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Make "Test and Hold" an Integral Part of Your Operation
By Larae Booker
"Test and hold" is a relatively simple concept: test product for adulterants; wait for the results; then ship
the product after results come back negative.
Not only is "test and hold" a common sense approach to food safety, it's also a good business practice. Industry,
regulators, and consumers all have a part to play in the food safety continuum, but ultimately you, the establishment, are
liable for the product that comes out of your door. Holding product pending test results is one way to protect your company
from the potentially devastating effects of a recall.
And, as Dr. Jay Wenther, executive director of the American Association of Meat Processors (AAMP), added, "Whether it's one
pound or thousands of pounds of product [subject to recall], you're liable."
The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) does not mandate holding product
pending test results, but strongly urges plants to take up the practice. And, industry associations like AAMP are stressing
"test and hold" to their membership. So, if it's such a simple concept that helps ensure food safety and makes perfect business sense,
what establishment wouldn't want to hold product?
For owners of small and very small plants, the answers aren't so simple. What about the small plant owner who sells product
on the same day for immediate use? What about establishments that make product with a short shelf life? Or those plants with
little to no space to store product while waiting for results? Is "test and hold" an option for them?
There is no single, uncomplicated answer. But the "to hold or not to hold" dilemma comes down to a matter of ability—if
you can hold product, it is recommended that you do so.
There are certain practices that make testing and holding product more feasible for plants of all sizes. Freezing tested,
finished products for a longer shelf life or creating systems to identify and track material by supplier or lot, for instance, are
some operational adjustments that help establishments control tested product. Plants may also take steps to better control product,
such as keeping tested product separated and working with FSIS inspectors to arrange advance notification when samples are taken.
AAMP was one of several industry associations that coordinated to produce these and more best practices in a document titled
Industry Best Practices for Holding Tested Products, issued in September 2005 and facilitated by the International HACCP Alliance.
The document offers considerations for establishments producing raw products, as well as those producing ready-to-eat products.
"What we've found," Wenther explained, "is that once our members make some minor changes—such as issuing specific guidelines for
their operation or using tags [to identify lots and suppliers]—they realize that holding the product is a good business practice
that can be accomplished." A little ingenuity and a few extra steps may make holding tested product possible at your establishment,
no matter how small it is.
A more troubling approach is to take no action at all. Given the low number of positive sample results, plants may be tempted to
think that a recall won't happen to them. The risk is minimal, but it still exits. And an upward trend in pathogen-related recalls in
recent years should have more plants considering the importance of holding tested product and incorporating the practice into their testing program.
Wenther likes to compare having a "test and hold" program in place at your establishment to having any type of insurance: "You'll wish you had it when you need it."
Therefore, take steps to hold tested product at your establishment. It protects you and your consumers. If you'd like more information on
implementing a "test and hold" program, the Industry Best Practices for Holding Tested Products document is available on the International
HACCP Alliance Web site at http://haccpalliance.org/sub/food-safety/
HoldingTestedProdSept1905.pdf (PDF Only).
The trade associations that assisted in developing this document are also good resources and are listed in it. For further assistance,
call FSIS' Office of Outreach, Employee Education, and Training at (800) 336-3747.
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Producing Partially Cooked Products? Review the Proper Labeling Requirements
By Denise Amann
In March 2006, FSIS posted a Class I recall notice announcing the voluntary recall of
approximately 75,800 pounds of frozen, stuffed chicken entrees. The cooked appearance of these uncooked chicken products may have
led consumers to believe that the products did not need to be heated to a safe minimum internal temperature prior to consumption.
In response, FSIS focused its efforts on additional labeling requirements for all partially cooked products with a cooked appearance.
Labeling is now required to clearly state that products of this type are only safe to eat with proper preparation.
Examples of commonly recognized products with these labeling requirements include: partially cooked beef patties, char-marked beef/chicken patties,
partially cooked breaded chicken patties and nuggets, partially cooked stuffed chicken products, partially cooked turkey products,
and partially cooked chicken Kiev. This list should include any meat product that is purchased by the consumer uncooked, raw, or not
ready to eat that has a cooked appearance, whether frozen or refrigerated.
In addition to the standard labeling requirements applicable to all inspected product, there are three criteria that must be met when
labeling partially cooked product with a cooked appearance.
- The label must contain a clear, concise statement that the product is not ready to eat. Statements that would be considered acceptable are "RAW," "RAW-Cook Thoroughly," "Uncooked," or "NOT Ready to Eat."
- The label must contain a specific endpoint internal temperature. For example, with partially cooked poultry products, "Product Must be Cooked to a Minimum Internal Temperature of 165 °F." This temperature will destroy Salmonella, the most heat-resistant pathogen of public health concern in raw poultry.
- The label must advise the consumer to determine internal temperature using a food thermometer. A food thermometer is the most accurate way to determine internal temperature. Changes in product texture or color are not accurate indicators that the product has reached a safe minimum internal temperature.
All of the items listed above must be located on the principal label adjacent to the product name and recognized easily by consumers.
The cooking instructions must also include the endpoint temperature as determined by using a food thermometer. As with all labels, the cooking
instructions can appear anywhere on the retail package and must include validated cooking method(s). As part of validating cooking instructions,
plants must maintain data that supports that the cooking instructions, when followed correctly, are practical and achieve a safe minimum internal
temperature throughout the product.
