U.S. Food Drug Administration Food Compliance Program |
10-01-97
National Drug Residue Milk Monitoring Program
(FY 98-00)
09-30-00
09C[][]0903039 (Grade A)
71008 (Non-Grade A) *
FIELD REPORTING REQUIREMENTS
Submit hard copy of all investigational reports, both state and Federal, relating to illegal drug use, distribution or labeling to CVM (HFV-246) for headquarters review and compilation of data.
Submit hard copy of all investigational reports, both state and Federal, relating to the contamination of milk offered for sale, the disposition of any adulterated milk, regulatory actions taken against the producer, or any subsequent seller of adulterated milk to CFSAN, Division of Cooperative Programs, HFS-625.
*Denver laboratory will report all results in LMS, use the LMS Compliance Data Reporting System Antibiotics in Feeds and Foods Screen form code ANT, PAC 03039 for Grade A milk and PAC 71008 for non-Grade A milk. Use form code KIT for test kit analysis only - the some PAC assignments described above apply.* In addition, Denver will provide a weekly summary of analytical findings to CFSAN, Division of HACCP, Laboratory Quality Assurance Branch (LQAB), HFH-450. LQAB will distribute this data to CFSAN, Domestic Programs Branch, HFS-636 and the States submitting samples. States will enter this data in the National Drug Residue Database.
States will report all results for the initial analysis of samples they analyze on Attachment A, and any subsequent samples for either confirmation of initial results or identification of violative producers on Attachment B. Investigations due to positive findings by the state central laboratories should be reported on Attachment C.
States will also transmit a copy of the record of the Sample Collection Report/Laboratory Results Report (Attachment A) to accompany samples submitted to FDA Denver laboratory. This record should be completed to include the Sample Collection Report (upper half) of the form. If any prior testing has been completed on the sample by the state, the lower half (Laboratory Results) of the form should be completed.
DENVER will immediately report positive findings, * after check analysis have been completed * to HFH-450 as indicated in 3.b. above. HFH-450 will immediately transmit this information to: FDA, Milk Safety Branch, HFS-626 and the state laboratory submitting the sample. Follow up samples will be collected as necessary to identify the producer. HFH-450 will transmit information relating to this program to the National Drug Residue Database monthly.
HFH-450 will also FAX the above information to the respective RMS and the respective state milk regulatory official submitting the sample.
At the time of sampling, the investigator is requested to collect information from the plant that specifies the total number of loads, the total volume in pounds of milk received the week prior to the sample being collected, the grade of milk contained in the truck, the identity of the finished product the milk will most likely be used for, and the identity of the producers contributing to the bulk milk pickup tanker sampled. This information is to be directed to HFH-450 on the Sample Collection Report/Laboratory Results Report Form. (see Attachment A)
PART I - BACKGROUND
The Food and Drug Administration (FDA) has primary responsibility for regulating most foods, including milk, shipped in interstate commerce. FDA's milk safety program relies on participation by state regulatory agencies. This participation is described in a 1977 Memorandum of Understanding (MOU) between the National Conference on Interstate Milk Shipments (NCIMS) and the FDA and is designed to provide assurance of a clean and safe national milk supply. The FDA, with the support of the NCIMS initiated the National Drug Residue Milk Monitoring Program (NDRMMP) in February 1991. The NDRMMP is designed to assist and supplement the longstanding NCIMS program.
The NDRMMP is designed to provide an indication of animal drug residues that may be present in milk and the extent that farmers, distributors, and veterinarians comply with the Federal Food, Drug, and Cosmetic Act, implementing regulations and applicable policies. In the past, the NDRMMP involved, in part, the analyses of raw milk samples in FDA laboratories. This revision will continue to utilize FDA laboratories for the analyses of raw milk samples, and will add "quick screening" analyses by state laboratories certified by the Office of Field Programs, Laboratory Quality Assurance Branch, HFH-450.
Three states will be scheduled to submit five samples each week of the fifty week program. This will result in 750 samples being analyzed by the FDA/Denver laboratory.
