QUESTIONS AND ANSWERS
Production Information on Post-Lethality
Ready-to-Eat Meat and Poultry Products
Note: Questions # 13f, 13g, 28 and
29 were added on Oct 15, 2004.
Questions # 30, 31, 32 and modification for #12 (in italics) were added on Oct 22, 2004.
Question # 33 and modification for #13e and 13f were added on Oct 29, 2004.
- QUESTION: Where can the form 10,240-1 be obtained?
RESPONSE: The form can be downloaded from the FSIS web site
or can be requested from FSIS by calling 202-720-3219.
QUESTION: Why is the plant category
question asked only on Page 3 of the form?
- QUESTION: If an establishment produces only Alternative 2 products, should it return only page number 2 of the form or should it return all three pages with notation on pages 1 and 3 that no Alternative 1 or 3 products are produced?
RESPONSE: The establishment can either
submit all three pages with a note on pages 1 and 3 saying
"no post-lethality exposed RTE products are produced with
this Alternative", or can submit only page 2 with a similar
notation that it does not produce products under
Alternatives 1 and 3.
- QUESTION: Page 3 of the form
(Alternative 3, Part 3C) asks what category (size) the
How is that determined?
RESPONSE: The category of a plant according to size (Large, Small and
Very Small) is determined on the basis of the Small
Business Administration´s definitions of a business and
referenced in the Pathogen Reduction/HACCP final rule (61)
FR 38806, as follows:
- Large establishments are defined as all establishments
with 500 or more employees
- Small establishments are defined as all establishments
with 10 or more employees but fewer than 500 employees.
- Very small establishments are defined as all
establishments with fewer than 10 employees or annual
sales of less than $2.5 million.
RESPONSE: The question on the size of the establishment was
placed on the page for Alternative 3 questions because FSIS
guidance on testing food contact surfaces varies according
to the size category of the establishment. Since FSIS
guidance for testing food contact surfaces for
post-lethality exposed products under Alternatives 1 and 2
does not vary according to the size category of the
establishment, this question was not necessary for RTE
product produced under Alternative 1 or Alternative 2.
QUESTION: How is the establishment
supposed to estimate their production volume? One year it
may be 60,000 pounds but the establishment could get an
order from one customer and increase production for that
item for additional 100,000 pounds. Are previous year´s
RESPONSE: The establishment can utilize the previous year´s production
amounts or estimate the current year´s production volume.
Please note that on the bottom right of Page 4 of FSIS Form
10,240-1, it states that producers should submit a revised
form any time there is a significant change in volume of
QUESTION: On the form where it asks
about "Annual Production" does FSIS want the total amount
of finished product or the amount of Meat/Poultry used to
manufacture the finished product?
RESPONSE: The total amount of
finished product produced in accordance with 9 CFR 430 and
without regard to the intended use of the product (e.g.,
for institutional purposes or retail sale).
QUESTION: When recording the annual
volume, what basis should be used: previous actual annual
production, or a projected total for the current year?
RESPONSE: Either total will be
sufficient. If the current year will differ significantly
from the previous actual annual production, projected
total for the current year is preferred.
QUESTION: Is the information provided
by the plant available through the Freedom of Information
RESPONSE: No, this is
proprietary information, and therefore exempt from
QUESTION: The official establishment
produces products under both FSIS and FDA jurisdiction.
Should they report all products regulated by FDA and FSIS
RESPONSE: No, report
only the products subject to 9 CFR 430 Form 10,240-1 form.
QUESTION: Does the "Fully Cooked" category include the
total of deli meats, hot dog products and others?
RESPONSE: No, the "Fully cooked" category refers to all
other fully cooked products that are not included in the deli meats and hot dog categories.
QUESTION: The establishment produces 3
different products covered by Alternative 2. Should they
all be totaled together on the same form?
RESPONSE: Yes, all products under Alternative 2
should be entered on the same form.
QUESTION: If an establishment produces
products that are not required to meet the requirements
of 9 CFR 430, does it need to complete and submit FSIS
RESPONSE: No, if a company´s product is not
subject to the regulatory requirements of 9 CFR 430, there would be no
need for the company to complete any portion of the form or to send in a
form. RTE products that are not post-lethality exposed
are not required to comply with 9 CFR 430. Establishments
are not expected to submit the survey form for the
following types of RTE products because they are not
Non-RTE products are not covered by 9 CFR 430, e.g.
partially cooked products; products intended for further
processing and labeled for further processing. For these
products, the establishment does not need to complete and
submit the survey form.
