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ICE CREAM AND RELATED PRODUCTS
"The Frozen Dessert Processing Guidelines" are available from the Milk Safety Branch (HFS-626) and provide recommendations to make an assessment of the safety and quality of frozen desserts from raw ingredients to packaged finished products.
Throughout the "Frozen Dessert Processing Guideline," each item or area has been assigned a suggested risk assessment: (H) High Risk, (M) (Moderate Risk), and (L) Low Risk. These are suggested, general, risk assessments and may not represent specific individual circumstances. If an observed condition constitutes a risk higher or lower than that suggested in the guideline, the corresponding action priority should apply.
IMPORTANT - The risk is automatically "H" or "High" when the problem observed is a critical processing element involving:
1. Proper pasteurization whereby every particle of milk, milk products, or mix may not have been heated to the proper temperature and held for the required time in properly designed and operated equipment ( PMO, Part II, Section 7, Item 16p(B)); or,
2. A cross connection exists whereby direct contamination of pasteurized product is occurring (PMO, Part II, Section 7, Item 15p (B)); or,
3. Conditions exist whereby direct contamination of pasteurized product is occurring.
The three risk categories are defined in terms of appropriate monitoring levels and action priority:
1. (H) High Risk: High level of control needed because of immediate impact on product safety. Potential for problem is high. Action Priority - No product should be processed until the problem is corrected. Product on hand should be checked for contamination if appropriate. If product on hand is found contaminated, appropriate action should be taken.
2. (M) Moderate Risk: Potential for a problem is somewhat limited to abuse or particular criteria. Timely monitoring is required because problems in these area could result in a risk to product safety. Action Priority - Correction of these problems is necessary within a short period of time. A few days of weeks may be reasonable. Specific additional monitoring is needed until correction has been accomplished.
3. (L) Low Risk: Monitoring needed only on inspection or random-checking basis. Risk potential is low, significant risk would only result from extensive abuse or extenuating circumstances. Action Priority - Correction is necessary to assure ultimate product safety. However the time frame for correction can be flexible and based around non-public health issues such as production schedules.
High (H) and moderate (M) risk observations should be documented on the FDA-483. Low risk (L) items should be included in a discussion with management.
Processing
See Frozen Dessert Processing Guidelines for processing, pasteurization and equipment guidelines.
If pasteurized mix is received from another plant and not re-pasteurized, thoroughly investigate the receiving practices. Verify that the tanker truck is either dedicated to receiving only pasteurized mix or, if used to haul other raw products (e.g. eggs, raw milk) or chemicals, assurances are present to show the truck is adequately cleaned and sanitized between hauls. Document the failure to re-pasteurize on the FDA 483, "List of Inspectional Observations," and collect representative finished product samples for Listeria, Salmonella and pathogenic E. coli analysis.
Examine can openers for fruit ingredients for production of metal shavings and for cleanliness.
Examine equipment prior to use for cleanliness (use blacklight: milkstone buildups indicate improper cleaning), including valves, piping, storage vessels, freezers and rubber gaskets at joints.
Be alert for possible routes of contamination in frozen novelties from the freezing brine (usually calcium chloride). Introduction of even small amounts of brine into the product through the use of cracked molds or splashing can lead to serious product contamination and consumer injuries.
Evaluate the finished ice cream mix pasteurization equipment and procedures (155oF for 30 minutes, 175oF for 25 seconds or their equivalents). (Frozen Dessert Processing Guidelines, page 33).
The first mix through the freezer usually is not a proper air/mix combination and adjustments are made as the first mix is collected and added back to the mix tank. If a poor air/mix ratio develops during processing adjustments will be necessary. This is messy in appearance, and mishandling increases the possibility of contamination. Mishandled mix needs to be re-pasteurized. If melt pots are used, they need to maintain the product above 145oF. Product needs to be kept below 45oF or above 145oF at all times.
Be alert for the use of Yellow numbers 5 and 6, either directly, or in added ingredients. Check for proper label declarations.
