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Welcome. I’m Sheila Johnson with FSIS. Joining me again is Joan Collins, a program
manager in the Office of Field Operations. She has been with FSIS for more than
20 years and has a great deal of experience training front line supervisors
on the statutes, Rules of Practice and administrative enforcement.
This is our last podcast in this four-part series on the Notice of Intended
Enforcement Action, or NOIE.
To date we have covered the Rules of Practice as they pertain to the types of
enforcement actions that FSIS may take, when notification in the form of an
NOIE is required, and how to appeal an NOIE. In this podcast, we’ll focus on
plant management’s response to an NOIE.
Thanks for being here, Joan.
You’re quite welcome.
All right, Joan, let’s say plant management has received an NOIE. They either
don’t feel there’s any basis for an appeal, or they have already filed an appeal
and it has been denied and they agree with the appeal decision. What happens
The plant owner or operator would have to provide a response to the NOIE. Remember,
the response must be made within three business days unless FSIS extends the
What type of information would the response need to include?
Any response to an NOIE needs to include an action plan that fully addresses
the reasons for the proposed withholding or suspension action stated in the
NOIE. The plan must also ensure regulatory requirements will be met if it’s
Can you explain a little more what you mean by “fully addresses” the reasons?
“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.
What happens next?
After the district manager receives the response, he or she will evaluate the
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
What happens when a district manager accepts an action plan contained in the
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.
So then, what is the most typical scenario that occurs after an NOIE is issued?
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.
When would the district manager implement the intended enforcement action?
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
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.
What happens next?
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
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.
When would the district manager defer the decision?
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.
How will the district manager notify the plant if an enforcement decision has
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
If the action plan is adequate, then what?
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
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.
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.
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
firstname.lastname@example.org. To learn more about food safety, try our web site
at www.fsis.usda.gov. Thanks
for tuning in.