- fully cooked product in cook-in-bag that is shipped
from the establishment in the intact cooking bag;
- products receiving lethality treatment and hot-filled
as long as the lethality temperature and sanitary
handling are maintained during the period of time in
which the product moves from the point of lethality to
the point of packaging. Establishments would need
documentation on file which supports that the lethality
temperature and sanitary handling are maintained
continuously from the point of lethality to the point of
- thermally processed commercially sterile products
QUESTION: Under which box would the
following products listed below fit, since they are not
listed on FSIS Form 10,240-1.
RESPONSE: The items listed on
each page of the form are examples only and are not
all inclusive. Some examples of products not listed
on the form:
QUESTION: How does an establishment
determine the classification of its product?
- Polish sausage (Would it be "fully
cooked" or "hot dog"?)
If it has received a lethality which is sufficient to render it
RTE, then it would be "Fully Cooked". It would not be a
"Hot Dog" product because polish sausage does not meet
the standard of a Hot Dog as defined by 9 CFR 319.180)
- Fully cooked bone-in picnic
shoulders and fully cooked bone-in hams that are not
typically sliced and assembled into a sandwich
If these products have received a lethality sufficient
to render them RTE, these products would all be
considered "Fully Cooked".
- Pork rinds, Chitterlings, Menudo
If these have received
a lethality which is sufficient to render them RTE, then they would be
- Beef sticks and summer sausage that are not
If these unfermented products have
been exposed to a lethality that is sufficient to result in
a fully cooked ready to eat product, then they would be
documented under "Fully Cooked Products".
- Does edible tallow, some of which bears
the mark of inspection and goes for further processing for
use in edible products and some of which does not, but is
further processed into cosmetics, soaps, etc., need to be
identified on FSIS form 10, 240-1?
tallow, produced under federal inspection, is eligible to
bear the mark of inspection. Therefore, post-lethality
exposed RTE fats and oils are subject to the requirements
of 9 CFR 430. However, edible tallow that is marked "for
further processing" and not considered RTE is not subject
to the requirements of 9 CFR 430 provided the establishment
has documentation to support this. Federally inspected RTE
fats and oils that are marketed by the establishment as
inedible products and shipped without the mark of
inspection are not subject to the requirements of 9 CFR
Those that are marked “for further processing”
are not subject to the requirements of 9 CFR430. Those that
are not intended for further processing, bear no label “for
further processing” and are considered post-lethality
exposed RTE are subject to the requirements of 9 CFR 430.
- Fully cooked hamburger and cheeseburger
sandwiches (under voluntary inspection) which are kept
frozen until the consumer microwaves them
Fully cooked hamburger and cheeseburger sandwiches are
traditional, closed face sandwiches which are prepared by
inserting inspected and passed fully cooked hamburger
patties between two biscuits, bun, or bread. These
sandwiches are under FDA jurisdiction and therefore are not
amenable to the Federal Meat Inspection Act. The Listeria
rule (9 CFR 430) is not applicable and the establishment
does not have to complete Form 10,240-1.
Sanitation SOP regulations (9 CFR 416.11 - 416.16) and
HACCP regulations (9 CFR 417) do not apply to non-amenable
product produced under voluntary inspection. If these
products are under voluntary inspection the sanitation
requirements of the voluntary regulations still apply
(i.e., still must be produced under sanitary conditions)
However, production of fully cooked hamburgers (i.e.,
the preparation of the meat patties) is under USDA
jurisdiction and is applicable to 9 CFR 430, and therefore,
Form 10,240-1 needs to be completed. If the establishment
produces fully cooked hamburgers and prepares the
sandwiches, the hamburger production is covered by the rule
and Form 10,240-1 needs to be completed.
- Fully cooked chicken wings which are
kept frozen until the consumer microwaves them
Fully cooked chicken wings fall under the fully cooked
category and are also covered by the rule because these are
post-lethality exposed during packaging.
RESPONSE: In determining the
classification of a product, the establishment has to
determine the principal lethality treatment that the
product receives or the lethality treatment that is
sufficient to render the product RTE.
QUESTION: If an establishment indicated that it does
not conduct any Listeria testing, should the plant be doing the testing?
RESPONSE: The establishment should
determine to what Alternative its product falls under and
make its decision as to whether it needs to do testing
based on the requirement of 9 CFR 430.
If the product is subject to the regulation, the establishment must select an
Alternative under which they will conduct their
operations. Whether or not the company is conducting
Listeria testing of some type will be dependent upon
which Alternative it has selected.
QUESTION: What method should be used to determine the proper category in Boxes 2 and 3 of any/each of the Alternatives when the product fits two or more categories (i.e. An "Other than Deli Product" such as fermented products that are sliced at the establishment but also sliced after distribution from establishment. An example would be hard salami or pepperoni that is sliced at the plant for distribution or at a deli for incorporation into a sandwich). Would the product be classified as Other than Deli/Fermented or as Deli/Sliced at Official Establishment and/or Deli/To be sliced after Distribution?