The "quick screening" analysis by the states will add approximately an additional 5,000 analysis to the results obtained from the FDA laboratory, and will encourage the use of these methods by the states as they become accepted for use by FDA. An important benefit of the NDRMMP is the transfer of analytical technology from FDA to state and industry laboratories and then the transfer of improvements and refinements among all participating laboratories.
The analytical findings from the NDRMMP should not be used to compare the raw milk in one state with that in another state. Raw milk moves in interstate commerce for processing and retail sale, and the actual state source might be erroneously assumed.
The results from the NDRMMP will help in the design of future education and compliance efforts for use by Federal, state, and local authorities. This initiative will enhance the NCIMS (PMO - Appendix N) residue testing program and provide information on which to focus regulatory priorities.
PART II - IMPLEMENTATION
PART III - INSPECTIONAL
NOTE:BECAUSE OF STATE BUDGETARY CONSTRAINTS, IT MAY BE NECESSARY FOR THE RMS TO ARRANGE FOR AN FDA CSO/CSI TO COLLECT THE ASSIGNED SAMPLES IF THE STATE IS UNABLE TO DO SO.
Please address samples to:
Food and Drug Administration
Denver Federal Center
Attn: Sample Custodian
Building 20, Entrance 10 W
6th and Kipling Streets
Denver, CO 80225-0087
Phone (303) 236-3062
Reports of investigations by FDA initiated in response to the Enforcement Plan will be prepared by the Federal investigator. Reports will be completed as expeditiously as possible and sent to the respective Regional Milk Specialist (RMS). The RMS will review the reports and forward them to appropriate supervisory investigators and/or compliance branch staff, to issue further inspectional requests as necessary.
Reports of Investigations Due to Positive Laboratory Results for Drug Residues (see Attachment C) completed by states will be, as soon as possible, sent to the respective RMS (See Field Reporting Requirements, section 6).
Both FDA and state laboratories should use Attachment D to report problems and or inconsistencies with the rapid test kits. Forward Attachment D forms to:
CVM, MPN II
Attn: Dr. Norris Alderson, HFV-500
7500 Standish Place
Rockville, MD 20855
PART IV - ANALYTICAL
- Each week three states will be scheduled to ship 5 tanker samples to the Denver laboratory. Three 6-ounce subsamples will be collected from the tanker, two, 6-ounce subsamples will be aseptically commingled and transferred to 6-ounce plastic bottles/bags prior to shipment to the Denver laboratory for analysis. One 6-ounce subsample will be retained by the state for analysis.
*Original analysis (charm screening kits) performed at the sensitivity given for the analytes of interest and positive findings on the screening will be identified (verified) and quantitated using the check procedure. The analytical values reported for the check (or quantitation procedure) must be above the established limit of quantitative for the procedure given.*
Original analyses that cannot be verified by a check analysis will be reported as negative.
DRUG |
SAFE/TOLERANCE LEVEL(ppb) |
Chloramphenicol | 1 |
*Florfenicol | 10* |
Chlortetracycline | 30 |
Oxytetracycline | 30 |
Tetracycline | 80 |
Sulfachloropyridazine | 10 |
Sulfadiazine | 10 |
Sulfadimethoxine | 10(21 CFR 556.640)2 |
Sulfamerazine | 10 |
Sulfamethazine | 10 |
Sulfapyridine | 10 |
Sulfaquinoxaline | 10 |
Sulfathiazole | 10 |
Novobiocin | 100(21 CFR 556.460)2 |
Ivermectin | 2 |
Clorsulon | 200 |
1
No level of chloramphenicol is acceptable2
Tolerance level* The sensitivity of CHARM II for the Sulfa drugs of interest are as follows:
* Note: At laboratory's option, TLC, LIB 3528 can be used as a check identification. *
NOTE: When the analysis of a milk sample collected, at random, under the NDRMMP indicates the presence of more than one sulfonamide, the laboratory will identify and quantify each sulfonamide.
