Center for Food Safety & Applied Nutrition FISH AND FISHERIES PRODUCTS HAZARDS AND CONTROLS GUIDE Second Edition, January 1998 |
The Third Edition of this guidance issued in June 2001. Below is an earlier version.
Unregulated drug use in aquacultured fish holding pounds poses a potential human health hazard. These substances may be carcinogenic, allergenic, and/or may cause antibiotic resistance in man. To control this hazard in food animals, all drugs, whether for direct medication or for addition to feed, must be approved by FDA. Under certain conditions authorized by FDA, unapproved new animal drugs may be used in conformance with the terms of an Investigational New Animal Drug (INAD) application.
Incentives for the use of animal drugs in aquatic animal species include the need to: 1) treat and prevent disease; 2) control parasites; 3) affect reproduction and growth; and, 4) tranquilization (e.g. during transit). Relatively few drugs have been approved for aquaculture. As a result, aquaculture growers may use unapproved drugs, general purpose chemicals that are not labeled for drug use, and approved drugs in a manner that deviates from the labeled instructions.
Labels of approved drugs list mandatory withdrawal times, where applicable. These withdrawal times must be observed to ensure that the edible tissue is safe when it is offered for sale. Tissue residue tolerances have been established for some drugs.
At each processing step, determine whether "aquaculture drugs" is a significant hazard. The criteria are:
Under ordinary circumstances, it would be reasonably likely to expect that unsafe levels of aquaculture drugs could enter the process during the receiving of any type of aquacultured fish, including:
Under ordinary circumstances it would also be reasonably likely to expect that unsafe levels of aquaculture drugs could enter the process during the holding of live lobster (e.g. lobster pounds).
Under ordinary circumstances it would not be reasonably likely to expect that aquaculture drugs could enter the process during the receiving of wild-caught fish. Currently, FDA is not aware of drug use in the grow-out of molluscan shellfish. If the agency becomes aware of such use, this Guide, and, in particular, Table 3-2 (Chapter 3) will be updated accordingly. On a regional basis, it may be reasonable for you to conclude that aquaculture drug use is not a significant hazard for other species, because they are not used by producers in your region.
"Aquaculture drugs" should be considered a significant hazard at any processing step where a preventive measure is, or can be, used to eliminate (or reduce the likelihood of occurrence to an acceptable level) the hazard, if it reasonably likely to occur.
Preventive measures for the control of aquaculture drugs used in aquacultrue operations can include:
(Note: The use of Investigational New Animal Drugs (INAD) is confidential unless an exception is made by the sponsor of the drug research. Thus, review of INAD drug usage records by the processor may not be practical in certain situations. Written certification from the grower to the processor stating that any INAD drug usage is in accordance with authorizations from FDA/Center for Veterinary Medicine, will be acceptable on a lot-by-lot basis.)
Preventive measures for the control of aquaculture drugs used during the holding of live fish (e.g. lobster pounds) can include controlled application of animal drugs in a manner consistent with:
List such preventive measures in Column 5 of the Hazard Analysis Worksheet at the appropriate processing step(s). Ordinarily this will be either the receiving step or the preharvest step. However, in the case of an integrated operation, where fish processing and grow-out, and, perhaps feed manufacture, are performed by the same firm, it may be possible and desirable to exercise preventive measures early in the process (ideally at feed manufacture), rather than at receipt of the fish at the processing plant. Such preventive measures will not be covered in this chapter. For the holding of live fish (e.g. lobster pounds) the preventive measure will usually be applied at the holding step.
If the answer to either question 1 or 2 is "Yes," the potential hazard is significant at that step in the process and you should answer "Yes" in Column 3 of the Hazard Analysis Worksheet. Except in the case of an integrated aquaculture operation, this will usually be the receiving step. If none of the criteria are met you should answer "No." You should record the reason for your "Yes" or "No" answer in Column 4. You need not complete Steps 12 through 18 for this hazard for those processing steps where you have recorded a "No."
It is important to note that identifying this hazard as significant at a processing step does not mean that it must be controlled at that processing step. The next step will help you determine where in the process the critical control point is located.
Intended use
In determining whether a hazard is significant you should also consider the intended use of the product, which you developed in Step 4. However, for aquaculture drugs, it is unlikely that the intended use will affect the significance of the hazard.
