IRRADIATION Q’s & A’s
May Lead to Updated
Versions in the Future)
Table of Contents
Packaging Material Issues
- Is the Agency reviewing labels for irradiated products or products
containing an irradiated meat or poultry component or can such labels be
Such labels must be evaluated by FSIS’s Labeling Consumer Protection Staff
(LCPS), Labeling Compliance Team (LCT), for an initial sketch approval.
Subsequent changes permitted by the generic labeling regulations (9 CFR 317.5
and 381.133) do not require re-approval through FSIS. However, FSIS will be
tracking the types and numbers of labels for irradiated products and products
containing irradiated meat or poultry ingredients for possible future
- Does the radura (irradiation logo) have to be green as was
previously required by the poultry regulations?
No. There are no longer any specific color requirements. However, other
countries may have different or additional requirements for importation of
- Are the labeling requirements for irradiated poultry the same as
those for beef?
Yes. The labeling requirements are identical for meat and poultry products
with respect to irradiation.
- When "irradiated" is part of the product name, e.g., "Irradiated
Beef," what other irradiation labeling is required?
The product labeling also must bear the radura.
- If a label bears the radura and a "treated with radiation" statement, but,
the company chooses to put the term "irradiated" with the product name, e.g.,
"irradiated beef patties," does the term "irradiated" become part of the
product name and need to be one third the size of the largest letter in the
Yes. Even though, in this case, the term "irradiated" is not required as
part of the product name, if a company chooses to include "irradiated" as part
of the product name, the product name sizing rules (i.e., no letter in the
product name can be less than one third the size of the largest letter in the
product name.) will apply.
- How can irradiated beef be identified in the ingredients
statement of a multi-ingredient product?
Irradiated beef can be listed in the ingredients statement either as
"Irradiated beef," or "Beef, treated by irradiation." The acceptability of
similar identifications of irradiated ingredients will be handled on a
- If a beef carcass is irradiated and then broken down into primal and
retail cuts, how would the primal and retail cuts be labeled?
The labeling of all single-ingredients products made from an irradiated
carcass must bear the radura and either the term "irradiated" as part of the
product name or the inclusion of a statement, such as, "Treated with
Radiation" or "Treated by Irradiation." Such labeling would also be required
at the grocery store for product that is packaged and placed in the display
counter for consumers.
- What are the requirements for labeling bulk irradiated product
at retail, e.g., irradiated beef in a butcher shop?
Point of purchase identification of an irradiated meat or poultry product
can be by a label on the package or by the use of placards or brochures
located next to the product.
- If ground beef is manufactured from irradiated beef or irradiated beef
trimmings, would it be labeled as "Ground Irradiated Beef?"
The product labeling would be required to include the radura and a
statement, such as, "Treated with Radiation" or "Treated by Irradiation." If
"irradiated" is part of the product name, e.g., "Ground Irradiated Beef," or
"Irradiated Ground Beef," the statement is not required. Additionally,
labeling a product as "Ground Irradiated Beef" still requires the product must
meet the standard for ground beef.
- How would a ground beef product be labeled if it was a combination of
irradiated beef and non-irradiated beef?
All that would be required on the label would be to list "beef" and
"irradiated beef" or "beef, treated by irradiation" in the ingredients
statement. However, in addition to the ingredients statement declaration, the
product label could include the radura and the required statement or the
radura and a product name which indicated the combination, e.g., "Irradiated
Ground Beef and Ground Beef," or "Ground Beef and Irradiated Ground Beef,"
depending on the order of predominance.
- What is the proper way to label a fabricated multi-ingredient product,
e.g., fresh sausage, made with only non-fluid seasonings and irradiated beef,
which is then packaged and irradiated?
The fresh sausage label would bear the radura and either be labeled as
"irradiated" sausage or contain a required statement, such as, "Treated with
radiation" or "Treated by irradiation." Secondly, the sausage ingredients
statement would identify the beef as either "Irradiated beef" or "Beef,
treated by irradiation."
- Would an irradiated meat or poultry component used in a multi-ingredient
product need to be labeled as "irradiated" in the ingredients statement of the
multi-ingredient product, if the finished product is also irradiated?
- Do point-of-purchase labeling requirements apply to restaurants?
No. There are no labeling requirements for irradiated products at
restaurants. However, FSIS is aware of several restaurants that voluntarily
disclose irradiation information on menus and encourages this type of
- What labeling statements about the purpose of radiation
processing have been authorized for use on labeling in conjunction with the
radura in addition to or instead of "Treated with radiation" or "Treated by
FSIS has reviewed and approved the following statements:
"Treated with irradiation for your food safety"
"Treated with irradiation for food safety"
"Treated with irradiation to improve food safety"
"Treated with irradiation to reduce the potential for foodborne illness"
"Treated with irradiation to reduce E. coli bacteria"
"Treated with irradiation to reduce pathogens such as E. coli and
"Irradiated for your food safety"
"Irradiated for food safety"
- Would FSIS consider the term "pasteurized" as an acceptable
term to describe the irradiation process?
