Officer Milk Safety Team |
CAPT Robert F. Hennes, RS, MPH, Chief Milk Safety Team |
When is accelerated sampling of the PMO required to be implemented?
When a dairy farm or milk plant has three (3) unsatisfactory sample results out of the last five (5) samples, accelerated sampling is required to be implemented.
Accelerated sampling is required following permit suspension or the issuance of a monetary penalty in lieu of a permit suspension resulting from high bacteria, somatic cell count and temperature results.
Accelerated sampling is required following permit suspension; or the product not being offered for sale in lieu of permit suspension; or the issuance of a monetary penalty in lieu of a permit suspension and the product is not offered for sale, resulting from high bacteria, coliform and temperature results.
How many samples are required to be collected and analyzed under the accelerated sampling requirements of the PMO?
Once the temporary permit is issued, based on an inspection or in the case of SCC, a satisfactory sample, samples must then be collected at a rate of not more than two (2) per week over a three (3) week period.
The maximum number of samples required during the three (3) week period would be five (5); however, a minimum of three (3) satisfactory sample results would be necessary to fully reinstate the permit.
Remember, all previous sample results for the specific standard suspension, including the one that caused the suspension, are disregarded and that all required samples are collected within the 3-week period of accelerated sampling.
No. Plant identification requirements are the name and address of the manufacturer, packer or distributor required by 21 CFR 102.5, and the identity of the plant where the milk was pasteurized from Section 4 of the PMO. When these requirements involve two facilities, then the plant code is commonly used to identify the pasteurization location. This avoids the confusion of two different facility names and addresses on the packaged product.
Yes, provided that the repacking firm is located in a state that has officially adopted the cottage cheese regulation option of the PMO and the product is intended for distribution in interstate commerce.
May a State regulate/inspect a Grade "A" milk plant under any Hazard Analysis Critical Control Point (HACCP) system or does it have to be the NCIMS HACCP Program?
Only the voluntary NCIMS HACCP Program is acceptable for regulating an IMS Listed Grade "A" milk plant.
During a rating or check rating of a BTU in a State that utilizes Appendix P. Performance Based Farm Inspection Program of the PMO, it is observed that a producer's categorization has not been changed from category 1 or 2 to category 3 following consecutive inspection violations on any inspection item and the inspection frequency has subsequently been missed; and the Regulatory Agency fails to take any official regulatory action following this consecutive debiting of the same item, should the Enforcement Report reflect: (1) "permit action" violation; (2) an "inspection frequency" violation; or (3) both a "permit action" and "inspection frequency" violation?
This would be considered both an "inspection frequency" violation debited under DAIRY FARMS-PART 1, Item 2-All dairy farms inspected at least once every six (6) months or as required in Appendix "P", and a "permit action" violation debited under DAIRY FARMS-PART 1, Item 10-Permit issuance, suspension, revocation, reinstatement, hearings, and/or court actions taken as required on FORM FDA 2359j-REPORT OF ENFORCEMENT METHODS.
Why are industry plant samplers not allowed to collect samples of commingled raw milk for pasteurization or samples of finished Grade "A" milk and milk products for official regulatory purposes?
At the current time, industry plant samplers cannot collect these samples because Section 6 of the PMO requires that these samples be collected by the Regulatory Agency. The purpose of the official regulatory sample is to evaluate compliance with the standards identified in the PMO and subsequent enforcement, if required. It is important that regulated parties not be involved, so as to avoid even the appearance of a conflict of interest.
What is the statement that must be recorded on the laboratory document if the temperature at the time of collection of the milk sample from a farm bulk tank is greater than 7°C (45°F) but less than 10°C (50°F) for the laboratory to accept the sample for testing?
There is no additional statement needed, provided the required information is on the bulk milk hauler/sampler's weigh ticket. However, the laboratory will need the temperature, time and date of collection. With that information provided, if the milk sample temperature control exceeds 4.4°C (40°F) on receipt at the lab, do not test microbiologically. Samples may be tested if: 1) the temperature, upon receipt at the lab and at the time of collection, does not exceed 7°C (45°F); 2) the time of receipt at the lab is less than or equal to 3 hours from collection; and 3) the sample receipt temperature is no greater than the temperature at collection.
What is a "representative farm raw milk sample"?
A "representative farm raw milk sample" is the sample collected from a farm bulk tank or silo in a manner complying with the sampling procedures set forth in Appendix B of the PMO and the SMEDP.