For each processing step where "aquaculture drugs" is identified in Column 3 of the Hazard Analysis Worksheet as a significant hazard, determine whether it is necessary to exercise control at that step in order to control the hazard. Figure 2 (Appendix 3) is a CCP decision tree that can be used to aid you in your determination.
The following guidance will also assist you in determining whether a processing step is a CCP for "aquaculture drugs":
Is the hazard the result of the use of aquaculture drugs during the raising of fish (i.e. aquaculture) or during the holding of live fish (e.g. lobster pounds)?
a. If you have such a relationship with the grower, then you may identify a pre-harvest step as the CCP for "aquaculture drugs." The preventive measure for this type of control is on-farm visits to review drug usage, coupled with a supplier's lot-by-lot certificate that any INADs used were used in conformance with the application requirements.
example:
A processor of aquacultured catfish that regularly purchases from the same growers would visit the grower before the fish are harvested and review the grower's drug usage practices and records. The processor could also receive a guarantee that any INADs used were used in conformance with the application requirements. The processor could then set the critical control point for aquaculture drugs at the pre-harvest step.
In this case, you should enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the pre-harvest step. This control approach will be referred to as "Control Strategy Example 1" in Steps 14 through 18. (Note: if you have not previously identified " aquaculture drugs" as a significant hazard at the pre-harvest step in Column 3 of the Hazard Analysis Worksheet, you should change the entry in Column 3 to "Yes.")
b. If you have no such relationship with the grower, then you may identify the receiving step as the CCP for "aquaculture drugs." At the receiving step you may exercise one of the following preventive measures:
example:
A processor of aquacultured shrimp that purchases raw material shrimp through various brokers could receive lot-by-lot certificates from the growers. The certificates would state that all drugs were used in conformance with applicable regulations and labeled instructions. The processor combines this monitoring procedure with quarterly raw material testing for verification.
In this case, you should enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the receiving step. This control approach will be referred to as "Control Strategy Example 2" in Steps 14 through 18.
example:
A processor of aquacultured shrimp that purchases raw material shrimp through various brokers could receive records of drug use (other than INADs) from the growers when the product is delivered. Additionally, the processor could receive a lot-by-lot certificate that would state that any INADs were used in conformance with the application requirements.
In this case, you should enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the receiving step. This control approach will be referred to as "Control Strategy Example 3" in Steps 14 through 18.
Note: A limited number of drug screening tests for aquaculture are available. Tests are not available to assay for all drugs that might be used in all aquacultured species. Processors should be cau-tioned that tests that have not been validated may be unreliable. These tests may fail to detect a residue or may give a false positive. FDA has not validated any of the aquaculture screening tests; nor has the AOAC International. Processors should assure themselves that the tests that they intend to use have otherwise been validated and are appropriate for the species and tissue to be tested.
example:
A processor of aquacultured shrimp that purchases raw material shrimp through various brokers could screen all incoming lots of shrimp with a bank of rapid tests that target the families of drugs likely to be used during grow-out.
In this case, you should enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the receiving step. This control approach will be referred to as "Control Strategy Example 4" in Steps 14 through 18.
Example:
A processor of aquacultured trout that regularly purchases raw material trout from the same grower could obtain a third party certificate, valid for one year, that attests that the grower operates under a Quality Assurance Program which covers aquaculture drug usage.
In this case, you should enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the receiving step. This control approach will be referred to as "Control Strategy Example 5" in Steps #14 through 18.
Example:
A processor that uses oxytetracycline in the holding of live lobster in a lobster pound would use the drug in accordance with the established withdrawal time and any other labeled instructions.
In this case, you should enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the holding step. This control approach will be referred to as "Control Strategy Example 6" in Steps 14 through 18.
It is important to note that you may select a control strategy that is different from those which are suggested above, provided that it assures an equivalent degree of safety of the product.
Proceed to Step 13 (Chapter 2) or to Step 10 of the next potential hazard.
For each processing step where "aquaculture drugs" is identified as a significant hazard on the HACCP Plan Form, identify the maximum or minimum value to which a feature of the process must be controlled in order to control the hazard.
You should set the critical limit at the point that if not met the safety of the product may be questionable. If you set a more restrictive critical limit you could, as a result, be required to take corrective action when no safety concern actually exists. On the other hand, if you set a critical limit that is too loose you could, as a result, allow unsafe product to reach the consumer.