At this time, labeling statements or claims for irradiated products that
include the term "pasteurization" are misleading. FSIS will continue to
examine this term in light of developments in irradiation technology and FDA
policy. In the future, use of the term "pasteurization" will be considered on
a case-by-case basis and would require significant documentation and
validation as to process controls that demonstrate that vegetative cells of
pathogens have been reduced to safe levels and produces a ready-to-eat
- We are aware that steam-pasteurization is currently permitted,
and that labeling can state that the product was steam-pasteurized. Why is the
phrase permitted on such product if not permitted on irradiated product?
The use of steam-pasteurization is only permitted for whole carcasses and
parts of carcasses that are to be further processed. Moreover, the labeling of
further processed products, such as retail cuts (e.g., ground beef, steaks)
and offal (e.g., tripe, intestines, etc.) with statements about reductions in
microorganisms or the use of the term "steam-pasteurized" is not permitted
because it is misleading to consumers.
- Can the terms "all," "pure," and "100%" be used on irradiated
Yes. The regulations in 9 CFR 317.8(b)(34) and 381.129(b)(5) specify the
terms "all," "pure," "100%," and terms of similar connotation shall not be
used on labels for products to identify ingredient content unless the product
is prepared solely form a single ingredient. Thus, irradiated, single
ingredient meat or poultry can be labeled in this manner.
- Is a "No MSG Added" claim acceptable on irradiated ground beef?
Since MSG is not classified as a non-fluid seasoning, it is not permitted
to be in a product that is subsequently irradiated. Therefore, a "no MSG
added" claim is a "negative claim" and may only be used if accompanied by the
statement "USDA regulations do not permit the addition of MSG to irradiated
- Can an irradiated product be labeled as "natural" or "certified
Organic by (a certifying entity)?"
The term "natural" can not be used since FSIS considers irradiation to be
more than minimal processing. Thus, such products would not meet the "natural"
criteria established by Policy Memo 55. Regarding the use of "certified
Organic by (a certifying entity)," we are not aware of any organization
providing organic certification that allows the use of irradiation. Further,
on March 13, 2000, AMS issued a re-proposed regulation on organic agricultural
products which does not permit the use of irradiation on products labeled
- How can a company label a box containing a variety of meat or
poultry products including some that are irradiated and some that are not
It must be perfectly clear to consumers which products are irradiated and
which products are not irradiated. The best method of conveying this
information is to include "irradiated" as part of the product name on the
principal display panel of all irradiated products as well as the radura on
- Does the labeling of the shipping container of irradiated
products require inclusion of the radura and other required information?
Not for a true shipper that is only labeled with the inspection legend and
a handling statement, if necessary, and that holds fully labeled products.
- Can whole livestock blood (dried or fluid) be irradiated?
Yes. Whole blood is considered a byproduct which can be irradiated provided
it does not contain additives, e.g., sodium citrate as an anticoagulant.
- If pork is irradiated to eliminate trichinae, can the pork be
labeled as "certified pork?"
Yes, if irradiation, in compliance with requirements in 21 CFR 179.26 for
treatment of trichinella spirallis, is used to treat pork and the company
demonstrates that viable trichinae have been destroyed or rendered ineffective
in causing infection, the resulting pork can be labeled as "certified pork."
Additionally, all of the other labeling requirements for the irradiated
product, i.e., use of the radura and the required statement or the radura and
"irradiated" as part of the product name would be required. Furthermore, when
such irradiated pork is used in a secondary product, the ingredients statement
must identify the pork as "Irradiated Pork" or "Pork, treated by irradiation."
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- Consider this situation: A company intends to use irradiated beef in its
beef patty; however, it is concerned about the availability of the irradiated
beef component. Can the company use "and/or" or "may contain" labeling with
respect to the irradiated beef component?
No. Consumers wishing to purchase products containing an irradiated meat
component consider the irradiated meat to be a "valuable" constituent of the
finished product. FSIS labeling regulations do not include provisions for
"and/or" labeling and policies have not permitted the use of a "may contain"
statement in reference to a "valuable" component, e.g., truffles, veal, etc.
FSIS policies have only permitted the use of a "may contain" statement with
"minor" ingredients, generally under two percent of the total formulation,
that do not affect the character of the product. FSIS has never considered the
meat or poultry components to be classified to be "minor" in this situation.
