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Preparing Yourself for a Food Safety Assessment, Part II: Tips from an EIAO
By Larae Booker
There is a person behind every FSIS process. In Vol. 2, No. 11 of Small Plant News, we
discussed the Food Safety Assessment (FSA): what it is, how and why it's conducted, and what you can do to prepare for it.
When it comes to the FSA, Enforcement, Investigations, and Analysis Officers (EIAOs) are the "people behind the process."
For this issue, we reached out to one of our EIAOs, Mr. Thomas Urban, of the Philadelphia District Office.
Urban, who has been with the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service
(FSIS) for 19 years, also serves as an Agency recruiter. He brings a knack for outreach and a passion for food safety
to both his inspection and recruitment efforts.
Small Plant News asked Urban to offer some advice to our readers about the FSA from an EAIO's perspective.
SPN: By the very nature of an FSA, there may be some concern out there in the Small Plant News audience
about working with EIAOs. What can you tell us about your District Office's approach to small plant outreach that might help ease some of those anxieties?
TU: There are many reasons why plants may have some apprehension about an FSA or working with the EIAO. Most of this is fear of the
unknown. Plants may wonder: What will the EIAO look for? What will the FSA find? Are we prepared and do we have the documents needed?
Our District works to reduce this stress as much as possible and promotes the Small Business Regulatory Enforcement and Fairness
Act. We were the first to implement the outreach packet—a packet of information to plants before or at the start of an FSA to
provide information and resources relevant to the plants' operations and an FSA. Due to the success of this outreach, it has become a
national outreach activity.
We also realize that although an establishment may be fully prepared for an FSA, there may be times that an FSA
would be more stressful, such as during the absence of key employees. Plants regularly relay this information, and we
work with the plant, when possible, to schedule the FSA when it is more appropriate.
Overall, we promote open communication and relate findings and guidance in an ongoing dialogue with management.
SPN: So it seems that communication and cooperation from both ends is important in conducting an FSA. In keeping with that, are
there any steps plant managers can take to be prepared for an assessment? How can they effectively work with EIAOs to conduct the FSA?
TU: Yes. Plant management is encouraged to cooperate with FSIS during the course of an assessment and to make requested plant
records available for review. Effectively working with an EIAO involves taking a proactive approach, asking questions, asking for guidance,
and raising concerns that you may have in your plant.
Upon being notified of an upcoming assessment, plant management should consider who would be the
best person, or persons, to make information available to FSIS and to be the contact point(s) if there are questions
or issues that need to be clarified during the review. This person should be familiar with the establishment's food
safety systems and should have access to the information that will be needed.
As part of an assessment, an entrance meeting and an exit meeting are held with plant officials. Plant managers
are encouraged to be available to participate at these meetings so that they can have a better understanding of
the FSA review process and the review findings. During the entrance meeting, the plant managers are encouraged
to discuss the documents and records that will need to be reviewed and to coordinate making this information
available for review if these documents are necessary to support the FSA findings. During the exit meeting, plant
managers should be prepared to raise any questions or concerns regarding the FSA findings or the expected next steps.
Plant management may gain more information by reviewing and becoming familiar with FSIS Directives
5000.1 Rev. 3, dated 06-25-08, and 5100.1 Rev. 2, dated 07-10-08, and by utilizing FSIS' Web site, www.fsis.usda.gov.
SPN: That is helpful advice, and thank you for pointing out that there are resources available to plant
owners that can help them prepare for an FSA. In your experience, what are some best and worst case scenarios
when working with plants to complete an FSA?
TU: Worst case scenarios for FSAs revolve around plant management being very apprehensive about the FSA
and the EIAO. Many times this situation is compounded when plant management hold back and doesn't fully
disclose everything they may need to provide the EIAO for a true reflection of the establishment and its programs.
This belief by some, that the less you provide or share, the better, often has the opposite effect because you haven't
provided everything necessary to properly reflect your controls.
Best case scenarios normally involve establishments that have been utilizing the resources available to
them. These plants are always asking questions of the local inspectors, keeping their eyes and ears open for
information regarding their processes and products, and are generally proactive in gaining support and guidance
from the several sources available to them. These plants do not fear the unknown; they gain confidence through
their informed approach and are better prepared to work cooperatively during an FSA.
SPN: If you had three things you'd like every small plant owner, operator, or manager to know about the FSA,
what would they be?
TU: First, I would tell them to look at the FSA as an opportunity to become more knowledgeable about
your overall food safety systems and to gain a better understanding of those areas that need strengthening or improvement.
I would also encourage every plant owner to be proactive before the FSA, during the FSA, and in your
relationship with the local inspection team and the EIAO. You will be better prepared for not only the FSA, but also
for questions that may arise. The FSA has become a good tool to reflect that FSIS and industry can work together,
and our positive relationship is a vital part of progress and growth.
Finally, I would challenge them to look at the FSA in a positive light. The findings and information collected
during the FSA reports may help to correct, prevent, or eliminate potential food safety concerns and result in
improvements to their establishment's overall food safety systems.
SPN: Thank you, Thomas. The FSA can seem like an intimidating, technical process to any plant, especially
to small and very small plant owners. However, it's great for our Small Plant News audience to know that there are
FSIS personnel like you behind them.
TU: You're welcome, and thank you for providing me the opportunity to give you first-hand input on how
the Philadelphia District Office conducts FSAs and its outreach activities.