As a practical matter it may be advisable to set an operating limit that is more restrictive than the critical limit. In this way you can adjust the process when the operating limit is triggered, but before a triggering of the critical limit would require you to take corrective action. You should set operating limits based on your experience with the variability of your operation and with the closeness of typical operating values to the critical limit.
Following is guidance on setting critical limits for the control strategy examples discussed in Step 12.
CRITICAL LIMIT:
Animal drugs are used on fish only if the drugs have been:
- Approved by FDA and used in accordance with proper withdrawal times and other labeled conditions;
OR
- Approved by FDA and used in an extra-label manner under a veterinarian's supervision in accordance with FDA regulations and guidelines. The regulations and guidelines are available from the FDA Center for Veterinary Medicine, HFV-230, 7500 Standish Place, Rockville, MD 20855;
OR
- Listed on the FDA "low regulatory priority aquaculture drug" list;
OR
- Permitted by FDA for use in food fish under the conditions of an INAD (as evidenced by a lot-by-lot written certificate from the grower).
CRITICAL LIMIT:
Certificate indicating proper drug usage accompanying each lot of incoming aquacultured fish.
CRITICAL LIMIT:
Animal drugs used on fish only if the drugs have been:
- Approved by FDA and used in accordance with proper withdrawal times and other labeled conditions;
OR
- Approved by FDA and used in an extra-label manner under a veterinarian's supervision in accordance with FDA regulations and guidelines. The regulations and guidelines are available from the FDA Center for Veterinary Medicine, HFV-230, 7500 Standish Place, Rockville, MD 20855;
OR
- Listed on the "low regulatory priority aquaculture drug" list;
OR
- Permitted by FDA for use in food fish under the conditions of an INAD (as evidenced by a lot-by-lot written certificate from the grower).
CRITICAL LIMIT:
No fish will be accepted that contains unapproved drug residues (other than those used within the provisions of an INAD application or used in accordance with the criteria specified in the "low regulatory priority aquaculture drug" list).
CRITICAL LIMIT:
Third party certificate indicating that the producer operates under a third party-audited Quality Assurance program for aquaculture drug use, either for each lot of incoming aquacultured fish or for each producer of incoming aquacultured fish.
CRITICAL LIMIT:FDA approved aquaculture drugs
Animal drugs are used on fish only if the drugs have been:
- Approved by FDA and used in accordance with proper withdrawal times and other labeled conditions;
OR
- Approved by FDA and used in an extra-label manner under a veterinarian's supervision in accordance with FDA regulations and guidelines. The regulations and guidelines are available from the FDA Center for Veterinary Medicine, HFV-230, 7500 Standish Place, Rockville, MD 20855;
OR
- Listed on the FDA "low regulatory priority aquaculture drug" list;
OR
- Permitted by FDA for use in food fish under the conditions of an INAD.
FDA approved aquaculture drugs with their approved sources, species and withdrawal times are listed below. Additional details on conditions of use (e.g. disease conditions and dosage levels) can be obtained from: the Code of Federal Regulations as cited below; the labeling for the product; the FDA Center for Veterinary Medicine; or "Guide to Drug, Vaccine, and Pesticide Use in Aquaculture," Texas Agricultural Extension Service, Publication B-5085.
FDA low regulatory priority aquaculture drugs
FDA's Center for Veterinary Medicine has identified a number of "low regulatory priority aquaculture drugs." The following list identifies these compounds and provides their indicated use and usage levels. These compounds have undergone review by the Food and Drug Administration and have been determined to be new animal drugs of low regulatory priority. Additional information on this subject can be obtained from: the FDA Center for Veterinary Medicine; or "Guide to Drug, Vaccine, and Pesticide Use in Aquaculture," Texas Agricultural Extension Service, Publication B-5085.
The Agency is unlikely to object to the use of low regulatory priority substances if the following conditions are met: 1) the substances are used for the stated indications; 2) the substances are used at the prescribed levels; 3) the substances are used according to good management practices; 4) the product is of an appropriate grade for use in food animals; and, 5) there is not likely to be an adverse effect on the environment.
The Agency's enforcement position on the use of these substances should not be considered an approval, nor an affirmation of their safety and effectiveness. The Agency reserves the right to take a different position on the use of any or all of these substances at some time in the future.
