[Federal Register Volume 77, Number 231 (Friday, November 30, 2012)]
[Rules and Regulations]
[Pages 71316-71321]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-1999-F-1267 (Formerly Docket No. 1999F-5322)]


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) is amending the food 
additive regulations to increase the maximum dose of ionizing radiation 
permitted in the treatment of poultry products, to include specific 
language intended to clarify the poultry products covered by the 
regulations, and to remove the limitation that any packaging used 
during irradiation of poultry shall not exclude oxygen. This action is 
in response to a petition filed by the U.S. Department of Agriculture, 
Food Safety and Inspection Service (USDA/FSIS).

[[Page 71317]]


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-1267 
(formerly Docket No. 1999F-5322) 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-1267 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 21, 1999 
(64 FR 71461), FDA announced that a food additive petition (FAP 9M4696) 
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 to amend the food 
additive regulation, Ionizing radiation for the treatment of food 
(Sec.  179.26 (21 CFR 179.26)) in item 6 of the table in paragraph (b) 
to: (1) Increase the maximum dose of ionizing radiation permitted in 
the treatment of poultry products; (2) include specific language 
intended to clarify the poultry products covered by the regulations; 
and (3) remove the limitation that any packaging used during 
irradiation of poultry shall not exclude oxygen.
    FDA's current regulation under Sec.  179.26(b)(6) permits the 
irradiation of fresh or frozen, uncooked poultry products that are: (1) 
Whole carcasses or disjointed portions of such carcasses that are 
``ready-to-cook poultry'' within the meaning of 9 CFR 381.1(b)(44) or 
(2) mechanically separated poultry product (a finely comminuted 
ingredient produced by the mechanical deboning of poultry carcasses or 
parts of carcasses) up to a maximum absorbed dose of 3.0 kiloGray (kGy) 
with the restriction that any packaging used shall not exclude oxygen.
    The amended regulation clarifies the range of poultry products that 
may be irradiated, increases the maximum dose of ionizing radiation 
permitted in the treatment of covered poultry products, and will remove 
the requirement that the packaging for covered poultry products must 
not exclude oxygen. The amended regulation clarifies that the 
regulation covers fresh (refrigerated or unrefrigerated) or frozen, 
uncooked poultry products that are: (1) Whole carcasses or disjointed 
portions (or other parts) of such carcasses that are ``ready-to-cook 
poultry'' within the meaning of 9 CFR 381.1(b) (with or without 
nonfluid seasoning; includes, e.g., ground poultry) or (2) mechanically 
separated poultry product (a finely comminuted ingredient produced by 
the mechanical deboning of poultry carcasses or parts of carcasses). In 
this document, the term ``poultry'' will be used to refer collectively 
to all of these products.
    This amendment will bring the poultry regulation into conformity 
with the current regulation permitting the irradiation of refrigerated 
or frozen, uncooked products that are meat, meat byproducts, or meat 
food products; i.e., it permits a maximum absorbed dose of 4.5 kGy for 
non-frozen products and 7.0 kGy for frozen products (Sec.  
179.26(b)(8)), and provides no limitation that the packaging shall not 
exclude oxygen, which would allow the use of packaging including 
modified atmosphere packaging and vacuum packaging.

II. Safety Evaluation

    FDA has previously evaluated the safety of irradiated protein food 
products in a variety of applications. Discussions of these 
applications have been presented in various Federal Register documents 
(see 51 FR 13376, April 18, 1986; 55 FR 18538, May 2, 1990; 62 FR 
64107, December 3, 1997; 65 FR 45280, July 21, 2000; and 70 FR 48057, 
August 16, 2005). FDA specifically reviewed the irradiation of flesh 
foods and concluded that the irradiation of refrigerated flesh foods is 
safe at the absorbed doses that were reviewed (see 62 FR 64107 at 
64111). FDA has also updated its review of the safety of irradiation of 
food with a thorough review of the literature to the present time and 
found no new studies on the irradiation of poultry (Ref. 1).
    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 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

[[Page 71318]]

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 
the three areas noted in this document, 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 relevant data and information. The 
safety data that have been obtained from irradiating various foods 
under various conditions support conclusions about the safety of 
irradiating the poultry products covered in this rule (Refs. 2 and 4 
through 7).