* The sensitivity of CHARM II for the tetracyclines of interest are as follows:
Chlortetracycline- 24 ppb
Oxytetracycline- 24 ppb
Tetracycline- 6 ppb *
Original and check analysis - * JAOAC, Vol. 71, No. 4, 1988, p. 776-778. *
Original and check analysis - LIB 3461.
* Note: Novobiocin, Ivermectin, and Clorsulon will be analyzed quarterly. *
All positive results obtained from the 750 FDA samples submitted by the states will be subject to confirmation. Except in the case of positive results for chloramphenicol (see Part III, page 2, B), it is not necessary to confirm positive results from the 5000 state samples analyzed by the states using official PMO methods.
*Food and Drug Administration
Attn: Michael Thomas, HFV-510
Division of Residue Chemistry
8401 Muirkirk Road
Laurel, MD 20708*
Notify Mr. Thomas *((301) 827-8020)* of all pertinent shipping information.
Selection of the appropriate laboratory to perform confirmatory analysis will be based upon the residue(s) involved and the availability of appropriate instrumentation and/or trained personnel. Contact the ORA/Division of Field Science for assistance in identifying a lab for confirmation.
Follow reporting requirements indicated on program cover sheet. Weekly reports of all analyses are to be FAXED to the Laboratory Quality Assurance Branch, HFH-450.
ORA/Division of Field Science and CFSAN/Laboratory Quality Assurance Branch will jointly, three times each year, implement a Quality Assurance Program to cover the residues analyzed under this program.
The quality assurance samples will be prepared by the Baltimore District Laboratory.
This Quality Assurance Program for the National Drug Residue Milk Monitoring Program (QAP-NDRMMP) is a segment of the National Check Sample Program (NCSP) which is a portion of the total FDA/ORA quality assurance effort. It involves the analysis of samples representative of those analyzed under the NDRMMP by the laboratory(ies) identified in the program.
Objective
The QAP-NDRMMP is designed to:
Samples and Methodology
Samples analyzed under this program will consist of milk and milk products regulated under the PMO. The samples will be prepared to represent the drug residues identified in the NDRMMP. Incurred residues will be used whenever possible.
For those residues where official methods for their detection have not been finalized, the issuance of QA samples containing these residues, will be considered on a case-by-case basis.
*Level: The fortification level for the sample prepared as the quality assurance sample should be approximately 1.5 X [X= safe or tolerance level of the residue in question]. *
Methods: The methods used in the sample analysis under this program will be those identified in the Analytical Section of the NDRMMP. The issuing laboratory will use "official" methods for testing the sample before it is issued. The appropriate Denver laboratory group; DENVAS or the Micro Section, will use those methods (LIB, test kits, etc.) used to test regulatory samples collected under this program.
Implementation: Issuance and Sample Analysis
DFS has the principal responsibility for managing this program and will coordinate the selection and distribution of samples.
Samples will be issued to the laboratory(ies) identified in the NDRMMP three (3) times in any given fiscal year and will encompass as many of the residues identified in the NDRMMP as practical.
DFS will work with the issuing laboratory, BLT-DO Laboratory, to determine which product (milk or milk products), residue(s) and residue level will be analyzed.
The issuing laboratory will perform a preliminary analysis (in triplicate) of the sample using the proper method and report the results to DFS. DFS will evaluate the acceptability of the preliminary analytical data obtained by the issuing laboratory. If the data is acceptable, then the sample(s) will be forwarded to the participating laboratory(ies).
The laboratory(ies) identified in the NDRMMP will examine the sample according to this program, advance instructions and/or instructions accompanying the sample. Quality assurance samples are subject to all of the requirements found in the Laboratory Procedures Manual and the NDRMMP. All worksheet documentation shall be recorded in the format required for a violative sample. This includes complete analyst worksheet attachments and sample summaries.
Due to the fact that initial tests used in the NDRMMP, are "screening tests", when positive samples are encountered, they will be further analyzed in the same manner as "regular" or "routine" positive samples.
The analyst worksheet must be accompanied by a Sample Summary (FD-465), signed by the supervisor who will state the laboratory conclusion and give a laboratory classification based on the original analysis.
