[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07926]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 179
[Docket No. FDA-2001-F-0049 (Formerly Docket No. 01F-0047)]
Irradiation in the Production, Processing and Handling of Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (``FDA'' or ``we'') is
amending the food additive regulations to provide for the safe use of
ionizing radiation for control of food-borne pathogens in crustaceans
at a maximum absorbed dose of 6.0 kiloGray (kGy). This action is in
response to a petition filed by the National Fisheries Institute.
DATES: This rule is effective April 14, 2014. See section VII of this
document for information on the filing of objections. Submit either
electronic or written objections and requests for a hearing by May 14,
ADDRESSES: You may submit either electronic or written objections and
requests for a hearing identified by Docket No. FDA-2001-F-0049, by any
of the following methods:
Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Submit written objections in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2001-F-0049 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section.
Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville,
FOR FURTHER INFORMATION CONTACT: Teresa A. Croce, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1281.
In a notice published in the Federal Register of February 6, 2001
(66 FR 9086), we announced that a food additive petition (FAP 1M4727)
had been filed by the National Fisheries Institute, 1901 North Fort
Myer Dr., Arlington, VA 22209 (petitioner). The petition proposed that
the food additive regulations in part 179, Irradiation in the
Production, Processing and Handling of Food (21 CFR part 179), be
amended to provide for the safe use of approved sources of ionizing
radiation for control of food-borne pathogens in raw, frozen, cooked,
partially cooked, shelled, or dried \1\ crustaceans or cooked or ready-
to-cook crustaceans processed with batter, breading, spices, or small
amounts of other food ingredients. In a letter dated July 16, 2009, the
petitioner asked FDA to modify the scope of the petition to exclude
consideration of breaded and battered crustaceans. Subsequently, we
published an amended notice of filing for the petition of February 6,
2001, in the Federal Register (74 FR 47592; September 16, 2009),
indicating that the petition proposed to amend the regulations in part
179 to provide for the use of ionizing radiation for the control of
food-borne pathogens in raw, frozen, cooked, partially cooked, shelled,
or dried crustaceans, or cooked or ready-to-cook crustaceans processed
with spices or small amounts of other food ingredients. On August 31,
2012, at our request the petitioner clarified the scope of its amended
petition from 2009 by providing us with a list of the particular
``other food ingredients'' that would be added to the crustaceans prior
to being irradiated (Ref. 2).
\1\ Dried crustaceans refer to crustaceans with a water activity
(aw) of 0.85 or below (Ref. 1).
The petitioner requested a maximum absorbed dose of 6.0 kGy to
achieve a 6-log reduction of Listeria monocytogenes.
II. Evaluation of Safety
Under section 201(s) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 321(s)), a source of radiation used to treat
food is defined as a food additive.\2\ While the source of radiation is
not literally added to the food, the radiation is used to process or
treat food, such that, analogous to other food processing technologies,
its use can affect the characteristics of the food. In the subject
petition, the intended technical effect is to reduce the microbial load
on and prolong the shelf life of crustaceans.
\2\ The term ``food additive'' means any substance the intended
use of which results or may reasonably be expected to result,
directly or indirectly, in its becoming a component or otherwise
affecting the characteristics of any food (including any substance
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food; and
including any source of radiation intended for any such use) (21
Under section 409(c)(3)(A) of the FD&C Act (21 U.S.C.348(c)(3)(A)),
a food additive cannot be approved for a particular use unless a fair
evaluation of the evidence establishes that the additive is safe for
that use. Safe or safety in the context of food additives ``means that
there is a reasonable certainty in the minds of competent scientists
that the substance is not harmful under the intended conditions of use.
It is impossible in the present state of scientific knowledge to
establish with complete certainty the absolute harmlessness of the use
of any substance.'' \3\
\3\ 21 CFR 170.3(i).
The FD&C Act does not prescribe the safety tests to be performed
and not all food additives require the same amount or type of testing.
The amount and type of testing required to establish the safety of an
additive will vary depending on the particular additive and its
Specifically, in evaluating the safety of a source of radiation to
treat food intended for human consumption, we must identify the various
effects that may result from irradiating the food and assess whether
any of these effects pose a public health concern. In this regard, the
following three areas of possible concern need to be addressed: (1)
Potential toxicity, (2) nutritional adequacy, and (3) potential
microbiological risk from the treated food. Each of these areas is
discussed in detail in this document. We have considered the data and
studies submitted in the subject petition as well as additional data
and information in our possession relevant to safety. This includes our
previous evaluations of the safety of the irradiation of other foods,
including the irradiation of poultry (``poultry rule'') (55 FR 18538;
May 2, 1990), the irradiation of meat (``meat rule'') (62 FR 64107;
December 3, 1997), the irradiation of molluscan shellfish
(``molluscan shellfish rule'') (70 FR 48057; August 16, 2005), and the
irradiation of fresh iceberg lettuce and fresh spinach (``fresh iceberg
lettuce and fresh spinach rule'') (73 FR 49593; August 22, 2008).
A. Radiation Chemistry
``Radiation chemistry'' refers to the chemical reactions that occur
as a result of the absorption of ionizing radiation. Numerous studies
regarding the chemical effects of ionizing radiation on different foods
under varied conditions have led to a sound understanding of the
fundamental principles of radiation chemistry.\4\ The knowledge gained
through these studies provided us with a knowledge base from which
general conclusions about irradiated foods can be drawn by
extrapolating from data on particular foods irradiated under specific
conditions to similar types of foods irradiated under different, yet
related, conditions. Overall, the data show that the type and amount of
products generated by the radiation-induced chemical reactions
(``radiolysis products'') are dependent upon the chemical constituents
of the food and the specific conditions under which the food has been
irradiated. The principles of radiation chemistry also govern the
extent of change, if any, in the nutrient level and the microbial load
of irradiated foods.
\4\ Several books provide more detailed discussions of radiation
chemistry with references to the large number of original research
studies, particularly in the area of food irradiation. Sources that
can be consulted for further information include, but are not
limited to: ``Radiation Chemistry of Major Food Components,'' edited
by P.S. Elias and A.J. Cohen, Elsevier, Amsterdam, 1977; ``Recent
Advances in Food Irradiation,'' edited by P.S. Elias and A.J. Cohen,
Elsevier, Amsterdam, 1983; and J.F. Diehl, ``Chemical Effects of
Ionizing Radiation,'' Chapter 3 in ``Safety of Irradiated Foods,''
Marcel Dekker, New York, 1995.
We have reviewed the pertinent data and information concerning
radiation chemistry as it applies specifically to crustaceans
irradiated at a maximum absorbed dose of 6.0 kGy. As described in the
review memoranda, our safety review of the conditions of use generally
focused on the effects of irradiation on the portion that individuals
are most likely to consume, i.e., the meat or flesh of crustaceans.