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, and 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 Poultry
    FDA has previously determined that flesh foods, including poultry, 
can be considered a single group for the purposes of evaluating the 
safety of irradiation because they are similar in composition (62 FR 
64107 at 64111). Specifically, the approximate composition of beef and 
lamb is 17 percent to 20 percent protein, 15 percent to 25 percent fat, 
and 56 percent to 65 percent water. Chicken (depending on cut and 
whether or not skin is included) is about 18 percent to 25 percent 
protein, 5 percent to 19 percent fat, and 57 percent to 75 percent 
water (Ref. 3). Fatty acids in the triglycerides from all flesh foods 
are comprised of the same predominant species: Oleic, palmitic, 
linoleic, and stearic acid.
    Because of the commonality in the chemistry of the components of 
flesh foods and the predictability of the types and amounts of 
radiolytic products produced when food is irradiated, the Agency 
determined in the 1997 rule permitting the irradiation of meat, meat 
byproducts, and certain meat food products, that the conclusions 
regarding the irradiation of specific flesh foods can be used to draw 
conclusions about the irradiation of flesh foods as a class (62 FR 
64107 at 64111). The effects of irradiation on non-frozen poultry 
irradiated at levels up to 4.5 kGy and in frozen poultry irradiated at 
levels up to 7.0 kGy are similar to the effects that occur in 
irradiated meat and have been shown to be safe.
    a. Protein. 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, meat byproducts, and certain meat food products (62 FR 64107 at 
64110) and molluscan shellfish (70 FR 48057 at 48059-48060). 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, 
FDA concludes that there will be no significant change in the amino 
acid composition of poultry that is irradiated at absorbed doses not to 
exceed 4.5 kGy for non-frozen products and not to exceed 7.0 kGy for 
frozen products.
    b. Lipid. FDA has also previously provided a detailed discussion of 
the radiation chemistry of lipids in the rules to permit the 
irradiation of meat, meat byproducts, and certain meat food products 
(62 FR 64107 at 64110-64111) and molluscan shellfish (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 
also 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).
    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. 8 and 9). 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 may produce furan (Ref. 10). 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. 11). 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. 11 and 13). Testing of irradiated poultry 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. 11, 
12, and 13). Therefore, the Agency concludes that the irradiation of 
poultry 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.

[[Page 71319]]

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. 5). 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). Additionally, FDA has looked at data and 
information in FDA files summarized by the Bureau of Foods Irradiated 
Food Committee (Refs. 14 and 15).
    In summary, FDA has reviewed data relevant to the assessment of 
potential toxicity of irradiated poultry. 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 poultry 
under the conditions proposed in the 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 made the following finding with respect to the nutritional 
impact of consuming non-frozen flesh foods irradiated at levels up to 
4.5 kGy and frozen flesh foods irradiated at levels up to 7.0 kGy: The 
effects of irradiation on the nutritional adequacy of irradiated flesh 
foods, which includes poultry, at or above the petitioned doses have 
been considered previously. Although the meat final rule (62 FR 64107, 
December 3, 1997), codified only the irradiation of red meat at up to 
the petitioned doses, the safety evaluation took into account the 
effects on the diet of irradiating all flesh foods. The Agency 
concluded that permitting the irradiation of poultry at the petitioned 
levels will not affect the nutritional status of poultry consumers 
(Ref. 3).
    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 poultry up to a 
maximum absorbed dose of 4.5 kGy for non-frozen products and not to 
exceed 7.0 kGy for frozen products will not have an adverse impact on 
the nutritional adequacy of the overall diet.

D. Microbiological Considerations

    In the 1990 final rule for irradiation of poultry (55 FR 18538), 
FDA determined that while irradiation at a dose of 3 kGy reduces the 
number of many pathogenic and spoilage bacteria, it does not eliminate 
the relatively radiation-resistant spore-forming bacteria such as 
Clostridium botulinum (55 FR 18541). FDA also determined in the final 
rule that C. botulinum, if present, would not render fresh poultry 
irradiated at 3 kGy toxic before normal signs of spoilage became 
apparent (55 FR 18542).\1\ As an extra margin of safety, however, the 
final rule established the limitation that packaging shall not exclude 
oxygen with respect to poultry, because C. botulinum does not grow in 
oxygenated environments (Ref. 18).
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    \1\ We note that C. botulinum is not able to grow at 
temperatures below freezing.
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    Since the final rule permitting the irradiation of poultry was 
published in 1990, the Agency notes that poultry production practices 
have changed, making C. botulinum contamination and growth less of a 
concern.\2\ As part of the 1990 rulemaking, the Agency considered the 
fact that C. botulinum type E could potentially contaminate fish meal, 
which was typically used in chicken feed. Currently, however, fish meal 
has almost been completely replaced with high protein soybean and corn 
meal. Additionally, C. botulinum does not produce toxin when held at 10 
[deg]C (Ref. 19), and current USDA/FSIS regulations generally require 
that poultry plants maintain poultry at temperatures below 10 [deg]C 
during processing (9 CFR 381.66(b)(1)). Finally, controlling 
microbiological contamination, including contamination from C. 
botulinum, is now required under mandatory USDA/FSIS poultry processing 
Hazard Analysis Critical Control Point plans (9 CFR part 417).
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    \2\ We note that C. botulinum generally occurs in very low 
numbers in chicken.
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    In addition to the changes in poultry production practices after 
the issuance of the 1990 final rule, a study published after the 
issuance of the 1990 poultry regulation demonstrates that lactic acid 
producing bacteria predominate on irradiated raw chilled meat at doses 
up to 5 kGy (Ref. 20) and flourish in an anaerobic environment that 
could potentially allow C. botulinum to grow. The growth of C. 
botulinum and other pathogens is inhibited by these non-pathogenic 
lactic acid producing bacteria (such as Lactobacillus species).
    All of the previously mentioned factors would render it unlikely 
that C. botulinum could either grow or produce toxin in poultry under 
the conditions of irradiation specified in the regulation as amended by 
this final rule, including removal of the restriction on packaging that 
excludes oxygen (Ref. 18). Further, the presence of spoilage bacteria 
will warn consumers of spoilage before any C. botulinum present would 
produce toxin.
    In summary, based on the available data and information, FDA 
concludes that irradiation of poultry under the conditions in this 
amended regulation will reduce or eliminate bacterial populations with 
no increased microbial risk from pathogens that may survive the 
irradiation process in either an aerobic or anaerobic atmosphere (Ref. 
18).

