IKE Scenario 01-03: 9 CFR 441.10 Implementation of Retained Water Regulation
On January 9, 2001, FSIS issued regulations to limit the amount of water retained or absorbed by raw, single-ingredient, meat and poultry products as a result of post-evisceration processing (9 CFR 441.10).
It is important to remember that the verification of the labeling requirements according to 9 CFR 441.10 is not food safety related. As such, the performance of this activity should be carried out accordingly (i.e., under normal circumstances only when the 04B04 procedure is scheduled).
Remember that the 04B04 procedure does not only include verification of retained water claims; it includes a range of labeling-related issues. For the purposes of this IKE, we have concentrated on the retained water component of the procedure.
You are a GS-09 processing inspector on a patrol assignment. You are assigned to a variety of different size meat and poultry establishments.
Ex. 1. On Monday you are at a medium size poultry plant performing the scheduled 04B04 verification procedure. You decide to review the plant's protocol for retained water and determine that the plant does not have a protocol on file, nor have they collected any data pertaining to whether or not their process would retain water. As a critical thinker, what action(s) do you take?
According to 9 CFR 441.10 (c)(1) "An establishment…must maintain on file and available to FSIS its written data-collection protocol. The protocol must explain how data will be collected and used to demonstrate the amount of retained water in the product covered by the protocol that is an unavoidable consequence of the process used to meet specified food safety requirements.
According to 9 CFR 381.129(a), “ No poultry product subject to the Act shall have any false or misleading labeling….” After discussing the issue with plant management you record the finding on an NR as an 04B04 non-compliance. You mark the “product/misbranding” indicator and cite 9 CFR 441.10(c)(1). You also retain all affected product, not yet shipped, until plant management can demonstrate that their label(s) are accurate.
Ex. 2. On Wednesday you are in a large poultry slaughter and processing plant. You are conducting the scheduled 04B04 verification procedure. You observe that the plant has the required protocol that was reviewed in Washington over a year ago, with no objection. You review the plant files and determine that the plant collected data based on that protocol using a laboratory analysis (drying) method and has these records on file. The plant appears to be following the procedures indicated in their protocol but has not performed any type of retained water labeling verification procedure for over six months. As a critical thinker, are there any actions for you to take?
Since the plant used a laboratory drying method to determine the amount of water retained, you realize that you must also use this method to verify the validity of their label. This means that you must observe the plant collecting their sample according to their protocol and/or use the plant’s data to calculate the amount of water retained and compare this value with the claim on the labels.
The retained water regulation (9 CFR 441.10) does not require that establishments verify the accuracy of their retained water statement at any particular frequency. However, since the plant’s most recent data is over six month’s old, you have questions as to the validity of the retained water statement on the labels.
You decide to ask plant management how they can assure you that they are continuing to ensure the accuracy of the stated retained water label claim given the extended period since their last retained water labeling verification procedure. During these discussions, plant management explains to you how they determined their verification frequency, which is twice a year. The plant gathered extensive data over a time-period of one year. They show you records demonstrating reasonably uniform bird size over this time period and that the current bird size was also the bird size used during their data-collecting phase. Since data was collected over an extended period of time, the plant feels that they have adequately taken water retention variability into account and adjusted their label to accurately reflect this variability. They also explain to you that their protocol took all food safety processes into account that could result in post-evisceration water retention and that they have not changed any of their processing procedures since the implementation of their protocol. In their opinion, this means that their existing labeling statement continues to accurately reflect the amount of retained water in their product and that their chosen verification frequency is adequate.
Once again, remembering that this is not a food safety issue, you determine there is no action necessary at this time, especially since the plant seems to have valid reasoning behind their verification frequency and there is no evidence of mislabeling.
Ex. 3. The following Tuesday, you are at a small red meat slaughter and processing plant. The 04B04 verification procedure is scheduled to be performed that day. While performing this verification procedure, you review the plant's protocol and then observe the plant's operations. During this review, you observe that the plant has introduced an anti-microbial intervention step (i.e., lactic acid wash) just prior to the entrance to the carcass cooler. This procedure was not included in the plant's protocol, reflected in the data collected from that protocol, nor does the plant have any additional data establishing no additional water retention through this change in their process. In addition, inspection personnel were not informed of the change to the plant's procedure. You realize that the retained water statement on the packaged product(s) may not be accurate. As a critical thinker, what actions do you take?
According to 9 CFR 441.10(c)(2) "the establishment must notify FSIS as soon as it has a new or revised protocol available for review by the Agency".
Also, 9 CFR 317.8(a) states "no product or any of its wrappers, packaging or other containers shall bear any false or misleading marking, label or other labeling and no statement, ….which conveys any false impression or gives any false indication of origin or quality or is otherwise false or misleading shall appear in any marking or other labeling.”
You discuss your findings with plant management and document the finding on an NR using the 04B04 code (product/misbranding). You cite the non-compliance with 9 CFR 441.10(c)(2) and 9 CFR 317.8(a). Furthermore, since the plant has made no effort to collect water retention data pertaining to the change in their process and cannot adequately demonstrate the validity of their label, you retain all affected product, not yet shipped.