Reserve samples should be retained until notice is given that they may be destroyed.
Reporting Analytical Results
The analytical package will be forwarded to DFS for evaluation whithin thirty (30) calendar days after receipt of the sample. As necessary, because of holidays or the nature of the analyses, exceptions to this 30-day time frame will be noted in the written instructions regarding the sample. Any justifiable request for an extension of the established due date should be directed to the Scientific Coordinator identified as DFS contact in the program.
Evaluation of the Analytical Package
The analytical package will be evaluated by DFS and BLT-DO with respect to the full requirements contained in the program and in the written instructions accompanying the samples.
Identified problems will be brought to the immediate attention of the analyzing laboratory for corrective follow-up.
A final evaluation will be prepared and issued by DFS within forty-five (45) calendar days after the receipt of the analytical package.
PART V - REGULATORY/ADMINISTRATIVE FOLLOW-UP
ENFORCEMENT PLAN (EP)
The EP is for use when a residue in grade A or non-grade A milk exceeds the tolerance or the safe level (as stated in Part IV, page 2) when analyzed using FDA - accepted methods. In addition, this EP will be used when a sample is positive when analyzed using official PMO methods.
This EP provides FDA district offices with guidance on enforcement action against adulterated milk and the illegal distribution, sale, and use of a drug that caused a residue. The EP is recommended for implementation with agreement by CVM, ORA, and CFSAN based on review of the analytical findings. Milk Safety Team, HFS-626, will be responsible for the overall coordination and monitoring (in cooperation with the Division of Enforcement and Programs, HFS-605) of all regulatory activity involving milk. The regulation of milk is under the purview of CFSAN, and the regulation of drugs is under the purview of CVM.
Under the MOU between the NCIMS and the FDA, states are responsible for the initial enforcement response to the incidents involving grade A milk. In addition, if the state can take action against non-grade A milk, FDA will cooperatively work with the state to effect enforcement action(s).
For state-collected samples, the RMS will arrange for contacting the State official to learn the planned action and request a copy of the plan. The state will share its milk enforcement plan with the RMS. The RMS will consult with the CFSAN Laboratory Quality Assurance Branch (LQAB) and the state milk sanitation agency and make a determination regarding the capability of the state laboratory to analyze raw milk, including methods, and determine if FDA assistance will be required. The RMS will notify DFS and the appropriate home district of a state request for analytical help. FDA will consider its analytical work-load to determine whether to assist the state or recommend another course of action. It is anticipated that the state will include its proposed action in its enforcement plan and undertake the follow-up outlined below.
When a sample contains a residue above the tolerance or the safe level (as stated in Part IV, page 2) or is positive when analyzed using an official PMO method:
In order for official samples to be obtained for use as a basis for FDA compliance actions against the culpable parties involved in the sale, distribution and/or use of drugs resulting in residues, 3-six-ounce sub-samples of milk should be obtained from each producer which contributed to the positive load. Two of these sub-samples will be submitted to the Denver laboratory, and one reserved for the state's analysis (if performed).
This section provides FDA districts with guidance on responding to a finding of residue above the tolerance or the safe level in grade A or non-grade A milk, or positive results from official PMO methods when state or local officials are not able to take appropriate action.
The RMS will report weekly any significant findings such as analytical results and involvement of FDA in investigations or sample analyses including numbers of milk samples expected to arrive at Denver for analyses. The RMS reports are to reflect the progress of the investigations and, if possible, to forecast resource needs and completion dates for each part of the follow-up.
Recommendations for enforcement action regarding adulterated milk or dairy products manufactured from adulterated milk should be submitted to the Division of Enforcement and Programs, Chief, Case Processing Branch, HFS-607.
The follow-up by FDA will employ routine procedures that may lead to investigations of producers, veterinarians, mobile drug peddlers, and others.