Economics
The term "overrun" relates to the air incorporated during the freezing process and is defined as the amount of ice cream obtained over and above the amount of mix frozen. Over run is normally 70-100%, and the air is as necessary in ice cream as the leavening in bread. The standard (21 CFR 135) limits the amount of overrun by defining the minimum weight per gallon of product. It may be calculated by either of two methods:
By volume:
% of overrun = (Amt. ice cream made - amt. mix used) x 100 Amount of mix used
By Weight at the freezer:
% of overrun = (Wt gal of mix - Wt gal of ice cream) x 100 Wt of gallon of ice cream
Sample Collection
Investigational
When factory conditions indicate a possible problem, collect evidence to support your findings, including product and environmental samples. Attempt to document a before-after pattern. Whole filters may be collected as well as gaskets which demonstrate filth. Document rodent and insect filth in raw materials. Bacterial sampling of product and testing for listeria and other appropriate pathogens can show contamination.
Official
Filth
Collect interstate samples of the finished ice cream. Sometimes lots are segregated by label or customer and an in-transit sample may be documented in the chill room or hardening room. Collect 10-1 qt. subs in duplicate.
Composition
Collect 10-1 qt. subs in duplicate.
Food or Color Additives
Collect a sample of the food or color base product and a sample of the product after it has been used in the ice cream product. Collect 10-1 qt. subs in duplicate.
Economics
Collect three fully labeled unopened containers to document misbranding.
Standards - See 21 CFR 135.
Labeling - See 21 CFR 101.
MILK PRODUCTS
Prior to conducting these inspections refer to IOM Subchapter 530 regarding food inspections.
Generally, a filled milk product is any milk, cream, or skimmed milk regardless of form (liquid, dried, etc.) or non-dairy imitation that contains, in whole or in part, any non-dairy fat. An imitation milk or milk product is any product which is intended to look, taste or be marketed as a substitute or replacement for a milk or milk product.
Processing
See Milk and Milk Products section of this guide for processing guidelines. Document in detail the pasteurization process. If a continuous process is used, provide a flow diagram showing each piece of equipment and temperatures at each point of the process.
Quality Control
Compare QC test results with finished product specifications, including the following:
1. Filth
2. Bacterial load, and if tested for pathogenic bacteria (e.g., Staph, Salmonella, etc.)
3. Vitamin fortification.
4. Protein analysis. Determine protein source.
5. Fat.
6. Moisture.
7. Pasteurization indicating tests, i.e., phosphatase.
If labeled as sterile, determine tests conducted to assure sterility.
Sample Collection
Investigational
Collect in-line samples to document conditions which could lead to the contamination of the products with filth and/or bacteria. This includes a 702b sample.
Collect finished product and raw material subs if a food or color additive violation is suspected.
Official
Filth
10-8 oz. subs in duplicate from the same code.
Composition or Phosphatase
10-8 oz. subs from the same code in duplicate.
Microbiological
10-8 oz. subs of the same code in duplicate. However, if analyzed for Salmonella, 30 subs will be required.
COOPERATIVE PROGRAMS - MILK SAFETY
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.
References
1. Grade "A" Pasteurized Milk Ordinance, Recommendations of the United States Public Health Service/Food and Drug Administration. Current Revision
2. Procedures Governing the Cooperative State-Public Health Service/Food and Drug Administration Program for Certification of Interstate Milk Shippers. Current Revision
3. Methods of Making Sanitation Ratings of Milk Supplies United States Public Health Service/Food and Drug Administration. Current Revision
4. Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products. United States Public Health Service/Food and Drug Administration. Current Revision
5. Grade "A" Condensed and Dry Milk Products and Condensed and Dry Whey - Supplement I to the Grade "A" Pasteurized Milk Ordinance. United States Public Health Service/Food and Drug Administration. Current Revision
6. Evaluation of Milk Laboratories - Recommendations of the United States Public Health Service/Food and Drug Administration. Current Revision
7. Milk and Milk Product Equipment - A Guide for Evaluating Sanitary Construction. United States Public Health Service/Food & Drug Administration/Center for Food Safety and Applied Nutrition. Also, 3-A Sanitary Standards for Dairy Equipment.
8. Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers. (IMS list.) The IMS list is issued quarterly (January 1, April 1, July 1 and October 1) by the United States Public Health Service/Food and Drug Administration.
9. 21 CFR 1/10; 101; 108; 110; 113; 130; 131; 133; 135; 173.310; and 178.1010.