It is my understanding that dairy processors have been asked for bio-security reasons by their trade association to "voluntarily" increase their milk pasteurization temperature(s). Those processors that have complied may have seen their heat-treated cream exceed the upper temperature limit for heat-treated product (less than 166°F). What is the current position on this issue?
This would technically be considered a violation of the PMO. At the current time, Rating Officers and Regional Milk Specialists should not debit this situation if observed during a rating or check rating. We also request that Regulatory Agencies use regulatory discretion when they observe this situation on routine regulatory inspections.
Are chickens, birds or other fowl that are observed in the holding area or return lanes, which have direct access to the milking parlor, considered a violation of the PMO?
No. There must be evidence that chickens, birds or other fowl have been in the milking area or they are actually observed in the milking area.
It has been stated that either Item 3r or Item 10r is an appropriate debit when the slide plate on a pipeline inlet valve is found soiled. Which is the correct location to debit this observed violation?
If soil enters the milk inlet when the slide plate is moved back or if the product contact surface of the slide plate assembly is soiled, Items 10a and 11a on Form FDA 2359a-THE DAIRY FARM INSPECTION REPORT should be debited. If the non-product contact surface of the slide plate is soiled and it is determined to be a significant violation, Item 3r would be debited.
What type of indicating thermometer is required on the milk line for farms that direct load milk tank trucks? Item 5r, Administrative Procedures #16.a. states: "This indicating thermometer shall comply with all applicable requirements in Appendix H." However, Appendix H does not speak to indicating thermometers on farm milk pipelines.
A mercury-actuated, direct reading or a digital indicating thermometer complying with the requirements listed in Appendix H, Section IV for "Indicating Thermometers Used in Storage Tanks" may be used for this purpose.
Where should the indicating thermometer be located on the milk line for farms that direct load milk tank trucks?
Item 5r requires that an accurate, accessible temperature recording device shall be located downstream from an effective cooling device which cools the milk to 7°C (45°F) or less. The indicating thermometer shall be installed as close as possible to the recording device for verification of recording temperatures.
What is the PMO definition of a vestibule, specifically as addressed within Section 7, Item 5r-Milkhouse-Construction and Facilities, Administrative Procedures #11 and Item 6r-Milkhouse Cleanliness, Administrative Procedures #3 of the PMO?
Item 5r, Administrative Procedure #11 states: "A vestibule, if used, complies with the applicable milkhouse construction requirements."
Item 6r, Administrative Procedures #3 states: "Vestibules, if provided, are kept clean."
The PMO does not specifically define a vestibule; however, the dictionary defines a vestibule as a small enclosed entrance room from the outside into a room (i.e., the milkhouse) or between two rooms (i.e., the milkhouse and other rooms, such as into a utility room or into the milking barn or parlor).
Is a gas water heater located in a milkhouse required to be vented to the outside?
No, unless it is creating a ventilation and/or cleaning problem.
An iron deposit is found in a CIP vat on a dairy farm, is it a violation of Item 6r or Item 14r?
The occurrence of an iron deposit in a CIP vat would not be an automatic violation. However, if the iron deposit creates a cleaning problem for the CIP vat or the milking equipment, it would be an Item 6r violation.
Yes, the referenced areas should be inspected for compliance with Items 8r-Water Supplies, 15r-Drug and Chemical Control and 19r-Surroundings, of the PMO. M-I-01-3 (PMO Dairy Farm Inspectional Area) states: "FDA has consistently defined that the inspection of a Grade "A" dairy farm includes the milkhouse, milking barn, stable or parlor, adjacent storage areas, cowyard and cattle housing areas, surroundings, waste disposal areas and the water supply and its distribution system. These areas may include dairy animal maternity areas, animal treatment areas or hospital barns, replacement heifer areas, offices, utility rooms, tool sheds (drug cabinets, refrigerators, etc.) or other areas where drugs, used to treat dairy animals, may be used or stored."
No. However, if the pasteurizer is creating cleaning conditions related to the surrounding area, it may warrant concern pursuant to Item 19r-Surroundings of the PMO.
If the potable water supply for a dairy farm is required by the Regulatory Agency to have a continuous disinfection system, must the water supply be bacteriologically tested each six (6) months?
No, the required applicable sampling frequency of the PMO would still apply.
