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Script: Notice of Intended Enforcement, Part 2, Requirements for Prior Notification |
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Intro:
Welcome to USDA's Food Safety and Inspection Service podcast. Each episode
will bring you cutting edge news and information about how FSIS is working to ensure public
health protection through food safety. While we're on the job, you can rest assured that
your meat, poultry, and processed egg products are safe, wholesome, properly labeled,
and packaged correctly. So turn up your volume and listen in.
Host:
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.
Last week, we discussed the Rules of Practice as they pertain to the types of enforcement
actions that FSIS may take. Today, we're going to talk about when FSIS is required to
provide notification in the form of a Notice of Intended Enforcement Action, or NOIE,
before taking an enforcement action.
Now, Joan, let's do a quick recap to remind our listeners what an NOIE is.
Guest:
Of course. An NOIE is issued to a plant when noncompliances do
not pose an imminent threat to public health, but may warrant a withholding or suspension
action if not corrected.
The Rules of Practice, found in Title 9 of the Code of Federal Regulations, Section 500,
lists eight specific situations in which FSIS may take a withholding or suspension action
without giving the establishment prior notification.
For any situations other than those eight, the Rules of Practice require that FSIS give a
plant prior notification before it takes any enforcement action. The NOIE is the written
format the Agency uses to fulfill that requirement.
Host:
So of the three types of enforcement actions FSIS may take as
defined by the Rules of Practice, an NOIE is given only prior to a withholding or suspension action?
Guest:
Correct. The third type of enforcement action, a regulatory control
action, is taken when immediate correction of a deficiency is required.
A regulatory control action may involve retention of product, rejection of equipment or facilities,
slowing or stopping of lines, or refusal to allow the processing of a specifically identified product.
Although plant management does not have to be notified in advance, they must be notified immediately
once the action is taken. This is the type of enforcement that most plant owners and operators are
familiar with.
Host:
OK. According to the Rules of Practice, when would the Agency take a
withholding or suspension action without giving the plant owner or operator an
NOIE, the written prior notification?
Guest:
FSIS can take a withholding or suspension action without prior
notification if the plant has:
- produced and shipped adulterated or misbranded product,
- violated a regulatory control action, or
- assaulted, threatened or intimidated an FSIS employee.
Other situations include the plant not having a Hazard Analysis and Critical Control Point — HACCP — plan,
or Sanitation Standard Operating Procedures — SSOPs — in place. Or if insanitary
conditions exist such that products in the plant would be rendered adulterated, FSIS can take
action without prior notification.
Host:
You mentioned that there were eight specific situations that do not
require FSIS to provide an NOIE before taking an enforcement action. I've counted six so far.
What are the last two?
Guest:
If a plant fails to destroy condemned product or carries out inhumane
slaughter or handling of animals, FSIS can also take a withholding or suspension action without
prior notification.
In each of these eight situations we've discussed, FSIS will notify the plant management orally and,
as promptly as circumstances permit, in writing.
Host:
And for all other situations, the plant would receive an NOIE first?
Guest:
You've got it! In all other situations, FSIS must provide the plant
with prior written notification, an NOIE. This gives the plant a chance to "demonstrate or achieve
compliance" before the Agency takes a withholding or suspension action.
Host:
All other situations is a pretty broad term. Could you provide for our
listeners some examples of specific situations where FSIS must provide the plant with prior notification?
Guest:
Sure. The Rules of Practice lists several specific situations where the
Agency must provide the plant with an NOIE before taking any action.
These include situations where — due to multiple or recurring noncompliances — the HACCP
system is inadequate, the SSOPs have not been properly implemented or maintained, or the plant
has not met sanitary conditions or sanitation performance standards.
The Rules of Practice also specify that FSIS must provide prior notification before taking a
withholding or suspension action when the plant did not meet the Salmonella performance
standard requirements or if it did not collect and analyze samples for E. coli Biotype I
and record results.
Remember, in all of these cases, there is no immediate threat to public health.
Host:
Who within FSIS issues the NOIE?
Guest:
The inspector-in-charge at a plant may initiate a withholding
or suspension action by discussing the noncompliance situation with the frontline supervisor
and the District Office.
If there is agreement that a withholding or suspension action is warranted, then the district
manager issues the NOIE.
Host:
And what type of information does the NOIE contain?
Guest:
The NOIE contains the action FSIS intends to take, the effective
date of the action, the reason for the proposed action, and the operations, products, or processes
affected.
It also explains plant management's right to appeal, and advises them that they have three
business days to appeal or respond…Of course, FSIS may extend the deadline to give
plant management more time. All of this is also provided for under the Rules of Practice.
Host:
Well, Joan, it's been a pleasure having you with us once again.
Thanks for coming in and explaining when FSIS is required to issue an NOIE prior to taking
an enforcement action.
Guest:
You're welcome!
Host:
And to all of our listeners, don't forget to join us for part 3
of our series which will start our discussion on appeal options available to a plant after
it receives an NOIE. Be sure to stay tuned to the FSIS Web site at www.fsis.usda.gov.
Thanks for listening!
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.
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Last Modified: May 27, 2009 |
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