1. Factors Affecting the Radiation Chemistry of Foods
Along with the chemical composition of the food, the specific
conditions of irradiation are essential to assessing the radiation
chemistry of a given food. The specific conditions include radiation
dose, physical state of the food (e.g, solid or frozen versus liquid or
non-frozen state, dried versus hydrated state), and ambient atmosphere
(e.g., air, reduced oxygen, or vacuum). The radiation dose directly
affects the levels of radiolysis products generated in a particular
food; therefore, we can extrapolate from data obtained at higher
radiation doses to draw conclusions about the amounts of radiolysis
products expected to be generated at lower doses. Generally, the types
of radiolysis products resulting from irradiation are similar to those
products generated by alternative food processing methods, such as
canning and cooking (Refs. 3 and 4).
The extent of chemical change that occurs when food is irradiated
is also determined by the physical state of the food. When the food is
in a frozen state, the initial radiolysis products have a greater
tendency to recombine rather than diffuse throughout the food and react
with other food components. Provided all conditions are the same,
including dose and ambient atmosphere, the extent of chemical change
that occurs in a specific food will be lower if the food is in a frozen
state than a non-frozen state because the radiolysis products are less
mobile in frozen conditions. Likewise, the extent of change in the
dehydrated state is less than the change that occurs in the fully
Furthermore, the atmosphere can affect the formation of radiolytic
products in a given food, thus having the potential to affect the
chemical composition of the food. Irradiation in oxygenated
environments facilitates the formation of additional oxidation-
reduction (redox) agents as a result of the interaction between oxygen
and the radiolysis products of water (e.g., hydrogen radical, hydroxide
radical, and solvated electrons (a free electron in a solution)).
Because all foods have components that are susceptible to redox
reactions, an atmosphere with high oxygen content increases the
likelihood of such occurrences and therefore, leads to the formation of
a greater number and variety of radiolysis products when compared to an
atmosphere with low oxygen content (Refs. 3 and 5). The final products
of radiation-induced oxidation reactions in foods are similar to those
produced by oxidation reactions induced by other processes (e.g.,
storage or heating in air).
In general, the types of radiolysis products generated by
irradiation are similar to those produced by other food processing
methods (Refs. 3 and 4). Radiation-induced chemical changes, if
sufficiently large, however, may cause changes in the organoleptic or
sensory properties of the food. Because food processors wish to avoid
undesirable effects on taste, odor, color, or texture, there is an
incentive to minimize the extent of these chemical changes in food.
Thus, in most cases, the dosage selected will be the lowest dose
required to achieve the desired effect, and the irradiation will be
conducted under reduced oxygen levels and/or on food held at low
temperatures or in the frozen state.\5\
\5\ In the case of crustaceans, irradiation would occur under
either chilled or frozen conditions. This temperature requirement is
not necessary for dried crustaceans because they are shelf stable
due to their low water activity.
2. Radiation Chemistry of the Major Components of Crustaceans
The major components of crustaceans are water, proteins, and
lipids. Irradiation of water produces reactive hydroxyl and hydrogen
radicals. These radicals are likely to recombine forming water,
hydrogen gas, or hydrogen peroxide; however, they can react with other
components of the irradiated food, in this instance, crustaceans,
forming secondary radiolysis products. While the most significant
effects of irradiation on the protein and lipid components of
crustaceans result from chemical reactions induced by radicals
generated from the radiolysis of water, additional radiolysis products
can result directly from the absorbed radiation. These products form in
very small amounts and are the same as or similar to compounds found in
food that have not been irradiated (Ref. 4).
Because meat is high in protein, lipids, and water, the radiation
chemistry of proteins, lipids, and water (in both liquid and frozen
states) was extensively discussed in the preamble to the meat rule (62
FR 64107 at 64110 to 64111). The radiation chemistry of proteins and
lipids discussed in the meat rule is also relevant to other flesh
foods, including foods such as poultry and fish, that may be referred
to as ``meat'' in common usage, but that do not conform to the
definition of meat in 9 CFR 301.2.
Crustaceans are similar to other flesh foods in that they consist
predominately of protein (up to 21 percent), lipid (approximately 1 to
2 percent), and water (74 to 84 percent). However, they differ from
other flesh food in that they contain lower levels of fat and slightly
higher levels of carbohydrate (up to 2.5 percent) by weight of the raw
edible portion (Ref. 6). While the carbohydrate level in crustaceans is
slightly higher than in other flesh foods, the overall level remains
a. Proteins. We have previously provided a detailed discussion of
protein radiation chemistry in the meat and molluscan shellfish rules.
Studies conducted with high-protein foods such as meat, poultry, and
seafood, have established that most of the radiolysis products derived
from proteins possess the same amino acid composition and may be
denatured (i.e., only altered in their secondary and tertiary
structures). Although the changes to proteins caused by ionizing
radiation are similar to those that occur as a result of heating, the
changes are far less pronounced and the amounts of reaction products
generated are far lower (Refs. 4 and 7). Studies have established that
there is little change in the amino acid composition of fish irradiated
at doses of 50 kGy and below, which is above the maximum absorbed dose
for crustaceans--6.0 kGy (Ref. 8). Therefore, we conclude that no
significant change in the amino acid composition of crustaceans is
expected to result from the conditions set forth in this regulation.
b. Carbohydrates. The main effects of ionizing radiation on
carbohydrates in foods have been studied extensively and discussed at
length in the scientific literature (Refs. 9 and 10) as well as in
reviews by such bodies as the World Health Organization (WHO) (Ref.
11). In the presence of water, carbohydrates react primarily with the
hydroxyl radicals generated by radiolysis of water resulting in the
abstraction of hydrogen from the carbon-hydrogen bonds of the
carbohydrate, forming water and a carbohydrate radical. Carbohydrate
radicals may result from ionization of monosaccharides such as glucose
or polysaccharides such as starch. In polysaccharides, the glycosidic
linkages between constituent monosaccharide units may be broken,
effectively shortening the polysaccharide chains. Starch may be
degraded into dextrins, maltose, and glucose. Sugar acids, ketones, and
other sugar monosaccharides may also be formed as a result of ionizing
radiation. Various studies have demonstrated that radiation-induced
products formed from starches of different origin are qualitatively
similar. The overall effects of ionizing radiation on carbohydrates are
the same as those caused by cooking and other food processing
treatments, and carbohydrates present as a component of food are less
sensitive to the effects of irradiation than pure carbohydrates (Ref.
3). No significant change in the carbohydrate composition of
crustaceans is expected to occur under the conditions set forth in this
regulation, i.e., at a maximum absorbed dose of 6.0 kGy.
c. Lipids. We have previously provided a detailed discussion on the
radiation chemistry of lipids in both the preambles to the meat and
molluscan shellfish rules (62 FR 64107 at 64110 to 64111 and 70 FR
48057 at 48060, respectively). This discussion noted that studies have
identified a variety of radiolysis products derived from lipids. These
include fatty acids, esters, aldehydes, ketones, alkanes, alkenes, and
other hydrocarbons, which are identical or analogous to compounds found
in foods that have not been irradiated, but have been subjected to a
different type of processing (Refs. 12 and 13). Heating food causes the
lipids to produce these types of compounds, but in levels far greater
than the trace amounts produced from irradiating food (Ref. 14).