If one observes a chemical burn (a discoloration, which has not pitted or pocked the milk product contact surface and the surface remains smooth) on the milk product contact surface of a farm bulk tank or other piece of equipment, and the equipment dealer/farm chemical supplier documents to the Regulatory Agency that this discoloration is indeed a chemical burn, is it a violation of the PMO?
During each routine regulatory inspection, the Regulatory Agency must assure themselves that the discoloration is not a deposit of cleaner or milk product, but is indeed, a chemical burn that is not causing any damage to the milk product contact surface or creating a cleaning problem. If the Regulatory Agency makes this determination, it would not be considered a violation of the PMO. However, just using the documentation from the equipment dealer/farm chemical supplier alone to make this determination would not be appropriate.
On a dairy farm, is a cover required for a vertical CIP tank that is used only for CIP and is not a combination milk receiver/CIP tank?
No.
No. Air injectors on CIP farm pipelines should be located in a clean area and operated so that they do not contaminate the milk or milk product contact surfaces or CIP surfaces. The milkhouse is the area of choice to locate an air injector.
Yes. Any location outside the milkhouse would require filtration of the air to prevent the access of insects, dust, condensation and other possible contamination.
Yes. If an air injector is placed in either of these locations, it would be considered a milk product contact surface and must be evaluated under Items 9r, 10r and 11r.
If the drain hose from a bulk milk tank washer or milk pump extends below the flood level of a trench drain would this be considered a violation of Item 14r of the PMO?
Yes.
Yes. However, the booklet will not suffice for the required labeling of individual containers of drugs that are used and stored on the dairy farm.
Yes. Such a booklet may be of value to the individual producer; however, it will not satisfy the labeling requirements of Item 15r of the PMO that each individual drug bottle/container contain the required labeling.
Is it a violation if a drug syringe or other drug administration equipment is observed in the hand-washing lavatory in the milkhouse?
Yes. This would be considered a violation of Item 15r of the PMO. Item 15r states: "Animal drugs and drug administration equipment shall be stored in such a way that milk, milking equipment, wash vats and hand sinks are not subject to contamination." Drug syringes or other drug administration equipment stored in the handwashing lavatory creates the potential to contaminate dairy farm employees' or bulk milk hauler/sampler's hands during handwashing. The violation would be debited on Item 15(b) on FORM FDA 2359a-DAIRY FARM INSPECTION REPORT.
May chlorine dioxide or aqueous ozone be used in cattle footbaths on a dairy farm for hairy foot wart control?
No. These two products, chlorine dioxide and aqueous ozone, are not acceptable for use in cattle footbaths on a dairy farm. We do not have sufficient safety information on the use of chlorine dioxide or aqueous ozone to accept their use in cattle footbaths. The actual or intended use of such products in a cattle footbath constitutes the use of an unapproved new animal drug (NAD). Under Item 15r of the PMO, the use or storage of unapproved NAD(s) on a dairy farm is not allowed.
If someone wants to use compounds to treat the feet of cattle, under the PMO provisions listed in the referenced M-I's and in addition to those in the paragraph above, they will need to obtain acceptance from CVM Compliance. That acceptance will require scientific data to support animal safety, human food safety, and the efficacy of the compounds. If a firm wants FDA to review a cattle footbath product for regulatory discretionary use, not NADA approval, but permission to market, they may request CVM to review the material.
Where does one debit an overlapping recording chart for the recording thermometer located on the milk pipeline for the direct loading of farm bulk milk tank trucks and for recording charts on farm bulk milk tanks manufactured after January 1, 2000?
This is a violation of Item 18r of the PMO and would be debited under Item 18(c), a one (1) point debit, on FORM FDA 2359a-DAIRY FARM INSPECTION REPORT.
Is it required that component parts from an IMS Listed Plant that does not assemble the final product be sampled at those plants?
No. Sampling of individual component parts is not required. Appendix J, Section C, Item 4 states: "When a single-service container or closure is made from one (1) or more component parts as defined in Appendix J, only those final assembled products that may have product-contact surface(s), must be sampled and tested for compliance with Section C."
May plant management use one extended run protocol to cover an entire Grade "A" milk plant, which produces multiple products and utilizes different processes and equipment?
No. This was never the intent and we do not believe that only one protocol can adequately cover all situations within an individual plant setting. An extended run protocol as described in Item 12p is specific to a product and/or process.