Investigative instructions can be found in Compliance Program 7371.002. Legal sanctions such as injunction, prosecution, seizure and warning letters are available. Compliance Policy Guide 7125.05 offers guidance in the investigation of illegal drug residues in meat, milk and eggs. Recommendations for enforcement actions regarding illegal distribution, sale, or use of drugs are to be submitted to CVM, Case Guidance Branch, HFV-236.
The reporting by FDA districts will also follow routine procedures. States may freely adopt the FDA compliance program guidance.
PART VI - REFERENCES, ATTACHMENTS, AND CONTACTS
7371.002 - Illegal Sales of Vet. Rx Drugs.
7371.006 - Illegal Drug Residues in Meat and Poultry.
Attachment A -Sample Collection Form/Laboratory Results Report Form for use by the States.
Attachment B -Initial Drug Residue Report/Laboratory Results Report.
Attachment C -Report of Investigation Due to Positive Laboratory Results for Drug Residues Form.
Attachment D -Test Kit Problem Form.
Attachment E -Form letter for advising States of certain laboratory findings.
Attachment F -FDA Denver Laboratory, State Request for Special Sample Analysis
ORA:
Barbara A. Marcelletti
Division of Field Investigations, HFC-130
(301) 827-5635
Randal Arbaugh
Division of Federal-State Relations, HFC-150
(301) 827-2904, FAX (301) 443-2143
CVM:
Dr. Linda Tollefson
Director, Office of Surveillance and Compliance, HFV-200
(301) 594-1768
Dr. N. E. Alderson (Beltsville Laboratory contact)
Director, Office of Science, HFV-500
(301) 827-8013
CFSAN:
Joe Smucker, Chief
Milk Safety Team, HFS-626
(202) 205-8178
Dr. Larry Maturin, HFH-450
Chief, Laboratory Quality Assurance Branch
(708) 728-4115, FAX (708) 728-4179
Manjeet Singh, Compliance Issues
Case Processing Branch, HFS-607
(202) 205-5191
DEN-DO:
PART VII - CENTER RESPONSIBILITIES
NDRMMP
Sample Collection Form/
Laboratory Results Report
SAMPLE ID#:____________________
COLLECTION DATE:_______________
TIME OF COLLECTION:____________
TEMPERATURE:___________________
FACILITY NAME:_________________
ADDRESS:_______________________
_______________________
PHONE:_________________________
FAX:___________________________
SITE (WHERE SAMPLE OBTAINED):
_______________________________
ADDRESS:_______________________
_______________________
WEIGHT OF PREVIOUS WEEKS MILK
(RECEIVED AT SITE):____________
DRIVERS (HAULERS) NAME:
_______________________________
TANKER ID (PERMIT#)____________
LOAD WEIGHT IN LBS:____________
PRODUCERS (ID) ON LOAD:
_______________________________
_______________________________
_______________________________
GRADE/ANTICIPATED USE OF MILK (LBS OF
EACH):_________________________
COLLECTOR:_____________________
(SIGNATURE/DATE)
LABORATORY RESULTS:
DATE OF ANALYSIS:______________
TIME OF ANALYSIS:______________
TEMPERATURE:___________________
CERTIFIED LABORATORY NAME:
_______________________________
ADDRESS:_______________________
_______________________
PHONE:_________________________
FDA #:_________________________
TEST KIT/PROCEDURE:
LOT #:_________________________
EXP. DATE:_____________________
POSITIVE CONTROL:______________
NEGATIVE CONTROL:______________
RESULT:________________________
COMMENTS:______________________
_______________________________
CERTIFIED ANALYST(S):
_______________________________
(SIGNATURE/DATE)
NOTE: THE ORIGINATING LABORATORY KEEPS THE ORIGINAL OF THIS FORM AND SENDS A COPY TO THE FDA/CFSAN, LABORATORY QUALITY ASSURANCE BRANCH, HFH-450, SUMMIT ARGO, IL. 60501-1399, PHONE 708-728-4120, FAX 708-728-4179. WHEN SUBMITTING SAMPLES TO FDA Denver LABORATORY, ENCLOSE A COPY OF THIS FORM FOR EACH SAMPLE.