One major difference between fish (both shellfish and finfish) and
other flesh foods is the predominance of polyunsaturated fatty acids
(PUFAs) in the lipid phase of fish. PUFAs are a subclass of lipids that
have a higher degree of unsaturation in the hydrocarbon chain compared
to saturated (e.g., stearic acid) or monounsaturated (e.g., oleic acid)
fatty acids. The PUFA subclass of lipids is generally more susceptible
to oxidation than saturated fatty acids due to their higher degree of
unsaturation. Therefore, PUFAs could be more radiation-sensitive
compared to the other lipid components, as suggested by some studies on
irradiated oil (Ref. 15). However, evidence from studies in meat
suggests that the protein component of meat may protect lipids from
oxidative damage (Ref. 3).
The effects of irradiation on PUFAs in fish have been described in
several studies we have reviewed, which are also discussed in detail in
the molluscan shellfish rule. These studies show that irradiation is
not likely to have a significant effect on the lipid composition of
seafood. For example, Adams et al. studied the effects of irradiation
on the concentration of PUFAs in herring and showed that irradiation of
herring fillets at sterilizing doses (50 kGy), well above the
petitioned maximum dose for crustaceans, had no effect on the
concentration of PUFAs (Ref. 16). Armstrong et al. conducted a study to
evaluate the effects of ionizing radiation on fatty acid composition in
fish and concluded that no significant changes occurred in the fatty
acid profiles upon irradiation at 1, 2, or 6 kGy (Ref. 17). Sant'Ana
and Mancini-Filho studied the effects of irradiation on the
distribution of fatty acids in fish, evaluating two monounsaturated
fatty acids and seven PUFAs before and after irradiation at 3 kGy (Ref.
18). They observed insignificant changes in the concentration of total
monounsaturated fatty acids and an approximately 13 percent decrease in
total PUFAs at 3 kGy; these losses were largely attributed to a loss of
the long chain PUFAs. Research conducted by FDA on various species of
seafood also demonstrated that the concentrations of PUFAs are not
significantly affected by irradiation (Refs. 19 and 20). More recently,
a study conducted by Sinanoglou et al. reported non-significant changes
in total fat and total fatty acids for mollusks and crustaceans with
irradiation at 4.7 kGy, confirming our earlier conclusions that
irradiation does not significantly affect PUFAs (Ref. 21). Therefore,
based on the totality of evidence, we conclude that no significant loss
of PUFAs is expected to occur in the diet under the conditions of
irradiation set forth in this regulation.
3. Radiation Chemistry of Food Ingredients Added to Crustaceans
The petitioner clarified that the ``other food ingredients''
intended to be added to the crustaceans prior to treatment with
irradiation included spices,\6\ minerals, inorganic salts, citrates,
citric acid, and calcium disodium EDTA (calcium disodium ethylene-
diaminetetraacetate).\7\ We considered the list of compounds and
determined that for any mineral or inorganic salt, there will be no
change in the exposure to radiolysis products because these compounds
are not impacted by the direct or secondary effects of irradiation
(Ref. 22). Furthermore, upon assessment of the organic compounds that
were requested, we determined that these compounds (i.e., citric acid,
citrates, and calcium disodium EDTA) will react when irradiated to form
products at low levels (concentrations below the parts per billion
level) that are similar to products that are formed as a result of
lipid oxidation reactions, such as carbon dioxide and formic acid. As
we stated in section II.2.c., we have previously evaluated the safety
of the radiolysis products formed as a result of lipid
oxidation reactions and have concluded that these products are not
harmful. Moreover, the addition of these specific organic compounds to
crustaceans prior to irradiation results in the formation of these
radiolysis products at such low levels that irradiation of crustaceans
with the proposed additional food ingredients will not meaningfully
increase exposure to radiolysis products (ibid.).
\6\ The term ``spice'' refers to dried or dehydrated aromatic
vegetable substances that are used in small amounts solely for
flavoring or aroma (e.g., black pepper, red pepper, and bay leaves).
This term is consistent with the currently regulated use of
``spice'' in Sec. 179.26(b)(5) (21 CFR 179.26(b)(5)).
\7\ This regulation addresses the irradiation of these ``other
food ingredients'' to the extent that their use in crustaceans is
authorized. The use of other ingredients in crustaceans prior to
irradiation must be consistent with existing food additive
regulations, generally recognized as safe determinations, and prior
sanctions. For example, calcium disodium EDTA is approved for use
under the conditions specified in 21 CFR 172.120 in cooked canned
shrimp and cooked canned crabmeat and is not approved for use in
other types of shrimp or crabmeat or in other crustaceans.
Overall, we concluded that the irradiation of all proposed
ingredients will not increase the exposure to radiolysis products when
used on crustaceans at levels consistent with good manufacturing
practices (GMP) and in accordance with other applicable laws and
4. Consideration of Furan as a Radiolysis Product
During our review of the chemical effects of irradiation, as a part
of the evaluation of this and other irradiation petitions, we became
aware of a report that suggested irradiating apple juice (``apple juice
report'') may produce furan (Ref. 23). Studies have demonstrated that
furan can cause tumors in laboratory animals. This prompted us to
initiate research on whether the apple juice report was accurate and
whether furan was a common radiolysis product in food. We confirmed
that certain foods form furan in low quantities when irradiated. Our
studies also show that some foods form furan when heated and other
foods form furan during storage at refrigeration temperatures (Ref.
24). Testing of irradiated raw shrimp and cooked crab meat show that if
furan is formed when these foods are irradiated, it is formed at levels
that are below the limit of detection of the available analytical
methods, or below the background levels of natural furan formation
during storage (Ref. 25). Therefore, because all crustaceans have
similar composition, we concluded that the consumption of irradiated
crustaceans will not increase the amount of furan in the diet.
5. Consideration of 2-Alkylcyclobutanones as Radiolysis Products
A class of radiolysis products derived from lipids, identified as
2-alkylcyclobutanones (2-ACBs), has been reported to form in small
quantities when fats are exposed to ionizing radiation. These compounds
were once considered to be unique products, formed in small quantities
during the irradiation process; however, a recent report has
demonstrated that 2-ACBs also can be detected in non-irradiated food
(Ref. 26). The type of 2-ACBs formed depends on the fatty acid
composition of the food. For example, 2-dodecylcyclobutanone (2-DCB) is
a radiation by-product of triglycerides with esterified palmitic acid.
Researchers have reported that 2-DCB is formed in small amounts (less
than 1 microgram per gram lipid per kGy) in irradiated chicken (Ref.
