200 ~C~ Street, S.W. Washington, DC 20204
March 15, 1985
TO: All Regional Food and Drug Directors Attn: Regional Milk Specialists
FROM: Milk Safety Branch, HFF-346
SUBJECT: Recent Seminar Discussions Enclosed are copies of the questions and answers which were discussed at the Region III Seminar held in 1984. Copies of this memorandum are enclosed for distribution to State milk anitation regulatory agencies and State Milk Rating Officers in our region.
Robert L. Sanders Deputy Chief Milk Safety Branch, HFF-346 Division of Cooperative Programs Center for Food Safety and Applied Nutrition
Questions and Answers from 1984
Region III Seminar
Q. 1. What is the procedure for obtaining copies of changes in the PMO per the 1983 conference?
A. Copies of the 1978 PMO are no longer available from the Government Printing Office. A limited number are available from Milk Safety Branch. The NCIMS; 1979, 1981 and 1983 changes were printed and distributed to all regulatory and rating agencies and industry. A limited number of these changes are available upon request (1 per individual request) from MSB. In the near future the total PMO with the 79, 81 and 83 changes will be reprinted and available from MSB.
Q. 2. What is FDA~s opinion and concerns relating to new technologies in the area of reverse osmosis and ultra filtration?
A. Reverse osmosis (R-O) and ultra filtration (U-F) are processes which employ very fine membranes cast upon a backing material and used to fractionate or separate components in a liquid according to there molecular size. The difference between U-F and R-O is basically in the porosity of the membranes used and the pressures under which they operate. The U-F process when applied to dairy products uses a membrane with a pore size such that the fat and protein molecules are retained on one side of the membrane (retentate) and allows most of the lactose, water and minerals to pass thru into the permeate. The U-F processes usually has been used for sometime in the processing of whey to separate whey proteins from the lactose and water portions.
The R-O process on the other hand uses a membrane with smaller pore size which allows only water and a few dissolved minerals to pass into the permeate. The R-O process is usually carried out at relatively high pressures. (300 psi and above) and utilizes these pressures to overcome the osmotic pressure within the fluids, hence the term reverse osmosis. The R-O process again has been used by the dairy industry to pre-concentrate whey from 5-6% solids to 10-15% prior to evaporation and drying.
FDA has recognized these processes, when applied to whey, and they are currently being used in Grade A plants to process Grade A sweet and acid whey to produce dry and whey protein concentrate which are then utilized as ingredients, where permitted by the Standards of Identity, to add to Grade A milk products. In recent years dairy and food technologist from various universities and industry have been investigating the use of U-F and R-O processes to produce cheese. FDA~s concerns with these foods look like and sometimes taste like cheese. FDA~s concerns with these foods is that they do not conform to the Standards of Identity for cheese index 2 C.F.R. Part 133. The cheese standards require that cheese be made from ~milk~. When milk is processed thru a R-O or U-F system the retentate is no longer ~milk~. Some of the resulting food, although it may look and taste like cheese, does not have the same physical and chemical properties as the cheese defined in Part 133 and may or may not be nutritionally equivalent.
Sanitation and cleaning and sanitizing of the U-F and R-O units are another concern, at least with the Milk Safety Branch. Most U-F and R-O systems operate on a recirculated batch process; that is the product is fed into the system and the retentate is recirculated until the desired total solids or concentration of constituents is reached. This may be as long as 10 to 12 hours in duration. The process generally takes place at temperatures of 75x-95xF. These temperatures are favorable to bacterial growth. Most membranes are very delicate in nature. They are affected by high and low pH~s and most cannot tolerate temperatures above 120xF or high chlorine concentrations. They must be kept continually wet. The backing upon which they are cast is open and porous in nature, usually it is a woven plastic fiber. All of these factors make cleaning, sanitizing and maintaining a sanitary condition very difficult. Most plants, working with their equipment and detergent supplies have been able to obtain satisfactory conditions. Some people have suggested that UF or RO units be placed on dairy farms. There might be a saving in transportation costs by taking out the water and lactose and leaving it at the farm. Milk Safety Branch has some real concerns about their use on dairy farms with raw milk which may be contaminated with pathogenic bacteria, particularly Staphylococcal Organisms.
Q. 3. When will information be available on labeling requirements relating to sodium?
A. Information is now available. After July 1, 1985 all products which require and contain nutritional labeling are required to contain information on sodium content.