10. M-a, M-b, M-I and IMS-a series memoranda, prepared by Milk Safety Branch (MSB).
11. Memorandum of Understanding Between Food and Drug Administration and National Conference on Interstate Milk Shipments (NCIMS), Federal Register, Volume 42, September 20, 1977. (See FDA Compliance Policy Guide 7158.01).
12. Standard Methods for the Examination of Dairy Products, APHA. Current Revision
13. Official Methods of Analysis of the AOAC.
14. Milk Safety Compliance Program (CPGM 7318.003).
Program Objectives
The objectives of the Agency's cooperative Milk Safety Program activities are to provide assistance to the states in the prevention of communicable diseases and in the implementation and enforcement of their milk regulations, and to advise states on matters relating to the preservation and improvement of public health as it relates to the production and distribution of Grade "A" fluid milk and milk products for human consumption. Activities assigned to the field to accomplish the program objectives are:
1. Promote the adoption, implementation and enforcement of uniform technical guidelines, administrative procedures, and regulatory standards provided in the Pasteurized Milk Ordinance (PMO) and related documents through provision of technical assistance and consultation, through meetings with State government officials and through consultation with national, state, and industry organizations.
2. Conduct check-ratings of IMS listed shippers and audits of listed single service facilities.
3. Support, certify and train State regulatory officials; and participate in regional seminars, state workshops and other training.
4. Evaluate State programs annually to measure effectiveness in maintaining adequate levels of conformity with the PMO and related documents; advise State program officials as to the program's strengths and weaknesses; and make recommendations on matters relating to the preservation and improvement of the public health and compliance with the PMO.
Program Operations
Check-ratings
State and local regulatory agencies are responsible for the enforcement of sanitation requirements on dairy farms, in pasteurization plants, dry milk plants and at receiving stations which are listed in the IMS list.
The FDA check-rates or "audits" interstate milk shippers to ensure that State ratings are being maintained.
Check-ratings are to be conducted only by nationally or regionally standardized milk specialist. Unless by prior agreement between State officials and FDA, the milk specialist should be accompanied by a State milk sanitation rating officer and a person from the local enforcement agency when conducting check-ratings. The same rating procedures are used for official state ratings, except the number of farms visited must be smaller.
Arrange the time to conduct a check-rating with the State Rating Agency. However, avoid giving advance notice of the listed shipper to be check-rated. (It is not desirable or intended that local enforcement agencies or listed shipper have such advance knowledge.) If the State Rating Agency repeatedly refuses to agree on a date(s) for check-rating, send a letter to that agency, with a copy to the Milk Safety Branch (MSB) stating that the State will be recommended for identification in the next quarterly listing as being not in compliance with Section VII-C-4 of the "Procedures".
FDA milk specialists will check-rate a certain number of listed milk shippers in each State, to assure that the State rating has been maintained.
The following schedule will be followed for check-ratings for farms, receiving or transfer stations, plants and plants with farms attached:
In no case can a check-rating be made with greater frequency than the official rating but all plants will be check-rated at least once every three years. In addition, all plants which are withdrawn from the IMS list as a result of a check-rating must be re-check rated six to nine months after they have been re-listed.
Randomly select the number of shippers in each state as specified in the annual work plans. However, if there is reason to believe that any shipper or his supply has deteriorated, prompt follow-up should be made. This would be in addition to random coverage of shippers.
Be sure that the selection of dairy farms visited during a check-rating are representative of the total supply. Visit at least one-half (1/2) the number of farms needed to make a state rating. Use a random method that assures the greatest number of farms an opportunity to be selected. The method used should also have some geographical dispersal of the farms selected.
After the check-rating, before leaving the area, discuss results with the State milk sanitation rating officer and/or regulatory official. Leave the individual(s) a signed copy of the completed FDA-2359h.
Results of completed check-ratings will be reported only to the State milk sanitation rating agency which originally certified the shipper for listing, the State regulatory agency, and FDA's MSB unless required to be released under the Freedom of Information Act. Refer to the C.P. for reporting instructions.
Follow-Up
1. Producer Dairies - The check-rating results will indicate (a) the published rating is being maintained; or (b) a new rating should be made; or (c) the certification of the shipper should be withdrawn by the State rating agency.
The criteria for the appropriate action to be taken is contained in Section VII-C-1 of the "Procedures".