27) and in even smaller amounts in irradiated ground beef (Ref. 28).
Both of these foods are of relatively high total fat and palmitic acid
content (Ref. 6).
In the molluscan shellfish rule, we provided a detailed discussion
of the significance of the formation of 2-DCB to the safety evaluation
of irradiated molluscan shellfish, a food which, like chicken, ground
beef, and crustaceans, contains significant amounts of triglycerides
with esterified palmitic acid (70 FR 48057 at 48065 to 48067). We
concluded that no issues were raised that had not been previously
considered in the meat and poultry final rules (70 FR 48057 at 48060
and 48065 to 48067). In our assessment in the meat rule, we considered
all of the available data and information, including the results of
genotoxicity studies and previously reviewed studies in which animals
were fed diets containing irradiated meat, poultry, and fish (62 FR
64107 at 64113). While 2-DCB and other alkylcyclobutanones would be
expected to be present in these irradiated foods, we found no evidence
of toxicity attributable to the consumption of these substances. The
macronutrient composition of crustaceans (protein, lipid, carbohydrate)
is comparable to other flesh foods (Ref. 6). Due to the similar lipid
levels, the formation of 2-ACBs in crustaceans is expected to be
similar to the levels of 2-ACBs produced in other flesh foods.
Therefore, considering all available data and information, the
formation of 2-ACBs from irradiating crustaceans under the conditions
proposed in this petition is not a safety concern.
B. Toxicological Considerations
To adequately evaluate the safety of irradiated food products, we
assessed all available toxicological data from the relevant toxicology
studies of which we are aware. For the toxicological evaluation of
irradiated crustaceans, the relevant studies are those studies
examining flesh-based foods, including studies on fish high in PUFAs.
These include 24 long-term feeding studies, 10 reproduction/teratology
studies, and 15 genotoxicity studies with flesh-based foods irradiated
at doses from 6 to 74 kGy. No toxicologically significant adverse
effects attributable to irradiated flesh foods were observed in any of
the studies, all of which were discussed in detail in the meat rule (62
FR 64107 at 64112 to 64114). The dose of irradiation used in the
relevant studies was similar to, or considerably higher than, the
maximum absorbed dose requested in this petition (6.0 kGy). Therefore,
these data demonstrate that crustaceans irradiated at levels up to 6.0
kGy will not present a toxicological hazard (Ref. 7).
In evaluating the safety of irradiated crustaceans, we also relied
upon the integrated toxicological database derived from the extensive
body of work reviewed by us (Ref. 29) and by WHO relevant to the
assessment of the potential toxicity of irradiated foods. Although
these studies are not all of equal quality or rigor,\8\ we concluded
that the quantity and breadth of testing, as well as the number and
significance of endpoints assessed would have identified any real or
meaningful hazard. The overwhelming majority of studies showed no
evidence of toxicity. In those few instances where adverse effects were
reported, we found that those effects have not been consistently
reproduced in related studies conducted at higher doses or for longer
durations, as would be expected if the effects were attributable to
irradiation (62 FR 64107 at 64112 to 64114).
\8\ For example, the number of animals used in many of the early
studies is smaller than that commonly used today. Complete
histopathology was not always done or reported. For some studies,
the data are available in only brief summary form. While many of
these studies cannot individually establish safety for the
previously cited reasons, they still provide important information
that, evaluated collectively, supports a conclusion that there is no
reason to believe that the irradiation of flesh foods presents a
Similarly, during the early 1980s, a joint Food and Agriculture
Organization/International Atomic Energy Agency, World Health
Organization (FAO/IAEA/WHO) Expert Committee evaluated the
toxicological and microbiological safety and nutritional adequacy of
irradiated foods. The Expert Committee concluded that irradiation of
any food commodity at an average dose of up to 10 kGy presents no
toxicological hazard (Ref. 30). In the 1990s, at the request of one of
its member states, FAO/IAEA/WHO conducted a new review and analysis of
the safety of data on irradiated foods. This more recent review
included all studies in our files that we considered as reasonably
complete, as well as those studies that appeared to be acceptable but
had deficiencies interfering with the interpretation of the data (62 FR
64107 at 64112). The FAO/IAEA/WHO review also included data from the
Department of Agriculture (USDA) and from the German Federal Research
Centre for Nutrition at Karlsruhe, Germany. FAO/IAEA/WHO concluded that
the integrated toxicological database is sufficiently sensitive to
evaluate safety and that no adverse toxicological effects due to
irradiation were observed in the dose ranges tested (Ref. 31).
Therefore, based on the totality of evidence, we conclude that
irradiation of crustaceans under the conditions proposed in this
petition does not present a toxicological hazard.
C. Nutritional Considerations
It has been well established that the nutritional value of the
macronutrients (proteins, fats, and carbohydrates) in the diet are not
significantly altered by irradiation at the petitioned doses (Refs. 32
to 34). PUFAs, particularly long-chain, omega-3 fatty acids, are
generally considered to be nutritionally important components of
seafood. As noted in section II.A.2.c., PUFA levels were not reduced
significantly by ionizing radiation. Thus, we conclude that, as with
molluscan shellfish (70 FR 48057 at 48060), potential losses of PUFAs
from irradiation of crustaceans would be expected to be minimal and
have no nutritional significance.
We have carefully reviewed the data and information submitted in
the petition, as well as additional information available in the
scientific literature, to determine the potential impact of irradiation
at a maximum absorbed dose of 6.0 kGy on the nutritional value of
crustaceans (Ref. 32). In this review, FDA considered all nutrients
known to be present in crustaceans, but focused primarily on those
vitamins having an established sensitivity to radiation and those
vitamins for which at least one of these foods \9\ may be identified,
under our labeling regulations, as either a ``good source'' or an
``excellent source,'' \10\ for contributing more than a trivial amount
to the total dietary intake of that vitamin (i.e., more than 1 to 2
\9\ Nutrient content data was available from the USDA Nutrient
Database (NDB) for Standard Reference, version 23 (SR-23) for the
following crustaceans: Crab (blue, king, queen, Dungeness), shrimp,
lobster, and crayfish (see Refs. 6, 32, and 35).
\10\ To be considered a ``good source'' a given vitamin, that
particular food must contain 10-19 percent of the Reference Daily
Intake (RDI) or Daily Reference Value (DRV) for that vitamin per
reference amount customarily consumed (RACC) (21 CFR 101.54(c)). A
food containing >= 20 percent of the RDI or DRV per RACC may be
labeled as an ``excellent source'' of that vitamin (21 CFR
\11\ This information is based upon individual food intake data
available from nationwide surveys conducted by USDA and maintained
in the USDA NDB SR-23. USDA's surveys were designed to monitor the
types and amounts of foods eaten by Americans and food consumption
patterns in the U.S. population. FDA routinely uses these data to
estimate exposure to various foods, food ingredients, and food
contaminants (see Refs. 6, 35, and 36).