III. Labeling

    Poultry products are subject to the Poultry Products Inspection Act 
(21 U.S.C. 451, 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.

[[Page 71320]]

    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 poultry. Many of the comments from PC and CFS 
were also submitted to the docket for the 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 previously mentioned 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 poultry, and the previous responses are sufficient to 
address these issues as they pertain to the rule to permit the 
irradiation of poultry 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 treat fresh (refrigerated and unrefrigerated) poultry 
food products \3\ with absorbed doses that will not exceed 4.5 kGy and 
frozen poultry products not to exceed 7.0 kGy is safe with no need for 
a requirement that the packaging shall not exclude oxygen, and 
therefore, Sec.  179.26 should be amended as set forth in this 
document.
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    \3\ The term ``fresh poultry'' is defined by USDA to include 
both refrigerated and unrefrigerated poultry food products.
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    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 poultry 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 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 shall be separately 
numbered, and each numbered objection shall 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 shall specifically so state. Failure to request a hearing 
for any particular objection shall constitute a waiver of the right to 
a hearing on that objection. Each numbered objection for which a 
hearing is requested shall 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 
shall constitute 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 
ionizing radiation source. Accordingly, this final rule should not be 
construed to be a statement that ionizing radiation used to treat 
poultry products, 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.


[[Page 71321]]


1. Memorandum for FAP 9M4696 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. Memorandum for FAP 9M4696 from E. Jensen, FDA, to R. Alrefai, 
FDA, dated December 10, 1999.*
4. Elias, P.S. and A.J. Cohen, ``Recent Advances in Food 
Irradiation,'' Elsevier Biomedical, Amsterdam, 1983.
5. 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.
6. Preservation of Food by Ionizing Radiation, edited by E.S. 
Josephson and M.S. Peterson, Vol. II, CRC Press, Boca Raton, 1982.
7. 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.
8. 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.
9. 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.
10. 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.
11. Memorandum for FAP 9M4697 from K. Morehouse, FDA, to L. 
Highbarger, FDA, dated February 20, 2008. *
12. 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.
13. 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.
14. Memorandum from Food Additives Evaluation Branch, FDA (HFS-156), 
to C. Takaguchi, Petition Control Branch, FDA, December 28, 1982.*
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. Internal Memorandum for FAP 9M4696 from J. Newland, FDA, to the 
file, dated July 7, 2000.*
19. Firstenberg-Eden, R., D.B. Rowley, and G.E. Shattuck. ``Factors 
Affecting Growth and Toxin Production by Clostidium Botulinum Type E 
on Irradiated (0.3 Mrad) Chicken Skins.'' Journal of Food 
Protection, 47:867-870, 1982.
20. Matilla-Sandholm, T. and E. Skytta. ``The Effect of Spoilage 
Flora on the Growth of Food Pathogens in Minced Meat Stored at 
Chilled Temperature.'' Lebensmittel-Wissenschaft Technologie, 
24:116-120, 1991.

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 revising 
entry ``6.'' under the headings ``Use'' and ``Limitations'' to read as 
follows:


Sec.  179.26  Ionizing radiation for the treatment of food.

* * * * *
    (b) * * *

------------------------------------------------------------------------
               Use                              Limitations
------------------------------------------------------------------------
 
                              * * * * * * *
6. For control of food-borne       Not to exceed 4.5 kGy for non-frozen
 pathogens in fresh (refrigerated   products; not to exceed 7.0 kGy for
 or unrefrigerated) or frozen,      frozen products.
 uncooked poultry products that
 are: (1) Whole carcasses or
 disjointed portions (or other
 parts) of such carcasses that
 are ``ready-to-cook poultry''
 within the meaning of 9 CFR
 381.l(b) (with or without
 nonfluid seasoning; includes,
 e.g., ground poultry), or (2)
 mechanically separated poultry
 product (a finely comminuted
 ingredient produced by the
 mechanical deboning of poultry
 carcasses or parts of carcasses).
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

    Dated: November 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28968 Filed 11-29-12; 8:45 am]
BILLING CODE 4160-01-P