| U.S.
Food & Drug Administration Center for Food Safety & Applied Nutrition FISH AND FISHERIES PRODUCTS HAZARDS AND CONTROLS GUIDANCE: Third Edition June 2001 |
(Return to table of contents.)
Certain food and color additives can cause an allergic-type reaction (food intolerance) in consumers. Examples of such food and color additives that are used on fish and fishery products include: sulfiting agents and FD&C Yellow #5. Sulfiting agents are mostly used during on-board handling of shrimp and lobster to prevent the formation of "black spot." They are sometimes used by cooked octopus processors as an antioxidant, to retain the red color of the octopus skin. FD&C Yellow #5 is used during in-plant processing. These food and color additives are permitted for use in foods, with certain restrictions, but their presence must be declared on the label. This label declaration is particularly important to sensitive individuals.
Certain other food and color additives are prohibited from use in food because of a determination by FDA that they present a potential risk to the public health. Examples of such food and color additives include: safrole and FD&C Red #4.
Additionally, a number of foods contain allergenic proteins that can pose a health risk to certain sensitive individuals. Appendix 6 contains a list of such foods that account for most of all food allergies. While the controls in this chapter are not directly applicable to the hazard of allergenic proteins, if these foods are part of or are directly added to your fishery product, you may use the principles contained in this chapter to ensure that the product is properly labeled. However, these controls are not designed to prevent the unintentional introduction of allergenic proteins from such foods into your fishery product because of cross-contact (e.g. use of common equipment, improper production scheduling, or improper use of rework material). Unintentional introduction of allergenic proteins must be controlled through a rigorous sanitation regime, either as part of a prerequisite program or as part of HACCP itself. The Seafood HACCP Regulation requires such a regime.
At each processing step, determine whether "allergens/additives" is a significant hazard. The criteria are:
1. Is it reasonably likely that a food or color additive that can cause an allergic-type reaction (e.g. sulfiting agents or FD&C yellow #5) or a prohibited substance (e.g. safrole and FD&C Red #4) will be introduced at a level that can cause an allergic-type reaction at this processing step (e.g. does it come in with the raw material or will the process introduce it)?
For example, under ordinary circumstances, it would be reasonably likely to expect that food or color additives that can cause an allergic-type reaction could enter the process under the following circumstances:
Sulfiting agents added directly to a finished food must be declared on a product's labeling regardless of the concentration of the sulfiting agent. When not directly added to the finished food, sulfiting agents must be declared on a product's labeling when the level is at or above 10 ppm.
2. Can the hazard be eliminated or reduced to an acceptable level here? (Note: If you are not certain of the answer to this question at this time, you may answer "No." However, you may need to change this answer when you assign critical control points in Step #12)
"Allergens/additives" should also be considered a significant hazard at a processing step if a preventive measure is or can be used to prevent or eliminate the hazard or is adequate to reduce the likelihood of occurrence of the hazard to an acceptable level, if it is reasonably likely to occur. Preventive measures for allergic-type reactions that can result from the presence of certain food and color additives (e.g. sulfiting agents and FD&C yellow #5) could include:
A preventive measure for the presence of prohibited food and color additives could include:
List such preventive measures in Column 5 of the Hazard Analysis Worksheet at the appropriate processing step(s).
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. If neither criterion is 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.
In determining whether a hazard is significant you should also consider the intended use of the product, which you developed in Step #4. However, in the case of allergens/additives, it is not likely that the significance of the hazard will be affected by the intended use of the product.
For each processing step where "allergens/additives" 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 #A-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 "allergens/additives":
1. In the case of shrimp or lobster for which you have identified sulfiting agents as a significant hazard, will the finished product label declare the presence of sulfiting agents?
In this case enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the finished product labeling step or receipt of product labels step, and enter "No" for the raw material receiving step. In addition, for the raw material receiving step enter in Column 5 that the hazard is controlled by the finished product labeling step or the receipt of product labels step. (Note: if you have not previously identified "allergens/ additives" as a significant hazard at the finished product labeling step or receipt of product labels step in Column 3 of the Hazard Analysis Worksheet, you should change the entry in Column 3 to "Yes".) This control approach will be referred to as "Control Strategy Example 1" in Steps #14 through 18.
Example:
A frozen shrimp processor that labels all finished product with a sulfiting agent declaration could set the critical control point for sulfiting agents (allergens/additives) at the finished product labeling step. The processor would not need to have a critical control point for this hazard at the shrimp receiving step.
b. If the finished product labeling will not declare the presence of sulfiting agents, you may identify the raw material receiving step as the CCP.
In this case enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the raw material receiving step. This control approach will be referred to as "Control Strategy Example 2" in Steps #14 through 18.