Q. 4. Has the incidence of antibiotics found decreased since the testing program has been in effect?
A. The State officials present at the seminar were polled and they reported no change in incidence of antibiotics found.
Q. 5. What is being done on KDB in finished milk products? A.FDA conducted a sampling program for KDB in milk. Between 3/20/85 and 5/15/85, 625 samples were analyzed and no KDB was found in any sample at the 1 PPB level. Several State agencies have also sampled milk and have not found any KDB.
Q. 6. The last IMS conference directed a study of the PI Count. What is the current status of this study? What actionable level are you looking at? Will information be available at the next IMS conference?
A.The 83 conference Did Not direct a study of the PI Count. They voted to allow the PI test as an alternate to the SPC at the regulatory agencies discretion. The NCIMS Executive Board with the concurrence of FDA set an effective date for adoption of this change as July 1, 1986. This effective date would allow the 85 conference to study the program further and possibly modify the recommendation. FDA thru a contractual agreement with 11 States is conducting a study to try to determine if the SPC or the PI gives a closer correlation to sanitary production conditions on dairy farms. This study started in September 1984 and will continue for 12 months. The results will not be available for the 85 conference. It is anticipated that the 85 conference will take some action to alter the 83 conference action regarding the PI Count.
Q. 7. Should the PI Count remain a quality screening test rather than a regulatory test? Support your comment.
A. No Comment at this time.
Q. 8. There have been many questions about satisfactory anti-siphon breakers on automatic washers. Since there is only a small amount of food grade chemicals involved, what degree of water system protection is necessary to meet the anti-siphoning requirement?
A. At this time we have not considered these a violation. Technically however the potential exists for cleaning and sanitizing compounds to be drawn into a water distribution system.
Q. 9. What states in the region use the EPA approved filter membrane testing procedure for water quality testing? Why isn't this test used? It is quicker and less expensive to run.
A. The membrane filter test is an approved test for water quality, and is being used by some states.
Q. 10. What progress is being made within the region to have each state responsible for the supervision of the plants and farms within their state boundaries to eliminate across state line supervision?
A. It was reported that some states have worked out an agreement with their neighboring states on this matter and progress is being made.
Q. 11. Why has FDA failed to take action against the sale of raw milk across line in the view of the very damaging correlation between the consumption of raw milk and milk borne diseases? We understand the NCIMS, the American Medical Association, national Milk Producers Cooperative and Public Health Officials are all supporting action to ban the sale of raw milk.
A.The PHS/FDA recommended milk ordinances since 1953 Edition have recommended the sale of only pasteurized milk and milk products. The Standards of Identity promulgated by FDA in 1973 have prohibited the interstate sale of raw milk in final package form for beverage use. Because of objections and requests for hearings filed by the ~Certified Milk Industry~, this portion was ~Stayed~ in respect to ~Certified Raw Milk~. Raw Milk hearings were held on October 10 and 11, 1985. The testimony presented at that hearing is being considered by FDA and a decision as to which direction to proceed is being developed at this time.
Q. 12. What can FDA do to encourage OMB and USDA/APHIS to support restoration of funding for the Brucellosis Eradication Program? The proposed Federal cut to $37.6 million from $69.5 million would doom accelerated eradication efforts in the last six highly infected states.
A. FDA by law is prohibited from lobbying the U.S. Congress. FDA when requested by Congress may present testimony to Congressional Committees on matter which are of concern to FDA. Animal disease control and its eradication is vested by congress to the U.S. Department of Agriculture.
Q. 13. On a recent check rating, a Bodmin pulsator was found to be dirty and debited on Item 10 & 11. Is this a proper debit? Why is this violation being debited 10 points under Item 10 & 11 rather than the previously marked 5 points Item 10?
A.On some Bodmin pulsators, older models manufactured before August, 1983 the pulsators were considered product contact surfaces; i.e. The product came in contact with the surface or liquids may drip, drain or be drawn into the milk. When product contact surfaces are found dirty they are debited under Item 10r, cleaning, and 11r, sanitizing, because an unclean surface cannot be properly sanitized. Other types of pulsators, have in the past not been considered as product contact surfaces because of their design. When they are found dirty they have been debited for violation of Item 10r but not 11r.
Q. 14. What can we do to require built-in vacuum breaker protection on portable high pressure pumps and similar equipment at the time of their production.
A. As a purchaser of such equipment, the dairy farmer can insist that this feature be built into the equipment he purchases. Some manufacturers do make them and they are available on request. Regulatory officials can point out to the manufacturers that proper installation must be made of these high pressure pumps to prevent less than atmospheric pressure on the suction side of pumps and the water supply system.
Q. 15. If a CIP line in a milk processing plant is found uncapped and the line is not connected to product or product lines is it debited and where?