2. Pasteurization Plants, Dry Milk Plants and Receiving and Transfer Stations - The check-rating results will indicate (a) the published rating is being maintained; or (b) a re-inspection should be made; or (c) the certification of the shipper should be withdrawn by State rating agency.
The criteria for the appropriate action to be taken is contained in Section VII-C-2 of the "Procedures".
3. Failure of State to Take Action - Section VII-C-3/4 of the "Procedures" indicates what action is to be taken if the state does not make the required follow-up.
4. Enforcement Check-Ratings - In the event the enforcement check-rating is more than ten points below the listed enforcement rating and below 80, a recommendation for a new milk sanitation and enforcement rating should be made by the regional office. A new State rating should be conducted within sixty (60) days after the request.
5. Miscellaneous - Ensure that any plant on the IMS List which receives Grade "A" raw milk, milk products or dry milk products from a source not on the IMS List is removed from the IMS quarterly listing after proper notification by the State Rating Agency. The withdrawal procedures are described in Section VII-C of the "Procedures".
At the same time the State rating agency notifies all receiving states of the withdrawal, the regional milk specialist must notify the FDA Food Service and Interstate Travel Sanitation personnel in the region/district; the regional milk specialist in receiving regions, and MSB (202-205-9175) HFS-626 .
Raw milk from an unlisted or delisted source may be processed in a Grade "A" milk processing plant that produces manufactured products provided the milk is segregated and processed under the direction of the appropriate regulatory agency and the product is appropriately labeled.
IMS List Preparation
The IMS list is published quarterly (January 1, April 1, July 1 and October 1). This listing covers:
1. Milk sources which have been rated by State milk sanitation rating officers who have been certified by FDA.
2. Manufacturers of single-service containers and related items which have been certified by State milk sanitation rating officers or a sanitation consulting firm.
3. Foreign manufacturers of single-service containers and related items which have been evaluated by a sanitation consulting firm.
4. Milk laboratories approved by FDA or State Milk Laboratory Evaluation Officers. This section includes Appendix N Certified Industry Supervisors.
5. Individuals certified by FDA as State milk sanitation rating officers, State Milk Sampling Surveillance Officers and State Milk Laboratory Evaluation Officers.
6. States not practicing reciprocity or complying with Appendix N of the PMO. ("*" is placed behind their names).
Milk Shippers
The milk specialist reviews each FDA-2359i (the State milk sanitation rating officers compilation of FDA-2359j, FDA-2359k, and FDA-2359l) for completeness and accuracy. If the form is unsatisfactory, it should be returned to the State rating agency for correction. Forward one complete, signed copy to MSB and retain the original in the regional office. Retain, in the regional office, the original "Release for Publication" form, giving written permission of the shipper to publish the listing. If the shipper does not agree to the release, submit the FDA-2359i to MSB without a signature in Block 10.
MSB must receive the FDA-2359i at least thirty days before the publication date in order for a shipper to be included on the IMS List.
Single-Service Containers/Closures
Manufacturers
The FDA regional milk specialist will receive from the State Rating Agency two copies of the FDA-2359d. This represents inspections and certifications made by State milk sanitation rating officers or by a sanitation consulting firm recognized by the state as satisfactory. The milk specialist shall review each submitted FDA-2359d for completeness and accuracy. If the form is unsatisfactory, it must be returned to the appropriate source for correction. Forward one complete, signed copy to MSB and retain the original in the regional office files. If the manufacturer does not agree to a release of the information, submit one copy of the unsigned FDA-2359d to MSB with the "No" box checked in Block 15.
The milk specialist will conduct audits of single-service manufacturers and issue a completed, signed copy of the FDA-2359c to the State rating agency representative before leaving the area. An FDA-2359c and a letter of recommendation should be submitted to the State rating agency with a copy sent to MSB.
Milk Laboratories
The milk specialist must maintain a regional office file for milk laboratories involved in official analysis of samples from IMS listed shippers. Record the name and address of each laboratory, date of the most recent evaluation, certification, and date of most recent split sample/quality control analysis.
Certified Individuals
The milk specialist will maintain a file in the regional office for each State milk sanitation rating officer, State Milk Laboratory Evaluation Officer, Appendix N Certified Supervisor and State Milk Sampling Surveillance Officer, certified by FDA and actively engaged in milk operations.