Example:
A frozen shrimp processor that receives shrimp directly from the harvest vessel and does not label finished product with a sulfiting agent declaration could set the critical control point for sulfiting agents (allegens/additives) at the raw material receiving step and test incoming lots of shrimp for the presence of sulfiting agents. The processor would not need to have a critical control point for this hazard at finished product labeling.Example:
A frozen shrimp processor that receives shrimp from another processor and does not label finished product with a sulfiting agent declaration could set the critical control point for sulfiting agents (allegens/additives) at the raw material receiving step and reject incoming lots that are identified as having been treated with a sulfiting agent (e.g. identified on the labeling or, in the case of unlabeled product, on documents accompanying the shipment). The processor would not need to have a critical control point for this hazard at finished product labeling.
c. If the finished product labeling will only declare the presence of sulfiting agents when it is present in the raw material, you may identify the finished product labeling step or the receipt of product labels step (where you can check labels for the presence of a sulfiting agent declaration) as the CCP. Testing or certification at the raw material receiving step will be necessary to ensure control at the CCP. However, the raw material receiving step would not need to be identified as a CCP for the hazard of "allergens/additives."
In this case enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the finished product labeling step or the receipt of product labels step, and enter "No" for the raw material receiving step. In addition, for the raw material receiving step enter in Column 5 that the hazard is controlled by the finished product labeling step or the receipt of product labels step. (Note: if you have not previously identified "allergens/ additives" as a significant hazard at the finished product labeling step or receipt of product labels step in Column 3 of the Hazard Analysis Worksheet, you should change the entry in Column 3 to "Yes".) This control approach will be referred to as "Control Strategy Example 3" in Steps #14 through 18.
Example:
A frozen shrimp processor that receives shrimp directly from the harvest vessel and labels finished product with a sulfiting agent declaration only if testing at receipt identifies a residue of a sulfiting agent could set the critical control point for sulfiting agents (allergens/additives) at the finished product labeling step or the receipt of product labels step. The processor would not need to have a critical control point for this hazard at the raw material receiving step.Example:
A frozen shrimp processor that receives shrimp from another processor and labels finished product with a sulfiting agent declaration only if the incoming lot was identified as having been treated with a sulfiting agent (e.g. identified on the labeling or, in the case of unlabeled product, on documents accompanying the shipment), could set the critical control point for sulfiting agents (allergens/additives) at the finished product labeling step or the receipt of product labels step. The processor would not need to have a critical control point for this hazard at the raw material receiving step.
2. In the case of cooked octopus for which you have identified sulfiting agents as a significant hazard, and in the case of products for which you have identified FD&C Yellow #5 as a significant hazard because you use one of these food and color additives in the product formulation, you should identify the finished product labeling step or receipt of product labels step (where you can check labels for the presence of a sulfiting agent or FD&C Yellow #5 declaration, as appropriate) as the CCP. The processing step at which you add a sulfiting agent or FD&C Yellow #5 would then not require control and would not need to be identified as a CCP for the hazard of "allergens/additives."
In this case enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the finished product labeling step or receipt of product labels step, and enter "No" for the treatment step. In addition, for the treatment step enter in Column 5 that the hazard is controlled by the finished product labeling step or receipt of product labels step. (Note: if you have not previously identified "allergens/additives" as a significant hazard at the finished product labeling step or receipt of product labels step in Column 3 of the Hazard Analysis Worksheet, you should change the entry in Column 3 to "Yes".) This control approach will also be referred to as "Control Strategy Example 1" in Steps #14 through 18.
Example:
A smoked sablefish processor that treats the fish with FD&C Yellow #5 before smoking could set the critical control point for FD&C Yellow #5 (allergens/additives) at the finished product labeling step or receipt of product labels step. The processor would not need to have a critical control point for this hazard at the treatment step.Example:
A cooked octopus processor that treats the fish with a sulfiting agent could set the critical control point for sulfiting agents (allergens/ additives) at the finished product labeling step or receipt of product labels step. The processor would not need to have a critical control point for this hazard at the treatment step.
3. In the case of products for which you have identified prohibited food and color additives (e.g. safrole and FD&C Red #4) as a significant hazard in incoming raw materials you should identify the raw material receiving step as the CCP.
In this case enter "Yes" in Column 6 of the Hazard Analysis Worksheet for the raw material receiving step. This control approach will be referred to as "Control Strategy Example 2" 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 "allergens/additives" 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 CL at the point that if not met the safety of the product may be questionable. If you set a more restrictive CL 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 CL 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 CL. In this way you can adjust the process when the operating limit is triggered, but before a triggering of the CL 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 CL.
Following is guidance on setting critical limits for the control strategy examples discussed in Step #12.