Irradiation of any food, regardless of the dose, has no effect on
the levels of minerals that are present in trace amounts (Ref. 3).
Levels of certain vitamins, on the other hand, may be reduced as a
result of irradiation. The extent to which a reduction in the level of
a specific vitamin occurs as a result of food irradiation depends on
the specific vitamin, the type of food, and the conditions of
irradiation. Not all vitamin loss is nutritionally significant;
however, and the extent to which a reduction in a specific vitamin
level is significant depends on the relative contribution of the food
in question to the total dietary intake of the vitamin.
Crustaceans, as a group, show some variation in vitamin content,
but all crustaceans are excellent sources of vitamin B12,
and certain crustaceans may be identified as good sources of folate,
niacin, riboflavin, pyridoxine, pantothenic acid, and vitamin C.
Certain crustaceans (i.e., shrimp and blue crab) contain vitamin E at
levels greater than 10 percent of the current Reference Daily Allowance
per reference amount customarily consumed (RACC). Of these vitamins
present in crustaceans, only vitamin C, thiamin, vitamin E, and, to a
lesser extent pyridoxine, are considered to be sensitive to irradiation
(Ref. 32). Although thiamin is present in other types of flesh food,
crustaceans are not considered a good source of thiamin (ibid.).
Despite the presence of vitamin C, pyridoxine, and vitamin E in
crustaceans, they make up a negligible amount of the dietary intake of
these vitamins in the United States. Based on data from the USDA
Continuing Survey of Food Intakes of Individuals (Ref. 35), the entire
food category of ``fish/shellfish (excluding canned tuna)'' contributes
to less than 1 percent of the vitamin C intake of the U.S. diet and
less than 2 percent of the vitamin E and pyridoxine intakes of the U.S.
diet. Furthermore, because crustaceans account for only 40 percent of
the entire category of ``fish/shellfish (excluding canned tuna),'' the
impact of these vitamin levels from consuming crustaceans will be of
even less significance (Ref. 32). Potential losses of vitamin C,
thiamine, vitamin E, and pyridoxine, as a result of irradiation of
crustaceans at a maximum absorbed dose of 6.0 kGy, are of minimal to no
consequence to the overall U.S. diet.
Other vitamins present in crustaceans (i.e., niacin, pantothenic
acid, vitamin B12, and folate) are relatively insensitive to
irradiation, particularly at the doses requested by this petition. Of
these vitamins, only vitamin B12 is provided in meaningful
amounts to the U.S. diet from the intake of crustaceans. The stability
of vitamin B12 to irradiation has been demonstrated in
numerous studies and was previously discussed in the molluscan
shellfish rule (70 FR 48057 at 48062). Molluscan shellfish contain the
highest amounts of vitamin B12 among foods considered to be
fish/shellfish; therefore, our evaluation and discussion in the
molluscan shellfish rule are relevant to this petition. Further, in its
review of this petition, we considered potential B12 losses
in crustaceans in addition to other irradiated foods containing vitamin
B12 (ibid.). We conclude that any potential losses of
radiation-insensitive vitamins in foods, irradiated under the
conditions described in this petition, would be minor and the resulting
impact on nutrient intake in the U.S. diet would be negligible (ibid.).
We also analyzed the contribution of crustaceans to vitamin D
intake and found that only 0.30 percent of dietary vitamin D for U.S.
adults (18 years and older) comes from the consumption of crustaceans
(Ref. 37). Due to this small contribution of vitamin D from crustaceans
to the overall U.S. dietary intake, the potential losses of this
vitamin from crustaceans irradiated under the conditions described in
this regulation would be minor and the resulting health impact would be
Based on review of the available data and information, we conclude
that irradiation of crustaceans with a maximum absorbed dose of 6.0 kGy
will not adversely impact the nutritional adequacy of the diet.
D. Microbiological Considerations
Irradiation at the requested doses will reduce, but not entirely
eliminate, the number of viable pathogenic (illness causing)
microorganisms in or on crustaceans. Furthermore, as discussed in this
document, irradiation of crustaceans is expected to extend the shelf-
life of the treated product by reducing the number of non-pathogenic
food spoilage microorganisms.
The predominant non-pathogenic bacterial flora of freshly caught
fish or shellfish are from the Pseudomonas group, with Acinetobacter
and Moraxella, generally present. As crustaceans begin to spoil, the
bacteria from the Pseudomonas group can increase to as much as 90
percent of the
total flora (Ref. 38). Escherichia coli, Vibrio spp., Listeria spp.,
Salmonella serovars, Staphylococcus aureus, and Clostridium botulinum
were identified by the petitioner as the human pathogens of public
health concern that are most likely to be present in or on crustaceans.
The level and route of entry of the different types of microorganisms
in crustaceans is variable, and this contamination can result from
harvesting, handling, and transportation (Ref. 39). Vibrios are
naturally present in marine environments, and consequently, present in
or on crustaceans. The petitioner provided data on the potential levels
of microbial pathogens in various crustacean seafoods. While most
observed levels of microbial pathogens are much lower, the petitioner
states that Listeria could be present at up to 10\4\ colony forming
units per gram (CFU/g), vibrios at 10\6\ CFU/g, salmonellas,
streptococci, and staphylococci at <10 CFU/g, and C. botulinum at no
more than 0.17 CFU/g. Yeasts and molds also may be present; however,
these organisms would be limited by aerobic packaging (i.e., oxygen-
permeable packaging) and the presence of normal spoilage bacteria (Ref.
The petitioner provided reports and published articles describing
the effects of irradiation on the microorganisms in or on crustaceans
as well as in or on other seafood. The effectiveness of irradiation is
a function of the sensitivity of the target microorganisms to ionizing
radiation at a dose that will retain the organoleptic and nutritional
characteristics of the food. The type and physical state of the food
product, its temperature, ambient atmosphere, and the survival of non-
pathogens also are factors that can either enhance or diminish the
survivability of the organisms treated with ionizing radiation. Data
show that the more complex the milieu, the greater the level of
radiation necessary to reduce the level of microorganisms (Ref. 41).