The milk specialist will receive and forward to the RFDD for signature each certification and/or recertification or withdrawal of certification of any State Milk Laboratory Evaluation Officer or State Milk Sampling Surveillance Officer as forwarded by the Laboratory Quality Assurance Branch ( LQAB).
Selection and Prestandardization Training
FDA milk specialists are expected to provide State officials expertise and guidance. It is important that they possess a high degree of knowledge in all areas of Milk Safety. Therefore, it is advisable to select individuals who are highly qualified by virtue of education, training and experience for such positions.
A selected individual should first be given a prestandardization course in general milk safety and FDA milk safety policy. The Regional Milk Specialist should determine the course content, based on the trainee's background and needs. The course should include, but not be limited to, the use and interpretation of the PMO, DMO, Methods of Making Sanitation Ratings of Milk Supplies, Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products, and all related inspectional report forms. The selected individual should attend State Training Branch (STB) Course 301 - "Milk Plant Sanitation and Investigation", 302 - "Milk Pasteurization Controls & Tests" , 306, "Dairy Farm Inspection", 510 - "Special Problems in Milk Protection" and 511 - "Advanced Milk Processing Workshop." Additional prestandardization training may be provided by LQAB.
It is desirable that the individual work with more than one milk specialist during training. This gives the individual the widest possible exposure to various types of industry operations, State agencies and milk specialists.
Standardization or Restandardization
All milk specialists must be standardized and restandardized by MSB. This is necessary so that all milk specialists can certify State milk sanitation rating officers.
For initial standardization, the RFDD or designee must make the request to MSB in writing. Each request for initial standardization should include a resume containing:
1. Education, training and work experience.
2. A list of all training courses attended.
3. A detailed description of individualized training conducted by other milk specialists.
Standardization requires joint inspections to determine proficiency at making check-ratings. Include inspections of the following:
1. At least twenty-five producer dairies (some at milking time);
2. Five pasteurization plants (of various sizes, using both HTST and vat process);
3. One dry milk plant;
4. One single service container and closure manufacturing plant.
You may count the pasteurization plant portion of the dry milk plant as one of the five pasteurization plant inspections. At least one enforcement rating must be completed successfully during the standardization process. To be standardized, an individual must show at least 80% agreement on each item of sanitation on farms, plants, transfer and receiving stations, sampling surveillance and single-service container and closure reviews.
To maintain standardization, a milk specialist must accomplish at least six plant check-ratings and six farm check-ratings each fiscal year.
In lieu of re-standardization every three years, MSB must work with each milk specialist three days each fiscal year. This will serve as both training and a continuous re-standardization of the milk specialist. If, at any time, MSB feels that a problem exists, it can require a full formal standardization. To maintain proficiency all milk specialists should attend the biennial IMS conference, their regional milk seminar, a 510 course a minimum of once every 2 years and other appropriate training courses.
Withdrawal of Standardization
Any individual who fails a re-standardization or who does not perform at least six plant check-ratings and six farm check-ratings in a fiscal year will be immediately removed from the roster of persons qualified to perform work operations requiring a milk specialist.
Certifications/Recertifications
MSB-standardized regional milk specialists are responsible for certifying and recertifying each State milk sanitation rating officer. To be certified or recertified, an individual must demonstrate a specified level of proficiency regarding milk safety, based on knowledge and use of rating procedures and inspection techniques found in the Procedures, Methods of Making Sanitation Ratings of Milk Supplies, the PMO, the DMO, and Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products. The regional milk specialist will notify the RFDD of each completed certification or recertification, so that a certificate can be issued, countersigned by the certifying milk specialist, to each certified State milk sanitation rating officer. The milk specialist must send a copy of each certificate to MSB. The certification will be valid for three years, unless withdrawn for cause. The milk specialist must also submit to MSB a copy of the RFDD's letter notifying the state rating agency of each certification or recertification.
Applicants may be certified in one of the following areas: Milk Pasteurization Plants; Dairy Farms; Transfer and Receiving Stations or any combination thereof.
