
[Federal Register Volume 77, Number 231 (Friday, November 30, 2012)]
[Rules and Regulations]
[Pages 71312-71316]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28967]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-1999-F-4617 (Formerly Docket No. 1999F-5321)]


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) is amending the food 
additive regulations to provide for the safe use of a 4.5 kilogray 
(kGy) maximum absorbed dose of ionizing radiation to treat 
unrefrigerated (as well as refrigerated) uncooked meat, meat 
byproducts, and certain meat food products to reduce levels of 
foodborne pathogens and extend shelf life. This action is in response 
to a petition filed by the U.S. Department of Agriculture, Food Safety 
and Inspection Service (USDA/FSIS).

DATES: This rule is effective November 30, 2012. Submit either 
electronic or written objections and requests for a hearing by December 
31, 2012. See section VIII of this document for information on the 
filing of objections.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing identified by Docket No. FDA-1999-F-4617, 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:
     Fax: 301-827-6870.
     Mail/Hand Delivery/Courier (For paper or CD-ROM 
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-1999-F-4617 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 of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.regulations.gov and insert the 
docket number, 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: Lane A. Highbarger, Center for Food 
Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1204.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Safety Evaluation
    A. Radiation Chemistry
    B. Toxicological Considerations
    C. Nutritional Considerations
    D. Microbiological Considerations
III. Labeling
IV. Comments
V. Conclusions
VI. Paperwork Reduction Act of 1995
VII. Environmental Impact
VIII. Objections
IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
X. References

I. Background

    In a notice published in the Federal Register of December 22, 1999 
(64 FR 71792), FDA announced that a food additive petition (FAP 9M4695) 
had been filed by the USDA/FSIS, 300 12th St. SW., rm. 112, Washington, 
DC 20250 (currently, Food Safety and Inspection Service, Stop Code 
3782, Patriots Plaza III, Cubicle 8-163A, 1400 Independence Ave. SW., 
Washington, DC 20250-3700). 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 a 4.5 kGy maximum dose of ionizing 
radiation to treat unrefrigerated (as well as refrigerated \1\) 
uncooked meat, meat byproducts,\2\ and certain meat food products to 
reduce levels of foodborne pathogens and extend shelf-life.
---------------------------------------------------------------------------

    \1\ For the purpose of this final rule, refrigeration 
temperature is a maximum of 40 [deg]F (4 [deg]C).
    \2\ The Agency notes that in the filing notice dated December 
22, 1999 (64 FR 71792), the phrase ``meat products'' was used while 
the petitioner used the phrase ``meat byproducts'' in their filing 
request dated August 19, 1999.
---------------------------------------------------------------------------

    FDA's current regulation under Sec.  179.26(b)(8) permits the 
irradiation of refrigerated or frozen, uncooked products that are meat 
within the meaning of 9 CFR 301.2(rr), meat byproducts within the 
meaning of 9 CFR 301.2(tt), or meat food products within the meaning of 
9 CFR 301.2(uu), with or without nonfluid seasoning, that are otherwise 
composed solely of intact or ground meat, meat byproducts, or both meat 
and meat byproducts. The foods covered under Sec.  179.26(b)(8) are 
subject to the Federal Meat Inspection Act (21 U.S.C. 601, et seq.), 
and, as described previously in this document, are defined by the USDA/
FSIS in Title 9 of the Code of Federal Regulations. In this document, 
the term ``meat'' will be used to refer collectively to meat, meat 
byproducts, and certain meat food products applicable to this notice.

II. Safety Evaluation

    FDA has previously reviewed the irradiation of meat and meat 
byproducts (62 FR 64107, December 3, 1997), and concluded that the 
irradiation of refrigerated meat and meat byproducts is safe. The 
current rulemaking concerns the irradiation of meat at temperatures 
that are above refrigerated temperature. FDA has previously reviewed 
and evaluated the safety of irradiated food products in a variety of 
applications. Discussions of these applications have been presented in 
various Federal Register documents (see, e.g., 62 FR 64107 and 70 FR 
48057, August 16, 2005). FDA has also updated its review