Reports and published articles provide data on the doses needed to
control several microorganisms of relevance, including various
Salmonella, Vibrio spp., S. aureus, L. monocytogenes, and E. coli. Due
to organoleptic considerations, the doses used will vary depending on
the type of crustacean; for example, absorbed doses greater than 0.7
kGy may affect the texture of non-frozen lobster meat, whereas other
types of crustaceans tolerate higher doses without experiencing
There is a large body of work regarding the radiation sensitivities
of non-pathogenic food spoilage microorganisms and pathogenic food-
borne microorganisms. Generally, the common spoilage organisms such as
Pseudomonas and the pathogens of concern are quite sensitive to the
effects of ionizing radiation. Chen et al. investigated the microbial
quality of irradiated crab meat products, including white lump meat,
claw, and crab fingers (Ref. 42). The D10 values \12\ for
spoilage bacteria ranged from less than 0.40 to 0.46 kGy. Further, it
was determined that the shelf-life of food products derived from the
claw and finger of crabs were extended approximately 3 days beyond the
unirradiated samples (ibid.). Following irradiation fresh, peeled, and
deveined tropical shrimps stored at 10-12 degrees Celsius were found to
have an increase in shelf-life to 10-14 days when irradiated at 1.5 kGy
and 18-21 days when irradiated at 2.5 kGy as compared to the
unirradiated control samples, which spoiled within 4 days (Ref. 43). In
a study performed by Scholz et al., irradiation at 5 kGy extended the
shelf-life of Pacific shrimp (Pandalus jordani) to 5 weeks when stored
at 3 degrees Celsius (Ref. 44).
\12\ D10 is the absorbed dose of radiation required
to reduce a bacterial population by 90 percent.
Information regarding doses needed for control of pathogenic
organisms in the petition and other information in our files show that
D10 values for vibrios can range from less than 0.10 up to
0.75 kGy depending on the crustacean, its physical state, temperature,
and other factors (Refs. 39, 42, 45, and 46). In frozen, unpeeled, and
uncooked shrimp, the D10 values for L. monocytogenes ranged
from 0.7 kGy to 0.88 kGy (Refs. 39 and 47) and in crab meat, the
D10 value cited in the literature was 0.59 kGy (Ref.
42).\13\ The D10 values cited in the published literature
for several Salmonella serotypes in grass prawns and shrimp homogenate
ranged from 0.30 to 0.59 kGy (Refs. 45, 49, and 50). Thus, irradiation
of crustaceans at a maximum absorbed dose of 6.0 kGy would be effective
at controlling pertinent pathogens (Ref. 40).
\13\ The petitioner requested a maximum absorbed dose of 6.0 kGy
to achieve a 6-log reduction of L. monocytogenes. Dividing the
treatment dose by the appropriate D10 value estimates the
log reduction for a given treatment dose (e.g., 6 kGy divided by
0.88 for frozen, unpeeled, uncooked shrimp has the potential to
yield a 6.8 log reduction) (Ref. 48). This demonstrates that it is
possible to achieve a 6-log reduction of L. monocytogenes with a
maximum absorbed dose of 6 kGy.
In evaluating the subject petition, we have carefully considered
whether irradiation of crustaceans under the conditions proposed in the
petition could result in significantly altered microbial growth
patterns such that these foods would present a greater microbiological
hazard than comparable food that had not been irradiated. In
considering this issue, we focused on whether the proposed irradiation
conditions would increase the probability of significantly increased
growth of, and subsequent toxin production by, C. botulinum because
this organism is relatively resistant to radiation in comparison to
non-spore forming bacteria. We have concluded that the possibility of
increased microbiological risk from C. botulinum is extremely remote
because: (1) The conditions of refrigerated storage necessary to
maintain the quality of crustaceans are not amenable to the outgrowth
and production of toxin by C. botulinum and (2) sufficient numbers of
spoilage organisms will survive such that spoilage will occur before
outgrowth and toxin production by C. botulinum (Refs. 40 and 51).
Based on the available data and information, we conclude that
irradiation of crustaceans conducted in accordance with current GMP
under 21 CFR 172.5 will reduce bacterial populations without increased
microbial risk from pathogens that may survive the irradiation process.
We have received numerous comments, primarily form letters, from
individuals stating their opinions regarding the potential dangers and
unacceptability of irradiating food. We have also received several
comments from individuals or organizations stating their opinions
regarding the potential benefits of irradiating food and urging us to
approve the petition. None of these letters contain any substantive
information relevant to a safety evaluation of irradiated crustaceans.
Additionally, we received several comments from Public Citizen (PC) and
the Center for Food Safety (CFS) requesting the denial of this and
other food irradiation petitions, as well as joint comments from CFS
and Food and Water Watch (FWW).
Overall, the comments were of a general nature and not specific to
the requests in the individual petitions. These comments raised a
number of topics, including studies reviewed in the 1999 FAO/IAEA/WHO
report on high-dose irradiation; a review article that analyzed studies
of irradiated foods performed in the 1950s and 1960s; the findings of a
1971 study in which rats were fed irradiated strawberries; the findings
regarding reproductive performance in a 1954 study in which mice were
fed a special irradiated diet; issues regarding mutagenicity studies;
certain international opinions; issues
related to ACBs, including purported promotion of colon cancer; the
findings of certain studies conducted by the Indian Institute of
Nutrition in the 1970s; general issues regarding toxicity data; our
purported failure to meet statutory requirements; data from a 2002
study purportedly showing an irradiation-induced increase in trans
fatty acids in ground beef; studies regarding purported elevated
hemoglobin levels and their significance; and an affidavit describing
the opinions of a scientist regarding the dangers of irradiation and
advocating the use of alternative methods for reducing the risk of
food-borne disease. The topics raised in the FWW/CFS comments included
issues with ACBs, our purported failure to define a list of foods
covered by the petition; general issues with toxicity data; purported
microbiological resistance; and purported negative effects on
Many of the comments from PC and CFS were also submitted to the
dockets for the rulemakings on the irradiation of molluscan shellfish
(Docket No. 1999F-4372, FAP 9M4682) and on the irradiation of fresh
iceberg lettuce and fresh spinach (Docket No. FDA-1999-F-2405, FAP
9M4697). For a detailed discussion of our responses to the previously
mentioned general comments, we refer to the molluscan shellfish rule
(70 FR 48057 at 48062 to 48071). For a detailed discussion of our
response to the FWW/CFS comments, we refer to our fresh iceberg lettuce
and fresh spinach rule (73 FR 49593 at 49600-49601).
Accordingly, because these comments do not raise issues specific to
irradiated crustaceans and because we have already responded to these
comments elsewhere, we are not further addressing these comments in
There were no additional comments submitted to this docket.
Based on the data and studies submitted in the petition and other
information in our files, we conclude that the proposed use of
irradiation to treat chilled or frozen raw, cooked, or partially cooked
crustaceans, or dried crustaceans, with or without spices, minerals,
inorganic salts, citrates, citric acid, and/or calcium disodium EDTA
used in accordance with applicable laws and regulations, is safe,
providing that the absorbed dose does not exceed 6.0 kGy. Therefore, we
are amending Sec. 179.26 as set forth in this document.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition
and the documents that we considered and relied upon in reaching our
decision to approve the petition are available for public disclosure
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec. 171.1(h),
we will delete from the documents any materials that are not available
for public disclosure.
V. Environmental Impact
We have previously considered the environmental effects of this
rule as announced in the notice of filing for FAP 1M4727 (66 FR 9086).
No new information or comments have been received that would affect our
previous determination that there is no significant impact on the human
environment and that an environmental impact statement is not required.
