Host:
Can you explain a little more what you mean by “fully addresses” the reasons?

Guest:
“Fully addresses” means that the action plan must include, at a minimum, a detailed description of acceptable corrective and preventive actions.

If compliance has already been achieved, plant management will need to fully explain the corrective actions taken as well as the preventative actions that have been put into place.

They must also provide information that demonstrates that the corrective and preventative actions are achieving the intended purpose and regulatory requirements have been met.

Host:
What happens next?

Guest:
After the district manager receives the response, he or she will evaluate the action plan.

The plant’s history is taken into consideration when determining whether the proposed actions are likely to be implemented effectively.

After assessing the response, the district manager will do one of three things: accept the action plan, implement the withholding or suspension action, or defer the decision.

Host:
What happens when a district manager accepts an action plan contained in the response?

Guest:
In the event that the plant’s response demonstrates that there is no need to take enforcement, then the District Manager would accept the establishment’s response and close the matter with a letter to the establishment.

Before deciding to accept the establishment’s response and close the matter without further action, the District Manager would also communicate with the FSIS inspection personnel about the establishment’s response to make certain that there were no continuing concerns.

However, our experiences have shown that only very rarely are NOIE type cases closed with a letter of information only. Remember, the decision to issue an NOIE is never one that is taken lightly. Each NOIE that is issued is based on careful evaluation and consideration of all the facts.

Host:
So then, what is the most typical scenario that occurs after an NOIE is issued?

Guest:
Most typically after an NOIE letter is issued, the plant responds by providing the District Manager a written response that includes the corrective and preventive measures the plant has taken or intends to take to address the NOIE findings.

Also, in many instances prior to providing a written response, the plant owner or plant representative will contact the District Office by telephone to discuss the NOIE findings and to make certain that there is a full understanding of all the issues before submitting a reply.

Host:
When would the district manager implement the intended enforcement action?

Guest:
There are a couple of situations when the district manager would implement enforcement.

The first is when a response is not received from the plant within the specified timeframe.

The district manager would also execute the enforcement action when, based on the assessment and evaluation of all pertinent information, he or she finds that compliance cannot or will not be achieved upon the plant’s implementation of the action plan.

Host:
What happens next?

Guest:
Once the decision has been made to implement an enforcement action, the district manager will then notify the plant of the enforcement decision and the basis for it.

If a suspension action is taken, the assignment of FSIS inspectors to the plant would be interrupted, and the plant would be provided a written notification called the Notice of Suspension. The written Notice of Suspension would describe the basis for the suspension decision.

Host:
When would the district manager defer the decision?

Guest:
The district manager may defer a decision when he or she believes that the plant’s proposed corrective and preventive actions are adequate but lack substantive evidence that is needed to make a definite decision.

In other words, the district manager may decide to defer enforcement if the plant has provided corrective and preventive measures that appear to satisfactorily address the concerns raised in the NOIE, but FSIS needs more time to verify that the plant’s measures have been effective.

So, whenever the decision is made to defer enforcement, FSIS also prepares a verification plan to verify the effectiveness of the corrective and preventive measures that were proffered by the plant to address the NOIE findings.


The verification plan lists the specific procedures that FSIS inspectors assigned to the plant will carry out to make certain that the plant’s corrective and preventive measures are effective.

Host:
How will the district manager notify the plant if an enforcement decision has been deferred?

Guest:
The district manager will issue a Notice of Deferral, a letter which describes the reasons that the decision has been made to defer enforcement. The district manager will also provide the plant a copy of the written verification plan discussed earlier.

Host:
If the action plan is adequate, then what?

Guest:
If over time, verification activities conducted by FSIS inspection personnel demonstrate that the plant’s corrective and preventive measures have been effective and are working, then the NOIE would be closed with a Letter of Warning. If the plant fails to adhere to the proposed action plan at any time during the period of deferment, the district manager may implement the withholding or suspension action.

Host:
Well, I think we’ve covered this topic pretty well. Just as a reminder, most of what we’ve discussed here today and in the previous three podcasts on the NOIE can be found in 9 CFR 500, the Rules of Practice.

Joan, it’s been a pleasure having you. Thanks for coming in and explaining how to respond to an NOIE.

Guest:
You're welcome.

Host:
And thanks to all of our listeners. Be sure to stay tuned to the FSIS Web site at www.fsis.usda.gov for future podcasts.

Outro:
Well, that’s all for this episode. We’d like your feedback on our podcast. Or if you have ideas for future podcasts, send us an e-mail at podcast@fsis.usda.gov. To learn more about food safety, try our web site at www.fsis.usda.gov. Thanks for tuning in.