[Federal Register Volume 73, Number 174 (Monday, September 8, 2008)]
[Notices]
[Pages 52001-52004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20653]


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DEPARTMENT OF AGRICULTURE

Food Safety Inspection Service

[Docket No. FSIS 2008-0028]


Irradiation as a Processing Aid

AGENCY: Food Safety and Inspection Service (FSIS), USDA.

ACTION: Notice of availability of petition and public meeting; request 
for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
that it has received a petition from the American Meat Institute (AMI) 
to recognize the use of low penetration and low dose electron beam 
irradiation on the surface of chilled beef carcasses as a processing 
aid. Based on its consideration of the data and information contained 
in the petition, FSIS believes that the petition has merit. FSIS will 
hold a public meeting on September 18, 2008, to review the information 
contained in the petition and to receive public comments on what action 
it should take with respect to the petition. A copy of the petition is 
available on the FSIS Web site.

DATES: The public meeting will be held on September, 18, 2008. Comments 
must be received by October 18, 2008.

ADDRESSES: The public meeting will be held from 9 a.m. to 1 p.m. at: 
L'Enfant Plaza Hotel, 480 L'Enfant Plaza, SW., Washington, DC 20024, 
(202) 484-1000.
    FSIS invites interested persons to submit comments on the petition 
and its reaction to the petition. FSIS will finalize an agenda on or 
before the meeting date and will post it on the FSIS Web page http://www.fsis.usda.gov/News?Meetings_&_Events/. The petition discussed in 
this notice is available for viewing by the public in the FSIS Docket 
Room and on the FSIS Web site http://www.fsis.usda.gov/News?Meetings_&_Events/ and http://www.usda.gov/regulations_&policies/Petitions/index.asp. The official transcript of the meeting will be available for 
viewing by the public in the FSIS Docket Room and on the FSIS Web site 
http://www.fsis.usda.gov/News?Meetings_&_Events/ when it becomes 
available.
    Comments may be submitted by either of the following methods:
    Federal eRulemaking Portal: This Web site provides the ability to 
type short comments directly into the comment field on this Web page or 
attach a file for lengthier comments. FSIS prefers to receive comments 
through the Federal eRulemaking portal. Go to http://www.regulations.gov and, in the ``Search for Open Regulations'' box, 
select ``Food Safety and Inspection Service'' from the agency drop-down 
menu, then click on ``Submit.'' In the Docket ID column, select the 
FDMS Docket Number FSIS-2008-0028 to submit or view public comments and 
to view supporting and related materials available electronically. 
After the close of the comment period, the docket can be viewed using 
the ``Advanced Search'' function in Regulations.gov.
    Mail, including floppy disks or CD-ROMs, and hand- or courier-
delivered items: Send to Docket Clerk, U.S. Department of Agriculture, 
Food Safety and Inspection Service, FSIS Docket Room, 1400 Independence 
Avenue, SW., Room 2534, Washington, DC 20250.
    All submissions received must include the Agency name and docket 
number FSIS-2008-0028. Documents referred to in this notice, and all 
comments submitted in response to this notice will be available for 
public inspection in the FSIS Docket Room at the address listed above 
between 8:30 a.m. and 4:30 p.m., Monday through Friday, except Federal 
holidays. Comments also will be posted on the Agency's Web site at 
http://www.fsis.usda.gov/regulations_&_policies/2008_Notices_Index/index.asp.
    Individuals who do not wish FSIS to post their personnel contact 
information--mailing address, e-mail address, telephone number-on the 
Internet may leave this information off of their comments.

FOR FURTHER INFORMATION CONTACT: For technical information, Patrick 
Burke: telephone--202/720-7974 and [email protected].
    Pre-registration for this meeting is recommended. To pre-register, 
please contact Robert Tynan by telephone at (202) 720-3884 or by e-mail 
at [email protected], Persons

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requiring a sign language interpreter or special accommodations should 
contact Robert Tynan as soon as possible.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Food Irradiation