VI. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object and the
grounds for your objection. Within each numbered objection, you must
specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
It is only necessary to send one set of documents. Identify
documents with the docket number found in brackets in the heading of
this document. Any objections received in response to the regulation
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
VIII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
FDA's review of this petition was limited to section 409 of the
FD&C Act. This final rule is not a statement regarding compliance with
other sections of the FD&C Act. For example, the Food and Drug
Administration Amendments Act of 2007, which was signed into law on
September 27, 2007, amended the FD&C Act to, among other things, add
section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)). Section 301(ll) of
the FD&C Act prohibits the introduction or delivery for introduction
into interstate commerce of any food that contains a drug approved
under section 505 of the FD&C Act (21 U.S.C. 355), a biological product
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for which substantial clinical
investigations have been instituted and their existence has been made
public, unless one of the exceptions in section 301(ll)(1) to (4) of
the FD&C Act applies. In its review of this petition, FDA did not
consider whether section 301(ll) of the FD&C Act or any of its
exemptions apply to irradiated crustaceans. Accordingly, this final
rule should not be construed to be a statement that irradiated
crustaceans, if introduced or delivered for introduction into
interstate commerce, would not violate section 301(ll) of the FD&C Act.
Furthermore, this language is included in all food additive final rules
and therefore, should not be construed to be a statement of the
likelihood that section 301(ll) of the FD&C Act applies.
The following sources are referred to in this document. References
marked with an asterisk (*) have been placed on display at the Division
of Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday. References
without asterisks are not on display; they are available as published
articles and books.
1. Food and Drug Administration, Center for Food Safety and Applied
Nutrition, Office of Food Safety, ``Fish and Fishery Products
Hazards and Control Guidance,'' 4th Ed., November 2011, Chapters 12
and 14, available at http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/seafood/ucm2018426.htm.
*2. L. Weddig, National Fisheries Institute, email message to T.
Croce, FDA, August 31, 2012.
3. Diehl, J. F., ``Chemical Effects of Ionizing Radiation,'' in
Safety of Irradiated Foods, 2nd Ed., Marcel Dekker, Inc., New York,
pp. 43-88, 1995.
*4. Memorandum for FAP 1M4727 from D. Folmer, FDA, to L. Highbarger,
FDA, August 2, 2002.
5. Diehl, J. F., ``Radiolytic Effects in Foods,'' in Preservation of
Foods By Ionizing Radiation, vol. 1, E.S. Josephson and M.S.
Peterson, eds., CRC Press, Boca Raton, FL, pp. 279-357, 1982.
6. U.S. Department of Agriculture, Agricultural Research Service,
USDA National Nutrient Database for Standard Reference, Release 23.
Nutrient Data Laboratory home page, http://www.ars.usda.gov/ba/bhnrc/ndl.
*7. Memorandum for FAP 1M4727 from I. Chen, FDA, to L. Highbarger,
FDA, April 7, 2003.
*8. Uderdal, B., J. Nordal, G. Lunde, and B. Eggum, ``The Effect of
Ionizing Radiation on the Nutritional Value of Fish (Cod) Protein,''
Lebensmittel-Wissenschaft Technologie, 6:90-93, 1973.
9. Adam, S., ``Recent Developments in Radiation Chemistry of
Carbohydrates,'' in Recent Advances in Food Irradiation, P.S. Elias
and A.J. Cohen, eds., Elsevier Biomedical, Amsterdam, pp. 149-170,
*10. Raffi, J., J. P. Agnel, C. Thiery, et al., ``Study of Gamma
Irradiated Starches Derived From Different Foodstuffs: A Way for
Extrapolating Wholesomeness Data,'' Journal of Agricultural and Food
Chemistry, 29:1227-1232, 1981.
11. WHO, ``Safety and Nutritional Adequacy of Irradiated Food,''
World Health Organization, Geneva, 1994.
*12. Kavalam, J. P. and W. W. Nawar, ``Effects of Ionizing Radiation
on Some Vegetable Fats,'' Journal of the American Oil Chemical
Society, 46:387-390, 1969.
13. Delinc[eacute]e, H., ``Recent Advances in Radiation Chemistry of
Lipids,'' in Recent Advances in Food Irradiation, edited by P.S.
Elias and A.J. Cohen, Elsevier, Amsterdam, pp. 89-114, 1983.
14. Nawar, W. W., ``Comparison of Chemical Consequences of Heat and
Irradiation Treatment of Lipids,'' in Recent Advances in Food
Irradiation, P. S. Elias and A. J. Cohen, eds., Elsevier Biomedical,
Amsterdam, pp. 115-127, 1983.
*15. International Consultative Group on Food Irradiation (ICGFI),
``Monograph on Irradiation of Fish, Shellfish, and Frog Legs,''
Fifteenth Meeting of the ICGFI, Vienna, 1998.
*16. Adams, S., G. Paul, and D. Ehlerman, ``Influence of Ionizing
Radiation on the Fatty Acid Composition of Herring Fillets,''
Radiation Physics Chemistry, 20:289-295, 1982.
*17. Armstrong, S. G., S. G. Wyllie, and D. N. Leach, ``Effects of
Preservation by Gamma-Irradiation on the Nutritional Quality of
Australian Fish,'' Food Chemistry, 50:351-357, 1994.
*18. Sant'Ana, L. S. and J. Mancini-Filho, ``Influence of the
Addition of Antioxidants in Vivo on the Fatty Acid Composition of
Fish Fillets'' Food Chemistry, 68:175-178, 2000.
*19. Morehouse, K. M. and Y. Ku, ``Gas Chromatographic and Electron
Spin Resonance Investigation of Gamma-Irradiated Shrimp,'' Journal
of Agriculture and Food Chemistry, 40(10):1963-1971, 1992.
20. Morehouse, K. M., ``Identification of Irradiated Seafood,'' in
Detection Methods for Irradiated Foods: Current Status, edited by C.
H. McMurray, E. M. Stewart, R. Gray, and J. Pearce, The Royal
Society of Chemistry, Cambridge, United Kingdom, pp. 249-258, 1996.
*21. Sinanoglou, V. J., A. Batrinou, S. Konteles, and K. Sflomos,
``Microbial Population, Physiochemical Quality, and Allergenicity of
Molluscs and Shrimp Treated With Cobalt-60 Gamma Radiation,''
Journal of Food Protection, 70(4): 958-966, 2007.
22. Memorandum for FAP 1M4727 from K. Morehouse, FDA, to T. Croce,
FDA, May 30, 2013.
23. Seibersdorf Project Report, International Programme on
Irradiation of Fruit and Fruit Juices, Chemistry and Isotopes
Department, National Centre for Nuclear Energy, Madrid, Spain, vol.
*24. Memorandum for FAP 9M4697 from K. Morehouse, FDA, to L.
Highbarger, FDA, February 20, 2008.