NDRMMP
INITIAL DRUG RESIDUE REPORT
LABORATORY RESULTS REPORT
SAMPLE ID# FOR LOAD TESTING POSITIVE:
_______________________________
SITE:__________________________
RESULT OF ANALYSIS:____________
CONFIRMING LABORATORY:
_______________________________
CONFIRMATION ANALYTICAL METHOD:
_______________________________
DATE OF REVIEW:________________
PRODUCER SAMPLES ANALYZED FOR TRACEBACK (NAMES OR ID#)(RESULTS):
NAME | RESULT |
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
___________________________________
NAME OF PRODUCER RESPONSIBLE:
_______________________________
ADDRESS:_______________________
_______________________
TEST KIT/PROCEDURE:____________
LOT #:_________________________
EXP. DATE:_____________________
POSITIVE CONTROL:______________
NEGATIVE CONTROL:______________
RESULT:________________________
State REGULATORY OFFICIAL CONTACTED:
WHO:_______________________________
HOW (PHONE/FAX):___________________
WHEN (DATE/TIME):__________________
ACTION TAKEN (DISPOSITION OF THE LOAD):
_______________________________
REGULATORY ACTION TAKEN AGAINST THE PRODUCER:
____________________________________
____________________________________
FDA CONTACTED:______________________
HOW (PHONE/FAX):____________________
WHEN (DATE/TIME):___________________
BY (PERSON MAKING CONTACT)__________
THIS REPORT SENT TO:________________
WHEN:_______________________________
SIGNATURE(S):
____________________________________ (CERTIFIED ANALYST/DATE)
____________________________________ (REGULATORY OFFICIAL/DATE)
NOTE: THIS FORM SHOULD BE USED FOR THE ANALYSIS OF INDIVIDUAL PRODUCER SAMPLES COLLECTED WITH A LOAD THAT TESTED POSITIVE. IF NO SAMPLES WERE AVAILABLE THAT CONTRIBUTED TO THE POSITIVE LOAD, AND THEY ARE COLLECTED AND ANALYZED LATER, ATTACHMENT A (SAMPLE COLLECTION FORM/LABORATORY RESULTS REPORT) SHOULD BE COMPLETED FOR EACH, AS WELL AS THE APPLICABLE PARTS OF THIS FORM FOR THOSE FOUND POSITIVE. THE REGULATORY AGENCY SHOULD KEEP THE ORIGINAL OF THIS FORM. A COMPLETED COPY OF THIS FORM SHOULD BE SENT TO: FDA/CFSAN, LABORATORY QUALITY ASSURANCE BRANCH, HFH-450, SUMMIT ARGO, IL. 60501-1399, PHONE 708-728-4120, FAX 708-728-4179.
NDRMMP
REPORT OF INVESTIGATION DUE
TO POSITIVE LABORATORY RESULTS
FOR DRUG RESIDUES
Laboratory ID# for:
positive bulk milk pickup tanker:___________________________
Violative milk producer:__________
Drug residue analysis result:____________________________________
Name/Title Investigator/Inspector:____________________________________
Agency: ____________________________
Address:____________________________
City/St/Zip:________________________
Telephone:__________________________
FDA Contact:________________________
This follow-up was initiated because:____________________________
____________________________________
Name milk producer:
Address:____________________________
City/St/Zip_________________________
Is the suspect drug still present on the farm? [] Y [] N
Does producer acknowledge treating animal(s): [] Y [] N
Brand name of drug(s) Used to treat animal(s)_____________________
Where was the drug obtained?