A. If the CIP line is not connected to a product pipeline or storage tank it is not in violation. If it is connected in such a manner that the product or product constant surfaces of equipment can be contaminated by insects, dust or liquid dripping, draining, or being draw into the product, and is uncapped; it is a violation of Item 15p. It should be debited under 15(a) on the Milk Plant Inspection Report.
Q. 16. Under IMS Procedures, can a hauler pick-up on the same tanker load of milk, supplies under different regulatory and rating authorities (i.e. mixed loads)?
A. Yes, Provided the regulatory agencies and rating agencies have worked out a mutual agreement specifying how the ratings are to be made and such agreement is not in conflict with the basic intent of MMSR.
Q. 17. Can fresh/treated cow milking equipment, if it does not comply with construction and/or cleaning requirements, be stored in the milk house. What are the debited areas?
A.If such equipment is stored in the milk house it must conform to the applicable requirements of Items 9r, 10r, 11r and 12r.
Q. 18. Are various milkshake drinks to be considered as flavored milk, frozen dessert mix, or non-standardized foods?
A. A precise answer would require a review of the specific label, including the ingredient statement, of the product. If it complies with the Standard of Identities for milk, low fat milk or skim milk with added flavorings it would be covered by the P.M.O. If it does not comply with the Standards of Identity it would be considered as a non-standardized food or a substitute food.
Q. 19. Should micro switch housings on a dual-stem flow diversion devices be sealed? If so, what is the debited item?
A. The PMO does not require that the micro switches of any flow diversion devices be sealed. Some manufacturers of dual stem flow diversion devices do provide for sealing of micro switch housings on their valves for the optional use by the plant operators.
Q. 20. If a producer ships from two bulk milk tanks and sample results indicate only one tank is violative for inhibitory substances, should both tanks be suspended from the market? Do you average zone sizes?
A. If either sample is positive for inhibitory substances, Section 6 of the PMO requires that no milk be offered for sale by the permit holder until it is shown by a subsequent sample to be free of antibiotics.
Q. 21. If a producer ships milk from two bulk milk tanks and sample results indicate only one tank is violative for somatic cell determinations, do you confirm both results and take an arithmetic average?
Q. 22. The proposed study on the PI test calls for two incubation procedures, one at 7xC for 10 days and the other for 18 hours at 55xC, then a standard plate count. In the interest of timely information, why do we even consider the 7xC for 10 days.
A. The phychrotrophic count (7xc for 10 days) was added to the PI contract study, strictly for scientific and technical reasons. The intent was to substantiate information in the literature that the phychrotrophic count parallels the preliminary incubation count. There is no intent to consider the phychrotrophic count as an official regulatory test.
Q. 23. An effort had been made to modify the approval requirements for laboratories conducting water quality tests by eliminating many of the heavy metal testing necessary for approvals. This would substantially reduce the range of approval requirements and would allow certified industry labs to conduct these tests. What is the current status of this possibility?
A. The PMO specifies that water analysis of farm water supplies be conducted in laboratories acceptable to the regulatory agency. Individual plant water supplies shall be sampled by the regulatory agency and examinations shall be conducted in ~an Official Laboratory~. Under the IMS program individual farm water supplies could be tested in industry, commercial or official labs. States can and in most cases do only approve these labs for microbiological testing. EPA has a water laboratory approval system whereby official laboratories may be approved for both. The EPA water laboratory approval system does not apply to laboratories testing individual water supplies.
Q. 24. What are the perceived benefits and problems with the farmer- owned and sanitized sample dipper vs. The driver sample dipper? What quality assurance checks are you expecting the drivers to conduct in his sanitizer or the farmer~s sanitizer? Why is it necessary to increase the administrative burden on this segment of the industry?
A. Either system, farmer-owned or hauler, is acceptable under the sampling surveillance program. If the sanitary condition of the farmer-owned dipper is neglected, only that farmer is effected, i.e. a contaminated sample may cause a high SPC. On the other hand a neglected hauler dipper could cause high SPC~s on all farms on the route. The hauler is expected to use an acceptable sanitizer, at the prescribed level, to sanitize his dipper between uses at each farm. The farmer is responsible for cleaning and sanitizing his own dipper. Nationwide experience has shown that the hauler dipper system generally maintains the best sanitary condition of the dippers. Since legal action can be taken against a farmer to suspend or revoke his permit as a result of samples taken by the hauler sampler. It is indeed important that every effort is taken to protect the integrity of the sample and insure that it truly represents an aliquot part of the milk being offered for sale. Industry has participated in the development of the sampling surveillance and to our knowledge still supports it.