Yes. The water-raw cream mixture may be flushed directly to the milk tank truck if the receiving milk plant condenses, concentrates or dries the cream, or if the shipping milk plant takes other appropriate actions to prevent the dilution or adulteration of the raw cream with added water, as set forth in Administrative Procedure #18. An example of an appropriate method to accomplish this is to flush the storage tanks and pipelines with potable water to a separate tank or vessel and capture this water-raw cream mixture for further processing. Other examples might include the use of a system or process designed, constructed and controlled that manually or automatically prevents the addition of water. The efficacy of this system should be verifiable if challenged.
No. Pasteurized cream must be flushed from storage tanks and pipelines with water that has been pasteurized or water that has had an equivalent process applied, as set forth in Administrative Procedure #2 as follows: "2. Except as permitted in Item 16p, there shall be no physical connection between unpasteurized products, dairy, non-dairy, or water, and pasteurized milk or milk products. Pasteurized non-dairy products or water not completely separated from pasteurized milk and milk products, shall be pasteurized at times and temperatures which meet at least the minimum times and temperatures provided for in Definition EE or in the case of water have undergone an equivalent process found acceptable by FDA and the Regulatory Agency or has undergone a hazard evaluation and safety assessment of the specific water supply and application involved and has been treated, as necessary, following a protocol acceptable to the Regulatory Agency, in consultation with FDA, to ensure the water will not compromise the safety of the milk or milk product."
No.
Yes.
Yes. The drain pipeline must be installed in compliance with M-I-86-16, Question 13, M-I-87-3, Supplementary Information Re: M-I-86-16, Question 13 (Constant Level Tank Drawings) and Item 15p(B), Administrative Procedure #3. Administrative Procedure #3 states: "Pasteurized re-circulation lines, divert lines, and leak-detect lines connecting to the constant-level tank shall be designed so that there is an air gap between the termination of these pipelines and the raw milk or milk product overflow level. This air gap must be equivalent to at least two (2) times the diameter of the largest of these pipelines."
Yes.
The interior of a drain pipeline without a properly installed and designed sight-glass cannot be observed and may affect the pressure relationship in the regenerator. Item 16d(a) on Form FDA 2359-MILK PLANT INSPECTION REPORT would be debited for leakage that may be occurring. If the drain pipeline is improperly sloped and prevents proper drainage, this would be an Item 10p violation and would be debited under Item 10(a) on Form FDA 2359.
Is it required that the leak protector valve on a vat pasteurizer be designed to: (1) prevent leakage of raw milk past the valve body; and (2) prevent the accumulation or retention of un-pasteurized milk in the passage of the valve when the valve is in the closed position?
Yes.
May a properly installed pressure relief valve be located in the holding tube?
No.
The PMO does not address a specific frequency requirement for the calibration of mercury-actuated test thermometers; however, Good Laboratory Practices recommends once per year.
Additional information can be found in Appendix I. Pasteurization Equipment and Controls - Tests, I. Testing Apparatus Specifications, Test Thermometer, Page 238 of the PMO.
An "Official" Regulatory or "Officially Designated" Commercial Laboratory, or a private laboratory, acceptable to the Regulatory Agency, may certify the test thermometers provided that the accuracy shall be checked against a thermometer, which is NIST traceable/certified and that the thermometer is checked at the temperature(s) of use.
No. This is the accuracy requirement for these test thermometers, and it is not acceptable to use a test thermometer that is found to be off by more than + .2°F throughout the specified scale range, which includes at least 7°C (12°F) below and 7°C (12°F) above the pasteurization or aseptic processing temperature at which the operating thermometer is used.
What is the procedure for regulatory enforcement on water samples taken from a recirculated cooling water system if the follow-up sample, taken within 30 days of the original unsatisfactory sample, is again unsatisfactory?
Item 17p, Administrative Procedure #10 states: "Recirculated cooling water systems, which become contaminated through repair work or otherwise, shall be properly treated and tested before being returned to use." "Corrective Action" in Section 1. PRIVATE WATER SUPPLIES AND RECIRCULATED WATER-BACTERIOLOGICAL, of Appendix G states: "When the laboratory report on the sample is unsatisfactory, the water supply in question shall again be physically inspected and necessary corrections made until subsequent samples are bacteriologically satisfactory." The Regulatory Agency should remove the system from use in cooling milk and milk products, until a satisfactory sample result is obtained, inspect the system and record the violation under Item 17(d) on FORM FDA 2359-MILK PLANT INSPECTION REPORT. Necessary corrections must be made to the system, including proper cleaning and sanitizing; and then resample the water and test.