Critical Limit: All finished product labels must contain a sulfiting agent or FD&C Yellow #5 declaration, as appropriate.
Critical Limit: Incoming lots of shrimp or lobster must not contain a detectable level of sulfite;
OR
Incoming lots of shrimp or lobster must be accompanied by a supplier's lot-by-lot certificate that sulfiting agents were not used;
OR
The labeling or shipping documents for incoming lots of shrimp or lobster received from another processor must not contain a sulfiting agent declaration;
OR
Incoming lots of raw materials must not contain a detectable level of prohibited food and color additives;
OR
Incoming lots of raw materials must be accompanied by a supplier's lot-by-lot certificate that prohibited food and color additives were not used.
Critical Limit: Finished product labels for product processed from raw materials that contain a detectable level of sulfite must contain a sulfiting agent declaration.
Enter the critical limit(s) in Column 3 of the HACCP Plan Form.
For each processing step where "allergens/additives" 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 CL is being met. That is, the monitoring process should directly measure the feature for which you have established a CL.
You should monitor often enough so that the normal variability in the values you are measuring will be detected. This is especially true if these values are typically close to the CL. Additionally, the greater the time span between measurements the more product you are putting at risk should a measurement show that a CL 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: Finished product labels for presence of sulfiting agent or FD&C Yellow #5 declaration, as appropriate.
What:Representative sample of each lot at receipt for sulfiting agent residual analysis, or prohibited food and color additive residual analysis, as appropriate;
OR
Supplier's lot-by-lot certificate that no sulfiting agent, or prohibited food and color additive, as appropriate, was used on the lot (with appropriate verification – see Step #18);
OR
Labeling or accompanying documents for each lot received from another processor, for the presence of a sulfiting agent declaration.
What: Finished product labels for presence of sulfiting agent declaration;
AND
One of the following:
OR
OR
Labeling or accompanying documents for each lot received from another processor, for the presence of a sulfiting agent declaration.
How: Visual examination.
How: Screening test for sulfiting agents or prohibited food and color additives, as appropriate;
OR
Visual examination of certificates;
OR
Visual examination of the labeling or accompanying documents, for lots received from another processor.
How: Visual examination of labels;
AND
One of the following:
OR
OR
Visual examination of the labeling or accompanying documents, for lots received from another processor.
Frequency: At least one label from every case of labels or one label from each pallet of pre-labeled packaging material delivered to the packaging area;
OR
At least one label from every case of labels or one label from each pallet of pre-labeled packaging material received at the firm.
OR
Once per day for on-site computer generated labels.
Frequency: Each incoming lot.
Frequency: At least one label from every case of labels or one label from each pallet of pre-labeled packaging material delivered to the packaging area;
OR
At least one label from every case of labels or one label from each pallet of pre-labeled packaging material received at the firm.
OR
Once per day for on-site computer generated labels.
AND
Each lot of incoming shrimp or lobster.
Who: Monitoring may be performed by the labeling equipment operator, the receiving employee, a production supervisor, a member of the quality control staff, or any other person who has an understanding of the proper content of the label.
Who: Monitoring may be performed by the receiving employee, a production supervisor, a member of the quality control staff, or any other person who that has an understanding of the proper screening procedure. Assignment of responsibility for testing procedures should be based, in part, on the degree of difficulty of the analysis.
Who: Monitoring may be performed by the labeling equipment operator, the receiving employee, a production supervisor, a member of the quality control staff, or any other person that has an understanding of proper content of the label or the screening procedure, as appropriate. Assignment of responsibility for testing procedures should be based, in part, on the degree of difficulty of the analysis.
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 "allergens/additives" is identified as a significant hazard on the HACCP Plan Form, describe the procedures that you will use when your monitoring indicates that the CL 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 CL 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: Segregate and relabel any improperly labeled product;
AND
Segregate and return or destroy any label stock or pre-labeled packaging stock that does not contain the proper declaration.
Corrective Action: Reject any incoming lot in which sulfiting agent or prohibited food and color additive, as appropriate, is detected or declared or which is not accompanied by a supplier's certificate.
Note: If an incoming lot that fails to meet a receiving critical limit is mistakenly accepted, and the error is later detected, the following actions should be taken: 1) the lot and any products processed from that lot should be destroyed, diverted to a nonfood use or to a use in which the critical limit is not applicable, or placed on hold until a food safety evaluation can be completed; and 2) any products processed from that lot that have already been distributed should be recalled and subjected to the actions described above.
Corrective Action: Segregate and relabel any improperly labeled product;
AND
Segregate and return or destroy any label stock or pre-labeled packaging stock that does not contain the proper declaration.
Enter the corrective action procedures in Column 8 of the HACCP Plan Form.