[[Page 71313]]

of the safety of irradiation of food with a thorough survey of the 
literature to the present time and found no new studies on the 
irradiation of meat (Ref. 1).
    Under section 201(s) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 321(s)), a source of radiation used to treat food 
is a food additive. The additive is not added to food literally, but is 
rather a source of radiation used to process or treat food such that, 
analogous to other food processing technologies, its use can affect the 
characteristics of the food. 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 under the conditions of that use. 
Importantly, the statute does not prescribe the safety tests to be 
performed but leaves that determination to the discretion and 
scientific expertise of FDA. Not all food additives require the same 
amount or type of testing to establish safety. The testing and data 
required to establish the safety of an additive will vary depending on 
the particular additive and its intended use.
    In evaluating the safety of a source of radiation to treat food 
intended for human consumption, the Agency 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 doing so, the 
following three general areas need to be addressed: (1) Potential 
toxicity, (2) nutritional adequacy, and (3) effects on the 
microbiological profile of the treated food. Each of these areas is 
discussed in this document.
    The term ``radiation chemistry'' refers to the chemical reactions 
that occur as a result of the absorption of ionizing radiation. Because 
an understanding of radiation chemistry is fundamental in addressing 
these three areas, key aspects of radiation chemistry are also 
discussed.
    FDA has fully considered the data and studies submitted in the 
subject petition as well as other data and information relevant to 
safety. The safety data that have been obtained from irradiating 
various foods under various conditions support conclusions about the 
safety of many irradiated foods, including unrefrigerated meat (Refs. 2 
through 6).

A. Radiation Chemistry

    The conditions under which foods are irradiated are important in 
considering the radiation chemistry of a given food. These conditions 
include: The radiation dose, the physical state of the food (e.g., 
frozen or dried), and the atmosphere in the package.
    The radiolysis products generated in any food are directly 
proportional to the absorbed radiation dose (Ref. 2). Radiation-induced 
chemical changes may cause changes in the organoleptic properties of 
the food. The radiation chemistry of food is strongly influenced by the 
physical state of the food. If all other conditions, including 
radiation dose and ambient atmosphere, are the same, the extent of 
chemical change that occurs in a particular food in the frozen state is 
less than the change that occurs in the non-frozen state. This is 
because of the reduced mobility, in the frozen state, of the initial 
radiolysis products, which will tend to recombine rather than diffuse 
and react with other food components. For similar reasons, if all other 
conditions are the same, the extent of chemical change that occurs in 
the dehydrated state is less than the change that occurs in the fully 
hydrated state (62 FR 64107 at 64110 and references cited therein).
1. Radiation Chemistry of the Major Components of Meat
    The major components of meat are proteins and lipids and the ratios 
vary. Ground beef is a food defined by USDA and ranges from 5 percent 
to 30 percent lipids. The ratio of protein to lipid in whole cuts of 
beef varies depending on many factors.\3\ FDA has extensively reviewed 
the radiation chemistry of flesh foods \4\ in its rulemakings on the 
use of ionizing radiation to treat meat (62 FR 64107) and molluscan 
shellfish (70 FR 48057). In the meat rule (62 FR 64107 at 64111), FDA 
concluded: ``In summary, the results obtained from chemical analyses of 
irradiated flesh foods establish that there would be very small amounts 
of individual radiolytic products generated by radiation doses 
comparable to those proposed in the petition. In addition, most of 
these radiolytic products are either the same as, or structurally very 
similar to, compounds found in foods that have not been irradiated. 
Because of their structural similarities to compounds found in foods 
that have not been irradiated, these radiolytic products would be 
expected to be toxicologically similar to such compounds as well. Thus, 
the available information regarding the radiation chemistry of the 
major components of flesh foods supports the proposition that there is 
no reason to suspect a toxicological hazard due to consumption of an 
irradiated flesh food.''
---------------------------------------------------------------------------

    \3\ Information on the composition of foods can be found at: 
http://www.nal.usda.gov/fnic/foodcomp/search/; the USDA National 
Nutrient Database for Standard Reference. Search with keyword: Meat.
    \4\ Defined by USDA as meat, fish, poultry, and egg products.
---------------------------------------------------------------------------

