[Federal Register Volume 77, Number 231 (Friday, November 30, 2012)]
[Rules and Regulations]
[Pages 71316-71321]
From the Federal Register Online via the Government Publishing 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