For each processing step where "allergens/additives" 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 record-keeping system for the control strategy examples discussed in Step #12.
Records: Record of labeling checks.
Records: Test results for sulfiting agent or prohib- ited food and color additives, as appropriate;
OR
Supplier's lot-by-lot certificates;
OR
Record of raw material labeling or accompanying document checks.
Records: Record of labeling checks;
AND
One of the following:
OR
OR
Record of raw material labeling or accompanying document checks.
Enter the names of the HACCP records in Column 9 of the HACCP Plan Form.
For each processing step where "allergens/additives" 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 improper use of food and color additives; 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: Review monitoring, corrective action, and, where applicable, verification records within one week of preparation;
AND
When supplier's certificates are used for monitoring, collect at least one representative sample per quarter, randomly selected from among your suppliers, and analyze for sulfiting agents or prohibited food and color additives, as appropriate. Additionally, collect at least one representative sample for each new supplier, and analyze for sulfiting agents or prohibited food and color additives, as appropriate.
Verification: Review monitoring, corrective action, and, where applicable, verification records within one week of preparation;
AND
When supplier's certificates are used for monitoring, collect at least one representative sample per quarter, randomly selected from among your suppliers, and analyze for sulfiting agents. Additionally, collect at least one representative sample for each new supplier, and analyze for sulfiting agents.
Enter the verification procedures in Column 10 of the HACCP Plan Form.
TABLE 19-1Control Strategy Example 1 - Labeling controls This table is an example of a portion of a HACCP plan relating to the control of sulfiting agents for a processor of wild-caught shrimp, using Control Strategy Example 1 - Labeling controls. It is provided for illustrative purposes only. Food and color additives may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants, food and color additives, and metal fragments). Example Only | |||||||||
| (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 | ||||||
| Labeling receipt | Sulfiting agents | All finished product labels must contain sulfiting agent declaration | Finished product labels for presence of sulfiting agent declaration | Visual | One label from each case of labels at receipt | Receiving employee | Segregate and return any labels that do not contain the sulfiting agent declaration | Label receiving record | Review monitoring and correction action records within one week of preparation |
TABLE 19-2Control Strategy Example 2 - Raw material screening This table is a an example of a portion of a HACCP plan relating to the control of sulfiting agents for a processor of wild-caught frozen shrimp, using Control Strategy Example 2 - Raw material screening. It is provided for illustrative purposes only. Allergens/additives may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants, and metal fragments). Example Only | |||||||||
| (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 | ||||||
| Shrimp receiving | Sulfiting agents | Incoming lots of shrimp must be accompanied by a supplier's certificate that sulfiting agents were not used on the lot | Supplier's lot-by-lot certificate that no sulfiting agents were used on the lot | Visual | Every lot of incoming shrimp | Receiving employee | Reject any incoming lot of shrimp that is not accompanied by a supplier's certificate | Copies of supplier's guarantees | Test one lot per
quarter for sulfiting agent residue, and test one lot
from each new supplier of shrimp for sulfiting agent
residue Review monitoring, correction action and verification records within one week of preparation |
TABLE 19-3Control Strategy Example 3 - Labeling controls with raw material screening This table is a an example of a portion of a HACCP plan relating to the control of sulfiting agents for a processor of wild-caught frozen shrimp, using Control Strategy Example 3 - Labeling controls with raw material screening. It is provided for illustrative purposes only. Allergens/additives may be only one of several significant hazards for this product. Refer to Tables 3-1, 3-2, and 3-3 (Chapter 3) for other potential hazards (e.g. chemical contaminants, and metal fragments). Example Only | |||||||||
| (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 | ||||||
| Finished product labeling | Sulfiting agents | Finished product labels for product processed from sulfite-containing raw material shrimp must contain a sulfiting agent declaration | Finished product labels for presence of sulfiting agent declaration | Visual | One label from each case of labels delivered to packaging | Packaging machine operator | Segregate and relabel any improperly labeled product | Label check record | Review monitoring and corrective action records within one week of preparation |
| Three shrimp collected randomly from each lot of raw material shrimp for sulfiting agent residual analysis | Malachite green test | Three shrimp from each lot of raw material shrimp | Quality control employee | Segregate and return any label stock that does not contain the proper declaration | |||||
See also:
Foodborne Pathogenic Microorganisms and Natural Toxins Handbook (Bad Bug Book)
Seafood Information and Resources
Seafood HACCP | Fish & Fisheries Products Hazards & Controls Guidance: 3rd Edition (2001)
Foods Home | FDA Home | Search/Subject Index | Disclaimers & Privacy Policy | Accessibility/Help
Hypertext updated by dav/kwg/dms 2002-JUN-14