    During its review of this food additive petition (FAP 9M4695), the 
Agency evaluated the changes that may occur from the irradiation of 
meat at temperatures greater than those previously approved. These 
evaluations are discussed in the following sections of this section 
II.A.1.
    a. Proteins. As noted previously in this document, FDA has 
previously provided detailed discussions of the radiation chemistry of 
proteins in its rulemakings on the use of ionizing radiation to treat 
meat (62 FR 64107 at 64110) and molluscan shellfish (70 FR 48057 at 
48059-48060). Those prior discussions support the findings in this 
rule. Studies conducted with high-protein foods (e.g., meat, poultry, 
and seafood), have established that most of the radiolysis products 
derived from food proteins have the same amino acid composition as the 
original protein and are altered only in their secondary and tertiary 
structures (i.e., they are denatured, Ref. 2). These changes are 
similar to those that occur as a result of heating, but in the case of 
irradiation, even at doses up to 50 kGy and when food is irradiated at 
temperatures ranging from -168 [deg]C to 60 [deg]C in various studies, 
such changes are far less pronounced than heating and the amounts of 
reaction products generated are far lower (62 FR 64107 at 64110). Based 
on these studies and on the analysis set forth in the prior rulemakings 
referenced previously in this document, FDA concludes that there will 
be no significant change in the amino acid composition of meat that is 
irradiated at doses up to 4.5 kGy at temperatures higher than 
refrigeration temperature.
    b. Lipid. FDA has also previously provided detailed discussions of 
the radiation chemistry of lipids in the meat rule (62 FR 64107 at 
64110-64111) and molluscan shellfish rule (70 FR 48057 at 48060). Those 
discussions also support this rule.
    To summarize the previous discussions, a variety of radiolysis 
products derived from lipids have been identified. These include the 
following: Fatty acids, esters, aldehydes, ketones, alkanes, alkenes, 
and other hydrocarbons (Ref. 2). Identical or analogous products are 
found in foods that have not been irradiated. In particular, heating 
food produces generally the same types of products, but in amounts far 
greater than the trace amounts produced by irradiating food (62 FR 
64107 at 64111 and references cited therein).

[[Page 71314]]

    A class of radiolysis products that is derived from lipids, 2-
alkylcyclobutanones (2-ACBs), has been reported to form in small 
quantities when fats are exposed to ionizing radiation. Any 2-ACB 
formed will depend on the fatty acid composition of the food, e.g., 2-
dodecylcyclobutanone (2-DCB) is a radiation byproduct of palmitic acid 
(Refs. 7 and 8). In the molluscan shellfish rule, the Agency noted the 
reported creation of 2-DCB in irradiated chicken and ground beef, which 
contain triglycerides with esterified palmitic acid. FDA did not find 
that the presence of low levels of 2-DCB raised a safety issue (70 FR 
48057 at 48060).
2. Furan
    During the course of reviewing the chemical effects of irradiation, 
FDA became aware of a report that suggested that the irradiation of 
apple juice might produce furan (Ref. 9). Because furan has been shown 
to cause tumors in laboratory animals, FDA has extensively researched 
the occurrence of furan in irradiated foods over the last 10 years. FDA 
has confirmed that certain foods form furan in low quantities when 
irradiated (Ref. 10). Studies conducted by FDA scientists and other 
researchers show that some foods form furan when heated and still other 
foods form furan during storage at refrigeration temperatures (Refs. 10 
and 12). Testing of irradiated non-refrigerated meat found no furan at 
the limit of detection in the tests and detected no furan above the 
background levels of natural furan formation during storage (Refs. 10, 
11, and 12). Therefore, the Agency concludes that the irradiation of 
meat at the requested maximum absorbed dose will not increase the 
amount of furan in the diet and does not present a toxicological hazard 
under the conditions proposed in the USDA/FSIS petition.

