Irradiation as a Processing Aid, 52001-52004 [E8-20653]
Download as PDF
<![CDATA[
52001
Notices
Federal Register
Vol. 73, No. 174
Monday, September 8, 2008
This section of the FEDERAL REGISTER
contains documents other than rules or
proposed rules that are applicable to the
public. Notices of hearings and investigations,
committee meetings, agency decisions and
rulings, delegations of authority, filing of
petitions and applications and agency
statements of organization and functions are
examples of documents appearing in this
section.
Dated: August 22, 2008.
Edward T. Schafer,
Secretary.
[FR Doc. E8–20685 Filed 9–5–08; 8:45 am]
BILLING CODE 3410–11–P
DEPARTMENT OF AGRICULTURE
Food Safety Inspection Service
[Docket No. FSIS 2008–0028]
DEPARTMENT OF AGRICULTURE
Irradiation as a Processing Aid
Office of the Secretary
Food Safety and Inspection
Service (FSIS), USDA.
ACTION: Notice of availability of petition
and public meeting; request for
comments.
AGENCY:
Privacy Act of 1974; Abolish Obsolete
System of Records
Office of the Secretary, U.S.
Department of Agriculture (USDA).
ACTION: Notice of abolishment for
USDA/FS–13 Geometronics Skills
Inventory record system.
AGENCY:
SUMMARY: A review of this Privacy Act
System of Records has concluded that
this system is no longer in effect and
obsolete. This system is being abolished
from the Forest Service System of
Records in accordance with the Privacy
Act of 1974 (5 U.S.C. 552a), as amended.
DATES: This notice is effective on
September 8, 2008.
ADDRESSES: For additional information
contact the Director of Engineering,
1400 Independence Avenue, SW.,
Mailstop 1101, Washington, DC 20250–
1101.
FOR FURTHER INFORMATION CONTACT:
Richard W. Sowa, P.E., Director of
Engineering, Telephone: (703) 605–
4646.
The
Privacy Act of 1974 (5 U.S.C. 552a), as
amended, requires that each agency
publish a notice of the existence and
character of each new or altered ‘‘system
of records.’’ 5 U.S.C. 552a(a)(5). This
notice identifies and abolishes a Forest
Service discontinued and obsolete
system of records. The Forest Service is
abolishing the following system of
records which, upon review, is no
longer used and is obsolete: USDA/FS–
13 Geometronics Skills Inventory. The
records have been destroyed according
to the Federal Records Disposal Act of
1943 (44 U.S.C. 366–380) and the
Federal Records Act of 1950, and as
designated in the Forest Service Records
Management Handbook (FSH) 6209.11.
mstockstill on PROD1PC66 with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
17:59 Sep 05, 2008
Jkt 214001
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 https://
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 https://
www.fsis.usda.gov/News?Meetings_&_
Events/ and https://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
PO 00000
Frm 00001
Fmt 4703
Sfmt 4703
on the FSIS Web site https://
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 https://
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 CDROMs, 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 https://
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 e-mail—
patrick.burke@fsis.usda.gov.
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
Robert.Tynan@fsis.usda.gov, Persons
E:\FR\FM\08SEN1.SGM
08SEN1
52002
Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices
requiring a sign language interpreter or
special accommodations should contact
Robert Tynan as soon as possible.
SUPPLEMENTARY INFORMATION:
mstockstill on PROD1PC66 with NOTICES
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 xrays. 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 multiingredient 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
VerDate Aug<31>2005
17:59 Sep 05, 2008
Jkt 214001
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 (https://
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
PO 00000
Frm 00002
Fmt 4703
Sfmt 4703
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/cm2 (high
inoculation) and twenty with a low
concentration of 3 log cfu/cm2 (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
E:\FR\FM\08SEN1.SGM
08SEN1
Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices
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/cm2). 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.
mstockstill on PROD1PC66 with NOTICES
2. The Process Does Not Have Any
Affect on Quality or Appearance
The MARC’s study also addressed
effects of low dose, low penetration ebeam 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 ebeam 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.