RESPONSE: For these types of products,
the establishment should place the product in the category
where it poses the highest risk. For this product, an
establishment can place it under Fermented Products or
under Deli Products. However, since it is sliced at the
establishment or sliced at the deli, it should be placed
under Deli Products since this is the higher risk category.
Also, if the establishment slices and packages the product,
the deli is not expected to slice it again. So for this
product, placing it under Deli Products/Sliced and Packaged
at the establishment would be a logical placement.
QUESTION: If sodium lactate is added
to a product as an antimicrobial inhibitor. Where can
an establishment get information on validation of Sodium
RESPONSE: When sodium
lactate was used as an antimicrobial inhibitor in the
product, there should be some documentation from the
manufacturer. That documentation may have provided
scientific studies as to how much lactate to add to the
specific product and the effectiveness of the amount added
in inhibiting the growth of Listeria through the shelf life
of your product. The manufacturer of the lactate should be
able to provide guidance on how to obtain the validation
information. The compliance guidelines for control of Listeria monocytogenes in post lethality exposed product
(on FSIS web site
http://www.fsis.usda.gov/RD_97-013F/) have references to some scientific documentation that is
QUESTION: Pages 1 and 2 (Block 3) want to know about validated log reductions. What is meant by "validation"?
RESPONSE: Validation is defined as the
process of ensuring that a defined set of control measures
is capable of achieving appropriate control over a specific
hazard in a specific food. For example, an establishment
that subjects its fully cooked, sliced, and repackaged
product to steam pasteurization would consider its product
to be under Alternative 1 or 2. To be able to consider the
product in Alternative 1 or 2, the establishment must have
supporting documentation that the treatment (steam
pasteurization) will reduce the number of L.
monocytogenes in the product by a certain number. This
supporting documentation must come from a validation of the
treatment. The validation of the treatment can be achieved
by a challenge study or by using a published study applying
the same time/temperature of treatment on the product and
other factors in the study.
QUESTION: FSIS Notice 49-02 says that a company that "produces post lethality exposed RTE products.." must provide production information to FSIS. What is meant by "post-lethality exposed"?
RESPONSE: Per 9 CFR 430.1, a ready to
eat post-lethality exposed product is a product that comes
into direct contact with a food contact surface after the
lethality treatment in a post lethality processing
environment. An example of post-lethality exposed product
is sliced and packaged luncheon meat. The luncheon meat is
first fully cooked in a bag, then taken out of the bag,
sliced and repackaged. Fully cooking the product is the
lethality treatment. After cooking (post-lethality) when
the product is removed from its cooking bag and sliced, it
is exposed to the post- lethality processing environment
and can get contaminated with L. monocytogenes.
QUESTION: For an Alternative 2 product that is frozen, is the appropriate response to the "validated or highest increase in L. monocytogenes allowed" - "not applicable" or "less than 1 log?"
RESPONSE: The appropriate response would be "less than 1 log" because there is no growth or outgrowth potential when products are frozen.
QUESTION: If a plant produces a barbecue product, (either beef or pork) is the tomato ketchup considered to be a secondary inhibitory if it has a pH of 4.7?
RESPONSE: Generally, topical application of tomato ketchup with pH of 4.7 would not be considered an effective secondary inhibitor. However, to be able to qualify as an inhibitor or antimicrobial agent, both the exposed surface of the product in which
L. monocytogenes can contaminate the product and the sauce should have a pH of less than 4.39 for an appropriate time (see Compliance
Guidelines at http://www.fsis.usda.gov/RD_97-013F/.
The establishment would need documentation to validate or support the antimicrobial activity of the antimicrobial agent.
QUESTION: Block B for Alternative 3 asks for the total percent of food contact surface (FCS)
and environmental samples positive for Listeria
spp. or Listeria-like organisms. The question does not differentiate between environmental and FCS test results. How will FSIS incorporate the differences in data from each type of sampling?
RESPONSE: The objective of the
question is to determine the effectiveness of sanitation
since that is the control for L. monocytogenes in
Alternative 3. Sanitation involves cleaning FCS and non-FCS
in order to eliminate L. monocytogenes from the
processing operation. In addition, since the frequency of
FCS testing relative to environmental sampling is very low
and the available data is small, both types of samples must
be considered together for the data to be meaningful.
QUESTION: What if an establishment does
not test food contact surfaces because the regulation does
not require this in Alternative 1 or with a post-lethality
treatment in Alternative 2? Should it put not applicable
"NA" or does less than 2 times a year also include not
RESPONSE: A response of
"less than 2 times" is not appropriate because it implies
that some level of testing occurs. If no testing is
conducted for Alternative 1 or Alternative 2 using a
post-lethality treatment, please write "No testing done".