B. Toxicological Considerations

    As discussed previously in this document, the available information 
from chemical analyses of irradiated foods suggests that there is no 
reason to suspect a toxicological hazard due to consumption of an 
irradiated food (Ref. 4.) The Agency notes that the large body of data 
from studies where irradiated foods were fed to laboratory animals 
provides an independent way to assess toxicological safety. These 
studies include those relied on by the Agency in previous evaluations 
of the safety of irradiated foods (see 51 FR 13376, April 18, 1986; 55 
FR 18538, May 2, 1990; 62 FR 64107; 65 FR 45280, July 21, 2000; and 70 
FR 48057, August 16, 2005). The Agency is also relying on additional 
data and information in FDA files (Ref. 13). The Agency reviewed the 
data from chemical analysis of beef irradiated at 45 kGy (Ref. 19) and 
concluded that, although there will be an increase in the yields of 
some of the radiolysis products produced by irradiating meat at 30-40 
[deg]C versus 5 [deg]C, the increase is no greater than an order of 
magnitude (Ref. 14), and is insignificant with respect to toxicity 
(Ref. 15).
    In summary, FDA has reviewed data relevant to the assessment of 
potential toxicity of irradiated meat. While all of the studies are not 
of equal quality or rigor, the Agency has concluded that the quantity 
and breadth of testing and the number and significance of endpoints 
assessed would have identified any meaningful risk. Based on the 
totality of the evidence, FDA concludes that irradiation of meat under 
the conditions proposed in this petition does not present a 
toxicological hazard.

C. Nutritional Considerations

    It has been established that the nutrient values of the 
macronutrients in the diet (protein, fats, and carbohydrates) are not 
significantly altered by irradiation at the petitioned doses (62 FR 
64107 at 64114 and Refs. 16 and 17). Minerals (e.g., calcium and iron) 
are also unaffected by irradiation (62 FR 64107 at 64114 and Ref. 17). 
Levels of certain vitamins may be reduced as a result of irradiation. 
The extent to which this reduction occurs depends on the specific 
vitamin, the type of food, and the conditions of irradiation. Not all 
vitamin loss is nutritionally significant; the extent to which the 
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 (62 FR 64107 at 64114).
    FDA has extensively reviewed the nutritional losses that occur when 
meat is irradiated (62 FR 64107 at 64114). During this review, FDA 
noted that the majority of meat would be irradiated at refrigerated 
temperatures or frozen, and possibly in a reduced oxygen environment, 
which would reduce the loss of vitamins. Although this rule covers 
irradiation of meat under unrefrigerated conditions, FDA concludes that 
this difference in temperature will not result in significant vitamin 
loss. Thiamine is known to be more sensitive to irradiation than other 
vitamins; FDA considered a worst-case scenario (e.g., thiamine levels 
in all these foods would be reduced by 50 percent) and the Agency 
concluded that, if all flesh foods (i.e., meat, poultry, and fish) were 
irradiated under such conditions, there would be no deleterious effect 
on the total dietary intake of thiamine as a result of irradiating 
flesh foods, including meat (62 FR 64107 at 64115).
    In summary, based on the available data and information, FDA 
concludes that amending the regulations, as set forth in this document, 
to allow for the use of ionizing radiation to treat unrefrigerated meat 
up to a maximum dose of 4.5 kGy will not have an adverse impact on the 
nutritional adequacy of the overall diet.

D. Microbiological Considerations

    FDA previously examined the effects of radiation-induced changes in 
the microbiological profile of meat and on the growth patterns of any 
surviving microorganisms, including Clostridium botulinum, to determine 
whether the microbiological safety of meat will be adversely affected 
by irradiation (62 FR 64107 at 64115). The Agency determined that 
irradiation of frozen and refrigerated meat and meat byproducts at a 
dose up to 4.5 kGy will not result in any additional health hazard from 
C. botulinum. Likewise, FDA also determined that irradiation will not 
result in any additional hazard from common pathogens other than C. 
botulinum (Ref. 18).
    The Agency has determined that, although the use would be modestly 
different in the current petitioned request, the microbial hazards that 
carcasses would be subjected to would be equivalent to the microbial 
hazards from meat that has been further processed, i.e., meat from a 
completely broken-down carcass that has been refrigerated. Moreover, 
the same doses of irradiation would be expected to be equally effective 
in lowering levels of pathogenic and spoilage microorganisms.\5\ 
Therefore, the Agency concludes, based on all the evidence before it, 
that irradiation of meat under the conditions set forth in the 
regulation presented in this document will not result in a 
microbiological hazard (Ref. 18).
---------------------------------------------------------------------------

    \5\ USDA/FSIS provided a list of pertinent pathogens from 
sources of the meat they regulate and irradiation D-values 
(conditions under which 90 percent of the microorganisms have been 
eliminated) derived from published sources. D-values are typically 
obtained at various temperatures and FDA considers the food matrix 
to be more important than temperature for D-values.
---------------------------------------------------------------------------

    In summary, based on the available data and information, FDA 
concludes that irradiation of meat conducted in accordance with good 
manufacturing practices will reduce or eliminate bacterial populations 
with no increased

[[Page 71315]]

microbial risk from pathogens that may survive the irradiation process 
(Ref. 18).