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New Humane Handling Materials Now Available
By Sally Fernandez
All livestock slaughter inspection establishments must meet the requirements of the Humane
Methods of Slaughter Act. Additionally, poultry slaughter establishments must follow
good commercial practices. If your plant slaughters livestock, you need to implement and maintain
a systematic approach to humane handling and slaughter to ensure compliance with the Act. FSIS now offers a
free DVD and companion guidebook (PDF Only)
titled Humane Handling Guidebook to help you avoid the pitfalls of noncompliance.
The FSIS policy guidebook explains the four key elements of the systematic approach FSIS recommends.
In this approach, plants focus on treating livestock in a way that minimizes excitement, discomfort, and
accidental injury the entire time the animals are held for slaughter. The guidebook also gives examples of types of
observations FSIS inspectors make to ensure that you're in compliance with the Act and with good commercial
practices. A list of research publications and a checklist for humane handling of livestock are provided at the end of the guidebook.
Dr. Temple Grandin, a world-renowned expert in humane handling methods, presents the information
in the DVD. Grandin provides guidelines to help you improve humane handling practices and discusses the
scoring system she developed for objectively evaluating animal handling and stunning. She also describes five
critical control points for you to follow to ensure humane handling. Grandin demonstrates humane stunning, shows
you how to make sure the animals are insensible, explains vocalization, and guides you through methods of moving
The guidelines reviewed in the DVD are best practices, not regulatory requirements. However, following the
guidelines will not only help you make sure you comply with Federal law, but will improve animal welfare, make
handling of animals easier and more efficient, and improve the quality of your product. The DVD also contains a
Spanish version of the presentation.
"This new DVD and guidebook set provides slaughter establishments with a helpful tool to maintain compliance
and is a great addition to our growing library of resources for small and very small plants," said Karlease Kelly,
assistant administrator of FSIS' Office of Outreach, Employee Education, and Training.
To receive your free copy of the companion guidebook and DVD, contact the Office of Outreach, Employee
Education, and Training at 1-800-336-3747 or order them through FSIS' online order form at www.fsis.usda.gov/Science/
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Avoiding Noncompliance Records
By Commander Jeff Tarrant, U.S. Public Health Service
The Noncompliance Record (NR), officially known as FSIS Form 5400-4, is generated whenever
FSIS inspectors determine that a plant has failed to meet one or more
regulatory requirements of the Federal Meat Inspection Act or Poultry Products
Inspection Act. It describes each noncompliance in clear and concise terms,
how FSIS notifies the plant of the issue, and identifies whether any regulatory action has been taken.
The NR is then provided to you for your review so you can determine the nature of the deficiency and what
action, if any, should be taken. You can appeal all or part of the NR and can (but are not required to) respond
in writing to FSIS regarding the documented deficiencies.
Some of the more common NRs involve monitoring procedures and frequencies of an establishment's Hazard Analysis and Critical Control
Point (HACCP) plan. In the Code of Federal Regulations, FSIS regulation 9 CFR 417.2 (c) (4) requires facilities
to "list the procedures, and frequency with which those procedures will be performed, that will be used to
monitor each of the critical control points to ensure compliance with the critical limits." Simply stated, each
HACCP plan must include monitoring procedures and frequencies.
For example, your HACCP plan may require that monitoring personnel examine 10 swine carcasses per hour for visible fecal
contamination prior to entering the carcass cooler. While performing verification for the monitoring requirement, FSIS inspectors determine
that your plant personnel performed seven carcass examinations between 9 a.m. and 10 a.m. Therefore, they determine that your
facility is not conducting monitoring procedures as specified in your HACCP plan and the incident must be documented as noncompliance on the NR.
In another example, let's say your HACCP plan specifies that the concentration of chlorine in the carcass rinse will be observed and
documented twice (per 8-hour shift) by your employee(s). While reviewing the chlorine concentration logbook, FSIS inspectors determine that
monitoring checks were conducted once (per 8-hour shift) during the last 3 days. Therefore, your plant is not performing the monitoring procedures
at the frequencies specified in your HACCP plan and the incidents must be documented as noncompliance on the NR.
These are just a few examples. But, by familiarizing yourself with the regulations that affect your establishment, you can ensure that
your facility remains in compliance. In future issues of Small Plant News, we'll address other common concerns
such as recordkeeping, supporting documentation, and record authenticity often documented on NRs.
For more information on noncompliance records, visit FSIS' Web site at www.fsis.usda.gov or contact the Policy Development
Division at 1-800-233-3935 or (402) 344-5000.
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Food Safety Resources
By Sally Fernandez
If you're producing ready-to-eat (RTE) products, you might be interested in the FSIS publication and DVD,
"Implementation of a Post-Packaging Heat Treatment to Reduce Listeria monocytogenes on Ready-to-Eat Products for Very Small and Small Establishments."
This publication is based on a study by Pennsylvania State University and was developed to assist you in moving from the Alternative 3 method to the Alternative
2 method to reduce Listeria monocytogenes (Lm) in RTE products. The study showed that post-packaging
heat treatment, using a hot water bath and recommended packaging, produced a 1 log or 90 percent reduction of
Lm on RTE products. The study validated that the process was effective and deemed acceptable by consumers.
The booklet gives a clear outline of the material, and the DVD demonstrates the techniques of the 10 steps to
use in the Alternative 2 method. The booklet and DVD are available at no cost. Use the online order form at www.fsis.usda.gov/Science/
or fax the form to (202) 690-6519.
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Small Plant NEWS
Editor: Keith Payne
Production: Sally Fernandez, Joan Lindenberger
Design: Gordon Wilson
Contact: Small Plant News, USDA/FSIS, Aerospace Building,
3rd Floor-Room 405, 14th and Independence Ave., SW, Washington,
DC 20250. 1-800-336-3747