    Food is most often irradiated commercially to extend shelf-life, 
eliminate insect pests, or reduce numbers of pathogenic microorganisms. 
Food irradiation for these purposes is practiced in many countries, 
including the United States. Food irradiation is the process of 
exposing food to high levels of radiant energy. One form of radiant 
energy used commercially is electron beam (e-beam). Energy from 
accelerated electrons is absorbed as they enter the surface of the 
product being irradiated. The electrons cause chemical bond breakage in 
the microorganisms immediately, in addition to damaging their 
deoxyribonucleic acid (DNA). However, not all microorganisms are 
destroyed at the same energy dose because of the differences in the 
amount of genetic material or their ability to repair their genetic 
material.
    In 1999, FSIS amended its regulations (64 FR 72168, December 23, 
1999) to permit the use of ionizing radiation for treating refrigerated 
or frozen, uncooked meat, meat by products, and certain other meat food 
products to reduce levels of foodborne pathogens and to extend shelf-
life. The FSIS regulations require the use of sources of ionizing 
radiation identified in FDA's regulations (21 CFR 179.261(a)). These 
sources include gamma rays, electrons generated from machine sources 
(e-beam), and x-rays. In 9 CFR 424.22(c), FSIS details the requirements 
for the use of irradiation by official establishments, including the 
labeling requirements for irradiated meat (9 CFR 424.22(c)(4)). The 
Agency requires that labeling for packaged meat food products 
irradiated in their entirety bear the radura logo along with a 
statement such as ``Treated with radiation'' or ``Treated by 
irradiation.'' FSIS requires that the logo be placed prominently and 
conspicuously in conjunction with the required statement, and that the 
statement appear as a qualifier contiguous to the product name (9 CFR 
424.22(c)(4)(i)). Also, FSIS requires that inclusion of an irradiated 
meat food product ingredient in any multi-ingredient product be 
reflected in the ingredient statement on the finished product labeling 
(9 CFR 424.22(c)(4)(iii)). FSIS requires that for unpackaged meat food 
products irradiated in their entirety, the logo and a statement be 
prominently and conspicuously displayed to purchasers either through 
labeling on a bulk container or some other appropriate device (9 CFR 
424.22 (c)(4)(iii)).
    In 21 CFR 179.26 (b), FDA lists the conditions under which ionizing 
radiation can be safety used. For the control of foodborne pathogens 
in, and extension of the shelf-life of, refrigerated uncooked meat, the 
amount of irradiation is not to exceed 4.5 kGy maximum for refrigerated 
products. The regulation does not list a minimum dose.