QUESTION: If a very small facility does
not have lines, how is the question about "each line" to be
RESPONSE: A line is
defined as the start of the process to the finished
product. A line does not refer to a sequence of equipment.
An establishment producing only 1 product would have at
least one line.
QUESTION: How is "authorized official" defined? Is this the person named on the grant of inspection or can any designated person at my establishment complete and sign the form?
RESPONSE: Each establishment should decide who within the organization is responsible for providing the information and signing the form.
QUESTION: Why does the form switch from year to month when asking about testing of food contact surfaces in Alternative 3 Block 3 A which asks about per month compared to Alternative 1 and 2 Block 3 C which is per year?
RESPONSE: Because Alternative 3
product would present greater risk for becoming
contaminated, if the food contact surface contains
Listeria monocytogenes, and the product and process
would not impede the growth of the pathogen throughout the
expected shelf-life. Thus, verification of good sanitation
is one way to demonstrate effectiveness of sanitation on a
more frequent basis. The other alternative control measures
have one or more steps to either reduce or eliminate the
pathogen should it be present. Thus, sanitation is not the
primary means of demonstrating effectiveness of the control
QUESTION: If an establishment produces
beef flavoring (paste) under USDA inspection, is it
required to complete the form?
If the product is post-lethality exposed and is considered
by your establishment to be used as a ready-to-eat product
(i.e., will not undergo further lethality treatment by the
consumer), then 9 CFR 430 is likely applicable and a form
must be completed. If the product is labeled "for further
processing" then 9 CFR 430 is not likely applicable and a
form is not required.
QUESTION: For multi-component products
like "lunchables" (contains meat, cheese, crackers, juice,
etc.) or chicken Caesar salad (chicken, salad greens,
dressing), for the "Annual production volume", which one
should be entered: a) the annual production volume of the
entire product; or b) the annual production volume of the
meat or poultry component?
For multi-component products where the meat or poultry
component is separated from the other components in the
package, such as in "lunchables", only the annual
production volume estimate for the meat or poultry
component should be reported. For multi-component products
where the meat or poultry component is mixed and in contact
with all the other ingredients, such as in chicken Caesar
salad, the production volume estimate for the entire
product should be reported.
QUESTION: If an establishment tests food
contact surfaces one time per week, taking 6 different
samples each time, with a total of 24 samples each month,
which answer should the establishment check: a) 4 times a
month; or b) more than 4 times a month?
The establishment can check "4 times" per month in the
block for testing food contact surfaces. The frequency of
testing is one time a week regardless of the number of
QUESTION: An establishment produces a number of different products under the same product category (e.g., deli products sliced and packaged at the official establishment) but each product either has a different validated log reduction or number of times the food contact surface (FCS) is tested per month. Should the establishment check each appropriate box for the same block (e.g., 3 checks for Block 3.A.) or complete a separate form for each product in the Alternative?
ANSWER: If the establishment has
more than one product under a product category, it should
use a separate form for each product because each product
may differ in production volume, log reduction achieved,
the amount of growth of L. monocytogenes allowed by the
antimicrobial agent or process, or the number of times a
FCS is tested. For example, for the product category "Deli
products sliced and packaged at the official
establishment", if the establishment has two or more
different products, it should complete one form for each
product, particularly addressing both Block 2 and Block 3.
If, for example, the products are different within the
category (e.g., sliced roast beef versus sliced roast pork)
but the lethality reduction, amount of growth of L.
monocytogenes, and FCS testing are the basically the same,
then only one form should be completed but the volume of
production should reflect the total volume for the product
QUESTION: Is a spray-dried meat or
poultry fat product considered to be RTE as per 9 CFR 430.4
ANSWER: Since the spray-dried
meat or poultry product receives a full cook and is shelf
stable, FSIS considers it to be RTE (refer to the
definition of RTE contained in Attachment 2 of the
Compliance Guidelines). If it is a post-lethality exposed
product, it is covered by the rule. However, if the product
is packaged immediately after the lethality treatment such
that there is no exposure to the post-lethality environment
during packaging (or the exposure is addressed through
special sanitary handling), and the establishment has
documentation to support this, the product can be
considered by the establishment to not be post-lethality
exposed and therefore not covered by the rule.
QUESTION: Should the Form 10,240-1 be
completed for fully cooked pickled pig's feet and pickled
cooked pickled pig's feet and pickled cooked sausage are
both considered by FSIS to be RTE products that are exposed
to the environment prior to packaging and are covered by 9
CFR 430. Therefore, Form 10,240-1 should be completed for
QUESTION: If an establishment is starting production of its RTE products in 4-5 months, does it have to submit Form 10,240-1 on the DUE date that FSIS established, or can it wait until production begins?
ANSWER: The establishment should complete the survey form for post-lethality exposed RTE products it is currently producing. The establishment should complete the form for new products when it starts producing them.
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