[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Rules and Regulations]
[Pages 20771-20779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07926]



[[Page 20771]]

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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.

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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, 
2014.

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:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    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, 
MD 20852.

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.

SUPPLEMENTARY INFORMATION:

I. Background

    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).
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    \1\ Dried crustaceans refer to crustaceans with a water activity 
(aw) of 0.85 or below (Ref. 1).
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    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.
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    \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 
U.S.C. 321(s)).
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    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\
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    \3\ 21 CFR 170.3(i).
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    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 
intended use.
    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

[[Page 20772]]

(``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.
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    \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.
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    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 
hydrated state.
    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\
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    \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.
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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 
relatively low.
    a. Proteins. We have previously provided a detailed discussion of

[[Page 20773]]

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

[[Page 20774]]

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.).
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    \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.
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    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 
regulations.
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).
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    \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 
toxicological hazard.
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    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 
U.S.

[[Page 20775]]

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 
percent).\11\
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    \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 
101.54(b)).
    \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 
negligible.
    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

[[Page 20776]]

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. 
40).
    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 
undesirable changes.
    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.

III. Comments

    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

[[Page 20777]]

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 
organoleptic properties.
    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 
this document.
    There were no additional comments submitted to this docket.

IV. Conclusions

    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.

VII. Objections

    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.

IX. References

    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.

[[Page 20778]]

*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, 
1983.
*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. 
8, 1966.
*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, 
50:5746-5750, 2002.
*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.
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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, 
5:383-390, 1990.
*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, 
16:118-120, 1962.
*45. Hau, L.-B., M.-H. Liew, and L.-T. Yeh, ``Preservation of Grass 
Prawns by Ionizing Radiation,'' Journal of Food Protection, 55:198-
202, 1992.
*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, 
1989.
*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, 
10:175-180, 1990.
50. Nouchpramool, K., S. Pungsilpa, and P. Adulyatham, ``Improvement 
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Energy for Peace (Bangkok, Thailand). (023535000; 4868000)), ISBN 
974-7399-29-6, 1985.
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, 
1967.

List of Subjects in 21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and record keeping requirements, Signs and 
symbols.

    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 
FOOD

0
1. The authority citation for 21 CFR part 179 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.


0
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) * * *

------------------------------------------------------------------------
                   Use                              Limitations
------------------------------------------------------------------------
 
                                * * * * *
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.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07926 Filed 4-11-14; 8:45 am]
BILLING CODE 4160-01-P