Certify only one applicant at a time, so as to avoid distraction. Do not use the results of the recertification process as a check-rating. Include inspections of:
1. Twenty-five producer dairies (some at milking time);
2. Five pasteurization plants (of various sizes, using both HTST and vat processes, which may include one transfer or receiving station);
3. One dry milk plant. You may count the pasteurization plant portion of a dry milk plant as one of the five pasteurization plant inspections;
4. One single service container and closure manufacturing plant.
The different requirements listed above will be dependent on the applicant's range of responsibility(ies).
Applicants must have attended the STB Course 302 - "Milk Pasteurization Controls and Tests" and demonstrate proficiency in applying equipment tests in at least one pasteurization plant.
Applicants must demonstrate the ability to conduct and compute milk sanitation compliance and enforcement ratings by completing the necessary forms. The milk specialist should submit to MSB one copy of each FDA-2359b; FDA-2359j; FDA-2359k; FDA-2359l; and notice of certification for each state milk sanitation rating officer certified by the milk specialist.
During the three year period that the certificate is valid, milk specialists should make periodic joint evaluations while check-rating. These periodic reviews should be made during some, but not all dairy farm inspections, and all pasteurization plant inspections. Results of these reviews may serve as a basis for issuing a new certificate without following the formal certification process described above, provided that a minimum of twenty-five farms, five pasteurization plants and/or five receiving and transfer stations have been reviewed for the specific type of certification required. Also one single service manufacturer of each type (paper & plastic) should be done if it is in the area of the rating officers responsibility. If at any time the milk specialist feels that the desired proficiency is not being maintained the process may revert to the procedure for a full certification.
In addition, during the three year period, all rating officers must have participated in at least one Regional milk sanitation rating officer's Seminar and attended at least one training course on "Special Problems in Milk Protection" (a 520 course) or other training courses judged by PHS/FDA to be equivalent and appropriate.
All certified state rating officers must complete a minimum of four ratings per year. In those states with less than twenty listed shippers there may be a maximum of two certified rating officers. In those states with a limited number of shippers, every effort must be made to maintain the rating officers proficiency.
Submit to MSB one copy of FDA-2359K; FDA-2359L; and notice of certification for each state milk sanitation rating officer recertified by the milk specialist.
Withdrawal of Certification
The milk specialist will recommend withdrawal to the RFDD if a state milk sanitation rating officer does not maintain the required proficiency or if the individual has failed to meet the criteria for certification (See Compliance Policy Guide, 7158.01 and Procedures). Send the notice of certification withdrawal to MSB.
State Milk Laboratory Evaluation Officers
When notified that a State Milk Laboratory Evaluation Officer has been certified or recertified by LQAB, LQAB will send a written notice to the state laboratory evaluation officer (LEO) with a copy to the regional/district milk specialist and to MSB. This certificate will be valid for three years, unless withdrawn for cause.
The milk specialist will receive and file a copy of the notice stating the result of the check evaluation made by LQAB.
Withdrawal of Certification
LQAB will assure that any state Milk Laboratory Evaluation Officer recommended for withdrawal by LQAB is so notified. A copy of that notification will be sent to the regional/district milk specialist and MSB. (See Compliance Policy Guide 7158.01).
State Milk Sampling Surveillance Officers
Regional/district milk specialists will standardize state milk sampling surveillance officers initially and every three years through a system of joint review of a minimum of five farm samplers and two plant samplers.
The regional/district milk specialist will send written notice of certification or recertification to the state laboratory evaluation officer with a copy to LQAB and MSB. This certification is valid for three (3) years, unless withdrawn for cause.
Withdrawal of Certification
The regional/district milk specialist will send written notice to the state Milk Sampling Surveillance Officer recommended for withdrawal with copies to LQAB and MSB. (See Compliance Policy Guide 7158.01).
Standardization of Milk Specialists for Sampling Surveillance
LQAB will standardize regional/district milk specialists initially and every three years through a joint review of a minimum of five farm samplers and two plant samplers. After initial standardization, this may be conducted throughout the three year period.
Review of State Milk Sanitation Programs
The milk specialist should evaluate each state milk program on a continuous basis. As weaknesses or problems emerge, they should be discussed with appropriate state personnel.
Evaluations are made to monitor the effectiveness of the state's program and to assist the state regulatory and rating agencies in strengthening their programs.
The regional milk specialist will identify and track public health problems and state control program needs from year to year to determine the status of public health protection, to identify trends in state controls over a period of time, and to help assess the relative impact of FDA program activities on promoting public health. State program evaluations will also provide key data for use in planning and prioritizing agency resources.