Classification of these substances as new animal drugs of low regulatory priority does not exempt facilities from complying with other Federal, State, and local environmental requirements. For, example, facilities using these substances would still be required to comply with National Pollutant Discharge Elimination System (NPDES) requirements.
Enter the critical limit(s) in Column 3 of the HACCP Plan Form.
For each processing step where "aquaculture drugs" is identified as a significant hazard on the HACCP Plan Form, describe monitoring procedures that will ensure that the critical limits are consistently met.
To fully describe your monitoring program you should answer four questions: 1) What will be monitored? 2) How will it be monitored? 3) How often will it be monitored (frequency)? 4) Who will perform the monitoring?
It is important for you to keep in mind that the feature of the process that you monitor and the method of monitoring should enable you to determine whether the critical limit is being met. That is, the monitoring process should directly measure the feature for which you have established a critical limit.
You should monitor often enough so that the normal variability in the values of the feature you dre measuring will be detected. This is especially true if these values are typically close to the critical limit. Additionally, the greater the time span between measurements the more product you are putting at risk should a measurement show that a critical limit has been violated.
Following is guidance on establishing monitoring procedures for the control strategy examples discussed in Step 12. Note that the monitoring frequencies that are provided are intended to be considered as minimum recommendations, and may not be adequate in all cases.
WHAT:
On-farm drug usage procedures;AND
Producer certificate indicating proper INAD usage.
WHAT:
Producer certificate indicating proper drug usage.
WHAT:
On-farm drug usage procedures;AND
Producer certificate indicating proper INAD usage.
WHAT:
Fish flesh for drug residues.
WHAT:
Third party certificate indicating operation under third-party audited QA program.
WHAT:
Type of aquaculture drug used;AND
Date and quantity of drug use;
AND
Any other conditions of drug use that are relevant to: the established withdrawal times; the labeled instructions for use; the extralabel use of an FDA-approved drug used under a veterinarians's supervision in accordance with FDA regulations and guidelines; the conditions specified in the FDA -low regulatory priority aquaculture drug- list; or, the conditions of the INAD application;
AND
Date of distribution of the finished product.
HOW:
Survey farm husbandry procedures, ask questions, and review drug usage records;AND
Visual for presence of INAD certificate.
HOW:
Visual for presence for lot-by-lot certificate.
HOW:
Review drug records;AND
Visual for presence of INAD certificate.
HOW:
Obtain samples and analyze for drugs, using rapid screening methods.
HOW:
Visual for presence of third party certificate.
HOW:
Visually observe drug use and distribution.
FREQUENCY:
At least once per year for each aquaculture site.
FREQUENCY:
Each lot received.
FREQUENCY:
Each lot received.
FREQUENCY:
Each lot received.
FREQUENCY:
Each lot received checked for presence of certificates. Certificates may be issued on a lot-by-lot or continuing basis, but at least annually.
FREQUENCY:
Every time aquaculture drugs are used during holding;AND
Every time the product is distributed.
WHO:
Field agent (employee or contractor) or any other person who has an understanding of animal drug usage and limits.
WHO:
Receiving employee or supervisor, production supervisor, member of the quality control staff, or any other person who has an understanding of the control procedure.
WHO:
Production supervisor, a member of the quality control staff, or any other personnel who has an understanding of animal drug usage and limits.
WHO:
Member of the quality control staff or contract laboratory.
WHO:
Receiving employee or supervisor, production supervisor, a member of the quality control staff, or any other person who has an understanding of the control procedure.
WHO:
Production employee or supervisor, member of the quality control staff, or any other personnel who has an understanding of drug usage and limits.
Enter the "What," "How," "Frequency," and "Who" monitoring information in Columns 4, 5, 6, and 7, respectively, of the HACCP Plan Form.
For each processing step where "aquaculture drugs" is identified as a significant hazard on the HACCP Plan Form, describe the procedures that you will use when your monitoring indicates that the critical limit has not been met.
These procedures should: 1) ensure that unsafe product does not reach the consumer; and, 2) correct the problem that caused the critical limit deviation. Remember that deviations from operating limits do not need to result in formal corrective actions.
Following is guidance on establishing corrective action procedures for the control strategy examples discussed in Step 12.
CORRECTIVE ACTION:
Reject product, if the CL is not met;AND
Discontinue use of supplier until evidence is obtained that drug treatment practices have changed.