- What are non-fluid seasonings?
Non-fluid seasonings are dried spices, e.g., thyme and basil, dried
flavorings from botanical sources, e.g., garlic powder and lemon powder, salt
and sugar. Ingredients such as MSG, autolyzed yeast extract, hydrolyzed
(source) proteins, and garlic have not been considered to be non-fluid
seasonings. For example, whole garlic is a vegetable, not a spice, while
garlic powder is a spice/seasoning.
- If non-meat/non-poultry ingredients, such as irradiated spices,
wheat flour, potatoes, and fruits, are added to an irradiated or
non-irradiated meat/poultry product, must the fact that they have been
irradiated be disclosed in the ingredients statement?
No. However we would permit this ingredient statement identification for
irradiated non-meat and non-poultry components.
- For the purposes of irradiation, are ingredients such as BHA,
BHT, TBHQ permitted in sausage products that will be irradiated?
At this time, no.
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PACKAGING MATERIAL ISSUES
- Do poultry products that are packaged and irradiated still need to be
packaged in air permeable packaging materials?
Yes, until FDA issues a final rule that no longer mandates the use of air
permeable packaging materials for irradiated poultry products. However,
poultry that is irradiated and packaged after irradiation is not required to
be packaged in air permeable packaging materials.
- If meat and poultry are packaged together and irradiated, would
they need to be packaged in air permeable packaging materials?
Yes. While red meat alone is not required to be packaged in air permeable
packaging materials if packaged prior to irradiation, because that requirement
still exists for poultry, a combination, e.g., beef roast and chicken breast
packaged together prior to irradiation would have to be packaged in air
permeable packaging materials.
- Can meat irradiated with electron beam be packaged in the same
packaging materials as meat irradiated by gamma ray?
Yes. Recently, FDA provided approval on a trial basis (until February 22,
2001) to permit any of the materials currently approved under 21 CFR 179.45 to
be used when pre-packaged meat food and poultry food products are treated with
X-ray, electron beam and gamma ray irradiation under the following conditions:
- "The irradiation processor will comply with all general provisions for
food irradiation listed in sections CFR 179.25 and 21 CFR 179.26(b);
- The machine sources of X-radiation and electron beams are used at dose
levels not to exceed that specified in section 21 CFR 179.45 for packaging
materials used, and at dose levels not to exceed those specified in 21 CFR
179.26(b) for the foods packaged;
- With the exception of the radiation source, as noted above, the
packaging materials must comply with all other provisions of 9 CFR 179.45;
- FSIS will monitor the participating establishments and immediately
inform FDA of any unexpected findings."
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- Can hot-boned meat or poultry be irradiated?
As of today, no. The regulation covers only refrigerated or frozen product.
However, FSIS has petitioned FDA to allow the irradiation of hot-boned meat
- Will USDA accept imported meat and poultry products that have
been irradiated in other countries into the US for distribution?
Yes, provided they were treated and labeled consistent with USDA
- If a company has its product irradiated, at another facility,
must the HACCP plan at the producing establishment incorporate the irradiation
step and CCP, or can there be two separate plans, i.e., one at the producing
establishment and one at the irradiation establishment?
FSIS considers any firm that irradiates meat food or poultry products to be
an official establishment. Official establishments are required to irradiate
meat food and poultry products only in accordance with HACCP systems. If an
establishment contracts for its products to be irradiated for the purpose of
reducing pathogens, we expect that establishment to have a CCP in its HACCP
plan for irradiation, even though it does not conduct the irradiation in its
own facility. Through review of receipts, certificates, and other records
provided by the irradiator, the establishment would monitor and verify that
its product was irradiated in accordance with its HACCP plan, contractual
specifications, and the regulations. We also expect an establishments that has
contracted out irradiation to address hazards it has identified to complete
and sign its pre-shipment review only after verifying that its products have
received the appropriate irradiation treatment by the contractor.
- Can meat be irradiated more than one time?
Yes, but the total permitted absorbed dosage can not be exceeded. In these
situations, it is the responsibility of the manufacturer to maintain records
to document permissible limits are not exceeded.
- What can be done with products that inadvertently receive too
high an irradiation dosage?
The products must be condemned as inedible and denatured.
- Are there special concerns with a fabricated multi-ingredient
product, e.g., fresh sausage, made with only seasonings and irradiated beef,
which is then packaged and irradiated?
Yes. Total dosage of irradiation permitted for beef and other components,
e.g., spices, could not be exceeded. Additional recordkeeping would probably
be necessary to ensure that the maximum absorbed dosage is not exceeded.
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