*25. Memorandum for FAP 1M4727 from K. Morehouse, FDA, to T. Croce,
FDA, August 18, 2010.
*26. Variyar, P. S., S. Chatterjee, M. G. Sajilata, et al.,
``Natural Existence of 2-Alkylcyclobutanones,'' Journal of
Agricultural and Food Chemistry, 56:11817-11823, 2008.
*27. Crone, A. V. J., J. T. G. Hamilton, and M. H. Stevenson,
``Effect of Storage and Cooking on the Dose Response of 2-
Dodecylcyclobutanone, a Potential Marker for Irradiated Chicken,''
Journal of the Science of Food and Agriculture, 58:249-252, 1992.
*28. Gadgil, P., K. A. Hachmeister, J. S. Smith, and D. H. Kropf,
``2-Alkylcyclobutanones as Irradiation Dose Indicators in Irradiated
Ground Beef Patties,'' Journal of Agriculture and Food Chemistry,
*29. Memorandum to the file, FAP 4M4428, D. Hattan, Acting Director,
Division of Health Effects Evaluation, November 20, 1997.
30. FAO/IAEA/WHO, ``Wholesomeness of Irradiated Food: Report of a
Joint FAO/IAEA/WHO Expert Committee,'' World Health Organization
Technical Report Series, No. 659, WHO, Geneva, 1981.
31. FAO/IAEA/WHO ``High Dose Irradiation: Wholesomeness of Food
Irradiated with Doses Above 10kGy: Report of a Joint FAO/IAEA/WHO
Study Group'' World Health Organization Technical Report Series, No.
890, WHO, Geneva, pp. 9-37, 1999.
*32. Memorandum for FAP 1M4727 from A. Edwards, FDA, to T. Croce,
FDA, April 4, 2011.
*33. Arvanitoyannis, I. S., A. Stratakos, and E. Mente, ``Impact of
Irradiation on Fish and Seafood Shelf Life: A Comprehensive Review
of Applications and Irradiation Detection,'' Critical Reviews in
Food Science and Nutrition, 49:68-112, 2009.
34. Shamasuzzaman, K., ``Nutritional Aspects of Irradiated Shrimp: A
Review,'' Atomic Energy of Canada Ltd. AECL-10090, Whiteshell
Nuclear Research Establishment, Pinawa, Manitoba, pp. 1-40, 1989.
*35. Cotton, P. A., A. F. Subar, J. E. Friday, and A. Cook,
``Dietary Sources of Nutrients among U.S. Adults, 1994 to 1996,''
Journal of the American Dietetic Association, 104:921-930, 2004.
*36. Memorandum for FAP 9M4697 from A. Edwards, FDA, to L.
Highbarger, FDA, July 16, 2008.
*37. Memorandum for FAP 9M4697 from L. Brookmire, FDA, to T. Croce,
FDA, June 19, 2011.
38. Grodner, R. M. and L. S. Andrews in ``Irradiation,'' pp. 429-
440, in Microbiology of Marine Food Products, Van Nostrand Reinhold,
New York, 1991.
*39. Rashid, H. O., H. Ito, and I. Ishigaki, ``Distribution of
Pathogenic Vibrios and Other Bacteria in Imported Frozen Shrimps and
Their Decontamination by Gamma-Irradiation,'' World Journal of
Microbiology and. Biotechnology, 8:494-499, 1992.
*40. Memorandum for FAP 1M4727 from R. Merker, FDA, to T. Croce,
FDA, April 11, 2011.
*41. Thayer, D.W., G. Boyd, W.S. Muller, et al., ``Radiation
Resistance of Salmonella,'' Journal of Industrial Microbiology,
*42. Chen, Y. P., L. S. Andrews, and R. M. Grodner, ``Sensory and
Microbial Quality of Irradiated Crab Meat Products,'' Journal of
Food Science, 61:1239-1242, 1996.
*43. Kumta, U. S., S. S. Mavinkurve, M. S. Gore, et al., ``Radiation
Pasteurization of Fresh and Blanched Tropical Shrimps,'' Journal of
Food Science, 35:360-363, 1970.
*44. Scholz, D. J., R. O. Sinnhuber, D. M. East, and A. W. Anderson,
``Radiation-Pasteurized Shrimp and Crabmeat,'' Food Technology,
*45. Hau, L.-B., M.-H. Liew, and L.-T. Yeh, ``Preservation of Grass
Prawns by Ionizing Radiation,'' Journal of Food Protection, 55:198-
*46. Ito, H., P. Adulyatham, N. Sangthong, and I. Ishigaki,
``Effects of Gamma-Irradiation on Frozen Shrimps to Reduce Microbial
Contamination,'' Radiation and Physical Chemistry, 34:1009-1011,
*47. Ito, H., H. O. Rashid, N. Sangthong, et al., ``Effect of Gamma
Irradiation on Frozen Shrimps for Decontamination of Pathogenic
Bacteria,'' Radiation Physics and Chemistry, 42:279-282, 1993.
48. Ley, F. J., ``The Effect of Ionizing Radiation on Bacteria,'' in
Manual on Radiation Sterilization of Medical and Biological
Materials. IAEA, Vienna, pp. 37-64, 1973.
*49. Nerkar, D. P. and J. R. Bandekar, ``Elimination of Salmonella
From Frozen Shrimp by Gamma Radiation,'' Journal of Food Safety,
50. Nouchpramool, K., S. Pungsilpa, and P. Adulyatham, ``Improvement
of Bacteriological Quality of Frozen Shrimp by Gamma Radiation,''
Office of Atomic
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51. Jimes, S., ``Clostridium Botulinum Type E in Gulf Coast Shrimp
and Shucked Oysters and Toxin Products as Affected by Irradiation
Dosage, Temperature, Storage Time, and Mixed Spore Concentrations,''
dissertation submitted to Louisiana State University, pp. ix and 1,
List of Subjects in 21 CFR Part 179
Food additives, Food labeling, Food packaging, Radiation
protection, Reporting and record keeping requirements, Signs and
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
179 is amended as follows:
PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF
1. The authority citation for 21 CFR part 179 continues to read as
Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.
2. Section 179.26 is amended in the table in paragraph (b) by adding
item 14 to read as follows:
Sec. 179.26 Ionizing radiation for the treatment of food.
* * * * *
(b) * * *
* * * * *
14. For control of food-borne pathogens Not to exceed 6.0 kGy.
in, and extension of the shelf-life of,
chilled or frozen raw, cooked, or
partially cooked crustaceans or dried
crustaceans (water activity less than
0.85), with or without spices, minerals,
inorganic salts, citrates, citric acid,
and/or calcium disodium EDTA.
* * * * *
Dated: April 4, 2014.
Assistant Commissioner for Policy.
[FR Doc. 2014-07926 Filed 4-11-14; 8:45 am]
BILLING CODE 4160-01-P