Yes. This question was originally asked and answered in M-I-00-7 (Question 22). At that time, MST asked that when such an observation was made to please advise the State Regulatory and Rating Agencies and Milk Safety Team in writing. In addition, MST asked that this item not be debited, when observed during State Ratings or Federal Check Ratings.
Yes. MST believes that by staying this violation for over four years, in order to allow time for correction, we have provided adequate time for industry to correct their manufacturing process. Item 19p.-CAPPING, CONTAINER CLOSURE AND SEALING AND DRY MILK PRODUCT STORAGE states: "The cap or closure shall be designed and applied in such a manner that the pouring lip is protected to at least its largest diameter and, with regard to fluid product containers, removal cannot be made without detection." Therefore, caps that can be removed from milk containers without detection are a violation of Item 19p and should be debited under Item 19(c) on Form FDA 2359-MILK PLANT INSPECTION REPORT.
An implementation date of January 1, 2006 will be established for debiting this violation on ratings and check ratings.
When evaluating whether Item 2-Adequate Training Program Provided on Form, EVALUATION OF SAMPLING PROCEDURES, is in compliance when conducting an Enforcement Rating, should the Regulatory Agency have in place a program for training industry plant samplers?
Yes.
May a milk sample dipper be made of food grade materials other than stainless steel?
Yes. However, the Regulatory Agency should evaluate them before use.
If a firm is only adding the adhesive labels to single-service containers, are they required to be IMS listed?
Yes. Firms that add adhesive labels to single-service containers are covered under Section A-Purpose and Scope of Appendix J of the PMO. This Section indicates that the standards of Appendix J shall apply to "printers" and "any other similar plants". In such firms during the process of handling the single-service containers and applying adhesive labels, the product contact surfaces of the single-service containers may be exposed to contamination from the environment of the plant, the equipment and/or personnel, unless the standards of Appendix J are being complied with.
Is it necessary for the Regulatory Agency to sample empty containers molded immediately prior to filling on a Form/Fill/Seal packaging machine when the heavy gauge plastic roll stock, not plastic film, is from an IMS Listed source?
Yes. Appendix J-Section C of the PMO does not require that heavy gauge plastic roll stock used to make containers molded on Form/Fill/Seal packaging machines to be sampled at the manufacturer and tested.
The mechanics of the Form/Fill/Seal packaging machine in molding cups from heavy gauge plastic roll stock is analogous to the final molding of pre-forms addressed in Section C of Appendix J. Therefore, samples of the final molded empty cups must be collected directly from the Form/Fill/Seal packaging machine in order to detect possible contamination of the cups after molding and prior to packaging.
At a dairy plant, receiving station or transfer station, an industry plant sampler or a licensed bulk milk hauler/sampler collects a milk tank truck Appendix N sample to be screened for drug residue. The sample is transferred immediately to the laboratory to be screened for drug residues by an Industry Analyst, who is not the sample collector.
No.
The container of milk for drug residue testing is required to have the sample date, truck ID and sampler initials on it.
The proper sanitizing and purging of the sampling cock is a "Sampling Procedures" requirement, and if violated, the violation should be debited under Item 9(e).
Item 3(e) would be debited when there is not a "sampling cock" available or a "sampling cock" has been installed on a milk storage tank in a manner that would not allow for the proper sanitizing and purging of the "sampling cock". Some milk storage tanks, i.e., silos, do not lend themselves to proper sampling procedures, unless provided with a properly installed "sampling cock".
During a hauler evaluation at a dairy farm, it was observed that the mechanical cleaning system was cross-connected with the farm bulk milk tank. If this were observed during a farm inspection, Item 14(b) on Form FDA 2359a-DAIRY FARM INSPECTION REPORT would be debited. Is it correct, that there is not an Item on FORM FDA 2399a-MILK TANK TRUCK, HAULER REPORT AND SAMPLER EVALUATION FORM to debit this observation?
Yes.
Will a DHRD/State Training Team sponsored HACCP Course fulfill one of the training requirements for State Rating Officers that are FDA certified to list HACCP plants?
Yes.