For more information about this and other labeling requirements, visit the Compliance Guidance Index on FSIS' Web site at
Or call the FSIS Labeling and Consumer Protection Staff at (202) 205-0623 or (202) 205-0279.
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Avoiding Noncompliance Records: Supporting Documentation Requirements
By Commander Jeff Tarrant, U.S. Public Health Service
In previous issues of Small Plant News, we introduced to you FSIS Form 5400-4, more commonly referred to as the Noncompliance Record (NR).
This document is generated whenever FSIS inspectors determine that an establishment has failed to meet one or more regulatory
requirements of the Federal Meat Inspection Act or the Poultry Products Inspection Act. An NR describes each noncompliance
in clear and concise terms, states how FSIS notified the plant of the issue, and identifies whether any regulatory action has been taken.
In this issue, we'll address common NRs originating from supporting documentation requirements. According to Title 9 Code of Federal
Regulations (CFR) 417.5(a), each establishment's recordkeeping system must contain a written Hazard Analysis and Critical Control Point (HACCP) plan,
the documents used to develop the HACCP plan, and the records that monitor and document readings at critical control points.
FSIS Inspectors are trained to review a plant's supporting documentation relating to their HACCP plan, hazard analysis, and any
decisionmaking documents. Supporting documentation that establishments often use include: scientific journal articles, Federal regulations,
pathogen modeling, processing authority, research applicable to the specific process, and historical data.
In an effort to understand 9 CFR 417.5(a)
better, let's look at a few examples of supporting documentation compliance and noncompliance.
FSIS Inspector Karen Brown (fictitious individual for this scenario) is reviewing a plant's hazard analysis documentation and process
flow diagram for its raw ground beef patty operations. During the inspection, she finds that all of the steps in the actual plant operations
are described in the flow diagram and each step is addressed in the hazard analysis. She also finds that the hazard analysis considers
potential biological, chemical, and physical food safety hazards at each step.
Where potential food safety hazards are identified, the plant has made a determination about whether or not they are reasonably likely to occur,
and recorded the basis for that decision. For the receiving step, this plant has identified that there is a physical food safety hazard,
"foreign material," but determined that it's not reasonably likely to occur on the basis that "plant records show that there has been no
incidence of foreign materials in products received in the plant."
Inspector Brown requests supporting documentation for this decision, and she is provided a copy of a procedure for physical examination
of raw material receiving and the raw material receiving examination log. Upon review, she determines that there are no significant findings
of foreign material. And, because the hazard analysis appears to have been conducted appropriately and is backed up with credible supporting
documentation, the inspector determines that the establishment is in compliance.
In another example, FSIS Inspector Josh Snow (fictitious individual for this scenario) is reviewing a plant's HACCP plan for baked chicken.
During the review, he observes that there is no stabilization critical control point. He is concerned by this and decides to review the hazard
analysis to determine how this decision was made.
Inspector Snow finds the plant concluded that since the product is rapidly chilled, a hazard is not likely to occur. In addition, he also
finds that the plant had no prerequisite program covering the stabilization of this product. The inspector concludes that the establishment
has no documentation supporting the verification procedure, due to the fact that chilling is not sufficient to state that a hazard is not
likely to occur, and is not in compliance with 9 CFR 417.5 (a).
Consequently, an NR is generated.
These are just a couple of examples of examining supporting documentation. By familiarizing yourself with the regulations that affect your
establishment, you can ensure that your facility remains in compliance. In the next issue of Small Plant News, we'll address another common
noncompliance topic—record authenticity. For more information on NRs, visit FSIS' Web site at www.fsis.usda.gov, or call the
Program and Policy Development Division at (800) 233-3935 or (402) 344-5000.
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Commonly Asked Questions & Answers
Q. If a plant relies on its own product cook tests for its validated cooking instructions, must the
cook tests be approved by a process authority?
A. No. Plants may rely on their own product cook tests, provided that the conditions studied in the validation
testing support the parameters stated in the labeled cooking instructions.
Q. What are some distinctions an establishment may use when validating cooking instructions for products that
contain raw or partially cooked poultry products, described in FSIS Notice 75-06, versus those for other not-ready-to-eat (NRTE) products?
A. The distinction relates to how the cooking instructions on the label for products that are for sale to the
consumer must be validated. For products that are produced specifically for food preparation operations (e.g., hotels, restaurants, school
lunch programs, and other institutions), this distinction does not apply.
To explain further, products covered by Notice 75-06, that appear to be ready-to-eat, but are not, must be labeled with cooking
instructions for the consumer indicating that the product must be cooked to an internal temperature of 165 °F. The cooking instructions on
the package must be validated as reaching this internal temperature.
For other NRTE products (those not covered by Notice 75-06), the cooking instructions on the label for products for sale to the consumer
may be based on the final internal temperature, or they may be based on a combination of an internal temperature and holding time to achieve
the appropriate lethality. These combinations can be found in Appendix A of the Compliance Guidelines for Meeting Lethality Performance
Standards for Certain Meat and Poultry Products (www.fsis.usda.gov/OPPDE/rdad/FRPubs/95-033F/
or in Time and Temperature Tables for Cooking Ready-to-Eat Poultry Products
RTE_Poultry_Tables.pdf, PDF Only),
which supplements Appendix A with updated information. For example, based on Time and Temperature Tables for Cooking Ready-to-Eat Poultry Products,
a product could be cooked to 160 °F and held at that temperature for 14.5 seconds to achieve the same lethality as cooking to 165 °F.
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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