On an annual basis an evaluation of each state's program will be provided to the state with a copy to MSB. A brief recommended format for this report may be obtained from MSB. The region at its discretion may opt for a longer report if deemed necessary. In addition, or as part of the annual state program evaluation, a complete evaluation shall be conducted annually and submitted to MSB on state compliance with Appendix N.
Submit copies of the state milk sanitation program evaluations as described in the Reporting Section of the CP.
Technical Assistance
Technical questions for the milk specialist may come from federal agencies, state agencies, educational institutions, industry or the public. The milk specialist may contact MSB for answers to questions and other guidance.
The milk specialist will distribute, upon receipt the following coded memoranda to state dairy regulatory agencies and state veterinarian associations and other interested parties:
1. IMS-a series, Consecutively numbered memoranda dealing with the IMS "methods" and "procedures".
2. M-a series, Consecutively numbered memoranda dealing with technical interpretations and applications of the PMO.
3. M-b series, Consecutively numbered memoranda dealing with equipment reviews.
4. M-I series, Consecutively numbed memoranda containing technical information useful in responding to inquiries from other government agencies and industry.
The milk specialist will also provide follow-up consultation and training as necessary, and review implementation by the state as part of the program evaluation. These efforts are to promote full and uniform implementation of all PMO requirements by the states.
Labeling Inquiries
Do not discuss, in depth, milk or milk product labeling questions when queried. The milk specialist should only answer questions about general mandatory labeling requirements, and direct other questions to the Office of Food Labeling or MSB, Center for Food Safety and Applied Nutrition. Inquiries from State/local milk personnel, with a copy of any written interpretation, instructions, and/or advice provided should also be sent to MSB.
Training
The milk specialist is responsible for coordinating milk safety training activities in the Region. They should recommend to the RFDD, for inclusion in the annual plan of national training, courses conducted by the State Training Branch based on identified training needs of the state.
The milk specialist is the principal liaison between ORA/DFSR/STB and the states regarding training needs and priorities.
The milk specialist will participate in STB courses as needed and may provide informal training for both industry and regulatory personnel.
All milk specialists should attend the biennial NCIMS. This Conference provides an opportunity to receive valuable information on the function and operation of the IMS program and the current positions of the milk industry and milk regulatory agencies.
Seminars
The milk specialist is responsible for conducting regional seminars once each year, as requested by the states. Such seminars are to promote uniformity in the interpretation of the PMO and related documents, laboratory methodology, state programs, and NCIMS procedures by both State milk sanitation rating officers and Laboratory Evaluation Officers. Other regulatory participants may be invited by the regional office. MSB & LQAB will participate in each seminar. All milk specialists in the region should attend. Industry/trade associations shall be included in those portions of the seminar as determined necessary and feasible by the milk specialist.
The milk specialist should poll the participants to determine problem areas to be covered and review the recent State Evaluations for other topics. To allow the headquarters participants to make travel plans, report location and date of each seminar to MSB at least three months in advance. Also provide information on facilities (conference room reservations, suggested motels/restaurants that are convenient, etc.) and the proposed agenda (topics, guest speakers, audio-visual presentations, etc.).
The milk specialist will consult with the states within the region, MSB and LQAB prior to finalizing the meeting agenda. Concurrence on the agenda by MSB will be required prior to distribution. The milk specialist will distribute the final agenda to MSB, DFSR, and participating states at least thirty days prior to the Seminar.
After the seminar, the milk specialist shall prepare and submit a narrative report including the final agenda, list of participants, expressed items of interest or concern, a list of questions from participants and proposed answers, and recommendations to DFSR and MSB. Refer to the Reporting Section of the CP for details regarding submission.
Workshops
The milk specialist should conduct workshops as required. Workshops serve the same purpose as seminars, i.e. to promote uniformity, but are open to other state regulatory, local regulatory, educational and dairy industry personnel. Workshops usually cover only one or two States in the region.
Equipment Review
Although the FDA neither approves nor disapproves equipment, this agency will review equipment for conformance with the PMO and related documents, upon request of the dairy industry and/or State and local milk sanitation agencies. When a milk specialist receives such a request, an evaluation and field review should be conducted. The regional/district milk specialist should then prepare a draft response which is forwarded to MSB. MSB is responsible for issuing the final response unless the milk specialist is so instructed. The region should provide a letter to the requester acknowledging receipt.