VerDate Aug<31>2005
17:59 Sep 05, 2008
Jkt 214001
These data appear to support that a
low dose, low penetration surface ebeam 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°C with aerobic
atmosphere), hetero- and homo-lactic
acid bacteria (LAB) (30°C with microaerobic atmosphere), total coliforms
(35°C with aerobic atmosphere), and
Biotype I E. coli (35–45°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 ebeam treated product increased to the
PO 00000
Frm 00003
Fmt 4703
Sfmt 4703
52003
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 shelflife. 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 MacroNutrients).
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 micronutrients, 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
E:\FR\FM\08SEN1.SGM
08SEN1
52004
Federal Register / Vol. 73, No. 174 / Monday, September 8, 2008 / Notices
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) ebeam 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.
mstockstill on PROD1PC66 with NOTICES
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
VerDate Aug<31>2005
17:59 Sep 05, 2008
Jkt 214001
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 online through the FSIS Web page located
at https://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
https://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
PO 00000
Frm 00004
Fmt 4703
Sfmt 4703
DEPARTMENT OF AGRICULTURE
Forest Service
Recreation Resource Advisory
Committees
Forest Service, USDA.
Notice of intent to renew the
Recreation Resource Advisory
Committees.
AGENCY:
ACTION:
SUMMARY: The Secretary of Agriculture
intends to renew five Forest Service
Recreation Resource Advisory
Committees (Recreation RACs) pursuant
to Section 4 of the Federal Lands
Recreation Enhancement Act passed
into law as part of the 2005
Consolidated Appropriations Act (Pub.
L. 108–447) on December 8, 2004. The
Recreation RACs operate in the Pacific
Northwest, Pacific Southwest, Eastern,
and Southern Regions of the Forest
Service and the State of Colorado, and
provide recreation fee recommendations
to both the Forest Service and the
Bureau of Land Management (BLM) as
appropriate. As required by the Federal
Advisory Committee Act, charters for
Federal advisory committees must be
renewed every two years.
DATES: The current charter for the
Recreation RACs expires September 28,
2008.
FOR FURTHER INFORMATION CONTACT: Julie
Cox, National Recreation RAC
Coordinator, USDA Forest Service,
Pacific Northwest Region, 333 SW. 1st
Avenue, Portland, OR 97208, (503) 808–
2984.
Individuals who use
telecommunication devices for the deaf
(TDD) may call the Federal Information
Relay Service (FIRS) at 1–800–877–8339
between 8 a.m. and 8 p.m., Eastern
Standard Time, Monday through Friday.
SUPPLEMENTARY INFORMATION:
Background
The Federal Lands Recreation
Enhancement Act (REA), signed in
December 2004, directs the Secretary of
Agriculture, the Secretary of the
Interior, or both to establish Recreation
RACs, or use existing advisory
committees to perform the duties of
Recreation RACs, in each State or region
for Federal recreation lands and waters
managed by the Forest Service or the
BLM. These committees make recreation
fee program recommendations on
implementing or eliminating standard
amenity fees; expanded amenity fees;
and noncommercial, individual special
recreation permit fees; expanding or
limiting the recreation fee program; and
fee-level changes.
E:\FR\FM\08SEN1.SGM
08SEN1
]]>Agencies
[Federal Register Volume 73, Number 174 (Monday, September 8, 2008)]
[Notices]
[Pages 52001-52004]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20653]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://
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 https://www.fsis.usda.gov/News?Meetings--
&--Events/ and https://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
https://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 https://
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
https://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 e-mail_patrick.burke@fsis.usda.gov.
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 Robert.Tynan@fsis.usda.gov, Persons
[[Page 52002]]
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 (https://
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
[[Page 52003]]
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
[[Page 52004]]
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 https://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 https://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