III. Labeling

    The meat products covered by this rule are defined under the 
Federal Meat Inspection Act (21 U.S.C. 601, et seq.). Therefore, the 
labeling of these products irradiated under the conditions set forth in 
the regulation must comply with any requirements imposed by USDA/FSIS 
under its authority to approve the labeling of such products.

IV. Comments

    FDA has received numerous comments, primarily form letters, from 
individuals that state their opinions regarding the potential dangers 
and unacceptability of irradiating food. FDA has also received several 
comments from individuals or organizations that state their opinions 
regarding the potential benefits of irradiating food and urging FDA to 
approve the petition. Additionally, FDA received several comments from 
Public Citizen (PC) and the Center for Food Safety (CFS) requesting the 
denial of this and other food irradiation petitions.
    Overall, the comments were of a general nature and not necessarily 
specific to the requests in the individual petitions, and did not 
contain any substantive information that could be used in a safety 
evaluation of irradiated meat. Many of these comments from PC and CFS 
were also submitted to the docket for this Agency rulemaking on 
irradiation of molluscan shellfish (Docket No. 1999F-4372, FAP 9M4682). 
The topics raised in these comments included the following: Studies 
reviewed in the 1999 Food and Agriculture Organization of the United 
Nations/International Atomic Energy Agency/World Health Organization 
(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 2-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; FDA's 
purported failure to meet certain 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 
foodborne disease. These comments have all been addressed by FDA in a 
previous rulemaking. For a detailed discussion of the Agency's response 
to each of the previous general comments, the reader is referred to the 
molluscan shellfish rule (70 FR 48057 at 48062 through 48071). Because 
these comments do not raise issues specific to irradiated meat and meat 
byproducts, and the previous responses are sufficient to address these 
issues as they pertain to the rule to permit the irradiation of meat as 
described in this document, the Agency will not address these comments 
further here.

V. Conclusions

    Based on the data and studies submitted in the petition and other 
information in the Agency's files, FDA concludes that the proposed use 
of irradiation to provide for the safe use of a 4.5 kGy maximum dose of 
ionizing radiation to treat unrefrigerated (as well as refrigerated) 
uncooked meat, meat byproducts, and certain meat food products to 
reduce levels of foodborne pathogens and extend shelf-life is safe, and 
therefore the regulations in Sec.  179.26 should be amended as set 
forth in this document.
    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the use of irradiation of unrefrigerated meat in 
response to the petition will be made available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person (see FOR FURTHER INFORMATION CONTACT). As 
provided in Sec.  171.1(h), the Agency will delete from the documents 
any materials that are not available for public disclosure before 
making the documents available for inspection.

VI. Paperwork Reduction Act of 1995

    This final rule does not provide for the collection of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required.

VII. Environmental Impact

    The Agency has carefully considered the potential environmental 
effects of this action. The Agency has determined under 21 CFR 25.32(j) 
that this action is of a type that does not individually or 
cumulatively have a significant effect on the human environment. 
Therefore, neither an environmental assessment nor an environmental 
impact statement is required.

VIII. Objections

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) either 
electronic or written objections. Each objection must be separately 
numbered, and each numbered objection must specify with particularity 
the provisions of the regulation to which objection is made and the 
grounds for the objection. Each numbered objection on which a hearing 
is requested must specifically so state. Failure to request a hearing 
for any particular objection constitutes a waiver of the right to a 
hearing on that objection. Each numbered objection for which a hearing 
is requested must include a detailed description and analysis of the 
specific factual information intended to be presented in support of the 
objection in the event that a hearing is held. Failure to include such 
a description and analysis for any particular objection constitutes a 
waiver of 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.