MSB should be notified of the request for evaluation as soon as practical.
The region is requested to provide MSB with a report of the review of any new or modified equipment. The report should include a narrative of the review, pictures, manufacturer's literature and any other supporting documents as needed. Inform the manufacturer that copies of their literature on the equipment will be needed for distribution. Submit the equipment review final draft to MSB in accordance with the reporting requirements in the CP.
Standards Review
The regional milk specialist should be thoroughly familiar with 3-A Standards and Practices and will review and comment on proposed standards and practices, when requested by MSB. Regional milk specialists may be requested by MSB to participate in National 3-A Standards meetings.
Outbreaks of Suspected Milk-Borne Disease
In the event of a disease outbreak, suspected of being milk-borne, immediately notify the Epidemiology Investigations Branch (HFC-161) at (301) 443-4667 or (301) 443-1240. Also advise MSB of the situation. This will enable FDA to prepare a coordinated plan for follow-up and correction of the problem. This applies to microbiological and chemical contamination. Refer to Field Management Directive #64 for complete instructions.
ITS Activities
The milk specialist should inform FDA personnel involved with the Interstate Travel Sanitation Program of any delisting of Certified Interstate Milk Shippers that may be selling products to interstate carriers.
It is particularly important that ITS personnel be notified when a firm is relisted.
Compliance Program Status Reports
At the end of each quarter the milk specialists are to submit a report covering the status of the CP activities. This report is to be submitted to MSB and DFSR (HFC-152) using the format provided as an attachment to the appropriate CP.
Miscellaneous Information
Manner and Attire:
See IOM Subchapter 140 for general information on plant safety and protective clothing.
Product protection, personal protection and good public relations dictate that a milk specialist dress appropriately for the activity in which they are engaged. Abide by the wishes of the management of the facility being inspected. In some firms they will furnish protective clothing. Always wear single-service or other suitable head coverings with a clean smock or laboratory coat when inspecting a milk processing plant. Do not wear the same clothing from one plant to another. Make sure that boots are properly cleaned and sanitized between plants. Do not wear the same clothing and shoes/shoe coverings used to inspect farms and plants. Remove all jewelry prior to the beginning of a plant review or checkrating.
Communications and Coordination
If work takes a milk specialist into an area served by an FDA Resident Post or into another district, notify the resident post or district office by phone, memorandum, or in person, of the nature of your business. This type of contact will provide better over-all coordination of FDA activities.
Publication of "Procedures"
After each NCIMS meeting, FDA will publish a new revision of the "PMO, DMO, Procedures, Methods, Single-service document and the Evaluation of Milk Laboratories (EML)" reflecting changes passed by the conference.
Forms Used in the IMS Program
All forms used in the IMS program can be obtained by placing an order with Consolidated Forms & Publications Distribution Center on form CFPDC-1, address: Washington Commerce Center, 3222 Hubbard Road, Landover, MD 20785.
Glossary
Adverse Actions - When the results of an FDA check-rating and State rating of a listed milk shipper are not in agreement, FDA notifies the State rating agency to: Reinspect; Conduct a New Rating; Withdraw the IMS certification (remove the milk shipper from the IMS list). The recommended action depends on the severity of the deficiencies.
Certification - The process which determines whether the applicant (a state employee working in the IMS area) can correctly interpret and apply NCIMS Procedures, appropriate sanitation standards, and other procedures relevant to the IMS Certification Program.
Check-rating - The designated FDA and NCIMS Procedures method to ensure that the published state rating of a milk shipper on the IMS list is valid and maintained during the interval between State ratings. An unsatisfactory FDA check- rating of a milk shipper may result in an adverse action.
Milk Specialist - An FDA field representative, standardized according to FDA procedures, who is an expert in milk safety and the implementation of the IMS Program.
Senior Milk Specialist - A milk specialist who has the primary responsibility for coordinating the implementation of the IMS Program in a specific Region or District.
Standardization - The process which determines whether an applicant (milk specialist) can correctly interpret and apply NCIMS Procedures, sanitation standards, and other procedures relevant to the IMS Program.