B. Processing Aids

    Under FDA's regulations, processing aids include substances that 
are added to a food for their technical or functional effect during 
processing but are present in the finished food at insignificant levels 
and do not have any technical or functional effect in that food (21 CFR 
101.100 (a)(3)(ii)(c)). FDA's regulations provide that processing aids 
are not required to be included on product labels.
    FSIS has relied on the FDA regulations on processing aids in 
regulating the labeling of meat and poultry products (http://www.fsis.usda.gov/PDF/Determination_of_Processing_Aids.pdf). FSIS 
does not require that the use of substances determined to be processing 
aids be declared on product labels. For example, for over a decade, the 
Agency has permitted the use of lactic acid and certain other organic 
acids as antimicrobial carcass washes applied post-slaughter but pre-
chiller. In this application, lactic acid and the other organic acids 
are classified as a processing aid, and no labeling is needed, because 
the effect of application of the substance is momentary and not 
lasting.
AMI Petition
    On July 8, 2005, AMI submitted a citizen's petition to FSIS 
requesting that the Agency officially recognize low dose, low 
penetration e-beam irradiation applied to the surface of chilled beef 
carcasses as a ``processing aid.'' The petition requested that 
information concerning irradiation treatment not be required on the 
label of any products derived from the carcass.
    The petition argues that low dose (<= 1.0 kGy surface dose), low 
penetration (20mm) e-beam irradiation is a processing aid because the 
electron beam has a functional effect of reducing pathogens on the 
carcass surface, but that once the energy from the electrons is 
absorbed, there were no further functional effects from the 
irradiation. According to the petition, low dose, low penetration e-
beam application results in only a small portion of the carcass 
receiving the e-beam irradiation exposure. The petition presents 
evidence that the use of e-beam irradiation is effective in reducing 
levels of Escherichia coli O157:H7 on the carcass; has no effect on 
organoleptic properties or appearance of the carcass; has no lasting 
effect on shelf life of the carcass or of product derived from the 
carcass; and produces no significant loss of either macro- or micro-
nutrients in the carcass or the product derived from the carcass. A 
summary of the scientific data presented in the petition follows:
1. The Process Is Effective at Reducing Levels of E. coli O157:H7
    The USDA Agricultural Research Service's Meat Animal Research 
Center (MARC) conducted a study on the effectiveness of low-dose, low 
penetration e-beam irradiation in reducing levels of E. coli O157:H7 on 
chilled beef carcass surface cuts. (Arthur, Terrance M. and et al. 
2005. Effects of Low-Dose, Low-Penetration Electron Beam Irradiation of 
Chilled Beef Carcass Surface Cuts on Escherichia coli O157:H7 and Meat 
Quality. Journal of Food Protection, Vol. 68, No. 4 2005, Pages 666-
672.)
    In the study, portions of beef cutaneous trunci muscle were 
selected to represent the carcass surface because the muscle, which 
covers portions of the beef plate and beef flank, is the outermost 
surface muscle and thus approximates the surface matrix of a beef 
carcass. Forty cutaneous trunci pieces were inoculated with E. coli 
O157:H7, twenty with a high concentration of 6 log cfu/cm\2\ (high 
inoculation) and twenty with a low concentration of 3 log cfu/cm\2\ 
(low inoculation). The forty samples were cut into equal portions for a 
total of eighty samples. One half of the high inoculated and low 
inoculated samples were treated with surface dosage of 1 kGy with 
approximately 15 mm of penetration. The remaining samples were not 
treated.
    Results for direct cell count plating show that while the E. coli 
O157:H7 contamination of the untreated samples remained around the high 
inoculation level (7.2 logs after attachment, 6.6 logs at 48 hours and 
5.9 logs at 120 hours) and the low inoculation level (3.9 logs after 
attachment, 2.9 logs after 48 hours, and 2.6 logs after 120 hours), E. 
coli O157:H7 was undetectable after 48 hours in irradiated samples that 
had been inoculated at the high level and was present at approximately 
0.1 log after 120 hours. For the low inoculation level, the irradiation 
treated samples