CORRECTIVE ACTION:
Reject lot, if the CL is not met.
CORRECTIVE ACTION:
Reject lot, if the CL is not met;AND
Discontinue use of supplier until evidence is obtained that drug treatment practices have changed.
CORRECTIVE ACTION:
Reject lot, if the CL is not met;AND
Discontinue use of supplier until evidence is obtained that drug treatment practices have changed.
CORRECTIVE ACTION:
Reject lot, if the CL is not met;
CORRECTIVE ACTION:
Hold the product until the drug residue is at or below tolerance. This may be accomplished by collecting and analyzing a representative sample of the product, using an approved method;OR
Destroy the product;
OR
Divert the product to a non-food use.
Enter the corrective action procedures in Column 8 of the HACCP Plan Form.
For each processing step where "aquaculture drugs" is identified as a significant hazard on the HACCP Plan Form, list the records that will be used to document the accomplishment of the monitoring procedures discussed in Step 15. The records should clearly demonstrate that the monitoring procedures have been followed, and should contain the actual values and observations obtained during monitoring.
Following is guidance on establishing a recordkeeping system for the control strategy examples discussed in Step 12.
RECORDS:
On-site audit report;AND
INAD certificate.
RECORDS:
Certificate.AND
Receiving record showing lots received and presence/absence of certificate.
RECORDS:
Grower's drug records;AND
INAD certificate.
AND
Receiving record showing lots received and presence/absence of certificate.
RECORDS:
Analytical results.
RECORDS:
Third party certificate;AND
Receibing record showing lots received and presence/absence of certificate.
RECORDS:
Drug use record;AND
Records indicating date of distribution of drug-treated product.
Enter the names of the HACCP records in Column 9 of the HACCP Plan Form.
For each processing step where "aquaculture drugs" is identified as a significant hazard on the HACCP Plan Form, establish verification procedures that will ensure that the HACCP plan is: 1) adequate to address the hazard of "aquaculture drugs"; and, 2) consistently being followed.
Following is guidance on establishing verification procedures for the control strategy examples discussed in Step 12.
VERIFICATION:
Review monitoring and corrective action records within one week of preparation.
VERIFICATION:
Visit all new aquacultured fish suppliers within the year and all existing fish suppliers at a predetermined frequency to review the grower's drug usage procedures;OR
Collect a representative sample of the raw material, in-process product, or finished product at least quarterly and analyze for drug residues.
AND
Review monitoring, corrective action and verification records within one week of preparation.
VERIFICATION:
Review monitoring and corrective action records within one week of preparation.
VERIFICATION:
Review monitoring and corrective action records within one week of preparation.
VERIFICATION:
Review monitoring and corrective action records within one week of preparation.
VERIFICATION:
Review monitoring and corrective action records within one week of preparation.
Enter the verification procedures in Column 10 of the HACCP Plan Form.
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) |
| Critical Control Point (CCP) | Significant Hazard(s) | Critical Limits for each Preventive Measure | Monitoring | Corrective Action(s) | Records | Verification | |||
|---|---|---|---|---|---|---|---|---|---|
| What | How | Frequency | Who | ||||||
| Pre-harvest | Aquaculture drugs | Animal drugs used on fish only if the drugs have been: a) approved by FDA and used in accordance with proper withdrawal times and other labeled conditions; b) approved by FDA and used in an extra-label manner under a veterinarian's supervision in accordance with FDA regulations and guidelines; c) listed on the "low regulatory priority aquaculture drug" list; or, d) permitted by FDA for use in food fish under the conditions of an INAD (as evidenced by a lot-by-lot written certificate from the grower) | On farm drug usage procedures | Survey farm husbandry procedures, ask questions, and review drug records | Once per year for each aquaculture site | Field agent | Reject
Discontinue use of supplier until evidence is obtained that drug treatment practices have changed | On-site audit report | Review monitoring and corrective action records within one week of preparation |
| Certificate indicating proper INAD usage | Visual | Same | Same | Reject | Certificate of INAD usage | ||||
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) |
| Critical Control Point (CCP) | Significant Hazard(s) | Critical Limits for each Preventive Measure | Monitoring | Corrective Action(s) | Records | Verification | |||
|---|---|---|---|---|---|---|---|---|---|
| What | How | Frequency | Who | ||||||