IX. 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) (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 (ll)(4) of the FD&C Act 
applies. In our review of this petition, FDA did not consider whether 
section 301(ll) of the FD&C Act or any of its exemptions apply to the

[[Page 71316]]

ionizing radiation source. Accordingly, this final rule should not be 
construed to be a statement that ionizing radiation used to treat meat, 
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.

X. 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, and are 
available electronically at http://www.regulations.gov. References 
without asterisks are not on display; they are available as published 
articles and books.

1. Memorandum for FAP 9M4695 from K. Morehouse, FDA, to L. 
Highbarger, FDA, dated August 10, 2010.*
2. Diehl, J. F., ``Chemical Effects of Ionizing Radiation,'' pp. 43-
88, in Safety of Irradiated Foods, Second Edition, Marcel Dekker, 
Inc., New York, 1995.
3. Elias, P. S. and A. J. Cohen, ``Recent Advances in Food 
Irradiation,'' Elsevier Biomedical, Amsterdam, 1983.
4. World Health Organization, ``High-Dose Irradiation: Wholesomeness 
of Food Irradiated With Doses Above 10 kGy,'' World Health 
Organization Technical Report Series No. 890, pp. 9-37, Geneva, 
1999.
5. Preservation of Food by Ionizing Radiation, edited by E. S. 
Josephson, and M. S. Peterson, Vol. II, CRC Press, Boca Raton, 1982.
6. Diehl, J. F., ``Radiolytic Effects in Foods,'' pp. 279-357, in 
Preservation of Food By Ionizing Radiation, Vol. I, edited by E. S. 
Josephson, and M. S. Peterson, CRC Press, Boca Raton, 1982.
7. Crone, A. V. J., et al., ``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.
8. 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.
9. 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.
10. Memorandum for FAP 9M4695 from K. Morehouse, FDA, to L. 
Highbarger, FDA, dated May 18, 2009.*
11. Locas, C.; and V. A.Yaylayan, ``Origin and Mechanistic Pathways 
of Formation of the Parent Furan--a Toxicant,'' Journal of 
Agricultural and Food Chemistry, 52:6830-6836, 2005.
12. Fan, X., and K. J. B. Sokorai, ``Effect of Ionizing Radiation on 
Furan Formation in Fresh-Cut Fruits and Vegetables,'' Journal of 
Food Science, 73(2): C79-C83, 2008.
13. Memorandum from Food Additives Evaluation Branch, FDA (HFS-156), 
to C. Takaguchi, Petition Control Branch, FDA, December 28, 1982.*
14. Memorandum for FAP 9M4696 from E. Jensen, FDA, to R. Alrefai, 
FDA, dated December 10, 1999.*
15. Memorandum to the file for FAP 4M4428, from D. Hattan, FDA, 
dated November 18, 1997.*
16. Underdal, 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.
17. Diehl, J. F., ``Nutritional Adequacy of Irradiated Foods,'' pp. 
241-282, in Safety of Irradiated Foods, Marcel Dekker, New York, 
1995.
18. Memorandum for FAP 9M4695 from R. Merker, FDA, to L. Highbarger, 
FDA, dated May 26, 2010.*
19. Merritt, C., Jr., P. Angelini, E. Wierbicki, and G. W. Shults, 
``Chemical Changes Associated With Flavor in Irradiated Meat,'' 
Journal of Agricultural and Food Chemistry, 23:1037-1041, 1975.

List of Subjects in 21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping 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 a 
new entry ``13.'' under the headings ``Use'' and ``Limitations'' to 
read as follows:


Sec.  179.26  Ionizing radiation for the treatment of food.

* * * * *
    (b) * * *

------------------------------------------------------------------------
               Use                              Limitations
------------------------------------------------------------------------
 
                              * * * * * * *
13. For control of foodborne       Not to exceed 4.5 kGy.
 pathogens, and extension of
 shelf-life, in unrefrigerated
 (as well as refrigerated)
 uncooked meat, meat byproducts,
 and certain meat food products.
------------------------------------------------------------------------

* * * * *

    Dated: November 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28967 Filed 11-29-12; 8:45 am]
BILLING CODE 4160-01-P