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were undetectable for E. coli O157:H7 after 48 and 120 hours. In 
addition to direct plating, researchers conducted enumeration of 
positive samples using the most probable number (MPN) technique. The 
results of the MPN analysis were similar to that from direct plating, 
indicating that the numbers of viable E. coli O157:H7 cells following 
irradiation were very low. There was no low-inoculation sample at 48 
hours and only one low-inoculation sample at 120 hours that had a MPN 
value above the limit of detection (minimum level of detection was 
0.036 CFU/cm\2\). All of the high-inoculation samples were above the 
limit of detection.
    These data appear to support the conclusion that a low dose (<= 1.0 
kGy surface dose), low penetration (20mm) surface e-beam irradiation 
process will produce a significant surface reduction of E. coli O157:H7 
on chilled beef carcasses. FSIS solicits comment on whether this 
conclusion is correct, and on whether there are data available that 
would support a different conclusion.
2. The Process Does Not Have Any Affect on Quality or Appearance
    The MARC's study also addressed effects of low dose, low 
penetration e-beam process on organoleptic properties of treated 
product. Spilt beef carcasses have thin external muscles that may be 
partially exposed from the carcass splitting process. During low dose 
e-beam irradiation of carcass sides, these muscles will receive various 
doses of radiation depending on their location and the extent of fat 
cover. In MARC's assessment of organoleptic impact, the flank steak was 
used as the model muscle because it is partially surface exposed; 
consistent in size, shape, and location; easy to access and remove; and 
possesses sufficient surface fat and surface layer molding to achieve 
variable penetration.
    None of the flank steak sensory attributes (aroma intensity, off-
aroma, tenderness, juiciness, flavor intensity, and off-flavor) were 
affected by any penetration treatment (10%-75% penetration). Three 
Hunter Color measurements (lightness, redness, and yellowness) were 
made in the MARC study, and all showed some treatment effects. However, 
the effects on lightness and yellowness were not linear with dose, and 
thus the investigators did not consider them to be meaningful 
treatment-related differences. The effects of treatment on redness 
values were linear. However, the researchers concluded that the 
magnitude of the effect was slight and would likely have no impact on 
consumer acceptance.
    These data appear to support that a low dose, low penetration 
surface e-beam process does not have any affect on quality or 
appearance. FSIS asks for comment on whether the available data support 
this conclusion.
3. The Process Does Not Have an Effect on Shelf Life
    A study of the effects of low dose, low-penetration e-beam surface 
exposure on the shelf life of beef was performed by Silliker Inc.
    Twelve chilled beef plates from a commercial beef slaughter 
facility were removed from beef carcasses and transported to a 
commercial irradiation facility. Six beef plates were designated ``air-
exposed,'' and three of these six were left untrimmed. Six beef plates 
were designated ``vac-pac,'' and all were trimmed. Six of these twelve 
were treated with low level (1 kGy), low penetration (15 mm) surface e-
beam irradiation. The other six were left untreated as controls.
    After the six beef plates were irradiated, the irradiated and 
control plates were randomly subdivided into four equal segments. Each 
segment was allocated into time slots of 1, 3, 6, and 9 days for air 
exposed, and 1, 10, 20, and 30 days for vac-pac. The following 
microbiological tests were performed at each measurement time: total 
aerobic plate count (APC) (35[deg]C with aerobic atmosphere), hetero- 
and homo-lactic acid bacteria (LAB) (30[deg]C with micro-aerobic 
atmosphere), total coliforms (35[deg]C with aerobic atmosphere), and 
Biotype I E. coli (35-45[deg]C with aerobic atmosphere). To provide a 
measure of oxidative rancidity, thiobarbituric acid (TBA) was analyzed 
throughout shelf life.
    For APC, LAB, and total coliform counts of air-exposed beef after 
nine days, the irradiated samples were within 1.5 logs of the non-
irradiated samples. For APC and LAB counts of vacuum packed beef after 
thirty days, the irradiated samples were within 1 log of the non-
irradiated samples, while the total coliform counts were equivalent. 
The vacuum packed beef TBA values ranged from limited, tolerably 
oxidized to somewhat oxidized over 30 days of shelf life. The air 
exposed beef TBA values ranged from limited, tolerably oxidized at 2 
days of shelf life to oxidized at 9 days of shelf life. All samples 
were below the range of rancidity.
    Based on the results of this study, the initial antimicrobial 
effects of the treatment appear to have been minimal, and over the 
course of shelf life, the APC and LAB counts on the surface e-beam 
treated product increased to the point that quantitative levels nearly 
approximated the non-treated controls at the end of the storage period. 
In addition, one of the principal measurements of shelf life and 
product spoilage--rancidity--as measured by TBA indicated that the 
treated samples would turn rancid slightly before the non-treated 
controls. These data appear to demonstrate that the e-beam surface 
treatment of beef plates does not have a lasting effect on the product 
shelf-life.
    Based on all of these data, a low dose, low penetration surface e-
beam process appears not to have any affect on shelf-life. FSIS asks 
for comment on this tentative conclusion.
4. The Process Does Not Produce Significant Losses of Nutrients
    A literature review and analysis on the effects of low dose, low-
penetration e-beam irradiation on the levels of micro and macro 
nutrients was conducted by Dr. Donald W. Thayer, a retired USDA--ARS 
researcher (Thayer, Donald. 2004. Literature Review and Analysis of the 
Effects of Beef Carcass Surface Irradiation on Micro- and Macro-
Nutrients).
    Concerning macro-nutrients, Dr. Thayer found that there were no 
significant differences in the peroxide and iodine values of lipids 
following irradiation up to 10 kGy of the m. longissimus dorsi of beef. 
Also, there were no significant changes following irradiation in the 
malonaldehyde concentration in beef m. longissimus dorsi (Hampson, 
J.W., et al., 1996. Effect of low dose gamma radiation on lipids in 
five different meats. Meat Science. 42:271-276). Concerning micro-
nutrients, Dr. Thayer found that several authors studied the effects of 
sterilization doses of gamma irradiation on vitamins in ground beef at 
1 kGy dose. According to Dr. Thayer's review, the water soluble 
vitamins in beef (niacin, vitamin B12, chorine, instill, and folacin) 
were ``unaltered.'' One water soluble and one fat soluble vitamin 
(thiamin and tocopherol) would likely be decreased. For these two 
vitamins, Dr. Thayer estimated, worse case, that the maximum net 
decrease in the U.S. diet would be only 0.021% for thiamin and 0.014% 
for tocopherol.
    Dr. Thayer concluded that ``beef carcass surface, low dosage (1.0 
kGy) electron beam irradiation will not produce a significant loss of 
either micro- or macro-nutrients from the U.S. diet.''
    Based on these findings, it appears that a low dose, low 
penetration surface e-beam process does not have any significant effect 
on micro and macro