| Receiving | Aquaculture Drugs | Certificate indicating proper drug usage accompanying all lots of incoming pond-raised shrimp | Presence of a certificate indicating proper drug usage | Visual | Each lot received | Receiving dock employee | Reject lot | Grower's drug usage certificate
Receiving record | Visit all new pond-raised shrimp suppliers within the year
and all existing suppliers at 25% per year on a rotating
basis to review the grower's drug usage procedures
Review monitoring, corrective action, and verification records within one week of preparation |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) |
| Critical Control Point (CCP) | Significant Hazard(s) | Critical Limits for each Preventive Measure | Monitoring | Corrective Action(s) | Records | Verification | |||
|---|---|---|---|---|---|---|---|---|---|
| What | How | Frequency | Who | ||||||
| Receiving | Aquaculture Drugs | Animal drugs used on fish only if the drugs have been: a) approved by FDA and used in accordance with proper withdrawal times and other labeled conditions; b) approved by FDA and used in an extra-label manner under a veterinarian's supervision in accordance with FDA regulations and guidelines; c) listed on the "low regulatory priority aquaculture drug" list; or d) permitted by FDA for use in food fish under the conditions of an INAD (as evidence by a lot-by-lot written certificate) | On-farm drug usage procedures | Review drug records at receipt | Each lot received | Production supervisor | Reject lot
Discontinue use of supplier until evidence is obtained that drug treatment practices have changed | Grower's drug usage records
Receiving record | Review monitoring and corrective action records within one week of preparation |
| Certificate indicating proper INAD usage | Visual | Same | Same | Same | Certificate of INAD usage | ||||
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) |
| Critical Control Point (CCP) | Significant Hazard(s) | Critical Limits for each Preventive Measure | Monitoring | Corrective Action(s) | Records | Verification | |||
|---|---|---|---|---|---|---|---|---|---|
| What | How | Frequency | Who | ||||||
| Receiving | Aquaculture Drugs | No fish will be accepted that contains unapproved drug residues (other than those used under an INAD application or included on the "low regulatory priority aquaculture drug" list) | Fish flesh for drug residues | Obtain samples and analyze for drugs using rapid screening methods | Each lot received | Quality assurance personnel | Reject lot
Discontinue use of supplier until evidence is obtained that drug treatment practices have changed | Analytical results | Review monitoring and corrective action records within one week of prepartion |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) |
| Critical Control Point (CCP) | Significant Hazard(s) | Critical Limits for each Preventive Measure | Monitoring | Corrective Action(s) | Records | Verification | |||
|---|---|---|---|---|---|---|---|---|---|
| What | How | Frequency | Who | ||||||
| Receiving | Aquaculture Drugs | Third party certificate indicating that the producer operates under a third party audited Quality Assurance Program that covers aquaculture drug usage | Presence of third party certificate | Visual, for presence of certificate | Each lot checked to see if covered by certificate, which is renewed annually | Receiving dock employee | Reject lot | Third party certificate of operation Receiving record | Review monitoring and corrective action records within one week of prepartion |
| (1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) | (9) | (10) |
| Critical Control Point (CCP) | Significant Hazard(s) | Critical Limits for each Preventive Measure | Monitoring | Corrective Action(s) | Records | Verification | |||
|---|---|---|---|---|---|---|---|---|---|
| What | How | Frequency | Who | ||||||
| Holding | Aquaculture drugs | Lobster will be withheld from distribution for 30 days
after treatment with oxytetracycline in accordance with the labeled
directions for use
No other aquaculture drugs will be used | Type of aquaculture drug used | Visual observation of drug use | Every time aquaculture drugs are used | Production Employee | Hold the product AND Collect a sample of the finished product and have analyzed for oxytetracycline residue by contact laboratory. If 2.0 ppm or less, release. If higher than 2.0 ppm, hold product an additional 5 days and then retest AND Destroy the lot when unapproved drugs are used | Drug use record | Review monitoring and corrective action records within one week of preparation |
| Date and quantity of drug use | Visual observation of drug use | Every time aquaculture drugs are used | Production employee | Drug use record | |||||
| Date of finished product distribution | Visual observation of drug use | Every time aquaculture drugs are used | Shipping supervisor | Shipping record | |||||
The Third Edition of this guidance issued in June 2001. Above is an earlier version.
Hypertext updated by j3b/ear/dms/kwg 2002-JUN-18