Veterinarian _____________________
Cooperative/Fieldman _____________
Mail order distributor:________
Feed/Supply store:_____________
Other:_________________________
Were label directions for drug use provided? [] Y [] N
followed? [] Y [] N
Was the drug extra-labeled? [] Y [] N
Was the drug compounded by a Veterinarian (not a commercial preparation?: [] Y [] N
Drug dosage form(s):
Injectable Intermammary Infusion
Bolus Feed Additive
Other:________________________
Were all drug(s) at this facility:
available for inspection? [] Y [] N
properly labeled? [] Y [] N
properly stored? [] Y [] N
Has producer completed a drug
residue avoidance program? [] Y [] N
Briefly describe PMO penalties assessed against this producer:
____________________________________
____________________________________
How many drug residue violations has this producer been responsible for during the preceding 12 months?_____
Comments:___________________________
____________________________________
____________________________________
Test Kit Problems Sheet1
Date:__________________
Lab:________________________________________ FDA#:__________________
________________________________________
________________________________________
============================================================================
Test Kit: __________ Lot#: __________ Exp. Date: __________
Date of Test: __________ Time: __________ Temp: __________
Sample ID:__________________________________________________
Collection Date:__________________________________________________
Performance Information, Complete as necessary:
Standard: __________ Other: __________
+Control Point: __________ -Control Point: __________
Positive Control: __________ Negative Control: __________
Test Results:
Duplicate #1: | _________ | Duplicate #2: | _________ | Interpretation: | _________ | Other: | _________ |
Sample tested in another laboratory: Yes No
Denver (FDA):_____________________________ Other:_______________________
If yes, list date sent/tested and result:
__________________________________________________________________________________
Nature of Problem and/or Comments:
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
__________________________________________________________________________________
1 - Please report any problems or inconsistencies you experience in using any of the rapid test kits to CVM so that they may be addressed.
Dear
In cooperation with the National Conference on Interstate Milk Shipments (NCIMS), we are analyzing raw milk under the National Drug Residue Milk Monitoring Program (NDRMMP) Compliance Program 7303.039 for possible drug residues. FDA's Milk Safety Program relies heavily on participation by State regulatory agencies under a Memorandum of Understanding between FDA and the NCIMS. The NDRMMP is intended to assist and supplement the NCIMS program.
In addition to reporting drug residues above tolerance or the safe level to appropriate authorities, where possible we also intend to report to you the result of analyses for samples containing drug residues below the tolerance or the safe level. We intend to work with appropriate State and/or local authorities if any follow-up is needed.
Milk samples that are determined to contain drug residues above tolerance or safe level will be confirmed by further chemical analysis and reported to appropriate authorities for action as outlined in Parts IV and V of the program. Milk samples that are determined to contain drug residues below the tolerance or safe level will not undergo further confirmatory analysis.
In this context, sample_____________, a (grade A/non-grade A) sample, collected by the _____________ of _________________ on _____________ was found to contain _________________ of _______________. This finding is (above/below) the FDA tolerance/safe level of _____________ for ___________. We are reporting this to you for your information and follow-up that is appropriate following the provisions of your State Action Plan.
We appreciate the cooperation of all parties involved in this program.
If you have any questions or comments, or you need the assistance of FDA in this matter, please contact me at (202) 205-8178.
Sincerely yours, | |
Team Leader, Milk Safety Team Center for Food Safety and Applied Nutrition |
Requestor's Name, Title State, Agency Address |
Alternate Contact Person |
Phone Number: | |
Fax Number: | |
FDA Milk Specialist: Date/Time Notified: | |
Sample Description: | |
Firm/Producer/Location: | |
Sample collection date/storage conditions: | |
Purpose of sampling/analysis, i.e. referral, suspect contamination, adverse health affects, misuse, etc. | |
SPECIFIC test requested, specific drugs: | |
Collaborative information concerning sample, producer and animal(s). What other tests have been performed?
State/Private Results? |
NOTE: CALL EMMA SINGLETON (301) 236-3060 TO REQUEST ANALYSIS. WHEN SUBMITTING SAMPLES, ENCLOSE A COPY OF THIS FORM FOR EACH SAMPLE. A COMPLETED COPY OF THIS FORM SHOULD ALSO BE SENT TO THE FDA REGIONAL MILK SPECIALIST AND TO FDA/CFSAN, LABORATORY QUALITY ASSURANCE BRANCH, HFH-450, SUMMIT ARGO, IL. 60501-1399, PHONE (708) 728-4120, FAX (708) 728-4179.
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