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nutrients. FSIS asks for comment on this tentative conclusion.
Processing Aid
    The AMI petition raised the issue of considering low dose, low 
penetration e-beam irradiation of the surface of beef carcasses to be a 
``processing aid'' whose use would not need to be disclosed in the 
labeling of products derived from the carcasses that were irradiated. 
FSIS has consulted with FDA about this issue, and FDA has advised FSIS 
that, tentatively, it would not object to treating low dose, low 
penetration e-beam irradiation on the surface of chilled beef carcasses 
as a processing aid. FDA is still considering this issue and will 
likely consult further with FSIS.
Issues To Be Discussed at the Public Meeting
    After considering the AMI petition, FSIS has tentatively concluded 
that there is merit to consider low dose (<=1.0 kGy) and low 
penetration (20mm) e-beam irradiation on the surface of chilled beef 
carcasses as a processing aid.
    Data submitted showed that low dose, low penetration surface e-beam 
irradiation will produce a significant surface reduction of E. coli 
0157:H7 on chilled beef carcasses. The e-beam treatment does not appear 
to have a lasting antimicrobial effect that would extend the shelf-life 
of the products, and it appears that there is no significant difference 
in color, odor, or taste between treated and untreated products. 
Relevant studies appear to support the assertion that the low dose, low 
penetration e-beam irradiation treatment would not produce any 
significant changes in the macro and micro nutrient content of the 
treated products. Further, the entire beef carcass is not irradiated, 
only the surface of the carcass.
Public Meeting and Comments
    FSIS is seeking comment both at the public meeting and during the 
comment period on the following questions and those raised throughout 
this document:
     Is there any additional evidence to support or contradict 
the evidence presented in the AMI petition on the specific application 
of a low penetration of 20mm and low surface dosage of <=1.0 kGy 
electron beam irradiation on the surfaces of chilled beef carcasses as 
a processing aid?
     Is there any evidence indicating that FSIS should consider 
the cumulative effects of the absorbed dose delivered in accordance 
with the AMI petition and any subsequent absorbed dose, such as a 
result of further irradiation of ground beef?
     Should FSIS consider requiring irradiation process 
controls if irradiation is considered a processing aid? If so, what 
would they be and what impact would they have on the low dose 
irradiation of chilled carcasses?
     Are there factors that FSIS has not considered? If so, 
what are they and what impact would they have?
Additional Public Notification
    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, in an effort to ensure that 
minorities, women, and persons with disabilities are aware of this 
notice, FSIS will announce it on-line through the FSIS Web page located 
at http://www.fsis.usda.gov/regulations/2008_Notices_Index/.
    FSIS also will make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade and farm 
groups, consumer interest groups, allied health professionals and other 
individuals who have asked to be included. The Update is available on 
the FSIS Web page. Through the Listserv and the Web page, FSIS is able 
to provide information to a much broader and more diverse audience.
    In addition, FSIS offers an e-mail subscription service which 
provides automatic and customized access to selected food safety news 
and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/.
    Options range from recalls to export information to regulations, 
directives and notices. Customers can add or delete subscriptions 
themselves and have the option to password protect their account.

    Done at Washington, DC on: September 2, 2008.
Alfred V. Almanza,
Administrator.
[FR Doc. E8-20653 Filed 9-5-08; 8:45 am]
BILLING CODE 3410-DM-P